‘No 3am moments’: MHRA chief June Raine on race for Covid vaccine

When Dame June Raine, chief executive of the UK medicines agency, found herself at the centre of Britain’s Covid-19 response three years ago, the unremitting pace and pressure held a grim kind of familiarity.

She says it evoked life as a junior doctor more than 40 years earlier, requiring her to draw on similar reserves of “buoyancy” and resilience.

On one occasion, she was the doctor in charge when a group of 30 was brought in to her hospital, all poisoned with carbon monoxide on a canal boat. “And if you have 30 admissions at the same time, that was [like] what was happening in Covid. So you deal with it, that level of intensity. I think if you’ve trained in medicine it’s, if you like, [an emergency department] way of working, and you go into that mode.”

The story of her leadership of the Medicines and Healthcare products Regulatory Agency is of two huge imperatives — first, to chart a new path for the agency after Brexit forced it to leave the embrace of the European Medicines Agency, then to set the international pace in approving life-saving Covid vaccines and therapeutics.

Raine had taken over as interim chief executive in September 2019 — her appointment was made permanent in early 2021 — and “the challenge at that time was opening up the opportunities of [Britain’s] EU exit”.

She felt the organisation had a chance to accelerate the way drugs were developed and brought to patients by focusing on the UK’s assets, including a strong science base, and its trove of “real world” data provided by its “cradle-to-grave” public health system.

Last month, that ambition bore fruit in a government announcement that the MHRA would operate a more streamlined approval process for the most cutting-edge medicines and devices in the hope of attracting global pharmaceutical companies to develop their medicines in the UK.

But three years ago much of this work had to be put on hold as a global epidemic forced a dramatic shift in priorities. “By December 2019 [or] January 2020, we were waking up to quite a different challenge,” she says with a certain understatement.

From very early on in the pandemic, she grasped the potential of her role as regulator at a time when vaccine and drug manufacturers were racing to develop products that offered the only prospect, however distant, of a path back to normality. She realised she could be “a very proactive part of the solution”. 

Raine had her first meeting with drug manufacturers in early March 2020, a time when most of the world was still oblivious to the huge toll the pandemic would take.

She took the pivotal decision that the agency would review the data produced by companies in real time, as it emerged, rather than waiting for the trial phases to be completed, as would normally happen with a novel medicine.

As scientists strained to beat all earlier records for how quickly life-saving treatments could be brought to market, Raine and her colleagues were able to inspect facilities and view and analyse pre-clinical data: “So we were running alongside [the companies] at every step of the way.” She emphasises that this work was done “at risk”, with no certainty that any of the vaccines or therapeutics would prove effective.

The need to reassure Britons that the prospective treatments would be safe was paramount from the start. Those early conversations with drugmakers were “about all the elements that a regulator needs to provide assurances to the public and to health professionals that the standards have been met”, she notes.

The EMA and the US Food and Drug Administration both took significantly longer to deliver their first approvals. Did she feel justified in pressing ahead with less data, given the stressful and fast-moving environment?

She corrects: “Not less data, enough data. And I think the data sets, particularly on the vaccines, were robust and very well analysed and spoke to the really superb efficacy and safety profiles that we knew would be appropriate for mass immunisation.”

Her confidence was bolstered by the knowledge that the MHRA had set in train “robust vigilance”, with the British public encouraged to submit their own reports about the vaccine, including any side-effects. This, and other forms of data collection and analysis, gave the agency “the ability to understand benefit-risk in the wide world”, she says.

At no point was there anything other than absolute respect for regulatory independence. And I would have shouted loud and hard if there had been

At the time, there were suggestions in Europe and the US that the UK had rushed it. Did she ever question her own approach?

“No self-doubt” or “3am moments” of introspection troubled her, she insists, explaining that the decisions the MHRA takes are less about absolute judgments on safety, than rigorous risk-benefit analyses. “The understanding of the risk environment we were in was really extremely clear. And therefore the understanding of the risk judgments we were making in that context, and the data that we had, and all the expertise coupled with those very secure vigilance plans, meant that we could take those decisions as soon as possible.”

She clearly believes events have vindicated her: no other regulator, she notes, “has differed materially in their later judgments”.

How did she conceive the human and organisational challenge of leading the agency through such a historically demanding time? First and foremost it involved “relentless prioritisation”, she recalls.

She and her colleagues were working in a highly charged environment, with government ministers desperately counting on the vaccines to pave the way to ending lockdown: did she ever feel conscious of political pressure?

She says firmly: “At no point was there anything other than absolute respect for regulatory independence. And I would have shouted loud and hard if there had been . . . The unwritten rule is that the regulator will advise the government without fear or favour, and at no point was there ever any pressure on judgments or on timeliness.”

Inevitably, dealing with a crisis of that magnitude brought new insights about her own working methods. One lasting lesson she learnt was the importance of “not dissipating activity on things that are interesting, but maybe not urgent or important”.

Her personal profile grew substantially during the crisis, through numerous appearances at televised news conferences. She implies she would never have sought the public eye but willingly did so in the interests of making certain that Britons understood the work involved in ensuring the vaccines were safe.

Initial modelling suggested only about half of Britons would take up the offer of a jab, so her focus turned to how to convince a larger proportion to be immunised.

It was vital to address “the questions that the public were asking”, she says, such as: “‘Has this been tested on people like me?’”

Ultimately, the UK had among the highest vaccination levels in the world, an achievement she partly ascribes to the agency’s high level of openness about its processes, and publication of copious online data about the vaccines’ safety and efficacy. “Hand on heart, there were no secrets. It was all there for people to digest,” she says.

Raine stresses the collective nature of the effort, in which she includes the hundreds of thousands of people who submitted reports about side-effects from the jabs.

She is clearly in her element as a regulator and — partly in the interests of persuading talented scientists to view regulation as part of their career path — determined to counter preconceptions that the role simply involves reacting to new scientific developments rather than playing an active role in maximising their potential.

“When we can see something coming, like the digital revolution, like artificial intelligence, for us as regulators it isn’t ‘science drives regulation’, it’s that we can drive science and technology.”

Every new development, such as the prospective advent of cancer vaccines, requires regulators to acquire knowledge and insight to reach the “risk-proportionate” conclusions. Of her staff, many of them scientists and clinicians, she says: “Everyone here is an innovator in their own right.”

Raine describes her own managerial style as “balanced, fair, listening, considerate but with high expectations”, adding firmly: “And they’re met.”

They were qualities needed in abundance during the height of the pandemic. Yet looking back on her time in the crucible of the Covid response, she believes her working life in some ways changed for the better because she was forced to shed anything extraneous to the central mission of battling the pandemic. “It enabled a very relentless focus on . . . one ultimate [purpose].”

And she takes pride in the enduring legacy of the period that she not only lived through, but helped to shape. “The access to those vaccines has saved around 20mn lives worldwide, and if we played a part in that, that’s what life is all about. That singular goal was what made a leadership role absolutely priceless.”