EuropaBio Acknowledges Need For Review Of Laboratory Animal Protection Directive

Main Category: Biology / Biochemistry
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 06 Nov 2008 - 8:00 PST

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EuropaBio, the European Biotech Industry Association, acknowledges the review of Directive 86/609, the laboratory animal protection Directive, but calls for a reduction of the bureaucratic burden the Directive places on SMEs. The legislation updates the rules and standards for breeding, use, housing and care of laboratory animals which were adopted over twenty years ago and now need to reflect advances in science and technology.

EuropaBio notes the great contribution biotechnology has made to the European Commission's "three Rs" principle of replacing, reducing, and refining animal testing and would like to see this work better supported. The biotechnology industry has promoted the use of alternative cell tests for toxicology and is increasingly using pharmocogenetics and genomics to better understand the cause of disease rather than use animals in the research and development of new therapies. Cell culture is currently the most successful and promising alternative to animal use. For example, cultured cells have been developed to create monoclonal antibodies, which previously required animals to undergo a procedure likely to cause pain and distress. Cell culture can supplement and could, one day, replace much of the animal testing done to assess the safety and efficacy of medicines. However, it is worth noting that current legislation requires an animal test to be carried out to prove safety.

"We fully support the highest standards for animal care and animal welfare but we are concerned with the bureaucracy proposed by the European Commission Directive, which does not improve the welfare of animals but disproportionately burdens small and medium enterprises" said EuropaBio's Secretary General Willy De Greef.

It is important for the competitiveness of the healthcare biotechnology industry that the European Commission recognizes and quantifies the extent of the bureaucratic burden that the new Directive places on innovative SMEs, especially in the area of ethical advice on the housing and care of laboratory animals. EuropaBio supports ethical review but calls on the European Commission to re-examine the bureaucracy involved and the potential for needless duplication which could hinder badly needed research.

About EuropaBio

EuropaBio is the European Association for Bioindustries, solely and uniquely bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 79 corporate members operating worldwide, 5 associate members, 6 BioRegions and 25 national biotechnology associations representing some 1800 small and medium sized enterprises involved in research. Its mission is to promote an innovative and dynamic biotechnology-based industry in Europe. http://www.europabio.org/

EuropaBio is a founding trade association of the EPAA, the European partnership for alternative approaches to animal testing, a joint initiative between industry and the European Commission.

http://www.epaa.eu.com