James Reilly (Dublin North, Fine Gael)
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Directive 2010/63/EU introduced a significant change in the systems for authorisation and conducting of scientific procedures on animals and in the monitoring of standards for animal welfare as compared to the previous legislation. I designated the Irish Medicines Board (IMB) as the Competent Authority for those functions related to the protection of animals used in scientific procedures, including the application of the 3Rs (i.e. principles of replacement, reduction and refinement). The IMB has the relevant expertise in relation to both human and veterinary medicine to undertake this regulatory work. Given that many of the additional requirements under the above Directive are of a highly specialised nature, the IMB has put in place a small but expert cadre of officials well versed and experienced in this area.

In transferring the functions involved to the IMB in 2013, my Department agreed to provide the IMB with the necessary funding for the setting up and provision of the service involved in 2012 & 2013; the provision of further exchequer funding for 2014, 2015 and 2016 being scaled back in a step wise fashion such that the IMB would be required to advance a sustainable funding stream for the regulation of the sector within this timeframe. Accordingly, the IMB consulted with the sector on the application of an appropriate funding model during 2013; based on the feedback from the consultation the IMB proposed a fee regimen and my Department sanctioned certain fees for the provision of IMB services earlier this year. The fees are included in the Irish Medicines Board (Fees) Regulations 2013 (S.I. No 501 of 2013).

The Department meets the IMB on a regular basis to review implementation of the legislation in this area and consider matters arising. It is not the case that the IMB is in any way seeking to disadvantage the research industry in Ireland. In this regard, the IMB is obliged to verify compliance with the requirements of the Directive in as practical a manner as possible and by so doing assist the industry in its development.