Medicines and Medical Devices Bill Debate
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Lord Bethell
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Medicines and Medical Devices Bill
Lord Bethell ExcerptsThursday 19th November 2020
(4 years, 1 month ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-VII(Rev) Revised seventh marshalled list for Grand Committee - (17 Nov 2020)
Baroness Thornton (Lab)
My Lords, I will be very brief, as it must be clear to the Minister that there is unanimity across the Committee in support of setting up this safer care task force. My noble friend Lord Hunt was quite right that this is about whether the Government take this report seriously, and for me this is also an issue of accountability. Recommendation 9 of nine states:
“The Government should immediately set up a task force to implement this Review’s recommendations.”
I hope that the Minister will just say, “Yes, we’ve done it”, so that we can now be told what the timeline for the task force will be and who will be involved. That is my hope from the Minister’s remarks, but if that is not to be the case, I hope that it might be the case in two or three weeks’ time when we move to the next stage of the Bill.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, again, I thank my noble friend and her team for their work to produce the report and to ensure that patients and their families have been heard. Above all, I pay tribute to all the patients and their families who have so bravely shared their experiences to inform this important report. The report has been impactful and has already served to firmly put patient safety at the top of the agenda for all the healthcare system, and we in the Government are committed to learning from it.
On the amendment, if I may put this delicately, we must please remember that this is not a Bill to respond to the review. The Bill provides the powers needed to be able to update the current regulatory regime for medicines, devices and clinical trials in response to the end of the transition period, although the Bill does have the best interests of patients at its heart.
If it was not for the ongoing impact of Covid-19 on the health and care system, I believe that we would be discussing little else but patient safety. But, as my noble friend Lady Cumberlege has acknowledged in this Grand Committee, Covid has had a challenging impact on all our priorities, including on her own work on the NHS maternity transformation programme —and, of course, on the publication of her report, which was scheduled for the beginning of this year but, because of Covid, happened only 16 weeks ago.
I can assure noble Lords that much activity is already under way. Officials from across the healthcare system have been working together intensely since the report’s publication. They have been meeting weekly since August to ensure that we fully understand the report’s recommendations and the best way forward.
My noble friend has rightly mentioned the importance of listening to and involving patients in the implementation process. We absolutely recognise the need for effective patient engagement to ensure that we get implementation right. The Minister of State, Nadine Dorries, will provide an update on this and other matters related to the report in December, and I shall be very happy to report likewise to this House.
These debates have been clear, and I can assure noble Lords that, as part of our consideration of the report, we will of course want to be informed by the debates on this Bill before responding in detail to this very important report. I am very sympathetic to the desire of my noble friend and others to see the Government move quickly in responding to her report, but I do not agree that this Bill is a sensible method of delivery for that response. It is a weighty report, and our response will be rightly scrutinised when the Government responds to Parliament, but an amendment in this Bill is not the right mechanism. We should not be making policy through legislation, for that rarely makes for good government policy-making.
Therefore, I hope that this is a probing amendment, seeking some reassurance, rather than a firm request. In that spirit, I welcome the opportunity to update the Grand Committee on some of the progress that we are making to date.
Recommendation 1 has been implemented. The Government have, on behalf of the health and care sector, apologised to those women, their children and their families for the time that the system took to listen and respond.
We debated my noble friend Lady Cumberlege’s amendment for a patient safety commissioner just a few days ago, so I shall not repeat all the points raised. It was an insightful discussion, and I will think on it further, as I said during the debate.
We shall shortly be debating Amendments 122 and 123, on establishing a redress agency and redress schemes, so I will not pre-empt those discussions.
On recommendation 5, I know that my noble friend is already aware of work to establish specialist centres for mesh removal, but I would like to say a little more in recognition of its importance. NHS England is working closely with providers to set up the specialist mesh removal centres and is currently working to prepare for launch next April. The service specification for mesh centres describes how all centres must come together in a clinical summit to agree how we can develop the service moving forward, to agree standards that all centres will work to and to share data and outcomes. The first summit will take place tomorrow, 20 November. I am pleased to note that clinicians from the devolved nations are invited to that session too.
On recommendation 6, the MHRA has already begun a substantial programme of work to change the culture of the agency. Key priority areas are: first, listening and responding to patients; secondly, better utilising scientific evidence to strengthen and speed up decision-making on safety; and, thirdly, becoming more open and transparent in everything that the agency does. The MHRA is strengthening its yellow card scheme to make it easier for both patients and healthcare professionals.
On recommendation 7, as my noble friend will also be aware, we have debated Clause 16 of the Bill. Significantly, its provisions will mean that, in future, we can collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures and from that agreed next steps.
On recommendation 8, the General Medical Council already has guidance covering financial and commercial arrangements and conflicts of interest, which came into effect on 22 April 2013. In addition, the GMC’s updated consent guidance came into effect on 9 November. This reaffirms that any conflicts of interest that a doctor or their organisation may have should be shared with patients where relevant. We are considering whether these arrangements should be strengthened further.
My noble friend Lord O’Shaughnessy spoke of a worrying attitude of fatalism in the system, but I should also flag the work being done by GPs, universities and the royal colleges on long Covid and the excellent work being done to protect patients. We are listening to patients, who are presenting highly complex symptoms, including mental health, renal, cardiac, respiratory and other issues. I host a weekly round table that has full engagement with representative groups. We have mobilised a whole-system response. We are linking research with guideline writing for primary care in real time. We are using data thoughtfully, and we are mobilising networks of concerned groups around the country and around the world. This reflects the priority that we have already put on the recommendations of the patient safety report.
My noble friend Lady Cumberlege and her team took two and a half years to complete their review and present their findings, and I am intensely grateful for that. It is imperative, for the sake of patients and especially those who have suffered greatly, that we give this independent report the full consideration it deserves. I look forward to updating the House following the Minister’s Statement in the other place before recess. I therefore hope that my noble friend Lady Cumberlege feels able to withdraw her amendment.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I do not believe that anyone wishes to come in after the Minister, so I call the noble Baroness, Lady Cumberlege.
Baroness Thornton (Lab)
I think this has been one of those really rather good and unexpectedly deep House of Lords discussions, going back into the mists of time. Until the noble Baroness, Lady Cumberlege, mentioned the redress Act, I had completely forgotten about it—it all came flooding back.
We have two quite different amendments in this group, and my noble friend Lord Hunt said at the outset that his Amendment 122 was a probing amendment. This is about opening up the discussion, which it certainly did—a discussion that has long needed resolving. The noble Lords, Lord Lansley and Lord O’Shaughnessy, were quite right in that it is an issue of the future; this group has one probing amendment about the future—what it should look like and how you create an agency that can address the issue of those harmed by medicines and medical devices. It is a very legitimate discussion, which needs to be had.
The second amendment, in the name of the noble Baroness, Lady Cumberlege, is about the future, what happens now and what happens about the harms that were done—the avoidable harms, in the case of hormone pregnancy tests, sodium valproate and pelvic mesh. That is very important indeed, and the noble Baroness is right to say that those harms must be specifically addressed by the Government and to push that. I think that is what we would be looking for—how the Government would implement those recommendations. I see the noble Baroness, and the noble Baroness, Lady Bennett, whose comments we very much welcomed and valued, but I do not think that was the last word. I hope she will involve herself in the next stage of the Bill. In fact, I am depending on it.
The Government have to address Amendment 123 in particular, because that is urgent and needs to be done now. I look forward to hearing what the Minister has to say about that in particular.
Lord Bethell (Con)
My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Bennett of Manor Castle—who indicated her interest in this along with my noble friend Lady Cumberlege—for raising the important issue of redress for those harmed by medicines and medical devices.
I share the review’s concern that patient voices were not heard, and I reiterate that we are committed to ensuring that the healthcare system does better at listening, learning and acting on patient concerns. Furthermore, we recognise that patients need to be at the centre of decision-making to ensure that their perspectives are built in.
Our focus is on improving the safety of medicines and medical devices so that in future there should be less need for redress. We are determined to increase patient safety and drive additional pre-market scrutiny and post-market surveillance of medical devices. For example, the yellow card scheme plays a vital role in providing an early warning that the safety of a product may require further investigation, and the MHRA is transforming and strengthening the system to make it easier for patients and healthcare professionals in the UK to directly report adverse incidents involving all medicines and medical devices. The UK has one of the safest medicines systems in the world and we will continue to make sure that patients and the public have access to the best and most innovative medicines.
Amendment 122, in the name of the noble Lord, Lord Hunt, would require the Secretary of State to bring forward proposals to establish a redress agency within 12 months of the Royal Assent of this Bill. Committing now to such an agency would short-cut the in-depth policy consideration that the review’s recommendation of a redress agency deserves, as a number of noble Lords have reasonably recognised. I understand that my noble friend Lady Cumberlege herself undertook substantial engagement with the affected patients and other parties as part of her review. Listening and consultation is a vital part of how we take forward any policy change, and it is even more important given the significance of this issue.
A redress agency would represent a significant addition to the current landscape for all stakeholders, and we need to give them time to contribute their perspectives and think through the implications for them. In particular, there is a need to work through what the determinations and parameters of such arrangements would be and how they would interface with current legal remedies—already complex—before we could agree to take forward this proposal. This would help us explore how that would affect the patient journey through different potential approaches, the costs and their value for money. We also need to be mindful of the potential impact on industry.
With regard to Amendment 123, tabled by my noble friend Lady Cumberlege, given that legal action is pending over hormone pregnancy tests, and as is usual when matters are sub judice, I am restricted in what I can say on this aspect of the amendment.
I know that the establishment of a specific redress scheme was my noble friend’s fourth recommendation in the report of the Independent Medicines and Medical Devices Safety Review. While I am very sympathetic to the desire of my noble friend and others to see the Government respond to her report and take forward her recommendations, I do not agree that policy should be made and deadlines set through primary legislation. Indeed, her report itself was sadly delayed during the current situation we find ourselves in.
I reassure the noble Lord, Lord Hunt, that we will respond to the issues raised in the amendment as part of our formal response to the Independent Medicines and Medical Devices Safety Review. The Government are considering all recommendations made in that review and will provide an update before the Christmas Recess. I hope that the noble Lord, Lord Hunt, has heard enough that is reassuring and feels able to withdraw Amendment 122, and that my noble friend Lady Cumberlege is similarly reassured not to move hers.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to conclude the debate on his amendment.
Lord Bethell
(1A) In relation to proposed regulations under section 16(1), the Secretary of State must specifically consult—(a) the Welsh Ministers,(b) the Scottish Ministers, and(c) the Department of Health in Northern Ireland.(1B) In relation to proposed regulations under section 1(1), 8(1) or 12(1), the consultation document must include a summary of the relevant authority’s assessment of the matters mentioned in section 1(1A) and (2), 8(1A) and (2) or 12(1A) and (2)(as the case may be).”Member’s explanatory statement
This amendment requires a relevant authority to carry out a public consultation before making regulations under any provision of Part 1, 2 or 3, and to set out the authority’s assessment of any matter to which the authority must have regard in making the regulations, as well as requiring the Secretary of State to consult the devolved administrations in relation to regulations under clause 16(1).
Lord Bethell
“Reporting requirements
(1) As soon as reasonably practicable after the end of each reporting period, the Secretary of State must lay before Parliament a report on the operation of any regulations made by the Secretary of State under sections 1(1), 8(1) and 12(1) that were in force at any time during the reporting period.(2) In preparing a report, the Secretary of State must consult such persons as the Secretary of State considers appropriate.(3) A report must include a summary of—(a) any concerns raised, or proposals for change made, by a person consulted in accordance with subsection (2), and(b) the Secretary of State’s response to those concerns or proposals, including any plan the Secretary of State may have to make further regulations under section 1(1), 8(1) or 12(1).(4) The reporting periods are—(a) the period of 24 months beginning with the day on which the first set of regulations under section 1(1), 8(1) or 12(1) comes into force, and(b) each successive period of 24 months.”Member’s explanatory statement
This new Clause imposes reporting requirements on the Secretary of State in relation to the operation of regulations made under Clauses 1(1), 8(1) and 12(1).
Lord Bethell
“(3) The procedure for making regulations under Part 1, 2 or 3 is to be determined in accordance with this table and subsection (4)—
If the regulations contain provision made in reliance on | the regulations are subject to |
section 5(1)(a) | the negative procedure |
section 10(1)(a) | the negative procedure |
section 14(1)(a) | the negative procedure |
paragraph 9 of Schedule 1 | the negative procedure |
section 6 | (a) the made affirmative procedure, where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health |
(b) the draft affirmative procedure in any other case | |
section 15 | (a) the made affirmative procedure, where the regulations contain a declaration that the Secretary of State considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health |
(b) the draft affirmative procedure in any other case | |
any other provision in Part 1, 2 or 3 | the draft affirmative procedure |
(5) Where regulations are subject to “the negative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations is subject to annulment in pursuance of a resolution of either House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they are subject to negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations is subject to—
(i) annulment in pursuance of a resolution of either House of Parliament, and
(ii) negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954.
(6) Where regulations are subject to the “draft affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they may not be made unless a draft of the regulations has been laid before and approved by a resolution of the Northern Ireland Assembly, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of—
(i) each House of Parliament, and
(ii) the Northern Ireland Assembly.
(7) Where regulations are subject to the “made affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations—
(i) must be laid before Parliament after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament,
(b) in the case of regulations made by the Department of Health in Northern Ireland acting alone, they—
(i) must be laid before the Northern Ireland Assembly after being made, and
(ii) cease to have effect at the end of the period of 40 days beginning with the day on which they are made unless, during that period, the regulations are approved by a resolution of the Assembly, and
(c) in the case of regulations made by the Secretary of State and the Department of Health in Northern Ireland acting jointly, the statutory instrument containing the regulations—
(i) must be laid before Parliament and the Northern Ireland Assembly after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament and by a resolution of the Assembly.
(8) In calculating the period of 40 days for the purposes of subsection (7)(a)(ii) or (c)(ii) in relation to Parliament, no account is to be taken of any time during which—
(a) Parliament is dissolved or prorogued, or
(b) either House of Parliament is adjourned for more than 4 days.
(9) In calculating the period of 40 days for the purposes of subsection (7)(b)(ii) or (c)(ii) in relation to the Northern Ireland Assembly, no account is to be taken of any time during which the Assembly is—
(a) dissolved,
(b) in recess for more than 4 days, or
(c) adjourned for more than 6 days.
(10) If regulations cease to have effect as a result of subsection (7) that—
(a) does not affect the validity of anything previously done under the regulations, and
(b) does not prevent the making of new regulations.”
Member’s explanatory statement
This amendment provides for urgent regulations made in reliance on clauses 6 and 15 (emergencies) to be subject to the made affirmative procedure rather than the negative procedure and for regulations under clauses 2(1)(j), (k) or (n) and 9(1)(f), (k) or (l) to be subject to the draft affirmative procedure rather than the negative procedure.
Baroness Thornton (Lab)
The only question I want to ask is the question the noble Lord, Lord Sharkey, has just asked. Can the Minister give a rational explanation about why certain parts of the Bill come into force at different times? The key question on commencement is whether the commencement schedule as drafted risks holding up any of the work that needs to be done or allows the Government to move too slowly on anything.
My colleagues in the Commons drew attention to this provision as essentially a means of saying, “at some point in the future”. Can the Minister give an indication of the timeframe in which the Government expect to get these regimes consulted on, regulated for and up and running? As the Bill is drafted, the timing is left rather open-ended.
Lord Bethell (Con)
My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which would require the Secretary of State to act in accordance with the guidance on the use of civil sanctions—I am sorry, I am on the wrong amendment.
Amendment 145, in the name of the noble Lord, Lord Sharkey, seeks to amend the commencement clause, Clause 44, so that all provisions would come into force on the day the Bill receives Royal Assent. I am confident that the amendment is not necessary. Clause 44(1) provides that the clauses needed to make emergency amending regulations will come into force the day the Bill receives Royal Assent.
Under Clause 44(2), a significant number of clauses come into force after the customary two-month commencement period. Chapters 3 and 4 of Part 3 come into force on a day the Secretary of State appoints which is specified in regulations. This combination of commencement provisions is for a good reason. Patients, stakeholders and Parliament must know what the law is before the law is made. The two-month commencement period allows the Government to continue to engage with industry and the relevant stakeholders properly before provisions come into force.
Importantly, Clause 44 provides for the necessary powers and provisions to come into force on Royal Assent should it be necessary, within that two-month period, to make regulations urgently in order to protect the public from an imminent risk of serious harm to health.
I understand that there may be concern about Clause 44(3), which allows the Secretary of State to determine when Chapters 3 and 4 of Part 3 come into force, but I assure the noble Lord that, again, this is for a good reason. Chapter 3 of Part 3 is concerned with enforcement and included in that is the introduction of a civil sanctions regime. Civil sanctions will act as a flexible, proportionate enforcement mechanism, enhancing the MHRA’s ability to incentivise compliance. The new civil sanctions regime requires supplementary regulations to be made under paragraph 9 of Schedule 1 before it can be fully operational. It is important that the MHRA engages with industry and stakeholders on these regulations and the accompanying guidance. Indeed, the Bill requires a consultation to be carried out before they are made. If these provisions came into force on the day the Bill achieved Royal Assent, we would have no time to make the necessary regulations. Our time to consult in advance on those regulations and the guidance would be severely condensed.
It is absolutely right that we consider the views of stakeholders and the public before making the supplementary regulations and bringing the new civil sanctions regime into force. I assure noble Lords that the Government are committed to bringing the enforcement and data and disclosure chapters into force as soon as is appropriate in order to enhance the safety of the medical devices regime. I hope the noble Lord, Lord Sharkey, understands the reasoning behind the clause and feels able to withdraw his amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received no request to speak after the Minister, so I call Lord Sharkey—
Lord Lansley (Con)
I thank the Deputy Chairman. I sent the email only about 30 seconds ago so I suppose, strictly speaking, that apologies on his part are not required. I should have anticipated the need to ask a question, but I am afraid I was prompted by listening to the noble Lord, Lord Sharkey, and the Minister’s reply. I want to ask one question: how can what will become Section 1 be brought into force without Section 2? I do not understand. If a power is to be used under Section 1, it must surely make provision about some of the long list of relevant areas in what will be Section 2. In the absence of Section 2 being in force, I cannot see how Section 1 works.
Lord Bethell (Con)
My Lords, I will seek to provide an answer to my noble friend. Should it not be quite the right answer I will endeavour to write to him. It is my understanding that no substantive provision of an Act should be brought into operation earlier than two months after Royal Assent. However, some sections of the Act can be brought into force on Royal Assent, typically those setting out how the Act is to be cited and what the procedure is for making regulations or commencing them. It is under those arrangements that the sequencing which he describes can be undertaken.
Lord Sharkey (LD) [V]
I thank the noble Lord, Lord Lansley, for his intervention. I will read Hansard carefully tomorrow to make sure that I understand not only his question but the Minister’s reply. I thank the Minister for his explanations—they were useful—and for the brief preview of his next speech.
Lord Sharkey (LD) [V]
We all know that the words “have regard to” create no real obligations, whereas the words “act in accordance with” do create real obligations. Clause 13 seems to contain important restrictions on the actions of the Secretary of State, but it does so via guidance. As the Bill stands, with its “have regard to” wording, that guidance has no statutory force. If the restrictions are to have any reality—and I assume that the Government would like them to, or they would not have written them into the Bill—we must replace “have regard to” with “act in accordance with” as the amendment proposes. We support the amendment.
Lord Bethell (Con)
My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which is designed to require that the Secretary of State must “act in accordance with” the guidance on the use of civil sanctions that he is required to publish under paragraph 13 of Schedule 1, as opposed to having regard to the guidance. Paragraph 13 requires the Secretary of State to prepare and publish guidance about the use of civil sanctions. More specifically, this guidance must cover the sanctions that may be imposed if a person commits an offence, the action the Secretary of State may take, and the circumstances in which action is likely to be taken.
I understand the intention behind Amendment 146 and recognise that it is crucial that civil sanctions are imposed in a transparent and consistent manner to ensure that the regime operates effectively. However, the current drafting of Schedule 1, including the obligation on the Secretary of State to publish and have regard to guidance on the civil sanctions regime, will ensure this transparency and consistency.
The guidance will be prepared after consultation with the devolved Administrations and others. The purpose of any guidance is to provide clarity to the civil sanctions regime and detail the circumstances in which different civil sanctions may be pursued. However, instances of non-compliance or criminal activity, where the medical device regulations are concerned, need to be dealt with on a case-by-case basis. The scale, complexity and severity of non-compliance can vary significantly. As such, any resultant enforcement activity needs to be proportionate, effective and commensurate with the non-compliance or criminal activity.
The amendment in the name of the noble Baroness, Lady Thornton, would bind the Secretary of State, acting through the MRHA, to act in accordance with guidance in every instance. This would limit the regulator’s ability to arrive at and undertake the most appropriate course of enforcement action commensurate to the multifaceted nature of the case at hand. The MHRA cannot set out every circumstance where it may be appropriate to impose civil sanctions. However, by preparing, consulting and publishing a clear set of guidance we can be clear on the framework and illustrate circumstances on how and why a civil sanction might be imposed without being exhaustive.
The regulator needs civil sanction guidance that is flexible enough to appropriately address all forms of non-compliance. To mandate following the guidance to the letter could potentially mean that no action can be taken if the MHRA encounters a new example of non-compliance that has not been explicitly catered for in the guidance but clearly warrants a civil sanction. Under such circumstances, the Secretary of State will, of course, comply with obligation to publish revised guidance as required in paragraph 13 of Schedule 1.
I remind noble Lords that recipients of civil sanctions can contest the imposition of a civil sanction before it takes effect by appealing to the First-tier Tribunal. It is also worth highlighting that, as currently provided, the guidance will be statutory guidance and the regulator must have regard to it when carrying out enforcement activity.
Furthermore, this type of provision is standard across the statute book. For instance, provisions requiring regulators and statutory bodies to “have regard” to statutory guidance can be found in a wide range of legislation, from Section 2 of the Higher Education and Research Act 2017 to Section 5 of the Business and Planning Act 2020. In a civil sanctions context, Section 63 of the Regulatory Enforcement and Sanctions Act 2008 provides that provisions conferring a power on a regulator to impose a civil sanction must also make provision relating to guidance—in particular, that the regulator “must publish guidance” about its use of a sanction and
“have regard to the guidance … in exercising its functions.”
The Ecodesign for Energy-Related Products Regulations 2010 has a similar civil sanctions regime. These regulations are concerned with the establishment of a framework for the setting of ecodesign requirements for energy-related products. In paragraph 28 of Schedule 5 to those regulations the market surveillance authority
“must have regard to guidance”
while exercising his or her functions with regard to the imposition of civil sanctions. I hope that the reassurance we seek is not unusual but in line with how civil sanction and, indeed, other regimes operate domestically. For that reason, I therefore ask the noble Baroness to withdraw Amendment 146.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I think that I have received no requests to speak after the Minister so, hoping that I have not overlooked the noble Lord, Lord Lansley, once again, I call the noble Baroness, Lady Thornton, to conclude this debate.