Can you hear me now? Yes? Good. Noble Lords will be relieved to hear that I will not start again. I will speak to Amendments 34, 36 and 37.
Clause 4 deals with clinical trials, which delivered £1.5 billion in GVA and £335 million to the NHS in 2018-19. They are an absolutely critical part of UK life sciences and part of what makes the UK a global leader in medical research. Anything that reduces the number or share of clinical trials in the UK weakens that leadership and could delay access to new drugs or treatments.
In its briefing, the APBI points out that our share of clinical trial applications and patient recruits has fallen since 2016. As the noble Lord, Lord Hunt, said, we now rank behind the US, Germany and Spain for phase 3 trials—and Covid has had a dramatic effect. The University of Southampton has published research showing that 1,500 clinical trials of new drugs and treatments for cancers, heart disease and other serious illnesses have been permanently closed down in Britain, with a further 9,000 suspended.
The Government know all this and acknowledge the importance of clinical trials. Given that, Clause 4 is a surprisingly weak response. It does not require the Government to do anything at all. It simply says that they may regulate—it does not say how they may regulate—and lists the areas in which they may regulate. This is another example of the abuse of secondary legislation. It gives unspecified policy-changing powers to Ministers without saying what these policies might be, except that they should do no harm—not a very demanding qualification.
When questioned about this and asked which bits of the CTR they will carry across, the Government’s response is, “The elements that are in the UK’s best interests.” These best interests are to be identified after consultation with interested parties. This all seems unnecessarily feeble. Researchers, commercial and academic, need certainty and stability as soon as possible. Ideally, they would like the provisions of the new UK regime to incorporate all possible provisions of the CTR as they come into force. We know what these provisions are. We know all the thinking behind them. The UK played a central part in their construction in the first place. Our amendments try to give some clarity and certainty to the situation.
Amendment 34 would replace “may” with “must”. It would oblige the Government to do something and does not just give them the power to do something if they feel like it. Substituting “must” for “may” would mean that the Government must make provision corresponding or similar to provision in the CTR.
Amendment 36 would modify this requirement slightly to acknowledge that we cannot adopt certain provisions of the CTR. These are the provisions that relate to the EU clinical trials information system and the assessment model involving co-ordinated decision-making on multi-state trials. Amendment 36 would add “where possible” to the requirement to make provision corresponding to or similar to provision in the CTR to allow for this.
Amendment 37 specifies two features of the CTR that the Government must incorporate. These are specified because they are new and very important, and for the avoidance of doubt about the meaning of “corresponding to” or “similar”. The two new features are the new definition of clinical trials and the allowing of co-sponsorship. In its briefing, CRUK notes that the MHRA has had considerable input in the new definition of clinical trials. It notes in particular that the new definition expands the scope of low-risk trials and excludes altogether some studies, such as pure pharmacology studies that are focused on how medicines work rather than on the extent to which they do. The CTR also defines and allows co-sponsorship, where two or more sponsors across multiple countries may share responsibilities.
CRUK regards this as a very positive move, allowing for more flexibility in trial set-up and helping to foster collaboration. We helped to design both these new features. We should ensure that they are incorporated into our new regulatory regime.