By Mary Gabb ([email protected] )

Since 1996, DTCA has existed only in the USA and New Zealand , but recent declarations from the European Commission (EC) suggest that the rules governing pharma communication with patients may be loosened.

In October, both the Wall Street Journal (WSJ) and the Financial Times (FT) reported intriguing recommendations from the “High Level Pharmaceutical Forum”, a 3-year programme run by the European Union to address specific public health considerations regarding pharmaceuticals and to promote industry competitiveness while sustaining national healthcare systems. The Forum was the brainchild of Günther Verheugen, the Vice President of the European Commission and Commissioner for Enterprise and Industry. The FT also reports that Mr Verheugen is drafting legislation to formally ease marketing rules for pharma.

Concerns about DTCA in Europe emerge from one of the Forum’s three mandates: that patients and citizens need access to better information on disease states and available drugs. But who should provide that information? Both the WSJ and FT report that proposed new rules would weaken the existing strict limits on pharma-provided information to patients. Under the new proposed rules, “objective and unbiased” print and on-line information about drugs would be permissible, but direct advertising would not.

But who determines what is objective and permissible? Where is the line drawn between information and advertising? What role would the European Medicines Evaluation Agency (EMEA, a European equivalent of the US Food and Drug Administration) play?

Efforts to have Mr Verheugen answer those questions were unsuccessful. Queries to his press officer were unanswered and his spokesman stated that “our experts are still working on this and will not be available for the coming weeks.”

The published final conclusions and recommendations from the Forum clearly state that “the ban on advertising of prescription medicines to the general public should continue”, but it also names the industry as one of the relevant players in healthcare that should ensure high quality information for patients.

Thus, it is not clear exactly what the EC is proposing and, if agreed to, when the changes would be implemented. But this discussion does suggest a possible change in attitude toward the role of pharma in providing healthcare information in Europe.