Introduction of new legislation on the Protection of Animals Used for Scientific Purposes

The Minister for Health, Dr. James Reilly T.D., announced today that EU Directive 2010/63/EU on the protection of animals used for scientific purposes has been transposed into Irish law. “This new legislation will apply from the start of the 2013 and will considerably strengthen the protection of animals still needed for research and safety testing” according to the Minister.

The regulations, titled the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012, introduce significant changes, including a requirement to perform detailed project evaluations before projects using animals can be authorised and higher standards of animal welfare, care and accommodation. “The regulations will play a significant role in terms of minimising the number of animals used and require that alternatives to animal testing be utilised where possible. The new laws will also ensure a level playing field for EU industry and enhance the quality of research conducted across all Member States” the Minister added.

The new legislation promotes the principles of the three R’s (replacement of the use of animals to the greatest extent possible with alternative testing methods, refinement of scientific procedures to improve animal welfare, and reduction in numbers of animals used). The European Environment Commissioner has said that the European Union will, once the Directive is transposed, have the highest standards of experimental animal welfare in the world.

The Minister has designated the Irish Medicines Board (IMB) as the Competent Authority (CA) for the purposes of this legislation. The IMB has the relevant expertise in relation to both human and veterinary medicine and in inspecting scientific activities and establishments to undertake this regulatory work. The authorisation of establishments, projects and key individuals involved in those projects will be a matter for the IMB from 1st January, 2013. Significant enforcement powers and penalties have also been included in the regulations to support the IMB in implementing this new legislation.

The Regulations will be available from the 1st January, 2013 which coincides with the date from which the Regulations come into effect. The number assigned to these Regulations is S.I. No. 543 of 2012.

ENDS

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