Europe Tackles 'Advertising in Disguise' Fears - Pharmaceutical Executive


Europe Tackles 'Advertising in Disguise' Fears

Pharmaceutical Executive

Industry echoed this tentative approval, but although EFPIA reasserted that it does not wish to see any "push" of information, it added that "citizens seeking information on their disease or therapy should be able to access it in both user-friendly formats and in their own language" and that "modern society already has access to a great deal of information via the Internet; future discussions should examine ways to ensure that high-quality information is accessible to all in their own language."

Still, industry could hardly have been expecting any special treatment this time around, especially since pharma's move to the Health Department. John Dalli laid his cards on the table as soon as he took up office, saying to MEPs, "Let us work hard to put the interest of consumers and patients first," at a hearing in January 2010, and declaring himself soon after a "guardian of consumers."

In light of this, it is worth asking if the revised proposals go far enough for the patient. BEUC, consistently one of the EC's most vociferous detractors in this debate, tempered its words of support by lamenting that "the most detrimental provisions for consumers such as printed communication" are gone, and that the proposals still feature a number of provisions "which could leave room for 'disguised advertising.'" The organization outlined that it was particularly concerned by the possibility for companies to decide which medicines they will provide information on, potentially leading to a bias in favor of those most profitable. It also warned of "derogations" from the general principle of preapproved information by competent authorities. As for the burden and cost of the approval and monitoring system, BEUC said: "If the European Medicines Agency does not validate the material within 60 days, the information submitted will be considered approved. But what will happen if they are suddenly overloaded by material to assess?"

Speaking to the Pharmalot blog, the patient advocacy group Health Action International Europe said the new proposals contained "loopholes," and argued that the printed materials prepared by drug makers and made available at pharmacies and physician offices could "open the door to advertising of prescription drugs." Drug makers, the group pointed out, would still be allowed to refer to medicinal products in information materials on health and diseases.

Mixed Messages

Even after appearing to welcome the proposals warmly, EPHA still had reservations about the freedom they afforded to pharma websites: "The role of the Internet should be limited to providing access to the Patient Information Leaflet and medicines' safety information from a single portal; providing it on pharmaceutical company websites would be misleading, confusing and inappropriate," it said.

John Dalli knows, as much as anyone, that you can't please all of the people all of the time. But if his revisions have failed to completely satisfy the demands of the hard-line patient groups, there's no question they serve unequivocally to cut off any blood supply that might have been cultivating what is commonly defined as DTC advertising, however sensibly it may be handled in Europe. The amendments are also striking in showing how European sentiments on this issue continue to differ markedly from those in the US. Just last week Pfizer boss Ian Read passionately defended DTC advertising as a "fundamental right;" denying the right of industry to speak directly to patients through drug advertising, he said, "leads to ignorance and the inability to judge." European policy will, for the foreseeable future at least, continue pursue an antithetical view to this, and instead defend as fundamental the patient's right not to be mistreated, misled, or manipulated. The implication, of course, is that industry is not to be trusted.


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