Translating cutting-edge scientific and technological innovation into better health outcomes for patients is at the heart of a new UK regulatory strategy published on 14 October.

The Medicines and Healthcare products Regulatory Agency (MHRA) 2030 Strategy makes commitments for the regulator to keep pace with rapid advances in science, technology and personalised healthcare. 

It aims to position the UK as a global leader in the development, launch and use of new medicines and technologies safely and effectively.

By 2030, the MHRA aims to be even more patient-centred, support patients having faster access to safe, effective treatments, and have more data-connectivity and global influence.

David Hill, Partner specialising in healthcare regulation at UK and Ireland law firm Browne Jacobson, said: “A regulator that keeps pace with AI-driven innovation, moves faster on clinical trial approvals and reduces barriers for rare disease and start-up developers is precisely what is required if the UK is to meet the ambitions set out in the NHS 10 Year Health Plan. The government's three-pillar transition – from hospital to community, from sickness to prevention and from analogue to digital – can’t succeed without a regulatory infrastructure that safely and effectively embraces innovation, and this strategy begins to build that.

“Recognition that regulatory agility is not a concession to industry interests, but a prerequisite for patient benefit., is welcome. The commitment to accelerate access to generic and biosimilar medicines, for instance, speaks directly to the NHS's financial sustainability, and the planned AI Medicines Development Action Plan and Centre for AI and Digital Health could, if executed well, give developers and investors the certainty they need to choose the UK as a launch market.

“Increasing diversity in clinical studies can further strengthen the UK’s potential to become a hotbed for rolling out novel technologies due to its cradle-to-grave records held by the NHS, a diverse population, and strong links between health information and the research community.

“That said, our work with international investors and NHS partners tells us that regulatory reform at the MHRA level is only one piece of a considerably more complex puzzle. In our white paper on ‘Advancing inward investment into the UK health sector’, we identified that regulatory complexity and fragmented procurement pathways have been among the most significant barriers to international investment in UK healthcare. The MHRA's own reforms will count for little if the infrastructure around them – procurement, data, workforce – remains fragmented.

“In particular, government should accelerate the aggregation and integration of primary, secondary, community, and social care datasets, while addressing the regulatory and legal barriers to international data sharing. The MHRA's commitment to real-world evidence generation and connectivity with the Health Data Research Service is encouraging, but it must be underpinned by a coherent UK health data strategy that creates genuine legal certainty for both domestic and international partners. At present, that broader framework is still missing.

“Meanwhile, a strategy document, however well-crafted, is only as credible as the resource commitment behind it. We would urge government to ensure the MHRA's funding model keeps pace with the ambitions set out today, particularly given the additional responsibilities this strategy places on the agency.

“The MHRA 2030 Strategy raises the ceiling of what is possible. The task now is to ensure the foundations are in place to reach it.”