Regulatory authorities in the EU member states “may not be in a position to fully address patients’ needs in terms of the substance of information [on medicines] 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 throughout the EU”.
This paradox, noted in the conclusions to a draft report from the European Commission on current practices in the provision of information on medicinal products to patients, sums up the arguments for a more active industry role in a rapidly proliferating field where official, regulated or validated sources of information collide with the relative free-for-all of the internet. If the Commission’s tone is noncommital, it reflects the political sensitivities of a discussion that consumer groups claim is a prelude to the back-door introduction of direct-to-consumer advertising of prescription drugs.
The Commission itself insists this is not the case, nor is there anything in the document put out for consultation until 30 June that suggests otherwise. The balance of benefits and risks in providing drug information to patients “indicates the need for clear rules that apply to information, ensuring its objectivity and avoiding any promotional character”, comments the Commission’s Directorate General for Enterprise and Industry. The moot point, though, is when that information shades into advertising. Consumer groups such as Health Action International argue that industry’s commercial imperatives make it incapable of supplying anything other than promotional information.
What the draft report does say is that the pharmaceutical industry “has the potential to be an important source of information to respond to the growing demand for more and better information from patients” – provided there are “adequate rules to ensure reliability, objectivity and quality of information”. Industry believes it should have the same right as non-industry bodies to provide quality information on its own products, the Commission points out.
Pharmaceutical companies also share the view of many patient organisations that what matters is the availability and quality of the information, rather than its source, the report adds. A number of these organisations also acknowledge the role of industry as a legitimate source of information on its own products, specifically through ‘pull’ mechanisms “whereby the patient is actively seeking out information and needs to know where and how to access it”. There is little support, however, for information provision that is not in response to patient demand, the Commission says.
The draft report ticks all the now familiar boxes about the hunger for health information, patient empowerment and the shift towards ‘partnership’ between more informed patients and healthcare professionals. But it also makes clear that the problem is not so much lack of information on medicines, or of efforts to provide it by regulatory authorities (some of them in public-private partnerships with industry), the Commission or the European Medicines Agency; rather, it is disparities of access, the varying reliability of the information provided and the lack of harmonisation in a field that to date has not been subject to specific EU legislation.
The wide diversity of approaches to information provision taken by the member states in the absence of a clear EU mandate has “created obstacles and uncertainties from a Community perspective”, the Commission comments. These include unequal access to information, determined mainly by member-state policy but also by ancillary factors such as technological skills, language, income and age; the lack of EU quality standards on information to patients, raising the risk of negative health consequences due to wrong, misleading or confusing information; and the risk that lack of information will lead to uninformed choices such as late diagnosis.
On the other hand, an increase in the quality and “appropriateness” of information on medicines “would be expected” to contribute to better conditions and more efficient use of resources in the health sector, the Commission maintains. “Better informed patients are expected to adhere better to treatments and to better understand clinical decisions,” it adds. “This should lead in the long term to social and economic benefits.”
Review obligation
The EU’s review of its pharmaceutical legislation introduced an obligation in Directive 2001/83/EC for the Commission to present a report to the European Parliament and Council during 2007 on “current practice with regard to information provision – particularly on the Internet – and its risks and benefits to patients”. The Commission was also asked, “if appropriate”, to come up with proposals “setting out an information strategy to ensure good-quality, objective, reliable and non-promotional information on medicinal products and other treatments”, as well as addressing the question of liability attaching to the information source.
Proposals during the pharmaceutical review to allow selective provision of drug information by industry on demand were thrown out by the European Parliament in 2004. The discussion has continued, though, through the Pharmaceutical Forum, the high-level EU initiative set up by the Commission in June 2005 to take forward outstanding issues from the G10 medicines process.
One of these was information for patients. A technical working group addressing this issue has been set up as part of the Forum, whose membership includes health ministers, members of the European Parliament and representatives of 10 stakeholder organisations spanning industry and public health interests. The Information to Patients Working Group provided input to the Commission’s draft report and, following a public consultation, will be making proposals to the next meeting of the Pharmaceutical Forum at the end of June.
