§ Mr. Ashleyasked the Secretary of State for Social Services for how long the code of practice about clinical trials with general practitioners has been under discussion; for how long there has been dispute over the issues yet unresolved; what these issues are; when he expects the code to be published; and if there is a code of practice for hospital clinical trials.
§ Mr. Kenneth ClarkeThe Government, the Association of the British Pharmaceutical Industry—ABPI—and the BMA have been working on proposals for a code of practice covering clinical trials of licensed medicines by GPs since 1979. There are still two major matters outstanding. These relate to the legality of doctors receiving payment for the administrative work involved in a trial and for supplying a drug directly to a patient for the purposes of the trial and the need for possible amendments to the NHS (General Medical and Pharmaceutical Services) Regulations and to the NHS (Charges for Drugs and Appliances) Regulations. Drafts of proposed amendments were first submitted to the BMA in January 1982, and revised versions were submitted to it in January 1983 following discussions. I am very anxious to conclude these discussions and proceed to early publication of the code.
I am not aware of a code of practice for hospital clinical trials although general rules governing the conduct of such research are contained in the declaration of Helsinki which is reproduced in the BMA Handbook of Medical Ethics together with paragraphs relating to ethical procedures.