Medical Research Regulation

Dáil Éireann Debate, Thursday - 30 April 2015

Thursday, 30 April 2015

Questions (162)

Seán Kyne

Question:

162. Deputy Seán Kyne asked 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]

Written answers

Minister for Health

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 JRA published 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.