The new directive, Directive 2010/63, will come into effect at the beginning of 2013. Being new to this legislation, I wanted to get a better understanding of the impact it would have, particularly on lab animals. So I’ve tried to summarize key elements and the thinking behind the new policy.

Revising Directive 86/609
After being in use for 20 years, the 1986 directive no longer reflected all the scientific changes that have taken place, including today’s use of transgenic animals, more sophisticated science and more non-animal research methods (alternatives).  There was also no mention of appropriate care and handling of different types of animals or any enforcement of good practice.

From a research point of view, authorization of a research study varied greatly from country to country, ranging from 30 days to more than 200 days.

So in summary there was a need to adapt to new thinking and technology, to set European standards that would help to create a level playing field across Europe and enforce good management of animal care.

Key objective of Directive 2010/93
The new legislation ensures that animals are used according to certain standards, and only as a last resort only because there isn’t a viable alternative method. Researchers must always apply the 3Rs principles – the least possible distress and pain, the lowest numbers and sound justification that the animals are really necessary.

Target audience of the directive
This directive governs virtually every sector that uses animals for research and development of products such as chemical and pharmaceutical industries as well as those developing cosmetic and consumer goods. Not only does this legislation affect the researchers, it also gives legal direction to lab animal breeders and transporters of lab animals.

Key legislative changes
The biggest shift in the text appears to be the move from optional best practice, to mandatory procedures. Below are some of the key changes:

Improved legislation:

• Each research project must pass a project (ethical) review. The proposed research must prove that it’s scientifically justified, and the researcher has applied the 3Rs principle of reduction, refinement and replacement. Part of the review now includes a cost/benefit assessment; showing the benefit to the patient or consumer, versus the harm done to the animal.
• The authorization system is now mandatory however most member states had this system in place already.
• The text has become clearer about the use of alternatives where they are available.
• The use of non-human primates has been restricted to essential biomedical research only.
• Some animal welfare staff are now mentioned and the role of the veterinarian and the animal welfare officer have been strengthened. There is now a requirement to have an animal welfare body within the research organization, which provides ongoing advice about, among other things, the 3Rs principles, accommodation, care and welfare of the animals and review of procedures.

New legislation:

• Member states must perform a certain number of inspections per year, some of which are unannounced.
• There are new detailed standards on caging and housing.
• The 3Rs principles are now very clearly referenced throughout the legislation, which removes any ambiguity.
• To increase transparency, research application must now include a non-technical summary outlining the process and objective of research project in layman’s terms. If the application is approved this lay summary will be published on the Internet.

All up, the legislation is much stronger than before and includes penalties for non-compliance.

Next steps
Right now all 27 member states are in the process of translating the new directive for national implementation on 1 January 2013. Over the coming months Animal Testing Perspectives will be following the activity at national level to see how the legislation is being adopted.

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