Skip to main content

Medicines and Healthcare Products Regulatory Agency

Volume 477: debated on Thursday 12 June 2008

To ask the Secretary of State for Health (1) what arrangements the Medicines and Healthcare products Regulatory Agency has in place to consider commercial interests when responding to freedom of information requests; (208741)

(2) what plans executive agencies of his Department have to review regulation of (a) unlicensed medicines, (b) off-label medicines and (c) medicinal products specifically manufactured to meet the special needs of a patient;

(3) what regulations are in place to prevent the promotion of unlicensed medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA), in conjunction with the Veterinary Medicines Directorate and representative trade associations, has developed guidance on the disclosure of information under the Freedom of Information Act 2000. When considering the release of information which would or would be likely to prejudice commercial interests, the MHRA will obtain the views of the person or company concerned before making a final decision to disclose or withhold the requested information.

The MHRA is leading a review of the regulatory arrangements in the United Kingdom which allow an authorised health care professional to commission an unlicensed medicinal product to meet the special needs of an individual patient. The MHRA issued a discussion document in February 2008 and interested parties have been invited to submit views by 30 June. There are no plans to review off-label use of medicines.

The Medicines (Advertising) Regulations 1994, as amended, prohibit the advertising of medicines which do not have a marketing authorisation, traditional herbal registration or homoeopathic registration in force. Additionally, the advertising of an unlicensed medicine for human use is prohibited under the Medicines for Human Use (Marketing Authorisation Etc) Regulations 1994 as amended and Schedules 2 and 4 of The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005.