By Peter O'Donnell
BRUSSELS (Reuters Health) – European plans to let drug companies give consumers more information on prescription drugs faced turbulent times on Thursday as one of the European Union's member states formally questioned the scheme.
A senior Dutch official confirmed to Reuters Health that the Netherlands would be looking for "clarification" in the upcoming discussions of the proposal in the EU's Council of Ministers.
"If it is advertising, we're against it," Dutch Health Ministry director, Leon Wever, said.
The plan was launched last July as part of a wide-ranging review of the EU rules on pharmaceuticals. The European Commission has stated that drug firms should be allowed to provide information directly to consumers for three categories of prescription drugs (AIDS, asthma, and diabetes)–something that is currently prohibited by EU law.
According to Wever, the European Commission is confused. He said he could "not understand" the position taken by the European Commissioner who had announced the proposal, Erkki Liikanen.
"Liikanen says the proposal does not intend to provide for direct-to-consumer advertising, but the actual text says that direct-to-consumer advertising can be introduced. What is the Commission trying to say to us?"
The Spanish Presidency is planning intensive work on the new proposals, with six working group meetings and a ministerial discussion scheduled in the first half of this year.
The Dutch health ministry says that there is convincing evidence that even the most limited use of direct-to-consumer information in the Netherlands boosts unnecessary medical consultations.
A spokeswoman for the inspectorate told Reuters Health that a 3-month media campaign for a nail fungus treatment–which carried neither the company nor the product name–led to patient consultations for this condition rising from an average of 2 per month per doctor to 20 per week per doctor.
Commissioner Liikanen's spokesman, Per Haugaard, denied that the Commission was planning the introduction of direct-to-consumer advertising.
"We are not intending to permit unsolicited direct-to-consumer advertising as it is conducted in the United States, but to empower consumers and patients to request information from industry," he told Reuters Health.
The information would be provided to patients only on request, such as when patients ask for a leaflet, and would have to conform to guidelines covering media and content, that will have to be agreed upon by the European Commission, the member states, the industry, and patients. All information would be subject to prior approval by the European Medicines Evaluation Agency, and in any case this would be a 5-year trial only, subject to annual review, he insisted.
The justification for the initiative, Haugaard said, was that anglophone patients can already obtain information from US Web sites. This information is not subject to any EU control, and is often incorrect because it is geared to products which might have the same name but are not identical in the US and the EU, he said.
He said the initiative was a response to calls from patient groups.
But patient groups at a meeting on the subject in Brussels today, organised by Health Action International, dismissed the Commission reasoning.
"This proposal has not grown from consumer needs, and…to the extent that it is comprehensible at all, it is…nonsense", said Charles Medawar, director of the UK group Social Audit. He claimed the proposal is driven by commercial imperatives, and underlined that it had been announced by the European Commissioner responsible for industry rather than the Commissioner responsible for health.
Meanwhile, the drug industry is playing a cautious line. Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), limited himself today to a description of the guidelines that EFPIA has created for its members' use of the Internet to provide information on their products.
"EFPIA did not ask for direct-to-consumer advertising", he told Reuters Health.