Written answers

Tuesday, 11 December 2012

Photo of Finian McGrathFinian McGrath (Dublin North Central, Independent)
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To ask the Minister for Health his views on correspondence (details supplied) regarding animal experimentation and EU Directives [55179/12]

Photo of James ReillyJames Reilly (Dublin North, Fine Gael)
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Directive 2010/63/EU on the protection of animals used for scientific purposes significantly strengthens the protection of animals still needed for research and safety testing. The Directive strongly promotes the principles of the three Rs (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). Significant changes in this regard are requirements to perform project evaluations including harm benefit analysis prior to authorisation of projects using animals and higher standards of care and accommodation. Many of the provisions set out in the Directive are mandatory. The Directive will be transposed into Irish law by year end and will take effect from 1 January, 2013. I would like to draw the attention of the Deputy 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 Safeguard Clauses set out in this Directive covers 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 authorisation of procedures involving severe pain, suffering or distress that is likely to be long lasting and cannot be ameliorated. Under Article 55(3), such exceptional provisional measures could, for example, be required to deal with an unexpected outbreak of a life threatening or debilitating clinical condition in humans or an outbreak of an highly infectious pathogenic disease. 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. 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. 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.

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 it 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.

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. Officials of my Department have met with stakeholder groups including animal welfare groups in relation to the Directive's provisions. My Department has met with consultants of the Irish Anti Vivisection Society and with Research and Development establishments in this area. The Irish Medicines Board (IMB) has also had meetings with stakeholders to inform them of the requirements which will apply from 1 January 2013 and has updated its website with relevant information.

I appreciate the time and effort devoted by individuals and stakeholder groups in this regard. The submissions received in response to the first public consultation were particularly welcome as the Directive was still under discussion at that stage. The second public consultation, of necessity, had a different focus given that the Directive was already finalised at that stage. The responses to the second public consultation are, consequently, primarily focused on the nuts and bolts of the transposition process itself and are of particular assistance to the Department in this regard.

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 forthcoming Irish Presidency of the European Union. I am sure the Deputy would agree that it is important to transpose the considerably enhanced protections afforded to animals in the Directive without delay. The Joint Committee, after consideration of the proposed Directive noted that the aim of the proposal is to improve the existing 1986 Directive. The Committee also recognised the scope allowed in the Directive for Member States to decide on practical transposition measures.

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