3. Our direct members include 40 leading pharmaceutical companies and 31 national associations;
4. EFPIA provides a voice in the EU scene for around 2,200 companies committed to researching and developing medicines to benefit patients now and in the future;
8. Why is the pharmaceutical industry so important to Europe? The industry employs more that 110,000 in research and development facilities in Europe; equivalent to the entire population of Maastricht or Bruges. Furthermore, the industry in total directly employs more than 630,000 people – equivalent to the population of city the size of Frankfurt. Indirect employment takes this figure to over 1 million people; roughly the size of Geneva This helps keeps Europe remain an important hub of innovation, able to attract high-quality researchers
9. Why is the pharmaceutical industry so important to Europe? Financially, the industry is a substantial contributor to the European economy
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11. This dual role was highlighted by the shift of responsibility for pharma from DG ENT to DG SanCo
12. The complex nature of healthcare policy is further complicated by the national competence for healthcare expenditure v. EU policy in health and other areas;
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14. The pharmaceutical R&D process is The estimated the average cost of researching and developing a new chemical or biological entity is now estimated at $ 1.3 billion; The pharmaceutical industry needs to finance this from own resources; High failure rates, the increasing cost of clinical trials and the resources needed to required for regulatory approval are the primary drivers for this exponential increase of R&D costs; Yet the chances of new substances becoming a marketable medicine remain small; as low as 1 to 2 in 10,000; This demands a sustained and substantial cash flow that manufacturers are only able to generate if they gain access to national markets as quickly as possible; increasingly expensive Estimated full cost of bringing a new chemical or biological entity to market ($ million)
16. Also, access to the best medicines is not optimal Only a few patients receive up-to-date breast cancer treatment Source: Schöffski (2004), Impediments to the Diffusion of Innovative Medicines in Europe
17. Are accusations of ‘selling sickness’ valid? No. The reality is that the European regulatory and approval process makes it impossible
18. ‘Disease Mongering‘ is a demanding scenario Manufacturers can’t simply ‘create’ a new disease they wish to treat; Any disease requires recognition and classification; Regulatory authorities need evidence that the treatment is not only effective but also cost-effective; Clinicians need to be convinced that any disease is deserving of intervention; Payers need to be convinced that the treatment warrants reimbursement; Patients need to be concerned enough to seek assistance and treatment Patients, physicians, payers, regulators all need to be convinced to make this a reality
19. A greater concern should be unmet medical need Source: Schöffski (2004), Impediments to the Diffusion of Innovative Medicines in Europe
20. Industry has made, and will continue make, a real difference Life expectancy at birth 30 years more than 100 years ago Huge reductions in mortality (e.g. HIV/AIDS, many cancers, cardiovascular diseases) Significant progress in quality of life (e.g. asthma, diabetes) Still addressing unmet needs in Alzheimer, multiple sclerosis, many cancers and orphan diseases Addressing Dutch Priority Medicines report
21. 5-year relative survival (%)* during 3 time periods, by cancer site 1975-1977 1984-1986 1996-2002 Site All sites 50 53 66 Breast (female) 75 79 89 Colon 51 59 65 Leukemia 35 42 49 Lung and bronchus 13 13 16 Melanoma 82 86 92 Non-Hodgkin lymphoma 48 53 63 Ovary 37 40 Pancreas 2 3 5 Prostate 6976 Rectum49 5 66 Urinary bladder 73 78 82 † 45 100 *5-year relative survival rates based on follow up of patients through 2003. †Recent changes in classification of ovarian cancer have affected 1996-2002 survival rates. Source: Surveillance, Epidemiology, and End Results Program, 1975-2003, Division of Cancer Control and Population Sciences, National Cancer Institute, 2006 (Johnson & Johnson, Dr P. Stoffels, 21.10.08)
22. Tackling the leading causes of death in Europe Infectious Kidney and ureter Genitourinary Mental Nervous /sense Circulatory Digestive Respiratory Cancers Source: Eurostat (figures for 2006)
23. Percentage of global R&D projects by therapeutic class Source: PhRMA project & CRA analysis
24. Number of projects in early-stage pipeline has grown significantly However success rates between phase II and III are decreasing Source: AVOS
26. We are working hard to build trust in our industry Historically our industry had a legacy of a highly regulated environment and a limited, expert audience; Therefore are striving to improve transparency in all areas and all relationships EFPIA codes of practice for Promotion of POMs to, and interactions with, healthcare professionals; Relations between the industry and patient organisations; EFPIA Leadership Statement on Ethical Practices
30. Dispelling some other myths: New drugs are discovered by academia In 2001, US Congress commissioned a study to determine which of the top-selling medicines originated from NIH Of the 47 medicines which sold in excess of $500 million Only four had NIH patent ties Of the four, two were the same drug (Epotin) The other 43 were developed and discovered by industry with no federal involvement Dept of Human and Health Services, NIH Report to Congress on Affordability of Inventions and Products, July 2001
31. Dispelling some other myths: ‘Me too’ drugs have little or new value In reality, ‘first in class’ is not necessarily ‘best in class’ Competition in the industry is so intense that nearly all classes had at least one drug in Phase 3 testing before the 1st in class was approved; Around 1/3 of 1st class drugs to reach the US market in 1990s were not the 1st to enter clinical development Multiple treatments in the same class lead to price competition. Of the 20 new entrants to existing classes from 1995 to 1999, 80% entered at a discount to the price leader The best selling medicine in the world – Lipitor – is actually a ‘me too’ DiMasi, J.A. And Pacquette , C. (2004). The economics of follow-on drug research and development. Trends in entry rates and timing of development. Pharmacoeconomics 22 (Suppl 2) 1 -14
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