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Mr. Llew Smith: To ask the Secretary of State for Health if he will make a statement on his response to the fourth report of his committee on the medical aspects of radiation on childhood cancer in the vicinity of Sellafield; and what further work he has asked Committee on Medical Aspects of Radiation in the Environment to conduct on the problem. [23838]
Mr. Horam: I refer the hon. Member to the reply I gave my hon. Friend the Member for Beckenham (Mr. Merchant) on 27 March, Official Report, columns 663-65.
Mr. Cousins: To ask the Secretary of State for Health what evidence of diagnostical practice and treatment protocols will be expected from future designated centres for gynaecological oncology services. [24257]
Mr. Horam: That is a matter to be agreed between commissioning authority and provider unit. Service configuration guidance for use by health authorities in their discussions with provider units is being developed.
Mr. Cousins: To ask the Secretary of State for Health what recent guidance he has issued to health authorities and trusts about the creation of designated cancer treatment centres; and by what process he intends such centres to be so designated. [24202]
Mr. Horam: EL(96)15 issued on 15 March gives further guidance on implementing the policy set out in the document "A Policy Framework for Commissioning Cancer Services". Copies of EL(96)15 have been placed in the Library.
Mr. Cousins: To ask the Secretary of State for Health what plans he has to designate centres for the treatment of gynaecological cancer; and if the existence and maintenance of agreed treatment protocols will form part of the tests for such designation. [24248]
Mr. Horam: The designation of cancer centres or units for the treatment of gynaecological cancer is a matter for the commissioning authority in discussion with provider units. The identification of local standards, to include treatment in line with agreed protocols and guidelines, should form part of contract negotiations.
Mr. Redmond: To ask the Secretary of State for Health if he will make it his policy to maintain a central record of oncology centres which have refused patients treatment on the grounds of lack of funds; and if he will make a statement. [24490]
Mr. Horam: It is for commissioning authorities in consultation with their provider units to determine the level and quality of services delivered to patients.
Mrs. Lait: To ask the Secretary of State for Health if work has commenced on the prior options reviews of establishments which his Department sponsors. [24542]
Mr. Horam: As indicated by my right hon. Friend the President of the Board of Trade in his announcement of the timetable for prior options reviews on 26 January
2 Apr 1996 : Column: 184
1996, Official Report, columns 421-23, the outcome of reviews of the National Radiological Protection Board, National Biological Standards Board and the public health laboratory service are due to be reported to Ministers by December 1996.
Work has recently commenced on the review of the National Radiological Protection Board. Views are being invited from any interested parties by means of an advertisement in "Government Opportunities" and by a direct approach to key organisations and individuals.
Mr. Simon Hughes: To ask the Secretary of State for Health, pursuant to his answers of 11 December 1995, Official Report, column 521, and 19 December 1995, Official Report, columns 1149 and 1153, when the final manuscript from Professor Jick relating to third generation oral contraceptives was received by the Medicines Control Agency; and if it was included in the papers dispatched by courier at 16:00 on 11 October 1995. [22259]
Mr. Malone: The final manuscript of Professor Jick's study was received on 11 October 1995, after the papers were dispatched by courier. A near final version of the manuscript was included with the papers dispatched to committee members. There was no substantive change to the analysis in the final version.
Mr. Hughes: To ask the Secretary of State for Health, pursuant to his answer of 19 December 1995, Official Report, column 1150, what new data, and from which studies, were presented to the Committee for Proprietary Medicinal Products at its meeting on 17 and 18 October 1995. [22260]
Mr. Malone: The committee was presented with findings from the three new epidemiological studies relating to the cardiovascular risks of second and third generation oral contraceptives; these were the World Health Organisation's study, the transnational study and the general practice research database study conducted by Professor Jick.
Mr. Hughes: To ask the Secretary of State for Health, pursuant to his answer of 19 December 1995, Official Report, column 1153, on which Minister's authority the "Dear Doctor" letter of 18 October 1995 relating to safety concerns regarding desogestrel and gestodene was issued. [22261]
Mr. Malone: The then Under-Secretary of State, my hon. Friend the Member for Bolton, West (Mr. Sackville).
Mr. Hughes: To ask the Secretary of State for Health, pursuant to the answer on 19 December 1995, Official Report, column 1149, when the Licensing Authority received a manuscript relating to the transnational study, and if the Licensing Authority received a final manuscript for that study. [22262]
Mr. Malone: I refer the hon. Member to the replies I gave the hon. Member for Gordon (Mr. Bruce) on 19 December, Official Report, columns 1149 and 1153. The Licensing Authority has not received a manuscript relating to the transnational study from the investigators. The Licensing Authority has seen the report of the study published in the British Medical Journal on 13 January 1996.
2 Apr 1996 : Column: 185
Mr. Hughes: To ask the Secretary of State for Health if a referral of the matters relating to combined oral contraceptives containing desogestrel or gestodene was made to the Law Officers in terms of paragraph 22 (i) or 22 (ii)(c) of "Questions of Procedure for Ministers" of May 1992, prior to the referral to the Committee for Proprietary Medicinal Products made on 11 October 1995. [23268]
Mr. Malone: It is not normal practice to disclose whether the advice of Law Officers has been sought in any particular case.
Mr. Hughes: To ask the Secretary of State for Health (1) what meetings have been held between the Licensing Authority and the pharmaceutical companies holding product licences for combined oral contraceptives containing desogestrel or gestodene since 7 November 1995; [23269]
Mr. Malone: Information about discussions held between the Licensing Authority and pharmaceutical companies is treated on confidence under the Medicines Act 1968.
Mr. Hughes: To ask the Secretary of State for Health, pursuant to the answer of 8 February, Official Report, columns 232-44, relating to the letter of 11 October 1995 from the Medicines Control Agency, for what reasons it is not normal practice to publish such documentation. [23270]
Mr. Malone: The relevant documentation is considered to be a confidential communication between regulatory bodies. Such communications are not normally published because they may contain information which is sensitive for commercial reasons or relates to the formulation of policy.
Mr. Hughes: To ask the Secretary of State for Health, pursuant to the answer of 19 December 1995, Official Report, column 1149, if regulatory action with respect to clinical trials of combined oral contraceptives has now been completed; and if he will make a statement. [23273]
Mr. Malone: I refer the hon. Member to the reply I gave him on 8 February, Official Report, column 386. In the case of clinical trials, the Licensing Authority would not normally make a public announcement.
Mr. Hughes: To ask the Secretary of State for Health, pursuant to the answer of 8 February, Official Report, column 344, whether 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 Committee for Proprietary Medicinal Products on 17 to 18 October 1995. [23275]
Mr. Malone: Those making the arrangements were aware of the requests that this issue be placed on the agenda of the Committee for Proprietary Medicinal Products on 17 and 18 October 1995.
2 Apr 1996 : Column: 186
Mr. Hughes: To ask the Secretary of State for Health, pursuant to the answer of 8 February, Official Report, columns 343-44 what was the legal basis for the referral of 11 October 1995 to the Committee for Proprietary Medicinal Products. [23277]
Mr. Malone: I refer the hon. Member to the replies I gave him on 8 February, Official Report, columns 343-44, and the hon. Member for Gordon (Mr. Bruce) on 19 December 1995, Official Report, column 1150.
Mr. Madden: To ask the Secretary of State for Health (1) what representations he has received about the safe use of Femodene ED; if he will list the names of those who have made such representations; and what action he has taken in response to such representations; [24297]
Mr. Malone: Femodene ED is a combined oral contraceptive preparation containing ethinyloestradiol and gestodene. It is one of the seven brands of oral contraceptive which was subject of advice from the Committee on Safety of Medicines in October 1995 in relation to the risk of venous thromboembolism. The advice of the CSM was based on research studies which indicated that oral contraceptives containing gestodene or desogestrel are associated with an increased risk of venous thromboembolism, compared with other oral contraceptives. The chairman of the CSM wrote to doctors and pharmacists on 18 October 1995 and a copy of his letter is available in the Library.
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