HANSARD
Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
- Considered in Grand Committee
- 4:37 pm
- Moved by
- That the Grand Committee do consider the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024.Relevant document: 13th Report from the Secondary Legislation Scrutiny Committee
- My Lords, I am grateful for the opportunity to debate these amendments, which represent the most substantial reform of UK clinical trials regulation in over two decades.Clinical trials are vital for developing safe and effective medicines, especially for those with limited treatment options, such as the estimated 3 million people living with cancer in the UK and the 17.5 million people managing long-term conditions. Last week, I saw for myself how innovative UK researchers are transforming cancer diagnosis and treatment. I joined the Science Minister, my noble friend Lord Vallance, at the Royal Marsden to learn about a research initiative that is using cutting-edge AI tools to improve breast cancer detection.To support innovation, our regulations need to be flexible and proportionate. This legislation will do just that by delivering streamlined and efficient regulations, removing barriers to innovation and creating a patient-focused research environment—something that noble Lords called for during Questions on the Statement repeat that we just dealt with in the Chamber. These reforms will support the development of new life-changing treatments for those in need and strengthen the UK’s position as a global leader in clinical trials.I turn briefly to why this change is necessary and timely. The reason is that the current legislation is based on the now-repealed EU clinical trials directive, so it therefore no longer aligns with the rapid advancements in medicine and technology. We have the opportunity to create a world-class regulatory environment for clinical trials, if we can deliver a modernised framework that supports the safe development of innovative treatments.I will outline, for the benefit of the Committee, the key aspects of the reforms. First, on risk-proportionate regulation, regulatory requirements will align with the risk level of a clinical trial. Low-risk trials will receive faster approval through automatic authorisation, without compromising patient safety. The second aspect is that of future-proofing. We have removed duplicative and granular legal requirements in favour of tailored guidance, ensuring flexibility for future innovations and moving beyond a one-size-fits-all approach. On international alignment, the UK will remain aligned to global standards, ensuring that trial data is recognised internationally and strengthening its position as a preferred site for multinational clinical trials. Then there is the important point of cementing the UK as a destination for international clinical trials. Streamlined processes will simplify applications and deliver globally competitive approval timelines. The final change that these regulations deliver is increased transparency. We want to ensure that trusted information about clinical trials is publicly available for the benefit of all.New legal requirements will thus be introduced to register a clinical trial, and publish a summary of results, including an easy-to-read summary for participants. These changes will build public trust in research by improving access to information about ongoing research and enabling informed decisions.
- I thank the noble Baroness, Lady Merron, for her clear introduction to this statutory instrument, which I broadly welcome. There are some important factors here. I particularly welcome the requirement to register clinical trials and publish a summary of the results within 12 months. It has been widely and long acknowledged, in the research community broadly, that there is an issue where less successful or failed trials, or those that are not seen to have interesting results, are not published. They can be as important, or more important, than the successful ones. The failure to publish them is driven by academic, publishing and promotion imperatives—and, I am afraid, by the profit motive in healthcare, where companies have very much sought to find the successful stories and bury the less successful ones. That is really positive and, if I would say one thing, it would be to encourage the Government to speak more about that, because it is important that people understand it. Given the issues that we have with trust across the board at the moment, I encourage them to highlight that we are actually strengthening and improving regulation.
- 4:45 pm
- With that in mind, I turn to some of the rhetoric that has come from the Government around this, and indeed some of the actions. I understand the argument about trials identified as low risk, particularly those using medicines that have already been approved for other purposes. But let us acknowledge that, historically, the use of some of our longest-serving medicines, medical devices and medical practice is often based on custom and practice rather than a strong foundation of evidence. It is important to make sure that what we are identifying as low risk really is low risk.
- I welcome the fact that the Health Research Authority has developed a set of questions around diversity and inclusion. We know that there is a big problem, in our whole medical system, with failing to acknowledge the needs of different groups and populations, particularly disadvantaged ones. That is potentially a useful step towards tackling health inequalities.
- I am slightly disappointed not to see a fast-growing and relatively new area here: a lot of work is being done now on the environmental impact of clinical trials. I particularly note the work of the Clinical Trials and Statistics Unit of the Institute of Cancer Research, which has developed a greener trials toolkit that enables managers to identify higher-emissions activities and implement targeted actions to reduce them. This calls for accepting carbon footprinting into the development stage of new trials and including it in funding applications.
- I note that, in this space, there are a number of all-voluntary actions, such as the NIHR’s carbon reduction guidelines, the UK CRC monitoring group’s green monitoring guidance and the UKTMN guide to efficient local management, but are the Government considering putting some of these environmental steps on a statutory basis, rather than simply relying on voluntary efforts? I do not think that much work is being done in this area, but the noble Baroness will be aware that I have done a great deal of work on the environmental impacts of human medicines in the environment. That is in the context of antimicrobial resistance and more broadly in terms of environmental impacts. Particularly in Sweden, there is a real drive towards encouraging looking at the environmental impacts of medicines while they are being developed, so that we can look to design medicines, at the clinical trial stage, that have a minimal environmental impact.
- Those are a few very specific things related essentially to this instrument, but a broader question that this instrument brings up is, how do we make clinical trials more effective? Of course, what we want is clinical trials that work and deliver effective medicines as soon and safely as possible.
- In that context, I note that I raised with the previous Government, but have not yet had the opportunity to raise with this one, the call for a human-specific technologies Act to support the full replacement of animals in medical research with new technologies. If we look at that in the context of clinical trials, the likelihood of a cancer drug being approved and progressing from small phase-run trials to larger clinical trials is less than 6%. Alzheimer’s disease has a clinical trial failure rate of more than 99%. We cannot rely on animal tests to indicate whether a drug is safe or effective in people; 92% of the drugs that show promise in animal tests fail to reach the clinic and benefit patients. Are the Government looking at that more broadly when they think about the whole ecosystem of developing new medicines and pharmaceutical trials? Given that I have just sprung that on the Minister, I will entirely understand if she would like to write to me about it later rather than deal with it now.
- My Lords, I start by congratulating the Minister; I hear her sniffles. She has been a champion of her brief in having to deal with two statutory instruments, as well as a Statement in the House. I thank her for being here.As the Minister said, the reforms proposed in this statutory instrument aim to create a more streamlined and flexible regulatory environment for clinical trials in the United Kingdom, while balancing safeguarding the interests of trial participants. The amendments seek to uphold the paramount importance of participant safety, ensuring that their rights and well-being remain central to the regulatory framework. By refining the evaluation and development process for new or improved medicines, these changes aim to expedite the delivery of therapeutic benefits to patients and society at large, and we on these Benches recognise that.The instrument will formalise the combined review process, which has been piloted since 2018 and become the exclusive route for clinical trial applications. This process offers a single application pathway and co-ordinated regulatory and ethics committee review, ending in a unified UK decision for clinical trials. That would be helpful for practitioners and those seeking to innovate, but there are still points that require clarification, and while the objectives of these amendments are commendable, I seek clarification from the Minister on several aspects.What measures are in place to ensure that the Medicines and Healthcare products Regulatory Agency and the ethics committees will be adequately resourced to manage the anticipated increase in workload resulting from the streamlined process? If no impact assessment has been made, what working assumptions are the department and NHS England working to regarding the workload that this new process will bring?Can the Minister provide detailed guidance on how the risk-based approach will be operationalised to ensure consistency across different types of trials? I note that she talked about international alignment, but how do the Government plan to align these regulatory changes with international standards to facilitate seamless multinational trials? What frameworks will be established to monitor the impact of these regulatory changes on trial efficacy and patient safety, which is really important? How will these findings be reported locally within the NHS? Will they be reported to Parliament at any point?
- My Lords, I thank the Minister for the laying of this statutory instrument. Like the noble Lord, Lord Scriven, I commend her on her valour and robustness, as well as the speed at which she managed to transport herself from the Chamber to here after the Statement repeat, having prepared for that and having been briefed by her officials.Like many other noble Lords, we welcome these regulations, which are grounded in the review by my noble friend Lord O’Shaughnessy and the subsequent consultation with stakeholders, including the Medicines and Healthcare products Regulatory Agency and Health Research Authority, aimed at modernising the regulatory framework that governs clinical trials in the UK. We know that the landscape for clinical research in the UK faced significant disruption during the Covid-19 pandemic, but we also know that we learned quite a lot from trying to get vaccines out very quickly in terms of ways to speed up trials and to make sure that we get the right balance between efficiency and processes, as well as making sure that people are safe. We need to make sure that we can boost the volume of clinical trials and boost patient recruitment.The O’Shaughnessy review identified the need for a more flexible and risk-proportionate approach to clinical trials. One very important point is that, while we cannot eliminate risk altogether, we can manage it. Where there is low risk, we should maybe not be placing so much emphasis on processes as compared with when there is high risk, but I also know that there may always be unintended consequences.Stakeholders such as the Association of the British Pharmaceutical Industry were vocal in their support for these reforms and had in fact been calling for them. The ABPI 2024 report, The Road to Recovery for UK Industry Clinical Trials, highlighted that the number of pharmaceutical industry trials initiated in the UK increased—it was just over 400—between 2022 and 2023, although that still remained 36% below the 2017 level. We therefore understand the need to bring forward these regulations to make sure that we improve the regulatory environment to further increase clinical trial activity.
- 5:00 pm
- In introducing the intent of this instrument, the Minister discussed the idea of greater transparency. Like the noble Baroness, Lady Bennett, we welcome the fact that clinical trials will be required to be registered on a public database—and not only the positive results but the negative results too. We can always learn from things that went wrong and not downplay them; when mistakes have been made, we can learn from them. Increased transparency is crucial for public trust. There is, I suspect, a need to ensure that sensitive information, such as proprietary data or details that could affect patient confidentiality, are handled properly. What safeguards will be in place to protect the interests of participants and sponsors while promoting greater transparency?
- We know that these measures will introduce greater flexibility and accommodate innovative trial designs. Noble Lords know that a one-size-fits-all approach is not appropriate; it is absolutely right that we are as flexible as possible. We will now see guidance, rather than rigid legislative details, used for specific requirements, which will allow researchers to tailor their trials to suit the needs of the study and the risks involved. Once again, that all makes complete sense on the surface, and we welcome it, but how do we avoid a situation where the lack of clear legislative requirements could lead to inconsistencies in trial design? We want flexibility, of course—these things should not all be the same—but, in having that, will this measure introduce some inconsistencies and perhaps complicate regulatory oversight? It is welcome but, once again, let us look out for unintended consequences. If flexibility is not managed, would it lead to varying standards across trials, thus creating gaps in safety and quality assurance? What is the intention to avoid that?