Medicines and Medical Devices Bill

Lord Hunt of Kings Heath Excerpts

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

[Baroness Jolly (LD) [V]]

My Lords, given that we are in Committee, I will not be making lengthy speeches, but I will raise what I think are the key issues in each of the groups. The amendments to the Bill relate to some of the constitutional issues. As a general rule, noble Lords do not much care for delegated powers because it is not considered good practice or procedure to give a Secretary of State carte blanche in any area. There are some areas in this Bill where the Secretary of State is being given powers that we would rather that he or she did not have.

As the Bill is skeletal and consists mostly of delegated powers, it is important and a good idea to ensure that appropriate steps are taken to set an end date on these, so sunset powers are being proposed. The noble Lords, Lord Lansley and Lord Kakkar, and the noble Baroness, Lady Thornton, have requested the Secretary of State to publish draft legislation to consolidate the legislation relating to human and veterinary medicine within three years of the Bill being enacted.

My noble friend Lord Sharkey and I have put our names to several amendments in this group. My noble friend calls for the super-affirmative procedure so that all powers given in the Bill will elapse after three years. I confess that this is the first time that I have seen that being used. The super-affirmative procedure involves an additional stage of scrutiny where Parliament considers a proposal for a statutory instrument before it is formally laid. This procedure is used for those instruments that are considered to need a particularly high level of scrutiny, which I think is certainly the case with this Bill.

Some of the amendments call for consolidation within three years, but in general what we are saying to the Minister is that there are not enough checks and balances. Please use the time between now and Report stage to look again, speak to Members of the Committee and bring forward government amendments—otherwise, I suspect that we may be voting on Report.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I have added my name to Amendments 1 and 140 tabled in the name of my noble friend Lady Thornton. As we are at the start of the Committee stage, perhaps I may remind the House of my membership of the board of the General Medical Council and my role as president of GS1 and the Health Care Supply Association.

I agree with my noble friend Lady Thornton about the clash between the first day of the Committee stage of this Bill and the Second Reading of the United Kingdom Internal Market Bill in the main Chamber. Today we are dealing with some of the most important debates in the whole Bill and when we come back on Report there will be a need to give more time to allow those people who could not be present today to make a full contribution to these debates. I hope that the usual channels will take that away. I am not quite sure about the procedure in these unusual circumstances, but in normal times I would have asked that the Committee stage procedure be used for these introductory debates on Report in order to allow for interventions. However, since interventions are now limited, that may not run well, although I think that noble Lords will understand what I am getting at.

This is an important Bill on patient safety and the health of our life sciences sector. It is striking in its brevity and in the extensive powers to be given to Ministers. The noble Lord, Lord Patel, has spelled out the wide range of delegated powers contained in the Bill, while a pungent analysis by my local university, the University of Birmingham, points out that, while delegated powers may be needed to ensure responsiveness in the EU exit transition period and to meet the challenges of technological change, they should not be used indefinitely or relied on to implement matters of policy. I am not going to repeat what the Delegated Powers Committee or the House of Lords Select Committee on the Constitution have said, but it is rare for two Select Committees to comment at the same time and in such a critical way about the skeletal nature of a Bill. It is to be hoped that the Government will listen carefully to what is being said.

At Second Reading, the Minister suggested that the sunset clause as proposed by my noble friend would emasculate legislation

“meant to give regulators the powers to be effective and to future-proof medical regulation in a fast-changing industry for many years to come. We must understand the impact on an industry that needs regulatory certainty or else, as many noble Lords have noted, will move elsewhere.”—[Official Report, 2/9/20; col. 433.]

I have to say to the Minister that most of the regulatory uncertainty has been caused by the Government’s failure to be clear about what regulatory regime they want for medicines and medical devices. They have now had four years to think about this and we are still nowhere near knowing what regulatory system they want to put in place. Are they going to go for alignment with the European Medicines Agency or do they want to strike out on their own? Do they want to ally with the US FDA? What on earth are the Government’s aims? The industry is at risk because of this huge uncertainty. The idea that we should allow the Government willy-nilly to get this Bill through and make whatever changes they want without the House treating it as primary legislation simply will not wash. I am absolutely convinced that the long-term regulatory system must be subject to detailed primary legislation. As far as I can see, the amendment to bring in a sunset clause is probably the most appropriate vehicle to ensure that that happens.

[Lord Kakkar (CB) [V]]

My Lords, in contributing to the first day in Committee on this Bill, I draw the attention of noble Lords to my registered interests, in particular to those as a professor of surgery at University College London and as the chairman of UCLPartners.

I support Amendments 50, 67 and 115 tabled in the name of my noble friend Lord Patel, to which I have added my name. The point has been well made by my noble friend that the ecosystem for the delivery of healthcare in our country and therefore the use of medicinal products, medical devices and veterinary medicines is a complex one that is attended by substantial legislation, much of which has been brought into force as a result of the European Communities Act 1972. It is therefore absolutely right, to echo a point made previously by the Minister, that there is a need for this Bill to ensure that such regulation can continue, so that we can continue to have a safe and effective healthcare system and take advantage of the essential requirement to avail ourselves of medicinal products and medical devices.

There is surely also an absolute obligation to ensure that regulation should avoid adding to the complexity that already exists. For those who have to labour under these regulations and ensure that they can present innovation and advances to benefit our fellow citizens within the context of the regulations, we should always be working to simplify them.

In this regard, we are all conscious of the fact that many different types of regulations touch on the healthcare system. There are those that pertain to ethics, and those that deal with the function and delivery of ethics committees and the evaluation of intervention at a local and national level. We have regulations that deal with the adoption and evaluation of innovation within the context of the MHRA, and with the evaluation of intervention and innovation pertaining to NICE. We have heard from the noble Lord, Lord Patel, about the medical device regulations enacted in 2002, which codify and implement various EU directives in this matter, and the substantial amendment attending medical device regulations in terms of the legislation passed as part of EU exit regulations in 2019.

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[Lord Woolf (CB) [V]]

I am most grateful to the noble Lord, Lord Lansley, for setting out the position we are in with such clarity. I will add just a few words to explain my involvement. It has already been pointed out that not many of my legal friends who I would expect to be concerned about this are present in Committee today. I am sure that the ones who one thinks of are busily engaged in the Chamber over a different piece of legislation which is causing them greater concern than the proposal here, although I believe that they would not disagree with my comments.

In this House, we naturally think as parliamentarians and are concerned about our process of scrutinising legislation, but bad legislation all too frequently ends up not being disputed in this House. That is not the end of the matter, however: the difficulties it creates then have subsequently to be sorted out, which is frequently done by judicial review in the courts. What the noble Lord, Lord Lansley, has said so well is very relevant to judicial review, and that is an area where I feel that, just as the doctors can comment about this Bill with a certain background of knowledge, I should refer to my entries in the register, which, at least with regard to judicial review, are quite important.

If the courts are to provide scrutiny at a later stage, they must know the purpose of the legislation. That is why what the noble Lord, Lord Lansley, has already said is so important. With blank cheques, the danger is that they can be used for all sorts of purposes. I have been trying, under the leadership of the noble Lord, to ensure that the blank cheques given by this legislation are as restricted as they can practically be, bearing in mind the situation in which we find ourselves.

I agree with what the noble Lord said about the amendments with regard to the present proposals. On the one hand, there is the proposal put forward by the Government; on the other is the proposal that the noble Lord, Lord Lansley, and I have suggested might be appropriate. My view, for the reason he indicated, is that our proposal is better, but, above all, I am attracted by the fact that what the Government are proposing is much better than what was there before. On that basis, with a degree of reluctance, I would be capable of being persuaded that we should accept what the Government offer, whereas I am quite satisfied that we should not have accepted what was there before.

Leaving the matter in that way, I hope that the further discussion which will no doubt take place will enable agreement to be reached on an amendment which achieves what is needed for the purposes I have indicated.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am glad that the Minister said that he was listening, and his amendments are important, particularly the one that makes the principle of the health and safety of the public the key consideration when making regulations under the parts of the Bill relating to human medicines and medical devices. He will be aware that concern was expressed by patient groups, in particular, about the Bill as originally drafted and the implication of the attractiveness provision. That concern takes us back to our first debate on “whither regulation in future”.

If we are not going to be aligned to the European Medicines Agency and are to plough it alone, the UK pharma industry will be at a huge disadvantage unless the Government offer an incentive. It may be a bung—the debate about state aid is very relevant to that—or much faster regulation. Otherwise, it is very difficult to see why the industry would continue to invest in R&D in this country. Its position could be as vulnerable as is the motor car industry as a result of the bumbling ineptitude of the Government in their Brexit so-called negotiation.

It is not far-fetched, it is a legitimate question to ask what on earth the Government really want from medicines and medical devices regulation. They may have issued all sorts of draft regulations, but we are clueless about what they are actually seeking to do. The MHRA is clearly not allowed to talk to anybody about this. I remember when the MHRA would talk to politicians and debate these things. It has clearly been given an instruction not to talk to anyone. We are absolutely clueless about the future direction of regulation. None the less, the amendments are clearly helpful, and no doubt we will consider them between Committee and Report.

I would, however, like to ask the Minister about Amendment 2 and its relevance to Northern Ireland. I understand that, exceptionally, it will be moved in Grand Committee because legislative consent takes three months to get through, which impacts on the Bill’s process. I understand that, but, as Parts 1 and 2 of the Bill affect Northern Ireland, does that similarly affect any amendment to Part 1 or 2 passed on Report? What is then the impact on Northern Ireland legislation?

Overall, however, most of the amendments are a constructive improvement, but we will obviously consider them further between now and Report.

[Baroness Barker (LD)]

My Lords, we must consider the whole Bill as building the foundations for the future of the medicines and pharmaceutical industry in this country. We do so in the knowledge that we have had a perhaps pre-eminent role in the world in pharmaceutical development because of the coming together of a number of factors—the European medicines regulations and all the conventions to which we are party, plus the existence of the NHS and the potential it offers for clinical research and our long tradition of working in the life sciences and biosciences sector.

The Minister definitely listened at Second Reading to the many voices of concern that perceived the Bill as it came to us as a weakening of the many factors that underpin our success in this area. He understood entirely, I think, that if we were to take away the pre-eminence of the health and safety of the industry, we would fatally undermine the whole basis of the construction of this very important sector for our economy.

The Minister has listened but not quite hard enough. I agree with the noble Lord, Lord Lansley, that Amendment 2 is an improvement, but it still leaves the decision-making on whether something promotes health and safety to the Secretary of State. I much prefer the construction in Amendment 5, to which my noble friend Lady Jolly has added her name.

My main concern in this group is with Amendment 51 on regulation for veterinary medicines. In his introduction, the Minister pointed to the fact that medicines for animals can work back into the food chain and to humans. I understand the interplay between taking into account things that are done to improve human well-being, animal well-being and the environment, but he will understand that, when people see the amendments, it will not be immediately apparent to them that human welfare is pre-eminent in the list. It says that the regulations must promote “one or more” of the three. I agree that the Minister has moved on the first set of amendments, but he has not gone anywhere near far enough on the regulations on veterinary medicines, so we may well need to come back to that at a later stage.

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The stakes are very high. Innovation will demonstrate the UK’s leadership role. The MHRA is a world-leading national regulatory body. While it will no longer have a seat at the table within the EU after the end of the transition period, introducing innovative ways of working to enhance our existing risk-based approach to trials regulation will allow the MHRA to continue to be influential in the development of regulatory policy around the world. Maintaining alignment with pharmacovigilance standards will also help the UK to maintain influence at an international level. I beg to move.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I support the two amendments in the name of my noble friend Lady Thornton. I have also put my name to Amendment 22 from the noble Baroness, Lady Finlay—she is currently in the internal markets Bill Second Reading debate—which links this to a definition of attractiveness, and to Amendment 39 in the name of the noble Lord, Lord Patel, which focuses on clinical trials for rare diseases and the importance of alignment with the European Medicines Agency.

At the end of this debate, I hope we will have a better idea of the Government’s approach to the regulation of medicines and medical devices. I do not want to repeat myself, but, as my noble friend said, the big question seems to be that at the moment the EMA covers 25% of global pharmaceutical sales and the UK on its own makes up 3%. We know that the NHS is a very poor customer in terms of adopting new medicines. The UK market is pretty hopeless for pharma. If we are not going to be aligned to the EMA, what will this mean for UK pharma in terms of future investment? My guess is that it will snap off that investment.

This is the big issue, which we do not yet understand. What is the Government’s aim? Is it the idea that a no-deal Brexit is a good thing and UK pharma will survive with a hopeless home market and all the problems of dealing with Europe? Countries will clearly not come to the UK first when they have the EMA next door, unless we offer fast-track licensing, which brings us back to patient safety, which is why the two link so much together.

I hope that this time the Minister will give us some idea of what the Government are aiming for. The same applies to medical devices, although there are some specific opportunities, because at the moment the MHRA has no involvement in the pre-market phase of medical device development. Is the intention that the UK develops a proactive regulatory role for devices that is more akin to the licensing of medicines? If so, what will be the implications for industry and patient safety? Clearly, there have been many issues about medical devices in the past which have not gone through such a robust regulatory regime. Is it the intention that the UK goes through a more extensive regime in the future under its own steam? What will the general implications be?

Again, we know that Covid-19 is having an impact on clinical trials, a significant number of which have been paused. It is my understanding that only 45% of studies are currently open to recruitment and only 36% of them have successfully recruited patients since 1 June. The ABHI has highlighted the need for a sustainable plan and aims to return clinical research to pre-pandemic levels by spring next year.

This is important because, despite the size and growth of the global market for clinical research, the UK’s share of clinical trial applications and patient recruits has fallen since 2016. The UK is now falling behind the US, Germany and Spain for phase 3 commercial clinical trials. What is to be done about that? What is the Government’s approach? Again, how does this relate to the future regulation of clinical trials?

I hope that the Government’s intention is to stimulate the UK’s clinical research environment, but part of that must be enabling multi-state UK-EU trials to continue. The idea that we can have multi-state trials that do not involve some agreement with the EU seems fanciful in the extreme. Again, at this stage, we are entitled to know from the Government exactly what they intend.

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

I call the noble Lord, Lord Sharkey.

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4: Page 1, line 6, at end insert—
“( ) The power under subsection (1) may not be exercised to—
(a) create a criminal offence of failing to comply with a provision made in regulations; or
(b) modify penalties for existing criminal offences.”
Member’s explanatory statement
This probing amendment would remove provisions for criminal offences to be created by delegated legislation. The DPRRC considered this an inappropriate delegation of power.

[Lord Hunt of Kings Heath (Lab)]

I have added my name to Amendments 4, 52 and 69, which would remove the provision for criminal offences to be created by delegated legislation.

The Government are developing a reputation for riding roughshod over the law, personal liberties and the role of lawyers. Indeed, the Internal Market Bill, debate on which is taking place in the Chamber today, is a reflection of that.

I am afraid that this Bill continues that trend, as indicated by the Delegated Powers and Regulatory Reform Committee in its very direct criticism of the criminal offence provisions. The committee drew attention to provisions in the Bill which give Ministers powers to create and modify imprisonable offences by statutory instrument. Thus regulations under Clauses 1 and 8 may create a criminal offence of failing to comply with provision made in such regulations that is punishable by imprisonment up to two years. Regulations under Clauses 1 and 8 may also amend the dozens of offence-creating provisions in the existing regulations. Regulations under Clause 12 may create new criminal offences relating to medical devices that are punishable by imprisonment for up to one year. Schedule 2 inserts a new regulation 60A and a new schedule into the 2002 regulations which make it a criminal offence, punishable by imprisonment for up to one year, to breach any of the provisions in the 2002 regulations that are listed in the new schedule. It goes on: Clause 14(1)(d) provides that regulations under Clause 12 may amend the new Schedule 30.

The powers conferred in all these provisions give rise to two concerns. As the Select Committee reported, it has previously expressed the view that it expects a compelling justification for the ingredients of a criminal offence to be set by delegated legislation. The powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences, yet the memorandum does not appear to contain any justification at all for this. The committee also points out that it has also said that where the penalty for a criminal offence may be set by delegated legislation, it would expect the maximum penalty to be included in the Bill, save in exceptional circumstances.

While the Bill limits the maximum penalty for offences created by regulations under Clauses 1 and 8, it is unclear whether this limit also applies to the many existing medicines offences which could be modified by regulations under Clause 1 or Clause 8. Again, the memorandum does not appear to shed any light on this. The Minister in his Amendments 43, 44, 64 and 65 has attempted to soften the pill by ensuring that regulations under Clause 1 (1) and Clause 8 (1) may not provide for an offence to be punishable with a sentence of more than two years. That is obviously welcome, but I do not think it goes far enough. From my reading of the amendments—no doubt we will hear about them later—they do not deal with the other substantial concern of the committee that the powers in Clauses 1, 8 and 12 would allow Ministers to create completely new criminal offences and make changes to the ingredients of existing offences. Given that, I do not think we can allow these delegated powers to be retained in the Bill. I beg to move.

[Lord Patel (CB) [V]]

My Lords, I shall speak to Amendments 42 and 63, in the name of the noble Baroness, Lady Thornton, to which I added my name and to which the noble Lord, Lord Hunt of Kings Heath, has just alluded. I also have my name to Amendment 92 in the name of the noble Lord, Lord Pannick, and the noble and learned Lords, Lord Mackay of Clashfern and Lord Judge. Noble Lords can immediately tell that I must be the tenth reserve speaking on this important amendment, but the noble Lord, Lord Hunt of Kings Heath, has laid out very clearly the problems with the government amendments that were brought in and the powers they seek.

I shall be brief on this as the Constitution Committee report spelled it out in its last line:

“The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


It was making a constitutional point.

As the noble Lord, Lord Pannick, who is a member of the Constitution Committee, cannot be here, I shall speak on his behalf. Paragraph 21 of the Constitution Committee’s report states:

“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”


The noble Lord, Lord Pannick, went on to say that the response of the Minister, the noble Lord, Lord Bethel, that regulations cannot be used to provide for an offence to be punishable with a sentence of imprisonment of more than two years is not satisfactory. A sentence of imprisonment of up to two years is a very serious matter. Parliament, not Ministers, should decide when such a potential sentence should be available to the courts.

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

I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to respond to the debate on his amendment.

[Lord Hunt of Kings Heath (Lab)]

I first thank my noble friend Lady Thornton for her words in support of the amendment and the noble Lord, Lord Patel, who was hoping to field an impressive cast list in this debate. I thought he did very well; I have always thought he would make a first-class lawyer—he should take that as a compliment.

At the heart of it, as he and the noble Lord, Lord Sharkey, said, this is a constitutional point: the advice we have had from a House of Lords Select Committee is that what the Government are proposing is constitutionally unacceptable. While the Minister’s amendments are always welcome, the fact remains that the Bill, after the Government’s amendments, would allow Ministers to create completely new criminal offences and make changes to existing offences. The Minister kindly explained this, but here we get to the heart of this Bill and the problem that many of us have with it. She talked about novel regulation and the need to keep pace with developments. I understand that.