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.The Right to Information
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.