§ Mr. AshleyTo ask the Secretary of State for Health if he proposes to increase the penalties on companies failing to report serious adverse drug reactions.
§ Mr. Mellor[holding answer 1 March 1989]: Any such change would require amendment to the Medicines Act 1968 and I have no plans for this at present.
§ Mr. AshleyTo ask the Secretary of State for Health (1) how many companies failed to report serious adverse drug reactions to the Committee on Safety of Medicines or licensing authority since 1972; and what penalties were imposed;
322W(2) if he will list the penalties which can be imposed under the Medicines Act on a company failing to report serious adverse drug reactions.
§ Mr. Mellor[holding answer 1 March 1989]: Because information on suspected under-reporting is held on files relating to specific products and containing full licensing information, a count of all possible instances of under-reporting since 1972 cannot be made without disproportionate cost. However, we believe the number to be very small. The vast majority of licensed medicinal products are subject to EC directives. Where, in such cases, there has been a breach of the licensing conditions under the Medicines Act and there is concern about safety, quality or efficacy, the licensing authority can suspend, revoke or vary a product licence, subject to the procedures laid down in the Act. In the case of medicinal products not subject to EC directives, such action can be taken whether or not there is a concern. Other options available to the licensing authority, where appropriate, include giving oral or written admonition to the chairman or managing director of the pharmaceutical company as well as requiring a written undertaking by the company that it will observe the licensing conditions in future.