§ Mr. Simon HughesTo ask the Secretary of State for Health what budget the Licensing Authority made available to the Committee on Safety of Medicines for each year from 1971 to 1994 in respect of its statutory role to promote the collection of adverse drug reactions. [20060]
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§ Mr. MaloneThe Medicines Control Agency undertakes the role of promoting the collection of adverse drug reactions on behalf of the committee and seeks its advice as appropriate. An overall budget of £821,986 was devoted to running and promoting the spontaneous adverse drug reaction reporting scheme in the financial year 1994–95. Information since 1971 is not readily available and could be provided only at disproportionate cost.
§ Mr. HughesTo ask the Secretary of State for Health if he will list the occasions since the coming into effect of the Medicines Act 1968 on which(a) the Licensing Authority, (b) the medicines division of the Department of Health, (c) the Medicines Control Agency or its staff and (d) the Committee on Safety of Medicines or its chairman have (i) sought and (ii) obtained an injunction or interdict preventing publication of information relating to the safety of medicines licensed or formerly licensed under the provisions of the Act; and if he will list for each case the date on which an injunction or interdict was sought, the products concerned, the grounds on which the action was taken, if the action was contested, and the outcome. [20064]
§ Mr. MaloneWe have no record of any such proceedings.
§ Mr. HughesTo ask the Secretary of State for Health what plans he has to review the procedures of the Medicines Control Agency. [20058]
§ Mr. MaloneThe procedures of the Medicines Control Agency are a matter for the agency chief executive operating within relevant statutory provisions and the agency's framework document. The chief executive is accountable to my right hon. Friend the Secretary of State for Health for the efficient management and overall performance of the agency. The agency is subject to regular review. The latest review was completed last year and a summary of its findings placed in the Library.
§ Mr. HughesTo ask the Secretary of State for Health what mechanisms are available to members of the Committee on Safety of Medicines who wish to raise matters of concern in relation to the workings of the committee. [20062]
§ Mr. MaloneCommittee members have the power to regulate the committee's procedures under schedule 1, paragraph 4 of the Medicines Act 1968. In addition, individual committee members are free to raise any issues which they consider to be of relevance to the workings of the committee, either with the chairman, at committee meetings or by writing to the appointing authority, the United Kingdom Health Ministers.
§ Mr. HughesTo ask the Secretary of State for Health what training in the interpretation of epidemiological data is provided to new members of the Committee on Safety of Medicines on their appointment. [20061]
§ Mr. MaloneMembers are appointed for their individual expertise in the fields of medicine, pharmacy or science. Their specialist knowledge and judgment contribute to the advice given by the Committee to the Licensing Authority. In addition, I refer the hon. Member to the answer that I gave him on 11 December 1995,Official Report, columns 521–24.
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§ Mr. HughesTo ask the Secretary of State for Health on what dates(a) he and (b) his ministerial colleagues met the chairman of the Committee on Safety of Medicines since 1 January 1995. [20063]
§ Mr. MaloneThe chairman of the committee met me on 3 October 1995.