EU revisa normas sobre DTC

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 Polish presidency of the EU’s Council of Ministers 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.