The Origins of Regulations for Pharmaceutical Products and Medical Devices – What Can be Learned for the Governance of Medical Devices in Europe?

Regulations are necessary for the governance of health products in order to protect public health and safely introduce new technologies. This article examines the history of regulations in the USA and EU for food, medicines and medical devices, to uncover the original motivations and objectives for legislative initiatives. The foundation of the US FDA in the early twentieth century resulted from concerns about adulteration of foods. Drug regulation in the 1930s was precipitated by the sulfanilamide scandal. The development of regulations for medical devices during the 1970s was accelerated by concerns about deaths attributed to devices, and complications with the Dalkon shield intrauterine device. In the EU, pharmaceutical regulation in 1965 followed the thalidomide scandal while the first directives for medical devices after 1990 followed petition from manufacturers and earlier concerns about pacemakers and heart valves. In Europe and the USA, pharmaceutical and device regulations have been initiated reactively in response to crises, as well as perceived deficiencies in regulatory frameworks. The European Commission is now conducting a review of the medical device regulations to consider possible legislative changes. This review of the history of regulations provides an opportunity to reconsider what is needed, proactively and on scientific and clinical grounds.