European Federation of Pharmaceutical Industries and Associations

European Federation of Pharmaceutical Industries and Associations (EFPIA) is a Brussels

Brussels

Brussels , officially the Brussels Region or Brussels-Capital Region , is the capital of Belgium and the de facto capital of the European Union...

-based trade union founded in 1978 representing the research-based pharmaceutical industry operating in Europe.

Through its direct membership of 31 national associations and 44 leading pharmaceutcial companies, EFPIA is the voice on the EU scene of 2,200 companies committed to researching, developing and bringing new medical treatments.

Figures published in 2008 by the European Commission (Eurostat)show that the pharmaceutical industry is the industrial sector which invests most in research & development (R&D)with 15.3% of total EU private R&D expenditure. Of the 635,000 people it employs in Europe, 117,000 work in R&D. (Source: Industry in figures - Edition 2009)

EFPIA also includes 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.

EFPIA Priorities

The industry's efforts are focused around four key areas - the AIMS - Roadmap of priorities (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.

Industry's Profile

The research-based pharmaceutical industry is a key asset of the European economy representing about 19.2% of global business R&D investments and about 3.5% of the total EU manufactured exports.

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 2007 and preliminary figures for 2008 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 2008, R&D investment in United States grew 5.6 times whilst in Europe it only grew 3.5 times. The latest study (Tufts University, Centre for the Study of Drug Development) released in 2007 estimated the average cost of researching and developing a new chemical or biological entity at € 1,059 million. Among 5,000-10,000 compounds investigated, only 1 will effectively reach the market as a medicine 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 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, 66% of sales of new medicines launched during the period 2004-2008 were generated on the US market, compared with 26% on the European market.

Source: Eurostat

Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is a 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.

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), Eli Lilly and Company

Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States...

(USA), Esai (Japan), Novartis (Switzerland), Novo Nordisk (Denmark), 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.

External links

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EFPIA Priorities

Industry's Profile

Innovative Medicines Initiative

Members

See also

External links