The matter the Deputy is referring to are the Safeguard Clauses set out at Article 55 of Directive 2010/63/EU on the protection of animals used for scientific purposes. These Safeguard Clauses 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 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.