EU sets out tough rules on medicines information

Europe will strictly limit the amount of information that drugmakers can supply to the public on prescription-only medicines and retain a ban on advertising under proposed rules set out on Tuesday.

The latest proposals from the European Commission amend those made in 2008, following criticism that the original ideas went too far in loosening restrictions governing communications between pharmaceuticals companies and patients.

John Dalli, European commissioner for health and consumer policy, said in a statement the new proposals would “further strengthen the control of authorized medicines.”

The new proposals from the Commission, the executive arm of the European Union, would allow information in only certain areas, such as information on the label and on packaging leaflets, information on prices and clinical trials, and instructions for use.

An earlier idea of letting drugmakers publish information about medicines on websites or in print—for example, in health supplements in newspapers—has been rejected under the new proposals, which state: “A publication in general print media will not be permitted.”

The tough line may disappoint drugmakers wanting more leeway to provide information directly to consumers in Europe, which they argue is needed in part as a counterbalance to sometimes unreliable data provided on the Internet.

But the Commission’s new line was welcomed by the European Public Health Alliance (EPHA), which represents healthcare professionals and patients, for keeping advertising at bay.

“The previous proposal was just a disguised way of giving pharmaceutical companies enough flexibility to promote their products directly to the public, in order to boost the sector’s growth,” said Monika Kosinska, the group’s secretary general.

NO U.S.-STYLE TV ADVERTS

In fact, the European pharmaceutical industry had never asked for a green light for U.S.-style direct to consumer (DTC) advertising, which some company executives anyway now view as a costly mistake.

DTC advertising of prescription drugs is only permitted in the United States and New Zealand, and the practice has been widely attacked by U.S. consumer groups, especially in the wake of the 2004 withdrawal of Merck & Co’s heavily promoted painkiller Vioxx.

Instead, drugmakers in Europe would like to steer a middle course between full-on television adverts and zero communication.

“Those citizens seeking information on their disease or therapy should be able to access it in both user-friendly formats and in their own language,” the European Federation of Pharmaceutical Industries and Associations said on Tuesday.

Consumer groups have long resisted any loosening of restrictions, arguing that drugmakers cannot be trusted to provide unbiased information.

The European Consumers’ Organization BEUC said the redrafting of the plans were a first tangible effect of the decision to move competence on pharmaceuticals policy from the Commission’s industry division to the directorate responsible for health.

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By Ben Hirschler

LONDON