Peter Rudd-Clarke, a regulatory and litigation partner in the life sciences and healthcare team at Osborne Clarke, outlines what reforms from the recent budget means for the UK medicines and medical device regulatory system.
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In the spring Budget delivered last month, the chancellor, Jeremy Hunt, announced reform to the UK's regulation of medicines and medical technologies. 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 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." Patient groups will hope that the extra funding for the MHRA accelerates access to innovative treatments and manufacturers will be interested to see whether the regulatory reform makes the UK a more attractive place to launch products.
Foreign approvals
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 the UK, there is currently a bottleneck issue in the approval of medical devices due to the UK system's lack of Approved Body capacity and post-Brexit budget cuts to the MHRA. Therefore, it seems likely that the government has taken these practical steps to allow foreign approvals to ease pressures on the UK bodies and to ensure there are sufficient supplies of medicines and medical devices in the UK.
Giving manufacturers an alternative route, which in practice may mean largely circumventing the UK's system, appears practical. However, doing so does pose questions for the UK on the extent to which its own system should diverge from the EU model.
New approval process
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.
Following the Budget, the MHRA published their long awaited response to the consultation on the regulation of clinical trials in the UK. Within this they echoed the point of accelerated approval across the regulatory system by outlining that measures will be introduced to streamline clinical trials to "find innovative ways to bring new treatments to patients faster and more effectively." Among the measures proposed are a number to ensure transparency, including a requirement to publish a summary of results within 12 months of the end of the trial and sharing trial findings with participants. Additionally, reviews of clinical trial applications will need to be completed within 30 days in general, with a maximum 10 days for a decision to be granted once the MHRA has received any final information.
Considering there has not been any reform in this area for over 20 years, this reform of the UK regulation of clinical trials enhances the government's promises of ensuring faster approvals of medicines and devices within the UK. This further announcement will no doubt be welcomed by patient groups who may be able to benefit from faster access to new treatments and also manufacturers who can use the new flexible clinical trial process to get their products on the market more quickly.
Pro-innovation regulation of technologies reviews
Prior to the Budget, an interim letter by Sir Patrick Vallance (UK government chief scientific adviser) was published outlining the UK's ambition should be to "deliver a progressive UK regulatory offer to unlock innovation in diagnostics, drugs and medical technologies (including devices), and provide a simple regulatory journey for companies to engage with." He went further in stating that the MHRA and NICE should adopt broader approaches to mutual recognition of products already approved by trusted international partner organisations.
Whilst the government's Budget reflected these measures set out in Vallance's letter, a further full report is expected to be completed by Vallance in early May. Within this report Vallance will provide the government with further recommendations, which he notes he expects will include recommendations on how "Artificial Intelligence applications can play a role in supporting human health outcomes."
What next?
Industry will want to see how the government responds to Vallance's further recommendations when published later this year and whether these will encourage the government and MHRA to further reform the regulation of medicines and medical technologies. The UK government's AI white paper, published on 29 March, also now provides the MHRA with the flexibility to follow a pro-innovative regulatory approach and so if Vallance recommends that the government should go further in regulating AI, then we could see even more flexibility in the regulation of innovative medicines and medical devices as the government strives to try and meet its goal of making the UK a global hub for innovative products.
It remains to be seen how a distinct UK approach towards regulation will co-exist with the announcement in the Spring Budget that the UK will allow products onto the market that have been approved under regulations elsewhere, particularly the EU.
