Statement by BIO Deutschland on the Draft Directive by the European Parliament and the European Commission on the Protection of Animals Used for Scientific Purposes

The industry association of the German biotechnology sector, the Biotechnology Industry Organisation of Germany (BIO Deutschland), warns against tightening requirements for studies on animals, particularly to the detriment of small and medium-sized enterprises, without this leading to verifiable improvements for the animals.

As the sector association, we represent the small and medium-sized enterprises of the German biotechnology branch. The majority of our members are active in the so-called "red" (medical) biotechnology sector, that is, they develop medication. To ensure the safety of patients, tests on animals are an indispensable element of biomedical research because around 70% of all severe side effects of new drugs can only be ascertained by such experiments. Most of these tests are stipulated by the drugs licensing authorities. We lobby for studies on animals to be conducted only when they are legally stipulated or essential for other reasons, when there are no other options and the burden on the animals is kept as low as possible. We wish to issue the following statement on the Draft Directive by the European Parliament and the European Commission on the Protection of Animals Used for Scientific Purposes, which has been submitted to the German Federal Ministry for Education and Research.

• In Article 35 of the EU Directive on the Protection of Animals Used for Scientific Purposes, a differentiated wording in the form of approval caveats and disclosure obligations in accordance with the valid German regulations (Section V of the German Animal Welfare Act) is vital.
• In Article 35 of the EU Directive, authorisation should be granted to "tests on animals" or "procedures" rather than to "projects" in terms of Article 3, Clause 1 of the EU Directive on the Protection of Animals Used for Scientific Purposes. As experiments are part of (entire) projects, and the authorisation in question only concerns these experiments, the use of the term "project" is misleading.
• Accrediting staff involved in animal experiments for a limited time period only, as stipulated by Article 20, Clause 3 of the EU Directive on the Protection of Animals Used for Scientific Purposes, creates unnecessary bureaucracy and costs. As staff have to prove that they are qualified in their initial accreditation procedure or when there are changes in personnel, this type of regulation, particularly as concerns innovative small and medium-sized enterprises, must be rejected.
• Article 24, Clause 2 of the EU Directive on the Protection of Animals Used for Scientific Purposes, must be extended to other professionally qualified individuals. Doctors and biologists (from the field of zoology) with specialist knowledge are also suited to undertaking the position of an animal welfare officer.
• Small and medium-sized enterprises are particularly harshly affected by the regulation on an ethics commission in companies (Article 25 of the EU Directive on the Protection of Animals Used for Scientific Purposes) and the double burden this places on employees. This regulation would lead to a higher workload and to increased bureaucracy, which is not necessary for animal welfare, especially when viewed in the light of the detailed examination of the ethical aspects carried out during the experiment authorisation procedure.