The UK'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 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 would establish a framework for the industry to provide factual, non-promotional information about the benefits and risks of their 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 European level via the Pharmaceutical Committee.

The EC has proposed two amending pieces of legislation:

1. A Directive amending, as regards information to the general public on medicinal products subject to medical prescription, Directive 2001/83/EC on the Community code relating to medicinal products for human use.
2. A Regulation amending Regulation (EC) No 726/2004 on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as regards information to the general public on medicinal products subject to medical prescription.

Information that could be disseminated directly to the public includes, for example, a summary of the product characteristics, informative announcements and reference material relating to pack changes or adverse reaction warnings, and information on the environmental impact of the medicinal 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 £525–630 million (609–731 million euro) in the UK alone.

However, although the UK government is supportive of the proposal it has also warned that a 'blanket approach' to advertisement vetting would not be proportionate to the risk of non-compliant information and would be overly bureaucratic. Introducing a regulatory role at a European level may also create scope for conflict between the European Agency and national courts.

The deadline for responses to the proposal is Friday 14 August 2009. The proposals regarding information dissemination are part of a wider pharmaceutical package that also includes provisions on pharmacovigilance and counterfeiting. Legislation on each area will progress independently.

The MHRA announcement and EC proposal can be found here.