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Medical Research Regulation

Dáil Éireann Debate, Tuesday - 23 October 2012

Tuesday, 23 October 2012

Questions (629, 660)

Seán Ó Fearghaíl

Question:

629. Deputy Seán Ó Fearghaíl asked the Minister for Health if he will consider the issues contained in correspondence (details attached); and if he will make a statement on the matter. [46010/12]

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Clare Daly

Question:

660. Deputy Clare Daly asked the Minister for Health if he will consult with experts and stakeholders prior to tabling new regulations in relation to animal testing in view of the fact that the directive gives considerable discretion to national Governments in some key areas such as the way in which animal pain, suffering and distress will be measured. [46252/12]

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Written answers

I propose to take Questions Nos. 629 and 660 together.

Directive 2010/63/EU will considerably strengthen the protection of animals still needed for research and safety testing. The Directive will also minimise the number of animals used and require alternatives to be used wherever possible, while 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 I strongly endorse this development. The Irish Anti-Vivisection Society (IAVS) has raised concerns about the level of consultation and scrutiny on the new Directive and about the transposition of Article 55 (Safeguard Clauses).

I cannot accept that consultation on and scrutiny of the Directive has been minimal. My Department sought the views of the public and interested parties in July, 2009 on the proposed Directive and again in October, 2011 in order to inform our transposition of the provisions of the Directive into Irish law. In both cases these public consultations were advertised in the National media and key stakeholder groups were also directly advised of the consultation process. Officials of my Department have met with a range of interested parties (including the IAVS on two occasions) on the Directive.

On the matter of scrutiny of the Directive, 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 Directive would be done by Statutory Instrument in order to ensure that this transposition would be implemented within the allowed timeframe. Failure to do so could delay the considerably enhanced protections the new Directive provides for animals - a circumstance which animal protection organisations would, quite correctly, take issue with. It could also result in EU infringement proceedings against the State during the Irish Presidency of the European Union. The Joint Committee, after consideration of the proposed Directive, agreed that no further scrutiny was required, given that the aim of the proposal is to improve the existing 1986 Directive and in view of the scope allowed in the Directive for Member States to decide on practical transposition measures.

Many of the Directives provisions are mandatory. The discretionary Safeguard Clauses set out at Article 55 cover exceptional circumstances in which Member States may, on scientifically justifiable grounds, provisionally authorise applications for derogations relating to a number of restrictions set out in the Directive, including the use of on non-human primates set out in Article 8 and authorisation of procedures involving severe pain set out in Article 15. The European Commission, assisted by an Advisory Committee (composed of Member State representatives and chaired by the Commission) must, subsequently, authorise or disallow any such provisional authorisation.

Such exceptional provisional measures could be required to deal with an unexpected outbreak of a life threatening or debilitating clinical condition in humans or to allow for experiments necessary for the preservation of species. The Safeguard Clauses would also allow for emergency measures in the event of a natural disaster that resulted in, for example, the contamination of land and livestock or the outbreak of an infectious pathogenic disease.

It is clear from the Directive that the replacement, refinement and reduction of animal testing is at the core of this legislation and I strongly endorse this objective. Nevertheless, and even if difficult to foresee, it is my considered view that is both reasonable and correct to make provision for exceptional emergency situations that might arise, if only to ensure that the necessary legislative tools are available to deal with such an eventuality. The Directive provides Member States with the legislative tools needed to respond in an effective way to such situations. Not to incorporate such tools in our transposition of the Directive might prove to be most regrettable if fate were to take a hand.

It will only be possible to introduce any such provisional measure by way of Ministerial Order after consultation with the Irish Medicines Board (the Competent Authority for the purposes of the Directive) and any such measure will be subject to EU Member State and Commission scrutiny and approval.

I would, finally, like to draw the attention of Deputies to the comments of European Environment Commissioner Potocnik who has said that the European Union will, once the Directive is transposed, have the highest standards of experimental animal welfare in the world. The new Directive will be transposed into Irish law during November and will become operational from 1 January 2013.

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