European Parliamentarians have this week rejected proposals by the Commission to allow prescription drugmakers to publish information to consumers about their products in printed media such as newspapers and magazines.
Members of the Parliament’s Environment, Public Health and Food Safety (ENVI) Committee have voted overwhelmingly to delete this proposal from the Commission’s long-delayed package of pharmaceutical legislation, first put forward in December 2008, and to emphasise the rights of patients to receive information rather than giving drugmakers the option of providing it, as the Commission has proposed.
According to the compromise text agreed by a large majority of the Committee, drugmakers should be required to make available the approved and most recent contents of Summaries of Product Characteristics for their product, its labelling and package leaflet, plus a publicly-accessible version of the assessment report. They also introduced a new article into the legislation which would oblige European Union (EU) member states to ensure that this “objective, unbiased information” is publicly-available, along with details of the diseases and conditions which the drug is used to treat and information on how to prevent them.
The new legislative text also states that drugmakers may provide consumers with other “well-defined, non-promotional information” on their products, such as environmental impact details, instructions for use and price or pack changes, although they would need to get regulatory permission first.
Moreover, such information would have to be supplied in electronic and printed form and in formats appropriate for the blind and partially-sighted, while printed material could only be sent to consumers if they had specifically requested it, the MEPs agreed.
A plenary vote in Parliament on the agreed text is due in December.
The Committee’s rapporteur, Swedish MEP Christofer Fjellner, who has long expressed frustration as the pharmaceutical package’s glacial progress, welcomed the compromise agreed by the panel. “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,” the Euractiv news source reports him as saying.
The vote was welcomed by both industry and consumer groups, with the European Federation of Pharmaceutical Industries and Associations (EFPIA) calling it a “step forward in the long-running debate on patients’ access to information.”
EFPIA director general Brian Ager commended the ENVI panel for its “pragmatic approach” which, he said: “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.
The Commission’s proposal had not sought to overturn the current ban on manufacturers providing prescription drug information to the public through broadcast media, and Mr Ager emphasized that EFPIA and its member companies have already made clear that they do not wish to see any “push” of information on specific medicines via television, radio or print mass-media. However, he added: “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.”
The European Consumers’ Organisation (BEUC) - which had slammed the Commission’s original proposal as “designed in the interests of the pharmaceutical companies” and warned that it would have “opened the door” to prescription drug advertising - said the vote was “a relief for European consumers.”
The work done by the ENVI panel “more adequately reflects consumers’ needs,” said BEUC director general Monique Goyens, adding: “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.”
However, Ms Goyens also urged the MEPs 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.
www.europarl.europa.eu
Links
www.euractiv.com
www.efpia.org
www.beuc.org
**Published in "Pharma Times"
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