Written Answers. - Clinical Trials.

Tony Gregory

Question:

373 Mr. Gregory asked the Minister for Agriculture, Food and Rural Development if the drug trials (details supplied) were properly licensed; if appropriate documentation was provided; the action that is being taken arising from any breach of the law or regulations; and if he will make a statement on the matter. [19380/00]

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.

Following receipt of a non-specific complaint about the conduct of the trial concerned, my Department carried out a thorough investigation, in the course of which reports were obtained from various individuals and bodies who had an involvement with the trial. Among the reports secured was one from the Garda Síochana, which had, on the basis of an earlier complaint received by them, carried out an on the spot investigation while the trial was in progress. The Department's investigation indicated that, while the trial was substantially conducted in accordance with the licence issued by my Department, it did not in fact take place at the site indicated in the application, and that one of the animals involved was euthanised during the course of the trial for reasons which, I understand, were not linked with the substance being trailed.
My Department has already conveyed the results of its investigation to the complainants, as well as to the clinical trial licence holder. On the basis of the information currently available, my Department does not foresee taking further action in this specific case.