EU Plans Review of Ban on Drugmakers’ Direct Communications With Patients - Bloomberg

European Union restrictions on pharmaceutical companies communicating directly with patients will be reviewed by regulators planning new draft rules, EU officials said.

The European Medicines Agency received a letter from the European Commission saying that it will review the policy, said Peter Arlett, head of the agency’s drug safety unit, at a meeting in London today. The rules are intended to make regulations more uniform across the 27-nation bloc.

“The European Commission will revise the proposals to clarify and harmonize the rules in what companies can and can’t say to patients,” Arlett said in an interview. It’s uncertain whether restrictions will be lifted, he said.

Previous debate suggests the measure probably won’t allow the type of direct-to-consumer television commercials that drugmakers air in the U.S., or general magazine or newspaper advertisements, said Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations, a trade group in Brussels.

EU regulators will suggest new rules “by September/October at the latest,” Frederic Vincent, a spokesman for the European Commission, said in an e-mail. Any proposal will need the support of EU governments and the European Parliament before it can come into force.

Previous Proposal

The proposal replaces an earlier draft by regulators three years ago that failed to win the backing of governments and lawmakers. The earlier version would have limited print ads to health-related publications, Bergstrom said in a telephone interview.

Members of the trade group would welcome being able to directly communicate with patients about their medicines and more consistent rules throughout European countries, Bergstrom said.

“We in industry are largely supportive,” he said. “Today it is a patchwork. If you are in the U.K. or Sweden you can usually get high-quality information rather than relying on your doctor, whereas in southern Europe there is nothing.

‘‘Our position is, it’s bizarre that you can get all sorts of other information’’ about medicines ‘‘on the Internet but we as producers are banned from giving it.’’

To contact the reporter on this story: Allison Connolly in Frankfurt at aconnolly4@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

via bloomberg.com

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