asked the Secretary of State for Social Services when he expects to issue the revised guidance from the Royal College of Physicians and the Association of British Pharmaceutical Industries relating to the testing of drugs on healthy volunteers; how often the working group on this matter has met; from whom it sought evidence; and what was the representation of each body on the working group.
The Royal College of Physicians set up a working party on medical research on healthy volunteers in 1984. I am informed by the college that it hopes to publish the working party's report as guidance to the profession in the autumn. I understand that the working party has meet nine times so far and has taken written evidence from many sources as well as oral evidence from professors of clinical pharmacology and toxicology and from representatives of the pharmaceutical industry; clinical research units; the Trades Union Congress; the Faculty of Occupational Medicine; the National Union of Students; the Health and Safety Executive; and our Department's medicines division. The working party is chaired by Sir Raymond Hoffenberg, President of the Royal College of Physicians. It consists of members and fellows of the Royal College, including a representative of the Association of British Pharmaceutical Industry; a lawyer; the Chairman of the Patients' Association; and an observer representing the Medical Research Council. When the revised professional guidance is available, we shall consider carefully, in the light of advice from the Medicines Commission on it, what our attitude should be.
asked the Secretary of State for Social Services (1) what information he has as to the number of deaths or serious side-effects that have occurred in each of the last five years amongst healthy volunteers taking part in the testing of drugs by the pharmaceutical industry;(2) what information he has as to the number of healthy volunteers in each of the last five years who have taken part in the testing of new drugs by the pharmaceutical industry.
We do not collect this information.
asked the Secretary of State for Social Services to what extent his Department's guidelines on drug testing require pharmaceutical companies to test drugs on animals before tests using healthy human volunteers are conducted; and if he will make a statement.
Our Department's guidelines on drug testing apply only to medicines for patients and not to tests on healthy human volunteers.
asked the Secretary of State for Social Services if he will seek powers to require drug companies testing new drugs on healthy volunteers to report adverse reactions to his Department; and if he will take steps to ensure that these reactions and those suffered by patients taking part in clinical trials are included in the register of adverse reactions.
I have nothing to add to my replies to the right hon. Member on 12 June and 26 June 1984 at columns 416 and 462.