HC Deb 06 January 2004 vol 416 cc310-2W
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(i) health professionals and (ii) the public; over how long on average the advertisements had been running before being withdrawn; and what sanctions were employed; [145361]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]

(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:

  1. (i) where a newly licensed product, subject to intensive monitoring, is placed on the market;
  2. (ii) where a product is reclassified, such as from prescription only medicine to pharmacy; or
  3. (iii) where previous advertising for a product has breached the Regulations.
A recent internal MHRA review considered the procedures of the advertising unit in the regulation of advertising for medicines in the UK. It identified measures to increase and improve the targeting of pre-vetting, increase the use of corrective statements for misleading advertising, take rapid action on complaints prioritising those from health professionals and increase transparency by the publication of reports on completed actions on complaints. The outcome of the review was endorsed by the Medicines Commission and has been submitted for publication in a peer-reviewed journal. A copy of the report has also been placed in the Library.

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.