Transitioning Up to Best Practice, or Down to the Bare Minimum? Global Harmonisation of Regulation of Therapeutic Goods

The COVID-19 pandemic has highlighted legal and ethical tensions within global markets for medical devices and pharmaceuticals. The global medical market is highly profitable, socially important, and tightly but inconsistently regulated. That regulation is ostensibly predicated on reducing risks to consumers by excluding unsafe therapeutic goods. Historically, market regulation has occurred nationally, with limited cross-recognition of approvals from other jurisdictions, reflecting the gravity of the state’s role in protecting its citizens and fostering local manufacturing. It is a persuasive rationale for the existence of the State. Globalisation of medical markets has prompted increased efforts at international harmonisation of those markets in line with neoliberal understandings of economies and the state. Standardisation of regulatory requirements across jurisdictions lowers compliance costs through reduced duplication of effort, incentivising investment in further research and development. However, there are risks associated with moving towards a globally harmonised regulatory framework, particularly if the threshold for an emerging single market is biased towards corporate stakeholders and provides inadequate protection to consumers from harms posed by therapeutic goods. This chapter examines whether protecting consumer safety remains the objective of a globally harmonised regulatory standard, or whether hegemonic market values have eroded the public harm minimisation foundations on which drug and device regulation are built.