European Union (Withdrawal) Bill

Lord Patel Excerpts

Report: 1st sitting: House of Lords
Wednesday 18th April 2018 Lords Chamber

Moved by

[Lord Patel]

9: Clause 3, page 2, line 30, at end insert—
“( ) For the purposes of this section, the Clinical Trials Regulation (2014/536) is deemed to be operative immediately before exit day, and therefore it forms part of retained EU law.”

[Lord Patel (CB)]

My Lords, I thank those who have put their names to my amendment: the noble and learned Lords, Lord Mackay of Clashfern and Lord Judge, and the noble Baroness, Lady Thornton. Many others wanted to add their names but were unable to do so: I see several nodding on either side and I thank them all. I also thank all noble Lords who spoke in Committee. There was strong support across the Committee, including, surprisingly to some perhaps, from the noble Lords, Lord Forsyth and Lord Lawson, and the noble Viscount, Lord Ridley, who cannot be accused of being strong remainers. Since then, we have had some very fruitful meetings with the ministerial team—the noble Lords, Lord Callanan and Lord O’Shaughnessy, the noble Baroness, Lady Goldie, and the noble and learned Lord, Lord Keen. I am grateful to them and their officials for meeting us all on two occasions. One was just yesterday and I apologise for my discourtesy in getting cross yesterday—I am sorry about that, it was for other reasons.

The amendment seeks to secure a commitment from the Government that they will align the UK with the clinical trials regulation. It is important to the research community, pharma and, indeed, the EU institutions that the UK strongly wishes to collaborate in clinical trials across the EU, and it is important to do so, particularly as we begin to develop medicines that are more precise—precision medicines for individuals. I hope that we will get some commitment from the Government to do so. That is as much as I am going to say. I beg to move.

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[Baroness Thornton (Lab)]

My Lords, I join everyone in thanking the Minister—the noble Baroness, Lady Goldie—and indeed the other Ministers who have been involved in the discussions. I thank them for the meetings we have had. I am sorry that I was not at the meeting the other day, but I thank her for sharing with me what she was going to say today. I am very happy that the Government have recognised the importance of this matter. Who would not be honoured to be on an amendment with the noble Lord, Lord Patel, and the noble and learned Lords, Lord Judge and Lord Mackay of Clashfern, and if they say that they are content, who am I to say that I am not? What will be necessary from now on is for the Government and all of us to reassure the medical professions and the researchers that this is exactly what will happen, so that they can plan with confidence clinical trials for the future.

[Lord Patel]

My Lords, briefly, I thank everybody who has spoken but particularly the Minister for the way in which she presented the solution. I say by the way to the noble Baroness, Lady Thornton, that we used the brains of the two noble and learned Lords for medical knowledge, not their legal knowledge. I thank them, as this will reassure the research communities, pharma and even the EU institutions of our commitment to collaborate with EU nations on clinical trials. I thank the whole ministerial team and I beg leave to withdraw my amendment.

Amendment 9 withdrawn.

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.”

--- Later in debate ---

[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.

--- Later in debate ---

[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.

European Union (Withdrawal) Bill

Lord Patel Excerpts

Committee: 2nd sitting (Hansard): House of Lords
Monday 26th February 2018 Lords Chamber

[Baroness Garden of Frognal (LD)]

My Lords, I have added my name to Amendment 10, tabled by the noble Lord, Lord Hunt, and have Amendment 163 in this group in my name and those of my noble friend Lord Storey and the noble Earls, Lord Clancarty and Lord Dundee. The noble Lord, Lord Hunt, has set out clearly why we feel that assurances on Erasmus+ and Horizon 2020 are essential if our world-leading universities are to retain their reputation and our students are to be given the best opportunities to broaden horizons.

Does the Minister recognise the benefits of scientific research—including, as the noble Lord, Lord Hunt, has set out, for the economy? In particular, can he provide some clarity on how the UK Government intend either to remain in or replace the range of EU funds as we leave the European Union? Of course, it is not only the funding. Crucial to research is collaboration. Working with other European researchers and academics has resulted in work of benefit to the UK, the EU and, indeed, worldwide. As a recent CBI report set out:

“With science and innovation increasingly becoming globalised, the UK’s role as a leading global scientific power is at risk without an agreement”.


What a loss it would be if we were to walk away from these EU programmes.

Horizon 2020, as we have heard, is the biggest EU research and innovation programme, with nearly €80 billion of funding available over the seven years of 2014 to 2020. In addition to Horizon 2020, there is a range of other EU-based funding, which has included, for instance, valuable support for environmental science and the environment, whose future must also be carefully considered by the Government. Protecting the environment is best done in collaboration. We believe that these funds are key.

Horizon 2020 is a highly important source of funding for research in the UK. There are other funds such as Interreg and Life, which support applied research in the UK and are instrumental in turning academic research into public policy and maximising its benefits for society. As for the Erasmus exchange programme, it has been described as one of the greatest culture and character-building programmes that you can have in your whole life. The Liberal Democrats have long wholeheartedly supported Erasmus. It is heartening to hear that wholehearted support coming from the Labour Benches—it would be even better to hear it from the Government Benches, and not just for the niggardly couple of years that Ministers have mentioned so far but as an ongoing and enduring commitment.

Erasmus is aimed at cross-border co-operation between states to aid the growth of international studying, international understanding and fostering good international relations—and my goodness we will need all those in spades, if and when we leave the European Union. With over 4,000 students involved in the programme at any one time, it offers an excellent chance of experience abroad, which, we know, is highly valued by employers. Those from disadvantaged backgrounds can be helped by the Erasmus+ EU grant to help cover the travel and subsistence costs incurred in connection with their period of study abroad.

Erasmus has been of life-changing importance to so many young people from all walks of life. It would be an act of folly not to continue this scheme for our young people. I hope the Minister will respond favourably to these two amendments, in the interests of students, researchers and the greater good of the country.

[Lord Patel (CB)]

I support this amendment and will go a bit further. As we have heard, the UK is a major player in research and innovation in European countries and worldwide. A recently published document, Building a Strong Future for European Science: Brexit and Beyond, is Wellcome’s recommendation from the future partnership project, based on a survey of 200 institutions and top scientists in Europe. It might form the framework based on which the Government may wish to negotiate beyond Brexit.

If nothing were to change and we were to remain as we are, there would be no problem—the UK would remain a major player in science and innovation. But on the basis that we will have to negotiate post Brexit, I would say, as the document says:

“Brexit presents the UK and EU with choices about their future relationship on research and innovation”.


European nations, including the United Kingdom as a major player, have developed,

“a world-leading location for research and innovation”.

The EU and associated countries—there are countries which are not part of the EU but are currently associated with Erasmus and other EU research programmes—

“should accelerate and deepen development of the European Research Area (ERA), to help Europe and EU Framework Programmes capitalise on the strengths and talents of a wider group of nations”.

Each of these nations, including the UK, contributes heavily to these programmes. We have to find a way to continue, both for Europe and for us.

An EU-UK research and innovation agreement for Brexit could be possible:

“Evidence and views gathered through the Future Partnership Project showed the importance of finding a way for the EU and UK to maintain their important partnership”.


There was a strong view, both from scientists and research organisations in Europe, outside the UK, that they would like this partnership and strong relationship to continue.

As to funding, as has already been mentioned:

“The EU’s Framework Programmes are the most effective multilateral funding schemes in the world”.


The UK needs to be part of this, so:

“The UK should therefore secure Associated Country status in an excellence-focused Framework Programme 9”—


that will follow programme 8—

“as this would be the best way to participate in European research. To achieve this, the UK should be pragmatic about the cost of a good deal to access FP9, and the EU should be pragmatic about the terms of FP9 association for the UK”.

There are benefits for both sides, which the science community certainly recognises.

There will, of course, have to be some alliance with regulation and research policy. A later amendment in my name relates particularly to clinical trials, which are important for the life sciences industry in this country. It is important, therefore, for,

“the UK to participate in the EU’s harmonised clinical trials system”,

including the new system that will come. The report states:

“A research and innovation agreement should promote dialogue on areas of research policy where the EU and UK can provide global leadership, for example on open research … A research and innovation agreement should support full researcher mobility between the EEA and UK”.


Proposals of this kind, which have come from Wellcome and the Royal Society, could be the framework for future negotiations, particularly on research and innovation.

[The Earl of Dundee (Con)]

My Lords, as has been said, that our current advantages from international student mobility might now be under attack is clearly of great concern.

In 2014-15, it was estimated that international students contributed around £25.8 billion in gross output to the United Kingdom economy. There are also the considerable social and cultural benefits to which they contribute, not least the United Kingdom’s soft power overseas.

Yet recently, and unfortunately, those heartening figures and prospects have got worse, with our market share slipping against rival English-speaking countries such as Australia, New Zealand and Canada, as well as against European countries, which now offer more courses in English.

These amendments seek to prevent further decline by protecting continuing UK participation in the Erasmus and Horizon 2020 schemes. As we know, the Government have guaranteed participation for the next three years.

Nevertheless, does my noble friend the Minister agree that, as other noble Lords have urged, by far the best plan is to negotiate with the EU to stay within these very effective education initiatives, while at the same time doing all we can to support and work with our universities to increase international student mobility both in Europe and elsewhere?