European Health Parliament - 7 recommendations on Healthcare in Europe by European Health Parliament

EUROPEAN HEALTH PARLIAMENT • 7 RECOMMENDATIONS ON HEALTHCARE IN EUROPE

EUROPEAN HEALTH PARLIAMENT 7 RECOMMENDATIONS ON HEALTHCARE IN EUROPE JUNE 2015

CONTENT > Forewords

by Olivier Costa, Jane Griffiths, Philippe De Backer and Giovanni La Via

> Recommendations • CROSS BORDER HEALTH THREATS • THE ECONOMIC DIMENSION OF HEALTHCARE • BIG DATA IN HEALTHCARE • ELECTRONIC/MOBILE HEALTH • PATIENT EMPOWERMENT AND CENTREDNESS • ACCES TO THERAPEUTIC INNOVATION • PREVENTION OF CHRONIC DISEASES

Seven recommendations on healthcare in Europe - European Health Parliament

Dear reader,

Health is today one of the key issues for European societies. Its importance is currently undervalued because of the focus of policy-makers, the media and citizens on other topics, such as the economic crisis, the shadow of war in several regions of the world, or the many challenges of global warming. It is nevertheless a central concern for all of us, especially at EU level. European health policy indeed enjoys new legal bases since the treaty of Lisbon and is undergoing a deep process of transformation. To improve or even just maintain public health at a reasonable cost is a major headache. Major reforms are required but there is no consensus on the objectives and on the means. Europe needs initiatives on the long run, based on knowledge, expertise and new ideas. They cannot come from the sole EU institutions: in the current context, they are not able to provide an efficient brainstorming, and are more in a position of reaction to events and management of crisis. Policy makers lack the capacity to think outside of the box: they thus are looking for new initiatives, concepts, and ideas. Scientists have the necessary expertise, but they are not entitled to set the political agenda; their role is to just to help the policy makers to do the right choices regarding the objectives they define. There is consequently a need for initiatives from the civil society to nourish the European debate on health. The European Health Parliament is an original answer to that situation. Gathering 80 young professionals and post-graduate students to confront their views, experiences, data and ideas is a way to bring inspiration to EU policy makers. The success of the call for application for the EHP proves that citizens â&#x20AC;&#x201C; especially in the young generation â&#x20AC;&#x201C; are mobilized and willing to contribute to such initiatives. The EHP project worked out because everybody among the participants and the organizers was convinced that it is the responsibility of citizens, media, private companies, higher education institutions and civil society organisations to contribute policy making, and that creating a network is a first necessary step to do so. The main challenge for the EHP members was to be able to think ahead. Since it takes years to set a point on the agenda, and then to develop a policy, the challenge was to consider the problems, the needs and the technology not as they are today, but as they will be in five or ten years. Looking at the wonderful job realized within the six committees, I guess that the EHP has succeeded in this respect. The College of Europe, which has been preparing young Europeans for leadership functions since 1949, is most grateful to its partners Janssen, EU40, Google and Politico, for this unique opportunity. For us, initiatives like the EHP are crucial. Our mission is not only to teach students in an academic way, but to give them a concrete experience of the EU policy making and to encourage them to develop their critical thinking, their capacities to work collectively, and their concrete involvement in EU affairs. We are very proud of our students, who worked under considerable time pressure on top of their very demanding study programmes at the College. The participants of the first session of the EHP have shown, I believe, that it is possible to contribute to the future of public health by creative thinking. I hope that their analyses and proposals will be useful for that purpose.

Olivier Costa, Director of Studies of the Political and Administrative Studies Department, College of Europe, Bruges.

European Health Parliament - Seven recommendations on healthcare in Europe

Societal health is a precondition for economic prosperity. It has a direct influence on economic outcomes in terms of productivity, labour supply, human capital and public spending.1 Public health and sustainable healthcare systems are therefore some of the most valuable assets of modern society. Investment in pharmaceutical research and development over the last 60 years has yielded medical advances that have increased life expectancy and resulted in a better quality of life for people around the world. Therapeutic innovations have led to a dramatic decline in death rates for diseases such as HIV/AIDS, cancer, polio and measles. Advances in personalised medicine not only promise to enhance the lives of patients and increase the quality of clinical practice and targeted care pathways, but also to retain quality whilst minimising overall healthcare costs through early-detection, prevention, accurate risk assessments and efficiencies in care delivery. Added to this, recent decades have seen remarkable advances in healthcare technology. Ultra-highresolution analytical instruments, desktop electron microscopy, gene therapy, translational research, stem cell therapies and microbiomics are just some of the new technologies that are transforming the drug development landscape. Despite such progress, now is not a time for complacency. There remain many urgent unmet medical needs that need to be addressed for the benefit of patients and society and it is more critical than ever that we establish a sustainable healthcare framework to bring solutions to fruition. As we continue to look to the future of both medical technology and healthcare systems, we must look to those who will play a part in shaping this future. In all likelihood, many members of the European Health Parliament will play a key role in influencing the healthcare systems of tomorrow. It is they who are likely to be some of the policy makers, researchers, physicians, financiers and advocates in the coming years. As such it is they who will be making key decisions such as how to balance cost and value with affordability, and how best to divide labour. They will be establishing collaboration between the public and private sectors, and making decisions on how to build sustainable healthcare systems. In short, it is they who represent the future of healthcare. The outstanding academic papers presented in this publication on seven formidable healthcare challenges demonstrate that this future is in safe hands. The parliament members involved have studied, analysed and debated each of the healthcare challenges and proposed creative, workable ideas to address them. But the value of the European Health Parliament initiative is greater than the sum of these papers. These young talents have learned first-hand the value in society of a multidisciplinary approach. They now understand the critical importance of collaboration across borders and disciplines, and crucially, they are equipped with the know-how to make this happen to tackle the worldâ&#x20AC;&#x2122;s future health problems. We have seen Europeâ&#x20AC;&#x2122;s healthcare future at work.

Jane Griffiths Company Group Chairman Janssen Pharmaceutical Companies of Johnson & Johnson Europe, Middle East & Africa

European Commission, 2013. Investing in Health: Commission Staff Working Document Social Investment Package. http://ec.europa.eu/health/strategy/ docs/swd_investing_in_health.pdf. Last accessed 20.5.15

Seven recommendations on healthcare in Europe - European Health Parliament

Dear readers,

Heroes are defined as persons who, in the face of adversity display courage or self-sacrifice - that is, heroism - for the greater good. And, what greater good is there than the provision of decent access to healthcare for all European citizens? That’s why I have called on the group of up-and-coming health experts involved in the ‘European Health Parliament (EHP)’, to be no less than heroes in their mission ahead. We could and should be heroes. How can we ensure Europe has a better healthcare in the future? By bringing together 80 bright young professionals with executives from the pharmaceutical and IT industry, patient organisations, and young members of the European Parliament to create a vivid, enthusiastic and visionary debate. Our mission is to develop and deliver a set of policy proposals for Europe’s future healthcare that will ultimately push European health policy and practice in the right direction. The European Health Parliament (EHP), a brand new initiative, has provided the ideal breeding ground for this group of 80 young burgeoning healthcare experts from across the EU to inject fresh new blood into this critical area of policy. The EHP motto, ‘Occupy Health Street’, is a direct challenge to established thinking and the vested interests. And that is exactly what healthcare in Europe needs right now; more excellence, not mediocrity, must be our driver. Europe’s health statistics should serve as sufficient provocation for valiant steps forward. Healthcare costs are rising, innovative treatments take longer to come to reach the patient and the standard of care is divers across the EU. We therefore could and should do better on healthcare. We have to break through barriers, focus our efforts in not just adapting but changing the system. Preserver what is good, but also fundamentally change what is not working. For this, we need forward looking young people. Europe’s new ‘healthcare heroes’ have already set an example. Their level of commitment and conviction - which I have witnessed first-hand - reveals much about the professionals who will be managing our healthcare in the future. As MEP, I believe it is my duty to support them and ensure that proposals are being implemented. When it comes to European healthcare, we could indeed be heroes, it is time to make a difference.

Philippe de Backer, Host and Supporter of the European Health Parliament

European Health Parliament - Seven recommendations on healthcare in Europe

I’m delighted to have the honour and privilege of introducing this high-level policy paper on how to improve Europe’s healthcare system. During the past decades, major progress has been made in the area of public health as a result of key achievements in European health research and medicine, improved living standards and levels of education, better nutrition, and better access to high quality healthcare. The result of economic development and successes in public health and health care has resulted in an increase in life expectancy. At the same time, fertility has been steadily declining in the EU since the mid-1960s and is currently, in particular, decreasing in particular in Eastern and Southern Europe. The share of older people is therefore growing, and is already greater than the proportion of children in the population. By 2060, the share of people in the population who are over 65 years of age will more than double in number, with an associated increase in neurodegenerative diseases, such as Alzheimer and other dementia. In the decade before the crisis, health was one of the fastest growing spending items for governments in most Member States, however, health budgets, particularly those related to prevention and health promotion, have been dramatically cut during the past few years. The economic crisis has led to adverse population health outcomes. The number of people suffering from depression has increased in several European countries, as a result of growing unemployment, financial hardship and stress. As stated in your analysis “Health is a value in itself and it is also a precondition for economic prosperity” and Health spending is a “growth friendly” expenditure. This state-of-play on Europe’s health shows that EU policies and strategies are needed to promote healthy lifestyles, protect healthy living standards and improve the prevention, early diagnosis and treatment of diseases. More attention must be given to improve the sustainability of health systems. It’s high time we appreciate the European Healthcare system for what it is: one of our biggest values and a fundamental precondition for economic prosperity.

Giovanni La Via, Chairman Committee on the Environment, Public Health and Food Safety

Seven recommendations on healthcare in Europe - European Health Parliament

RECOMMENDATIONS

CROSS BORDER HEALTH THREATS

Authors Katrina Murray Éva Hajdók Frederik Mesdag Roberto Morosini Astrid Nédée Aleksandra Opalska Eva Oyón Sam Proesmans Maira Seini Katrien Venken Jessica Wright

Executive summary Disease does not respect national borders. Disease can spread from country to country in the time of an airplane journey. Within the EU, member states retain primary responsibility for healthcare, including responding to cross-border health threats such as the spread of disease. Given the freedom of movement within the EU, member states need to be well prepared to respond to these threats. However, the answer is not to close European borders, but rather to strengthen national healthcare systems, with proactive support from EU institutions, to prevent disease and protect European citizens. The paper uses a framework of comparing novel and emerging threats through a case study of seasonal influenza, compared with a case study of tuberculosis, and its multi-drug resistant strain (MDR-TB), to assess long term endemic threats. From this framework, four key recommendations are made to European policy makers: 1. The EU should develop a public and defined framework for disease intervention in the event of a cross-border health threat emerging. 2. The EU and its member states should develop a proactive vaccination plan, including monitoring coverage rates and supporting vaccination development, to prevent emerging threats such as seasonal influenza. 3. The EU should strengthen political efforts to eradicate MDR-TB, with a focus on exacerbating factors such as social marginalisation, to deal with long term threats. 4. The EU should enhance cooperation to deal with cross-border health threats, ensuring a level playing field between its member states to allow a proactive and preventative response. Cross-border health threats will always be a challenge in an EU with open borders. Disease does not stop at our national borders, so our health care systems in turn must be equally mobile, cross-national and proactive.

Cross Border Health Threats - European Health Parliament

I. INTRODUCTION Disease does not respect national borders. Neither should European healthcare. Outbreaks no longer remain localized, so they are harder to contain. The WHO estimates more than two million people cross international borders each day. With these cross-border movements comes the spread of communicable diseases such as HIV-AIDS, malaria, tuberculosis, influenza, Q fever and Ebola. An infectious disease can spread as fast as an airplane can fly, depending on its incubation period. Worldwide, infectious diseases are responsible for around 20% of all deaths (Saker et al., 2004). When they are not contained, diseases can have devastating impacts. Moreover, cross-border health threats are not solely linked to disease, but can also be created by environmental risks, bioterrorism, sanitation problems and more. The situation in Europe Freedom of movement in the EU has been a major achievement, but there are associated risks, not least the risk of health threats being easily transmitted across open borders. EU-wide coordination is necessary for an effective and sustainable solution. To date, health policy is managed at national level, with the EU in only an advisory role. This paper will use the EU’s own definition of a serious cross-border health threat, as a “lifethreatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin” which risks spreading across the national borders of member states as defined in Decision 1082/2013/EU on serious cross-border threats to health. The focus of this paper is on EU-level action and responses, however it must be acknowledged that effective action at the international level is equally important. When and how should the EU respond to cross-border health threats? To make practical proposals to European healthcare policymakers and professionals, this paper will address the circumstances under which the EU should intervene in cross-border health threats. It will also outline the current gaps and inconsistencies with the current EU response to cross-border health threats. For the purposes of this paper, we have divided infectious diseases into two broad categories where the response requires a similar, albeit not identical, framework: • Novel and emerging threats: sudden and large scale threats, which require a single concentrated response such as influenza, Ebola, SARS or MERS. • Long term threats: known or foreseeable threats that require a longer-term strategy, such as multi-drug resistant tuberculosis (MDR-TB), HIV, polio and STIs.

European Health Parliament - Cross Border Health Threats

This paper will focus on influenza outbreaks as a novel and emerging threatcategory and MDR-TB as a long-term threat. The EU faces other significant public health challenges , but these examples permit a broad assessment of the framework. Does the EU provide added value in preventing health threats? The EU is ideally placed as a regional organization to protect EU citizens and member states from major public health threats, by acting to prevent health threats spreading and providing rapid responses when a threat emerges. Member states stand to benefit from increased international cooperation, starting at European level. Improved communication and coordination systems can support a faster and more effective response. In times of emergency, member states should respond in a mutually supportive way, rather than taking actions which could negatively impact each other.

Figure 1. Flight paths of Europe illustrating the constant movement of people across European borders. (Markieta, 2013)

Cross Border Health Threats - European Health Parliament

II. SITUATION ANALYSIS For every disease there is a unique response. However, to maximise existing funding, legislation and coordination mechanisms, we propose two broad categorisations of disease response. The first deals with novel and emerging threats and we illustrate this framework through a case study of influenza. But there are also long-term threats that can be foreseen, requiring a very different response, and to illustrate this we have focused on TB. Lessons learned from influenza and TB can be used for other diseases in our proposed framework.

The legal framework in a nutshell The scope of EU action in health policy - as a shared competence - is set out in Article 168 of the Treaty on the Functioning of the European Union, . EU health policy complements and supports national policies on issues where coordination, cooperation and exchange of information, knowledge and best practice are essential. EU legislation to control communicable diseases has been in place since 1998, replaced in 2013 by a new decision on serious cross-border threats to health (Decision 1082/2013/EU). Moreover, the existing framework on communicable diseases has been extended to cover coordination at EU level of preparedness and response planning1. •

EU alert systems: if a member state detects a threat to citizens’ health and safety, it notifies the European Commission through one of the EU’s rapid alert systems. Furthermore, the Commission may recognise a public health “emergency situation” independently from the WHO to allow a quicker response.

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EU Health Security Committee (HSC) coordinates health security measures, and preparation and planning of the responses to an emergency (28 member states, Norway, Iceland and Switzerland, under the Commission’s chairmanship).

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European Centre for Disease and Control (ECDC) is an EU agency designed to strengthen Europe’s defences against infectious diseases, with a mission to identify, assess and communicate current and emerging threats to human health posed by infectious diseases.

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EU-wide research networks, funded by the European Commission, emphasise the role of research and development in the prevention of health threatCase study 1: Novel and emerging threats: Influenza

1 Until 2013, member states were not legally bound to exchange information on their national preparedness plans. Sharing plans would avoid inconsistencies and help achieve a common and consistent vision.

European Health Parliament - Cross Border Health Threats

Case study 1: Novel and emerging threats: Influenza A serious cross-border health threat that can be classified as a short-term, immediate threat is influenza, particularly an influenza pandemic. Influenza is an infectious disease caused by an everchanging group of influenza viruses that spreads easily from person to person with an incubation period of only a few days. It is an airborne disease transmitted by coughing or sneezing as well as by contamination. Seasonal influenza epidemics occur each winter; it is a common disease with up to 10% of adults worldwide becoming infected annually. The virus usually causes rapid-onset respiratory and systemic symptoms including fever and muscle pain. This tends to resolve within a week, but for high-risk groups (young children, those with chronic illnesses and the elderly), complications can lead to hospitalisation or death. The WHO estimates that seasonal influenza causes up to 500,000 deaths and 5 million cases of severe illness each year, with most influenza deaths in industrialised countries occurring in the over 65 year old population (World Health Organisation, 2014). There is significant annual variation but the ECDC estimates that influenza results in 38,500 excess deaths, many avoidable, each (non-pandemic) year in Europe (European Centre for Disease Prevention and Control, 2010). The costs of an epidemic are not paid only in human terms; all influenza cases pose significant economic and social burdens to the EU through reduced workforce productivity and increased demands on health services. A seasonal influenza epidemic can in total cost developed countries €56.7 million per million people (Eliyahu & Meijer, 2009). The ability to prevent death, serious illness and economic slowdown resulting from influenza makes this a vital issue for Europe to tackle. According to the WHO, influenza vaccination is the “most effective way to prevent the disease and/or severe outcomes” (World Health Organisation, 2014), particularly for those in high-risk groups. WHO recommends annual vaccination for: • older adults (65+ years of age) • pregnant women • children (6 months to 5 years) • individuals with chronic illnesses • healthcare workers

Cross Border Health Threats - European Health Parliament

Each year the major influenza viruses circulating in humans are slightly different as they accumulate small genetic changes in a process called antigenic drift. A new influenza vaccination must therefore be prepared annually, in light of the WHO Global Influenza Surveillance and Response System monitoring. WHO recommends vaccine compositions for the Northern and Southern hemisphere influenza seasons. It also works with countries’ health systems to improve diagnostic capabilities, measure virus susceptibility to antivirals, and monitor outbreaks. Major epidemics and pandemics occur when the genetic change is significant and the population has little immunity to the new influenza strain. These antigenic shifts can also occur through interaction with animal viruses - which is thought to have happened in the 1918 influenza pandemic (Taubenberger, 2006). The 1918 Spanish Flu pandemic had a devastating impact around the world, killing 3-6% of the population. (Taubenberger, et al., 2006). In this unprecedented pandemic, half a billion people were infected and it is estimated that 50 to 100 million people died. This unusually high mortality rate (up to 20%) compares to a ‘normal’ influenza case-fatality rate of 0.1%. (Patterson, & Pyle, 1991). As the emergence of a new pandemic strain is unpredictable, no one can tell when the next devastating pandemic will occur. Preparation is therefore essential. In 2009, the Council of the European Union adopted the Council Recommendation on seasonal influenza vaccination, which called for “concerted action at the level of the European Union…to mitigate the impact of seasonal influenza by encouraging vaccination among risk groups and healthcare workers”. Member states were encouraged to have their own plan and policies to improve vaccination coverage amongst their designated high-risk groups. The Recommendation aimed to ensure that 75% vaccination target for older age groups was met by the 2014-15 influenza season, and then to extend the same target to other risk groups. The ECDC considers it “unlikely that the target will be met in the 2014-15 influenza season” (European Centre for Disease Prevention and Control, 2015). Influenza is not going away. It changes every year, but with a strategy focused on vaccination as a first priority, EU governments can be proactive in minimising deaths and economic damage.

European Health Parliament - Cross Border Health Threats

Case study 2: Long-term threats: MDR â&#x20AC;&#x201C; TB Tuberculosis (TB) is a bacterial disease that spreads from person to person through the air, often as a result of coughing or sneezing. It is one of the leading causes of death in the world, with 1.5 million dying in 2013. It is the second deadliest infectious disease(after HIV/AIDS), despite being both preventable and curable. In Europe alone, the disease infects 360,000 and kills 38,000 people each year (TB Europe Coalition, n.d.). As such, it constitutes a significant cross-border health threat for the European Union. The growing prevalence of multidrug-resistant tuberculosis (MDR-TB) is a major concern. MDR-TB is a specific type of TB where the bacteria are resistant to the major first-line TB drugs. Drug resistance tends to result from antibiotic misuse, which can arise from inadequate or incorrect treatment, or from patients not completing the full treatment course. MDR-TB therefore occurs most often where strategies to effectively control TB have failed. It is therefore worrying that the WHO European region has some of the highest rates of MDR-TB in the world.

Percentage of notified TB cases with multidrug resistance among new laboratory-confirmed pulmonary TB cases, European Region, 2013 <1 1 - 1.9 2 - 5.9 6 - 9.9 10 - 15 > 15 Not included or not reporting

Figure 2. Percentage of MDR-TB amongst new TB cases in 2013. (European Centre for Disease Prevention and Control/WHO Regional Office for Europe, 2014)

Cross Border Health Threats - European Health Parliament

As seen in Figure 2, four EU member states (Latvia, Estonia, Bulgaria and Lithuania) are in the ‘red zone’ of MDR-TB risk countries. A further 11 of the 27 countries with the highest MDR-TB burden worldwide are in the WHO European region, compounding the risk of MDR-TB further becoming a major cross-border health threat. Some member states are reporting that up to 35% of their new TB cases are drug-resistant with the associated difficulty and expense of treatment. (European Centre for Disease Prevention and Control/WHO Regional Office for Europe, 2014) Europe has not yet effectively addressed the issue of MDR-TB. Over half of MDR-TB cases are not detected and fewer than 50% are cured (Boas, 2015). As a single TB patient can infect up to 15 other people in their community, drastic action is therefore required, including major political and financial commitments. As in the rest of the world, there is a clear causal association between the disease of TB and poverty. Therefore the challenge of TB is not only to the medical community but also to social systems more broadly. TB is an opportunistic disease, and takes advantage of people whose immune systems are weakened from poor living conditions, malnutrition, drug or alcohol abuse or from diseases such as HIV - populations least able to self-refer and then to self-manage treatment. As a result, stigma surrounds TB diagnosis, so patients are further disadvantaged and discriminated against as well as discouraged from seeking treatment (Christodoulou, 2011). Because of the strong association with HIV infection, Eastern Europe, where HIV prevalence is five times higher than in Western Europe, is facing a disproportionate challenge . One of the principal control strategies recommended by WHO, and at the centre of its STOP TB Strategy, is DOTS – that is Directly Observed Treatment, Short Course (World Health Organisation, n.d.) For DOTS to be effective, government commitment is required to support TB monitoring, recording and training, as well as standardised treatment observed by a healthcare worker, along with drug supplies and a standardized assessment of treatment efforts. Cooperation on TB at the EU level started with the European Tuberculosis Surveillance Programme (EuroTB) in 1996. The European Tuberculosis Surveillance Network was set up as a continuation of EuroTB in January 2008. Jointly coordinated by the WHO Regional Office for Europe (WHO/Europe) and the European Centre for Disease Control (ECDC), the network of TB surveillance experts meets annually to discuss TB epidemiology in Europe and progress towards elimination.

European Health Parliament - Cross Border Health Threats

WHO/Europe and ECDC publish joint annual surveillance reports on progress towards TB eradication. In 2008, the ECDC developed a Framework Action Plan to Fight TB in the EU, which provided analysis of the current issues, and identified capability gaps and recommendations for EU member states and EEA/EFTA countries, to be implemented at both national and EU level. More recently, the Latvian Presidency of the European Council (January-June 2015) has identified TB prevention and control as a priority area of focus, leading to the first Ministerial Conference on TB and MDR-TB. In their Joint Declaration, EU leaders recognised that â&#x20AC;&#x153;TB and MDR-TB are also a cross-border health threat in the globalised world where overall the mobility of the population is increasingâ&#x20AC;?. Conference participants agreed to implement the WHO End TB Strategy, seeking a 75% reduction in the number of deaths and a 50% reduction in the number of cases by 2025 (World Health Organisation, 2015). However, implementation gaps continue across the EU. In most low-incidence countries, TB rates are stable or decreasing slowly, and incidences are concentrated amongst high-risk and vulnerable populations. On the other hand, countries with high overall TB incidence face much higher rates of reinfection and relapse, reporting many more cases of MDR-TB. There are also challenges with regard to equal access to social protection, health care, diagnostics, treatment and follow-up support. As things stand, TB will be a problem for many years to come. However, building on the political will demonstrated by the Latvian presidency to make TB a priority healthcare issue, real action can have real impacts. A future-oriented policy to prevent the spread of TB both within and between EU member states is in the best interest of EU citizens and governments alike.

Cross Border Health Threats - European Health Parliament

III. RECOMMENDATIONS Disease is a fact of life. European freedom of movement is a fact of life. Therefore, we must accept the very real risk of novel and emerging health threats and longer-term infectious diseases spreading across EU borders if we do not take action. We therefore make four recommendations to avoid or mitigate the risks posed by cross-border health threats.

Recommendation 1: The EU should develop a public and defined framework for disease intervention The European Union is in a unique position to respond to cross-border health threats. But it must define a strategy under which this will happen, and make this publically available. This will create a predictable framework for intervention, with healthcare stakeholders well briefed on when to expect EU support. The EU does not have its own healthcare assets, infrastructure or staff to directly tackle an outbreak, and cannot therefore be a front-line responder in its own right. The benefit of defined disease-measurement criteria would be to create a clear, consistent and predictable plan for EU intervention, rather than a rushed, ad-hoc intervention was was the case in the EUâ&#x20AC;&#x2122;s response to Ebola. Although this is not an exhaustive proposal, we suggest that the European Commission develop a publicly available framework measuring the disease impacts in the table overleaf to assess when EU intervention is warranted. If a disease was found to meet a certain degree of severity on the above criteria, it would then trigger a broad EU level response. The nature of the response would reflect whether the disease was a novel and emerging threat or a long-term challenge. Accordingly, the response would be different, to acknowledge the nature of the cross-border health threat. This could include further implementation of the facility for joint acquisition of treatment assets that was introduced after the H1N1 influenza pandemic. It could also include funding for treatment acquisition, joint actions to undertake prevention measures, or joint research efforts. However, we would maintain the active and crucial role of national healthcare services as firstresponders and initial coordinators of response. EU action in this respect would bolster, rather than replace, national health care systems.

European Health Parliament - Cross Border Health Threats

Spread of infection

• Are at least three EU member states impacted? • What is the geographical spread of the disease (i.e. is the disease affecting neighbouring countries, or spreading ad-hoc)? • Is the disease widespread in densely populated urban communities? • Is the disease likely to impact agricultural production or enter food supplies? • Do EU borders need to be temporarily closed to prevent disease spread? • Do temporary quarantine restrictions need to be imposed to prevent spread of disease?

Treatment options and availability

• Do member states have stocks to treat the disease or do they need to be acquired? (e.g. Tamiflu stocks) • Can member states jointly procure medications and equipment and reduce costs? • Can solidarity measures be used to acquire medication for member states with no previous access to treatment?

Morbidity/ Incubation

• Does the disease have a high morbidity rate? • Does the disease have a quick or slow incubation period? Is it likely that carriers will transmit the disease without being aware of infection?

Known vs. Unknown Disease

• Is this disease a new one (e.g. SARS)? Or a new strain of an existing disease (e.g. annual influenza cycle) • Is joint EU research needed to find a solution to the disease? • What steps are needed to prevent the spread of a new disease?

Cost of treatment vs. non-treatment

• What is the cost per patient of EU-subsidised treatment? • What are the possible impacts on national health systems of treatment? • What is the impact of non-treatment – e.g. economic impact of workers taking time off, or more serious such as impairment or death?

Method of transmission

• Is the disease airborne, waterborne, spread by contact with infected bodily fluids or other? • Does the disease come from organic sources, or is there a possibility of a bio-terrorist origin?

Environmental and behavioural circumstances

• Do cultural aspects/beliefs have any impact on transmission? • Are there particular environmental challenges that could increase the rate of infection?

Cross Border Health Threats - European Health Parliament

Recommendation 2: Proactive plan for influenza prevention: Reduce the human and economic cost of influenza in Europe through an effective vaccination strategy and monitor vaccination coverage rates in all EU countries Pandemic influenza is an excellent example of a short-term sudden health threat facing Europe that needs a pan-European response to effectively mitigate the impact. The cross-border threat from a new or potential influenza pandemic could be tackled using the framework proposed in Recommendation 1, bringing the EU’s resources together to prevent a serious short-term threat if it meets appropriate criteria. Pandemic influenza would almost certainly meet the threshold for intervention and trigger a European reaction. However, the EU must also combat the recurrent threat of seasonal influenza, which has an impact on the health of European citizens and businesses every year. At present, Europe has failed to achieve the 75% target of influenza vaccination coverage among high-risk groups. Just two countries, the UK and the Netherlands, have reached or almost reached this target for older age groups. Vaccination coverage among other risk groups is far from the 75% target, and in some countries little or no data at all is available. (European Centre for Disease Prevention and Control, 2015).

Seasonal influenza vaccination rates in older age groups in EU/EEA

Achieved or almost achieved 75% Not achieved 75% Country unable to provide data

Data from ECDC report: Seasonal influenza Vaccination in Europe Overview of vaccination recommendations and coverage rates in the EU Member States for the 2012-13 influenza season

Figure 3. Seasonal influenza vaccination rates in older age groups. (Data from European Centre for Disease Prevention and Control, 2015)

If all European countries could reach the target of 75%, 9,000 to 14,000 deaths from influenza would be prevented, a significant and quantifiable impact (“The State of Health of Vaccination in the EU,” 2014). Few member states have demonstrated an active commitment to vaccinating either their highrisk groups or the general population. Therefore, the risk of seasonal influenza presenting a major cross border health risk to the EU remains significant if the status quo continues.How to increase influenza vaccination coverage?

European Health Parliament - Cross Border Health Threats

HOW TO INCREASE INFLUENZA VACCINATION COVERAGE? Recommended Action Points for Member States: • Influenza vaccination must become a priority in all member states. Vaccination is recognized by the ECDC as “most effective public health intervention to mitigate and prevent seasonal influenza” (European Centre for Disease Prevention and Control, 2015). • Member states should achieve the 75% target for influenza vaccination amongst the older adult high-risk group by 2020 with agreed intermediate annual targets. Member states should produce action plans with concrete and measurable steps to reach these targets. Targets for other risk groups should also be developed and plans implemented. • Member states should be obliged to measure and report influenza vaccination rates to the ECDC, including a breakdown of vaccination rates among high-risk groups. If the vaccination rates drop below agreed benchmarks for progress towards the 75% target, the ECDC will make recommendations and/or provide assistance on how to raise rates quickly. • Member states should be encouraged to reduce financial hurdles to vaccination for those in risk groups. They should have a system in place so that access to yearly vaccination of all patients in risk groups is guaranteed, e.g. having free sample of the vaccine available. Those in risk groups are likely to have a lower income. The ECDC reports that in a third of member states, the cost of influenza vaccination is paid by the patient. For example, older adults were not reimbursed for vaccination costs in 10 member states and needed to pay an additional out of pocket payment in another 11 countries (European Centre for Disease Prevention and Control, 2015). Recommended Action Points for the EU: • The EU will coordinate a biannual meeting of government, industry and civil society stakeholders to exchange best practices on increasing vaccination uptake both in the general population and in high-risk groups. The forum could also be used for exchanges on influenza management more broadly, including treatment options and reducing impacts on economic output. • Member states should harmonize the definition of high-risk categories of individuals who require influenza vaccination. At present, there are different recommendations among member states as to who is high-risk. Pregnancy is considered a risk in all but 3 countries. Furthermore, the qualifying chronic diseases vary across member states as do age cut-offs and whether household contacts of those at risk should be vaccinated. In order to present a coordinated European vaccination strategy, public health authorities should assess the evidence for each group’s risk status and the feasibility of standardizing the high-risk groups across the EU. • The EU will implement a joint procurement plan produced ahead of the influenza season. The joint procurement plan will build on existing legislation on medical procurement. It will particularly focus on plugging capability and equipment gaps in member states, ensuring sufficient stocks of both vaccination and treatment medication. If required, the EU could consider special funding to ensure a level playing field among member states. • The EU should support research and development into future influenza vaccines. Public health authorities have a far stronger case to promote wide vaccination with a more effective vaccine. This should become one of the research priorities for both industry and the European Commission.

Cross Border Health Threats - European Health Parliament

When an effective vaccination strategy is in place to combat the recurrent threat of seasonal influenza at the member states and EU level, this strategy can be easily adapted in the case of a potential influenza pandemic. More broadly, strong vaccination plans and procurement efforts are effective ways to tackle novel and emerging threats before they take hold and cross borders. The EU therefore must prioritize vaccination at all levels including research, production, procurement, and monitoring.

Recommendation 3: Strengthen political efforts on TB eradication, with a focus on social marginalisation In addition to its debilitating effects on patients, tuberculosis (TB) has a significant impact on the economy as the majority of sufferers are of working age (15 to 54 years old). The TB Europe Coalition estimates that TB, including MDR-TB, costs Europe €6 billion every year (Boas, 2015). TB treatment is expensive, and MDR-TB treatment even more so. Costs vary throughout Europe from €3,500 to €50,000 depending on the member state where the patient is treated and the strain of TB they have. Costs drastically increase for MDR-TB, which is why eradicating this should be a priority. Without targeted action to tackle TB and to ensure that incidence of the MDR strain does not increase because of inadequate treatment patterns, the risk of TB becoming a major European cross-border threat increases. In light of WHO calls for further analysis of the human factors behind the spread of MDR-TB, the EU should support major research efforts to identify and address why patients fail to follow a sufficient and correct treatment course for TB. In the short term, providing training and financial assistance to ensure treatment in the presence of a medical professional, i.e. DOTS, rather than self-managed treatment, could have immediate benefits including reducing MDR-TB developing in TB patients. However, both front-line medical workers and policy makers must be sensitive to the patient’s needs, acknowledging that TB often strikes already vulnerable populations. The EU must ensure a level playing field for treatment both of TB and of MDR-TB. Notably, support to member state health systems most under strain from the disease should be prioritised. The EU could consider the use of structural funds to ensure treatment in rural areas in particular, where treatment facilities are limited, hard to reach, or too expensive to access. Access to treatment is linked also to the identification of TB patients at an early stage in their disease. Accordingly, member states must further develop concrete action plans to effectively respond to TB outbreaks and make efficient use of resources to prevent TB from spreading in the first place. Member state public authorities should be encouraged to make full use of support by the EU and other partners, and immediately flag to the EU any risk of a major cross-border spread of TB. Poverty is both a cause of TB and a consequence. TB and MDR-TB cannot ever be eradicated without addressing the root socio-economic factors behind this link. It is beyond the scope of this paper to suggest fundamental changes to society. Policy makers must appreciate this in developing solutions. However, as an immediate intervention, we suggest the promotion of a ‘one-stop shop’ for TB patients where they can access not only supervised treatment, but also advice and practical help in housing, jobs, accessing the social security system and so on.

European Health Parliament - Cross Border Health Threats

HOW TO REDUCE TB INCIDENCE IN EUROPE? Recommended Action Points for Member States: • Member states must commit to national action plans, based on the WHO DOTS Framework, to ensure the reduction and adequate treatment of standard TB. Those action plans should also target the eradication of MDR-TB as an urgent political and social priority. • Member states which require support to provide equipment and training necessary for efficient diagnosis and care should request support from the EU and other partners such as the WHO. • Member states must immediately notify the EU through the ECDC should a risk of TB spreading across borders become apparent. • Member states should work together to exchange best practices and develop strategies so that professionals - healthcare workers, social workers, civil society representatives and educators in contact with high risk populations - are provided with the tools and information to identify potential TB and refer to health services for follow up, as well as providing support for patients to complete TB treatment. Recommended action points for the EU: • The EU must demonstrate firm political commitment, backed by significant funding, to work towards the eradication of MDR-TB in Europe. The aim should be to lift all EU member states and neighbouring European countries out of the WHO ‘red zone’ for MDR-TB rates in the coming years. This will ensure that MDR-TB does not spread further in Europe. • The EU will develop a proposal for “one-stop shop” TB treatment facilities that provide not only supervised medical care but also access to social support, in an attempt to reduce the marginalisation of vulnerable groups. • The EU will develop awareness campaigns for those on the front line of treatment and for the broader community, to explain symptoms and the importance of timely and complete treatment. Wider campaigns should attempt to reduce the current stigma associated with TB and highlight the highly curable nature of standard TB with the right treatment. • The EU should investigate options for the prevention of TB through tackling poverty and other social determinants and what support can be provided to member states with long-term funding support.

Novel and emerging threats can have devastating and immediate consequences on the EU’s health systems, but long-term threats such as TB can also have negative impacts. Without adequate political will, diseases such as TB can become drastically more threatening, developing into untreatable forms of MDR-TB. If these long-term threats are not given adequate attention, they can grow and spread across borders. Dedicating more resources, more research money and more attention from the European health community to TB is critical.

Cross Border Health Threats - European Health Parliament

Recommendation 4: Enhance EU cooperation on cross-border health threats and level the playing field between Member States The considerable variations and the extreme diversity in the structure and performance of surveillance systems for communicable disease prevention and control between EU member states constitute a serious obstacle to EU-wide, effective response. Several reasons underlie these inequalities: a lack of trust, different infrastructure, insufficient capabilities, and a lack of treatment and products in emergency situations. A number of diseases remain under-diagnosed and under-reported, complicating efforts to understand their occurrence and burden or to develop appropriate public health interventions. Some diseases are not under surveillance or are not routinely reported at EU level. For other diseases, reporting according to the agreed EU case definitions remains a significant challenge for some member states. Event surveillance at national and European level is critical for rapid detection and control. Variable capacities could be problematic if a state with weak public health capacity harbours infectious diseases that can spread. Moreover, national economic difficulties and limited budgets in can mean cuts in public health spending and in research and development for new medicines and vaccines. It is increasingly difficult to provide resources for communicable disease control. This could harm existing communicable disease prevention and control activities, and widen the gap between the EU and member states. This is why all member states should have effective systems in place to deal with serious crossborder outbreaks, along with the means to cooperate at EU-level. It is necessary to take care of the weakest parts of the chain, to contribute to a solid EU system of surveillance and prevention. Therefore, effective interoperability of national healthcare systems is crucial. National and international preparedness plans and capacities should be constantly updated and functional. Sharing resources would allow member states to make more specific choices, tailored to the national situation, making the whole framework more effective. Our core proposals to improve interoperability are: â&#x20AC;˘ Make broader use of joint procurement drawing upon the previous examples. In 2006: proposed joint procurement for Tamiflu was rejected. In 2009: some member states joined a joint procurement initiative to tackle the H1N1 pandemic In 2014: the Joint Procurement Agreement set out the modalities under which EU countries can jointly acquire pandemic vaccines and other medical countermeasures. â&#x20AC;˘ Develop an open coordination instrument on European Public Health (with member states required to make a commitment to spend a certain percentage of their GDP on public health and prevention of cross-border health threats) â&#x20AC;˘ Give the ECDC more means to ensure the reliability of collected data. If a country has an extremely weak surveillance system for some diseases, the ECDC should intervene to support the country.

European Health Parliament - Cross Border Health Threats

Note should be taken of Decision 1082/2013/EU on cross-border health threats, which provides guidance on improving preparedness and strengthening capacities to respond to health emergencies. Engaging end-users and stakeholders on the specifics of the Decision is an important first step. Also useful would be the development of a network of public-health risk assessors to respond to emerging cross-border incidents. The decision also allows the EU to trigger its pharmaceutical legislation to accelerate the provision of vaccines and medicines in the event of a public health emergency, including pandemics. Measures taken at national level must not counteract and reduce the effectiveness of measures taken in another EU member state or at EU level to prevent the further spread of infectious diseases. National preparedness plans and capacities must therefore be up-to-date and complementary. To tackle cross-border health threats, member states need to develop and strengthen the capacities to respond to any health event, including coordination, command and control mechanisms, as well as communication between sectors and with national and local levels. This should also be coordinated, together with other member states, and should take into account what action the EU is taking to complement member state action. The use of shared resources would allow member states to make more specific choices, tailored to the national situation, making the whole framework more effective.

Cross Border Health Threats - European Health Parliament

IV. CONCLUSIONS As the EU becomes increasingly open, diseases are increasingly able to spread across borders. Therefore, governments must be prepared, proactive and always on the front foot to respond to new diseases immediately and to find solutions to long-term threats. Our framework has divided cross-border health threats into novel and emerging threats requiring immediate deployment of research and development and seeking innovative solutions, and a second category of longer-term threats requiring political will and comprehensive approaches to lead to real solutions. The case studies used to outline these two frameworks – influenza and TB – provide a useful insight into the challenges and opportunities the EU faces in coordinating responses to crossborder health issues. However, we acknowledge the multitudes of other diseases, both known and unknown, that present major risks for the EU. Therefore, our paper has focused on four key recommendations to European policymakers and healthcare stakeholders to provide realistic, achievable, but also ambitious responses to cross-border health threats. A public and common framework triggering EU intervention will ensure a coherent and predictable response. A strong focus on vaccine development and prevention is a useful response to novel threats, while strong political coordination and political will can have a real impact on longterm threats. Finally, EU member states must commit to cooperation, and use the EU’s institutions and resources as a force multiplier for their own actions. Cross-border health threats will always be a challenge in an open Europe. Those threats will include known diseases with a long-term impact on our health care systems, and new threats arriving without warning, or changing regularly. Disease does not stop at national frontiers, and therefore our health care systems must respond in kind. Our health systems must transcend national borders, beginning with the EU.

European Health Parliament - Cross Border Health Threats

V. REFERENCES Boas, V. (2015). Press Release: Europe’s Leaders Approve Riga Declaration on TB and MDR-TB. Retrieved from http://www.tbcoalition.eu/2015/03/31/press-release-europes-leaders-approveriga-declaration-on-tb-and-mdr-tb/ Christodoulou, M. (2011). The stigma of tuberculosis. The Lancet, 11(9), 663-664 doi: http://dx.doi.org/10.1016/S1473-3099(11)70228-6 Eliyahu, H. & Meijer, A. (2009). EUPHIX Influenza - Consequences for individual and society. Retrieved from http://preview.euphix.org/object_document/o5886n30475.html European Centre for Disease Prevention and Control. (2010). Revised estimates of deaths associated with seasonal influenza in the US. Retrieved from http://ecdc.europa.eu/en/activities/sciadvice/ _layouts/forms/Review_DispForm.aspx?List=a3216f4c-f040-4f51-9f77-a96046dbfd72&ID=394 European Centre for Disease Prevention and Control. (2015). Seasonal influenza vaccination in Europe – Vaccination recommendations and coverage rates, 2012–13. Retrieved from http://ecdc.europa.eu/en/publications/Publications/Seasonal-influenza-vaccination-Europe-2012-13.pdf European Centre for Disease Prevention and Control/WHO Regional Office for Europe. (2014). Tuberculosis surveillance and monitoring in Europe 2014. Stockholm: European Centre for Disease Prevention and Control. Retrieved from http://ecdc.europa.eu/en/publications/Publications/ tuberculosis-surveillance-monitoring-Europe-2014.pdf Markieta, M. (2013). Flight paths of Europe. Retrieved from http://www.bbc.co.uk/news/magazine-22690684 Patterson, K. D., & Pyle, G. F. (1991). The geography and mortality of the 1918 influenza pandemic. Bull Hist Med, 65(1), 4–21 PMID 2021692 Saker, L., Lee, K., Cannito, B., Gilmore, A., & Campbell-Lendrum, D. (2004). Globalization and infectious diseases, A review of the linkages. Geneva:UNDP/World Bank/WHO Special Programme on Tropical Diseases Research. Retrieved from http://www.who.int/tdr/publications/documents/seb_topic3.pdf Taubenberger, J. (2006). The Origin and Virulence of the 1918 “Spanish” Influenza Virus. Proc Am Philos Soc. 150(1), 86–112 Taubenberger, J., & Morens, D. (2006). 1918 influenza: the mother of all pandemics. Emerg Infect Dis [serial on the Internet]. Retrieved from http://wwwnc.cdc.gov/eid/article/12/1/05-0979_article DOI: 10.3201/eid1201.050979 TB Europe Coalition. (n.d.). TB in Europe. Retrieved from http://www.tbcoalition.eu/what-is-tuberculosis/tb-in-europe/

Cross Border Health Threats - European Health Parliament

The State of Health of Vaccination in the EU. (2014). Retrieved from http://ec.europa.eu/health/vaccination/docs/20141223_state_health_vaccination_en.pdf World Health Organisation. (2010). The STOP TB Strategy. Retrieved from http://www.who.int/tb/publications/2010/strategy_en.pdf?ua=1 World Health Organisation. (2014). Influenza (Seasonal). Retrieved from http://www.who.int/mediacentre/factsheets/fs211/en/ World Health Organisation. (2015). The END TB Strategy. Retrieved from http://www.who.int/tb/post2015_TBstrategy.pdf?ua=1 World Health Organisation. (n.d.) The five elements of DOTS. Retrieved from http://www.who.int/tb/dots/whatisdots/en/ss

European Health Parliament - Cross Border Health Threats

THE ECONOMIC DIMENSION OF HEALTHCARE

Authors Ann Marie Borg Celine Aerts Katrijn Depuydt Alexander Jacobs Diana Kanecka Jean-Michel Luyckx Anne Peters Elise Renault Ines Rohmer Fausta Todhe Kim Van Aken Sofie Van Mulders

Executive summary Evaluating the current European healthcare system scenario marks a first step towards aspiring to improve it. Thus, before looking ahead and proposing ways for a more effective functioning of health systems, we must first identify the challenges and barriers to delivering equitable and sustainable high quality care services to all European citizens. In light of ageing demographics, the economic climate, dwindling resources, increasing demand and rising costs, it is important to explore ways of doing more and better with less, and proposing smart and feasible solutions for better healthcare, whilst safeguarding common EU health values. Improving healthcare across the EU calls for political will and enhanced co-operation between and within EU countries, and pulling resources together, especially in cases of specialised care and rare diseases. This co-operation is not about reinventing the wheel, but more about sustaining and maximising what we have achieved over recent decades and re-thinking the way we do things. Delivering healthcare must also become patient-centred. A one-size-fits-all approach to healthcare must make way for a more personalised, inclusive and integrated care approach that empowers patients to play a more active role in their own health. The use of ehealth and telemedicine, tailored to patientsâ&#x20AC;&#x2122; needs, has role here. But balance is needed between innovation and the use of new medical technologies and equity, ensuring that all patients have equal affordable access to the latest, high quality and safe medical treatments. The paper opens with an exploration of the healthcare challenges Europe is facing particularly in light of the recent economic crisis which triggered enhanced EU intervention in healthcare and the call for more efficient yet sustainable care. Against this background, it then brings forward concrete recommendations on how to design and manage European healthcare systems in such a manner that we are able to do MORE and BETTER with LESS. We demonstrate how European governments can reap simultaneous economic and health benefits if they begin to see health as an investment rather than a cost and account for cost-effectiveness and sustainability of their health services across the healthcare life course; be it through preventive and diagnostic provisions of care, curative or more complex interventions and palliative care. Consequently, the paper illustrates solutions for better and cost-effective healthcare system practices at different stages of healthcare delivery - in primary, secondary and tertiary crossborder care settings.

The Economic Dimension of Healthcare - European Health Parliament

I. INTRODUCTION Evaluating the current European healthcare system scenario marks a first step towards aspiring to improve it. Thus, before proposing ways for more effective functioning of health systems, we must first identify the challenges to delivering equitable and sustainable quality care services. Although action should start as close to the citizen as possible, Member States (MS) are to work together to combat common health system challenges embracing common EU health system values enshrined in the 2006 Council Conclusions (OJ, 2006). Currently, MS are unenthusiastic about Commission initiatives in the area, but the Council of Health Ministers has repeatedly invited the Commission to actively contribute to the reflection process on modern, responsive and sustainable health systems. The Commission’s Communication on accessible, effective and resilient healthcare services has responded with strong arguments for addressing these challenge and with an outline of future options at EU level (European Commission, 2014). However, few concrete actions are proposed and developing effective strategies remains work in progress. This paper takes as its point of departure the Commission’s ‘Investing in Health’ policy agenda and the European discourse on healthcare fiscal sustainability within the context of the European semester and Country-Specific Recommendations (CSRs) related to health or long-term care. The Commission continues to urge MS to pursue healthcare reforms - increasing the cost-effectiveness and long-term sustainability of the sector, strengthening prevention and primary care services, reducing ‘inappropriate’ lengths of hospital stays, enhancing out-patient care, increasing the use of IT systems and hospital restructuring among others (Greer et al., 2014). But little is elaborated on how this can be achieved and what concrete measures can be taken to make national health systems more sustainable for future generations. Some solutions are possible with prompt action. But this will need a paradigm shift and a vision of the post-economic-crisis situation, as a catalyst for change, as an opportunity opening doors to re-think the way we manage healthcare systems and preserve what is worth preserving. We need to move away from silos and a one-size-fits-all approach, and aim for a more personalised and integrated care approach that empowers patients to play a more active role in their own health. The use of ehealth and telemedicine, tailored to patients’ needs, has a role here. But balance is needed between innovation in medical technologies and equity, to ensure that all patients have equal affordable access to the latest, high quality and safe medical treatments.

European Health Parliament - The Economic Dimension of Healthcare

II. EARLY DIAGNOSIS

SAVES LIVES AND CAN AVOID SOME COSTLY HEALTH CARE PROCEDURES

“Chronic diseases hamper citizens from contributing to society and generate increasing and unsustainable healthcare costs which are poised to rise as the population ages” (Commissioner Vytenis Andriukaitis, Letter to the EU Health Ministers, 7 April 2015).

Screening and Cancer Early diagnosis is crucial in determining suitable treatment at a stage when a disease is still amenable to easier management. Almost half of the people who are diagnosed with cancer are diagnosed late, which makes treatment less likely to succeed and decreases their chances of survival. General practitioners and primary care professionals have a critical role in determining early detection and early intervention, and an essential element in this regard is screening. In the fight against cancer, a leading cause of death in the EU, EU institutions have committed themselves to reducing its incidence and protecting citizens by tackling risk factors and promoting early detection and treatment. In 2003, the Council issued a Recommendation on cancer screening, recognising its importance as an effective tool of preventive care for major diseases, and inviting MS to implement national programmes ensuring high coverage and quality assurance at all levels (Council of the European Union, 2003)., These approaches are largely supported at national and European level alongside European guidelines for the organisation of cancer control and screening policies. But there is more to be done to address the gaps in implementation of screening across Europe (Advisory Committee on Cancer Prevention, 2000; Arbyn et al., 2009; Von Karsa et al., 2008). Empowering professionals to promote screening participation rates is fundamental, but this needs to go hand in hand with empowering patients and improving access to information and health literacy.

CASE 1: Despite the Commission’s initiative to issue a recommendation on population-based primary screening programs for colorectal cancer in people of 50 to 74 years of age (OECD, 2014, p. 100). to date, some MS are still introducing such organized programmes. Participation rates remain low, with Germany being an exception, where screening rates reached 55% in 2008 (ibid.). Across the EU, the average screening rate for the EU14 population of age 50 to 74 was only 12.7% (ibid., p. 101). These low screening rates, considered jointly with a Swiss study that showed that testing for colorectal cancer generates an overall cost saving of about € 3.7 million p.a. in Switzerland (Blank PR et al, 2011), emphasize the need for more European guidance and the stimulus of best practice exchange.

The Economic Dimension of Healthcare - European Health Parliament

The rationale behind the seemingly innovative concept of screening with the aim of early disease detection dates back 150 years ago when testing the public for the potential or health risk of developing a disease was developed (Gray et al., 2009). However, the roadmap to achieving this objective is less straightforward, and at the heart of the debate on evidence-based screening is the issue of quality and coverage. The central point in the early work of the World Health Organisation (WHO) on screening, developed over 45 years ago, holds today: “In theory, screening is an admirable method of combating disease […] In practice, there are snags” (Wilson & Junger, 1968, p. 7). The challenge is the ability to maximise treatment provision for those patients who need it the most and at the same time avoid potential harm to those who are not at risk. With the advances in medical technology, screening tools are able to deliver increasingly accurate information, permitting the determination of early diagnosis and provision of the appropriate therapy. The cost savings potential from implementation of comprehensive screening programs for targeted population groups is well-established. Early detection facilitates early intervention, which can limit healthcare costs. The use of early diagnostic tools targeting those who demonstrate an increased risk of or susceptibility to a disease is important in this regard. For instance, companion diagnostic tests are able to provide information on whether or not the patient is likely to respond to a therapy - “If patients receive only those medicines that are best suited for them, health outcomes for society as a whole will improve. And healthcare systems across Europe will save money.” (European Commission, 2011, p. 5). Where available, companion diagnostics can be the key to more accurate diagnosis and more personalised care, by delivering targeted therapy to those who need it and are likely to respond to it. Determining the right treatment for the right patient also conveys economic benefits by reducing the cost of treatment, because targeted care can stop or slow the progression of the disease and limit hospital stays. Further reduction of costs can be achieved through prevention and implementation of early detection mechanisms. As shown in the following cases, early diagnosis can lead to less costly treatment and faster patient recovery.

CASE 2: A recent study has shown that targeted cervical cancer screening and HPV vaccination programmes lead to savings of about € 114,832 per cohort (KCE, 2015, p.23). However, so far only half of EU countries have implemented cervical cancer screening procedures (OECD, 2014, p.96) and there are differences with respect to the periodicity of screening, efficacy, coverage, quality of delivery and scope of target group (ibid.; Arbyn et al., 2009). More than simply recommending the extension of the screening procedures to all EU MS, we also call for the harmonization of procedures cross-country, to increase effectiveness and save financial resources, in the avantgarde as well as the lagging countries. It must also be recognised that for implementation to be successful, it should cater for the needs of MS, adapted according to their socio-economic context and clinical, cultural and organisational aspects.

Going Beyond the Usual Suspects Early diagnosis and intervention means early recovery and less demand for complex specialised care, which often increases as a disease progresses. The examples below highlight how the use of screening methods for conditions other than the usual suspects i.e. cancer screening - can lead to savings and positive health outcomes.

European Health Parliament - The Economic Dimension of Healthcare

CASE 3: Testing for enteroviral meningitis decreases the duration of antibiotic treatment by more than two days and cuts down hospitalisation by two days through earlier discharge of patients with savings per patient amounting to â&#x201A;Ź 1,116 per patient (MedTech Europe, 2012, p.23).

CASE 4: Deployment of screening systems during labour can decrease neonatal infarctions and length of stay by 90%. Implementation of such screening in a Paris hospital led to reduction of neonatal hospitalisation days by 47% and reduced ICU bed days by 90% (MedTech Europe, 2012, p.23).

Conclusions and Call for Policy Action The EU should draw on MS screening programs, the work of the European institutions, and existing collaborations, and should continue to support MS in the promotion and implementation of evidencebased screening. Allowing all stakeholders to follow cross-EU best practices could lead to uniform early diagnosis procedures across the EU. In addition, the economic benefits of early diagnosis should prompt the development of an EU tool for policy evaluation and identification of cases where screening programs can be quantified as a viable, cost-effective solution. In this regard, the EU can extend its work using this tool by demonstrating how early detection and intervention can counteract the negative economic impact of a condition, e.g. cervical cancer, as well as including direct medical and indirect loss of productivity costs. Although the economic burden of a given condition can vary from country to country depending on various factors, this can help in advising MS on how population-based implementation of certain diseasespecific screening programs is likely to have a positive impact on healthcare spending and health outcomes. Moreover, the European Semester may continue to be used as a means to propose more focused national screening targets adapted to the needs and morbidity patterns of the MS in question that will result in more cost-effective primary health care services. Long-term cost-savings will automatically be accompanied by improved health, and will yield net positive savings to national healthcare budgets. Therefore, it is important that the EU is able to provide a tailored assessment and generate recommendations concerning the benefits of early diagnosis for a spectrum of cases, so that MS recognise the value of implementing high quality screening programs. To be meaningful, the project should identify what screening programmes are needed and in which areas.

GENERAL RECOMMENDATION: Facilitate the development of EU guidelines on frequency, scope and depth of screening and early diagnosis procedures, which could include tailored MS assessment. This could be achieved through collaboration among stakeholders under the joint structure of the EU working group tasked to work in this area. As highlighted across the four cases, substantial net-costs savings can be achieved if corresponding procedures are effectively and universally implemented.

The Economic Dimension of Healthcare - European Health Parliament

III. TELEMEDICINE AS AN AL-

TERNATIVE TO FREQUENT AND LENGTHY HOSPITALISATION

“As regards professionals and health centres, ICTs mean faster transfers of information at lower cost, greater flexibility in the coordination of resources and, as a result, improved clinical and economic management as well as better service for all citizens”. (Marina Geli, former Catalan Minister for Health, 2010)

Hospitalisations are expensive: what can we do to lower the cost? Hospital expenses are a main cost driver of European healthcare costs. According to Eurostat (2015a), the EU average share of hospital expenditure of total health expenditure rose from 38.71% in 2003 to 41.58% in 2012. If reforms are not implemented, the rising costs of healthcare are unlikely to decline. The challenge is intensified by an ageing European population, highlighting that Europe will continue to face an increasing rate of care-dependent older people and non-communicable diseases as the leading cause of chronic illness and disability - for which, the average length of stay in hospitals tends to be higher (Eurostat, 2015b). Consequently, from an economic perspective, societal demographic changes along with varying but increasing demands will require an alternative approach that is economically sustainable for the EU. One solution could be telemedicine, which would prevent unnecessary acute or long-term hospitalisations. Provided that health care systems can further enhance integration and coordination, technological innovation together with new and modern forms of service delivery organisation can represent a viable solution to developing more personalised home care and community care. From a patient’s perspective, home care medicine could be beneficial in a multitude of ways: (i) it is delivered in the patient’s home environment close to his/her social support network; (ii) it empowers patients responsibility in the management of their own health; (iii) it reduces the possibility of hospital acquired infections; and (iv) it can reduce re-hospitalization (Council of the European Union, 2009). In fact, Eron et al. (2010) have shown that home care as opposed to hospital care allows patients to recuperate from illness, injury, or surgical procedures more quickly and effectively. Furthermore, results from patient satisfaction studies on telemedicine indicate high levels of perceived satisfaction, often above the rates of expected satisfaction for traditional forms of health delivery. Results from provider satisfaction studies are generally quite positive as well (Whitten & Love, 2005). Based on the current economic climate and the body of evidence, the overall objective of this section is to focus on telemedicine as a potential alternative to long-term hospital care; thereby shifting from inpatient to personalised or community-based outpatient care.

European Health Parliament - The Economic Dimension of Healthcare

Proposals for the evolution of telemedicine: MedAssist and HealthInn Evidence has shown that a significant number of patients do not adhere to and/or complete their assigned treatments (Martin et al., 2005). Accordingly, we propose the development of “MedAssist”, to remotely provide better support to patients maintaining an independent life, through three main services: • Ensuring that patients adequately follow their treatments by reminding them to take their drugs or to complete their daily exercises. • Supplying the patients with the necessary tools and information on how to conduct home-based monitoring of physiological data (e.g. weight, blood pressure, pulse oximetry and respiratory rate) that would be automatically transmitted to the health centre for monitoring. • Offering online follow-up and consultations with health professionals. This could decrease the probability of having to be (re-)hospitalised, whilst stimulating better access to healthcare providers (Clark et al., 2007).

MedAssist is able to act as an interface between patients and health professionals and thereby enable a small team of health professionals to better support a group of patients by providing tailor-made treatment that meets patients’ specific needs. To further enhance communication and coordination between health professionals and patients and at the same time act as a form of ‘support group’, an online health intermediary platform called “HealthInn” could be created so that patients can exchange their experiences, ask questions about the management of their disease, and receive prompt medical advice. Ultimately, such a platform also enables patients to feel empowered, taking an active role in managing their health with the guidance of professionals. However, data protection, transparency and ethical considerations must be taken into account in the development and deployment of ehealth tools. For example, the European project Giraffplus combines technologies and long-term monitoring (network of sensors monitoring physiological data and activities) to promote independent living for the chronically ill and elderly citizens. Social interaction with close relatives and health professionals was also made possible thanks to the help of a telepresence robot.

The Economic Dimension of Healthcare - European Health Parliament

Cost-efficiency of telemedicine Telemedicine is deemed cost-effective when the cost per quality-adjusted life year (QALY) is decreased compared to traditional approaches of providing care. Indeed, telemedicine saves time and money for the patient and providers whilst achieving lower hospital admissions and re-admissions by replacing emergency care with routine care. But the economic benefit depends on the targeted location and population as well as on the medical specialisation required. Notable examples: For post total knee arthroplasty, when all costs are included, in-home rehabilitation has been proved to be cost saving when there is a minimal distance from the medical centre or when patients have mobility or travelling difficulties (Tousignant et al. 2015). In the case of chronic heart failure, which is a serious clinical issue associated with a significant economic burden, the implantation of cardiac electronic devices is increasing and requires monitoring. Studies have shown that with remote monitoring, fewer patients saw their condition deteriorate when compared with standard care (Arya et al., 2008). According to Boriana et al. (2013), the waiting time for clinical decisions was reduced, as was the frequency of health centres visits, resulting in higher cost efficiency as a whole. Roselyne Bachelot, former French Minister for Health and Sports, also noted that â&#x20AC;&#x153;Home based telemonitoring of simple clinical indicators [...] transmitted to a first aid centre could enable us to not only prevent the appearance of acute complications in patients suffering from chronic heart failure, but also to save them from having to travel to consultation, and prevent unplanned hospitalisationsâ&#x20AC;? (European Commission, 2010). Regarding hypertension management, home blood pressure management telemonitoring showed a high degree of acceptance by patients, and the quality of services provided by telemedicine was considered as good as in traditional consultations. It was also associated with lower medical costs in comparison to standard care, even if it was to a certain extent offset by the cost of the technology. Such telemonitoring also lowered the social costs related to increased frequency of cardiovascular events when hypertension was not controlled, and was particularly effective with non-adherent and high risk patients (Omboni et al., 2015). Research into the cost-effectiveness of telemedicine is increasing, but gaps remain (The Health foundation, 2011), particularly when considering large sample studies. Nevertheless, there is a general tendency for studies to support the concept of telemedicine cost-efficiency, especially for specific disease groups such as hypertension, diabetes, respiratory, metabolic and cardiac diseases (Clark et al., 2009). Furthermore, the methodologies used and the type of medical devices that are considered differ significantly across studies, which makes it difficult to obtain a comparative and global overview of the results. Transferability of cost-effectiveness findings across countries also need to account for wider differences in the relative cost of medical technology vis-a-vis labour workforce costs.

European Health Parliament - The Economic Dimension of Healthcare

Challenges and Funding of telemedicine The implementation of telemedicine across the EU faces challenges. Telemedicine brings new ways of practising medicine and delivering care but is likely to face resistance. Some of this reluctance can be explained by a lack of awareness regarding the benefits of telemedicine. Accordingly, awareness must be raised to incentivise health professionalsâ&#x20AC;&#x2122; involvement in the development and implementation of telemedicine, as they may know best what is needed on the ground. Another challenge is the variety of devices associated with independent systems, which requires interoperability. Furthermore, devices should be affordable and user-friendly in order to cater for all segments of the population and lessen the risk of inequalities in their use (Marschang et al., 2014). Another barrier to the wider use of telemedicine is the low level of reimbursement. In fact, availability of and access to telemedicine often depend on patientâ&#x20AC;&#x2122;s willingness to pay out-of-pocket. Therefore, in order to avoid the perpetuation of inequalities and enhance the affordability of new technologies in health, MS should incorporate telemedicine in their payments and reimbursements schemes in a way that incentivises better use and uptake of telemedicine both by patients and health professionals (e.g. reimbursement to the patients for HealthInn online consultation, and lower payments to hospitals if hospitals choose to discharge with standard follow-up instead of discharging with MedAssist when medically possible). Additionally, in order to facilitate the availability of telemedicine within their healthcare infrastructure, MS could seize EU funding opportunities through EU Structural and Investment funding and/ or through the Public Health Programme, particularly in relation to the development of ehealth innovations. Under the Horizon 2020 Programme, funding is also foreseen to support the development of healthcare innovative projects and strengthen their evidence base, as is currently the case with the SAEPP project which aims to allow frontline clinicians to provide more high-level patient care on the spot and in turn, help reduce unnecessary commuting to hospitals.

GENERAL RECOMMENDATION: Investing in patient continuity of care before and after hospitalisation using telemedicine tools for targeted patients and diseases would help avoid further hospitalisations, known to be costly and moderately popular amongst patients. Telemedicine services have the potential to enhance patient empowerment, and increase their quality of life and independence. When well-integrated within the healthcare delivery process, such solutions also have the potential to enable more efficient provision of healthcare, thereby contributing to better health systems sustainability.

The Economic Dimension of Healthcare - European Health Parliament

IV. WELCOME TO THE

EUROPEAN CENTRES OF EXCELLENCE - SPECIALISED CARE AT YOUR DOORSTEP?

“Europe [is] a giant ‘natural laboratory’ for health systems, with enormous potential for countries to learn from each other. European cross-border healthcare is the key to unlocking that potential…” (Nick Fahy, Luxembourg, September 2010).

Taking the Directive on cross-border healthcare forward Deemed the first piece of EU legislation enacted specifically in the area of healthcare services, the Directive on patients’ rights in cross-border healthcare (2011/24/EU) is ground-breaking in the field of healthcare cooperation. Yet little is known of what value EU involvement in cross-border healthcare activities could generate. This led the Committee to explore the opportunities related to putting the concept of European Centres of Excellence (CoE) into practice and bringing together highly specialised healthcare providers from different MS across the EU. Chapter IV of the Patients’ Rights Directive relates to co-operation of health systems, including the setting up of European Reference Networks (ERNs) between healthcare providers and centres of expertise in the MS, aimed at pooling resources in specialized healthcare and improving access to and provision of high-quality specialized care especially in the area of rare diseases (Art. 12, OJ, 2011). Although the setting up of such networks at national level is voluntary, the Commission has an important role to play in encouraging and facilitating the process. As provided for in the Directive, the Commission is mandated to define the ERN criteria through implementing acts. The next step will be a call for networks in the fourth quarter of 2015. Subsequently, the networks will be established in the second quarter of 2016. In an expert conference organised in June 2014, it became clear that ERNs face challenges, but offer promising opportunities. This section examines the opportunities from sharing best practices in cross-national networks and pooling of knowledge and resources, facilitating more cost-effective use of resources across MS, particularly in light of financially constrained health systems. We believe that there is potential for European co-operation and sharing of resources where expertise is rare, in highly specialised healthcare areas. This is especially important for MS in border regions or those that are unable to provide high quality specialised treatment to patients because of lack of infrastructure, capacity constraints or very low numbers of patients requiring such treatment because of the low prevalence of a disease. In this respect, cooperation on rare diseases can generate substantial efficiency gains.

European Health Parliament - The Economic Dimension of Healthcare

Nonetheless, in order to determine what value ERNs can bring to the picture, it is important to define them. Since the Directive does not specify the exact meaning of the concept of ERNs, their structure or function, achieving a common understanding of the elements that constitute a reference network (Palm et al., 2013) is a challenging task for policy-makers in implementation. Based on a recent study, with examples of network governance models, a European centre of reference network can be portrayed as a focal point (medical centre/hospital/clinical team) bringing together different healthcare providers and centres of excellence with similar specializations and expertise across borders (Palm et al., 2013). Since the geographical scope of an ERN is EU-wide, a steering committee working at EU level guiding and assisting the network particularly in its early stages of establishment is crucial. With regard to its disease-focused scope, ERNs may include specialised oncology care and more common chronic conditions such as diabetes. This section gives recommendations as to how the ERN initiative might be successful. We analyse a case in France and Germany where similar cooperation between healthcare providers is already in place. Although on a smaller scale, it could serve as a pilot project for the official centres of excellence.

Taking stock of ‘ERN predecessors’: two case studies Cross-border collaboration has been tried and tested before, but there is room for improvement, and previous experiences could help to take the concept further. We analysed two cases of cooperation on a small bi-lateral scale. The University Hospital Aachen, Germany and the Maastricht University Medical Center+, the Netherlands are located in the Euregio Meuse-Rhine, “a particularly active and long-established entity composed of the wider and adjacent border regions of Belgium, Germany and the Netherlands” (Glinos, Doering & Maarse, 2013; p111). The collaboration includes the creation of the first crossborder European Vascular Center Aachen-Maastricht” (University Hospital Maastricht and Maastricht University, n.d.). Additionally, vascular surgery was the “first area of active collaboration” (Glinos, Doering & Maarse, 2013; p113). The establishment of the hospital arose from a long-standing regional history “of political and institutional collaboration” (University Hospital Maastricht and Maastricht University, n.d.). The cooperation was formalized in 2004 (Glinos, Doering & Maarse, 2013), but challenges persist.

The Economic Dimension of Healthcare - European Health Parliament

Aachen and Maastricht made use of their geographical proximity in combining resources, but the Cross Border Hospital of Cerdanya (Spain – France) was established because of the large distances to access national acute care facilities: “On the Spanish side, there is a hospital in Puigcerdá with, however, limited capacities, [and] on the French side, the next hospital for acute care is about 150 km away” (Institute of Public Health NRW, 2007; p105) Also in this case, collaborating in healthcare – and more specifically running a joint hospital – was subject to long discussions before the hospital officially opened in 2013.

Potential opportunities for ERN funding EU involvement in the area of cooperation for specialised treatment may need to go beyond providing top-down solutions to MS, as the Commission may not have the right expertise. However, it can provide opportunities for dialogue between MS at an EU level, so that Europe can be a ‘test bed’ for different solutions to similar problems, as well as facilitating funding opportunities to support MS in their efforts. Co-operation in health systems falls under softer measures of the Directive. However, their inclusion in the Directive allows for funding for a long-term co-operation structure at EU level. Instruments that deserve further exploration in terms of their funding potential for innovations in healthcare infrastructure, as well as for transnational actions, include European Structural and Investment Funds (ESIF). The cross-border hospital collaboration between Aachen and Maastricht has also been partly funded by EU funds via the INTERREG Community initiative. The cross-border hospital of Cerdanya made use of European Regional Development Funding (ERDF) as part of the “France-Spain-Andorra” cross-border cooperation operational programme - a continuation of three generations of cross-border cooperation programmes between these countries within the framework of the INTERREG Community Initiative (European Commission, 2014).

Recommendations to make ERN’s and cross-border healthcare collaboration a success story Besides creating a clear governance structure for knowledge sharing and care coordination among EU countries, the innovative character of ERNs can also lead to long-term economic benefits for MS, reducing costs while improving health outcomes and patient access to healthcare, and overcoming the barriers of distance. This is particularly relevant for small countries with limited capacity and resources to provide comprehensive highly specialized services, because it can improve access to treatment for their citizens even if this means going to the nearest hospital in a neighbouring MS (Rare Diseases Task Force, 2006).

European Health Parliament - The Economic Dimension of Healthcare

In the future, it will be difficult for stand-alone regional hospitals to offer a full range of care services, because some treatments require adequate population levels. Concentrating resources via ERBs and considering joint procurement of medicines and medical devices where appropriate could maximise cost-effective use of resources. (Rare Diseases Task Force, 2006). In fact, concentrating certain medical procedures in a limited number of hospitals has demonstrated that it can improve health and outcomes (in terms of mortality rates) (Palm et al., 2013) ERNs offer opportunities for pooling data and know-how and provide training for health professionals. Furthermore, they could act as benchmarks to share best practices (Rare Diseases Task Force, 2006). Rare Diseases Europe (EURORDIS), a non-governmental patient-driven alliance, identifies sustainable funding as well as continued evaluation as key to determining the success of ERNs, and considers the establishing of good co-ordination among ERNs as a vital component (n.d.). In brief, despite some short-term administrative burdens, in the long-term ERNs have the potential to reduce costs due to centralization of resources and economies of scale, while ensuring Europe-wide access to high quality healthcare. Although funding opportunities under Horizon 2020 could facilitate this, the EU could also consider setting up a financial framework dedicated to cross-border healthcare cooperation, which could fund comparative studies and innovative projects to advance the agenda on ERNs. It would also be beneficial to invest in projects that set the groundwork for cross-border cooperation in health care, e.g. supporting language courses for medical students at universities within border regions. Cultural differences should be taken into account as they may affect the success of cross-border developments. Evaluating and monitoring the work of projects is crucial for continuous learning and could facilitate best-practice sharing. Previous cases show that patients demand faster and simpler access to healthcare. Learning for the example from the ‘Euregio Meuse-Rhine’ case, where collaboration between health insurance funds in the respective border zones is well-established, it is important to consider facilitating the adequate reimbursement for patients’ treatment received in a European centre of excellence. ERNs must also ensure that there are quality and safety mechanisms in place that are monitored regularly. The functions of an ERN should not only include best practice dissemination between the centres of reference within the network and to the outside world and pooling of resources, but more importantly, provide patient referral to a centre within the network that is best suited to a patient’s treatment needs. Also, with the participation of healthcare providers, after receiving treatment at a centre of reference, discharged patients should receive adequate continuity of care (Palm et al., 2013). Despite the challenges that remain to date - no agreed definition and standards on these specialised centres, how they will operate in practice and how they will be inter-connected via a network, if implemented accordingly - ERNs have the capacity to act as focal points and shared facilities for exchange of knowledge and expertise, providing opportunities for learning and further training even from a Research and Development perspective.

The Economic Dimension of Healthcare - European Health Parliament

V. CONCLUSIONS â&#x20AC;&#x153;In the future, there will be no real Europe, without a Europe of Healthâ&#x20AC;?. (David Byrne, former European Commissioner for Health, n.d.)

Empirical evidence on the links between health and wealth is not a new phenomenon (World Bank, 1993; Suhrcke et al., 2005). In fact, studies have demonstrated how economic returns from health investment can boost the economy (Mackenbach et al., 2007; WHO Europe, 2008) as well as contribute to social well-being (Figueras et al., 2008). However, in recent years, there has been a growing fear that health systems are becoming unsustainable and stretched beyond their means. Hence, making an economic case on savings in health through prevention and managing of illness in the most efficient and sustainable manner is important. This paper has sought to put forward recommendations for cost-effective solutions across healthcare, touching upon different stages of health care services provision across Europe. Starting with prevention and primary health care, the diffusion of screening innovations needs to be continually evaluated to assess their effectiveness and uptake and more research could be done in this regard. Financial pressures may lead to under-estimating the importance of prevention and screening practices that in the long-term ease costly complex tertiary care burdens. Policy-makers may have adequate evidence to support the implementation of organised and population-based screening programs but do not invest in the appropriate human or financial resources to do so. Hence, the readiness of the health system must be coupled with political will and priority-setting in the assimilation of innovations. The development and availability of new health technologies is shifting the functioning of health systems and the roles and responsibilities of patients. Boosting prevention programmes using ehealth tools may be seen as dehumanising the relationship between patients and professionals, but it provides opportunities to save time and improve the efficacy of patient-doctor contact, empowering patients and allowing for more personalised care. Health literacy and ICT solutions will be needed, however, to produce satisfactory results. The paper also explored opportunities related to one of the prime areas for cross-border healthcare networking and collaboration - the establishment of ERNs especially for rare diseases where pooling of resources to effectively treat such diseases is essential. However, more work is needed to assess the economic added value of setting up these centres of excellence and how their establishment can be facilitated. The input from civil society and patient representative groups should be welcomed in informing policy-makers on what is needed on the ground from a patientsâ&#x20AC;&#x2122; perspective.

European Health Parliament - The Economic Dimension of Healthcare

Research and data collection is crucial and we suggest that the Commission supports further funding for research, particularly in cost-of-illness studies that estimate the burden of a disease in monetary terms – in a language that speaks to decision-makers. There is also a need for more well-designed and in-depth economic evaluations on telemonitoring interventions, or so-called ‘getting out of the hospital’ programmes. Research to date has not focused on collating robust financial data, and more evidence is needed to support the claim that discharging patients early to hospital-at-home care delivers savings for healthcare systems (The Health Foundation, 2011). Recent Council Conclusions on innovation for the benefit of patients (Council of the EU, 2014) show committment to advancing the agenda on innovative ways of managing the health sector. However, to do this through showcasing the economic benefits of innovations in healthcare, a move is needed away from the premise that investing in healthcare innovation is costly, and towards recognising the cost-effectiveness in the long-term despite short-term investments. The Committee recommends that the European Parliamentary Interest Group on Innovation in Health and Social Care explores the above further and calls upon the Commission to consider developing concrete solutions on how healthcare systems can become more cost-effective and sustainable in order for MS to be able to live up to the health-related CSRs as part of the European semester. The independent expert panel on effective ways of investing in health that was set up in 2012 could be a useful asset and contribute further to the European semester work on healthcare systems. Governments often have a desire to see the immediate results of their actions, so there is a risk that economic benefits of cost-effective promotion and prevention measures that often take years to mark their impact can be overlooked. Commissioner for Health and Food Safety Andriukaitis has pledged to push MS to act on their health commitments and move away from cure, focusing their efforts instead on the promotion and prevention that are at the heart of public health. We urge the Commission and MS to step up efforts on health systems by making health a political priority which merits careful consideration. As spelled out in the Commission’s ‘Investing in Health’ agenda, health expenditure is a social investment in our future and in the future of generations to come (European Commission, 2013). Higher healthcare expenditure does not necessarily mean better health, but timely and smart investment today will reap benefits tomorrow. Without health, there is no growth and no gains, and despite the importance of the economic dimension in healthcare, there is no economy without people. Thus, it is important to create an enabling environment for cost-effective healthcare reforms and maintain a long-term perspective.

The Economic Dimension of Healthcare - European Health Parliament

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Council of the European Union. (2006). Council Conclusions on Common values and principles in European Union Health Systems. (2006/C 146/01). Official Journal of the European Union. Retrieved from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2006:146:0001:0003:EN:PDF Council of the European Union (2003). Council Recommendation of 2 December 2003 on cancer screening (2003/878/EC). Official Journal of the European Union L327, 34 - 38. Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:327:0034:0038:EN:PDF Council Conclusions. Council Conclusions on innovation for the benefit of patients. EPSCO Council Brussels, 1 December 2014. Retrieved from http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/145978.pdf Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights in cross-border healthcare. Official Journal of the European Union L 88/45, 04.04.2011.Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF Eron, L et al. (2010). Telemedicine: The Future of Outpatient Therapy? Clinical Infectious Diseases. 51(4). pp: 224-230. doi: 10.1086/653524. European Commission. Commissioner Vytenis Andriukaitis. Letter to the EU Health Ministers, 7 April 2015, Retrieved from: https://ec.europa.eu/commission/2014-2019/andriukaitis/announcements/letter-eu-ministers-health_en European Commission (2014). A cross-border hospital in Cerdanya improves healthcare for French and Spanish citizens. Retrieved from http://ec.europa.eu/regional_policy/index.cfm/en/projects/spain/a-cross-borderhospital-in-cerdanya-improves-healthcare-for-french-and-spanish-citizens. European Commission Implementing decision of 10 March 2014, setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks, (2014/287/EU), recital n°6 European Commission. (2011). Conference report: European Perspectives in Personalised Medicine 12-13 May 2011, p. 5. Retrieved from: http://ec.europa.eu/research/health/pdf/personalised-medicine-conference-report_en.pdf European Commission. (2013). Investing in Health. Commission Staff Working Document: Social Investment Package, February 2013. Retrieved from http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf European Commission (2014). Draft thematic guidance fiche for desk officers health version 2. Guide for Health Investments under the European Structural and Investment Funds (ESIF) 2014-2020. Retrieved from http://www.esifforhealth.eu/Existing_knowledge.htm European Commission (2014). Commission Communication on effective, accessible and resilient health systems. Retrieved from http://ec.europa.eu/health/healthcare/docs/com2014_215_final_en.pdf European Commission. 2010. The European Files: the telemedicine challenge in Europe, June-July 2010, n°20, Retrieved from https://www.myesr.org/html/img/pool/2010europ-files-telemedicine_en-1.pdf

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European E-Business Market Watch (2004). Case study by Empirica: Cross-Border Cooperation for Healthcare provision in Euregio Meuse-Rhine. Retrieved from http://ec.europa.eu/enterprise/archives/e-business-watch/ studies/case_studies/documents/Case%20Studies%202004/CS_SR10_Health_2-Euregio.pdf EURORDIS Rare Diseases Europe, (2012). European Reference Networks for Rare Diseases – Position Paper. Retrieved from http://www.eurordis.org/publication/european-reference-networks-rare-diseases EURORDIS Rare Diseases Europe, (n.d.). Eurordis policy fact sheet - European Reference Networks of Centres of Expertise. Retrieved from http://www.eurordis.org. http://www.liof.com/data/files/alg/id58/Cardiovascular%20centre%20CARIM.pdf Eurostat (2015a). Health care expenditure by providers. Retrieved from: http://appsso.eurostat.ec.europa.eu Eurostat (2015b). In-patient average length of stay. Retrieved from: http://appsso.eurostat.ec.europa.eu Eurostat (2015c). Life expectancy at birth, by sex. Retrieved from: http://ec.europa.eu/eurostat Fahy, N. (2010). Foreword. In: Cross-border health care in the European Union: Mapping and analysing practices and policies. In M. Wismar & W. Palm et al. (Eds.), Cross-border health care in the European Union: Mapping and analysing practices and policies (pp. ix- x). Copenhagen: WHO Regional Office for Europe on behalf of the European Observatory on Health Systems and Policies. Figueras, J., McKee, M., Lessof, S., Duran, A., & Menabde, N. (2008). Health systems, health and wealth: Assessing the case for investing in health systems. Background Document for the WHO European Ministerial Conference on Health Systems. Retrieved from: http://www.together4healthinnovation.eu/uploads/Socio%20Economic%20Papers/Figueras%20Tallin%2008.pdf Geli M. (2010), E Health in Catalonia, The European Files, The Telemedicine challenge in Europe, N°20, pp 12-13 Giraffplus project: available online at http://www.giraffplus.eu/, consulted on 17 April 2015 Glinos IA, Doering N & Maarse H (2013). Local roots, European dreams: evolution of the Maastricht–Aachen University Hospital collaboration (the Netherlands–Germany). In: Hospitals and Borders [World Health Organization, p109-134] Gray, M. A. J., Sheppers, S., Ilson, E., Lees, R., Pearce-Smith, N. (2009). Screening. In M.A.J. Gray et al. (Eds.), Evidence-based healthcare and public health: how to make decisions about health services and public health. United Kingdom: Churchill Livingstone Henderson et al. (2013). Cost effectiveness of telehealth for patients with long term conditions (Whole Systems Demonstrator telehealth questionnaire study): nested economic evaluation in a pragmatic, cluster randomised controlled trial. Retrieved from: http://www.bmj.com/content/346/bmj.f1035 Institute of Public Health NRW (2007). Evaluation of Border Regions in the European Union (EUREGIO). Retrieved May 14, 2015 from http://ec.europa.eu/health/ph_projects/2003/action1/docs/2003_1_23_frep_en.pdf [Final Report]

European Health Parliament - The Economic Dimension of Healthcare

Mackenbach, J.P., Meerding, W.J., & Kunst, A.E. (2007). Economic implications of socio-economic inequalities in health in the European Union. Luxembourg: Office for Official Publications of the European Communities. Retrieved April 3, 2012, from: http://ec.europa.eu/health/archive/ph_determinants/socio_economics/documents/socioeco_inequalities_en.pdf. Marschang, S. et al. (2014). Health inequalities and Health. Report of the eHealth Stakeholder group of the European Commission DG CONNECT. Retrieved from: http://www.epha.org/m/231 Martin, L et al. (2005). The challenge of patient adherence. Ther Clin Risk Manag. 1(3). pp: 19-199. Retrieved from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1661624 MedTech Europe (2012). Creating Value in European Healthcare, p. 23. Retrieved from: http://www.reforminghealthcare.eu/uploads/documents/MedTech%20Europe%20-%20Value-based%20 Innovations%20-%20Brochure%2028%20Sep.pdf Organisation for Economic Co-operation and Development (OECD) (2012). Health at a Glance: Europe 2012, OECD Publishing. Retrieved from http://dx.doi.org/10.1787/9789264183896-46-en Organisation for Economic Co-operation and Development OECD (2014). Health at a Glance: Europe 2014, OECD Publishing. Retrieved from: http://dx.doi.org/10.1787/health_glance_eur-2014-en Olesen, J., Gustavsson, A., Svensson, M., Wittchen, H. U., & JĂśnsson, B. (2012). The economic cost of brain disorders in Europe. European Journal of Neurology, 19(1), 155-162 Omboni, S. et al. (2015). The role of Telemedicine in Hypertension Management: Focus on Blood Pressure Telemonitoring, Current Hypertension Reports. Retrieved from: http://www.ncbi.nlm.nih.gov/pubmed/25790799 Palm, W., Glinos, A. I, Rechel, B., Garel, P., Busse, R., & Figueras, J. (2013). Building European Reference Networks in Health Care: Exploring concepts and national practices in the European Union. Copenhagen: WHO Regional Office for Europe on behalf of the European Observatory on Health Systems and Policies. Series no. 28. Retrieved from http://www.euro.who.int/__data/assets/pdf_file/0004/184738/e96805-final.pdf Rare Diseases Task Force (2006). Centres of Reference for rare diseases in Europe: State-of-the-art in 2006 and recommendations of the Rare Diseases Task Force. Retrieved from http://ec.europa.eu/health/ph_threats/non_com/docs/contribution_policy.pdf Smart Ambulance European Procurers Platform (SAEPP) project. Retrieved from: http://www.smartambulanceproject.eu/, consulted on 8 May 2015 Stuckler, D., Basu, S., Suhrcke, M., Coutts, A., & McKee, M. (2011). Effects of the 2008 recession on health: a first look at European data. The Lancet; 378, 124â&#x20AC;&#x201C;125. Retrieved from http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61079-9/fulltext Suhrcke, M., McKee, M., Arce, R.S., Tsolova, S., & Mortensen, J. (2005). The Contribution of Health to the Economy in the European Union. Brussels: European Commission, Health & Consumer Protection Directorate-General. Retrieved from: http://ec.europa.eu/health/ph_overview/Documents/health_economy_en.pdf

The Economic Dimension of Healthcare - European Health Parliament

The Health Foundation (2011). Evidence in brief: Getting out of hospital? The evidence for shifting acute inpatient and day case services from hospitals into the community. Retrieved from: http://www.health.org.uk/public/cms/75/76/313/2539/ TFEU. (2008). Consolidated Version of the Treaty on the Functioning of the European Union. Official Journal of the European Union, C 115/47, 9.5.2008. Retrieved from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2008:115:0047:0199:en:PDF Tousignant, M. et al. (2015). Cost analysis of in-home telerehabilitation for post-knee arthroplasty, Research Centre on Aging. University Institute of Geriatrics of Sherbrooke, J Med Internet Res. 2015 Mar 31; 17 (3): e83. University Hospital Maastricht & Maastricht University (n.d.). The Cardiovascular Centre. Retrieved March 30, 2015 from http://www.liof.com/data/files/alg/id58/Cardiovascular%20centre%20CARIM.pdf Von Karsa, L., Anttila, A., Ronco, G., Ponti, A., Malila, N., Arbyn, M. et al. (2008). Cancer Screening in the European Union. Report on the implementation of the Council Recommendation on cancer screening. First Report. Luxembourg: Office for the Official Publications of the European Communities. Retrieved from http://ec.europa.eu/health/ph_determinants/genetics/documents/cancer_screening.pdf Whitten, P. and Love, B. (2005). Patient and provider satisfaction with the use of telemedicine: Overview and rationale for cautious enthusiasm. Symposium, 51(4). pp: 294-300. Retrieved from: http://www.bioline.org.br WHO (2006). Prevention of Mental Disorders: Effective Interventions and Policy Options. WHO Publishing. Retrieved from: http://www.who.int/mental_health/evidence/en/prevention_of_mental_disorders_sr.pdf WHO Europe (2008). The Tallinn Charter: Health Systems for Health and Wealth. Retrieved from: http://www.euro.who.int/__data/assets/pdf_file/0008/88613/E91438.pdf World Bank. (1993). World development report 1993: investing in health. Washington, DC: World Bank. Retrieved from: http://www-wds.worldbank.org/external/default/WDSContentServer/IW3P/IB/1993/06/01/000009265_39 70716142319/Rendered/PDF/multi0page.pdf Wilson JMG, Jungner G. (1968). Principles and practice of screening for disease. Retrived from: http://whqlibdoc.who.int/php/WHO_PHP_34.pdf

European Health Parliament - The Economic Dimension of Healthcare

BIG DATA IN HEALTHCARE

Authors Arthur Stril StĂŠphanie Dheur Nicolas Hansroul Andrea Lode Sofia Meranto Matthieu Moulonguet Ivo Ruff

Executive summary The spread and evolutions of information technologies and digital tools have enabled an entire new dimension of big-data storage and analytics that can bring tremendous improvements across industries, including healthcare. This paper recommends the creation of a European wide connected Electronic Health Records Organisation (EHRO) empowering patients by enabling the effective collection and usage of patientsâ&#x20AC;&#x2122; health data across member states, revolutionising healthcare and ultimately leading to better health outcomes for patients and payers irrespective of national borders. The creation of the EHRO aims at overcoming past hurdles and challenges faced by various member states, and catapults Europe to the forefront of the new digital century of health. A raft of recommendations and steps are provided, explaining how such an organisation would support member states to build, connect and use this platform. The proposal illustrates a scale-up approach leveraging on prototypes and building from existing pillars of success, while using an open and transparent approach to platform creation. A patient driven opt-in system will lead to fast adoption, while targeted education campaigns and an incentivebased system at health provider level will accelerate uptake and build trust. The system will not only empower patients and assist clinicians, but also will provide a wealth of knowledge to advance medical science, preventing diseases and improve health for everyone.

Big Data in Healthcare - European Health Parliament

I. SITUATIONAL ANALYSIS Introduction As acknowledged in 2013 by Stanford professor Atul Butte, “hiding within [existing] mounds of data is knowledge that could change the life of a patient, or change the world”. Extracting this knowledge is, according to him, the “fastest, least costly, most effective path to improving people’s health”. Indeed, while the growth of information technologies and digital tools have transformed industries from banking to transport, the age-old foundations of the healthcare sector have yet to be shaken. It is high time the healthcare sector wakes from its slumber and takes steps to modernise and improve its functioning, for the benefit of patients, health practitioners and European countries alike. The explosion of personal health data is a direct consequence of this evolution. New technologies (whether specifically designed for healthcare or not) progressively enable patients to easily access specific health parameters (e.g. their vital functions, medication intake, or response to their treatment) and to better connect with physicians, other health practitioners, and researchers. While much of this data remains insulated and fragmented along different paper-based and digital platforms, it has been widely recognised that the combination and mining of these datasets – Big Data for healthcare – could be used to achieve improvements in diagnosis, quality of care and, more generally, patient satisfaction. Since the millennium, the European Union has recognised the importance of accompanying its member states in these transformations, and has increased its efforts and resources aimed at connecting European healthcare. The first European eHealth Action Plan adopted in 2004, and the many initiatives, regulations and policies that have since followed, embody the commitment of the European Union to make eHealth more than an ambition . Examples include the creation of the eHealth Network, the adoption of the 2011 Directive on the Application of Patient’s rights in cross border healthcare, the 2012-2020 eHealth action plan, and pilot projects such as Antilope, e-SENS, PALANTE, PARENT, and SALUS. However, it is easy to drown in the endless sea of datasets and possibilities to combine them. In 2010, Google’s Eric Schmidt drew attention to the fact that “there were five exabytes of information created between the dawn of civilization through 2003, but that much information is now created every two days”. In healthcare, there are typically three broad categories of data sets available, all with their own associated array of challenges: (a) Electronic Health Records (“EHRs”), providing real-time medical and treatment history of a patient; (b) biological footprints, such as personal genomic information derived from single-nucleotide polymorphism analysis or whole-genome sequencing; and (c) “quantified self” data, the measure of an individual’s daily life (physical activity, food intake, sleep patterns, etc.). This paper is devoted to the first category, EHRs, since it is the area where a policy solution is the most relevant for society at large and where the benefits of data mining and analysis can be best exploited, ultimately leading to an improvement in health and cost savings. Nonetheless, ideas raised in this paper would also apply to biological footprints and “quantified self” data.

European Health Parliament - Big Data in Healthcare

It is not yet possible to provide truly connected European healthcare or ensure the effective collection and usage of data to improve the quality of healthcare for all European citizens. Big Data is noton the digital and health agenda of all EU member states. Some have recognised its potential and are working intensively on it, but others have struggled to incorporate it into their policies and healthcare delivery. This is another example of the challenges presented by fragmentation. This paper aims at introducing the European Health Records Organisation (EHRO), an innovative tool to develop Electronic Health Records (EHRs) across Europe, with a view to making them available to all EU citizens. After a review of the benefits that offer such tools, and the challenges currently preventing implementation, the proposal will cover seven points essential to implementation of EHRO. This project is discussed in the wider perspective of Big Data, considering in particular its impact on European healthcare and the patient community.

What are the potential benefits of using Electronic Health Records? Focusing on EHRs at EU level could create value for patients, health practitioners and governments. Here, the main short- to mid-term benefits are outlined. Patients would be able to receive appropriate treatment across member states, in particular by sharing personal health information with any physician in the EU (conditional on the patient’s consent) and avoiding unnecessary medical fees and administrative burdens (such as duplication of medical analyses). They would possess a centralised, up-to-date and easily accessible health “database”, while retaining ownership and ensuring appropriate use of their data. Healthcare practitioners would have a comprehensive view of the patient’s medical background and history over time, thereby enabling them to offer the most appropriate treatment. This would avoid misunderstandings with patients over their health condition (e.g. due to differences in languages, or in national names of drugs), and would save time and improve their ability to provide service to patients. It would also promote the development of telemedicine, by attracting patients from abroad through diagnoses and monitoring services via remote systems.

Big Data in Healthcare - European Health Parliament

Member states would be able to develop a single electronic health platform that could be rolled out across all national administrative units. It would achieve a better balance of costs and benefits in healthcare budgets through improvement of treatment and avoidance of duplicate medical tests. More importantly, it make it possible to obtain better health data and insights into the state of health of the population, along with the ability to tailor specific prevention programmes, improve reimbursement systems, or increase focus on areas of unmet need. These opportunities are only the short- to mid-term opportunities. Further benefits stemming from the large-scale analysis of European EHRs are highlighted below under “Future prospects for Big Data applications”.

Main challenges In order to fully unlock these sources of value, three key challenges remain at EU level: standardisation (the creation of common tools and norms to ensure interoperability), access control (the definition of the relevant level of access for each group of stakeholders, as well as of data ownership) and communication (the development of a relevant outreach to patients and healthcare providers). The first challenge is to ensure that the European Union creates and guarantees a mature and interoperable environment for health records for all its member states and citizens. For example, a Portuguese woman who wants a second opinion for a cataract surgery from a renowned Spanish expert should be able to effortlessly carry with her all the relevant medical data and the results from her previous ophthalmological tests conducted in Portugal. A Belgian patient who would like to avoid a 6-month waiting time to attend a consultation with his orthopaedic doctor, and who decides to seek treatment in the Netherlands, should be easily able to make the Dutch doctor aware of his entire medical background. Theoretically, each European citizen possesses their own EHR, which is a repository of their lifetime health data and treatment journey. Therefore, in practice, European citizens should have access to the regularly updated version of their medical data, in a secure electronic format, whenever and wherever in the European Union. This is currently far from being the case. The deployment of EHRs within the EU remains fragmented. The member states are at differing stages in organising the way health data is recorded and stored in their healthcare systems. Moreover, not only are there differences between them, but also in many cases they do not have uniform systems within their different national administrative levels. Thus, a general practitioner in the countryside may still use paper records, while public hospitals in the capital may solely rely on electronic records. Similarly, individual regions may have had positive experiences with a local version of connected EHR systems, bringing forward a smart analysis of the data collected and successfully implementing changes in their health care provision, while others have not reached such level of maturity. The challenges of access control and communication stem from the fact that not only are EU citizens and patients little aware of the existence of central recording and storage systems, but they also chiefly mistrust them. Following recent scandals, such as the revelations about the U.S. National Security Agency’s practices, Europeans are very conscious that their data could be in the hands of unexpected actors. Indeed, 43% of the respondents to the most recent Eurobarometer survey on cyber security “are concerned about someone misusing personal data”, a number that has risen by six percentage points since the last survey of its kind in 2013 (European Commission, 2015). Hence, clear and strict rules would have to be established in regards to data access, while communication plans should insist on reinforcing the citizens’ right to (health) data protection.

European Health Parliament - Big Data in Healthcare

II. PROPOSAL: THE EUROPEAN HEALTH RECORD ORGANISATION The proposal Our objective is to reinvent Electronic Health Records in order to offer each European citizen the ability to build throughout their lifespan a comprehensive, easy-to-use and secure personal health record, constantly accessible and portable within any other member states of the EU. This is in line with the aim of further empowering patients during the care process, while making them aware of their options to access and make use of their own medical data according to their individual needs. At the same time, this is an opportunity for the European Union to stand as a defender of citizensâ&#x20AC;&#x2122; rights and privacy by ensuring the comprehensive security and confidentiality of health data. In order to achieve this goal, the creation of EHRO, a permanent body dedicated to the design and rollout of Electronic Health Records at European and member state level, is an important step forward. EHRO could integrate or otherwise benefit from the assets and participation of existing structures such as the eHealth Network or IHE-Europe. The goal of this centralised body would however not be the storage of health data, which would remain at national level. While the exact structure, participants and sources of funding of EHRO remain beyond the scope of this paper, we describe the key features of its implementation.

Implementation of the EHRO 1. BUILD ON PILLARS OF SUCCESS The original capabilities and structure of epSOS (Smart Open Services for European Patients), see e.g. (LindĂŠn, 2014), and EXPAND (Expanding Health Data Interoperability Services), see e.g. (Marques, et al., 2015), can be leveraged by building on their successes. The goal of the EXPAND project is to progress towards an environment of sustainable cross border eHealth services established at EU level. EpSOS has already developed a legal draft framework relating to the roll-out of electronic prescriptions, which could be further expanded to incorporate EHRs. Our recommendation is to use the same processes and structure that the epSOS and EXPAND projects have already created, tried and successfully tested, for the purpose of scaling up to a large project such as the evisaged EHRO. One of the early take-aways from both initiatives is the necessity to ensure mature infrastructures for producing and using the content. As such, ensuring national points of contact in each EU member state, such as a national agency to oversee Electronic Health Records and a neutral body with a strong mandate to facilitate the interaction between agencies, is critical for long-term sustainability and success.

Big Data in Healthcare - European Health Parliament

2. SCALABILITY APPROACH To manage the complexity of EU-wide implementation, a start could be made with a software and infrastructure prototype in one pilot-country or a small number of like-minded countries. This would allow the complete structure of the system to be built from the ground up, with constant improvements in light of actual experience. This would, subsequently, make possible the expansion of the system to more countries, as the complexity and requirements become better known.New opt-in countries will be able to adapt more easily. To help this scalability process, it is essential to have national contact points in all EU member states, even in those which do not have an immediate intention to opt in Regular meetings between national contact points will encourage sharing experiences and discussing the main obstacles ahead, so as to better address them when they arise. The European Health Records project might benefit from the well established EXPAND and existing e-Health Network.

3. AN OPEN AND TRANSPARENT APPROACH TO PLATFORM CREATION For the software platform creation, it would be helpful to adopt an open source software architecture approach. The use of a web collaborative approach would allow for more efficiency as well as more transparency. The project team will lead the development of the platform with its own developers, but the use of open source software will permit external software designers, healthcare practitioners and other experts to actively participate. The proactive involvement of such actors in the discussion and the design of the prototype through an interactive platform can lead to greater efficiency: this is a way of ensuring that the platform will include all the relevant information for practitioners, organised in the most practical manner. The software has to be designed so that all practitioners can intuitively make the best use of it, without any delay. In addition, the open source approach and its collaborative implications will reduce the costs of design. Besides the potential gains in terms of efficiency, an open source mechanism also makes the process more transparent, reinforcing trust in the system. Healthcare practitioners and patients will be more confident about such a platform if they have been able to voice their concerns and suggestions during the design process, ensuring it does not appear as a “black box”. The use of open source software will also allow for more flexibility: it makes the platform more adaptable to national specificities - an important factor, since each member state depends on different health software architecture at hospital level. Open software architecture also makes it simpler for private software vendors to adapt their software to feed into the EHRO system. For example a vendor of ultrasound imaging systems could load the patients’ scans and related data directly into the system, allowing healthcare professionals comprehensive access directly within EHRO to patient information from a variety of systems operated by different vendors. Open software, rather than a closed system, has advantages illustrated by the experience with the UK’s care. data. After contracting the development to multiple private vendors, the initiative was left with no access to the source code when multiple vendors walked out on contracts. An open source software platform can avoid such a scenario, by ensuring the software becomes a public good rather than a private commodity. For all these reasons, an open and transparent approach to platform creation seems to be the best way to achieve the main objectives, which are building trust in the whole system and maximising practicality and efficiency.

European Health Parliament - Big Data in Healthcare

4. PLATFORM SECURITY To ensure universal access across member states, a single secured cloud-based platform with rigorous privacy and access controls is needed. An OrBAC-based multilevel security policy could be assigned to prevent users from accessing information for which they lack authorisation (Cuppens & Cuppens-Boulahia, 2011). This platform would be based on the patientsâ&#x20AC;&#x2122; ultimate decision to selectively share information according to their wishes or concerns. The patient would retain full control over which information to share whether for medical or research purposes. Only health professionals working for the exclusive interest of the patient would have access to the data, only with the explicit consent of the patient. For access to data for research purposes, an independent supervisory board would ensure that future access would be allowed only for legitimate scientific research purposes. Ensuring the privacy and confidentiality of all European patients is a priority. Basic principles would govern access to a patientâ&#x20AC;&#x2122;s medical records via their EHR. The overarching principle will be to apply the European legislation regarding data protection and e-privacy (as well as future amendments)1. More specifically, access should be prohibited to a patientâ&#x20AC;&#x2122;s records in situations not directly related to delivering or supporting healthcare. A healthcare professional should access only the patient records required for work and only during the period required for execution (time-limited access rights), and everyone accessing patient records should be bound by rules of non-disclosure (professional secrecy). No data should be communicated to third parties in any form without explicit consent of the patient. Access to patient records must always be subject to the consent of the patient. When properly designed, security of computerised medical records is better than for paper records. The destruction or loss of a unique paper file is irreversible, and viewing of a paper file is not logged. Computerised records permit backup copies at remote locations, and all accesses can be logged. Scrupulous safeguards, security measures and data protection requirements are necessary to ensure the safety and security of all patient data collected and stored on computers and to ensure operability in practice. As security conditions still vary between member states, alignment of minimum standards between member states is needed to ensure equal levels of security safeguards are in place across all member states.

5. OPT-IN PRINCIPLE The key to user acceptance lies in empowering current and possible future patients and healthcare practitioners to select their degree of participation in EHRO. Using an opt-in process will give users full control over their own health records, while allowing those individuals reluctant to participate because of privacy, technology or other concerns - to remain with the current paper-based system. Opting in will create a person-specific EHR account on the online platform, where the user will find a simple interface giving access to the growing repository of personal health information collected. Transparent user settings will allow a patient to authorise a trusted healthcare professional to access their health records. More advanced settings could enable a patient to limit the information that is shared - such as only records of the most recent 5 years, or pertaining to a certain condition. They could limit the period during which a healthcare professional may access their data. Underage citizens may have their EHR managed by their legal guardian until they come of age. Approved practitioners will be able to view the data for which they have been given permission and add new information based on their consultation with the patient. The system will become a trustworthy and well-used service only when patients have full and dependable control over their EHR.

1 Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data; Directive 2002/58/EC concerning the processing of personal data and the protection of privacy in the electronic communications sector; Council of Europe Convention 108 for the Protection of Individuals with regard to Automatic Processing of Personal Data.

Big Data in Healthcare - European Health Parliament

6. EDUCATION CAMPAIGN European citizens themselves can make or break any European initiative, and this is particularly true when personal health is involved and where patient engagement is essential. A recent study by Harvard Business School on the Affordable Care Act (Quelch & Norris, 2014) suggests that properly marketing structural healthcare reforms is a pivotal factor of success: “the sheer scope of the [Affordable Care Act], passed after more than a decade without any major healthcare legislation in the US, ensured that it would be complex and tough to sell to the public. […] But that was just the problem: Congress and the Obama Administration didn’t sell it. […] By using a marketing-based approach, […] government officials can ensure that the laws they spend so much time and energy crafting are utilised by the people who need them most” (Blanding, 2014). A public marketing and education campaign is thus of crucial importance for each country’s roll out and pre-roll out phase. Valuable lessons can be drawn from previously successfully deployed initiatives that faced hurdles because of inadequate consultation of the public and weak communication of the value to patients and practitioners alike. Initiatives like care.data launched by the NHS have shown limited success so far, in particular because citizens were not sufficiently informed of the programme and of its potential benefits (Triggle, 2014). Addressing potential fears about the new technology will be crucial. Putting the empowerment of the individual in the foreground will help to overcome privacy concerns. Widespread citizen outreach by well-targeted communication channels, demonstrating in full transparency the advantages of participation in the initiative, will ensure fast acceptance and uptake.

7. ACCELERATE UPTAKE AT PRACTITIONER-LEVEL This system can work only with wide adoption by healthcare practitioners. Although we believe that providers will appreciate the value of such an interconnected platform, a complementary incentive system will be required. The main challenges to adoption from a provider side are implementation costs and training. For this reason utilising a milestone-based payment system is recommended. At the healthcare practitioner level, important milestones could be (a) opt-in and software installation; (b) completion of the new user training; (c) first X patient records created or updated. EHRO may provide incentive payments to eligible professionals and eligible hospitals as they adopt, implement, upgrade or demonstrate meaningful use of certified EHR technology. Similar incentive systems have been successfully implemented in the U.S. in the Medicare/Medicaid framework (CMS. gov, 2015). In order to ensure widespread adoption and use, the communication strategy should look at partnering with medical and paramedical associations such as the European Federation of Nurses Associations, the Standing Committee of European Doctors or the European Association of Senior Hospital Physicians.

European Health Parliament - Big Data in Healthcare

Future prospects for Big Data applications Beyond the improvement of day-to-day delivery of care, the widespread use of EHR will make it possible to generate a wealth of information on patients and the healthcare system. Public and private organisations are expected to greatly benefit from the ability to explore and analyse such data.

PRIVATE ENTITIES In the long term, the EHRO database could allow (under specific conditions) the participation of private entities, such as life science, research, and insurance companies, thereby opening the door to benefits from data analytics, not just for these entities but for society as a whole. Developers of medicines, vaccinations and therapies could analyse the available records on prescription and drug usage to determine hitherto unknown circumstances or problems affecting the efficacy and safety of their products throughout a heterogeneous group of patients, presenting a great number of possible varieties of the conditions in question. This would allow them to improve and advance the science and safety of their products, which should impact directly on the quality of treatment of all patients. Similarly, insurers could reform their own compensation systems with the pharmaceutical industry, and offer incentives and rewards for products with an especially good efficacy record. This may be done in parallel with Health Technology Assessments performed by public reimbursement systems. In their direct relationship with the insured, insurers could analyse EHRO records to specifically target at-risk groups with preventive measures. Through such measures, insurance companies could save money otherwise spent on therapies, while patients would also benefit from support. The potential benefits are numerous, but careful consideration is needed to commercial effects and the requirements of data protection. An independent supervisory board should be able to rule on access to patient data, on the one hand, and on how a private entity could act on this data. The decision criteria of the supervisory board would be made public. Information on aspects allowing identification of a person (such as address, financial details, family records) should never be available, unless the person in question has given specific consent. Essentially, if access by private third parties is to be granted, a good balance must be struck between the benefits of data analysis for society and healthcare delivery, and how far to rein in commercial interests.

Big Data in Healthcare - European Health Parliament

PUBLIC ENTITIES With soaring healthcare costs in Europe, a primary challenge for the European healthcare sector will be finding how to curb spending. As the World Bank notes, “public expenditure on healthcare in the EU could jump from 8% GDP in 2000 to 14% in 2030 and continue to grow beyond that date” (The Economist Intelligence Unit, 2011). Further, Europe will soon be confronted by the health challenges of an ageing population, the rise in chronic diseases and increased costs of medical innovation and technology. Data analytics, in particular of EHRs, offers an important contribution to meeting these challenges. EHRO would provide member states and decision makers with deeper insights into the state of health of their populations, and allow them to allocate funds to areas of highest unmet needs. A growing problem in the European healthcare sector is governments’ lack of knowledge about the effectiveness of their expenditure. As the demand for spending increases and the need to balance budgets grows, sound analysis of returns on investment will be increasingly important. Currently, restrictions on access to patient data are an obstacle to advancing investment analyses. Improved access and transparency of data would permit more appropriate investments by governments in the healthcare sector, and help avoid wasteful spending - through more robust Health Technology Assessments or optimising healthcare infrastructure networks. Patients may opt in to use of their data by public researchers after a prior approval by the independent supervisory board. Medical research typically needs long-term observation following large human and material investments, and a systematic design is required to avoid biases through all stages during these long follow-ups. For example, EHR data could help to achieve an overview of the population before sampling, including how to stratify a population in study (Moseley, Hsu, Stone, & Celi, 2014). Differentiated settings would be possible, allowing individual patients to decide whether to make their data available to science, and how: in clear, pseudonymised, or anonymised and aggregated format, for which period of time, and even for which area of research. Disease prevention or epidemics detection authorities should also benefit from the data. They, in turn, would be able to study disease patterns (such as geographic spread or prevalence in population groups) by monitoring spikes in the appearance of specific diseases. Through this type of data analysis, counter-measures to flu epidemics or worse outbreaks could be initiated faster and thus more effectively. The ability to quantify medical information that data analytics provides can offer opportunities to enhance the understanding about patterns of diseases and their origins. It facilitates the mapping of genetic data to identify at-risk demographics for chronic diseases, cancer or heart diseases. The World Health Organisation found that “at least 80% of all cases of heart disease, stroke and diabetes are preventable” (The Economist Intelligence Unit, 2011), so one of the effective use of EHR databases could be earlier detection and prevention of diseases, rather than treatment at a late stage. This would provide healthcare practitioners earlier identification mechanisms, and allow them to better and more effectively treat patients, for example with more individualised or tailored treatment plans. In the long-term, the application of big data analytics could provide an invaluable public good. The implementation of the EHRO body is a first step towards these greater benefits, because it will allow for the aggregation of standardised data at the EU level, thereby facilitating valuable analyses in the future and providing an immeasurable public good.

European Health Parliament - Big Data in Healthcare

III. FINAL WORDS Fragmentation in the European healthcare sector and of data will be the key challenge for Europe in the coming years in order to achieve the tremendous potential of Big Data analytics. Healthcare, as a public good and associated with many sensitive issues for patients and practitioners alike, requires the support and leadership of public authorities in the drive towards unleashing the digital revolution in this field. This can be best achieved through the establishment of a clear legal framework for collecting and accessing medical records. Unless supervised by public bodies with strong yet impartial mandates, such initiatives are unlikely to succeed in delivering the desired far-reaching positive impacts. The recommendation for an EU-wide coordinated action to facilitate easy access, sharing and interoperability of electronic health records and future Big Data analytics aims at improving healthcare in Europe in the future. The proposal is to create a European Health Records Organisation, in charge of designing and rolling out a standardised electronic platform for medical records throughout Europe. Such a platform will greatly facilitate the aggregation of medical data at the European level for research purposes, helping notably the prevention of chronic diseases and epidemics. At the same time, it will empower patients by ensuring a higher level of protection for their data and improving their ability to receive medical treatment in another EU country, in the most efficient manner with the best quality treatment. With appropriate and rigorous safeguards, notably on personal data protection, the use of Big Data will be essential for improving healthcare for decades to come. The creation of EHRO constitutes a significant step towards this revolution in medical research and healthcare improvement. Letâ&#x20AC;&#x2122;s improve healthcare for Europeans. Letâ&#x20AC;&#x2122;s make Europe a leader in this field. Think Big. Think of Big Data.

Big Data in Healthcare - European Health Parliament

IV. REFERENCES Blanding, M. (2014). Marketing Obamacare. Harvard Business School Working Knowledge. CMS.gov. (2015, February 18). Medicare and Medicaid EHR Incentive Program Basics. Retrieved from Centers for Medicare & Medicaid Services: http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Basics.html Cuppens, F., & Cuppens-Boulahia, N. (2011). Organisation Based Access Control - Multilevel Security Policies. Encyclopaedia of Cryptography and Security. European Commission. (2015). Special Eurobarometer 423 - Cyber Security. LindĂŠn, F. (2014, July 1). Smart Open Services for European Patients - Open eHealth initiative for a European large scale pilot of patient summary and electronic prescription. Retrieved from epSOS: http:// epsos.eu/fileadmin/content/pdf/deliverables/epSOS_letter_to_contributors_1July2014_01.pdf Marques, L., Kustra Mano, L., Thorp, J., Kolitsi, Z., Karla, D., Wehnert, J., et al. (2015, February 23). Management report â&#x20AC;&#x201C; Year 1. Retrieved from EXPAND: http://www.expandproject.eu/wp-content/uploads/2015/02/EXPAND-D1.1-Management-report-Year-1.pdf Moseley, E., Hsu, D., Stone, D., & Celi, L. (2014). Beyond Open Big Data: Addressing Unreliable Research. J Med Internet Res, 16(11):e259. Quelch, J., & Norris, M. (2014). Access Health CT: Marketing Affordable Care. Harvard Business School Case Study. The Economist Intelligence Unit. (2011). The Future of Healthcare in Europe. Triggle, N. (2014, February 19). Care.data: How did it go so wrong? BBC News.

European Health Parliament - Big Data in Healthcare

ELECTRONIC/MOBILE HEALTH

Authors Yasemin Şener Giulia Albertino Kolia Bénié Donatien Depuydt Martina Francesca Ferracane Mélody Lemaistre Simona Pronckute Jean-Baptiste Reiland Maarten Timmers

Executive summary ‘EU Member States are facing major health-related and societal challenges that could threaten the sustainability of their healthcare systems.’ This accurate diagnosis calls for urgent political action, at EU and national level. There is a need for innovative solutions, both therapeutic and organizational, that will accompany the health and societal changes. e/mHealth might have the potential to be a game-changer. But to unleash this potential, a comprehensive political strategy going beyond mere technicalities will also be needed, since mHealth cannot be viewed only as a public health issue. It touches R&D, ethics, industry and social policies. The e/mHealth market is growing rapidly and the policy environment cannot lag behind it. This paper aims to identify steps across policy areas for the uptake of mHealth in Europe. > Research, Development and Innovation (R&D&I) is fundamental for the development of mHealth solutions that address patients’ needs. The EU treaty objective of creating a European Research Area gives a legal base for initiatives to foster the development of mHealth across the Member States. > Market Access means bringing mHealth solutions to patients - through harmonised certification of devices and applications, data privacy, and security regulation. > Awareness among patients and healthcare practitioners – is essential if these new therapeutic solutions are to be used. > Integration into healthcare systems will be easier if physicians and patients are convinced of its potential by evidence of its quality and cost-effectiveness – although the sensitive issue of pricing and reimbursement, where the EU competence is limited, will need attention. e/mHealth should be considered as the building block of a comprehensive political health strategy, contributing to better health and economic outcomes by preventing chronic diseases and redefining the patient’s position within the traditional healthcare system. It will also feed the healthcare Big Data, and access to these innovative solutions, and their reimbursement, will feature prominently on the EU health policy agenda.

Electronic/Mobile Health - European Health Parliament

I. RECOMMENDATION AT A GLANCE The private sector has already recognised the potential of e-/m-health solutions. The lack of regulatory harmonisation is not preventing it from changing the way our healthcare systems are working. Innovations so far relate more to digital solutions than traditional health care services, and the EU can help promote these solutions within the European single market. The EU should go beyond technical regulatory harmonisation and support the entire innovation process, from the laboratory through to uptake by physicians.

European Health Parliament - Electronic/Mobile Health

II. INTRODUCTION The EU Member states are facing common health and societal challenges such as an ageing society and a strong increase of chronic diseases, often related to the fact the people live longer. Chronic diseases are now responsible for 86% of all deaths, and an estimated €700 billion per year are spent on the treatment of these conditions i.e. 70 to 80% of the overall healthcare budgets. This demands a complete re-definition of the healthcare system.To deliver better health outcomes with limited resources requires developing and implementing innovation throughout the healthcare system. Innovation will be a determinant of the future financing and sustainability of European healthcare systems. Innovation must be therapeutic, to deliver better health outcomes to patients, and organisational, modifying the way healthcare services will be provided. Electronic and mobile health (hereafter eHealth1 and mHealth2) have the potential to help Member states to tackle the complex health challenges and unmet needs they face. The technologies already available (e.g. smart-phones, smart-watches, PDA…) give patients tools to monitor their health on an ongoing basis. Technology may even be used for disease prevention, disease management and diagnostic measures. Mobile access and the use of mobile phones, smart-phones, laptops, and tablets is nearly ubiquitous. Developed markets already have a mobile phone penetration exceeding 100%. The use of smartphone technology is growing significantly across generations reaching > 50% market penetrations (see figure 1). Mobile phones in use have long exceeded 6 billion, and smartphone users are predicted to total more than 2 billion by 2016 (eMarketer, 2014).

1 eHealth, defined by the European Commission in its eHealth Action Plan 2012-2020 as “using digital tools and services for health”, is a generic term which covers different areas such as electronic health records, telemedicine, e-Prescription and m-Health. For further information please visit: http://europa.eu/rapid/press-release_MEMO-12-959_en.htm 2 mHealth is defined by the World Health Organisation as “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices”

Electronic/Mobile Health - European Health Parliament

Smartphone Penetration Across the EU5 Countries Source: comScore MobiLens EU5, 3 month Avg ending Dec 2012, 13 +

64% 51%

57% EU5

Average

53% 53% 66%

Figure 1: Smartphone Penetration Across the EU5 Countries Source: comScore Mobiliens, 2013

The global market for mobile health is growing fast and expected to be worth €23 billion by 2017 (PWC, 2012, p. 4). Mobile health services are broadly solutions for the patient (wellness, prevention, diagnosis, treatment and monitoring services) or health care system solutions (e.g. health care practitioner support, administration, and so on). Monitoring services and application are expected to account for nearly 65%, corresponding to $15 billion by 2017. It is projected that EU and APAC will have the biggest market share of about 30% each, offering significant economic growth opportunities. As mobile applications are not bound by regional borders, the call for a single digital market is louder and more relevant than before. Within the EU, Denmark, Finland, Sweden and the UK offer the best market condition for mHealth to flourish based on eHealth adoption, regulatory framework, level of digitalization, practitioners’ perspective, and market size (source: EU Countries’ mHealth App Market Ranking 2015). Germany and France, although huge markets, are hampered by lack of regulations, digitalization and adoption (by consumer and practitioners) diminishing and complicating their market potential and growth prospects. The attraction of mobile health is confirmed by investments from players such as Apple, Google and Samsung, currently shaping this market. Google boosted its investment in Health Sciences from 9% to 36% in 2014 (Barr, 2014). In 2014 Apple launched Healthkit, a central platform for health information, gathering data from sources such as glucose measurement tools, food and exercisetracking apps and Wifi connected scales.. Apple’s Healthkit has been adopted by top US hospitals, and acts as a repository for patient-generated health information to help physicians monitor patients with chronic conditions such as diabetes and hypertension (Farr, 2015). Google Inc (GOOGL.O) and Samsung Electronics (005930.KS) have released similar services and are reaching out to hospitals and other medical partners.

European Health Parliament - Electronic/Mobile Health

With the mobile health market evolving rapidly, EU health policy is addressing e-Health and m-Health issues within its areas of competence: • A first action plan in 2004 focused on electronic prescriptions and computerised health records. • In 2012, after a public consultation, the Commission adopted a second plan for 2012-2020, following the adoption of the directive on patient’s right in cross-border healthcare. The e-Health Network established in 2012 has already finalised several reports to increase the uptake of eHealth in the European Union, and the European Parliament has supported the Commission’s plan. • In April 2014, DG CONNECT’s Green Paper consultation on mobile health explored questions of privacy, patient safety, legal frameworks and cost-effectiveness. Based on the results, the Commission will discuss potential policy actions with stakeholders throughout 2015.

Despite the efforts, limited progress has been made so far. The nine barriers to mHealth implementation identified by the WHO back in 2012, depicted in the figure below, still hold true today, and competing priorities, lack of policy, regulations and knowledge and cost effectiveness remain the top challenges for mHealth diffusion.

Nine key barriers to implementation of mHealth identified by the WHO Share of countries listing barrier as important 60%

50%

40%

30%

20%

10%

Priorities

Knowledge

Policy

Cost effectiveness

Legal

Operating costs

Demand

Technical expertise

Infrastructure

Other

Ecosystem barriers Regulatory / policy barriers

Source: WHO: BCG analysis

Figure 2: Barriers to mHealth Implementation Source: (WHO, 2012, p. 21)

Our paper is mostly based on the review of scientific literature, policy and think tank reports and some private-funded reports by consultancy firms., We also interviewed EU policy-makers, NGOs, civil society representatives and physicians..

Electronic/Mobile Health - European Health Parliament

III. MHEALTH: A TARGETED APPROACH AND A HOLISTIC PERSPECTIVE Our paper is focused on mHealth, as a component of the generic e-Health sector. mHealth growth requires attention from policy-makers, to integrate solutions throughout the patient pathway of wellbeing, prevention, diagnosis and treatment. mHealth demands a rethink of the healthcare system. The private sector is no longer just the pharmaceutical, biotech and medical devices industry. IT companies, network infrastructure and telecom companies are also crucial - although the role of the health care practitioner and the place of patients remain central. A holistic perspective combining targeted Research & Development and Innovation, dedicated market access policies, increased awareness among patient and practitioners and close integration in the healthcare system is necessary to pave the way to successful mHealth integration in Europe.

European Health Parliament - Electronic/Mobile Health

mHealth Integration in the Overall Healthcare System: Challenges and Opportunities Most mHealth apps currently focus on well-being (wellness, fitness, diet, and so on) rather than disease management. The lifecycle of the few quality-based disease management apps is short, as health care practitioners cannot easily review the monitoring data generated owing to insufficient integration in the overall care process, and patients should not be expected to interpret their own health data. Integration of these new tools into care at all levels is essential, with the public sector ensuring quality and wide access, and the private sector focusing on cost-efficiency and innovation. With such solutions, “mHealth will be a major factor in providing personal toolkits that will ultimately help those manage predicted vulnerabilities, chronic illness, and episodic acute conditions.” (PWC, 2014, p. 3) More targeted will be possible, including through remote monitoring, tele-consultation, video conferencing, access to patient records and prescriptions, and reminders to patients and alerts to doctors in the event of failure to adhere to treatment. Remote patient monitoring of heart rate, respiration rate, body temperature and blood glucose level would allow doctors’ to intervene early in response to abnormal signals, reducing more costly later interventions and easing health care expenses. mHealth also permits health care management plans, helps patient education, and builds patient-physician relationships. Disease management can be turned into mobile games that award prizes for patients’ adherence to treatment. And applications can help communication between the hospitalised patients and their families through regular updates on patients’ development and through video conferences both with the patient and the doctors.

Electronic/Mobile Health - European Health Parliament

Several challenges hamper the integration of mHealth into the overall care process and prevent health care practitioners and patients embedding these tools in daily practice. The mHealth Green Paper (European Commission, 2014) and other healthcare stakeholders (Advance Healthcare Network, 2014) note: • The wide range of Apps available makes choice difficult. • A lack of evidence and quality control regarding their safety and cost-effectiveness • A lack of interoperability between mHealth and eHealth solutions • A lack of processes/infrastructure for prescribing mHealth apps • A lack of professional guidelines for mHealth use • Malpractice liability concerns • Data privacy and security concerns • A lack of reimbursement models for remote care by physicians/healthcare professionals or for self-care • A lack of reimbursement for patients’ purchases of apps and wearable devices. These challenges also provide an answer to the question ‘why has mHealth not been integrated to health care systems already?’ We approached this question by imagining a 4-steps journey of a mHealth application from its development to its reimbursement.

RECOMMENDATIONS: • The private sector has already recognised the potential of e-/m-health solutions, and the lack of regulatory harmonization is not preventing it from bringing changes in the way our healthcare system is working. These innovations have more to do with digital solutions than traditional health care services and therefore the EU is a key player in ensuring that these solutions thrive safely and harmoniously within the European single market. • The EU approach towards e-/m-Health should go beyond the necessary technical regulatory harmonisation and promote a holistic approach which embraces the entire journey of these innovations, from laboratory research until final uptake by the physicians.

European Health Parliament - Electronic/Mobile Health

a. Research & Development & Innovation With its ambition to create a European Research Area and the adoption of the Horizon 2020 (H2020) strategy in 2014, the European Union demonstrated its commitment to address Research and Innovation . Four current EU funding opportunities directly related to e/m health represent more than €200 million More than 450 proposals were submitted for the H2020 call “personalising health and care”, which has a budget of €185 million and covers eHealth interoperability, self-management of disease, and ICT solutions for health… Part of the €50 million budget from the call for electronics components and systems for industrial leadership was also dedicated to smart health. The EU should design an ambitious pan-European initiative to foster research and innovation in digital health and become world leader in this field – such as a strategic platform of projects addressing e/ mHealth issues and Big Data, involving Apps developers, patients, healthcare professionals, academic researchers, policy-makers and healthcare, IT and telecom companies. Funding, involvement and reward-sharing need to be taken into consideration. The EU should be in the driving seat on governance, to ensure equity and that the interests of the citizens are not driven by private companies. Centralised coordination is crucial to ensure its performance. The IMI structure, a joint undertaking between the EU and the pharmaceutical industry, could be an example. Before launching a dedicated platform, a mHealth specific research project could be launched within IMI scope, as a test, linked to one of the IMI health priorities - diabetes, psychiatric diseases or ageingassociated diseases. To integrate e/mHealth solutions into the healthcare system, the Research, Development and Innovation step is crucial. By increasing collaboration between EU stakeholders, mHealth solutions designed to answer unmet medical needs could be more efficiently developed.

RECOMMENDATIONS: • Launch an EU strategic platform dedicated to digital health that would gather all the stakeholders, based on an IMI-type structure, • Take into account patients’ and healthcare professionals’ perspectives from the start of Research and Innovation. “User-friendly” and “User-centricity” should be the motto of all mHealth solution.

Electronic/Mobile Health - European Health Parliament

b. e/mHealth Market Access: the Call for a Single Digital Market The European Union is not a single market for e/m-health solutions, with barriers ranging from the absence of a truly digital single market to the scattered regulatory framework for certification of medical devices. If e/m-health solutions are to thrive and maximize the welfare of European citizens, data should be allowed to flow freely across the European market. More open dialogue should be promoted and explicit reference to health data should be made in reference to digital single market agenda. Mobile applications do not have borders, so artificial constraints imposed on the flow of data between different applications and their users represent a serious barrier. Companies are discouraged from entering the market and users are denied the benefits of new applications. Privacy and security regulations must take into account both the need for users to share their data with their practitioners in real time and,the need to prevent misuse of the data. The debate over data privacy and security as preconditions for patient adoption of e/mHealth solutions underestimates the value that patients place on receiving high-quality and cost-efficient healthcare services through the provision of their data. The real issue is not whether or not to share medical data (patients are already doing so through the thousands of apps in the market) or whether or not a practitioner should sign additional forms to access patient data, but rather how to maximize the benefits from data sharing, and how to prevent misuse of data for commercial purposes. e/mHealth also faces serious barriers in relation to medical devices. Within the common European regulatory framework, local certification requirements have been imposed by Member States. The lack of uniform qualification and classification of a medical device across the EU has resulted in a fragmentation of the internal market and significant discrepancies in the time required for medical devices to reach the patients across Member States (see figure 3). The cost of entering the European market rises considerably as a result of this patchy regime, with companies required to comply with 28 different sets of requirements to reach consumers across the Union.

Figure 3: Comparison of time to market in pre-market approval and reimbursement processes for medical devices in different countries Source: Basu & Hassenplug, 2012

European Health Parliament - Electronic/Mobile Health

Another critical issue is the lack of transparency. Many start-ups find it difficult to apply for certification and this is preventing innovation, especially in the apps market. To make the overall regulatory framework more transparent, there should be online desks providing guidance on European regulations. Practitioners should be able to access information about the certification process of an application and receive guidance on issues related to legal liability. A separate fast certification for apps should be created. Online submission and certification would be a start towards helping SMEs, and could allow start-ups to benefit from immediate access to the market of 520 million consumers.

RECOMMENDATIONS: â&#x20AC;˘ Healthcare is evolving towards digital technology, but market access depends on free flow of data and the achievement of a single digital market in the EU. â&#x20AC;˘ Open and transparent dialogue should take place on data privacy and security, as well as to make sure that medical data can be effectively employed to provide high-quality and timely treatment to patients. â&#x20AC;˘ The regulatory environment for medical devices should be transparent and harmonised and should include a new fast certification process for mobile apps.

Electronic/Mobile Health - European Health Parliament

c. mHealth awareness among patients and healthcare practitioners To guarantee integration of mHealth in the health care system, awareness of the potential, quality and reliability of mHealth tools is needed amongst the target population, notably patients, physicians and healthcare institutions. Since the number of medical apps is increasing, actions should be envisaged to professionals (physicians and healthcare institutions) and patients. Physicians have shown reluctance over the use of mHealth apps among their patients. Recent studies suggest that, contrary to expectations, the phenomenon is present across generations (PWC, 2014, p. 10). Insufficient digital skills among older professionals could be overcome as technology becomes more pervasive. But more effort is required to overcome the unwillingness of professionals to change their work practices because of their fear of reducing their productivity, adding costs[5 ](Accenture, 2012, p. 8) or empowering patients (increasing control on doctorsâ&#x20AC;&#x2122; performance). As shown in picture 4, physicians would benefit from mHealth tools to improve the quality of service and ensure easier access to care. To guarantee integration of mHealth into the healthcare system, decision makers should involve healthcare professionals in the process, and reorganise healthcare management at national level: common guidelines should be developed at EU level to define principles of interoperability of healthcare services among member states.

WHAT WOULD SPUR DOCTOR ADOPTION OF MHEALTH 36%

Improved quality of care/better health outcomes

32%

Easier acces to care for existing patients

32%

Reduction in administrative time for medical personnel, allowing greater time for patients

29%

More efficient internal processes/communication

28%

Ability to reach previously unreachable patients

26%

Patient expectations/demand

25%

Lower overall cost of care for patients

17%

Opportunity to provide new services/tap into new markets

16%

Ubiquity of smartphones and applications in all areas of life

14%

Encouragement by regulators

13%

Expectation/demand of medical personnel or employees

Source: Economist Intelligence Unit, 2012

Source: Basu & Hassenplug, 2012

European Health Parliament - Electronic/Mobile Health

Figure 4: Comparison of time to market in pre-market approval and reimbursement processes for medical devices in different countries

Awareness raising among patients is also needed, and inequality must be countered in the use of electronic devices and the internet, due to geographical, economic and social reasons, whether this is the lack of internet connection in remote areas or the unwillingness of old people to change their habits. Collaboration between the public and the private sector could improve internet connection, ensure free wifi in public areas, promote the market of new technologies and improve IT literacy: the private sector is interested in expanding access to - and hence the market for - new IT tools. But guidelines and regulations of the digital market should be enforced at EU level. Collaboration between governments and the private sector could promote targeted campaigns among the population with the aim to boost patients to use mHealth tools and build trust in these new technologies. Another barrier is linked to concerns over inadequate data protection: personal information could be used by private companies (such as insurances, employers, etc.) for commercial purposes, or medical databases could be hacked and information sold. This complex issue, closely connected to the collection and storage of big data, is dealt with in more depth in the paper on Big Data in this publication. Patients’ awareness could be raised by: I. Specific computers/”automatic teller machines” in pharmacies where patients could access mHealth apps and devices for online consultations, booking medical appointments, specific analyses, or updating of medical data. Pharmacists could support customers unfamiliar with the technology. II. National campaigns with mobile exhibitions showcasing the opportunities of mHealth and making people familiar with these new technologies. Apps or add-on devices that can diagnose/ monitor diseases such as diabetes could be displayed, with staff on hand to demonstrate them, provide on-the-spot free consultations, and suggest specific training for people suffering from the disease. Technology can help self-management of chronic diseases such as diabetes through patient education, problem solving, and disease monitoring. A person newly diagnosed with diabetes must learn approximately 150 different tasks to achieve disease self-management – more than can be learnt during a brief hospital stay or a brief educational session, but attainable with remote professional support and monitoring.

RECOMMENDATIONS: • Launch targeted actions for awareness-raising: specific initiatives should be foreseen to increase healthcare professionals’ willingness to use and promote the use of mHealth as well as to reach patients. More and better information would permit patients to use mHealth apps safely and effectively without privacy concerns. > Develop EU guidelines for healthcare management reorganisation. > Involve healthcare professionals in healthcare reorganisation. > Provide patients with tools to benefit from mHealth (e.g. “the Pharmacy initiative”). > Organise awareness raising campaigns for patients.

Electronic/Mobile Health - European Health Parliament

Physicians and Clinical management: a case study Patient background • John is a 55 year-old Caucasian man with diabetes and asthma. He is a civil servant, working at the European Commission in Brussels; his office is 15 minutes by car from his home. He was diagnosed with type 2 diabetes three years ago on blood tests, performed when he received his annual check-up at work. At the time, he was obese, weighing 120 kilos for 1,78m (BMI = 37,8). • He stopped smoking for the 2000 New Year’s Eve and, drinks some Belgian beers from time to time with colleagues. He lost 15 kilos with a strict diet and daily exercise, going to work on foot (1h/day). He also started metformin treatment and his glucose blood levels declined within 6 months. • Last spring, his asthma worsened due to allergies to pollen and air pollution in the area around his office. Exercise has been less regular, and he has attended numerous family gatherings. He has gained 20 kilos and his glucose blood level has increased dramatically. After the occurrence of a foot ulcer and an e-consultation via Skype, his new physician, Dr. Mary, specialised in diabetology at CHU Brugmann, decided to hospitalize John as an emergency and to switch to insulin treatment to quickly balance his glycemia before irreversible clinical scarrings. Clinical examination Dr. Mary starts to examine John. John gets questioned about his pathology and refers to the website Doctissimo (any other ‘medical’ website for the public). Dr. Mary answers John’s questions but prefers to be narrower, using PubMed, the famous medical search engine. Electronic devices present in John’s bed at the hospital allow monitoring of weight, blood pressure, glycemia, heart beats, temperature. If there is any problem, Dr. Mary receives notification on her mobile phone and can discuss with the nurses, if she’s not around. Hospitalization John’s foot ulcer is clinically managed by nurses, but electronically monitored by a device which sends the temperature, moisture level, blood pressure and bacteria flora to the biological laboratory. The results are available on the physician’s mobile app, when she visits John in the unit later. Self-Management After discharge, John needs to monitor his glucose levels three or four times a day. He uses the Finger Print Test to check if he is in hypo- or hyperglycemia. All the data are collected, and his physical activity is recorded via his mobile phone and specialised apps like iRunner. His diet is adapted each day depending of his glycemia, and sent automatically by the app developed by chef Jamie Oliver. If John has new questions about diabetes self-management, he can stay in touch with Dr. Mary via Skype >> This scenario gives a simple picture of a patient’s interaction with the healthcare system. It outlines the key moments at which patient/practitioner interaction takes place and outlines some of the applications and information technology tools that may be used by the patient and the practitioner in the course of the patient’s journey through the system. The scenario shows the use of administrative and, clinical tools and shows how practitioners can guide patients in successful and critical use of the internet in order to support and empower themselves.

European Health Parliament - Electronic/Mobile Health

d. The question of reimbursement A major obstacle to the development of mHealth services is the lack of an appropriate reimbursement model. Healthcare clinics are reluctant to use m-health services. The European Commission report says mHealth services are not reimbursed in the Member States. European governments do not allocate budgets for telemedicine (Mobile Health Global, 2015). Further, clinics and doctors are often afraid to lose revenue if their patients pay them fewer visits. As a result, there is little or no incentive for a doctor to offer remote care via the internet or to use mHealth digital tools.

What are the reimbursement solutions for mHealth in the EU? The creation of a specific budget for mHealth in the Member States could help. The first step to create a playing-field for mHealth is to provide a fund for mHealth in every Member State. This fund should not be on a case-by-case basis to allocate funds for mHealth projects but be a real tool for reimbursement. It would be justified because mHealth saves money for the Member States and the healthcare sector in general. But mHealth does not fit easily into every national reimbursement model. For instance, in Denmark, the reimbursement model is not based on the number of medical acts performed but on the number of patients. Each hospital benefits from a flat fee per patient negotiated with the health minister. This system gives a significant economic freedom to the hospitals. Their aim has been to keep the same access to health while reducing the costs by 20%. This model is an incentive to modern approaches and innovation. Further, it has considerably boosted the use of mHealth by the hospitals to remotely monitor patientsâ&#x20AC;&#x2122; health and thereby save expensive bed days. It could also be a good way to fight physiciansâ&#x20AC;&#x2122; reluctance to apply mHealth in their daily practices. mHealth is a turning point in the healthcare sector for several reasons. Partly because it is an upsidedown approach. Before mHealth, reimbursement models were based on the number of assessments per patient performed by a physician. In addition, the reimbursement scheme was established by the national healthcare system and applied top-down. Clinics, physicians and patients had no influence on the reimbursement level applied. mHealth significantly changed this approach into a bottom-up approach. mHealth empowers patients to take control over their own health (through self-care) and manage their own disease with remote support from their healthcare practitioner. This results in less need for physical assessments and more virtual/digital support. The healthcare sector needs to learn to deal with mHealth driven by patientâ&#x20AC;&#x2122;s demand, no longer imposing care top-down. Traditional reimbursement schemes cannot apply to mHealth as it drives the change from a performance-based to a quality-based healthcare system. For instance, tele-monitoring is a significant time and cost saving, since a patient does not need to pay the trip to the doctor or to take a half-day off work. Firms and insurance companies will save some costs as well, if their workers or clients do not need to spend as many days in hospitals or if their health condition is better monitored. It is the time to think about a new innovative business model in the healthcare and to think who actually benefits from the added value of mHealth. The Member State does not need to be the only fund provider but collaborate with relevant stakeholders, as reimbursement is a key factor in the distribution of mHealth services over the EU. Insurance companies are taking a bigger role in funding digital health companies and in reimbursing their solutions (Mobile Health Global, 2015). Moreover, reimbursement should not focus on smartphones as a delivery tool for mHealth, but should include other devices - personal digital assistants, smart watches and other body-worn devices or implants (Mobile Health Global, 2015).

Electronic/Mobile Health - European Health Parliament

PwC and GSMA predict that global mHealth revenues will increase over the next years. The market opportunity for mHealth is promising. But reimbursement models are largely dependent on patient involvement and a gradual evolution of healthcare models (PWC, 2013, p. 1). The solution for mHealth depends on involving society more widely: physicians, patients, employers and payers, with the goal of improving the quality of the healthcare system in the EU (Harbaugh, 2009, p. 9).

RECOMMENDATIONS: • Offer financial support for the development of necessary infrastructures in the creation of reimbursement models. • Create an earmarked reimbursement fund for mHealth to enhance physicians’ and patients’ use of mHealth and to encourage industries to develop new mHealth tools. • mHealth tools may be applied to disease prevention and disease management. In both cases, quality of life may be improved and need reduced for costly medical assessments, while still providing high-quality care. Current reimbursement models based on fee-per-performance and number of assessments performed do not apply to mHealth. Patient and physician reimbursement models for the use of mHealth tools should be based on capacity for disease prevention, quality, and reduction of healthcare costs.

European Health Parliament - Electronic/Mobile Health

IV. OVERVIEW OF RECOMMENDATIONS KEY RECOMMENDATION: MHEALTH INTEGRATION INTO THE HEALTHCARE SYSTEM • The private sector has already recognised the game-changing potential of e-/m-health solutions and the lack of regulatory harmonisation is not preventing it from bringing substantial changes in the way our healthcare system is working. These innovations have more to do with digital solutions than traditional health care services and therefore the EU is a key player in ensuring that these solutions thrive within the European single market. • The EU approach towards e-/m-Health should go beyond the necessary technical regulatory harmonization and promote a holistic approach which embraces the entire journey of these innovations, from laboratory research until final uptake by physicians.

a. Research and Development and Innovation • Based on an IMI-type structure, an EU strategic platform dedicated to digital health that would gather all the stakeholders could be launched • The patients’ and healthcare professionals’ perspective should be taken into account at the beginning of Research and Innovation. “User-friendly” and “User-centricity” should be the motto of all mHealth solution.

b. Market Access • Healthcare is evolving towards a digitised sector and therefore market access relies on free flow of data and the achievement of a truly single digital market in the EU. • For this to happen, it is crucial to engage in an open and transparent dialogue on data privacy and security, as well as to make sure that medical data can be effectively employed to provide high-quality and timely treatment to patients. • A transparent and harmonised regulatory environment for medical devices will be essential and should include a new fast certification process for mobile apps.

Electronic/Mobile Health - European Health Parliament

c. mHealth awareness among patients and healthcare practitioners • Launch targeted actions for awareness-raising: specific initiatives should be foreseen to increase healthcare professionals’ willingness to use and promote the use of mHealth as well as further steps to reach patients. More and better information would let patients use mHealth apps safely and effectively without privacy concerns. > Develop EU guidelines for healthcare management reorganization. > Involve healthcare professionals in the healthcare reorganization process. > Provide patients with useful tools to benefit from mHealth (e.g. “the Pharmacy initiative”). > Organize campaigns of patients awareness raising.

d. Reimbursement • Offer financial support for the development of necessary infrastructures in the creation of reimbursement models. • Create an earmarked reimbursement fund for mHealth to enhance physicians’ and patients’ use of mHealth and to encourage industries to develop and produce new mHealth tools. • mHealth tools may be applied for disease prevention and disease management. In both cases quality of life of people and patients may be affected resulting in less need for costly medical assessments, while still providing high-quality care. As a consequence the current reimbursement models based on fee-per-performance (number of assessments performed) do not apply to mHealth. Patient and physician reimbursement models for the use of mHealth tools should be based on their ability to prevent disease and provide quality, resulting in overall reduction of healthcare costs.

European Health Parliament - Electronic/Mobile Health

V. CONCLUSION mHealth has the obvious potential to revolutionize the current healthcare systems and the way we think about health in general, creating a mind-shift from treatment to prevention over the long-term. Its breakthrough however is being hampered by the failure to integrate these new tools into the current overall healthcare process. EU policy-makers cannot anymore hide behind the Article 168 of the Treaty on the Functioning of the European Union which states that health policy is a national competence and the EU can only complement the Member Statesâ&#x20AC;&#x2122; initiatives. By definition, mHealth demands a single digital market and therefore the only appropriate approach to unleash its potential is at European level. The momentum is here for an ambitious European strategy that will enable Member States to define a roadmap towards a sustainable digitally-driven healthcare system.

Electronic/Mobile Health - European Health Parliament

VI. REFERENCES Accenture. (2012). Connected Health: The Drive to Integrated Healthcare Delivery. Accenture. Advance Healthcare Network. (2014, February 07). Integrating mHealth into Healthcare: What’s the Solution? Retrieved May 2015, from Executive Insight: https://healthcare-executive-insight. advanceweb.com/Columns/mHealth/Integrating-mHealth-into-Healthcare-Whats-the-Solution.aspx Apple Helathkit. (n.d.). Retrieved May 2015, from http://www.applehealthkit.com/ Barr, A. (2014, December 15). Google Ventures Shifts Focus to Health Care. Retrieved May 2015, from Wall Street Journal: http://blogs.wsj.com/digits/2014/12/15/google-ventures-shifts-focus-to-healthcare/ Basu, S., & Hassenplug, J. C. (2012). Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes. The New England Journal of Medicine , 485-488. comScore Mobiliens. (2013, February). The Impact of Connected Devices on Consumer Behaviour. Retrieved May 2015, from http://www.gsma.com/spectrum/wp-content/uploads/2013/03/ comScore_The-Impact-of-Connected-Devices-on-Consumer-Behaviour.pdf eMarketer. (2014). 2 Billion Consumers WOrldwide Smartphones by 2016. Retrieved May 2015, from eMarketer: http://www.emarketer.com/Article/2-Billion-Consumers-Worldwide-Smartphones-by-2016/1011694 European Commission. (2014). Green Paper on Mobile Health. Brussels: EC. Farr, C. (2015, February 05). Exclusive: Apple’s health tech takes early lead among top hospitals. Retrieved May 2015, from Reuters: http://www.reuters.com/article/2015/02/05/us-apple-hospitals-exclusive-idUSKBN0L90G920150205 Harbaugh, N. C. (2009). Pay For Performance: Quality and Value Baed Reimbursement. Mobile Health Global. (2015, January 05). Interoperability, Clinical Evidence And Reimbursement, Necessary For Mhealth To Move Forward. Retrieved May 2015, from Mobile Health Global: http://www.mobilehealthglobal.com/in-the-news/news/126/interoperability-clinical-evidence-andreimbursement-necessary-for-mhealth-to-move-forward PWC. (2014). Emerging mHealth:Paths for growth. PWC. PWC. (2013). mHelath Insignhts: The global mHealth market opportunity and sustainable reimbursement models. PWC. PWC. (2012). Touching Lives through Mobile Health: Assessment of the Global Market Opportunity. PWC. WHO. (2012). BCG Report - The Socioeconomic Impact of Mobile Heatlh.

European Health Parliament - Electronic/Mobile Health

PATIENT EMPOWERMENT AND CENTREDNESS

Authors Cynthia Bonsignore Elena Brolis Alexandra Ionescu Valeria Karusinova Zornitsa Mitkova Filip Raps Vilde Renman Nina Ricci Fedotova

Executive summary There is a widespread consensus that empowering patients is good for healthcare systems. Empowerment is increasingly recognised as an essential element of future high-quality, patientcentred healthcare systems with regard to tackling the expanding burden of chronic diseases. Patients are expected to take more control over their illnesses or treatments where possible, and doctors are expected to encourage or ‘empower’ them to do so. But how do we translate this into reality at all levels (i.e. individual, organisational, and national)? The Patient Empowerment and Centredness Committee call for the adoption of a Pan-European framework to ensure that patient empowerment is a top priority for Europe’s healthcare systems and contributes to improved healthcare across Europe’s national realities. Achieving patient-centredness is a key enabler in the process of creating sustainable and equitable systems for all. A concrete action plan on health literacy and information to patients relating to all aspects of health is needed. Although empowerment is much more than education, the right information and resources are fundamental tools for enabling patients to become equal partners in the team managing their health. The informed patient also needs a counterpart: the health professional who creates the right environment to enable patients’ active participation in the decision-making process. There is clearly a need for targeted education of health professionals to build the skillset needed to effectively communicate with empowered patients, and to provide advice to less empowered patients on how they can take a more active part in the management of their condition. This strategy should embed patient involvement at every level of the health system. This involves supporting the active participation of citizens with chronic diseases in their own care, but also in policymaking and in designing future care delivery systems.

Patient Empowerment and Centredness - European Health Parliament

I. INTRODUCTION This Committee focuses on patient empowerment and centredness as it believes that approaching healthcare provision with a focus on creating patient-relevant outcomes is necessary, and is more likely to guarantee its sustainability and effectiveness. It is time for patient empowerment and centredness to become part of the strategy for achieving quality healthcare systems. Patients are increasingly willing to learn about what is happening to them and to take an active role in the management of their own care. Consequently, healthcare professionals are dealing with more informed patients who want to have their say in the decisionmaking process that affects their health and treatment options. Some health professionals or decision-makers may be reluctant to enter into patient-centred healthcare, wary that empowered patients will represent a burden rather than a solution.

Definitions Empowerment can be seen as a multidimensional process that helps people gain control of their lives, increasing their capacity to act on issues that they themselves define as important (Luttrell, 2009). The Patient Empowerment and Centredness Committee defines empowered patients as people who: • have the necessary knowledge, skills, attitudes and self-awareness about their condition to understand their lifestyle and treatment options and make informed choices about their health; • have the capacity to become ‘co-managers’ of their condition in partnership with healthcare professionals, with the aim of managing their condition when necessary and also to the extent they wish to do so, because choosing to not be empowered is also considered as a form of patient empowerment; • have control over the management of their condition in their daily life; • ideally, have the capacity to develop the self-confidence, self-esteem and coping skills needed to manage the physical, emotional and social impacts of their disease or condition in everyday life.

European Health Parliament - Patient Empowerment and Centredness

The Patient Empowerment and Centredness Committee defines a patient-centred approach as one that: • places the outcomes, interests and overall experience of patients at the centre of the healthcare system; • takes into account patients’ medical needs, together with their social and psychological needs, as well as lifestyle preferences; • requires healthcare professionals to have the knowledge, skills and attitudes to manage each patient’s individual needs; • gives the patients a place at the ‘decision-making’ table alongside healthcare professionals, health stakeholders and policy-makers. Current research describes patient empowerment as a necessary process towards a patient-centred system that can improve patients’ outcomes during their treatment (Robbins & Curro, 2013).

Scope The Committee decided to limit the scope of the paper in order to avoid duplicating the work of other European Health Parliament Committees, while being mindful that patient empowerment and centredness are relevant across the entire spectrum of healthcare topics. Challenges facing modern healthcare systems include the demographic shift, increasing costs of treatments, limited access to innovative care, intra-European differences and lifestyle trends. Empowerment and involvement of individuals should take place continuously, to allow people to make decisions concerning their lifestyle and treatment of their conditions or diseases. This paper will focus on the situation for people diagnosed with a chronic condition, but without focusing on a specific illness, age group or gender (WHO, 2002), but concentrating on care delivery and the related patient experience in the post-diagnosis period.

Patient Empowerment and Centredness - European Health Parliament

II. CURRENT SITUATION Citizens’ right to healthcare is enshrined in the European Charter of Fundamental Rights (OJEC, 2000), as well as in international declarations (Nations) where empowerment is a core value. Healthcare provision is increasingly patient-centred, with the patient becoming an active subject rather than a mere recipient of healthcare. In promoting patient empowerment, some countries have run multiple awareness-raising campaigns and even introduced laws on the matter. The French Act of 2 March 2002 called for a ‘‘health democracy’’ in which patients’ rights and responsibilities are revisited, giving patients an opportunity to take control of their own health. Since 2005, the European Commission has repeatedly invoked patients’ rights in cooperation with health stakeholders. Some health and patient associations have also followed the path of patient empowerment through different Bills of Rights or Declarations (Laur, 2013). The Committee has also built on some aspects of the EMPATHiE study report on “Empowering patients in the management of chronic diseases” published by the European Commission in March 2015 (EMPATHIE, 2015). The Committee provides recommendations around three main enablers of patient centredness and empowerment: information to patients, patient involvement, and the relationship between healthcare professionals and patients.

Information to Patients A key component of patient empowerment and centredness is patients’ access to accurate and highquality information about their disease and the treatment options available to them. This is commonly defined as health literacy, which entails “people’s knowledge, motivation and competencies to access, understand, appraise and apply health information in order to make judgments and take decisions in everyday life concerning healthcare […] (EMPATHIE, 2015).” Overall, health literate individuals tend to exhibit healthier behaviours that lead to a higher state of wellbeing, increased life expectancy, and lower chances of developing a chronic disease than people who are less health-literate (Sorensen, 2012). The European Commission is promoting patient access adequate information about diseases and treatments, but so far mainly linked to transparency and research and innovation in relation to medicinal products, (see Directive 2001/83/EC and Directive 2001/83/EC). ’Information to patients’ is included in legislation or recommendations, but is not the subject of separate treatment.

European Health Parliament - Patient Empowerment and Centredness

Today, a vast amount of health information is available online, but patients need to know where to find reliable information from trustworthy sources. The European Commission’s recent paper on Digital Health Literacy focused on the use of the Internet to search for health-related information. The EU eHealth Action Plan 2012-2020 – Innovative Healthcare for the 21st Century also looks at how greater access to services and information and the use of social media for health can strengthen patientcentred care and empowerment. The EU institutions have initiated non-legislative health measures that touch upon information to patients, notably the 2009 Council Recommendation on Patient Safety, which states that patients should be informed and involved in the patient-safety process and have access to objective and understandable information about the risk of infections on the premises of a healthcare delivery organisation. Between 2005 and 2008, the ministerial “High Level Pharmaceutical Forum” concluded that information to patients should be of higher quality and that existing partnerships and collaborations between various partners should be strengthened. The latest legislation linked to information to patients is the Cross-Border Health Directive on the application of patients’ rights in cross-border healthcare (2011/24/EU) that entered into force on 25 October 2013. This requires Member States to set up National Contact Points (NCPs) responsible for providing patients with information on their rights in cross-border healthcare provision. Unfortunately this has still not been implemented across all Member States, where it has, the information is not always complete or in line with patients’ expectations or needs, suffering from non-functioning web links or contact only by telephone. Other initiatives highlight the importance of informed patients. Health information for patients and the general public - a 2008/2009 review by the World Health Organization - evaluates evidence-based “encyclopaedia” for patients and the general public developed by the German Institute for Quality and Efficiency in Healthcare.

Patient Empowerment and Centredness - European Health Parliament

Patient - Healthcare Professional Relationship The relationship between a healthcare professional and a patient is multi-faceted, going far beyond medical expertise about the disease. It is crucial in providing patients with a better healthcare experience. Continuity of care, integration of care and shared decision-making are three key aspects of this relationship. Continuity of care encompasses the ability of a patient to form a therapeutic relationship with a doctor through a series of consultations, and the level of centralised coordination, collaboration and follow-up when the patient has contact with multiple care providers (Freeman, 2010). A large body of research suggests that continuity is a determinant of positive patient experience, better patient outcomes and lower costs for the healthcare system (Freeman, 2010); (Ovretei, 2012) (The King’s Fund, 2010); (J R Soc Med., 2003). Some non-harmonised practices in Member States are successful examples of driving continuity of care. In the Netherlands and Denmark, nurses and general practitioners are responsible for managing and coordinating multidisciplinary teams providing care to chronic patients; healthcare strategies in Sweden and Finland have re-defined the role of Advanced Nurse Practitioners, who are effectively assuming many of the responsibilities of physicians, offering increased access to primary care, earlier intervention possibilities and a bettercoordinated flow of healthcare (Federation, 2010). In Germany and Ireland there is a focus on early diagnosis of chronic diseases and on post-hospitalisation remote monitoring through a general practitioner or specific agencies (ESG, 2015). Integration of care provides a holistic perspective of the relationship between patients and healthcare professionals, based on the needs of each individual. It avoids duplication and gaps in service delivery and eliminates confusion among patients receiving care from several healthcare practitioners – as is often the case for people living with chronic diseases with complex needs and receiving social-service and community-care support. Supporting self-management can also help make care more efficient and optimise the relationship between healthcare providers and patients. Shared decision-making means allowing patients and healthcare professionals to make healthcare decisions together, more in line with patients’ preferences and values. Shared decision-making increases patient engagement and knowledge, diminishes anxiety related to the care process, improves health outcomes, and reduces unwarranted variations in care (ESG, 2015). Different models of the patient-healthcare professional relationship have been identified. Working in partnership and dialogue provides the most added value. With an increasing experience level of the patient, shared decision-making helps align the doctor’s interest in treatment and the patient’s preferences and expectations (Bieber, et al., 2006).

European Health Parliament - Patient Empowerment and Centredness

This model may need to be revisited to include a team-based approach, reflecting the way the patient is connected to other professionals in the health and social sectors.

MOVE TO

Figure 1 Physician-Patient Relationship Models

Patient Empowerment and Centredness - European Health Parliament

Patient Involvement The concept of patient empowerment is often equated with patient involvement, but although closely interrelated, these two concepts are not exactly the same (Holmström, 2010) (EPF, 2012). The Committee defines patient empowerment as a necessary process on the road to patient involvement to achieve a patient-centred healthcare system. Published models of patient empowerment have stated the need for patient involvement and participation (EPF, 2012). Patient involvement is based on the premise that patients are in a position to have specific expertise derived from living with a disease or condition, and this represents a valuable source of knowledge: • At individual level, patients, their families and caregivers take part in decisions about to their healthcare (e.g. through shared decision-making or self-management); • Patients or their representatives participate at provider-level (e.g. in hospitals) using their specific experiences with learning and educational tools in order to design better services; • At the highest (or policy) level, through their representative organisations, patients can offer guidance to decision-makers on quality care that is also cost-effective, and can therefore contribute to the debate for re-shaping healthcare systems. Not all patients choose to become involved at all levels. Research has shown a positive trend in involvement in the last decade, when less than 50% wished to be involved in decision-making, ( (Elwyn, et al., 2003) (Schneider, 1998) (Benbassat & Pilpel, 1998) (Guadagnoli, 1998)). The desire for involvement varies between social groups., Younger and better-educated people are more likely to want to play an active role. However, many older people and people from disadvantaged groups also want to play an active role in decisions about their care, and clinicians should encourage people to participate. Making this choice itself can already be a form of patient empowerment (Coulter & Collins, 2011). The main barriers for implementing patient involvement can be summarized as follows (Qual, 2012): • Communication is key but the time needed to communicate effectively can be an issue; • Resourcing and asset requirements for achieving patient involvement; • General lack of recognition by healthcare professionals of patients’ expertise and ability to contribute; • Power imbalances and attitudes between qualified professionals and the (perceived) lack of scientific/medical knowledge among patients. Over the years, patient groups have been giving individual patients a stronger voice. They are also involved in disease education for patients and healthcare professionals by providing helplines, emotional support, information, access to treatment and generally fighting for patients’ rights. And they conduct advocacy discussions about the healthcare system. The European Medicines Agency (EMA) is committed to working closely with patients and other stakeholders. It involves them in many areas of its work (Human Scientific Committees, Patients’ and Consumers’ Working Party), a practice which is now well established under the “EMA Framework for interaction with patients and consumer organisations”. Patients’ organisations and pharmaceutical companies also work together in discussions over EU policies where they have a common agenda. The European Federation of Pharmaceutical Industries and Associations engages in dialogues known as ‘Patients-MedTech’, which are examples of some of the constructive exchange platforms that have been set up. Their aim is to foster transparent and ethical exchanges of information and to help patients to speak with an independent voice.

European Health Parliament - Patient Empowerment and Centredness

III. TOOLBOX OF SOLUTIONS FOR PATIENT EMPOWERMENT AND PATIENT CENTREDNESS

ENSURING THAT THE FUNDAMENTAL PRINCIPLES OF PATIENT EMPOWERMENT AND CENTREDNESS ARE EMBEDDED INTO AN EU FRAMEWORK • The Committee acknowledges that there is currently no EU strategy on patient empowerment and centredness, despite the recognised benefits patient-centered health systems provide (IAPO, 2015). The Committee calls upon decision-makers to adopt a European framework to ensure that patient empowerment becomes a reality and contributes to improved healthcare across Europe’s national systems. This will guarantee that patient-centredness becomes a principle guiding policy-makers when creating sustainable and equitable systems for all. • The Committee urges the European institutions to play a coordination role and look into how gaps in healthcare provision across EU Member States can be bridged. The Committee endorses the recommendation for EU-level cooperation on patient empowerment made by the EMPATHiE research project of the European Commission in 2015. The EU institutions should play a coordination role in fostering national initiatives on patient empowerment and centredness in accordance with the subsidiarity principle. • The Committee further recommends that the EU institutions ensure that Member States comply with the basic principles of patient empowerment and centredness.

DEVELOP A QUALITY CARE STANDARD FRAMEWORK AND INDICATORS ON PATIENT EMPOWERMENT AND CENTREDNESS TO ASSESS THE STATUS AT NATIONAL LEVEL • The Committee draws attention to the fact that measuring patient empowerment and patientcentredness is possible only if common standards are developed, such as ISO or QISMET (QISMET, 2015). A recent European report discussed the importance of measuring, evaluating and comparing the quality of health care systems at EU level to promote accountability, to inform effective policy development, and to help health care providers learning from each another. It said the proposed common understanding of such quality statements should take into account the following dimensions: safety, clinical outcomes and patient involvement (European Commission, 9 October 2014). • As such standards need to be created by a panel of experts within a technical committee, the Committee further suggests working with the Directorate-General for Health and Consumers or the Scientific Committee on Emerging and Newly Identified Health Risks on developing a common measurement across the Member States for its institutions delivering health care. The Committee recommends a two-fold standard for patients and health professionals, outlining rights and responsibilities at national level. Also suggested is the development of the Health Systems Performance Assessment (HSPA) that includes quality of care and patient safety, and a common and comprehensive set of indicators as a basis for measurement (European Commission, 9 October 2014).

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Information to Patients DEVELOPMENT OF AN EU ACTION PLAN ON HEALTH LITERACY AND INFORMATION TO PATIENTS THAT COMPRISES INCENTIVES AND A FRAMEWORK TO ADOPT NATIONAL HEALTH INFORMATION PLAN • The Committee suggests, when adopting an EU strategy on patient empowerment and centredness, the inclusion of an action plan on health literacy and high quality information for all citizens, spanning many aspects of care-provision. • The Committee requests social and economic incentives to boost health literacy with the support of patient organisations. The European Health Literacy Survey (HLS-EU) found that 11.83% of respondents had inadequate health literacy and that on average nearly every second person participating in the survey had limited health literacy. Moreover, good health literacy also has the potential to provide financial benefits to healthcare systems. A Canadian study showed that 3-5% of healthcare spending arises from limited healthcare literacy; this money could be spent on empowering and informing patients (WHO, Health Literacy: The Solid Facts, 2013). • The Committee calls upon the EU institutions to encourage Member States to adopt a national health information action plan to provide information about health, prevention, empowerment and patient-centredness. This could be done through: • National public health campaigns and seminars, workshops and training sessions, starting with schools. When diagnosed with a chronic disease, patients only see their doctor once in a while and need to self-manage the rest of the time without having ever been given adequate advice. These patients might feel less discriminated against or intimidated by their condition if the public in general were more aware of the challenges that their conditions pose. • A broader information network, website, or platform could be launched where patients could access all kinds of relevant health information (e.g. about different diseases and different treatment options). • The Committee encourages EU institutions to widen the scope of legislative and non-legislative measures related to information to patients so that they cover a wider range than merely information about medicines or patients’ rights. • The Committee suggests that the European Commission should play a coordination role after legislation is adopted and implemented at national level to ensure that patients and the public at large are aware of changes to their rights. In 2013-2015, the European Patients’ Forum (EPF) organised a series of regional conferences in collaboration with the European Commission to encourage national patients’ groups to make full use of the opportunities afforded to them by the Cross-Border Healthcare Directive. The outcome of these conferences will feed into the European Commission’s report and a major event has been scheduled for July 2015.

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Patient - Healthcare Professional Relationship GENERAL RECOMMENDATIONS • The Committee calls for the creation of a framework including qualitative and quantitative criteria for measuring different aspects of an improved patient-healthcare professional relationship, taking into account the patient perspective, in order to define steps to be taken by healthcare providers. • The Committee calls upon the European institutions to set up a system for providing training to healthcare professionals, based on an approach encompassing patient empowerment and centredness. These aspects should be included in Continuous Professional Development, to ensure consistent communication so that the workforce is capable of addressing these issues adequately. This training should equip healthcare professionals with the tools and techniques needed (e.g. motivational interviews) to communicate effectively with empowered patients.

CONTINUITY OF CARE AND SELF-MANAGEMENT • The Committee acknowledges that despite positive developments in continuity of care in many Member States, there is still a need for specific actionable information regarding the implications for, and expectations from, patients and healthcare professionals in co-promoting and improving continuity of care. • The Committee calls on the EU institutions to support access to quality and evidence-based programmes so that citizens can develop the confidence, knowledge and skills to actively manage their health. Although different conditions require different approaches, supporting self-management can alleviate the pressure on health and social services caused by workforce shortages, rising demand for services, demographic change and budgetary constraints.

INTEGRATED CARE • The Committee recommends support for local initiatives that can help identify the most effective interventions for developing patient centredness in an integrated health delivery model. Since there cannot be a single definitive model of integrated care applicable to all national healthcare systems , more evidence is needed of what does and does not work well in each system. National healthcare systems should collect data from healthcare providers to identify where integrated care and better relationships with patients have the most impact in improving outcomes, and what barriers, either institutional or structural, discourage change. Providing administrative guidance, tools and incentives for further expansion can help countries and regions lagging behind to develop working solutions based on local needs.

Patient Empowerment and Centredness - European Health Parliament

SHARED DECISION-MAKING • The Committee recommends leveraging currently available tools for shared decision-making in establishing an EU framework. Establishing and reporting principles of shared decisionmaking, can help healthcare systems at national level evaluate the quality of treatment provided. • The Committee further proposes the implementation of training programs for healthcare professionals and patients in the principles of shared decision-making. These could increase the efficiency and effectiveness of interactions between patients, their families and healthcare professionals.

Patient Involvement • The Committee urges the European institutions to enhance awareness of the patient’s contribution. There are still power imbalances in the attitudes relating to qualified professionals and those sitting opposite them. Such differences in attitudes could be overcome with specific coaching of secondary support (e.g. nurse, home caregiver). The skills acquired could be translated into validated certified programs, supporting patients in achieving a balance when communicating with healthcare professionals or researchers. Using a disease-specific questionnaire during a coaching session (online when available), the patient would be better able to express the wish to be involved. This information would be valuable for the healthcare provider in reviewing and evaluating current treatment success, willingness to self-manage, and even negative experiences. • The Committee recommends further exploration of existing tools and principles such as OPTION (Observing Patient Involvement) to support higher levels of patient involvement in decision-making and coaching, as these have experienced barriers to implementation in today’s healthcare systems.

PATIENT INVOLVEMENT IN REGULATORY MATTERS • The Committee calls on EU decision-makers to create a framework for a regulatory process that ensures patients are involved in healthcare research and policy-making. Initiatives in place already (IMI, EUPATI) represent steps towards European patient involvement, but harmonisation is still missing. • There no adequate structure where patients’ experiences can be exchanged between countries. To remedy this, the Committee recommends involving patients in ethics committees on a constant basis, to provide a common framework for interaction. • The Committee also emphasises that patient organisations representing individual patients require assets and means to function. Sustainable financial viability (not depending on year-onyear financial support) would reinforce the credibility and independence of patients’ coalitions.

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IV. CONCLUSIONS Patient empowerment and centredness are necessary on all levels to build high quality and sustainable European healthcare systems. Achieving high levels of patient empowerment and centredness requires a complete shift in mindset over healthcare design and delivery. It also challenges European healthcare systems, requiring specific strategies, including embedding meaningful patient involvement in every level of every healthcare system. The Committee recognises that this will be no easy task. However, change is needed, as empowered patients have proved to be an enduring force that can have an ever higher impact on healthcare systems. Patients can take more responsibility for their care by collaborating with healthcare professionals, adopting preventive measures, seeking earlier diagnoses, and adhering to treatment. These actions will bear fruit in the long run.

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V. REFERENCES Ajoulat, I., & d’Hoore, W. &. (2006). Patient Empowerment in Theory and Practice: Polysemy or Cacophony. Patient Education and Counceling , doi10.1016/j.pec.2006.09.008. Ajoulat, I., Marcolongo, R., & Bonadiman, L. &. (2008). Reconsidering Patient Empowerment in Chronic Illness: A Critique of Models of Self-Efficacy and Bodily Control. Social Science & Medicine, 66, pp. 1288-1239. Anderson, R. M. (2010). Patient Empowerment: Myths and Misconceptions. Patient Educ Couns., 79(3), pp. 277-282. Anderson, R. M., Funnel, M. M., M, B. P., Arnold, M. S., & Fitzgerald, J. T. (1995). Patient Empowerment: Results of a Randomized Controlled Trial. Diabetes Care, 18(7), pp. 943-949. Benbassat, J., & Pilpel, D. &. (1998). Patients’ preferences for participation in clinical decisionmaking: review of published surveys. Behavioural Medicine, 84, pp. 81-88. Bieber, C., Muller, K. G., Blumenstiel, K., Schneider, A. R., Wilke, S., Hartmann, M., & Eich, W. (2006). Long-term effects of a shared decision making intervention on physician-patient interaction and outcome in fibromyalgia. A qualitative and quantitative 1 year follow-up of a randomized controlled trial. Patient Education and Councseling(63), pp. 357-366. Coulter, A., & Collins, A. (2011). Making Shared Decision-Making a Reality. No decision about me, without me. The King’s Fund. Davis, K., & Schoenbaum, S. C.-M. (2004). A 2020 Vision of Patient-Centered Primary Care. JGIM. Delaney, S. (2014). Walking the Talk in Patient-Centric Pharma. Life Sciences Practice. Delbanco, T., Berwick, D. M., Boufford, J. I., Edgman-Levitan, S., Ollenschläger, G., & Plamping, D. &. (2001). Healthcare in a Land Called People Power: Nothing About Me Without Me. Health Expectations, 4, pp. 144-150. Diabetes Care. (2013, December 11). Retrieved December 12, 2013, from Diabetes Care Johnsone & Johnson: http://diabetescare.jnj.com/Pages/NewsDetail.aspx?nid=320&cat=GCN Elwyn, G., Edwards, A., Wensing, M., Hood, K., Atwell, R., & Groll, C. (2003). Shared Decision Making: Developing the OPTION Scale for Measuring Patient Involvement. Qual Saf Health Care, pp. 93-99. EMPATHIE, H. P. (2015). Empowering patients in the management of chronic diseases. Final Report. EPF. (2012). The Value + Handbook. European Patient’s Forum. Epstein, r. M., Fiscella, K., & Lesser, C. S. (2010). Why The Nation Needs A Policy Push On Patient Centered Health Care. Health Affairs, 29(8), pp. 1489-1495.

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ESG. (2015). Acting together: A Roadmap to Sustainable Healthcare. European Steering Group. European Commission, E. P. (9 October 2014). Future EU Agenda on quality of health care with a special emphasis on patient safety. EXPH Opinion. Federation, E. H. (2010). Chronic Diseases: A clinical and managerial challenge. European Hospital and Healthcare Federation. Freeman, G. a. (2010). Continuity of Care and the patient Experience. The King’s Fund. Groene, O., Lombarts, M., Klazinga, N., Alonso, J., & Thompson, A. &. (2009). Is Patient-Centeedness in European Hospitals Related to Existing Quality Improvement Strategies ? Analysis of a CrossSectional Survey (MARQuIS study). Qual Saf Health Care, 18 (supplement I), pp. i44-i50. Guadagnoli, E. &. (1998). Patient participation in decision-making. Soc Sci Med(47), pp. 329-339. Holmström, I. &. (2010). The Relation Betwen Patient Centeredness and Patient Empowerment: A Discussion on Concepts. Patient Education and Counceling, pp. 167-172. IAPO. (2015). Internationa alliance of patient’s organisations. J R Soc Med. (2003). Towards a theory of continuity of care. Jr Soc Med, 96(4), pp. 160-166. Jorm, C. M., Dunbar, N., & Sudano, L. &. (2009). Should Patient Safety Be More Patient Centered. Australian Health Review, 33(3), pp. 390-399. Laur, A. (2013, September). Patients’ responsibilities for their health. Medico-Legal Journal, 81(3), 119-123. Lee, T. H., & T, C. (2014). Engaging Doctors in the Healthcare Revolution. Harvard Business Review. Luttrell. (2009, November). Understanding and operationalising empowerment, l.-Working Paper 308. Overseas Development Institute. Luxford, K., & Safran, D. G. (2011). Promoting Patient-Centered Care: A Qualitative Study of Facilitators and Barriers in Healthcare Organizations With a Reputation For Improving The Patient Experience. International Journal for Quality in Health Care, 23(5), pp. 510-515. Mancini, J., Genre, D., Dalenc, F., Ferrero, P. K., Martin, A.-L., Roche, H., . . . Gamet, C. &.-R. (n.d.). Patient’s regrets after participating in a randomized controlled trial depended on their involveemnt in the decision making. . Moore, G. (2011, May 26). Hierarchy of Powers Framework. (PR Lear) Retrieved April 18, 2014, from PR Lear: http://pr-lead.com/hierarchy-of-powers-framework-geoffrey-moore-from-mohr-davidowventures/

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Nations, U. (n.d.). UN Universal Declaration of Human Rights the UN International Covenant on Economic, Social and Cultural Rights and the European Convention on Human Rights in Biomedicine. OJEC. (2000). Official Journal of the European Communities. Retrieved from Article 35 on Healthcare (OJC 364, 18.12.2000).: http://www.europarl.europa.eu/charter/pdf/text_en.pdf Ovretei, J. (2012). do changes to patient-provider relationships improve quality and save money ? . The Health Foundation. Porter, M. E. (2013). The Strategy That Will fix Healthcare. Harvard Business Review(October), p. 50. QISMET. (2015). Quality Institute for Self-Management and Training. Retrieved 2015, from http://www.qismet.org.uk/ Qual, E. C.-T. (2012). Patient Involvment; Eurobarometer Qualitative Study. Brussel. Rinchen, P. (2010). Time to Learn: Understanding Patient-Centred Care. British Journal of Nursing, 19(14). Robbins, D. A., & Curro, F. A. (2013). Defining Patient Centricity: Opportunities, Challenges, and Implications for Clinical Care and Research. Therapeutic Innovation & Regulatory Science, 47, p. 349. Schneider, C. (1998). The practice of autonomy: patients, doctors, and medical decisions. New York: Oxford University Press. Shaller, D. (2007). Patient-Centered Care: What Does It Take. The Commonwealth Fund. Sorensen. (2012). Health literacy and public health: A systematic review and integration of definitions and models. BMC Public Health. The Kingâ&#x20AC;&#x2122;s Fund. (2010). How to deliver high-quality, patient-centred, cost-effective care ? WHO. (2002). WHO. (2013). Health Literacy: The Solid Facts.

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ACCESS TO THERAPEUTIC INNOVATION

Authors Magdalena Kalata Raquel Bello Simon Benadiba Ida Fallesen Loic Galmard Shane Mccollam Julien Patris Clara Zachmann

Executive summary There are multiple explanations to inequity on access, multiple views as to what constitutes a priority in healthcare, and multiple perceptions of what qualifies as an innovation. Together among this multiplicity of ideas, there is a clear need for an improved approach to enhance patient access to the best innovation that medical technology has to offer. A first step in connecting the dots is the development of a tool that would assist in identifying and prioritising the areas of health where EU collaboration could be appropriate to reduce health inequalities between and within Member States. The Sub-Committee on Access to Innovative Therapies has developed a â&#x20AC;&#x153;matrixâ&#x20AC;? approach designed to define the level of EU intervention required to enhance the access of innovative therapies across Europe. This tool could be used to assess current and future EU policies or to support the development of an EU budget in the field of health. By assessing the medical unmet need and the access issues, the matrix identifies where national and where European integration on a specific disease area may be most appropriate. Based on this initial research, the further development of improved access for patients and a reduction of unnecessary barriers are envisaged through a three-step approach, including concrete actions at both EU and Member State level. 1. UNDERSTAND: Creation of a European Access Observatory (EAO) to annually assess the uptake of new products and therapeutic alternatives in Member States. 2. MAXIMISE: Leverage valuable EU initiatives to address the existing barriers to access. 3. ANTICIPATE: Development, in collaboration with healthcare stakeholders and policymakers, an EU-level analytical tool to support the prioritisation and decision-making specifically focused on addressing access questions in health policies.

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I. INTRODUCTION Europe’s population of 500 million citizens is ageing rapidly, with the European Commission and the Economic Policy Committee estimating that the demographic burden will increase exponentially over the next three decades. As the working age population is set to decrease by 16%, the elderly population is projected to increase by 77% by 2050 - a change that will require more resources. Job market reform will be needed to ensure sufficient contributions are made into the social protection systems of Member States. Healthcare budgets are under pressure, and high rates of chronic diseases, which swallow 80% of healthcare budgets, demand smarter spending to mitigate the management costs. The sustainability of current approaches is under scrutiny, and solutions are needed if the patients of tomorrow are to benefit from cost-effective innovative therapies, advances in medical technologies, and ways of communicating medical information. Discussions are underway at European and national level about how to create the right environment for viable healthcare systems that incorporate European notions of equity and solidarity, and that can overcome the lack of policy coordination in the EU and with member states, currently resulting in an inefficient use of resources. Within this broader discussion of Europe’s healthcare systems, access to therapeutic innovation is of particular concern. Inequalities between and within Member States have grown in recent years, as is evident from the Euro Health Consumer Index 2014 (Bjornberg, 2015). Recent public health issues, such as the H1N1 pandemic or the launch of innovative but expensive Hepatitis C therapies, have highlighted questions about European collaboration on access. They further serve to demonstrate that Member States face some common challenges, but that their ability to respond effectively to those challenges is influenced by differences in healthcare systems, health policies, and socio-economic conditions. Europe-level discussions have increasingly been addressing inequalities in access. The role of the EU has been limited to that of a coordinator, facilitator, or idea generator, but with access issues still unresolved, the status quo on health policy is being challenged by some stakeholders keen to promote reflections on whether access to innovative therapies should fall under the influence of the European Union. There might indeed be a case for greater collaboration at European level in promoting access to therapeutic innovation. However, there are multiple elements contributing to inequity in access, multiple views as to what constitutes a priority in healthcare, and multiple perceptions of what qualifies as an innovation. Access is not a single problem, not is it one on which stakeholders share a definition; it is a set of distinct problems that require distinct solutions, and clearer identification of where the added-value of European action and policy response might be the most appropriate. To re-evaluate the role of Europe in improving access to therapeutic innovation, it is necessary to first understand the current hurdles to access and then develop the tools needed to overcome them. The European Health Parliament Sub-Committee on Access to Innovative Therapies will consider these points with the aim of: • Developing a tool allowing for the categorisation of health and access issues according to some pre-defined criteria; and • Providing a set of recommendations based on our findings.

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II. SITUATIONAL ANALYSIS The health policy landscape is evolving and an increasing number of initiatives at the EU level or through joint national initiatives are delivering policy responses in the healthcare sector. Within the EU-wide policy framework, this ranges from European Commission and European Parliament initiatives to stakeholder coalition responses, which are focused on driving more efficient, effective, and streamlined approaches to access. Yet an important question still remains: Are such initiatives demonstrative of a harmonised integration framework and successful in increasing integration at EU level?

A. Horizon 2020 Horizon 2020 is the largest EU Research and Innovation Programme thus far, with nearly €80 billion available in funding over a period of seven years (2014 to 2020), as well as leveraging some private investments. The programme releases calls within specific areas, including medical technologies and pharmaceuticals (European Commission), with two especially relevant packages currently underway focusing on: “Health, Demographic Change and Well-being” and “Future and Emerging Technologies”. Within this framework the second Innovative Medicines Initiative (IMI2) has a €3.3 billion budget for 2014-2024, roughly half from Horizon 2020 and the remainder from companies that belong to the European Federation of Pharmaceutical Industry Associations and other life science industries and organisations. The supporting companies do not receive any EU funding, but they contribute to specific projects, for example, by donating their researchers’ time or providing access to research facilities or resources. The IMI2’s annual Work Plan for 2015 includes more information about strategic objectives, specific challenges and funding.

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B. European Semester Despite the limited competencies seceded by Member States to the European Union, the European Semester has since 2011 provided enhanced recommendations as to how national healthcare systems can be reformed in a fiscally efficient manner. While not all countries were originally part of the initiative, each edition has brought additional countries into its scope. But there is continued reluctance at Member State level to adopt these recommendations, because of concerns over subsidiarity, or over further cuts in the wake of the post-crisis austerity measures. In addition, existing recommendations are overly focused on financial and quantitative targets, with little considerations given to more qualitative targets and long-term reforms (e.g. increasing uptake of generic medicines to enhance access to therapies, as was the case in Ireland). The most recent recommendations from the European Parliament Committee on the Environment, Public Health and Food Safety highlighted the risk that the European Semester was promoting short-term thinking about investment rather than considering health as a long-term investment and a value in its own right (ENVI Committee, 2015).

C. Patient Access Partnership on Equity of Access to Quality Healthcare The European Patientsâ&#x20AC;&#x2122; Forum and the Bulgarian National Patient Organisation joined forces to invite key stakeholder to initiate the Patient Access Partnership , conceived to reflect on sustainable provision of equitable patient access to quality healthcare in the EU. The objective is facilitating the dialogue between European and national health stakeholder on access, identifying hurdles for patients, assessing gaps within EU Member States, collaborating with EU-led or national initiatives, and developing innovative and sustainable solutions. The initiative is supporting a European Parliament Interest Group on Access to Healthcare, hosted by MEP Andrey Kovatchev (EPP, BG). This group offers an open platform for exchange, with the vision of transferring the best practices identified by members of the partnership.

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D. Health Technology Assessment (HTA) Initiatives Collaboration on access has gained greater attention at EU level, but these discussions are not entirely new; they are part of a trend toward a more prominent EU role. The first milestone toward a more unified pharmaceutical market was reached through the regulatory integration that came with the establishment of Centralised Procedures and common EU legislation on pharmaceuticals with a -defined assessment methodology. But differences in national systems, particularly in methodologies and evaluation for reimbursement decisions, constitute additional hurdles in terms of equal access. Discussions on health technology assessment (HTA) and the merits of cooperation emerged, and several projects have been financed through the EU research programme, FP7, which is now Horizon 2020. One of the outcomes is EUnetHTA, and this has been transformed into a “joint action,” originally envisaged to run in two cycles between 2010 and 2015, but now about to be extended into a third cycles. This increased cooperation has led to concrete deliverables for pharmaceuticals including: common HTA methodologies, joint pilots, IT tools, and training facilities. Perhaps more importantly, it helped to create an HTA community across national organisations, which culminated with the set-up of the European HTA Network. The Health Technology Assessment Network was created on the basis of Directive 2011/24 on the Application of patients’ rights in cross-border healthcare and in October 2014 formally adopted the Strategy for EU Cooperation on HTA as based on input from formally appointed representatives from Member States, plus Norway and Iceland. While the network intends to enhance cooperation between national and European bodies under the auspices of the overarching vision that “evidence is global, decision is local” (HTA Network, 2014), the European Network on HTA (EUnetHTA) still exists and supports the work for HTAN on a technical level through the development of good practice methods, processes, and core models for assessment of various technologies. HTA collaboration has also been reinforced with initiatives led by the European Medicine Agency (EMA). Parallel scientific advice is one such example, which allows EMA and HTA agencies to be equal partners in a multistakeholder procedure, leading to early-dialogues between the pharmaceutical manufacturer, EMA and HTA bodies. The lack of a joint report was at first considered a procedural weakness, but in practice this offers flexibility and holds out the prospect that the procedure will lead to useful advice for the manufacturer, despite differences between national HTA bodies. In addition, the recent revision of the EU Pharmacovigilance legislation led to the creation of the Post Authorisation Safety Studies and Post Authorisation Efficacy Studies, which further allows for the reassessment of new innovative medicines over their life cycles. The Innovative Medicines Initiative (IMI) also finances projects relating to HTA and relative effectiveness, for instance with the IMI Get Real projects, contributing to the generation of real world data.

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E. Price & reimbursement and access initiatives Apart from HTA collaborations, discussions on collaboration in the field of pricing and reimbursement (P&R) have also been taking place. The Network of Competent Authorities for Pricing and Reimbursement (CAPR) is a platform between Member States that was set up at the initiative of the Slovenian Presidency. The objective of the network is to identify and address common issues in the field of P&R. Participation in the network is voluntary, and like the EUnetHTA platform, a key addedvalue of the platform is bringing together national authorities in the field of P&R. Another initiative, led by the European Commissionâ&#x20AC;&#x2122;s DG Enterprise, was the Process of Corporate Social Responsibility in the field of Pharmaceuticals. Divided into several work streams, its outputs included a report on the use of Managed Entry Agreement (MAE) in Europe, as well as on access to biosimilar medicines, featuring a consensus paper â&#x20AC;&#x201C; What You Need to Know about Biosimilar Medicinal Products. Another work stream within the project considered orphan drugs. By way of the Mechanism of Coordinated Access to Orphan Drugs (MOCA), it identified options for collaboration, including horizon scanning, early dialogue, possible collective value assessment or HTA, and joint pricing or procurement. Perhaps the most tangible output was the Transparent Value Framework â&#x20AC;&#x201C; a multicriteria decision analysis tool designed to assess the value of an orphan drug while accounting for its specificities, with the aim of facilitating pricing decisions.

F. Access to Innovation in Health and Social Care The European Parliament Interest Group on Access to Innovation in Health and Social Care is an initiative that began for the 2014-2019 term with the aim of bringing together Members of the European Parliament, as well as other healthcare stakeholders, to improve patient access to innovation in health and social care. The group was launched in May 2015, intends to develop policies to make public health a priority in the European Parliament, prioritising innovation and ensuring that patient-centricity is central to healthcare systems and the provisions of solutions.

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G. Universal Access to Health roundtable A year after the EU elections, the European Patients Forum, the European Generic and Biosimilar Medicines Association, the International Association of Mutual Benefit Societies, and Doctors of the World held a roundtable on Universal Access to Health, as a follow-up to the dialogue initiated a year earlier. Through this platform, MEP Karin Kadenbach (S&D, AT), Boleslaw Piecha (ECR, PL) Alojz Peterle (EPP, SL), as well as healthcare stakeholders, addressed the ways in which universal access to healthcare across the EU can be ensured. A consensus among the group was that beyond open dialogue, it is essential to ensure tangible and concrete follow-up actions to harness this partnership in tackling access to health.

H. European Patients Academy on Therapeutic Innovation (EUPATI) Initiated under the first IMI, EUPATI is a five-year project running until 2017, developing education material, training courses, and a public online library as a means of educating patients and the lay public on sustainable infrastructure and up-to-date information on therapeutic innovation in a scientifically objective and reliable way. Ultimately, EUPATI aims at empowering patients, placing them at the heart of healthcare systems as well-informed and trained patient advocates. Most recently, EUPATI published best practice guidance on how to engage patients. It has also published on online e-Learning tool, and it organises webinars and works with medicines agencies on considering the role of patients in R&D.

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III. SOLUTIONS Background and objectives European integration and collaboration in the context of access to innovative therapies may be the answer to calls for improved equality across Member States, but this would require a drastic redistribution of competences in the field of health. Even if applied in limited instances on very specific areas of health, a shift from complete national – or regional – authority over disease management to a system in which the European institutions would have a bigger role is remote from today’s reality. Yet from the perspective of the European Health Parliament Sub-committee on Access to Innovative Therapies and as evidenced through our qualitative and quantitative research, there is demand among European policymakers and, more indicatively, European citizens, for a tool that would assist in identifying and prioritising those areas where EU collaboration could be appropriate and could support national healthcare systems. For this report, the Sub-Committee has developed a Multi-Criteria Decision Analysis (MCDA) tool. As a concept, it is not new, but thanks to renewed attention, it has been rejuvenated in the form of the Mechanism of Coordinated Access to Orphan Drugs (MOCA). This led to the creation of the Transparent Value Framework, a multi-criteria tool to assess the value of an orphan drug. While MOCA is a European initiative, Member States have also considered similar approaches. For instance, in Belgium, the Federaal Kenniscentrum – Centre federal d’expertise (KCE) published a report on Incorporating societal preferences in reimbursement decisions – Relative importance of decision criteria according to Belgian citizens (Cleemput I, 2014). This study aimed at measuring public preference weights for reimbursement based on two deliverables, (i) an extensive literature review on societal preferences, (ii) a study amongst the general population. The Sub-Committee has considered these two approaches, not to develop a MCDA model designed to assess the value/reimbursement of a pharmaceutical product, but to assess the non-product specific value of an EU intervention. From our perspective, two elements would justify an EU priority: • The existence of an unmet medical need; and • The added-value of a European intervention (as opposed to national intervention).

(Priority for EU) =

U M N A V nmet

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edical

eed x

dded

alue

Such a tool could be used for several purposes: • Assessment of current (and future) EU policies; • Establishment of a list of priority health areas at the EU level; • Creation of a special EU Fund to reduce health inequalities, in which: > The allocation of the budget could be defined according to areas that should be a priority and where EU support is critical; and > The fund could be revised on a regular basis (i.e. every 5 years). • Support for the development/allocation of an EU budget in the field of health (in addition to appropriate expert and stakeholders consultations); and • Identification of those disease areas where EU-level solutions to access should be considered.

Methodology A three step approach has been applied:

Theoretical criteria for matrix

Criteria Weight Estimation

Matrix Validation

Methodology: Literature review

Methodology: Questionnaire

Methodology: Experts interviews

The Sub-Committee also adopted a set of criteria to define both the unmet need and the added value of a possible EU intervention. The criteria selected for determining unmet medical need are largely inspired by the studies mentioned above, including the Transparent Value Framework and the KCE report. The following criteria in terms of unmet need were identified: • Prevalence; • Cause of mortality; • Five-year survival rate; • Pain caused to the patients; • Disability caused to the patients; • Burden caused to the healthcare system; and • No treatment available

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The criteria for assessing the “added value” of EU intervention were based on a literature review of existing barriers to access to new therapeutic options. These criteria gather a broad range of potential barriers ranging from scientific and research challenges to economic hurdles (budgetary constraints), and including other relevant dimensions such as information of patients and physicians, as well as differences in Member States P&R decision-making processes. As mentioned in the introduction, there are many potential hurdles to access, and identifying an exhaustive and justified list is a difficult exercise in itself. The following criteria were identified as possible barriers of access: • Lack of scientific knowledge for the disease; • Complexity, risk, and cost of the research; • Limited economic appeal of investing in developing a new treatment option; • Health budget limitations; • Health budget limitations in the short term (“cash-flow problem”); • Uncertainty regarding the actual expenses the product will have in real-life; • Budgets prioritized to other disease areas / treatment options (“National priority”); • No clear value of the treatment in terms of its price/costs (“cost-efficiency uncertainty”); and • No clear value of the new treatment in real life (“real-life clinical uncertainty”).

Unmet Need score Acces Issue score

1 2 3 4 5 6 7 8 9 10

National policies

Member states collaboration initiatives

E.U. collaboration/solidarity

E.U. legal Intervention

Total E.U. Integration

Table 1: Theoretical Matrix

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116

A. Weight of criteria To make full use of the matrix and obtain a score for each disease area to help prioritise between disease areas and access issues, it is essential to estimate the relative importance of each criteria. For that purpose, the Sub-Committee has developed a standard questionnaire in which participants were requested to rank each of the criteria. This questionnaire was shared with the members of the European Health Parliament and students from the College of Europe (see questionnaire in Annex I). The choice of this population was made on the basis of gathering the views of individuals from different Member States. However, there are some limitations as the engaged population primarily consisted of young, highly-educated Europeans with a reasonable level of knowledge and/or interest in health policies, and perhaps a favourable bias toward European integration. As mentioned previously, enhanced integration at European level in the field of health and access is a leap forward in terms of general integration. Even in the absence of further integration, ensuring that current EU funds and efforts are allocated in the most efficient manner in light of what EU citizens consider a priority is of utmost importance in a democratic Europe. From that perspective, the tool could be used within current EU policies, with a view to prioritise EU funds and policies. To supplement the information provided, the methodology adopted involved a third step: expert reviews, conducted through qualitative interviews. This allows the Sub-Committee to correct some of the biases that may arise. The questionnaire was sent in March 2015, tallying a total of 71 respondents by April 2015. The matrix will be revised and updated based on new data cut-offs. The qualitative interviews were carried out during the same period and engaged 7 Members of the European Parliament and health experts on the European level.

B. Results from the Access Survey Based on the breakdown of the criteria in the questionnaire, which is detailed in Annex I, the following weight was assigned for the evaluation: • Prevalence (20%) • Cause of Mortality (18%) • 5 years survival rate (14%) • Pain caused to the patients (14%) • Disability caused to the patients (12%) • Burden caused to the healthcare system (11%) • There is no treatment available (11%)

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The respondents considered the criteria that should be taken into account to determine if a European intervention would be needed, exploring three situations: • When a suitable treatment does not exists; • A suitable therapeutic option exists, but it is not financed by some healthcare systems; and • There is a suitable treatment option, financed by healthcare system but patients have no access to it.

Each of these situations involved different causes of the access problem. The respondents were asked to evaluate separately the value of a European intervention in each case. The similar results obtained in all cases suggest a bias in the responses, indicating a middle-high range of the scale. Thus while the questionnaire results suggest little differences between the situations, some conclusions or tendencies can still be identified. The results suggest that in instances when there is no existing treatment, a European intervention would be of more value. When there is a suitable therapeutic option, the national budget limitations, lack of infrastructure, and lack of knowledge among physicians and patients were considered to be situations in which a European intervention should be considered. Furthermore, the lack of suitable treatment was attributed to the complexity, risk and cost of research or limited economic appeal of investing in developing a new treatment option. A smaller subset of the respondents thought that the lack of scientific knowledge on the disease was responsible. On the other hand, when a suitable therapeutic option exists but is not financed by some healthcare systems, respondents justified this according to: a. Health budget limitations; b. Health budget limitations in the short-term (“cash-flow problem”); c. Uncertainty regarding the actual expenses the product will have in real-life; d. Budget is prioritized to other disease areas / treatment options (“National priority”); e. There is no clear value of the treatment, regarding its price/costs (“cost-efficiency uncertainty”); and f. There is no clear value of the new treatment in real life (“real-life clinical uncertainty”).

Table 2: A suitable therapeutic option exists, but is not financed by all healthcare systems

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When there is a suitable treatment option that is financed by healthcare system, but patients still do not have, respondents indicated that the following criteria is responsible: a. Lack of appropriate/enough infrastructures, leading to inefficiencies and poor patient management b. Under-diagnosis of the patients (medical education issue) c. Long waiting time before patients can actually see a doctor d. Patients have to undergo several tests / alternative therapeutic options before being eligible for the therapeutic innovation (restriction in reimbursement criteria) e. Physician prefers existing therapeutic options for clinical reasons f. Physician prefers existing therapeutic options for cost reasons g. Patient or physician is not aware of the new treatment option

Table 3: A suitable treatment option exists and is financed, but patients still do not have access.

The results also show that when the problem is linked with the organisation of the health system, a European intervention would be valuable, especially when there is a lack of information among the physicians and when the infrastructures are inappropriate. Likewise, the responses suggest that a European intervention would be more valuable when the problem is linked to health budgets. To combat this problem, the majority of respondents were positive about the creation of a European fund to reduce health inequalities between European countries, which would predominantly be focused on the better organisation of infrastructure of the health system. Considering the results from the survey, each sub-item of the priority equation should integrate a weight on a scale of 10, with a binary evaluation score of 0 or 1 for each criterion.

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Some predefined cut-offs were defined to select disease area priorities and assess unmet medical need. The disease will receive a score of 1 if some characteristics are met. There is an important limitation in this method, as deciding only one cut-off point is too simple taking into account the wide range of situations and characteristics among all diseases. For the purpose of this paper the method was simplified as follows:

Prevalence: Affects more than 0.1% of the population. Cause of mortality: Disease causes more than 50.000 deaths per year across Europe. 5-year survival rate: Less than 75% of patients are alive five years after their diagnosis. Pain: More than 50% of patients suffer from moderate to severe pain, according to a Brief Pain Index (BPI) equal or more than 3. Disability: Disease induces more than one million disability-adjusted life years (DALYs) â&#x20AC;&#x201C; the sum of life years lost due to premature mortality and years lived with disability, as adjusted for severity - across the EU Member States. Economic burden (healthcare cost + indirect cost): Total cost per patient per year is higher than 43.000â&#x201A;Ź.

This objective and simple assessment will allow the matrix to qualify the urgency related to the unmet medical need and provide the first key item of the priority score (Annex II). In the same binary assessment, a review of each access issue criteria should be done to define the access issue score and complete the matrix bellow: ACCESS ISSUE REVIEW Criteria

Lack of scienceknowledge for the disease Complexity, risk and the cost of the research Limited economic appeal of investing in R&D Health budget limitations Cash-flow problem issue Uncertainty regarding expenses in real-life Budget is prioritized to other disease areas Cost-efficiency uncertainty Real-life clinical efficacy uncertainty Inappropriate infrastructures restriction criteria before being eligible to the innovation Time to physician acces Under-diagnosis of the patients Physician prefer existing therapeutic options for clinical reasons Physician prefer existing therapeutic cost reasons Patient or physician are not aware of the new treatment option Physician prefer existing therapeutic options for vested interest Innovation mismatches with some cultural concerns (eg. Religion) Innovation does not fit to country specific atypical situation Acces Issue score

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Eval. (Yes=1; No=())

Weight 0,63 0,72 0,68 0,64 0,56 0,49 0,54 0,50 0,41 0,63 0,49 0,49 0,50 0,40 0,41 0,59 0,48 0,39 0,46

Score

C. Validation of matrix by experts Following the expert interviews conducted by the Sub-Committee, the responses were analysed based on overarching themes in terms of barriers and possible opportunities. While the stakeholders interviewed had a variety of backgrounds – representing industry, patients, Members of the European Parliament, healthcare professionals, and academia – they consistently perceived access as a long-term investment that cannot be stifled by short-term budget cuts and austerity measures. Furthermore, the experts agreed that the varieties that exist within the EU, and even within Member States, make it inherently difficult to agree on a unified approach to access. More importantly, while fragmentation between Member States poses significant problems, the on-the-ground result for patients is a significant concern when one country’s citizens have access to a therapy that their neighbours across the border may not have at their disposal. Patients have a right to access healthcare at all stages – from preventive care to current treatments to innovative therapies. However, they must also be informed at all stages to ensure that the decisions they are making are well-informed and the best option for them. Where therapies are under development, healthcare professionals and patients both reinforce the message that research and clinical trials must be conducted in such a way that patients are self-determined and involved in the process. In line with the results of the quantitative survey, the experts identified key areas of EU cooperation as possibilities for future development. Cross-border collaboration on pricing and reimbursement, for instance, was a common theme addressed by several of the stakeholders. Investment in infrastructure, as indicated by the qualitative survey’s emphasis for the allocation of a European health fund, was a reoccurring theme within the scope of the expert interviews. Integrated healthcare systems with smart spending were perceived as the foremost way of moving forward, albeit with the experts acknowledging that an access policy cannot be dictated by the EU, but requires a top-down and a bottom-up approach to be truly successful.

D. Application – two case studies The “matrix” approach aims at defining the level of EU intervention required to enhance the access of innovative therapies across Europe. By assessing the medical unmet need and the access issues, the matrix identifies where national and where European integration on a specific disease area may be most appropriate. Through the following two case studies – on Hepatitis C and diabetes – the SubCommittee has assessed the relevance of the approach and highlighted its strengths and weaknesses.

HEPATITIS C The Hepatitis C (HVC) landscape has radically changed over the past five years. As is the case with numerous infectious diseases, prevalence and progression is associated with poverty and a difficult socio-economic situation, which in turn leads to significant discrepancies between EU Member States. Nevertheless, new innovative therapies have demonstrated a strong ability to change the future of the disease, including the possibility of eradication, but several access issues and on the ground patient access are not resolved across the EU. The Sub-Committee aims to examine whether the matrix is a relevant tool to identify appropriate policies to sustain access of HVC drugs in 2015.

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By integrating the evaluation results and considering criteria weight for unmet need, the unmet need is evaluated at 3.2 (Table 3). Unmet Medical Need review - Hep. C in 2015 Criteria

Eval. (Yes=1 ; No=0)

Criteria Weight

Prevalence

2,0

Death/y

1,8

5 y / survival rate

1,4

Pain

1,4

Disability

1,2

Economic burden

1,1

Therapeutic alternative

1,1

Unmet medical Need score

3,2

Unmet medical need review would suggest that Hepatitis C medical need in 2015 is low to moderate. Unmet Need score Acces Issue score

1 2 3 4 5 6 7 8 9 10

3,2

Hep.C: 9,95 3,11

Member states collaboration initiatives

In the Hepatitis C case study, the disease has been considered as a uniform disease, whereas the long duration of the disease and the different phases a patient has to endure could justify it being considered as different medical needs. The disease progresses slowly over years in most patients, from a state in which the liver does not show fibrosis (F0) through different fibrosis grades (F1-F4), which can lead to cirrhosis or liver cancer. The urgency of need to treat for each patient is different as pain, disability and mortality increase through the phases. If this assessment had been made taking into account the most severe patients F3-F4, the results might have been different as the unmet need would have been higher and the score would also have increased with more probably 1 scores in pain, disability, mortality and economic burden. If the assessment is made for a disease with such heterogeneous patient groups, the tool would be of more value used separately for each patient group or disease phase.

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DIABETES While type 2 diabetes is a condition that has been part of the healthcare landscape for a long time, the significant rise in prevalence and incidence in recent years has added a new dimension and placed a significant strain on healthcare budgets. Yet despite more and more cases arising every year, the policy framework on diabetes is not changing as rapidly as its landscape, nor are patients gaining access to innovation that would help them to best manage their disease. Often, this is the result of under-diagnosis, but other factors â&#x20AC;&#x201C; such as national policies, prioritisation and prevention initiatives â&#x20AC;&#x201C; also play a role. Is there a role for the EU to play in this environment? Though national statistics vary, diabetes is an EU-wide problem, one that has a broad impact on healthcare systems. The nature of diabetes also implies that the appropriate care for diabetes patients is widespread, encompassing lifestyle aspects alongside continued treatment, management, and monitoring. As such it has a profound impact on healthcare systems and requires an integrated approach, particularly considering that diabetes is strongly linked to other complications and comorbidities, including cardiovascular disease â&#x20AC;&#x201C; the leading cause of death in Europe. Research into the condition is high on the agenda, with national projects as well as EU initiatives, such as those under the scope of Horizon 2020, considering diabetes care. Nevertheless, innovation in the field is not as rapid as it could be, particularly when considering aspects like interoperability of devices, which would help patients to better monitor their insulin intake and blood glucose levels in an easier way. According to the matrix assessment characterising unmet need and access surrounding diabetes care, the condition received a score indicating ad hoc collaboration between Member States and at the EU level. Unmet Need score Acces Issue score

1 2 3 4 5 6 7 8 9 10

5,4

Diabetes 2,75

Member states collaboration initiatives

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DISCUSSION Another limitation of the matrix is that health systems across the EU are different and linked to a wide range of problems that lead to reductions in access to treatments. The different causes of the access problems can vary among member states, making more difficult the assessment in the second dimension of the matrix. When determining the causes of the problems, another limitation is that in most cases the cause is not 100% clear. For example some stakeholders would state that there is no health budget limitation but that the value of the treatment is not clear among the physicians, whereas physicians would state that budget cuts are limiting their freedom in prescribing treatments. When assessing this dimension, it would be necessary to make a deep analysis of the real cause of the problem, not only to determine if a European intervention is needed, but also to ensure that the type of intervention will solve or palliate the problem. One of the challenges of this type of approach is to balance simplicity and complexity. If the tool is too simple the results could lead to a mistaken action, but if the tool is too complex and the analysis is too deep the tool would not be used, and would be only a theoretical approach, with no practical implementation. Despite the limitations of the tool, the aim of this paper is to open a workflow in the EU that addresses unmet needs related to different diseases and ensure that a European intervention would take place if the value is demonstrated.

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IV. CONCLUSIONS The health environment in the European Union is uncertain. Patients have no guarantees that a therapy proven to be effective and approved for market access will actually reach them at the local level. Initiatives undertaken thus far – across borders, nationally and by the European Union – are making strides forward, but have ultimately not succeeded in overcoming all the existing barriers. What is evidenced by these efforts, however, is that the missing link seems to be a comprehensive strategy that allows for governments, both national and EU, to have a clear view of where their input would have the greatest positive impact for patients. A significant point of concern in such strategic discussions is the question of competencies and where the EU influence begins and ends in relation to Member States. To address this point specifically, creating a scientific assessment to analyse where cooperation is of benefit and where action locally is most efficient, the EHP matrix tool emphasises that an evaluation is possible and could very well help to inform decision makers at all levels. The experts engaged in the interview process also expressed hope that full advantage would be taken of existing initiatives and legislation, where it is appropriate and presents opportunities for patients and the sustainability of healthcare systems. With that in mind, the EHP Sub-Committee on Access to Innovative Therapies proposes concrete recommendations that have arisen throughout research, outreach, and review with experts to ensure access becomes more than a discussion point for Europe.

Top recommendations The EHP Sub-Committee on Access to Innovative Therapies encourages awareness-building through developing knowledge and understanding at the European level of the existing barriers to access in Europe as they appear in national healthcare system environments and in disease areas. This is envisaged through a three-step approach, including concrete actions at both EU and Member State level.

1. Create a European Access Observatory (EAO) to annually assess the infiltration of new products and therapeutic alternatives in Member States. The EAO would: • Not be a fundamentally new structure, but rather an entity leveraging existing networks; • Be responsible for defining a common definition and methodology to assess access; • Carry out an annual access survey for Member States to respond to.

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The annual results should be the object of a multi-stakeholder discussion engaging patients, pharmaceutical and medical technology industry representatives, policymakers, public health authorities, and regulatory bodies, as relevant. Such a meeting would be coordinated by the European Commission. The results of the annual report and subsequent discussions would be public information in an effort to promote transparency, as well as to encourage responsible uptake, investment and accountability.

2. Maximise the value of current EU initiatives to address the existing barriers to access, such as: • Promote consistency and cross-fertilisation across all on-going discussions at EU level pertaining to access, including open dialogue and mutual leveraging of outcomes and proposals; • Enhance stakeholder engagement and involvement in all initiatives, in particular those led by the Council, to encourage the implementation of achievable recommendations and monitoring progress; • Consider the best methods for appropriate follow up on the Corporate Social Responsibility Process initiated by Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (formally DG Enterprise and Industry); • Incorporate concrete qualitative (compliance, adherence, health and socio-economic outcomes) and quantitative (increased access) recommendations regarding access to cost-effective innovative therapies as part of the European Semester.

3. Develop, in collaboration with healthcare stakeholders and policymakers, an EUlevel analytical tool to support the prioritisation and decision-making specifically focused on addressing access questions in health policies by: • Conducting a European-wide study on societal preferences regarding unmet medical needs and access to innovation under the auspices of the EU Health Programme 2014-2020 or Horizon 2020; • Financing academic research dedicated to the development of a “matrix” or similar tool that would serve to define and measure unmet medical need in a consistent manner across Europe; and • Engagement of all relevant stakeholders in the discussions.

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V. REFERENCES AASLD. (2014, November). The cost debate on HCV treatment in Europe. Barkhuizen, e. a. (1999). Musculoskeletal pain and fatigue associated with chronic hepatitis C: A report of 239 hepatology clinic patients. American Jounral Gastroenterol, 1355-60. Bjornberg, A. (2015). Euro Health Consumer Index 2014. Health Consumer Powerhouse. Brabant, M. (2010, May 29). Insulin giant pulls medicine from Greece over price cut. BBC News. Cleemput I, D. S.-O. (2014). Incorporating societal preferences in reimbursement decisions â&#x20AC;&#x201C; Relative importance of decision criteria. Brussels: Health Services Research: Belgian Healthcare Knowledge Centre (KCE). Decode Study Group. (2003). Age- and Sex-Specific Prevalence of Diabetes and Impaired Glucose Regulation in 13 European Cohorts. Diabetes Care, 61-69. Diane C. Zelman, M. G.-S. (2005). Validation of a modified version of the brief pain inventory for painful diabetic peripheral neuropathy. Journal of Pain and Symptom Management, 401-410. EASL. (2015). EASL Clinical Practical Guidelines. European Association for the Study of the Liver. ECDC. (2010). Hepatitis B and C: Current Situation in the EU/EEA. Stockholm: European Centre for Disease Prevention and Control. ENVI Committee. (2015). Opinion of the ENVI Committee on the European Semester for economic policy coordination: Annual Growth Survey 2015. European Parliament. EU Clinical Trials Register. (1995-2015). Clinical trials for Type 2 diabetes mellitus. Retrieved May 10, 2015, from EU Clinicat Trials Register: https://www.clinicaltrialsregister.eu/ctr-search/search?query=Type+2+diabetes+mellitus EUnetHTA. (2010). EUnetHTA. Retrieved May 10, 2015, from EUnetHTA and the HTA Network: http://www.eunethta.eu/eunethta-and-hta-network European Commission. (n.d.). What is Horizon 2020? Retrieved May 10, 2015, from Horizon 2020: The EU Framework Programme for Research and Innovation: http://ec.europa.eu/programmes/horizon2020/en/what-horizon-2020 European Commission, DG SANCO, C2. (n.d.). Estimates of cost of diabetes per year in the European Union and in other European countries. Retrieved 10 2015, May, from The burden of diabetes: The economic costs: http://ec.europa.eu/health/major_chronic_diseases/docs/idf_cost_2011.pdf

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European Federation of Nurses. (2012). Carising in Crisis: The impact of the financial crisis on nurses and nursing. EFN. European Medicines Agency. (1995-2015). EMA - Disease Area - Diabetes. Retrieved May 10, 2015, from European Medicines Agency: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/landing/ diabetes_disease_area.jsp&mid=WC0b01ac058034ed08 Eurostat. (2014, December 10). Causes of death. Retrieved May 10, 2015, from Eurostat: http://appsso.eurostat.ec.europa.eu/nui/submitViewTableAction.do;jsessionid=-cY_ WFcGMvyjiJekJqnvtlNqc68F61k-V33WHSRPa7jyGa51D6fR!-315593280 Federation, I. D. (2014). IDF Diabetes Atlas: Sixth Edition. Health and Environment Alliance. (2014). Health costs in the European Union: How much is related to EDCS? HEAL. Hilde Luijks, T. S.-J. (2012). Prevalence and incidence density rates of chronic comorbidity in type 2 diabetes patietns: An exploratory cohort study. BMC Medical, 128. HTA Network. (2014). Strategy for EU cooperation on HTA. European Commission. Huckans, e. a. (2014). Multi-analyte profile analysis of plasma immune proteins: Altered expression of peripheral factors is associated with neuropsychiatric symptom severity in adults with and without chronic hepatitis C virus infection. Brain and Behavior , 123-142. Innovative Medcines Innitiative. (2010). IMIDIA. Retrieved May 10, 2015, from IMIDIA: http://www.imidia.org/index.php Innovative Medicines Innitiative. (2012). DIRECT. Retrieved May 10, 2015, from DIRECT: http://www.direct-diabetes.org/index.php International Diabetes Federation. (2004). Towards a European Framework for Diabetes Prevention and Care. Dublin: IDF. International Diabetes Federation. (2014). IDF Diabetes Atlas: Sixth Edition. Jacobsen, H. (2013, September 9). EU countires singled out for misguided healthcare budget cuts. EurActiv. Jaret, P. (2015, March 11). What can I expect over time with hepatitis C? HealthDay: News for Healthier Living.

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Joergens, V. (2014, September). The mission of the EASD is to promote excellence in diabetes care through research and education. Retrieved May 10, 2015, from Medical devices in diabetes care: http://www.imdrf.org/docs/imdrf/final/meetings/imdrf-meet-131112-belgium-presentation-easdmds-in-diabetes-care.pdf MĂźhlberger, e. a. (2009). HCV-related burden of disease in Europe: A systematic assessment of incidence, prevalence, morbidiity and mortality. BMC Public Health, 34. Murray, e. a. (1997). Global mortality, disability, and the contribution of risk factors: Global burden of disease study. The Lancet, 1436-42. Negro, F. (2014). Epidemiology of hepatitis C in Europe. Elsevier - Digestive and Liver Disease, S158-S164. Ogdie, e. a. (2015). Prevalence and risk factors for patient-reported joint pain among patients with HIV/Hepatitis C co-infection, Hepatitis C mono-infections and HIV mono-infection. BMC Musculoskeletal Disorders, 93. Organisation for Economic Cooperation and Development. (2012). The Diabetes Epidemic and Its Impact on Europe. OECD. Organisation for Economic Cooperation and Development. (2014). Health at a Glance: Europe 2014. Retrieved May 2015, from OECD: http://dx.doi.org/10.1787/health_glance_eur-2014-en Panos Kanavos, S. v. (2012). Diabetes expenditure, burden of disease and management in 5 EU countries. London: London School of Economics. Philipa Mladovsky, S. A.-Q. (2009). Health in the European Union: Trends and analysis. Copenhagen: World Health Organisation. Silk, A. (2014, November). Interoperability for diabetes diagnostics devices and diabetes management systems. US Food and Drug Administration. Vietri, e. a. (2013). The burden of hepatitis C in Europe from the patientsâ&#x20AC;&#x2122; perspective: A survey in 5 countries. BMC Gastroenterology, 16. Warren Kaplan, R. L. (2004). Priority Medicines for Europe and the World - A public health approach to innovtaion. Background paper 5. Geneva: World Health Organization. Winslow, R. (2012, July 9). New strategies for treating diabetes. Retrieved May 25, 2015, from Wall Street Journal: http://www.wsj.com/articles/SB10001424052702303292204577517041076204350

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World Health Organisation. (2015). Global Alert and Response: Hepatitis C. Retrieved May 18, 2015, from World Health Organisation: http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index3.html World Health Organisation. (2015). Hepatitis: Data and Statistics. Retrieved May 22, 2015, from WHO Regional Office for Europe: http://www.euro.who.int/en/health-topics/communicable-diseases/hepatitis/data-and-statistics Yusuf S, H. S. (2004). Effect of potentially modifiable rirsk factors asociated with myocardial infarction in 52 countries (the INTERHEART study): Case-constrol study. Lancet, 937-52. Zelman DC, D. E. (2005). Identification of cut-points for mild, moderate and severe pain due to diabetic peripheral neuropathy. Pain, 29-36.

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PREVENTION OF CHRONIC DISEASES

Authors Johanna van Vrede Pierre Bouygues Silvia Gómez Recio Uzo Madu Peter Mcguigan Kate O’Regan Marta Pabian Manon Reuters Rakhee Shah Beatriz Yáñez Jiménez

Executive summary Alcohol is a major contributor to loss of life and to the burden of chronic disease in Europe. The harmful use of alcohol is associated with a wide range of physical, psychological and social harms, and the costs to individuals, communities and society are widely recognised. While a single uniform alcohol policy relevant to all member states is close to impossible, there is a necessity to complement national actions, create synergy between individual national policies and share best practice. This report suggests that progress has been made at both strategic EU and Member State levels, with a decline in consumption and changes in drinking patterns in some countries over the past thirty years. However, Europeâ&#x20AC;&#x2122;s per capita alcohol consumption still remains the highest in the world and a coordinated and collaborative EU response is therefore imperative. There is currently a unique window of opportunity in Europe for a significant expansion of activity in the prevention of alcohol-related harm. This committee proposes strong recommendations supported by sound evidence aimed at changing the way in which alcohol-related harm is prevented at a European level.

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I. INTRODUCTION Alcohol is a major contributor to loss of life and to the burden of chronic disease in Europe. The harmful use of alcohol is associated with a wide range of physical, psychological and social harms and the costs to individuals, communities and society are widely recognised. While a single uniform alcohol policy relevant to all Member States is close to impossible, there is a necessity to complement national actions, create synergy between individual national policies and share best practice. This report suggests that progress has been made at both strategic EU and Member State levels, with a decline in consumption and changes in drinking patterns in some countries over the past thirty years. However, Europeâ&#x20AC;&#x2122;s per capita alcohol consumption still remains as the highest in the world and therefore, a coordinated and collaborative EU response is still imperative. An emerging theme from the paper is that there is currently a unique window of opportunity in Europe for a significant expansion of activity in the prevention of alcohol-related harm. This committee proposes strong recommendations supported by sound evidence aimed at changing the way in which alcohol-related harm should be prevented at a European level.

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II. ALCOHOL CONSUMPTION & HEALTH HARM Alcohol is a psychoactive substance with dependency-producing properties. It is a causal factor in more than 200 disease and injury conditions (World Health Organisation, 2014). High alcohol consumption is associated with an increased risk of developing chronic diseases, specifically mental and behavioural disorders, alcohol dependence, liver cirrhosis, some cancers and cardiovascular diseases. The WHO Global Status Report on Alcohol (2014) estimates that worldwide 3.3 million lives are lost annually as a result of the harmful use of alcohol, which represents 5.9% of all deaths worldwide. In the EU, alcohol abuse is the leading risk factor for ill-health and premature deaths for the working age population (25-59 years) (Scientific Opinion of the Science Group of the European Alcohol and Health Forum, 2011). Although many of the problems outlined are associated with high levels of alcohol consumption, long term moderate alcohol consumption is also known to increase the risk of developing NCDs (OECD, 2014). Likewise, both heavy and long term moderate drinking can have devastating effects for women during pregnancy often leading to miscarriages and a range of birth defects, known as foetal alcohol spectrum disorders (FASD) (Mullally, et al., 2011). While average alcohol consumption has been decreasing in the EU, the proportion of young people displaying harmful and hazardous consumption patterns has increased in many member states. Europe is home to 7.3% of the world’s population yet accounts for roughly a quarter of total alcohol consumption worldwide, making it the highest consumer of alcohol in the world (World Health Organisation, 2014). This ratio has obvious negative consequences, the most worrying being the high number of alcohol-related fatalities. Alcohol-related harm is responsible for 1 in 7 male deaths and 1 in 13 female deaths in the group aged 15–64 years in the EU, resulting in approximately 120,000 premature deaths each year (World Health Organisation, 2012a). The EU region records the highest percentage of heavy episodic drinkers; 22.9% of European drinkers “binge drink” according to the WHO (World Health Organisation, 2014). As studies have shown, the consumption of large quantities of alcohol in short periods greatly increases the risk of alcoholrelated diseases, such as liver cirrhosis (McCambridge, 2006). In addition, the type and strength of the alcohol consumed are significant factors for a person’s risk of disease. Many member states have displayed a strong convergence of drinking habits, especially among younger demographics. For example, within 12 member states, among the 15-19 year old age group, more than 30% participate in “binge drinking” (World Health Organisation, 2014). Although the reasons for such convergence are multifactorial, there is no doubt that the availability and low cost of alcohol has supported this type of binge drinking culture. As a general rule, high-income countries have the highest per capita alcohol consumption and the highest prevalence of heavy episodic drinking (Ibid.). To address these problems, it is helpful to describe the current policy context to see where improvements might be made.

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III. CURRENT HEALTH SPENDING AND RESOURCES DISTRIBUTION

Health expenditure in the EU accounts for around 10% of GDP and almost 15% of public spending (European Commission, 2013). There is a strong relationship between the overall income level of a country and how much the country spends on health. It is therefore not surprising that in 2012 the Netherlands (EUR 3,829), Austria (EUR 3,676) and Germany (EUR 3,613) were the highest per-capita spenders on health, (adjusted for countriesâ&#x20AC;&#x2122; different purchasing powers), well above the EU average (EUR 2,193). Romania (EUR 753) and Bulgaria (EUR 900) were the lowest-spending countries among EU members in the same year (OECD, 2014).

Figure 1: Health expenditure per capita, 2012. Source: OECD Health Statistics 2014, http://dx.dol.org/10.1787/health-data-en, Eurostat Statistics Database, WHO Global Health Expenditure Database, retrieved the 13.05.2015.

On average, around three-quarters of health spending comes from public sources and the ranking by public share of spending is similar to overall health spending. Of the EU member states, only Cyprus sees private spending on health outweighing public financing, though Latvia and Bulgaria also have high levels of private spending. By contrast, the Netherlands, the United Kingdom and most of the Nordic countries have levels of public financing exceeding 80% (Ibid.).

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The breakdown of health spending across the EU reveals that most spending is accounted for by inpatient and outpatient care – almost two-thirds of current health expenditure on average in 2012. A further quarter of overall health spending is typically allocated to medical goods (mainly pharmaceuticals), while 10% goes towards long-term care, and the remaining 6% to collective services, including public health and prevention services and administration. At present, 97% of health budgets are spent on treatment, whereas only 3% are invested in prevention (European Commission, 2007).

treatment prevention

97% Figure 2: Budgetary expenditure on treatment and prevention in the EU

As the economic crisis emerged in 2008, health budgets were initially maintained, but began to fall in 2009 in some of the countries hardest hit by the economic crisis (e.g. Estonia). More widespread reductions were observed in 2010 and 2011 in response to fiscal pressures and the need to reduce large deficits and debts (Morgan and Astolfi, 2014). By 2012, some countries experienced renewed growth in health spending, albeit at much lower rates compared to the pre-crisis period. But health spending continued to fall in 2012 in Greece, Italy, Portugal and Spain, as well as in the Czech Republic and Hungary. Greece has seen per capita health spending fall by 9% each year since 2009, in contrast to yearly growth of more than 5% between 2000 and 2009. This has left the per capita level 25% lower in 2012 than in 2009. Ireland and the Slovak Republic also suffered significant reversals in per capita health spending after previously strong growth (OECD, 2014). Health spending in EU countries generally comes from national governments’ budgets. However, the European Commission supports some investments in health across the EU, through Horizon 2020 – health research (EUR 6bn), European Structural and investment funds for health (EUR 5.3 bn), and the EU Health programme 2014-2020 (EUR 321 mn).

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IV. STATE OF PLAY: EU AND NATIONAL HEALTH POLICY Prior to his appointment as President of the European Commission, Jean-Claude Juncker accepted that there had been a “lack of social fairness” in the European economy since the crisis of 2008 (Juncker, 2014). In his political guidelines for the next Commission, he clearly outlined that he wanted to see the renewal of Europe’s social economy (Ibid.). It is hard to judge if this recalibration towards the social market economy has occurred, but it is conspicuous within Juncker’s “10 point plan” that health is absent from that agenda (Juncker and Timmermans, 2014). Likewise, in Juncker’s mission letter to Commissioner for Health and Food Safety Vytenis Andriukaitis, there is no reference to prevention of NCDs. It is also difficult to know whether Commissioner Andriukaitis will focus on prevention of alcohol-related harm as he has yet to release a work programme. However, DG SANTE has listed the prevention of NCDs and specifically alcohol-related harm as a priority in the Third Health Programme 2014 – 2020 (European Commission, 2014), while prevention of disease is addressed in the recent Commission staff working document, Investing in Health (European Commission, 2013). The lack of priority given to health in the high level objectives of the European Commission is of concern. Alcohol-related harm is one of the priorities for WHO at the global level, since alcohol not only causes NCDs but also increases the risk of acute health conditions (e.g. accidents). For that reason, and with the objective of reducing the worldwide burden caused by alcohol abuse, WHO launched in 2010 the Global Strategy to Reduce the Harmful Use of Alcohol, which focuses on ten areas for national action, including health services’ response, alcohol availability, marketing, pricing and drink-driving policies. In previous work on reducing the harmful use of alcohol, the Commission adopted an EU alcohol strategy in 2006 (European Commission, 2006), and progress has been made in some areas - most notably, establishing the Committee for National Alcohol Policy and Action (CNAPA), the European Alcohol and Health Forum (EAHF) and the Committee on Alcohol Data, Indicators and Definitions1. These EU coordinated initiatives have assisted in the development of alcohol policies in many member states. They have led to improvements in the collection of quality data, the sharing of information and best practice between member states, the implementation/review of national alcohol strategies, the convergence of member states’ alcohol policies, and a framework for common indicators on alcoholrelated harm. The EU alcohol strategy has also mobilised the industry, the NGO sector and member states - which, in 2014, called for a new and ambitious strategy to tackle harmful use of alcohol (Committee on National Alcohol Policy and Action, 2014ab.

1 The CNAPA consisted of a forum whereby member states could coordinate health policies and share evidence of best practice, the EAHF was comprised of stakeholders such as industry and NGOs, where it was hoped that constructive dialogue would eventually lead to progressive and innovative commitments aimed at reducing alcohol related harm and finally the Committee on Alcohol Data, Indicators and Definitions has been set up to develop key indicators for alcohol consumption and alcohol related harm.

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Last year, through CNAPA, member states produced the Action Plan on Youth Drinking and on Heavy Episodic Drinking (Binge Drinking), which focuses on prevention of alcohol related harm in the fields of youth drinking and heavy episodic drinking (Committee on National Alcohol Policy and Action, 2014b). Meanwhile on the International stage, the WHO has been active in promoting global strategies to reduce alcohol-related harm. In 2010, the WHO reached consensus, for the first time, among all its 193 members on a global strategy to reduce harmful use of alcohol (World Health Organisation, 2010). And in 2012, the WHO European region’s 53 member states endorsed an action plan to reduce harmful use of alcohol by 2020 (World Health Organisation, 2012b). Nonetheless, there is more work that can be done at EU and international level to assist member states in reducing alcohol related harm. In this paper we call for a number of new measures at EU level. At present, member states have the main responsibility for alcohol policy in the EU. As a result, there are 28 member states implementing and focussing on different alcohol policies. Such policy dispersion, together with diverse levels of prosperity, has weakened effective implementation of an EU-wide policy. For example, many member states have not adopted a written national policy on alcohol (World Health Organisation, 2014). Six member states have no national legislation to prevent illegal alcohol either in the production or sale. There is still no EU-wide age limit on purchasing alcohol. Taxation measures and rates of tax on alcohol products vary greatly across the EU; some member states do not imposes any tax on wine. The availability of alcohol is also not uniform across the Union; some countries have little regulation, and any amount of alcohol can be sold to consumers at any time of day. Two member states have still not established maximum blood alcohol content for driving (BAC) of 0.5 mg/ml or less (Zamparutti, et al., 2012). Only France has legislated for health warnings to be placed on alcoholic beverages, while no country has made it mandatory for alcohol producers to provide ingredient/nutrition information on their products - although .In recent weeks, some alcohol producers have committed to voluntarily provide nutritional information. Members of the European Parliament have voted in favour of a Resolution calling on the European Commission to create a new EU Alcohol Strategy that would include mandatory nutritional labelling (Cirio et al., 2015). The EU’s problem with alcohol-related harm has no easy ‘quick fix’, since is no clear EU health policy on alcohol. Likewise, because of the disparate nature of health policy in the EU, which is formulated by 28 member states of different levels of wealth, alcohol consumption and alcohol-induced NCD burdens, addressing one of the EU’s main problems remains difficult. All alcohol related deaths are, nevertheless, avoidable, and could be prevented through adequate policy measures. Although public health is a direct competence of the member states, only supported by the EU, the EU should take a more proactive role in supporting member states in regulation. It should support member states legislation on public health issues such as alcohol, and clearly define the terms and conditions so as to deflect accusations of distorting the internal market and enforcing uncompetitive trade restrictions.

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V. A NEW AND STRENGTHENED EU ALCOHOL STRATEGY The most recent EU Alcohol Strategy was developed a decade ago (2006). Since then, many advances have been made in data collection, including on the burden of alcohol, consumption patterns and the effectiveness of health policies. But alcohol-related harm continues to need priority attention, through the EU Alcohol Strategy 2006-2012, and other actions. On 29 April 2015, the European Parliament adopted a Resolution calling on the European Commission to present a new EU Alcohol Strategy to tackle health harm for 2016-2020. This resolution is in line with the call from EU Health Ministers for the Commission to take action on the health impacts of alcohol (Sneiders, 2015). The members of the EHP consider this a turning point that opens possibilities for stronger and more targeted actions in preventing alcohol-related harm. A new and strengthened EU Alcohol Strategy could become a coordinated action of different policies and recommendations to minimise one of the key health determinants of NCDs. Recalling the EP Resolution of April 2015, the members of the EHP have outlined below key areas where the new EU Alcohol Strategy should be developed and enhanced:

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Governance The Committee on National Alcohol Policy Action (CNAPA) has proven to be a valuable mechanism for the dissemination of evidence-based knowledge and support to member states to reduce alcohol related harm. However, since it was established the committee has only met five times, consequently hindering real advances in the sharing of information and best practice. We therefore recommend: • The CNAPA meet on a quarterly basis to review trends in alcohol consumption and harm across member states. • A report on the development and implementation of policy, along with the publication of annual reports and recommendations to the EC and member states.

We also believe that the European Alcohol Health Forum needs a similar review: • The EAHF needs clear goals aligned with the priorities of the Alcohol Strategy; • It should develop goals aimed at reducing alcohol consumption in young people • It should monitor and analyse commitments made, for benefit and for correct implementation. Monitoring is essential to ensure commitments are effective.

EU targets: At present, there are wide disparities between individual member states alcohol policies, implementation and sharing best practice. Therefore, we recommend: • The EU, in agreement with member states, set clear annual targets for the implementation of alcohol policies such as national alcohol strategies; • The EC set targets for the reduction of NCDs over a clear timetable; • The EC produce annual Country Specific Recommendations to member states outlining their progress in implementation of health policies and; • All targets and policies agreed upon at EU level should have a horizontal approach towards other health policies of the EU and member states.

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Labelling Labelling provides a unique opportunity for governments to disseminate health messages and allow consumers to make informed choices. However, despite being classified by WHO as a group 1 carcinogen (International Agency for Research on Cancer, WHO, 1988), alcohol is exempt from current EU regulations on labelling of food products and soft drinks. The food label ‘is one of the most highly valued and sought after communication channels in the marketplace’ (Blewett et al., 2011). Despite small improvements taking place thanks to CNAPA efforts, the assessment of the EU Alcohol Strategy showed that only ‘limited’ progress had been achieved in labelling (Zamparutti et al., 2012). The EHP believes that the EU is missing an opportunity to reduce alcohol-related harm by failing to include clear information and health warnings on the labels of alcoholic consumables.

INCLUSION OF HEALTH WARNINGS The most frequent criticism of alcohol labelling in the EU is that there is no requirement to feature warnings about the possible consequences of alcohol consumption. Labels are not required to carry advice for pregnant women (currently any print information on certain brands of wine is a voluntary measure), warnings about drinking and driving, or information about the health outcomes of excessive alcohol consumption (such as liver cirrhosis and/or cancer). According to a Eurobarometer (2010) study, 79% of European citizens questioned are in favour of alcoholic drinks labels including health warnings on drinking during pregnancy and driving with alcohol.

QC10a. Would you agree or disagree to put warnings on alcohol bottles with the purpose to warn pregnant women and drivers of dangers of drinking alcohol?

Totally agree

Tend to agree

Tend to disagree

Totally disagree

Don’t know

EU27

QC10b. Would you agree or disagree to put warnings on alcohol adverts with the purpose to warn pregnant women and drivers of dangers of drinking alcohol?

Totally agree

Tend to agree

Tend to disagree

Totally disagree

Don’t know

EU27

Figure 3: Survey about labelling of alcoholic beverages Source: Special Eurobarometer, “EU’s citizens attitudes towards alcohol”, 2010, http://ec.europa.eu/ health/alcohol/docs/ebs_331_en.pdf, retrieved the 13.05.2015.

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The EU should build upon the recent tobacco labelling experiences, which have proven to be a success. Good quality studies report that tobacco warnings have an effect on behaviour, including quitting smoking, attempting to quit or reducing smoking (Argo and Main, 2004), and that pictorial warnings seem to have greater impact than text-only warnings (Beatty and Allsop, 2009). However, research suggests that warning labels may increase awareness of the risks associated with excessive alcohol consumption, but this does not necessarily translate into behavioural changes in at-risk groups (Wilkinson and Room, 2009). Some studies indicate that pictorial health warnings about alcohol have a more positive effect on behaviour change (Guillemont and Léon, 2008) and that this change may be easier in certain groups than others. The EHP strongly recommends that all EU member states: • IInclude a clear pictorial health warning outlining the risk of drinking during pregnancy; • Include a clear pictorial warning about alcohol reducing the ability to drive safely.

CLEAR INFORMATION ON MAXIMUM RECOMMENDED CONSUMPTION The maximum recommended consumption of alcohol varies according to the alcoholic graduation/ concentration of beverages (NHS Choices, 2015), which makes it difficult for consumers to assess if they are exceeding the recommendations. The EHP recommends that: • The new EU Alcohol Strategy implements the “unit” as the standardised measure for alcohol consumption; • All alcoholic beverages containers indicate the daily maximum intake recommendation for men and women; • Spirits containers provide additional measures to empower customers to correctly estimate their consumption (e.g., cap dosage system; units indicated with marks in the bottles);

INCLUSION OF CALORIC CONTENT AND INGREDIENTS Alcohol is said to provide “empty calories”, as it is rich in sugar but contains no nutrients (proteins, fats, vitamins) (Drinkaware, 2013). As a highly caloric good, its overconsumption can result in overweight or obesity. However, in a clear violation of the consumers’ right to information, alcohol is currently exempted from stating its caloric content in labels. Additionally, consumers should have the right to be informed about all the ingredients alcoholic products contain, as is the case with all other drink and food products. The EHP recommends that: • The inclusion of calorific content in labels be compulsory and enforced within a reasonable period of time, as an EP ENVI Committee Resolution from April 2015 requested (European Parliament, 2015). • All alcoholic products labels feature a list detailing all the ingredients and components.

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QC9.2 To what extend do you agree or disagree with the following? Alcohol advertising targeting young people should be banned in all EU Member States - EU Totaly agree

EB72.3 October 2009 (EU27)

51%

EB66.2 Oct. - Nov. 2006 (EU25)

50%

INCLUSION OF AGE LIMIT

Tend to agree

Tend to disagree

76%

Disagree

QC1a During the past 12 m (beer, wine, sprits, c

26%

13%

EB72.3 October 2009 (EU27)

26%

14%

EB66.2 Oct. - Nov. 2006 (EU25)

We strongly recommend the inclusion of a defined age limit for the consumption of alcohol on the labels of all alcoholic products, as well as indications of the legal consequences of sales to underage consumers.

QC9.3 To what extend do you agree or disagree with the following? Selling and serving alcohol to people under the age of 18 years should be banned in all EU Member States - EU Totaly agree

EB72.3 October 2009 (EU27)

EB66.2 Oct. - Nov. 2006 (EU25)

Tend to agree

69%

65%

Tend to disagree

76%

Disagree

20%

22%

6% 3%

EB72.3 October 2009 (EU27)

EB66.2 Oct. - Nov. 2006 (EU25)

Figure 4: Survey on legal drinking age, Source: Special Eurobarometer, “EU’s citizens attitudes towards alcohol”, 2010, http://ec.europa.eu/ health/alcohol/docs/ebs_331_en.pdf, retrieved the 13.05.2015.

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QC1a During the past 12 m (beer, wine, sprits, c

Marketing Some member states already have regulation in place to control marketing of alcohol (e.g. the Loi Evin, in France). At EU level the Audiovisual Media Services Directive (2010/13/EU) states that alcohol beverages shall not be aimed specifically at minors, but young people are still often targeted or not appropriately protected from marketing on alcohol (e.g. exposure through sponsorship of major sports and music events).

QC9.2 To what extend do you agree or disagree with the following? Alcohol advertising targeting young people should be banned in all EU Member States - EU Totaly agree

EB72.3 October 2009 (EU27)

51%

EB66.2 Oct. - Nov. 2006 (EU25)

50%

Tend to agree

Tend to disagree

76%

Disagree

26%

13%

EB72.3 October 2009

26%

14%

EB66.2 Oct. - Nov. 2006

Figure 5; Survey on the marketing of alcohol targeted at young people, Source: Special Eurobarometer, “EU’s citizens attitudes towards alcohol”, 2010, http://ec.europa.eu/ health/alcohol/docs/ebs_331_en.pdf, retrieved the 13.05.2015..

QC9.3 To what extend do you agree or disagree with the following? Selling and serving alcohol to people under the age of 18 years should be banned in all EU Member States - EU

The EHP recommends strengthening the implementation of the AVMS Directive at national level: Totaly agree

Tend to agree

Tend to disagree

Disagree

• The locations and messages of alcohol marketing should be regulated. Building upon the success of tobacco marketing controls and the French Loi Evin, alcohol advertising should be limited in public EB72.3 76% 69% 20% 6% 3% 2% October 2009 (EU27) settings • Commercial communication should be messaged appropriately, with sensitivity applied when targetingEB66.2 minors, so as to prevent the impression that consumption contributes towards social or 65% 22% 8% 4% 1% Oct. - Nov. 2006 (EU25) sexual success.

EB72.3 October 2009

EB66.2 Oct. - Nov. 2006

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Pricing: Taxation TAXATION There is evidence that “price affects drinking in all types of beverages and across the population of drinkers from light drinkers to heavy drinkers” (Karlsson and Österberg, 2009). Higher taxes have often been used to achieve non-fiscal targets, such as on cigarettes, so as to reduce tobacco consumption, or on cars and fuel, to lessen the negative environmental impact of driving. WHO studies found that increasing taxes on alcoholic beverages helps attain public health goals. But a study by Rand Europe for the European Commission reported that “the real value of the EU alcohol minimum excise duty rates, and of member states alcohol taxation, has decreased since the mid-1990s in most EU countries”(Rand Europe, 2009). We applaud the efforts of the Scottish government to bring in a Minimum Unit Price (MUP) to address Scotland’s increasing alcohol consumption, and we await the ruling of the European Court of Justice on this matter. The EHP recommends that, in order to deter people from consuming large amounts of alcohol, and to improve the health of Europe’s population, Excise duties be increased and wine excise duties introduced. • Retailers of alcoholic drinks should no longer be permitted to absorb the excise duties, but must pass them on to consumers. • Minimum excise duty rates should be streamlined across the EU in line with a country’s per capita GDP. • The revenues gathered through taxation should be invested in promoting citizens’ health, via education campaigns and other preventive measures for tackling alcohol and related health problems, availability of alcohol-free activities, promotion of healthy lifestyles, etc.

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Role of EU health systems in supporting prevention and reducing alcohol related harm The new remote monitoring tools offered by eHealth and mHealth applications have a role in monitoring the habits of individuals and providing advice when needed. Uptake of eHealth and mHealth implies the development of adequate regulations at EU level, notably in data privacy and electronic health records. Health applications could raise awareness about individual consumption on alcohol, or information and education on alcohol-related harm. Health professionals could make greater use of eHealth tools to target wider but also younger populations with information on health determinants. To support shifts towards prevention in people’s behaviour, health systems should target the young population, and take health education to communities, schools and workplaces, as a public health measure. Health systems should change their focus from treating diseases to promoting prevention. The EHP recommends • Increased support to gather evidence about the use of applications to promote health education and monitor lifestyles (like alcohol consumption) among the population, especially young people. • Measures in some member states to reduce access to and availability of alcohol among high-risk communities - through restricting opening times, locations and quantities for alcohol purchases.

Investments in Health Promotion: Health promotion should become a cultural habit in our societies, overcoming the challenge that it is not the most effective tool where habits are long-established. Information about the consequences should be made clear to all citizens. Health professionals should be adequately trained to provide guidelines and advice on alcohol consumption and related harm. • The EHP recommends more investment in health professionals’ education to enhance their role in informing and warning citizens about alcohol related harm.

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es - EU

QC1a During the past 12 months, did you drink any alcoholic beverage (beer, wine, sprits, cider or other alcoholic beverages)? - EU

Yes

EB72.3 October 2009 (EU27)

76%

24%

Changing the EU drinking culture through education EB66.2 Oct. - Nov. 2006 (EU25)

75%

25%

Drinking forms part of Europe’s culture and it is considered as part of a social activity, important for social relations, behaviour, and interactions. The Eurobarometer study confirms the important role alcohol plays in our lives.

s - EU

QC1a During the past 12 months, did you drink any alcoholic beverage (beer, wine, sprits, cider or other alcoholic beverages)? - EU

Yes

EB72.3 October 2009 (EU27)

76%

24%

EB66.2 Oct. - Nov. 2006 (EU25)

75%

25%

Figure 6: Survey on the frequency of alcohol consumption, Source: Special Eurobarometer, “EU’s citizens attitudes towards alcohol”, 2010, http://ec.europa.eu/ health/alcohol/docs/ebs_331_en.pdf, retrieved the 13.05.2015.

Unofficial rules and the self-imposed protocols of drinking rituals have more influence on levels of consumption and drinking behaviour than ‘external’ controls. Alcohol can differentiate the ‘insider’ and ‘outsider’ group in a society or among peers. Experimenting with alcohol is a common phase for many teenagers in the transition to adulthood. It is present during important moments of people’s lives and carries a symbolic message of success or luxury. Advertising and promoting an image of alcohol related to social success is particularly powerful in these periods, making education campaigns and limitations in publicity and marketing all the more important. The EHP recommends: • Increasing the availability of information about alcohol-related harm, and the health consequences arising from the consumption of alcohol. This information should be displayed in schools, universities and public spaces in a variety of formats, including an “ex-alcoholic programme” to raise awareness by using the personal experiences of people that suffered the consequences of abusing alcohol. • Increasing the presence of educational campaigns in the communication channels most used by young people. • Diminishing the positive image of alcohol conveyed by advertising, and disconnecting it from the context of leisure.

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VI. CONCLUSION Alcohol is part of European culture, and the EU benefits economically from the production and sale of alcoholic beverages. But Europe is experiencing the high health and social cost of alcohol abuse, and its links to chronic disease. The EHP therefore makes evidenced-based recommendations in this paper and encourages EU and national policy makers to consider implementing these proposals as a way to reduce the harmful effects of alcohol consumption. Although cultures and habits vary across the EU, and not all approaches can or should be mandated across the region, there should be an EU alcohol policy which can assist member states in tackling alcohol-related harm. Local and individual targeted approaches should be supplemented by select, unified measures applicable across all member states. The rationale is simple: Europe as a region suffers disproportionately from alcohol-related harm and needs to confront this problem through the cooperation of all member states, which can be most effective through EU-wide policies. That is why we call for a new EU alcohol strategy. A coordinated package of alcohol policies must be implemented, including economic measures such as pricing and taxes, as well as more effective promotion of education and information on labels of alcoholic beverages. If these policies are implemented across the EU they will reduce the burden of alcohol related harm and the chronic disease associated with it.

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VII. REFERENCES Argo,J.J. and Main, K.J. (2004) ‘Meta-analyses of the effectiveness of warning labels’, Journal of Public Policy & Marketing, 23. Beatty, S. and Allsop, S. (2009) Reducing Drug-Related Harm: What the Evidence Tells Us, IP Communications. Blewett, N. et al. (2011) Labelling Logic: Review of Food Labelling Law and Policy, Australia and New Zealand Food Regulation Ministerial Council. Available at: http://www.foodlabellingreview.gov.au/internet/foodlabelling/publishing.nsf/content/ 48c0548d80e715bcca257825001e5dc0/$file/labelling%20logic_2011.pdf (Accessed: 16th May 2015). Cirio, A. et al. (2015) ‘Motion for Resolution further to Question for Oral answer B8-0108/2015 pursuant to Rule 128(5) of the Rules of Procedure on Alcohol strategy (2015/2543(RSP))’, European Parliament. Available at: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP// TEXT+MOTION+B8-2015-0357+0+DOC+XML+V0//EN (Accessed: 16th May 2015). Committee on National Alcohol Policy and Action (2014a) scoping paper - Member States call on the European Commission for a new and comprehensive strategy to tackle harmful use of alcohol and alcohol related harm, Brussels: Committee on National Alcohol Policy and Action. Available at: http://ec.europa.eu/health/alcohol/docs/eu_scoping_paper_cnapa_en.pdf (Accessed: 16th May 2015). Committee on National Alcohol Policy and Action (2014b) Action Plan on Youth Drinking and on Heavy Episodic Drinking (Binge Drinking) (2014-2016). Brussels: Committee on National Alcohol Policy and Action. Available at: http://ec.europa.eu/health/alcohol/docs/2014_2016_actionplan_youthdrinking_en.pdf (Accessed: 16th May 2015). Drinkaware (2013) The facts about Calories in Alcohol, Available at: https://www.drinkaware.co.uk/media/314286/calories%20in%20alcohol.pdf (Accessed: 16th May 2015). Eurobarometer (2010) EU citizens’ attitudes towards alcohol, Belgium: European Commission. Available at: http://ec.europa.eu/health/alcohol/docs/ebs_331_en.pdf (Accessed: 16th May 2015). European Commission (2006) An EU strategy to support Member States in reducing alcohol related harm, Brussels: European Commission. Available at: http://ec.europa.eu/health/ph_determinants/ life_style/alcohol/documents/alcohol_com_625_en.pdf (Accessed: 16th May 2015). European Commission (2007) Together for Health: A Strategic Approach for the EU 2008-2013 (White Paper), Belgium: European Commission. Available at: http://ec.europa.eu/health-eu/doc/whitepaper_en.pdf (Accessed: 16th May 2015). European Commission (2011) The 2012 Ageing Report: Underlying Assumptions and Projection Methodologies, Belgium: European Union.

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European Commission (2013) Investing in Health: Commission Staff Working Document, Brussels: European Commission. Available at: http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf (Accessed: 16th May 2015). European Commission (2014) ‘Regulation (EU) No 282/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the establishment of a third Programme for the Union’s action in the field of health (2014-2020) and repealing Decision No 1350/2007/EC’, Official Journal of the European Union. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0282&from=EN (Accessed: 16th May 2015). European Parliament (2015) ‘European Parliament resolution of 29 April 2015 on Alcohol Strategy’. Available at: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2015-0174 Guillemont, J. and Léon, C. (2008) Alcool et grossesse: connaissances du grand public en 2007 et évolutions en trois ans [Alcohol and pregnancy: Public knowledge in 2007 and its changes over three years]. Évolutions, 15. International Agency for Research on Cancer, World Health Organization (1988) Alcohol drinking, Lyon: World Health Organization, International Agency for Research on Cancer. Juncker, J.C. (2014) ‘A New Start for Europe: My Agenda for Jobs, Growth, Fairness and Democratic Change’, Strasbourg 22 October. Available at: http://ec.europa.eu/priorities/docs/pg_en.pdf (Accessed: 16th May 2015). Juncker, J.C. and Timmermans, F. (2014) ‘Letter to President Schultz and President Renzi’. Available at: http://www.euractiv.com/files/letter_by_juncker_to_parliament_and_council.pdf Karlsson, T and Österberg, E. (2009) Alcohol affordability and cross-border trade in alcohol, Finland: Swedish National Institute of Public Health. McCambridge, L. D.A. (2006) ‘ Liver cirrhosis mortality rates in Britain from 1950 to 2002: an analysis of routine data.’, Lancet, 367(9504), pp. 52-56 [Online]. Available at: https://researchonline.lshtm.ac.uk/12329/1/cambridgeleon.pdf (Accessed: 16th May 2015). Morgan, D. and Astolfi, R. (2014) ‘Health Spending Continues to Stagnate in Many OECD Countries’, OECD Health Working Papers, 68(), pp. [Online]. Available at: http://www.oecd-ilibrary.org/docserver/download/5jz5sq5qnwf5.f?expires=1431827733&id=id&acc name=guest&checksum=39EFCD32767DC6BB233E8C9AC3187898 (Accessed: 16th May 2015). Mullally, A. et al. (2011) ‘Prevalence, predictors and perinatal outcomes of peri-conceptional alcohol exposure - retrospective cohort study in an urban obstetric population in Ireland’, BMC Pregnancy and Childbirth, 11(27), pp. [Online]. Available at: http://www.biomedcentral.com/1471-2393/11/27 (Accessed: 16th May 2015).

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NHS Choices (2015) Live Well: Alcohol units. Available at: http://www.nhs.uk/livewell/alcohol/pages/alcohol-units.aspx (Accessed: 16th May 2015). OECD (2014) Health at a Glance: Europe 2014, : OECD Publication. Available at: http://dx.doi.org/10.1787/health_glance_eur-2014-en (Accessed: 16th May 2015). Rand Europe (2009) The affordability of alcoholic beverages in the European Union Understanding the link between alcohol affordability, consumption and harms, UK: European Commission. Scientific Opinion of the Science Group of the European Alcohol and Health Forum (2011) Alcohol, Work and Productivity, Italy: European Union. Available at: http://ec.europa.eu/health/alcohol/docs/science_02_en.pdf (Accessed: 16th May 2015). Sneiders, O. (2015) ‘Health Ministers in Riga agree on the need for common EU nutrition and alcohol policies’, Latvian Presidency of the Council of the European Union, 21 April. Available at: https://eu2015.lv/news/media-releases/1353-health-ministers-in-riga-agree-on-the-need-forcommon-eu-nutrition-and-alcohol-policies (Accessed: 16th May 2015). United Nations (2002) World Population Ageing: 1950-2050, New York: United Nations Publications. Wilkinson, C. and Room, R. (2009) ‘Warnings on Alcohol Containers and Advertisements: International Experience and Evidence on Effects’, Drug and Alcohol Review, 28. World Health Organisation (2010) Global strategy to reduce the harmful use of alcohol, Italy: World Health Organisation. World Health Organisation (2012a) Alcohol in the European Union Consumption, harm and policy approaches, Denmark: World Health Organisation. World Health Organisation (2012b) European action plan to reduce the harmful use of alcohol 2012– 2020, Denmark: World Health Organisation. World Health Organisation (2014) Global status report on alcohol and health 2014, Luxembourg: World Health Organisation. Zamparutti, T. et al. (2012) Assessment of the added value of the EU strategy to support Member States in reducing alcohol – related harm, Brussels: European Commission.

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EUROPEAN HEALTH PARLIAMENT • 7 RECOMMENDATIONS ON HEALTHCARE IN EUROPE

EUROPEAN HEALTH PARLIAMENT 7 RECOMMENDATIONS ON HEALTHCARE IN EUROPE JUNE 2015