Controversial plans to allow pharmaceutical companies to publish medicines information in newspapers have been scrapped by MEPs. The original proposal from the European Commission had been branded "advertising in disguise" by consumer groups, who welcomed the Parliament's U-turn.
BEUC, the EU consumer lobby, had been fiercely critical of the EU executive's plan when it was published in December 2008 but expressed relief at the decision by the European Parliament's public health committee to rewrite the directive.
Advertising prescription medicines is banned throughout Europe, but the Commission was willing to allow companies to provide information in print while retaining the ban on broadcast media.
MEPs said they had now changed the emphasis of the proposal to focus on patients' rights to information rather than making the provision of information an option for pharmaceutical companies.
The public health committee amended the directive to require member states to provide citizens with objective and unbiased information on medicines, and said the public should be protected from unsolicited communication from industry.
The public should be able to access details of what the medicine does, an assessment report on the medicinal product, and details of how to prevent the diseases which it treats, according to the latest draft legislation.
Under the new proposal, member states will have to set up dedicated websites and make information available in printed form.
Pharmaceutical companies will be allowed to provide the public with other "non-promotional information" on the environmental impact of the product or its effect on prices, although they will need permission from regulators to do this.
The industry welcomed the vote, which comes just one week after a full sitting of the Parliament backed new rules on pharmacovigilance.
Swedish MEP Christofer Fjellner (European People's Party) said the compromise text, agreed by a large majority of the committee, would shift the focus from producers' rights to patients' rights.
He said the reworded directive would mean consumers got better quality information without giving unlimited freedom to companies to promote products.
"Today, anyone but pharmaceutical companies is allowed to inform on prescription drugs, which is unacceptable. The producer has the best knowledge on these products. Now we will allow the industry to spread information, but of course within strict limits and under strict supervision," Fjellner said.
He said it was important that citizens would get less information as a result of the regulation and the strong support of the ENVI committee put the Parliament in a strong position to negotiate with member states and the EU executive.
Green Swedish Green MEP Carl Schlyter said the reworked directive put the interests of patients and consumers first when it comes to prescription medicines, adding that the Commission's version had been "driven by the interests of the media and pharma industries".
"As a result of today's vote, the legislation now provides greater transparency on prescription medication based on patients' needs, rather than information to promote the commercial interests of the pharmaceutical industry," he said.
Pharma firms would have to provide official documents on their websites, or in printed form upon request, and may provide some other information based on quality criteria and subject to approval by the competent authorities or the European Medicines Agency upon specific request. So the information will be 'pulled' according to needs, rather than 'pushed' based on what the industry wants to make available," he concluded.
Brian Ager, director-general of EFPIA, the industry group representing research-based pharmaceutical firms, welcomed the vote, which he said reflected a "pragmatic approach".
"This contrasts with the situation in a number of member states, where there has been a reluctance to even discuss options for providing citizens and patients with improved access to information about their illnesses and treatments. Such an approach ignores the reality of the modern information society, and perpetuates inequalities of access to information that currently exists between member states," he said.
Ager said the vote is a step forward but any new legislation would need to provide a viable legal framework if it is to be effective.
"It should build on existing best practice within the EU, and not introduce costly and unnecessary bureaucracy, delivering neither real benefit in the quality of information nor public health gains," he added.
EFPIA said it has already published concrete proposals to reform the current situation, which would set solid criteria distinguishing information from advertising. Ager said the industry has made clear that they do not with to see "push" information on specific prescription medicines on TV, radio or in print mass-media.
"However, 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," he said.
The European Generic Medicines Association (EGA) said the vote would prevent "the exertion of undue commercial influence over consumers by the industry. In a statement, the group said it was particularly pleased with amendments which will restrict companies to providing information on their own medicines only.
Monique Goyens, director-general of BEUC, the European consumers' organisation, said the vote "more adequately reflects consumers' needs". "While the pharmaceutical industry can still decide on which particular medicines and on which diseases they communicate, the European Parliament obliges public authorities to provide for more and better information on health, diseases and medicines," she said.
The BEUC chief urged the legislators to continue their work so as to avoid introducing a bias in favour of "blockbuster" medicines and against non-drug therapies. "European patients should have the right to receive non-promotional and user-friendly information on prescription medicines from independent sources," she said.