The City Law School academic co-authors a study in an updated report titled, ‘UK Regulation after Brexit Revisited’.
Jean Monnet Professor of EU Law in The City Law School, Professor Tamara Hervey, has co-authored the Medicines section of the most recent UK in a Changing Europe report, ‘UK Regulation after Brexit Revisited’ – which draws on an earlier Nuffield Trust report published in February 2021.
The report looks at how UK regulation has developed since EU rules ceased to apply to the UK, with the partial and highly significant exception of Northern Ireland, and the impact of both continuity and change in key areas of social and economic activity.
‘Medicines’, co-authored by Professor Hervey, Dr Mark Dayan, Dr Mark Flear and Dr Nick Fahy, analyses the divergence between the UK and the EU in the key areas of the approval of new medicines and clinical trials since 1st January 2021, when the UK regulations implementing EU legislation on medicines and medical devices became ‘retained EU law’ under the European Union (Withdrawal) Act 2018.
Professor Hervey and colleagues, argue that, “eighteen months after the end of the transition period, divergence between the UK and EU has started to emerge due to actions on both sides. The EU has adopted new regulations, so that differences now exist in areas such as clinical trials. Meanwhile, the shift of powers that were previously held by the EMA to the UK MHRA has seen the different regulators make different decisions about what to approve and when.”
They go on to make the point that “while the UK government has used a rhetoric of competitive divergence, emphasizing its new freedom to enact changes that would have been impossible while the UK was a member state, significant changes in the substance of UK law have yet to materialise.”
The authors dispute the claim made by former Secretary of State for Health, Matt Hancock, that the early delivery of the Covid-19 vaccine was “because of Brexit”.
In the conclusion of their section, the writers say the UK is caught in a dilemma with regard to wanting to “use the domestic control over medicines regulation to make the UK a more competitive place to test and launch medicines, while on the other, its small size compared to the EU makes it less attractive, and greater divergence increases the costs of launching and providing products in the UK.”