§ Mr. Gryllsasked the Secretary of State for Social Services what decision he has reached on the proposals of the Committee 264W on Safety of Medicines relating to the post-marketing surveillance of drugs; and if he will make a statement.
§ Dr. VaughanI attach great importance to adequate arrangements for monitoring adverse reactions to drugs on the market. The Committee on Safety of Medicines, serviced by officers of the Department, has provided a national system of drug monitoring since 1964. This scheme has stood the test of time and it is based on reports from doctors, coroners, the pharmaceutical industry, other drug regulatory authorities and scientific publications. The Department also funds a number of regional centres engaged in this work, a good example being the new drug surveillance research unit at Southampton university.
I have, however been considering possible ways in which the present arrangements might be improved within the resources available, including two proposals for pilot schemes put forward by the Committee on Safety of Medicines (CSM) known as retrospective assessment of drug safety (RADS) and record linkage. I am advised that these two pilot schemes would be very costly and if they were eventually established on a permanent, national basis, would be prohibitively so. Moreover, in the case of RADS serious doubts remain about its feasibility. I have reluctantly concluded therefore that in the present economic climate with the paramount need to restrain public expenditure it would be inappropriate to fund either of these pilot projects at the present time.
I believe, however, that we should build on the development work which has been done and that there should be continuing research into new and cost-effective methods of post-marketing surveillance of drugs. The DHSS will therefore consider sympathetically applications for grants into work on this subject. I also welcome the objectives of the scheme recently announced by the Royal College of General Practitioners on drugs surveillance.
In order that fuller benefit might be derived from the present monitoring system, doctors are being reminded of the importance of submitting yellow card reports to the CSM. The committee will also be consulted on other ways of making better use of existing data.