The possibility of such a shift is illustrated by some of the other responses to the public consultation—notably from consumer and health activist organizations. Health Action International (HAI) Europe, for instance, accused the current European pharmacovigilance system not only of weakness but of helping "to sustain the illusion that drug benefits to health hugely outweigh the harms." Penned by inveterate critics of the drug industry, including Charles Medawar and Andrew Herxheimer, the HAI contribution claims that "the present drug regulatory posture involves abuse, by default, of both scientific and democratic first principles," with collusion between regulators and industry, and negligence of broader health issues. It urges immediate involvement in EU regulation of officials who are more health conscious, and less industry conscious.

Such critical comments form only a minority of the inputs to the consultation, but a powerful minority nonetheless, and a potential impediment to the passage of legislation which would simplify the EU rules of pharmacovigilance. EU officials are well aware of the intrinsic volatility of the European legislative process, in which public opinion can often be easily roused when legislation becomes labeled as pro-industry and antipublic. In this case, it seems that an official attempt is being made to head off negative sentiment at the earliest stage, by presenting this largely industry-friendly initiative as primarily citizen friendly. Whether this rather frail subterfuge will have its desired effect remains to be seen. But the fact that the attempt is being made demonstrates in itself that, in many respects, vox populi is already becoming vox dei.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.