MHRA pro-innovation vision points to bright life sciences future for UK

Speaking at the Ethical Medicines Industry Group (EMIG)'s Quarterly meeting, Lawrence Tallon, the new MHRA Chief Executive Officer, set out a really positive vision that left the audience totally uplifted on so many levels. For years, the MHRA had been a regulatory beacon to the world, but a combination of the effects of Brexit, COVID and budgetary cuts had left the agency trying to play catch up. At the 2023 PING (Pharmaceutical Industry Network Group) Conference, the challenges were open for all to see. The MHRA were trying their best, but were battling to keep the UK credible as a life sciences destination. No more. The agency is well and truly back on track, with staffing levels now in excess of what they had ever been before these challenges, enabling a more strategic focus rather than firefighting. The approval times are now faster than Japan and mainland Europe, and on a par with the US. But much more than that, they are ready to play a central role in leading the world on life sciences regulatory matters going forward.

At the EMIG Quarterly meeting in January, Mr Tallon explained how they were ready to take forward a pro-business, pro-innovation and pro-patient agenda. These were not mutually exclusive. By listening to patients, you could tell that whilst there is still a desire for the regulator to watch out for safety and efficacy, there is also a significant downside in not adopting the latest innovations - patients and their families more often than not want to trial the latest medicines, particularly if they are facing little other hope. The MHRA's driving mission is to put patients first.

Working collaboratively with industry and with patients is clearly a key theme for how the MHRA will behave, and Mr Tallon explained that there was a big desire by people across the MHRA to do that. 
This was a pivotal time also for the National Health Service, with satisfaction having plummeted from 70% to 20% - but it does not have to be that way. Adopting innovation can help to turn this around.

Not only that, but economic growth had been tepid since the global financial crisis, but life sciences has the potential to be a real driver for further growth. It is also a relatively clean industry and can lead to sustainable long term growth - as well as a more healthy population. The MHRA wants to be seen to be a part of helping to achieve that. Mr Tallon sees this clearly, having come from a background of being on the side of the regulated rather than regulator.

Setting out his vision, Mr Tallon highlighted the following in particular:

• Pharmacovigilance - The Yellow Card scheme is good, but can lead to under and over reporting. There can be richer access to data from hospitals, pharmacy and community - building on the Yellow Card Scheme.
• Criminal enforcement - The MHRA will step up action against criminals so that patients can have more confidence that the medicines they are getting have the correct active pharmaceutical ingredient, are in the right dose, and have been manufactured and supplied using approved quality premises and systems. There has developed a plethora of untrustworthy sources for many hot items such as weight loss, sleeping pills and fillers. Better enforcement is needed to maintain public trust.
• More people and better use of technology by the MHRA - To enable faster turnarounds and excellence every time.
• Clinical trials - The time for assessments have been cut from 91 to 41 days. This can get even better.
• Catalyst for innovation - The MHRA sees this as a central role, including in ILAP (the Innovative Licensing and Access Pathway), as well as advanced therapies. The UK in particular is a leader in cell and gene therapies and addressing rare disease, and a pro-innovation focus can cement that. AI as a medical device is another exciting area where the MHRA can lead.
• Partnerships and collaborations - The MHRA will work even more collaboratively with bodies in the UK, whether with the devolved nations or NICE (the National Institute for Health and Care Excellence); as well as internationally as a leading player in national groups of international regulators. The US / UK pharma trade deal will have helped this too.
• UK's unique data - The Health Data Research Service (HDRS), which was trailed in the UK's Industrial Strategy and Life Sciences Sector Plan, can really make the UK stand out. This £600m investment can really enable the use of data coming from a single payer with diverse data at scale. The UK has not maximised this opportunity, but now it will be able to - and the recent appointments of Nicola Blackwood and Mel Ivarsson into the roles of Chair and Chief Executive of the HDRS are massively exciting.

Encouragingly, Mr Tallon spoke about how he saw spending on medicines as being an investment in health and industry, and not a cost. He was looking to reach out further with industry to make this happen. Summing up, he said that success meant patients getting access to safe and effective medicines faster.

Hear more about this

VWV's 2026 PING Conference will look at the UK's bold Life Sciences Sector Plan and how it will lead Europe by 2030. The Life Sciences Sector Plan has a few key themes, including regulatory reform - streamlining regulation and market access, by supporting the MHRA to be a faster, more agile regulator. Other aspects of the PING Conference will focus on manufacturing, the HDRS, international trade and inward investment.

If you have any thoughts on the UK's position having a leading life sciences pro-innovation regulator or would like to be invited to the PING Conference, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team.