EU May Change Direct-to-Consumer Rules

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking opinions on a European Commission (EC) proposal that would allow drugmakers to disseminate certain information on prescription medicines directly to European Union patients. Currently, there are differing national rules and practices across the EU regarding the dissemination of information for prescription-only medicines and, in the context of a single European market, the EC wants greater harmonization of medicines information to ensure that all European citizens can access the same information.

Although there would be no amendment to the current ban on direct-to-consumer advertising of prescription-only medicines, the EC’s proposal would establish a framework for industry to provide factual, nonpromotional information about the benefits and risks of medicines to the public based on a set of quality criteria. Only certain communication channels, excluding television and radio, would be allowed, and monitoring and control would be enforced by regulators at a national level and at a regional level via the EU’s pharmaceutical committee.

The EC’s proposal would specifically amend Directive 2001/83/EC on the community code relating to medicinal products for human use and Regulation (EC) No 726/2004 on community procedures for the authorization and supervision of medicinal products for human and veterinary use and on establishing a European Medicines Agency. The proposal is part of a broader pharmaceutical package that also includes provisions regarding pharmacovigilance and counterfeiting. Legislation in each area will be addressed separately.

Information that could be disseminated directly to the public includes, for example, a summary of the product’s characteristics, informative announcements and reference material relating to packaging changes or adverse-reaction warnings, and the environmental impact of the product. Information relating to human health or diseases, provided there is no reference to medicinal products, may also be provided. It has been estimated that better awareness of symptoms and disease prevention will result in annual average savings of  EUR 609-731 million ($863-1.035 million) in the UK alone.

Although the UK government is supportive of the EC proposal, according to an MHRA announcement, it has warned that a 'blanket approach' to advertisement vetting would not be proportionate to the risk of noncompliant information and would be overly bureaucratic.

Introducing a regulatory role at a European level may also create scope for conflict between the European Medicines Agency and national courts.

The deadline for responses to the proposal is Aug. 14, 2009.

Stephanie Sutton is an assistant editor at Pharmaceutical Technology Europe.