Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024

Lord Scriven Excerpts

Monday 10th February 2025 Grand Committee

[Lord Scriven (LD)]

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?

Finally, can the Minister explain and elaborate on the consultation process undertaken with key stakeholders regarding these changes, including patient groups, industry representatives and academic researchers, in the development of these amendments? Were there any differences that emerged from the stakeholders and how have the Government dealt with them?

In conclusion, while we on these Benches support the intention behind these regulations, it is imperative to ensure that the implementation is robust and effective. I look forward to the Minister’s responses on the matters I have raised—less croaky responses, I hope.

[Lord Kamall (Con)]

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.

I turn to the detail of the regulations. One major change that noble Lords have already alluded to is the consolidation of the regulatory and ethics review process, enabling researchers to submit a single application for both regulatory approval and ethics review. While this change is aimed at improving efficiency—which we completely accept and welcome—there is a concern that any changes from consolidating these processes may put additional pressure on the regulators and ethics committees. The noble Lord, Lord Scriven, referred to that. If the single application process becomes overloaded, we risk delays in review times rather than the acceleration that was intended by these measures in the first place. It is essential that we have the resources and infrastructure in place to handle the increased workload effectively. Can the Minister therefore say how the Government will make sure to avoid that sort of overload? We completely understand why they want to consolidate the processes, but will it add extra pressure and will the resource be there to make sure that they are not overloaded and we do not just end up going back to square one, or even make things worse?

In addition, for low-risk trials, automatic regulatory authorisation will be granted, which will further streamline the approval process and free up resources for the more complex, higher-risk trials. Once again, while this makes sense, we have to be aware of possible unintended consequences or concerns that will be raised. The automatic approval of low-risk trials could, for example, raise concerns over oversight and monitoring. The intention to expedite the approval process for those with lower-risk profiles is laudable, but will there be clear criteria in place to ensure that the appropriate level of scrutiny is maintained, particularly in ensuring patient safety? As I said, while we support the intention, particularly for low-risk trials, we must always be aware of unintended consequences or unforeseen complications. Nevertheless, we completely understand why this is being done, and it is something to be welcomed.