The Pharmaceutical Journal
Vol 273 No 7326 p734
20 November 2004

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Tighter rules planned for drug safety advisers

People who advise health ministers on the licensing and safety of medicines and who are members of advisory committees and boards will be subject to tighter rules covering their financial interests.

In addition, the Committee on Safety of Medicines and the Medicines Commission are to be replaced with a new commission for safety and efficacy of medicines, which will have no industry representatives.

These developments are part of a previously announced restructuring of committees, established under Section 4 of the Medicines Act 1968 to advise UK health and agriculture ministers that are collectively known as the licensing authority (PJ, 21 February, p206). Currently, these committees are the CSM, the Advisory Board on the Registration of Homoeopathic Products, the Veterinary Products Committee and the British Pharmacopoeia Commission. The Medicines and Healthcare products Regulatory Agency provides administrative support for them, among other functions.

The new rules on financial interests will apply to members of these committees, along with any subcommittees, expert advisory groups and a list of experts that can be called on for special advice.

There will be lay and patient representation at all levels of the new structure and a new code of practice on the declaration of personal and non-personal interests will apply to everyone. Members of all Section 4 committees, including the new commission, will not be allowed to hold personal company interests, nor will the chairmen of subcommittees and expert groups.

Lord Warner, Parliamentary Under-Secretary of State for Health, said: “We think that the time has come to respond to some of the concerns that the arrangements for declaration of interests is not as wide ranging as it might be. There are wider ranges of interests that could be perceived by people as affecting the impartiality of people advising in this area.” He added that the new code of practice addressed issues of wider concern about interests that people might have through family connections and departmental research grants.

An Association of the British Pharmaceutical Industry spokesman said: “While we are firmly of the belief that that the current system has worked with the degree of probity you need, we understand why the Government feels the need to demonstrate more clearly that this is the case.”