Government Gazette - 2018 - Vol 3

Government Gazette Vol 3; 2018

£10.00, €11.00 ISSN 2042-4170

on food & wine

Ten reasons why you should be in Brussels this Christmas performance

Are you making the most of your emotions? end of 2018

driving the day

Theresa May’s uphill Brexit battle

REALITY CHECK

Has Jean-Claude Juncker kept his promises? end of an era of angela merkel

Exclusive interview with Angela Merkel’s biographer

inside

• Blockchain • Diesel disgrace • Artificial intelligence • European elections • Colorectal cancer • Diabetes • AIDS

Seb Dance MEP on why Brexit is a disaster

EUROPEAN PROSTATE CANCER AWARENESS Prostate Cancer DAY Screening: a call

to action for Europe

TUESDAY 22ND JANUARY 2019 14.00-16.00 HRS Room ASP 6Q1, European Parliament

Hosted by Alojz Peterle Lecture by Vytenis Andriukaitis

For programme & free registration see epad.uroweb.org

Government Gazette Vol 3; 2018

Government Gazette

Managing Editor Arvind Venkataramana editor@governmentgazette.co.uk +44 (0) 20 3137 8655 Commissioning Editor Janani Krishnaswamy janani.krishnaswamy@governmentgazette.co.uk +44 (0) 20 3137 8653 Editor, Performance Supplement Meliissa Gokhool melg@governmentgazette.co.uk Publisher Matt Gokhool matt.gokhool@governmentgazette.co.uk +44 (0) 20 3137 8653 Advertising and sponsorship sales advertising@governmentgazette.co.uk +44 (0) 20 3137 8653 © 2018 CPS Printed by Mail Boxes Etc., 334 Kennington Ln, Vauxhall, London SE11 5HY. The acceptance of advertising does not necessarily indicate endorsement. Photographs and other material sent for publication are submitted at the owner’s risk. The Government Gazette does not accept responsibility for any material lost or damaged.

also inside 26 end of 2018 Seb Dance MEP who shot to fame after mocking Nigel Farage in the European Parliament in February last year talks about his highs and lows this year, and particularly about why Brexit is a disaster.

08 the long, painful end of angela merkel

Featuring an exclusive interview with Prof Matt Qvortrop, Angela Merkel’s biographer and an op-ed from Peter Cleppe from think tank Open Europe

30 hiv & aids

54 colorectal cancer

Now is the time to change public perception on colorectal screening.

Special Report analyses the state of the digestive burden in Europe

32 end of 2018

Its time to accelerate our efforts against HIV and AIDS. Our special report offers a new vision towards a zero HIV strategy and offers recommendations for policymakers

What’s the buzz about EP’s Slovenian beekeeper? Excerpts from an exclusive interview with Alolz Peterle, President of the Member Against Cancer group

44 diabetes Beyond ‘surviving’ with diabetes: Nathan Gill MEP writes about why the paradigm must change

60 colorectal cancer Prof Phil Quirke writes about the link between microbiomes and colorectal cancer. Can colorectal cancer be a bacterial disease?

22 book review Stacie Goddard’s When Right Makes Might argues ‘battles over rights are essential in the struggle over might’ including an exclusive interview with the author.

20 on the ground

Amid widespread threat of organised social media manipulation growing at a large scale and increasingly more campaigns are using automated bots, junk news, and disinformation to polarise and manipulate voters. How prepared is Europe in the build-up to the elections in May?

30 diabetes Report on Diabetes analysis the current state of the epidemic and presents a roadmap to improve management of diabetes in Europe

10 reality check

34 climate change

Over the past five years, even though Juncker has apparently had more disagreements with his colleagues, he successfully managed to modernise the political machinery in Brussels. Has Jean-Claude Juncker delivered on his promises?

Miriam Dalli MEP reviews Europe’s position as leader in climate change and writes about why Europe should tackle its diesel disgrace now

28 policy analysis

86 performance

Ximena Calo makes an analysis into this year’s Parlemeter survey

76 behind the scenes

30 antimicrobial resistance Clara Eugenia Aguilera Garcia MEP writes about EU action against AMR

36 blockchain How can EU harness blockchain for a forward-looking trade policy?

30 event coverage iCPS Roundtable: How can Europe fast-track its commitment for HIV and AIDS?

68 digital transformation How do we get EU industry get ahead with emerging technologies?

72 hiv & aids

Getting behind the scenes at this year’s European testing week

www.governmentgazette.eu | 04

46 diabetes management Prof John Nolan from EASD writes about ways to enable European healthcare systems to cope with the diabetes pandemic

64 ai & colorectal cancer

Dr Yuichi Mori from Showa University in Yokohama talks about how AI is getting faster at detecting cancer

94 bladder cancer

Prof Hein van Poppel writes about EAU’s vision to improve management of the neglected cancer in Europe

Are you making the most of your emotions?

editorial view Government Gazette, Vol 3, 2018

Janani KRISHNASWAMY Commissioning Editor

Brussels is hoping for the best, but fearing the worst

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s it is, the European Union is not in good shape. Less than 24 hours after British Prime Minister Theresa May faced down her own leadership challenge, French Emmanuel Macron is to face a vote of no confidence — following a month of civil unrest over his economic reforms. Theresa May won a vote of no confidence defeating the Brexiteers’ masterplan to unseat her and install a new leader of their own.

Though May’s grip on power appears to be stable for the time being, the United Kingdom is at a critical time in negotiations with the European Union. Calling it ‘the umpteenth distraction’, European media are unimpressed by May’s confidence vote.

As we approach the Brexit cliff edge, Brussels warns that the concessions offered by the Italian government on its planned budget is a step in the right direction, but is not there yet. With Europe on a crisis mode, Angela Merkel’s successor is sure to face appalling domestic and foreign policy challenges intensified by a weakening Europe.

Brussels is hoping for the best, but fearing the worst while May has embarked on yet another journey to the European political capital. While Westminster remains in political turmoil, MEPs have ridiculed May’s eleventh hour attempts to persuade MPs to back her deal. According to sources at the European Parliament, Brussels has very little appetite to renegotiate Brexit withdrawal.

Underlining the gravity of the moment, European Parliament’s Brexit steering group calls it “the best deal possible, in fact: it is the only deal available.”

With Juncker insisting he will step down when his term ends next year, Europe’s capital is abuzz with various scenarios. The race to become the next Juncker is just getting fierce.

Manfred Weber, a Bavarian politician who has served as a leader of the European People’s Party won by a landslide to clinch the political group’s spitzenkandidat position. While Maroš Šefčovič withdrew from the Socialist race, Commission First Vice-President Frans Timmermans remains the only S&D spitzenkandidat.

The European Green Party has elected Ska Keller and Bas Eickhout as their leading spitzenkandidats, while Czech MEP Jan Zahradil has been put forward by the European Conservatives and Reformists Group.

With a new batch of MEPs, a new president of the European Council and European Central Bank, as well as new commissioners due to take up their posts next year, the new president faces an uphill struggle to reshape the bloc over their next five-year term.

We have covered some of the most crucial and noteworthy political developments in the EU — including the battle for the presidency of the European Commission, the upcoming elections in Europe and the long, painful end of German Chancellor Angela Merkel. Amid threat of organised social media manipulation growing at a large scale, we’ve looked at the level of preparations in the build-up to the elections in May. Yes, you’re right. We have changed our editorial — to fit in your likes and dislikes.

We have introduced a new tribute column Footprints, to recognise the outstanding contribution of a fellow policy maker or EU organisation towards the special cause. This time, we have featured Jean-Claude Juncker, making an assessment of his performance as president of the European Commission.

In a lively interview, Angela Merkel’s biographer, Prof. Matt Qvortrup talks everything about the woman with a doctorate in quantum physics who became the undisputed queen of Europe and an anchor of stability.

We also interviewed a handful of political figures for their reflections on 2018 and their predictions for the New Year — our December edition features two key interviews, including a British MEP who feels he is being dragged from a job he loves by a Brexit he believes will be a disaster.

We also caught up with Alojz Peterle, one of the rising stars of the European People’s Party, representing Slovenia, who serves as the president of the European Parliament’s all-party MEPs Against Cancer group. EP’s Slovenian beekeeper demands stronger political will and the implementation of a

concept of health in all policies.

As we approach the end of another eventful year, we are feeling the effects of climate change more than ever before. Now is the time to tackle Europe’s diesel disgrace now.

In our environmental bulletin, Miriam Dalli MEP argues that a fight against climate change cannot stop at words but requires concrete and meaningful action from us all, including policymakers, industry players and stakeholders. The European Diesel Summit, held in Brussels, highlighted solutions that already exist to put the dangerous legacy of the Dieselgate scandal to an end.

In the interim, the advance of digital technology is changing our way of life at breakneck speed. Our technology bulletin this quarter features Emma McClarkin MEP who writes about how EU can harness blockchain for a forward-looking trade policy. Sharing an analogous vision for a greater digital Europe, the iCPS Digital Transformation Roundtable in Brussels earlier this year discussed how to make European industry more digital and fit for the future.

In the current chapter of healthcare, we present policymakers with difficult decisions about where best to direct scarce public resources. We have also taken a closer look at Europe’s digestive burden and reflect on Europe’s progress to conquer the diabetes epidemic.

As December 1 marks the 30th anniversary of World AIDS Day, people around the world are fighting towards a HIV-free world. In our special coverage on HIV and AIDS, we assess the gaps in HIV care continuum and look at what strategies work where and when.

Government Gazette | 05

LETTERS TO THE EDITOR

Brexit Deal: Reaction to Theresa May’s withdrawal agreement text Just desserts for two years of empty rhetoric The Brexit deal is quite something that the Conservatives’ Brexit fudge has already sparked countless Cabinet resignations, including the Minister responsible for negotiating it. Theresa May is finally getting her just desserts for two years of empty rhetoric, fantasy and cakeism, and the dish of the day is government crumble. In the face of such an omnishambles and with the statistical certainty that May will not get her deal through the Commons, it is time to face the reality that it is the people that must be trusted to find a way through this mess. Greens are committed to the People’s Vote and giving the people the final say on this deal—with remaining in the EU an option on the ballot.

Keith Taylor MEP

One-sided This is a deeply damaging and one-sided Withdrawal Agreement which the UK should not sign.

It does not take back control of anything, sentences us to more delay and rows with the EU prolonging uncerttainty for business and costs a huge sum of money for nothing.

Disappointing The deal is very disappointing and falls short of delivering a clear break from the EU nor giving any certainty over future relations. There is still a very long way to go to make sure we deliver the democratic vote of the British people.

Emma McClarkin MEP

Necessary step forward This is an important and necessary step in the process which will result in the UK leaving the European Union in an orderly manner.

Since UK voters decided democratically to leave the EU, the EPP has always emphasised the importance of guaranteeing citizens’ rights on both sides of the Channel, of finding a settlement on the UK’s financial commitments to the EU and avoiding a hard border between Northern Ireland and the Republic of Ireland.

Further analysis of the agreement will be needed in the days to come. We welcome the positive recommendations of Taoiseach Leo Varadkar. They indicate that our negotiators were successful in safeguarding our red lines. I would like to thank Michel Barnier for the extraordinary work that he and his team have been doing.

Manfred Weber MEP www.governmentgazette.eu | 06

John Redwood MP

Miserable deal

Theresa May is trying to sell a miserable deal.

We rely on readers like you to uphold a free press Letters for publication in the Government Gazette should be sent to editor@ governmentgazette.co.uk Please note that we may edit letters. Submission and publication of all letters is subject to our terms and conditions.

This deal doesn’t appease hardline Brexiteers, or appeal to the Remainers in the Tory Party, or meet Labour’s tests, or satisfy the Northern Irish MPs from the DUP. There are legitimate concerns about giving away control as part of this settlement, as it will tie the UK to EU rules without any say in how they may be changed in the future.

Poorer

All MPs must ask themselves if this is better than the deal we’ve already got as a member of the EU. If they are honest with themselves, they know it isn’t - and that’s why they must vote this deal down. Then they must hand the final decision back to the British public for a People’s Vote, with the option of remaining in the EU.

The deal is so far removed from what was promised and narrowly voted for; it makes us significantly poorer than our current deal with the EU, it does not give the security Business craves as it means negotiations in perpetuity, why would anyone vote for this?

Catherine Stihler, Labour MEP for Scotland

Seb Dance MEP

I have spent nearly 20 years in the European Parliament and I know how important it is for the UK to have a voice at the top table.

BREXIT BRIEFING

Theresa May’s uphill Brexit battle

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t looks like Brexit is falling apart — albeit at a snail’s pace. The European Union and the United Kingdom are entering one of the darkest and uncertain periods in modern history, with the most knowledgeable political analysts unsure of what the near future holds.

Theresa May won a vote of no confidence defeating the Brexiteers’ masterplan, but none of her problems have been solved. Her deal is opposed not just by the opposition but also by hard-line, pro-European backbenchers and antiEuropeans in her own party.

Theresa May’s political crisis dramatically deepened as EU leaders have rejected “any form of renegotiation whatsoever” of her ailing Brexit deal.

A day before her vote of no confidence, she abruptly decided to pull a parliamentary vote on her Brexit deal, throwing Britain’s plan to leave the European Union up in the air.

The UK has been witnessing the highest levels of parliamentary unrest in the past weeks — all of which has been greeted with joy

by Brexit’s opponents.

The Brexit vote might be

delayed until early January; however the ultimate deadline for the vote is January 21. This would allow less time for the ensuing Brexit legislation to be passed through parliament before March 29.

After suffering a historic mortification on count of her government being the first to be found in contempt of Parliament for refusing to release key legal advice on Brexit, Theresa May now leads a government with a working majority of just 13.

Only seven Tory rebels are needed to defeat it.

On December 10, the European Court of Justice ruled that the UK could revoke article 50 independently — without needing the permission of every other EU member state.

This means Britain could prevent a no-deal Brexit if it wanted.

Remainers have hailed the verdict which could potentially destabilise May’s argument that members of Parliament face a choice between the deal she had negotiated with Brussels or an economically catastrophic nodeal exit.

A summit of the European Council would be called for, in the wake of the meaningful

vote in the UK — if and when it happens. On the other hand, if the British MPs were to reject May’s deal, this could trigger another round of changes which will be put to MPs for the second time. If the deal has been blocked once, there might still be another chance for a second vote — prior or not prior to the resignation of the prime minister or an attempt to pass an amendment for a second referendum.

The biggest question in Westminster right now is when the vote will happen next.

There might be further renegotiation with the European leaders offering May an extension to Article 50 if needed to stop a no-deal Brexit.

Or she might push the deal to a Commons vote once again. This may be true, though a lot of Brussels-watchers think a second referendum or a Norway-style deal could eventually emerge.

While the EU heads of state and government had already approved the withdrawal agreement, prior to the Commons vote, they are still willing to renegotiate Brexit withdrawal. Dutch foreign minister Stef Blok has said the EU would still be willing

to “look carefully” at any new proposals; nevertheless warned that further talks would not be easy.

According to known sources, EU officials have only offered to provide “clarifications” of the withdrawal agreement, rather than reopening the text.

Given the thorny state of affairs of this intervention, and given the tremendous intricacy of all the subjects related to the UK’s withdrawal, Europe’s chief Brexit negotiator, Michel Barnier reportedly said “the deal that is on the table is the only and the best deal possible” and raised the prospect of the UK remaining under EU control until the end of 2022, a proposal that would cost billions and enrage Tory Brexiteers.

Truth be told, the EU has enough on its plate with the riots in France, the political disorder in Germany and the budget stand-off with Italy.

“While certain member states would certainly like to see more, they have to swallow it for now,” one diplomat said.

European Commission President Jean-Claude Juncker has warned the UK that it will not get a better Brexit deal than the current one.

Government Gazette | 07

european commission

A performance appraisal of Jean-Claude Juncker

reality check

Has Jean-Claude Juncker delivered on his promises? first president of the European Commission to be selected by the Spitzenkandidaten process — an extraconstitutionalsystem that has reconfigured the European Union’s institutional balance.

FOOTPRINTS

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ean-Claude Juncker might go down in history as the European Commissioner who lost Britain, but the true significance of his leadership may well emerge only in retrospect. Deeply regretting Britain’s decision to leave, Juncker had unremittingly tried not to ‘exaggerate’ the situation, welcoming the country as a significant trade partner as well as security partner.

Fast forward five years back. The United Kingdom was the only country to publicly oppose Juncker’s candidacy with a strong personal attack from the former Prime Minister David Cameron.

“It is time Europe developed what Juncker coined ‘Weltpolitikfähigkeit’ – the capacity to play a role, as a Union, in shaping global affairs, if Europe should become a more sovereign actor in international relations.” www.governmentgazette.eu | 08

Nevertheless, Juncker won the backing of 26 out of 28 leaders of the EU, and a majority in the European Parliament approved the former Luxembourg Prime Minister to be president of the European Commission. He was well over the 376 votes minimum that he needed. There were 250 votes against him, 47 abstentions and 10 spoilt ballots.

Juncker was the

At the beginning of his mandate, Team Juncker collectively promised to deliver a more innovative Digital Single Market, a deeper Economic and Monetary Union, a Banking Union, a Capital Markets Union, a fairer Single Market, an Energy Union with a forwardlooking climate policy, a comprehensive Migration Agenda, and a Security Union.

Over the past five years, even though Juncker has apparently had more disagreements with his colleagues, he has successfully managed to modernise the political

machinery in Brussels, led by many of his result-oriented reforms.

Juncker’s overhaul of the Commission, its organisation and working methods, has been radical. Though not quite as radical as the method of his appointment, it has, without doubt, supported him in accomplishing whatever advancement the European Commission has achieved so far.

Getting to the root causes of unemployment, and notably of youth unemployment was a top priority of Juncker when he took over five years back. During his tenure, his team did everything possible to avoid seeing a “lost generation” in Europe.

Never have so many men and women – 239 million people – been in work in Europe. Youth

unemployment has hit a historic low. At 14.8%, it is reportedly the lowest since year 2000.

Europe has also reaffirmed its position as a trade power.

Our global trading position is the living proof of the need to share sovereignty. The European Union now has trade agreements with 70 countries around the world, covering 40% of the world’s GDP. These agreements – so often contested but so unjustly – help us export Europe’s high standards for food safety, workers’ rights, and the environment and consumer rights far beyond our borders.

Juncker displayed an admirable show of political capital in bringing back Greece from the brink of the

abyss that its debt levels would have pushed its economy into.

Thanks to his efforts,Greece has successfully exited its programme and is now back on its own two feet.

“

While an escalating percentage of unemployed youth, high suicide rates and illegal immigrants are still a matter of much concern for the Greeks, the satisfaction that the debt crisis has been averted is a significant achievement.

Passionate in his defence

Through thick and thin, I have never lost my love of Europe. jean-claude juncker of the single currency which he described as an “affair of the heart,” Juncker’s plan for the economic development of the EU has exceeded expectations. His Fund for Strategic Investments has triggered 335 billion euro worth of public and private investment.

The Juncker Commission had made reasonable progress on migration — that what is often acknowledged — with five of the seven Commission proposals to reform our Common European Asylum System having been agreed. His efforts to manage migration have borne fruit, with migrant numbers down by 97% in the Eastern Mediterranean and by 80% along the Central Mediterranean route. EU operations have helped rescue over 690,000 people at sea since 2015.

“Never have so many men and women – 239 million people – been in work in Europe. Youth unemployment is at 14.8%. This is still too high a figure but is the lowest it has been since the year 2000.”

State of the Union 2018 Most recently, Juncker stressed a need for legal routes for migration into Europe.

Finally, Juncker has displayed considerable diplomacy in sensitive areas of policy.

One cannot miss Juncker’s efforts to improve communications within and outside the European Commission.

Juncker and other members of the European Commission have been available to meet the press and to address the other institutions, particular the European Parliament. When the ‘Luxleaks’ scandal broke out, for example, Juncker surprised the European Parliament by appearing personally to defend himself.

While the Brexit vote has turned out to be Juncker’s low-water mark, particularly overshadowing all his achievements in maintaining the economic stability of the eurozone and handling numerous economic crises efficiently, he has

An appraisal of Juncker’s performance is not complete without a mention about his radical reforms — including the ambitious new strategy that proposes to make all plastic packaging recyclable or reusable by 2030 and the revolutionary,yet arguably draconian, data protection law which made Europe the world’s data police.

“More democracy means more efficiency.

Europe would function better if we were to merge the presidents of the European Commission and the European Council …

Europe would be easier to understand if one captain was steering the ship. Having a single president would better reflect the true nature of our European Union as both a Union of states and a Union of citizens.”

pledged to help Britain rejoin the EU after Brexit, which he refers to as a “historical error and tragedy.”

In his own words, he said: “we’re not at war with Great Britain.”

In a candid interview during the Brexit negotiations, the European Commission president reportedly mourned that the former Prime Minister, David Cameron, had blocked him from campaigning during the 2016 referendum.

In another recent meeting with the British media, Juncker went on to claim “the EU could have swung the Brexit referendum in favour of Remain if David Cameron had not prevented it from intervening in the 2016 campaign over membership.”

However, he insisted that the EU would accept the result of the British referendum and “make the best of it.”

Government Gazette | 09

direct access to key decision makers across europe Organises high-level policy discussions on pressing European policy issues Trusted platform of engagement between policy makers and stakeholders Offers exclusive networking opportunities with Europe’s key policymakers and thought leaders For more information visit www.publicpolicyexchange.co.uk Follow us @PublicPolicyEx www.governmentgazette.eu | 04

BRUSSESLS NEWS ROUND-UP

A burning ambition for EU’s top post EU rules would bar Weber from holding two posts EPP hopeful Manfred Weber will not be able to do Commission’s top job while also leading his Christian Social Union party back in Bavaria anymore.

The European Banking Authority’s chair, Andrea Enria, is set to become the new chief of the European Central Bank’s supervisory arm.

According to a revised code of conduct issued by the European Commission, approved earlier this year, no candidate will be able to hold multiple “management responsibilities.”

Weber wins by a landslide to clinch EPP Spitzenkandidat position The current head of the EU’s executive Commission, Luxembourg’s Jean-Claude Juncker, will step down next year. His successor must be agreed by leaders of the EU member states following elections to the European Parliament next May.

abuzz with various scenarios.

With Juncker insisting he will step down when his term ends in two years, Europe’s capital is

After a hard-fought five-weeklong fight, Weber racked up 492 of the 619 votes.

Manfred Weber has secured the support of seven of the eight heads of EU countries belonging to the European People’s Party for his bid to be European Commission president, EPP officials said.

Members may participate in national politics provided this does not compromise their availability for service in the Commission and the priority given to their Commission duties over party commitment.

Conservatives endorse Czech MEP for Commission top job In 2014, when the Spitzenkandidaten process was used for the first time, the European Conservatives and Reformists Group (ECR) did not put forward a candidate. This time around, ECR has endorsed Czech MEP Jan Zahradil as their nominee for the Commission President, as the voice of proeuropean but anti-federalist political force.

Finland’s former PM Alexander Stubb loses nomination

Maroš Šefčovič withdraws from Socialist race European Greens pick leading duo The European Green Party has elected Ska Keller of the German Greens Bündnis 90/Die Grünen and Bas Eickhout of the Dutch Greens GroenLinks as the leading spitzenkandidates ahead of the European elections in May. Ska Keller who is the current co-president of the Greens/EFA Group in the European Parliament has been nominated for a second time for European Commission president. Eickhout has been an MEP since 2009 and is leader of the GroenLinks delegation in the European Parliament.

With a burning ambition for EU’s top job, Ska Keller said “as Greens, we stand to defend Europe and its values. We want to make Europe more ecological, social and democratic so that it can fulfil its promises. There is much at stake at the coming elections.

As Greens we will show that we can lead with a positive vision of Europe. These times need courage and we stand ready.”

European Commission Vice President Maroš Šefčovič pulled out from the race to become the Social Democrats’ lead candidate for the EU elections in May next year.

His move reportedly came after two internal party debates, the last of which happened at a meeting of Socialist leaders before the October EU summit. He has decided to back the only other contender in the race to be the political grouping’s Spitzenkandidat, Commission First Vice-President Frans Timmermans.

In a letter seen by Politico, he wrote that despite the fact he “felt a personal obligation to visibly contribute” to his party’s success, he would rather close the ranks behind one candidate at a time when social democratic parties are in retreat across the Continent.

Government Gazette | 11

regional

The long, painful end of Angela Merkel

the beginning of an end The end of Merkel’s era in Germany Democratic Party (CDU), spreading a sense of worry across Germany and Europe. She also declared that she plans to remain chancellor until her term ends in 2021 but will not run for another term as German leader.

opinion

T

As former British prime minister Margaret Thatcher used to say, “there is no alternative” to Angela Merkel.

www.governmentgazette.eu | 12

he era of German Chancellor Angela Merkel — who has ruled Germany for 13 years and was also regarded as the world’s most powerful woman for over a decade — is drawing to a close.

On October 29th, Merkel announced her decision to step down as leader of the Christian

Merkel’s announcement came hours after her party recorded the worst election results since 1966 in the western state of Hesse, and two weeks after her conservative allies in Bavaria received a similar blow.

With three of the EU’s most powerful institutions run by Germans, German influence has always been strongly felt within the continent. Angela Merkel has commanded the European centre stage

over the past eighteen years, as a symbol of stability.

As one of her biographers notes: “Merkel is still more popular in Germany than Macron is in France and Trump in the United States or May is in Britain.” In fact, he noted that she is more popular than most of the European leaders.

Her decision to step down may not come as a huge surprise, but nevertheless it shook political Berlin, given the potential repercussions following the end of her chancellorship.

Merkel’s well-timed departure precisely reflects what she said in an interview nearly 20 years ago: “Some day I want to find the right way to leave politics,” she

had said in 1998. “It’s a lot harder than I used to imagine. I don’t want to be a half-dead wreck.”

An extremely calculated, watchful, systematic, pragmatic and sometimes exasperatingly noncommittal politician, Merkel would be the second-longest-serving chancellor in recent German history after Helmut Kohl.

With ‘Thatcherite doggedness’, she carefully navigated through Europe’s worst financial crisis since the Great Depression, the European debt crisis, and then the surge of immigrants.

While some of her critics think she is wavering, indecipherable and often panders to public opinion, they often describe her as a tactical

diplomat who is reluctant and unable to challenge old German orthodoxies. In fact, the verb – “merkeln” – was coined to describe her alleged indecisiveness.

Merkel calls for an EU army

However, she commands respect even from those who disagree with her. Throughout her 13 years in power, Merkel managed to build a name for herself nationally and internationally. She was named repeatedly “the most powerful woman in the world” by Forbes magazine.

As one of her biographers note: “She’s a German patriot more than a European. She’s very much interested in what is good for Germany, and what is good for Merkel’s liberal agenda of open borders turned against her and led to a spectacular rise of the far right. Her welcoming approach to refugees arguably marks the biggest turning point in her career Germany is also, by implication, good for Europe.”

Merkel was viewed as the scandal-free face for the CDU, when she started as chancellor of Germany, however none imagined that she would hold onto the position for 18 years and rule as chancellor for 13 of them.

In the end, Kohl’s ‘little girl’ — who came into politics from nowhere — proved everyone wrong and showed that she knew how to play the power game better than many of the men who looked down on her and saw her as politically harmless. She has an astounding record in outfoxing, outlasting, and outmanoeuvring full-ofthemselves male rivals.

Germany and Europe may well survive her departure, but her exit has added an element of insecurity in an already uncertain political atmosphere with the Brexit deadline looming large.

Politicians have to be effective, credible and stable, and Merkel has been a personification of all that, and much more.

As former British Prime Minister Margaret Thatcher used to say: “there is no alternative” to Angela Merkel.

F

our years ago, Jean-Claude Juncker said a joint EU army would show the world that there would “never again be a war between EU countries.”

In her recent address to the European Parliament, German Chancellor Angela Merkel threw her support for the creation of an EU army to complement NATO. Echoing the recent calls of French President Emmanuel Macron, she noted that the EU should speak with one voice on a global stage.

To be “heard in a globalised world, Europe needs to grasp its destiny more firmly in its own hands, because the times where we could rely unreservedly on others are over”, she said. Deliberating the developments in recent years, she said establishing a proper European army that

“Europe needs to grasp its destiny more firmly in its own hands, because the times where we could rely unreservedly on others are over.” “would show the world that there would never again be a war between EU countries.”

“The times when we could rely on others are over,” Merkel said.

As is the case at the moment, “we have more than 160 defence or weapons systems and the United States has only 50 or 60, when each country needs its own administration, support and training for everything, we are not an efficient partner.” If we want to use our financial resources efficiently and are pursuing many of the same objectives, she says “nothing speaks against us being collectively represented in NATO with a European army.”

However, in the long run, she noted that Europe has to become more capable to act.

“We have to reconsider our ways of deciding and to renounce the principle

of unanimity where the European treaties allow and wherever this is necessary. I proposed a European security council, in which important decisions can be prepared faster.”

She also highlighted that economic success; research and innovation are vital for Europe and pointed to the need for reliant Frontex border controls and a common European asylum system.

“Europe is our best chance for peace, prosperity and a good future. We must not let this chance slide; we owe this to ourselves and to past and future generations. Nationalism and egoism must never have a chance to flourish again in Europe.

Tolerance and solidarity are our future. And this future is worth fighting for”, she closed.

Government Gazette | 13

regional

The long, painful end of Angela Merkel

europe will survive merkel’s departure Government Gazette caught up with Angela Merkel’s biographer, Matt Qvortrop immediately after she declared that she would not seek another term when her chancellorship expires in 2021.

Days before Annegret Kramp-Karrenbauer was chosen to succeed Angela Merkel as leader of the Christian Democrats (CDU), he said Europe might have difficulty in finding a leader who is “quiet, calm and pragmatic” as Merkel, but noted that all three candidates in his opinion, are pragmatic German politicians.

THE LAST WORD

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s the head of the country’s biggest political party for 18 years, and its chancellor for 13, Angela Merkel has been very much a pragmatist, a politician who has always been interested in making sure that Germany ticks along.

While her critics might argue that her decision to let in refugees might have tarnished her legacy; in reality, Merkel is celebrated for her courage and compassion.

Regardless of the mistakes she made in handling the eurocrisis , migration or Germany’s diesel scandal, her moniker as the ‘Queen of Europe’ is only half in jest. It’s inevitable that her exit will create a vacuum.

Speaking exclusively with Government Gazette, Prof Matt Qvortrup, one of her biographers — who drew a fascinating tale of Angela Merkel’s political ascent — says: “Europe will survive Merkel’s departure,” though Europe needs a politician who can symbolise stability, and Germany would “worry there isn’t somebody who is tried and tested in the way that she is.”

Merkel surprised everyone by announcing the end of her chancellorship, but how

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there is little reason to be concerned.

As Qvortrup reassures — in the long run — there will be stability in Germany.

However, he says he would be “a little bit more worried,” if he was a British Brexiteer.

There are two scenarios one should consider, which will have equal results.

Prof Matt Qvortrup is professor of applied political science at Coventry University and the author of Angela Merkel: Europe’s Most Influential Leader will her decision affect Europe?

While even some of the biggest critics of the German leader are worried about what will happen next, Qvortrup thinks both Germany and Europe might survive her departure.

Since Merkel has been a deep stabilising force in Germany, and political extremists are waiting to exploit her void, it is natural to worry who will succeed her and how the country will shape up in the years to come.

While Germany and

Europe might have difficulty in finding a leader who is “quiet, calm and pragmatic” as Merkel, all three candidates who seek to succeed Merkel at the helm of the party, in his opinion, are pragmatic German politicians.

The German political system is based on consensus. Whoever comes in will have the interest of Germany and Europe at heart.

Whatever is good for Germany is good for the EU and vice versa.

Therefore, from a European point of view,

If Angela Merkel stays in office, “she will be in a position where she cannot make controversial decisions, she can’t give into the march, and she cannot be too flexible as it will not be approved within the coalition.”

Furthermore, in dealing with Brexit, Merkel has consistently used the German term “Rosinenpickerei” – a slightly stronger equivalent of cherry picking. She has been adamant that Britain will not get access to the single market without accepting free movement of people and without paying into the budget.

“Whoever takes over after her — including Friedrich Merz — who is a German business politician will not do it either.”

German businesses have been very adamant that there can be no diluting of the single market. So Brexiteers will not have

TOBIAS SCHWARZ/AFP/Getty Images

Merkel will step down as chancellor when her current mandate runs out in 2021 and says she has no plans to seek a post at the European Commission any flexibility.

has been in power longer than most of her European counterparts.

“She is still more popular in Germany than Macron is in France — with whom she has remained in good terms— and Trump is in the United States or May is in Britain.”

Cautioning Britain about the obstinate nature of German businessmen, Qvortrup argues that: “it is going to be more difficult for Theresa May to get any concessions.”

So, it might be problematic for Britain.

But, Europe will have nothing to worry about.

Europe will survive Merkel’s departure.

In his lively account of the woman with a doctorate in quantum physics who has become the undisputed Queen of Europe, Qvortrup elaborated how she carefully outmanoeuvred her male colleagues and made Germany the strongest economy in Europe.

As leader of Europe’s most economically powerful nation, Merkel

In his lively account of the woman with a doctorate in quantum physics who has become the undisputed queen of Europe, Qvortrup elaborated how she carefully outmanoeuvred her male colleagues and made Germany the strongest economy in Europe.

The indispensable leader of Germany — what with her scientific approach to politics and highly rational thinking —has been an “embodiment of the middle” and has repeatedly demonstrated to the world that she can work with just about anyone, and maintain some of the toughest of relationships.

With a quiet, unassuming persona — that is unlike a lot of bombastic politicians —she wields enormous influence by relying on

reason, cooperation, and networking.

The German chancellor doesn’t humiliate, intimidate or boast.

Her leadership style, as Qvortrup says, is very much summed up in the word ‘merkeln’, which was the word of the year in Germany in the year 2015.

‘To Merkel’ is to think about things, to carefully weigh up the pros and cons, and once you have considered and deliberated this, you make a decision.

A physicist by training, she was a research scientist doing pioneering work on nanotechnology.

She also grew up in a very intellectual family. She has got a combination of scientific approach and rational thinking.

The pros of her scientific background, her traditional, German intellectual style and protestant thinking, he said, is that: “there will no tweets in the middle of the night or go off like a fire cracker, when something has to happen.”

Noting that Merkel played an impressive role in responding to the Ukraine crisis, much similar to the banking crisis of 2008, where she weighed up the consequences, in an extremely methodical manner, Qvortrup noted that Merkel didn’t have the luxury to do so with the refugee crisis, especially because she was more emotionally attached to it.

“Merkel is intellectually stimulated, and is highly evidence-based — which Government Gazette | 15

regional

The long, painful end of Angela Merkel

Merkel is still more popular in Germany than Macron is in France and Trump in the United States or May is in Britain is relatively rare these days.”

However, there are issues which require a snap decision too.

It may help to consider a little known episode from her private life, which came during her divorce from her first husband, Ulrich Merkel — from whom she kept her name. The marriage had turned cold and the two scientists had grown apart but Angela Merkel was her usual self: kind, smiling and giving every impression that she was open to a solution.

“One day she packed her bags and left the apartment. She had weighed up all the consequences and analysed the pros and cons… and said: ‘If you don’t think this is working, then I keep the washing machine and you keep the furniture, and I’m out,’ in a very pragmatic way.”

Acknowledging that Merkel’s demise started after the Hesse elections, Qvortrup said she would have liked to form a coalition with the Green party and the Liberal party. www.governmentgazette.eu | 16

When Germany faces the divorce with Britain, “Britain will keep the old furniture and Germany will walk away with the high-tech washing machine.”

Her decision to step down perhaps reflects her introspective style of leadership.

What’s the reason for Merkel’s decision to step aside as party leader?

Some people argue that it is the rise of the right in Germany. But, a lot of other people in the left of Germany like what she does. For instance, the fact that the Green party has risen in the Hesse elections last weekend is a case in point.

“The reason why Merkel’s party lost was because of the Green party. However, the Green party defended her immigration policy, and in some way she is closer to the Green party than her own.”

Acknowledging that Merkel’s demise started after the Hesse elections, Qvortrup said she would have liked to form a coalition with the Green party and the Liberal party.

The fact that she was losing out in the local elections meant that she would probably win the leadership of her own party.

However, “she would have only won by the low 70s or high 60s, percentage wise” and that might have been a “possible humiliation.”

Further, her recently chosen spokesperson in the parliamentary group did not win. She was weakened internally and decided to phase herself out. The logic behind her pragmatic decision to step down might have come from her logical recognition about her brand — which was not the electoral asset that it once was.

It’s certainly going to be

tough when she actually steps down.

She was a capable enough physicist, but we are told she didn’t particularly like that. It was only when she discovered politics that she found her true platform — and it is going to be difficult for her to be retired.

While she is interested in opera and all sorts of arts, she is a 24/7 politician.

Being unsure of what Merkel might do after her powerful reign as chancellor; Qvortrup said he would like to see her as the president of the European Commission though Merkel says she has no plans to seek a post at the European Commission.

Annegret Kramp-Karrenbauer elected to succeed Merkel as CDU leader

Merkel’s biggest mistake?

OPINION

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hile Merkel has remained more popular than most politicians within Europe, in her 13 years as chancellor — and passing through some of the toughest financial crises — her popularity declined for the first time in 2015 with the refugee crisis. In welcoming refugees, Merkel encouraged a movement of people into Europe that her own country was reluctant to suck up.

Merkel’s “liberal agenda of open borders” turned against her and led to what they refer to as a “spectacular rise of the far right.”

Some have argued that Merkel’s welcoming approach to refugees is her catastrophic mistake.

Although she still won the 2017 election, the refugee crisis marked a turning point in her career — with her popularity sinking to its lowest levels since 2011.

While it remains questionable whether this ultimately resulted in her decision to step down as CDU leader, Merkel’s departure ignites hope of a brand new start among CDU’s young members, “free of her controversial migration policy.”

Endrik Schulze, who heads the Berlin chapter of the youngest section of the CDU youth wing, who was interviewed by the Observer said: “Politics isn’t supposed to be static — it should be dynamic. We were all tired of the same face.”

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nnegret KrampKarrenbauer, a former state premier, has been chosen to succeed Angela Merkel as leader of the Christian Democrats (CDU).

The result is seen as making it more likely that Merkel will be able to see out her fourth term until 2021.

Kramp-Karrenbauer won by just 25 votes, defeating Friedrich Merz and Health Minister Jens Spahn.

Merz, an economics lawyer who was ousted as parliamentary leader of the CDU by Merkel in 2002, this time received 482 votes in the second round, and 392 in the first.

Spahn who secured 175 votes out of 999 — which was still higher than what was expected, was not eligible for the second round.

The young generation at CDU agree that the party needs a new chair “who doesn’t polarise too much.”

Dubbed as mini-Merkel — a title she resolutely disregards — KrampKarrenbauer also emerged as the favourite to succeed Merkel as chancellor.

Though there was general agreement that the CDU will struggle to hold together without her rock-solid leadership, opportunities of her departure outweighed the risks.

When Merkel declared that she would not seek another term when her chancellorship expires in 2021, she nominated Kramp-Karrenbauer as

her preferred successor.

suffered serious losses at the recent Bavarian elections, the centre-right party have lead Germany for nearly 50 years and remains the strongest political force in the country.

Kramp-Karrenbauer - or AKK as her fans call her, is a mother of three, a strict Catholic who has served the state of Saarland as its interior minister and has 18 years of leadership experience. Merkel told the party faithful it was “time for a Inspite of being change”. supportive of Merkel’s Earlier in the day, liberal agenda of open Angela Merkel received borders, Kramprapturous applause from Karrenbauer favours her Christian Democrats, tightening migration. after delivering an She is also reportedly emotional speech against same-sex marriage marking the end of 18 and has strongly argued years as party leader in against abortions. Some which she said she had say she takes a liberal been honoured to serve approach to other issues, them. supporting a women’s During her valedictory quota and minimum speech, Merkel urged wage. her party not to abandon Though she is reportedly the “the art and power of more conservative than good compromise” that her predecessor, she told brought CDU back from her party delegates she the verge of a financial was “not a mini version” crisis at the close of the of Merkel, but her “own Kohl era. person”.

Avoiding the Promising to bring controversial issues that greater impetus to the have undermined her party as it seeks to standing in recent years, claw back the millions she said “we need to of voters it has lost to preserve what makes us rightwing populists and strong.” the Greens in recent She also urged the party years, she said : “We to ensure it was “wellshould harness the equipped, motivated and boost this competition united” to face the tough has given us, and use challenges of the future. it to propel the party’s success.”

Though the CDU

Government Gazette | 17

regional

The long, painful end of Angela Merkel

the beginning of an end A closer look at Merkel’s mistakes Peter CLEPPE

Head of Brussels Office, Open Europe

INSIDE-OUT

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ngela Merkel may well be a very skilled politician, but does that also make her a good politician? A closer

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look at the actual policies she delivered reveals that is not the case.

First of all, there were her chaotic migration policies, where she basically abdicated responsibility in the midst of the refugee crisis in August, 2015 by deciding to suspend the so-called Dublin rules.

Those rules force asylum seekers to apply for asylum in the first safe country of arrival.

This didn’t cause the crisis, which had been raging for months, but it signified defeat. This was part of an overall failure by European countries to police the EU’s external border and organise orderly asylum procedures for people

mostly coming from Turkey which, despite great challenges, manages to provide shelter to refugees.

It all made already complex integration challenges even harder and also led to more crime. Worst of all, terror groups abused the chaos.

Merkel was at the centre of this pan-European policy failure.

Her attempts to divert attention from her own mistakes by pushing to outvote Central and Eastern European countries on the question of mandatory spreading of refugees in the passport-free Schengenzone – an impossible endeavour, when people can travel

freely– moreover, helped to sour relations with these vulnerable democracies which were welcomed to the West after they escaped the Soviet yoke.

Also, when it comes to economic reform, she doesn’t deserve a lot of credit, despite the good economic performance of Germany during her time in power. The key reasons for this were welfare reforms introduced by her predecessor, Gerhard Schroeder, in 2003. By 2005, when Merkel entered office, Germany’s “unit labour cost competitiveness” had been restored. Her decision to introduce a federal minimum wage was actually a step backward and may well

price the most vulnerable out of the labour market in the future.

Her energy policies, which include the phasing out of nuclear power, are very problematic as well. These are estimated to cost €1.1 trillion by 2050 and have already hit German consumers and industry hard. They are meant to reduce CO2 emissions but Germany is missing both its national and EU targets here nevertheless, also because of the increased reliance The migration chaos and mishandled eurozone crisis have further tarnished the EU’s reputation in the eyes of an already sceptical British public. on “dirty”coal. In the absence of nuclear power, this source of energy provides the backup power needed when the wind doesn’t blow and the sun doesn’t shine.

Merkel also played a very questionable role in the eurocrisis, breaking the sacred ban on eurozone transfers that had been inserted in the EU Treaty in return for Germany giving up its stable national currency.

This has hurt support for the EU and caused a lot of anger.

Those having to pay for the bailouts weren’t happy and neither were those having to accept the conditions linked to the transfers, sometimes even in the form of socalled “Troikas” – teams of foreign officials sent to supervise national policy.

Until today, she continues to push for more transfers and new bureaucracies, in a bid to stabilize the euro. She has been arguing for a eurozone budget and for the creation of a “European Monetary Fund”. These are the wrong kind of solutions. Since 2010, this approach has been tested and the eurozone is still a very shaky construct. Budgetary supervision from Brussels largely fails to force countries to reduce debt.

One approach that has not yet been tried is to create a sovereign insolvency mechanism, whereby eurozone countries that default

on their debt would continue to be allowed to use the euro, while financial institutions based in these countries would lose their preferential access to the cheap money provision by the European Central Bank.

Some non-EU countries, like Montenegro, currently already have such a status. It permits a certain degree of monetary stability while avoiding the easy money dynamic and epic buildup of debt levels that we’ve witnessed in the eurozone. A lot of that debt was private debt, but it had been issued by banks enjoying cheap financing from the ECB. What happened with the creation of the euro was that banks no longer had to obtain funding from their national central bank, but could in many cases obtain much cheaper funding from the ECB. That easy money wasn’t a blessing.

It led to unsustainable public investment, most notoriously in Greece,

but also to unsustainable private investment, for example in the Spanish and Irish real estate sectors. When the bubbles had busted, to save the euro, politicians like Merkel preferred to kick the can down the road and decided to organise bailouts.

During the eurocrisis, Merkel went for the easy option: enable more debt to cope with a debt crisis. “Emergency loans” were issued, but loans with artificially low interest rates are of course transfers. The fact that her own Finance Minister, Wolfgang Schäuble, disagreed with her in 2015, when he preferred to consider excluding Greece from the eurozone, shows that other, more sustainable, choices were available.

If one day we witness a eurozone break-up that is much more painful than would have been the case if politicians like Merkel hadn’t allowed the continuing build-up of debt, then it will be clear who is to blame.

The migration chaos and mishandled eurozone crisis have further tarnished the EU’s reputation in the eyes of an already sceptical British public. Merkel played a role in both and also when former UK Prime Minister David Cameron made a last-ditch attempt to reform the EU, so to decrease the chances of Brexit, Merkel wasn’t very constructive either.

She ruled out changes to the EU Treaty early on, which made any extensive reform of the EU virtually impossible.

Her latest intervention to support the creation of an EU army, which is bound to undermine NATO and confuse the West’s security infrastructure, is yet more proof it’s time for her to leave office.

The opinions expressed in this article are the author’s own and do not reflect the view of Government Gazette.

Government Gazette | 19

european commission

Monitoring social media during elections in Europe

European elections face growing threat of organised social media manipulation on the ground

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lthough the 2016 presidential election might have attracted the greatest media enquiry, the US is far from being the only target; Russia is actively exporting its interference platform to other countries, including in Europe.

Despite efforts by governments in many democracies in introducing new legislation designed to combat fake news on the Internet, the problem is growing at a large scale, according to a new report from the Oxford Internet Institute (OII). The number of countries where formally organised social media manipulation occurs has significantly increased, from 28 to 48 countries globally.

With each passing election, there is a growing body of evidence that national leaders, political parties, and individual political candidates are using social media platforms to spread disinformation.

Professor Phil Howard, coauthor and lead researcher notes that authoritarian regimes are increasingly using ‘task forces’ created to combat fake news as a new tool to legitimise censorship.

In May, 2019 up to 350 million voters across the European Union will take to the polls to elect 705 MEPs. There isn’t any particular piece of intelligence saying that somebody is going to target the European Parliament elections, or indeed one of the series of elections that is due to take place across the continent.

But if you look at the track www.governmentgazette.eu | 20

record, you have to say that there is a chance – some might call it a likelihood – that someone will seek to do just that and small groups of vulnerable voters are bound to be beleaguered. EU Justice Commissioner VěraJourová recently pointed to Russia as the “most cited source of activities interfering with elections in Europe.”

Reportedly, more campaigns are using automated bots, junk news, and disinformation to polarise and manipulate voters.

While automated bot accounts continue to be a well-used tactic, online commentators and fake accounts are used to spread pro-party messages, as well as being used to strategically share content or post using keywords to game algorithms and get certain content trending.

They are also being used to report legitimate content and accounts on a mass scale, causing them to be taken down temporarily. According to OII, there is growing evidence that disinformation campaigns are moving on to chat applications and alternative platforms.

In October, the European Commission announced that Facebook, Twitter, Google and others have agreed to wipe out fake news on the web, with detailed individual

roadmaps containing concrete actions showing how these tech platforms plan to extend their tools against disinformation, ahead of the EU elections.

In the build-up to elections, Facebook has pledged to train all political groups at the European Parliament on election integrity and use of Facebook as a campaigning tool. In addition to offering inperson security training to the most vulnerable groups, who face increased risks of phishing attacks, Google has promised to announce the introduction of new political advertising transparency tools, including a new process to verify EU election advertisers to make sure they are who they say they are.

Ahead of the elections in May, the European Commission is reportedly planning to ask social media platforms including Facebook, Twitter and Google for monthly reports on Russian disinformation campaigns.

In a statement proposing the new rules, VěraJourová said: “We need to draw lessons from the recent elections and referenda.”

“We want to minimise the risk in the upcoming elections, ranging from non-transparent political advertising to misuse of people’s personal data, especially by foreign actors.

I want Europeans to be able to make a free decision when casting their vote. To ensure this, the online anarchy of election rules must end.”

Besides providing guidance on the application of the EU data protection law, the European Commission also presented a slew of preventive measures, including a recommendation on election cooperation networks, online transparency, protection against cybersecurity incidents and fighting disinformation campaigns.

As the European elections of May 2019 will take place in a very different political and legal environment compared to 2014, the European Commission has called on member state authorities and

political parties to assume greater responsibility to protect the democratic process from foreign interference and illegal manipulation.

To equip Europe with the right tools to deal with cyber-attacks, the European Commission proposed in September, 2017 a wide-ranging set of measures to build strong cybersecurity in the EU. This included a proposal for strengthening the EU Agency for Cybersecurity, as well as a new European certification scheme to ensure that products and services in the digital world are safe to use.

The European Commission also issued a recommendation in February, 2018 which highlights key steps to further enhance the efficient conduct of the 2019 elections.

It was Abraham Lincoln, of course, who said that: “the ballot is stronger than the bullet”. We have to make sure that remains true, even though today’s cyber bullets are getting harder to spot and certainly harder to stop.

MEPs fight against election meddling

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embers of the European

Parliament’s LIBE committee have also recently voted that social media firms must do more to prevent their platforms from being used to influence the outcome of political elections.

MEPs are calling for Facebook to make “substantial modifications” to its social networking platform to bring its operations into line with EU data protection laws, which forbid the exploitation of social media for electoral fraud.

They also want Facebook to undergo a “full and independent audit” of its data security and protection procedures, and for the results to be presented to the European Commission and

Parliament at a later date.

Election interference is a huge risk for democracy, the tackling of which requires a combined effort involving service providers, regulators and political actors and parties.

Highlighting the biggest risks in the forthcoming election period, Claude Moraes, chair of the Civil Liberties Committee and rapporteur, said individual member states have been taking action against election interference targeting small groups of vulnerable voters, but urgent proposals are necessary to ensure users’ privacy rights are protected.

In particular, he emphasised: “the need for much greater algorithmic accountability and transparency with regard to data processing and

analytics by the private and public sectors and any other actors using data analytics,” as an essential tool to guarantee that individuals are appropriately informed about the processing of their personal data.

Recent requirements that have been introduced in the US to verify the identity, location and sponsor of political advertisements are a good response and the same standards should be applied here in the EU. MEPs are calling for a number of measures to prevent a repeat of the scandal, including an audit into the activities of the advertising industry on social media and for data protection authorities to carry out a thorough investigation into Facebook to ensure that data protection rights are upheld.

Government Gazette | 21

book review

When Right Makes Might - Rising Powers and World Order - Stacie E. Goddard

How a rising power’s right makes might

WHEN RIGHT MAKES MIGHT

Rising Powers and World Order Cornell Studies in Security Affairs

Stacie E. Goddard

Talk matters.

Great powers listen to what rising powers say they are going to do, and why they are going to do it. Rising powers understand this and attempt to shape patterns of mobilization against their actions through their legitimation strategies.

BOOK REVIEW

I Goddard address the question of how states assess each other’s intentions. www.governmentgazette.eu | 22

f you thought a state’s ambitious military spend will plainly indicate if it will decide to go to war, or counter a competitor, Stacie E. Goddard offers a bracing slap in the face.

Power transitions can be tremendously dangerous, she says.

When new powers rise, they inherently threaten

the existing great powers.

A clash of catastrophic proportions is likely, if not inevitable. However, deciphering intentions of an adversary can be exceptionally challenging.

In her latest book, When Right Makes Might, she lays out her theory of how great powers divine the intentions of their adversaries. The consequence of a future change in the balance of power, she says is to be

found not only in the realm of military and economic power, but also in the battle over the rules and norms of the international system.

She argues that capabilities of a rising power will only reveal limited information about a state’s intentions: it is not what a rising power has in terms of resources, but how it intends to use these resources that matters.

According to conventional wisdom, a great power response rests on how it perceives its challenger’s intentions.

Rising powers with limited aims, might preserve international norms, demand more economic resources, but not threaten existing great powers.

Under such circumstances, great powers often turn to accommodation as the

best way to manage a new power’s rise.

However, a rising power with revolutionary aims, in contrast, poses a significant threat and must be contained or confronted, even if doing so risks war between the great power and its emerging adversary.

To understand the dynamics of rising powers, she says “we must take the role of legitimacy in international relations seriously.”

This is the basic hypothesis of Goddard’s latest book, When Right Makes Might. According to the book, the decision to accommodate, contain, or confront a rising power is based how great powers gauge the ambition of a challenger’s aims. Goddard departs from conventional theories of international relations by arguing that great powers come to understand a contender’s intentions not only through objective capabilities or costly signals but by observing how a rising power justifies its behaviour to its audience.

In Goddard’s universe, everything boils down to a relentless drive for norms.

This book calls for a return to a richer understanding of the instruments and mechanisms of power politics in our theories of international relations

Unlike rationalists and realists — for whom uncertainty is “epistemological” and who suggest rhetoric is a mere window-dressing for power — Goddard argues that “rhetoric fundamentally shapes the contours of grand strategy.” She argues that legitimacy — one of the three currencies of power — is not marginal to

international relations; it is essential to the practice of power politics, and rhetoric is central to that practice.

In fact, the existence of legitimate rules signals the presence of authority.

The concept of legitimacy has long held a central place in political thought, but only in recent years have scholars started to look closely at questions of legitimacy in international affairs. In today’s world of democracies, international legitimacy is both more important and more difficult to achieve than ever.

There’s no doubt that a great power will worry about an emerging peer’s newfound strength, but their ‘costly signals’ — including accumulation of military strength — are actually vague indicators of their true intentions.

As Goddard points out, how a state intends to use its resources matters more than mere accumulation of resources. Even what we commonly think of as costly behavior— invasion, conquest, aggression—often fails to reveal clear aims.

Rising powers use legitimation strategies to shape the meaning of events.

Goddard’s “legitimation theory” explains that rising powers have the ability to shape the meaning of their behaviour through their legitimation strategies.

Rising challengers will try to persuade the great powers that, even if they increase their might, their ambitions will remain

within the boundaries of what is right.

She argues that legitimation strategies are significant, simply for the reason that they are “a critical factor of collective mobilisation, both at home and abroad.” It is for this reason that they shape perceptions of a rising power’s intentions through three mechanisms.

First, legitimation strategies can signal restraint and constraint, a willingness to abide by international norms and secure the status quo.

Second, legitimation strategies set rhetorical traps: when rising powers frame expansion as legitimate, they deprive opposing audiences of grounds on which to mobilize against them.

And finally, legitimation strategies are likely to be successful when they appeal to a state’s identity: a rising power can mobilize support for its demands by evoking principles and norms fundamental to a threatened state.

The cases in this book provide extensive evidence that much of rising power politics involves the search for certainty, with great powers seeking enough information about the rising power’s ambitions to form a coherent and reasonable response to its rise.

The bulk of this book is devoted to four qualitative studies of rising powers, their legitimation strategies, and great power strategy: Britain’s decision to accommodate the rise of the United States in

early nineteenth century; the decision of the European powers to allow for growing Prussian power in the 1860s; Britain’s appeasement of Hitler’s rise in the 1930s, and its turn toward confrontation after the Munich crisis in 1938; and U.S. decisions to contain and confront the rise of Japan in the twentieth century.

Towards her conclusion, she doesn’t fail to discuss the U.S.-China relations.

This book is certainly not the first to call for a rhetorical turn in international politics.

Earlier realists such as Morgenthau, Carr, and Aron understood this connection between rhetoric, legitimacy, and power, and for that reason treated these factors as significant in their own studies of international politics.

Goddard’s classic examination of how great powers divine the intentions of emerging adversaries is an enduring contribution to modern political analysis.

If you publish a book you think is relevant for policymakers, do mail us at editor@ governmentgazette. co.uk and send us a copy to review.

Please note that we may receive several books to review every quarter. Submission and publication of reviews is subject to our terms and conditions.

Government Gazette | 23

books

Interview with the author of When Right Makes Might

WRITER’S DIGEST

Government Gazette asks

Are battles over rights essential in the struggle over might?

B

Stacie E. Goddard is the author of When Right Makes Might - Rising Powers and World Orders

ritain understood early on that the United States was going to be a rising power, even as early as the nineteenth century. The United States recognised Japan was a rising power. The international community recognises China as a rising — if not an already risen —power.

While they understand that, there is always an incredible amount of uncertainly of what rising powers are going to do with their new found power.

We often end up seeing leaders attempting to figure out, from a series of actions, what is it that a rising power is going to do. Those actions — in and around themselves — can be indeterminate.

They can be read in a number of different ways, Goddard says.

A lot of international relations theorists think about the amount of uncertainties that there is in international politics.

They try to find out how leaders of a state try to manage that

www.governmentgazette.eu | 24

uncertainty. There is a great amount of literature trying to get inside the intentions of a state, with most scholarship thinking about power, legitimacy and narrative.

Theorists and political analysts constantly look at what leaders are saying and how that actually constructs and gives meaning. That’s what got Goddard thinking about how great powers divine the intentions of rising powers.

To make judgments about a challenger’s intentions, “great powers look not only to what the rising power does; they listen to what a rising power says—how it justifies its foreign policy,” said Stacie E. Goddard, author of the new book When Right Makes Might - Rising Powers and World Orders.

When new powers rise, their leaders recognise that they operate in an atmosphere of uncertainty in which their adversaries are unsure of aims and interests, because of which she says

legitimation theories become crucial in justifying actions of a rising power.

Goddard departs from traditional realists and argues that great powers come to understand a contender’s intentions not only through objective capabilities or costly signals but by observing how a rising power justifies its behaviour to its audience.

While Goddard’s book fits more comfortably on a college reading list than on the browser’s night table, her goal is not merely academic. However, as she points out, the argument of this book — if correct — can have significant implications for academics and policymakers alike.

In an exclusive interview with Government Gazette, Goddard talks about her latest book, power politics, what inspired her most and her theory of legitimation which explains how leaders of great powers divine the intentions of rising powers.

Goddard thinks legitimation strategies are at the heart of deciphering intentions of a rising power.

For political scientists, a big question in recent years has arisen when they have tried to interpret China based on its actions in the South China Sea. What is China doing here? Is this minimal incursion into a territory which it ultimately sees as a space of its own? Is it a stepping stone for some power projection beyond the South China Sea? There is a question of whether China will remain a firm partner in the “liberal international order” or become a “revisionist power,” one that will overturn existing institutions in pursuit of its global agenda.

She agrees it is difficult to explain China’s actions.

Whatever agreement exists over China’s growing power, there is considerable debate over how China intends to use it. Some are increasingly concerned that China’s ambitions are “growing in step with its power.”

In this scenario, China’s move toward a revolutionary strategy, one that upends the status quo in the AsiaPacific, is inevitable.

As China’s power has grown, its aims have remained relatively consistent; though it has become somewhat more assertive about its aims in the South China Seas, the substance of these claims has not changed, nor has it sought broader territorial or economic revision. For those who believe China has limited aims, a continued strategy of engagement is a wise choice, indeed the only way to avoid unnecessary conflict.

Goddard notes that: “leaders spend a lot of time listening to the explanation given by states about their behaviour — and it is here where legitimation becomes really important.”

The type of rhetoric a state uses, in some way or the other, she says justifies its action.

Here’s when powers try to appeal to international rules and norms. They either try to show that they comply with these norms or show themselves as revolutionary. And, here’s where my theory comes to play.

Finally, Goddard says the legitimation theory will have impact for both policymakers and academics — beyond rising power politics.

deciphering intentions

What kind of power does China want to be?

T

he U.S. and China are playing a dangerous game. China’s military has been transformed since it last fought a war, against Vietnam in 1979.

It has rearmed and either copied, developed or bought many of the missile and stealth technologies required of a 21st century superpower.

By now it spends more than three times as much on defense as Russia, and it is closing a still enormous gap with the United States.

On the other hand, great power competition, not terrorism is now the primary focus of the United States foreign policy. Ask why. In presenting a new strategy, which will set priorities for the Pentagon for years to come, Defense Secretary Jim Mattis called China and Russia “revisionist powers” that “seek to create a world consistent with their authoritarian models.”

This is perhaps the latest sign of shifting priorities

the case that—far from being a revolutionary power—its advances will preserve, and perhaps even protect, the prevailing status quo.

after more than a decade and a half of focusing on the fight against Islamist militants. The big question is whether this the United States is striving to prove their leadership through such confrontational strategies, or is it a recognition of the intentions of its adversaries?

Is China’s ‘costly signals’ indicative of its true intentions?

As Goddard’s legitimation theory challenges conventional understandings of costs, uncertainty, and identity in international politics, perhaps China’s accumulation of military reserves may not be indicative of its super

power ambitions.

Managing uncertainty in the international system involves, not merely providing information about an objective world, but also constructing and fixing the meaning of events.

Rising powers often try to convince the great powers that, even as they increase their might and make revisionist demands, they will do so within the boundaries of what is right: that their growing strength will reinforce, not undercut, the rules and norms of the international system.

If a rising power can portray its ambitions as legitimate, it can make

In contrast, if a rising power’s claims are illegitimate—if they are inconsistent with prevailing rules and norms— then great powers will see its actions as threatening, making containment and confrontation likely.

The confrontation strategy of the United States is clearly a case in point. As US Defense Secretary Jim Mattis points out in his strategy, China and Russia seek to create a world consistent with their authoritarian models — being inconsistent with prevailing norms.

Their departure from international norms has caused a great power such as the United States to alter the prevailing status quo and turn to a strategy of confrontation.

Government Gazette | 25

end of 2018...

Seb Dance mep on why Brexit is a disaster

A HIGH POINT “Without question the highlight for me was the march in London of nearly 3/4 million people demonstrating for a European future.

Before the Brexit disaster I would never have believed such a huge display of public will in favour of Europe would be possible. It’s ironic that it has taken Brexit to give voice to what must now be one of - if not the largest pro-European movements in any European country. “ www.governmentgazette.eu | 26

mid uncertainties about whether the Brexit deal would fail to pass a parliamentary vote, Government Gazette caught up with Seb Dance, Labour’s deputy leader in the European Parliament, who shot to fame after mocking Nigel Farage in the European Parliament in February last year.

In an interview with Government Gazette, he hopes we can still avert the Brexit disaster, talks about the huge wave of European favouritism — that he vows would last for the foreseeable future, discusses his high and lows of 2018 and chats about his expectations for the new year. He is one among those British MEPs who feel they are being dragged from a job they love by a

Brexit they believe will be a disaster.

What did you learn in 2018?

You learn a lot in this job! The principle lesson would be the importance of standing up for what you believe; no matter how difficult or unpopular that might be in the moment.

I cannot think of a time when the values and politics I believe in have been more under threat.

The temptation is there to “ride the wave” of populism and modify one’s public beliefs in order to try and win support. It doesn’t work. 2018 has confirmed that for me - the future for the left, progressives and social democrats is to be honest about the challenges we face on climate change,

migration, on automation and the world of work and to call out those with the simplistic, scapegoating “solutions”.

The populists tell people what they want to hear and in so doing are: (a) failing to actually solve the initial problem and (b) increasing the inevitable disappointment and anger that people feel because of (a). Playing with people’s futures like this is not just morally wrong, it’s reckless and fantastically myopic.

It could lead democracies to a very dark place where trust between voters and institutions breaks down completely. Interestingly, those prepared to be honest are increasingly gaining in polls, whereas those attempting to triangulate, suffer.

By all means we must adapt our tactics but not at the expense of a strategy where we set out and explain clearly the real challenges ahead - and what our response to those should be.

Three words you would use to sum up the EU. Freedom, unity, strength.

What are your hopes and expectations for 2019?

That the mess that is Brexit doesn’t happen! I still hope we can avert disaster.

Your high point of 2018?

Without question the highlight for me was the march in London of nearly 3/4 million people demonstrating for a European future. Before the Brexit disaster I would never have believed such a huge display of public will in favour of Europe would be possible. It’s ironic that it has taken Brexit to give voice to what must now be one of - if not the - largest pro-European movements in any European country.

Whatever happens with Brexit, this movement is not going anywhere. If Brexit goes ahead in March, it will only grow. It may be too late to save the UK’s membership of the EU this time, but it will be critical in shaping the UK’s future (and re-entry!).

My expectation, however, is that it will go ahead. In that case we move from “Brexit” to “Trexit”: withdrawal from (or reneging on the obligations of ) the transition period. This will dominate British politics for the foreseeable future as Britain’s glacial political class wakes up to the fact that we’ve signed up to a really bad deal; following the rules with no say. It’s my firm belief that leaving the EU like this will not be sustainable and will cause more problems in the long run. It will be a neverending discussion and may even end in a scenario closer to “no deal” than we think now.

I very much hope that 2019 is the year that the far-right fails to make the gains that everybody now fears they will. I hope it is the year that the left finds its confidence and starts to tackle the charlatans on terms that people can understand and identify with.

In Parliament, the Irish Taoiseach Leo Varadkar’s speech at the start of the year helped set the year off on an optimistic tone. His speech was forward-looking, modern and collaborative.

It really felt like a confirmation of the journey Ireland has been on within the EU. Ireland has made incredible strides to becoming one of the

If we believe in our values then we shouldn’t try and bend them to suit the agenda of others. The

Seb Dance, who is Labour’s deputy leader in the European Parliament, shot to fame after publicly mocking Nigel Farage in the European Parliament in February EUs most robust modern democracies with a strong sense of European identity without losing its unique culture of which I - as an Irishman as well as a Brit will always be proud.

Your low point of 2018?

Earlier in the year, the UK’s

“

I cannot think of a time when the values and politics I believe in have been more under threat.

Seb Dance is MEP for London and deputy leader of the Labour group in the European Parliament.

former bungling Foreign Secretary, Boris Johnson was replaced with Jeremy Hunt, in a move most of us hoped would signal an end to some of the worst embarrassments wrought on the UK by his predecessor.

Unfortunately, one of Hunt’s first acts was to give a speech at the Tory Party conference

comparing the EU to the USSR; a move which offended many Europeans, particularly the millions who actually lived through the nightmare of Soviet control.

This was followed by more crass remarks within the European Parliament itself from a Conservative MEP who should know better.

last year. In his final months in the Parliament, the Labour spokesperson on environment has been standing up for the people of London.

The danger for the UK is we spend too much time talking about ourselves to ourselves. We have forgotten to seek alliances, to build trust and to be realistic about geopolitics. These were always the UK’s key strengths - and they’ve gone AWOL.

European elections will be a key point for Europe; how progressives react to them will be more of a determining factor than the results themselves.

This interview is part of a series of Government Gazette’s End of 2018 interviews.

Government Gazette | 27

analysis

Parlemeter 2018 – Taking up the challenge

Ximena CALO Reporter

Ireland reports greatest satisfaction of EU membership

T

here has been significant upturn in the support for Europe, following the UK referendum in 2016. More than 60% of Europeans believe that their country’s EU membership is a good thing, reaching a new high since the time between the fall of the Berlin wall in 1989 and the adoption of the Maastricht Treaty in 1992.

Europe has gradually shed its murky outlook on democracy.

This increasing optimistic

If there was a referendum on EU membership today, only the Czech Republic and Italy would vote to leave with 83% of the Irish public voting to remain

outlook on the EU parallels with a 67% of them who consider their countries have benefitted from being a member state, while it is contrasted by less than a quarter of respondents suggesting an opposing scenario in their country’s case.

Ireland has reported the greatest level of satisfaction for the European Union; with 85% of respondents saying that membership is a ‘good thing’.

An even larger percentage of respondents felt that Ireland had benefitted from EU membership (92%), this compares to an EU average of 68% of people who feel their country has benefitted since joining the Union.

However, 40% of Irish respondents were ‘not interested’ in the upcoming European elections due to be held in May 2019. This represented a 4% decrease in interest for the EU Elections in Ireland since April 2018.

Based on a different Pew Research www.governmentgazette.eu | 28

Center survey conducted in late 2017 across eight countries, younger Europeans are somewhat more supportive of the EU. In half of the European countries surveyed, people aged 18 to 29 were more likely to say EU membership has been good for their country’s economy.

In the UK, where leaders are currently negotiating the country’s exit from the EU, a strong majority of those under 30 (75%) said the institution has benefited the British economy. In comparison, only around half (53%) of Britons 50 and older said the same. The gap between the youngest and

oldest groups was about as large in France.

Younger Europeans in most countries were more supportive of their national governments transferring more powers to the EU – although still only about one-third of those under 30 approved of such a measure. In Denmark, for example, 34% of those under 30 supported transferring more national powers to Brussels, compared with 27% of those aged 30 to 49 and only 16% of those 50 and older.

If there was a referendum on EU membership today, only the Czech Republic and Italy would vote to leave, with 83%

of the Irish public voting to remain. Interestingly, if there was a vote today, 51% of Britons surveyed would choose to remain.

The results of the census suggest that an increasing positive view on EU membership is correlated with perceptions that regionalism has brought ‘good governance’ and improved democracy.

However, this is generally the norm for smaller members. Concurrently, citizen engagement remains higher at a national level than a regional one. While 68% of the electorate believed it was important to vote in national elections, only 49% considered it

Younger Europeans view news media less positively, rely more on digital platforms than adults

T

he unprecedented impacts of technological advances have driven various traditional aspects of our societies to become reinvented and adapt to a dynamic environment. One of these areas is, naturally, the way in which people consume current events. According to a cross-generational study by the Pew Research Center on the sources employed by Europeans to access the news, there seems to be a significant correlation between a person’s age group and their preferred news source.

important to participate in European elections.

and attitudes about the elections.

Importance of voting does not always equal turnout. While only a minority of 12% express concerns relating to accessibility, nonparticipationor lack of interest in elections related to distrust in political systems and lack of confidence about the power of the electorate.

According to the survey, there has been an increase in the level of awareness about elections. Compared to a similar survey conducted six months back, 41% of Europeans could correctly identify the election date in May 2019, recording a 9% increase.

The 2018 Parlemeter also took a closer look at citizens’ views on the upcoming European Parliament elections, showing an overall increased awareness about the next ballot while painting a multi-coloured picture of opinions

However, 44% still could not say when the elections will be taking place. With 51% of citizens declaring to be interested in the elections, citizens’ campaign priorities have evolved over the past sixmonth period.

The study included eight European countries which, altogether, represent 69% of the European Union’s population.

Although in each variable studied there exist some variations between countries, there are evident trends if different age groups are compared, especially when it comes to the use of social media as sources of information.

While 87% of those contemporary to the popularisation of the television– that is, those 50 years or older – still tend to rely on this platform for their daily news intake, 73% of young Europeans prefer the Internet. It is interesting to note, however, that the percentage of people in each country is more uniform for the middle-aged groups – 30 to 49 – with people consuming news from all television, the Internet, print, and radio. In this sense,

the middle generation seems to bridge the gap between the young and the old. The biggest intergenerational gap occurs in Denmark, with 59 percentage points separating the age categories on the extremes and the lowest gap occurs in Italy, where young adults tend to rely on traditional sources of information and are separated by their older counterparts by 26 percentage points only.

Although Italy and Denmark widely differ on the amount of young adults in the respective countries that get informed through the TV, these two countries share the highest amount of 18 to 29-year-olds who use social media for news daily.

Yet, a majority of the people in this age group – 59% – use social media in all eight countries surveyed. The fast pace at which information flows on social media platforms also means that this age group is exposed to a wider variety of sources of information.

In fact: “in nearly all countries, younger adults are less likely than the oldest age group to agree on one outlet as their primary news source.”

The United Kingdom represents a notable exception, however, with 44% of younger adults and 51% of those 50 and older relying on the BBC as their unique, dominant source.

Government Gazette | 29

Clara Eugenia AGUILERA GARCĂ?A mep

Vice Chair, Committee on Agriculture and Rural Development

It’s in your hands

R

ecently, the European Commission released a new Eurobarometer on antibiotic resistance. It is

www.governmentgazette.eu | 30

still surprising that nearly half of the respondents still think that antibiotics are effective against viruses, or that 58% of respondents do not know

that the use of antibiotics to stimulate growth in farm animals has been banned in Europe since 2006. It is obvious that there is still room for

the market and use of medicated feed through a new Regulation.

Medicated feed is a safe and controlled way to treat animals, ensuring an accurate dosage of the veterinary medicines.

This is crucial when thinking about our work in fighting against antibiotic resistance. The report was approved by great majority by the European Parliament last October.

improvement when it comes to information and knowledge of the society regarding the use of antibiotics, both in the human and veterinary sector.

We believe that work should be done in order to increase awareness among citizens about the benefits of antibiotics and their responsibility in protecting those medicines for future generations. Initiatives such as the European Antibiotic Awareness Day should be encouraged, always following a “One Health” approach.

Antibiotic resistance is

a growing problem globally and brings huge societal and economic challenges; therefore, action at member states, European and international level is urgently needed. In my role in the European Parliament as vicechair of the Committee on Agriculture and Rural Development and rapporteur on the proposal on medicated feed, I have dealt several times with issues related to antimicrobial resistance (AMR). AMR .

Recently, we have taken a significant step in the battle against antibiotic resistance, updating and harmonising rules on the manufacture, placing on

These rules are under the new general regulation of veterinary medicinal products (VMP). This is particularly the case where we have established the total prohibition of prophylactic use of medicated feed containing antibiotics in the medicated feed regulation. Prevention is always better than cure, but when the only solution is to administer a VMP (via medicated feed) we will have stricter rules of use and manufacture for a therapeutic tool in the hands of our veterinarians.

These updated rules will ensure responsible use of antibiotics. We believe that prevention is always better than cure, this is why responsible use should be seen as a holistic approach encompassing biosecurity, good nutrition, good housing, herd health plans and good vaccination strategies.

It is in this context, and where disease still occurs,

that antibiotics should be responsibly used to protect the health and welfare of animals.

I believe that when it comes to AMR, the problem is twofold; on the one hand the misuse and the overuse of antibiotics have increased the rate at which resistance is developing, and on the other there is a lack of new effective medicines. Therefore, work needs to be done in order to find solutions to support better rewards for innovation, while promoting the responsible use of antimicrobial agents in both animal and human medicine.

Particularly, it is of the utmost importance that Europe provides incentives to drive research and innovation in the future “Europe Horizon” for the development of new antibiotics, diagnostics, vaccines, alternatives to antibiotics, etc, both in thehuman and animal health sectors.

Europe has recently put forward a number of legislative proposals, including the veterinary medicinal products, medicated feed and animal health law. It is also important that member states continue to develop and update national strategic plans to fight antibiotic resistance, always following the one health approach and under the umbrella of the European plan to ensure

coordination.

We are aware of great achievements in the veterinary sector, such as reduction of 20% of antibiotics sales for food producing animals since 2011, including critical antibiotics.

While it’s clear that the Commission has limited competence in healthcare, I believe that the discussion at an EU level predominately focuses on veterinary medicines and agriculture and should in fact extend to human medicine.

It is important to bear in mind that this is a multisectorial challenge, which is why it is necessary to work together with the public health sector, the environment and other areas. In addition, resistance to antibiotics knows no borders, which is why a global approach with the commitment from all countries is needed to face this challenge.

To conclude, more incentives for the development of new effective tools such as new antibiotics, vaccines, diagnostics, etc, strict control on responsible and prudent use of antibiotics, promotion of awareness among the society and the commitment of all the sectors will be critical if we want to be successful in tackling antibiotic resistance.

Government Gazette | 31

What’s the entire buzz about EP’s Slovenian beekeeper?

END OF 2018

A

lojz Peterle has been one of the rising stars of the European People’s Party, representing Slovenia, serving as the president of the European Parliament’s all-party

www.governmentgazette.eu | 32

MEPs Against Cancer group.

Government Gazette caught up with EP’s Slovenian beekeeper who demands stronger political will and the implementation of a concept of health in all

What did you learn in 2018?

Applications utilising AI are able to analyse data that help us understand prevention, treatment, and patient outcomes in new ways. Such progress is fascinating and exciting, but as our systems become more advanced, autonomous and human-like, we need to address complex questions regarding the definition and protection of personhood.

One of the big topics this year has been Artificial Intelligence (AI).

Throughout discussions I’ve partaken in, it has become increasingly apparent to me that we must establish a unified approach to advances in the field, speaking in terms that incorporate both science and ethics.

AI is presenting us with new horizons across society, especially in the field of health.

For example, I have heard some strange proposals that would give legal personality to robots. Additionally, there are questions regarding responsibility for AI technology, such as self-driving cars, if it malfunctions and causes harm. As this field progresses and becomes more integral to our daily lives, there will be challenging questions ahead.

policies. Peterle shared with us some of his experiences in 2018 and his expectations for the New Year.

His highest point this year — as expected — was the World Bee Day, when the Commission inched a step closer to Juncker’s pledge to save the bees.

Your high point of 2018?

The high point of this year was World Bee Day, which was celebrated for the first time on May 20th. This was a result of the hard work of the Slovenian Beekeeper’s Association and the Slovenian government to ask the UN to set aside a special day to acknowledge the important role that bees and other pollinators play in sustaining our ecosystem. This particular date was chosen because it is the birthday of Anton Janťa, the pioneer of beekeeping and a Slovenian.

To see such global support for the protection and promotion of bees was a great encouragement as it showed international awareness regarding the importance of global cooperation on the issue is growing. As a beekeeper, I know that even the smallest bee can have a big sting on our society if its role as a pollinator is threatened.

Your low point of 2018?

This year, I had to say goodbye to a few dear friends because of cancer.

As a cancer survivor, cancer is personal and also central to my work at the national and European levels. Chairing the Members Against Cancer group in the European Parliament has given me many opportunities to become aware of new technology and methods of treatment directly from global experts.

Yet, in spite of the advances we continue to make, we are not successfully addressing the disease in terms of prevention, treatment or cross-border cooperation.

One in three European citizens will develop a form of cancer in their lives and on e-fourth

of all deaths in the EU are due to cancer, two statistics which should drive us to act.

We have seen how pooling resources within the EU has been a great benefit to our societies and economies, we should now work to keep health understood as a resource as we continue working to eradicate cancer. More Europe will not be possible with more cancer.

Three words you would use to sum up the EU.

spectrum.

Our politics are becoming increasingly polarised and divided, and our capacity for constructive dialogue has been destroyed. In view of this, debates on the future of Europe are needed now more than ever to determine the common future we will share together.

If we want to decide on our tomorrow, we must begin by remembering our past.

I hope for a strong, proEuropean majority in the European Parliament after the elections in May.

I would like this process to continue gaining attention in 2019 and for the EU to rediscover its sense of a common good. More importantly, we must remember what this really means. It is what defines Europe and should be central to all we do.

There is no other option than for the European project to continue and grow stronger. In the past year, we saw shifts in public opinion towards the ends of the political

Regarding the Western Balkans, I’d like to see the EU deliver on its promises for the regions and bring these countries closer to their European futures. Saying

Peace, freedom and community.

What are your hopes and expectations for 2019?

that we support the European perspective is not enough; we need to follow through with concrete initiatives.

We have some unique opportunities now, including completing the visa-free travel for the citizens of Kosovo and to include the Western Balkans countries into the free mobile roaming zone of the EU. These are two small gestures that will greatly benefit the citizens of these countries, demonstrating our commitment to the development of the region.

Additionally, I would like to see health higher on the political agenda of all European institutions.

Health, especially with regard to prevention, should be understood as an economic category, as preventing an illness is a far lesser burden than treating it.

Government Gazette | 33

environment

Putting the dangerous legacy of the ‘Dieselgate’ scandal to an end

Let’s tackle Europe’s diesel disgrace now Miriam Dalli MEP reviews Europe’s position as leader in climate change

W

hen I sat down with European Commissioner for Climate Action Miguel Arias Cañete for our first trilogue on October 10th, both the European Council and the European Parliament presented their positionson the Regulation setting the emission performance standards for new passenger cars and light commercial vehicles.

It was the first in a series of interinstitutional negotiations that will follow, and its objective was to set the tone for the discussions that follow.

Just a few days before, the European Parliament gave a strong mandate for the negotiations to kick off, with a solid result of 389 members voting in favour.

As the lead negotiator on this legislative proposal, I fought hard for a Parliament position that endorsed a CO2 emissions cut from new cars of 20% by 2025 and a 40% cut by 2030. It was a clear position that carmakers should ensure that zero- and lowemission vehicles make up a 35% market share

of sales of new cars and vans by 2030 and 20% by 2025.

But on the eve of the first trilogue, the Council of Ministers agreed to a 15% target by 2025 and a 35% by 2030 for cars, leaving several member states disappointed with the final outcome.

Several states insisted that

Is Europe really a leader in fight against climate change?

I must admit that I am not convinced of the outcome as well, more so because the European Union has placed itself as “a leader” in the fight against climate change and the reduction of greenhouse gases. the so-called general approach adopted by the Council had become weaker as the discussions progressed.

I must admit that I am not convinced of the outcome as well, more so because the European Union has placed itself as “a leader” in the fight against climate change and the reduction of greenhouse gases. Such a fight www.governmentgazette.eu | 34

cannot stop at words but requires concrete and meaningful action from us all, including policymakers, industry players and stakeholders, together with measures that rope in consumers as well.

When I took on the rapporteurship of this

legislative file, I knew exactly what I wanted to achieve and my resolve strengthened the more I held meetings with the carmakers, technical experts, social partners, consumer organisations and environmental NGOs. Here is our opportunity to harness

a global challenge and put Europe’s car manufacturing industry at the forefront before other continents take over.

The continued decarbonisation of the transport sector is in line with the commitments under the Paris

Agreement.

skill development and retraining of workers in the sector in order to help the transition to clean mobility.

Reducing CO2 emissions from vehicles is an opportunity on multiple fronts: safeguarding the environment, reducing the impact of pollution on our health, increasing the supply of clean cars on the market, making them more affordable for consumers, investing in infrastructure to make the transition happen, boosting innovation and competitiveness and investing even more in our workers.

Doubts were raised about the capacity and capability in infrastructural investments in Europe.

I believe that market forces will push development in the right direction. We can help this process with policy measures being proposed in the Parliamentary text, namely by finding synergies between political, economic and financial stakeholders working together across the European Union, regional and local levels and also supported by stronger Union funding instruments.

The Parliament is also mandating the Commission to propose legislation that would provide consumers with accurate and comparable information on the fuel consumption and to develop a real-world CO2 emissions test, with the aim of using it for compliance purposes.

As we dedicate the coming weeks to negotiating among the three institutions, I look forward towards a constructive and productive approach. At the end of the day, it is our duty as policymakers to ensure a deal with a long-term vision for all.

Concerns were raised about jobs. As the European Parliament, we are strongly advocating for a socially acceptable and just transition towards zero-emission mobility. The EU can, and should, promote european diesel summit

Lobbyists demand greater action at EU level

T

hree years after Dieselgate there still is no European solution.

We’ve got a piecemeal approach where dirty diesels are not being fixed but are increasingly exported east. We need a European solution based on the principle that dirty diesels must be either fixed or scrapped.

Though efforts have been made at the national and city levels to reduce the external costs of certain transportation methods, there is still much work to be done regionally. The European Public Health Alliance

(EPHA), EUROCITIES, and Transport and Environment (T&E) recently presented a declaration proposing five initial cooperative measures to tackle the air pollution issue.

The EU should start by eliminating the 43 million dirty diesel vehicles that are still circulating around member countries. The proposal also calls for the creation of the ‘EU Clean Air Fund,’ strengthening the legislation at the European level, and coordination among EU countries for the

recall and fixing of automobiles.

The petition has sprung three years after the Dieselgate scandal which raised awareness of the air pollution issue, but did not provoke noticeable legislative changes. As Lisa Boni – secretary of EUROCITIES – recognises, it is not sufficient for non-governmental organisations to “encourage alternatives, such as public transport, walking and cycling.”

This movement also requires “greater action at EU level to clean up

dirty diesels and promote sustainable urban mobility.”

As other clean-air lobbyists explain, the proposed measures are not only important for the environment, but also to prevent premature deaths. William Todts, executive director of T&E, argues that even if “all Europeans have the right to breathe clean air […] only 2% do, while more than 400,000 die prematurely every year as a result.” Sascha Marschang, director of EPHA, shares this view, but with a slight twist.

Although Marschang does recognise the evidence linking air pollution and premature deaths, he believes that getting policymakers to act is by emphasising healthcare costs. “Making the invisible visible and calculating the actual healthcare saving,” he explains, “would make it easier for decision makers to implement the necessary policy measures to ensure cleaner air and a healthier life.”

Government Gazette | 35

technology

Blockchain finds its way

How can the EU harness blockchain for a forward-looking trade policy?

THE LAST WORD

T

here is little doubt that blockchain is the buzzword of 2018. From the bitcoin bubble to the proliferation of new blockchain applications, politics and industry are abuzz with the hype that blockchain will be the next transformative wave of the digital revolution.

Emma McClarkin,

rapporteur on Blockchain in the European Parliament’s International Trade committee writes about her own initiative report

www.governmentgazette.eu | 36

This is indeed an incredibly exciting field, within which innovations are emerging on a daily basis.To this end, I am encouraged to see my fellow members of the European Parliament are quite rightly becoming increasingly aware of blockchain’s widespread potential beyond cryptocurrencies.

As the rapporteur on my Own Initiative report on “Blockchain:

A forward looking trade policy” in the European Parliament’s Committee on International Trade, I hope to continue to raise much needed awareness about the opportunities and challenges of this emerging technology and expand understanding of how this technology works.

My report has come at the perfect time to explore the uses and applications of blockchain and distributed ledger technologies to international trade.

There is tremendous potential for blockchain to revolutionise the way businesses trade and exchange information, goods and ideas.

However, while we are right to extol the opportunities blockchain has to offer, I believe as politicians we must proceed with a rational and laser-like focus

on the challenges and current limitations to this technology. Blockchain is not a silver bullet that can solve all the world’s problems and given this, I was careful to focus on specific applications of blockchain to international trade within my report.

For example, my report focuses on the role of permissioned blockchains in international trade, as opposed to permissionless blockchains.

Permissioned blockchains are akin to conventional databases, in that the contents of the ledger are only available to selected users through a rules-based control mechanism. It is the extra element of control of users, in addition to the secure level of access on permissioned blockchains, which explains why I believe there is greater scope right now to examine its application to

international trade.

My report focuses on several areas in which blockchain has the potential to improve the trading environment, and provide businesses and consumers alike with trading confidence.

First, my report investigates how the EU’s trade policies could be strengthened by incorporating blockchain into its operations.

We often discuss the underutilisation of the EU’s Free Trade Agreements, owing to various reasons, although one of which is the complex rules to benefit from preferential access.

Blockchain can ease the process for proving origin and compliance and simplifying administrative burdens, thereby boosting exports.

Second, my report focuses on the application of blockchain to external aspects

of customs and trade facilitation. Blockchain can improve transparency throughout supply chains, strengthening the certainty of the provenance of goods, upholding consumer protection and improving trust and business stability. Moreover, the reduction of barriers in supply chains through the implementation of blockchain is estimated to boost global trade by up to 15 percent.

There are several exciting pilots within the logistics industry that have already demonstrated the potential of blockchain to reduce transportation costs, make the industry more environmentally-friendly, and boost economic performance overall.

For example, IBM have worked extensively on integrating blockchain into supply chains, from collaborating with Walmart and Maersk on reducing tracking times along the supply chain. Within the public sector, the South Korean government has launched a permissioned blockchain platform to facilitate cross-border trade by enhancing collaboration between customs authorities and regulatory agencies.

My report also recognises that SMEs could be one of the greatest beneficiaries of blockchain. The technology could make it significantly easier for SMEs to interact with customs authorities and other businesses along the supply chain, to enable them to internationalise their exports. Blockchain could facilitate peer-topeer communication and collaboration tools that could significantly ease how SMEs do business.

Despite this abundant potential, there are still a number of

challenges to blockchain implementation that will need to be addressed.

To this end, my report also investigates the importance of secure data flows for preventing the use of fraudulent documentation and counterfeit goods entering the supply chain. Enabling the free flow of cross-border data is integral to both trade and the blockchain architecture.

Furthermore, my report also recognises the need to further investigate the relationship between blockchain and the implementation of the EU’s General Data Protection Regulation (GDPR). I am positive that blockchain can provide solutions for GDPR implementation, as both initiatives are underpinned by common principles of ensuring secured and self-governed data. Nonetheless, it is essential that the Commission continues to look in to maximising compliance in the design of blockchain systems.

My report also looks at two further challenges to blockchain implementation: interoperability and scalability. The interoperability of different blockchain systems is vital for creating an ecosystem

My report has come at the perfect time to explore the uses and applications of blockchain and distributed ledger technologies to international trade.

There is tremendous potential for blockchain to revolutionise the way businesses trade and exchange information, goods and ideas.

through which supply chains and public bodies can harness the benefits of blockchain.

It is important the EU create an environment for start-ups to design new systems that are compatible with other blockchains and existing digital applications. In addition, the scalability challenges associated with the implementation of blockchain systems, particularly with regard to expanding international trade networks, must be considered as pilot projects start to flourish.

So with the opportunities there to grasp, my report outlines several recommendations to the European Commission. It is essential the Commission build on

its existing progress by closely engaging with developments in the area of blockchain, in particular the ongoing pilots implemented in the international supply chain.

The Commission should develop a set of guiding principles tailored to industry to provide a level of certainty and encourage innovation, working closely with stakeholders to address interoperability and scalability challenges.

These are just some of the

recommendations that need serious consideration.

We must ensure Europe remains a global leader in blockchain, as countries across the world are launching innovative initiatives and pilots daily. This applies not just to the development of regulation and policy, but to the technology itself. The digital technology revolution is here.

DIABETES REPORT Recommendations to reshape policy making

Roadmap to improve management of diabetes in Europe

The state we are in at a glance 1.

2.

3.

4.

5.

Currently 29 countries out of 47 are implementing a national plan addressing diabetes and another 10 have announced plans for future.

Though 95% of European countries target obesity, smoking and harmful use of alcohol, prevention remains poorly funded.

47 countries reportedly have some form of diabetes guidelines, but stakeholders are reportely less aware of existing guidelines.

Secondary prevention, attempting to put diabetes into remission, or preventing pre-diabetes hyperglycaemia states from progressing, has also been disappointing.

Nearly 75% of countries in the region do not recommend continuous universal education to people with diabetes.

Its time to diffuse the diabetes time bomb According to IDF, diabetes affects around 382 million people worldwide. In Europe, prevalence estimates now stand at 8.5% of the population aged between 20 and 79 years – meaning that 56.3 million people are living with diabetes in the whole of Europe. This is forecast to rise to 68.9 million by 2035.

To reverse this trend, it is pertinent to tackle the persisting gaps and missed opportunities in the EU battle against diabetes. The basis for such an action lies in an objective and factual assessment of the situation.

Diabetes is becoming a public health crisis due to unhealthy diet, physical inactivity and increases in obesity levels. If those affected by diabetes do not correctly manage their condition, they are likely to become progressively ill and debilitated, and over time diabetes can damage the heart, blood vessels, kidneys, eyes and nerves.

We have the opportunity to do something. Education at the point of diagnosis is crucial as that is when the shock level is highest, and people are more likely to make dramatic changes to lifestyle.

What’s inside icps diabetes europe 2018

How can Europe manage diabetes more effectively? Healthcare policymakers and key members of the diabetes community in Europe recently came together at the iCPS Diabetes Europe roundtable to discuss next steps for diabetes care and prevention.

Parliament Perspective Beyond ‘surviving’ with diabetes, Nathan Gill MEP is living proof of why the paradigm must change

Challenge the current lifestyle Dr Bruno Almeida from the Portugese Diabetes Association calls for a new perspective

Assessment of prevention and care Prof Philip Home from Newcastle University presents a plan to hold back the diabetes tsunami

UK Perspective Dr Jenifer Smith from Public Health England proposes a cautious optimism in preventing Type 2 Diabetes

Focus on outcomes Prof John Nolan from EASD offers a strategy to enable healthcare systems to cope with diabetes

Data is a key player in the diabetes policy puzzle Kris Doggen from APDP takes us a step towards a comprehensive diabetes data registry

Role of nurses Dr Gottlobe Fabisch from VDBD discussed the vital role of nurses and education experts

Industry Perspective Michael Kloss from Ascensia writes about developing holistic digital solutions

Industry perspective Collaboration is essential to improve current landscape of diabetes, writes Dr. Robert J. Heine from Lilly

Monica Sorensen from the Norwegian Directorate of Health writes about the effects of salt

Healthier food products through partnership

Call for action European policymakers should do more to increase awareness about risk factors and the disastrous complications of the fatal disease.

Europe must prioritise actions to prevent people from becoming overweight and obese, beginning before birth and in early childhood.

Member states should invest more in the foundations of lifelong physical well-being in our youngest children.

Europe needs to create more supportive social environments for physical activity It is essential that we pursue pragmatic solutions to manage diabetes. Whilst every European country is finding its own way to solve common challenges in managing diabetes, anything that is common and can be used to compare should be used, in order to build a data framework to better manage the fatal disease.

How can Europe manage diabetes more effectively?

Despite 30 European countries boasting national plans covering diabetes, the disease currently affects nearly 60 million people in Europe. If this situation is to change, urgent action is required at the policy level and broader collaboration is essential among policymakers, professional societies, healthcare professionals and patient organisations. Canvassing for a change in the world of diabetes policymaking, the International Centre for Parliamentary Studies recently brought together key stakeholders to discuss strategies to improve prevention and management of diabetes in Europe.

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N

early 30 European countries have national plans covering diabetes and 10 countries have such a plan for the future.

Ninety-five percent of them target obesity, smoking, harmful use of alcohol, and promote healthy diets and physical activity.

Yet, sadly, diabetes currently affects almost 60 million people

across Europe. While several countries have made progress towards developing a systematic policy response to the diabetes burden, overall investment in and implementation of comprehensive strategies for the prevention and treatment of diabetes has varied.

To reverse this trend, it is pertinent to tackle the persisting gaps and missed opportunities in the EU battle

against diabetes. In order to review the current progress of diabetes management in Europe and address the complications in managing the fatal disease, the International Centre for Parliamentary Studies brought together eminent parliamentarians, healthcare professionals, academic experts and industry stakeholders in a high-level policy roundtable on May 16th, 2018 in Brussels.

iCPS DIABETES EUROPE 2018

Data is a key player in our fight

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central theme to emerge from the roundtable discussion was the importance of good data repository systems and the need to liberate data to strengthen our battle against diabetes.

Although the growth of the diabetes burden is undisputable, the scarcity of comparable data makes it difficult to quantify this increase at national and European levels. Given the key role of robust, comprehensive data in informing policies, it is surprising to note that more than 83% of diabetes registers are reportedly incomplete.

Chaired by Prof Philip Home, former editor of reputed international diabetes journals, including Diabetic Medicine and IDF’s Diabetes Voice, the iCPS Diabetes Europe Roundtable 2018 housed over 40 experts coming from more than 20 European countries, who examined a wide assortment of issues ranging from prevention, active surveillance, the importance for data sharing and

greater collaboration, reimbursement and the need for promoting active lifestyles.

Following a policy update from the European Commission, Prof John Nolan from the European Association for the Study of Diabetes (EASD) launched the European Diabetes Forum, a new initiative of EASD, which aims to address the full landscape of diabetes research and clinical care in Europe. Ambitious to

advance diabetes research and care, he noted that it’s time to accelerate and strengthen our capacities to collect, analyse, and use healthcare data.

Delegates agreed that a coherent strategy on diabetes public awareness, research, prevention, management and long-term monitoring is a sine qua non, and tabled a few significant recommendations for policymakers.

While numerous apps, companies, hospitals and healthcare providers collect a variety of personal data, more needs to be done to improve intelligent data collection, interconnecting data and getting better at data interpretation and sharing, in order to improve patient outcomes and treatment modalities. While maximising the use of data still remains a challenge in the light of data privacy laws, it is crucial to remain more transparent on how we process patient information. It is imperative to develop standards for data collection and usage in the treatment and management of diabetes.

It is consequently crucial for European policymakers to toughen the national capacity to collect, analyse and use representative data on the burden and trends of diabetes and its key risk factors. More needs to be done in order to improve the quality of data. Member states must develop, maintain and support a European diabetes registry. Learning from best practices and cancer registries, Europe should build a centralised patient-focused data registry to improve analysis of data on patient experiences.

Government Gazette | 41

Tackling the burden of Diabetes

healthcare

Is Diabetes losing out to other diseases like cancer?

Delegates at the ICPS Diabetes Europe 2018 call on policymakers and politicians to necessitate, as soon as possible, a societal change towards diabetes and table a few significant recommendations to improve management of the fatal disease Despite political engagement efforts and the work of international and national diabetes associations across Europe, politicians are yet to understand the gravity of the situation at hand.

We need stronger political mobilisation and investment.

Delegates agreed that more awareness should be created at the political level to implement national strategies to manage diabetes.

Delegates at the ICPS Diabetes Europe 2018 call on policymakers and politicians to necessitate, as soon as possible, a societal change towards diabetes and table a few significant recommendations to improve management of the fatal disease.

Delegates 2018: President, Albanian Diabetes Association; VP of Global Regulatory Affairs, Ascensia Diabetes Care ; Head, Patient Advocacy and Professional Organizations, Ascensia Diabetes Care ; Researcher, Portuguese, Diabetes Association (APDP) ; Associate Professor, Austrian Diabetes Society (ÖDG); Endocrinologist, Belgian Health Care Knowledge Centre; Manager Knowledge & Innovaton, Dutch Diabetes Research Foundation; Special Advisor to the President, European Association for the Study of Diabetes; President, Estonian Diabetes Association; Endocrinologist, Estonian Diabetes Association; Scientific Officer in charge of diabetes and obesity research, European Commission - Research & Innovation; Director Insulins and Dulaglutide, Global Patient Safety, Eli Lilly, ; Distinguished Lilly Scholar, Eli Lilly; Co-Chair, EU Diabetes Working Group, European Parliament; Head of the Health Division, Federal Ministry of Health; President, Foundation of European Nurses in Diabetes (FEND); Chair, Finnish Diabetes Association; General Secretary, Hungarian Diabetes Association; Project Coordinator, IDF Europe; Director of the Department of Population Health, Luxembourg Institute of Health; Chief Officer at Person’s Health Department, Ministry of Health; President, Portuguese Society of Diabetology; National Diabetes Prevention Programme Director, Public Health England; President, Romanian Diabetes Federation; General Secretary, Romanian Diabetes Federation; Lead Researcher Diabetes Care Quality, Scientific Institute of Public Health; Professor of Internal Medicine, Society of Turkish Endocrinology and Metabolism; Professor of Internal Medicine, Society of Turkish Endocrinology and Metabolism; President, Spanish Society of Diabetes (SED); Podiatrist, Swiss Society of Podiatrists; Senior Advisor, The Norwegian Directorate of Health; Associate Professor, Université Libre de Bruxelles; Director, University Hospitals of Leicester; Senior Lecturer and Senior Nurse Research Associate, University Hospitals of Leicester

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Policy recommendations 1. There’s a need for a systemic and societal change regarding public attitudes towards diabetes. European policymakers should do more to increase awareness about risk factors and the disastrous complications of the fatal disease.

2. Europe should fill the key gaps in the diabetes knowledge base.

It is pertinent to make an honest analysis of failed initiatives. More importantly, we need to analyse what strategies worked well and what did not. In particular, lessons from the past need to be articulated well in order to plan for the future of diabetes care in Europe.

3. We should build the capacity of ministries of health to exercise a strategic leadership role, engaging stakeholders across sectors and

society. Accountability of national diabetes plans should be increased and prevention strategies should be implemented at the European level.

4. Europe must prioritise actions to prevent people from becoming overweight and obese, beginning before birth and in early childhood. We should implement policies and programmes to support women with gestational diabetes, to increase the consumption of healthy foods and to discourage the consumption of unhealthy foods, such as sugary sodas, thereby increasing regulation on food producers.

5. Two patient communities that require maximum attention and care are the children and adolescents and the elderly. Special care needs to be taken in drafting specific strategies to

improve prevention, diagnosis, care and management of diabetes within these factions of society.

6. Member states should invest more in the foundations of lifelong physical well-being in our youngest children; create communities that foster health-promoting behaviours and broaden health care to promote health outside the medical system.

7. There should be greater focus on education and health literacy for children and populations at high-risk, to improve prevention and reduce the cost burden of diabetes.

8. Europe needs to create more supportive social environments for physical activity. A combination of fiscal policies, legislation, changes to the environment and raising

the course of the disease, greater importance should be given to the role of the specialist nurse. Due to the complexities of modern diabetic care, at least one named specialist nurse should be assigned to a patient at every level of care.

awareness of health risks works best for promoting healthier diets and physical activity at the necessary scale.

9. There is an urgent need to develop strong nutrition standards for school lunch, reduce marketing and access to unhealthy food at schools and create healthier food environments.

10. It is essential that we pursue pragmatic solutions to manage diabetes. Whilst every European country is finding its own way to solve common challenges in managing diabetes, anything that is common and can be used to compare should be used, in order to build a data framework to better manage the fatal disease.

11. As the specialist nurse occupies a central position in caring for and supporting patients and their families over

Now is the moment for a shift from reforming individual legal instruments and policies to devising a long-term framework vision.

12. It is pertinent to bridge the gaps between technology providers, pharmaceutical companies, science, regulators and academia to better understand the missed opportunities and challenges in managing diabetes. Europe should embrace innovation more effectively, support new initiatives and take the lead in stakeholder consultation.

13. Europe should find new approaches for a patient-centred and personalised approach to diabetes management.

14. It is crucial that

industry and healthcare systems work handin-hand to provide access to medicines, improving prevention and care of diabetes in Europe. There is also an urgent need to increase availability and access to insulin pumps and improve reimbursement mechanisms of selfmonitoring tests. In addition, Europe should do more to improve and efficiently regulate self-management interventions.

15. The huge increase in low-cost healthrelated apps to improve management of lifestyle diseases raises three important issues: Are apps developed according to evidenced-based guidelines or on any evidence at all? Is there any evidence that apps are of benefit to people with diabetes? And what are the current regulation mechanisms for

healthcare apps? Despite the high potential of low-cost health-related apps in improving healthcare, more needs to be done to insist on regulation of mobile medical applications at the European level.

There are no simple solutions to address diabetes but coordinated, multi-component intervention can make a significant difference.

Everyone can play a role in reducing the impact of all forms of diabetes.

Governments, healthcare providers, people with diabetes, civil society, food producers and manufacturers and suppliers of medicines and technology can collectively make a significant contribution to halt the rise in diabetes and improve the lives of those living with the disease.

Is Europe making sufficient progress?

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s of August 2014, a CHRODIS policy brief reported that seven of the 22 countries, including Austria, Belgium, Bulgaria, France, Germany, Latvia and Lithuania had no formal National Diabetes Plans (NDPs), in place. Denmark and Finland had concluded a previous NDP and

not (yet) developed a follow-up, while in the Netherlands the NDP has been succeeded by a new national strategy and the implementation of ‘Diabetes Care Standards’.

In Norway and Sweden, diabetes was included as part of an overall strategy targeting chronic diseases more. Broadly, Austria, France and Germany reported not

having an NDP in place as such but referred to national diabetes disease management programmes (DMPs) as the major approach to addressing diabetes through several disease-specific and nonspecific measures. remain more transparent on how we process patient information.

It is imperative to develop standards for data collection and

usage in treatment and management of diabetes.

It is consequently crucial for European policymakers to toughen the national capacity to collect, analyse and use representative data on the burden and trends of diabetes and its key risk factors.

More needs to done in order to improve the quality of data. Member states must develop,

maintain and support a European diabetes registry. Learning from best practices and cancer registries, Europe should build a centralised patient-focused data registry to improve analysis of data on patient experiences.

Government Gazette | 43

Recommendations to reshape policy making

DIABETES REPORT

Beyond ‘surviving’ with diabetes: living proof of why the paradigm must change

Nathan L. GILL mep

Member of the European Parliament

disastrous consequences for public health.

When I was first diagnosed, I decided to ignore current government dietary guidelines, in particular advice on how much sugar and how many carbs I was allowed to consume.

Reducing my intake of both sugar and carbohydrates immediately after diagnosis, I was able to completely erase the need to take Metformin and I didn’t need insulin injections for well over a year.

B

eing diagnosed with diabetes is a life changing event, as I discovered in 2012.

I immediately decided to make major lifestyle changes in order to beat this disease.

As with other sufferers of serious, lifelong conditions I have struggled over the last six years to find a sustainable way to not only survive but thrive with this chronic disease. Being a Member of the European Parliament, and travelling internationally weekly, has not helped.

Finding solutions to this complex condition is not just a challenge for individuals, but also for public health organisations and governments.

Diabetes is currently the fastest growing health crisis of our time with the number of people diagnosed with diabetes in the UK more than doubling in the last twenty years.

Latest data shows that in the UK, almost 3.7 million people have been diagnosed with diabetes and 12.3 million people are at increased risk of Type 2 diabetes. Further afieldthere are around 33 million people in the European Union who suffer with diabetes and according to the latest WHO statistics, around 422 million people worldwide have diabetes, with www.governmentgazette.eu | 44

predictions that this number will double in the next twenty years.

Diabetes is becoming more prevalent and is therefore a public health crisis due to unhealthy diet, physical inactivity and increases in obesity levels. If those affected by diabetes do not correctly manage their condition, they are likely to become progressively ill and debilitated, and over time diabetes can damage the heart, blood vessels, kidneys, eyes and nerves.

Despite this pessimistic outlook, there are some simple solutions sufferers can take in order to help reduce both the amount of medicines needed to treat the illness, and the long-term problems associated with this condition.

In the UK, current government advice recommends that people put starchy carbohydrates at the base of their diet. These guidelines are absolutely wrong and have been a major contributor to the increase in obesity-related illnesses in the UK over the past three decades.

In 1977, government dietary guidelines in the USA changed (followed by the UK in 1983), replacing a foundation of satiating and nutritious fullfatwhole foods for starchy carbohydrates, resulting in a thirty-five-yeardiet fad with

After reading The Pioppi Diet, written by British Consultant Cardiologist Dr Aseem Malhotra, I felt that this was a lifestyle plan that could not only get me back on track with my health goals, but could also be a lifelong solution.

The “21-Day Lifestyle Plan”, notably reduces sugar intake to ten times lower than recommended by the government. Dr Malhotra has been on a mission to not only reduce the growing levels of diabetes and obesity in the UK and Europe, but in some cases reverse the effects of diabetes. I have joined Dr Malhotra in this important operation to change current government guidelines and I have hosted two events

We have an opportunity to save millions of lives by not only changing existing guidelines, but helping the misinformed public make better choices.

at the European Parliament in the last two years highlighting not only the problem, but some solutions.

The history of tobacco control should have taught us that legislation to reduce the availability, affordability and acceptability of smoking had the biggest impact in reducing the consumption of cigarettes, and had this occurred decades earlier, when the first scientific studies linking smoking and lung cancer were published, millions of premature deaths from lung cancer and heart disease could have been prevented.

I am a big believer in education before taxation and in individual liberties over government regulation, but these are extenuating circumstances. We have an opportunity to save millions of lives by not only changing existing guidelines, but helping the misinformed public make better choices.

A campaign of more effective education combined with efficient legislation, will also save national health services and public health organisations hundreds of millions, in a time where hard decisions are being made with the public purse.

We have the opportunity to do something. Education at the point of diagnosis is crucial as that is when the shock level is highest, and people are more likely to make dramatic changes to lifestyle. I wish that my GP had given me a book or video extolling the correct direction I should take; empowering me to take responsibility and control of my disease, instead of my disease taking control of me and my life.

We need to act, and we need to act now.

A plan to hold back the diabetes tsunami by the practising HCP is that cultural attitudes and fashions have a bigger impact than anything apart from taxation done by governments, who then need to be facilitating rather than programmatic.

However, there is good evidence of success of school initiatives, and the infrastructure for enabling that is of course already in place.

Prof. Philip HOME Professor of Diabetes Medicine

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t the time of the IDF/WHO St Vincent Declaration in 1989 (1), there was optimism in Europe that implementation of new understandings on optimal delivery of diabetes care, plus new technologies, and continuing research, could optimise the well-being of the many people afflicted with diabetes.

The understandings remain, the medication and monitoring technologies have indeed bounded forward, and levels of research across many domains are higher than ever. Indeed for those who have practised in diabetes care for the past four decades, care quality has been transformed, not least with advances in patient education and structured care, the latter partly with electronic support.

Paradoxically, the diabetes community is less optimistic than ever.

The problem of course is that society’s adoption of a higher calorie intake with reduced physical activity is promoting a higher incidence of type 2 diabetes, just at a time when the middle- and later-aged population is increasing.

Further, these people are surviving in burdened health for longer (due to better glucose, lipid, and blood pressure

control). Type 2 diabetes is a progressive (not a ‘chronic’) disease, meaning that the need for more complex and expensive therapies multiplies the burden further for all parties. Indeed the burden is societal, and not just because of cost, with amarked impact on productivity and employability in later middle age. I know of countries globally where the effect on senior politicians and heads of state has negatively impacted local and indeed international policies.

Primary, secondary or tertiary prevention?

Primary prevention is clearly highly desirable, and has strong overlap with the related conditions of obesity and arterial disease in people who will not develop diabetes. The case for targeting our children is strong, not least because they are the parents of tomorrow, and because they can influence their own parents. The former is important because some feeding behaviours in humans seem to be programmed in the first years of life, and are relatively immutable thereafter.

This probably accounts for why prevention programmes aimed at adults (even after an event such as a heart attack or development of diabetes) have limited efficacy. Indeed, as with tobacco, the impression gained

Secondary prevention, attempting to put diabetes into remission, or preventing prediabetes hyperglycaemia states from progressing, has also been disappointing. Bariatric surgery can be successful, particularly the more complex and risky gut by-pass operations, but are hardly a general solution, and guidelines often restrict them to people already with complications (ie, to tertiary prevention) for reasons of both cost and health benefit: risk.

More recently, low-caloriediet approaches have been successfully trialled in primary health care, with surprisingly good remission rates (~50 %) at 1 year (2), but long-termefficacy remains to be determined, and this is a research priority. But it will still leave a large population with progressive hyperglycaemia with a high probability of developing burdensome and high cost vascular complications (eg, eye, heart, kidney damage).

Structured diabetes care The issue then of provision of quality diabetes care cannot be ducked, for both health burden and societal reasons. It is not a simple or inexpensive issue because people progress within the first decade of the condition to insulin therapy, which is a burden to provide, and accordingly is presently marked by considerable clinical inertia. - The good evidence base for structured patient education is notably in contrast to the paucity of its provision to diabetes populations in Europe, even where endorsed and recommended by payers for over a decade, as in the UK by NICE. Structured diabetes care also includes things like annual

surveillance for development of retinopathy and for foot problems, both now preventable complications. Further, some newer medications apparently can prevent the decline into end stage renal disease (3), another high cost complication, and one almost usual in type 2 diabetes in older people.

I list these things because it then becomes clear that without national programmes and guidelines, and indeed without plans for their implementation, we are going to continue to fail to deliver to a majority with diabetes the care required to preserve their health, and prevent them becoming a social and cost burden on their communities.

It will also be evident that such programmes need to avoid being hijacked by the promise of population educational initiatives that have a weaker evidence base, and will still currently leave us with a burden that is breaking most health systems.

The views expressed here are those of the author, and do not seek to represent those of any organisation with which he is or was associated.

References: 1. World Health Organisation (Europe) and International Diabetes Federation (Europe),‘Diabetes care and research in Europe: the St. Vincent declaration’, Diabetic Medicine,7, 1990,pp. 360-360.

2. Lean, M.E.J., W.S. Leslie, A.C. Barnes, N. Brosnahan, G. Thom, L. McCombie et al.,‘Primary care-led weight management for remission of type 2diabetes (DiRECT): an open-label, cluster-randomised trial’, Lancet,391, 2018, pp.

541-551. doi: 10.1016/S01406736(17)33102-1.

3. Wanner, C., S.E. Inzucchi, J.M. Lachin, D. Fitchett, M. von Eynatten, M. Mattheus et al.,‘Empagliflozin and progression of kidney disease in type 2 diabetes’,N Engl J Med,375, 2016, pp. 323-34. doi: 10.1056/NEJMoa1515920.

Government Gazette | 45

healthcare

Tackling the burden of diabetes

Enabling healthcare systems to cope with the diabetes pandemic

T

he St Vincent Declaration (1) (WHO and IDF-Europe,1989) set goals and tasks to reduce the burden of diabetes and its complications. A follow-up assessment in 2009 stated that despite some good progress, “significant gaps” still existed and “urgent action is needed” to stem the rising epidemic (2). The European Diabetes Index of 2014 (3) provided a comprehensive update and recognised that progress between 2008-2014 had been very slow for most European countries, with, for example, national diabetes registries (partial or complete) found in only 7 of 30 countries.

Europe has the highest global prevalence of type 1 diabetes with increasing prevalence over recent decades. Given the dramatic increase in type 2 diabetes, mainly due to obesity, prevention of diabetes must be a high priority. Translation of the successful prevention trials into public health policy has not yet occurred.

A growing scientific understanding of the early events leading to type 1 diabetes has led to new research aiming to prevent type 1 diabetes. The primary prevention of diabetes

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remains crucial to any concerted approach to the pandemic.

Prof John J. NOLAN

Professor (adjunct), Endocrinology & Metabolism, Executive Director, European Diabetes Forum acting in the name and on behalf of European Diabetes Forum (EUDF) AISBL in constitution

Poor outcomes, stigma and lack of Data 60 million Europeans have diabetes (4). In fact there are 2 etiologically distinct diseases: type 1 and type 2 diabetes. For people with type 1 diabetes, a tendency to consider all of diabetes as one disease has often led to a lack of public understanding and focus on the challenges of this disease.

People with type 2 diabetes (affecting more than 90%) have lacked a cohesive voice and sense of urgency in public debate and thereby policy shaping. The public narrative that diabetes is mainly a self-inflicted lifestyle issue stigmatizes both people with type 1 diabetes and type 2 diabetes and is one of the important reasons thatdiabetesis losing out toother medical conditions for political attention and resources.

Most healthcare systems are poorly fitted to the daily needs of the person with chronic diseases, especially diabetes, and fail to track the impact on lives mainly through complications.

There is a wide gap between daily “clinical reality” and what according the guidelines should

be achieved with the currently available treatment options.

Diabetes outcomes are suboptimal, but reliable data on outcomes throughout Europe are lacking. Economic data on diabetes and its complications is at best unclear or simply unavailable.

Focus on outcomes End-organ complications of diabetes are the main cause of death, suffering, and loss of quality of life and complications are the main driver of costs.

Many serious outcomes are hidden from public awareness because they present in other fields of clinical medicine and the healthcare system.

Important examples: cardiovascular and renal complications. Diabetes has fallen behind other disease areas such as cancer and cardiovascular disease for the attention of the public, policy makers and payers. A clearly focused and Europe-wide strategy for the accurate tracking and improvement of the relevant

outcomes, can transform this field and have substantial impact at reducing the suffering and costs that arise because of preventable complications.

Rationale for the creation of the European Diabetes Forum: Following the St. Vincent declaration, it was left to member country organizations to implement its actions, even though no central management or formal system of follow-up was established. Although some national progress was made, ownership and accountability for the actions of the declaration were lacking on both a European and a national level.

Over the course of the years, many initiatives have taken place to address diabetes, however stakeholders have worked to some degree in isolation, without the opportunity to contribute to the unified and overall agenda, and the full landscape of this complex disease.

The European Association for the Study of Diabetes

(EASD) has recently founded the European Diabetes Forum (EUDF), which aims to address the full landscape of diabetes care in Europe. To truly improve outcomes for people living with diabetes, the EASD appreciates that it needs to bring together multiple stakeholders from all sectors of the diabetes and healthcare landscape. This includes, research, industry, scientific societies, patient organisations, payers and institutions connected to diabetes-related co-morbidities across Europe.

The EUDF will make it possible for all these contributors to collaborate to advance the agenda of diabetes and advocate policy change to enable the systems of healthcare to cope with the diabetes pandemic.

EUDF is a long-term initiative, taking accountability and ownership for the implementation of key projects.

Thus, it may serve as the central point of contact and conductor for both European and national policy initiatives.

Access to current treatment options is highly variable throughout Europe, as are the ways in which healthcare systems provide diabetes care. Optimal use of economic resources to ensure people with diabetes achieve the best possible outcomes, should be a key area in diabetes care delivery.

The establishment of local versions of the EUDF’s structure at national level will be key to its success. The mission of the EUDF is to ensure the translation of research into policy actions towards better diabetes care at national level.

References: 1. The Saint Vincent Declaration on diabetes care and research in Europe.

Acta diabetologia. 1989, 10 (Suppl) 143-144.

2. Felton Anne-Marie, Hall Michael S (2009). “Diabetes - from St. Vincent to Glasgow, Have we progressed in 20 years?”. British Journal of Diabetes and Vascular Disease. 9 (4): 142–44.

3. Euro Diabetes Index 2014, https:// healthpowerhouse.com/publications/ 4. IDF Diabetes Atlas, http://www. diabetesatlas.org/

Diabetes nurses and education experts have a vital role in diabetes care Dr Gottlobe FABISCH Managing Director, VDBD

I

n Germany, structured education of diabetes patients is an integral part of diabetes therapy.

Diabetes nurses and trained education experts in diabetes (“Diabetesberaterinnen”) ensure the implementation of such education programmes accompany and support patients in their self-management of the disease- often over a long period of time. Thus, specialised nurses and education experts play an important role in the care of diabetes patients.

As the German Association of Diabetes Nurses and Education Experts in Diabetes, the VDBD calls on European decisionmakers: 1. To acknowledge the important role of diabetes nurses and education experts in diabetes care as partners of GPs and dialectologists; 2. To ensure appropriate remuneration of diabetes nurses and education experts for their

valuable contribution in diabetes care;

certainly are important factors that need to be addressed.

3. To assign a specialist nurse / education expert to every patient at each level of care;

Therefore, the VDBD makes a plea for a paradigm shift towards primary prevention by changing living conditions and:

4. To provide access to digital devices for every diabetes patient and to bridge gaps in order to avoid that the digital divide turns into a medical divide, given the benefits and increasing role of digital devices in diabetes care; 5. To oblige each EU member state to adopt a national diabetes strategy and concrete measures for its implementation.

As a member of the German NCD Alliance DANK, the VDBD also engages in primary prevention, going beyond lifestyle modifications. The VDBD recognises diabetes — in particular type 2 — as both an economic and a social justice issue. Modern living conditions, for instance processed food with a high level of sugar, salt and fat,

• To introduce a “healthy VAT” for food products, ie, to increase VAT for energy dense products, such as sugary sodas, andto lower VAT for healthy food,such as vegetables; • To create more supportive social environments for physical activity and to introduce at least one hour per day of physical activity in schools and kindergarten; • To implement strong nutrition standards in schools and kindergarten andto reduce access to unhealthy food at schools; • To ban advertisement addressed to children promoting the consumption of processed and energy dense food.

Government Gazette | 47

healthcare

Tackling the burden of diabetes

Collaboration is essential to improve the current landscape of diabetes Dr. Robert J. HEINE

Distinguished Lilly Scholar

population (4).In the United Kingdom,DRP accounted for 6.1% –8.3% of visual impairment certification from 2008 to 2010 (5).

join forces,eg, governments, health-care providers, insurers, peoplewith diabetes, pharma companies and others, can the needle be moved.

Remarkably, the smallest decline in incidence was seen for endstage renal disease.

The European Association for the Study of Diabetes launched in 2017 an important initiative: the European Diabetes Forum (EUDF ). The most important objective for the EUDF will be to generate new data on a panEuropean basis that will allowthe overarching goal to be addressed:

Because of the rise in diabetes prevalence the number of people affected by these complications is on the uptrend. The risk of developing these complications in people with diabetes is about 2-fold for CVD and more than 6-fold higher for kidney disease, compared with persons without diabetes. The relative risk is particularly high among patients younger than 55 years of age (6).

These complications are preventable.

Comprehensive therapy of the main risk factors inpeople with type 2 diabetes substantially lowers the incidence of severe vascular complications (7). In clinical practice, this comes down to controllingHbA1c, Blood Pressure and plasma Cholesterol levels, and cessation of smoking: ABC-s.

What are the main challenges?

D

iabetes currently affects nearly 60 million people in Europe.The prevalence of diabetes is increasing, mainly as a result of the obesity epidemic. The IDF forecasts the prevalence to be more than 70 million people in 2040. Approximately 627,000 people aged 20-79 died from diabetes during 2015 in the European region and diabetes was responsible for 9 percent of total health expenditures in Europe (1). Cardiovascular disease (CVD) is the main cause of death – and as diabetes oftentimes is not registered as the underlying disease in people dying of CVD, these numbers probably are serious underestimations.

Preventing people from becoming overweight and obese, beginning early in life, is the obvious – albeit very challenging – public health intervention.

Public health policies and programmesneed to be put in place to promote exerciseand discourage consumption of fast

www.governmentgazette.eu | 48

food and soft drinksthat contain high levels of sugar.

Caring for people with diabetes Good care primarily includes education focused on developing self-management skills and mental well-being, and controlling the various risk factors for microvascular complications (eye and kidney disease and neuropathy) and cardiovascular disease.

Have we made progress over the last few decades? We may argue that glucose control has improved, resulting in a lower incidence of some of the microvascular complications (diabetic retinopathy (DRP) in particular). The incidence of severe DRPhas been shown to have declinedin Scandinavia since 1975–1979, and the incidence of other diabetesrelated complications has been reported to have decreased in the US (2, 3).

However, there is no reason for great optimism, or complacency.

DRP still is the leading cause of vision loss in the adult

1. The large and still increasing number of people with diabetes.

2. The uptrend in people with diabetes-related complications impacting the health care and societal economics.

3. The vast majority of people are treated by non-specialists in community care.

4. The health care system is not equipped to manage a complex chronic disease in primary care.

For example, in the EU, only about 6.5% of people with diabeteswere shown to achieve their ABC target goals (8).

5. In Europe, there is a scarcity of data on the quality of delivered care.

Consequently, it is crucial for European policymakers to prioritize the capability and capacity to collect, analyse and use representative dataon the burden and trends of diabetes and key risk factors (ABC-s) to enable monitoring of the quality of delivered care.

There are no easy solutions to this European challenge.

Only if the major stakeholders

Every person with diabetes in Europe will receive high quality diabetes care.

The first step will be to gather available data andto collateexisting data on diabetes care from several available sources.Next, a truly European sustainable database/inventory will be built allowing for realtime monitoring of the quality of diabetes care.

The EUDF can only succeed in their mission when all stakeholders in Europe commit to this critical project.This is a truly exciting and important initiative that will determine the outcome of the 60 million people with diabetes in Europe.

References: 1. IDF Diabetes Atlas, [website], (http://www.diabetesatlas.org/acrossthe-globe.html) 2. Kytö, J.P. et al., on behalf of the FinnDiane Study Group,‘Diabetes Care’, 34(9), 2011, Sept, pp. 2005– 2007. Published online 2011, Aug 19. doi: 10.2337/dc10-2391 3. Gregg, E.W. et al., N Engl J Med,370, 2014, pp. 1514-23.

4. Cheung, N., P. Mitchell andT.Y. Wong,‘Diabetic retinopathy’, Lancet,376(9735), 2010, pp. 124–36.

5. Arora, S., S. Kolb, E. Goyder and M.McKibbin,‘Trends in the incidence of visual impairment certification secondary to diabetic retinopathy in the Leeds metropolitan area, 2005–2010’,Diabet Med,29(7), 2012, pp. e112–116.

6. Tancredi, M., A. Rosengren, A.M. Svensson et al.,‘Excess mortality among persons with type 2 diabetes’, N Engl J Med,373, 2015, pp.

1720–1732.

7. Gæde, P. et al.,‘Effect of a Multifactorial Intervention on Mortality in Type 2 Diabetes’, N Engl J Med,358, 2008, pp. 580-91.

8. Stone, M.A. et al., ‘Quality of Care of People with Type2 Diabetes in Eight European Countries’, Diabetes Care,36, 2013, pp. 2628–2638.

Diabetes Report 2018

Call for a new perspective challenge the current lifestyle perspective in our society.

Dr Bruno ALMEIDA Researcher, Portugese Diabetes Association

P

eter, a 16-year-old basketball player, started showing symptoms of polyuria (frequent urination) and polydipsia (excessive drinking), losing about 5 kg in the last 4 months. He was diagnosed with type 1 diabetes and begantaking rapid-acting insulin four to five times a day, andone injection of long-acting insulin. He was told that he had to start counting the amount of carbohydrates at mealtimes in order to administer the insulin that his pancreas is no longer producing.

Additionally, he will have to administer insulin to lower his blood glucose and, if that was notbad enough, he will also have to adjust his rapid-acting insulin every time he exercises.

These complex and timeconsuming procedures are carried out on average five times a day - for each meal - 35 times a week, which is more than 1,800 times a year. This is the daily routine of a person with type 1 diabetes.

Life is no longer just lived, but it must be calculated. Nevertheless, Peter’s life is completely different from that of a young man with diabetes in 1922, before insulin

was discovered.

Over the years, more purified insulins have been developed with length of action that is closer to the physiological conditions, and the forms of glycemia measurement have become simpler, with the availability of new devices which do not require finger prick to collectcapillary blood, such as the continuous subcutaneous insulin infusion systems.

However, these systems are not available for all people with type 1 diabetes in Europe. And it is exactly here, in the field of technology development, that I think there should be more investment with respect to type 1 diabetes, namely with the possibility of co-funding of these systems by European states, which could really make a difference in people’s lives.

A decrease in inequities is not only important in type 1 diabetes, but it is also fundamental in the so-called 21st century pandemic: type 2 diabetes. With a growing number of people affected by this disease, which is associated with a sedentary lifestyle, poor physical activity and overeating, it is urgent to change and

There is a need to intervene at the food level by creating ways to alert people to the excesses of sugar, salt and fat which are present in many processed foods.

Perhaps increasing taxes on these types of foods? But above all, reaching out to the young people and creating school programs about healthy eating and the importance of physical activity.

The key message is “act now to change the future,” keeping in mind that it is necessary to prevent and early diagnose type 2 diabetes but also to fight the emphasis on abundance in our society (the urge to purchase and consume food all day long) and the level of poverty (most of the hypercaloric and high-sugar foods are also the cheapest).

The fundamentals for changing the future are: education about healthy lifestyles starting from day care, with an integrated curriculum throughout the person’s academic life; promoting and encouraging physical activity; and educating and raising people’s awareness of future risks associated with obesity and diabetes.

In a digital society, where mobile devices are not an accessory, but increasingly a “garment”, there is a need for European public health services to provide apps with integrated information about feeding /exercise.

Again, technology plays a very important role in type 2 diabetes as a therapeutic tool,

so it would be worth creating consensus around this matter to consider the development of these medical device apps, with the possibility of public funding after prescription.

But in this age of info-inclusion, we cannot forget the least included in the technological wave, who represent our mirror to the future: the elderly.

With the progressive increase of the average life expectancy, diseases like type 2 diabetes are becoming more and more a part of their lives, not as a disease that has been going on for several years but one that is often diagnosed in that stage of their lives.

More and more people over the age of 80 are diagnosed with type 2 diabetes as a result of the inexorable ageing of the cells and increase in insulin resistance.

In the face of this new reality, it is necessary to reach consensus on diagnosis, glycaemic goals, therapy and, above all, to enable caregivers to deal with this disease.

The European healthcare policymakers should look at these people and develop disease management programmes for this vulnerable population.

Only a joint intervention of medical societies, decision makers, and economic players can change our future. Working together will be worth the effort and we will all benefit from the fight against this pandemic called diabetes!

Government Gazette | 49

healthcare

Tackling the burden of diabetes

Dr Jenifer SMITH Programme Director, Public Health England

Cautious optimism in preventing type 2 diabetes

A

s the national public health agency, Public Health England (PHE) has been developing the evidence base to support action on obesity.

Current polices include legislation, voluntary action with the food industry and behaviour change campaigns.

Alongside this, NHS England has commissioned the first nationally delivered behavioural intervention programme for prevention of type 2 diabetes.

In 2014 (1), the English NHS reflected that: “spending more on bariatric surgery for obesity than on a national roll-out of intensive lifestyle intervention programmes that were first shown to cut obesity and prevent diabetes over a decade ago” warranted a new, proactive focus on prevention.PHE, the NHS, and Diabetes UK (a voluntary sector organisation supporting people with diabetes) formed a partnership to implement at scale a national evidence-based diabetes prevention programme modelled on proven UK and international models.

Subsequently, the Government’s commitment and overall approach to childhood obesity was published. Childhood Obesity: A plan for action (2,3), set out actions described below to tackle obesity, including the introduction of a soft drinks industry levy (SDIL) and a sugar reduction and reformulation programme.

A structured and monitored UK reformulation and reduction programme has charged the food industry retailers, manufacturers and the out of home sector(restaurants, takeaways, deliveries, etc) to achieve a 20% reduction in sugar in ten food product categories by 2020, a 20% calorie reduction by 2024and meet existing salt targets. This means:

www.governmentgazette.eu | 50

Whilst yet to meet the 5% first year target across all the categories, this demonstrates encouraging progress. Allowing for activity in the pipeline, PHE expects that the 2019 report will provide a much clearer indication of commitment by industry to this approach.

At this point,government canreassess and consider whether additional levers may be required.

Healthier You: the NHS Diabetes Prevention Programme The Healthier You: NHS Diabetes Prevention Programme (NHS DPP) (5) was launched in 2016,providing a behavioural intervention for individuals aged 18 years or over with nondiabetic hyperglycaemia (NDH), defined as HbA1c of 42 – 47 mmolor 6.0 – 6.4% or fasting plasma glucose (FPG) of 5.5 – 6.9 mmol/l.

The intervention is groupbased and consists of at least 13 sessions lasting between one and two hours, with 16 hours of contact time, across a period of at least nine months. Each session covers topics geared towards the programme’s main goals of weight reduction, dietary improvements, and increased physical activity. They are underpinned by behavioural theory and delivered using behavioural techniques.

• Action across the food manufacturing and supply chain including the “out of home” sector.

• Guidelines for the foods/drinks categories contributing most to intakes.

• Consistent and transparent monitoring across the industry, by sectors, across food/drinks categories, and for top business.

• Significant stakeholder engagement.

• Marketing and campaigning to encourage consumerpreference towards reformulated and improved products.

Progress towards a 5% sugar reduction in the first year of the programme was published in May, 2018 (4) showing: • Reductions in sugar levels in

5 of 8 food categories where progress has been measured, with an overall 2% reduction in total sugar per 100g across all categories.

• Reductions in the calorie content of products likely to be consumed in a single occasion in 4 of 6 categories where guidelines were set and where progress has beenmeasured; an overall 2% reduction in calories in products likely to be consumed in a single occasion across the 6 categories.

• Within the SDIL, a 11% reduction in sugar levels per 100ml plus a 6% reduction in calorie content of drinks likely to be consumed on a single occasion. In addition, a shift in volume sales towards products with levels of sugar below 5g per 100g (outside the SDIL).

Following a staged rollout, national coverage was achieved in April 2018 and 100,000 interventions will be available annually. There has been significant enthusiasm, with 185,000 people referred and 78,000 taking up the programme to date. The programme is achieving a higher than predicted rate of uptake and is reaching groups who are most at risk of developing type 2 diabetes (6), with 25% of patients from Black and Minority Ethnic (BME) groups in the first year whilst just under half (44%) of those taking up the programme are men.

Referral routes into the programme vary according to local case finding pathways and include opportunistic testing in primary care as well as blood sugar testing as part of The NHS Health Check programme (7), currently available for

individuals aged 40 – 74 years.

On completing the programme, individuals are referred back to their general practitioner to have annual reviews of their blood sugar and weight.

Early outcome data and provisional analyses suggest that over 50% of individuals will attend at least 60% of the programme and achieve an average weight loss of 3.7kg –sufficient for reducing blood sugars and exceeding the outcomes predicted on the basis of the evidence review.

References: 1. NHS England, Five Year Forward View,[website], 2014, www.england.nhs.uk/wpcontent/uploads/2014/10/5yfvweb.pdf 2. UK Government, Childhood Obesity: a plan for action 2016, chapter 1, [website], www.gov. uk/government/publications/ childhood-obesity-a-plan-foraction 3. UK Government, Childhood Obesity: a plan for action, chapter 2, [website], https:// www.gov.uk/government/ publications/childhood-obesitya-plan-for-action-chapter-23.

4. Public health England,Sugar Reduction and wider reformulation programme: report on progress towards the first 5% reduction and next steps, [website], May 2018, https://assets.publishing.service. gov.uk/government/uploads/ system/uploads/attachment_ data/file/709008/Sugar_ reduction_progress_report.pdf 5.NHS England, NHS DPP Overview and FAQ, [website], https://www.england.nhs.uk/ wp-content/uploads/2016/08/ dpp-faq.pdf 6. Barron, E., R. Clark, R. Hewings, J. Smith and J. Valabhji,‘Progress of the Healthier You: NHS Diabetes Prevention Programme: referrals, uptake and participant characteristics’, Diabetic Medicine, December 2017.

7. Public Health England, NHS Health Check Best Practice Guidance, [website], 2017,www. healthcheck.nhs.uk/document. php?o=1308

Kris DOGGEN

Lead researcher diabetes care quality, Sciensano

Moving towards a comprehensive diabetes data registry

H

aving good data on the number of people with diabetes (PWD), the quality of their care, and their outcomes is essential to guide policy with regard to the prevention and treatment of diabetes. In this article, the author draws lessons from the Belgian experience and reflects on ways to integrate existing information in a comprehensive national and European diabetes registry.

In Belgium, the bulk of knowledge on the burden, treatment and outcomes of diabetes is generated by Sciensano (www.sciensano. be), the national public health institute. To estimate the burden of diabetes we measure the prevalence of diabetes through regular national health information surveys (HIS).

Using HIS, we also monitor the prevalence of risk factors. To monitor the quality of diabetes care, we organise regular audits among primary and secondary care providers.

With regard to diabetes prevalence, we have observed that the prevalence of selfreported diabetes collected by HIS is lower than the prevalence estimated from administrative databases on the reimbursement of glucose-lowering drugs and specific diabetes care programmes. Wedecided that the prevalence estimated from reimbursement data is to be preferred, among other reasons because this data is collected continuously as opposed to data from HIS. This allows the production of annual statistics, which are essential to guide policy. A drawback of the administrative databases is, however, that there is still a 1-2 year lag in the availability of data, thus potentially

precluding timely decisions by policymakers.

A line of research that has been neglected in Belgium is the study of diabetes incidence rather than prevalence using these administrative databases, even though policy changes may be more readily visible in the evolution of incidence rates.

With regard to the monitoring of quality of diabetes care and the outcomes of care, efforts to collect data have been rather siloed in Belgium. There are three care programmes and each of these programmes has its own audit system to evaluate quality of care. Some of these audits are continuous and are used in the context of quality circles. Others have been ad hoc efforts to evaluate the programme.

We recommend that if an audit system is set up, it should be a continuous and not an ad hoc effort. Only then is it possible to continuously support care providers in their local quality improvement initiatives by providing timely and useful feedback reports. Moreover, we deem that setting up costly data flows for a one-time data collection is an inefficient use of resources.

With regard to quality of care monitoring, there remain several challenges. First, the audit systems in the different care programmes should be aligned. We recognise, however, that it may be difficult to reconcile the different interests of the stakeholders. Second, the potential of enriching the clinical data with administrative data sources has been insufficiently harnessed. Finally, the audits have focused mostly on processes of care, rather than outcomes of care, even though the latter are more tightly related to “value” for PWD.

Zooming out to the European level, we need to make sure that national diabetes registries are able to talk to each other. Efforts to arrive at interoperability are actually quite mature.

Sciensano has collaborated in the EUBIROD project (www. eubirod.eu) which aimed to implement a sustainable European diabetes registry through the coordination of existing national/regional frameworks and the systematic use of a common technology.

This collaboration has resulted in a data dictionary and multiple rounds of data collection, proving that the generation of a European diabetes registry is feasible today.

We wish to make some final recommendations. First, we recommend that research organisations in this area consider making existing data collections interoperable and fill the gaps where needed, before considering the creation of a single new national diabetes registry. In this context we also recommend that policymakers take a firm stand when it comes to ensuring interoperability between data collection systems. Second, to support policymakers, we recommend the periodical generation of a single national report on the prevalence of risk factors, the number of PWD, the quality of their care, and their outcomes, even if data does not come from a single comprehensive diabetes registry. Information is too often fragmented and this hampers good decision-making.

To facilitate these changes, EU initiatives should support the member states in making the right strategic decisions.

In our view, working on these aspects will bring the dream of a comprehensive European diabetes registry closer.

Government Gazette | 51

healthcare

Tackling the burden of diabetes

Developing holistic digital solutions for people with diabetes Michael KLOSS

Concerns remain about the variation in the quality of apps that are on the market, and it is imperative that new digital standards are put in place to protect patients and deliver the best possible self-management experience.

These are not challenges and risks that are unique to diabetes, but as the usage of digital solutions in diabetes management becomes more widespread, they are priorities for the wider diabetes community to address. We believe that industry has a role in both driving innovations in this area and helping to ensure high quality standards are used in digital diabetes solutions.

CEO, Ascensia Diabetes Care

At Ascensia, we see the future of our company at the forefront of digital diabetes solutions and interconnected diabetes management. We want to create systems that enable more effective diabetes selfmanagement through data capture, analysis, feedback and coaching.

D

iabetes management in Europe is evolving due to major increases in the rate of diabetes, changes in healthcare systems and the shifting needs of people with diabetes.

The number of people who are being diagnosed with diabetes is on the rise, driven largely by an increase in the prevalence of type 2 diabetes. Not only is this leading to an increase in the total cost of treating diabetes, but an increase in the cost due to diabetes-related complications.

Funding and resource within healthcare systems is becoming more limited, leading to more rationalisation of care.

As European healthcare systems need to become more cost effective, digital solutions have a critical role to play both in helping people with diabetes to better manage their condition, and also reducing the risk of diabetes-related complications.

Although there have been advances in digital technology

www.governmentgazette.eu | 52

that are helping patients capture their data more easily and providing coaching or peer support, more progress is required to reduce the burden of this disease.

At Ascensia, our efforts are dedicated to finding new cutting edge digital solutions to support people with diabetes. This will not be easy and we know that these new solutions will provide new challenges and risks. Since data collection is an integral part of digital diabetes management, data security and data protection have become critical aspects for companies, policymakersand regulators to consider.

Regulation and clinical evidence remain vital in healthcare, and both areas need to evolve to suit the requirements of digital health solutions. Studies need to be designed differently to be able to evaluate safety and effectiveness, and regulators need to find ways to assess apps differently that provides the appropriate safeguards without stifling innovation.

We have set ourselves the goal to provide holistic solutions that enable people with diabetes to use data and connectivity to help improve all aspects of their diabetes management.

Blood glucose data is just the start of this and for someone with diabetes it is about bringing together various pieces of information about their condition. We are only just at the beginning of this journey and the future will enable us to connect more devices and data sources together.

For future solutions to truly support diabetes management they cannot be solely about data collection, but will need to provide actionable insights based on that data, such as coaching, medication advice, support with lifestyle improvements or disease management recommendations.

This is an area where we want to lead and our future systems will be designed to provide actionable feedback and personalised recommendations.

As the technology advances further through machine learning and artificial intelligence (AI), we hope that future solutions can begin to provide predictive feedback and identify when a patient could be

on course for an issue, to allow for earlier intervention.

With data security and data protection as key aspects of any digital solution, we need to have safeguards in place to protect users’ data. As a company, we have been actively involved in the Diabetes Technology Society’s DTSec initiative, the cybersecurity standard for network-connected medical devices.

Recently, the CONTOUR NEXT ONE and CONTOUR PLUS ONE systems from Ascensia were certified by the DTS Cybersecurity Standard for Connected Diabetes Device Security, and are the only devices to have achieved this standard.

We have also built safeguards into Ascensia’s cloud systems to keep the data secure, including the latest cryptographic techniques.

Future digital solutions for diabetes management will need to seamlessly integrate into the lives of people with diabetes and automate the collection of data from the individual. At the moment, many patients are using a variety of systems that each use different data and are not connected with each other.

We want to change that entirely by providing a solution that connects various sources of data and various systems. Data needs to be able to move seamlessly and safely between systems, in order to benefit patients.

It needs to make the lives of people with diabetes simpler and minimise the effort they need to manage diabetes.

These innovations and technological advances can only happen by working with all stakeholders in the diabetes community. As a medical device company, Ascensia is looking forward to working with pharmaceutical companies, technology and software players, policymakers, healthcare professionals, media, bloggers and people living with diabetes.

By deeply understanding the patient need and collaborating with partners in the diabetes community, we can make a real difference for those living with diabetes.

Healthier food products through partnership

S

alt is high on the in ternational health agenda.

Excess of salt intake increases blood pressure and the risk for cardiovascular and renal morbidity(1),and a population-wide reduction in the intake of salt is regarded by WHO as one of the most costeffective measures countries can take to improve the health of their population. It has been suggested that reducing salt intake to recommended levels could prevent 2.5 million deaths every year globally (2).

Most people consume an average of 9-12gof salt each day which is twice the recommended dailyintake limit of 5g(2g sodium/ day)(3).The Norwegian health authorities haveas a goal to lower the population’s salt consumption to 8g/day in 2021 and 7g/day in 2025 (representing a 30% reduction from 2015) (4). The long-term goal is 5g/day. The first goal is a reduction of average salt intake by 15%by 2018.

About three-quarters of the salt we consume comes from packaged, prepared and restaurant foods.

To stimulate the industry to reduce its use of salt, a “salt partnership” was commenced in 2014 between Norwegianfood and catering industries, trade organisations and associations, NGOs and research institutions and the Norwegian Directorate of Health (NDH).The NDH invited a range of stakeholders to develop an agreement, plan for skills development and set salt reduction targets for about 100 product groups. The agreement was signed by 53 actors and launched in 2015.

The partnership is organised through a steering committee under the leadership of NDH and six working groups, run by the food industry:1. bread and cereal products, 2. meat products, 3. fish products, 4. other foods, 5. dairy and edible fats and, 6. hotel, restaurant and catering.

Specific salt targets for each food category can be found at this site: https://helsedirektoratet. no/english/salt-and-the-saltpartnership#salt-reduction-targets.

The steering committee includes representatives from each working group, as well as representatives from research institutes, trade associations, NGOs, retailers and the authorities.

Areas of cooperation and input The partnership has agreed to

Monica SORENSEN Senior Advisor, Norwegian Directorate of Health

prioritize resources to carry out the following actions to reach the targets for public salt reduction: • Development and implementation of a common monitoring and reporting system of salt intake where trends in urinary sodium excretion in the population will be one of the indicators.

• Development and implementation of a universal system for monitoring salt content in food categories, drinks and meals.

• Development and implementation of kitchen practice guidelines to improve healthy cooking and food preparation skills in canteens, restaurants, kiosks, petrol stations, convenience stores etc.

• Introduction of public awareness campaigns and follow-upof the development in knowledge and attitudes regarding the use of salt in the food industry and in the population.

1. A public-corporate coalition to help reduce high fat, sugary and salty foods Following the success of the salt partnership, the Norwegian Ministry of Health (MoH) broadened the agreement with the food industry associations and suppliers in December, 2016. The agreement (a Memorandum of Understanding, MoU),which was signed by 11 partners and lasts until December 2021, intends to improve public health by limitingthe population’s intake of salt, sugar and saturated fat and increasethe intake of fruits, vegetables, whole grain products and seafood(5).

By June, 2018 95 businesses had signed affiliation with the partnership. This includes producers, wholesalers, retailers, the catering industry and business organisations. The overall goal is to increase the percentage of the population who have a balanced diet in accordance with the official dietary guidelines. Norway aspires to become one of the top three

countries where people live the longest, that the population gains more healthy life years and that social inequity is reduced.

The Global Burden of Disease project has shown that besides smoking and illegal drug use, Norwegians’ unhealthy food and alcohol consumption are the most important risk factors for death before age 70. National studies of food intake show that the intake of vegetables, fruits, berries, whole grain and seafood is inadequate and that the intake of sugar, saturated fat and salt is too high. Especially, among children and adolescents the intake of sugar is of concern. For example, data from 2015 shows that the average intake of added sugar in 8th graders is 62g/dayand this is strongly correlated with socioeconomic background (6, 7).

the prioritised focus areas.

The food industry has granted their obligation to make it easier for their customers to choose healthy options by developing new products that meets the intention of the agreement. The partners will report on their progress regularly to the MoH. The coalition should not be of hindrance in the partners’ sale of products that are not promoted in the agreement and there are no financial commitments tied to the partnership.

The authorities are obliged to monitor the population’s diet, initiate national information campaigns and collaborate with research institutions to improve our knowledge of food intake and health outcomes.

References: 1. Whelton, P.K., L.J. Appel, R.L. Sacco, C.A.M Anderson, E.M. Antman, N. Campbell et al.,‘Sodium, Blood Pressure, and Cardiovascular Disease’, Further Evidence Supporting the American Heart Association Sodium Reduction Recommendations,126(24), 2012, pp. 2880-2889.

The agreement includes the following focus areas:

2. WHO, Global action plan for the prevention and control of noncommunicable diseases 2013–2020, 2013.

1. Reduction of salt content in food as described above through the salt partnership.

3. WHO, Guideline: Sodium Intake for Adults and Children,2012, Geneva.

2. Reduction of added sugar in food and reduction of the population’s sugar consumption by 12.5%by 2021. The population’s consumption of added sugar was13% in 2015, and the goal is to reduce the intake to 11% in 2021. The long-term goal is 10%.

4. National Directorate of Health, Action plan to reduce salt consumption 2014-18’ (in Norwegian only), 2014, Oslo.

3. Reduction of saturated fat in food and reduction of the population’s consumption of saturated fat from 14% in 2015 to 13% in 2018 (measured by food supply statistics). The long-term goal is 10%.

4. Increasing the population’s consumption of vegetables, fruits, berries, whole grain and seafood by 20%by 2021 in accordance with the national strategy for improving the diet in Norway (2017-2021) (8).

5. All involved partners should use their available means to towards changing consumer behaviourto move in a healthier direction.

5. National Directorate of Health, Partnership for a healthier diet, 2016, https://helsedirektoratet.no/ english/partnership-for-a-healthierdiet.

6. Institute of Basic Medical Sciences, University of Oslo, Norwegian Directorate of Health, Norwegian Food Safety Authority, NORKOST National Food Consumption Survey 2010-2011, 2012, Oslo, Norway.

7. Hansen, L., Myhre, Andersen, L.F., UNGKOST 3,2016, Oslo.

8. Ministry of Health and Care Services, Norwegian National Action Plan for a Healthier Diet,[website], 2017, Oslo, Norway, https://www. regjeringen.no/en/dokumenter/ norwegian-national-action-planfor-a-healthier-diet--an-outline/ id2541870/

6. All partners should collaborate on the facilitation of monitoring Government Gazette | 53

Recommendations to reshape policy making

COLORECTAL CANCER report

EU action against colorectal cancer

State of the digestive burden

COLORECTAL CANCER

If Europe should benefit from the existing screening programmes, public perception about colonoscopy should change.

RISK FACTORS

BLOOD IN STOOLS

FAMILY HISTORY OF CRC

A CHANGE IN BOWEL HABITS

HEAVY ALCOHOL CONSUMPTION

ABDOMINAL PAIN

HIGH CONSUMPTION OF PROCESSED MEAT

LOSS OF APPETITE

OBESITY

UNEXPLAINED WEIGHT LOSS

LONG-TERM INFLAMMATORY BOWEL DISEASE

L Ru Lithu

Austria

DON’T

SMOKE

INTAKE

EXERCISE REGULARLY

HEALTHY

SCREENING

WEIGHT

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BODY

MEAT + FATS PROCESSED

SATURATED

Est

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Some of the biggest challenges in screening of colon and rectal cancers relates to negative attitudes to screening tests. Public awareness of colonoscopy and the benefits of the procedure remain low.

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However, there are vast differences in programme types and start inequalities in participation rates, which range from less than 1% in Hungary to 65% in the Netherlands.

SYMPTOMS

Screening is in place for colorectal cancer throughout Europe and there is strong evidence that these programmes reduce incidence and mortality rates through early detection and prevention.

Colorectal cancer (CRC) is the second most common cancer in Europe, accounting for over 14% of One European dies every 3 minutes from CRC.

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Now is the time to change public perception on screening

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UEG White Book 2014 (Farthing, M, Roberts, S, Samuel D, Williams D, et al. Survey of digestive health across Europe: Final report. Part 1: The burden of gastrointestinal diseases and the organisation and delivery of gastroenterology services across Europe, Gastroenterology Journal, December 2014 vol. 2 no. 6 539-543). International Agency for Research on Cancer. Available at: https://www.iarc.fr/

What’s inside Together, we can beat colorectal cancer iCPS Colorectal Cancer Europe Rooundtable European Commission initiative on colorectal cancer Luciana Neamtiu, Project Officer, European Commission Could bowel cancer be a bacterial disease?

Prof Phil Quirke, Department of Pathology & Tumour Biology, University of Leeds Optimising tumor board participation in colorectal cancer diagnosis Dr Georgios Pechlivandis, National Representative of Greece, ESCP Collaboration for better patient outcomes Prof Peter Christensen, Chair of the Communications Committee, ESCP Research suggests AI is faster at detecting cancer An interview with Dr Yuichi Mori from Showa University in Yokohama Global collaboration in colorectal surgery is key to evolving treatment Petr Tsarkov, Director of the Clinic of Coloproctology Importance of translational research Prof Renato Cannizzaro, Gastroenterologist Surviving with colorectal cancer Nick Thomas-Symonds, MP, UK Parliament

healthcare

EU action against colorectal cancer

Together, we can beat colorectal cancer

Call for action Member states must pay particular attention to multidisciplinary and patient-centred pathways from diagnosis, to treatment, to survivorship.

Member states should support awareness campaigns in the EU on lifestyle factors which cause CRC, aimed particularly at teenagers.

Member states should invest more in the foundations of lifelong physical well-being in our youngest children.

Europe needs to create more supportive social environments for physical activity.

It is essential that we pursue pragmatic solutions to manage colorectal cancer. EU member states should be called on to ensure that appropriate policies are adopted across Europe to ensure that efficient CRC screening programmes are implemented. Patients must be involved in every step of the decision-making process.

W

hile Western Europe is currently trying to improve its screening programmes, most of Eastern Europe doesn’t have one. Eastern European governments are not making screening programmes a priority, quality assurance mechanisms are not effective and EU guidelines are not always being followed.

Participation rates are low, just 11 percent in Latvia for example and attendance at

www.governmentgazette.eu | 56

colonoscopy referral appointments following a positive test result is also poor. Some countries are planning and piloting organised programmes, but not all are effective.

Access to treatment and screening programmes widely vary across Europe. Eastern European countries are not making screening programmes a priority and participation rates at screening remains fairly low. Europe should break the barriers of inequity in the colorectal cancer screening and end the

stigma associated with the disease.

While colorectal cancer is preventable, treatable and beatable, a lot remains to be done. There’s a need for stronger lobbying at the political level to put colorectal cancer on the same level as other cancers.

To raise awareness, understanding and knowledge of management of colorectal cancer, the International Centre for Parliamentary Studies (iCPS) brought together policymakers,

scientific experts, European associations and patient groups in a high-level policy roundtable on April 25th, 2018 in Brussels to discuss the next steps to lower risks and improve management of the digestive cancer.

Chaired by Prof Phil Quirke, Professor of Pathology at University of Leeds who has led bowel cancer screening programmes across the United Kingdom and is an honorary member of six international surgical societies, the iCPS Colorectal Cancer Europe Roundtable 2018 housed over 20 experts coming from more than 15 European countries, who examined a wide assortment of issues ranging from prevention, framework for screening, the importance for data sharing and greater collaboration, treatment options and the need for promoting active lifestyles.

Following an epidemiological update from Dr MarilysCorbex from the World Health Organisation and a viewpoint from Dr Luciana Neamtiu from the European Commission, Jola Gore-

Booth, Founder/CEO of EuropaColon delivered a passionate viewpoint about the difficulties faced by patients.

Ambitious to advance colorectal cancer research and care, she noted that it’s time to change the public perception about colonoscopy.

Delegates agreed there is a need to move towards a more personalised screening programme based upon personal risk assessment, taking into account factors such as age, lifestyle and hereditary risk. To support and supplement a more personalised approach to screening, experts call for a shift in the role GPs in personalised screening.

While screening programmes differ widely across Europe, some of the biggest challenges in screening of colon and rectal cancers relates to negative attitudes to screening tests. The promotion of CRC screening for older adults is becoming increasingly difficult because reading CRC prevention information may evoke embarrassment, fear, and anxiety towards the screening procedure and

on developing early diagnosis techniques, in order to save thousands of lives from digestive cancers including a more targeted approach to ensure at-riskpatients don’t ‘slip through the early-detection net’ 13. To properly assess quality of CRC care, it is important to assess clinical outcomes, process outcomes and patientreported outcomes.

cancer diagnosis.

Some of the key recommendations tabled at the roundtable include: 1. Medical oncologists treating CRC must have in-depth understanding of the prognostic and predictive clinical and molecular factors that contribute to indication setting,treatment intensity and duration of drug therapies.

2. It is important to establish care pathways and multidisciplinary teams, following the same approach to auditing, quality assurance and accreditation of a ‘unit’ that is emerging in breast cancer.

3. EU member states should be called on to ensure that appropriate policies are adopted across Europe to ensure that efficient CRC screening programmes are implemented.

4. There’s a need for empowering personalised health through data sharing of randomised clinical trials.

5. Urgent action is required in maintaining high-standards of education and training.

Members of an MDT should have special training in order to

deepen their knowledge in colorectal cancer.

Medical oncologists treating CRC must have in-depth understanding of the prognostic and predictive clinical and molecular factors that contribute to indication setting and treatment intensity and duration of drug therapies.

6. Member states must pay particular attention to multidisciplinary and patient-centred pathways from diagnosis, to treatment, to survivorship. Experts in geriatric oncology, nuclear medicine, oncology pharmacy, psycho-oncology, palliative care and nutrition should be part of MDTs treating colorectal cancer patients.

7. Patients must be involved in every step of the decision-making process. Their satisfaction with their care must be assessed throughout patient care pathways.

It is also essential that patient support organisations are involved whenever relevant.

8. Access to medicines and treatments: There is still a high need for new treatments – so high-risk research should be encouraged.

Patient involvement in Health Technology

Assessment (HTA) must be strengthened to ensure that it is meaningful; more clarity and harmonisation are needed, with a long-term perspective on health and innovation. Price flexibility and more creative approaches must be introduced to increase access to medicines, and the system overall must be faster to allow quicker access.

9. The system can only be sustainable with increased screening and early detection, high prices for high medical value, and low prices after loss of exclusivity.

10. Member states should support awareness campaigns in the EU on lifestyle factors which cause CRC, aimed particularly at teenagers and young adults.

11. The European Commission should encourage implementation of CRC screening in accordance with EU guidelines and insist that member states publish progress reports once every two years, in order to make dissemination of CRC screening-related research.

12. European governments should focus their efforts

14. Supportive or palliative care that relieves symptoms and physical pain as well as reduces psychological suffering remains insufficiently prioritised in many EU countries.

Some patients with metastatic disease can be cured but do not always get the multidisciplinary assessment they should.

Governments should improve quality of care and increase awareness and access to palliative care.

15. Together, we can beat this disease. Increasing awareness about lifestyle factors, educating about screening, improving quality of life and addressing high-risk groups is crucial, to end colorectal cancer in Europe. The role of diet and exercise in the prevention of colorectal cancer cannot be underestimated. Europe should act on obesity, continue to load up on fish and fruit, and cut back on soft drinks to prevent colorectal cancer.

16. Some patients with metastatic colorectal cancer can be cured but do not always get the multidisciplinary assessment they should.

Europe is failing in terms of quality of life and survivorship.

Delegates 2018: Founder/CEO, EuropaColon; Medical Doctor, Member of the Screening Committee of the Ministry of Health, Military University Hospita Prague; Section Head of Pathology and Tumour Biology, Leeds Institute of Cancer and Pathology; Specialist - Colorectal Cancer Screening, Estonian Health Insurance Fund; Abdominal Surgery Doctor, Coloproctologist, Lithuanian University of Health Sciences; Associate Professor Colorectal Surgery, Karolinska Institutet; Project Officer, European Commission - JRC; Nurse Specialist, Ministry of Health; Lead Doctor, Ministry of Health; Board Member, Swiss Society of Gastroenterology; Delegate, Swiss Society of Gastroenterology; VicePresident, Austrian Breast & Colorectal Cancer Study Group; MD Gastroenterologist, Oncological Reference Center; Professor of Gastroenterology, British Society Gastroenterology; Health Expert, Evidence and Evaluation, Austrian Public Health Institute; Chair of ESCP Communications Committee; Vice President, Hellenic Society of Gastroenterology; Professor of Gastrointestinal Oncology, UEG; Director Colorectal Surgery, Metropolitan Hospital - European Society of Coloproctology; Surgeon, Oncology Institute Cluj-Napoca IOCN; Head of the Cancer Center, Scientific Institute of Public Health; Technical Officer, WHO Regional Office for Europe

Government Gazette | 57

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Forfood positive cHanges tocancer Young peopLes’ and diagnosis, the first edition of this reason the Commission Habits couLd potentiaLLY Reduce will tHis such guidelines was published in update and develop guidelines canceR buRden bY up to 70% 2010. Moreover, the Council of and quality criteria for colorectal the EU asked the Commission cancerscreening, diagnosis, (Council Conclusions on treatment, and care. reducing the burden of cancer) Colorectal cancer is the second to develop voluntary quality most commonly diagnosed assurance schemes for screening cancer and second leading and care, and facilitate the cause of cancer-related deaths development and updating of in Europe.We know from the web-based quality assurance European Cancer Information and evidence-based guidelines System (ECIS), there are more on cancer (breast, cervical and than 350,000new cases every colorectal). year. Predictions show that more The Commission is currently than 170,000peoplewill die addressing the update and from colorectal cancer in the development of guidelines and EUthis year. an associated quality-assurance Moreover, there are persistent scheme for breast cancer through differences in the survival its European Commission rates of patientsacross Initiative on Breast Cancer Europe, with lower survival (ECIBC). This work will serve rates consistentlyobserved as an example for updating in some countries. These the European guidelines on differences point to health colorectal cancer called the inequalities that can be European Commission Initiative tackledthroughcoordinated on Colorectal Cancer (ECICC).

European action.

The ultimate aim is to make In 2003, the Council of the EU available to European healthcare recommendedpopulation-based systems and services a voluntary screening for breast, cervical and model based on evidence and

applicable to the entire patient’s pathway.

The ECICC will be based upon national studies as well as stakeholders’ involvement and endorsementand will be steered by the European Commission’s Joint Research Centre which upholds the principle of independence from all national, private and commercial interests.

The ECICC will transparently promote the engagement and inclusion of all parties (experts, stakeholders, researchers and citizens) throughout the development process.

ability.

The ECICC will update the guidelines published in 2010 and will ultimately propose a quality assurance scheme developed using a personcentred approach andbased, where possible, on scientific evidence.

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Countries engaging in ECICC include the EU member states plus Albania, Iceland, the Former Yugoslav Republic of Macedonia, Montenegro, Norway, Serbia, Switzerland, and Turkey, givinga total of 36 participating countries.

These countries have already been asked to nominate a national contact to ensure national representation, participation and endorsement for the duration of the project.

Thispermanent exchangebetween the Commission and the 36 countries helps ensure scalable design towards implement-

The ECICC will empower individuals and patients by focusing on ‘their needs’. In other words, the Guidelines and Quality requirements will be transparently available and easy to understand, thus fostering informed decision-makingabout one’s own health.

The quality assurance scheme will seek to co ver the entirecolorectal cancer pathway, from screening of asymptomaticindividuals and diagnosis through to treatment, rehabilitation, management of recurrence and palliative care.

The ECICC will help str eamline screening practices, identifying a population’s segments whichshould be screened and the testing technique(s) that should be encouraged, according to updated evidence.

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healthcare

EU action against colorectal cancer

Could bowel cancer be a bacterial disease?

Prof Phil QUIRKE

Department of Pathology & Tumour Biology, University of Leeds

T

he human large bowel (colon) contains over a trillion bacteria (1013), equivalent to the number of human cells in the entire human body (1).

This mass of colonic bacteria weighs approximately 0.2kg (contributing to 50% of the weight of the colon), and in any one individual comprises over 150 different bacterial species plus additional viruses and fungi (1, 2). However, until recently this

As more and more of the world’s population adopt a Western diet and the rate of bowel cancer increases, it is also directly relevant and topical – now is a critical time to study and understand the microbiome, not only in bowel cancer but in many human diseases.

complex microbial ecosystem has been largely overlooked, owing to the fact that the majority of these bacteria are difficult to culture and study outside the body. Advances in technology have circumvented this issue, allowing the accurateidentification of bacteria based on either their genetic material or the metabolites which they produce. Since this pivotal point, the field of microbiome research has expanded exponentially.

Researchers have shown that the composition of the microbiome increases in complexity within the first few years of life, influenced by both the method of delivery and whether infants are bottle or breastfed, before remaining relatively stable for the rest of the individual’s life (although it may experience rapid perturbations subject to changes in diet, infection and medication, especially antibiotics) www.governmentgazette.eu | 60

(2). The important role that these commensal bacteria play in human health is starting to be appreciated;: they compete with harmful and potentially pathogenic bacteria,; metabolise foodstuffs, medications and vitamins,; maintain the mucus layer which lines the bowel; and influence the development and maintenance of the immune system and bowel (3).

show an association with an altered microbiome, including diseases of the bowel, metabolic diseases, immune-related diseases, cardiovascular diseases and neurological diseases (3). Given the direct interaction between the microbiome and the lining of the large bowel wall, the association between an altered microbiome and bowel cancer is currently under intense investigation.

Given the important role that the microbiome plays in health, it is perhaps unsurprising that alterations in the microbiome are being associated with disease. Perhaps what is surprising is the huge number of diseases which

A Western diet (high in fat, sugars and red meat and low in fibre) has for a long time been recognised as a risk factor for bowel cancer.

Countries consuming a Western diet have a higher incidence of bowel cancer than

countries which do not have a Western diet, and people who emigrate to such high-risk countries and adopt the Western diet acquire the associated increased risk (4). A research study investigated the potential underlying mechanism by temporarily switching the diets of native Africans and African-Americans (5).

They showed that the change in diet changed the microbiomes of the two groups, the metabolites that the respective microbiomes produced and the rate of proliferation of the lining layer of the bowel wall.

Studies have shown that people with bowel polyps (the precursor lesions to bowel cancer) and bowel

cancer have different microbiomes to healthy people with normal bowels (6).

In general, the microbiome of people with bowel cancer contains more bacteria which metabolise bile into carcinogenic compounds and fewer bacteria which produce short chain fatty acids (thought to be protective against the development of bowel cancer). Certain specific bacteria in particular seem to be increased in patients with bowel cancer.

One example of such a bacterium is Fusobacterium nucleatum (F.nucleatum), a bacteria which is commonly found within the mouth of healthy individuals but also has the ability to cause periodontitis.

In laboratory studies,F. nucleatum has been shown to be able to trigger a cancerpromoting cell signalling pathway, tobind and invade into the cells ofbowel cancer and even spread to other parts of the body with those cancer cells (7-9).

Interestingly, treatment with antibiotics has been shown to limit the growth of bowel cancer containing F.nucleatum(9). In humans, F.nucleatum containing bowel cancers have a worse prognosis and are more likely to develop resistance to certain chemotherapeutic agents (10,-11).

The concept that bowel cancer might be a bacterial disease is an interesting one.

In fact, many cancers have an infectious cause including the association between Helicobacter pylori (H. pylori) and gastric (stomach) cancer in addition to a type of gastric lymphoma; Human Papilloma virus (HPV) and cervical

cancer in addition to cancers of the head and neck; Hepatitis B and C virus and liver cancer; and Epstein-Barr virus and certain lymphomas in addition to cancers originating at the back of the nose. This association between certain cancers and infections highlights the careful balance between symbiosis versus pathogenesis and between an immune response which counters infection versus an immune response, with its resultant inflammation, which inadvertently harms human cells, causing DNA damage and subsequently cancer.

The current evidence for an association between bowel cancer and the microbiome is persuasive, although longitudinal studies in humans are required to determine whether the association is causal or not. Even if the microbial changes are secondary to the development of bowel cancer, they could still potentially prove useful as an adjunct to bowel cancer screening or diagnosis, with a number of studies suggesting that combining microbiome data with existing screening methods improves the accuracy of screening (12-21 16).

Should the association between the microbiome and bowel cancer be found to be causal, there is the potential for new methods to treat bowel cancer such as probiotics, prebiotics, antibiotics, dietary changes or faecal microbiome transplants and potentially vaccines.

Lessons could be learnt from the aforementioned infection-associated cancers, such as H. pylori which is eradicated withantibiotic treatment and vaccination against HPV. Furthermore, a causal association would radically alter our understanding of bowel

cancerand might lead to population prevention strategies.

The microbiome is a highly exciting and potentially illuminating area of research. As more and more of the world’s population adopt a Western diet and the rate of bowel cancer increases, it is also directly relevant and topical – now is a critical time to study and understand the microbiome, not only in bowel cancer but in many human diseases.

References: 1. Sender, R.et al., ‘Revised Estimates for the Number of Human and Bacteria Cells in the Body’,PLoSBiol.,2016 Aug 19;14(8), Aug 18 2016,:e1002533. doi: 10.1371/journal. pbio.1002533. eCollection 2016 Aug. Revised Estimates for the Number of Human and Bacteria Cells in the Body.Sender R et al.

2. Lloyd-Price, J. et al., ‘The healthy human microbiome’,Genome Med.,2016 Apr 27;8(1), Apr 27 2016, :p51. doi: 10.1186/s13073-0160307-y.The healthy human microbiome.

Lloyd-Price J et al.

3. Shreiner, A.B., ‘Gut microbiome in health and in disease’,CurrOpin Gastroenterol.,2015 Jan; 31(1), Jan 31 2015, :pp.

69–75. doi: 10.1097/ gut microbiome in health and in disease.Andrew B. Shreiner et al.

4. Haggar, F.A. et al.,‘Colorectal Cancer Epidemiology: Incidence, Mortality, Survival, and Risk Factors’., Clinics in Colon and Rectal Surgery.,2009, 22(4), 2009, pp.191-197.

5. O’Keefe, et al.,‘Fat, fibre and cancer risk in African Americans and rural Africans’,. Nat Commun.,2015, 6, 2015, p.6342.

6. Keku, T.O. et al.,‘The gastrointestinal microbiota and colorectal cancer’,. American Journal of Physiology - Gastrointestinal and Liver Physiology.,2015, 308(5), 2015, pp.G351-G363.

7. Abed, J. et al.,‘Fap2 Mediates Fusobacterium nucleatum Colorectal Adenocarcinoma Enrichment by Binding to Tumor- Expressed Gal-GalNAc’,. Cell Host Microbe.,2016, 20(2), 2016, pp.215-225.

8. Rubinstein, M.R., et al.,‘Fusobacterium nucleatum promotes colorectal carcinogenesis by modulating E-cadherin/beta-catenin signaling via its FadA adhesin’,. Cell Host Microbe.,2013, 14(2), 2013, pp.195-206.

9. Bullman, S. et al., ‘Analysis of Fusobacterium persistence and antibiotic response in colorectal cancer’,. Susan Bullman et al. Science, 23 Nov 2017,: eaal5240,DOIdoi: 10.1126/science.aal5240 10. Mima, K., et al.,‘Fusobacterium nucleatum in colorectal carcinoma tissue and patient prognosis’,.

Gut,.2016, 65(12), 2016, pp.1973-1980.

J Proteome Res.,2015, 14(9), 2015, pp.38713881.

13. Zeller, G. et al.,‘Potential of fecal microbiota for earlystage detection of colorectal cancer’,.

MolSystBiol,.2014, 10, 2014, p.766.

14. Zackular, et al.,‘The human gut microbiome as a screening tool for colorectal cancer’,.

Cancer Prev Res (Phila).,2014, 7(11), 2014, pp.1112-1121.

15. Yu, J. et al.,‘Metagenomic analysis of faecal microbiome as a tool towards targeted non-invasive biomarkers for colorectal cancer’,.

Gut.,2017, 66(1), 2017, pp.70-78.

16. Baxter, N.T. et al.,‘Microbiota-based model improves the sensitivity of fecal immunochemical test for detecting colonic lesions’,. Genome Med.,2016, 8(1), 2016, p.37.

This article was coauthored by Dr Caroline Young and Dr Henry Wood from University of Leeds.

11. Yu, T. et al., ‘Fusobacterium nucleatum Promotes Chemoresistance to Colorectal Cancer

by Modulating Autophagy’,Cell,.2017 Jul 27;170(3), July 17 2017, :pp. 548-563., e16.,doi: 10.1016/j. cell.2017.07.008.

Fusobacterium nucleatum Promotes Chemoresistance to Colorectal Cancer by Modulating Autophagy.

Yu T et al.

12. Amiot, A., et al.,‘(1) H NMR Spectroscopy of Fecal Extracts Enables Detection of Advanced Colorectal Neoplasia’,.

Government Gazette | 61

healthcare

EU action against colorectal cancer

Optimising tumor board participation in colorectal cancer diagnosis Dr Georgios PECHLIVANDIS National Representative of Greece, ESCP

M

ultidisciplinary team meetings (MDTs), or tumour boards, were initiated in the mid-to-late 1990s in response to perceptions of inappropriate cancer treatment (1). Most national and regional guidelines now suggest that all new colorectal cancer cases should be discussed at an MDT meeting, with rectal cancers being discussed also preoperatively (2-5). This is not supported though by strong evidence(6).

Several non-randomised trials have examined the effect of MDTs on colorectal patient survival and have reported an association with improved survival (7-11). In many of these studies the comparison was to historical cohorts.

Thus, improved outcomes could possibly reflect other improvements in patient care as in staging, in surgery particularly of liver metastases, in chemotherapy and radiotherapy (11).

An Australian study (12) has suggested that their MDT meeting rarely changed management in routine colon cancer cases, but management did change in 50% of complex cases. These included rectal cancer pre-operative assessments, recurrences, metastatic disease and malignant polyps. Similarly, a studyfrom New Zealand, found that for patients with stage 1 and 2 colorectal cancers rarely had their management been impacted (13). They suggested a two-tier system, where all patients are listed, but only complex cases are discussed in detail.

A 2017 systematic review of www.governmentgazette.eu | 62

commissioning cancer services – the Calman–Hine Report. A Report by the Expert Advisory Group on Cancer to the Chief Medical Officers of England and Wales,London, UK Department of Health, 1995.

2. Cancer Council Victoria,‘Optimal care pathway for people with colorectal cancer’, [website], 2014,http:www.cancer.org.au/ ocp 3. Oncology GGPi, Evidencebased Guideline for Colorectal Cancer, Berlin, Germany, 2014.

16 studies reported that MDT meetings for patients with GI malignancies are responsible for changes in diagnoses and management in a significant number of patients, and the treatment plans formulated are implemented in 90-100% of discussed patients (14).

MDT meetings certainly also have other benefits, including better communication among clinicians, provision of most up to date treatments, education and training, and improved coordination of care. They are an important part of care for colorectal cancer patients, although the resources required to run them are significant (15).

Ideally, all patients with newly diagnosed colorectal cancer should be discussed at an MDT meeting. Discussion should be mandatory for patients with rectal cancers, metastatic or recurrent disease (16). MDT members’ individual and combined training in colorectal oncology is a prerequisite in order to obtain the best decisions. The Norwegian rectal cancer project, the Danish Colorectal Cancer Group (DCCG) project and the Spanish Rectal Cancer project are perfect examples for the astonishing improvement of their patients’ outcome.

Those projects were based on educating surgeons, radiologists, pathologists and oncologists who will form the colorectal MDTs. They have also implemented other important elements such as CRC registry, centralisation of CRC care, and CRC screening programme (17-19).

References: 1. Expert Advisory Group on Cancer, A policy framework for

4. Chang, G.J, et al.,‘Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of colon cancer’, Dis Colon Rectum,55(8), 2012, pp. 83143.

5. National Collaborating Centre for Cancer, The Diagnosis and Management of Colorectal Cancer - Evidence review United Kingdom, National Institute for Health and Care Excellence, 2011.

6. Meagher, A.P.,‘Colorectal cancer: are multidisciplinary team meetings a waste of time?’, ANZ J Surg,83(3), 2013, pp.

101-103.

7. Palmer, G. et al.,‘Preoperative tumour staging with multidisciplinary team assessment improves the outcome in locally advanced primary rectal cancer’, Colorectal Dis,13(12), 2011, pp.

1361-1369.

8. Ye, Y.J. et al.,‘Impact of multidisciplinary team working on the management of colorectal cancer’, Chin Med J (Engl),125(2), 2012, pp. 172177.

9. Wille-Jørgensen, P. et al.,‘Result of the implementation of multidisciplinary teams in rectal cancer’, Colorectal Dis,15(4), 2013, pp. 410-413.

10. Munro, A. et al.,‘Do Multidisciplinary Team (MDT) processes influence survival in patients with colorectal cancer?

A population-based experience’, BMC Cancer,15, 2015, p. 686.

11. Lan, Y.T. et al.,‘Improved outcomes of colorectal cancer patients with liver metastases in the era of the multidisciplinary

teams’, Int J Colorectal Dis,31(2), 2016, pp. 403-411.

12. Ryan, J andI. Faragher,‘Not all patients need to be discussed in a colorectal cancer MDT meeting’, Colorectal Dis,16(7), 2014, pp. 520-526.

13. Fernando, C.et al.,‘Colorectal multidisciplinary meeting audit to determine patient benefit’, ANZ J Surg,Nov 3 2015.

14. Prades, J. et al.,‘Is it worth reorganising cancer services on the basis of multidisciplinary teams (MDTs)? A systematic review of the objectives and organisation of MDTs and their impact on patient outcomes’, Health Policy,119(4), 2015, pp.

464-474.

15. Basta, Y.L. et al.,‘The Value of Multidisciplinary Team Meetings for Patients with Gastrointestinal Malignancies: A Systematic Review’, Ann SurgOncol,24(9), 2017, pp.

2669-2678.

16. Pillay, B. et al.,‘The impact of multidisciplinary team meetings on patient assessment, management and outcomes in oncology settings: A systematic review of the literature’, Cancer Treat Rev,42, 2016,pp. 56-72.

17. Guren, M.G. et al.,‘Nationwide improvement of rectal cancer treatment outcomes in Norway, 1993-2010’,ActaOncol,54(10), 2015, pp. 1714-1722.

18. Lene, H. et al.,‘Improved survival of colorectal cancer in Denmark during 2001–2012 – The efforts of several national initiatives’,ActaOncol,55,S2, 2016, pp. 10–23.

19. Ortiz, H. et al.,‘Spanish Rectal Cancer Project. Impact of a multidisciplinary team training programme on rectal cancer outcomes in Spain’, Colorectal Dis,15(5), 2013, pp. 544-551.

focus from multidisciplinary to ‘multi-professionality’ to reflect the importance of nurses, stoma therapists, physiotherapists, dieticians, psychologists and community health care professionals in cancer patient treatment and care. We can only do that if our teaching and training programmes are designed with a collaborative and multidisciplinary approach in mind.

Prof Peter CHRISTENSEN

Chair of the Communications Committee, ESCP

Collaboration for better patient outcomes

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olorectal cancer is the second most commonly diagnosed cancer, as well as the second cause of death from cancer, in Europe. Every year, there are a quarter of a million new cases diagnosed.

Moreover, persistent differences in the survival of patients across Europe suggest that there are health inequalities that could be reduced through coordinated European action. That is why the establishment of a European Initiative on Colorectal Cancer offers so many opportunities.

In Europe, we have much to celebrate regardingadvances of colorectal cancer treatments.

But there is also room for improvement. For instance, many survivors of colorectal cancers suffer adverse effects on their mental and emotional states which surgery alone can’t address. This demonstrates the need to improvepatient care to focus on the whole individual.

At the recent Colorectal Cancer Europe Roundtable we discussed this at some length and concluded that a holistic and collaborative approach, with the patient voice rooted firmly in the centre of the collaboration,is the most effectiveway to

achieving this.

Our recommendation is to further support collaborative training and research, enhance screening programmes, and implement quality control protocols to disseminate best practice. Patient perspectives should be involved in all aspectsof these initiatives to raise awareness among patients, healthcareauthorities and politicians.

As the leading professional organisation for coloproctologistsin Europe, the ongoing activities of the European Society of Coloproctology (ESCP) are already embedding such approaches and theories.

Our ongoing researchhas shown that management and treatment of colorectal cancer is best performed in a multidisciplinary collaboration between endoscopists, radiologists, pathologists, radiotherapists, oncologists and surgeons. Indeed, we’ve found that state-of-the-art treatment can only be achieved in a close, multidisciplinary collaboration between differing specialists.

Perhaps the best way to look at this, then, is to switch the

At ESCP we proactively support thisthrough an educational portfolio including our annual Scientific Meeting, as well asregularly updated online resources and interactive masterclassesacross Europe. We correspondingly offer structured programmes for training in modern surgical approaches, such as laparoscopiccomplete mesocolic excision and robotic colorectal surgery (both minimally invasive surgeries for colorectal cancer).

Thiscombined approach is aimed at educating coloproctology professionals across Europe to the highest standard; and we areproactively backing up our educational endeavours with a strategic communications and engagement programme, which includes using social media to connect with professionals of varying disciplines.

We know that screening for colorectal cancer will increase awareness and early diagnosis, which in turn leads to better outcomes and more organpreserving curative treatments.

However, there is still a need for more trials within the field of early cancer detection so that we canreach consensus on which interventions work best in which circumstances.Collaboration will be integral to success in this.

Another core aim of the ESCP is to promote and support clinical and translational research in all areas of coloproctologythroughout Europe.Discovery continues alongside numerous new developments in technical and medical approaches across all cancer disciplines, and our infrastructure and network of trained clinicians already facilitate multinational randomised trials and cohort studies in contribution to this.

and our members, ESCP has run a series of pan-European cohort studies since 2015 and now has data from more than 11,000 colorectal cancer operations, with further studies planned for 2018 and 2019.

The results of these trials are shared as widely as possible to supportindependent research and collaborative trials.

In speaking of research and collaboration, the issue of quality control cannot be overlooked. To achieve a standardised and coherent quality of training, research and collaboration, we need national registries on outcomes for all units treating colorectal cancer that should also be open to the public. National societies should set up nationwide standards in collaboration with relevant European organisations so that we can achieve similar high standards of treatment throughout the region.

Talk of collaborative training, research and qualitycontrol is futile if not centred on the patient, who is the very reason for the collaboration in the first place. As survival from colorectal cancer continues to improve, patients are facing organ or psycho-socialconsequences which need to be catered for.

This is where a collaborative approach delivers its best advantages.

Indeed, quality of life for most patients will improve substantially on simple and inexpensive treatment algorithms using a collaborative ethos. The key is to use dedicated patientreported outcome measures to further inform doctors, therapists and nurses, as well as to inform follow-up programmes with more focus on the patient’s perspective.

Ultimately, the buck does not stop with oncologists and surgeons, but rather with an entire team of medical and care professionals who work together for the whole-person recovery and health of each patient. If we work collaboratively across Europe to an agreed goal — the outcomes for colorectal cancer patients can and will improve.

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healthcare

EU action against colorectal cancer

Research suggests AI is faster at detecting cancer expect a great advance in the area of automated polyps/cancers detection in a couple of years.

FOR THE RECORD

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olonoscopic polypectomy for all adenomatous polyps is considered to contribute to the reduction of both the incidence and mortality of colorectal cancers.

However, a substantial number of unnecessary polypectomies are carried out for non‐ neoplastic polyps because of endoscopists’ misdiagnoses, resulting in considerable financial concerns.

A new endoscopic system powered by artificial intelligence was recently shown to automatically identify colorectal adenomas during colonoscopy.

The system, developed in Japan, has recently been tested in one of the first prospective trials of AI-assisted endoscopy in a clinical setting, with the results presented at the 25th UEG Week in Barcelona, Spain.

A new endoscopic system powered by artificial intelligence was recently shown to automatically identify colorectal adenomas during colonoscopy.

The system, developed in Japan, has recently been tested in one of the first prospective trials of AI-assisted endoscopy in a clinical setting, with the results presented at the 25th UEG Week in Barcelona, Spain. www.governmentgazette.eu | 64

The new computeraided diagnostic system uses an endocytoscopic image — a 500-fold magnified view of a colorectal polyp – to analyse approximately 300 features of the polyp after applying narrow-band imaging (NBI) mode or staining with methylene blue.

The system compares the features of each polyp against more than 30,000 endocytoscopic images that were used for machine learning, allowing it to predict the lesion pathology in less than a second.

Preliminary studies demonstrated the feasibility of using such a system to classify colorectal polyps; however, until today, no prospective studies have been reported.

The algorithm showed a very high accuracy rate according to your results — was this expected?

Were you and your team surprised?

We were surprised at the performance of the machine learning at first, because AI was significantly superior to novice endoscopists in terms of diagnostic abilities.

Dr Yuichi Mori from Showa University in Yokohama, Japan, involved 250 men and women in whom colorectal polyps had been detected using endocytoscopy Speaking to Government Gazette recently, Dr Yuichi Mori from Showa University in Yokohama, Japan, who involved 250 men and women in whom colorectal polyps had been detected using endocytoscopy, explained: “The most remarkable breakthrough with this system is that artificial intelligence enables real-time optical biopsy of colorectal polyps during colonoscopy, regardless of the endoscopists’ skill.

This allows the complete resection of adenomatous polyps and prevents unnecessary polypectomy of non-neoplastic polyps.”

“We believe these results are acceptable for clinical application and our immediate goal is to obtain regulatory approval for the diagnostic system,” added Dr Mori.

Moving forwards, the research team is now undertaking a multicentre study for this purpose and

the team are also working on developing an automatic polyp detection system. “Precise on-site identification of adenomas during colonoscopy contributes to the complete resection of neoplastic lesions,” said Dr Mori. “This is thought to decrease the risk of colorectal cancer and, ultimately, cancerrelated death.”

Is AI the future of colorectal cancer detection?

Compared to the research on automatic pathological prediction of polyps/cancers, that of automatic detection of polyps/cancers is delayed because it needs more computer power and more learning material.

Actually, we cannot find any prospective trial on this academic field, while we have more than five prospective studies in automatic pathological prediction of polyps. However, with the emergence of deep learning, more and more studies are reported nowadays, thus we can

Why is there so much hope that AI systems can diagnose cancer better than humans? What makes AI better at this role than humans?

In my view, AI has two major strengths compared with a physician. First of all, AI is definitely objective. It is well known that a physician sometimes makes different diagnosis even on the same endoscopic images, if these images are shown at different times or in different situations. However, AI always outputs the same diagnosis. The second strength is the number of endoscopic images which AI has learned.

We have already trained the AI with more than 70,000 endoscopic images from over 2,000 colorectal polyps. Such a large number of polyps cannot be experienced in a routine practice for a physician.

What are the current limitations of AI in detecting and diagnosing cancer or other diseases? How can these limitations be overcome?

The biggest limitation of AI systems for colonoscopy is that there are only a few studies evaluating the usefulness of AI systems in a clinical setting.

Most available studies are experimental ones, thus the real performance of AI in a clinical practice is unknown. Therefore, we have to keep it in mind that the real performance of AI systems might be worse than we thought.

In this point of view, it is strongly required to conduct high-quality, prospective clinical trials to validate “real performance” of the

AI system before its implementation into a clinical practice. As for our AI model, we have already published a total of five pre-clinical studies in which sensitivities and accuracies were almost over 90% in diagnosis of neoplastic lesions.

How can this help save the lives of patients?

Precise, on-site identification of

adenomas during colonoscopy contributes to whole resection of neoplastic polyps.

Resection of all neoplastic polyps is believed to decrease both the future incidence of colorectal cancers and cancer-related death, which is a big benefit for patients.

What kind of savings could such a technological

advancement bring to the cost of colorectal cancer screening?

We believe that this AI system offers good cost-effectiveness by avoiding some of the cost for polypectomy and subsequent pathological examinations. If the AI system correctly identifies neoplastic polyps requiring resection from non-neoplastic polyps not requiring resection,

a large amount of costs related to unnecessary polypectomy for nonneoplastic polyps can be saved (eg, the cost for polypectomy and pathological assessment is approximately US$400 under Japanese National Health Insurance). This can be a good financial benefit for a colorectal cancer screening programme.

Global collaboration in colorectal surgery is key to evolving treatment Petr TSARKOV

Director of the Clinic of Coloproctology

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ver the last two decades, my particular focus in coloproctology has been developing and championing the latest research and techniques in relation to dissecting lymphatic metastases of the para-aortic and lateral pelvic regions in colorectal cancer patients.

It may come as quite a surprise to some coloproctologists that the perception of para-aortic and lateral lymph node dissection as an exclusively Eastern invention is not completely accurate.

In fact, the earliest procedures were first proposed by surgeons in the United States approximately 70 years ago, but it was a complex procedure and some patients began to experience an unacceptable levelof urinal discomfort and impotency post-surgery.

Following these complications and the strengthening influence of radiotherapy, the procedure became a

subject of unspoken taboo in the Western colorectal surgery world and was quickly disregarded.

Extended lymph node dissection was difficult to achieve effectively, given the limited surgical view in a very narrow space and there was no Magnetic Resonance Imaging (MRI) during this time to utilise for clarity. Although strong evidence is still lacking to support para-aortic lymph node dissection in rectal cancer treatment, over time, innovative approaches have presented positive results which have helped to prevent common local recurrences and increase the survival rate of patients.

For cases which involve advanced gynaecological and urological cancers in particular, lateral pelvic lymph node dissection is a routine procedure andfor that reason, some European colorectal surgeons may refer to gynaecologists and urologists for training. However, there

are some significant differences between the pelvic and lower rectal areas which European surgeons must be taught. In rectal cancer, patients’ metastases to lymph nodes on the pelvic side walls are not a rare occurrence.

Besides contemporary chemotherapy and radiotherapy, the removal of the pelvic side walls lymph nodes may add to an improved survival rate in rectal cancer patients in Western countries.

Significant efforts were undertaken in Japan to improve the surgical technique, decrease the side effects and enhance oncological benefits.

Japanese surgeons began to suggest that the lateral lymph nodes should be removed altogether – particularly around the left colon and the rectum using emerging technologies.

Great strides were achieved and back in 1999, I learned firsthand from the experts in Tokyo who were leading this pioneering research by undertaking an intensive training course.

Dr Takashi Takahashi (Cancer Institute Hospital), Dr Takeo Mori (Komagome Hospital) and Dr Yoshihiro Moriya taught me their approach to extended lymph node dissection.

A Japanese randomised study (JCG01212) presented an almost twotimes reduction of local recurrence rate in low rectal cancer patients who had prophylactic lateral lymph node dissection, compared to those who had not. This was a promising result which first indicated that this procedure could become a beneficial mainstream tool. I carried this experience with me and implemented it back in Russia at the Sechenov First Moscow State Medical University.

There’s an increasing interest amongst Western colorectal surgeons regarding extended lymph node dissection in colorectal cancer patients. The overall fiveyear survival rate after rectal cancer treatment in Japan is over 80 percent, while in most developed countries in Europe it is currently around 60 percent. This statistic can be changed; however, European policymakers must look at regulating standard training programmes for European surgeons.

Training programmes for removing pelvic side wall lymph nodes in rectal cancer patients have previously been held in Japan; however, colorectal surgeons in Europe are not taught this technique. It is

essential that many more surgeons from around the world are trained in, testing, and practising these techniques in order to deliver the safest and most unified approach to treatment.

By applying these methods in Western countries that have been perfected for decades in Japan and Korea — albeit in a different section of the colorectal region — we will start to see remarkable improvements in both quality of life post-surgery and patient survival rates.

Global collaboration and research is essential to evolve any kind of innovative approach to treatment. I recently delivered a presentation on this topic at the European Society of Coloproctology’s (ESCP) 13th Annual and Scientific Meeting in Nice, France, where delegates from around the world came together to exchange knowledge and best practice in the colorectal field.

Europe should share this outlook to continue developing and innovating its approaches to treatment and policymaking.

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healthcare

EU action against colorectal cancer

Importance of translational research Prof Renato CANNIZZARO

MD Gastroenterologist

C

olorectal cancer represents one of the most important malignant digestive neoplasm and has poor prognosis when metastasised to lymph nodes or distant organs. Most colon tumours develop via a multistep process involving a series of histological, morphological, and genetic changes that accumulate over time (1).

The incidence of colorectal cancer is higher in highly industrialised countries, while in developing countries is not so common. This observation strongly suggests that microbial and environmental factors, apartfrom age, male sex, hereditary factors, might have an important role in colorectal cancer development.

Survival has been reported to differ between European countries and to show improvement with time (2).

Largest reductions have been observed in Western and Northern Europe. Changes in mortality and reduction of colorectal cancer are a result of the combined influence of better public awareness of the disease, reduced prevalence in risk factors such as smoking and alcohol drinking, greater participation to screening, and improved treatment and patient management protocols (3). There has been growing interest in encouraging and supporting members of the public institutions as well as informing citizens about health matters, including screening and being more engaged in decisions about their own healthcare.

Multiple studies have shown that a provider recommendation is a strong predictor of colorectal cancer screening participation.

The odds of participating in any method of colorectal cancer www.governmentgazette.eu | 66

screening for all age groups increased with a clinician’s recommendation (4). This data, joined to data about differences in colorectal cancer survival and screening participation between different parts of Europe, underline the importance of screening communication and the importance to create a screening communication European campaign to increase screening adhesion in all European countries.

In Europe, screening for colorectal cancer has substantially contributed to the downward trends in colorectal cancer incidence and mortality over the last two decades, also thanks to the endoscopic removal of polyps that can be precursors of colorectal cancer (3,5).

AIGO, the Italian Society of Hospital Gastroenterologists and Endoscopists, has the goal to develop understanding of the digestive pathologies, as well as to promote progress in the field of prevention, diagnosis, treatment and rehabilitation of digestive diseases. The EQuIPE(Evaluating Quality Indicators of the Performance of Endoscopy) in collaboration with the AIGO group in a study demonstrate that a quality colonoscopy in anorganised colorectal screening programme can improve the adenoma detection rate and cecal incubation rate, which are two important quality indicators of colonoscopy (6).

Screening for colorectal cancer includes in addition to the tests, information-education of the population of interest, a complex organisation that facilitates access to tests and the preparation of follow-up protocols for people with a positive test.

Italian studies showed that

increased compliance with colorectal cancer screening recommendations has the potential to improve patients’ health and well-being, and to reduce colorectal cancer morbidity and mortality rates (1,6-7).

An adequate level of cleansing is critical for the efficacy of colonoscopy. Cecal intubation rate and adenoma detection rate (ADR) are, as reported above, two quality indicators of colonoscopy and are associated to the quality of bowel cleansing (8). Both European and American guidelines recognise that new treatments for bowel cleansing with low-volume PEG preparations are characterised by better patient tolerability, than high-volume ones permitting a high quality colonoscopy increasing cecal intubation rate, ADR and the detection of neoplasia. Low-volume preparations appear to have a non-inferior efficacy to highvolume PEG preparations and boast better patient tolerability.

Sedation practices are usually used in colonoscopy ensuring high quality, comfortable and safe colonoscopy.

Evidence suggests that intensive follow-up after curative resection of colorectal cancer is associated with a small but significant improvement in survival. It’s necessary to keep the followup time correct to avoid unnecessary examinations and to diagnose metacrone lesions (adenomas and cancer).

Continued improvements in risk stratification (possibly through genetic markers), disease detection, and treatment will increase the benefits of postoperative surveillance (9,10).

At the same time, new treatments have been developed and their availability improved.

It’s very important to have a European vision in tackling the costs of new antiblastic drugs for metastatic colon cancer, because constant advances in surgical techniques and therapeutic protocols have also been key in the reduction of colorectal cancer mortality (3). The role of the Referral Oncological Center in developing new technologies and treatment is important,especially in the

multidisciplinary approach of colorectal cancer. Adoption of progress in surgical techniques and adjuvant chemotherapy and/or radiotherapy, increased proportions of patients resected for cure and decreased operative mortality might have contributed to increases in survival (7).

References: 1. Simon, K. , ‘Colorectal cancer development and advances in screening’, Clin Interv Aging,11, July 19 2016, pp. 967-976.

2. Snaebjornsson, P., L. Jonasson, E.J. Olafsdottir, N.C.T. van Grieken, P.H. Moller, A. Theodors, T. Jonsson, G.A. Meijer andJ.G. Jonasson,‘Why is colon cancer survival improving by time? A nationwide survival analysis spanning 35 years’, Int J Cancer,141(3), Aug 1 2017, pp.

531-539.

3. Ait Ouakrim, D., C. Pizot, M. Boniol, M. Malvezzi, M. Boniol, E. Negri, M. Bota, M.A. Jenkins, H. Bleiberg and P.Autier,‘Trends in colorectal cancer mortality in Europe: retrospective analysis of the WHO mortality database’, BMJ,351, Oct 6 2015, p. h4970.

4. Geller, B.M., J.M. Skelly, A.L. Dorwaldt, K.D. Howe, G.S. Dana andB.S. Flynn,‘Increasing Patient / Provider Communications about Colorectal Cancer Screening In Rural Primary Care Practices’, Med Care,46(9 Suppl 1), Sept 2008, pp. S36–S43.

5. Triantafillidis, J.K., C. Vagianos, A. Gikas, M. Korontzi and A.Papalois,‘Screening for colorectal cancer: the role of the primary care physician’, Eur J Gastroenterol Hepatol,29(1), Jan 2017, pp. e1-e7.

6. Zorzi, M., U. Fedeli, E. Schievano, E. Bovo, S. Guzzinati, S. Baracco, C. Fedato, M. Saugo andA.P. Dei Tos,‘Impact on colorectal cancer mortality of screening programmes based on the faecal immunochemical test’, Gut,64(5), May 2015, pp. 784790.

7. Zorzi, M., C. Senore, F. Da Re, A. Barca, L.A. Bonelli, R. Cannizzaro, R. Fasoli, L. Di Furia, E. Di

Giulio, P. Mantellini, C. Naldoni, R.Sassatelli, D. Rex, C. Hassan andM. Zappa,‘Equipe Working Group. Quality of colonoscopy in an organised colorectal cancer screening programme with immunochemical faecal occult blood test: the EQuIPE study (Evaluating Quality Indicators of the Performance of Endoscopy)’, Gut,64(9), Sept 2015, pp.1389-1396.

8. Brenner, H., A.M. Bouvier, R. Foschi, M. Hackl, I.K. Larsen, V. Lemmens, L. Mangone and S.Francisci,‘EUROCARE Working Group. Progress in colorectal cancer survival in Europe from the late 1980s to the early 21st century: the EUROCARE study’, Int J Cancer,131(7), Oct 1 2012, pp. 1649-1658.

9. Hassan, C., M. Bretthauer, M.F. Kaminski, M. Polkowski, B. Rembacken, B. Saunders, R. Benamouzig, O. Holme, S. Green, T. Kuiper, R. Marmo, M.Omar, L. Petruzziello, C. Spada, A. Zullo and J.M.Dumonceau,‘European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline’, Endoscopy,45(2), 2013, pp.

142-150.

Keeping the pressure on governments is crucial to save lives Nick THOMAS-SYMONDS mp Member of Parliament for Torfaen

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y mother, Pam Symonds – my wonderful Mam – was my inspiration in life and in politics. Her kindness, compassion and care for others shaped me in the most profound way. I lost her to bowel cancer on New Year’s Day: she died at home surrounded by her family’s love.

Almost two years before, on January 19th,2016 after a blood test, Mam had been told that she was likely to have cancer.

Ironically, that day, I had just contributed to a debate in Parliament on cancer drugs.

Mam never told me the news directly; when I learned what had happened from my wife, Rebecca, I knew there would be tough times ahead but could not have prepared myself for how difficult it was going to be.

Days later it was confirmed that Rebecca was pregnant.

I’d missed out on meeting my paternal grandmother, Mary, who had died five months before I was born. Mam was immediately worried about history repeating itself.

She was so close to my two young daughters, Matilda and Florence, and she told me that she just wanted to live to hold her new grandchild.

Mam had had symptoms for some months, and had been sent to a dietician; unfortunately, bowel cancer is often mistaken for other conditions, such as irritable bowel syndrome.

Once the blood test revealed the problem, the cycle of treatments began. There were the three gruelling rounds of chemotherapy.

Waiting for scan results was an agony in itself, not knowing if the news was good or bad. One chemotherapy session worked

partially then one worked well, and lengthened Mam’s life. Sadly, in April, 2017 the final round made her so ill that she could not continue the course. She faced this with great courage, cared for magnificently by my father, Jeff, and supported by all our family and friends.

Mam did at least live to see her first grandson, William, born in September, 2016.

William himself then suffered acute kidney failure at seven weeks old, and underwent five operations in four months.

Throughout this period, Mam always worried far more about him than herself, and it is a great comfort to me that she saw him flourish after his final surgery and was with us to celebrate his first birthday.

Mam was 70 when we lost her.

Arguing to improve screening will not bring her back, but I hope that it will spare other people the worst aspects of our family’s ordeal. For bowel cancer can be treated if caught at an early stage: with Mam, it had spread to her liver before it had been picked up. It was with these thousands of other families in mind that I secured a debate on bowel cancer screening in Parliament on May 1st, 2018.

Driving this issue up the political agenda is so important, and makes a difference.

As with many other fields of medicine, bowel cancer screening is becoming more precise.

The standard screening test was considered to be the faecal occult blood test—the FOB test—and all men and women between 60 and 74 received a home test kit, but that has been changing across the UK. The new, more sensitive, test is the faecal immunochemical test—the FIT test—which can

detect more cancers. This can be set to different sensitivity levels: as the argument is advanced for more sensitive test levels, enabling more and more traces of human blood to be detected, this has to be matched with an expansion of pathology and endoscopy services as more people are referred on for further investigation. Similarly, as we argue for the screening age to be lowered to 50, this additional investigative capacity is even more crucial.

In the UK, Scotland already screens people using the FIT test at age 50. The Welsh government is introducing the FIT from March, 2019. Bowel scope screening is available in some areas of England at 55, and I was promised by Steve Brine MP, the Parliamentary Under-Secretary for Health and Social Care, that the FIT test will be rolled out in the autumn: he told me in the debate I secured that: “as soon as I can give that date I will tweet it and tag him”. There is no devolved government in Northern Ireland at present, but I hope that there will be a decision soon for when the FIT test will be routinely available there.

Advancing these arguments, and keeping the pressure on governments, is crucial to save more lives. Yet, at the same time, we must also make the case for the tests being taken up. For participation rates remain an issue. We should send a very simple message to people that their bowel cancer screening test kits should not be ignored. I know only too well how tough it is to see those we love most suffer from this dreadful disease; let’s do all we can to improve things for everyone who could be affected.

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icps digital transformation europe 2018

How do we get the EU industry ahead with emerging technologies?

T

echnologies are having a profound impact in our economy and society, transforming products, processes and business models in every industry from construction, healthcare and agriculture to tourism and media. European industry can build on its digital supremacy and strong presence in traditional sectors to seize the range of opportunities that technologies such as the Internet of Things, artificial intelligence, big data, advanced manufacturing, 3D printing and blockchain technologies offer. Europe can immensely benefit from this revolution, as digitalisation of products and services can add more than €110 billion of annual revenue for our industry by 2020.

Currently, EU businesses are not taking full advantage of these emerging technologies or the innovative business models offered by the collaborative economy. The state of the digitisation of industry varies across sectors, particularly between high-tech and more traditional areas, and also between EU countries and regions. There are large disparities between large companies and SMEs. The Digital Transformation Scoreboard 2018 data analysis show that more member states perform considerably above the EU-28 average in terms of digital technology integration.

Northern and western EU member states score highest in terms of digital transformation.

Nevertheless, improvements are necessary for eastern and southern member states, which still lag behind.

At the International Centre for Parliamentary Studies, we share the vision of a greater digital Europe — one with a harmonised regulatory framework, one where investors have a longtermstrategy with focus of today and the future and one where businesses are not left behind due to lack of skills.

We brought together policymakers, industry leaders spearheading digital initiatives in their organisations and academics, in Brussels in March this year to discuss how to make European industry more digital and fit for the future. The objective of the event was to shape policy recommendations with a view to prepare Europe for digital transformation.

The event commenced by discussing strategies to reduce the disparities between sectors, member states, regions and companies.

Delegates took stock of the European Commission’s initiative on digitising European industry and addressed key policy challenges on digitalising Europe. Delegates agreed that

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we should build on the 15 national initiatives for digitising industry that have been launched across Europe in recent years, and ensure that actions taken by member states can complement and reinforce each other.

With value chains increasingly distributed across Europe, the further digitisation of industry brings challenges that

can only be addressed through a coordinated EU-wide effort. Seven more initiatives are under preparation. Europe needs to join forces under a common strategy that takes digitalisation of the EU’s economy forward in order to unlock the full potential of the 4th industrial revolution.

It is expected that €50 billion of public and

private investments will be mobilised in support of the digitalisation of industry, facilitated by linking national initiatives addressing digitalisation and related services. The EU Commission also aims to invest €500 million in a pan-EU network of digital innovation hubs (centres of excellence in technology) where businesses can obtain advice and test digital innovations.

To reinforce the EU’s competitiveness in digital technologies, the DEI initiative should support both the development of digital industrial platforms and large-scale piloting and Public-Private Partnerships (PPPs) that provide the digital technology building blocks of the future.

Major recommendations and findings of the roundtable were as

follows: 1. The explosion in the use of digital technologies is changing the dynamics of competition in many industries, and Europe should make the best of this opportunity to make European industry more digital and fit for the future.

2. The level of digitisation widely varies according to size of company,

sector and region. Small and medium enterprises (SMEs) represent 99% of the economic fabric of Europe but only 1 in 5 are currently digitised.

As SMEs constitute the backbone of the European economy, a primary objective of EU investment must be to help SMEs in the digital transformation process.

3. As 5G is bound to

change the productivity and transform many industries, it is crucial to speed up the work on standardisation and stimulate 5G trials. We need to know more about 5G, as a unique system, and about all its technical challenges. It is time for all partners, and the European Commission in cooperation with industries and research institutions to test and retest solutions related to: the network latency and responsiveness, increased network capacity and data rate requirements.

A harmonised spectrum allocation is a necessary condition for the successful implementation of 5G. 4. AI is the next big thing and there is a need to maintain European human values. Europe should take the lead at the global level in setting the framework for the responsible development and use of AI, by developing a code of ethics and clarifying applicable laws and regulations.

5. The EU has more digital specialists than before but skills gaps remain. To make the most of the digital transformation we must ensure that all Europeans are ready for these changes.

Technologies change exponentially and can also be used to accelerate digital skills. Adapting the workforce and our education and learning systems, together with major investments in reskilling citizens are needed. The first key challenge is to enlarge offers for tomorrow’s industries, train in tomorrow’s skills, and bolster cooperation in

Europe and internationally.

6. Member states and regions play a key role in establish Digital Innovation Hubs (DIHs) that support the digital transformation of the industry in their regions.

The hubs would need to expand their tasks and need to invest in reaching out to companies that are not yet thinking about their digital transformation. This is quite often done by expanding the ecosystems with other actors that are already active in that domain.

7. Europe should not be reliant on other countries and there is a need to do more as technologies are accelerating. Top priorities for coming years will be strengthening the strategy for Cybersecurity, Artificial Intelligence, 5G, Internet of Things, Big Data, Quantum Computing, HighPerformance Computing, Microelectronics and Nanoelectronics.

8. Europe needs to be autonomous with respect to future solutions and there will be interconnection between all industrial suppliers.

There is a need for strategic autonomy and to support this, regulations on digital technologies in Europe need to be addressed in a coordinated way.

Overall, there is a need to unite and stand together, and promote European competitiveness.

Government Gazette | 69

HIV REPORT A new vision in the fight against HIV & AIDS

State of the epidemic at a glance

Its time to accelerate our efforts

1.

Reductions in AIDS-related deaths continue at a pace that puts the 2020 milestone within reach.

We have done much; we have not done it all. When there are evidence-based approaches to revert the course of the HIV epidemic in our Region, we cannot afford doing ‘business as usual.’

2.

The global rate of new HIV infections is not falling fast enough to reach the 2020 milestone.

We need urgent collective action in line with the 2030 Agenda for Sustainable Development and other global and regional policy frameworks. We will not be able to attain the Sustainable Development Goals if we do not manage to reverse the incidence of HIV and curb its epidemic.

3.

As deaths decline faster than new HIV infections, the number of people living with HIV has grown to 36.9 million [31.1–43.9 million].

4.

The collection and analysis of more granular data is needed to guide efforts to reach key populations with services.

5.

New epidemic transition measures show whether countries and regions are on the path to ending the AIDS epidemic.

We have the tools and power to lead the way to end AIDS ahead of 2030. We already observe promising trends in several countries of our Region. I am confident that with sustained implementation of evidence-based approaches to prevention, testing, treatment and care, the number of new HIV infections will decrease. In collaboration with partners, WHO is supporting countries to make this a reality.

Dr. Zsuzsanna Jakab, WHO Regional Director for Europe

What’s inside How can Europe fast-track its commitment for HIV and AIDS? iCPS HIV/ AIDS Europe Roundtable 2018 Behind the scenes at this year’s European Testing Week Ben Collins and Valerie Delpech, Co-chairs, European Testing Week Time is running out to reach UK’s vision of getting to zero Ian Green, Chief Executive, Terrence Higgins Trust Europe should start preparing for PreP Prof Sheena McCormack, Professor of Clinical Epidemiology, UCL A new perspective on HIV Prof Jeffrey V. Lazarus, Associate Professor, University of Barcelona Protecting public health through the Abbott Global Surveillance Program Mary Rodgers, Senior Scientist, Abbott HIV healthcare and prevention in Norway under pressure Leif-Ove Hansen, Chair, HIVNorway Quality of Life – A realistic ambition for HIV care across Europe Stephen Rea, Head of External Affairs and Communications, ViiV Healthcare AHF Europe calls for rapid HIV testing Anna Zakowicz, Europe Deputy Bureau Chief, AHF Sweden faces new challenges – how do we reach sustainable health?

Peter Manehall, Ombudsman, HIV Sweden

iCPS HIV/AIDS EUROPE 2018

CALL FOR ACTION Europe should expand the uptake of PrEP, the use of anti-HIV drugs by at-risk, HIV-negative individuals to keep from becoming infected Policymakers should support testing and sustain efforts to identify HIVpositive individuals as soon as possible and offer them antiretroviral treatment We need to upscale involvement of the HIV community in priority setting at country level Europe should adopt an integrated, outcomes-focused, and patient-centred approach to long-term care Finally, we should expand national monitoring of long-term care and outcomes, fund studies to provide information on the long-term health of people living with HIV and combat stigma and discrimination within health systems

AIDS is our number one enemy.

This enemy can be defeated.

Four principles — love, support, acceptance and care for those affected—can make us winners. nelson mandela

Europe is at the halfway point to the 2020 targets; the pace of progress is not matching the global ambition. While we have done much; we have not done it all. Now is the time to accelerate our efforts and come up with a more inclusive rightsand evidence-based HIV response. iCPS brought together key stakeholders to fast-track Europe’s efforts and scale=up access and provisions of antiretrovial treatment.

www.governmentgazette.eu | 72

How can Europe fast-track its commitment for HIV and AIDS?

I

n Europe, access to HIV treatment and care has been improving over the past few years.

However, coverage with antiretroviral treatment remains very low in countries of eastern Europe and central Asia (EECA) (28% in 2016, compared to 76% in western and central Europe), and late diagnosis – affecting the WHO European Region overall and EECA in particular – delays

the start of lifesaving treatment, leading in turn to more deaths and disease.

In 2014, UNAIDS set the target of ending the HIV epidemic by 2030.

They estimated that this was possible if the so-called “90-90-90” targets for engagement with key stages in the HIV care continuum were achieved by 2020: 90% of individuals with HIV diagnosed; 90% of diagnosed individuals on ART; 90% of ART-

treated individuals virally suppressed.

Today, Europe is close to achieving the UNAIDS 90-90-90 target, according to research published in the Journal of Acquired Immune Deficiency Syndromes.

To support European countries in scaling up antiretroviral treatment and care, and to analyse the current policy guidelines and strategies on combating HIV/AIDS in the EU and member states, the International

Collaboration between civil society and national institutions is key

By Vitaly Djuma, Executive Director, Eurasian coalition on male Health

I

f the history of the HIV epidemic has taught us one thing, this would be that a sustainable HIV response is only possible with concerted efforts of non-governmental organisations (NGOs) and communities from one side, and national governmental systems from the other.

Communities and community-based organisations of gay men and other men who have sex with men (MSM) have vast experience with piloting successful interventions; however, rolling them out at a wider scale is only possible with legislative and financial support from governments.

Centre for Parliamentary Studies (iCPS) recently hosted a policy roundtable in Brussels on March 20th, 2018.

The roundtable gathered regional and national experts and civil society groups engaged in scaling up access and provisions of antiretroviral treatment, as well as public health experts working in the field of HIV treatment and care from across the region.

A supportive, safe

and enabling policy environment is fundamental to reducing the global impact of HIV. However, there is no question that the gap between the creation of international and national HIV policy and the lives of those fighting the epidemic in communities around the world is often too wide.

The success of the global AIDS response hinges on greater alignment across these two areas and ensuring that people-

centred policy reflects the needs and desires of those whose lives it most directly affects.

Despite their increasing number and efficacy, biomedical interventions alone will not be enough to bring an end to the epidemic.

Vulnerability to HIV and limited access to health services are driven by persistent structural barriers, including stigma, discrimination, criminalisation and violence.

Recent examples of this cooperation in the WHO European Region include the nationwide introduction of preventive measures such as preexposure prophylaxis (PrEP) in France, Norway and Belgium, which has been advocated for by gay communities and is now funded by national health systems. In Ukraine, representatives of gay and MSM communities are equal partners in the National HIV Coordinating Council, which sets up strategies and directions for the national HIV response. In Georgia, the National Centre for Disease Control (NCDC) works hand in hand with community-based lesbian, gay, bisexual and transgender (LGBT) organisations, including Equal Movement and Tanadgoma, to tackle the alarming 22% HIV prevalence among MSM in the country. While NGOs work directly with communities to raise awareness and to mobilise and provide prevention and referral services, the NCDC ensures medical interventions including antiretroviral drugs for treatment and PrEP. We need these good examples to be replicated throughout the whole region to defeat HIV by 2020.

Government Gazette | 73

Is there a prevention crisis?

A

ccording to UNAIDS, the number of AIDSrelated deaths is reportedly the lowest this century, with fewer than 1 million people dying each year from AIDS-related illnesses, thanks to sustained access to antiretroviral therapy. Three out of four people living with HIV now know their status—the first step to getting treatment.

And now a record 21.7 million people are on treatment—a net increase of 2.3 million people since the end of 2016. The scale-up of access to treatment should not be taken for granted, though. In the next three years an additional 2.8 million people must be added each year, but there are no new commitments to increase resources, there is an acute shortage of healthcare workers and there is

Delegates 2018 Scientific Director EMEA, Abbott Molecular; Europe Bureau Chief, AIDS Healthcare Foundation - AHF Europe; Europe Deputy Bureau Chief, AIDS Healthcare Foundation - AHF Europe; Senior Vice President Global Access, Cepheid; Policy Officer, European AIDS Treatment Group - EATG; Policy Officer, European Commission - DG SANTE; Director of North-North Cooperation, European & Developing Countries Clinical Trials Partnership (EDCTP); Executive Director, European & Developing Countries Clinical Trials Partnership (EDCTP); Assistant to MEP Daniele Viotti, European Parliament; Head of Division Communicable Diseases, Federal Office of Public Health; Chair of the Board, GAT; Executive Director, The Global Network of People Living with HIV (GNP+); Director of Programmes, Regional expert for Europe, The Global Network of People Living with HIV (GNP+); Chair, HivNorway; Representative, Hellenic Centre for Disease Control and Prevention; Representative, HIV Outcomes initiative; Researcher, Inserm; International HIV/AIDS Policy, Institute of Tropical Medicine Antwerp; Deputy Head Infectious Diseases Research Unit, Luxembourg Institute of Health, Department of Infection and Immunity; MEP, LGBTI Intergroup - European Parliament; Manager of GF HIV Program, National Center for Disease Control and Public Health; Member, NPS Italia Onlus; Advisor to the Vice Prime Minister of Ukraine, Office of the Prime Minister; Analyst, Public Health Agency of Sweden; Director Marketing, Strategic Accounts & Public Health EMEA, Qiagen; President, Qazaq association “Equal to Equal” ; Head of Infectious Diseases Departement and of Clinical Trials at ANRS, StLouis Hospital, ANRS and University of Paris Diderot; Chief Executive Officer, TZL Executive Director of Digital and Communications, Terrence Higgins Trust; Head of AIDS Reference Centre, University Hospital Erasme; Technical Officer, Unitaid; Associate Professor, University of Barcelona; Director, Global Strategic Projects UNAIDS 90-90-90, ViiV Healthcare; Senior Advisor, HIV/AIDS Department and Global Hepatitis Programme, World Health Organization; Technical officer, Joint TB, HIV and viral hepatitis programme Division of Health Emergencies & Communicable Diseases, World Health Organization Regional Office for Europe

www.governmentgazette.eu | 74

continuing stigma and discrimination.

There is a prevention crisis. The success in saving lives has not been matched with equal success in reducing new HIV infections. New HIV infections are not falling fast enough.

HIV prevention services are not being provided on an adequate scale and with sufficient intensity and are not reaching the people who need them the most.

Acceptance of condoms, voluntary medical male circumcision, preexposure prophylaxis, cash transfers must be increased rapidly and not be secondary prevention tools. And I await the day when there is a functional cure and a vaccine against HIV. Children are being left behind.

The good news is that 1.4 million new HIV infections have been averted since 2010, but I am distressed by the fact that, in 2017, 180 000 children became infected with HIV, far from the 2018 target of eliminating new HIV infections among children. While the overall HIV treatment level is high, there is a huge injustice being committed against our children—only half of under-15s living with HIV were being treated last year. Stigma and discrimination still has terrible consequences.

The very people who are meant to be protecting, supporting and healing people living with HIV often discriminate against the people who should be in their care, denying access to critical HIV services, resulting in more HIV infections and more deaths. It is the responsibility

of the state to protect everyone. Human rights are universal—no one is excluded, not sex 3 workers, gay men and other men who have sex with men, people who inject drugs, transgender people, prisoners or migrants. Bad laws that criminalize HIV transmission, sex work, personal drug use and sexual orientation or hinder access to services must go, and go now.

Women and girls continue to be disproportionately affected. It is outrageous that one in three women worldwide has experienced physical or sexual violence.

We must not let up our efforts to address and root out harassment, abuse and violence.

Policy recommendations 1. EU countries that have more capacity should help eastern and central European countries in providing evidence from research.

2. Existing vaccines against HPV don’t have a policy in Europe. It is a priority and we need to stress for merging these and call for a new vaccine.

3. We need to have evidence of what works and what doesn’t. There’s a need for evidence based results and organised data sharing.

4. More EU/EEA member states report that coverage and uptake of comprehensive prevention interventions are not reaching enough people to impact the number of new infections. Europe should expand the uptake of PrEP, the use of anti-

HIV drugs by at-risk, HIV-negative individuals to keep from becoming infected.

5. Policymakers should supporting testing and sustain efforts to identify HIV-positive individuals as soon as possible and offer them antiretroviral treatment.

6. Europe should adopt an integrated, outcomesfocused, and patientcentred approach to long-term care.

7. There’s a need to improve retention in care for those who are HIVpositive.

8. Organisations should increase awareness among risk groups and increase access for these people for health services to drive down better HIV outcomes.

9. Stigma has a harmful effect on everything from

Civil society relies on public funding to provide effective harm reduction services

By Ganna Dovbakh, Executive Director, EHRA

H

arm reduction is not just about distributing syringes and needles or implementing other HIV prevention activities. It is about civil society peers becoming the most effective vehicle between people using drugs and health and social services.

In order for harm-reduction services provided by civil society to be sustainable and effective, it is crucial to secure domestic funding and to have the cooperation of local authorities. This applies to testing and treating of HIV, TB and hepatitis, as well as to supporting employment and social integration of people who inject drugs.

Good examples from the European region include the Czech Republic and Estonia, who support a full package of services for people using drugs, and cities such as Riga (Latvia) and Porto (Portugal), which provide drug users with effective referral systems. In Portugal, for example, instead of imprisonment and punishment, the provision of comprehensive social support for people leads to HIV prevention and treatment as well as to reintegration in social life. This mix of nonrepressive drug policy and effective healthcaresaves costs for local communities. The Eurasian Harm Reduction Association (EHRA) is now trying to transfer the Portugal and Czech approaches to other countries in eastern Europe.

prevention to diagnosis and treatment. Therefore fighting stigma and discrimination against people living with HIV and key populations remains high on the agenda.

10. We need to upscale involvement of the HIV community in priority setting at country level.

11. We should expand national monitoring of long-term care and outcomes, fund studies to provide information on the long-term health of people living with HIV and combat stigma and discrimination within health systems.

12. Besides prevention, testing and treatment, we need strong and visionary declarations, fully funded NGOs and a political will.

13. It is essential to

continue working with partners across the HIV community to better understand and address the evolving medical and social challenges affecting PLHIV. 14. Finally, better education of patients, healthcare providers and policymakers is needed to inform them about the need for a continued investment at all levels.

From 29 countries of central and eastern Europe and central Asia, members of EHRA are ready to collaborate with national and local authorities to make services available and protect rights.

However, with the ongoing changes in the nature of the drug scene and the increasing use of new psychoactive substances, we also need to learn new ways for health and social services to meet the new needs of drug users and provide universal health coverage.

We are learning, for example, how to provide harm-reduction counselling online, how to build cooperation with ambulance and mental health specialists, and how to procure new distribution materials and drug tests to reduce health risks from using new drugs. From health and social authorities in countries we expect flexibility and understanding of people’s needs. We are willing to make everything possible to save lives.

Government Gazette | 75

healthcare

Towards a zero HIV strategy

Ben COLLINS

Co-chair, European Testing Week

Valerie DELPECH

Co-chair, European Testing Week

Behind the scenes at European testing week settings (e.g. in bars, on the street, etc), lobbying with policy makers, engaging with local media, and training/ capacity building.

T

he WHO European Region is the only region where rates of new HIV infections are increasing, with almost 80% of people newly diagnosed each year living in Eastern Europe and Central Asia (EECA). HIV continues to affect vulnerable keypopulations including people who inject drugs (PWID), men who have sex with men (MSM), transgender people, sex workers, prisoners and migrants.

Of the newly diagnosed, over half (51%) are diagnosed with a CD4 below 350 copies/ mL, meaning they were possiblyunaware of their infection and were diagnosed only after several years.1Late presentation can result inpotential risk of onward transmission, poorer long-term health outcomes due to delay in treatment and higher

www.governmentgazette.eu | 76

health care costs.

Viral hepatitis B (HBV) and C (HCV) are also major health challenges in WHO Europe, affecting 15 million and 14 million people respectively. , Chronic HBV and HCVcan cause severe complications including cirrhosis and liver cancer.3,4 Coinfection with viral hepatitis is common among people at risk ofand living with HIV due to common modes of transmission, through condomless sex and sharing of injecting equipment.

European Testing Week In 2013, European Testing Week (ETW) was launched by HIV in Europeand has grown into amultifaceted awareness campaign that encourages community, health care and policy organisations throughout Europe to unite for one week to increase HIV and hepatitis testing

efforts and promote the benefits of earlier testing.

During 23-30 November 2018, more than 700 organisations from across 50 countries took part.

ETW provides information, at both scientific and community levels, to support local and regional activities for safe and voluntary testing for all, especially key populations. It has an active public online platform where partners register and use social media to promote their ETWrelated events, testing advocacy and interact with local/international communities.

There is no minimum participation requirement and the organisation coordinates their own activities. Novel and best practices are collected through an annual evaluation and showcased through the ETW website. Examples include outreach testing in unconventional

ETW partners with the European Centre of Disease Prevention and Control and AIDS Map to create and maintain the European Test Finder, an online search engine, in 16 languages, where users find their nearest testing centre for HIV, hepatitis and sexually transmitted infections (STIs). The European Test Finder aims to increase visibility and access to testing services.

Impact of European Testing Week In the yearly postETW online survey, participants are asked to record their testing efforts, successes and challenges.

Over the past 3 years (2015-2017) participants have consistently reported a 50% or more increase in HBV, HCV and/ or HIV testing during ETW compared to their average week with specific increases among key populations such as MSM and younger populations.In addition in 2017,participants reported increases in activities among people presenting with an STI (other than HIV), migrants originating from countries with generalised HIV/HBV/ HCV epidemics and people with indicator conditions for HIV. A major challenge is

the lack of political and government engagement in European Testing Week One in eight participants in the evaluations conducted over the past 4 years consistently identify lack of political and government support as a major challenge.

Shortage of funds is also reported particularly by community organisations.

ETW has also developed materials to support advocacy and collaborations with policy makers and in 2017, supported a joint statement by aboration to ensure access to safe, confidential and voluntary HIV and hepatitis testing for key populations and all.

With increasing focus on joint efforts to encourage integrated testing and prevention efforts, particularly through the EU-funded INTEGRATE Joint Action and the new ECDC public health guidanceon integrated testing for HBV/HCV/ HIV, ETW aims to continue supporting combined testing efforts to increase and promote testing strategies that reduce late diagnosis andare culturally sensitive to key populations and reduce stigma and discrimination.

ETW is keen to work with government institutions toadopt a public health and evidence-based approach to HIV and hepatitis testing.

Government institutions can sign up for ETW at testing week.eu.

Ian GREEN

Time is running out to reach UK’s vision of getting to zero

Chief Executive

W

e are at a pivotal moment for the HIV epidemic in the UK. For the first time, we have in our reach the opportunity to end new HIV infections. That’s why, for this World AIDS Day, our focus at Terrence Higgins Trust was ‘Zero HIV’.

We need to see the UK commit to the ambitious but achievable aim of zero new HIV transmissions and the end of HIV-related stigma.

Because we won’t do one without the other.

In the UK, we are making great progress – we have seen new HIV infections reduce by 28% since 2015, driven by a 31% decline in new diagnoses in gay and bisexual men. London as a city has seen a 44% reduction in new diagnoses in that group and now have met the UNAIDS 90-90-90 targets, which means 90% of people living with HIV are diagnosed; 90% of those are on treatment; and 90% of those on treatment have an undetectable viral load, which means they can’t pass on HIV. We know what we have to do to end HIV in most groups and combination prevention is key. At Terrence Higgins Trust we have been at the forefront of piloting innovative testing programmes including HIV self-testing, where you test at home and get a result within 15 minutes, and distributing HIV tests through ‘click and collect’ delivery –like picking up any other product you buy online. Our aim is to fully normalise HIV testing.

We also work hard to utilise both digital and face to face opportunities to reach communities most affected

by HIV. For example, our national prevention programme uses the most up to date social marketing evidence to target health promotion messages using social media. While across the UK, organisations arereaching out to communities at greater risk of HIV, in churches, bars and at football matches.

HIV treatment is a huge success story.

We now have the robust evidence to say that people living with HIV and on effective treatment can’t pass it on – which is instrumental when it comes to both preventing new transmissions and

eliminating HIV stigma.

That’s why we launched our Can’t Pass It On campaign – explaining in clear, simple language this incredible breakthrough.

But it’s not ‘job done’ in the UK. Progress is not equitable, with some areas of the UK and some groups seeing slower progress in ending new HIV infections. Similarly, new outbreaks – including in people who inject drugs in areas of Scotland –are continuing.

Disappointingly, despite the potential to ‘get to zero’, no UK country has committed to actually doing it. 90-90-90 is still the goal – but that is likely to be achieved in the UK in the next year or so and isn’t ambitious enough.

There is no national strategy in England setting out what needs to happen and who is responsible, despite being the country in the UK which sees by far the highest number of new HIV diagnoses.

A mainstay of HIV testing in the UK remains sexual health clinics. In England, demand has risen 13% – while the budget is being cut by a quarter.

Austerity and cuts by national governmentare having a direct impact on the potential to end HIV. Similarly, in Wales, some areas are still without a sexual health service, meaning long journeys to access basic HIV prevention interventions.

Pre-Exposure Prophylaxis (PrEP) is a pill you can take to prevent HIV and a game-changer as we work towards zero.

However, despite being almost 100% effective when taken as prescribed and being far cheaper than a lifetime of HIV treatment, PrEP isn’t universally available in England. Instead, it’s provided through a capped three-year trial and at least one person who was denied access has now tested positive for HIV. In Wales, we are seeing high numbers of individuals decline PrEP,

We need to see the UK commit to the ambitious but achievable aim of zero new HIV transmissions and the end of HIV-related stigma.

while in Scotlandthere are waiting lists in some areas.

Information is key.

We and our partners have been pushing to make sex education compulsory in all schools. In Wales and England, the governments have now made this commitment.

But there is a way to go until all schools provide the quality education on HIV and sexual health needed to protect themselves and others from HIV transmission.

We have the opportunity to end HIV transmissions in the UK, but are we doing everything to get there? No –because HIV has gone down the priority list.That’s why the very real worry is that the incredible progress that has been made is at risk of being undone.

And why we must urgently see UK countries commit to ending new HIV infections, produce clear national strategies on how they are going to get there, and invest in HIV and sexual health services so that this can be achieved.

We want to see the UK be the first country to get to zero HIV – but we need action.

Government Gazette | 77

healthcare

Towards a zero HIV strategy

Prof Sheena McCORMACK Professor of Clinical Epidemiology; MRC Clinical Trials Unit

Europe should start preparing for PrEP

I

n October, 2018 the EPIC research team from New South Wales, Australia, reported a substantial reduction in new HIV infections at population level following the rapid roll-out of pre-exposure prophylaxis (PrEP).

PrEP differs from postexposure prophylaxis – taking anti-HIV medicines after a risk of exposure to HIV – as the drugs are taken in anticipation of risk.

Currently there is only one combination of antiHIV medicines licensed for use as PrEP: tenofovir disoproxil combined with emtricitabine. However, this combination is available from several manufacturers.

The HIV epidemic in many European countries resembles the Australian epidemic. New infections acquired in-country are concentrated geographically and by acquisition group, with men who have sex with men (MSM) living in large conurbations most affected.

Australia has achieved a higher level of testing than Europe in MSM, following successful testing campaigns and an immediate offer of treatment. www.governmentgazette.eu | 78

The HIV epidemic in many European countries resembles the Australian epidemic. New infections acquired in-country are concentrated geographically and by acquisition group, with men who have sex with men (MSM) living in large conurbations most affected. Australia has achieved a higher level of testing than Europe in MSM, following successful testing campaigns and an immediate offer of treatment so that individuals are noninfectious within a few months. In spite of this, the rate of new infections in MSM has been constant for several years in New South Wales.

In this setting, PrEP was able to reduce the new infectionsat populationlevel by50% in the gay suburbs of

Sydney and rural New South Wales. There was little impact on the non-gay suburbs of New South Wales for reasons that are not fully understood.Similar gains have been seen in the UK with the introduction of informal PrEP through self-purchase, particularly in London where testing and treatment were already at a high level and the epidemic in MSM was driven largely by individuals who had recently acquired HIV and believed themselves to be HIV negative.

As long ago as April,

2015 the European Centre for Disease Prevention and Control (ECDC) advised European Union member states to consider integrating PrEP in their existing HIV prevention package for those most at risk, starting with MSM. This followed the results of the PROUD and Ipergay studies, conducted in MSM in England and France respectively.

Both observed an 86% reduction in HIV infections within the studies, and zero infections in individuals

taking PrEP at the time of likely exposure.

Although these studies provided robust support for the biological effectiveness of PrEP, there was residual scepticism about the population benefit amongst public health practitioners.

Nonetheless, efforts to integrate PrEP began with France leading the way in January, 2016 and implementing a national programme.

Norway followed, and then Belgium, but other countries waited until

Fig 1: PreP implementation in Europe HIV requires a life-time of treatment and is an infection associated with co-morbidities including cardiovascular disease, diabetes, other infections such as TB and hepatitis, and depression.

Furthermore, HIV impacts the young with high rates of acquisition observed in MSM under 25 years of age. Other groups that are affected

by HIV include people who inject drugs and those in socio-sexual networks that include individuals who have migrated from countries where HIV is common.

they could purchase the generic drug at considerably reduced prices, and most have yet to offer PrEP in their national HIV prevention package, so progress has been slow. The cost of the drug has been the largest obstacle and the range in prices that governments are currently paying (€50 to €428 for 30 pills) is frankly shocking. Where and how to deliver PrEP is also cited as a barrier, and there is little sense of urgency in countries where the number of new HIV infections each year is low in comparison to

the burden from other diseases.

HIV is paying no attention to Brexit and has no respect for borders – getting to zero HIV infections that could be prevented in Europe is a shared goal that should unite us

Whilst governments delay, there has been substantial informal PrEP use through self-purchase from online pharmaciesto fill the gap,but this includes individuals who have had no tests and do not know their HIV status.

Now that we know there is a substantial population benefit, it is time for EU member states with epidemic patterns similar to New South Wales to shake off their apathy and embrace PrEP. Why? Because

These two groups may also benefit from PrEP, but the more pressing needs are adequate services for needle exchange and opiate substitution therapy for people who inject drugs, and more generally to increase HIV testing and the offer of immediate treatment.

with HIV. Secondly to put in place a more equitable pricing for drugs and vaccines used for prevention as these are funded from public health budgets which have limited funding.

HIV has no respect for borders – getting to zero HIV infections that could be prevented in Europe is therefore a shared goal. We have the tools and it is the right thing to do – the Australians have shown us how effective a partnership between civil society, politicians and healthcareproviders can be, so let us follow suit in Europe.

With this in mind, there are a number of steps EU governmentscould take to accelerate efforts to control HIV, as we have the tools to achieve this in Europe. Firstly to make the necessary legislative changes to enable self-testing for HIV,nurse-prescribing, and treatment for undocumented immigrants living Government Gazette | 79

healthcare

Towards a zero HIV strategy

a new perspective on hiv

Long-term health, well-being and chronic care Prof Jeffrey V. LAZARUS Associate Professor

be a long-term condition, but one which poses very specific health and wellbeing challenges. These challenges include but are not limited to: • An increased risk of developing a range of other health conditions (comorbidities); • Reduced quality of life due to the impact of long-term treatment, drug side- effects, and multiple comorbidities; and • Stigma and discrimination, both within the health system and outside of it, which can in turn result in mental health conditions, social isolation and loneliness.

T

Having addressed the issue of longevity, society now needs to help people with HIV to retain good health and lead rewarding lives. www.governmentgazette.eu | 80

he nature of the HIV epidemic has changed. As a result of advances in antiretroviral therapy (ART), HIV need no longer be a fatal disease.

For people living with HIV (PLHIV) who are diagnosed early and receive effective ART to suppress viral replication, HIV has become a chronic condition, with lifespan approaching those of the general population. However, a long life expectancy is not the same as living in good health and with a good quality of life. The evidence is that for many PLHIV this is currently not the case.

The HIV Outcomes multi-stakeholder initiativearose out of a shared recognition among leading HIV experts that a new perspective is required that recognises HIV to

European health systems need to develop effective, lifelong approaches to the treatment and care of PLHIV. In some health systems, such action is already being taken.

HIV, clinicians, public health professionals, and the wider HIV community.

Two expert roundtables were held (December, 2016 and June, 2017) to identify priority issues in relation to the long-term health and well-being of PLHIV. In September, 2017 an expert workshop was used to develop and discuss draft recommendations.

The recommendations were then launched at the European Parliament on November 29th, 2017with cross-party support from Members of the European Parliament (MEPs) Christofer Fjellner (European People’s Party, Sweden), Eva Kaili (Socialists and Democrats, Greece) and Gesine Meißner (Alliance of Liberals and Democrats for Europe, Germany).

However, further work is needed to upscale, coordinate and mainstream those actions. Best practices should be shared and disseminated not only among HIV specialists, but also to contribute to wider debates about the management of complex conditions.

In a joint statement, the hosts said that: “Having addressed the issue of longevity, society now needs to help people with HIV to retain good health and lead rewarding lives. As representatives of the European Parliament’s leading political groups, we fully support the aims of this initiative.”

To this end, the HIV Outcomes initiative developed a series of recommendations: “A New Perspective on HIV: Long-term Health, Well-Being, and Chronic Care”, which aim to inform and inspire the development and adoption of such new approaches and policies.

The recommendations are the outcome of a year-long collaborative process to capture the perspectives and expertise of people living with

Delivering the keynote address at the November event, European Health Commissioner, Vytenis Andriukaitis, emphasised that while HIV need no longer be a fatal disease, it “still damages the lives of so many people, and causes not only much suffering and illness, but also discrimination and stigmatisation.” On the occasion of World AIDS Day 2017, the Commission called for increased efforts to improve long-term health

outcomes for PLHIV. IhorPerehinets of the Division of Health Systems and Public Health at WHO Europe said that broader health system reforms are needed to fully implement the HIV Outcomes recommendations.

To address the challenges posed by long-term chronic disease and multi-morbidity, to which HIV Outcomes draws attention, progress is needed in the implementation of integrated care – an area where WHO provides advice and support to its member governments.

UNAIDS also participated in the launch. Peter Ghys, Director of the Strategic Information Department said that the recommendations are highly relevant to all countries, and particularly those that have already made progress with the 90-9090 targets.

The content of the recommendations, which should be reflected in any future national and European level HIV strategies, aim to complement other initiatives focusing on HIV prevention, diagnosis, and universal access to treatment and care, where significant efforts are still needed in many European countries.

It is the intention for the recommendations now to be disseminated at national level, with a view to identifying best practices as well as recurring challenges in improving both quality of care and quality of life for PLHIV.

Mary RODGERS Senior Scientist

Protecting public health through the Abbott Global Surveillance Program

A

ccurate blood screening and diagnostic test results are critical to patient care and safeguarding the blood supply. Since the first HIV test was developed at Abbott and licensed by the FDA in 1985, the risk of transfusiontransmitted HIV infections has been reduced from 1 in 90 in some US cities to 1 in 2 million(Busch et al., 1991; Zou et al., 2010). However, with increased global travel, military deployments, and immigration, the geographical footprint of rare HIV-1 strains is expanding(Beloukas et al., 2016; Oster et al., 2017).

Profound genetic diversity is found amongst HIV strains, with two major types (1 and 2) and HIV-1 consisting of 4 groups (M, N, O, and P). The pandemic group M includes nine subtypes and currently 96 circulating recombinant forms (CRFs).This extensive sequence heterogeneity is a challenge for the design of blood screening and diagnostic tests, which fundamentally rely upon sequence conservation.

Therefore, vigilant global surveillance of divergent HIV strains is an imperative first step to ensuring that all infections can be detected regardless of strain or geographic location.

The Abbott Global Surveillance Program (AGSP) is the most extensive viral surveillance program of its kind. The AGSP was established in 1995 after nearly a decade of previous research in HIV. Since then, the program has collected more than 67,000 clinical specimens from 40 different countries on six continents through collaborations with hospitals, research institutions,

By employing random hexamers or HIV-sequence specific primers to generate NGS libraries, complete genome sequencing has identified regions of recombination that would have otherwise been missed by subgenomic sequencing(Berg et al., 2015; Luk, 2015; Rodgers et al., 2017a). Importantly, these are universal approaches that do not require a priori knowledge of the group or subtype of HIV in a sample, which makes them excellent tools for viral surveillance.

blood banks, and public health agencies(Brennan et al., 2006).

Characterisation of HIV and hepatitis viruses (eg, HCV, HBV) from these specimens has resulted in more than 5,000 new viral sequences and 85 peerreviewedpublications. These AGSP sequences and specimens serve as the foundation for the development of HIV and viral hepatitis assays that can tolerate viral diversity. Most notably, some of the rarest strains of HIV have been identified and sequenced through the AGSP including11/17 sequenceconfirmed Group N infections identified to date(Bodelle et al., 2004; Rodgers et al., 2017b; Rodgers et al., 2018; Vallari et al., 2010; Yamaguchi et al., 2006a; Yamaguchi et al., 2006b). Likewise, one of the two known Group P infections was discovered within the AGSP specimen library(Vallari et al., 2011). Although the Abbott ARCHITECT HIV Combo Ag/Ab and RealTime HIV-1 tests were designed prior to the discoveries of these divergent strains of HIV, both tests readily detected Groups N and P infections without any modification, illustrating the importance of a robust viral surveillance program for assay development (Rodgers et al., 2018).

High levels of viral diversity and co-infection have been encountered in AGSP studies conducted in Africa.In one AGSPstudy recently completed in South Cameroon, a hotspotfor newly emerging strains of HIV and HTLVwith the potential to spread globally due to the close proximity of humans to non-human primates, amongst 13,700 participants we identifieda diverse set of HIV infections: 7 HIVGroup M subtypes,25 Group O, 2 Group N, 12 CRFs and 27 unique recombinant forms (URFs) (Rodgers et al., 2017b).

As the HIV pandemic continues to evolve, recombinant strains of HIV are becoming increasingly common (Beloukas et al., 2016; Oster et al., 2017). To accurately characterise the full depth of HIV genetic diversity, the AGSP has recently developed sensitive methods for generating full length genome sequences using next generation sequencing (NGS) technology (Berg et al., 2015; Luk, 2015).

References

Furthermore, a rare HBV AE recombinant was identified and the fifth known HTLV3 infection was confirmed.

Importantly, all of the samples carrying these strains were detected by serological assays on the ARCHITECT instrument (Rodgers et al., 2017b). The characterisation of these emerging strains highlights the need for continued HIV/HBV/ HTLV surveillance to ensure diagnostic tests and research keep pace with viral evolution.

As the only diagnostic test manufacturer with such a unique long-standing and large-scale surveillance program, Abbott provides a vital tool to stay ahead of these dynamic viruses.

1. Beloukas, A. et al., ‘Molecular epidemiology of HIV-1 infection in Europe: An overview’, Infect Genet Evol 2016.

2. Berg, M. G. et al., ‘A Pan-Hiv Strategy for Complete Genome Sequencing’, J Clin Microbiol, 2015.

3. Bodelle, P. et al., ‘Identification and genomic sequence of an HIV type 1 group N isolate from Cameroon’, AIDS Res Hum Retroviruses, 20 (8), 2004, pp. 902-908.

4. Brennan, C. A. et al., ‘HIV global surveillance: foundation for retroviral discovery and assay development’, J Med Virol, 78 Suppl 1, 2006, pp.

S24-29.

5. Busch, M. P. et al., ‘Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening. The Transfusion Safety Study Group’, Transfusion, 31 (1), 1991, pp. 4-11.

6. Luk, K.-C ., M.G. Berg, S.N. Naccache, B. Kabre, S. Federman, D. Mbanya, L. Kaptue, C.Y. Chiu, C.A. Brennan and J. Hackett Jr.,‘Utility of Unbiased Next-Generation Sequencing for HIV Surveillance’, 2015.

7. Oster, A. M. et al., ‘Increasing HIV-1 subtype diversity in seven states, United States, 2006-2013’, Ann Epidemiol, 27 (4), 2017, pp.

244-251 e1.

8. Rodgers, M. A. et al., ‘Sensitive Next-Generation Sequencing Method Reveals Deep Genetic Diversity of HIV-1 in the Democratic Republic of the Congo’, J Virol, 91 (6), 2017a.

9. Rodgers, M. A. et al., ‘ARCHITECT HIV Combo Ag/ Ab and RealTime HIV-1 Assays Detect Diverse HIV Strains in Clinical Specimens’, AIDS Res Hum Retroviruses, 34 (3), 2018, pp. 314318.

10. Rodgers, M. A. et al., ‘Identification of rare HIV-1 Group N, HBV AE, and HTLV-3 strains in rural South Cameroon’, Virology, 504, 2017b, pp.141-151.

11. Vallari, A. et al., ‘Four new HIV-1 group N isolates from Cameroon: Prevalence continues to be low’, AIDS Res Hum Retroviruses, 26 (1), 2010, pp. 109-115.

12. Vallari, A. et al., ‘Confirmation of putative HIV-1 group P in Cameroon’, J Virol, 85 (3), 2011, pp.

1403-1407.

13. Yamaguchi, J. et al., ‘HIV-1 Group N: evidence of ongoing transmission in Cameroon’, AIDS Res Hum Retroviruses, 22 (5), 2006a, pp.

453-457.

14. Yamaguchi, J. et al., ‘Identification of HIV type 1 group N infections in a husband and wife in Cameroon: viral genome sequences provide evidence for horizontal transmission’, AIDS Res Hum Retroviruses, 22 (1), 206b, pp. 83-92.

15. Zou, S. et al., ‘Prevalence, incidence, and residual risk of human immunodeficiency virus and hepatitis C virus infections among United States blood donors since the introduction of nucleic acid testing’, Transfusion, 50 (7), 2010, pp. 14951504.

The article is co-athored by Michael Berg and Gavin Cloherty from Abbott.

Government Gazette | 81

healthcare

Towards a zero HIV strategy

Leif-Ove HANSEN

Chair HivNorway. Nurs, Master in Health Administration

HIV healthcare and prevention in Norway under pressure

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he healthcare system in Norway is changing. The corporate model, a new financing system with tender and competitive bidding for medication has altered healthcare for people living with HIV(PLHIV) and HIVprevention.

HivNorway is an independent, national organisation committed to safeguarding the rights of people living with HIV as well as working to reduce the spread of HIV. We are the only organization in Norway working for the rights and interests of people living with HIV. We had a breakthrough when the new section 237 of the Penal Code was amended by the Norwegian Parliament in June, 2017. The Act now clearly states that a person living with HIV that has taken adequate steps to prevent transmission, like using a condom or being on successful ART treatment, cannot be prosecuted. In summary, the new Act states: • A person cannot be prosecuted if on successful ART treatment • A person cannot be prosecuted if using condoms • Oral sex is not seen as hazardous behaviour • Consensual sex with a person living with HIV frees the person from criminal liability

www.governmentgazette.eu | 82

• Exempted for punishment are also infections from sex workers and injecting drug users, as well astransmission from mother to child The greatest breakthrough in the last few years in HIV prevention, PrEP - a pill a day for preventing HIV for people who are HIV negative- was also a political struggle in Norway. After years of lobbying,the Minister of Health finally approved PrEP for HIV prevention in Norway in 2016.

In 2018, we can see that changes made in the financing of healthcare are having anunforeseen and negative impacton both obtaining consultations and prescriptions for PrEP.At the largest sexual health clinic in Norway, Olafiaklinikken, there is now a waiting list for PrEP consultations. People are getting HIV while they wait for a prevention tool that works and is available.

Over 200 people are waiting and estimated times for consultations are 8-12 months. The reason for this is simple, there is a way in to specialist care in hospitals, but there is no way out. The financing structure demands that all HIV medication is prescribed by a specialist doctor. Healthy patients that could easily get their PrEP consultation, prescription and

follow-up from their general medical practitioner now have to go to a hospital to see a specialist doctor.

Healthcare for PLHIV Healthcare is now organised in a corporate model, where the four hospital regions receive funding from the state for medication, including HIV medication.

To manage the procurement of medication, the hospital regions have made combined superstructure(Sykehusinnkjøp HF) to administrate the tenderpharma to the hospital regions.

In addition,prioritisation between patient groups has now been implemented. This means that PLHIV falls to the back of the line. We can also see these changes occurring for other chronic diagnoses. The argument being that we have a limited budget for healthcare and that we need to “all contribute” to lowering costs so that others can get healthcare. That is, PLHIV should show solidarity with others by accepting cheaper/ poorer treatment.

PLHIV are scared that they might have to change medication each year because of tender and competitive bidding on HIV medication.

Both access to HIV medication and access to new developments in HIV medication are now uncertain. The criteria for

what is a good combination for HIV treatment are vague, but it is clear that cheapest as possible HIV treatment within tolerable treatment regimens, is the norm for the future. The infection diseases doctors have for a decade told HIV patients that one pill a-day-regimes are preferable, and that they should have access to the newest and best treatment, now this principle is gone.

Trapped in specialist healthcare for life Both PLHIV and PrEP users are now trapped in specialised healthcare in Norway. The medication they use every dayhas to be prescribed by a specialised doctor at a hospital.

In HivNorway’s opinion this is a use of specialised care that most of these patientsdo not need or do not want, and it is clearly a miss-useof public money.

HivNorway hopes the Norwegian Health Minister and the Norwegian Parliament will change their decision and give prescription rights for HIV medication to general medical practitioners.

They must also return the financing for HIV medication back to the state, andto stop the tender and competitive bidding that will put at risk HIV treatment as prevention, that is the greatest preventive measure for HIV.

Quality of Life – A realistic ambition for HIV care across Europe co-morbidities as well as various psychosocial needs. If the current policy landscape adapts to address these diverse elements towards an inclusive approach to HIV care, this should lead to positive consequences for individuals, for the health system and for society.

Stephen REA

Head of External Affairs and Communications

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ooking at the epidemic across Europe today, the existing paradigm that focuses on viral load alone when considering effective HIV treatment doesn’t fully reflect today’s reality of living with HIV.

Understanding, measuring and improving quality of life among people living with HIV is key to achieving the 90-90-90 goals. Without it, millions of PLHIV will not be able to live their life to the fullest – healthy, connected and free of stigma.

Dr. Graham Brown Senior Research Fellow, Australian Research Centre in Sex Health and Society, La Trobe University

Tremendous progress has been made over the past 30 years but the HIV landscape continues to evolve and alongside it, the needs of people living with HIV (PLHIV).

With the “90-90-90” targets, UNAIDS set out to ensure that 90% of people living with HIV know their status, and 90% of those to be on treatment and 90% of those on treatment to achieve viral load suppression, as well as achieve zero stigma and discrimination.

However, we must recognize that while an undetectable viral load is indeed a crucial treatment milestone, it also should not be the end of the story.

Across 29 European countries, 60% of PLHIV were virally suppressed in 2016, so what other clinical and public health goals should be considered to ensure that those PLHIV live long and live well?

In today’s Europe where viral suppression is one of the end-goals, some important health-related challenges for people with HIV remain.

Some are familiar – treatment adherence and management of side effects–whilst new ones have emerged as life expectancy increases and health conditions relating to ageing has today become a reality for the majority of PLHIV across the region.

What may be missing both from the Global Health Sector Strategy and the HIV policy discourse is a vision informed by evidence, for what health systems should aim to accomplish concerning long-term care for all PLHIV. As the existing population of PLHIV increases and ages, treatment strategies will need to adapt to the realities of a lifetime of living with the virus, which includes managing and treating multiple

We approach this challenge at ViiV Healthcare by exploring innovative solutions, whether new medicines or advances in care, and move beyond the status quo to find new ways of navigating the challenges of the HIV epidemic.

Taking a patient-centred and holistic view of the care, management and treatment of PLHIV in turn helps deliver better health-related outcomes.

By working with partners across the HIV community to better understand and address the evolving medical and social challenges affecting PLHIV, we can support the provision of a new standard of care by identifying best practice in healthcare settings and enabling the sharing of those most relevant.

Our work in this area shines a light on the gap between theory, policy and practice and develops evidence that can assist policymakersto take informed decisions to make the most efficient use of finite resources.

Quality of Life (QoL) is a key area to focus on as part of the current policy gap in HIV care.Investing in research is required to get better insights into the multiple-factors that affect QoL, to ensure care of PLHIV is optimized and measured beyond clinical outcomes. Through targeted initiatives, often in partnership with

healthcare providers and PLHIV groups on the ground, ViiV Healthcare has supported the development of a validated scale to assess quality of life of PLHIV, the PozQoL (https:// www.ncbi.nlm.nih.gov/ pubmed/29678156).

In addition, an innovative study in the US (RISE) gathers real world insights from PLHIV on the burden associated with HIV and its treatment, and assesses their healthrelated quality of life through mobile devices.

This aims to help healthcare workers and policymakersaddress the issues affecting people living with HIV today (https://clinicaltrials. gov/ct2/show/ NCT03400293).

These studies explore challenges and opportunities to enhance the clinical care experience for PLHIV in relation to stigma and discrimination within the broader management of co-morbidities connected to ageing.

We call for policymakersand influencers to consider advocating for the update of health policies to include QoL measures for the management of HIV. By exploring and supporting the uptake of new tools and interventions as part of healthcare delivery, both the clinical and psychosocial issues can be addressed which will reduce the burden that chronic management of HIV has on health systems.

For more on ViiV Healthcare work in HIV visit: https://www. viivhealthcare.com/ mapping-an-hiv-freefuture.aspx Government Gazette | 83

healthcare

Towards a zero HIV strategy

AHF Europe calls for rapid HIV testing awareness of their HIV status.

Rapid testing in community based services is limited or non-existent in many European countries.

Anna ZAKOWICZ Europe Deputy Bureau Chief

Democratising testing by tailoring services, informed by the local epidemic context, and offering these services within the community is paramount to increasing early diagnosis. The AIDS Healthcare Foundation (AHF) Europe, is calling for governments to act now and develop policies and implement legal changes to be in line with international guidelines.

IAPAC ’s guidelines on the continuum of care(2015) recommendscommunity based testing in efforts to increase testing coverage.

A Increasing HIV testing coverage in all settings is vital for Europe to have a significant impact in reducing new infections.

AHF Europe’s Rapid testing approach demonstrates just how effective this can be. www.governmentgazette.eu | 84

ccessible HIV testing and early detection remains a challenge in Europe.

Approximately half (51%) of diagnosis of HIV in 2016 in the European region was diagnosed at a late stage of infection.

This not only means that those diagnosed will be starting treatment later, but the risk of onward transmission increases.

Offering rapid testing in all settings, medical (including indicator disease testing) and community based,is a proven strategy to increasing people’s

The World Health Organisation in 2015, recommended lay (non-medical) testers be utilised in community based testing, implementation of task shifting and increasing the acceptability of testing among key population groups. Despite these highly regarded recommendations published a number of years ago, little action has been taken within Europe.

AHF‘s Rapid Testing Program (RTP) model is an advocacy initiative used tobring accessible, convenient and free HIV testing to communities in 39 countries around the world.

AHF Europe began the RTP in 2009 in Odessa, Ukraine, and now operates in eight European countries: Russia, Ukraine, Estonia, the Netherlands, Georgia, and in partnership in Greece (Positive Voice

and the City of Athens), Lithunia (Demetra) and Portugal (GAT).

Rapid testing can be done cost-efficiently and effectively on a wide sustainable scale to help people learn their HIV status and be linked to care.

By the end of 2017, over one million rapid tests had been performed

by AHF Europe and partners, with 4% zeropositivity rate (over 41 thousand cases), over 66% of those with reactive results linked to care, and over 11 million condoms distributed.

Over 270,000 of the one million tests were performed in the EU. Using rapid testing in medicaland community based testing with lay testers was fundamental in achieving this milestone. Such initiatives like AHF Checkpoint Amsterdam can be effective for migrant populations.

Using rapid HIV testing in community based settings with lay testers allows for successful targeted testing for key population groups.In 2017, in the EU,almost 55 thousand people were tested by AHF’s RTP, over 13 thousand (24%) people tested were MSM, and nearly four thousand (7%)were injecting drug users (IDUs).

Among the 757 people that tested positive in the EU, 313 (41%) were MSM and 206 (27%) were IDUs. The targeted testing approach not only facilities a high find rate, but also shows how tailoring the approach to the local epidemic can reach the people most in need.

European Testing Week (ETW) serves as an example of the effective way to use the AHF RTP

modelfor community based organisations that start, or are thinking of starting, HIV testing activities for their communities. ETW is an initiative that was launched by HIV in Europe in 2013 to help more people to become aware of their HIV status.

Between 2013 and 2017, AHF supported 28organisations, 11 EU (11 organisations) and five non-EU countries (17 organisations) during ETW. Over 26 thousand people were tested, with 622 reactive results and a 1.6% zero-positivity rate in the EU and 3% positivity rate in non-EU countries.

Rapid HIV testing in both EU and non-EU countries demonstrates a potential to reach people who have never been tested or those who know their status but are not in care.

AHF Europe believes that cost-efficient and sustainable initiatives that aim at the promotion and delivery of testing can support countries with achieving the first step (HIV diagnosis) in the treatment continuum.

Without new policies to guide the implementation of the scale-up of rapid testing to all settings, a change of the legal environment to allow non-medical testers to test, changing the testing algorithm to use two rapid tests for HIV diagnosis, and the joint effort of all stakeholders involved, the dream to end the HIV epidemic in Europe will remain just a dream.

Peter MANEHALL Ombudsman, HIV Sweden

Sweden faces new challenges – how do we reach sustainable health? morbidity.

The co-morbidities that are affecting those living with the virus include kidney disease, osteoporosis, cardiovascular disease, cancer, diabetes and depression.

Why does this group of people have a higher likelihood of comorbidities? It is due to a variety of factors, including theHIV drugs taken for a long period of time to obtain viral suppression, the inflammation in the body due to HIV (even during treatment), lifestyle choices like alcohol consumption and smoking and, of course, ageing itself.

S If Sweden stays vigilant, we have a golden opportunity to prevent many cases of co-morbidities.

We can predict vulnerability to co-morbidities by, for example,looking at risk markers likelength of time with HIV infection, low level of CD4 and the use of certain HIV drugs, in combination with lifestyle.

weden was the first country in the world to reach UNAIDS’ ambitious 90-90-90 target ahead of 2020.

The UNAIDS target means that 90 percent of all people living with HIV should know their HIV status, 90 percent of all people with diagnosed HIV infection should receive sustained antiretroviral therapy, and 90 percent of all people receiving antiretroviral therapy should have viral suppression.

If Sweden stays vigilant, we have a golden opportunity to prevent many cases of co-morbidities. We can predict vulnerability to co-morbidities by, for example,looking at risk markers likelength of time with HIV infection, low level of CD4 and the use of certain HIV drugs, in combination with lifestyle.

However, while Sweden was successfully reaching these HIV treatment goals, new challenges within HIV have risen: ageing and quality of life for people living with HIV.

Furthermore, in certain groups like the migrant population in Sweden, there is a fear to become left out of their social network and/or of losing their residence permit by disclosing that they are carrying HIV (this is not the case). This makes the migrant population a vulnerable group as the two factors mentionedcan greatly affect the possibilities for treatment.

In Sweden, we have for the first time an ageing generation living with HIV. In fact, about 45% of people carrying the virus are 50 years old or older. With age, there is also an increasing risk of co-morbidities. Looking ahead to year 2030, 84% of those living with HIV will have at least one co-

In order to meet the challenges with ageing HIV patients and comorbidities, we need multidisciplinary and cross functional strategies that are focused on the risk markers. For instance, there is a need for geriatric specialists to cooperate with experts within infectious disease

or primary care in charge of caring for elderly living with HIV. There is an obvious connection between ageing with co-morbidities and quality of life. But of course, quality of life is an issue for all people living with HIV, regardless of age. Stigma and discrimination are great factors of quality of life and they are unfortunately still a problem in Sweden.

Almost all expert groups I have been part of have discussed the apparent lack of knowledge of HIV outside infectious disease clinics, mainly within Swedish primary care.

This is a major problem as it contributes to discriminatory treatment of those living with HIV. This year, the European initiative HIV Outcomes is doing an evaluation of two EU member states, including Sweden. I am part of the “HIV Outcomes: The Status of HIV in Sweden” working group. The group’s initial reflections on the five European policy recommendations made by the European initiative in 2017were presented at a seminar at the European Parliament on November 27th, 2018. A short summary: 1. Adopt an integrated, outcomes-focused, and patient-centred approach to long-term HIV care.

Cross functional cooperation needs to be strengthened in Sweden between, for instance, primary care and geriatric care.

2. Expand national monitoring of long-term HIV care and outcomes The high quality Swedish InfCareHIV registry has decided to work on a fourth 90 target focused on improving quality of life

for people living with HIV. 3. Fund cohort studies to provide information on the long-term health of people living with HIV. There is a significant interest in conducting cohort studies in Sweden and a vast amount of data is available through the InfCareHIV registry.

However, national financing of efforts to combat HIV and other infectious disease has been reduced in Sweden in the past couple of years.

It is therefore uncertain how the InfCareHIVcohort will be financed in the future.

4. Combat stigma and discrimination within health systems • There is a significant need for increased knowledge on the needs of people living with HIVwithin the Swedish health system, especially primary care, dentistry as well as countyprovidedgeriatric and home care. A powerful, long-term, national initiative to minimising HIV stigma is needed.

5. Upscale involvement of the HIV community in priority setting at country level • There is good involvement of organisations working with HIV on a national level in Sweden. However, on a regional level there is a need of involvement of people living with HIV to shape, plan and organise local healthcare.

HIV Sweden is Sweden’s national rights and advocacy organisation for all people living with HIV and all those affected by HIV in Sweden.

Government Gazette | 85

performance

Make your mind your ally

www.governmentgazette.eu | 86

James GROSS

Professor of Psychology

Dr Gross is a leading researcher in the areas of emotion and emotion regulation, and editor of the Handbook of Emotion Regulation. He has received numerous teaching awards, including Stanford’s highest teaching award, the Walter J. Gores Award for Excellence in Teaching. His papers have been cited over 100,000 times.

E

motions can be helpful, directing our attention to key features of the environment, finetuning our thinking, and readying responses that help us achieve our goals. However, emotions also can be harmful, misdirecting our attention, compromising our thinking, and leading us to act in ways we later regret.

Cultivating emotions that are helpful – and managing emotions that are harmful – is the job of emotion regulation.

When asked, people often describe efforts to decrease negative emotions, especially

Are you making the most of your emotions?

anger, sadness, and anxiety. People also report trying to increase positive emotions, especially love, interest, and joy. Less frequently, people try to increase negative emotions (e.g., when being stern with a child), or decrease positive emotions (e.g., to avoid gloating after a hard-fought tennis match).

To see how one might make the most of one’s emotions, it is useful to first think about how emotions arise. Figure 1 shows that emotions arise in situations that are attended to and appraised or evaluated as being relevant to one’s current goals. The responses generated by these unfolding appraisals involve changes in a person’s feelings, behaviors, and physiology (brain and body). Like many other responses a personmakes, emotional responses often change the situation that gave rise to the response in the first place.

If the emotion is helpful, we are likely to let the emotion just run its course. However, if the emotion is unhelpful -because it is either the wrong type or intensity for a given situation-, we may try to alter it.

Figure 2 distinguishes five families of emotion regulation strategies based on where in the emotion-generative process they have their primary impact. Because they operate at different stages in the “assembly” of an emotion, different

strategies have quite different consequences.

Although there is no single “appropriate” form of emotion regulation, some of these have more to recommend than others. The simple rule of thumb is that the earlier one can intervene, the more powerfully one can influence emotion.

Situation selection is the most forward-looking approach to emotion regulation. It involves actions that make it more likely one will end up in a situation that gives rise to the emotions one wants to have. Although is a very powerful strategy (for example, when avoiding a work function that would make one anxious) it can sometimes come at too steep a price in terms of other goals one may have (such as building new contacts at work).

Situation modification refers to directly modifying a situation so as to alter its emotional impact. A simple example would be changing where one is sitting at a party.

Like situation selection, this strategy is very powerful, but cannot always be employed without compromising other valued goals.

Attentional deployment refers to directing attention within a given situation in order to influence one’s emotions.

One example is distraction, whichfocuses attention elsewhere.

This strategy is very effective, particularly, when emotions are intense. Here too there

might be a tradeoff, because distraction may mean missing out on key information.

Cognitive change refers to modifying how one appraises a situation so as to alter its emotional significance. This strategy has been found to be helpful in many contexts.

For example, finding alternate ways of thinking about why a colleague might have rushed by one at work without saying hello (e.g., they were distracted, or running late for a meeting) might head off less helpful ways of thinking that could lead to unnecessary upset (e.g., they hate me).

However, it is not always possible to come up with such alternative ways of thinking when they are needed.

experience an emotion either at home or at work, give some thought to whether that emotion is likely to be helpful or harmful. If it seems likely to be harmful, recall that there are many ways to alter that emotion’s trajectory.

The belief that one’s emotions can be changed for the better has itself been shown to predict positive outcomes. And these outcomes become even better when that belief is coupled with the selection of more rather than less helpful forms of emotion regulation.

Response modulation occurs late in the emotion-generative process, after emotional responses have already been initiated. One common form of response modulation is expressive suppression, in which a person tries to inhibit ongoing negative or positive emotionexpressive behavior.

Although this strategy is common it unfortunately tends to magnify rather than diminish one’s physiological responses without making one feel better. In fact, suppression has been shown to increase the blood pressure not only of the person who is suppressing, but also the person who is interacting with the suppressor.

So the next time you Government Gazette | 87

Mark BOWDEN

Tracey THOMSON

How you can use body language to appear more calm and confident

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orking life never ceases to be a cause of stress. Deadlines, responsibilities, the rigours of maintaining excellence and high performance, and just too many items to action are some of the pressures that can get us down and feeling tired, overworked, and stressed. All these emotions can knock our sense of confidence and our self-worth, making us feel small. So how can we use our body language to build ourselves big again, manage stress, feel more confident, become more calm and assertive and in so doing, always come across as trustworthy and credible?

When we feel small and unconfident, our body language can often display these feelings to others, as we will often minimise our size and impact by displaying submissive expressions. Submissive body language is characterized by gestures that make us look like we are caving in, defensive, reclusive or indecisive — in short, body language that makes us look powerless. Submissive gestures show that we do not want to take the power position, nor do we want to be in control… when the reality may be entirely the opposite!

Submissive body language may also have us making less noise. We take up as little nonverbal real estate as possible – be it physical, aural, or temporal. When we are more confident not only do we often take

up more physical space but we also maximise the volume of the sounds that we make and the time we take up with all of this. In a meeting this will come across as “speaking up” or “getting our point through,” but of course at the overly confident or dominant end of the spectrum it can come across as “hogging the air space”.

opportunity to compound the effect of giving off passive or submissive body language. Body language expert and TED Talk sensation Amy Cuddy explains a correlation between the bad posture so many of us experience from using smartphones and the psychological damage and changes in behaviour that result from what she calls the iPosture.

Naturally, context is key to all body language and so submissive body language can appear more extreme when seen in contrast to more dominant gestures that take up space, sound, and time. Some of these submissive gestures include: cringing, which looks smaller and non-threatening; head bowing; wide eyed innocent “startled” staring of the freeze, flight, fight, faint system; hunched shoulders of fear or passiveness; and even physical imbalance.

Citing studies that link depressed postures to lower self-esteem and mood, greater fear, and more negative verbal reactions to questions, Cuddy’s research finds that the “slouchy, collapsed position we take when using our phones actually makes us less assertive — less likely to stand up for ourselves when the situation calls for it,” and she recommends we counter these physical effects with exercises and stretches… or trips to the osteopath! The good news is that there are some things that we can quite simply and effectively do for ourselves.

Crossed, defensive postures can also trigger others into feeling you are submissive or indecisive.

When you cross your body you hinder your ability to move, and therefore although you may feel less vulnerable, you may look to others and even feel in yourself more passive. Not a great position to be assertively negotiating from!

Add to this the physical and psychological impact of always holding and staring down at our smartphones, and there is the

So with all the stress, overwork, pressure to be responsive and accompanying postures forcing you into looking and feeling submissive and non-assertive, let’s look at how you can counter these postures, assert yourself through your body language, help yourself regain your calm, shed the stress, and show colleagues and employers that you are capable, trustworthy and credible. Here are three top tips that you can do right now:

Take Space Try taking up more physical space.

First off, sit up straight. If you are at a table, move your chair back 6 inches so you are showing off more of a physical presence to others at the table. Place your hands on the table so that you are taking up more territory as well. Place your smartphone on the table and push it away from you to take up even more territory and also to keep yourself from reaching for it and hiding away with it. You can even stand up sometimes when you are speaking or making important points.

Torso Talk Place your hands in what we have trademarked the TruthPlane, the horizontal plane that extends 180 degrees out of your navel area. Bringing the audience’s unconscious attention to this vulnerable area of your body makes them feel that you are very confident. By assuming this physicality, you will feel confident too! And by showing your palms open you will also feel more open and commanding while still giving a universally recognised ‘friendly’ gesture.

Reveal Yourself Avoid having your hands at mouth level when speaking, for example when sitting at a table with your

chin in your hands, often a physical symptom of feeling stress and pressure weighing us down and making us look more passive or submissive. We lip read more than we think, and when the picture of the words is taken away it becomes harder to verify the language.

The audience will perceive or create negative feelings about your intentions — in the absence of information, we ‘make it up’ and always lean towards the negative to prepare for the worst when theorising about the inner thoughts of others. And by covering yourself up and minimising the space you take you may compound the feeling that you have nothing worth saying in the first place!

Given that we can often judge our own feelings and worth from the context of others’ reactions to us, it is quite instinctual for us to unconsciously read others’ body language in order to form theories as to how they feel about us and so how we are. But yet most of us stand little more than a 50/50 chance of reading others right.

We will mostly err on the side of a cautious, negative reading of their judgements about us — better to be safe than sorry. And of course when we ourselves are feeling a little stressed, low or anxious, our judgements of others will mirror this and skew the accuracy. So by

concentrating on controlling your own body language rather than looking at others’ for validation, not only will you start to trust yourself more around your own confidence but also win the trust and confidence of others.

About the authors: Mark Bowden and Tracey Thomson are co-authors of TRUTH & LIES What People are Really Thinking, a fresh, insightful, myth-busting guide to reading body language in the postdigital age. Mark Bowden is voted #1 Body Language Professional worldwide, and as a thought leader in nonverbal communication is sought after internationally for his keynote speeches and communications training through his organization TRUTHPLANE. With a popular TEDx talk, he has four books, including bestselling Winning Body Language.

Tracey Thomson as Co-Founder of TRUTHPLANE advises companies and individuals on questions around communication and body language. Her background directing and training performers internationally in the psychology of movement as well as her professional experience gives her unique insights into human behaviour.

bladder CANCER report Recommendations to reshape policy making

State of bladder cancer policy in Europe

Reducing risk factors Measuring the value of care Although bladder cancer is the fifth most common cancer in the European Union, resource provision including funding for research and reimbursement has not kept pace with other forms of cancer.

The European Union has been successful in supporting member states in the development of screening programmes supplemented with guidelines for breast, cervical and colorectal cancer. However, bladder cancer, being the second most frequent malignancy of the urinary tract after prostate cancer, it yet remains outside of health policy priorities, with awareness levels being still quite low.

Statistics show that up to half of all people diagnosed with bladder cancer in Europe, will die within five years. Only an estimated 1 in 10 patients with metastatic bladder cancer in Europe survive, and this rate has not significantly changed in nearly a decade.

Though it has one of the highest lifetime treatment costs per patient of all cancers, bladder cancer care accounts for only 3% of all cancer cost in the European Union. Moreover, there are enormous differences in the money that is actually spent on treating bladder cancer, ranging between 8 euros in Bulgaria and 93 euros in Luxemburg.

What’s inside Prof. Hein van POPPEL Adjunct Secretary General for Education

EAU’s viewpoint to manage bladder cancer in Europe

Zenichi IHARA Health Economics Manager

How do we ensure an accelerated improvement in bladder cancer management?

Dr Peter SOLLEDER Executive Director, New Applications

OPAL1® PDD – a flexible visualization with IMAGE1 S™ to support urologists

Ashok K. GUPTA VP, IO Clinical Development

The promise of immuno-oncology in bladder cancer

healthcare

State of Bladder Cancer policy in Europe

iCPS BLADDER CANCER EUROPE 2018

How can we re-prioritise our efforts towards tackling Europe’s most neglected cancer?

B

ladder cancer is the sixth most common cancer in the EU, but it has long been under-prioritised and overlooked relative to the impact it has on patients. A wide range of challenges face those with the disease, including delayed diagnosis, a lack of awareness among GPs and a protracted and complex pathway for patients to navigate.

The International Centre for Parliamentary Studies brought together policymakers and healthcare experts in the field to explore these issues, and who put forward a number of recommendations for how to address some of these concerns at the European level.

We call on policymakers to ensure, as soon as possible, that all women and men with bladder cancer in Europe are better diagnosed and treated by specialist multidisciplinary teams that work to deliver superior care and quality of life.

Here’s what Europe should do in order to initiate the change: 1. It is important for us to ensure that at the European level, bladder cancer discourse is being heard.

We should partner in coordinated efforts to bring bladder cancer higher up the EU agenda in the hope of improved treatment outcomes for all bladder cancer patients in Europe.

2. Early recognition of symptoms and prevention will play a crucial role in the management of bladder cancer. Urologists and other experts must be educated to identify risk factors and early symptoms so that patients stand a better chance of having access to the right cancer treatment.

3. The awareness of bladder cancer is still low in Europe.

Despite its prevalence, specific aspects of the disease are often overlooked. A public campaign is recommended to increase awareness not just at the patient level, but with their family doctors and healthcare practitioners about www.governmentgazette.eu | 92

specific symptoms.

4. In many cases, there are significant delays in diagnosing bladder cancer in women.

More needs to be done to raise awareness to help them spot the symptoms earlier, and the considerable misdiagnosis should be averted.

5. We need to throw a spotlight on the role of oncology nurses in early diagnosis and effective treatment of bladder cancer. The EU should do more to increase awareness about the significant relation between patients and specialist oncology nurses. The EU should also ensure that a greater

number of clinical nurse specialists (CNS) are available within multidisciplinary teams.

6. Effective care requires a concerted, multidisciplinary approach. It is crucial to integrate the expertise of urologists, oncologists, radiation therapists, imaging experts and specialist nurses, and ensure equitable access to all patients diagnosed with bladder cancer across Europe.

7. With smokers being up to four times more likely to contract bladder cancer, the EU needs to do more to raise awareness among these groups and reduce

smoking rates.

8. While other kinds of cancer including breast cancer, prostate cancer and colorectal cancer have national screening programmes in place to facilitate earlier detection, bladder cancer is often overlooked, predominantly because of the intrusive nature of available screening options. However, the EU should initiate screening for bladder cancer in high-risk groups such as those with occupational risks and a history of smoking, and continue to reduce and monitor the exposure to carcinogenic chemicals.

9. Research is essential

vital to make the best use of what we have at hand. It is important to provide equitable access and reduce the disparities in reimbursement.

While payment schemes currently do not incentivise outcomes, the EU should address these intrinsic shortcomings within reimbursement and ensure that patients get access to the best therapies and treatment options.

11. As accurate and sensitive detection of bladder cancer is critical to diagnose this deadly disease at an early stage, there is an urgent need for more translational research to identify new biomarkers and novel therapeutic targets. The EU should do more to help and support the genomic landscape and biomarker discovery.

in better understanding the risk factors and complexity of bladder cancer. The EU should support more research projects and help companies in identifying ways to support academics in their clinical research. As the economic burden of bladder cancer is high compared to other cancers, there is an urgent need to increase research on epigenetic factors, precision medicine and liquid biopsies.

10. While there is an urgent need to develop revolutionary, simplified and cost-effective imaging devices to improve early diagnosis of bladder cancer, it is

CALL FOR ACTION We should partner in coordinated efforts to bring bladder cancer higher up the EU agenda in the hope of improved treatment outcomes for all bladder cancer patients in Europe.

It is crucial to integrate the expertise of urologists, oncologists, radiation therapists, imaging experts and specialist nurses, and ensure equitable access to all patients diagnosed with bladder cancer across Europe.

More needs to be done to raise awareness to help them spot the symptoms earlier, and the considerable misdiagnosis should be averted.

The EU should initiate screening for bladder cancer in high-risk groups such as those with occupational risks and a history of smoking, and continue to reduce and monitor the exposure to carcinogenic chemicals.

The EU should stop the mono-disciplinary management of bladder cancer and opt for a patient-centric multidisciplinary approach and precision management. fighting bladder cancer.

Providing unified access to promising innovations remains crucial at an EU level.

12. Effective multidisciplinary collaboration is imperative in order to implement existing knowledge, enable priority research, and reduce costs. The EU should stop the monodisciplinary management of bladder cancer and opt for a patient-centric multidisciplinary approach and precision management.

14. The EU has been quite ambitious in supporting member states in the development of cancer screening programmes, supplemented with guidelines for breast, cervical and colorectal cancer. The European Parliament should do more to support the implementation of and endorse the clinical guidelines developed by the European Association of Urology.

13. As quality of life often decreases following a bladder cancer diagnosis and continues for a prolonged period in patients with metastatic disease and long-term survivors of muscle-invasive bladder cancer, the EU should do more to improve on the clinically relevant endpoints of survival and perk up the quality of life of patients

15. Treatments are often pushed into the market, without sufficient data.

Collection of patientdriven clinical data relating to bladder cancer is lacking at an EU level and we need to confront these issues.

The EU should develop a more confidential way of recording clinical data and ensure sharing of best practice within the healthcare community.

16. People diagnosed with bladder cancer face several challenges including the stigma associated with the disease, delayed diagnosis and equitable access to optimal diagnostic and

treatment options.

The EU should do more to reduce stigma associated with bladder cancer, increase the access to MRI and improve the quality of imaging options.

Delegates at iCPS Bladder Cancer Europe Director, Oncology Policy, AstraZeneca; Adjunct Secretary General for Education, European Association of Urology; President, ESUR - European Society of Urogenital Radiology; Director, ECPC - European Cancer Patient Coalition; Chief Operating Officer, EONS - The European Oncology Nursing Society; EU Affairs Policy Manger, ECCO - European CanCer Organisation; MEP’s Against Cancer Group Member, European Parliament; President, Estonian Society of Urologists; Secretary, Europa Uomo; Clinical Nurse Specialist, Ghent University Hospital; Medical Oncologist, Hospital 12 de Octubre de Madrid; Medical Surgeon, Italian Society of Urology; Executive Director, New Applications, Karl Storz; Senior Manager, Health Economics, Olympus Europa; Associate Professor of Urology, Ospedale San Raffaele - Urological Research Institute; Secretary General, Turkish Society for Radiation Oncology Head of Urology Department, University of Szeged; Specialist in Internal Medicine, University Hospital Hamburg

Government Gazette | 93

healthcare

State of Bladder Cancer policy in Europe

EAU’s viewpoint to manage bladder cancer in Europe Closing gaps and breaking barriers

Prof. Hein van POPPEL Adjunct Secretary General for Education

B

ladder cancer —that for 95% emerges from the epithelial lining of the urinary tract — is the 5th most expensive cancer on a global perspective and the most expensive cancer per patient.Seventy to 80% of them are called non-muscleinvasive bladder cancers (more superficial), while 20 to 30% invade in the muscular layer of the bladder and will potentially disseminate and kill the patient because of distant metastases(1).

Bladder cancer care accounts for 3% of all cancer cost in the European Union, but there are enormous differences in the money that is actually spent on treating bladder cancer (eight euros in Bulgaria and 93 euros in Luxemburg) (Leal et al, 2015). The relatively high cost of bladder cancer care is due to expensive procedures for diagnosis and follow-up (cystoscopies, transurethral resections, intra-vesical chemotherapy or immuno-therapy, surgery, chemotherapy and radiotherapy).

Not only smoking but also professional exposure to toxic agents are responsible for the vast majority of, thus, avoidable bladder cancers and the European Union has identified a number of occupations and industries with a high www.governmentgazette.eu | 94

risk of bladder cancer amongst their workers.

In the last 25 years, bladder cancer mortality, in contrast with many other malignancies, has not decreased significantly. It is a reasonable assumption that groups at risk because of tobacco use or occupation should be screened for microscopic hematuria, followed by urine cytology and/ or endoscopy and ultrasound (3).

Nevertheless as compared to prostate cancer, bladder cancer is not very well known in the general population.

Many international eminent people have been diagnosed with and treated for prostate cancer, while few bladder cancer patients are known in the media.

Bladder cancer also targets lower social economic classes where

smoking habits have hardly been influenced by the European antitobacco campaigns.

Moreover, the research funding for the different human cancers is about the lowest for bladder cancer, be it in the UK or the USA while five times more research funding is allocated to breast, lung and bowel cancer (4).

The European Association of Urology (EAU) has been extensively using their publications (European Urology and European Urology Focus) to demonstrate the impact of smoking and smoking cessation, and has significantly contributed to the Smoking Edition of European Files with the aim to decrease the consumption of tobacco in Europe (5). In 2016, the EAU assisted the European Cancer Patient Coalition (ECPC) in

preparing and then launching the White Paper on Bladder Cancer at a meeting of the International Centre for Parliamentary Studies.

The EAU has published the EAU Guidelines on the management of bladder cancer to assist medical professionals in the evidence based treatment. Expert panels on muscle invasive and non-muscle invasive bladder cancer included an international multidisciplinary group of urologists, radiationoncologists, medicaloncologists, radiologists, pathologists, nurses and patients (6,7).

The EAU guidelines are considered worldwide as the best evidence based recommendations available today, and the guidelines on bladder cancer are endorsed by the national urological societies of

What does the EAU expect from Europe Continued funding for awareness raising campaigns post -2020, including on the importance and the causes of bladder cancer Strong enforcement of the EU rules on tobacco products Limit professional toxic exposure

Address the issue of screening in higher risk-groups through the EU Joint Action on cancer Recognize occupational bladder cancers Address the lack of funding for trials and translational research by continuing to prioritize health in future funding for EU research framework programmes Endorse the EAU Guidelines on Non-muscle and Muscle Invasive Bladder Cancer

Promote multi-disciplinary collaboration as the gold standard for care Centralise bladder cancer care in expert centers

the 28 European Union member states, by the American Society of Clinical Oncology (ASCO) and also by the national societies of China, Australia, India, Indonesia, Argentina, Columbia, Hong-Kong, Algeria, Malesia, New Zealand, Taiwan and Thailand. However, the dissemination of the guidelines and compliance with the guidelines in the delivery of care for patients with bladder cancer is still insufficient. There is a marked under-useof the guideline recommended care in a potentially curable cohort and the national societies must do more to make their members aware of, and to ensure the use of, guidelines in daily practice.

Next to our guidelines, the EAU has extensively invested in drafting and providing Patient Information, based on the guidelines, which can be seen as a translation of the guidelines into language that patients can easily understand.

The patient information brochures have been translated into more than 17 languages and are available online for every healthcare provider or patient.

Indeed every urological patient in Europe should have access to the highest quality patient information in the framework of patientcentriccare.

Improving quality of

90

ADENOCARCINOMA SMALL CELL CARCINOMA SARCOMA

OF BLADDER CANCERS CASES.

BLADDER CANCER “HOT SPOTS” ESTIMATED NUMBERS OF ANNUAL NEW BLADDER CASES

UP TO

78

% OF PATIENTS WILL EXPERIENCE RECURRENCE WITHIN 5 YEARS.

5-YEAR SURVIVAL RATE THE FIVE-YEAR SURVIVAL RATES VARY GLOBALLY,

BY REGION (THOUSANDS)

DEPENDING ON THE STAGE AND TYPE OF BLADDER CANCER.

NORTH AMERICA

91.7

0

ASIA

EUROPE

198.8

191.1

50

100%

98%

STAGE 0

88%

STAGE I CENTRAL AMERICA

AFRICA

2.7

63%

STAGE II

24.4

46%

STAGE III

SOUTH AMERICA

STAGE IV

AUSTRALIA & NEW ZEALAND

23.7

15%

3.6

Source: GLOBOCAN 2018

COMMON BLADDER CANCER RISK FACTORS

WORKPLACE

SMOKING

EXPOSURES

RACE

OLD AGE

GENDER

SIGNS & SYMPTOMS

HISTORY

FEELING AS IF YOU HAVE TO GO RIGHT AWAY, EVEN

BLOOD

WHEN THE BLADDER

IN THE URINE

IS NOT FULL

PAIN OR BURNING

LOWER BACK PAIN

DURING URINATION

ON ONE SIDE

BEING UNABLE

HAVING TO URINATE

TO URINATE

MORE THAN USUAL

© 2018 Bristol-Myers Squibb Company

care for bladder cancer patients

The EAU will continue to work with the different national urological societies to further increase awareness of the importance and the causes of bladder cancer. We will continue to put our efforts in further dissemination of the guidelines on the management of bladder cancer for caregivers, as well as disseminate adequate information to patients and relatives.

The EAU is heavily committed to further research on personalised/ precision medicine through collaboration with the European Alliance for Personalised Medicine (EAPM).

Bladder cancer is not a disease that can be addressed by a mono-specialist

FAMILY

AND ETHNICITY

healthcareprofessional (HCP). In the different stages of the disease, multi-disciplinary collaboration is absolutely mandatory which is most easily achievable by centralising care in expert bladder cancer centres (9). The EAU, together with the European Board of Urology has accredited a number of bladder cancer centres where the highest quality of patient care, education and research is guaranteed.

While some progress has been made in the treatment of bladder cancer by the use of neoadjuvant and adjuvant cytotoxic intravenous chemotherapy, there is today new hope since the advent of the immunooncologic agents, the checkpoint inhibitors, that are less toxic and, when efficient, seem to

TREATMENT OPTIONS A PATIENT’S TREATMENT OPTIONS ARE LARGELY DEPENDENT ON THE STAGE OF DISEASE AND MAY INCLUDE:

provide a substantial survival benefit in our advanced bladder cancer population.

In order to further strengthen our multidisciplinary efforts in the quality of care of bladder cancer patients, the EAU organises the European multidisciplinary meeting of urological cancers (EMUC) together with the European Society of Medical Oncology (ESMO), the European Society for Radiotherapy and Oncology (ESTRO), the European Society of Urogenital Radiology (ESUR) and The European Society of Pathology (ESUP).

We are working together with the American Society of Clinical Oncology (ASCO) and have planned in the near future a consensus meeting on issues on

CHRONIC BLADDER IRRITATION AND INFECTIONS

SURGERY

INTRAVESICALTHERAPY (chemotherapy/ immunotherapy)

muscle-invasive bladder cancer, where there is not enough evidence today to make reliable guidelines, together with the guidelines experts of ESMO. Together with the latter organization, the EAU will organise Bladder Cancer 18, an EAU Update on Bladder Cancer in summer 2018.

References: 1. Siegel, R., CA Cancer J Clin, 2012.

2. Leal, J. et al., Eur Urol, 2015.

3. Ferlay, J. et al., ‘Cancer Incidence and Mortality Worldwide’, IARC CancerBaseGlobocan, 2012.

4. Boormans and Zwarthoff, Bladder Cancer, 2016.

5. Crivelli, J.J. et al., ‘Effect of smoking on

RADIATION THERAPY

outcomes of urothelial carcinoma: a systematic review of the literature’, Eur Urol, 2014.

6. Babjuk, M. et al., ‘EAU guidelines on nonmuscle-invasive urothelial carcinoma of the bladder: update 2013’, Eur Urol, 2013.

7. Witjes, J.A. et al., ‘Updated 2016 EAU guidelines on muscleinvasive and metastatic bladder cancer’, Eur Urol, 2017.

8. http://patients.uroweb. org/library/bladdercancer 9. Goossens-Laan, C.A. et al., ‘A systematic review and meta-analysis of the relationship between hospital/surgeon volume and outcome for radical cystectomy: an update for the ongoing debate’, Eur Urol, 2011.

Government Gazette | 95

healthcare

State of Bladder Cancer policy in Europe

Zenichi IHARA

Health Economics Manager

How do we ensure an accelerated improvement in bladder cancer management?

I

t was exciting to see the movement created three years ago has kept its momentum under the leadership of Prof van Poppel. The focus this year was on the lack of general awareness of bladder cancer as well as the opportunities, including utilising the latest knowledge and technologies, at both national and European levels to ensure healthcare systems can deliver better outcomes to patients.

Participants included a range of diverse stakeholderswho represented their respective role, all vital for a consistent voice.Representing the medical deviceindustry, Olympus’ point was to ensure the effective implementation of existing means to fight the disease.

Awareness and prevention The recommendationsdiscussed on the promotion of awareness, prevention and early detection of bladder cancer were tangible and actionable.This included, advocating for warning labels on cigarette packets, which today often only mentions the risk of respiratory and cardiovascular diseases – but not bladder cancer. Whilst, in terms of screening, it was agreed that it would bemore efficient to focuson high-risk populations such as those at occupational exposure to risk factors,including certain industrial chemicals. While policy decisions at the European level cannot impose theimplementation of these suggestions to the medical associations of each member state, policymakerscan receive a unanimous voice and put it on the agenda for discussions to increase the exposure of bladder cancer as a public health priority.

Clinical guidelines and available technologies Utilisation of available evidence and medical technologies, ie, ‘making the best out of what we have,’ should also be a focus to harvest the low-hanging fruits.

Cystoscopy, which is an endoscopy procedure to look inside the bladder, is a decisive step to correctly diagnose the presence of

www.governmentgazette.eu | 96

the lesions. Endoscopic imaging is also a useful tool during minimally invasive surgery, since the resection of lesions, eg, non-muscle invasive bladder cancer, can be done through natural human orifices (urethra), ensuring the quick recovery of the patient.

An additional feature toendoscopy is filtered light (eg,narrow-band imaging, or NBI) which enhances the vascular structure on the images with the push of a button, which leads to easier detection of the lesions compared with healthy tissue. NBI has shown to improve the detection rate during diagnosis, and when used in resection procedures, to reduce the recurrence of bladder cancer (1-3).

Medical technologies that contribute to early diagnosis and minimally invasive therapy are key to delivering improvement in patient and clinical outcomes, as well asthe reduction of overall healthcare costs. In this example, higher detection rate with NBI compared with conventional cystoscopy will initially lead to more patients with positive diagnosis.

This means more patients will require surgical procedures; however, it isa minimallyinvasive procedure since they are detected earlier, and because NBI also reduces the recurrence of the disease, fewer patients will undergo successive surgeries. While the exact calculation of costs is geography- and casedependent, a back-of-theenvelope calculation would suggestthat approximately €100-€200 may be saved

per case in Western European countries, which is worth a deepdive. This calculation did not include further effects of later diagnosis and disease progression, includingpatient outcomes and costs due to complete removal of the bladder or chemotherapy.

Regarding medical technologies, implementation factors such as the learning curve, compliance to the process, and expertise/experience make a difference. This is why, on top of awareness and endorsement, continuous training and feedbackarecrucial to ensure the delivery of the outcomes. Industry was explicitly mentioned during the roundtable as a driver of expert training.

Olympus organises peerto-peer expert training across Europe with more than 150 participants yearly, which comes in addition to increasing the awareness at meetings and congresses. Engagement with relevant stakeholders must continue, including supporting medical staff such as nurses, and most importantly, dialogue with patients.

Funding and reimbursement Finally, we need to think about incentives as a lever to drive and sustain thesechanges.

For instance, there is a ten-fold difference in the reimbursement tariff of outpatient diagnostic cystoscopy in Western European countries, ranging from less than €50 to more than €500 per case. The local situation needs to be considered for the actual price tag, but

such variances might not be a consistent message to healthcare providers. The reimbursement system today is mainly a reactive mechanism tothe running costrather than a proactive direction toward better health outcomes. It should not be a retrospective compensation scheme for the costs incurred but an investment for better outcomes and costs saved. The overall budget impact can be calculated at country or account level, where incentivescan be thought of, for instance, in two ways: 1) bypromoting a certain procedure (eg, day-case surgery tariff being higher than the one with two days or more), and/or 2) as value-based related to the outcomes provided based on agreed outcome measures.

Those of us involved should keep deliveringand pushing.

References 1. Xiong, Y. et al., ‘A metaanalysis of narrow band imaging for the diagnosis and therapeutic outcome of non-muscle invasive bladder cancer’,PLoS One, 12(2), 2017, p. e0170819.

2. Kang, W. et al., ‘Narrow band imaging-assisted transurethral resection reduces the recurrence risk of non-muscle invasive bladder cancer: A systematic review and meta-analysis’,Oncotarget, 8(14), 2017, pp. 2388023890.

3. Li, K. et al., ‘Diagnosis of narrow-band imaging in non-muscle-invasive bladder cancer: a systematic review and meta-analysis’, Int J Urol, 20(6), 2013, pp. 602-609.

Dr Peter SOLLEDER Executive Director, New Applications

OPAL1® PDD – a flexible visualization with IMAGE1 S™ to support urologists ready for new technologies.

Source: Univ.

Prof. Dr. Kurt Miller, Charité Universitätsmedizin Berlin, Germany

F

luorescence is a long known physical phenomenon that is becoming increasingly important in surgery as it offers the possibility to detect and identify structures in real-time which, importantly, are not visible under ordinary white light. Through the various target applications, ease of use and simple implementation in the operating theatre, surgeon technique and clinical outcomes are improving through widespread global use.Fluorescence imaging is based on the property of certain molecules to emit light after exposure to light of a particular wavelength. Fluorophores can be classified into two groups: endogenous and exogenous fluorophores. Endogenous fluorophores are, for example, structural proteins, Porphyrins, Lipids and Vitamins. Exogenous fluorophores are drugs that contain Cyanine dye, photosensitizers or molecular markers, eg, GFP. PDD allows detection of abnormal cellsof the urotheliumatat an early stage. Common applications for PDD, also known as Blue Light Cystoscopy (BLC), include the early detection of non-muscle invasive carcinoma of the bladder.

A timely detection of tumours in early stages and full resection greatly improve the prospects for recovery.

Bladder cancer ranks as the ninth most common cancer worldwide with 430,000 new cases and more than 165,000 deaths annually. It has a high recurrence rate with an average of 60-80%, of which 40-60% recurs within 2 years.

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence.

There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

The OPAL1® technology for PDD allows improved visualisation of tumours in the bladder,especially small and flat lesions which are difficult to detect using white light cystoscopy.

The principle of tumour detection is based on the characteristicsof altered metabolic activity of malignant cells which results in the accumulation of 5-ALA metabolic products.

5-ALA is an intracellular intermediate in the heme biosynthesis process, excess concentrations of 5-ALA lead to an increased accumulation of fluorescent protoporphyrin IX in tumour cells.

Hexaminolevulinate (Hexvix®/Cysview) leads to an increased accumulation of fluorescent protoporphyrin IX (PPIX) in the tumour cells. To achieve the detection of early malignant changes compared to healthy tissue, the PDD endoscopic

system transmits blue light into the bladder. Abnormal cells are precisely distinguished through their typical pink/red colouring relative to the blue healthy surrounding tissue.

Compared to standard white light cystoscopy, BLC improves detection of non-muscle invasive bladder cancer especially Ta/T1 and CIS, and enables the complete removal of malignant cells that results in an improved diagnosis and management of bladder cancer and leads to increased benefit for both patients and the healthcare system.

KARL STORZ, in conjunction with University Hospital Grosshadern in Munich, developed the first equipment for PDD of bladder cancer as early as 1995. This improved technology is now used routinely in many clinics for bladder diagnostics.

KARL STORZ thus set an important milestone in the early detection of bladder cancer. With PDD in FULL HD image quality, the camera platform IMAGE1 S™, which can be used for all specialties,and can easily be expanded to include PDD fluorescence imaging – this makes the system futureproof and

Furthermore,KARL STORZ provides its customers with optimum support for medical training and further education. KARL STORZ believes that the use of simulators and virtual reality (VR) in medical training holds great potential in this area to acquire the technical skills required for minimally invasive surgery under standardised conditions, with tactile force feedback in a controlled and risk-free environment.

KARL STORZ, therefore, offers VR simulators for urology (UroTrainer) including PDD, gynecology (GynTrainer) and arthroscopy (ArthroTrainer). They provide training in basic skills such as handeye coordination and diagnostic tours as well as complete procedures such as, for example, transurethral resection of bladder tumours (TURB) including the function of PDD or prostate resection (TURP).

References: 1. Globocan, Incidence/ mortality by population, International Agency for Research on Cancer.

2. Sievert, K.D., B. Amend, U. Nagele, D. Schilling, J. Bedke, M. Horstmann, J. Hennenlotter, S. Kruck and A. Stenzl,‘Economic aspects of bladder cancer: what are the benefits and costs?’, World J Urol,27, 2009, pp. 295300,doi:10.1007/s00345009-0395-z

Government Gazette | 97

State of Bladder Cancer policy in Europe

healthcare

The promise of immuno-oncology in bladder cancer Ashok K. GUPTA VP, IO Clinical Development

I

mmuno-oncology (IO) – the science of stimulatingthe body’s immune system to recognise and respond totumours –is one of the most mising advancesincancer researchin recent years.

Unlike conventional therapies, IO medicinesdo not directly kill cancers, but use a variety of different mechanisms to educatethe body’s own immunesystem to identifyand destroy tumour cells.

Thanks to research and regulatory approvals, immunotherapy is quickly becoming a mainstay of cancer treatment across multiple tumour types.Today, research into immune checkpoints and other immunosuppressive behaviours has helped contributeto a resurgence of interest in the development of diseaseand ability to elicit an immune response in bladder cancer as a target for these agents.

Despite progress, the need has never been greater Although bladder cancer was the fifth most common cancer in 2012 inthe European Union, treatment research has not kept pace with other forms of cancer.Only an estimated 1 in 10 patients with metastatic bladder cancer in Europe survive,and this rate has not significantly changed in nearly a decade.

In recent years, however, different

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immunotherapies have begun to show potential in improving survival rates over standardof-care chemotherapy in advanced disease.

There are many factors that may impact a cancer’s response to IO medicines, and we are still uncovering new markers every day. In bladder cancer and other tumour types specifically, tumour mutational burden (TMB) – the number of mutations a tumour cell carries – may be informative with regards to immunotherapy sensitivity. TMB is thought to result in an increased expression of neoantigens – antigens that specifically arise through mutations and are expressed by tumours. The presence of a greater number of neoantigensmay aid T cells in recognising the tumour and mounting an appropriate immune response to the cancer.

Where we are today Cancer can evade the immune system by tricking our bodies into not recognising tumour cells. Cancer does this by decreasing tumour-antigen presentation within our body,deactivating cytotoxic T cells(the cells in our body that kill cancerous and damaged cells), upregulating immune checkpoints, and maintaining an immunosuppressive tumour microenvironment – the area immediately surrounding the tumour,

which contains both immune and cancer cells.

This tricks our body into not activatingan immune response, despite the presence of tumour cells.1 Immune checkpoint inhibition, such as blockade of the programmed cell death-ligand 1 (PD-L1) pathway, iscurrently the most widely studied systemic immunebased approach for the treatment of bladder cancer.

PD-L1 works to suppress the immune response against tumour cells; expressed on a variety of normal cells, it works normally by binding to programmed death 1 (PD-1) to inhibit effector T-cell activity.

Tumour cells hijack this mechanism byexpressing PD-L1 tofool T cells into thinking the tumour is a healthy cell, thereby evading an immune response. Blocking the binding of PD-1 to PD-L1 inhibits this immunosuppressive mechanism and helps re-activate T cells against the cancer.

Where we’re going tomorrow Beyond checkpoint inhibition, we can employ the immune system to fight cancer in a multitude of ways: by priming a new anti-tumour immune response, by strengthening an existing but weak immune response, or by reversing tumour suppression through removal of barriers to the immune response. Studies have shown that combining checkpoint inhibitors with chemotherapies, other small molecules, and even other immunotherapiesmay amplify results by overcoming multiple

mechanisms of immune evasion and targeting non-redundant pathways. ,,, Many targeted therapies also modulate the immune response (e.g., T-cell proliferation and responsiveness to tumour antigens), which makes them attractive candidates for combination with immunotherapy because of the potential for additive effects.

In particular, small molecules such as EGFR, MEK, VEGFR and PARP inhibitors have properties that may enhance response to immune checkpoint inhibitors, such as anti–PD-L1.9 AstraZeneca’s commitment to immunotherapy By identifying novel immunotherapy targets and exploringtreatment approaches that combine different immunotherapies, each with a unique mechanism of action,we can deliver the next generation of precision medicine options for patients with bladder cancer.

AstraZeneca, together with its global biologics research and development arm, MedImmune, is committed to unlocking the potential of IO and is evaluating multiple therapiesfor their potential to deliver durable responses and improve survivalfor patients withbladder cancer.

References: 1. Dangi-Garimella, S. “The Promise of ImmunoOncology.” American Journal of Managed Care.

2015;21(3) 2. Cancer.net “Understanding Immunotherapy.” Available at: https://www.cancer. net/navigating-cancercare/how-cancer-treated/ immunotherapy-andvaccines/understanding-

immunotherapy Date accessed: May 2018 3. International Agency for Research on Cancer.

“GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012: European Union” Available at: http://globocan.iarc. fr/Pages/fact_sheets_ population.aspx Accessed May 2018.

4. European Cancer Patient Coalition. White Paper: Bladder Cancer. 2016.

5. Miller, L. The Rapid Uptake of Immunotherapy in Bladder Cancer. Targeted Oncology. 2017 6. ESMO.org. “Tumour Mutational Load: ESMO Biomarker Factsheet.”

Available at: http:// oncologypro.esmo.org/ Education-Library/ Factsheets-on-Biomarkers/ Tumour-Mutational-Load Date accessed: May 2018.

7. Cheng W, et al.

Unwrapping the genomic characteristics of urothelial bladder cancer and successes with immune checkpoint blockade therapy.

Oncogenesis. 2018;7(2) 8. McDermott DF, Atkin MB. PD-1 as a potential target in cancer therapy.

Cancer Med. 2013;2:662673.

9. Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012;12(4):252264.

10. Dizon DS. Krilov L, Cohen E, et al. Clinical cancer advances 2016; annual report on progress against cancer from the American Society of Clinical Oncology [published online ahead of print February 4, 2016]. J Clin Oncol. 2016;34(9):9871011. doi:10.1200/ JCO.2015.65.8427.

11. Melero I, Berman DM, Aznar A, et al. Evolving synergistic combinations of targeted immunotherapies to combat cancer. Nat Rev Cancer. 2015;15:457-472.

12. Drake CG. Combination immunotherapy approaches.

Ann Oncol. 2012;23:viii41viii46

ADVERTORIAL

Adrian ZEVENBERGEN

Managing Director, European Space Imaging

View from outer space: an approach for smarter decision making

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atellites view the Earth as a whole - collecting data without regard to political boundaries. In an everchanging and uncertain world, very high resolution (VHR) satellite imagery is fast becoming a common tool to predict future threats, monitor development outcomes and minimise risk at all levels of government. As such, policy makers now need to be provided with more information than ever before and usually this information is time critical.

Information derived from optical satellite imagery provides a whole new way of looking at the world. As well as tabled data, VHR imagery can provide a 3D overview of the state of the Earth and allows you to see the current situation in near-real-time, permitting optimised responses for the best possible outcome. It adds another level of detail that can serve numerous purposes and is an indispensable source of information gap filling.

Security Surveillance for Safer Borders The power of VHR data lies in the detail. It can provide empirical answers to questions concerning multiple humanitarian and border security applications. Due to the resolution of the imagery, tents and cars can easily be identified from the sky allowing the movement of refugees to be monitored in addition to the mapping of displaced populations. The technology also provides more measured border security controls both at a domestic and international level. Oceans are large and ships are small however through the aid of satellite technology, policy makers knowledge

of the entire ocean and not just coastal zones, can be significantly increased. The wide reach of the technology also means that no area of the ocean is unable to be captured. As a result, countries can reduce the number of illegal immigrants entering, reduce the death toll of human lives at seas and increase internal security within the country by preventing cross-border crime.

Agriculture Insights for Modern Frameworks VHR imagery provides the opportunity for multispectral analysis to be conducted. With multispectral imagery, it is possible to extract additional information that the human eye fails to see. Too often the issue regarding the lack of basic information required for sustainable food security poses a threat to governments.

Without up to date information on the types of crops, planting dates, soil conditions as well as water resources, it can be difficult for governments to make smart decisions regarding agriculture policy and planning.

Urban Planning for Smart Cities Supporting sustainable growth taking into account the capacity of local infrastructure, any environmental barriers and without exceeding budget limits poses a major challenge to government. It is estimated that in less than 40 years, 70% of the world’s population will reside in cities and therefore policy makers need to be implementing smart solutions now in order to avoid future chaos. Such solutions can be beneficially enhanced with use of remote sensing applications. When combined with GIS software, satellite imagery plays a crucial

role in applications such as land and materials classification, traffic flow management, smart utilities and energy efficiency, waste management and human population mapping.

In addition, satellite data is fast and reliable and can be used to monitor the change of the city and predicting its growth.

A Digital World Furthermore, satellite imagery is collected digitally which allows for fast delivery and unlike aerial imagery, there is no data loss during the scanning process. The data takes into account real time weather assessments to maximise the success of the collection and covers a larger ground area than possible with aerial imagery or drones. Additionally it offers logistical simplicity by cutting out the need for permits, air traffic control, equipment, pilots or personnel on the ground. This is especially important when the area of interest is in a crisis or conflict zone or the information is time sensitive.

About European Space Imaging European Space Imaging is the leading supplier of very high resolution satellite imagery and derived services to customers in Europe, North Africa and the CIS countries. Established in 2002 and based in Munich, Germany, they have been reliably supplying imagery and supporting EU earth observation programmes controlled by the EU Commission, European Space Agency, FRONTEX, Joint Research Centre, European Maritime Safety Agency (EMSA) and others for more than 15 years

on food & wine

Ten reasons why you should be in Brussels this Christmas

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inter time in Brussels is the best time to make most of its culinary and drink culture. Belgian food, which might come across as a bit heavy during the summer months, now truly comes into its own.

1

For a relaxed lunch before or after visiting the Christmas market, we love to stop at Café des Minimes, just off Sablon, which offers a lunch choice of 2 starters, 3 mains (fish, meat, vegetarian) and 1 delicious dessert.

2

Tired from visiting the many Brussels museums? Then stop at Kwint which serves modern style dishes and overlooks the Grand Place. If however you are after a quick bite then look out for Pistolet Original which serves a delicious range of Belgian ‘pistolets’, little round white breads sandwiches.

3

During a cold wintery day, Belgian brasseries are perfect to enjoy a traditional Belgian dinner – we love Les Brassins to try out sausages and stoemp (mash with potatoes and a seasonal vegetable), nothing beats Vincent for classic steak and frites or Au Stekerlapatte for daring Brusselair dishes like bloempanch (black pudding pie).

4

Game season is also in full swing. Michelin starred Bozar Brasserie serves pure seasonal bliss on a plate with game terrines.

Brugmann is a must if you are looking for a New York inspired restaurant serving venison carpaccio. And Colonel is a must for every meat lover.

6

If you are looking for something a bit lighter before the festive season starts, then head to Francois for exquisitely served seafood and fish dishes, Le Scheltema to combine a stroll through Grand Place with traditional croquettes des crevette (shrimp croquettes) or La Quincaillerie, which features a lovely oyster bar all through November and December (and is also celebrating 30 years of existence this year).

7

No one does desserts better than Brussels.

We are not even going to try to list all the chocolate shops which lure you during this period with gorgeous Advents calendars, creamy hot chocolates and box of pralines.

8

With St. Nicolas – a big Belgian celebration – around the corner, everybody will be heading to Maison Dandoy for their speculoos biscuits. Hide away from the craziness of Christmas shopping in Patisserie Renard. Enjoy the most unusual and divine flavour combination, all packed into tiny choux, at Chouconut.

9

But enough about food! Long and cold days call for warming and hearty beers or a glass of wine. For speciality Christmas beers we tend to try out local favourites like Moeder Lambic, A la MorteSubite or Monk all located within walking distance from Grand Place.

10

Wine bars are the latest Brussels trend so we have listed 5 of our favourites on our blog which will take you through different communes of Brussels from 1170 to 1060.

about the author Andreea Gulacsi works and lives in Brussels, and keeps an expat food blog at www.onfoodandwine.com

electoral technology

Election participation in the age of convenience Samira SABA

Integrated Communications Director

Voting channel

Cost per ballot

Early Voting in country centres

€ 5,07

Advance Voting in country centres

€ 6,24

Election Day Voting in country centres

€ 4,61

Advance Voting in polling stations

€ 20,41

Election Day Voting in polling stations

€ 4,37

I-Voting

€ 2,32

can make elections more inclusive, efficient and transparent. Examples from theUnited States, Norwayand Estonia serve to prove the case in point.

According to the U.S. Election Assistance Commission, the number of Americans who have voted early or sent an absentee or mail-in ballot has increased from some 25 million in 2004 to 57 million in 2016.Likewise, the number of early votersgrew from 10.2 million in 2004 to 35 million in 2018.Though the change in preferences has been rapid, it should not come as a surprise.

Convenience has become a key decision driver for many of us.

Offering multiple options to cast a ballotis the logical thing to do, yet, it carries significant implications for election administrators. More days of voting mean more days to protect ballot boxes; it implies managing poll workers for longer hours; it increases the cost of the overall process.

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n this age of convenience, where people have grown accustomed to shop, bank and networkat the press of a key, heading to the poll on election day has lost some of its appeal.

Across the planet people are demanding more and better channels to participate in elections.

Technology is key if we are to get this increasingly complex and mobile electorate to vote.

Well-designed technology

Different voting methods running simultaneously led to some lengthy and cumbersome tallying processes during the U.S. elections held last November. It is fair to say that the recordbreaking turnout – the highest midterm turnout (49.3%) in more than 50 years– and certain razorthin races helped spark all kinds of conspiracy theories and fraud accusations.

But fake news aside, some Florida officials had a difficult time verifying signatures on provisional, absentee and military ballots vis a vis the ones on file. Mailedin ballots took longer to process as they depended

on the efficiency of the problem-ridden postal service. In other words, the technologies (or lack-of-thereof ) used to facilitate the different voting methodsproved inefficient.

Curiously enough, the signature is proving to be a pain point in voter enfranchisement. This method of identification continues to fall out of favour especially among younger people who are more likely to key in a password than put a pen to paper to sign.

As a result, a report by Daniel Smith from the University of Florida found that younger voters were four times more likely to have their absentee ballots rejected than voters older than 65.

Online voting could well help solve many of these challenges election management bodies are experiencing. Though not a silver bullet to solve all problems, online voting isshaping up to be an excellent substitute for other forms of remote voting.

A well-designed online voting system enables all voters to conveniently cast their ballots at any time and from anywhere.

Votes cast online can be tallied on Election Day without delay. Issues with signatures for voter authentications simply become a thing of the past.

Earlier this year, Norway conducted a referendum in Finnmark, the Northernmost province. Voters had the option to cast a ballot online or to head to a polling station to cast a traditional vote in paper. An overwhelming 85% preferred to vote online again proving that convenience is king in

today’s world.

A recent study conducted

by Robert Krimmer and othere xperts from the Tallinn University of Technology in Estonia suggests that online voting has increased voter turnout in the country by1.5% in local elections and 5% in national elections. Voting is 16 times faster and is used by people of all ages.

The studyalso concludes that online voting is considerably more costeffective than all other forms of voting available in Estonia. See the table.

As poll authorities experiment on ways to stoke participation with an increasingly mobile and dispersed electorate, it is critical that voters are given secure and accessible alternatives to engage in democracy.

It is time to modernise elections.

Promoting Citizen Participation in the Digital Era We help countries modernize their elections with

innovative technology solutions that increase transparency, maximize security and make the overall process more inclusive.

Visit our website to learn more about our company. www.smartmatic.com

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