Making regulation a catalyst, not a barrier, for UK life sciences

MHRA CEO argues that for the UK's long-term health and prosperity, regulation should help lead, rather than follow, innovation

Whilst the U.K. finds itself in a temporary political interregnum, it will be our country's ability to navigate long-term trends in science and technology that will define our enduring success in a highly competitive geopolitical future.

That will require both policy changes and rethinking some of the barriers that have held us back, including our approach to balancing risk with the benefits of innovation. And it will require a thoughtful and open approach to harnessing the benefits of AI.

We are in a period of extraordinary scientific discovery, helping us predict, prevent, diagnose, treat and cure diseases more effectively than we could have dreamt of a generation or two ago.

I moved from the hospital sector to healthcare regulation a little over a year ago, when I became CEO of the MHRA. I came to realise that if we want to harness cutting-edge science and technology to transform patient outcomes and experience, regulation is a key part of the jigsaw. And it needs to change its shape in an era of personalized medicines and AI.

There is plenty of progress to learn from. Whereas food scarcity was once the cause of malnutrition, disease and death, now calorie abundance in the developed world has given rise to obesity, Type II diabetes and a host of other diseases. Suddenly, in historical terms, we have a new class of highly effective medicines in the GLP-1 receptor agonists to combat obesity and diabetes, potentially with multiple other purposes on the horizon.

Our ability to anticipate, treat and survive cancer has come on leaps and bounds in a generation, particularly through personalized therapies that harness the immune system of our own bodies to identify and attack cancerous cells.

HIV was an infectious disease that struck fear into individuals and communities as a probable death sentence a generation ago. With the right treatments, it is now a manageable chronic condition; and we must ensure that remains the case in the global south too.

When we faced the most devastating infectious pandemic of this century so far, COVID-19, we were able to develop vaccines at unprecedented speed, saving many millions of lives worldwide and demonstrating what science, health systems and regulation can achieve together under pressure.

Among the most profound advances of our times is the discovery and deployment of cell and gene therapies to treat, amongst other things, rare diseases which affect some 3.5 million people in the U.K. alone.

I have seen first-hand the life-changing impact of developments such as these as a hospital executive in the NHS. I remember well, not only the hope this gave to the children and their families, but also the halo effect for the whole hospital group, when the Evelina London Children's Hospital first delivered a new gene therapy for children with the devastating, degenerative condition of spinal muscular atrophy.

How do we keep pace to regulate these powerful new treatments and the adaptive technologies that are being used to develop them?

The MHRA is rethinking how we regulate for the greatest benefit to patients. The common thread in our strategy is to shorten timelines, reduce requirements that have low impact, and speed the generation of new therapies to patients.

MHRA's new rare disease framework will take a novel approach to evidence-generation, replacing the traditional three-phase clinical trial and licensing with a new, iterative Investigational Marketing Authorisation. This new approach will cut years from the traditional development timescale of these treatments without compromising safety.

The pace of advances in AI and digital technologies is exponential, inspiring both awe and fear. We can envisage scenarios now, or in the very near future, where AI may be better at identifying a tumour on a scan than a human.

But it is almost impossible to envisage a scenario when anyone would want their cancer diagnosis broken to them by a computer, rather than a skilled and compassionate clinician. We need to blend the technological future with the intrinsically human qualities of healthcare.

Harnessed well, and with strong safeguards, AI could make healthcare faster, safer, more precise and more personalized.

But to realise this potential, regulation needs to change and evolve retaining what works well for pharmaceuticals, while creating a new regulatory paradigm for novel types of product development and performance.

That is why the MHRA established a National Commission on AI in healthcare. It brings together patients, clinicians, academics, technologists, investors and ethicists to define a new regulatory approach. The Commission will publish its final report in September and I anticipate we will see these findings point to fundamental changes.

It is too easy for regulators, in any sector, not just healthcare, to be overly cautious in decision-making. I've witnessed it myself as a hospital executive on the receiving end of regulation. That can inhibit the pace of innovation.

Safety is non-negotiable, but I do not believe regulation should be a barrier to innovation or paternalistic to patients; it should be empowering of informed patient choices when different treatment options are available.

Above all, we need systems that are faster, highly expert and more open to innovation. This is how we are trying to compete globally and make the U.K. one of the best places in the world to develop and deploy innovative medicines. We should be in no doubt that global competition for investment in life sciences is fierce, and we either lead and adapt or we will get left behind.

Last week I gave a guest lecture at Cedars-Sinai's Global Healthcare Grand Rounds, routinely recognized as one of the best hospitals in the United States, that, for 125 years has been serving the diverse communities of Los Angeles and beyond, most recently opening the Cedars-Sinai Clinic London in Harley Street Health District. There I set out this challenge: how can we ensure regulation keeps pace with the science and technology now reshaping healthcare?

The UK and US are already taking decisive steps together. The new Economic Prosperity Deal will strengthen collaboration in pharmaceuticals and health AI and support closer alignment in regulatory decision-making.

Together we can set global standards, so that safe, effective and innovative medicines and technologies can reach patients more quickly in our countries. That is also in the best interests of economic growth driven by our world-class science sectors.

Our guiding motivation is clear: putting patients' best interests at the heart of our regulatory system, which means listening to them carefully, protecting them from avoidable harms and facilitating access to innovative medicines and technologies that could transform their lives, as quickly and safely as possible.

If we get this right, regulation will not follow innovation, it will help to lead it.

This article was published in BioCentury

Read Lawrence's speech at Cedars-Sinai International Global Healthcare Grand Rounds