Spring Budget 2023 | UK chancellor announces new regulatory model for medicines and medical technologies
Published on 16th Mar 2023
Move raises the question of whether regulatory framework for medicines and medical devices will diverge from the EU model in a meaningful sense
The chancellor, Jeremy Hunt, has announced reform to the UK's regulation of medicines and medical technologies in yesterday's Budget. In a bid to position the UK as a global hub for innovative products, the Medicines and Healthcare products Regulatory Agency (MHRA) will get additional funding to accelerate access to new products and manufacturers will be able to leverage approvals from overseas regulators.
The chancellor has outlined how funding will change the role of the MHRA, stating that it will receive an extra £10 million over the next two years to put in place "the quickest, simplest, regulatory approval in the world for companies seeking rapid market access".
The rapid approval of medicines will also be introduced, with the Budget confirming that the MHRA is "exploring partnerships with trusted international agencies, such as in the US, Europe and Japan to provide simple, rapid approvals for medicines and technologies that have received their approval from 2024".
In the House of Commons, the chancellor went further, stating that the MHRA would move to a new model to allow "often near automatic sign-off for medicines and technologies" that have already been approved by regulators in jurisdictions such as the US, Europe and Japan.
In addition, from 2024, the MHRA will introduce a new approval process for the most "impactful" innovative medicines and devices, examples being cancer vaccines and artificial intelligence therapeutics for mental health. This is hoped to accelerate patient access to treatments and build on the success associated with the UK's rapid approval of Covid-19 vaccinations.
Osborne Clarke comment
The Budget is sketchy on the detail of the government's planned reform of regulations affecting medicines and medical devices. It follows government consultations that took place in 2021 and 2022 on how best to reform to the UK's regulations following Brexit. However, in both cases, the life sciences industry awaits the government's concrete plans for reform.
Patient groups will hope that the extra funding for the MHRA accelerates access to innovative treatments and manufacturers will be interested to see whether reform makes the UK a more attractive place to launch products. Nevertheless, yesterday's announcement raises the question of whether the UK regulatory framework for medicines and medical devices will diverge from the EU model in any meaningful sense, particularly as the UK population appears set to receive medicines and medical technologies that have been approved by overseas regulators and then given "near automatic sign-off" by the UK regulator.
It is possible that the government has heeded the practical problems following Brexit caused by the UK system's lack of Approved Body capacity and post-Brexit budget cuts to the MHRA. Giving manufacturers an alternative route, which in practice may mean largely circumventing the UK's system, appears practical. It also suggests that the post-Brexit reform to the UK's life sciences regulatory system may, in the end, diverge very little from the EU model.
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This article was produced with the assistance of Charlie Hennig, Knowledge Executive