§ Mr. Simon HughesTo ask the Secretary of State for Health (1) at what date and time the Committee on Safety of Medicines met to consider safety issues relating to the third generation oral contraceptive; [4301]
(2) at what date and time papers relating to potential safety concerns about third generation oral contraceptives were first made available to all members of the Committee on Safety of Medicines. [4302]
§ Mr. MaloneThe Committee on Safety of Medicines met on Friday 13 October at 10 am to consider the issues relating to third generation oral contraceptives. The papers for the meeting were dispatched to all members of the committee at 4 pm on 11 October by express courier service and were received by members at 10.30 am the following morning. Prior to this, some members of the CSM and expert external advisers had met on 10 October to consider the papers. Some advisers were also provided with each element of the data as it became available and a series of meetings were held to discuss the evidence as it evolved between June and October.
Prior to the availability of the new epidemiological evidence on third generation oral contraceptives, the CSM had reviewed the safety of third generation oral contraceptives and gestodene-based oral contraceptives in particular on three occasions, in 1989, 1991 and 1995.
§ Mr. HughesTo ask the Secretary of State for Health if he will list the costs, including travel costs and emoluments, of supporting the sub-committees of the Committee on Safety of Medicines, for each year since 1991. [4306]
§ Mr. MaloneThe information requested in respect of the sub-committtees of the Committee on Safety of Medicines—biologicals, chemistry, pharmacy and standards, pharmacovigilance and safety and efficacy—is as shown in the table for each financial year since 1990–91. The figures include members' fees, travel, hotel, and other miscellaneous costs.
- 1990–91: £116,265.26
- 1991–92: £120,427.43
- 1992–93: £113,874.82
- 1993–94: £121,778.89
- 1994–95: £92,741.42.
§ Mr. HughesTo ask the Secretary of State for Health (1) if he will list the names, professional appointments, date of first appointment to the Committee on Safety of Medicines and the total duration of membership of each member of the Committee on Safety of Medicines as at 1 October; [4304]
(2) how many members of the Committee on Safety of Medicines have a qualification in epidemiology. [4303]
519W
§ Mr. MaloneThe membership of the Committee on Safety of Medicines and information requested is shown in the table. Dr. Janet Darbyshire has a formal epidemiological qualification and in addition Professor M. D. Rawlins, chairman, and Professor M. J. S. Langman have extensive experience in pharmacoepidemiology.
Name Professional appointment Appointed Duration until 1 October 1995 Professor M. D. Rawlins (Chairman) Pharmacology— Newcastle University January 1980 15 year 9 months Professor A. M. Breckenridge Professor of Clinical Pharmacology— Liverpool University January 1981 12 years 9 months Dr. Kate L.Costeloe Reader in Neonatal Paediatrics, University of London Medical College January 1981 2 years 9 months Dr. Janet H. Darbyshire Head of MRC's HIV Clinical Trials Centre January 1993 2 years 9 months Hon. Consultant in Thoracic Medicine and Hon. Senior Lecturer in Epidermiology, University College London Medical School Professor D.S.Davies Professor of Biochemical Pharmacology at Royal Postgraduate Medical School Hammersmith Hospital January 1993 2 years 9 months Professor Anne Ferguson Professor of Gastroenterology and Head of Department of Medicine —Edinburgh University January 1993 2 years 9 months Professor A.T.Florence Dean of the School of Pharmacy— London University January 1981 14 years 9 months Professor A.M.Geddes Head of Department of Infection— Birmingham University January 1993 2 years 9 months Professor E.C.Gordon-Smith Professor of Haematology—St. George's Hospital Medical School, London January 1990 5 years 9 months Professor K.Gull Director of the Research and Graduate School, School of Biological Sciences, Manchester University January 1993 2years 9 months Professor H.S.Jacobs Professor of Reproductive Endocrinology, University College and Middlesex School of Medicine January 1984 11 years 9 months Dr.W.A. Jerrett General Practitioner—Glamorgan January 1987 8 years 9months Dr.B.J. Kirby Consultant Physician and Deputy Director of the Postgraduate Medical School—Exeter University January 1993 2years 9 months Miss Gillian C.N. Lachelin Reader and Consultant Obstetrician and Gynaecologist — University College and Middlesex School of Medicine January 1993 2 years 9 months Professor M.J.S. Langman Professor of Medicine and Dean of the Faculty of Medicine and Dentistry—Birmingham University January 1987 8 years 9 months Dr.A.V.P. Mackay Medical Director of the Argyll and Bute January 1993 2 years 9 months NHS Trust and McIntosh Lecturer in Psychological Medicine—Glasgow University Professor J.M. Midgley Professor of Pharmaceutical and Medicinal Chemistry-Strathclyde University January 1990 5 years 9 months Professor B.K. Park Professor of Pharmacology and Therapeutics— Liverpool University January 1993 2 years 9 months Professor J.C. Petrie Professor of Clinical Pharmacology— Aberdeen University January 1993 2 years 9 months Professor A.Li Wan PO Professor of Clinical Pharmaceutics— Nottingham University January 1993 2 years 9 months Professor Anne E. Tattersfield Professor of Respiratory Medicine— Nottingham University January 1993 2 years 9 months
§ Mr. HughesTo ask the Secretary of State for Health if he will list the remuneration which the chairman and members of the Committee on Safety of Medicines received in respect of their work on the committee the last year for which figures are available. [4307]
520WThe committee consults as necessary other disciplines not represented on the committee, including experts in epidemiology, and when the need arises co-opts them on to the committee as "members for the day". The sub-committees of the Committee on Safety of Medicines additionally provide a range of expertise which may not be represented on the main committee.
§ Mr. MaloneFor the financial year 1994–95, the chairman received £2,358 in attendance and preparation fees and the members received among them £34,294 in attendance and preparation fees in respect of 11 one-day meetings. In addition, the chairman and members were 521W reimbursed their travel, hotel and other miscellaneous cost.
§ Mr. HughesTo ask the Secretary of State for Health what statutory provisions govern the Committee on Safety of Medicines. [4305]
§ Mr. MaloneThe Committee on Safety of Medicines is a committee established by Ministers under powers in section 4 of the Medicines Act 1968. The committee was established by the Medicines (Committee on Safety of Medicines) Order 1970, S.I. 1970/1257, to give advice—with respect to safety, quality and efficacy—on medicinal products for human use and to promote the collection and investigation of information about adverse reactions, to enable such advice to be given.
The Medicines Commission and Committees Regulations 1970, S.I. 1970/746, made under powers in schedule 1 to the Medicines Act 1968, provide inter alia for the terms of office of members of committees established under section 4.