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

Caroline Johnson Excerpts

Monday 3rd February 2025 General Committees

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

It is a pleasure to serve under your chairmanship, Sir Desmond. The Minister said that 17.5 million people in the United Kingdom are living with a long-term health condition. Every time the news comes on of an evening, they will hope that it brings some hope of a new treatment that promises the cure or effective treatment of their condition, or the condition of one whom they love. Unfortunately, the news today tells them that AstraZeneca has cancelled its investment in the UK, which is a big loss for life sciences and cures for people in this country.

Never the less, these regulations are a positive change. This instrument will reform the UK’s clinical trial regulatory regime with the aim of delivering a more

“proportionate, streamlined and effective clinical research environment”

by amending the Medicines for Human Use (Clinical Trials) Regulations 2004. These draft regulations are a response to a public consultation launched under the Conservatives in 2022, which asked for feedback on how the regulation of clinical trials could be improved and strengthened in the UK.

I agree with the Minister that we have an opportunity, now we have left the European Union, to design a world-class, sovereign regulatory environment for clinical trials that supports the development of innovative medicines and ensures that the UK retains and grows its reputation as a world-leading base for life sciences, generating opportunities for skilled jobs in the UK. As Conservatives, we welcome innovation and want to support UK patients getting early access to new and innovative treatments. For those reasons, we welcome the changes.

Among the many changes this instrument would make, it would legislate for a notification scheme to enable lower-risk clinical trials to be automatically approved by the licensing authority, where the risk is similar to that of standard medical care. A favourable opinion from an ethics committee would still be required to safeguard people taking part in the trial. The impact assessment estimates that around 20% of initial clinical trial applications would qualify for the notification scheme.

When asked about eligibility criteria for the scheme, the Medicines and Healthcare products Regulatory Agency explained that an application would be eligible if the medicine being investigated is used in line with its authorised use or established practice, supported by evidence; a previous similar clinical trial of a product has been approved in the last two years; or the same trial has been approved in the United States or a European economic area country.

While the clinical trial sponsor is responsible for determining whether the application meets the criteria for notification, the MHRA stated that a verification process would ensure their determination is correct. The notification scheme currently exists on an opt-in basis. The MHRA says that that has reduced the time required to initiate lower-risk clinical trials by more than 50% without compromising patient safety. That will clearly help people to get the new treatments quicker, and is to be welcomed.

We consider that the draft regulations will simultaneously remove obstacles to sponsors’ carrying out clinical trials, while ensuring the focus remains on protection of those participating in the trials. It will remove the aspects of legislation that are more prescriptive, in favour of introducing greater flexibility and more risk proportionality, to reflect that trial design and operation is evolving with innovations in the products that trials investigate. Ultimately, these proposed new requirements will ensure that trial participants and their safety are at the heart of legislation.

One thing I would like the Minister to clarify is that on the one hand he was saying that this change in regulation will be revolutionary for people getting trials and drugs more quickly, whereas on the other hand he gave a de minimis amount in terms of the financial benefit. Could he explain that contradiction?

[Andrew Gwynne]

I thank the shadow Minister for her support for this piece of secondary legislation, which marks the most substantial update to UK clinical trial regulations in more than two decades. This is an important step forward to deliver a more efficient and adaptable regulatory framework, all while ensuring the safety of the trial participants. The reforms will deliver a proportionate, flexible and efficient clinical research environment, with patients at the very heart of the process.

The shadow Minister raised the issue of AstraZeneca and the support for life sciences in the UK. Without straying too much from the measures before us, Sir Desmond, I want to reassure the Committee that this Government are fully committed to supporting the UK’s life sciences sector. Today we have heard about how vital clinical trials are in driving the health and wealth of the UK. The sector has experienced strong growth in recent years; between 2022 and 2023, the number of UK industry-led clinical trials increased by 3.7%. The UK has also gone up in the global rankings for phase 2 trials, moving from sixth to fourth place.

That progress is a testament to our thriving research ecosystem, something that was developed under the previous Government and that we want to build on, which is what this set of regulations is all about. They are about making sure that our country is at the cutting edge of the latest developments in medical science and that British patients are able to access those treatments as early as possible, through clinical trials and then through the early adoption of those medicines once they are brought to market.

The shadow Minister asked about the de minimis assessment. An assessment of the updated legislation has been produced, which estimates that there will be a total transition cost of approximately £720,000 to business for organisations to familiarise themselves with and operationalise the changes. It is expected that the annual total benefit to businesses will be £1 million, primarily due to the changes in the approval processes. I sought to correct the record in my opening remarks because it had originally been anticipated that we would need to have the full assessment, but on closer scrutiny that is not necessary because of the reasons that I have just set out.

[Dr Johnson]

When the Minister talks about £1 million, is that the benefit to businesses in the current level of trials? Or is that his estimate of the rise in the number of trials as a result of the changes?