Medicines and Medical Devices Bill

Baroness Thornton Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, the amendments in this group relate to the introduction of a commissioner for patient safety. We have supported this proposal right from the publication of the review, First Do No Harm.

At Second Reading and in Committee we supported the amendments tabled by the noble Baroness, Lady Cumberlege, to put the patient safety commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review. I was pleased to add my name to Amendment 65, tabled by the noble Baroness, Lady Cumberlege, that we are debating. Along with all the government amendments, it will enable the progress of the commissioner’s appointment. I join others in congratulating the noble Baroness, Lady Cumberlege, and the Minister, the noble Lord, Lord Bethell, for getting the patient safety commissioner accepted so quickly by the establishment.

The critical issue is to be independent, and to be seen to be independent by example. As the noble Baroness, Lady Finlay, mentioned, both the children’s and the victims’ commissioner have remained independent, and I am sure would be useful allies and candid friends in the world of commissioners—who, as the noble Baroness, Lady Cumberlege, underlined, are not regulators.

I look forward to the time when in every NHS healthcare setting there will be easily accessible information on the role of the patient safety commissioner, and the way to contact them. We welcome the department’s commitment to working at pace, and there are many parliamentarians here today who will be keen to ensure that it does just that.

As the noble Baroness, Lady Cumberlege, said, there is a time pressure to appoint the commissioner. I join the noble Lord, Lord O’Shaughnessy, the noble Baroness, Lady Bennett, and others, in their concern for the pace of the appointment. What body will have oversight of setting up the office of the patient commissioner? I wonder whether the Minister could tell the House when he would expect the office to be up and running—in a year, in two, or more?

[Baroness Thornton (Lab)]

My Lords, I can only join in with the congratulations that everybody has expressed in this debate today. I congratulate of course the noble Baroness, Lady Cumberlege, and support her—as we have from these Benches throughout. I also congratulate and thank the Minister, the noble Baroness, Lady Penn, and also somebody who I do not think has been mentioned but I do remember sitting giving his wisdom in the many discussions we have had, who is of course the noble Earl, Lord Howe. I think the team were very wise indeed to have him sitting with them.

I am not going to say very much because I think we are there with this. Most of the questions that needed to be asked have been asked: on speed, independence, resourcing and powers, and on the issue of “relevant person”, which several noble Lords mentioned. These are the key issues.

One issue that has not been mentioned—here I thank the PSA for its brief—is the need to ensure that there is no reduction in public protection in any other areas of government policy, and that the remit of the role should link closely with the work of the other bodies involved in patient safety.

Finally, I have to say that I agree with the noble and learned Lord, Lord Mackay of Clashfern, that there has to be a four-country element in this. As the role is intended to cover only England, there should be consideration of how the link with equivalent or complementary mechanisms will work in the other countries of the UK. Otherwise, we might find ourselves with a dissonance here, which will not be in patients’ interests.

[Lord Bethell (Con)]

My Lords, I will save my Hollywood thank-yous for the end of the process, but profound thanks will need to be said. I want to say specific thanks to those who have spoken in the debate on these amendments. There have been a large number of very thoughtful comments. The noble Baroness, Lady Thornton, and my noble and learned friend Lord Mackay both mentioned four nations and devolution. The noble Baroness, Lady Bennett, spoke on gender, my noble friend Lord O’Shaughnessy on industry advocacy, and the noble Baroness, Lady Ritchie, on Northern Ireland. It is a very long list, and I cannot address every contribution. What I will do instead is address what I think have been the key points in the debate on these very important amendments.

Amendment 65 was tabled by my noble friend Lady Cumberlege before the Government’s own. I am extremely grateful to her and her team, who have written to me expressing their thoughts. The government amendment would not have been possible without her continued engagement and that of other noble Lords whose experience and knowledge have been essential in shaping the Government’s thinking. Although there are differences between our amendments, we are agreed on the fundamental point that we must create a patient safety commissioner in order to give the voice of patients its rightful prominence. My noble friend Lord O’Shaughnessy has made that point extremely clearly and effectively.

More broadly, I hope that the amendment in my name assures my noble friend Lady Cumberlege and the House of the seriousness with which the Government takes the report First Do No Harm. The Government will continue to review this report. We made a Written Ministerial Statement on the report and its recommendations yesterday, and will respond to the whole report shortly.

A patient safety commissioner, as proposed in Amendment 65, would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. The Government entirely agree that listening to patients is essential to preventing the sorts of issues highlighted in the report. On this, our visions for the patient safety commissioner are as one.

However, Amendment 65 in the name of my noble friend Lady Cumberlege differs in specific ways. Her proposed new subsection (2) provides that the Cabinet Office would host and fund the patient safety commissioner. My noble friend has argued here and in Committee—and, indeed, in her report—that this would be necessary to safeguard the independence of the commissioner. I simply do not agree. It is common practice for commissioners to be sponsored by the government department with relevant policy responsibility, and it is entirely unclear to me what the benefit of sponsorship elsewhere would be. The process of public appointments is set out clearly; there is no question of undue influence by the sponsoring Secretary of State. The process is there—in fact, it is public. Nor does the identity of the sponsoring department amend or change the powers and functions of the commissioner; it is simply how the body is supported.

There are also differences in the way in which my noble friend’s intention is executed. In her report, she was clear that working with other bodies was necessary and, as I would hope, obvious as part of any commissioner’s remit. However, Amendment 65 is unclear as to how the commissioner would interact with other regulatory bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and any other persons, including regulators and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants. These bodies also have their own routes for reporting. For example, as we know from the vaccines rollout, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme.

Without differentiation between taking receipt of direct reports to further a broader investigation and acting as an ombudsman, Amendment 65 might create a body overwhelmed by patient reporting and investigating individual cases. The noble Lords, Lord Patel and Lord Hunt, both referred to past agencies here, but where the best route to resolution sits elsewhere. The report itself said that the commissioner should not investigate individual cases, yet this boundary is absent from the amendment.

Proposed new subsection (7) enables the commissioner to require information from public bodies and others for the purposes of producing and laying before Parliament reports regarding patient safety, but “other” would extend to private individuals—a very expansive group indeed. The amendment tabled by my noble friend provides for the commissioner to make reports only to the Secretary of State and Parliament, and not to a range of bodies as in the government amendment. Nor does my noble friend’s amendment provide for what would happen if these individuals did not respond.

“Relevant person” is a broad definition. I am confident that it will enable the commissioner to engage with the organisations necessary to fulfil their functions effectively. In addition, proposed new paragraph 3(1)(b) of Schedule A1 would enable the commissioner to receive information from and consult

“any other person the Commissioner thinks appropriate”.

This provides the commissioner with all the relevant tools necessary. A vital difference between my amendment and the proposals of my noble friend is that, in mine, provisions are made for the patient safety commissioner to make reports and recommendations to relevant public authorities or persons, and for that authority or person to have a duty to respond to these; I think that is vital.

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Moved by

[Baroness Thornton]

2: Clause 1, page 1, line 8, at end insert “for a period of three years beginning with the day on which this Act is passed.”
Member’s explanatory statement
This amendment provides a sunset provision for Part 1 of the Bill requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 2 and 3 of the Bill, and the amendments in the name of Lord Patel requiring consolidated legislation.

[Baroness Thornton (Lab)]

My Lords, in moving Amendment 2 I will speak also to Amendments 27 and 40 in my name. I also support the amendments in the names of the noble Lords, Lord Patel and Lord Kakkar, and of the noble and learned Lord, Lord Mackay.

This amendment would provide a sunset provision for Part 1, requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 2 and 3 and the amendments in the name of the Lord, Lord Patel, requiring consolidated legislation. We discussed all these issues in Committee. Through discussion, the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, and others have joined together to put this together as a suite of amendments, which makes sense.

At Second Reading, the noble Lord, Lord Blencathra, said:

“Thus it grieves me to say that the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy. Of course, it is not unique; it is just one more Bill stuffed full of Henry VIII clauses but devoid of substantive content. It is the barest skeleton, all to be filled in with negative secondary legislation.


I am speaking in my capacity as chair of the Delegated Powers Committee. We considered the key clauses—Clauses 1, 8 and 12—and concluded that they contain inappropriate delegations of power. We say that


‘the Government have failed to provide sufficient justification for … the Bill adopting a “skeleton bill” approach, with Ministers given very wide powers to almost completely re-write … regulatory regimes’.”—[Official Report, 2/9/20; col. 415.]


Here we are some distance away from that remark. Indeed, the question we must ask is: have we succeeded? Is the Bill less atrocious now than at the beginning when the DPC was so scathing?

All of us, in particular the Minister, the noble Baroness, Lady Penn, and the Bill team, have listened and improved the Bill. The Government have worked hard to meet some if not all of the Constitution Committee’s and the Delegated Powers Committee’s recommendations.

We believe that this suite of amendments, in a way, builds on those improvements that have already been made to the Bill. They propose a very simple objective that was articulated from the very beginning. It is neither democratic nor safe to run medicines, devices and veterinary medicines through regulation alone in the long run. Our regulatory framework needs to be in primary legislation. This must be achieved in a timely fashion, hence these amendments. Sooner or later—and there is agreement on this—there will need to be consolidation in primary legislation. We would prefer it to be sooner. We think that some agreement is necessary on this.

While I recognise the need to get this legislation on the statute book, the Minister must know about the disquiet that some of this has caused and the need to address the issues of accountability in regulation. The truth is that while we are very pleased to now have affirmative regulation, it is very rare for that to be rejected once it reaches Parliament, however unsatisfactory it might be. In fact, we have learned a great deal about regulation over this year of Covid regs.

The amendments in my name and those of the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly, would amend Parts 1, 9 and 14, which concern the three objectives of the regulation of medicine, medical devices and veterinary devices, with a three-year sunset provision. In Committee, I proposed that there should be consolidation of regulatory legislation within a two-year period, so I hope the Minister might recognise that we have been quite generous here because we have now extended that to three years.

Other noble Lords who are much better qualified than I will discuss the merits of the group. I look forward to hearing their discussion. In the meantime, I beg to move.

[Lord Patel (CB) [V]]

My Lords, I support the amendments in the name of the noble Baroness, Lady Thornton. As she said, they should be read in conjunction with my Amendments 26, 39 and 63 on the need for consolidating legislation, which I will come to in a minute.

As has previously been debated, the Bill confers an extensive range of delegated powers relating to medicines, veterinary medicines and medical devices. Previously, the power to create relevant secondary legislation in the UK was derived from the European Communities Act 1972. Those delegated powers were simply to allow the implementation of laws in the UK that have already been consulted on, debated and scrutinised at EU level and by our own EU committees in the Lords.

The powers in the Bill are such that areas of policy that previously would have been subject to greater scrutiny at EU level may now be amended without similar levels of scrutiny in the United Kingdom. They do not, as such, represent an equivalent conferral of power to the legislature seen under the previous regulatory arrangements.

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[Lord Bethell (Con)]

My Lords, I thank noble Lords for an extremely powerful session on these amendments. I confess that I completely share the aspiration voiced by many noble Lords about Britain having the best possible legislation on life sciences in the world. As the Life Sciences Minister, that is a natural ambition, but it is also a real possibility, and it is what we are working towards at the department, and through the Bill. But I have severe reservations about whether this approach is the right mechanism, and I would like to address those directly.

The noble Baroness, Lady Thornton, has tabled Amendment 2, which relates to the sunset clause, and with this amendment it would be convenient to speak to Amendments 26, 27, 39, 40 and 63. I will come to Amendment 2 shortly but, first, I cannot say that Amendment 26 is a big surprise. The noble Lord, Lord Patel, who authored it, indicated as much when he and other noble Lords discussed these matters after the excellent debate in Grand Committee. The intent of his amendment is to require the Government to publish draft legislation within three years—legislation that consolidates medicines and medical devices regulation. I understand the arguments made during Committee, and again here today, that the regulation could benefit from clarification and those arguments made on how secondary legislation could be used. The amendments in the name of the noble Baroness, Lady Thornton, go further. They would append a sunset clause after three years—I repeat, three years—requiring not draft legislation but passed legislation.

I start by addressing the timing put forward. The noble Lord, Lord Patel, asks for the Government to publish draft legislation within three years of Royal Assent. I assume that he intends this consolidation effort to include changes made under the delegated powers in the Bill, including policy that may be made to, for example, take forward a national falsified medicines scheme. The noble Baroness’s amendment would have the delegated powers lapse entirely, leaving us without the ability to amend or supplement the regulatory regimes at that point. In reality, three years between Royal Assent and draft legislation ready for publication that consolidates the existing legislation and includes any changes made under the Bill is just not long enough. Each change to the regulatory regimes will take time. Public consultation must be conducted and amending regulations must be laid, debated and so on. We do not intend—in fact, it would not be possible—to front-load policy changes into the first half of 2021, let alone 2021 at all.

Noble Lords have spoken to the importance of consultation. I say it would not just be the Government front-loading legislation; it would be about asking the affected sectors to engage with a lot of consultation very quickly and in parallel. That does not seem the right way to go about it at all. It inevitably means that the sorts of exciting policy changes that support our life sciences sector and protect patients will take an enormous amount of time to stand up. Developing and consulting on policy proposals that require legislative changes takes time, as does the drafting of any proposed legislation. Before getting to the point of drafting the legislation and so on, you need to have made an assessment of what it would be appropriate to consolidate —and that takes time.

The Human Medicines Regulations 2012 were the product of a consolidation exercise that required extensive consultation. Consultations were run while explanatory documents setting out changes so far, and so on, were all prepared before the regulations were made. Let me be clear on the timescale involved in that exercise. A concept paper was issued by the MHRA in 2009. There was an expectation that consolidating human medicines regulations, including looking at the Medicines Act 1968, would take around three years to complete. That concept paper was put out to consultation; a response was published and further consultation took place in 2010.

The first complete draft of the regulations was published in August 2010 and a number of specific consultations also run in that year. A further consultation, following the consultation on the draft regulations of August, was run between October 2011 and January 2012. Three years is the time it takes to do the comprehensive exercise that the noble Lord, Lord Patel, alludes to in his amendment, and that exercise did not involve making up new primary legislation in the first place: it resulted in the Human Medicines Regulations 2012. The noble Lord has extended his amendments to medical devices and veterinary medicines as well.

The noble Lord cannot mean us to start a review the day after this Act is given Royal Assent, with the intention of bringing forward proposals within three years. There would be no legislation made under the Act to assess. I cannot see an exercise of seeing what to consolidate and then preparing the drafting taking less than a year altogether. In fact, it would more likely take much longer if the consolidation is intended to be as far-reaching as the noble Lord and others have very powerfully indicated. Taken together, the noble Lord’s amendments would mean that the process would need to start by 2022, but not all the legislative change to be brought forward under the Bill’s powers would yet be made and in effect.

I anticipate that a consolidation exercise as proposed by the noble Lord would wish to consider the practical effects and operation of such a complex and comprehensive body of legislation. In order to do that, we would need time for the secondary legislation to be made to deliver policy. Industry then has to comply with revised regulatory changes and the MHRA needs to assess how it works. This does not, as the noble Lord may recognise, amount to a realistic exercise. We will not have all the pieces to assess before he asks us to conduct the assessment and also provide an alternative. Change takes time. The standstill period for medical devices, for example, lasts two and a half years, in recognition of this, so while some changes are likely to be made to the regulatory regimes within three years, some will not. When his proposal amounts to no more than a year of operable amending legislation to assess and consolidate—perhaps less—it is therefore impracticable.

This issue is compounded by the noble Baroness’s Amendments 2, 27 and 40, which would introduce a sunset clause to the regulation-making powers in Parts 1, 2 and 3 of the Bill, in effect creating a new cliff edge at the end of three years, after which the existing regulatory regimes cannot be updated. If what the noble Baroness seeks is similar to what the noble Lord, Lord Patel, seeks—an assessment of whether secondary legislation is the right place for the regulatory regimes—I say to her that the means simply do not fit the ends. Introducing a cliff edge in legislation is unhelpful. It forces legislation on to the timescale of a sunset clause. It does not allow for pandemics or for the consideration of new developments that arise and need to be addressed.

The noble Baroness’s amendments would further compress the timescale, stripping out another year. Working back from a sunset clause of three years’ time, we would need Royal Assent of a new Act by then. Let us be generous and provide for a year of parliamentary scrutiny. We began this Bill in February last year; it is January now and we must allow parliamentary drafters to do their job of translating policy intent into clauses. The noble Baroness and the noble Lord have both argued in favour of a very different drafting approach: let us give them, say, a year. While that may seem a long time, I suggest that many noble Lords have experienced the challenges of drafting amendments. There are questions about intent and about the choice of language, and these would apply to tens and possibly hundreds of clauses. Suddenly, that time is not very long at all. That then leaves us with a year from Royal Assent to begin the drafting process—not even the assessment process. All the problems I have already mentioned, including the inability to set up a regime to assess and not only pass legislation but implement that legislation, apply, but much more urgently.

We must also consider the impact on those who are being regulated. The arguments I advanced in Committee on the uncertainty that this would create for businesses, manufacturers and, importantly, patients apply very gravely but would become even more critical. In effect, we would be making regulation in 2021—potentially substantive, bold new regulation to protect patients from harm and ensure the highest standards of safety for medical devices—but we would also be saying that this would be immediately under review, and potentially completely rewritten within three years. The new policy to be delivered by these regulatory changes would not be able to come into force, be implemented and enforced before we would be back here again. I simply cannot think that this is good regulation.

I am sympathetic to the issue of how Parliament assesses our plans. There are, of course, avenues open to Parliament to consider whether it wishes to express a view to the Government on any particular topic. We have Select Committees to scrutinise government policy and we have provided for a reporting requirement in the Bill that gives Parliament the opportunity to reflect on the legislation we have made under the Bill in the first two years and any plans we have at that point to make further changes in response to concerns and proposals raised in relation to it. There are institutions such as the Law Commission that can be called upon to take a view on whether legislation is the right legislation, or too complex. However, if noble Lords want me to say, “In three years, we will have made changes under this Bill that are right to consolidate, and we will be in a position then to review and assess and produce something for Parliament to look at,” I simply cannot give them that assurance; nor can I say anything similar to the noble Baroness.

We need to make changes to the regulatory regimes and follow the full and thorough processes to do so, including public consultation and, most likely, draft affirmative amending regulations. We need to have them working, understood and operable by industry and the regulators. Getting that up and running is where I think we need to direct our resources, before we can think about reviews of how it works. To that end, I hope the noble Baroness understands why I am not able to concede here. I hope she feels able to withdraw her amendment and that the noble Lord will not feel compelled to press his.

[Baroness Thornton (Lab)]

I thank the Minister for that. The words, “Yes, Minister” came to mind. It was a very long, wordy way of saying no, but I suppose he had to say it. I thank the noble Lords, Lord Patel and Lord Kakkar, the noble and learned Lord, Lord Mackay, and the noble Baroness, Lady Jolly, for their support and their speeches, as well as my noble friend Lord Hunt and other noble Lords. I particularly agreed with the noble Lord, Lord Naseby. Although we may disagree about sunset clauses, he absolutely hit the nail on the head about the need for consolidation. We link these together because we think there needs to be a time limit.

The Minister said absolutely nothing about what he thinks may happen next. It is simply not acceptable, and the House of Lords scrutiny committees—the Constitution Committee and the Delegated Powers Committee—said that it is not acceptable, democratic, accountable or even safe to continue to run this area of public policy simply by regulation. Since the Minister and the Government have not brought forward anything that actually tackles that problem, that is what this suite of amendments seeks to do. All the discussion we have had in the past hour tells me that we are right to do this.

I say to the noble Lord, Lord Lansley, who mentioned the Law Commission during our discussions about this, that that is a bit of a phantom. We all know that the Law Commission works on a three- to four-year cycle. It is a law unto itself: the Government cannot instruct the Law Commission to do anything, quite rightly. That may or may not be the right way forward, but it could take 10 or 15 years: it certainly does not hurry itself. So, in theory it is quite a nice idea, but I suspect that it would probably not work within the time limits we have before us.

I listened carefully to the Minister. It was a classic explanation of why something cannot be done and, on that basis, since the Minister seems to think that nothing can be done, I beg to test the opinion of the House.

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[Baroness Jolly (LD) [V]]

My Lords, these amendments, led by my noble friend Lord Sharkey with eminent cross-party support, replace the affirmative procedure for delegated powers in the Bill with the super-affirmative procedure.

Because of the skeleton nature of the Bill, outlined in the previous group, it is key to ensure that Parliament is able to properly scrutinise regulations made under the Bill. The super-affirmative procedure, which affords a committee of either House the opportunity to comment on a draft of the regulations and make representations, is in our view the best way to do it.

The past year has made clearer than ever the need for outward-facing health policy with public health and safety at its heart. The regulations brought forward under this Bill are central to doing this, and the highest level of scrutiny is needed to ensure their success.

One of the first things I had to learn when joining the House was the sovereignty of the House. My 10 years in your Lordships’ House have taught me to spot Henry VIII powers and call them out. As the noble Baroness, Lady Andrews, said, these amendments are hardly revolutionary, so I urge the Minister to accept them.

We need well-grounded legislation, and this Bill gives the department carte blanche to do what it likes. The amendments tabled by my noble friend give Members of the House the opportunity to scrutinise in a proper way and that, after all, is what the public expect of us.

[Baroness Thornton (Lab)]

The noble Baroness, Lady Jolly, and I are not in a competition about who can speak most briefly, but we have promised the Minister that we will—I overshot my promised three minutes by a minute in an earlier speech.

I say from these Benches that we will support this amendment and we are very pleased to be doing so. I reread the debate and discussion in Grand Committee, and I was actually so impressed with my remarks that I am nearly tempted to read them out again, but I will not do so. I also have to say that the whole debate was very good and important.

As my noble friend Lord Hunt says, this is not just about this Bill; this is about how the Government intend to move forward in terms of legislation and policy and subject themselves to appropriate scrutiny. That is what this amendment is about, in our view, and that is why we will support it.

[Lord Bethell (Con)]

My Lords, I am afraid I will breach the convention on short speeches, but only because this has been an incredibly powerful debate. The points were made very thoughtfully, and I am grateful for the fact that they were made briefly. I want to tackle them head on and perhaps, I hope, persuade the noble Lord, Lord Sharkey, to back off from these amendments.

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Moved by

[Baroness Thornton]

5: Clause 1, leave out “public health” and insert “the health and safety of the public”
Member’s explanatory statement
This amendment provides that the appropriate authority’s overarching objective in making regulations under Clause 1 must be safeguarding the health and safety of the public.

[Baroness Thornton (Lab)]

As I said to the noble Lord and the Bill team yesterday, these are probing amendments and I do not have any intention of pressing them. That is because I accept that the Minister and the Bill team have done a very good job of making this part of the Bill work much better.

It is always worth rehearsing in the Chamber some of the arguments that we have had outside the Chamber, because people often go back to the Hansard record to ask why we changed words from this to this. That is why the noble Baroness, Lady Jolly, and I put down some of these amendments. We have had some extremely useful discussions outside the Chamber, as we should have done, so I hope the noble Lord understands that that is why these amendments are being put today.

Under my Amendment 5, the overarching objective in making regulations under Clause 1 must be safeguarding public health. This is a probing amendment on the difference between “public health” in the government amendment before us today and the “health and safety of the public”, which was the phrase used in the amendment introduced in Committee. It is worth explaining why we accept that that change was sensible.

It is my understanding that “public health” is a broader and more subjective concept that may encompass economic interests, or may relate to increased pharmaceutical investment and innovation, and other factors beyond health and safety, which may conflict with them in some circumstances. Does the Minister agree that we have to explain the less strong commitment that is included in the Bill? Safeguarding public health is also not the same as protecting the safety of medicines and medical devices. It is very important that we are clear about that in the powers given to the Secretary of State in determining what would contribute to safe- guarding public health.

I congratulate the drafters on changing “attractiveness” to “favourability” and “benefits” and “risks” in my Amendments 12, 34 and 48. These amendments seek to probe the criteria that determine whether benefits outweigh risks and require the assessment to be published. The government amendments in this group replace the consideration of UK attractiveness with reference to it being a “favourable” place in which to conduct clinical trials and manufacture and research new medicines, medical products and services. The theme that runs through the whole of this legislation, as has been mentioned by many noble Lords, is that that is the place we want to be in, and the country we want to be, as we move forward.

Proposed new subsection (3A) looks like an attempt to allay concerns, stating that, where regulations impact on safety, they may be made only if the benefits outweigh the risks. It is worth putting on the record the discussion that we had about benefits and risks. Risk and benefit analyses are a well-established feature of clinical trials regulations and ethics committees, but they normally have more well-defined parameters than simply a risk-benefit assessment, yet these are precisely the regulations that these powers will allow to be made. This is why we need to make sure that we are clear what we are talking about here. This comes back to scrutiny and the need for the ability to scrutinise the Government’s assessment of risks and benefits in making regulations. These arguments pertain to Clause 9 for veterinary medicine and Clause 14 for medical devices. That is why we wanted to have this discussion.

[Lord Sharkey (LD) [V]]

My Lords, I welcome the amendments in this group. They add clarity to the obligations laid on the Secretary of State in making regulations under Clause 1(1) and its counterparts.

I particularly welcome Amendment 12 in the names of the noble Baroness, Lady Thornton, and my noble friend Lady Jolly, as it seems particularly important. It requires the Secretary of State to publish the criteria used in determining the benefits and risks caused by regulation and to set out how they have been weighed against each other. This amendment touches on the whole issue of transparency in devising regulations. The level of transparency that Amendment 12 requires should certainly apply to the factors listed in the Minister’s Amendment 9. These factors, which the Secretary of State must have regard to, are the safety of human medicines, the availability of human medicines and the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to carry out research related to human medicines, conduct clinical trials, or manufacture or supply human medicines. These are all clearly important, and I am glad that the Minister has added manufacturing to this list, as I suggested in Committee.

The list contains three rather vague notions: “likelihood”, “favourable” and “being seen as”. For all these terms, we need to know what definitions will be used and what evidence will be required in support. For “being seen as”, the question arises: being seen as by whom? What weight will be given to different views from different sectors? If, for example, it turns out that academic researchers and pharma companies have different views about the favourability of the UK, how are they to be weighted? On “likelihood”, could the Minister say whether he considered the word “desirability” instead, which seems closer to what we want here?

I hope the Minister is able to give reassurance on the points I have raised and that he accepts the merits of Amendment 12 and its counterparts.

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[Lord Bethell (Con)]

My Lords, I completely concur with the noble Baroness, Lady Jolly. This has been a fascinating debate but I will restrict my comments to a few specifics in answering some of the questions raised by noble Lords. I shall start by talking briefly about risks and benefits, which I hope will provide further reassurances to noble Lords regarding their questions on these points.

A regulatory change that, for example, makes changes similar to those made to ensure the smooth vaccination programme for Covid-19, will require different assessment to those that change the medical devices regulatory regime to step up scrutiny of medical devices. The noble Lords, Lord Patel and Lord Kakkar, spent some time in Committee speaking to the importance of medical device regulation, and I agree with them. The amendments that I have tabled are silent on whether the impact on safety must be negative or positive to have the “lock” kick in. It applies to both.

However, it will come down to what the change is in order to determine what constitutes a risk in that scenario versus a benefit. That is obvious in the case of the Covid vaccine rollout. There is greater benefit to a smooth rollout of the vaccine programme than the risk of increasing the number of healthcare professionals who can deliver it. Risks can be mitigated, and they should be. Changes can also be highly technical. They may affect the safety of medicines or medical devices in a minor way but not to the same degree or extent as other changes. It would be impracticable to develop criteria that apply in all circumstances to all regulatory changes.

In response to my noble friend Lord O’Shaughnessy, I should reassure him that it is not our intention to in any way water down or reduce standards in the life sciences area. Instead, it is our intention to use this legislation to champion the UK’s wonderful life sciences sector.

We have often spoken of safety—I thank the noble Baroness, Lady Thornton, for her words on that matter—and of the vital importance of the regulator putting this at the heart of its work. Our regulator is stuffed full of scientists and experts. They are able to support the Secretary of State in making that assessment, based on the evidence. Would this change impact the highly regulated safety considerations, and are they the right ones to make? We need to empower those experts to make those recommendations, in specific circumstances. I hope that noble Lords agree with me that the Bill is better for the changes that we have already sought to make, that the questions behind these further changes are answered, and that we have reached a point of conclusion.

[Baroness Thornton (Lab)]

That debate was definitely worth having, notwithstanding the fact that the noble Lord, Lord Lansley, explained the process that we had gone through when discussing what to do and how to improve the Bill regarding these aspects. They were important discussions. The noble Lord, Lord O’Shaughnessy, asked pertinent questions that the Minister has answered and are now on the record. I thank the noble Baroness, Lady Jolly, for explaining why we felt that it was important to have this discussion. I also thank other noble Lords for their remarks and the support they have given. I beg leave to withdraw my amendment.

Amendment 5 (to Amendment 4) withdrawn.

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[Baroness Jolly (LD) [V]]

My Lords, this amendment, led by my noble friend Lord Clement-Jones, would narrow the use of data in relation to falsified medicines to that which ensures patient safety. The use of patient data is a really delicate issue. As currently drafted, Clause 3 allows for regulations to be made about

“the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.”

The Minister has said that we want to explore creative uses of information. I am not quite sure what the general public would think of that statement. I am not quite sure what I think of that statement. As my noble friend Lord Clement-Jones has said, this is an incredibly wide remit granted to the Government. Restricting it to information that ensures patient safety, as in the amendment, will help protect patients’ information. In his summing up I would like the Minister to outline how this amendment will work in practice, and we will consider whether this might be brought back at Third Reading.

[Baroness Thornton (Lab)]

I am grateful to the noble Lord, Lord Clement-Jones, for his full and comprehensive explanation of the background thinking behind this amendment. It is clearly important that we understand and have clarity about the scope of Clause 3, and it is that clarity we seek from the Minister this evening. As my noble friend Lord Hunt said, we are urging the Minister to respond about how Clause 3 might be used. It is not good practice when you are law-making to put something in a Bill that might just come in useful at some point. The House probably needs a wider explanation and reassurance about this clause and how it will be used.

[Lord Bethell (Con)]

My Lords, I am enormously grateful for that helpful debate. Let me try to provide some of the clarity and reassurances noble Lords have sought. Amendment 14 to Clause 3 would add constraints to the use of data collected as part of the operation of any national falsified medicines scheme. I understand that the intention of Amendment 14, in the name of the noble Lord, Lord Clement-Jones, is to prevent the use of data collected for any additional use other than for the purpose of ensuring patient safety. We discussed this at length in Committee and afterwards, and I am grateful to the noble Lord and to other noble Lords who have given up their time to discuss this important issue. I know that the noble Lord has returned to this because he thinks it is worth continued debate, so I would like to reassure him that we have thought very carefully indeed about the power in Clause 3(1)(b).

I will start with the context of the power to use information collected as part of any potential future national falsified medicines scheme. First, it is important to note that the overarching principles of the Bill set out in Clause 1 also apply to, and are constrained by, the powers in Clause 3.

Amendment 4 in my name would ensure that in making regulatory changes under Clause 3—not just around how information will be used—the appropriate authority’s overarching objective must be safeguarding public health. In making that assessment, one of the things the appropriate authority must have regard to is the safety of medicines. Further, we have provided for a clear and unambiguous lock on patient safety; that is, as part of the decision-making process behind regulatory changes, if proposed changes have an impact on the safety of human medicines, the appropriate authority may make those changes only if the benefits outweigh the risks.

Secondly, of course, any regulations providing a framework for the use of the information will be subject to parliamentary scrutiny under the draft affirmative procedure. So, the scope of Clause 3(1)(b), which is the focus of our discussion, is not unfettered. I have discussed previously the statutory requirement to consult before making regulatory changes. Powers at Clause 3(1)(a), (2) and (3) will provide us with the means to make the regulatory changes to establish a verification system, if appropriate. As part of the effective operation of any such system, information will need to be collected. It is only once we have established the need for a verification system, and how it could work, that we can fully consider how the information it collects could be used to deliver additional benefits for the UK and for patients. Clause 3(1)(b) and (3) enable us to make appropriate best use of the data collected as part of a national focused scheme and ensure that the appropriate authority must have regard to the importance of ensuring that information is retained securely.

I want to reassure noble Lords by being as clear as I can that the data in question is that which would be collected for the prevention of the supply of falsified medicines—that is, as part of the operation of any verification scheme. I reassure noble Lords that we could not expand the data being collected using Clause 3(1)(b) as part of a verification scheme. However, we want to maximise the use of data collected as part of any verification scheme where it is in the public interest. In this, we would be learning from the EU scheme, which, for example, allows data to be used beyond patient safety for reimbursement purposes and in delivering a solution that works at a national level. I reassure the Chamber by being as clear as I can be that the powers in Clause 3 do not include the collection of patient data. As with the current European scheme, there are no plans for any future national falsified medicines system to collect patient data.

My concern is that putting such a limit on the use of information at this time could constrain or limit options ahead of our engagement with stakeholders. Critically, it may not allow for the data to be used for all potential research purposes. We are not in a position at this moment, ahead of our engagement with stakeholders, to list all the potential ways in which data sources might be combined for research and wider public health purposes, which can go beyond patient safety. We want to be guided by our stakeholder engagement and not to restrict that process unnecessarily before we have had a chance to hear how this data could be used for public interest purposes.

We are also proposing a staged approach to engagement and consultation. We are committing to a clear and separate consultation and engagement: first, a consultation around the need for and details of any system concerned with the prevention of falsified medicines; and secondly, a specific consultation around other uses of the data collected under Clause 3(1)(b). As I have said, any regulatory changes that will provide a framework for the use of the information would be subject to parliamentary scrutiny under the draft affirmative procedure.

I believe that by developing these proposals through consultation and engagement, we are improving our policy-making and its subsequent implementation. I remind the House that we have no scope for changing these provisions at Third Reading, so if the noble Lord, Lord Clement-Jones, wants to press the matter, he will need to do that today, but I hope instead that he will have had enough clarity and reassurances from the Dispatch Box to be able to withdraw his amendment.

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[Baroness Jolly (LD) [V]]

My Lords, today’s final amendment, tabled by the noble Lord, Lord Field of Birkenhead, and signed by my noble friend Lady Walmsley and the noble Baroness, Lady Meacher—all long-term campaigners on this issue—would require regulations to be introduced to allow doctors to prescribe medicinal cannabis products. I know that the movers of the amendment have been campaigning for ever—probably as long as I have been in the House—and can be excused their despair at the inactivity of GP prescribers.

The Home Office changed the status of medicinal cannabis two years ago, after a long campaign, but it has not been widely prescribed. The need for clarity on this matter was brought to the forefront by the news that nine year-old Alfie Dingley, whose use of medicinal cannabis has greatly improved his health, is no longer able to access his medication from the Netherlands due to Brexit. The Lib Dems have long been advocates of making medical cannabis accessible to those whose health would greatly benefit from it, and we support this amendment.

Will the Minister tell us what she can do to persuade the medical profession that cannabis has real medicinal value? Why are doctors deaf to children such as Alfie, and why are children such as Alfie and his parents left in the lurch? I hope that the Minister will be able to accept the invitation from the noble Baroness, Lady Meacher, to join her in a meeting with Dr June Raine, the chief executive officer of the MHRA.

[Baroness Thornton (Lab)]

The noble Lord, Lord Field, will know from this afternoon’s Question that I have huge sympathy on this issue, and I also completely recognise the frustration that exists around this subject. As I said earlier, “Come on, Prime Minister: if you can solve Brexit, in your own terms, I am sure that you will be able to solve this one, too.”

“Irresponsible” is not a word I would use to describe the noble Lord, Lord Field. He was very temperate in his introduction of the amendment. It is shameful, as the noble Baroness, Lady Meacher, said, that only three prescriptions have been issued properly by the NHS for free use. That means there is something is seriously wrong here. I thank my noble friend Lord Hunt, who is quite correct: this does require political muscle. The noble Baroness, Lady Bennett, is quite right, because this issue also completely exposes the inequalities we see in our society, whereby people who are fortunate enough to be able to afford to buy cannabis products can do so, while those who cannot, cannot, and then they suffer the consequences of that—literally. The noble Baroness, Lady Jolly, mentioned despair, and I agree with her.

So I do think that, as a result of this short but very potent debate, the Minister needs to commit at least to the meeting with the MHRA and the movers of the amendment.