MHRA leaders tout pragmatic approach to regulation post-Brexit

WASHINGTON – Top executives at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) say they are trying to be pragmatic about their resources and want to learn from other regulatory partners when evaluating new products. At the same time, they want to take a leadership role on the global regulatory stage based on their expertise.

Speaking at the DIA Global Annual Meeting, MHRA CEO Lawrence Tallon told attendees of an MHRA town hall that while Brexit and COVID-19 significantly disrupted the agency’s ability to review products coming to market, MHRA has since bounced back and is taking a pragmatic approach to regulating products, considering its limited resources.

"The combination of the disruption of Brexit, the success, but also the workload by COVID, and then various governmental changes led to a contraction of the size of the agency and the expertise of our people,” said Tallon. “And so, while demand was going up, our ability to serve that demand was going down.”

Tallon noted that the UK’s economy is growing at a slow pace, there are significant pressures on its healthcare system, and there’s a lack of healthcare workers in the pipeline. He said the current government sees the life sciences industry as a crucial driver to boost the country's economy and wants to invest in MHRA so that the UK is seen as a life sciences hub.

Julian Beach, interim executive director for healthcare quality and access at MHRA, echoed the sentiment and said that over the past few years MHRA has been working to streamline its regulatory processes without compromising patient safety. He said this has paid off in terms of the speed with which they are now able to get new products on the market. This has been possible, he said, thanks to pragmatic decision making and by asking questions such as whether their decision impacts safety, whether the question needs to be asked, and what they can look at before a product dossier is submitted to speed up the review.

Beach also said that MHRA wants to learn from regulators in the US, Europe and Asia and build on their expertise to make regulatory decisions.

Tallon also said the UK is very keen to increase its international reliance and recognition of partnerships to reduce hurdles so that sponsors don't have to seek multiple overlapping approvals. He also said that they realize they can't have all the expertise in-house and will rely on their network of experts and partners, and a close collaboration with the medical industry to help with their decision making.

During a plenary session panel discussion the previous day, Tallon said he is an internationalist who believes the best way to solve the world's major healthcare problems is by working across borders. He added that one of his key priorities is looking at opportunities for MHRA to adopt ideas from other regulators.

"It's difficult for any one country, particularly one the size of the UK, to get its arms around the full span of new treatments and technologies becoming available to patients in development," said Tallon. "We need more international reliance and recognition... The skill is knowing when to be a leader and when to be content to learn from others."

At the same time, Tallon noted that MHRA has brought in more people with expertise and wants to take a global leadership role in defining risk-proportional regulations.

MHRA leaders tout pragmatic approach to regulation post-Brexit

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