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Brexit may have caused widespread disruption in the relationship between the UK and EU regulatory systems, but the Medicines and Healthcare products Regulatory Agency believes the UK's departure from the EU will be a "catalyst for change” in the way that the agency deals with medicines and medical devices.

“As we count down to the first of January 2021, and the end of the transition period after EU exit, our focus is naturally on a smooth transfer to the new system with the UK as a standalone regulator,” according to June Raine, long-term interim chief executive of the MHRA.

Another driver of change at the agency is COVID-19. Raine said the pandemic experience had led to a “fundamental re-examination of the very principles on which regulation is based” and offered the MHRA a “unique opportunity to evaluate the systems we operate and to do things differently.”

She added: “We are convinced the MHRA can take its place at the center of the life science ecosystem to be the enabling regulator we want to be.”

Raine was speaking at the MHRA/BioIndustry Association regulatory innovation conference, which she described as “a landmark conference in a year like no other.” People, she said, were now “more aware than ever that someone may depend on the medicines, vaccines and diagnostics this great industry develops and produces.” COVID-19 had “transformed R&D, regulators, industry and the health care service.”

The question, Raine said, was what this transformation meant for the UK regulatory system. “Today we have a big question in front of us. Are going to aim, depending on a possible COVID-19 peak, to go back the pre-coronavirus normal, or are we going to look at positive learnings so far and resolve together to press ahead and take the transformation of innovative medicines development in the UK to its full potential, to a new era?”

"The patient voice must rightly be at heart of regulation, whether clinical trials, product development or safety monitoring" – June Raine, MHRA interim chief executive

Raine’s presentation at the 17 September online conference was on the “UK innovation ecosystem – a transformed regulatory role.” She said that the country was now at “an inflection point in regulation, possibly the biggest change of all.”

This inflection point, she said, signified a shift from “that regulatory perspective at population to a focus on patient health” and “a commitment to patient-centric systems.” The patient voice “must rightly be at heart of regulation, whether clinical trials, product development or safety monitoring, rather than that rather amorphous concept of public health.”

The impact of COVID-19 on regulatory transformation had been “profound,” Raine said. One issue was how to make “risk-proportionate scientific judgements” in the context of COVID-19, “a disease whose full pathology and full implications were unknown as evidence accrued. Moving fast has been the imperative. A second challenge was how to maintain the independence of regulatory scientific decision making while maximizing collaboration with other stakeholders.

Empowering MHRA Teams

On the practical front, Raine said the agency had reacted to the coronavirus crisis by empowering its teams to “take decisions on the run” and had introduced new flexible processes and ways of working. The MHRA was delivering “innovation in regulation, and regulation for innovation – a vital concept today,” she noted. In terms of performance, the MHRA was “no longer measuring processes but looking at outcomes, delivery times, and patient benefit.”

Moreover, partnerships and collaboration with the likes of the National Health Service, health technology appraisal bodies and the National Institute for Health Research had been “vital”, for example in reducing approval times for COVID-19 clinical trials. “This is the kind of collaboration that proves what we can deliver if we work together.”

Raine also gave details of the new licensing pathway that the MHRA will put in place for innovative new therapies from the beginning of January 2021, including a new “innovative medicine designation” and a “target development profile” for each product filed for review at the agency. (Also see "UK Presents New Licensing Pathway For Innovative Drugs" - Pink Sheet, 18 Sep, 2020.)

Minister Praises Collaboration

The UK government’s view on all this was presented by Lord Bethell, who was appointed minister for innovation in March this year.

Lord Bethell, a former government whip who is possibly best known to the public as manager of the famous Ministry of Sound nightclub from 1993 to 2001, praised the “collaborative relationship between industry, academia and government.” He said the importance of the industry’s role had been “thrown into sharp relief” by the pandemic and saluted the “genuine desire of industry to deliver treatments, tests and vaccine to patients.”

He also praised Raine and her team for the “innovative, modern regulatory environment” they were creating for the life sciences industry, which would be “increasingly important after the end of the transition period when we aim to create the best regulatory environment in the world.”

The UK also wanted to build “the best clinical trials regime in the world”, he said, adding that the UK Recovery trial had shown “the huge power of the British clinical trial platform.”

"We have seen that safe regulation doesn’t mean we can’t be flexible, and that innovation doesn’t mean risking patient safety" – Lord Bethell, UK innovation minister

Looking at the regulatory lessons to be learned from COVID-19, Lord Bethell said there should be no turning back. “We have seen that safe regulation doesn’t mean we can’t be flexible, and that innovation doesn’t mean risking patient safety,” he declared.

He said he was “massively proud of the pragmatic approach” the MHRA had taken under Raine’s leadership and “I firmly believe it would be a mistake to step back into a rigid regulatory framework.”  There was also “a clear opportunity for us to exploit the UK’s independence from the EU regulatory regime,” he claimed. “When I spoke to the Secretary of State after being appointed, he gave me a very clear mandate to ensure the MHRA is a world leading regulatory body and that the UK is a tier one destination for life sciences. The MHRA and the Office for Life Sciences have been working really hard to make this happen.”

The minister said that the Medicines and Medical Devices Bill, which is currently undergoing scrutiny in the House of Lords, was “a critical element to ensuring we can regulate and support innovation in the future.” The bill gives the government the power to update the regulation of medicines and devices “so that the UK continues to maintain a dynamic life sciences industry and is able to respond to the innovations of the future,” Lord Bethell said.

"The secretary of state and I, and the British government, are committed to working with you. We want the UK to have the best regulatory environment for medicines and devices, the best for patients, and the best for your sector. I challenge all of you to work together in a spirit of collaboration.”

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