Amendment 2

Medicines and Medical Devices Bill - Report (1st Day) – in the House of Lords at 3:15 pm on 12th January 2021.

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Baroness Thornton:

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.

Photo of Baroness Thornton Baroness Thornton Shadow Spokesperson (Health)

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.

Photo of Lord Patel Lord Patel Chair, Science and Technology Committee (Lords), Chair, Science and Technology Committee (Lords)

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.

As has been mentioned, the House of Lords Constitution Committee recommended that, although delegated powers are appropriate to make provision for minor and technical matters, it is essential that primary legislation is used to legislate for policy and other major objectives. The risk of delegated powers that provide significant flexibility is that substantial policies are amended, and not merely implemented, by secondary legislation. That was also emphasised in the report of the Delegated Powers and Regulatory Reform Committee, which concluded that the Bill represents an unjustified delegation of power. I admit that the Government state that the Bill is intended to be primary legislation and they have brought in amendments to improve it, but, although amendments in Committee increased the scrutiny that these powers will be subject to, they still cover wide areas of policy that should properly be the subject of primary legislation.

As the Bill stands, the delegated powers conferred would allow the Government to make substantial policy changes in these areas through secondary legislation as a matter of course into the indefinite future. These powers conferred by the Bill go far beyond what is either necessary or prudent, and for that reason there should be a time limit on them. Therefore, I support this amendment.

Before speaking to my own amendments, I thank the noble and learned Lord, Lord Mackay of Clashfern, the noble Baronesses, Lady Thornton and Lady Jolly, and the noble Lord, Lord Kakkar, for putting their names to them. My amendments would require draft consolidated legislation for human medicines, veterinary medicines and medical devices. Together, the new clauses that I propose and the other, related amendments would require the Secretary of State to publish draft consolidated legislation within three years. I realise that that is a tall order, and there might be some discussion about the period required to streamline the existing regulatory framework.

As I said, these amendments are linked to the one moved by the noble Baroness, Lady Thornton, providing for the three-year sunset provision. They would create an obligation to draft primary consolidating legislation in respect of human medicines, veterinary medicines and medical devices and are intended to be read together. The need for clauses requiring consolidated legislation is inextricably tied to the time-limiting of powers conferred by the Bill, as primary legislation will still be needed to form the basis of the regulatory regimes in these areas.

Of equal concern is that the existing regulatory regimes for medicines and medical devices are complex and unwieldy, spanning multiple pieces of primary and secondary legislation that implement several EU directives. This existing complexity has only been added to by several more pieces of secondary legislation in these areas, implemented in preparation for Brexit.

In Committee, I tabulated at length—it ran to a couple of pages—the different regulations that have been brought in, since the early days, because of the directives and regulations. For example, currently the regulatory regime for medical devices consists of the Medical Devices Regulations 2002, which implemented three different EU directives, and the Medical Devices (Amendment etc.) (Exit) Regulations 2019. The 2019 regulations were intended to ensure that the existing Medical Devices Regulations continued to operate correctly once we left the EU, but then other regulations were added to it. Those are examples of how many different regulations there are and, therefore, of the need for consolidation.

In addition to those uncertainties, in the final months of 2020 several new statutory instruments were laid before Parliament setting out complex new systems of regulation for medicines and medical devices as between Northern Ireland and the rest of the UK. The situation with Northern Ireland greatly adds to the complexity of regulation and has implications that we are only just beginning to understand. This matter should be of prime consideration. Once the shape of relations with the EU becomes more apparent, clarifying this complex relationship will become a priority for stakeholders and patients alike.

As it stands, the Bill merely grants powers to create future regulations through statutory instruments, simply adding to the existing regulatory complexity. Not consolidating or clarifying any of these issues could lead to further uncertainty among stakeholders about their obligations. This demonstrates the need both to time-limit these delegated powers and to ensure that consolidating primary legislation is introduced to Parliament after three years—although, as I said, I recognise that it might take longer—in order to subject any policy changes to adequate scrutiny.

The lack of detail in the Bill and the broad delegation of powers, with no indication of the substantial content of future regulations created by them, provide no clear or certain path ahead for regulations covering medicines and medical devices to be either scrutinised or relied on by stakeholders. For those reasons, these amendments and those linked to the amendment moved by the noble Baroness, Lady Thornton, will limit the extent of these broad delegated powers and require the Government to return with consolidated legislation in respect of human medicines.

Photo of Lord Mackay of Clashfern Lord Mackay of Clashfern Conservative

My Lords, I strongly support the amendments dealing with consolidation. I regard it as very important that the legislation that controls medicines, medical devices and veterinary medicines is consolidated in a way that makes it possible for an interested person easily to achieve knowledge of the regulations. After all, when you think of how important medicine is—we have just had a considerable debate about its safety—it is important to make sure that those who administer and operate the system know the rules. If you do not know what the rules are, the chances are that you will be misled into thinking that you know when you do not know at all. Therefore, it is important to make sure that we do everything we can to lay before those who practise these arts the true rule that has been set down, and it should be possible for them to reach it without too much research into a number of statutory instruments.

We just need to think for a moment about the current virus regulations. I have had occasion to look at them from time to time, and it is quite difficult to follow what is required at a particular moment in England, Scotland or other parts of the United Kingdom. If that is the position in relation to the virus, it is obvious that the general position in relation to these sciences as a whole will be even more difficult. Therefore, I regard it as vital—indeed, as a fundamental duty of government—to ensure that the regulations on these important matters are clear and the rules accessible.

I am not very keen on the sunset clause because, if it operated without consolidation, we would be in a pretty difficult position. Therefore, I regard it as vital to require consolidation.

I am aware of the difficulty of consolidation. For a short time, I was the chairman of the committee on consolidation and, when it sat, it was extremely difficult to get a quorum because people did not find the exercise interesting. But unfortunately, although it might not be very interesting or novel, in the sense that you are not doing anything very new, it is absolutely vital to allow the system to work properly. So I regard it as important that that is put into the statute as an obligation. If we are allowing the Government to legislate in these important areas by statutory instrument —the criticism has been levelled that they are doing so too much—that should be replaced in a reasonable time. Three years is probably quite reasonable, but I am very willing to hear whatever is said about that. I regard it as very important that this is an obligation on the Government as a condition of getting away with this method of legislating quickly in this area.

Photo of Lord Kakkar Lord Kakkar Crossbench

My Lords, it is a pleasure to speak in support of Amendments 29, 36 and 63 in the name of my noble friend Lord Patel, to which I have added my name, and broadly for the principles of the other amendments in this group. This is a critical area of public policy, as we have heard in this debate and in the excellent debates on these questions in Grand Committee. We have also heard that the regulations—the legislation attending medicines, medical devices and veterinary medicines, and their regulation in our country —have appeared on the statute book as a result of facilitations through the European Communities Act 1972. These represent in many ways a haphazard patchwork of regulation, created over time, with good intention, but obviously with the need to be consolidated and brought to a clear and precise place, as we heard from the noble and learned Lord, Lord Mackay of Clashfern, in such a way that any party interested in this vital area, which impacts on the lives of every citizen, can do so with simplicity, understanding obligations, understanding their rights and protections and being able to act confidently with regard to the rule of law.

The current regulations represent a challenge, and as a result of our departure from the European Union, there remains much contemporary regulation, agreed at the European level, with specific reference to clinical trials and medical devices, that has yet to be incorporated into domestic legislation, once again representing an important challenge with regard to the framework within which we are to proceed.

The Government rightly have stated that patient safety is at the forefront of their thinking when it comes to regulations regarding medicines and medical devices. To bring clarity will improve safety and will also achieve the Government’s other stated objective of ensuring that our country can continue to lead globally in the life sciences. We have seen the benefits of that leadership during the Covid pandemic, in terms of innovation, the application at scale and pace of that innovation for the benefit of our citizens, and the sharing of that knowledge globally.

Therefore, it is difficult to understand why Her Majesty’s Government would reject the opportunity to commit to consolidating legislation so that simplified, clear, effective and intuitive regulatory regimes exist in our country and can deliver the objectives that we all agree upon. In Grand Committee, we heard from the noble Lord, Lord Lansley, an interesting proposition that the Law Commission might be approached to support the task of consolidating legislation in this area of public policy. We have heard from the noble and learned Lord, Lord Mackay of Clashfern, that when he chaired a committee of consolidation there was little interest in dealing with some of the more demanding and exacting elements with the fastidious nature that is required to create effective consolidated primary legislation. Has the Minister had an opportunity to explore whether the Law Commission might be approached on the basis of the Law Commissions Act 1965, to determine whether it would be in a position to propose and engage with the consolidation of legislation regarding medicines, medical devices and veterinary medicines, as part of its forthcoming 14th programme under the obligations and opportunities afforded by the Law Commissions Act?

A failure to do this would be a lost opportunity. There is strong support for this Bill and a recognition that it must be passed in its current fashion as rapidly as possible. However, there is also a strong recognition that many of the issues are tied up in long-standing regulation created over a period of time, without the clarity and benefit of understanding the opportunities and risks offered by modern medical practice and innovation in healthcare. Not to consolidate would put our country behind rather than at the forefront of the opportunities that are afforded by being leaders in this area.

Photo of Baroness Masham of Ilton Baroness Masham of Ilton Crossbench 3:45 pm, 12th January 2021

My Lords, I support these amendments. It seems totally sensible to consolidate legislation so that it is not fragmented and some medicines do not get missed. Medicines and medical devices are vital to some people. We depend on many of our medicines and devices coming from abroad, so bringing legislation together for human and animal medicines will help prevent mistakes. We are an island and crossing the borders has already caused problems with filling in the forms. With much-needed medicines there should not be a risk of not receiving them.

Photo of Lord Lansley Lord Lansley Conservative

My Lords, I am very pleased to follow the noble Baroness, Lady Masham, who rightly emphasises the importance of accessible and understandable legislation in this area. There are two issues. As my noble and learned friend Lord Mackay of Clashfern said, there is the question of the sunset clause and the question of the preparation of consolidated legislation.

On Amendment 2 and a sunset clause, I believe that we should reserve the imposition of sunset clauses for legislation where we anticipate that those powers may not be needed in future. This is not the case with this legislation. With the end of the transition period we require our own domestic legislation for medicines, veterinary medicines and medical devices, so these regulations and these powers will be required.

The points made by the noble Baroness, Lady Thornton, quite legitimately, about the framework—the rather skeletal nature of the Bill as introduced to this House—must be dealt with in other ways, and in the group led by Amendment 4, we have substantive changes which make it a framework rather than simply a skeleton, and give us greater assurance about how the powers are structured in the Bill. I hope that if she reflects on it the noble Baroness will realise that shutting down these powers three years after Royal Assent would be a very taxing imposition. It would probably mean that in less than a year and a half, Ministers would be thinking about the reintroduction of legislation. We would risk the powers in this Bill being shut down in order for a Bill very like it to be introduced in a couple of years’ time. I see no intrinsic purpose in that, so I cannot support Amendment 2.

I do however want to specifically refer to the other issue of consolidation and Amendments 26, 39 and 63, in the name of the noble Lord, Lord Patel. There is a general proposition that people agree that, notwithstanding that additional regulations are going to have to be made in the weeks and months ahead using these powers, they will continue for the time being to be a complex mix of powers. Some will use this legislation, some will be in retained EU law and some will be in existing and other statutes and regulations.

What we want, as my noble and learned friend Lord Mackay of Clashfern quite rightly emphasised, is legislation in this important area that is understandable and accessible. These are not regulations for the benefit of lawyers; they are regulations for the benefit of practitioners, so they need to be very clear. The noble Lord, Lord Kakkar, helpfully and kindly referred to the points I made in Committee about the role of the Law Commission. As I understand it, indeed, I think it is well to remember two things about this. First, Law Commission members are the experts in the process of codification and simplification. Consolidation of legislation is valuable, but it is even better for it to be codified and simplified so that the end result is far more accessible and understandable to practitioners.

So I would very much recommend that we proceed by asking the Government to put the areas of human medicines and medical device regulation, and perhaps veterinary medicine as well, into the work programme of the Law Commission. As I understand it, the 14th programme of work for the Law Commission will be the subject of discussion between the Government and the Law Commission up to the spring of 2022. The work programme of course will happen subsequently. So I do not think any rigid timetable should be imposed. I hope that the noble Lord, Lord Patel, would not insist upon a three-year limit or his amendment for this purpose because I hope that, at the end of this process with the Law Commission, we will end up with something much better that is brought forward as a Law Commission Bill—which can have an expedited process of scrutiny and passage through both Houses. As a former Leader of the House of Commons, and therefore responsible for the Government’s legislative programme, I say that all the evidence tells me that, if a requirement to insert a Bill into the Government’s legislative programme can be avoided, it should be.

We have been there with a Law Commission Bill on the regulation of clinical professions and professions allied to medicine, which is still waiting for legislation, because it included not only codification and simplification but substantive changes to the policy—so I am afraid that it is still waiting. So let us not go down that route; let us do the very sensible thing rightly initiated by the noble Lord, Lord Patel, which is call for consolidation, making sure that it is not about changing policy but about making the legislation work effectively for the benefit of the various practitioners and those who depend on them. And let us work through the Law Commission. I hope that, if the Minister were to tell the House that he and the Government were willing to proceed in that direction, without a timetable in place, the noble Lord, Lord Patel, would not press his amendment when the time comes.

Photo of Lord Hunt of Kings Heath Lord Hunt of Kings Heath Labour

My Lords, rather like the noble Lord, Lord Lansley, I see this as a group of amendments in two parts. The argument for consolidated legislation from the noble Lord, Lord Patel, was very ably supported by the noble and learned Lord, Lord Mackay, and I very much support it. For those working in the health service or in industry, trying to wrestle with all the elements of legislation that cover health is very difficult indeed, and the case for consolidating legislation every so often is a very powerful one. I very much hope that the Government will take note of this, bearing in mind of course that there have been strong arguments from NHS England for a further NHS reorganisation Bill, which might be coming within a short space of time. On that issue in particular, the reorganisation of the NHS, the need to consolidate legislation following such a Bill becomes very persuasive indeed.

Where I do not really agree with the noble Lord, Lord Lansley, is on his remarks on Amendment 2 and his suggestion of a sunset clause. He argued that the problem with that is that you shut down the powers and therefore the Government need to produce another Bill, because we obviously need a regulatory regime. Sticking to the three years in my noble friend’s amendment would mean that work would have to start within 18 months. That does not argue against the principle of a sunset clause, although there can be debate about the length of time in which the new Bill needs to be enacted.

The fact is that this Bill conveys a huge number of delegated powers to Ministers. In a pungent analysis, the University of Birmingham points out that, while delegated powers may be needed to ensure responsiveness to the EU transition period and to meet the challenges of technology change, they should not be used indefinitely or relied on to implement matters of policy. This is the problem. If we take this Bill and we do not have some changes in the future, Ministers ever after will be able to ram changes to medicines and medical devices regulation through the House, and the amount of scrutiny in relation to secondary legislation is limited.

The Delegated Powers and Regulatory Reform Committee was very clear in criticising Ministers for failing to provide a sufficient justification for parts of the Bill adopting a skeletal approach. The recent report from the House of Lords Constitution Committee also said that it recognises

“that the existing powers to amend these complex regulatory regimes will cease to have effect on 31 December 2020 and that alternative arrangements are required. If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses.”

That surely must be right.

At Second Reading the Minister suggested that sunset clauses would emasculate the Bill, and in Committee he said that a sunset clause

“will not change the very good reasons why delegated powers are necessary.”—[

I think we come then to the fundamental argument: that many noble Lords disagree with the extent of delegation that is going to be given to Ministers for all time. The only proper defence against that is to agree to the kind of amendment my noble friend has proposed in relation to a sunset clause. For that reason, I very strongly support her.

Photo of Lord Naseby Lord Naseby Conservative

My Lords, in the past I have had the privilege of working with two pharmaceutical companies, a US pharmaceutical company Upjohn and Reckitt pharmaceuticals. I think that as a country we face a unique opportunity at this point caused by Brexit and a situation where we have a major industry which has all the potential to be a world leader. But this point in time is going to go away unless we act. This is a watershed Bill. It creates an opportunity to enhance the role of the UK Medicines and Healthcare products Regulatory Agency. The industry and all of us should want the UK to be an attractive market for investment in medicines, medical devices and therapies for all our UK patients. It creates an opportunity to make significant improvements in UK clinical research environments and, very importantly, it increases the commercial trial activity to make the UK the number one destination for life sciences supporting UK public health.

This is a real opportunity but, as other noble Lords have said, there is a mish-mash of no end of Bills that need to be consolidated. I support what the noble Lord, Lord Patel, said. Having worked with two of these major pharmaceutical companies and sat down with their lawyers, as I have in the past, particularly in the days of PPRS, if you are in industry you realise that there is so much legislation to be so careful about. Consolidation therefore should be taken very seriously.

Sitting here this afternoon, I do not actually know what the right procedure should be. However, having been in the other place, I am very wary of Law Commission Bills. They do not have a history of working quickly and still do not necessarily result in something positive happening on the ground in the context in which they are working. I urge my noble friend on the Front Bench to sit down with, among others, the ABPI and the other leading authorities involved in this industry to talk about how we can get consolidation put together. That way, anybody thinking of investing in the life sciences in the UK will realise that we have a well-organised ship. They will know that they can choose the area where their own expertise is, and exactly what the situation is there.

As for sunset clauses, I have never been in favour of them in what I would call the creative part of industry. It seems that they usually do not work because the nature of this industry is that some developments take years and years to come to fruition. The market changes. Gosh, we have just had a prime case history in Covid-19, to which the world has responded—and, in particular, our people have responded. But even now, we do not know the answer to all the different phases of it. So I hope my noble friend on the Front Bench will recognise, as I am sure he does, that we have an absolute watershed Bill here, creating a huge opportunity for our country. However, personally I would not put a sunset clause in. I would like to see some work done, particularly to have consultations with industry on which consolidated legislation would really work.

Photo of Baroness Jolly Baroness Jolly Liberal Democrat 4:00 pm, 12th January 2021

As the noble Lord, Lord Hunt of Kings Heath, and others have said, these amendments relate to sunset provisions and consolidated legislation. As we have already heard, the Bill is largely a skeleton Bill and allows the Secretary of State or a relevant authority to make legislation by statutory instrument on policy issues relating to human medicines, veterinary medicines and medical devices. Can the Minister confirm whether the SIs referred to will come before the House? Will he also confirm that the SIs we see will live up to the expectations of the noble Lord, Lord Blencathra, and his committee?

It is important that there is a limit on how long the delegated powers should last. The amendments in the name of the noble Baroness, Lady Thornton, would mean that, after the suggested three years have elapsed, the policy objectives of the Government would be clearer and they could return with primary legislation. The amendments in the name of the noble Lord, Lord Patel, would require the Government to publish the consolidated primary legislation in draft form. We support these measures but, for the intervening period, we believe that the powers should be subject to the additional scrutiny required by my noble friend Lord Sharkey’s amendments in the next group.

Photo of Lord Bethell Lord Bethell The Parliamentary Under-Secretary for Health and Social Care

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.

Photo of Baroness Thornton Baroness Thornton Shadow Spokesperson (Health)

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.

Ayes 324, Noes 241.

Division number 1 Medicines and Medical Devices Bill - Report (1st Day) — Amendment 2

Aye: 324 Members of the House of Lords

No: 241 Members of the House of Lords

Ayes: A-Z by last name

Nos: A-Z by last name

Division conducted remotely on Amendment 2

Amendment 2 agreed.

Photo of Baroness Garden of Frognal Baroness Garden of Frognal Deputy Chairman of Committees, Deputy Speaker (Lords) 4:32 pm, 12th January 2021

My Lords, we now come to the group beginning with Amendment 3. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in this group to a Division must make that clear in debate.