The controversial update of the European Union’s legislation on the protection of laboratory animals is moving towards a final plenary vote in the European Parliament this September, after a second-reading report by rapporteur Elisabeth Jeggle was approved by Parliament’s Agriculture Committee with no votes against and four abstentions.

The approved text reflects the common position adopted in early June by the EU’s Council of Ministers on draft Directive 8869/10, noted the Committee on Agriculture and Rural Development. The new legislation will replace the existing Directive 86/609/EEC on the protection of laboratory animals.

The European Commission’s proposed revisions to Directive 86/609/EEC were first published in November 2008. After a good deal of lobbying and political wrangling, a plenary vote by the European Parliament in May 2009 adopted by a large majority a number of the contentious amendments to the Commission’s proposals that had been taken up by the Agriculture Committee at the first reading.

The regulatory process was then stalled by the European Parliament’s elections in June 2009, leaving the new Parliament to negotiate with member state representatives on a first-reading agreement. The Council of Ministers announced a provisional agreement on draft Directive 8869/10 last May.

Still diluted

Animal welfare groups continue to complain that key provisions aimed at improving the protection of laboratory animals have been significantly diluted as the new legislation moves into its final stages.

However, the Agriculture Committee said the draft Directive as it stood would cut down the use of animals in scientific experiments; require national competent authorities to assess the animal welfare implications of every experiment conducted, with a view to promoting alternative testing methods and reducing the levels of pain inflicted on animals; tighten up rules on the use of primates in research; and oblige national governments to ensure inspections are carried out on at least 33% of laboratories using animals.

The approved text “strives to strike the right balance between improving animal welfare and assisting research against diseases”, the Committee stated. For the European Coalition to End Animal Experiments (ECEAE), though, the Committee’s vote was a missed opportunity to introduce key amendments that would have ensured common standards on animal protection were applied across the EU.

“Yet, the Rapporteur and other committee members insisted that the draft law was the best compromise possible and asked MEPs to avoid delaying the revision process by voting in favour of the few amendments tabled,” the ECEAE commented.

Specifically, it added, amendments tabled by the Greens and MEP Brian Simpson were aimed at confirming that strong restrictions on the use of non-human primates would be in place, that non-animal alternative methods would be used when these were immediately available, and that Member States could adopt stricter rules than the EU legislation.

“Although these amendments reflect the demands of the Parliament at its First reading, the MEP members of the AGRI Committee rejected them,” the ECEAE said.

Non-human primates

While the Agriculture Committee members generally endorsed the proposed ban on the use of great apes in scientific experiments, it felt that restrictions on experiments with other non-human primates, such as ouistitis and macaques, could hamper research into neurodegenerative diseases such as Alzheimer’s.

The revised text therefore allows for use of these primates if there is scientific evidence that the goals of the test cannot be achieved without these species, the Committee noted.

On the issue of alternatives to animal testing, the Committee’s report specifies that all member states must ensure an alternative method is used instead of animal testing whenever that method is “recognised by Community law”.

If animal welfare groups still feel the proposed Directive has lost its teeth, the pharmaceutical industry has its own qualms about the compromise version. When the Council of Ministers adopted its common position , the European Federation of Pharmaceutical Industries and Associations (EFPIA) acknowledged the effort to “strike a balance between improving welfare and maintaining Europe’s research”.

But it also expressed disappointment that “certain provisions risk creating legal uncertainty without bringing any welfare benefits”. This theme is taken up in a recent submission from a bioscience sector coalition to the UK’s Home Office, advocating principles for the implementation and transposition of Directive 8869/10 into national law.

The revised Directive “has not always achieved clarity or consistency in its drafting”, the submission notes. “In situations of uncertainty, the emphasis should be on achieving the outcomes of good science, animal welfare and the 3Rs [replacement, refinement and reduction] rather than on defining regulatory processes.”