§ Mr. Simon HughesTo ask the Secretary of State for Health what meetings took place between his Department and the manufacturers of third generation oral contraceptives between July and the end of September 1995; and if concerns about the safety of their products were discussed at those meetings. [25589]
§ Mr. MaloneI refer the hon. Member to the reply that I gave him on 16 April at column 488.
§ Mr. HughesTo ask the Secretary of State for Health which company his Department employed in October 1995 to print, collate and post the letter to general 499W practitioners informing them of safety concerns about third generation oral contraceptives; and if he will make a statement. [25810]
§ Mr. MaloneThe Medical Direct Mail Organisation.
§ Mr. HughesTo ask the Secretary of State for Health which members of the Committee on Safety of Medicines subcommittee briefed on 10 October 1995 about third generation oral contraceptives were not members of the committee. [25590]
§ Mr. MaloneI refer the hon. Member to the reply that I gave the hon. Member for Gordon (Mr. Bruce) on 19 December 1995 at column1151. The ad hoc working group which met on 10 October 1995 included members of the Committee on Safety of Medicines and invited experts who were not members of the committee.
§ Mr. HughesTo ask the Secretary of State for Health what assessment he has made of the safety of oral contraceptives following the most recent meeting of the Committee on Safety of Medicines; and if he will make a statement. [27332]
§ Mr. MaloneMinisters rely on their advisory committees for an assessment of such issues.
§ Mr. HughesTo ask the Secretary of State for Health what attachments were enclosed with the letter of 11 October 1995 relating to oral contraceptives containing desogestrel or gestodene in order to inform consideration of the relevant issues by the Committee for Proprietary Medicinal Products. [27354]
§ Mr. MaloneI refer the hon. Member to the reply that I gave him on 2 April at column185.
§ Mr. HughesTo ask the Secretary of State for Health who represented the United Kingdom at the three meetings of the Committee for Proprietary Medicinal Products held on(a) 17–18 October 1995, (b) 26–27 October 1995 and (c) 16 to 18 April 1996. [27355]
§ Mr. MaloneThe two members of the Committee for Proprietary Medicinal Products nominated by the United Kingdom, supported as necessary by experts relevant to the items under consideration.
§ Mr. HughesTo ask the Secretary of State for Health if the consideration of safety issues by the Committee for Proprietary Medicinal Products relating to oral contraceptives containing desogestrel or gestodene took place on the basis of article 8 of directive 75/319/EEC. [27357]
§ Mr. MaloneI refer the hon. Member to the reply that I gave him on 8 February at column344. The Medicines Control Agency made a written request that the Committee for Proprietary Medicinal Products include the matter for discussion at its meeting of 17–18 October 1995. The subsequent CPMP position statement dated 27 October 1995 makes reference to article 8 of directive 75/319/EEC.
§ Mr. HughesTo ask the Secretary of State for Health what advice the Committee on Safety of Medicines communicated to the relevant pharmaceutical companies about the product licences relating to desogestrel or gestodene, following its meeting on 13 October 1995; [27368]
500W(2) what advice the Committee on Safety of medicines gave regarding action on the product licences relating to desogestrel and gestodene at its meeting on 13 October 1995. [27362]
§ Mr. MaloneI refer the hon. Member to the reply that I gave him on 8 February at column343. The advice of the Committee on Safety of Medicines to the licensing authority is confidential.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 19 December,Official Report, column 1153, on what date the final report of the World Health Organisation study on oral contraceptives was produced; and if he will make a statement. [27370]
§ Mr. MaloneA number of reports of the World Health Organisation's findings were provided to the Medicines Control Agency between July and October 1995; the report referred to in the answer given on 19 December 1995 at column1153 provided the final results on venous thromboembolism of the WHO study. The MCA subsequently received a copy of the manuscript which was submitted to The Lancet for publication, dated 13 October. This document was not different in any important way from the previous report received by the MCA.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 2 April,Official Report, column 185, if clinical trials with oral contraceptives containing gestodene were terminated in October 1995. [27364]
§ Mr. MaloneI refer the hon. Member to the reply that I gave him on 8 February at column346.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 2 April,Official Report, column 185, if the referral to the Committee for Proprietary Medicinal Products of 11 October 1995 was made by one of the United Kingdom's representatives on the Committee for Proprietary Medicinal Products. [27365]
§ Mr. MaloneYes. The written request that the Committee for Proprietary Medicinal Products include the safety of oral contraceptives on the agenda of its meeting of 17–18 October was made by one of the United Kingdom's representatives on the committee.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 2 April,Official Report, column 184, if the then Under-Secretary of State, the hon. Member for Bolton, West (Mr. Sackville), was consulted prior to the written request that the Committee for Proprietary Medicinal Products consider safety issues relating to oral contraceptives containing desogestrel or gestodene; and if he authorised the request to the CPMP. [27366]
§ Mr. MaloneDisclosure of information such as that requested would be in breach of the long-established convention, observed by successive Governments, protecting the confidentiality of the internal decision-making process.
§ Mr. HughesTo ask the Secretary of State for Health if the chief executive of the Medicines Control Agency authorised the request of 11 October 1995 to the Committee for Proprietary Medicinal Products relating to desogestrel and gestodene. [27367]
501W
§ Mr. MaloneThe chief executive of the Medicines Control Agency agreed with the United Kingdom delegate to the Committee for Proprietary Medicinal Products that this would be an appropriate issue for the committee to consider at its meeting of 17–18 October 1995.
§ Mr. HughesTo ask the Secretary of State for Health if the Committee on Safety of Medicines has made a re-assessment of the safety of desogestrel and gestodene in the light of evidence in December 1995 and January 1996. [27369]
§ Mr. MaloneI refer the hon. Member to the reply I gave him on 25 April at column281.