Direct-to-Consumer Advertising – in Europe?

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.

Drug approval agencies

Health Outcomes Communicator is starting a regular series describing the major drug approval agencies and healthcare systems in countries across the world. In this first article, we’ll start with two of the largest drug approval agencies – the Food and Drug Administration in the United States (US FDA) and the European Medicines Evaluation Agency (EMEA).

US FDA

The main role of the US FDA is ensuring the safety and efficacy of human and veterinary drugs and medical devices, although it also regulates the safety and accurate representation to the public of foods, cosmetics, and electronic products that emit radiation.

The FDA’s role in biological products includes product and manufacturing establishment licensing, safety of the nation’s blood supply, and research to establish product standards and develop improved testing methods. With regard to drugs, its oversight includes product approvals, over-the-counter and prescription drug labelling, and drug manufacturing standards, through the Center for Drug Evaluation and Research (CDER).

It is also involved in post-drug approval processes, such as post-marketing surveillance, prescription drug advertising and promotional labelling, pharmaceutical industry surveillance, medication errors, drug shortages, and therapeutic inequivalence reporting. It does not have oversight over drugs of abuse with no approved medical use.

According to the FDA’s website, “The agency grew from a single chemist in the US Department of Agriculture in 1862 to a staff of approximately 9100 employees and a budget of $1.294 billion in 2001”. The formal agency emerged from the passage of the Federal Food and Drugs Act of 1906.

EMEA

A newer body, the EMEA was developed in 1995. Like the FDA, its main role is “the protection and promotion of public and animal health by regulating medicines for human and veterinary research”. The EMEA is a decentralised body in the European Union (EU), with headquarters in London. As such, the EMEA uses scientific resources from the 25 EU member states.

However, because it is a single agency, companies wishing to apply for a new drug approval file a single marketing authorisation application to the EMEA. Upon review and approval by the Committee for Medicinal Products for Human Use (CHMP), a positive opinion is sent to the Commission, ultimately resulting in a single market authorisation valid for the entire EU.

The CHMP also arbitrates disagreements among member states concerning the marketing authorisation of a particular medicinal product, and can issue an “urgent safety restriction” to inform healthcare professionals about changes in the way a medication can be used (similar to the “black box warning” by the FDA). Moreover, the EMEA is involved in post-authorisation evaluation of drugs for human consumption including pharmacovigilance. The EMEA also reviews applications regarding orphan drugs (ie, drugs for rare diseases) and provides scientific opinion on traditional herbal medicines via the Committee on Herbal Medicine (HMPC), established in 2004.