Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

It is bad enough that this is a skeleton Bill. The root of the problem is the Government’s desire to take powers to make policy before they have decided what that policy is. We should make sure that the powers in the Bill to act without proper parliamentary scrutiny expire as soon as enough time has passed to allow them to be replaced by primary legislation, subject to proper parliamentary scrutiny. I hope the Minister can agree. If not, I expect us to return to the issue on Report.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, I thank all those involved in this first group; indeed, they are the team who, I feel, are likely to be walking with us through a great many groups of amendments. I enormously regret the fact that some noble Lords are unable to make this session, but I thank the usual channels for their efforts in the challenging process of trying to programme the hybrid House, and for finding time for this session, and for the Bill, in a packed programme.

We are starting with one of the most important groups of amendments, which address the principles behind the Bill. I believe that is the purpose of Amendment 1, in the name of the noble Baroness, Lady Thornton, and also her Amendment 140, Amendment 139, in the names of the noble Lord, Lord Sharkey, and the noble Baroness, Lady Jolly, and Amendments 50, 67, 115 and 141, in the name of the noble Lord, Lord Patel.

Although there is some variation in the specific effects of the amendments—such as which clauses they amend and which clauses come under their scope—they all look ahead towards drawing a line under the Bill, whether that be through a sunset clause or by asking the Government to return with consolidated legislation.

I emphatically believe in the Bill. I have listened to the criticisms of the Delegated Powers and Regulatory Reform Committee, and noted the comments of the noble Baroness, Lady Thornton, and the noble Lord, Lord Patel. Those points have been powerfully made in the report, on Second Reading and here today.

I know that the report may have inspired some of these amendments, because the committee considered sunsetting the Bill to be an appropriate response—but only if the Bill had remained as previously drafted. However, as your Lordships know, I have engaged extensively with noble Lords on these matters, and have tabled many amendments to address the specific concerns that we are debating today.

A sunset clause, reviewing these matters again in two or three years’ time, will not change the very good reasons why delegated powers are necessary. It would be an unhelpful precedent, which could lead to a rolling review of all legislation. My noble friend Lord Lansley, a former Leader of the House of Commons, and my predecessor, my noble friend Lord O’Shaughnessy, both made that point very powerfully.

The noble Lord, Lord Patel, is right to say that clarity is important, but that will come through consultation. As I respond to this point, and to my noble friend Lord O’Shaughnessy and to the noble Lord, Lord Sharkey, it is worth remembering that we have published six illustrative SIs—so it is not true that we have provided no examples of how the powers could be used. I want to ponder on this well-made thought, and give further thought to how we might go further. It is hard to see how sunsetting the whole Bill would bring additional clarity to the situation.



Returning to first principles, particularly patient safety, we need to react quickly and effectively to harm. Taking swift action, such as making changes to how medicines can be administered in the community—as we are doing in relation to the Covid vaccine—is absolutely necessary when the situation requires it. So sunsetting Clauses 1 and 12 would mean also sunsetting Clauses 6 and 15. We would have no emergency provision at all until that could be replaced—a regulatory cliff edge that I would find difficult to explain to patients who needed that flexibility to get the necessary treatment.

Harm can be also significant and require more fundamental regulatory change. The report of the noble Baroness, Lady Cumberlege, suggests that the system has been slow to move and respond, and that patients have not been heard. We cannot predict or pre-empt every risk of patient harm that will emerge. Patient safety cannot wait for primary legislation. When new measures have been introduced—such as databases of medical devices under Clause 16—I cannot think why we would want to go backwards. Saying that we should no longer be able to track and trace patients, nor be able to update the data types that should be recorded to protect patients, does not make sense. Using measures in the Bill such as the information system in Clause 16, we will do better for UK patients. This is not only what the Government want but what patients want. I hope that such a system will mean that the Government will know which patients have been affected by which specific device so that they can avert problems in future.

Secondly, the changes range on a scale from significant to relatively minor, for which primary legislation would be inappropriate. For instance, changing labelling to include pictograms is not a matter that needs to wait for a future Bill.

Thirdly, this is a modern and fast-changing industry, as the noble Lords, Lord Hunt and Lord Kakkar, put it so well. In two or three years’ time, we may still need to preserve our ability to amend and update regulations. We will need to provide confidence to businesses, patients and other parties that the statute book will keep pace with change. While much will be said on the attractiveness of the UK, this is a very real issue.

In response to the comments of the noble Baroness, Lady Thornton, on the benefits of a new round of consultation, perhaps even more serious is the fact that two or three years is simply not enough time for all the regulatory changes to take place—especially when we are obligated to consult all the people that noble Lords will identify when we come to that debate. Bills take time. This Bill was announced last year and was introduced in February. We are not there yet. We simply did not have enough time to judge its efficacy before we had to write it again.

On noble Lords’ amendments seeking to consolidate the legislation made in under three years, I say this: the Human Medicines Regulations were the consequence of a consolidation exercise. The Medicines Act 1968 was originally the method for regulating the way in which medicines were licensed for use in the UK. However, a number of changes were made over the years through regulations, which Parliament approved, to regulate medicines under that Act better. As such, the Human Medicines Regulations were meant to provide exactly what the noble Lord, Lord Patel, asked for: streamlined legislation that places regulatory matters in a single set of regulations.

Nor was there a lack of consultation on this approach. At the time, the MHRA took action to draw on stakeholder views and a formal consultation was run in late 2010. Parliament considered it appropriate to redirect into secondary legislation regulatory matters that required frequent changes to respond to potential safety concerns or changes in how medicines might be produced. The MHRA indicated that, should further consolidation be needed, this could be revisited. The noble Lord asked me whether there are ways of considering consolidation in the future. I must listen to him but, again, I say that three years is not a very long time at all for regulatory changes.

We recently published guidance for businesses that sets out the expected arrangements for the end of the transition period, in order to provide enough time to bring forward a standalone regulatory system and give businesses time to comply. That period of standstill will run for two and a half years; in that context, it is unlikely that, in the space of two years, there will be regulatory change that is so significant that it requires consolidation.

If your Lordships seek assurance on the visibility of how the Government will make regulations, or if your Lordships are asking me to specify our plans for how quickly we might move to the current regulations inherited from the EU, let me say this: we do not intend to make changes for the sake of it. We will do what is in the UK’s best interests. Whether our choices mean that our regulatory framework is similar to or different from regulations made by the EU does not change that approach. Regulations, rather than primary legislation, are the appropriate vehicle to protect patients best. Changes will be made subject to public consultation, and the amendment that I have tabled—on reporting obligations—will enable Parliament to consider and reflect on the Government’s use of powers in plans.

I am listening. I have proposed changes to improve the Bill—we will come to those later, having reflected on the debate—but I will face a real challenge in the new year as a result of the gap that will open up at the beginning of January if this Bill is not finished by then. I would not want to put in my place another Minister for Innovation who might also need swift regulatory change for UK patients, whether that is getting medicines approved quickly or changing who can administer them.

I hope that the noble Baroness has heard enough to reassure her and that she feels able to withdraw Amendment 1. I hope that other noble Lords with amendments in this group do not feel the need to move them.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

I have received a request to speak after the Minister from the noble Lord, Lord Patel.

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[Lord Patel (CB) [V]]

My Lords, I am grateful to the Minister for his response and, to a degree, his assurance that he is at least prepared to look at ways to consolidate the legislation. I do not accept his point about time. We are not asking that this Bill be held up; we are asking that the Government consider over the next three years bringing in legislation to consolidate the current legislation.

I am also grateful to the noble Lords, Lord Lansley and Lord O’Shaughnessy—both of whom are experienced in dealing with matters related to medicine in their own right—for their comments and support. I hope that, in the debate on the next group of amendments, the Minister will confirm in a more tangible way how he will address this issue because when we discuss those amendments, we will have an opportunity to come back to what he has said about the government amendments.

[Lord Bethell (Con)]

My Lords, I hear the noble Lord, Lord Patel, very clearly. The arguments that he made during our conversations and engagement earlier were powerful. The comments made by my noble friends Lord Lansley and Lord O’Shaughnessy, one of whom is my predecessor and one of whom is a former Health Secretary, were also extremely persuasive.

The Government do not think that putting consolidation in the Bill is wise, but we hear the points made by the noble Lord, Lord Patel, loud and clear. We would definitely consider this matter at a future date if the arguments made were persuasive and agreeable.

[Baroness Thornton (Lab)]

My Lords, I thank all noble Lords who took part in this preliminary and important debate on the Bill.

The noble Lord, Lord Patel, made an important point concerning primary legislation after three years. The Minister seemed to suggest that three years is not long enough. That cannot be right; three years is certainly long enough. Without the principles and policy that my noble friend Lord Hunt spoke about, rule by regulation is not only inadequate but probably quite dangerous. That lies at the heart of this group of amendments.

The noble Lord, Lord Kakkar, made the important point that we have a well-designed regulatory framework in the UK; this amendment is not about disrupting that. He also said that the Bill should be about improving the framework; that is exactly right.

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Moved by

[Lord Bethell]

2: Page 1, line 6, at end insert—
“(1A) The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
Member’s explanatory statement
This amendment provides that the appropriate authority may only make regulations under subsection (1) of Clause 1 if satisfied that they would promote the health and safety of the public.

[Lord Bethell (Con)]

My Lords, Amendments 2, 7, 51, 54, 56, 68 and 72 are a package intended to respond to the comments made at Second Reading and the consideration of the Bill by your Lordships’ Delegated Powers and Regulatory Reform Committee and the Constitution Committee.

I have said at both the Dispatch Box on Second Reading and in meetings with a number of noble Lords that I am listening and ready to make improvements to the Bill where they are necessary. I am ready to provide reassurance about how the powers are intended to be exercised. Amendments 2 and 68 would require that regulations may be made only if the appropriate authority is satisfied that the regulations promote the health and safety of the public. A number of noble Lords spoke in favour of clarity regarding how the considerations applied in making regulations and whether the first consideration—that of safety—had primacy. This was a point made by the noble Baronesses, Lady Barker, Lady Andrews and Lady Walmsley, and by the noble and learned Lord, Lord Woolf. Their remarks on how the Government could improve the nature of the framework Bill were ones that I paid particularly close attention to. In making legislation, there is a delicate balance between making it absolutely clear that regulatory change will not be made that is contrary to promoting the health of the public and not binding the Government so completely that necessary regulatory change that is not explicitly for the purpose of promoting the health of the public is not possible. This amendment seeks to provide that comfort: that the Government’s making of regulations must satisfy that obligation.

Amendment 51, on veterinary medicines, is drafted differently to reflect the specific circumstances of how veterinary medicines are made. For example, a medicine that might be suited to the health of an animal might unhelpfully contribute to antimicrobial resistance in humans. An overarching requirement to be satisfied that regulatory change promotes the safety of animals, without reflecting that we must also consider the safety of animals as food products in the food chain, would have inadvertent consequences. Amendments 7, 54, 56 and 72 are consequential to these.

I have considered carefully the alternative constructions tabled by your Lordships. I wanted to demonstrate our absolute commitment to patients’ health and safety that is at the heart of this Bill. My noble friend Lady Cumberlege’s report has highlighted the importance of this.

My amendments do not fetter our ability to make good regulations that will enable the development of new medicines and devices in the UK and ensure the availability of those medicines. But, in doing so, the requirement to be satisfied will protect against the inadvertent impact on the health of the public. This will answer the requirement to make it clear how the Bill is a framework Bill, as opposed to a skeleton Bill, providing that test against which regulations can be measured.

I hope that these amendments provide assurance not only to those in this House who sit on the Delegated Powers and Regulatory Reform Committee and the Constitution Committee but to others who are keen to see the Government reflect my noble friend’s recommendation that patient safety be put first. I beg to move.

[Lord Lansley (Con)]

My Lords, I am glad to have this opportunity to speak to my Amendment 5 and to Amendments 70 and 76 in this group. I am particularly grateful to the noble and learned Lord, Lord Woolf, and the noble Baroness, Lady Jolly, for putting their names to Amendment 5. As the Minister rightly said, he set out to respond in government Amendment 2 to the remarks of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee. We discussed this a lot at Second Reading. The essence of the argument that I among other noble Lords made was that the Bill was a skeleton, the skeleton approach was criticised by the Delegated Powers Committee and we needed to move it from a skeleton to a framework by making it clear that the power to make regulations is for a purpose. The noble and learned Lord, Lord Woolf, and I set out to do that in our amendment: to express a purpose rather than have a power that essentially had no test other than whether the Secretary of State had had regard to certain factors—there was no objective test that could be examined, because it is very easy for Ministers to say that they have had regard to something.

Why did we have the objective of safeguarding public health? The relevant EU regulation, which is the EU human medicines directive 2001/83/EC, as amended, says at what is essentially its first article:

“The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.”


Therefore, rather than invent our own purpose, we thought that the starting point for the legislation should be to reflect the same objective as incorporated into the regulation-making power up to now. The Minister may well say, “But the EU regulation is not only based on the public health treaty objective but on the internal market objective”. However, Article 3 of the EU regulation, which follows that, is quite clear:

“However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.”


Therefore, the other legal bases, if anything, tend to act alongside and be balanced with the original treaty objective, which is to safeguard public health. It seems that there is therefore nothing inherently wrong in our own power to set out the objective, which is to safeguard public health, and then to set alongside it in the subsequent subsection the other considerations to which the Secretary of State must have regard. We will go on to discuss those, but they include the safety of human medicines, the attractiveness of the UK as a place to conduct clinical trials, and so on.

This is the test: why are we moving from the current legislative basis to a new one? What is inherently better in saying that Ministers must be satisfied that they will promote the health and safety of the people and in what sense is that different from safeguarding public health? Noble Lords might well say, “You have won—you put your amendment down and the Minister has put government Amendment 2 down, and they say more or less the same thing”. We submit that they do not quite say the same thing, since the government amendment’s construction is that the Secretary of State “must be satisfied that”. Our construction is that it

“must have the objective of”.

I am not qualified to say any more about this matter; I will leave that to my noble friend in this regard, the noble and learned Lord, Lord Woolf. An objective test should be expressed in the legislation in objective terms, not in subjective terms of whether the Secretary of State is satisfied.

Amendment 70 does a similar thing in relation to medical devices. Amendment 76 begs the question: is the safety of a medical device to be assessed in the absence of knowing its therapeutic use? It may well be that the answer is that assessing the safety of a medical device must necessarily consist not only of the approval process but of understanding its use in therapeutic settings. If the answer is that that will necessarily be the case and if Clause 12 of the Bill means that anyway, I am perfectly happy to accept that. However, I am looking for an assurance from the Minister that that is what Clause 7 means: safety of a medical device is not simply through its approval processes but through understanding in the approval process how it will be used in therapeutic practice.

In conclusion, from what I have said we do not think that government Amendment 2 is better than our Amendment 5. However, government Amendment 2 is clearly better than what is in the Bill at the moment, because it gives us a purpose for which the regulation-making power is to be used. I make a plea to noble Lords. At this stage, in Committee, I would far rather change the Bill by accepting the government amendment and its sequelae, as we would say, and therefore send the Bill to Report in at least a form that one Front Bench agrees with than not change the Bill and have to have this same debate all over again on Report. We might have the same debate, but it would clarify for the benefit of noble Lords on Report if at least the Bill has moved from where it has been to show how the Government are seeking to meet the objectives set out at Second Reading and by the Delegated Powers Committee so that we can look at it again properly on Report. I of course reserve my position and that of my noble friends whose names are attached to this amendment, as we might well want to come back to the issue on Report and say that our formulation with an objective test is better than the subjective test that government Amendment 2 implies.

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[Baroness Thornton (Lab)]

Like the noble Lord, Lord Sharkey, I shall have a minor moan. It is normal practice to give fellow Peers sight of government amendments at least on the day are put down, so even though the Bill team had not managed to discuss their intention with Opposition parties and other noble Lords involved in Committee, we received the letter from the Minister explaining the amendments on Thursday. I hope the Minister and the Bill team will not continue to leave things so late. I remind the Minister that he has a whole Bill team and a department at his disposal. Other noble Lords write their own speeches, do their own research and need more time to give amendments due consideration. I am fortunate to have some excellent support and we work very hard on our side to get our amendments down as early as possible to give other noble Lords the opportunity to consider them and discuss them with us. The Government should always bear in mind the unequal nature of resourcing in this place.

We need to see these amendments for what they are. Of course, they are mostly worthy and we welcome the improvement, but essentially, to echo the words of the noble Lord, Lord Patel, they are there to placate and circumvent. We are late in the day in beginning to understand the nature of these amendments and we now understand the urgency of them as a result of our earlier discussions, for which I thank the Minister and his team. We are waiting for reassurance from the Minister about what happens at the next stage.

The noble Lord, Lord Lansley, made some very important and pertinent points, particularly about the difference between the objective test and the subjective test. It is clever and very important. He is on the side of objectivity and the Government’s amendments are definitely on the side of subjectivity. I agree with him that Amendment 2 is not as good as his Amendment 5. The noble and learned Lord, Lord Woolf, also said something very pertinent and quite correct about not giving blank cheques. He accepts what the Government are offering, but made the point that further discussions are needed and an amendment might be needed as we move forward.

I say to the noble Lord, Lord O’Shaughnessy, that I do not have a principled objection to government amendments coming forward; it is just that we need to know the context for them. The noble Lords, Lord Lansley and Lord Kakkar, and others, including the noble Baroness, Lady Jolly, made a very important point about safeguarding public health, and I hope the Minister will be able to address it. I can probably feel an amendment coming on on that one.

[Lord Bethell (Con)]

My Lords, I am enormously grateful to my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, for Amendments 5 and 70. I greatly appreciate their scrutiny and contribution on the way in which regulations under the Bill might be made. I am grateful to my noble friend for his constructive dialogue with my officials. His experience and expertise in making legislation on health matters is a real benefit to all of us.

My noble friend and the noble and learned Lord, Lord Woolf, have drawn on the framework of legislation in the EU context. I am grateful for their explanatory statement on the basis of the amendment. My noble friend knows that I pressed very hard to see whether this is something we could accept. The challenge your Lordships have set me is why, if this framework exists in EU legislation, is it too constricting for the Bill? The answer is that examples of significant recent EU legislation in relation to human medicines, clinical trials and medical devices include: directive 2001/83/EC, regulation 726/2004, regulation 536/2014, and regulation 2017/745. In other words, while citing the aim of safeguarding public health in Article 168, on public health, of the Treaty on the Functioning of the European Union, these pieces of legislation were also made in reliance upon Article 114 of the treaty, being measures for the approximation of laws which have as their objective the establishment and functioning of the internal market. To make that point again, safeguarding public health is not the only objective of the EU legislation in relation to medicinal products and medical devices. That is why we have a challenge in this area and why we have posited our amendment.

I shall say something about the other government amendments, specifically replying to the noble Lords, Lord Hunt and Lord Sharkey, and other noble Lords who commented on them. The overall timing of the Bill means that currently, it cannot reach Report any earlier than mid-November. If we start the consent process with Northern Ireland then, it will add a minimum of two months past the end of the Bill’s timeline. To explain to the noble Lord, Lord Sharkey, we need to start the consent process now in order to make further changes. The Government need to demonstrate that this is a policy they wish to make in order for Northern Ireland to get that process properly under way. We have written to Northern Ireland seeking consent to make changes. Parts 1 and 2 of the Bill are transferred to Northern Ireland. I sought consent from Northern Ireland on the Bill as a whole when the Bill was introduced, and again after the change made on Report to Clause 16.

We sought to make government amendments at the earliest opportunity to respond to the DPRRC, partly to demonstrate how significantly we take that report and partly to start this process. That process has now started, but it has not concluded. It does not preclude noble Lords from further consideration and, as my noble friend Lord Lansley, indicated, the Bill has moved. The process of consent is unavoidably three months long in order for the Northern Ireland Assembly to conduct its work. That is why we have had to start now. In reply to the noble Lord, Lord Hunt, I can supplement the legislative consent Motion at a later date.

I will listen. I understand and acknowledge that the noble Baroness sees this as the beginning, not the end, and I acknowledge that she will return to the issue on Report. Accepting these amendments today does not prevent her doing so, and I will continue to listen.

I completely hear what the noble Lord, Lord Hunt, says about engagement with the MHRA. I would be glad to arrange a suitable engagement with June Raine from the MHRA and parliamentarians to discuss these points.

To the noble Lord, Lord Patel, I confirm that the efficacy of a medical device is assessed as part of the process of obtaining a CE certificate. The therapeutic value of a device is not part of the CE certificate assessment; that is a function carried out by NICE. On the point made by the noble Baroness, Lady Barker, on the food chain, I would be glad to arrange a follow-up discussion on the veterinary medicines directorate with the relevant Defra Minister. To the noble Baroness, Lady Jolly, Defra and BEIS are content with this amendment. To the noble Baroness, Lady Walmsley, the medical devices section of the overarching bit at the beginning of the Bill is a carry-on from the sentencing enforcement, and in Part 3 enforcement is in relation to medical devices only. I do not think these are reasons to rewrite the purpose.

I obviously hope to win the argument on some of this, but that will come from extensive engagement and thorough communication going forward, for which I thank noble Lords. I therefore hope that the noble Baroness feels able to accept these reassurances, and I am grateful that my noble friend considers this sufficient reassurance not to move his amendments.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

I have received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.

[Lord O’Shaughnessy (Con)]

I thank my noble friend for addressing the point about therapeutic use, but I think I am slightly more confused now than I was before. He talked about NICE, but of course, NICE does not assess every medical device and assesses from a health economics perspective, as opposed to a purely regulatory, safety and efficacy perspective. It is not something that need detain us, but perhaps he could follow up afterwards with a bit more detail.

[Lord Bethell (Con)]

I would be happy to conduct that follow-up.

Amendment 2 agreed.

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[Baroness Jolly (LD) [V]]

It was almost inevitable, looking at the amendments that were coming up and knowing the people who would be discussing them in Committee, that this was going to be one of the most interesting debates. It has been fascinating and well informed. The amendments relate to our future relationship with the EMA and other international organisations after Brexit. My Amendment 125 in this group is on future regulatory alignment; I am grateful to my noble friend Lady Sheehan for her contribution.

The Government have not been forthcoming on whether they will pursue regulatory alignment and, more importantly, what the implications of not doing so would be. I would be grateful if the Minister clarified that second point. Our clinical trials are hugely important and widely respected. The clinical trials information system is critically important; the noble Lord, Lord Lansley, made that vital point. What aspect of the role of the EMA are we trying to replace? It has four parts: to facilitate development and access to medicines; to evaluate applications for marketing authorisations; to monitor the safety of medicines across their life cycle; and to provide information to healthcare professionals and patients. We need urgent clarification on how the future information system will work, who will host it, how it will be staffed and how we will share our research.

As the noble Lord, Lord Patel, said, we do not have a large enough population for significant research without partners. Are we clear that we could work with the FDA in the US—or, indeed, with the TGA in Australia? Would that give us a sufficient body of people from which to take on our research? Perhaps. Are there any moves to seek full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use? I am sure that the Minister will have the answers but the regulations must have regard to the desirability of alignment, somehow or other, with the rest of the world. We cannot work as a small unit—perfectly formed, maybe, but we are small compared with the US, Europe and other groupings.

How is this going to be measured and monitored? The noble Lord, Lord Hunt, spoke about the fast-track licensing of medicines and devices. The point he made so clearly is that public safety has to be paramount so we cannot rush this sort of thing. We have to get it right; if people have to wait, so be it. It has been interesting to hear the reflections of the noble Lord, Lord O’Shaughnessy, because he was sitting in the hot seat of the department. I wonder whether he is glad that he is not there now.

The other interesting amendment concerns the definition of attractiveness, which included collaboration with the EMA. The noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, attempted a definition. I am sure that if we were all given a piece of paper and asked to write down our definition of attractiveness, there would probably be as many answers as there are people in the debate today. I would like a definition from the Minister: how is this to be measured and by which body?

Without a doubt, under the provisions of Amendment 34, regulations must be made, while under Amendments 35 and 36, they should correspond with the EU clinical trials regulations. Amendment 38 provides that we must continue our collaboration with the EU in whatever form we can manage between us. We also need to look hard at clinical trials portals, not only with the EU but with our other partners in future.

[Lord Bethell (Con)]

My Lords, as the Minister for Innovation, I am very keen on the UK’s continued leadership in this area; I have made it something of a personal cause. I am very proud of the fact that the MHRA approves around 950 medicinal trials a year, over half of which are multinational.

We know that once an early phase trial is established in this country, the industry is more likely to keep its later phase multi-country trials here. I would say to the noble Lord, Lord Hunt, and others who have questioned this point, that I can confirm that the purpose of the measures in this Bill are absolutely to build on our established strengths so that the UK has the opportunity to anchor international drug development in this country and grow that capability. I am committed to international standards, international partnerships and multi-country clinical trials. It is of course important that we work with our international partners both within the EU and globally to the benefit of patients. I assure noble Lords emphatically that we are committed to international co-operation.

However, I do not agree that our future relationships will be furthered by mandating the consideration of alignment with EU regulations and the European Medicines Agency. The UK has a long track record of jointly tackling global challenges with strong international links already in place between research and innovation communities. The UK works closely with many other regulators; those relationships are underpinned by many shared international standards. The EU bases its regulations on exactly those standards, as do we, and we will continue to do this going forward.

As a number of noble Lords have noted, we have the opportunity to create a better regulatory framework. The feedback from the industry is that an agile, proportionate UK system with familiar data submission requirements would increase the UK’s attractiveness as a place to conduct multinational studies, even if we are operating outside the EU’s network. My noble friend Lord O’Shaughnessy’s quote from the ABPI made this point. The powers in the Bill as it stands will allow us to develop exactly that kind of system.

Progress is already happening. The MHRA and the Health Research Authority are already taking steps to streamline the approvals process for UK clinical trials and are currently piloting a new process that has been shown to reduce overall approval times by more than 30%. I say to the noble Lord, Lord Sharkey, that this change does not rule out co-operation. Data generated in a UK clinical trial will continue to be admissible to support regulatory activity in the EU—and, indeed, globally. We can also look at how we can go further in making clinical trials and their results transparent and visible to the public. Co-operation does not require alignment.

Amendment 3 in the name of the noble Baroness, Lady Thornton, also suggests considering alignment with EU licensing processes. In the short term, the MHRA has already taken steps to recognise for two years future EMA decisions for medicine licences approved through the centralised authorisation procedure from January 2021. In the long term, there are opportunities to establish new UK routes to market, such as a new expedited pathway for innovative products, and to establish shorter assessment timeframes.

We have the ability to make corresponding or similar provisions to the EU CTR, but Amendment 38 would oblige us to align. Amendment 35, in the name of my noble friend Lord Lansley, does something similar. My noble friend makes the point that we have the opportunity to do better than the EU CTR, and that is very much our intention. That regulation replaces current separate regulatory authority and ethics approvals with a single national decision for a trial. The UK could adopt a similar methodology and associated data requirements for approvals, but in a much quicker timeframe. We have already introduced the combined ways for a working pilot to streamline approvals by the MHRA and ethics committees, and industry has told us that our scheme is one of the most appealing among the various pilot schemes in the EU, leading to a reported 30% reduction in timelines. The UK may wish to go further and develop our existing national system to further adapt requirements according to risk so as to reduce unnecessary burdens, such as academic trials involving a marketed product already in common usage.

In his Amendment 49, the noble Lord, Lord Sharkey, suggests that there would be benefits in adopting certain definitions in the EU CTR. These include the EU’s revised definition of a clinical trial and co-sponsorship set out in the EU clinical trials regulations. Under the EU CTR, this new definition of clinical trials is an attempt to avoid current variation in interpretations in different member states. Whether this will have the intended effect remains to be seen. EU legislation already includes a definition of a clinical trial, and the MHRA offers trial sponsors free advice on whether their study meets that definition, to ensure a consistent interpretation. If we wished to amend our definition of a clinical trial corresponding to that in the EU CTR, the Bill as drafted would enable that.

My noble friend Lord Lansley is right that the EU CTR introduces a single submission portal and co-assessment model, but I confirm that member states involved still have to individually authorise the trial, and therefore one or more member states could refuse authorisation. The portal is an IT system, the method of delivery. This does not mean centralised EU approval of a trial. Where a member state has national restrictions that require separate approvals outside the scope of the EU CTR, the sponsor would still have to seek the approval separately of the individual member state, in addition to the processes for seeking authorisation for the trial through the EU portal under the EU CTR. Industry has told us that if the UK has a rapid approval system, the lack of access to the EU portal is not a particular issue.

Amendment 52 introduced by the noble Lord, Lord Patel, suggests provision to develop a clinical trials portal that aligns with the European Medicines Agency for medicines for rare diseases. The EMA’s IT system does not address complex trial designs, such as umbrella, basket and platform trials that involve the use of master protocols. These are the very trial designs that have delivered the UK’s successes in Covid-19 research. On the EU portal, it is also extremely unlikely that the EU would agree to UK involvement, even if one were to request it, given that it is for EU member states and EEA countries. There are many other reasons why the UK is such an attractive place to run global rare disease trials: our world-class research infrastructure and centres for excellence, and so on and so forth.

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[Lord Patel (CB) [V]]

My Lords, the Minister referred to the large number of trials that are started in the United Kingdom. Can he say how many phase 3 trials have been started here? He also referred to the platform that the MHRA has developed with regard to Covid that accelerated the delivery of drugs, which is correct. However, that is not the same as a platform for rare diseases.

I agree that the licensing that was done at speed, within six months, would normally have taken two years: for instance, the licensing of the use of Remdesivir, produced by Gilead Sciences for the treatment of Covid-19. However, that is not the same as the noble Lord’s implication that it could be used for rare diseases. Those require a larger database, which Covid had, because there is no shortage of Covid data. Furthermore, he said that the EU portal means that individual countries have to approve. That is correct, but the approval is a speedier process because it has gone through the portal, unlike before.

[Lord Bethell (Con)]

My Lords, I will be happy to write to the noble Lord with the precise figures for phase 3 trials. However, he is right that they are incredibly important. The Bill must defend our position on phase 3 trials, which are very much the sharp end of the clinical trials process.

The learning from RECOVERY is that it is not a direct read-across to rare diseases. The noble Lord is right that in rare disease trials, we are often trying to drill down into very small communities, whereas 113,000 signed up for RECOVERY, and tens of thousands took some of the drugs that went through the trial process. However, it is the general capability of being able to run significant platforms, manage ethics at speed, get regulatory sign-off for these trials, and have a clinical trials regime which suits many different purposes. That is our objective, that is why we are putting through these reforms, and that is why we believe that the Bill can support a modernisation of our clinical trials regime.

On the European trials process, the noble Lord is entirely right that the portal contributes to speedy processes. However, it is not the only way of having a speedy sign-off of trials through Europe; we believe there are other ways of doing that.

[Baroness Thornton (Lab)]

Responding to the very last thing that the Minister said, he will have to tell us what those other ways are during the course of this discussion.

This has been a well-informed debate, as I assumed it would be. I think I was right in saying that this issue is at the heart of the Bill and how we move forward. My noble friend Lord Hunt—I thank him for his support —was quite right that this is the big issue. As the noble Lord, Lord Sharkey, said, this is the start of the discussion that we are going to have about attractiveness and where that lies and how it can express itself.

The noble Lord, Lord Lansley, put his finger on various important issues to do with clinical trials. He asked the key question, which I do not think the Minister answered. It is: if we diverge, what will that mean and how will it happen? I did not hear an answer to that question. The answer will determine what some of us do next as we move forward with this Bill. The noble Lord, Lord Kakkar, was completely correct when he said that it is vital that we get this right for the future of life sciences in the UK.

I am grateful to the noble Lord, Lord Patel, for his support for our amendments. He reminded us that we had this discussion during the passage of the main Brexit legislation, when we were told that it was not the appropriate place to such a discussion so the amendment was withdrawn. Now, at the last minute, this must be the place where we have these discussions and come to some conclusion on them.

The noble Lord, Lord O’Shaughnessy, is right. As we strike out on our own as a country, we will need new relationships and we will need to take advantage of what is on offer in the rest of the world. The transition will be very important because what happens in the meantime is vital. We will also need to ensure patient safety in this laissez-faire world, as the noble Lord explained, for example, if we decide to ignore the portal and strike out without it.

I do not doubt for a moment the Minister’s emphatic commitment to making this a success, but as we move forward, this Committee will need to understand much more than what the Minister has told us so far on the risks and opportunities. My final request to the Minister is that we will need a cross-party meeting of some depth—possibly more than one—to discuss this matter with his Bill team and the MHRA. We had such a meeting. It feels as if it was aeons ago, but I think that it was in February, perhaps March. Anyway, it was before we went into lockdown. We absolutely will need meetings and discussions before we move on to the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.

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Moved by

[Lord Bethell]

7: Page 1, line 7, leave out “making regulations under subsection (1)” and insert “considering whether they would”
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 1 in considering whether regulations made under subsection (1) would promote the health and safety of the public.