medicinesmatter The Irish Phar maceutical Healthcare Association
SUMMER 2003
THE ROLE OF MEDICINES IN THE DELIVERY OF A WORLD-CLASS HEALTH SERVICE The recently announced Health Reform package emphasises the need for accountability, greater efficiency and improved financial management. It is only right that the State should seek to ensure value for the money it is investing in the health services. However any analysis of the sums invested on new medicines must be balanced against the true value of medicines to our health services. For example less time spent in expensive hospital care, an improved quality of life with less time lost from work or education. Alarm has been expressed at the growth in the State’s expenditure on medicines but a simple analysis highlights the reasons for that growth (see box).
It would be a matter of concern for the research based pharmaceutical industry, which has invested over €12 billion in the Irish economy and which provides employment to over 20,000 people, should a system be introduced which would favour old products over new products and make it difficult to develop a market for potentially better products with enhanced efficacy, safety and/or quality profiles. The Brennan Commission proposal to restrict the number of medicines reimbursed under the GMS Scheme, would not be in the best interests of patients. The implementation of this proposal would mean the abolition of the current single tier system of access to whatever medicine a doctor believes is appropriate for his/her patient, regardless of the patient’s wealth. Such a system would deny poorer patients access to the full range of modern medicines. The decision on which medicines, if any, to prescribe should be one for a patient’s doctor alone, and should not involve third parties. At a time when the concern is to achieve value for money questions must be asked about the benefit of employing a whole bureaucracy to develop, maintain and keep updated the lists necessary to operate a reference pricing system. The reference pricing system in Norway had to be abandoned shortly after its introduction, because it ended up costing money rather than saving it.
WHY IS THE MEDICINE BILL GOING UP EVERY YEAR? An increasing population An aging population •
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New treatments becoming available and more patients availing of them, for example proton pump inhibitors and new cardiovascular medication Ireland is starting from a low base with poor life expectancy and one of the lowest utilisation of medicines in the European Union. In the context of a doubling of health expenditure and the introduction of public health initiatives such the cancer strategy and the cardiovascular strategy it is only to be expected that spending on medicines will increase as the healthcare system endeavours to
improve life expectancy and quality of life. •
Increasing research and development costs, which now stand at over €895m
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Epidemiological evolution – the increased incidence of chronic and non-communicable diseases such as asthma, diabetes and obesity which are generally quite costly to treat.
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State decisions to enhance eligibility and alter the administration of certain community drug schemes.
The proposal that the Irish Medicines Board (IMB) assess the cost effectiveness of new medicines, may have the affect of delaying the admission of new authorised medicines to the community drug schemes. Such a situation would see some patients having their access to new treatments delayed and again would introduce an inequity into the Irish system whereby patients with money would get access to all medicines whilst other patients would have to go without. It is surprising that the Brennan Report should suggest that the (IMB) be given a role in the decision on whether a medicine should be reimbursed. As far as IPHA is aware, there is no other country in Europe where decisions on the authorisation and reimbursement of medicines are made by the same agency – rightly, they take the view that these two processes should be kept separate as authorisation decisions are based on a scientific assessment of quality, safety and efficacy whereas reimbursement decisions involve broader public health and policy considerations such as whether a State can afford the product or whether it is fair to deny patients access to a medicine. The consultative phase now commencing offers an opportunity for constructive debate. The ultimate objective of the introduction of reforms should be to help rather than hinder the creation of a world class health service, where modern medicines play a valuable role.
CLINICAL TRIALS DIRECTIVE The Department of Health & Children is currently drafting legislation to transpose (suggest the word reverse here, easier to understand) the Clinical Trials Directive 2001/20/EC in to Irish law. IPHA has recently submitted a detailed paper to the Department setting out the industry’s views on how the Directive could best be implemented. One of IPHA’s stated objectives is to enhance the environment for clinical research in Ireland so that the State can continue to attract high quality international clinical trials. The issues to be addressed in the implementation of the Directive from IPHA’s perspective, are: how best to formulate a single national opinion for multi-centre trials, how to enhance the functioning of ethics committees through the country and the need to streamline the six-day rule associated with the giving of consent for clinical trials in Ireland.
VALUE OF MEDICINE BOX MIGRAINE The Migraine Association of Ireland estimate that approximately 70,000 work days are lost as a result of migraine and that the total cost to the economy in terms of absenteeism and lost productivity exceeds €33 million annually. This, for an illness which 96% of GP’s in a 1999 IMS survey expressed the view that treatments can effect a significant improvement in patients’ quality of life. Unfortunately, the same survey found 59% of migraine sufferers had never consulted their GP over the condition. SCHIZOPHRENIA Schizophrenia costs the Irish economy more than €150 million annually. 90% of this cost relates to hospital care costs and could according to research, be reduced by an annual €70 million through the use of modern medicines. ASTHMA Appropriate medicines therapy as part of a disease management programme for asthma has not only been shown to be cost effective but may also lead to significant improvements in patients’ quality of life. An audit carried out
among 50 patients with severe asthma attending a specialist asthma clinic in Leeds showed that after six months, steroid costs had risen from €2,252 to €11,460. However, the cost of hospital admissions fell from €46,600 to €10,075, producing a net saving of €36,525. The alternative to the use of modern medicine is not cost free; it may involve longer hospital stays, longer less effective treatments, invalidity, sick pay and a poorer quality of life. Diabetes is a good example of the benefits of early intervention. The care of diabetes costs the Government approximately 10% of the total health budget. More than half of this money goes on the management of the complications of diabetes. There are estimated to be 87,000 people diagnosed as having diabetes and a further 80,000 who have diabetes but do not know it. Targeting and early diagnosis of this group would show the biggest dividends in terms of benefit from early intervention and reducing later costs, associated with managing the complications of diabetes, to the State.
REVIEW OF EU PHARMACEUTICAL LEGISLATION CHILDHOOD VACCINATION IPHA recently made a submission to the Expert Group established by the Minister for Health and Children to examine and report on the process in place to ensure the continuing quality of vaccine products licensed for use in Ireland.
Number of Cases Notified
IPHA expressed concern at the dangerously low level of vaccination uptake, particularly given the sharp increase in the number of cases of measles being reported in the State. The latest figures from the National Disease Surveillance Centre (NDSC) show that there were 303 measle cases reported between November 2002 and February 2003, a 500% increase on the figure of just 50 cases for the same period last year. 350
An important milestone in the review of the EU pharmaceutical legislation occurred on 2nd June, namely, the political agreement of the EU Health Ministers on the Commission’s amended proposals for a new Regulation on the European Medicines Evaluation Agency1 and amendments to the Codified Directive on human medicines2. The main points agreed at that meeting are as follows: • The scope of the Centralised Procedure is to be widened. Thus, in addition to biotechnology products, the Centralised Procedure will also become mandatory for the authorisation of medicines for the treatment of cancer, AIDS, neurodegenerative diseases and diabetes. For medicines in other disease areas there will be a choice between the Centralised and Decentralised procedures. A review process will be introduced to add further disease areas to the mandatory Centralised Procedure diseases in due course. •
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Regarding data protection, 10 years' regulatory data protection will apply to all mandatory Centralised Procedure products. For all other products (optional
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Centralised/Decentralised products), the period of data protection will be 10 years, but with the possibility for generic producers to apply for a marketing authorisation after 8 years. There will also be an additional one year's data protection for significant new indications, but only for mandatory Centralised Procedure products (see above). The Council’s decision not to provide similar data protection for significant new indications in other disease areas is illogical, and provides no support for further research in these areas. The Commission’s proposal for a pilot project on information to patients in three disease areas (AIDS, asthma & diabetes) has been dropped.
Political agreement has not yet been reached on the Veterinary Directive aspect of the review package and it is not yet fully clear when this will be achieved. Agreement on all three elements of the package (Regulation, Human Directive and Veterinary Directive) will be necessary to reach a “Common Position” in the Council, and thus initiate the next step of the legislative procedure (second reading in the European Parliament). All going well, the second reading in Parliament will
Amended proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products 2 Amended proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
G10 Medicines
NEWS FROM THE G10 PROCESS The G10 Report which was presented to the Commission in May this year was the result of discussions on the issues surrounding pharmaceutical industry competition, innovation and the provision of medicines in Europe. The process involved representatives of the industry, the Member States, the European Commission and other interested parties, including patient groups.
by State systems or medicines sold into private markets."
All over the world, Governments struggle to balance the rights of patients to have the best available treatments with the limited resources available to the EU’s health services. The G10 Group reviewed the current arrangements in Europe and recommended changes with a view to creating a situation where patients could have speedy access to the best treatments, the State could achieve value for the money invested in healthcare and the pharmaceutical industry could have a climate in Europe in which innovation was encouraged and rewarded.
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It would enable European patients to access new medicines at the same time in all European countries without having to resort to cross-border purchasing.
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It would not impact on Member States’ ability to negotiate or control the price of reimbursed medicines and would have no budgetary impact on their public finances.
The G10 Recommendations cover a wide range of issues including; the benchmarking of performance, access to innovative medicines, the timing of reimbursement and pricing negotiations, the generic market, the nonprescription market, incentives for research, enhanced information, patient information leaflets, the funding of patient groups, relative effectiveness, pharmacoviligance. A proposal which has attracted particular attention is Recommendation VI which states that: “That the Commission and Member States should secure the principle that a Member State authority to regulate prices in the EU should extend only to those medicines purchased by, or reimbursed by, the State. Full competition should be allowed for medicines not reimbursed
It embodies the concept that a Member State’s authority to regulate pharmaceutical prices should extend only to those medicines purchased or reimbursed by the State. The implementation of this principle would offer opportunities for all “stakeholders”:
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For Community authorities: it would favour the Treaty goals of improved competition and the establishment of the Single Market, which, for medicines, remain unfulfilled despite progress in other aspects of healthcare policy.
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For Industry: it would allow for some market-based pricing flexibility and open up the prospect of enabling a viable private market for some medicines which might meet industrial and social policy objectives.
In advance of the Irish Presidency of the European Union in the first half of 2004 the Tanaiste Mary Harney T.D. has been asked to become a member of the G10 implementation group. During the Italian Presidency of the EU in the second half of 2003 the process will be moved forward through the holding of a conference involving all the partners involved in the G10 process. Progress to date will be reviewed and future actions agreed.
ACCESS TO MEDICINES IN POOR COUNTRIES On 28 April, senior executives of the researchbased pharmaceutical industry took part in a new EU Round Table on Access to Medicines convened by Commissioners Lamy and Busquin to assess progress of the EU Plan for Action and recommend practical action ahead of the G8 Summit in Evian (1-3 June). Industry delegates reiterated their commitment to work with all parties on measures which have a real capability to make a sustainable impact on access to better health in the developing world. They emphasised the need to promote public-private partnerships as the best possible model to improve access to vital quality healthcare. Virtually all participants stressed the importance of finding ways to increase the global funding
available to affected countries and to strengthen local healthcare infrastructure, build hospitals, provide clean water, train doctors, educate people, diagnose and prevent the spread of killer diseases, etc. In late May the European Union agreed a regulation aimed at encouraging the provision of essential medicines to developing countries at sharply reduced (“tiered”) prices. The research-based industry supports the objectives behind the new Regulation - i.e. to tackle the diversion of medicines away from patients in poor countries and, hence, to encourage more widespread discounted pricing. However the industry believes that the Regulation is too rigid in some aspects and may not fully achieve its objectives.
IPHA HOLDS SEMINAR ON MEDICINES LEGISLATION IPHA recently held a special seminar for member companies on Medicines Legislation in Ireland. The seminar informed members of the pharmaceutical industry about the legislation regulating medicines in Ireland from various perspectives including manufacturing, wholesaling, marketing authorisations, labels and package leaflets, supply routes and controlled drugs legislation. The Irish Medicines Board’s Head of Enforcement Mr Hugo Bonar outlined how the IMB’s Enforcement Unit operated and the type of issues it was concerned about. These included: • Samples - Ensuring that company’s practices in relation to the provision of free medical samples to doctors and dentists are in line with IPHA’s Code of Marketing Practice and the Advertising Regulations. •
Verifying the bona fides of persons who are supplied with medicines - The importance of having procedures in place to check the bona fides of all customers supplied with medicinal products and in particular, their entitlement to receive them.
from L-R: Mr Stewart Hutton, Roche Consumer Healthcare, Mr Hugo Bonar, Head of Enforcement, Irish Medicines Board, Ms Leonie Clarke, Regulatory Affairs Manager, IPHA and Mr Tony Murphy, Roche Consumer Healthcare.
IPHA RAISES MONEY FOR HOMELESS CHARITY The Fifth Annual IPHA Charity Golf Classic was held at Glen of the Downs Golf Club on Friday 27th June. The proceeds of this year’s event went to Threshold, an Irish charity which has been working for the last twenty five years for justice on housing and homelessness in Ireland. The golfers took the opportunity to demonstrate their skills while experienced walkers took to the Wicklow Way. 33 teams enjoyed very pleasant golf in sunshine for most of the day. The outing concluded with a barbecue and prize giving at the Glen of the Downs Golf Club which was thoroughly enjoyed by participants as they admired the stunning views from the deck terrace.
From L-R: Mr Philip Chambers, Mr Chris Fitzgerald, Department of Health & Children, Ms Aideen Hayden, Chairperson, Threshold, Ms Anne Nolan, Chief Executive, IPHA, Mr Tom Mooney, Dept. of Health & Children and Mr Patrick Burke, Director, Threshold.
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, Cathy Curran, Leonie Clarke and Brian Murphy Publisher: © Irish Pharmaceutical Healthcare Association Design and production: Slick Fish Design, Dublin
IPHA NEWS PHARMACEUTICAL INDUSTRY RAISES FUNDS FOR THE SPECIAL OLYMPICS The Irish Pharmaceutical Healthcare Association (IPHA) raised over €51,000 for Ireland’s Special Olympics fund for 2003. Twenty one of IPHA’s member companies donated generously to what was one of Ireland’s biggest and most prestigious sporting events to date. The Special Olympics World Games took place from 20th-29th June in various sporting facilities within the greater Dublin area. Eighty medical centres were established at various venues during the Games at an estimated cost of €500,000 for medical equipment, bandages, oxygen etc. The pharmaceutical industry was delighted to be able to help in funding these medical centres through the money raised. IPHA President Michael Dempsey said “It gives me great pleasure to see that the Irish pharmaceutical industry supported this event in such a generous way. The Special Olympics World Games had the unique opportunity of combining the excitement of sport with the opportunity for personal distinction and pride”
Mr Michael Dempsey, President, IPHA, Ms Anne Nolan, Chief Executive, IPHA and Ms Mary Davis, CEO, 2003 Special Olympics World Games.
COMPANIES WHO CONTRIBUTED TO THE IPHA SPECIAL OLYMPICS FUND ARE: Abbott Laboratories Limited A Menarini Pharmaceuticals Ireland AstraZeneca Pharmaceuticals Ireland Ltd Boehringer Ingelheim Ireland Limited Boots Healthcare Limited Bristol Myers Squibb Pharmaceuticals Eli Lilly & Company (Ireland) Ltd Fujisawa Pharma Janssen-Cilag Health Limited Janssen Pharmacy Healthcare
Lundbeck Ireland Limited Merck Sharp & Dohme Limited Novartis Ireland Limited Pharmacia Ireland Limited Roche Products (Ireland) Limited Sanofi-Synthelabo Ireland Limited Serono Pharmaceuticals Limited Servier Laboratories (I) Limited Shire Pharmaceuticals Ireland Limited Solvay Healthcare Limited
IPPOSI SEMINAR ON “TURNING RESEARCH INTO CURES” IPHA sponsored the 3rd annual meeting of the Irish Platform of Patient Organisations, Science & Industry (IPPOSI) which took place in Dublin on Thursday 27th March. IPPOSI is an off-shoot of the Medical Research Charities Group, which is an informal group of thirteen charities involved in research promotion - Fighting Blindness, Alpha One, Irish Cancer Society, Children’s Medical and Research Foundation, Irish Heart Foundation, Mater Foundation, Richmond Brain Research Foundation, Cystic Fibrosis Society, Asthma Society of Ireland, Arthritis Foundation, Meningitis Research Foundation, Debra Ireland and Diabetes Federation Ireland. These charities have been working for the past two years with industry (Irish BioIndustry Association) and several individual scientists. The Platform is modelled on the European Platform for Patients’ Organisations, Science and Industry (EPPOSI www.EPPOSI.org) which is a coalition between patients, science and industry aimed at improving the legislative and regulatory procedures necessary to encourage the early development of therapies throughout Europe.
From left to right: Mr Michael Griffith, Fighting Blindness Ireland and IPPOSI, Dr Conor O'Carroll, Conference of Heads of Irish Universities, Dr Ruth Barrington, Chief Executive, Health Research Board, and Ms Leonie Clarke, Regulatory Affairs Manager, IPHA.
The theme of the 2003 IPPOSI Meeting was “Turning Research into Cures”, and it focused on initiatives to create a world-class legislative, regulatory and practical environment to expedite the development of therapies in Ireland. Over 50 people attended the meeting from the research charities, IPHA member companies, IMB, HRB, Enterprise Ireland, Science Foundation Ireland, Higher Education Authority, the universities and the Irish BioIndustry Association.