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Safety of Medicines
Mr. Simon Hughes: To ask the Secretary of State for Health if the Licensing Authority, the Medicines Control Agency, the Medicines Division of the Department of Health or the Committee on Safety of Medicines have sought to prevent publication in peer-reviewed journals of information derived from yellow card data. [27351]
Mr. Malone: Yes. Permission to publish information derived from yellow card data might be refused if it were considered that inappropriate use was being made of the data.
Mr. Hughes: To ask the Secretary of State for Health if he will list all legal actions relating to the anti-depressant Mianserin in which the Licensing Authority or Committee on Safety of Medicines has been involved; and for each action if he will indicate whether the Licensing Authority or the CSM initiated the action, what was the legal basis of the action, what was the outcome and what were the legal costs incurred by the Licensing Authority or the CSM. [27352]
Mr. Malone: The Licensing Authority, the Medicines Commission and the Committee on Safety of Medicines were involved in judicial review proceedings in connection with Mianserin in 1988 and 1989. The actions were initiated by the pharmaceutical company Organon Laboratories Ltd. in 1988 under section 107 of the Medicines Act 1968 and included applications for several interim orders between 20 December 1988 and 3 January 1989, prior to judicial review proceedings which took place in February 1989. Two applications for review were sought by Organon. The Licensing Authority lost the case on appeal in January 1990. Details of the legal costs are no longer held.
Mr. Hughes: To ask the Secretary of State for Health if he will list all legal actions relating to Triazolam in which the Licensing Authority or the Committee on Safety of Medicines has been involved; and for each action if he will indicate whether the Licensing Authority or CSM initiated the action, what was the legal basis of the action, what was the outcome and what were the legal costs incurred by the Licensing Authority or CSM.[27353]
Mr. Malone: The Licensing Authority is currently involved in judicial review proceedings in connection with Triazolam. The action was initiated by Upjohn Ltd. in 1993 under section 107 of the Medicines Act 1968. The case has not yet been concluded.
Mr. Hughes: To ask the Secretary of State for Health if he will list the members of the pharmacovigilance subcommittee of the Committee on Safety of Medicines for the period from 1 January 1996. [27363]
Mr. Malone: The membership of the sub-committee on pharmacovigilance is as follows:
Professor A. Breckenridge (Chairman): professor of clinical pharmacology, Liverpool university
30 Apr 1996 : Column: 509
- Professor Darbyshire OBE: head of the Medical Research Council's HIV clinical trials centre, University college London medical school
Dr. K. Beard: consultant physician in geriatric medicine, the Victoria infirmary, Glasgow
Ms A Lee: principal pharmacist, drugs and poisons information centre, regional drugs and therapeutics centre, Newcastle
Dr. T. MacDonald: senior lecturer, department of clinical pharmacology, Dundee university
Professor K. MacPherson: professor of public health epidemiology, London school of hygiene and tropical medicine
Dr. M. Pirmohamed: lecturer in clinical pharmacology and therapeutics Liverpool university
Professor L. Ramsay: consultant physician at Hallamshire hospital and professor of clinical pharmacology and therapeutics, Sheffield university.
Mr. Malone [holding answer 21 March 1996]: Information about the safety of medicines is obtained from numerous sources of which the United Kingdom's yellow card scheme is only one. It is unusual for licensed medicines to be withdrawn from the market solely on the basis of information from yellow cards.
| Brand name (drug substance) | Year action taken(18) | Major safety concerns |
|---|---|---|
| (a) Medicines whose licence has been suspended by the Licensing Authority | ||
| Opren (benoxaprofen) | 1982 | Hepatotoxicity, serious skin reactions |
| Flosint (indoprofen) | 1983 | Gastrointestinal toxicity, multi-system toxicity |
| (b) Medicines whose licence has been revoked by the Licensing Authority | ||
| Zomax (zomepirac) | 1983 | Anaphylaxis, renal failure |
| (c) Medicines whose licence was withdrawn by the licence holder | ||
| Osmosin (indomethacin--modified release) | 1983 | Small intestinal perforations |
| Zelmid (zimeldine) | 1983 | Neuropathy, convulsions, hepatotoxicity |
| Methrazone (feprazone) | 1984 | Serious skin reactions, multi-system toxicity |
| Pexid (perhexiline) | 1985 | Neuropathy, hepatotoxicity |
| Merital (nomifensine) | 1986 | Haemolytic anaemia, renal failure |
| Glauline eye drops 0.6 per cent. (metipranolol) | 1990 | Uveitis |
| Micturin (terodiline) | 1991 | Cardiac arrhythmias |
| Roxiam (remoxipride) | 1994 | Aplastic anaemia |
(18) The year the action was taken relates to the year in which the product was removed from the market.
30 Apr 1996 : Column: 510
Medicines Control Agency
Mr. Simon Hughes: To ask the Secretary of State for Health (1) what is the scheduled retirement date for the chief executive of the Medicines Control Agency; [27356]
- (2) what is the scheduled retirement date of the head of the post-licensing business of the Medicines Control Agency. [27361]
Mr. Malone: Personal information about individual members of staff is confidential.
Mr. Congdon: To ask the Secretary of State for Health if he will list the key business targets for the Medicines Control Agency for 1996-97. [27885]
Mr. Malone: I have today placed a copy of the 1996-97 key business targets of the Medicines Control Agency in the Library. The agency's business plan will be placed in the Library in the near future.
DEFENCE
Serco Ltd.
Mr. Redmond: To ask the Secretary of State for Defence (1) what assessment he has made of the risks of a conflict of interest arising in respect of his Department's permanent secretary and his relationship with Serco Ltd.; and if he will make a statement; [26699]
- (2) what contracts his Department and his agencies have with Serco Ltd.; what is the current cost; when each contract ends; what are the penalties involved should he seek early termination of the contract; and if he will make a statement. [26677]
Mr. Arbuthnot: The permanent secretary has no relationship with Serco Ltd.
My Department's central contracts records show that there are about 150 current contracts with various Serco companies, including Serco Ltd. The total value is approximately £125 million. These do not include contracts placed by various defence agencies, which are the subject of separate replies from chief executives. To provide details of the values of each individual contract and to research details of the end dates could be carried out only at disproportionate cost.
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Although each contract will probably contain the Ministry's standard "break" condition which enables the Ministry to terminate the contract after a given period without penalty, there may be other termination provisions tailored to the circumstances of a particular contract. Again, details of these could be researched only at disproportionate cost.
I have asked the chief executives of the Defence Evaluation and Research Agency, the Meteorological Office and the Hydrographic Office to write to the hon. Member.
Letter from J. P. Clarke to Mr. M. Redmond, dated 30 April 1996:
Letter from John Chisholm to Mr. Martin Redmond, dated 30 April 1996:
You recently asked the Secretary of State for Defence a Parliamentary Question relating to contracts placed by the Ministry of Defence and Defence Agencies with Serco Limited. As your question relates in part to the Hydrographic Office and such issues fall within my responsibility as Chief Executive of the Hydrographic Office, I have been asked to reply to you.
The Hydrographic Office currently does not have any contract with Serco Limited.
I hope this information has been helpful.
Letter from J. C. R. Hunt to Mr. Martin Redmond, dated 30 April 1996:
The Secretary of State for Defence has asked me as Chief Executive of the Defence Evaluation & Research Agency to reply to your question about contracts with Serco Ltd.
DERA currently has about 240 contracts and enabling arrangements with Serco Ltd at a total value to £76M. All these contracts will have an early termination clause but I am afraid that it would involve disproportionate costs to check the precise terms of each and also to list the normal end date of each contract.
I am sorry I could not be more helpful.
As Chief Executive of the Meteorological Office I am replying to your recent question to the Defence Secretary concerning contracts with Serco Ltd.
Currently we have no such contracts.
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