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New Directive may not reach national laws until 2010
Further delays to the revision of the Directive on animal experimentation mean that the changes may not be implemented into national legislation until as late as 2010
One of the most important parts of the revision of the Directive on animal experimentation will be the impact assessment. For all new European legislation proposed by the Commission, they are required to have an independent assessment of how the legislation could affect issues such as competitiveness, the environment, etc. Sources within the pharmaceutical industry and academia have already expressed concern about the effect of an overly-bureaucratic new directive on animal research.
The promised call for tender for an impact assessment of the proposed revision of the Directive has not yet been published. According to Directorate General Environment, they have been too busy with the revision of the REACH chemicals policy to have been able to proceed with the call for an impact assessment. It now looks unlikely that it will be completed this year. Only after the impact assessment is available will officials begin drafting the legislative proposal, which will then need to go to other DGs for ‘inter-service consultation’ before it can be published.
The Commission has also referred a number of questions to a specialist committee of the European Food Safety Agency (see March’s Bulletin) and their opinion, which was originally expected to be available in early 2005, now looks as though it will not be ready until the autumn. The committee intends to call witnesses on specific issues during the spring and summer, as well as undertaking a literature review.
It may well be that the European Parliament will not begin to debate the legislative proposal until well into 2006, and possibly even later. The whole Parliamentary process can take at least two years, and implementation in the Member States a further two, so national legislation to implement the Directive may not be in place until at least 2010.