It has been a hectic three years as pharma companies have been preparing for the UK to become a ‘third country’ in EU terms and the requirements for the UK’s post-Brexit regulatory system have not been clear. However, our view is that the MHRA remains agile and pragmatic, and immediately after Brexit unique opportunities are likely to emerge as it becomes a fully sovereign regulator.
A new UK regulatory system: setting the gold standard globally?
For well-established products the MHRA will continue to expand its reputation as a global gold standard regulator, whose approvals provide a global assessment benchmark and subsequent basis for access to the international markets for industry; while we believe the UK should continue to be seriously considered as a site for clinical development for companies of all sizes.
Fortunately, the MHRA has always had an excellent reputation as a gold standard regulator with a pragmatic patient-benefit approach and a history of contributing to novel technologies. There is a wealth of relevant knowledge here in the UK as the MHRA was a major contributor to the design of the EMA’s standards and procedures, and often provided up to 40% of the EMA’s seconded staff.
“Historically the MHRA has provided a pragmatic position on regulatory expectations and we expect this to continue.”
Nick Littlebury, Deputy Managing Director Regulatory
We see opportunity as the MHRA is more agile, freed from its formal EU ties and can work directly on a wider range of procedures and product types and still remains highly proactive and cost-conscious: a gold standard regulator, ensuring patient safety but also providing a pragmatic assessment to enable clinical development and innovation. The agency is developing a range of incentives for clinical development programmes including scientific advice, PIPs and Orphan Drug designation. Historically the MHRA has provided a pragmatic position on regulatory expectations with a robust assessment and we expect this to continue.
For any company planning to launch products, the UK market is certainly a smaller prize than the entire EU or the US, but we believe this may create an opportunity.
Post-Brexit Britain may be an ideal pilot market or provide a de-risking stepping stone.
- The MHRA standards are currently aligned closely to the EMA
- The MHRA is well-regarded globally, and is an influential regulatory opinion leader with world-class experts
- The MHRA can be an integral part of regulatory assessment through development
- The post-Brexit MHRA is likely to be even more proactive as it strives to ensure UK patients retain access to safe, innovative treatments
- The MHRA remains globally respected for its opinions and decisions as drug safety and monitoring evolves.
We believe that for certain companies and products launching first in the UK should mean the ability to influence regulatory strategy, using an efficient process, and thus reduced time to market – regardless of whether the plan is launching in one country at a time, regionally or even globally. If issues do arise, the MHRA’s prompt responses may be a form of ‘early warning’ for potential issues with other regulators in larger markets.
Taken together these mean the UK alone should not be viewed as an afterthought, but as an integral part of any regulatory strategy: we believe it offers those companies working towards market launches in the EU, or indeed anywhere else in the world, a valuable early engagement and stepping stone for efficient regulatory assessment.
The MHRA after Brexit should offer a rapid yet thorough analysis, and hopefully authorisation, in a pilot market of over 60 million from a regulator that is hugely respected by its counterparts. With a pedigree of gold standard regulation, a pragmatic risk-benefit approach and a history of contributing to novel technologies, early dialogue with the UK and its MHRA post-Brexit may be a prudent move for companies planning launches.
The Brexit negotiations are ongoing, but the deadline of 1st January 2021 is close. Diamond can provide the services and the agile response to ensure that your portfolio remains in compliance, and that opportunities are realised.
For more details and to speak to our team - contact James Wisely using the form below or call +44 (0)7876 664 543.