Unless it is amended, the new EU Directive on the Protection of Animals used for Scientific Purposes, as proposed by European Commission and European Parliament, could seriously impede the further advancement of European medical and veterinary research. The Directive requires amendments and further reinforcement of the fundamental principles applied to the use of animals in scientific research. These conclusions are published in a position paper from the European Medical Research Councils (EMRC), the Standing Committee for Medical Sciences at the European Science Foundation (ESF). This position paper also has the support of the Champalimaud Foundation, EUROHORCs, Foundation for Polish Science, the Pasteur Institute and the Wellcome Trust.

The paper presents a consensus on the subject reached within the European medical research community, drawing on the conclusions of the high-level Expert Group of European scientists coordinated by the ESF-EMRC and summarising the policy of ESF's Member Organisations. It aims to provide input into the discussion on the revision of the existing EC Directive on the protection of animals used in scientific research (86/609/EEC).

According to the Professor Roger Lemon, the Chair of the EMRC's Expert Group "The new European Directive on animal testing should employ more clearly the fundamental guiding principles for the use of animals in medical research, thereby ensuring an appropriate level of protection of animals used for scientific purposes, including non-human primates, while at the same time allowing for continued progress in scientific research".

In particular, three main themes run through the conclusions of the Expert Group:

• The overarching significance of the 3Rs in animal testing as a guiding principle – Refinement of scientific techniques, Reduction in numbers of animal used, and Replacement of animal procedures with non-animal procedures. As a complementary measure to the implementation of the Directive, the Expert Group emphasizes the need of properly funded 3Rs led-research programmes initiated or enhanced by the EU Member States and European Commission.

• The importance of the harm-benefit analysis for each prospective project involving animals in research and coupling this to the improvement of animal welfare to the highest level compatible with the scientific objectives of the project.

• The need of efficient decision making with the minimum bureaucracy in implementation of the Directive, including defined time limits for licensing of research by the permanent ethical review body and the competent authority.

Besides those general recommendations, the paper identifies and comments on key areas of the Directive where a better defined and more balanced approach is necessary to facilitate both animal welfare issues and protect the future of health sciences in Europe. Unamended, the current draft of the Directive will hamper basic biomedical and veterinary research; such research is the wellspring of all major discoveries, and leads through translation to real clinical benefit.