Stakeholders in the European Partnership for Alternative Approaches to Animal Testing (EPAA) have renewed their commitment to the collaboration, as EU ministers get to grips with a controversial update of the European Union’s legislation on the protection of laboratory animals.

At the EPAA’s annual conference in Brussels last week, the European Commission and leading companies from the seven industry sectors involved in the partnership – pharmaceuticals, chemicals, bio-industries, cosmetics, soaps and detergents, crop protection and animal health – agreed to extend the collaboration beyond its initial five-year term.

The EPAA was originally launched in November 2005 to promote the development and implementation of 3Rs (replacement, reduction and refinement) methods and alternative approaches to animal testing for regulatory purposes. Partners include the Commission’s Directorate General Enterprise and Industry, DG Research, DG Environment, DG Joint Research Centre and DG Health and Consumer Protection, some 40 companies from the aforementioned sectors, and their respective European trade associations.

Speaking at the conference, Günter Verheugen, vice-president of the European Commission, said the EPAA was “quite a unique co-operation” across industry sectors that had “gained a sound reputation” worldwide.

“At the same time, I would like to stress that the EPAA creates strong expectations,” Verheugen told the conference. “It is therefore important to renew our commitment to this joint initiative. I would urge industry and Commission services to translate such a renewed commitment in concrete measures and sufficient resources.”

Odile de Silva of L’Oréal, who is co-chair of the EPAA Steering Committee, confirmed that industry’s commitment to the EPAA and its activities “remains solid, and this is why we want to continue with this successful partnership. The EPAA has proved it can deliver in building trust and promoting new thinking among both companies and institutions, and in disseminating the 3Rs culture more broadly”.

Animal testing Directive

The 3Rs principles, as well as specific measures such as requiring member states to designate a national reference laboratory for the validation of alternatives to animal testing, were incorporated into the proposed revisions to Directive 86/609/EEC published by the European Commission in November 2008.

However, animal welfare groups have been dismayed by what they regard as the significant dilution of provisions to improve the protection of laboratory animals as the Commission’s proposals have made their way through the EU regulatory process.

That included last May’s plenary vote in the European Parliament, which adopted by a large majority many of the contentious amendments taken up by Parliament’s Agriculture and Rural Development Committee. The biopharmaceutical industry also had some qualms about the parliamentary vote, suggesting that some of the provisions in the legislation as it stood could be detrimental to research without benefiting animal welfare.

Member state experts in the EU’s Council of Ministers are now seeking a common position with the reconstituted Parliament on the amended proposals, occasioning another wave of lobbying from stakeholders.

According to the UK Home Office, the current Swedish presidency of the European Union is hoping to agree a Council first-reading position at the 14-15 December session of the Agriculture Council, paving the way for agreement on a revised Directive at a second reading in Parliament next year.

“Through the Council working party, Sweden has been building greater flexibility into the draft text to reduce its impact on costs and bureaucracy and has abandoned some of the more prescriptive requirements in the Commission proposal,” the Home Office said. “Although a significant amount of detailed drafting remains to be done, the framework envisaged by Sweden appears to be workable and would allow the UK to maintain or improve current standards of welfare and animal protection.”

House of Lords report

Meanwhile, the House of Lords European Union Committee in the UK has warned, in a report on the proposed revisions to Directive 86/609/EEC, that the legislation will fail to meet its objectives unless there are proper safeguards to ensure its requirements are implemented consistently across the member states.

As such, the Committee sees it as “critical” that effective arrangements are in place for national inspection by member states of sites where animals are used in scientific procedures. To make sure common standards are applied, the European Commission should play a “robust” role in monitoring the implementation of the Directive, the Committee believes.

“The justification for having a new Directive was the inconsistent implementation of existing requirements,” commented Lord Sewel, chairman of the Sub-Committee on Environment and Agriculture.

“It is disappointing that, as the Commission’s original proposal has progressed, the drive towards common standards has faltered. We see a real risk that the new system will be no better than the existing one, with its wide variations in standards observed.”

More generally, whatever legislation emerges “must be a levelling-up of standards of animal welfare across all Member States, with no weakening of standards in the UK”, the report says.

Where the Commission’s proposals imply more stringent controls than those currently operating in the UK – for example, limitations on the re-use of animals in experiments or requirements for the care or accommodation of laboratory animals – “careful consideration of the feasibility and impact of these changes is essential and may point to some adjustment”, it states.

Animal welfare groups such as the British Union for the Abolition of Vivisection (BUAV) and the Dr Hadwen Trust for Humane Research (DHT) have welcomed some of the Committee’s recommendations, such as restricting the use of non-human primates to research into life-threatening or debilitating conditions, and making all animal procedures subject to authorisation procedures, including ethical review.

“In many respects, the Committee report … explicitly supports the Commission’s original vision,” DHT commented. “In doing so it recommends the UK government supports many of the key welfare clauses that MEPS and Member State Ministers have so far failed to retain.”

The Committee’s report can be downloaded from http://www.publications.parliament.uk/pa/ld200809/ldselect/ldeucom/164/164i.pdf.