Medicines and Medical Devices Bill

Debate between Lord Patel and Baroness Thornton

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

[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.

Medicines and Medical Devices Bill

Debate between Lord Patel and Baroness Thornton

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

[Baroness Thornton (Lab)]

My Lords, at last we begin the scrutiny of this important Bill.

Although we have been keen to make progress with the MMD Bill, if I might call it that, it is not at the expense of proper debate, and I am afraid we feel that some of the amendments before us today will not benefit from the contributions they deserve because of the clash with the Second Reading of the Internal Market Bill and the rules of the hybrid House, which seem to mean we lose the contributions of at least four, five or possibly six noble Lords who have either put their names to amendments or are keen to take part in our discussions today.

The procedure, if the House were sitting normally, is that noble Lords would “Box and Cox” between the Chamber and the Grand Committee. As it is, they are not allowed to do so and I put on record that either scheduling or rules need to ensure this does not happen again. I would be very grateful if the Minister and his colleagues ensured that the usual channels are aware of this. This clash will not deter those who are absent, I am sure, from making their contribution either later in Committee or on Report.

The group of amendments right at the beginning of this Bill concerns sunset provision, a time limit on delegated powers and draft consolidated legislation. As my honourable friend Alex Norris MP said at the beginning of the Committee session in the Commons,

“we should not just wave … off to secondary legislation without understanding what that might mean and whether there might be a better way to do it … The proposed arrangements allow the Secretary of State and his successors to make hundreds or more individual decisions to change our current regulatory regime into a markedly different one, one statutory instrument at a time, which I do not think is desirable.”—[Official Report, Commons, Medicines and Medical Devices Bill Committee, 8/6/20; col. 4.]

I agree with my honourable friend.

This is a skeleton Bill. Its aim is to provide the Government with powers to regulate on critical, life-and-death matters involving medicines, devices, humans and animals. It is at risk of inadequate scrutiny; it has an overreliance on delegated powers; it gives rise to potential regulatory divergence in Northern Ireland; it has a need for streamlined primary legislation, not statutory instruments; and it gives rise to concerns regarding patient and user safety.

It has to be said that the Delegated Powers and Regulatory Reform Committee and the Constitution Committee agreed with my honourable friend and us at Second Reading, and were particularly unimpressed by the delegated powers memorandum the department produced. It said:

“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made using the powers. The Government has not provided the exceptional justification required for this skeleton approach. We accept that regulatory regimes in policy areas such as these require frequent adjustment, and so need to be flexible, but the Government has not made a persuasive case for conferring largely unrestricted delegated powers that can be used to rewrite the existing regulatory framework. We recognise 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. This would allow Parliament to scrutinise a new bill which provides sufficient detail on the policy it is being asked to approve.”


This Bill gives Ministers very broad powers indeed. We acknowledge this and are seeking full justification for them. Those are just the opening remarks from both those committees, which agreed that Clauses 1, 8 and 12 contain inappropriate delegations of power and that the Government have failed to provide sufficient justification for this part of the Bill, adopting a skeleton Bill approach, with Ministers given very wide powers indeed.

Instead of seeking to justify such powers, the Government have downplayed them by suggesting that they are like-for-like replacements for the existing powers in Section 2(2) of the 1972 Act. The delegated legislation committee found this not to be the case. The Section 2(2) power is subject to a very significant built-in constraint; it is a mechanism for transposing into UK law EU rules on medicines and medical devices that the UK is required to follow. The new powers are subject to no such constraint; they would give Ministers free rein to legislate in those areas. The Government claim that the new powers are constrained in significant ways, but the reasons found for those constraints were described as “more apparent than real”.

I suggest that over the next few weeks we need to make those constraints real, democratic and accountable, and at the same time support medicine and devices safety and supply, and promote and protect innovation and research. Given the threatening no-deal scenario which seems to be looming, it becomes even more urgent that the issues dealt with in this legislation are clear and that the routes to ensuring medicine supply, safety, research and innovation are also clear and protected, in the interests of the NHS and patients, through parliamentary accountability.

This suite of amendments aims to open that discussion. Amendment 1 in my name and that of my noble friend Lord Hunt provides a sunset clause for Part 1 of the Bill, requiring the Government to return with primary legislation. We need this to happen because it is not satisfactory or democratic to run such an important part of public policy through regulation alone. We feel that three years is a generous, sensible and reasonable amount of time. It allows for a settling in of the new regime following Brexit and time for new legislation to be framed.

Our Amendment 140 follows the advice of the two committees and ensures that there is a time limit on delegated powers.

My Amendment 116 inserts a new clause which requires the Secretary of State to publish draft consolidated legislation within two years to streamline the existing regulatory framework. It offers the Secretary of State two years of that considerable power, but asks him—it might be “her” at some point—to return in two years’ time with a comprehensive set of regulations across medicines for humans and animals, medical devices and, critically, the proposed new regime surrounding the Medicines and Healthcare products Regulatory Agency.

This would provide a chance for proper consultation across the sector, including with patient groups, industry bodies and interested companies, as well as more parliamentary scrutiny to set up the regime that we all want—a safe one, an effective one and a world-class one. It would also give us two years of life outside the European Union and would really help us to land in that place and find out how different we intend to be, certainly in this sector. I beg to move.

[Lord Patel (CB) [V]]

My Lords, as I had four minutes to speak on Second Reading, it is inevitable that it will take me longer to speak to my amendments in Committee. I refer to Amendments 50, 67 and 115 in my name, and am grateful to the noble Lord, Lord Kakkar, for his support.

Amendment 50 requires consolidated legislation for medicines, veterinary medicines and medical devices. Together with Amendments 67 and 115, it creates the same obligation in respect of veterinary medicine and medical devices and intends to complement a later amendment calling for the powers of this Bill to be time-limited to three years. The Bill confers an extensive range of delegated powers in relation to medicines, veterinary medicines and medical devices. The Government state that they intend the Bill to be the primary legislation in this area while providing no substantive content to the law.

The powers granted in this Bill go far beyond what is necessary or prudent. The existing regulatory regime for medicines is complex and unwieldy, running to more than four pieces of primary and secondary legislation implementing several EU directives in preparing for Brexit. This complexity is mirrored in respect of medical devices as the Bill merely grants powers to create future regulation through such statutory instruments. It does not provide a clear picture of the future shape of regulations that can be scrutinised. This adds to the existing regulatory complexity.

The lack of detail in the Bill in its current form could lead to uncertainty among stakeholders as to their obligations. There is a need for clarity, for regulatory bodies, manufacturers, patients and other end-users, which makes the case for more streamlined primary legislation. The lack of detail in the current Bill, the broad delegation of powers with no indication of the substantive content of future regulation created by them provides no clear or certain path ahead for medicines and medical devices that can be scrutinised or relied on by stakeholders. For this reason, this amendment, together with similar amendments for veterinary medicines and medical devices, requires that the Government return with consolidated legislation in due course.

I refer briefly to Amendment 115, which relates to medical devices. As with medicines, the regulation relating to medical devices is complex and unwieldy. Currently, it consists of the Medical Devices Regulations 2002, which implement three different EU directives and the Medical Devices (Amendment etc) (EU Exit) Regulations) 2019, which came into force at the end of the EU exit implementation period and runs to over 200 pages of detailed amendments. The 2019 regulations were intended to ensure that the existing medical devices regulations continue to operate correctly, once we had left the EU, but they also mirror and implement key aspects of EU regulation on medical devices, Regulation (EU) 2017/745 MDR.

The regulations were due to be implemented this year, but following the European Union withdrawal agreement, they will come into effect at the end of the transition period. The MDR was also due to be implemented during the transition period. Had it done so, it would have automatically become part of UK law. However, due to the disruptions of Covid-19, the implementation date of MDR was postponed by a year. The situation is complicated further by the ambiguous operation of the 2019 regulations in light of the postponement until the end of the transition period, much like the MDR. The 2019 regulations contain clauses which set specific dates and periods of transition between the implementation of different provisions and considerations.

I hope I have made the point that there is a need to have consolidated legislation. The current Bill will simply add to the existing body of regulations without consolidating or clarifying any of these issues. This demonstrates the need to time-limit these delegated powers and ensure that consolidation primary legislation is introduced to Parliament after three years, in order to subject any policy changes to adequate scrutiny.

Healthcare (International Arrangements) Bill

Debate between Lord Patel and Baroness Thornton

Report stage (Hansard): House of Lords
Tuesday 12th March 2019 Lords Chamber

[Lord Patel (CB)]

My Lords, I had amendments that the Minister responded to at the Dispatch Box and I accepted her explanation at the time. Now I take the point that the noble Lord, Lord Clement-Jones, is trying to raise, that those principles that she enunciated about data protection included the Caldicott principles. As that reassurance was given at the Dispatch Box, I think it will cover the issue.

[Baroness Thornton]

My Lords, I added my name to the amendment in the name of the noble Lord, Lord Clement-Jones, and I am grateful that he has made the argument so I do not need to repeat it. Of course, I spoke about this in Committee and, like other noble Lords, I was reassured at the time by the explanation given by the noble Baroness, Lady Manzoor. Since then, however, the Bill team has actually made available the Bill data processing factsheet, which is very useful. It explains things in great detail, so I wondered whether it might be a good idea if this was given to everybody involved with this Bill. I do not know whether the noble Lord has seen this, but it is a very useful piece of information. Otherwise, I was satisfied in Committee, and if the Minister answers the questions, I am sure that I will remain satisfied.

Healthcare (International Arrangements) Bill

Debate between Lord Patel and Baroness Thornton

Committee: 1st sitting (Hansard): House of Lords
Tuesday 19th February 2019 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I start by welcoming the Minister to her first experience of the House of Lords in Committee. I hope that it will not be too painful an experience and I wish her well over the next two days in Committee.

In moving Amendment 1, I shall speak also to the other amendments in this group. These amendments deal with the powers and scope of this legislation. Amendment 1 reduces the scope of the Bill, enabling the Secretary of State to make healthcare agreements with the EEA, European Union and Switzerland only. Amendment 2 is a paving amendment limiting the scope of the Bill. Amendment 3 in the name of the noble Lord, Lord Marks, addresses the exercising of the power to make healthcare payments. Amendment 5 would prevent regulations being made unless they specify the process for settling disputes, including the names of responsible bodies and their jurisdiction and procedure.

Amendments 12, 13 and 14 are paving amendments limiting the scope of the Bill. Clause stand part and Amendment 44 are both in the names of the noble Lords, Lord Patel and Lord Kakkar, and the noble and learned Lord, Lord Judge. I say to the Minister that had these three distinguished noble Lords put down an amendment on a Bill that I had been dealing with, I would pay close attention to what they had to say; certainly, the rest of us will be doing so. Amendments 45, 46 and 47 are all paving amendments concerning the scope of the Bill; they include changing its title to reflect its new scope.

The amendments in my name and that of the noble Baroness, Lady Jolly, as well as that in the name of the noble Lord, Lord Marks, clause stand part and Amendment 44, are all expressions of concern to bring the scope of the Bill in line with the issue we face today, with increasing urgency: that is, the looming date of exit from the European Union and its implications for reciprocal healthcare. We need to discuss what the legislative framework should be to facilitate reciprocal healthcare in the circumstances of both Brexit with a deal and Brexit without a deal. What are the appropriate powers needed by the Government under each of these circumstances?

Unfortunately, what we have before us is a Bill that casts its net much wider than the European Union. Noble Lords do not have to take my word for this—the House of Lords Constitution Committee, whose report was published yesterday morning, says:

“While the exceptional circumstances of the UK’s departure from the European Union might justify legislation containing broader powers than would otherwise be constitutionally acceptable, this does not extend to giving effect to new policy unrelated to Brexit. The Bill should be limited to the making of arrangements for future reciprocal healthcare arrangements with countries that participate in the existing European Health Insurance Card scheme”.


The DPRR Committee noted in its first report in November the “breath-taking scope” of this Bill, commenting that,

“the scope of the regulations could hardly be wider”.

The committee said:

“It is one thing to introduce skeletal legislation needed in the event of no EU withdrawal agreement. But this Bill is as much to do with implementing future reciprocal healthcare agreements entered with non-EU countries. Indeed, it goes much wider than merely giving effect to healthcare agreements and covers the provision of any healthcare provided by anyone anywhere in the world.”


It concluded that the powers in the Bill were,

“inappropriately wide and have not been adequately justified by the Department”.

In other words, let us leave making healthcare arrangements with the rest of the world until we have dealt with the issues before us today: the 27 million EHIC holders and the healthcare needs of several hundred thousand fellow citizens in both the EU and UK.

When addressing the issue of the scope of the Bill in relation to reciprocal healthcare agreements with states other than the EU, the Minister says in her letter sent to noble Lords last night that,

“it is appropriate that we take this opportunity to consider how we may want to strengthen these”—

that is, other agreements—

“and seize the opportunities that a more global approach following EU exit can offer”.

The letter goes on to say that the Bill has an important forward-facing policy aim. I realise that these are seductive words, as we all want to be part of forward-facing policies—of course we do—and, post Brexit, there is no doubt that we will need to address several issues, which will include healthcare trade policy. The Minister is at pains to assure us that the Government are committed to public service and to ensuring that the NHS is free at the point of use and adequately funded. Perhaps we can have a discussion some other time about the adequacy of the funding, but the Minister was firm in her statement about this matter at Second Reading, and I would have expected no less. However, her assurances miss the point which I made then and will make again for clarification, and which I think the Minister needs to address. The scope and powers of this Bill enable the Secretary of State to arrange contracts with providers to our NHS from anywhere. The noble Baroness has not denied this, either at Second Reading or in the letter she sent yesterday. This matter concerns those who might be suppliers of services and goods to our NHS. While it might be the legitimate scope of a trade Bill, or even a future healthcare trade Bill, it is not appropriate in this Bill, which seeks to protect and ensure reciprocal healthcare across the European Union.

My contention at Second Reading and my contention now is that the breadth of scope which introduces new Brexit policy, combined with the “breath-taking” powers in this Bill, pretty much confers on the Secretary of State the ability to make deals with anyone he wants to anywhere in the world. That is a matter for concern. Is it possible for the Secretary of State to undertake such deals? Perhaps the noble Baroness could tell us. Certainly, as was shown in the first Delegated Powers and Regulatory Reform Committee report in November, and repeated in its report last week, the Government have not yet convinced that committee and they certainly have not convinced these Benches.

The Constitution Committee takes the view that the Bill goes beyond the powers necessary to enable the Government to respond effectively post Brexit on healthcare arrangements and,

“allows for the creation of new policy relating to healthcare agreements with countries outside of the EU”.

I think the Constitution Committee is correct, particularly when it refers to the powers in the Bill and suggests that they should not extend to give effect to new policy unrelated to Brexit.

At Second Reading, I said to the Minister that the Government would have to convince the House—and certainly these Benches—about the new policy agenda, which is accompanied by huge powers which encompass the world. So far the Minister has not convinced me, but I would say that that is not her main challenge. She has not convinced either the DPRR committee or the Constitution Committee and that is a matter for major concern. I beg to move.

[Lord Patel (CB)]

My Lords, before addressing the amendments in my name and the names of my noble and learned friend Lord Judge and my noble friend Lord Kakkar—the clause stand part debate and Amendments 5 and 44—I welcome the Minister to the House and to her first experience of Committee. I sympathise with her, as she has to take this Bill through; she was not part of it from the very beginning, as it had already passed in the House of Commons. However, I have no doubt that she will do well.

I start by saying that if we were not in these times of uncertainty about leaving the European Union, this Bill—if it had been brought to the House in the state that it is in today—would have received the most stringent scrutiny and would have been drastically amended. However, because we do not want UK citizens who live in, work in and visit the European Union to feel the threat of not getting healthcare, we might be more constrained in the way we deal with this. I accept that this Bill is essential to serve the needs of UK citizens who live in EU countries and EU citizens who live in the United Kingdom, allowing them to benefit from the reciprocity of the current healthcare arrangements.

I have to say that, in all its clauses, this Bill is quite wide in its power and scope and goes way beyond what is required to deliver the EU arrangements. I could go on, but the House’s Delegated Powers and Regulatory Reform Committee laid it out much more clearly, and I hope my noble friend Lord Lisvane, who is on that committee, has something to say. He nods, so I am sure he will join in. I summarise what the committee said regarding the Bill:

“There is no limit to the amount of the payments … no limit to who can be funded world-wide … no limit to the types of healthcare being funded … regulations can confer functions”,


anywhere in the world. The committee continued:

“The regulations can delegate functions to anyone anywhere”.


That shows how wide the Bill’s scope is.

European Union (Withdrawal) Bill

Debate between Lord Patel and Baroness Thornton

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

[Baroness Thornton (Lab)]

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

[Lord Patel]

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