In the United States, the long-standing culture of direct-to-consumer (DTC) advertising, provides the primary basis by which patients are informed about both conditions and treatments. It is controversial, with many on either side of the debate finding little middle ground. The U.S. is nearly unique, with New Zealand being the exception, in the world in allowing DTC by medical product manufacturers.
Last year, however, the European Union began to explore some new territory with a proposed package of legislation that are referred to as the "Pharmaceutical Package" – containing three legislative proposals under three arms: (1) Fighting counterfeit medicines; (2) Improving pharmacovigilance; and (3) Information to patients about prescription products.
The idea behind the third element is to bring into focus a comprehensive strategy for the EU on patient information to provide greater access to information on existing medications, without allowing DTC advertising.
The primary elements of the proposal is as follows:
- Clarification that the provision of information on RX-only medicines directly to the public by marketing authorization holders is allowed provided that clearly defined conditions are fulfilled (ban on advertising will continue)
- Establishing harmonized conditions on the content of information which marketing authorization holders are allowed to disseminate;
- Setting up harmonized quality standards for such information, to ensure that it is of high-quality and non-promotional;
- Determining the authorized channels for providing information, in order to exclude unsolicited means of dissemination;
- Introducing the obligation for Member States to establish a monitoring system to ensure that the provisions on conent of information, quality standards and dissemination channels are complied with and ensure enforcement in the case of non-compliance;
- Establishing specific monitoring rules for information disseminated through websites, to take into account the cross-border nature of information and to allow Member State cooperation.
Unfortunately, the EU is moving no faster on this front than the FDA is moving on enunciating some guidelines on social media in the U.S. The draft proposal is stalled in the EU and is likely to be amended. The soonest there could be action on the amended package would not likely be until May, 2010. In the meantime, for both the FDA and the EU, each week passes brings with it changes and enhancements in communications that make the job of regulation all the more complicated.
Many thanks to my colleague Aoife Gallagher in Brussels who supplied the background on the package and provided me with the bullet points outlined above.
