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Timing of the Revision for Directive
The timetable for the revision of Directive 86/609 is firming up, but there will still be a long time to wait.
For some time now observers in Brussels have been reporting that the first sighting of the legislative proposal to revise Directive 86/609 was not likely to be made before 2005. In September this timetable was confirmed by Dr Beatrice Lucaroni, from DG Research, speaking at a workshop organised by EFPIA, the European pharmaceutical industry association.
Dr Lucaroni said that the Animal Health and Welfare Panel of EFSA, the European Food Safety Authority, had been asked to give an opinion on the content of the revised Directive, and that this was not expected until March 2005. After this the proposal would be drafted and there would be a further stakeholder consultation, and only afterwards would the legislative proposal be finalised and passed to the European Parliament.
The EFSA panel have been asked to give opinions on a number of issues including:
Should some invertebrates be included in the revised Directive on the grounds of their sentience? (The European Parliament Environment Committee own initiative report specifically mentioned cephalopods and decapods in this regard).
Should fetal and embryonic forms be included, again on grounds of sentience, and if so, at which state of gestation?
Which experimental animals should always be purpose-bred?What are the most appropriate and humane methods of euthanasia?
The stakeholder consultation which will follow the publication of the draft proposal will be open to a far wider range of groups and opinions than was the Technical Expert Working Group (see EBRA Bulletin Summer 2003), which reported last year. Patient representatives at the EFPIA workshop said they felt particularly strongly about not having been consulted earlier, and they are likely to press for their views to be taken just as seriously as those of the animal rights groups in the consultation process.
One thing that still remains unclear is how and when the proposed revised Directive will be subject to an impact assessment. All EU legislation has to be given an impact assement to judge what effect it will have on areas such as competitiveness, health, the environment and others. These impact assessments can be conducted in one of two ways - giving either a simple ort a more detailed assessment. EFPIA is now calling for a full and detailed impact assessment to be conducted on the draft revised directive at an early stage.