Review Of Laboratory Animal Protection; Directive Needs To Balance Animal Welfare, Research Realities And Patient Needs

Main Category: Veterinary
Article Date: 12 Nov 2008 - 4:00 PST

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EFPIA, the voice of the research-based pharmaceutical industry in Europe, acknowledges the release of the review of Directive 86/609 on the protection of laboratory animals, launched by the European Commission today. EFPIA remains committed to contributing constructively to this legislation, which sets out rules and standards for breeding, use, housing and care. The original legislation was adopted over 20 years ago and clearly requires updating to reflect advances in science and technology. EFPIA has called for a fair and factual debate, with a focus on improving animal welfare where necessary, ensuring that the EU remains an attractive location for investments in fundamental and applied medical research.

"Today, Europe already provides the highest standards of protection of laboratory animals in the world. This review is an opportunity to further harmonize standards. However, any new provisions in the legislation should be based on sound scientific evidence, and should not unnecessarily increase red tape. The review needs to balance animal welfare, research realities and patient needs", commented Director General of EFPIA, Brian Ager. "EFPIA and its member companies are committed to continuing all efforts to replace, reduce and refine animal research wherever feasible."

Animal research has played a vital role in virtually every major medical advance of the last century. Even today, no full replacement for animal research exists in finding ways to treat, for example, various forms of cancer, cystic fibrosis, Alzheimer's Disease, dementia and epilepsy.

Nowadays, 90% of research and development for medicines is conducted without the use of laboratory animals. The pharmaceutical industry has pioneered numerous alternative methods including synthetic animal proteins, imaging technologies, and in vitro tissues and cells. Non-animal research methods tend to be much less expensive, providing an economic as well as an ethical incentive to continue their development.

Almost 80% of animals used in research are rodents. Only 0.1% of research animals used today are non-human primates. The use of a limited number of non-human primates remains unavoidable in numerous therapy areas including Alzheimer's Disease, cancer, hepatitis, malaria, multiple sclerosis, Parkinson's Disease and tuberculosis.

About EFPIA

EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 32 national associations and 43 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 2,200 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.

The pharmaceutical industry accounts for no less than 19,3% of global business R&D expenditure. It is the sector with the highest ratio of R&D investment to net sales (15,9%). However, between 1990 and 2007, R&D investment in United States grew 5.2 times whilst in Europe it only grew 3.3 times, and there is rapid growth in the research environment in emerging economies such as China and India.

Today around 645,000 people work in this sector and it is estimated that three to four times more employment is generated indirectly both upstream and downstream. A significant proportion of people employed are highly skilled and 107,000 work in research and development. The European research-based pharmaceutical industry generates a substantial trade surplus, which was estimated at about €49,000 million for 2007. It has contributed significantly to reducing the European Union's trade deficit in high-tech products - today almost a quarter of the EU's high-tech exports are pharmaceutical products.

EFPIA