Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024
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Baroness Merron
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
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
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 The reason is that the current legislation is based on the now-repealed EU clinical trials directive, so it therefore no longer aligns with the rapid advancements in medicine and technology.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.
Of course, these reforms will also bring benefits to the National Health Service. Evidence shows that hospitals that undertake research have better patient care outcomes and improved staff retention. Improved efficiency in conducting clinical trials will therefore enhance research efforts and foster innovation in prevention, diagnosis and treatment across various conditions. Those conducting clinical trials will also benefit from a streamlined and risk-proportionate regulatory framework, reducing delays and admin burdens. These reforms, I am glad to say, will stimulate growth in the UK’s life sciences sector and position the UK as a global hub for clinical trials.
I beg the Committee’s indulgence as I correct an administrative error made in the Explanatory Memorandum. It incorrectly stated that an impact assessment was produced. However, since the projected costs and benefits to business were below £5 million annually, a de minimis assessment was conducted and published instead.
Before I conclude, I re-emphasise that participant safety remains absolutely paramount. While this legislation streamlines processes and removes barriers to innovation, what it does is to prioritise robust oversight of all clinical trials, ensuring that the safety of trial participants is never compromised. By modernising our approach, I believe we can strengthen the UK’s position as that global leader, as well as fostering innovation and having the highest safety standards. These reformed regulations accelerate the delivery of tomorrow’s emerging medicines into today’s reality for patients. I beg to move.
Baroness Bennett of Manor Castle (GP)
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.
Baroness Merron (Lab)
My Lords, I am most grateful to noble Lords for their time and their constructive contributions. I feel that we are all moving in the same direction, and I appreciate the welcome for these regulations. I also appreciate the understanding that I am not firing on all cylinders, but be warned: I will be at some point.
Noble Lords have heard the details of the amendments, which, as I said in my opening speech, represent the most significant reform of UK clinical trials regulation in more than 20 years. As I said in my opening comments, I am conscious of the fact that I have just come from the Chamber, where we heard questions about this very area. So these regulations do seem very timely. If I miss anything in response, I will of course be very pleased to write to noble Lords.
In delivering a more efficient and adaptable regulatory framework, and in accelerating life-saving treatment through streamlined and future-proof processes, the reforms will put patients at the heart of clinical trial processes, as we well as strengthening the UK’s position.
I turn to some of the key points that noble Lords have raised. On the matter of safety clinical trials of course carry varying levels of risk. No clinical trial is entirely without risk, but the MHRA maintains a rigorous regulatory oversight to safeguard patient safety in all clinical trials, and this legislation does not change that. There will be no compromise on the protection of participants. However, we are removing requirements from the current legislation that simply offer duplication or no additional value when it comes to identifying safety risks. As I and other noble Lords have acknowledged, this is about removing obstacles but ensuring that safety is paramount to ensure that regulators, researchers and participants are all aware of potential risks and can take action to deal with them as appropriate.
I very much welcome the removal of unnecessary administrative burdens; I am sure that all noble Lords do. By increasing the opportunities in the UK to access innovative medicines at an earlier stage, we will expand patient access to new therapies and reinforce the reputation of the NHS as a world-leading platform for health and life sciences.
The noble Lord, Lord Kamall, and the noble Baroness, Lady Bennett rightly highlighted the matters of transparency and public trust. I am very glad to see the new transparency requirements because, for the first time, there will be a legal requirement for sponsors to register a clinical trial, publish a summary of results and offer to provide participants with an easy-to-understand summary of what the research has found. Clear guidance is being produced to ensure that the summary for participants is accurate, tailored and appropriate for the audience, which includes translation into different languages and an awareness of suitable formats, as highlighted by the noble Baroness, Lady Bennett.
A recent study commissioned by the HRA highlighted the importance of transparency, with 69% of respondents stating that they would have greater confidence in research if participants were informed of the outcomes. These measures will therefore foster greater trust and engagement with clinical research, and I certainly welcome that.
The noble Lord, Lord Kamall, asked about the protection of pharmaceutical companies’ legitimate interests in protecting commercially sensitive information, and asked what safeguards are in place. I can assure him that we absolutely respect and understand the need for commercial confidentiality. The new regulations will permit research sponsors to request deferrals for registration and the publication of results, including offering to share these with participants where this is necessary to protect commercially confidential information. Deferrals could be granted for up to 30 months, with the possibility of further deferrals, where justified, up to a maximum of 10 years. I hope that these provisions will safeguard the very legitimate interests of companies, while also maintaining the overall goal of transparency, to which we are all committed.
We recognise the scale and the vibrancy of the UK’s life sciences industry, particularly those conducting clinical trials. Throughout the development of the reforms, we have engaged with the clinical trial community and received widespread support across key stakeholders, including businesses, academics and charities. The public consultation generated over 2,000 responses and demonstrated a strong appetite from the research community for updating and improving clinical trial regulations. We will continue working closely with the research community to produce guidance that supports the smooth implementation of these new regulations.
Noble Lords were very helpful in raising a number of considerations. The noble Lord, Lord Kamall, asked about the criteria for automatic authorisation and for information about low-risk trials. The criteria have been designed to ensure that sufficient scientific evidence already exists regarding the safety of the product and the methodology that has been used in the clinical trial—essentially, that we can be assured that the medicine is safe. The evidence must have been reviewed previously and approved by the MHRA or, where applicable, by regulatory authorities in the EU, the EEA or the USA. Additionally, the legislation defines the criteria for a clinical trial to be eligible for automatic authorisation. I hope that this is helpful to the noble Lord, as his point is very valid.
On the matter of implementation, raised by the noble Lord, Lord Scriven, particularly regarding guidance on risk proportionality, guidance will be published in advance of the regulations coming into force. This will ensure that researchers and those undertaking clinical trials understand the changes and have time to prepare. We are working with stakeholders across the sector and taking views into account to ensure that the guidance is as clear and helpful as possible. The guidance will be promoted by a wide range of channels to ensure that it reaches stakeholders across the research and clinical trial participant community. This is vital as we bring in this legislation.
The noble Lord, Lord Scriven, also raised a point relating to the performance of the MHRA. Since September 2023, all regulatory assessments for clinical trial initial applications and substantial amendments to protocols have been completed within the current statutory timescales of 30 days and 35 days, respectively. The latest performance information about the MHRA regarding clinical trials assessment shows strong consistency and, I am glad to say, no backlogs. The updated legislation will introduce key measures to make it easier and faster for applicants to gain approval. Noble Lords have acknowledged the need to ensure that the UK remains a prime destination for clinical trials.
The noble Baroness, Lady Bennett, raised questions about automatic authorisation. I understand why noble Lords are raising these matters. This is new territory and noble Lords need to be reassured. There are clear criteria embedded in the legislation to ensure that only appropriate clinical trials can use this automatic authorisation route. The criteria are based upon the MHRA stakeholders who were consulted on their extensive experience of clinical trials and the participant safety risks associated with them. I can give the reassurance that, where there is a significant safety concern with the product, clinical trials will not be eligible for automatic authorisation and must undergo full regulatory assessment.
The noble Lord, Lord Scriven, mentioned stakeholder engagement. Following the public consultation, a number of policies were adapted to ensure that the regulations did not have any unintended consequences, as the noble Lord, Lord Kamall, said. Let me give one example. The feedback indicated that patient and public involvement would be best addressed in guidance rather than in legal requirements, in order to give that flexibility and to enable it to be kept up to date.
The noble Baroness, Lady Bennett, mentioned the environmental impact at the stage of clinical trials. I will be pleased to write to her on that point.
As I believe this debate has shown, we are in agreement that, by improving the clinical trial regulatory framework, these changes will expand patient access to cutting-edge therapies, boost the UK’s life sciences sector and reinforce the reputation of the NHS as a leader in health research. On this basis, I hope that noble Lords will feel able to support these vital regulatory changes.