Written Answers. - Drug Trials.

Tony Gregory

Question:

528 Mr. Gregory asked the Minister for Health and Children 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. [19379/00]

The trials referred to were licensed by the Department of Agriculture, Food and Rural Development under the Animals Remedies Regulations, 1996. All documentation in relation to the conduct of the trials in question was submitted to the animal health and welfare division of that Department.

My Department administers a licensing scheme in regard to largely medical and scientific research. However, we received no application for a licence for the trials referred to by the Deputy which related to a particular type of animal remedy. Concerns were subsequently raised that perhaps the trials should also have been licensed by my Department. We received information on the purpose and nature of these trials from the Department of Agriculture, Food and Rural Development and, following receipt of expert advice from a veterinarian in that Department, we concluded that the trials would not have required licensing from my Department.