Professor James Levine: When policy becomes medicine
Source: gov.uk (2025-10-16)

How regulation can spark life-saving innovation.

MHRA Foreword

The regulation of medicine must not be seen as an obstacle, but rather a catalyst for innovation. This tenet is central to the government’s recent long-term health plans for the health service and life sciences sector, as well as the MHRA’s five-year strategy currently under development. There are already many examples of this in practice, from the MHRA’s world-first decentralised manufacturing framework (https://www.gov.uk/government/news/cutting-edge-personalised-treatments-made-while-you-wait-will-deliver-specialised-care-to-patients-more-quickly), to its new National Commission (https://www.gov.uk/government/news/new-commission-to-help-accelerate-nhs-use-of-ai) on the Regulation of AI in Healthcare.

The Innovative Licensing and Access Pathway (ILAP) is another strong example and is the focus of our next guest blog, written by esteemed physician, academic and scientist Professor James A Levine. Here, he talks about how ILAP’s “smart regulation” approach attracts investment and gets treatments to patients sooner – how “rules themselves can heal”.

Professor James A Levine is currently President of Fondation Ipsen (https://www.ipsen.com/us/), where he leads international efforts in rare disease research, education, and awareness. This blog builds on his recent article (https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/bcp.70285) to the British Journal of Clinical Pharmacology of the potential of an ILAP metapolicy on the UK’s life sciences strategy

Guest blog: Professor James Levine MD MBA PhD, President, Fondation Ipsen

What do you think about when someone talks about a new medicine? Most people think about something tangible: a pill in a blister pack, an injection or an infusion at the hospital. But sometimes the most powerful medicine is not a product at all. It is a policy - the rules that decide whether a patient receives a new treatment this year, five years from now, or not at all.

Policy may sound dry, but not for my mum; it saved her life. My mother had breast cancer1 and received a brand-new medicine called, Herceptin or Trastuzumab, which was being evaluated by the medicine regulators makers. The regulators had allowed trials of Herceptin in people. My mother was one of the first recipients and it saved her life. The trial was successful; Herceptin is now commonly used. Government regulators can save lives.

For families waiting on a rare disease treatment, every month matters. For biotech innovators, every delay risks closing the lab doors for good. And for the NHS, every breakthrough must balance patient need with affordability. This is where smart regulation changes everything.

Policy as a Catalyst

For decades, the regulation of medicines was seen as an obstacle—a necessary but frustrating process to get through before a medicine could reach the people who need it. But today, that story is being rewritten. Regulation is becoming a catalyst, helping innovators and patients move faster, together.

The UK’s Innovative Licensing and Access Pathway (ILAP) is a good example. ILAP gives promising new therapies an “Innovation Passport,” opening the door to early advice, closer collaboration with regulators, and faster delivery to patients. It brings together regulators from across the UK, turning what used to be a confusing maze into a coordinated pathway. For a biotech company, this means less guesswork and clearer guidance. For patients, it means treatments arriving sooner. And for the UK, it means becoming a global hub for life science innovation; companies will want to work here.

Cutting Through the Red Tape

New medicines are constantly being invented in university labs by British scientists. But often, the barrier to getting these innovations to people isn’t the science, but the system. Great discoveries can stall not because they do not work, but because government approval processes can be too slow, complex or expensive.

This is why regulation matters. Done right, it is not “red tape,” but “how can we help?” The regulator’s first priority is to protect people from new treatments that are too dangerous but after that, they want to help. The regulators can be the connective tissue that links patients, doctors, scientists, and companies into a working system. ILAP, the UK regulator’s innovation hub, shows how this can work: by simplifying steps, reducing duplication, and encouraging the use of real-world data. ILAP helps innovators spend less time on paperwork and more time on patients. ILAP wants to see patients cured. In this sense, regulation doesn’t just oversee innovation—it is part of innovation itself.

The Ripple Effect

When regulation accelerates innovation, the benefits ripple beyond a single medicine.

Take ILAP as the example. ILAP by its “let’s help” approach encourages companies to use cutting-edge tools—AI diagnostics, digital health platforms, and large-scale NHS datasets. Companies come to the UK knowing this. Universities are already adjusting their courses to train the next generation of experts in regulatory science and health economics. Law firms and investors see new opportunities in biotech deals in the UK. Even local economies benefit as new innovation districts grow around clinical trial centers.

For patients, these ripple effects are very real. In recent years, national policy decisions - aligned with innovative regulatory frameworks—have enabled new treatments to reach patients significantly earlier than expected. For thousands of people at risk of serious illness, those policies were as important as the medicines themselves. They showed how the right framework, aligned with innovative regulation, can transform an exciting therapy into a national health benefit. People in the UK are living better lives because of the “let’s help” regulatory approach.

And the impact is not limited to one disease area. Several oncology and rare disease therapies have already benefited directly from ILAP-linked Innovation Passports, accelerating their path to patients. These examples show how MHRA’s proactive approach can shorten the wait in areas where time is most critical.

For families of children living with rare diseases, the promise is even greater. When every day waiting is a day lost, faster pathways can mean the difference between hope and despair.

A Shared Responsibility

None of this works in isolation. Patients, regulators, scientists, industry, and policymakers all share responsibility for making innovation succeed. That is what makes ILAP so different; it is a whole-system approach. No single player dominates; instead, everyone is part of the same conversation.

Still, there are challenges ahead. ILAP needs broader international recognition, so UK innovations are valued worldwide. It must remain simple enough for small biotech companies to navigate. And the MHRA itself must be supported to handle the growing demand.

These are real hurdles, but they are also opportunities. By addressing them, ILAP can become not just a UK success story, but a global model.

When Policy Becomes Medicine

What strikes me most about ILAP is not the number of Innovation Passports issued, but what they represent: the idea that rules themselves can heal.

When a child with a rare disease gets access to a therapy earlier than ever before - that is policy as medicine. When a patient at risk of heart attack receives earlier access to treatment through a bold national agreement - that is regulation saving lives. And when the UK positions itself as a leader in science and innovation, it is not just the economy that benefits - it is every patient whose life is touched by progress.

As someone who has spent three decades in medicine, I believe this is the future. Regulation will increasingly be seen not as a barrier, but as a tool to improve health. The challenge for all of us - patients, companies, regulators, and policymakers - is to design policies not just to manage risk, but to maximize life.

Because sometimes, the most powerful medicine does not come in a vial. It comes in the form of a rule, written with vision, that opens the door to healing. Ask my Mum; new medicines save lives.

With the next wave of Innovation Passports soon to be announced, we will see again how regulation itself can serve as medicine - an approach that turns policy into progress.

1. http://www.amazon.com/Go-Flow-Gemma-Levine/dp/xx-xxxx-xxxx#detailBullets_feature_div