New guidance on the advertising of medicines has been published by both the Proprietary Association of Great Britain and the Medicines Control Agency.
The PAGB launched a new edition of its code of practice for the advertising of over-the-counter medicines to health care professionals on November 4. At the same time, it published a set of guidelines aimed at helping its member companies interpret the code correctly.
Speaking at a press briefing in London before a meeting of the association, Mrs Sheila Kelly (executive director, PAGB) said that the new code and its guidance notes had been under preparation for two years. There had been extensive consultation with the pharmaceutical industry, the MCA and the Royal Pharmaceutical Society. She said that one of the benefits of the consultation had been the establishment of the Medicines Advertising Liaison Group, which included representatives of regulatory bodies and the pharmaceutical and advertising industries.
Mrs Kelly said that, for pharmacists, one of the biggest changes to the new code of practice would be the rules covering free samples. Previously, product samples could be sent to members of the public if they had been specifically requested. This was no longer allowed. In addition, the rules covering samples given to health care professionals had been tightened to ensure that products given out were genuine demonstration or identification samples and not simply disguised promotions.
So far as pharmaceutical companies were concerned, a major change was the introduction of a requirement to name a person within the company who would be responsible for the final signing off of promotional materials. This person would also be the main point of contact in the event of any dispute or query.
Alongside the launch of the PAGB's new code, the Medicines Control Agency took the opportunity to announce the publication of a new set of guidelines covering the advertising and promotion of medicines. The guidelines are intended to support amendments made to the medicines advertising regulations earlier this year (PJ, February 27, p278).
Mrs June Raine (head of post-licensing division, MCA) said that the new guidance did not represent any change of policy or position on the MCA's behalf, nor did it introduce any new measures itself. It was designed to be read alongside the regulations and the codes of practice published by the PAGB and the Association of the British Pharmaceutical Industry.
She also said that details of a new independent review panel for disputes about medicines advertising under the regulations were likely to be announced shortly. The panel would consist of three members: a legally qualified chairman, a lay member and a relevant expert drawn from a pool of professionals. The panel had been formed in response to criticism from the PAGB during consultation on the advertising regulations. The PAGB had obtained legal opinions that, without such an appeal mechanism, the MCA would be in breach of the European Convention on Human Rights if it was the final arbiter on decisions it was making itself.
"Code of practice of advertising over-the-counter medicines to persons qualified to prescribe or supply (and professional code guidelines)," Proprietary Association of Great Britain, Vernon House, Sicilian Avenue, London WC1A 2QH (tel 020 7242 8331).
"Advertising and the promotion of medicines in the United Kingdom," Medicines Control Agency. ISBN 0-11-702438-4. Stationery Office, London. £15.