Dáil Éireann Debate, Tuesday - 28 November 2023
563. Deputy Neasa Hourigan asked the Minister for Health when the harm/benefit analysis of proposed animal experimentation projects are conducted, whether his Department considers the utility of the product to be tested on animals, or the utility of the product a component substance of which is to be tested on animals, as a factor in that harm/benefit analysis; and if he will make a statement on the matter. [51870/23]
View answerThe Health Products Regulatory Authority (HPRA) is the competent authority in respect of the use of animals for scientific purposes within Ireland. Any project on animals conducted in Ireland must be evaluated by the HPRA in accordance with Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes. This legislation is transposed into Irish law by the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (S.I. No. 543 of 2012).
The Regulations specify that a project can only be authorised:
• When justified from a scientific or educational point of view or required by law;
• When non-animal studies are unsuitable and cannot deliver the scientific objectives being sought;
• When the project ensures that any required animal procedures are conducted in the most humane and environmentally sensitive manner possible; and
• When the expected project outcome is justified by the harm/benefit analysis.
In accordance with Directive 2010/63/EU the HPRA conducts a harm/benefit analysis on each project application within 40 working days of receipt. The HPRA publishes the results of its analysis of project applications on the European Commission ALURES (Animal Use Reporting - EU System) Non-Technical Summary (NTS) database which has been developed for this purpose.
