Seán Kyne (Galway West, Fine Gael)
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Question 551: To ask the Minister for Health the progress made on the transposition of directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes; if he views primary legislation as the best method of implementing the directive, particularly as such a method stimulates and facilitates debate on topics of significant public interest; and if he will make a statement on the matter. [6911/12]

James Reilly (Dublin North, Fine Gael)
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Directive (2010/63/EU) on the protection of animals used for scientific purposes will strengthen the protection of animals still needed for research and safety testing. The Directive will also play a significant role in minimising the number of animals used and require alternatives to be used where possible, whilst ensuring a level playing field for EU industry and enhancing the quality of research conducted in the EU. The "Three Rs" principle of replacing, reducing, and refining animal testing is firmly anchored in the new legislation and this is something that I strongly support.

In July 2009, my Department provided an information note to the Joint Committee on European Scrutiny on the then proposed Directive and indicated that the transposition of the agreed Directive would be done by Statutory Instrument (i.e. Regulations). Section 2 of the European Communities Act, 1972 states that "acts adopted by the institution of those Communities shall be binding on the State and shall be part of the domestic law" while Section 3 enables the Minister to make Regulations to transpose Directives into national law. It is my view that this is correct mechanism to adopt but I acknowledge that there may be some matters which require primary legislation.

The Directive is required to be transposed into Irish law by 10 November, 2012 and to take effect from 1 January, 2013. My Department sought the views of the public and interested parties in July, 2009 on the proposed Directive. These views informed Ireland's position as negotiations on the proposed Directive progressed at EU level. My Department again sought the views of the public and interested parties in October, 2011 after the adoption of the Directive. My officials have also met with industry and animal welfare groups on the Directive. Many of the provisions set out in the Directive are mandatory.