§ Mr. Ashleyasked the Secretary of State for Social Services if he will classify the drugs whose safety has been discussed by the Committee on Safety of Medicines in the last year according to whether the number of prescriptions issued annually for the drug was (a) over 5 million, (b) over 2 million, (c) over 1 million, (d) over half a million and (e) under half a million.
§ Mr. Hayhoe[pursuant to his reply, 10 July 1986]: Between July 1985 and June 1986 the Committee on Safety of Medicines gave advice to the licensing authority on safety, quality and efficacy in relation to 110 applications for product licences and clinical trial certificates; none of these products had previously been generally available. 422W During this period the Committee also kept under review the safety of all medicinal products which were being marketed or undergoing clinical trials. In particular it examined and discussed the safety of 14 specific drug substances, classified by the number of prescriptions dispensed during 1984 (the latest year for which information is available), as follows:
- (a) none
- (b) one
- (c) one
- (d) one
- (e) seven
Figures for the remaining four substances arc not available.
Prescribing figures are for NHS prescriptions dispensed by retail pharmacists in Great Britain. The figures are derived from estimates made from samples of 1 in 200 prescriptions for England and Wales, and 1 in 100 prescriptions in Scotland.
§ Mr. Ashleyasked the Secretary of State for Social Services, in the last five years, how many drugs have been discussed by the Committee on Safety of Medicines; in how many cases (a) the drug was voluntarily withdrawn by the manufacturer, (b) withdrawn by order of the committee, (c) had the usage changed on the advice or instructions of the committee and (d) no regulatory action taken at the time or subsequently.
§ Mr. Hayhoe[pursuant to his reply, 10 July 1986]: In the calendar years 1981 to 1985 the Committee on Safety of Medicines gave advice to the Licensing Authority on safety, quality and efficacy in respect of 809 applications for product licences and clinical trial certificates. The Committee also discussed the safety of some 80 drugs or groups of drugs (that is, drugs having the same active substance or in the same therapeutic class) which were already being marketed or were undergoing clinical trials. Following consideration by the Committee of these 80 drugs or groups of drugs, licences or certificates were revoked in eight cases by the licensing authority acting on the advice of the Committee; licences or certificates were voluntarily surrendered by the licence holders in 13 cases for reasons which did not necessarily relate to safety; and there were 27 cases for which licences or certificates were varied. No formal licensing action was advised or taken on the remaining 32 drugs or groups of drugs but the Committee drew the attention of the medical profession to particular aspects in about half these cases through its regular bulletin, "Current Problems", or in published articles.
§ Mr. Ashleyasked the Secretary of State for Social Services how many drugs, whose safety is currently being assessed by the Committee on Safety of Medicines, have over one million prescriptions issued for them annually; and which are these drugs.
§ Mr. Hayhoe[pursuant to his reply, 10 July 1986]: The Committee on Safety of Medicines continuously monitors the safety of all drugs, and is at present actively assessing the safety of seven drugs which had over one million prescriptions in.1984, the latest year for which figures are available. The seven drugs fall into two categories; non-steroidal anti-flammatories, and anti-hypertensive agents. For reasons of confidentiality and taking account of section 118 of the Medicines Act 1968 it would not be appropriate for me to give further details. The CSM has already given general advice to doctors on 423W some possible effects of non-steroidal anti-flammatory drugs in its bulletin "Current Problems" and in published articles "CSM Updates" in the British Medical Journal. The CSM will decide whether to recommend any further action when it has completed its examination of all the scientific evidence. Prescribing figures are for NHS prescriptions dispensed by retail pharmacists in Great Britain. The figures are derived from estimates made from samples of 1 in 200 prescriptions for England and Wales, and 1 in 100 prescriptions in Scotland.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will list the five drugs for which the monthly number of yellow card adverse reaction cards has increased most in the last six months; if he will give the latest figures for the monthly number of reports and the percentage increase.
§ Mr. Hayhoe[pursuant to his reply, 10 July 1986]: I regret that this information cannot be provided without disproportionate expense. Cumulative numbers and the nature and the severity of adverse reaction reports, considered in relation to changes in drug usage and the indications for the drug, have more meaning in assessing the safety of medicines than merely the number of yellow cards received for a medicine in a particular month, or differences between monthly figures.
§ Mr. Ashleyasked the Secretary of State for Social Services what procedures are adopted to ensure the integrity and independence of the Committee on Safety of Medicines when the safety of a drug is being discussed and members of the committee have themselves or through their departments received money from the company manufacturing the drug.
§ Mr. Hayhoe[pursuant to his reply, 10 July 1986]: Members of the Committee on Safety of Medicines are required to inform the head of medicines division of my Department of any relevant financial interest, including any consultancies in the pharmaceutical industry. Members are also required to declare at meetings any interests which they may have, whether direct or indirect, in a product under consideration, or in the company concerned. Where they have a direct interest they understand that they must take no part in the discussion except where the chairman considers such a contribution would be justified. Such declarations are entered in the minutes of the meeting.
I have no reason to believe that members of the Committee—for whose work I am most grateful—have not maintained the highest level of integrity, objectivity and professional expertise.
§ Mr. Ashleyasked the Secretary of State for Social Services when the Committee on Safety of Medicines scrutinises the safety of a drug, which individuals, organisations and institutions are (a) informed and (b) requested to give their views or provide evidence; and, in particular, what information is given to the manufacturing company and what information is sought from it.
§ Mr. Hayhoe[pursuant to his reply, 10 July 1986]: Before advising the licensing authority on an application for a product licence or clinical trail certificate, the Committee on Safety of Medicines considers the safety, quality and efficacy of the medicinal product in the light of all the scientific evidence, including the full documentation that the applicant is required to provide. When the Committee 424W considers the safety of products which are already marketed or undergoing clinical trials it will take account of any company reports of adverse reactions, which the licence holder is required to make. The licence holder may also be asked for further evidence, information or analysis. In addition, in particular circumstances the European Community's Committee on Proprietary Medicinal Products, other drug regulatory agencies, professional organisations and other bodies and individuals may be informed in confidence that the Committee is considering a product and asked for evidence or opinion.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will request his officials to discuss with their counterparts in the United States Food and Drug Administration the advantages and disadvantages of their activities being governed by the Freedom of Information Act; if he will request them to prepare a report on their conclusions; and if he will place the report in the Library.
§ Mr. Hayhoe[pursuant to his reply, 10 July 1986]: From occasional informal discussions with their counterparts in the United States Food and Drug Administration, officials from medicines division in my Department maintain a broad awareness of many of the advantages and disadvantages of the United States regulatory scheme including the effects of the United States Freedom of Information Act but I do not consider a report to be necessary at this time.
§ Mr. Ashleyasked the Secretary of State for Social Services if he will initiate legislation to exempt the committee proceedings of the Committee on Safety of Medicines from the Official Secrets Act.
§ Mr. Hayhoe[pursuant to his reply, 10 July 1986]: No; nor have I any plans to alter the provisions of the Medicines Act 1968, section 118, which makes it an offence for any person to disclose to any other person any information obtained by or furnished to him in pursuance of the Act, unless the disclosure was made in the performance of his duty.
§ Mr. Ashleyasked the Secretary of State for Social Services on how many occasions his Department has discussed with the Committee on Safety of Medicines the question of secrecy about the proceedings of the committee; and what were the conclusions.
§ Mr. Hayhoe[pursuant to his reply, 10 July 1986]: None. Members of the Committee on Safety of Medicines are aware from the time of their appointment of the requirement of section 118 of the Medicines Act 1968, and that they should respect the confidentiality of committee papers and proceedings.