Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737	.OG 00/05
	29 June 2000

Dear Mr Medawar,

Further to my letter of 6 June, I am enclosing a copy of Dr Munro's report of the internal review of the decision taken on 20 April. As you will see, Dr Munro has concluded that, although the decision to withhold a copy of the paper or detailed information could be justified under exemptions 2 and 10 of the Code, he considers that the MCA should have provided you with an outline of the content of the paper presented to the Medicines Commission on direct to consumer advertising (DTCA). In meeting Dr Munro's recommendation, I am also taking the opportunity to reply to the further points you raised in your letter of 12 May.

The Medicines Commission asked the MCA to prepare a discussion paper on DTCA on 18 November 1999 and I enclose an edited extract from the minutes of that meeting. As you will see, the request stemmed from an earlier short paper tabled by the MCA on "Disease awareness campaigns" (an edited copy of that paper is also enclosed). MCA responded to the Commission's request on 11 February 2000 and the paper, which had been expanded to consider DTCA, was discussed by the Commission on 17 February 2000. The paper was drafted jointly by a member of the MCA Board and one of the Commissioners, with contributions from another MCA Board Member.

The paper prepared on 11 February began by explaining that the Medicines (Advertising) Regulations 1994 and the Medicines (Monitoring of Advertising) Regulations 1994, as amended (which implemented Directive 92/28/EC into UK law) made it an offence for any person to issue an advertisement which is likely to lead to the use of a prescription only medicine. It also explained that the Directive and implementing Regulations did not cover individual correspondence about a medicine. Nor did they cover factual informative announcements and reference material provided they did not include any product claims - or statements relating to human health or diseases, again provided there is no reference, direct or indirect, to a medicinal product. Last under this section, the paper confirmed that Government approved vaccination campaigns were exempt from the prohibition on DTC advertising of prescription medicines to the general public and that there is no current legislation relating to the advertising of medical devices.

The paper then listed the steps taken to ensure the law was upheld - the industry self-regulatory system, regulatory bodies such as the ITC and enforcement action by the MCA. It also noted the range of information available to patients such as regular health articles in newspapers and magazines, access to information on prescription medicines on overseas websites and the ABPI Compendium of Summaries of Product Characteristics now available through the Internet. The paper also acknowledged that many patients expected sufficient information to enable them to exercise a degree of choice in relation to the medicines which were prescribed.

The paper noted that the rapidly increasing number of' sources of information could be of variable quality and that the borderline between health information and commercial or product promotion would need further thought as, if it is possible to spell out precisely, specifically and effectively the "borderline" between patient information and commercial promotion, it could make an important contribution to public health.

The paper then went on to suggest a range of advantages and disadvantages of any suggestions to change current arrangements. These were broad ranging and did not include any financial estimates. Nor did the paper discuss the relationship between consumer and patient groups and commercial funding, or the editorial independence of press and media or the extent to which experience in the USA might be relevant to DTCA in the UK. No individuals or organisations representing consumer or patient interests were consulted in the preparation of this paper which, as I have said before, was to provide the Commission with a basis for discussion. The paper therefore drew no conclusions or recommendations for future action. The Commission have asked the MCA to develop proposals for their future consideration.

If you remain dissatisfied with the internal review you may, as you know, ask a Member of Parliament to make a complaint on your behalf to the Parliamentary Commissioner for Administration who may decide to conduct his own investigation.

CLICK HERE TO READ ON

	Contents page
	List of correspondence with MCA/CSM