§ Mr. Pavittasked the Secretary of State for Social Services (1) when representations are made to the Medicines Commission as an appeal by the applicant for a licence to produce Pharmaceuticals against a Minister's decision, what safeguards exist to ensure that a member is not giving consideration to a product of a company which is in competition with his own;
(2) if a member of the Medicines Commission has access to information and data which are considered by either the Committee on Safety of Medicines or the Veterinary Products Committee.
§ Sir K. JosephThe members of the Medicines Commission do not have access84W to information being considered by the Committee on Safety of Medicines or the Veterinary Products Committee in connection with a licence application. But if the Committee concerned recommends that a licence should be refused, or should be granted otherwise than in accordance with the application, the applicant may ask to be heard by, or to have the opportunity of making written representations to, the Commission with regard to that recommendation.
The Medicines Commission cannot consider the representations adequately unless it is in possession of the Committee's findings and recommendations and the reasons for them and the applicant's reasons for disagreeing, and unless the original application and supporting documentation are available for consultation at the meeting.
A similar situation would occur in relation to representations concerning clinical trial or animal test certificates or in relation to proposals by the licensing authority to suspend, revoke or vary licences or certificates. Before the Commission proceeds to consider the recommendations it will be ascertained whether any member of the Commission has an interest in the company concerned, or whether his company is interested in a field in which the product that is the subject of the representations would be in competition, so that the Commission can ensure that its proceedings are not prejudiced.