Directive 2010/63/EU protection of animals used for scientific purposes – Topical Issues Debate

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Speech by Minister for Health, Leo Varadkar.   I would like to thank the Deputy for raising this matter as it provides me with an opportunity to outline to this House the position in relation to this matter.  Directive 2010/63/EU on the protection of animals used for scientific purposes introduced a significant change in the systems for authorisation and conducting of scientific procedures on animals.

The introduction of this legislation into Irish Law will significantly enhance the welfare of animals used for scientific purposes.

My Department has designated the Health Products Regulatory Authority, formerly Irish Medicines Board, as the Competent Authority for the purposes of this legislation. This includes ensuring the application of the 3Rs. There are replacement, reduction and refinement. The HPRA 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 HPRA has put in place a small but expert cadre of officials well versed and experienced in this area.

In preparing for its role as Competent Authority in this area, the HPRA undertook extensive engagement with the industry on implementation of the Directive and continues to do so.

In transferring the functions involved to the HPRA in 2013, the Department agreed to provide the HPRA 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 gradually scaled back so that the HPRA will ultimately regulate the sector from within its own funding. Accordingly, the HPRA consulted with the sector on the application of an appropriate funding model during 2013. Based on the feedback from the consultation the HPRA proposed a fee regimen and my Department sanctioned certain fees for the provision of HPRA services in 2014.

The fees are included in the Irish Medicines Board (Fees) Regulations 2013 (S.I. No. 501 of 2013). A similar process will be taken during 2014 in relation to the fees for 2015.

The Department meets the HPRA on a regular basis to monitor and review implementation of the legislation in this area and consider matters arising. The introduction of this legislation into Irish Law will significantly enhance the welfare of animals used for scientific purposes. In this regard, the HPRA 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.

Finally, we are mindful of the importance of research to the Irish economy.  However, we also need to be cognisant of the potential implications of any changes made in this area for the regulation of other research undertaken by the HPRA.

Closing Speech

From the outset, my Department committed to monitor and review the implementation of this legislation. As part of this process, we have met with different stakeholders to ensure that, as much as possible, all views are taken on board. We will continue to meet with stakeholders and these discussions will help identify further enhancement to the implementation of the legislation.