Two apparently well-meaning legal initiatives from Europe aimed at fighting falsified or substandard medicines could have the unintended consequence of exposing medical researchers and drug manufacturers to criminal prosecution, according to a new commentary in the journal Harvard Public Health Review (HPHR).
Under one of the new proposals, the Council of Europe (CoE) would enact a new treaty called the MEDICRIME Convention that would criminalize “counterfeit” medicines and medical devices. But the definition of “counterfeit” is so broad that if researchers were to use placebos, or misrepresent medicines—common practice in blind clinical trials—it could be considered illegal.
Other draft legislative provisions, from the UN Office of Drugs and Crime (UNODC), would deem experimental medicines or placebos “fraudulent” if their packaging or labeling was false. But truthfully identifying placebos in clinical trials would defeat the purpose of a blind trial in which caregivers or patients are not supposed to know which drugs are being tested.
Authors of the HPHR commentary note that “combatting the criminals who make intentionally falsified and recklessly substandard medicines is extremely important work,” but they urge the UNODC and the CoE to “freeze their plans, and reboot their efforts,” so that the proposed initiatives don’t interfere with scientific research.