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6 Jan 2004 : Column 308W—continued
Museums
Miss Kirkbride: To ask the Secretary of State for Culture, Media and Sport if she will make an assessment of the impact of the Government's free admissions policy on museums that are not included in the policy. [145562]
Estelle Morris: There are a number of factors that influence museum attendances, and it would be difficult to isolate the specific impact of free admission. The Renaissance in the Regions programme complements the free admission policy by providing substantial support to regional museums. The early indications are that the Renaissance investment is already paying dividends, with a 40 per cent. increase in the number of schools visiting museums in Phase 1 of the programme, and a 74 per cent. increase in contacts between those museums and community groups.
Ofcom
Mr. Boswell: To ask the Secretary of State for Culture, Media and Sport if she will make a statement on the readiness of Ofcom to assume regulatory duties on 29 December. [145086]
Estelle Morris: The Office of Communications (Ofcom) is well prepared to take on its regulatory functions and vesting took place as planned on 29 December 2003.
HEALTH
BCG Vaccination
Tony Lloyd: To ask the Secretary of State for Health what assessment he has made of the number of medical professionals trained in the techniques necessary to administer the BCG vaccination. [144390]
Miss Melanie Johnson [holding answer 18 December 2003]: This data is not held centrally. Strategic health authorities are responsible for organising and delivering local immunisation programmes.
Delayed Discharges
Miss McIntosh: To ask the Secretary of State for Health if he will make a statement on delayed discharges
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in (a) the Craven, Harrogate and Rural District Primary Care Trust and (b) the Hambleton and Richmondshire Primary Care Trust area. [145621]
Miss Melanie Johnson: Service and Financial Framework returns for quarter two of 2003–04 show that there were 24 patients in the Craven, Harrogate and Rural District Primary Care Trust (PCT) area whose transfer of care had been delayed, and six in the Hambleton and Richmondshire PCT area. A copy of the report is available in the Library.
Craven, Harrogate and Rural District PCT has agreed a strategy with all key stakeholders that aims to maintain people in their own homes where possible with support from a multi-disciplinary team. This will ultimately be available 24 hours a day, with access to diagnostics and secondary care as appropriate.
Hambleton and Richmondshire PCT is working with North Yorkshire Social Services to develop interim care beds and alternatives to people waiting in the acute hospital.
Influenza Vaccination
Mr. Burstow: To ask the Secretary of State for Health what assessment has been made by the Joint Committee on Vaccination and Immunisation of the number of at risk children who would benefit from the current influenza vaccination, broken down (a) by type of condition and (b) by age groups (i) 0 to four and (ii) five to 14 years. [142963]
Miss Melanie Johnson [holding answer 9 December 2003]: At their meeting on 10 November 2003, the Joint Committee on Vaccination and Immunisation agreed that all children aged over six months in an at risk group should be offered flu vaccination.
Mr. Burstow: To ask the Secretary of State for Health for what reasons the Department does not monitor the uptake of influenza vaccinations for children in at risk groups. [142964]
Miss Melanie Johnson [holding answer 9 December 2003]: I refer the hon. Member to the response I gave him on 16 December 2003, Official Report, columns 890–91W.
Hospital Acquired Infections
Tim Loughton: To ask the Secretary of State for Health what target he has set for reducing death and disablement from hospital acquired infections. [145047]
Miss Melanie Johnson: No specific targets were set in the Chief Medical Officer's new action plan, "Winning Ways—Working together to reduce Healthcare Associated Infections", launched on 5 December 2003. We will monitor implementation through the national health service performance management system, strategic health authorities and the mandatory surveillance system.
Levonelle
Jim Dobbin: To ask the Secretary of State for Health what research has been conducted in teenage girls on the safety of an increase in the dosage of the emergency hormonal contraceptive Levonelle to a single dose of two tablets taken together. [145303]
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Miss Melanie Johnson: The dosing instructions for Levonelle (levonorgestrel 0.75mg) were revised recently to recommend that two tablets should be taken at the same time; previously one tablet was taken with the second tablet 12 hours later. There has been no increase in the dosage as the quantity of levonorgestrel ingested remains the same. This followed advice from the Committee on Safety of Medicines who were satisfied as to the safety and efficacy of this revised regimen and the likely improved compliance. The pivotal evidence in support of the change is a World Health Organisation sponsored study evaluating 4,136 women aged between 14 and 52 years (mean age 27 years) who attended family planning clinics requesting emergency contraception. In excess of 2,700 women were given levonorgestrel, and of these, 439 were teenage girls. Side-effects were minor and no significant difference in the proportion of women developing side-effects was noted between the women taking two levonorgestrel tablets at the same time and those who took them 12 hours apart. A copy of the publication has been placed in the Library.
Medicines (Advertising)
Dr. Gibson: To ask the Secretary of State for Health (1) how many staff at the Medicines and Health Care Products Regulatory Agency are employed to investigate breaches of the Medicines (Advertising) Regulations 1994; [145356]
- (2) what the outcomes were of the review of advertising activities carried out by the Medicines and Health Care Products Regulatory Agency earlier this year; which organisations and individuals were invited to contribute to this review; and how the report has been made publicly available; [145360]
(3) how many of the complaints investigated by the Medicines and Health Care Products Regulatory Agency were found to be in breach of the Medicines (Advertising) Regulations in (a) 2001, (b) 2002 and (c) 2003; for each of these years, how many of the complaints that were upheld related to advertisements targeted at (i) health professionals and (ii) the public; over how long on average the advertisements had been running before being withdrawn; and what sanctions were employed; [145361]
(4) what criteria are employed by the Medicines and Health Care Products Regulatory Agency in investigating complaints; and under what conditions pre-vetting of advertising material is carried out; [145362]
(5) what provisions have been made by the Medicines and Health Care Products Regulatory Agency to take on additional staff to pre-vet advertising material when medicinal products are switched from prescription-only to over-the-counter status; [145357]
(6) how many complaints were investigated in 2002–03 by the Medicines and Health Care Products Regulatory Agency in response to complaints from (a) health professionals, (b) pharmaceutical companies and (c) the public; [145358]
(7) what self-regulatory controls are in place for medicine advertising and promotion; and when the Government last carried out a spot check to determine the effectiveness of the self-regulatory system; [145359]
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(8) what mechanisms exist for independent scrutiny of the Medicines and Health Care Products Regulatory Agency activities in relation to its role to monitor and enforce regulations on pharmaceutical company advertising and promotion. [145363]
Miss Melanie Johnson: The control of medicines advertising is based on a long established system of self regulation underpinned by the statutory role of the Medicines and Healthcare products Regulatory Agency (MHRA). There are two main industry self regulatory bodies, the Prescription Medicines Code of Practice Authority (PMCPA) and Proprietary Association of Great Britain (PAGB). Both operate codes of practice for advertising of medicines and systems for investigating complaints against their codes. Advertising by PAGB member companies aimed at the public is pre-vetted by the PAGB prior to publication. There are also general controls on non-broadcast and broadcast advertising operated by the Advertising Standards Authority and the Office of Communications.
Investigation of complaints and routine scrutiny of published advertising for medicines, concentrating on newly licensed products, provide an ongoing check on the effectiveness of the self-regulatory systems for medicines advertising. The MHRA meets regularly with the regulatory and self regulatory bodies to discuss current issues in medicines advertising.
The MHRA investigates all complaints received about advertising against the requirements set out in the Medicines (Advertising) Regulations 1994. In 2002–03, 157 complaints about medicines advertising were investigated including 93 from health professionals, 16 from pharmaceutical companies and 48 from members of the public. The number of advertisements found to be in breach of the Regulations following investigation by the MHRA were 104 in 2001, 85 in 2002 and 108 in 2003. One quarter concerned advertisements aimed at health professionals and the remainder at the public. Information is not collected by the Agency on the length of time the advertisements had been running before being withdrawn.
The primary sanction employed where advertising is considered to breach the Regulations is to require immediate withdrawal and amendment of the material. Additionally, in three cases in 2001, one in 2002 and five in 2003, all subsequent material was required to be submitted for pre-vetting. In 13 cases the company was required to issue a corrective statement, one in 2001, one in 2002 and 11 in 2003. One case was referred for enforcement action in 2001 and two in 2003. A public statement was also recently made on the outcome of three investigations into inducements to pharmacists.
The MHRA has published criteria in Guidance Note 23—Advertising and Promotion of medicines in the UK (a copy of which is available in the Library) based on which it will consider requiring advertising material to be submitted for pre-vetting, including:
- (i) where a newly licensed product, subject to intensive monitoring, is placed on the market;
(ii) where a product is reclassified, such as from prescription only medicine to pharmacy; or
(iii) where previous advertising for a product has breached the Regulations.
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The MHRA employs four staff whose primary role is to regulate advertising for medicines, including investigation of breaches of the Medicines (Advertising) Regulations 1994. These staff draw on the wider resources of the MHRA to provide additional specialist advice on advertising casework as required. The MHRA anticipates that it will be able to manage any increase in the requirement for pre-vetting due to increases in reclassification from prescription only to over-the-counter status from within its existing resources.
The National Audit Office and the Public Accounts Committee recently scrutinised the work of the MHRA, including its role in reviewing medicines advertising and promotion but did not make any recommendations in this area nor suggest any further review was necessary. The recent initiative to publish on the MHRA website the outcome of complaints investigations will increase the transparency of the MHRA's role in enforcing the regulations on advertising and promotion of medicines.
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