Pharma industry softens stance on ‘advertising’ plan

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Europe’s pharmaceutical companies will allow an independent authority to vet information provided to patients under a controversial proposal that would allow industry to communicate directly to consumers.

The compromise may break the deadlock on the directive, which was first unveiled by the EU executive in 2008. The proposal has since been shelved by EU member states amid concerns that companies could not be trusted to provide impartial information to the public. 

Critics claim companies will be unable to draw the line between advertising and scientific information on their products. 

Arthur Higgins, president of EFPIA, the pharma industry umbrella group, said it would agree to submit to a prior approval process all information it intends to publish online and in newspapers. The move is seen as an effort to remove remaining barriers to the introduction of the new rules. 

The authorities could then decide whether data on how the medicine works, its side-effects and potential interaction with other therapies is purely factual. Information deemed to be akin to advertising or marketing literature would not be approved for publication. 

Speaking at an event in the European Parliament hosted by French MEP Françoise Grossetête, Higgins said “high quality, non-promotional information on diseases and treatments” would allow patients to responsibility for their health. 

“Patients need to be equipped to make informed choices about their condition and possible treatments. Such information should be available from a range of high-quality sources, including the industry,” he said. 

Higgins expressed disappointment that health ministers had apparently put the plan on ice and urged MEPs to prevent the proposal from being “diluted or worse still dropped”. 

The directive on information to patients has met with a mixed response from MEPs, but there are signs that the Parliament is more willing to embrace the proposal than ministers in EU member states. 

Grossetête said MEPs should join with patient groups to form a united block against health ministers who have blocked the directive. 

However, not all consumer and patient groups are supportive of the plan. BEUC, the European Consumers’ Organisation, branded it “advertising in disguise” when it was first published. 

German liberal MEP Holger Krahmer said EU law on medicines has yet to embrace the information age. He said all citizens can access and publish information, adding that the only group prevented from publishing data on medicines is the industry that manufactures them. "Current European law has not arrived in the 21st century," he said. 

This view was echoed by Mary Baker, president of the European Federation of Neurological Associations  (EFNA), who said well-informed patients are more cost-effective in the long-run because they are empowered to make better choices. 

Irish Socialist MEP Nessa Childers said patients had suffered in the past due to lack of transparency and reliable information on psychiatric medicines. She told the meeting, which was co-sponsored by EFPIA, that she was concerned by the accuracy of health information on the Internet. "We must have reliable databases," she said, adding that the industry could be one source of information. 

proposal to change the rules on providing medicine information to patients was included in the 'pharmaceutical package' presented by the European Commission in December 2008 (EURACTIV 11/12/08). 

The controversial measures, which would allow pharmaceutical companies to provide information directly to consumers for the first time, was partly to blame for repeated delays to the long-awaited pharma package. 

Critics say allowing companies to provide factual information on their own products will open the door to advertising of prescription drugs. Proponents of the plan say quality information in all EU languages should be provided so that consumers are not taken in by poor quality online information (EURACTIV 02/09/09). 

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