European Federation of Pharmaceutical Industries and Associations
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Founded in 1978, the European Federation of Pharmaceutical Industries and Associations or 'EFPIA' represents the research-based pharmaceutical industry operating in Europe. Through its direct membership of 32 national associations and 43 leading pharmaceutcial companies, EFPIA is the voice on the EU scene of 2,200 companies committed to researching, developing and bringing to patients new medicines that improve health and the quality of life around the world.
"If we can stimulate R&D in Europe and reward innovation, the research-based pharmaceutical industry will not only be able to improve healthcare and bring new innovative medicines faster to European patients, it will also contribute to the Lisbon objective of economic growth, to create more and better jobs, and therefore guarantee high living standards for current and future generations of European citizens." Brian Ager - Director-General EFPIA
The pharmaceutical industry's commitment to innovation has never been stronger. By the European Commission own reckoning, it spends more on R&D than any other industry. It contributes 15.3% of total EU private R&D expenditure. Of the 645,000 people it employs in Europe, 107,000 work in R&D. EFPIA also include two specialised groups focusing on vaccines and biotechnology respectively:
- European Vaccines' Manufacturers (EVM) produce approximately 80% of vaccines used worldwide.
- European Biopharmaceutical Enterprises (EBE) harness biotechnology to develop approximately one-fifth of new medicines.
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[edit] EFPIA Priorities
"EFPIA supports a vision of modern and sustainable healthcare systems in Europe, where patients have equal and early access to the best and safest medicines, which supports innovation, empowers citizens to make informed decisions about their health and ensures the highest security of the medicines supply chain." Arthur J. Higgins - President of EFPIA
To turn this vision into reality, industry's efforts are focused around four key areas - the AIMS (Access, Innovation, Mobilization, Security) programme.
- Access refers to the need to continue to work towards speeding up regulatory approval and reimbursement processes for new medicines; removing government controls on medicines that are not reimbursed; and ensuring that Health Technology Assessment (HTA) does not become a fourth hurdle to market access.
- Innovation focuses on efforts towards creating a strong science base in Europe and making Europe an attractive location for the best researchers; ensuring a fair reward for innovation, including incremental innovation and ensuring a high level of protection for Intellectual Property Rights.
- Mobilization is about joining forces with key stakeholders to address the challenges of an ageing population and deliver modern and sustainable healthcare; to fight damaging cost-containment policies; to empower patients and citizens to take an active role in managing their health through better access to information from multiple sources; to highlight industry's contribution to access to medicines and to promote new incentives for research into diseases affecting the developing world.
- Security refers to the need to strengthen the integrity and transparency of the pharmaceutical supply chain by addressing the safety concerns of parallel trade; raising public awareness on the risk of counterfeits; and increasing the traceability of pharmaceutical products.
[edit] Industry's Profile
Europe has a great deal to gain in health and economic terms from a strong and competitive indigenous research-based pharmaceutical sector.
- As well as contributing to the longevity and well-being of every European citizen, the research-based pharmaceutical industry is a key asset of the European economy representing about 19% of global business R&D investments and about 3.5% of the total EU manufactured exports. The industry employs approximately 643,000 people of which 107,000 work in R&D in Europe.
- Since the early 1990s, the research-based pharmaceutical industry in Europe has been losing competitiveness with respect to its main competitors, in particular the US. Data for 2006 and preliminary figures for 2007 confirm the vulnerability of Europe’s research-based pharmaceutical industry. Benchmarking and performance indicators show Europe's relative lack of attractiveness for pharmaceutical R&D investments.
- Between 1990 and 2007, R&D investment in United States grew 5.2 times whilst in Europe it only grew 3.3 times. The latest study released in 2007 estimated the average cost of researching and developing a new chemical or biological entity at € 1,059 million. The development of a new medicine is a highly complex, risky and increasingly costly process with no guarantee of success. Among 5,000-10,000 compounds investigated, only 1 will effectively reach the market as a medecine after 10-12 years of intensive R&D.
- There is rapid growth in the research environment in emerging economies such as China and India. The current tendency to close R&D sites in Europe and to open new sites in Asia will show dramatic effects in the next few years if nothing is done to maintain the pharmaceutical discovery expertise in the EU.
- The United States still dominates the biopharmaceutical field, accounting for the three quarters of the world’s biotechnology revenues and R&D spending.
- In 2007 North America accounted for 45.9% of world pharmaceutical sales against 31.1% for Europe. According to IMS Health data, 65% of sales of new medicines launched during the period 2002-2007 were generated on the US market, compared with 24% on the European market.
- The fragmentation of the EU pharmaceutical market results in a lucrative parallel trade which benefits neither social security nor patients but deprives the industry from additional resources to fund R&D. Parallel trade was estimated to amount to € 4,300 million (value at ex-factory prices) in 2006.
- It would be too simplistic to attribute the relative lack of attractiveness of Europe for pharmaceutical R&D to one single factor. Contributing to this problem are the economic and regulatory framework, the science base, the investment conditions, and societal attitudes towards new technologies.
[edit] Innovative Medicines Initiative
The Innovative Medicines Initiative (IMI) is a unique public-private partnership designed by the European Commission and EFPIA. It is a pan-European collaboration that brings together large biopharmaceutical companies, small- and medium-sized enterprises (SMEs), patient organisations, academia, hospitals and public authorities. The initiative aims to accelerate the discovery and development of better medicines by removing bottlenecks in the drug development process. It focuses on creating better methods and tools that improve and enhance the drug development process, rather than on developing specific, new medicines.
The European Commission and EFPIA have jointly established a new-non-profit European Community body. This organisation has a legal mandate to award research grants to European public-private collaborations conducting innovative research projects that focus on implementing the recommendation of the IMI Research Agenda.
The IMI Research Agenda was established under the lead of industry following intensive consultations with a broad range of stakeholders from across Europe. It identifies the principal research bottlenecks in the biopharmaceutical R&D process and sets forth recommendations to overcome these bottlenecks by focusing on four areas:
- Predicting safety: this addresses bottlenecks related to accurately evaluating the safety of a compound during the pre-clinical phase of the development process, but also impacts the later phases in clinical development.
- Predicting efficacy: this addresses bottlenecks in the ability to predict how a drug will interact in humans and how it may produce a change in function.
- Knowledge management: this addresses the more effective utilisation of information and data for prediciting safety and efficacy.
- Education & training: this closes existing training gaps in the drug development process.
IMI will make Europe more attractive for biopharmaceutical R&D investments and boost the competitiveness of European life science R&D. By directly addressing the challenges facing the biopharmaceutical sector in Europe, IMI has the potential to:
- modernise the development of medicines
- expand European expertise and know-how in new technologies to attract biomedical R&D investment to Europe
- anchor R&D jobs in Europe and reverse the brain drain
- enhance Europe's economy by improving the conditions for the biomedical industry and intensifying the collaboration of all stakeholders.
[edit] Members
EFPIA represents the pharmaceutical industry operating in Europe. Some Members of EFPIA include the following:
Abbott Laboratories (USA), AstraZeneca (UK/Sweden), Bayer Healthcare AG (Germany), Boehringer Ingelheim (Germany), Bristol Myers Squibb (USA), Chiesi Farmaceutici (Italy), Esai (Japan), Novartis (Switzerland), Pfizer (USA), sanofi-aventis (France),Solvay Pharmaceuticals (Belgium)
A full list of Members Companies as well as Member Associations is available at EFPIA's website.
[edit] External links
- European Federation of Pharmaceutical Industries and Associations
- Innovative Medicines Initiative
- European Vaccine Manufacturers (EVM)
- European Biopharmaceutical Enterprises (EBE)
