Research organisations from both the academic and the commercial sector have gone on the offensive as proposed revisions to the European Union’s animal testing Directive, 86/609/EEC, start their passage through the European Parliament.

The Parliament’s Agriculture and Rural Development Committee will today agree amendments to the proposal that was adopted by the European Commission after a series of delays last November. The proposal will then go to the full European Parliament.

According to campaign group Animal Defenders International (ADI), MEPS have tabled more than 500 amendments to the revisions put forward by the Commission last year. A “fierce lobbying campaign by those in the primate trade and research industry threatens to tear apart the proposals and open up a free-for-all in animal experimentation in Europe taking UK animal protection back to levels last seen in 1876”, ADI claims.

The UK’s Royal Society for the Prevention of Cruelty to Animals (RSPCA) voiced fears that the Agriculture Committee would “opt to weaken the way the proposed law will regulate the use of animals in experiments because of exaggerated claims that life-saving research will grind to a halt in Europe if the proposal is approved in its current form”.

The scientific community “often says that animal welfare is of paramount importance to them and that UK laws are the strongest in the world”, comments RSPCA senior scientist Barney Reed. “Now the European laws are up for revision, many of these same people are arguing against the inclusion of important controls that have been operating successfully in the UK for many years.”

The UK bioscience sector weighed in with a Declaration warning that many of the proposals in the revised draft Directive, as well as some of the amendments proposed since last November, “could undermine animal welfare either directly or by driving research abroad, or would hinder bioscience with little or no animal welfare benefit”.

The Declaration was co-signed by representatives of the Association of the British Pharmaceutical Industry, the BioIndustry Association, the Wellcome Trust, the Medical Research Council, the Biotechnology and Biological Sciences Research Council, the Association of Medical Research Charities, the Biosciences Federation, Understanding Animal Research and the Institute of Animal Technology.

This coalition said it hoped the update of Directive 86/609 would result in more emphasis on the ‘3Rs’ of Reduction, Replacement and Refinement in animal research; harmonisation of animal welfare standards across Europe; and balanced regulation, consistent across the EU Member States.

“However, we remain deeply concerned that elements of the draft revised Directive could have a number of potential adverse impacts on bioscience research, on medical and scientific progress and on scientific and commercial competitiveness, both in the UK and across Europe,” it added. “Many of the proposals could damage research or drive it abroad, while others could present unworkable administrative burdens without any gain in animal welfare.”

Among the areas of particular concern about the proposed revisions are:

- The expansion of the Directive’s scope in Article 2 to cover certain classes of invertebrate, including larval and embryonic forms of vertebrate animals. This “would present an unworkable administrative burden without any gain in animal welfare, given that for most such forms sentience has not been scientifically established”, the Declaration argues.
- Article 8 on the use of non-human primates (NHPs) in research. While agreeing that “careful harm-benefit assessment is required before primate use in research is authorised” – something that already occurs in most countries, the coalition says – it draws the line at attempts to impose sweeping restrictions on, or to phase out /ban completely, NHP use. “This could have a serious negative impact on the ability of fundamental and applied science to bring much needed medical advances to UK citizens and patients across the world,” the research organisations claim.
- The classification of severity levels in Article 15. “It is very important that severity levels of procedures are properly and precisely defined within the Directive, not least since this is relevant to important judgments elsewhere in the Directive,” the Declaration states. “Clear bands must appropriately encompass all levels of regulated use, so as to encourage refinement from one band to a lower one.”
- Article 32 and annex IV on the care and accommodation of laboratory animals. As originally proposed, the Directive “is overly prescriptive about cage sizing and environmental requirements”, the Declaration asserts. “As well as greatly increasing costs for research, some proposals are actively deleterious to welfare. The commercial pressures on breeders to move out of high-cost countries could have very negative consequences for welfare.”
The Commission’s proposals were also criticised in a position paper issued by the European Medical Research Councils (EMRC), the standing committee for medical sciences at the European Science Foundation (ESF).

Presenting “a consensus on the subject reached within the European medical research community”, the EMRC warned that the revised Directive as it stood “could seriously impede the further advancement of European medical and veterinary research”.

The EMRC highlighted three main themes running through the conclusions on the Commission’s proposals reached by a high-level expert group of European scientists co-ordinated by the Research Councils and the ESF:

- The overarching significance of the 3Rs as a guiding principle in animal testing. As a complement to the implementation of the Directive, the Expert Group emphasises the need for properly funded 3Rs-led research programmes, initiated or enhanced by the EU Member States and the European Commission.

- The importance of harm-benefit analysis for each prospective project involving animals in research. This should be coupled with the improvement of animal welfare to the highest level compatible with the scientific objectives of the project.
- The need for “efficient decision-making with the minimum bureaucracy” in the implementation of the Directive, including defined time limits for licensing of research by the permanent ethical review body and the relevant competent authority.