Abstract

Conducting clinical trials has never been harder, but it may soon become criminal too, under two dangerously unwise legal initiatives emanating from Europe. Two well-meaning legal texts designed to fight falsified or substandard medicines—one from the Council of Europe (CoE), and another from the UN Office of Drugs and Crime (UNODC) but drafted by the Irish Medicines Board—are so negligently done that they would expose honest researchers and drug manufacturers to prosecution, simply for their involvement in something so basic as a placebo-controlled trial. If clinical trials are not unwittingly to lead to criminal trials, the research community must intervene against these errant legal proposals becoming binding.

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