After nearly two years of delays, hard lobbying and impassioned debate, the European Union’s revised directive on the protection of laboratory animals has completed its passage through the legislative system and must now be implemented by the member states.

A compromise version of Directive 8869/10, agreed between the European Commission, Council of Ministers and European Parliament, was voted through in a full plenary session of the Parliament last week. It replaces Directive 86/609/EEC on the protection of laboratory animals, giving member states 24 months to transpose the new provisions into national law. Directive 8869/10 will take effect on 1 January 2013.

The aim of the revised directive, the European Commission said, was to strike a balance between improving the welfare of animals used in scientific procedures, ensuring fair competition for industry, and fostering research activity in the European Union.

“Today’s vote ends a long negotiation process, which has shown how sensitive and important the issues at stake are,” commented Environment Commissioner Janez Poto_nik. “However, everyone agreed that it is vital to improve the situation for animals still needed in scientific research and safety testing, whilst maintaining a high standard of research and improving the focus on finding alternative methods to animal testing. The European Union will soon have the highest standards of experimental animal welfare in the world.”

The European Commission’s proposed revisions to Directive 86/609/EEC were first published in November 2008. A plenary vote by the European Parliament in May 2009 adopted by a large majority a number of the contentious amendments to the Commission’s proposals that had been taken up by the Agriculture Committee at first reading.

The process was then stalled by the European Parliament’s elections in June 2009, leaving the new Parliament to negotiate with member state representatives on a first-reading agreement. The Council of Ministers announced a provisional agreement on draft Directive 8869/10 last May and a common position was adopted by the EU’s Council of Ministers in early June.

Widening gap

Explaining the rationale behind the revised directive, the Commission cited “a variety of weaknesses” in Directive 86/609/EEC and a widening gap in standards as a number of member states passed their own laws on the protection of laboratory animals.

“Our knowledge of animal welfare requirements and their capacity to experience pain, suffering and distress has increased since 1986 and the research environment has also evolved,” it added. “Many provisions of the directive currently in force are open to interpretation and some are more political than regulatory in nature. It does not include ethical reviews or requirements to obtain authorisations for experiments.”

Moreover, the Commission noted, EU legislation has never before explicitly addressed the ‘3Rs’ concept, which seeks to replace, reduce and refine the use of animals in scientific research.

Among the key provisions in Directive 8869/10 are:

• All animal experiments are now subject to pre-authorisation and ethical review. The directive also sets minimum housing and care requirements for laboratory animals and there is a strong emphasis on proper application and enforcement of the new rules through systematic controls and regular inspections. 
• The scope of the directive has been widened to include specific invertebrates and foetuses in their last trimester of development, as well as animals used for basic research, education and training.

• There are measures to encourage the development of alternative testing methods, such as a requirement to establish at EU level a reference laboratory responsible for co-ordinating and promoting the 3Rs. Member states must ensure the promotion of alternative testing methods at national level.

• However, the stipulation in Directive 86/609/EEC that animal experiments should not performed “if another scientifically satisfactory method, not entailing the use of an animal, is reasonably and practicably available” has been amended so that researchers are obliged to use alternative methods only if they are recognised in Community legislation. The original provision, the Commission said, had resulted in “misinterpretation and ambiguity”, prompting court cases in various member states.

• A general prohibition on the use of great apes like chimpanzees, bonobos, gorillas and orang-utans, other than in exceptional circumstances such as the unexpected outbreak of a life-threatening or debilitating disease in humans.

• The Commission’s draft law would have restricted the use of other primates such as ouistitis and macaques, but MEPs argued this could hamper research into neurodegenerative conditions such as Alzheimer’s disease. The Parliament and Council therefore agreed to allow the use of these primates if there is scientific evidence that the research objectives cannot be achieved otherwise.

Reactions from the various lobbying constituencies to the final text of the animal testing directive were predictably mixed.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) acknowledged rather than welcomed the approved directive, saying it “should bring direct and tangible animal welfare benefits and allow essential medical research to continue in Europe to deliver the new and innovative treatments that society wishes to see”.

“It is clearly better for Europe that such advances are made here in Europe, where animal welfare is a key consideration in the research framework,” the EFPIA added. But it remained “disappointed that certain provisions run the risk of creating legal uncertainty without bringing any welfare benefits. We hope that member states will address these concerns when transposing the text into national legislation”.

The European Coalition to End Animal Experiments (ECEAE) described the adoption of the new directive as “a missed opportunity to introduce measures that would have given greater protection to animals used in experiments”. Proposals to include strong restrictions on the use of non-human primates and the re-use of individual animals in experiments had been dropped, as had provisions for a clear ban on procedures involving severe and prolonged suffering.

Citing a heavy lobbying effort by “the multi-billion pound animal research industry”, the ECEAE said a number of significant issues with strong public support had been ignored during the revision process. These included a long-term strategy to reduce and ultimately replace the use of animals in scientific research; bans on the use of cats or dogs and on all experiments that do not address serious or life-threatening human conditions; and the implementation of a data-sharing system to avoid duplication of experiments.

Another animal protection organisation, Humane Society International, took a pragmatic view. “Whilst Europe’s new law on animal experiments was always bound to favour commercial interests over animal welfare, there is still much to celebrate,” commented Emily McIvor, senior EU adviser on research & toxicology.

The revised directive would markedly strengthen animal protection in many of the newer EU member states, where only minimum standards currently applied, McIvor noted. In other countries such as the United Kingdom and Germany, “it is likely to be ‘business as usual’ with few new restrictions on animal use”.

Humane Society International said it hoped other countries would “now follow Europe’s lead so that standards are improved globally. For countries like the United States, where millions of laboratory-bred birds, rats and mice used in experiments receive no legal protection under the country’s Animal Welfare Act, matching EU standards would be a huge step forward”.