Medicinal products for human use containing botulinum toxin are authorised in Ireland and in other EU Member States under Directive 2001/83/EC and Regulation No. 726/2004. In accordance with the terms of the products' marketing authorisations, the safety and potency of product batches must be tested to ensure that the medicines are safe and effective. The same standards apply irrespective of the final use of the medicinal products. Although non-animal test methods have been developed and are already used for quality control of a number of the medicinal products concerned, they are not yet available for all. Furthermore, even when non-animal test methods are available and deployed, some animal studies are still needed to cross-check the validity of in vitro test results, as well as for testing the reference standards against which potency is calibrated. Nonetheless, significant progress has been achieved in this area in Ireland, with, for example, a 20% reduction in the number of animals used for regulatory purposes in 2021 compared to 2020.
The legislation governing the use of animals for scientific purposes in Ireland is based on EU legislation, and is among the world's most advanced legislation in protecting animals. The EU Directive 2010/63/EU on the protection of animals used for scientific purposes was transposed into national law in the European Union (Protection of Animals Used for Scientific Purposes) Regulations 2012 (S.I. No. 543 of 2012). The ultimate goal of this legislation is the complete replacement of animal use for research and testing. However, for the moment, the use of live animals continues to be necessary to protect human and animal health and the environment.
In Ireland, the Health Products Regulatory Authority (HPRA) is the competent authority which oversees the conduct of animal studies. Testing of botulinum toxin products can only be carried out when the HPRA has evaluated and approved an application to test such products on animals. The project authorisation process includes:
• Consideration of the justification for conducting the testing, to confirm that it is necessary to use animals to achieve the objectives of the proposal;
• Consideration of whether alternative non-animal test methods that could replace the use of animals are available;
• Consideration of the number of animals proposed for use, to ensure it is the minimum number possible;
• Consideration of the principle of Refinement, to ensure that welfare impacts on animals are minimised and testing is conducted in the most humane manner possible.
The HPRA uploads a non-technical project summary for each project to an EU database, known as ALURES. The reports are unique for each study that is authorised, but full information on the study justification can be accessed from the summary.
