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Environment Committee highly critical of 1986 Directive

Difficulty in gathering information about the implementation of the 1986 EU Directive meant that her report was not as comprehensive as she would have wished, said Jill Evans in the European Parliament on 2 October. The Green MEP from the UK was introducing her report for the Environment Committee on the implementation of the 1986 Directive on the protection of animals used for experimental and other scientific purposes. She would be tabling further amendments to the report herself, she said. The report is already highly critical of both the existing Directive and the way in which it is implemented.

When the European Commission announced its intention to have a "fully-fledged" revision of the Directive, the Environment Committee swiftly announced its decision to produce its 'own-initiative' report on the Directive. Own-initiative reports have no role in European legislation, but they are seen as important indicators of the parliament's policies. But by producing such a report so quickly, the Environment Committee is clearly seeking to set the agenda for the lengthy revision process.

The draft report begins by stating that there is an urgent need to revise the Directive and claims that it has not been satisfactorily implemented in all Member States. The process of implementation is described as having been "at best a slow process". It points out that different countries have different methods of authorising, monitoring and reviewing animal research projects and that the effectiveness of controls vary between countries.

There is particular discussion of transgenic animals in the report, which comments that the current range of genetic techniques were not known when the Directive was written in 1986 and there has been a considerable increase in the genetic manipulation of laboratory animals since then. It calls for better recording of the numbers of transgenic animals used in the EU, that they should all be recorded and traced throughout their lives and that any transgenic animals with "debilitating deformities" which cause any distress should be immediately and humanely killed.

There is also criticism of the use of primates in research, which the report considers a cause for "great concern" and calls for a complete review of the practice.

In total the report puts forward 16 proposals for revising the Directive, many of which are unsurprising. It calls for stricter licensing procedures; better training for animal researchers; a ban on the use of animals for education, weapons and cosmetics testing; and a central database of animal experiments to ensure there is no repeat testing.

The influence of animal rights groups on the report is noticeable. Some of the allegations made by the British Union for the Abolition of Vivisection against the University of Cambridge are repeated almost verbatim in the introductory section of the report and referred to in the closing explanatory statement as listing "a catalogue of suffering".

Despite the contentious nature of the issue, and the considerable interest shown by MEPs in the past, there was little discussion at this first presentation of the own-initiative report, with only one other MEP speaking. The first vote will take place at the Environment Committee's next meeting on 4 and 5 November.

Revision of the existing Directive was overdue to reflect changes in science and in society's thinking on animals, said Jill Evans. It had been introduced primarily to avoid distortions in trade rather than to protect animals, and even with this rather limited Directive there had been many infringements and problems with implementation in Member States.

The 1986 Directive had aimed to reduce animal use and this had been achieved, with an overall reduction of 40-50% across Member States, she said. But the decrease was starting to slow down due to the increasing use of transgenic animals. Transgenics were an important area that any new Directive should address.

Evans thought that the most important point in her proposals was the call for a central EU inspectorate. In 1986 the Commission had called for a Standing Committee but this had not been agreed, with the result that it had been much more difficult to detect and act on infringements.

Collection and monitoring of data was another central issue. The 3rd Commission report on experimental animal use in the EU was due out in a few months, but a standardised data collection system had only been adopted in 1999. Even so, there were still discrepancies: for example France kept very detailed data whereas Luxembourg only monitored overall numbers, she said. A central database would also avoid duplication.

She had been impressed by evidence of infringements gained by NGOs, said Evans, for example recent BUAV allegations about Cambridge University, and complaints that stray dogs and cats were being used in some countries. Breaches were often due to poor communication internally and a casual attitude to animals she said, and this showed that the current system was inadequate.

Many of the shortcomings in animal care could be attributed to poor training, and she hoped that the revised Directive would also address this on a pan-European basis.

In conclusion, she said, there were shortcomings in the existing Directive, made worse by a lack of proper implementation across the board.

Torben Lund, a former Danish Health Minister and Socialist MEP, called Evans' report "excellent". It had flagged up the many failings in compliance with the existing Directive, he said, including its failure to achieve reduction in animal experiments in the longer term. He was therefore pleased that Evans had included transgenic animals in her report.

Objective criteria to assess the value of animal experiments needed to be developed, together with an effective cost-benefit analysis. There was much pressure from society against animal experiments, and any assessment of their value should provide information not just from the EU, but internationally. Negative results should also go into any database so that these experiments were not repeated, he said.

Lund ended by attacking "the particularly distasteful and nasty campaign" being waged by the chemical industry in an attempt to stop legislation in their sector. If alternatives to animal experimentation could be found for cosmetics, they could also be found for chemicals. Methods using fewer animals could also be developed. The chemical industry's claim that new legislation at EU level would mean experimenting on 50 million animals was just an attempt to scare MEPs and the Commission, he said.

Replying for the Commission, Juergen Vogelgesang, of DG Environment, thanked Jill Evans for her report. The Commission was already at the first step of revision, he said, and the Working Group to be set up next year would give a technical opinion on Jill Evans' proposals.

First reactions in the scientific community and pharmaceutical industry have been lukewarm. "We believe that proposals for revision of the Directive should be based on fact, evidence of best practice in laboratory animal science, and a clear grasp of the ethical issues as they relate to both animals and humans. Any unsubstantiated statement of reference to investigations where there is as yet no definitive outcome could bias the debate unfairly", said EFPIA, the European pharmaceutical industry federation.

Dr. Mark Matfield, Director of the UK RDS, went further: "Reading the report, I was concerned that Jill Evans had apparently not found time to visit any animal research laboratories to find out how well Directive 86/609 was implemented across Europe. The report's focus on the implementation of the Directive distracts it from addressing the important issue of regulating animal research across the EU in a way compatible with the need to foster basic research and encourage our research-based industries."

The report's recommendations in full

Whereas new knowledge on housing laboratory animals as well as scientific developments make the revision of Directive 86/609/EEC urgent
Whereas Directive 86/609/EEC has not been satisfactorily implemented in all Member States and implementation of the requirements and longer term objectives have at best been a slow process.
Whereas five Member States (Austria, Ireland, Italy, Luxembourg, Portugal) have not yet completed the ratification or accession to the Convention.
Whereas the collection and collation of statistical information on the use of animals in experiments remains problematic.
Whereas the required statistical data does not provide the details required to monitor the implementation of Article 7 of the Directive.
Whereas Member States still apply differing standards to authorising, monitoring, and review of experimental projects.
Whereas the effectiveness of controls varies between Member States.
Whereas the application of the three Rs - Replacement, Reduction, and Refinement varies widely between research establishments.
Whereas the requirement that unnecessary duplication of experiments be avoided is not adequately enforced.
Whereas all animals used for scientific purposes are not included in the Directive.
Whereas the variety of potential applications of genetic manipulation were not fully known in 1986, but statistics show a significant rise in the number of animals used in these experiments and an annual increase is predicted.
Whereas there has been rapid growth in research linked to the development of xenotransplantation which raises questions about the status of animals.
Whereas the continued use of non-human primates for experimental and other purposes causes great concern.
Whereas even though there has been progress through the work of ECVAM, the development of alternative methods has not been adequately encouraged throughout the Member States.
Whereas research facilities have received licences for experiments far less intrusive and painful than those actually undertaken.
Whereas there is evidence of researchers exceeding the numbers of animals for which they have been licensed yet not reporting this.
Whereas animals are being left unsupervised for long periods of time - even whilst recovering from traumatic experiments and food and/or water deprivation is being practised.
Whereas, in its recommendation for second reading amending Council Directive 76/78/EEC on the approximation of the laws of the Member States relating to cosmetic products, the European Parliament considers the prohibition of animal experiments for cosmetics as essential.
Whereas the UK Animals (Scientific Procedures) Act 1986 already states that even if one animal suffers severely, that a moderate suffering licence should not be granted.
Considers that the scope of the Directive needs to be aligned to the scope of the Council of Europe Convention which also covers animals used for education and training purposes.
Calls on the Commission to fulfil its commitments, pursuant to the Protocol of amendment to the European Convention, to present, before the end of 2003, a proposal in order to adapt the provisions of Directive 86/609/EEC, and to incorporate the amendments and rules of procedure shown opposite.

Evan's recommendations for amendments to the Directive

Member States should be obliged to set up an ethical review procedure as part of the authorisation system for approving animal experiments.
Animal experiments should be recognised as exceptional ethically highly problematical procedures not to be generally sanctioned and not as normal scientific methods.
Certainly ethically unacceptably purposes for animal experiments should not be permitted.
These should include:
Experiments on animals considered as endangered under Appendix 1 of the CITES and Annex C.1 No. 3626/82 should be prohibited.
The practice of allowing non-human primates to be used for experimentation must be reviewed.
The definition of an animal should be widened to include embryonic and foetal forms as well as Cephalopods and Decapods.
A central database should be established for approved, currently performed, and finalised animal experiments to ensure that there is no repeat testing.
The data that must be collected under Directive 86/609 should be more detailed and include the number of transgenic animals used as well as taking into account the level of pain suffered.
Transgenic animals must be included in the Directive and be fully recorded and traceable throughout their lives.
GM animals and animals born bearing debilitating deformities as a result of previous experiments that cause the animal to suffer sporadic or continuous pain or discomfort must be killed humanely at the earliest possible opportunity.
Article 22 should be better implemented so that there be no unnecessary duplication of experiments nor should there be any legal need to duplicate experiments in order for a product to be marketed in a particular country.
Licensing procedures should be stricter than in Directive 86/609/EEC - licence applications should include a cost benefit analysis and state the degree of pain to be caused by experiments.
A central EU inspectorate should be established to guide inspectors within the Member States with the power to visit facilities where animal experiments are being undertaken - both private and public, without any prior warning, and have the power to revoke any licence that is not being adhered to.
An EU-wide training course for those undertaking research using animals as well as those responsible for the care of animals used for experiments should be introduced.
Only qualified technicians should be allowed to look after animals used for experiments and a minimum staff to animal ratio must be adhered to - especially when any animal is recovering from experimentation and/or anaesthetised procedures.
The minimum housing and care-taking standards which are in Appendix II must be made mandatory.

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