§ Mr. Simon HughesTo ask the Secretary of State for Health if the United Kingdom representatives on the Committee for Proprietary Medicinal Products notified his Department that it had discussed the referral made by the United Kingdom on 11 October 1995 in the context of article 12 of directive 75/319/EEC on 27 October; and if he will make a statement. [26165]
§ Mr. MaloneI refer the hon. Member to the reply that I gave him on 8 February at columns343–44.
§ Mr. HughesTo ask the Secretary of State for Health (1) pursuant to his answer of 25 March,Official Report, column 428, if licensing action has started with respect to oral contraceptives containing desogestrel and gestodene; [26250]
(2) what plans the Medicines Control Agency has to vary the product licences of third generation oral contraceptives. [26574]
§ Mr. MaloneI refer the hon. Member to the reply that I gave to the hon. Member for Gordon (Mr. Bruce) on 19 December 1995 at column1149.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 14 March,Official Report, column 752, if at the meeting on 3 October 1995 he and the chairman of the Committee on Safety of Medicines discussed issues relating to the safety of desogestrel and gestodene. [26255]
§ Mr. MaloneNo.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 2 April,Official Report, column 175W 184, if the Jick manuscript faxed to the Medicines Control Agency after dispatch of papers to the Committee on Safety of Medicines on 11 October was made available to the committee on 13 October. [26251]
§ Mr. MaloneNo. A near final version of the manuscript from the Jick study was included with the papers despatched to committee members prior to the meeting. There was no substantive change to the analysis in the final version.
§ Mr. HughesTo ask the Secretary of State for Health what steps he took prior to authorising the issuing of the "Dear Doctor" letter of 18 October 1995 to establish that the Committee on Safety of Medicines had based its advice on all available relevant evidence; and if he will make a statement. [26292]
§ Mr. MaloneI refer the hon. Member to the reply that I gave to the hon. Member for Gordon (Mr. Bruce) on 19 December 1995 at column1152.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer of 8 February,Official Report, columns 344–45, which pharmaceutical companies were contacted by the Medicines Control Agency prior to the meeting of the Committee on Safety of Medicines of 13 October 1995 with a view to establishing continuity of supply of combined oral contraceptives. [26253]
§ Mr. MaloneI refer the hon. Member to the reply I gave him on 2 April at column185.
§ Mr. HughesTo ask the Secretary of State for Health if the Medicines Control Agency received unpublished data from the study of oral contraceptives by Professor Richard Farmer and colleagues prior to the meeting of the Committee of Safety of Medicines on 13 October 1995. [26252]
§ Mr. MaloneNo.
§ Mr. HughesTo ask the Secretary of State for Health if he will make a statement on the safety of third generation oral contraceptives following the recent announcement from the committee for proprietary medicinal products. [26601]
§ Mr. MaloneI refer the hon. Member to the statement that my right hon. Friend the Secretary of State made to the House on 23 October 1995,Official Report, columns 701-2. Since that time further evidence has become available which strengthens the basis for the Committee on Safety of Medicine's advice. The justification for that advice is not altered in the light of the recent position statement issued by the Committee for Proprietary Medicinal Products.
§ Mr. HughesTo ask the Secretary of State for Health what plans he has to alter the procedures for dealing with future marketing authorisation applications for third generation oral contraceptives. [26573]
§ Mr. MaloneNone. Future applications for marketing authorisations for third generation oral contraceptives will be assessed according to existing procedures.