medicinesmatter The Irish Phar maceutical Healthcare Association
CALLS FOR GREATER RESEARCH RESOURCES Calls for a greater emphasis and resources for research were heard at IPHA’s recent annual conference. “Research should not be something limited to a doctor’s spare time,” said Dr Brendan Buckley, Department of Pharmacology and Therapeutics at UCC and member of the IMB’s Advisory Committee. The current funding environment was inadequate, Dr Buckley claimed – “… with researchers living from grant to mouth.” Innovation in the development and delivery of medicines, meanwhile remained vital in order to end “the enormous unrelieved burden of disease”, creating a need for new diagnostics that demanded the collaboration of the industry, academia, patients and government. “The choice for Ireland is producing bulk chemicals and competing with Bangladesh or ‘innovation’,” said Dr Buckley. Mr Michael Griffith of Fighting Blindness, claimed that it is patients who are likely to suffer most in the resulting wait for new cures: “Of 30,000 known human conditions only a quarter of them are treatable.
NOVEMBER 2005
CLINICAL TRIALS DATA OPENED UP A new initiative by the pharmaceutical industry now enables anyone to monitor the trials of new medicines and see how they are progressing. Patients and healthcare professionals can now refer to clinical trial data on new medicines and vaccines being developed around the world through a free service linking studies from all five continents. Access to trial data is provided through the website portal, www.ifpma.org/ clinicaltrials (see link from www.ipha.ie website), which contains more than 250,000 links, enabling users to access “non-promotional” information on the stage and progress of trials. The initiative launched by International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and IBM, provides coverage of ongoing trials worldwide, with extensive information on the medicines being trialled, the specific purpose of the trials, the stage they are at, where trials are being conducted and more (see box). “The portal provides doctors, patients and their families with simple access to the most complete information on clinical
trials of drugs and vaccines, “ said Dr Daniel Vasella, CEO of Novartis and president of the IFPMA. “The launch of this portal shows the pharmaceutical industry’s commitment to full transparency in the interests of patients and healthcare professionals.” “This is an effective, important and very valuable resource for professionals and patients alike,” said IPHA President Conn Clissmann. “Enabling everyone to find what potentially life-saving medicines are currently being developed, and being completely open about the stages and purpose of trials they are undergoing, helps better informed decisions to be made about the medicines patients use. By working to provide easy access to everyone on the medicines currently being developed and how our research-based industry is showing its commitment to transparency. “This information about products in development complements our well-established source of nonpromotional information about medicines already approved and available in Ireland at www.medicines.ie.” said Mr Clissmann.
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www.ifpma.org/clincialtrials INFORMATION AVAILABLE IFPMA has designed the website with public in mind, it claims, and extensive guidance and glossaries are provided to assist searches. The Portal allows two broad types of information to be searched for. One is listings (registries) of on-going clinical trials, providing access to basic information, including: brief title, description in lay terms, trial phase, trial type (e.g. interventional), trial status, trial purpose (treatment / diagnosis / prevention), intervention type (e.g. drug / vaccine), condition or disease, key eligibility criteria (including gender & age), location of trial and contact information.
Minister Micheàl Martin, TD with IPHA President Conn Clissmann at IPHA’s conference The Search for Innovative Solutions in Irish Healthcare.
The other broad category of information to which the Portal provides links to, is the results of completed clinical trials, which are made available in a standard, nonpromotional, summary format by various on-line databases. The IFPMA is keen to point out that this is just the first phase in an ongoing development in “putting useful information into the hands of patients and carers as quickly as possible.”
IPHA NEWS EFPIA INTRODUCES NEW MARKETING CODE OF PRACTICE The European Federation of Pharmaceutical Industry Associations (EFPIA), has introduced a revised code of
EUROPEAN PHARMA UNDER THE WEATHER Europe’s pharmaceutical industry is in need of medication itself, according to a new report from The European Commission published earlier last month. Declining R&D activity has already seen the lion’s share of new medicines development move to the US, and a number of reasons are cited: mounting price pressures, inadequate intellectual property protection; shorter exclusivity periods; poor co-ordination of private and public funding and a low information exchange between academic and business activities are all mentioned as contributory factors to a decline in the industry’s competitiveness in Europe.
practice in the promotion of new medicines. EFPIA, of which IPHA is the Irish member, represents all of the continent’s national pharmaceutical healthcare associations as well as a number of multinational pharmaceutical companies, and Ireland will be expected to comply with the new stipulations in its own version of the Code. The sixth edition of IPHA’s Marketing Code is currently under review and will be implemented shortly. The new European Code of Practice, is intended to harmonise standards of best practice in pharmaceutical marketing throughout Europe.
CINEMA FICTION August saw the US release of the film ‘The Constant Gardener’, which is scheduled for a November release here. The film includes Ralph Fiennes and Rachel Weisz and has been tipped as a potential award winner by the American press. Medicines Matter makes mention of it, as the pharma industry too plays a key role in the cast, with suggestions of manipulated trials, mass death, destruction and much evil. As with the actors appearing in the film, ‘The Constant Gardner’ is a work of fiction, (Ralph Fiennes, for example is not really married to Rachel Weisz). Some media coverage can be expected.
Only one compound in 13 now reaches the market, compared with one in 8 between 1995 to 2000, according to the Report. The good news is that bolstering the industry is now a priority of Enterprise Commissioner Gunter Verheugen. “The continued lack of international competitiveness and the economic and strategic significance of this industry to the European economy as a whole make a more comprehensive approach worth considering,” says the Report. The pharmaceutical industry accounts for 2.8% of EU industrial production, while ‘value added’ per employee is around a third higher than in other high tech sectors. Mr Verheugen has suggested the establishment of a Pharmaceuticals Forum made up of figures from industry and government plus stakeholders such as patient groups and health professionals. Biotech is also seen as a growth area, with the Commission estimating that bio accounts for 20% of marketed medicines and 50% of those in the pipeline.
FDI LINKED TO RESEARCH CAPABILITY A new report from the United Nations meanwhile shows that the availability of researchers is now a key driver in attracting foreign direct investment. The World Investment Report claims that the reasons for companies investing have changed considerably, and that cost and availability of research manpower increasingly influences their decision to invest. This same theme was echoed at the IPHA conference – see page 4 – with R&D investment being singled out as a key component in continuing the success of the industry here. Meanwhile, in a recent RTE interview, the Governor of the Central Bank, John Hurley, said
that an increased R&D capability is vital to maintaining our standard of living. Intertrade Ireland the cross- border body, has also published a report on what’s required for Ireland to be one of the top 5 global economies in income terms: ‘Engineering a Knowledge Economy’ recommends closer integration of industry and third level education, with more investment in research. And The European Commission has just launched an ‘upgrade’ to its Lisbon Agenda plans to secure 3% of GDP investment in R&D by 2010 which includes tax incentives and “greater knowledge transfer between public research and industry”.
PHARMACEUTICAL INDUSTRY’S CONTRIBUTION TO THE DEVELOPING WORLD The pharmaceutical industry has from time to time been criticised, and indeed sometimes vilified, for its role in the developing world. The new film “The Constant Gardener” sees some of the old charges rehashed. The healthcare crisis in the developing world is of a truly frightening magnitude and everyone, including the pharmaceutical industry, has a responsibility to seek to enhance its contribution to tackling the crisis. As noted by the UN Secretary General Kofi Annan poverty and a lack of basic healthcare infrastructure to distribute medicines are the greatest barriers to access to medicines in the developing world. 95% of the medicines on the World Health Organisation (WHO) essential medicines list are offpatent. TB, malaria, polio and measles are killing thousands of people, yet the medicines to cure them are mostly out of patent and cheap. The industry has contributed over $4.1 billion in donated medicines and financial assistance to the developing world in the period 1998-2003. In 2003 alone the total exceeded $1.47 billion. The industry is also involved with hundreds of partners such as development organisations, healthcare charities and Governments in 120 countries on 5 continents. For example the industry is involved in the Global Alliance for TB Drug Development, a public-private partnership involving the WHO and others to halt the rise and reverse the spread of the world’s oldest infectious disease by developing new and faster-acting tuberculosis medicines.
IPHA NEWS MEDICINES.IE LAUNCHED The consumer version of IPHA Medicines Compendium, medicines.ie is now taking hits. Featuring all the information from the Medicines Compendium, the website is designed to provide patients with fast and easy access to information on their medicines. The site also includes help sections and advice on using medicines. “It is vitally important to the health and wellbeing of the country that this independent information is readily available, free to both the medical profession and to the general public,” says Conn Clissmann of the IPHA. Medicines.ie is available on the web without charge and without advertising or any product promotion. “We in the pharmaceutical industry in Ireland, feel it is very important that such independent information on our products is readily accessible and in the public domain,” said Mr Clissmann.
OVER 6,000 IPHA MEDICINES COMPENDIUM DISTRIBUTED FREE The IPHA Medicines Compendium comprising the SPCs (Summary of Product Characteristics) and PIL (Patient Information Leaflet) for nearly 2,000 medicines currently available in Ireland was distributed to healthcare professionals in September. Over 6,000 CDs have been distributed by the IPHA to GPs and pharmacists, nationwide with many thousands of information leaflets for patients being distributed later this month.
“Some of the information is quite technical, of course, “says Dr Rebecca Cramp, who heads the project, “but the Medicines Compendium provides the information approved by the regulatory authority, and includes information such as possible side effects; interactions with other medicines etc. When users combine this information with package information leaflets (PILs) that accompany all medicines, the Compendium and medicines.ie provides patients with a very powerful and useful resource. “
INTERNAL COMMUNICATIONS CAMPAIGN LAUNCHED FOR PHARMA INDUSTRY A multi media presentation kit is being distributed to IPHA members and others for use in industry sites across the country. ‘The DNA of a Healthier Ireland’ campaign is designed to provide those working in the industry with a clear picture of how the sector is contributing to the health and well being of the country. Using the positioning statement: “Medicines Make A Difference – Your Work Makes A Difference”, the campaign follows requests from IPHA members, and is designed to show how different functions combine and contribute to creating lifesaving medicines. The presentation kit, comprising PowerPoint presentation plus extensive notes, aids and display material for the workplace will be arrive in industry sites through November. The following text is from a menu card intended for display on canteen tables: “Working in pharmaceuticals is different from other industries. What you produce here helps people get on with their lives- -– it helps them fight and prevent disease; it helps extend their lives and it helps them improve the quality of the lives they lead. “Research based pharmaceutical companies have created 90% of all medicines; they have helped increase life expectancy by a third and have virtually eliminated killer diseases such as TB, polio and pneumonia.”
INDUSTRY REPORT PUBLISHED Business and Finance magazine produced IPHA’s Industry Report, which provides a cross section of the industry incorporating the views of the IDA, IPHA members and other industry bodies, including IBEC’s Pharmachemical Ireland. The thirty page report provides a snapshot of Ireland’s largest export sector, including a history of its evolution, new statistics and a clear picture of the challenges ahead. The publication is intended to provide a single reference on the current state of the sector and its future, and has been distributed to third level institutions, stakeholders and members of both organisations. The document can be downloaded from the IPHA website at www.ipha.ie, and a limited number of additional copies are available on request from IPHA offices: amybrophy@ipha.ie
CONFERENCE SUMMARY CALLS FOR GREATER RESEARCH RESOURCES (CONTINUED) Innovation is definitely needed and urgently”, says Mr Griffith.” I think that especially because of the political difficulties this problem can only be tackled by partnership. Working groups must be established comprising regulators, industry, scientist and patient groups.” A full conference report is available from the IPHA website: www.ipha.ie
INNOVATING IRELAND’S FUTURE HEALTHCARE IPHA’s members heard about the challenges and the possible solutions facing the industry nationally and European-wide at IPHA’s annual conference on September 29th. Innovation in both the provision of healthcare and the business of making medicines was the theme of the morning long event, which featured speakers from Goodbody’s Stockbrokers, EFPIA, IMB, TCD and patient groups. The meeting was also addressed by Minister Micheàl Martin, TD.
Encouraging Innovation in Ireland
Professor Dermot Kelleher is professor of Clinical Medicine at TCD and has been heavily involved in applying academic research and innovation in the industry here. Ireland’s tradition of medical innovation is only now being restored, he claimed. “We’re getting to a respectable level of innovation here,” he said. “The challenge now is developing the right culture… Knowledge here is the driver of economic growth.” The timing for creating an innovative capability in Ireland for the development of medicines, especially biotech, is now ideal, Professor Kelleher maintained. Infrastructural investment is now paying practical dividends; there is a clear innovative capability in the county’s universities, and just a small number of ‘hits’ – successful products - are required for success. He also argues that innovation outsourced to smaller companies can out perform their more cautious patrons. “So the time is right for academic/industry partnerships” said Professor Kelleher. “Ideas are key. New technologies level the playing field giving smaller companies similar capabilities to larger ones.”
‘Innovate or Die’ - The Research Imperative
Irish Pharmaceutical Healthcare Association Franklin House 140 Pembroke Road Dublin 4 Ireland T: +353 1 660 3350 F: +353 1 668 6672 E-mail: info@ipha.ie Website: www.ipha.ie Content: Anne Nolan, Brian O’Grady, Brian Murphy Publisher: © Irish Pharmaceutical Healthcare Association Design and production: Slick Fish Design, Dublin
The growing output and contribution of orphan medicines, was an example of the role smaller innovation-led pharma businesses could contribute to world health, through what Dr Brendan Buckley, of UCC described as “dreamdriven development process” of high level of innovation and low overheads. “Orphan developers are often very small with no direct funding and minimum legislation experience,” he said, yet they have managed to make a valuable contribution to world health by bringing eight new medicines in the last five years, for which there had been no previous satisfactory treatment, with one million patients likely to benefit. According to Dr Buckley, the need to consolidate robust intellectual property legislation, together with “a change in the brownie points system of academia”; and adequate funding were vital components to creating a future for Ireland’s medicines industry. But perhaps the most fundamental problem remains Ireland’s taxation system, which encouraged property to the detriment of the capital investment needed to make indigenous businesses work. “This is very anti-innovative. We really need to change the culture here,” he said. Instead Ireland’s tax regime needs to be transformed to make capital available for investment in new ventures, by penalising the attraction of property investments
and incentivising business investments he claimed. The current climate of available funding was inadequate, he claimed – “… with researchers living from grant to mouth. Research should not be something limited to a doctor’s spare time.” “Ireland is starting to come up on the radar of the industry as being somewhere you can do good science, “ said Professor Kelleher during the summing up, claiming that an entrepreneurial culture was required here to generate the innovation capability Ireland needed. “We need lot of ‘little pharma’ companies being encouraged to set up here… We’re getting towards respectable levels of innovation here the challenge now is developing the right culture.”
Minister Martin on the Need for Change “This is an industry that has its footprint all over the country and we are very conscious that not only do we have to bed down and consolidate , but we also have to change our activities and move up the much quoted value chain” , said Minister Martin at the event.
After visiting pharma companies worldwide, the Minister said the signs for further FDI investments were very positive: “The news is good in terms of pipeline and in terms of the quality and skills in Ireland, “he said, claiming Ireland’s pharmaceutical capability is viewed very favourably overseas. The Minister also pointed to the role the industry plays in the health and well being of the country: “The contribution of medicines is often taken for granted... We need to make more of this connection and challenge people. As a society we cannot have an ‘eachways’ bet on this.”
Ireland’s Biggest Exporter
IPHA’s President Conn Clissmann, continued the message, claiming that developing new medicines is where the future lies for the Irish industry. “Ireland is now the world’s biggest net pharmaceutical exporter…. I fear we’re in danger of taking this for granted just because we’ve become so used to the extraordinary capability we have managed to create here. We spend more on innovation than any other sector and more than half of the 24,000 employed in the pharmaceutical sector are third level graduates. Make no mistake that this is the sort of industry that can lead Ireland’s economy well into the 21st century.”
Conn Clissmann, IPHA President; Minister Martin; Anne Nolan CEO IPHA, Minister Martin, and Dr Dermot Kelleher of the HSE.
A FULL WRITE UP OF THE CONFERENCE IS AVAILABLE FOR DOWNLOAD FROM THE IPHA WEBSITE WWW.IPHA.IE