Origins of the Commission proposal

  1. The European Commission initiated the revision process in June 2003 by assembling a Technical Expert Working Group (TEWG), composed of representatives of NGOs, Member States, Acceding Countries and the European Commission.  The TEWG was split into a number of working parties which were asked to address a series of questions defined by the Commission.  The reports of the TEWG were published in early 2004.   
  2. After reviewing the TEWG reports, the Commission concluded that a number of questions required further scientific input.  In July 2004, the Commission invited the European Food Safety Authority (EFSA) to produce a scientific opinion on these points.  The EFSA is the only EU body charged with providing independent scientific advice that has animal welfare within its official remit.  The EFSA Panel on Animal Health and Welfare published it's report on these matters in December 2005. 
  3. In late 2005 the Commission retained Prognos, a Swiss consultancy firm, to carry out an impact assessment on the policy options being considered for the revision.  As part of this impact assessment, a public consultation was conducted via a dedicated web site during July and August 2006. There were two versions of the public consultation: a lay version and an expert version.  The lay version asked general questions about views on animal experimentation and what species and types of experiments should be regulated.  The results of the lay consultation are unlikely to be representative because the web site was not able to distinguish between distinct individual responses and multiple responses made by the same person. The expert version, which was addressed to “experts in the area of animal welfare, animal testing, animal science, natural sciences (especially biology, medicine, pharmacology and toxicology), legal and economic affairs related to these areas” only permitted one response per person.  It set out the preliminary impact analysis of the policy options being considered by the commission, asking whether the respondent agreed with the various assessments that had been made.  Thus, it provided quite detailed information from the Commission about what they were considering to include in the revised directive.  The European Biomedical Research Association have produced a detailed analysis of these policy options.
  4. The results of the public consultation were released in early 2007.  There were 283 responses to the expert questionnaire, making over 12,000 detailed comments.  There was a large and prevailingly negative response to the citizens questionaire, although this was almost certainly a manipulated result.  Anti-vivisection groups had encouraged their members to respond to this and it was possible for the same person to make multiple responses.
  5. In January 2007, the Commission  held a meeting for Member States and key stakeholders to consider a working paper giving initial suggestions for the wording of certain key parts of the new Directive.  The participants were asked to provide comments and feedback.  The Commission made it clear that the suggested wording was preliminary and they expected some of it to change as a result of the comments received.  Many of these initial proposals followed the ideas suggested in the preliminary impact assessment which was used for the expert consultation in July and August 2006.  A number of the suggestions made by the Coalition have been incorporated, but there are still a significant number of matters of concern for the academic research community and we will continue to press the Commission for these to be addressed.
  6. In November 2007, the interservices consultation process started. The Environment Directorate-General within the Commission formally circulated a draft of the proposed new directive to several other Directorates-General, giving them a few weeks to make comments.   Concerns were raised by other parts of the Commission and negotiations are still being held between the Environment Directorate-General and ther other Directorates-General to attempt to resolve these.

  7. In May 2008, the Environment Directorate-General formally requested a scientific opinion from the Scientific Committee on Health and Environmental Risks (SCHER) on the the need for non-human primates in biomedical research, production and testing of products and devices.  This was in reaction to a Written Declaration adopted by the European Parliament in September 2007, calling on the European Commission to set a timetable to replace the use of non-human primates in research and testing with alternatives.  The Commission's response stated that this was not possible with current scientific knowledge.  They requested the scientific opinion from SCHER, by October 2008, to provide independent scientific information for this debate.

  8. On 5 November 2008, the European Commission formally adopted their proposal for the new directive and sent it to the European Parliament and European Council for a first reading.  The full text of the proposal, in 22 different languages. can be found here.