§ Mr. RadiceTo ask the Secretary of State for Health in how many cases in 1991–92 the licensing authority determined an application for the grant of a licence under the Medicines Act in a way which differed from the advice of the Medicines Commission; and if she will identify each of those cases.
§ Dr. MawhinneyNone.
§ Mr. RadiceTo ask the Secretary of State for Health (1) if she will place in the Library a copy of the Committee on Safety of Medicines' policy on the disclosure of information about adverse drug reactions;
(2) if she will place in the Library a copy of the Medicines Control Agency's policy on disclosure of information.
§ Dr. MawhinneyThe Medicines Control Agency has access to company data about medicinal products to carry out its functions under the provisions of the Medicines Act 1968. The Act places a responsibility on Ministers to protect the confidentiality of that information and makes it an offence for anyone to disclose it except in the performance of their duty.
It is the policy of the Medicines Control Agency to maintain the commercial confidentiality of information provided by the pharmaceutical industry and to protect the anonymity of individuals identified in information to which it has access; this applies to information made available to the Committee on Safety of Medicines. Information on adverse drug reactions is disclosed by the agency to doctors, pharmacists and related groups when relevant to specific safety concerns.