At the Medicines and Healthcare products Regulatory Agency (MHRA), we are at a pivotal moment in our journey to become a global leader in our field.
Over the coming months, we are developing a new multi-year strategy that will define our direction, mission, values and focus through to 2030. This is more than a planning exercise; it’s an opportunity to consider carefully the role we play in the health and life sciences ecosystem, and how we can best serve patients and the public in a rapidly changing world.
As I approach six months in post as the MHRA’s Chief Executive, I’ve been reflecting on the scale and complexity of the challenges we face, and I am excited by the opportunities they present.
Giving patients confidence in their choices
The landscape of healthcare, science and regulation needs to evolve rapidly. From the rise of personalised medicine and AI-driven diagnostics; to the growing consumerism of healthcare, where people need reliable information to guide their choices; and the disruptions we have experienced to global supply chains; the MHRA must adapt to remain effective, trusted and pioneering.
One of the most fundamental questions we face is: how do we best serve the patients of this country? Our central role is to protect patient safety, and that will always be the cornerstone of the agency; but we know that high-quality care is about more than safety alone. It’s also about effectiveness, timeliness, experience; and increasingly, about empowering patients to make informed choices within what we are thinking of as the “preference zone” (another next blog in this series from Sir David Spiegelhalter will explain this concept further).
Briefly, this is the space where treatments meet acceptable standards of safety and efficacy, but may not be universally recommended as the standard of care, and where patients, supported by their clinicians, should be able decide what’s right for them, based on their prognosis, circumstances and preferences.
For example, I spoke recently with an extraordinary man who was one of the first people to successfully undergo the novel gene-editing therapy for Sickle Cell Anaemia. He knew this ground-breaking treatment carried risks, but he made the choice to have the treatment, which has effectively “cured” him, because the alternative was continual, severe pain. Whilst he still faces challenges, he can now look forward to a life without pain and to seeing his young child grow up. To his immense credit, he uses this opportunity to campaign for wider availability of gene therapies, especially in the global south where they are so needed.
The role of the regulator is not to eliminate all possible risks – to do so would mean denying access to such novel therapies which hold great potential – but to ensure medicines and health technologies are acceptably safe and effective and to frame those choices for patients, advised by their clinicians.
To support this ‘quality choice architecture’, we are working to define a clearer framework for risk-proportionate regulation. This needs to have due consideration for both safety and innovation. It should allow us to be more agile and responsive, without compromising trust, and to best serve the preferences of the patients of our country.
Specialist and comprehensive – working with trusted partners
We are also working through how to balance finite resources with growing demand. It is no secret that the MHRA struggled to maintain its performance targets in recent years. I am reassured that that this Government has committed to a strong and well-resourced MHRA as a cornerstone of the UK life sciences system. That sector needs to thrive for the good of the health service and the economy, and we want to continue to be a foundational partner in its success.
We have built back expertise that was lost after the European Medicines Agency departed London. The MHRA is now appreciably larger than its pre-Brexit size, in terms of its scientific experts and other roles, and is back on top of its performance targets, providing a fast, expert and open service.
But to balance the rising demand for our services with available resources, we must make strategic choices about where we specialise in regulatory science, and where we rely on trusted international peer regulators so that we can cover comprehensively the full span of medicines and devices that should be available to UK patients.
We will also make greater use of automation and AI in the period ahead to continuously improve our speed, accuracy and productivity, ensuring our regulatory processes are not a barrier to innovation, but a catalyst for it.
A strategy built on engagement
Our new strategy will not be written behind closed doors. We are committed to engaging widely and openly, and have already begun conversations with patients, clinicians, researchers, industry, international partners, and the wider public, as well as with our expert and committed staff. We are working to hear the views of all of those groups on the big questions we face.
We know we don’t have all the answers, and we believe the best strategy will be one that is co-created with those we serve and those we work alongside.
Looking ahead
The years to 2030 will be critical for the MHRA. We know we have to adapt to regulate scientific and technological advances such as gene and cell therapies for personalised medicine, and AI as a medical device. We need to support the UK’s ambitions in life sciences innovation and to respond to the growing complexity of global health challenges. We must also be ready to speak with authority and clarity in an age of insidious misinformation.
Above all, we must continue to protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices/technologies.
This is a moment to think ambitiously, to listen openly, and to act decisively.
As we continue to shape our strategy, we will keep listening and learning from the partners who share our ambitions. The challenges, some of which I’ve outlined here, are significant, but so too are the opportunities. I have every confidence that the MHRA, through the talent and dedication of our people, will rise to meet these challenges and continue to serve patients and the public with distinction.
