The European Commission is proposing to allow companies to advertise anti-HIV drugs direct to consumers in new plans due to be published on July 18.
Although details are not finalised, Commission officials are understood to have decided that it is now impossible to ban advertising in Europe that is available via the internet, and that attempts should instead be made to regulate the practice at a European level.
Initially, advertising would only be permitted for treatments for HIV infection, diabetes or asthma, because the treatments for these conditions are licensed in all European Union countries (although not routinely available in some for financial reasons). Advertising would be permitted for a trial period of five years.
The proposals are contained in a wider review of the activities and functions of the European Agency for the Evaluation of Medicinal Products (EMEA), which is responsible for licensing new products throughout the EU. They must be approved by the EU Council of Ministers and the European Parliament before advertising can commence, and proposed regulations regarding types of advertising, content and imagery remained to be drafted.
In the United States, where direct to consumer advertising has been permitted on TV since 1997, the Food and Drug Administration has recently cracked down on drug company marketing of anti-HIV drugs that was deemed inappropriate.
In a letter issued on April 27 the FDA gave pharmaceutical companies 90 days to withdraw adverts which depicted models untypical of the majority of people living with HIV. FDA Director of Drug Marketing Thomas Abrams said:
"Images that are not generally representative of patients with HIV infection are misleading because they imply greater efficacy than demonstrated by substantial evidence, or minimize the risks associated with HIV drugs.... Examples of such images range from robust individuals engaged in strenuous physical activity to healthy-looking individuals giving testimonials of a specific drug's benefit. However, not all individuals have a response to ARV therapy; in fact, some patients will still have disease progression despite ARV therapy. Furthermore, some images minimize the significant side effects profile associated with HIV drugs, including metabolic change such as fat redistribution or facial wasting.".
The announcement followed strong protests from activists and public health officials in San Francisco, who argued that muscular, athletic models in drug adverts, notably Merck's Crixivan mountaineer advert, were encouraging an over optimistic view of the potential benefits of the drugs, and underplaying the continuing seriousness of an HIV-positive diagnosis.
Direct to consumer advertising will also raise marketing costs, and inevitably push up drug prices in Europe, say critics of the move.