Written answers

Thursday, 30 April 2015

Department of Health

Medical Research Regulation

Photo of Seán KyneSeán Kyne (Galway West, Fine Gael)
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162. To ask the Minister for Health the funding and other mechanisms being pursued to encourage the development of non-animal alternative bioscience research methods knowns as the three Rs, replacement, reduction and refinement, to meet the obligations of Article 47 of Directive 2010/63/EU. [17109/15]

Photo of Leo VaradkarLeo Varadkar (Dublin West, Fine Gael)
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My Department recently nominated a representative to the PARERE Network (Preliminary Assessment of Regulatory Relevance) established under Article 47(5) of Directive 2010/63/EU. The PARERE Network is hosted by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) and was established to expedite the process of regulatory acceptance of alternative methods. It also provides advice on the regulatory relevance and suitability of alternative approaches proposed for validation and provides a framework for the sharing of experience and expertise in this area among Member States.

I have been advised by the Health Product Regulatory Authority (HPRA) that at EU level, the EURL ECVAM promotes the development and dissemination of alternative methods. In addition, the Joint Research Authority (JRA) gathers information on alternative methods useful in assessing the toxicological properties of chemicals. The JRApublished a report on alternative methods for regulatory toxicology in 2014.

Furthermore, the HPRA have advised that the European Medicines Agency through its working group on the application of the 3Rs in regulatory testing of medicinal products is active in identifying opportunities for the implementation of the 3Rs in relation to the testing of human and veterinary medicinal products. Progress is being made in this field over the last number of years with the regulatory guidelines for new medicines being adapted to foster the application of the principle of the 3Rs, not only at the European level, but indeed globally.

The HPRA ensures that the 3Rs are applied to the authorisation of projects that are to be conducted in this country.

Photo of Seán KyneSeán Kyne (Galway West, Fine Gael)
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163. To ask the Minister for Health the outcomes from the collaboration between the Irish Medicines Board, renamed the Health Products Regulation Authority, and the European Commission regarding the identification and validation of alternative approaches to animal research that could be developed; and if he will make a statement on the matter. [17110/15]

Photo of Leo VaradkarLeo Varadkar (Dublin West, Fine Gael)
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I have been advised by the Health Products Regulatory Authority (HPRA) that the development of alternative methods to animal research is an on-going activity. Along with other Member State competent authorities, the HPRA attends meetings with the EU Commission in relation to progress in this and other areas. Through their participation in these meetings and through the contacts they have established the HPRA is kept informed of new developments in the sector. The HPRA, in turn, apply this knowledge in the assessment of applications for projects involving animals and in the overall regulation of the scientific animal sector.

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