Medicines and Medical Devices Bill

Lord Patel Excerpts

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.

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[Lord Patel (CB) [V]]

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

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

[Lord Bethell (Con)]

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

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

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[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.

[Lord Patel (CB) [V]]

My Lords, before I start, I should point out that someone is typing with their microphone on, which interferes with the sound, so would they mind turning it off?

The noble and learned Lord, Lord Woolf, said that other legal Members of your Lordships’ House were not able to be present today. That is a pity, because I thought that I had amassed a good legal team in the noble Lord, Lord Pannick, and the noble and learned Lords, Lord Mackay of Clashfern and Lord Judge, to support some of my amendments. I wonder what comments they might have made on what the noble and learned Lord, Lord Woolf, said.

I find myself in support of what the noble Lord, Lord Lansley, said. I would be interested to hear the Minister’s response to the question whether market approval of a device also means that it has therapeutic approval. I know that the noble Lord, Lord Kakkar, has an amendment on the therapeutic values of devices.

I do not find myself in total agreement with what the Government have produced and I do not think that Amendment 2 is satisfactory. Let me try to explain and we will see what the comments are. The amendments are about promoting public safety and insert into Clauses 1, 8 and 12 a new subsection (1A), so that the Secretary of State may only make regulations under those clauses where

“satisfied that they would promote the health and safety of the public.”

However, this is coupled with the insertion of the words “considering whether they would” to replace the start of subsection (2) in each clause. That means that, in the decision on whether the regulations would promote the health and safety of the public, the appropriate authority must have regard to the safety of medicines—or veterinary medicines or medical devices—their availability and the

“attractiveness of the relevant part of the UK as a place”

to conduct clinical trials or supply medicines, or develop or supply veterinary medicines or medical devices. That would be the effect of the amendments. That construction is open to the interpretation that the “attractiveness” of the UK is to be treated as part of what promotes public safety; the Minister might want to comment on that. If so, the amendment would not address the concern—indeed, it would appear to prevent the argument being made—that attractiveness and the safety of medicines and medical devices can sometimes be in conflict and that considerations of attractiveness undermine considerations of safety. This is in line with the Government’s repeated assertion that attractiveness cannot be in conflict with safety. In essence, the amendment appears to make little substantive change.

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[Lord Kakkar (CB) [V]]

My Lords, I shall speak in support of the amendment in the name of the noble Lord, Lord Lansley, to which I have added my name. Important arguments have been made with regard to the need to ensure that we can move away from the clinical trials directive which is currently the basis for such legislation in our country, and to adopt the clinical trials regulation to which our regulatory authorities have made such an important contribution over recent years.

On previous occasions Her Majesty’s Government, with specific regard to the 2018 EU withdrawal agreement Bill and the 2018 Trade Bill, made clear commitments that we should implement the clinical trials regulation in full as part of a negotiated agreement incorporating its legislative and non-legislative provisions; or, in the event that no agreement can be reached, that an element of the regulation would be adopted to the greatest extent possible on a unilateral basis in domestic legislation. We have received further reassurances in terms of the withdrawal agreement Act that the Government would give priority to taking the necessary steps to bring into UK law without delay all the relevant parts of the EU clinical trials regulation that were within the control of the United Kingdom. With regard to the Trade Bill, in September 2018, the House was reassured in the strongest possible terms by Her Majesty’s Government that a commitment was being made to implementing the regulation. However, when the Bill before us was considered in the other place, no such commitment was made and therefore, this probing amendment is vital.

I know that arguments have been made that not all the elements of the regulation are within the power of Her Majesty’s Government to implement, but as we have heard from the noble Lord, Lord Lansley, there is the opportunity to deal with the clinical trials portal and information system in a different way and to design, as other amendments propose, a system that might be agreeable. Arguments have also been made that the clinical trials regulation itself, although a substantial improvement on the current directive, is not perfect, and that the GCP and ICH guidance to which the clinical trials regulation makes reference need themselves to be advanced. Work is being undertaken in that regard.

The European clinical trials regulation provides for referring to guidance on the operational delivery of clinical trials or other guidance, so that should not be seen as an impediment. The real concern here is that while, unfortunately, impediments and hurdles to the adoption of the clinical trials regulation may be identified, that would be the wrong thing to do. The regulation is important. The current clinical research legislation under which we labour in our country is not ideal, which is why we have this regulation. On many occasions, Her Majesty’s Government have committed to the adoption of the regulation, so can the Minister indicate why the opportunity provided by this Bill should not be taken to fulfil those undertakings and thus provide us with the greatest possible certainty regarding the conduct of clinical research in our country? This is vitally important to patients, to the economy and to sustaining a viable life sciences ecosystem.

[Lord Patel (CB) [V]]

My Lords, I support Amendment 38, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to Amendment 39. I am grateful to the noble Lord, Lord Hunt, who has already spoken, for lending his support. I have listened carefully, and I support what has been said about the issues raised, particularly about whether we remain aligned with the EU trials mechanism or whether we are to be part of that mechanism.

During the EU withdrawal debate this issue was discussed at length. In fact, there was an earlier opportunity for the amendment to be put—as noble Lords may remember, it was widely supported—but I withdrew it, because the then Minister, the noble Lord, Lord Callanan, said that at an appropriate time, when legislation was brought in, the Government would address the issue. By that I supposed he meant that they would address the issue of remaining part of the EU clinical trials regime—but this Bill does not do that.

What options are available to the United Kingdom? One of them, of course, is to remain and participate in the EU clinical trials regime, if that is possible. An alternative is silent participation, as in the EEA model. That would mean that we could not vote, we could not lead projects and we could not raise objections. The third option is to be independent and aligned. The noble Lord, Lord Lansley, referred to that, and I agree with him that the important part of the EU clinical trials regime is its portal—a portal that the UK played a major part in developing—through which companies can apply for clinical trials.

The fourth option is to be independent and divergent: the UK would create a new clinical trials system. There is no time to do that by the end of 2020, but over time the UK could create a new system and build alliances. However, the risks need to be clearly understood, and balanced. Where will the companies go? Will they go where they have a bigger market, and a bigger opportunity, with larger numbers of patients for the trials, or will they conduct their trials in the United Kingdom?

There might be novel ways to approach this, and I understand that the MRHA is discussing and trying to develop a novel way of conducting clinical trials, which might be more attractive to companies. But of course, as we do not know what those are and we are not being told what they are, we cannot comment on them.

Currently, what looks like the best option is to be part of the EU clinical trials mechanism. With clinical trials for rare diseases, it is even more important for the UK to remain aligned with, or to be part of, the EU processes for rare diseases in relation to trials, to the data that will be available, and to medicines—for example, treatments developed for muscular dystrophy and metabolic disorders.

About 3.5 million people in the UK suffer at some point from one of the 7,000 or so rare diseases. The number for which treatment is available is small; hence the great need for collaborative research, data collection and the development of medicines, because a larger population is needed for clinical trials. Companies such as Silence Therapeutics, which the noble Baroness, Lady Thornton, mentioned, use gene silencing technologies for developing novel therapies for rare diseases. Others, such as Sarepta, use gene therapy for developing medicines. Companies such as Gilead Sciences are developing CAR T therapy; it was the first to introduce CAR T therapy for cancers in the United Kingdom. All those companies have said that they would wish to remain in the United Kingdom to do their trials, if the environment was right.

The treatments that will utilise innovative techniques, such as gene silencing, are often used to treat rare diseases that affect a limited number of people, as I said. The number of patients with a rare disease in an individual country such as the UK is likely to be low by definition. However, for clinical trials to work, they require large numbers. Unified and streamlined international processes are essential to ensure that the application authorisation processes of these clinical trials can continue to work both effectively and at pace.

By implementing the clinical trials regulation, the UK can remain eligible for access to the central EU portals and processes for clinical trials, which ensure that clinical trials can recruit enough patients for rare diseases and include submissions, reporting and authorisation requirements and, particularly importantly, inclusion in patient registries. Those were developed as part of the EU-wide MHRA initiative to develop registries for rare diseases.

The UK should also seek to maintain alignment with patient safety and pharmacovigilance standards, as mentioned by the noble Baroness, Lady Thornton, to give patients and clinicians confidence in trials that are conducted in the UK and to support the UK’s ability to host trials that need to take place in multiple countries. Without this level of alignment, it is likely that clinical trials, particularly for innovative treatments such as gene silencing, will not be able to go ahead in the United Kingdom, denying UK patients access to new treatment options at an early stage.

I will end by saying a few words in support of Amendment 125 in the name of the noble Baroness, Lady Jolly. Given the global nature of the Human Medicines Regulations, the UK should be a member of the ICH—the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Having recently joined as an observer on Project Orbis and the Access Consortium, the UK can work towards providing a leadership role on global regulatory standards, and it is more likely to do that if it is part of the EU clinical trials mechanism.

[Baroness Barker (LD)]

My Lords, the noble Lord, Lord Hunt of Kings Heath, succinctly set out what we all know: post Brexit, the UK as a market will be significantly less attractive than it was as part of a single regulatory system for the development of medicines and clinical trials. The economics of that are inescapable. However, it is also true, as the noble Lord, Lord Lansley, said, that however much some of us may wish that we continued to be aligned with what will inevitably be a developing clinical trials basis in Europe, it may not be within our gift to do so. However, what we can do, and what all the amendments in this group attempt to do, is encourage the Government to come clean about the extent to which they will seek in future to maintain an ongoing alignment with those clinical trials regulations in Europe.

The noble Lord, Lord Patel, mentioned—as I intend to—the announcement last week of the UK participation in the Orbis trials, which are the new mechanism for fast-tracking cancer treatments, with players from the US, Canada and Australia. I still think that, given the history of this country as a leading player in the life sciences and biosciences fields, and given the amount of investment in research that we have traditionally had and which we must seek to maintain in the NHS and within our universities, if we do not signal at this stage a willingness to keep the regulations in place and ensure that we remain aligned with the European system, we stand to lose a great deal—not least involvement in the clinical trials information system. The Government would be well advised to take some, if not all, of these amendments, which all seek to do the same thing.

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

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

[Lord Patel (CB) [V]]

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

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

[Lord Bethell (Con)]

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

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

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

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[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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[Lord Kakkar (CB) [V]]

My Lords, I support the noble Lord, Lord Sharkey, and everything he has said in moving Amendment 6. These are clear matters of principle, and although one must accept that government Amendment 133 is an attempt to provide concessions on them, the noble Lord has set out clearly why adoption of even the affirmative procedure will not provide sufficient scope for appropriate scrutiny of what may turn out to be exceedingly important regulations.

The argument for adoption of the super-affirmative procedure has been well made, and I shall not repeat all the noble Lord’s arguments, save to say that in moving his amendment he also dealt with all the potential arguments that could be put against what is proposed in the amendments. In those circumstances, bearing in mind the importance of the issues that the legislation will cover, and the deep anxieties already expressed in Committee about the nature of the Bill, both in practical terms and in terms of its constitutional implications, Her Majesty’s Government should seriously consider accepting these important amendments.

[Lord Patel (CB) [V]]

My Lords, Amendments 137 and 138 in this group are in my name. They have partly been answered by government Amendment 133, and I shall speak about all three. My amendments are probing amendments, which would prevent regulation exercise in respect of Clauses 6 and 15 in relation to the disapplication of certain provisions in the medicines and medical devices regulations where there is a serious risk to public health. The reasons for this are the same as those set out earlier on the amendment tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath.

The Government do not require the negative procedure to intervene swiftly in emergency scenarios, as the affirmative procedure is available, and safeguards parliamentary scrutiny. That is what the amendment is about. The Government have tried to respond to it, to some extent, through their Amendment 133, which removes subsections (3) to (9) of Clause 42 and inserts instead many new subsections, including a table detailing which specific provisions will be subject to the negative procedure, the “made affirmative” procedure and the draft affirmative procedure.

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

My Lords, I have received one request to speak after the Minister. I call the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

I thank the Minister most sincerely for her extensive response. I understand some of the points she made. I am also grateful that she is going to write to me and other noble Lords about the definitions that I questioned in my speech.

I accept that at times the Government will need to have powers in emergencies, but some of the examples the Minister gave were not really emergencies. I made the point that in such situations government Amendment 133 and the table do not allow for parliamentary scrutiny. The fact that there is no sunset clause means that the Government will have power to make regulations under both the negative and the affirmative procedure for evermore. That cannot be right. Yes, there will be a learning process, but there should be more ability for Parliament to scrutinise.

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

I call the Minister to respond to the point made by the noble Lord, Lord Patel.