The EU regulation of medical devices and pharmaceuticals in comparative perspective

This paper provides a comparison of European Union regulatory policy for pharmaceuticals and medical devices. The discussion highlights key similarities and differences in regulatory approach for the two sectors. More importantly, it explores the balance that has been struck between public health, health care, and industrial policy as "competing" objectives within the respective regulatory regimes. It is argued that, despite both sectors being affected by the same institutional rules and constraints at the EU level, and both being central to the delivery of high-quality health care in Europe, there are a surprising number of differences between the regulatory frameworks. That this stems in part from their different "launch" times, hence different institutional conditions of regulation, and commensurate political climates, as well as reflecting different aims and goals among member-state and EU-level policy makers, are among the paper's main conclusions.