My Lords, I refer to my interests as declared in the register.
I pay tribute to all those who have worked tirelessly to deliver lightning-fast and globally important Covid trials, including RECOVERY, REACT and the Genomics England genomic host sequencing study. These have been a clear demonstration of the strength of the MHRA and UK life sciences. However, surely none of us can read my noble friend Lady Cumberlege’s heartrending report or watch the race to a Covid vaccine without knowing that we have more to do. Therefore, although this Bill has been triggered by Brexit, it is in fact timely regardless of Brexit.
A great deal has been said regarding the delegated powers—I note my noble friend Lord Lansley’s comment regarding framework Bills—and we will have time in Committee to cover all this, but I add that while current frameworks governing MMD will be retained, the loss of the ECA Section 2(2) power causes specific challenges for operating a safe and responsive regulatory regime. By its nature, MMD regulation requires frequent, prompt updating. The Human Medicines Regulations 2012 have been updated 11 times using Section 2(2). Over and above this, as has been mentioned, we have significant decisions to come on MDR, CTR, in vitro diagnostics and much that is as yet unknown.
Passing this Bill will mean that we will be able to shape our MMD regulatory environment in a far more tailored way. We may well choose to mirror upcoming EU regulations. The MHRA has been clear that we want a seamless process for multisite clinical trials not just across Europe but globally. However, there are other areas, such as genomics and cell and gene therapies, where innovative regulation may be highly desirable for novel trial design or surrogate end points, for example.
From Genomics England to Wellcome Sanger and Biobank, we have a unique concentration of institutions, skills and industry that puts us at the forefront of this field. This is a position that we must maintain. Furthermore, genomics drives two of our most highly skilled and high-growth sectors: life sciences and data science. These are critical to our economic recovery. However, primarily, these technologies should be assured and accelerated due to their promise for patients: more accurate diagnostics, personalised medicines, and screening tools that may even help prevent certain diseases altogether. The value of knowing that you carry a faulty BRCA1 gene and therefore have an increased risk of ovarian or breast cancer is well known. However, combining this genotyping with emerging tech such as polygenic risk scoring can sharpen that risk profile and prevent inappropriate interventions. The same is true of familial hypercholesterolaemia, promising to improve care of the highest-risk CVD patients.
We know that gene editing tools are producing entirely new casts of medicine, including cell and gene therapies such as the blood cancer drug Kymriah. It was the UK that struck the first full-access deal in Europe for this breakthrough CAR-T therapy, and there is promise of much more, with 12% of global ATMP trials happening here. The benefit of cell and gene therapies is patient-specific treatment with curative potential. The challenges include cost, complex manufacturing and short shelf lives. This Bill would help, enabling approved therapies to be processed at the bedside, and much more.
Genomics and other such tech generate vast swathes of data, and none of us needs to be reminded of the challenge and urgency of regulating the intersection of novel medicines, medical devices and health data. This Bill would help us develop a future-proof health data regulatory framework that could unlock the potential of ML in healthcare while maintaining the highest ethical and data standards. But align or innovate, it will be our decision. Clause 41 makes it clear that these decisions will be fully consulted on and largely subject to the affirmative procedure, but it would be helpful for the Minister to clarify the points raised by the noble Lord, Lord Sharkey.
The balance to be struck is articulated in all three sections, which call for Ministers to consider safety, access and attractiveness of UK life sciences. Of course, patient safety is paramount, but a sick patient is not safe if they cannot access the treatment they need, and they will not be able to do that if the UK becomes an unattractive environment to trial and launch the best treatments. This requires rigour and prompt intervention to ensure the highest standards of patient safety, yes,
and I fully support the patient safety commissioner and an effective devices register, but it also requires addressing barriers to access and uptake and creating certainty and right-touch regulation that limits bureaucracy and takes a proportional approach to fostering innovation in life sciences. That way, not only will UK patients get the best and safest care but we will ensure our life sciences sector remains one of the most productive in the country and one of the most innovative in the world.
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