Contribution
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.