§ Mr. BlunkettTo ask the Secretary of State for Health (1) if she will make a statement on her policy on the use in the NHS of post-marketing surveillance trials by drugs companies;
(2) if she will list the drugs used by the NHS in post-marketing surveillance trials in the last 12 months; and if she will make a statement.
§ Dr. MawhinneyPost-marketing surveillance studies are the responsibility of pharmaceutical companies and not the NHS or the Department of Health. These studies are designed to gain information on the safety of medicines in everyday clinical practice and therefore could not be done without the involvement of the NHS. Voluntary guidelines on the conduct of company-sponsored PMS studies have been in force since 1988. Under these guidelines, companies are requested to provide information on these studies to the Medicines Control Agency. 5W The MCA has reviewed PMS studies conducted under the guidelines and their findings were published in the British Medical Journal inJune 1992. In the light of these findings, the guidelines are now being reviewed.
Information supplied by companies to the MCA is considered confidential under section 118 of the Medicines Act 1968. A list of individual drugs on which PMS studies are being conducted cannot therefore be published by the Department of Health.