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Permalink 03:27:03 pm, by Tom, 744 words, 5004 views   English (UK)
Categories: News

A step closer to new EU directive on animal research

Those of you who have been following the Pro-Test blog for a while will be aware that European Union (EU) is in the process of replacing Directive 86/609, the directive that covers the "laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes" with a new directive that better reflects the current state of the art of medical research and expected future developments, and does more to harmonize the regulations governing animal research in individual EU member states.

The proposed new directive on animal research was drafted by the European Commission in December 2008 and then sent to the European Parliament for its first reading. In common with the overwhelming majority of medical researchers in the EU we had grave concerns about some aspects of the proposed directive. Fortunately just before the June 2009 European elections, the EU parliament adopted a long list of amendments that it wanted incorporated, resolving many of the worries we had about the potential impact of the new directive on medical research in the EU. We were particularly pleased to see that the amendments protected the use of non-human primates in basic research, as these animals are of critical importance to fields such as neuroscience and virology.

This would usually have been sent to the European Council, a body that represents the governments of the individual EU member states, for them to give the proposal its first reading. However, to speed matters along, the Council initiated a trialogue procedure, in which representatives of the three parts of the EU legislature - the Commission, the Parliament and Council - hold private meetings to reach agreement on the text of the proposed directive.

The trialogue reached agreement on the text by December 2009, apart from a few details of committee procedure which needed to be clarified by legal experts, in the light of changes required by the Lisbon Treaty that entered into force on 1 December 2009. This agreement was marked by a formal letter from the European Parliament to the Council.

The clarification of the committee procedure points, followed by the legal checking of the text took until May, after which the Council agreed the text on 11 May and formally adopted it last week on 3 June.

We believe that the agreed directive strikes an excellent balance between the need to ensure that animals used in medical research are treated humanely, and the need to develop new treatments for terrible diseases and ensure that the EU remains at the forefront of medical science.

The next stage is that the draft directive will be sent back to the European Parliament for its second reading. Since the text is subject to a formal trialogue agreement this should be relatively swift and may involve as little as one vote in favour in the Agriculture Committee this summer and another at a plenary session of the full EU parliament probably in early autumn. At that point the Directive would be formally adopted into EU law.

There is certain to be some debate at each meeting and it is quite possible that the some EU parliamentary groups may put down amendments, but it is not thought likely that any will get the majority support they require. However, those experienced in the EU legislative process warn that one should always expect the unexpected. Some animal rights groups are continuing to lobby the parliament against the proposed text, so it would be a mistake to assume that its adoption is certain. That only happens when the ink is dry on the final document. We urge scientists to keep in touch with their MEP and to be ready to make the case for the well regulated use of animals in medical research.

Once the directive is adopted as EU legislation, all Member States must, within 2 years, pass (or amend existing) national legislation to make the provisions of the directive legally binding. It is possible that the UK parliament will need to amend the Animals (Scientific Procedures) Act 1986 that regulates animal research here, but it is more likely that any changes required will be achieved through changes to Home Office regulations, since nothing in the Animals (Scientific Procedures) Act 1986 appears to conflict with the new EU directive.

The adoption of the new directive by the EU council is excellent news, and represents one more step on the long and winding road towards an EU directive on animal research that we can all be proud of.


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