MEDICINES CONTROL AGENCY

"DISEASE AWARENESS" CAMPAIGNS BY THE PHARMACEUTICAL

INDUSTRY

Issue

1. Pharmaceutical companies are "pushing at the boundary" of current legislation that bans direct to consumer promotion of prescription-only medicines (POMs). In a recent case concerning awareness of treatments for bladder problems, a company developed a TV commercial, and a newspaper advertisement encouraging people to go to their doctors. In neither case was a medicinal product named, although the company name appeared in both cases.

Background

2. Industry is encouraged under Directive 92/27 EEC to provide health education information in its PILs and other product information. Consumer demand for this has increased and the Internet has fuelled demand and consumer expectations. The Internet carries an increasing amount of advertising of medicines, not all of it rational and informed. Regulation of the Internet is notoriously difficult. But there are implications here for Ministers both in relation to commitments to informed consumers and freedom of information and for possible increased costs to the drugs bill. These have not yet been fully assessed.

Legal Position

3.              PARAGRAPH EDITED UNDER EXEMPTION 4(D) - LEGAL PROFESSIONAL PRIVILEGE - OF THE                    CODE OF PRACTICE ON ACCESS TO GOVERNMENT INFORMATION          

In the light of further interest, we are seeking to confirm the legal position. Neither European nor UK legislation at present addresses specifically disease awareness campaigns or Internet advertising.

Europe

4. Other Member States (eg. Ireland and France) have had similar disease awareness campaigns and they also have concluded that it does not infringe European law. The European Commission is establishing in the New Year a forum of Member States to debate access to healthcare information by consumers which may lead in time to changes in the legislation. The European forum will focus on the borderline between advertising/promotion and health information. European lawyers will be closely involved.

Action

5. Ministers would welcome the Medicines Commission's advice on this important issue.

Medicines Control Agency
November 1999
Contents page
What's New?