The UK’s BioIndustry Association (BIA) has expressed disappointment with a long-awaited proposal on animal testing adopted by the European Commission yesterday.

Following a series of delays and reports of disagreements within the Commission during the inter-services consultation on revisions to Directive 86/609/EEC, a proposal has finally emerged that, according to the Commission, will “contribute to minimising as far as possible the number of animals used in experiments”. Directive 86/609/EEC covers the protection of laboratory animals across all industrial sectors in the European Union.

The proposed revisions also aim to “strengthen the protection of animals still used in scientific procedures in line with the European Union’s Protocol on Animal Welfare, ensure a level playing field throughout the EU for industry and enhance the quality of research conducted in the EU”, the European Commission stated.

But the BIA has complained of “unnecessary” regulatory burdens on scientists that “do nothing for – and in some cases worsen – animal welfare, and which will certainly drive research away from Europe to countries with low standards of animal welfare”.

The association’s chief executive, Aisling Burnand, commented: “One would expect that the proposed Directive would take into account the most up-to-date scientific and ethical practices, however this does not seem to be the case. The research community will feel that their core concerns have not been respected and indeed in some areas it could even have a negative impact on animal welfare.”

The history of the amendments goes back to 2002, when preparatory work for a new directive to address weaknesses in the existing EU legislation on animal testing and widening welfare standards between member states began in the Directorate General for the Environment. The European Parliament also adopted a report calling on the Commission to propose amendments to Directive 86/609/EEC in November 2002.

One feature of the proposals, which will now be considered by the European Parliament and the Council of the European Union, is that they “firmly” anchor the ‘3Rs’ principle of replacing, reducing and refining animal testing, the Commission noted.

“It is absolutely important to steer away from testing on animals,” said European Environment Commissioner Stavros Dimas. “Scientific research must focus on finding alternative methods to animal testing, but where alternatives are not available the situation of animals still used in experiments must be improved.”

The main differences between the proposed new Directive and the existing provisions are:

- The Commission’s proposal would make ethical reviews compulsory as well as requiring authorisation of experiments involving animals.
- It would widen the scope of the Directive to include specific invertebrate species and foetuses in their last trimester of development, as well as larvae and other animals used in basic research, education and training.
- It would set minimum housing and care requirements for laboratory animals.

- It would confine the use of laboratory animals to second-generation or older animals, subject to transition periods, to avoid taking species from the wild and exhausting those populations.
- The proposal says alternatives to animal testing must be used where available and the number of animals used in projects must be reduced to a minimum. Member states would have to improve breeding, accommodation and care methods to eliminate or reduce to a minimum any possible pain, suffering, distress or lasting harm caused to animals.

As expected, the proposal does not outlaw the use of non-human primates in research, despite the adoption in September 2007 of a written declaration from the European Parliament calling for a timetable for the replacement of all primates in scientific procedures.

The Commission has, however, proposed restrictions on the use of non-human primates as well as a ban on the use of great apes (chimpanzees, bonobos, gorillas and orangutans) in scientific procedures, except in special circumstances where the survival of the species itself is at stake or where there is an unexpected outbreak of life-threatening or debilitating disease in humans.

Contrary to BIA’s assertions, the Commission insists the proposed revisions strike a proper balance between promoting research and competitiveness and ensuring that animal welfare is upheld. “Under the revised Directive research activities in the EU are enhanced due to measures that reduce the bureaucratic burden and that foster a non-competitive approach to research inside the European Union,” it said.

“It is hoped the revision will greatly improve the quality of scientific research, boost innovation and promote the development of alternative methods,” the Commission added.