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The EC's latest proposals have thrown water on Europe's firey Direct-to-Consumer advertising debate. But is it enough to keep the flames at bay?
Three years after the European Commission (EC) came under fire for proposed changes to its information-to-patients guidelines, last month finally saw a much-anticipated raft of proposed revisions outlined by John Dalli, the European Commissioner for Health. More than a political hot potato, the issue of European DTC advertising has become, according to Applied Clinical Trials' Peter O'Donnell, an "explosive cocktail of debate," one that has been made "all the more volatile by the proliferation of online information about medicines." Dalli has been acutely aware of the need to tip the scales of the debate in favor of patients and healthcare professionals, not least because, in the intervening period, responsibility for pharma has been shifted to his department from its previous home within Enterprise and Industry.
The Enterprise department's 2008 position on the issue seemed to please no one. In suggesting that drug makers could sidestep the ongoing European ban on DTC advertising by providing reliable medical information about their drugs to the public via television and radio, the Internet and the print media, it attracted a storm of protest from patient and healthcare organizations. The European Public Health Alliance (EPHA) branded the proposals "just a disguised way of giving pharmaceutical companies enough flexibility to promote their products directly to the public." The Picker Institute, a non-profit body concerned with advancing patient-centered healthcare, said that the plans were "clearly driven by the pharmaceutical industry's commercial concerns." Reeling off a litany of complaints, the European Consumers' Organization BEUC added that the proposals failed to set out an information strategy and were based on an unworkable distinction between information and advertising rather than an assessment of consumers' information needs.
While industry was understandably supportive of any attempt to harmonize information-to-patients practices, the European Federation of Pharmaceutical Industries and Associations (EFPIA) also took exception to the plan to allow "push" communication for prescription medicines through television, radio and print media, arguing that distinction should be made between cases where the patient is passively receiving the information and those when he is actively searching for it.
European Parliamentarians similarly gave the proposals short shrift, maintaining, in German MEP Jorgo Chatzimarkakis's words, that it is "a fundamental principle in a democratic society that citizens have a right to access information." Members of the Parliament's Environment, Public Health, and Food Safety (ENVI) Committee voted in large numbers to delete the proposal from the Commission's package of pharmaceutical legislation, put forward in December 2008. Echoing EFPIA's comments, the MEPs urged that the guidelines promote the rights of patients to receive information rather than give drug makers the option of providing it.
Keen to show it has taken these feelings on board, the EC press release accompanying Dalli's announcement of the new revisions last month stressed how the amended proposals will lead to "better empowered patients," put their safety first, and "further strengthen" their rights and interests. Not surprisingly, the revisions maintain the current advertising ban on prescription-only medicines and allow for "only certain information," such as prices, information on clinical trials, or instructions for use. There is, however, permission for the dissemination of information through "limited channels of communication," such as officially registered websites or "printed information made available when specifically requested by members of the public," a measure that appears to legitimize the "pull" approach while roundly discarding the controversial "push."
This time the proposals were tentatively welcomed by patient organizations. Monika Kosinska, EPHA's Secretary General said the EC had "taken the public health perspective on board" and noted the obligation for pharma to provide certain information only after authorization from competent authorities "with satisfaction." EPHA even agreed that that "the Internet can be a useful place to provide information." The European Patients' Forum "applauded" the Commission's recognition of the importance of patient empowerment, while BEUC said that the revisions reflected the "first tangible effect of the shift of competence on pharmaceutical policies." This may not be a ringing endorsement of Dalli per se, but certainly seems an approving nod in his department's direction.
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.
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.