Medicines and Medical Devices Bill

Baroness Thornton Excerpts

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

Moved by

[Baroness Thornton]

1: Page 1, line 6, at end insert “for a period of three years beginning with the day on which this Act is passed.”
Member’s explanatory statement
This amendment provides a sunset provision for Part 1 of the Bill requiring the Government to return with primary legislation.

[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 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.

[Baroness Thornton (Lab)]

My Lords, I thank all noble Lords who took part in this preliminary and important debate on the Bill.

The noble Lord, Lord Patel, made an important point concerning primary legislation after three years. The Minister seemed to suggest that three years is not long enough. That cannot be right; three years is certainly long enough. Without the principles and policy that my noble friend Lord Hunt spoke about, rule by regulation is not only inadequate but probably quite dangerous. That lies at the heart of this group of amendments.

The noble Lord, Lord Kakkar, made the important point that we have a well-designed regulatory framework in the UK; this amendment is not about disrupting that. He also said that the Bill should be about improving the framework; that is exactly right.

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[Baroness Thornton (Lab)]

Like the noble Lord, Lord Sharkey, I shall have a minor moan. It is normal practice to give fellow Peers sight of government amendments at least on the day are put down, so even though the Bill team had not managed to discuss their intention with Opposition parties and other noble Lords involved in Committee, we received the letter from the Minister explaining the amendments on Thursday. I hope the Minister and the Bill team will not continue to leave things so late. I remind the Minister that he has a whole Bill team and a department at his disposal. Other noble Lords write their own speeches, do their own research and need more time to give amendments due consideration. I am fortunate to have some excellent support and we work very hard on our side to get our amendments down as early as possible to give other noble Lords the opportunity to consider them and discuss them with us. The Government should always bear in mind the unequal nature of resourcing in this place.

We need to see these amendments for what they are. Of course, they are mostly worthy and we welcome the improvement, but essentially, to echo the words of the noble Lord, Lord Patel, they are there to placate and circumvent. We are late in the day in beginning to understand the nature of these amendments and we now understand the urgency of them as a result of our earlier discussions, for which I thank the Minister and his team. We are waiting for reassurance from the Minister about what happens at the next stage.

The noble Lord, Lord Lansley, made some very important and pertinent points, particularly about the difference between the objective test and the subjective test. It is clever and very important. He is on the side of objectivity and the Government’s amendments are definitely on the side of subjectivity. I agree with him that Amendment 2 is not as good as his Amendment 5. The noble and learned Lord, Lord Woolf, also said something very pertinent and quite correct about not giving blank cheques. He accepts what the Government are offering, but made the point that further discussions are needed and an amendment might be needed as we move forward.

I say to the noble Lord, Lord O’Shaughnessy, that I do not have a principled objection to government amendments coming forward; it is just that we need to know the context for them. The noble Lords, Lord Lansley and Lord Kakkar, and others, including the noble Baroness, Lady Jolly, made a very important point about safeguarding public health, and I hope the Minister will be able to address it. I can probably feel an amendment coming on on that one.

[Lord Bethell (Con)]

My Lords, I am enormously grateful to my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, for Amendments 5 and 70. I greatly appreciate their scrutiny and contribution on the way in which regulations under the Bill might be made. I am grateful to my noble friend for his constructive dialogue with my officials. His experience and expertise in making legislation on health matters is a real benefit to all of us.

My noble friend and the noble and learned Lord, Lord Woolf, have drawn on the framework of legislation in the EU context. I am grateful for their explanatory statement on the basis of the amendment. My noble friend knows that I pressed very hard to see whether this is something we could accept. The challenge your Lordships have set me is why, if this framework exists in EU legislation, is it too constricting for the Bill? The answer is that examples of significant recent EU legislation in relation to human medicines, clinical trials and medical devices include: directive 2001/83/EC, regulation 726/2004, regulation 536/2014, and regulation 2017/745. In other words, while citing the aim of safeguarding public health in Article 168, on public health, of the Treaty on the Functioning of the European Union, these pieces of legislation were also made in reliance upon Article 114 of the treaty, being measures for the approximation of laws which have as their objective the establishment and functioning of the internal market. To make that point again, safeguarding public health is not the only objective of the EU legislation in relation to medicinal products and medical devices. That is why we have a challenge in this area and why we have posited our amendment.

I shall say something about the other government amendments, specifically replying to the noble Lords, Lord Hunt and Lord Sharkey, and other noble Lords who commented on them. The overall timing of the Bill means that currently, it cannot reach Report any earlier than mid-November. If we start the consent process with Northern Ireland then, it will add a minimum of two months past the end of the Bill’s timeline. To explain to the noble Lord, Lord Sharkey, we need to start the consent process now in order to make further changes. The Government need to demonstrate that this is a policy they wish to make in order for Northern Ireland to get that process properly under way. We have written to Northern Ireland seeking consent to make changes. Parts 1 and 2 of the Bill are transferred to Northern Ireland. I sought consent from Northern Ireland on the Bill as a whole when the Bill was introduced, and again after the change made on Report to Clause 16.

We sought to make government amendments at the earliest opportunity to respond to the DPRRC, partly to demonstrate how significantly we take that report and partly to start this process. That process has now started, but it has not concluded. It does not preclude noble Lords from further consideration and, as my noble friend Lord Lansley, indicated, the Bill has moved. The process of consent is unavoidably three months long in order for the Northern Ireland Assembly to conduct its work. That is why we have had to start now. In reply to the noble Lord, Lord Hunt, I can supplement the legislative consent Motion at a later date.

I will listen. I understand and acknowledge that the noble Baroness sees this as the beginning, not the end, and I acknowledge that she will return to the issue on Report. Accepting these amendments today does not prevent her doing so, and I will continue to listen.

I completely hear what the noble Lord, Lord Hunt, says about engagement with the MHRA. I would be glad to arrange a suitable engagement with June Raine from the MHRA and parliamentarians to discuss these points.

To the noble Lord, Lord Patel, I confirm that the efficacy of a medical device is assessed as part of the process of obtaining a CE certificate. The therapeutic value of a device is not part of the CE certificate assessment; that is a function carried out by NICE. On the point made by the noble Baroness, Lady Barker, on the food chain, I would be glad to arrange a follow-up discussion on the veterinary medicines directorate with the relevant Defra Minister. To the noble Baroness, Lady Jolly, Defra and BEIS are content with this amendment. To the noble Baroness, Lady Walmsley, the medical devices section of the overarching bit at the beginning of the Bill is a carry-on from the sentencing enforcement, and in Part 3 enforcement is in relation to medical devices only. I do not think these are reasons to rewrite the purpose.

I obviously hope to win the argument on some of this, but that will come from extensive engagement and thorough communication going forward, for which I thank noble Lords. I therefore hope that the noble Baroness feels able to accept these reassurances, and I am grateful that my noble friend considers this sufficient reassurance not to move his amendments.

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Moved by

[Baroness Thornton]

3: Page 1, line 6, at end insert—
“( ) In making regulations under subsection (1), the appropriate authority must have regard to the desirability of—
(a) regulatory alignment with the European Medicines Agency’s medicines regulation;
(b) regulatory alignment with EU clinical trials regulations;
(c) recognition of and participation in the European Medicines Agency’s medicines licensing processes.”
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the desirability of regulatory alignment with EU regulations.

[Baroness Thornton (Lab)]

My Lords, in many ways this group of amendments is at the heart of the Bill. The Minister will know that there is real anxiety among stakeholders, be they large or small pharma, researchers or patient groups, particularly now that we might face a no-deal exit at the end of this year. Life sciences companies have concerns about the administrative and cost implications of having to file for marketing authorisation with a separate national licensing authority after Brexit. It will be important to consult closely with the industry—industry groups, but also individual companies that have specific expertise in high tech areas—to ensure that the regulatory regime is robust, internationally competitive and fit for future scientific breakthroughs.

The amendments in my name and that of my noble friend Lord Hunt require the appropriate authority to have regard to the desirability and necessity of regulatory alignment with EU regulations. The amendments in the name of the noble Lord, Lord Patel, the noble and learned Lord, Lord Mackay of Clashfern, the noble Baroness, Lady Finlay, the noble Lord, Lord Lansley, the noble Baroness, Lady Jolly and the noble Lord, Lord Kakkar, in this group have similar objectives.

The UK via the MHRA plays a leading role in developing the clinical trials regulation, which came into force in 2014. Due to the length of the implementation period of the regulation, the UK is not currently committed to implementing it in full following the end of the transition period. Failing to implement this longstanding legislative proposal would create significant uncertainty for life science companies.

I am grateful for all the briefing we have received over the last few months from organisations and companies which have a great deal of interest at stake in the Bill. For example, Silence Therapeutics wants to make ground-breaking treatments available to patients in the UK as quickly as possible and to conduct clinical trials in the UK. In order to ensure that the UK remains a competitive and attractive destination for clinical trials, it thinks the Medicines and Medical Devices Bill should provide for continuing alignment with EU clinical trials regulations—the UK was involved in the development of that—and, in the immediate term, ensure harmonisation of clinical trial and medicines regulatory processes, while enabling international collaboration for the benefit of patients, at the end of the transition period. It also thinks the Bill should adopt an approach to clinical trials that will allow the UK to lead the world in innovation while assuring patient safety standards. These seem to me to be reasonable tests of this legislation and indicate the challenge it faces.

The danger is that the European Medicines Agency covers 25% of global pharmaceutical sales and the UK on its own makes up only 3%. The odds are that companies will want to submit applications for new drugs to the EMA before the MHRA, meaning that the UK will lose its advantage and UK patients will risk getting slower access to the latest medicines. While the Bill could help maintain patient access to new medicines and UK access to pan-European clinical trials, its capacity to achieve this will be subject to the shape of the future relationship between the UK and the EU.

On medicine access, will the Bill allow the Government to establish new regulations on marketing authorisations for new medicines? If so, how and when? Does a no-deal outcome mean an independent UK marketing authorisation process, along the lines set out in the Medicine and Healthcare products Regulatory Agency’s plans for a no-deal outcome which came out in 2018 and 2019 and which some of us lived through. Is this what might be used? Alternatively, could the UK choose unilaterally to continue to recognise a new European marketing authorisation as valid? Has that been considered? Depending on the outcome of UK-EU negotiations, what will happen if the MHRA is unable to participate and contribute its expertise in the European Medicines Agency’s marketing authorisation process?

On clinical trials, will the Government replicate the EU’s clinical trial application system, thereby reducing the administrative burden on UK-EU collaboration? This would be necessary if the MHRA had to develop a separate clinical trial application system that would operate in parallel to the EU’s. Is this the case?

Given the influence that the UK-EU future relationship will have on how the Bill’s powers can be used, will the Minister guarantee to encourage, update and consult the medical research sector as negotiations progress? Are the Government doing so already? Perhaps the Minister can give some positive reassurance by describing some of the recent discussions and negotiations. I am aware that this is in line with the ethos of Clause 40, which requires the Government to consult relevant people and organisations when proposing regulatory changes.

Treatments that utilise innovative techniques such as gene silencing are often used to treat rare diseases. These affect limited numbers of people and are often used in areas of unmet need, where no effective treatment options are available. The number of patients with a rare disease in an individual country, such as the UK, is likely to be low by definition, but for clinical trials to work—the House has discussed this many times—they require a large number of patients to take part. As a result, these trials are conducted across multiple countries.

Unified and streamlined international processes are essential to ensure that the application and authorisation processes for these clinical trials can continue to work 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 they can recruit enough patients from different countries to be successful. These processes include clinical trial submissions, reporting and authorisation requirements and, particularly importantly, inclusion in patient registries.

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[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.

[Baroness Thornton (Lab)]

Responding to the very last thing that the Minister said, he will have to tell us what those other ways are during the course of this discussion.

This has been a well-informed debate, as I assumed it would be. I think I was right in saying that this issue is at the heart of the Bill and how we move forward. My noble friend Lord Hunt—I thank him for his support —was quite right that this is the big issue. As the noble Lord, Lord Sharkey, said, this is the start of the discussion that we are going to have about attractiveness and where that lies and how it can express itself.

The noble Lord, Lord Lansley, put his finger on various important issues to do with clinical trials. He asked the key question, which I do not think the Minister answered. It is: if we diverge, what will that mean and how will it happen? I did not hear an answer to that question. The answer will determine what some of us do next as we move forward with this Bill. The noble Lord, Lord Kakkar, was completely correct when he said that it is vital that we get this right for the future of life sciences in the UK.

I am grateful to the noble Lord, Lord Patel, for his support for our amendments. He reminded us that we had this discussion during the passage of the main Brexit legislation, when we were told that it was not the appropriate place to such a discussion so the amendment was withdrawn. Now, at the last minute, this must be the place where we have these discussions and come to some conclusion on them.

The noble Lord, Lord O’Shaughnessy, is right. As we strike out on our own as a country, we will need new relationships and we will need to take advantage of what is on offer in the rest of the world. The transition will be very important because what happens in the meantime is vital. We will also need to ensure patient safety in this laissez-faire world, as the noble Lord explained, for example, if we decide to ignore the portal and strike out without it.

I do not doubt for a moment the Minister’s emphatic commitment to making this a success, but as we move forward, this Committee will need to understand much more than what the Minister has told us so far on the risks and opportunities. My final request to the Minister is that we will need a cross-party meeting of some depth—possibly more than one—to discuss this matter with his Bill team and the MHRA. We had such a meeting. It feels as if it was aeons ago, but I think that it was in February, perhaps March. Anyway, it was before we went into lockdown. We absolutely will need meetings and discussions before we move on to the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.

Amendment 3 withdrawn.

Moved by

[Lord Hunt of Kings Heath]

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.

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[Baroness Barker (LD)]

My Lords, I just want to add to what my noble friend Lord Sharkey said. This is a matter of principle; from the two reports by the two committees that have been cited and from the Second Reading debate, the Government can be in no doubt about the strength of feeling on it. In the light of those, the Government’s response in the government amendments in this group is, frankly, rather pathetic and not at all acceptable.

The Bill represents an enormous upheaval for one of the critical areas of our industry. The pharmaceutical industry is of immense importance to this country. Apart from anything else, to add criminal offences created through delegated powers by means of a Bill that is so spare and lacking in detail does a huge disservice to people who want to continue to pursue not just high-quality but ethical production of badly needed medicines in this country and within international frameworks. If the best the Government can do is to table the amendments in this group, they do the industry a great disservice.

[Baroness Thornton (Lab)]

I do not think that I need to say much in response to the remarks that were, I think, unanimous in their support for my amendment and the other amendments in the group. The cap on the sentence is not a good enough response by the Government. Earlier in our debates, I made a remark about amendments designed to circumvent; I am afraid that the government amendments before us are exactly that kind of amendment. They will not serve, I am afraid.

Unless the Government are prepared, as I hope they are, to table amendments that actually solve the problems and address the issues raised by the Constitution Committee and the Delegated Powers and Regulatory Reform Committee—they could not have been clearer on this issue: in this country, we do not set up criminal offences and their sentences by delegated legislation—there is nothing more for me to say, other than that I hope the Government will think again.

[Baroness Penn (Con)]

My Lords, it is perhaps appropriate if I begin by speaking to the government amendments—Amendments 43, 44, 64 and 65 in the name of my noble friend Lord Bethell —in this group. In doing so, I thank my noble friend Lord Blencathra for his committee’s report. As previously noted, we have listened to that report, and the changes that we propose through these amendments are intended to address the specific concern in that report regarding penalties for existing criminal offences.

As drafted, Clause 5(1)(b) already provides a restriction limiting the maximum penalty to imprisonment for two years when creating a criminal offence. The DPRRC asked us to explain whether the penalties for existing offences could be amended when there was no maximum specified in the Bill. I want to be clear that we do not intend to increase the penalties for existing offences.

Amendments 43 and 44 would work together to amend Clause 5. They make it clear that, under Clause 1, we may not make regulations that provide for a criminal offence to be punishable by more than two years’ imprisonment. This will apply to both new and existing criminal offences. For veterinary medicines, Amendments 64 and 65 seek to achieve the same by amending Clause 10.

The government amendments will, I hope, remove any concern that powers in Clauses 1 or 8 could be used to make regulations extending sentences for existing offences beyond two years’ imprisonment.

I now turn to Amendment 4 and the other amendments in this group to which noble Lords have spoken. The ability to enforce breaches of the regime governing medicines is a power originally conferred on the Secretary of State in the interest of protecting public health. This was introduced by the Medicines Act 1968 and provisions around offences are found throughout the Human Medicines Regulations 2012. They are also contained in the Veterinary Medicines Regulations 2013.

Offences deter potentially harmful activity and make it possible to take punitive measures against those whose actions put people, animals and the environment at risk. As we make necessary updates to the regulatory requirements, we must be able to remain consistent with the current enforcement regime, which already imposes criminal sanctions. It would not be right that a person may face a criminal sanction for breaching current requirements but not for breaching new regulatory requirements, for example relating to novel technologies and medicines. As with other changes to provisions, making changes to offences will be subject to the draft affirmative procedure, and we will make offences proportionate and necessary. It is imperative that we are able to balance novel regulation with enforcement of that regulation.

It cannot be ignored that crime involving medicines is increasing. Furthermore, criminal activities adapt to new environments and technology. In recent months we have seen opportunistic criminals selling online unauthorised and unapproved medicines and devices for the treatment, prevention or diagnosis of Covid-19, including antimalarials, self-testing kits, “miracle cures” and “antiviral misting sprays”, which could cause harm and unnecessary stress to patients. Enforcement capabilities must be able to keep pace with criminal exploitation. Delegated powers afford us our continued ability to enforce the regulatory requirements for medicines and devices for public protection. To be effective, they must be enforceable.

The Veterinary Medicines Regulations 2013 contain numerous criminal offences for breaches of the regulations; again, this is for the purposes of enforcement. The Veterinary Medicines Directorate’s enforcement strategy is risk-based; it focuses on proportionality, consistency, transparency and targeting. The VMD works with businesses and individuals to assist them in complying with the legislation through the provision of advice and guidance. However, where necessary the VMD will use more formal means of enforcement to secure compliance. It is critical that we have the delegated powers to enforce this.

We have always been clear that we are trying to provide greater clarity on how to enforce the regulations on medical devices. The regulator’s ability to have teeth when we are looking to raise medical device safety standards in future is essential. The report from my noble friend Lady Cumberlege tells us that.

The Bill is also clear on the maximum time limit for imprisonment, which applies to any new criminal offence introduced. This limit matches the current system for devices, where criminal offences for medical devices are already punishable for up to six months. The devices regulations are in place to protect public health; breaches of those regulations put people at risk and can cause significant harm. It is only appropriate that there is a clear consequence for any such actions, including potential criminal prosecutions. We will of course have regulations subject to the duty to consult at Clause 41, which will mean the public have the opportunity to comment on the necessity and proportionality of the approach.

I hope the necessity of enforcing the new regulations, and the safeguards the government amendments have provided, persuade the noble Lord to withdraw his Amendment 4 and others not to move theirs.

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[Baroness Jolly (LD) [V]]

I speak in support of these amendments in the names of my noble friend Lord Sharkey and other eminent noble Lords. I confess that I had not heard of the super-affirmative procedure until my noble friend sat me down and talked me through it, and it struck me as being eminently sensible and doable, and this is exactly the right sort of Bill—or the regulations contained herein are exactly the right sort—for the super-affirmative procedure. I ask all noble Lords to support this amendment and those who support it.

[Baroness Thornton (Lab)]

My Lords, I thank the noble Lord, Lord Sharkey, for his comprehensive introduction to this group of amendments, particularly those that he is supporting.

We are minus at least four noble Lords from this debate because of the clash with the other Bill. I have certainly made my view known to the usual channels in the next booth that we cannot continue to discuss this Bill in those circumstances because we will be missing too many people who have a stake in the Bill and amendments down. I cannot imagine what the noble Lord, Lord Forsyth, is saying to his own Benches about this—actually, I probably can, and it will not be polite, I suspect. He put his name down to this amendment and, presumably, found out that he was not allowed to speak in both the Second Reading debate and in this Committee at the same time. I can see why that rule is there, but we are finding that this really does not work.

While the affirmative procedure offers nothing like the scrutiny given to a Bill, which typically goes through several substantive stages in each House and can be amended, we agree wholeheartedly with the DPRRC’s view that Clauses 1, 8 and 12 contain inappropriate delegations of power. We are where we are, and we therefore take the view that the affirmative procedure should apply. Amendment 134 provides for all regulations to be made subject to the draft affirmative procedure rather than the negative procedure and for urgent regulations to be subject to the made affirmative procedure rather than negative procedure.

Both the DPRR Committee and the Constitution Committee have expressed considerable concern at the inappropriate use of the negative procedure in this Bill. For example, Clause 2(1)(n) provides that regulations under Clause 1 may make provision about prohibitions relating to the supply of human medicines. Clause 42(9) provides for such regulations to be subject to the negative procedure. The explanation given for this in the memorandum, which I think I referred to in the very first debate in this Committee, is as follows:

“proposals to make changes to existing provisions, or to introduce new provisions enabling the supply, administration or prescribing of medicines are made to reflect shifts in best practice following extensive consideration and scrutiny by the relevant professional bodies.”

The DPRRC found this an unconvincing explanation. I probably do as well. It noted:

“It isn’t clear why consultation with relevant professional bodies lessens the requirement for scrutiny in Parliament. Indeed, if proposed changes are sufficiently important for there to be extensive consideration and scrutiny by professional bodies, this supports requiring the higher level of scrutiny in Parliament that the affirmative procedure affords. Furthermore, the prohibitions to which clause 2(1)(n) applies are sufficiently important that breach of them is a criminal offence (punishable, in the case of 4 of the 5 prohibitions, by imprisonment for up to two years). Even accepting the appropriateness of the delegation of powers in clause 1, we take the view that the affirmative procedure should apply. The consultation requirement imposed by clause 41 of the Bill is to be welcomed but we are concerned at consultation being presented as a substitute for Parliamentary scrutiny. On the contrary, if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”


The committee also highlighted and raised concerns about Clause 9(1)(f), which provides that regulations under Clause 8 may make provision about the categories of person who may apply for veterinary medicines. The EM states:

“any proposals to make changes to existing powers or to introduce new powers for veterinary professionals to supply, administer or prescribe medicines will be subject to extensive consideration and scrutiny by professional bodies”.

Again, the committee found this unconvincing for the same reason, and took the view that the affirmative procedure still applies. I must say, I wholeheartedly agree with its assessment. As it says,

“if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”

My amendment also addressed the egregious provisions of Clause 42 that provide that where any such regulation needs to be made urgently to protect the public from imminent risk of serious harm to health, the negative procedure applies instead. The Government’s justification for departing from the affirmative procedure was that:

“It is appropriate for regulations made in these circumstances to be subject to the negative resolution so that they can come into force immediately and provide an efficient means of addressing an imminent serious public health risk. We expect that such regulations would only need to be in place for a very short period of time, potentially shorter than it would take to schedule and hold debates”.


This is wholly inadequate.

The DPRRC stated:

“We are wholly dissatisfied by departments repeatedly arguing for powers otherwise subject to the affirmative procedure to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure … Even accepting the appropriateness of the delegation of powers in clauses 1 and 12, if the affirmative procedure provides the appropriate level of Parliamentary scrutiny for regulations made in reliance on clauses 6 or 15 in non-urgent cases then, in the absence of cogent reasons for the negative procedure to apply in urgent cases, we take the view that the made affirmative procedure should apply in urgent cases.”


The Constitution Committee concurred, recommending that

“the emergency powers in this Bill are subject to the made affirmative procedure, rather than the negative procedure, such that Parliament is required actively to approve them.”

The Minister will be well aware that regulations under the “made affirmative” procedure can be made and laid as expeditiously as can regulations subject to the negative procedure. They can also be laid during a parliamentary recess, unlike draft affirmative instruments. Quite frankly, it is insulting that the Government have the gall to argue for emergency powers to be subject to less scrutiny under the negative procedure, especially in the current climate when hundreds of emergency regulations have been introduced with considerable haste using the “made affirmative” procedure. Can the Minister say how this dereliction ever made it into the Bill, never mind through the Commons? I imagine that the Minister might be quite embarrassed to put her name to the Bill, which is perhaps why the Government have introduced Amendment 133 at the 11th hour.

I also speak in support of the super-affirmative amendments in the name of the Lord, Lord Sharkey. They are supported by Members across the House—including my noble friend Lady Andrews who is not here to give her support although she is extremely enthusiastic about this amendment.

Given that this is a skeleton Bill, the use of the super-affirmative procedure seems a sensible and proportionate mechanism. In this case, it would allow relevant parliamentary committees, in consultation with stakeholders, opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. It has been used effectively by Governments of all colours, who recognise that it allows them flexibility when they need to bring forward regulations, while consultation and scrutiny happen before any amendments come to the House by affirmative resolution.

That is particularly important given that many areas in which we expect regulations to be laid, ranging from life sciences and clinical trials to hub and spoke pharmaceutical models, could make the contents of the SIs—and, in the absence of policy details in the Bill, even examples of draft regulation that have been published in respect of other Brexit legislation—controversial. I hope that the Minister recognises the merit of this proposal.

[Baroness Penn (Con)]

My Lords, I will begin by speaking to government Amendment 133 on behalf of my noble friend Lord Bethell. It provides significant changes that I know many will welcome. We have listened to the concerns raised about parliamentary scrutiny on emergency powers. I assure noble Lords that we have carefully considered their views and the different amendments that have been put forward on this topic.

As a result, government Amendment 133 would change applicable parliamentary procedure for reactive emergency regulations to the “made affirmative” procedure. It also provides that regulations about prescribing, advertising, packaging and labelling in relation to human and veterinary medicines will no longer be subject to the negative resolution procedure, but instead to the draft affirmative procedure. Using the “made affirmative” procedure when making regulations reactively in emergency situations affords the Government the required speed and flexibility to react to emergencies while providing that Parliament can scrutinise what has been done and why. When we make the regulations proactively, we must demonstrate the need to protect the public from the risk of serious harm; these regulations will be subject to the draft affirmative procedure.

It is important to acknowledge that the emergency powers are not intended to be used. However, as the noble Baroness, Lady Thornton, said, we are in a situation where we are currently using emergency powers, so she is correct that the “made affirmative” procedure has been put to good effect during the current pandemic. None the less, these powers are a measure of last resort to protect the public from the risk of serious harm to health.

We want to avoid using the powers reactively where possible. It is already a condition in the regulations that the situation must be accompanied by a declaration of the urgent need to protect against the imminent risk of serious harm to health. I note the questions asked by the noble Lord, Lord Patel, about the definition of that statement. I will write to him further on that matter.

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

We now come to the group beginning with Amendment 8. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

May I ask for some clarification? Normally in Committee—under normal life, as it were—we would not start another group that would take at least three-quarters of an hour or so if we knew we were going to rise at a set time. I want some guidance as to why we will start this group now, when we know that we will not finish it within the time allowed. We might get through my speech and the next one, but that will be it. I am looking for guidance, Lord Chair.

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[Baroness Penn (Con)]

My Lords, I understand that the need to rise at a set time is part of the needs of the hybrid House. With other Grand Committees that have taken place in this circumstance, we have made progress on groups and had to adjourn mid-group. That is incredibly important in order to make progress on legislation when we are operating to time-constrained sessions.

[Baroness Thornton (Lab)]

I have to register my objection to that. If we want a proper debate, this is not just about people making timed speeches; it is about a debate. A debate should be a coherent whole, not one or two speeches and then continuing after maybe a week’s break. Would I be allowed to make my opening speech again when we go back on the second day of Committee?

[Baroness Penn (Con)]

My Lords, we would not have a second opening speech. If the noble Baroness has strong objections, we can adjourn.

[Baroness Thornton (Lab)]

I think we should. This is an important debate and we need it as a whole debate. I would be very grateful if that could be considered. I promise to make a small speech when we restart.

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

That concludes the work of the Committee this afternoon. The Committee stands adjourned. I remind Members to sanitise their desks and chairs before leaving the Room.