Declaration of Support for the 'Parish Report'

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This Declaration explains why the UK's key bioscience organisations urge MEPs to vote in May 2009 in favour of the Parish Report of the AGRI committee, on the revision of EU Directive 86/609 on the protection of animals used for scientific purposes.

We represent key bioscience organisations in the UK. Together we reflect the perspectives of academia, industry, SMEs, charities and other research funders, as well as patient and medical groups. We consider research using animals to be a small but vital part of the overall effort to develop better scientific insights, better clinical treatments for humans and animals, and a better understanding of the impact of environmental changes.

We welcome the revision of European Directive 86/609, which we hope will result in: a greater emphasis on the ‘three Rs’ of reduction, refinement and replacement of the use of animals for research purposes; improvement and harmonisation of animal welfare standards; as well as balanced regulation, competitive biomedical research and patient benefits across the EU.

Despite significant reservations, we consider the Parish Report adopted by the Agriculture committee on 31 March 2009 to be an acceptable compromise at this stage, and a significant improvement on the Commission’s proposal of November 2008.

We recognise the difficulties Members of the European Parliament may have in balancing the various views of different organisations on an issue of significant public concern. We note that the report represents the culmination of the work of the three committees dealing with the Directive (ENVI, ITRE & AGRI).

The Agriculture committee has amended many of the unnecessarily restrictive and bureaucratic measures proposed by the Commission. These would have hindered bioscientific research, and introduced a substantial workload with little or no animal welfare benefit. The most problematic Commission proposals were highlighted in our Declaration of Concern of March 2009. We do, however, have strong reservations about some amendments in the Parish Report, which would impact negatively on scientific research that uses animals. In addition, some of the problems with the original Commission proposal remain. These outstanding issues, summarised below, will need to be addressed in future stages of the revision of this Directive.

Despite these concerns, and to ensure that well-regulated research can continue, we urge MEPs to support the Parish Report in early May.

22/04/09

Major outstanding concerns with Parish Report and Commission proposal

Scope: The Parish report is a very significant improvement on the original Commission proposal. But too many non-sentient species of animals are still included, for example, minute juvenile forms of invertebrate animals such as crabs. Statistics would still need to be reported for all vertebrates irrespective of developmental stage, so for instance non-sentient fish larvae in their tens of thousands would have to be counted, making for a practical and administrative nightmare.

Data-sharing: While at first glance it is an appealing ideal, compulsory data-sharing is simply unworkable. It would infringe commercial confidentiality as well as undermining the peer-review process and the proper routes to publication of results in the scientific literature. Unnecessary duplication of animal experiments is already avoided, although there is sometimes a need to validate data. The proposal fails to recognise existing initiatives that enable appropriate data-sharing, and rules that require researchers to establish whether or not experiments have been conducted before. While we support sharing data where legally and practically manageable, enforcing it under all circumstances would cause insurmountable difficulties and would divert resources from the 3Rs.

Authorisations: The report has not succeeded in clarifying fully the complex and obscure Commission proposals for the process of authorising licences to work on animals. However, we support the principle that those projects where there is the least animal suffering should require notification to the regulatory body (with the option for the project to be subject to consideration) rather than prior authorisation. The safeguard of ethical review is built into the Directive and will still apply in these cases.

Alternatives: Unfortunately, proposals requiring international acceptance of non-animal alternatives were not adopted. This is likely to mean that animal studies would be required outside the EU even when they are prohibited within the EU.

Cage sizes: We continue to be concerned that the setting of mandatory cage sizes in Annex IV is unnecessarily inflexible. Some drafting errors in the Annex would undermine animal welfare, and the proposals could lead to enormous costs with proportionately little or no benefit for animal welfare. The sensible proposal to turn Annex IV into guidance was withdrawn by the Agriculture committee at the request of the Commission.

Agriculture and wildlife research: Several articles, probably unintentionally, would restrict the ability to undertake essential research on farm animals (eg under commercial conditions for welfare purposes) and on wildlife (eg in environmental studies).

Poor wording: There are still several important areas where the wording is either contradictory between articles or is unclear in its meaning. For instance, it remains unclear what level of regulation will apply to animals killed humanely for their tissues.

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