Direct to consumer advertising of drugs in Europe

The promotion of prescription drugs to the public (“direct to consumer advertising”) is currently used only in the United States and New Zealand. A systematic review of the clinical and economic consequences confirmed that this form of advertising influences patient demand and doctors' prescribing behaviour, but evidence of health benefits or improvements in underuse was lacking.1 A more recent report from the Institute of Medicine confirmed that direct to consumer advertising increases the early use of new drugs and asked for a two year moratorium of such advertising for newly approved drugs.2 Requests were made to revise the legislation towards limiting or even banning such advertising both in the US and in New Zealand3 4 after rofecoxib (a heavily advertised drug) was withdrawn from the market because it increased heart attacks.5 A proposal to modify the current ban on direct to consumer advertising will be considered by the European parliament in the next few months in the context of a wider series of reforms “to improve the regulatory, non-regulatory and research and technological development framework for pharmaceuticals” (summarised in a document now open for public consultation until 12 October).6

At the request of the European parliament, the Enterprise and Industry Directorate General of the European Commission released a report for consultation at the end of April 2007 on “current practice with regard to provision of information to patients on medicinal products.” The report focuses on information publicly available on the internet from regulatory bodies or official sources in member states,7 which consists mostly of information on package leaflets, databases of approved drugs and regulatory reports, and other sources of information from regulatory bodies on approved drugs.

The conclusion of the report is clear though problematic: “Member States may not be in a position to fully address patients' needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals through Europe.”7 In other words, after an unsystematic review of information for patients available in Europe through regulatory bodies or Ministry of Health websites, the report states that the available information is not sufficient for patients' needs, and it suggests that the information possessed by the producers could plug this gap. Curiously, the document never mentions direct to consumer advertising but calls for a partnership in the production of information, supporting the idea that producers are a reliable source of information for patients and consumers.

Although the aims of the report are laudable, the methods it uses are scientifically weak: the report does not describe how literature was reviewed or the data collected; many statements are unsupported; and several comprehensive documents recently published on this subject are not mentioned.1 2 3 4 8 9 10 Also, the identity of the authors is unclear.

Despite what is stated in the report, several examples of good information sources for patients are now available in Europe.11 The difficulty for the public is finding them and distinguishing between promotional material and unbiased evidence based information. Information should be reliable (evidence based, arising from a systematic evaluation, and unbiased), comparative (with respect to all treatment options), and adapted to users (evaluating the potential problems of generalising to other populations, with consideration of patients' values and preferences).11 These three principles also apply to prescribers in evaluating the risk-benefit profile of an intervention and in defining the strength of a recommendation when producing a guideline.12

The idea of a public-private partnership stems from the recent second progress report of the European Commission's High Level Pharmaceutical Forum that proposes “to organise a platform to bring together relevant stakeholders to explore ways to exchange good practices and on ways to overcome barriers to accessing information.”13 Although it does not support direct to consumer advertising, this standpoint suggests that reliable information could come jointly from producers and regulatory bodies. However, such a partnership would confuse their separate roles and responsibilities.

So where do we go from here? We think that a partnership between drug companies and drug regulatory authorities in the area of information, and even more so in the field of drug evaluation,14 15 16 would be confusing. Therefore, we propose two areas of real partnership with the drug industry that would reinforce public trust in the system.

The first would entail a real commitment to waive confidentiality and give full access to data on the effectiveness and safety of drugs. Giving full access to all clinical trial protocols (not just those that are registered for publication purposes) and to the periodic safety update reports available to regulatory agencies would enhance transparency.

A second more institutional partnership is based on the fact that patients' needs and not industry patents should be the focus of regulatory bodies. For this reason, the European Medicines Evaluation Agency should move from the Enterprise and Industry Directorate General to the Health and Consumer Protection Directorate General to avoid the current conflict between supporting the competitiveness of the drug industry and the interests of patients.

The most sensible way to protect public health would be to Identify sources of unbiased and systematically reviewed information and maintain the current European legislation on drug promotion, while reinforcing the role of the European Medicines Evaluation Agency.