MEDICINES
matter May 2008
Achieving sustainable health spending It has become more and more apparent that the period ahead will be a challenging one for the State as it seeks to finance an ever growing health budget, and for the pharmaceutical industry, as it seeks to develop and make available new treatments to patients. The IPHA report, Healthcare Facts and Figures 2008, highlights how public expenditure on health quadrupled in the period 1998-2008 to reach an all time high of over €16 billion this year, accounting for almost a quarter of all current Government expenditure. Nonetheless public expenditure on health in Ireland, remains low relative to our Western European neighbors. Given our demographic and epidemiological trends, it will increase still further in the years ahead. The question is whether we can achieve value for money from the ever increasing amounts invested in health. A growing and ageing population will have significant implications for public spending and, in particular, health expenditure, as the elderly typically require two to five times as many resources as those under 65.
health spending to be targeted in a way that maximises the health benefits. This is crucial to the sustainability of health spending.
IPHA/HSE AGREEMENT The appropriate use of medicines is particularly vital in this respect. The State and the pharmaceutical industry through a long-term partnership have ensured that all patients, regardless of their means, have access to the full range of modern therapies. This relationship has supported and encouraged innovation and has been key to the improvement of our healthcare system, patient health and our country’s economic development. Ireland currently has an efficient system which allows authorised products to be put on the reimbursement list in a timely manner, enabling prompt access for all patients to new treatments. Medicines prevent, treat and cure disease, improve quality-of-life, control pain and suffering, reduce the need for costly, painful surgery, ease the burden on care-
givers, delay or avoid costly long-term nursing care and save lives. And, in the context of limited healthcare resources, access to medicines can empower patients to manage more of their own care with timely, effective and convenient treatment. This allows the State to save millions in healthcare costs which may be invested back into the health services. The industry recognises and supports the State’s need to ensure that it gets value for money for the large sums it is investing in the health services, including on medicines. A mechanism to assess value for money is welcome however industry believes that it should be consistent with the State's proinnovation outlook and not result in bureaucratic delays or, even worse, patients being denied access to new innovative medicines. New treatments, in fact, can help patients to recover more quickly, reducing hospitalisation costs, reducing time spent off work and lengthening life expectancy. It is vital that any reforms that are undertaken in the health services should both foster innovation and speed its application in all areas where there will be benefits to health outcomes.
With one in five persons in Ireland obese and every second person overweight, the incidence of chronic disease is set to increase. This too will have a significant impact on health expenditure. Ireland needs to continue with its pro-innovation outlook and commit to ensuring that innovative solutions in terms of treatments and service delivery can facilitate the development of the efficient and effective health service we all desire. The ‘Personal Health Check Programme’, promised in the Programme for Government, needs to be rolled out as a matter of priority. Comprehensive health screening would enable
“MyPortal” IN THIS ISSUE
Prof Kamal Sabra, Head of the HSE Corporate Pharmaceutical Unit, Mr John McLaughlin, IPHA President and Ms Anne Nolan, IPHA Chief Executive at the IPHA Annual Meeting ‘Ensuring Innovation Delivers for Irish Patients’.
Medicines in the community
New medicines development
Getting serious about innovation and more...
Did you know? Achieving sustainable health spending (continued) CLINICAL RESEARCH There is a need to make innovation and the innovation process work for patients. Ireland has a unique opportunity which needs to be grasped now, not tomorrow. Healthcare providers in Irish hospitals and academic institutions have shown that they have the ability to participate and drive world-class research but they are limited by current structures and practices. The opportunity to take part in clinical trials allows clinicians to develop a familiarity with innovative therapies which can speed patient access to such therapies once they are licensed. One of the biggest obstacles to the effective, speedy commencement of clinical trials in Ireland had been the issue of a standard indemnity. Last year, IPHA agreed a single standard indemnity form for all pharmaceutical company led trials conducted in the 56 HSE hospitals in Ireland. Many private hospitals have now also introduced this standard indemnity, due to its benefits. However, this momentum needs to be sustained. The ethics committee approval system needs to be standardised and its predictability enhanced. We need to have full compliance with the existing legislation and we need protected time for research clinicians and the development of a career structure for all clinicians, nurses and other health professionals if we are serious about attracting a worthwhile programme of clinical trials and world-class researchers to Ireland.
Developing adequate capabilities for clinical research will help bring the fruit of Irish-based research faster to patients through translational research, in line with the Government’s Science, Technology and Innovation Strategy. This is consistent with the Government’s commitment to support new translational research centres such as the newly created Trinity Academic Medical Centre and the Dublin Academic Health Care Centre. There is also a unique opportunity for Ireland to position itself as a hub for translational research that would open the door of the country’s excellent research capabilities to research and development collaborations with research-based pharmaceutical companies. Indeed,
In 1995 AIDS was transformed from a death sentence into a manageable chronic disease and thanks to more than 20 antiretroviral medicines discovered and developed entirely by the pharmaceutical industry, death rates from AIDS have plunged by 80% in the US and Europe.
bringing early stage clinical trials to Ireland from discoveries made in R&D laboratories will help ensure prompt access for Irish patients to innovative medicines once the medicine has been approved, thanks to the familiarisation of consultants at very early stage of the testing of medicines. Ultimately, innovative solutions, such as focusing on the complications of illness before they occur and treating them appropriately, are key to sustaining health spending.
IPHA President, Mr John McLaughlin giving the welcome speech at the IPHA Annual Meeting “Ensuring Innovation Delivers for Irish Patients”.
Medicines in the community The development of new treatments and initiatives by the State to improve public health, coupled with an increasingly ageing population, means that expenditure on the community medicines schemes has increased steadily in recent years.
Specifically, the General Medical Services (GMS) Scheme which provides free medical services to persons who would not otherwise be able, without undue hardship, to afford such services, rose over three fold (308%) in the ten years 1998 to 2007. Changes in rules relating to medical card eligibility lead to substantial increases in the earlier part of the period (2000/2003) with the average annual increase being over 22%. In more recent times (2004/2007) the average annual increase has been nearly halved to just 11.5%. The key factor behind the increase was the granting of medical cards to everyone over 70 years old. Whilst less people overall have medical cards than in 1994, the number of persons over 65 with such cards has increased by over one third in the same period. The elderly typically utilise 2-5 times as many health resources as those under 65, so not surprisingly as more of this age cohort received medical cards the cost of the scheme increased dramatically.
Getting serious about innovation If Ireland is serious about meeting its objective of increasing our level of innovation, focus needs to be continued on creating an environment where investment is welcome, R&D is fostered, and innovative ideas are valued and protected. There needs to be a greater realisation that the advances of pharmaceutical innovation are continuous. Not all innovative medicines are a result of “breakthroughs”. In fact, most medicines on the market today were created after ongoing, incremental steps were made to improve products and treatments. Ongoing improvements provide patients with medicines that are more effective, have fewer side effects, are easier to take, and are more tailored to a patient’s individual needs. Ongoing pharmaceutical innovation not only produces new therapeutic benefits for patients, but also leads us closer to “breakthrough” discoveries.
Medicines are an integral and increasingly important part of the Irish healthcare system. They prevent, treat and cure disease, improve quality-of-life, control pain and suffering and save lives. And, in the context of limited healthcare resources, access to medicines can empower patients to manage more of their own care with timely, effective and convenient treatment.
Pharmaceutical innovation is one valuable component of health care. The diversity of medicines generated by innovation permits greater choice and therapeutic precision and plays an increasingly valueadded role in health care delivery. Patients who suffer from depression, for example, benefit significantly from the variety of medicine choices available to them. For instance, one new anti-depressant may have fewer side-effects for a particular patient than a different but similar one. Medicines are an integral and increasingly important part of the Irish healthcare system. The benefits of ongoing pharmaceutical innovation are farreaching. New medicines help control and prevent disease, but they can also cut down on expensive surgeries and shorten hospital stays. The forward strides of pharmaceutical innovation provide net benefits to the health care system and the economy, and ultimately provide patients with the best treatment options available. Overall, that means an improved quality of life for people. Not having access to innovative medicines has obvious implications for the quality of care that patients receive.
The Strategy for Science, Technology and Innovation was welcome news for the Irish pharmaceutical sector. Money invested in pharmaceutical R&D directly benefits patients – who receive the latest treatments – and it supports the Irish scientific community who are critical in moving Ireland further up the international value chain. In order for the State to ensure maximum return on its investment it is important that the Irish trading environment remains favourable to industry – not just with regard to R&D. For the pharmaceutical industry to remain strong all key environmental factors – from promoting a strongly collaborative relationship with the HSE to promoting new innovative technical capabilities – must be actively pursued so that pharmaceutical companies in Ireland meet their potential.
Did you know? In 1975, surgery was used to treat peptic ulcers. With the discovery of a new class of medicine – H2 antagonist blockers – and the launch of a further new class of medicines – proton pump inhibitors – in the late 1980’s, the management of peptic ulcer diseases has been revolutionised. As such the need for surgical operations have steadily declined and have almost been eliminated.
New medicines development offers hope that there will be future breakthroughs Many changes are taking place in the way we discover new treatments and cures for disease. Cancer, diabetes, heart disease, and other deadly conditions affect millions. New medicines have led to improved treatments of certain forms of breast cancer, hypertension, and AIDS, while other medicines have slowed the decline of degenerative conditions such as Alzheimer’s disease or arthritis.
92
HIV/AIDS
197
Mental Health As impressive as advances in pharmaceuticals have been, the work is far from over. Millions of people with serious diseases and conditions, and a health care system struggling with rising costs and gaps in quality, can benefit from new medicine discoveries. There are currently over 600 medicines in development to combat cancer. These include 96 for lung cancer; 79 for breast cancer; 66 for colorectal cancer and 79 for prostate cancer. Additional medicines target brain, kidney, ovarian, pancreatic, skin and other cancers. Researchers right across the pharmaceutical industry are working on 277 medicines for two of the leading causes of death in Ireland – heart disease and stroke – keeping up the momentum of drug discovery that has helped cut deaths from these diseases by more than 40% in the past 15 years. Twenty-five years ago, the treatment for heart attacks was simply bed rest. Today, doctors have medicines that can stop a heart attack in mid-stream as well as other high-tech treatments.
Children
219
Neurological Conditions
241
Heart Disease and Stroke
277 303
Rare Diseases Infectious Diseases
338
Biotech
418
646
Cancer Women
700
Ageing
900
0 Source: Note:
100
200
500 400 300 Number of Medicines
600
700
800
900
PhRMA, Innovation.org 2007 data for Children, HIV/Aids, Infectious Diseases, Rare Diseases, Women, 2006 data for Biotech, Mental Health, Neurological Disorders, Ageing, Cancer
Many of these potential new medicines will fail in clinical trials. But some may represent tomorrow's breakthroughs to cure or prevent disease, reduce disability and improve quality of life for patients.
Good news for Pharma Ireland, but continued support required According to the IPHA report, Healthcare Facts and Figures 2008, the research-based pharmaceutical industry is one of the principal contributors to the growth of the Irish economy. It employs 24,500 people directly with as many people employed in providing services to the industry. In 2006, pharmaceutical exports exceeded €14.8 billion maintaining Ireland’s position as the largest net exporter of pharmaceuticals in the world. While using the broader pharmachem measure, exports exceeded €36 billion, or nearly 50% of all exports from the State. However, with a downturn in the pharmaceutical industry globally due to growing generic competition, stricter regulatory requirements and an unwillingness by some Governments to fund and support innovation, Ireland needs to continue with its commitment to supporting and fostering innovation which is central to the further development of the Irish economy.
The increasing complexity of medicines development The complexity of diseases researched today, together with the ever-increasing safety concerns make it difficult to succeed in R&D. In fact, the probability of success is less than one percent. Despite the largest ever (and growing) number of compounds in R&D pipelines, the number of new innovative medicines reaching patients has not increased significantly. The discovery, development, testing and gaining of regulatory approval for new medicines has become an even more highly complex, lengthy, risky and expensive process with each success built on many, many prior failures. As an example, termination of late stage human testing (Phase III) of pipeline compounds went from 30 to 50% in the 1990’s. To turn out just one to two products requires about a hundred discovery projects or approaches, involving upwards of 7 million compound tests in early screening assays. This level of screening produces about a thousand compounds with some of the criteria researchers are looking for. Follow-up molecular design and sophisticated biological testing narrows the number of development candidates. Once safety is confirmed in animal studies, compounds are advanced into human clinical trials where efficacy, safety and toleration are confirmed. As such the cost of developing a medicine has gone from ₏149 million in 1975 to ₏1,059 million in 2007.
From concept to product: steps in the genesis of a medicine
10,000 molecules screened
100 molecules tested
10 candidate molecules 1 medicine
Research phase 0
Test phase 5 years 10 years R&D
Development phase 10 years
Administrative Procedures 15 years
Commercialisation phase 20 years
2 to 3 years
Patent filing
It takes an average 10 to 12 years to develop a new medicine from the time it is discovered to when it passes the regulatory standards of safety, quality and efficacy and is available to patients. Once on the market the average medicine has only 8 to 10 years of effective patent protection left before facing generic competition. Moreover around 70% of medicines that eventually reach the market do not provide
Patent expiry
sufficient return to recoup their R&D expenditure before they lose patent protection. As a consequence, the return on investment is highly dependent on a limited number of successful products. The fact is that committing resources into researching new medicines is really an act of faith, which requires massive expenditure with no guarantee of return.
IPHA welcomes two new Board members Ms Elizabeth Reynolds B.Comm. (Hons) M.B.S. and Mr David Gallagher B.Agr.Sc. M.B.S. recently joined the IPHA Board of Directors and the IPHA Prescription Medicines Division Strategy Board respectively. Ms Elizabeth Reynolds attended University College Dublin where she graduated with an Honours Degree in Commerce and a Masters Degree in Business Studies (Marketing). She is currently Vice President and General Manager of GSK Consumer Healthcare Ireland. Elizabeth has significant experience within the Consumer Healthcare Industry having worked in various positions both in the UK and Ireland. She is a Council Member of the Beverage Council of Ireland as well as an Executive Board member of the Nutrition and Health Foundation. A graduate of University College Dublin with a Bachelor of Science Degree and the Michael Smurfit Business School Ireland/KU Leuven, Belgium with a Masters Degree in Business Studies, Mr David Gallagher is currently Managing Director of Pfizer Healthcare Ireland, a position he was appointed to in May 2007. David has significant international experience in the pharmaceutical and biotechnology sectors having worked in various positions within the industry globally.
“MyPortal” gives patients and doctors a means to keep informed about clinical trials The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Clinical Trials Portal (CTP) which provides an easy-to-use, single point of access to a comprehensive array of online information about ongoing clinical trials sponsored by the international research-based pharmaceutical industry, and summary results of completed trials has been further improved with the introduction of “MyPortal”. “MyPortal” allows users to record search criteria, to simply repeat searches and to request e-mail alerts when new trials are posted that match criteria they have specified. To make information found by the Portal more readily understandable, explanations in everyday language are made available for technical expressions, via convenient mouse-over-activated text balloons. The entire portal interface has also been redesigned for greater clarity and the display of search results has been refined, to help users find trials of interest more quickly. Industry is acutely aware that patients, especially those with serious long-term conditions, have an interest in keeping themselves informed about trials of new candidate medicines, as do the doctors treating them. “MyPortal” will make it easier for them to do so. The improvements also confirm industry’s determination to translate clinical trials transparency into a more accessible, practical self-help health tool for patients and doctors. You may visit the Clinical Trial Portal at www.ifpma.org/clinicaltrials.
Did you know? New innovative medicines have resulted in 8 out of every 10 children with leukaemia surviving. Death rates for all childhood cancers have dropped by over 50%. The five-year survival rate for women with breast cancer has increased by 80%.
Medicines Matter is published by the Irish Pharmaceutical Healthcare Association (IPHA) which represents the international research-based pharmaceutical industry in Ireland. Its member companies include both manufacturers of prescription medicines and non-prescription or consumer health care medicines. Irish Pharmaceutical Healthcare Association Franklin House 140 Pembroke Road Dublin 4 Ireland Tel: (353 1) 660 3350 www.ipha.ie Fax: (353 1) 668 6672 www.medicines.ie E-mail: info@ipha.ie www.feelbetter.ie
Content: Anne Nolan, Brian Murphy, Ronan Collins, Michelle Kurtz, Rebecca Cramp Publisher: © Irish Pharmaceutical Healthcare Association Ltd Design and production: Slick Fish Design, Dublin