Dáil Éireann Debate, Tuesday - 25 April 2023
593. Deputy Paul Murphy asked the Minister for Health his views on the continued use of the LD-50 test on animals given the availability of alternative tests that do not cause suffering to animals; and if he will make a statement on the matter. [19449/23]
View answerMy Department has liaised with officials in the Health Products Regulatory Authority (HPRA) with regard to this question. The HPRA is the relevant government agency with responsibility for the implementation of the legislation on the protection of animals used for scientific purposes.
The validation and regulatory acceptance by EU medicines regulators of non-animal tests as an alternative to the use of the LD-50 test for quality control and safety tests of some medicinal products is welcomed. In line with the legal obligations laid down in Articles 4 and 13 of Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes, approval to use animals for LD-50 testing of certain medicinal products is granted strictly on the basis of robust justification that no non-animal method is available and recognised under EU legislation. However, there are medicinal products on the market for which as yet, no alternative tests have been successfully validated or been granted regulatory approval as a replacement for the LD-50 test.
