§ Mr. McLoughlin
asked the Secretary of State for Social Services what action he proposes to take to deal with the increased work in connection with human medicines arising under the Medicines Act 1968.
§ Mr. Newton
Applications for licences of various sorts have been rising by about 10 per cent. a year. It is encouraging to see this evidence of success in an industry that is responsible for an important part of health care provision in this country, and one of the objectives of the new pharmaceutical price regulation scheme that we introduced last October is to provide further encouragement to research and development in this field. But this increase in activity — and increases in applications for export certificates and in work on adverse reactions, enforcement and other aspects of medicines control—has necessarily given rise to a substantial increase in the work undertaken by the Department's division concerned with the administration of the Medicines Act.
We have added a number of posts to the staff of medicines division, and are reviewing the use of information technology for all aspects of the Division's work. But licence applications and other work on the control of medicines are expected to increase year by year, and it is important to ensure that our arrangements are fully capable of meeting future needs. I have therefore decided to commission an independent study of the matter. It will be carried out by Dr. John Evans, previously a Deputy Chief Medical Officer in DHSS, and by Mr. 239W Peter Cunliffe, who will retire from the Chairmanship of the pharmaceuticals division of ICI at the end of this month. Their terms of reference will be:To examine the issues for DHSS arising from the continued increases in licence applications and other work under the Medicines Act and to recommend ways of dealing expeditiously with this work, while maintaining adequate standards for the safety, efficacy and quality of human medicines in the United Kingdom".