I propose to take Questions Nos. 465 and 568 to 570, inclusive, together.
The legislation governing animals used for scientific purposes in Ireland stems from EU Directive 2010/63/EU and is among the world’s most advanced legislation concerning animal welfare. This Directive represents an important step towards achieving the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so. Accordingly, and in line with the EU legislation, my Department is not considering a plan to prohibit the use of animals for scientific purposes.
The restrictions and standards set by the Directive aim to enhance animal welfare and ensure that animals are used in studies only when their use is strongly justified and following independent assessment. The Directive firmly anchors in EU Legislation the 3Rs principles, i.e. Replacement, Reduction and Refinement.
In Ireland, the Health Products Regulatory Authority (HPRA) is the competent authority for the authorisation of studies using animals for scientific purposes. My Department does not maintain records of establishments. In accordance with the legislation, the HPRA authorises and inspects the establishments where studies are conducted, and therefore has records of all such establishments.
In 2019, the HPRA performed 31 inspections, of which 32% were unannounced. The HPRA was satisfied with overall levels of compliance nationally.
There are four classifications of severity of procedures in the Directive which are ‘non-recovery’, ‘mild’, ‘moderate’, or ‘severe’. Over the two-year period from 2017 to 2019, the percentage of animals reported as experiencing an actual severity of severe has reduced from 29% to 13%, which in absolute terms represents a decrease in the numbers of animals experiencing severe severity from 70,596 in 2017 to 18,550 in 2019. The reduction in the proportion of procedures reported as severe is attributed to the reduction in regulatory use of animals, as well as efforts made by the HPRA, animal welfare bodies, and animal users, to reduce the severity of procedures through the implementation of refinements and earlier humane endpoints.
In accordance with the requirements of the Directive and national legislation, the details of all projects are publicly available in the non-technical project summary reports on the HPRA website. Annual statistical reports are also available on the HPRA website (http://www.hpra.ie/homepage/veterinary/scientific-animal-protection/statistical-reporting).
My Department provides funding to the Health Research Board (HRB). The HRB has advised that out of a total of 725 HRB funded applications since 2016, less than 1% include animal work. The HRB has significantly reduced the amount of funding for animal research over the years by limiting eligibility for animal research only to specific cases.
In addition, the HRB expect researchers to adhere to the general principles and best practice outlined in the guidance provided by the Health Products Regulatory Authority. The HRB has also worked with Science Europe and other like-minded funders and stakeholders across Europe to reaffirm its commitment to ensuring responsible research involving animals.