My Department has statutory responsibility under EU and national pharmaceutical legislation (Council Directive 81/851 EEC and the Animal Remedies Regulations, 1996) for the operation of a licensing regime in relation to clinical trials. The Department of Health and Children also has statutory responsibility in this area and operates a licensing regime focused on the protection of animals being used for experimental or other scientific purposes.
The clinical trial referred to by the Deputy was licensed by my Department on the basis of the appropriate details furnished in the relevant application. For the sake of clarity, I should point out that under the relevant legislation, the issue by my Department of a licence is not contingent on the issue of a licence by the Department of Health and Children. While that is a matter entirely for decision by the Department in question, I understand that in this case, it concluded that the trial would not require licensing by it.