Attachment to MCA letter dated 21 December 2000




1 Current UK and EC law clearly prohibit direct to consumer advertising of prescription medicines. The Medicines (Advertising) Regulations 1994 and the Medicines (Monitoring of Advertising) Regulations 1994, as amended implement Directive 92/28/EC on the advertising of medicines for human use into UK law. The Regulations make it an offence for any person to issue an advertisement which is likely to lead to the use of a prescription only medicine. Government approved vaccination campaigns are exempt from the prohibition on DTC advertising of prescription medicines to the general public.

2. The Directive and implementing Regulations do not cover individual correspondence about a medicine, factual informative announcements and reference material provided they contain no product claims*, or statements relating to human health or diseases provided there is no reference, direct or indirect, to a medicinal product.

"a product claim " is generally interpreted as a recommendation relating to the use or benefits of the product (including safety or efficacy).

3. The current prohibition on direct to consumer advertising of prescription only medicines is overseen by the industry self-regulatory system, regulatory bodies such as the ITC and is backed by MCA enforcement. There is no current legislation relating to the advertising of medical devices.

4. The Medicines Commission asked for a paper setting out the issues on direct to consumer advertising of prescription medicines to enable the matter to be considered with a view to advising Ministers of this rapidly developing situation. Whilst we are not aware of any direct approach from industry to change the law, companies do want 'health education/disease awareness" campaigns arguing that there is a need for better communication between themselves and the public. The industry believes that it is important for patients to have information about medicines which is soundly based and that the manufacturer is best placed to provide accurate and comprehensive information. UK patients also have access to information on prescription medicines through the Internet on overseas websites, notably from the USA where DTC advertising is permitted. The ABPI Compendium of Summaries Product Characteristics is now available on the Internet and can be accessed by the public.

5. A significant development over recent months has been disease awareness campaigns by pharmaceutical companies. During 1999, Pharmacia and Upjohn ran a major campaign on bladder problems. There were differences of opinion among both health professionals and lawyers on whether it is encompassed by the Advertising Regulations. More recently there has been material in the press in relation to the availability of betaferon for the treatment of multiple sclerosis. For a number of years there have been "advertorials" in many newspapers and magazines. [*1

6. Whilst the provision of health education and patient information is permitted in the European Directive on patient information leaflets and labelling, the latest developments in disease awareness campaigns by companies brings out sharply the fundamental issue of when health information becomes commercial or product promotion. [*1 The MCA has been involved in discussions with companies advising that the current MCA practice is to assess each individual campaign on its own merits albeit to the same criteria.

7. Patients' expectations are also changing rapidly. They expect to have a patient information leaflet with their medicine and sufficient information to enable them to become involved in decision making and to exercise a degree of choice in relation to the medicines which they are prescribed. Many patient groups and their members - for example, MV patient groups and long-term conditions groups - are extremely knowledgeable about their diseases and the medications available to treat them. It is arguable that the current law in relation to DTC advertising does not necessarily operate in the best interest of these patient groups - There are a rapidly increasing number of' sources of information of variable quality eg. on the Internet, to which the public will inevitably have access.

8. [*] It is also arguable that disease awareness campaigns are inherently biased. [*] The borderline between patient information and product promotion is being severely tested and it is clear that the challenges are going to become greater over the coming months and years. 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.

9. There are a number of factors to be considered in the debate on DTC' advertising:

Arguments for changing current arrangements

                    9.1 Modern media make the current legal position increasingly difficult to regulate;

9.2 Patients (particularly in some groups) are increasingly interested, well-informed and able to make their own judgements and wish to have improved choice and involvement in decision making;

9.3 Industry argue that it is better to have controlled responsible, kite-marked information which could help avoid irresponsible advertorials and campaigns.

Arguments for keeping current arrangements

9.4 [*] The information is bound to be geared to selling the company's own product and the information would not be compatible with providing impartial information to patients;

9.5 Many patients cannot fully interpret the information and it could create and manipulate concepts of need for unnecessary medicines

9.6 DTC advertising puts pressure on prescribers and distorts the doctor-patient relationship,

9.7 Change would lead to increased promotional costs which could not be controlled via the PPRS:

9.8 It would create advantages for larger companies at the expense of smaller ones.

10. This paper does not draw specific conclusions but is intended to Medicines Commission with a basis for discussion on the issues of direct to consumer advertising and health awareness campaigns.


Executive Support and Post Licensing Divisions
11 February 2000


*] information withheld under exemption 2 of the Code of Practice on Access to Government Information
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