HL Deb 22 June 1976 vol 372 cc292-4

Baroness FISHER of REDNAL asked Her Majesty's Government:

What are the procedures for checking side-effects and ineffectiveness of pharmaceutical products used by the National Health Service.


All new medicinal products marketed for use in the National Health Service require a product licence. Such licences are only issued when full information on the quality, safety and efficacy, which would include the results of animal studies as well as reports of clinical studies in patients, has been examined to the satisfaction of the Committee on Safety of Medicines. Products already on the market are being systematically reviewed by the Committee on Review of Medicines.

An additional safeguard is the continuous monitoring of all medicinal products by the Committee on Safety of Medicines by its adverse reaction reporting system. It is a condition of any product licence that the holder shall report any adverse reactions coming to his notice. In addition, specially commissioned epidemiological studies are carried out on certain products and the Department of Health and Social Security maintains close links on questions of safety and efficacy with other drug regulatory authorities and the World Health Organisation. If any significant problem arises, appropriate action is taken to inform doctors of it and if necessary the product is withdrawn from the market.

House adjourned at eight minutes past nine o'clock.