Ensuring Post-Brexit UK is a ‘Maker’ Rather than a ‘Taker’ of Global Norms and Standards: The Case of the International Council on Harmonisation

Abstract

How can post-Brexit UK become (more of) a ‘maker’ rather than a ‘taker’ of global norms and standards or regulation? This paper focuses on the example of the International Council on Harmonisation (ICH) and its work in harmonising Good Clinical Practice (GCP) in relation to clinical trials for pharmaceuticals. By reference to this example, the paper underlines the importance of the ICH to global standard setting for GCP and the necessity of UK engagement in this forum post-Brexit. Brexit will ensure the UK is no longer represented in the ICH as part of the EU's delegation. The UK will therefore have to become a member of the ICH in its own right. That is provided the UK wants to have a voice and play a role in crafting the standards with which it will have to comply anyway. Subsequently the paper charts a path towards maximising UK participation in the ICH and in the crafting of the global standards that will continue to apply to the UK (and in the EU and other key markets) post-Brexit.

Keywords: ICH, Clinical Trials, Good Clinical Practice, Standards, EU, Brexit