§ Mr. Simon HughesTo ask the Secretary of State for Health, pursuant to his answer of 19 December 1995 to the hon. Member for Gordon (Mr. Bruce),Official Report, column 1153, if he will publish the full text of the advice of the Committee on Safety of Medicines to the Licensing Authority. [12979]
§ Mr. MaloneSuch advice is confidential. The recommendations made by the Committee on Safety of Medicines at the meeting on 13 October 1995 were published in a letter from the chairman dated 18 October 1995 which was sent to doctors and pharmacists. Copies of this letter are available in the Library.
§ Mr. HughesTo ask the Secretary of State for Health (1) under what legislative provision the opinion of the committee for proprietary medicinal products on the safety of combined oral contraceptives, which was requested on 11 October 1995, is being obtained; [12976]
(2) if he will publish the text of the formal referral made on 11 October 1995 by the licensing authority to the committee for proprietary medicinal products; and if he will state the legal basis for that referral. [12973]
§ Mr. MaloneThe Medicines Control Agency has an obligation to keep other member states informed of issues on the efficacy, quality and safety of medicines. In accordance with these obligations, on 11 October 1995 the MCA requested in writing that the safety of combined oral contraceptives be placed on the agenda of the Committee for Proprietary Medicinal Products meeting of 17 to 18 October, after important new evidence about this344W issue became available. It is not normal practice to publish such documentation. The matter was not referred to the Committee for an opinion under article 12 of directive 75/319/EEC.
§ Mr. HughesTo ask the Secretary of State for Health if those who made arrangements on 11 October 1995 for the meeting of the Committee on Safety of Medicines on 13 October 1995 were made aware of the formal referral regarding safety concerns relating to desogestrel and gestodene to be considered by the pharmacovigilance sub-committee of the Committee on Safety of Medicines; and what factors led to the referral. [12965]
§ Mr. MaloneNo such referral was made to the pharmacovigilance sub-committee. I presume the hon. Member is referring to the written request made on 11 October 1995 that the Committee for Proprietary Medicinal Products place the issue on the agenda of its meeting of 17–18 October. I refer the hon. Member to the reply I gave the hon. Member for Gordon (Mr. Bruce) on 19 December 1995,Official Report, columns 1149–50.
§ Mr. HughesTo ask the Secretary of State for Health, pursuant to his answer to the hon. Member for Gordon (Mr. Bruce) of 19 December 1995,Official Report, column 1149, if the outside experts who attended the working group of the Committee on Safety of Medicines on 10 October and the meeting of the CSM on 13 October were informed that the proceedings were subject to the Official Secrets Act 1989. [12966]
§ Mr. MaloneNo. Attendees of the meeting of the Committee on Safety of Medicines on 13 October 1995 and the working group meeting of 10 October 1995 were informed that the papers and proceedings of the meetings were confidential and should not be disclosed. The papers and proceedings are subject to section 118 of the Medicines Act 1968.
§ Mr. HughesTo ask the Secretary of State for Health what factors precluded consideration between July 1995 and October 1995 of safety concerns relating to desogestrel and gestodene by the pharmacovigilence sub-committee of the Committee on Safety of Medicines. [12967]
§ Mr. MaloneI refer the hon. Member to the reply I gave the hon. Member for Gordon (Mr. Bruce) on 19 December 1995 at column1151.
§ Mr. HughesTo ask the Secretary of State for Health what steps the licensing authority took prior to issuing the "Dear Doctor" letter of 18 October 1995 to establish the availability of oral contraceptives deemed to be suitable alternatives to those oral contraceptives which had given rise to safety concerns. [12972]
§ Mr. MaloneAppropriate steps were taken. The Committee on Safety of Medicines did not advise that all women on oral contraceptives containing gestodene or desogestrel should be switched to alternative preparations immediately. In a press release issued by the Department, women taking these pills were strongly urged to continue taking them, but to see their doctor, preferably before finishing their current cycle, to discuss whether a change of pill was necessary. Women who could not visit their surgery or family planning clinic before the end of their present cycle were advised to start the next pack. Discussions regarding supply were held with 345W pharmaceutical companies. We are not aware of major difficulties in the supply of alternative preparations that arose as a result of the CSM's advice.
§ Mr. HughesTo ask the Secretary of State for Health what representations he has received relating to safety concerns on combined oral contraceptives containing desogestrel or gestodene; and what steps he has taken in response to any such expressions of concern. [12974]
§ Mr. MaloneMy Department has received representations from a number of sources, including doctors and other health professionals; bodies representing health professionals; members of the public; the pharmaceutical companies concerned and representatives of the pharmaceutical industry, and has responded to the issues raised.