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April 12, 2021updated 16 Jun 2022 12:44pm

How a focus on patients and delivery helped MHRA rise to the Covid-19 challenge

John Quinn, technology chief at the UK's Medicines and Healthcare products Regulatory Agency, on how it delivered a world-beating vaccine approval process despite Brexit and lockdown.

By Edward Qualtrough

Last year, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) found itself at the sharp end of the two biggest forces to have shaped the country in recent years: Brexit and the pandemic. The agency was not only able to withstand the upheaval but oversaw a world-beating approval process for the Covid-19 vaccine. According to John Quinn, interim executive director of technology, digital, data and delivery at MHRA, this success was enabled in part by the fact it had placed delivery at the core of its technology function.

Quinn was speaking at Tech Monitor Live: Technology and leadership in the post-pandemic recovery, about business transformation initiatives at the independent agency, and a year in the spotlight as clinical trials and vaccine approval became the UK’s best path out of successive lockdowns caused by the coronavirus pandemic.

[View Tech Monitor Live sessions on-demand]

John Quinn, MHRA

John Quinn, MHRA executive director of technology, digital, data and delivery. (Photo courtesy of the MHRA)

Like many organisations, the MHRA moved to working remotely in March 2020. The urgency of its work in light of the pandemic gave the organisation the impetus to make the shift to remote working without sacrificing any rigour from its vaccine approval process.

“It was about the mindset and the ability to think about making those decisions very early – it was as much about the will of the organisation and the recognition very early on in the UK that vaccines were going to be a path out of this,” Quinn explained. “Our chief executive June Raine set the agenda very clearly and gave us a clear mission to make sure we had as much rigour as we would always have, that we had to make sure what we were approving was safe.”

“The process was always there,” he said. “What changed was the energy, the focus, the decision-making.”

Transforming under lockdown

One of the biggest challenges was moving committee meetings online, Quinn recalled. “These people are used to getting in rooms with big piles of paper and working in quite a regimented way, but moving online was not really a debate and I think really helped facilitate the process by which we went through.”

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The MHRA was not starting from scratch, however, as it had invested time and effort to develop a more digital workplace in the preceding years. As an organisation with inspectors working remotely as far afield as China and India, there had always been a need to support a distributed workforce. With laptops already rolled out, within a week its 1,300 staff were working from as many locations, initially using Zoom for virtual meetings before adopting Microsoft Teams.

Meanwhile, the agency was dealing with the implications of Brexit, which meant leaving the EU Medicines Agency and its various processes and systems. “While we were doing this, of course, we also had to leave the European Union and the 11 or so systems we were dependent on in the regulation process,” Quinn recalled.

This meant MHRA had to replace everything from portals and case-processing to how the body manages data, how it makes decisions, and how it publishes them. Putting users, and most importantly patients, at the centre of service design was the MHRA’s starting principle. “Both the chair and chief executive have a really clear vision about what the agency will be in future, and that’s fundamentally putting the patient at the heart of this,” Quinn said.

“We implemented a whole range of new systems and services that went live on 1 January 2021, with very little interruption or flicker of complaint. If we hadn’t done all that then we wouldn’t be able to work in the way that we have, and productivity has improved as a result.”

Delivering change

Another vital ingredient of the agency’s success in the last year has been its focus on delivery. Formerly the CIO of the agency, Quinn’s current title – interim executive director of technology, digital, data and delivery – reflects its significance.

“Who helps deliver change in an organisation? If you purely came at it from a technological perspective you would just be delivering component change,” Quinn explained.

“We do everything from business analysis, service design, process re-engineering, enterprise architecture through to data modelling, transformation and then the application of technology. All of that I think is the core part of delivery; it’s not just the technology, it’s the change itself and we’ve been doing that for years.

If you’ve not got delivery at the core, whether that’s products or projects, you’re missing a trick.

“In government we talk a lot about DDaT – digital, data and technology,” Quinn said. “But if you’ve not got delivery at the core, whether that’s products or projects, you’re missing a trick.”

Leading a distributed workforce and keeping employees motivated during such a challenging period of uncertainty, have been some of the biggest challenges for many leaders during the pandemic. For Quinn, reflecting on the MHRA’s mission and how his technology, digital, data and delivery function was contributing to the agency’s goals provided a stimulus for employees to make a difference on a scale unimaginable before March 2020.

“We’re always mapping back to how we’ve helped,” Quinn said. “We believe the MHRA, through its work over the past year, will have saved millions of lives globally as a result of its fast work and its action. Now that’s a good reason to want to come to work.”

Future technologies at the MHRA

With a remit to license medicines and devices, the MHRA is now looking to the future and how the impacts of telehealth, internet of things-connected devices, and also the use of innovations like artificial intelligence in drug development will impact its work.

Quinn suggested a federated approach involving partners in the healthcare ecosystem would help answer the problem and harness the skill sets to make safe decisions about new medicines and devices.

“Regulation has to be able to help and be part of the conversation in order to not slow down the technology, whether they were biological or devices themselves,” Quinn said. “One question is, can we keep pace with what these things can do for you?”

Fundamentally, Quinn thinks the platform to utilise emerging digital technology innovations will be built from having good data. “At some point some of these new technologies like AI, machine learning and blockchain will become more mature. But while that’s happening, there’s a ton of stuff we already have which could turn the lights on if we really started doing them. And like all these things, the data and its quality is really critical.”

Quinn was speaking alongside SGN Director of IT & Innovation Andrew Quail, Vertical Aerospace CIO Madhu Bhabuta, and Covéa Insurance Chief Technology and Information Officer Graeme Howard at Tech Monitor Live: Technology and leadership in the post-pandemic recovery.

[View Tech Monitor Live sessions on-demand]

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