Europe Revises ‘Advertising In Disguise’ Proposal

Europe Revises ‘Advertising In Disguise’ Proposal

October 12th, 2011 // 12:50 pm @

Three years after issued a widely criticized proposal that would have allowed drugmakers to publish product information in consumer newspapers and magazines, the European Commission has, as promised, issued an updated version. And policy makers vow this will strengthen regulatory controls over authorized medicines and how pertinent information is communicated to the public.

The original effort, which was unveiled in 2008, was designed to provide more reliable medical advice, given that the Internet allows widespread dissemination of questionable information and since drugmakers are prevented from circulating data. But the proposal was criticized for weakening existing EU restrictions on contacts between drugmakers and patients (you can read the initial proposal here).

Now, the EC will maintain its current ban on US-style direct-to-consumer advertising and allow only certain sorts of info to be communicated, such as info found on product labeling, prices, clinical trial data and usage instructions. And only limited channels would be permitted, such as registered web sites or printed info requested by consumers. A publication in general print media will not be permitted. Also, any info must evidence-based, factually correct, not misleading and understandable (here is the proposal in the directive form and as a regulation).

“The revised proposals put rights, interests and safety of patients first,” says John Dalli, European Commissioner for Health and Consumer Policy, in a statement. “They oblige industry to provide certain key information to patients and set clear rules for additional, voluntary information on prescription medicines. In addition, they further strengthen the control of authorised medicines.”

In response to the revised proposal, drugmakers offered general support, while maintaining that a “viable legal framework” without “unnecessary bureaucracy” is needed. And the European Federation of Pharmaceutical Industries and Associations, which never actually sought permission for DTC ads, agreed to support the use of “quality criteria that will distinguish information from advertising and ensure patients can receive helpful, non-promotional information on medicines.

“EFPIA and its member companies have made it clear that they do not wish to see any ‘push’ of information on specific prescription medicines via TV, radio or 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,” according to a statement from the trade group.

One patient advocacy group, however, was somewhat critical. “This document contains loopholes that open the door to advertising of prescription drugs to the public disguised as patient information,” Teresa Alves, Coordinator at Health Action International Europe, says in a statement sent to us. “The rewritten proposals may be misinterpreted and misused, although they represent an improvement on the original version introduced by the Commission in December 2008.”

She cited three examples. For instance, HAI argues that printed materials prepared by drugmakers could be made available at pharmacies and physician offices. The group then maintains that implementing procedures at a national level for clearing information to be disseminated can be problematic, given that regulators, such as the FDA, have difficulty monitoring this activity.

HAI also objects that drugmakers would still be allowed to refer medicinal products in information materials on health and diseases, provided no reference is made to a specific product. HAI argues that evidence from industry “awareness campaigns” in the Netherlands shows that even when information is not branded, info on health conditions can be “framed to support drug treatment and to increase the sales of a particular product.”

Source: Pharmalot

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