European Union (Withdrawal) Bill

Lord Patel Excerpts

Committee: 6th sitting (Hansard): House of Lords
Monday 12th March 2018 Lords Chamber

Moved by

[Lord Patel]

84: Clause 7, page 6, line 13, at end insert—
“( ) No regulations may be made under this section which make changes to EU-derived domestic legislation concerning the regulation of clinical trials until the Secretary of State has laid a report before both Houses of Parliament assessing the costs and benefits of adopting EU Regulation 536/2014.”

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[Lord Patel (CB)]

My Lords, Amendment 84 in my name and those of the noble Baronesses, Lady Thornton and Lady Jolly, and the noble Viscount, Lord Ridley, is a very simple amendment that seeks clarification about how the Government intend to deal with the clinical trials regulation when it comes into force. The amendment is not designed to be political, or to interfere with the aims of the Bill. It has been tabled to bring to the Government’s attention a very specific issue with the forthcoming clinical trials regulation as the UK withdraws from the EU and the implication that will have on clinical trials.

The CTR is a significant improvement on the existing regulations governing clinical trials that it will replace, the clinical trials directive. It has the potential to benefit both patients and the research environment in the UK, yet it is also in a somewhat unusual position with regard to the Bill. It will reform the governance of clinical trials across the European Union. The UK was central to its development, with both the MHRA—the Medicines and Healthcare products Regulatory Agency—and individual researchers contributing their expertise. It was adopted in 2014, with the UK’s full support. However, due to a minor technical delay with the set-up of the data-sharing portal it will not come into effect until late 2019, rather than this year as planned. As such, it will come into effect after exit day and will not be covered by Clause 3 and what it converts into UK law. It will be the existing clinical trials directive that is covered by the current Bill.

If we do not take steps to adopt the CTR, we will fall out of alignment when it comes into effect and our ability to undertake collaborative clinical trials with our EU partners will cease. To reduce the uncertainty that is of concern to the research community and pharma, the Government should commit to aligning with the CTR when it comes into effect, and provide details of how they will seek to do this.

The CTR is a major improvement upon the current clinical trials directive, harmonising the approach to conducting clinical trials across the EU. It will include a co-ordinated, centralised approval process and a portal which decreases the administrative burden for clinical trials and support. It is transparent and, since it is a regulation, it will immediately come into law across member states, ensuring clinical trials governance across the EU. The current divergence in how the clinical trials directive is applied in member states results in substantial delays in opening trials involving more than one country.

The CTR allows for a more risk-proportionate approach to trials and authorisation, extending them to investigational medicinal products and enabling the optimised use of medicines that already have marketing authorisation. Other benefits include quicker trial set-up, ambitious timelines for review, flexibility and the simple reporting of adverse reactions leading to improved patient safety. Patients also benefit from being involved in clinical studies, which are the gold standard for developing evidence to see whether a new intervention is suitable to become standard practice. They also provide patients with opportunities to access innovations at an early stage in their development. Through enhanced collaboration, the CTR would provide increased opportunities for UK patients to access clinical trials. Collaboration is particularly important on rare diseases, where patient pools are smaller. Streamlined co-operation on trials looking at these diseases is crucial in making progress in research and improving outcomes.

The CTR also has implications for UK science and innovation. The Prime Minister said in her Statement last week that,

“our partnership will need to cover agreements in other areas, including … a far-reaching science and innovation pact”.—[Official Report, Commons, 5/3/18; col. 28.]

The UK’s life sciences are strong and the UK is a world leader in medical research. Looking at existing medicine, for instance, around 25% of the world’s top 100 prescription medicines were discovered and developed in the UK, while three of the five top-selling drugs to treat rheumatoid arthritis and other inflammatory conditions globally are innovations based on UK science. Unfortunately, we did not commercialise them so we do not get the billions with which they now benefit pharma.

The Government’s recent Life Sciences Industrial Strategy sets out the UK’s ambition to strengthen the environment for clinical trials. The strategy mentions opportunities to improve translational science and attract more clinical trials from industry. Alignment with the CTR will facilitate this ambition to come to fruition sooner.

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[Baroness Goldie]

I am not in any way diminishing the important point that the noble Lord makes. I am pointing out that there are many types of clinical trials—for example, at the moment we are engaged in partnerships with non-EU countries. However, the Prime Minister has made it clear that we desire to have the closest possible relationship with the EU. We think that the systems we have been engaged in around clinical trials have been very strong, good and important.

[Lord Patel]

My Lords, it was not my intention to intervene. I am sorry to do so but it has been forced upon me. I think there is a fundamental failure of understanding here. Clinical trials are planned over a long time: it takes at least six to eight months to plan a clinical trial; it takes a lot of collaboration to find out whether we will be able to recruit the same category of patients; and we are required to understand whether the people who volunteer to join the trial have the necessary patience to do so. Because of this time lag, my amendment seeks to raise a very simple question. We had agreed to a regulation—the new clinical trials regulation—and we believed that it would come into force this year and therefore would be incorporated into the current European Union (Withdrawal) Bill. By a quirk of fate, that will not happen. But we have already agreed to have it in the Bill, so, as the noble Lord, Lord Forsyth, said, what is the problem with incorporating it in the Bill?

[Baroness Goldie]

The problem is that the Bill is intended to transfer a body of law from A to B. At the moment, this regulation is incomplete: it has not been enacted and it is not currently in the body of EU law. That is why there is a risk that it will not be covered under this Bill.

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[Baroness Goldie]

I must apologise to the noble and learned Lord; the Chief Whip sat down and bumped into me, so I was distracted from hearing what he had to say. I certainly offer to come back to that point.

[Lord Patel]

My Lords, it is difficult for me to sum up. The message is quite clear to me, although that might merely be perception, that my friend, the noble Baroness, Lady Goldie, is in some difficulty. It is quite clear to all those who understand the amendment—and, more importantly, the European trials regulation and the law as specified in the Bill—that there is no reason why we cannot incorporate this into the Bill.

The noble Lord, Lord Warner, suggested that we might need to bring another amendment; I suppose he means with the view to having a vote. That was not my intention when I tabled the amendment. It was merely to clarify the Government’s position on importing the European trials regulation into the Bill as we are the prime movers of the regulation and we are formulating it. The solution identified by the noble and learned Lord, Lord Mackay of Clashfern, seems to be the answer to cover all such regulations that we might have agreed to and might come into force. This is not the first time that he has come to my rescue. He has done so twice before, on admixed embryos and on mental health having equal esteem. Both times they were put to the vote and the votes were won—so that is a warning.

I hope the Minister might agree that more work needs to be done on this by Ministers. I am glad to understand that the noble Lord, Lord Callanan, is to meet with Cancer Research UK and others at some stage in March, I assume to discuss this and other science issues. I hope he will agree that there might be a place for the Ministers to meet and see whether there is a solution. Otherwise, I fear that either there will be an amendment in the form suggested by the noble and learned Lord, Lord Mackay, or, if it is not me, somebody else will table an amendment. We can tell from the support this amendment received even from strong Brexiteers such as the noble Lords, Lord Lawson and Lord Forsyth, and the noble Viscount, Lord Ridley, that such an amendment might be carried.

[Viscount Ridley]

As a result of this debate, could the noble Lord consider the possibility that he, I and the other supporters of the amendment have been doing so on false pretences—that is, on the assumption that some action is needed to make it come into law—whereas, if the noble Baroness, Lady Ludford, and the noble and learned Lord, Lord Judge, are right, perhaps it automatically does? That might explain the problems that we have got into today, and we would have wasted an hour and a quarter on something that might not matter.

[Lord Patel]

I thank the noble Lord. That is why I hope the meeting will help the noble and learned Lord, Lord Judge, and others to clarify that the amendment was not necessary, in which case we are saying that any such regulation that we have agreed to stands. On that basis, I beg leave to withdraw the amendment.

Amendment 84 withdrawn.