Only a whiff of populism

The official justification for this initiative, with its emphasis on public consultation and providing better public health protection, has a disconcerting whiff of populism. But closer examination of the proposals suggests a more subtle strategy underlies the EU approach.

For a start, the EU announcement offers no comfort to any simplistic and utopian vision of a world of perfect medication devoid of any awkward safety issues. Instead, it acknowledges frankly that all medicines have some risks, that authorization decisions are a balance of benefits and risks, and that the safety profile of a medicine cannot be fully known prior to authorization.

Crucially, they disclose that the industry input has been hugely influential in the result, with a focus on the need for simplified and consistent mechanisms to eliminate national divergences and duplications. EuropaBio, the biotech industry association, supported harmonized pharmacovigilance procedures and homogenous decision making, with one single framework, one single report, one single European entry for each reporting, and one centralized database. "This single interface," it said, "would save financial resources, without ignoring any safety imperatives, and would allow industry and the authorities to invest in other areas."

The European Federation of Pharmaceutical Industries and Associations (EFPIA) similarly urged one pharmacovigilance system, in one language, with one set of binding rules for all stakeholders, one assessment, and one voice for pharmacovigilance communication. In language that finds its reflection in the EU's February announcement, EFPIA called for "clear and concise, unambiguous provisions that would simplify, strengthen, and provide legal certainty to the EU legislative framework for pharmacovigilance."

Problems voiced

GlaxoSmithKline complained about "the sheer volume of regulations," "contradictory and often unclear procedures" that can be "both complex and confusing," and that "expose individuals responsible for pharmacovigilance in Europe to civil and criminal liability." It called for "the adoption of a single regulation on pharmacovigilance, with clear and concise provisions to provide legal certainty," with "a single set of simplified rules for expedited and periodic reporting of adverse drug reactions in the EU, and a single point for electronic reporting."

Similar problems occasioned by reporting requirements were also raised at a recent European Forum for Good Clinical Practice discussion. Although it did not form part of an official submission, the meeting—on working with ethics committees—demonstrated to EU officials the deep dissatisfaction among clinical trial experts with the current situation. In particular, an overwhelming majority of participants objected to the requirements to send all reports of suspected and unexpected serious adverse reactions to ethics committees, which are, as a result, inundated with raw data that they cannot handle.

Why the "public" tag?

So why, if the proposal is largely industry-friendly, does the EU's February announcement lay such emphasis on public consultation and on public interest? A clue may be found in a comment from EFPIA: "Current negative opinion regarding pharmaceutical companies and regulatory agencies underlines the need for better communication between industry and regulators, and with the media, patient organizations, professional interest groups, and the public on topics associated with the safety of medicines." Decoded, this observation more or less implies that public opinion does matter, because if it is ignored, it can easily become inflamed, and then lead to more draconian controls not only on pharmacovigilance but on clinical trials and authorization in general.