Thu 11th February 2021
Royal Assent (Lords Chamber)
Royal Assent (Hansard)
Royal Assent: Royal Assent (Hansard)
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Tue 2nd February 2021
Medicines and Medical Devices Bill (Lords Chamber)
Ping Pong (Hansard)
Ping Pong (Hansard): House of Lords
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Wed 27th January 2021
Medicines and Medical Devices Bill (Commons Chamber)
Ping Pong
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Thu 21st January 2021
Medicines and Medical Devices Bill (Lords Chamber)
3rd reading (Hansard)
3rd reading (Hansard): House of Lords
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Thu 14th January 2021
Medicines and Medical Devices Bill (Lords Chamber)
Report: 2nd sitting (Hansard)
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355 interactions (38,790 words)
Tue 12th January 2021
Medicines and Medical Devices Bill (Lords Chamber)
Report stage (Hansard): House of Lords
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Thu 19th November 2020
Medicines and Medical Devices Bill (Grand Committee)
Committee: 7th sitting (Hansard)
Committee: 7th sitting (Hansard): House of Lords
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Tue 17th November 2020
Medicines and Medical Devices Bill (Grand Committee)
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Wed 11th November 2020
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Wed 4th November 2020
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Wed 28th October 2020
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Mon 26th October 2020
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Mon 19th October 2020
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Wed 2nd September 2020
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Wed 24th June 2020
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Tue 23rd June 2020
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Report stage
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Mon 2nd March 2020
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Royal Assent

(Royal Assent (Hansard))
(Royal Assent: Royal Assent (Hansard))
(Royal Assent (Hansard))
(Royal Assent: Royal Assent (Hansard))
(Royal Assent (Hansard))
(Royal Assent: Royal Assent (Hansard))
Thursday 11th February 2021

(3 weeks, 3 days ago)

Lords Chamber

Read Hansard Text Bill Main Page

The following Acts were given Royal Assent:

Pension Schemes Act 2021,

High Speed Rail (West Midlands-Crewe) Act 2021,

Medicines and Medical Devices Act 2021.

Medicines and Medical Devices Bill

(Ping Pong (Hansard))
(Ping Pong (Hansard): House of Lords)
Tuesday 2nd February 2021

(1 month ago)

Lords Chamber

Read Hansard Text
Department of Health and Social Care

Commons Amendments

Relevant documents: 19th and 33rd Reports from the Delegated Powers Committee, 10th Report from the Constitution Committee

Lord Duncan of Springbank Portrait The Deputy Speaker (Lord Duncan of Springbank) (Con)
- Hansard - - - Excerpts

My Lords, hybrid proceedings will now resume. There are no counter-propositions, so the only speakers are those listed and the Minister’s Motion may not be opposed. Short questions of elucidation from listed speakers after the Minister’s response are permitted but discouraged. A Member wishing to ask such a question must email the clerk. We will now begin.

Motion A

Moved by

Lord Bethell Portrait Lord Bethell
- Hansard - - - Excerpts

That this House do not insist on its Amendments 2, 3, 12, 13, 14, 23, 24, 25, 30, 40, 48, 49 and 50 and do agree with the Commons in their Amendments 50A, 50B and 50C in lieu.

50A: Clause 42 page 24, line 36, leave out subsections (3) to (9) and insert—

“(3) The procedure for making regulations under Part A1, 1, 2 or 3 is to be determined in accordance with this table and subsection (4)—

If the regulations contain provision madein reliance onthe regulations are subject tosection 5(1)(a)the negative proceduresection 10(1)(a)the negative proceduresection 14(1)(a)the negative procedureparagraph 9 of Schedule 1the negative proceduresection 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 casesection 15(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 caseany other provision of Part A1, 1, 2 or 3the draft affirmative procedure (4) Provision that may be made by regulations subject to the negative procedure may be made by regulations subject to the draft affirmative procedure.

If the regulations contain provision madein 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 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

any other provision of Part A1, 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 a Northern Ireland department 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 a Northern Ireland department 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.”

50B: After Clause 42, insert the following new Clause—

“Part 4A

Report on Operation of Medicines and Medical Devices Legislation

Report on operation of medicines and medical devices legislation

(1) The Secretary of State must, before the end of the relevant period, publish a report on the operation of medicines and medical devices legislation.

(2) The report must, in particular, include an assessment of whether—

(a) some or all medicines and medical devices legislation should be consolidated or otherwise restructured,

(b) provisions of medicines and medical devices legislation should be included in regulations or Acts of Parliament, and

(c) powers to make regulations should be modified or repealed.

(3) In preparing the report, the Secretary of State must take into account any report relating to the operation of medicines and medical devices legislation made by a Parliamentary Committee.

(4) The Secretary of State must lay a copy of the report before Parliament.

(5) In this section—

“medicines and medical devices legislation” means—

(a) the law relating to human medicines within the meaning of section 7 (interpretation);

(b) the Veterinary Medicines Regulations 2013 (S.I. 2013/2033);

(c) the Medical Devices Regulations 2002 (S.I. 2002/618);

(d) Parts 1 to 4 of this Act; (e) regulations made under those Parts;

“Parliamentary Committee” means a committee of the House of Commons or of the House of Lords or a joint committee of both Houses;

“relevant period” means the period of 5 years beginning with the day on which this Act is passed.”

50C: Clause 44, page 26, line 8, at end insert—

“(ha) Part 4A.”

Motion B

Moved by

Lord Bethell Portrait Lord Bethell
- Hansard - - - Excerpts

That this House do agree with the Commons in their Amendments 11A, 11B, 11C and 11D.

11A: After Clause 6, line 6, after “where” insert “—

(a) the disclosure is”

11B: Line 8, at end insert “, and

(b) the relevant authority considers that the disclosure is in the public interest.”

11C: Line 9, leave out subsection (3)

11D: Line 20, leave out “subsection (7)” and insert “subsections (6) and (7)”

Motion C

Moved by

Lord Bethell Portrait Lord Bethell
- Hansard - - - Excerpts

That this House do agree with the Commons in their Amendments 22A, 22B and 22C.

22A: After Clause 10, line 6, after “where” insert “—

(a) the disclosure is”

22B: Line 8, at end insert “, and

(b) the relevant authority considers that the disclosure is in the public interest.”

22C: Line 9, leave out subsection (3)

Motion D

Moved by

Lord Bethell Portrait Lord Bethell
- Hansard - - - Excerpts

That this House do agree with the Commons in their Amendments 32A, 32B and 32C.

32A: Clause 35, line 3, after “where” insert “—

(a) the disclosure is”

32B: Clause 35, line 5, at end insert “, and

(b) the relevant authority considers that the disclosure is in the public interest.”

32C: Clause 35, line 8, leave out subsection (4C)

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
- Hansard - - - Excerpts

My Lords, with the leave of the House, I beg to move that the House do agree with the Commons in their Amendments 11A to 11D, 22A to 22C, 32A to 32C, and 50A to 50C en bloc. I pay tribute to noble Lords on all sides of the House in reaching consensus on the issues dealt with in these amendments. They were put down in the other place after cross-party discussions and I believe they reflect the aims and agreement of the House.

Amendments 11A to 11D, 22A to 22C and 32A to 32C all make minor amendments to Lords Amendments 11, 22 and 32. These amendments, in the name of the noble Baroness, Lady Thornton, made further changes to the clauses allowing the MHRA and the VMD to share information with relevant persons, such as regulators, outside the UK. Lords Amendments 11, 22 and 32 create a new safeguard that information could be shared only when in the public interest or for pharmacovigilance. I thank the noble Baroness very much for her remarks on Report. She made it very clear that the reference to pharmacovigilance was illustrative. Pharmacovigilance is very important, but it is also very much in the public interest and so does not need to be included outside the reference to the public interest. It is already captured. The Commons amendments therefore remove the reference to pharmacovigilance and the purpose of the amendments remains.

The majority of the Commons amendments deal with the variety of ways that noble Lords sought to create means to bring the Bill, and the principles of the Bill, back before Parliament in the future. Three methods were put forward and, in fact, noble Lords eloquently pressed the point on all of them. Lords Amendments 2, 13 and 24, which were tabled by the noble Baroness, Lady Thornton, put forward a sunset on delegated powers. Lords Amendments 3, 14, 25, 30, 48 and 49, which were tabled by the noble Lord, Lord Sharkey, put in the super-affirmative procedure. Lords Amendments 12, 23 and 40, in the name of the noble Lord, Lord Patel, put forward the idea of bringing forward consolidated draft legislation within three years. I do not intend to repeat my arguments against all three; I have said throughout this Bill that we have been listening carefully to all noble Lords who have put forward very clearly their continued concerns.

Commons Amendments 50A, 50B and 50C are an alternative, which I believe we can agree avoids the issue of introducing a “cliff edge” for legislation—and potentially patient safety—but importantly provides the reassurances that noble Lords quite reasonably sought. They collectively create an obligation for the Secretary of State to prepare a report on the operation of the legislation within five years of Royal Assent, and the amendments specify the considerations that must be addressed in that report: first, whether the legislation should be consolidated or restructured; secondly, whether legislation ought to be in regulations or in Acts of Parliament; and, thirdly, whether any of the powers to make regulations should be modified or repealed.

This would mean actively considering all the questions raised by noble Lords. It would give the time needed for making changes to the current legislation governing medicines and medical devices using the Bill’s powers, and allow for those changes to bed down and for those complex areas of law to reach a steady state, before considering these important issues.

The Secretary of State must also take into account any report of a parliamentary committee in preparing that report. This would mean that if any committee—whether your Lordships’ Delegated Powers and Regulatory Reform Committee or the Health Select Committee in the other place—decided to take a view on the operation of the legislation in the intervening time, its conclusions and considerations would have to be taken into account. If any committee should choose to do so, perhaps on the basis of the post-legislative memorandum that must be prepared within three to five years of the Bill being enacted, Parliament will have expressed a view before being presented with the Secretary of State’s report.

I think this is a satisfactory compromise. It meets the principle of parliamentary review without the practical impact on patient safety of powers lapsing. It ensures that Parliament has the ability to express a view and for that view to be heard, without asking for review before it is practicable. Amendment 50A makes the necessary changes to reinstitute the parliamentary procedure changes made at Lords Committee stage, in place of the super-affirmative.

I hope that noble Lords will be content to accept the amendments from the House of Commons. I beg to move.

Lord Patel Portrait Lord Patel (CB) [V]
- Hansard - - - Excerpts

My Lords, I am extremely grateful for the amendments that the Government have brought from the Commons. I am grateful to the Minister and his team for working so diligently with the rest of us, and to all noble Lords who supported my amendments. It is not unusual—but it is infrequent—for the votes that the Government did not get through in the Lords to be reconsidered in the Commons and brought back as government amendments. I am very content that the amendments that the Government have brought are very satisfactory and I congratulate them. I thank the noble Lord, Lord Bethell, the noble Baroness, Lady Penn, the noble Earl, Lord Howe, and the legal team for working with us throughout the Bill. That is all I am going to say.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
- Hansard - - - Excerpts

My Lords, I too shall be brief and I too am grateful to the Minister and his team for giving Peers an opportunity to see the Commons amendments to the Bill before they were tabled, so that we might give some feedback. One of the things that has made this Bill a pleasure to work on is the open way in which political parties and Cross-Benchers have worked together, as well as the way that the Minister and his team have worked with us. We particularly welcome the clauses that have come to us from the Commons; they make the Bill a more explicit and effective piece of legislation than when it was debated either in Committee or on Report in this House.

Baroness Thornton Portrait Baroness Thornton (Lab)
- Hansard - - - Excerpts

My Lords, I am very grateful to the Minister and his team for the manner in which they have engaged and worked with us throughout the passage of this Bill, particularly at this final stage. The amendment in lieu is a good compromise that reflects the need for scrutiny to be at the heart of the Bill. It provides a mechanism to examine the powers of the Act in five years’ time and will open the door for the restructuring and consolidation of the post-Brexit medicines and medical devices regulatory regime. We believe that this will prove both desirable and necessary, and look forward to working with the Minister on such issues when the time comes.

We welcome the requirement that the Secretary of State must specifically consider whether this should be in the form of primary or secondary legislation and hope that this will lead to policy being put into a future Bill rather than scrolled away in regulations. The Secretary of State will also have to take account of all parliamentary committee reports. This would include post-legislative scrutiny undertaken by a Select Committee, as well as the DPRRC and Constitution Committee, whose oversight played a crucial role in reshaping a skeleton Bill into a framework Bill; I thank the noble Lord, Lord Lansley, for explaining that to us all. I hope the Minister can assure me that stakeholders will also be consulted. I am sure that that will be the case. It is very important, given that they are the end users of the legislation, and for the report to have value and credibility it must reflect the experience of regulators, industry, patients and medical professionals.

Finally, the tidying-up amendment that retains the requirement to share information in the public interest is an important provision because it will allow for substantive and ethical issues relating to the sharing of public data to be considered. This is of the utmost importance, given the role that the NHS and patient data may have in future trade deals.

Lord Bethell Portrait Lord Bethell (Con)
- Hansard - - - Excerpts

My Lords, I do not intend to repeat much of what I said at Third Reading. Many thanks to the noble Lords who have contributed to the changing shape of the Bill. From Committee to ping-pong, we have listened, heard proposals for change and brought workable, practicable compromises forward.

I wish to repeat the remarks made by the noble Baroness, Lady Thornton. She congratulated all of us on the effective communication that has made it possible to make considered progress on this Bill, despite all the challenges that Covid-19 has presented us with. This a very fair assessment; I agree with it completely. From the report of my noble friend Lady Cumberlege to the demonstrated expertise of our medicines regulator, the MHRA, we have seen the importance of patient safety, clinical trials, our life sciences sector and effective regulation bear out in our hospitals, clinical trials and patient community.

I look forward to the debates ahead of us on the regulations that will be made under the Bill. They will be important, as we set forward on our course for the best possible regulatory regime for the UK, with the patient at its heart.

Lord Duncan of Springbank Portrait The Deputy Speaker (Lord Duncan of Springbank) (Con)
- Hansard - - - Excerpts

Noble Lords will be pleased to know that no one has requested to speak after the Minister.

Motions agreed.

Sitting suspended.

Medicines and Medical Devices Bill

(Ping Pong)
(Ping Pong: House of Commons)
Wednesday 27th January 2021

(1 month, 1 week ago)

Commons Chamber

Read Hansard Text Bill Main Page
Department of Health and Social Care

Consideration of Lords amendments

Rosie Winterton Portrait Madam Deputy Speaker (Dame Rosie Winterton)
- Hansard - - Excerpts

I must draw the House’s attention to the fact that financial privilege is engaged by Lords amendments 1 and 54. If any amendment engaging financial privilege is agreed to, I will cause the customary entry waiving Commons financial privilege to be entered into the Journal.

Before Clause 1

Establishment and core duties etc

Rosie Winterton Portrait Madam Deputy Speaker (Dame Rosie Winterton)
- Hansard - - Excerpts

With this it will be convenient to discuss the following:

Government motion to disagree with Lords amendment 2.

Government motion to disagree with Lords amendment 3.

Lords amendments 4 to 10.

Lords amendment 11, and Government amendments (a) to (d) thereto.

Government motion to disagree with Lords amendment 12.

Government motion to disagree with Lords amendment 13.

Government motion to disagree with Lords amendment 14.

Lords amendments 15 to 21.

Lords amendment 22, and Government amendments (a) to (c) thereto.

Government motion to disagree with Lords amendment 23.

Government motion to disagree with Lords amendment 24.

Government motion to disagree with Lords amendment 25.

Lords amendments 26 to 29.

Government motion to disagree with Lords amendments 30 and 31.

Lords amendment 32, and Government amendments (a) to (c) thereto.

Lords amendments 33 to 39.

Government motion to disagree with Lords amendment 40.

Lords amendments 41 to 47.

Government motion to disagree with Lords amendment 48.

Government motion to disagree with Lords amendment 49.

Government motion to disagree with Lords amendment 50.

Government amendments (a) to (c) in lieu of Lords amendments 2, 3, 12 to 14, 23 to 25, 30, 40 and 48 to 50.

Lords amendments 51 to 56.

Jo Churchill Portrait Jo Churchill
- Hansard - - Excerpts

I am extremely pleased to be back at the Dispatch Box to speak to this Bill. It is a changed Bill since we last looked at it but one that still has the patient at its heart. I am pleased that it comes back to us with the same spirit of consensus and collaboration that it left us with.

Since we had the Bill’s Third Reading, the pandemic’s evolution and the importance of the regulation of clinical trials, the roll-out and regulatory approval of a vaccine, and the ability of healthcare professionals to get medicines into patients has bought into sharp focus precisely how essential this Bill is. The Government made a number of amendments to the Bill through the other place in response to Committees of the House, the report of the independent medicines and medical devices review, led by Baroness Cumberlege, and, importantly, as a result of genuine, cross-party discussions on how to make this Bill better.

I am glad to say that the Bill still—and for those who know me, this is my passion—puts patients first: patients who will have the opportunity to trial new treatments; patients whose safety is paramount; patients who need to see quick and effective action from regulators in the event of an emergency. The Bill that left us on Report had a new change to it, anticipating Baroness Cumberlege’s report. The medical device information system, which will transform post-market surveillance of medical devices and improve the ability to track down patients and prevent harm, followed talks across this House and in the other place. I reiterate my thanks in particular to the hon. Members for Washington and Sunderland West (Mrs Hodgson) and for Central Ayrshire (Dr Whitford) for their contributions to that effort.

We said on Report that we awaited the conclusions of the Cumberlege review and that we would take steps when the review was published. I can tell the House now that we have, and Lords amendment 1 establishes a Patient Safety Commissioner—a champion for patients in relation to medicines and medical devices. I pay tribute to all those who have spoken here and in the other place of the impact of harm on patients and on women—those who have not been listened to whose stories are difficult and heart-wrenching. Much was said during the Bill’s passage in the other place about the whole system change to enshrine the voice of patients at the heart of the process and our commitment to it. The Patient Safety Commissioner will act within and outside the system. They will be an advocate for patients and ensure that the patient voice is primary. The commissioner will be able to seek information, make reports without fear or favour and expect responses, and, more importantly, get change.

Lords amendments 1, 41, 47, 54 and 56 together provide for both the appointment of a Patient Safety Commissioner and regulations to support this appointment. I congratulate Baroness Cumberlege and her team, and thank her and others who contributed to getting this into the Bill so quickly after her report.

Lords amendment 31 provides for a small but important change that was also recommended in that review: a power to put the devices expert advisory committee on to a legislative footing.

I am very conscious of the passion and commitment shown by the hon. Member for St Helens South and Whiston (Ms Rimmer) when we were last discussing the Bill. She has shown admirable determination. I am pleased to draw her attention to Lords amendment 8, which the Government were happy to support in the other place. That important amendment provides for provisions about the origin and treatment to be made in relation to the regulation of human medicines.

We have had two reports, one from the Delegated Powers and Regulatory Reform Committee and one from the House of Lords Constitution Committee.

When we last stood opposite each other, the hon. Member for Nottingham North (Alex Norris) challenged me on how to make it clear that patient safety was the absolute priority. I thank him and his team, and those who work in the other place, for their constructive dialogue on these issues. We all want to see patients receiving effective, safe medicines and medical devices, and we all want to ensure that the UK remains at the forefront of pharmaceutical innovation. Amendments 4, 5, 6, 7, 15, 16, 17, 18, 19, 26, 27, 28 and 29 all change the nature of the regulatory powers in clauses 1, 8 and 12. They introduce an objective to safeguard public health, putting it at the heart of regulations. They remove the word “attractiveness” from the Bill and set out what I hope is as agreeable here as it was in the other place—a list of the types of activity we would hope the UK would be a favourable place to conduct. Importantly, they apply a safety lock. Regulations that affect the safety of a medicine or a medical device can be made only if the benefits outweigh the risks.

Hon. Members here were very clear that we should go further to demonstrate that patient safety was absolutely paramount. These changes do that, but they also assist in turning a Bill that was called a skeleton Bill into a true framework Bill that makes it clear how delegated powers will be used and how, in making regulatory changes, safeguarding public health remains key. These changes better reflect the discussions in this House and the other place, and answer the criticisms of the DPRR and the Constitution Committee.

We have also made changes to criminal offences—another area of earlier concern. Amendments 9, 10, 20, 21 and 55 clarify the maximum penalty that may be created by regulations. Both the DPRR and the Constitution Committee recommended increased parliamentary scrutiny, and the shadow Minister’s colleagues also pressed for public involvement.

Amendments 44, 45 and 46 all provide for Parliament to have multiple opportunities to inform, and be informed by, the Government’s plans for regulatory changes. First, consultations have become public consultations under clause 44. Secondly, the appropriate authority is obliged to produce an assessment of how the regulatory proposal meets the overarching framework considerations at the time of going out for consultation. As Members are aware, the Government prepare a response to the consultation, and how the consultation responses are considered will be made public in that way. The amendments introduce a reporting requirement that means a separate report back to Parliament every two years summarising how regulations made under clauses 1, 8, 12 and 18 have been operating during that time. It must include any concerns raised, what has been done as a consequence, and any plans for further changes to regulations. This gives the flexibility for Parliament to be interested in—and if individual Members or Committees wish it, to submit responses to—any individual consultation, without requiring it to.

Last time we discussed this Bill, the hon. Member for Nottingham North asked whether we could accept a sunset clause as a way of settling his colleagues’ concerns as to how we might use the powers contained in the Bill. I hope that he can agree that how these powers can be used has materially changed as a result of the Bill’s going through the other place. Another option that was put forward in the other place, as well as a sunset clause, was a requirement to bring forward and publish draft legislation. Unfortunately, we cannot accept these changes. Three years is simply not long enough to have a fully settled regime in a steady state to make reassessment practical, and amendments 2, 12, 13, 23, 24 and 40 would definitely introduce a cliff edge for new legislation. That is not the best way to go about legislation in general, but in this Bill, where essential changes could be needed to protect patients, there are better and more effective alternatives. Lords amendments 3, 14, 25, 30 and 48 to 50 also introduce the use of the super-affirmative procedure for regulatory changes that introduce significant new policy or changes to policy. Quite aside from how difficult it would be to assess what “significant” means, it is very much using a sledgehammer to crack a nut—as we are often guilty of doing in this place. In both cases, I have heard the arguments for these amendments. People are concerned about the lack of detail in the new likely changes to the existing regulatory regimes, in particular for medical devices, and therefore Parliament wants greater visibility of what happens next. We have stressed the critical importance of consultation and have made changes there, and we have provided the reporting, as I have outlined.

Amendment (b) in lieu, in the name of my right hon. Friend the Secretary of State, proposes an alternative that goes further. This would require a report to be prepared within five years of Royal Assent that looked at the operation of the legislation. It would oblige the Secretary of State to take into account a report of any parliamentary Committee. That could mean, for example, a Select Committee choosing a report on the basis of a post-legislative scrutiny memorandum, and that report would need to address a series of considerations, such as whether the legislation needs restructuring or consolidating, whether certain parts of the legislation should be an Act of Parliament, and whether any of the powers in the Bill need amending or repealing. That provides the time needed to get the regulatory system into a steady state. It allows for consideration of how the system works on the ground and of all the factors that the hon. Member for Nottingham North and others have fairly raised in arguing in support of their amendments. I hope that he will support this solution.

I do not intend to spend very long on Lords amendments 11, 22 and 32 to 39, not because they are not important, but because they have been arrived at with significant consensus. We introduced these important powers to allow for information to be shared with relevant persons, such as regulators and regulatory networks outside of the UK, in order to give effect to international arrangements. These amendments provide safeguards on data shared by the Medicines and Healthcare Products Regulatory Agency and the Veterinary Medicines Directorate. They define patient information. They provide a definition of relevant persons with whom information can be shared. Government amendment (a) to Lords amendment 11 would remove the reference to pharmaco-vigilance from the requirement to share information in the public interest, as, of course, pharmacovigilance is in the public interest and therefore covered.

Madam Deputy Speaker, I do not intend to spend any time at all—you may be glad to hear—on Lords amendments 51 to 53, which make consequential commencement changes.

To finish, the Bill has gone through with a great deal of well-informed, well-intentioned debate and changes. I am pleased that the constructive discussions that we had before it left us have continued. The other place has brought something back to us that I hope we can agree delivers for UK patients and the UK life sciences industry, which is vital and enables us to build a stand-alone regulatory system for the UK for the future and one that has patients absolutely at its heart.

Alex Norris Portrait Alex Norris (Nottingham North) (Lab/Co-op)
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It is a pleasure to resume proceedings on this Bill, and we are now very close indeed to the finish line. For us and, I think, for all Members, this has always been about patient safety and about making sure that people of the United Kingdom have the best access to medicines and medical devices. The exchanges so far have been of a high quality in both content and tone. As the Minister has characterised, the Bill started as a skeleton, but it is certainly thin no more. There is much in there that will make a significant difference to our country.

I have been proud to take the lead for the Opposition since the Committee stage, and I thank my predecessor in the earlier rounds, my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson), for setting the tone for us. I am also grateful to the Minister for her level of engagement and for giving us generous access to her officials and the Government in general throughout this process. The stages of the Bill through the Commons were of a high quality, and clearly considerable progress has been made in the other place, which we consider today. 

I welcome the Government’s concessions on the Bill, and I congratulate my colleagues in the other place, particularly Baronesses Thornton and Wheeler and Lord Hunt, on their hard work on and dedication to securing these vital amendments. That hard work will ensure that the Bill will promote patient safety and privacy, as well as proper consultation and scrutiny. I might even be mischievous enough to say that I tabled a number of these amendments in Committee, but I was unable to get them accepted at that point. I am therefore delighted to see them accepted at this stage.

We will support the Lords amendments where the Government have indicated their support, and where they have tabled amendments in lieu we will accept those as a reasonable compromise. I therefore do not intend to divide the House this evening. Similarly, I do not intend to speak to all 56 amendments, but I might cover a few of the pertinent major themes.

The Minister was right to say that in previous exchanges I challenged her to demonstrate that safeguarding public health and, critically, patient safety was uppermost, and that is reflected in Lords amendments 4 and 5. I knew from the outset that that was the Minister’s intention, and I think the amendments improve and make the Bill clearer, as well as future-proofing it for future Ministers and—dare I say it?—future Governments. It is important that that was done, and we appreciate that.

On Lords amendment 1, it is welcome that the Government have heeded the second recommendation in the Cumberlege review, and legislated for an independent Patient Safety Commissioner. We were lucky to have a review as seismic as that one, which crystallised many decades of suffering and pain for lots of people who had been crying in the darkness and ignored for a long time. That report was a cathartic moment, but it cannot remain just a report, and the fact that we had primary legislation that was the perfect vehicle for the independent Patient Safety Commissioner was a real blessing. I am pleased we were able to find a way to include that.

Mark Tami Portrait Mark Tami (Alyn and Deeside) (Lab)
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Does my hon. Friend agree that many of the people he said were in the dark often felt that they were on their own, and it was only when groups were set up that they realised otherwise? Many doctors were telling them there was not a problem.

Alex Norris Portrait Alex Norris
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Yes, and I met as many of those groups as I possibly could. That commonality in the story of people often being ignored and left alone, or told that they were wrong, lying or making it up, added insult to the significant injuries that they had suffered. That collective action was a big part of people getting their salvation and securing that review which then vindicated them so strongly. That is so important. The presence of the independent commissioner will ensure that patient wellbeing is prioritised and there will be a voice for those citizens. That is an essential step forward to ensure that our wonderful national health care system is responsive and hears challenging messages, even if perhaps it does not always want to. That will give people a voice, which is important.

We welcome the amendments on transparency and accountability, and I pay tribute to the hon. Member for Central Ayrshire (Dr Whitford) for her leadership at other stages of the Bill. Frequent reporting will ensure that the system is monitored and accountable, which is good. With Lords amendment 31 the Bill will provide for the establishment of the independent statutory device expert advisory committee, to ensure that the regulation of devices is transparent, and that decision making is better structured and more accountable. That can only be a good thing. Making urgent regulation subject to positive affirmation, as in amendment (a) in lieu, will allow the regulatory system to respond to changing situations, while ensuring proper accountability and scrutiny.

As the Minister says, amendment (b) in lieu sweeps up and replaces the Lords amendments that relate to sunset clauses and clauses on the super-affirmation procedure. It was not quite what I was after, but I think it is a pretty fair deal. It is certainly more than I thought I would get—perhaps I should not say that before the amendments have been made. As a former trade union negotiator, I always thought that going in and getting 60%, 70% or 80% for our members was a pretty good outcome, so we will certainly take that. The five-year review is a good thing as it gives the Government more time—those arguments were well made by the Minister, and on reflection I think they are right.

At the root of this, the Secretary of State is acquiring significant powers, and it is right to review that as well as to have scrutiny down the line, and an opportunity for right hon. and hon. Members to determine whether the system might need consolidating or restructuring. That is vital to improve the quality of the regulatory system. I am really pleased that we got there, and with where we have arrived. I welcome the opportunity in Lords amendment 8 for the use of human tissue in medicine to be further regulated, thus preventing the NHS from being compromised by the trade in harvested organs, including those from ethnic minorities and political prisoners in authoritarian states. My hon. Friend the Member for St Helens South and Whiston (Ms Rimmer) will be pleased with that inclusion. It is her hard work that made that happen, and I commend her for it, as she battled away. She feels strongly about this, and what has come out is very positive indeed. As I say, I commend her greatly for that.

Briefly, I shall pick up a couple of outstanding things from the medicines and medical devices safety review, which the Minister may deal with in her response. Again, significant progress has been made in the Bill and in associated regulations to make those recommendations a reality, but there are still a number of things outstanding that are accompanied by the words “in due course”, so I would be keen to get a sense from the Minister of when that is. She will be asked about that by others, as will her colleague, the Minister for Patient Safety, Suicide Prevention and Mental Health, and many right hon and hon. Members. It is an important part of finishing the process that those recommendations are adopted. The decision has clearly been made that they were not within the scope of the Bill or that the Bill was not the best place for them. I hope that when she closes the debate the Minister will detail the Government’s plans or at least a timetable for plans to address that.

Finally, the Bill—certainly the guidance relating to it—has advanced the idea of making fundamental change to community pharmacy by moving towards a hub and spoke model. I will say what I said in Committee and on Report. The Government have chosen not to include that in the Bill—that is their decision—but I believe that they intend to do it, and it will be a seismic change for community pharmacy. I hope to hear from the Minister a clear commitment to something so significant that it requires wide-ranging consultation with all manner of stakeholders to make sure that we do it right. I think that that is the case, but I am keen to have on-the-record clarity.

In conclusion, the Bill deals with patient safety and making sure that the British people have access to the best medicines and medical devices. We have fought hard to make it the best Bill that we can, and I am really proud and pleased with the progress that we have made.

Anthony Mangnall Portrait Anthony Mangnall (Totnes) (Con)
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It is a pleasure to follow the hon. Member for Nottingham North (Alex Norris), and to have followed the Bill from afar. It is a shining example of cross-party support, and to see it emerge from a skeleton Bill into a framework Bill is a credit to everyone who participated in Committee and in the House of Lords, and to Members across the House.

It is, in short, a pleasure to be able to speak in this debate, and I support Lords amendments 1 and 54. The creation of a commissioner for patient safety has long been sought, and it will not only enhance the fact that the NHS is viewed as one of the safest healthcare systems in the world but will reinforce the view that it is an organisation that can learn from its mistakes. One such mistake is the unconsented and experimental use of TVT mesh. The intent was for the best of purposes, but in fact it caused utter devastation, both physically and emotionally, to those who suffered adverse side effects. Those effects went unreported and were misdiagnosed for a great length of time, and change was down to people such as Janet Peck and Susan Morgan—two of my constituents and victims themselves—who fought hard for action to be taken. Their determination and hard work have resulted in the excellent report by Baroness Cumberlege, which calls for the appointment of a Patient Safety Commissioner, which the Bill seeks to put in place, to ensure that scenarios such as those surrounding TVT mesh become never events.

The Minister for Patient Safety, Suicide Prevention and Mental Health gave a heart-felt and meaningful apology to those who have been failed by medical treatments as outlined by the Cumberlege report last year. The new position will be welcomed by patients and practitioners alike, and I hope that the Minister responding to the debate will go further and explain the commissioner’s remit and the parameters of their work, and how recruitment will find a suitable person to report back. I welcome the fact that the Government will respond further to the independent medicines and medical devices safety review. Finally—much of what I wanted to say has already been said—I pay tribute to Susan and Janet. Their fortitude and determination have helped to shape the Cumberlege report and shape this Bill and, as we have already heard, their repeated efforts to ensure that patient safety is put first have allowed the Bill to be created in such a way that it will have a long and meaningful impact on those who seek the best service possible from the NHS. As has already been said, the cross-party support is a credit to this House. I congratulate all Members who have taken a significant step in helping to shape the Bill.

Marie Rimmer Portrait Ms Marie Rimmer (St Helens South and Whiston) (Lab) [V]
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In 2018, the imported bodies of political prisoners and human rights abuse victims in China were on display in Birmingham. It was supposed to be a Real Bodies exhibition, to inform the public about biology, yet in reality it was a barbaric travelling circus. The British public unknowingly paid £15 each to view the remains of these poor souls.

Since I learned of that horrific display, I have become determined to work on behalf of these human rights abuse victims to end forced tissue and organ harvesting. Our nation and the people who live here must not be complicit in the brutal acts of the Chinese communist regime. The first step is to put a stop to the importing of tissue and organs of human rights abuse victims. Currently, neither the human tissue regulations nor the Human Tissue Act 2004 requires appropriate consent for imported human tissues to be used in medicines. After several attempts to bring forward an amendment to achieve this, both here and in the other place, the Government have finally included a negotiated amendment in this Bill, which I welcome.

That amendment provides the opportunity to prevent complicity in this crime within the UK medicine industry, and gives Ministers the powers to do the right thing. It is important to stress that the amendment has not dealt with the issue of organ transplant tourism, or the issue of plastinated unclaimed bodies being imported and commercially displayed, as we saw in Birmingham. The amendment is a welcome start, but it is only the beginning; there is much more to do.

I hope the House will forgive me if I place my thanks on record, as securing that amendment has been a long, drawn-out battle across both Chambers. First, I congratulate Lord Hunt of King’s Heath for persevering so tenaciously, along with his co-signatories Lady Finlay, Lady Northover and Lord Ribeiro. I also thank Lord Alton and Lord Collins for their tireless efforts on this issue. Finally, I thank my hon. Friend the Member for Nottingham North (Alex Norris) for his support and advice.

One of my predecessors as MP for my home town, St Helens, was Sir Hartley Shawcross, the chief British prosecutor at the Nuremberg trials. Just like the Nazis he prosecuted for, among many reasons, using human beings for medical experiments, I hope and pray that one day, those responsible for these despicable, heinous acts will be prosecuted for their crimes against humanity, for that is what forced organ harvesting is. Last year, the China tribunal, led by Sir Geoffrey Nice QC, a former lead prosecutor at The Hague, concluded that

“Forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one—and probably the main—source of organ supply”,

and that

“In regard to the Uyghurs the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”

The amendment sends a very clear message that we will not tolerate such appalling acts against humanity and that we will deliver for the people of China, not for the Communist party of China. Let the amendment truly mark the beginning of a new relationship with China—a relationship that is not naive. Today, Holocaust Memorial Day, is the day when the world says “Never again” to genocide. Let this be the start of the Government putting those words into practice.

Jim Shannon Portrait Jim Shannon (Strangford) (DUP) [V]
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I thank the Minister for all the work that she has done on the Bill, and I commend the hon. Member for Nottingham North (Alex Norris) for his dedication.

The Bill seeks to address the regulatory gap by introducing dedicated regulation-making powers covering the fields of human medicines, including clinical trials of human medicines, veterinary medicines and medical devices. That is clearly absolutely necessary, and the most pertinent reason is one about which I wrote to the Secretary of State for Health and Social Care just last week: the ability of my young constituent Sophia Gibson to have continued access to her medication post Brexit. Her family were informed that there would be issues sourcing the medication—medicinal cannabis—that has made such a difference to her life. Her parents began their battle, still traumatised from their last battle to source this life-saving medication, and we began to work on it. The Secretary of State and the Northern Ireland Department of Health have worked hard, and initial reports are that we will produce the medication here, in co-ordination with the lab that creates it in the Hague. That is good news, although I await confirmation. It would appear that this is just one story that is working out, but it flags the necessity of the United Kingdom of Great Britain and Northern Ireland creating and prescribing our own medications. That is why this legislation is vital.

I echo and support wholeheartedly the comments of the hon. Member for St Helens South and Whiston (Ms Rimmer) in relation to the commercial forced organ harvesting that is happening in China against Falun Gong members, Christians and Uyghur Muslims. We need to address that, and I know that the Minister and other Ministers have that responsibility. It is very worrying, and I echo the hon. Lady’s comments about that.

I know that the thousands of people who believe that their quality of life has been affected by mesh, for example, will wonder why this legislation has not been in place before. I ask for clarity that the aim of the Bill will be achieved and that it will allow for much greater scrutiny and accountability in the world of medical devices.

The Lords amendments make a few suggested additions to the Bill. There is an understanding that we must allow our medical field the ability to produce medication and medical devices, but also that it must be better regulated and offer better protection to those who rely on these devices. The Bill extends to England, Northern Ireland, Scotland and Wales. Parts 1 and 2, relating to human medicines and veterinary medicines respectively, are within the legislative competence of the Northern Ireland Assembly. A legislative consent motion has been sought for those parts, and I welcome that following close on the heels of this debate.

Our goal is not simply to pass continuity legislation post Brexit but to improve and upgrade our legislation, and that is what the Bill achieves. The Government indicated in the background briefing to the Queen’s Speech and in a press release that they intend to use these powers to support the development of medicines and medical devices in the NHS and amend prescribing power. That needs to happen, and it needs to happen now; will the Minister confirm that that is the case? The Government stated in the explanatory notes to the Bill that they intend to use these powers to keep the existing regulatory frameworks updated, while consolidating the enforcement regime for medical devices. In addition, the Bill will provide the Secretary of State with the ability to impose civil sanctions as an alternative to criminal prosecution for breaches of the medical device regime.

I have long worked with those who believe that the use of mesh in their bodies has caused substantial harm—not just females and ladies, but males. I have had a number of meetings with them about that. We are all aware that, when something is termed a medical device and not a medication, the testing is less stringent. The civil sanctions will provide the emphasis that we all want to see, to ensure that any device placed in a person’s body has been tested to a high standard before widespread use. I commend the Government, and I commend all Members for their contributions.

Jo Churchill Portrait Jo Churchill
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When taking a Bill through the House, we always hope that it will be one that hon. Members from both sides can understand, support and improve. Our intention to have a gold standard of medicines and medical device regulation in this country, and to put the patient at the heart of it, has been long understood and has very much formed the foundation stone of the Bill.

I am very grateful for the support of hon. Members here; the spirit of collaboration is how we get this Bill done now—today. I would like to address one or two of the questions that hon. Members brought up. I reiterate my thanks to the hon. Member for Nottingham North (Alex Norris). He was right when he said that the timing of the Cumberlege report was fortuitous. In this House, we have been able to make sure that patient safety has been addressed. He was also right to say that it was a collective effort, and he and other Members were right in saying that the Bill very much reflects the voice of campaigners who often feel that their voices go unheard. Today, they have not gone unheard.

Mark Tami Portrait Mark Tami
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May I also mention the former Member for Pontypridd, Owen Smith, who is no longer in the House? He set up the all-party parliamentary group on surgical mesh implants, which did so much work to highlight this issue.

Jo Churchill Portrait Jo Churchill
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Indeed.

This has been a long time coming, and Members from both this House and the other place have been involved. I pay particular tribute to Janet Peck and Susan Morgan, the constituents of my hon. Friend the Member for Totnes (Anthony Mangnall), and their quiet determination to make sure that their challenges were seen and noticed. The Government then took the right decisions in helping them make sure that this does not happen to others. That was the right thing to do.

The hon. Member for Nottingham North asked me to address two or three points. We plan to respond in full to the report later in 2021. It has been incredibly impactful and has already served to put patient safety at the top of the agenda for the whole health and care system. If it had not been for the covid-19 pandemic, I think we would be discussing little else than patient safety because of the Bill before us. Just as covid-19 impacted on the publication of the report, it has impacted our response time. But I assure the hon. Gentleman that that response will come later in the year.

The hon. Gentleman also asked about the speed of the appointment of a patient safety commissioner. I very much want the right person. I cannot give a precise time, but I want to underscore the importance of patient safety and our belief that the patient safety commissioner will and must be effective in amplifying the voice of patients and improving patient safety in the use of medicines and medical devices. I hope that the process will not take too long, but we must appoint the right person, who will truly give the right voice.

On hub and spoke, which the hon. Gentleman and I both agree is so important, there will be a full public consultation. The Government will then report to Parliament, and include a summary of the concerns raised in the public consultation. To ensure that we get the right model to assist pharmacy going forward, we intend to be totally transparent.

To the hon. Member for Strangford (Jim Shannon), I can give an unequivocal yes. We have a thriving life science sector in the UK, contributing over £80 billion a year to the economy and over a quarter of a million jobs. We want to ensure that the UK remains an important market for medicines and medical devices, and to bring products to market here.

As I close, it is perhaps unusual to be pleased that there have been quite so many changes or challenges on a Bill, but I think they have been the right changes and the right challenges. To that end, I thank all hon. Members who have challenged and who have assisted in those changes. I also thank all those who have assisted behind the scenes—the Bill team, my officials and so on. We have arrived at a Bill that I think carries the support of all sides and of both ends of the Parliament, and one where patients, the sector and the public can understand how we do good work and how this Bill will work for them.

Lords amendment 1 agreed to, with Commons financial privileges waived.

Lords amendments 2 and 3 disagreed to.

Lords amendments 4 to 10 agreed to.

Government amendments (a) to (d) made to Lords amendment 11.

Lords amendment 11, as amended, agreed to.

Lords amendments 12 to 14 disagreed to.

Lords amendments 15 to 21 agreed to.

Government amendments (a) to (c) made to Lords amendment 22.

Lords amendment 22, as amended, agreed to.

Lords amendments 23 to 25 disagreed to.

Lords amendments 26 to 29 agreed to.

Lords amendment 30 disagreed to.

Lords amendment 31 agreed to.

Government amendments (a) to (c) made to Lords amendment 32.

Lords amendment 32, as amended, agreed to.

Lords amendments 33 to 39 agreed to.

Lords amendment 40 disagreed to.

Lords amendments 41 to 47 agreed to.

Lords amendments 48 to 50 disagreed to.

Government amendments (a) to (c) made in lieu of Lords amendments 2, 3, 12 to 14, 23 to 25, 30, 40 and 48 to 50.

Lords amendments 51 to 56 agreed to, with Commons financial privileges waived in respect of Lords amendment 54.

Medicines and Medical Devices Bill

(3rd reading (Hansard))
(3rd reading (Hansard): House of Lords)
Thursday 21st January 2021

(1 month, 2 weeks ago)

Lords Chamber

Read Hansard Text
Department of Health and Social Care

Third Reading

Relevant documents: 19th and 33rd Reports from the Delegated Powers Committee, 10th Report from the Constitution Committee

Clause 17: Power to make regulations about medical devices

Amendment 1

Moved by

1: Clause 17, page 12, line 4, leave out from “subject” to end of line 8 and insert “to the super-affirmative procedure set out in section 51”

Member’s explanatory statement

This amendment is to correct the drafting.

Lord Sharkey Portrait Lord Sharkey (LD) [V]
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My Lords, Amendments 1 to 8, in my name and that of my noble friend Lady Jolly, are to correct drafting. None of them, individually or collectively, alters the meaning or substance of the parts of the Bill that they would amend. I beg to move Amendment 1.

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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The noble Lord, Lord Sharkey, made his points cogently on Report. We do not intend to oppose the amendments on the Marshalled List, as they are technical tidying amendments, consequential on those in the name of the noble Lord, Lord Sharkey, that were passed on Report.

Lord Sharkey Portrait Lord Sharkey (LD) [V]
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I am very grateful to the Minister.

Amendment 1 agreed.

Clause 21: Information systems

Amendment 2

Moved by

2: Clause 21, page 14, line 21, leave out from “subject” to end of line 25 and insert “to the super-affirmative procedure set out in section 51”

Member’s explanatory statement

This amendment is to correct the drafting.

Amendment 2 agreed.

Clause 52: Super-affirmative procedure: Northern Ireland

Amendments 3 to 8

Moved by

3: Clause 52, page 34, line 32, leave out “section 11(1), section 17(1) and section 21(1)” and insert “and section 11(1)”

Member’s explanatory statement

This amendment is to correct the drafting.

4: Clause 52, page 34, line 36, leave out “order” and insert “regulations”

Member’s explanatory statement

This amendment is to correct the drafting.

5: Clause 52, page 34, line 43, leave out “ an order” and insert “regulations”

Member’s explanatory statement

This amendment is to correct the drafting.

6: Clause 52, page 35, line 5, leave out “order in its initial form, or a revised draft order” and insert “regulations in their original form, or revised draft regulations”

Member’s explanatory statement

This amendment is to correct the drafting.

7: Clause 52, page 35, line 8, leave out “order”

Member’s explanatory statement

This amendment is to correct the drafting.

8: Clause 52, page 35, line 10, leave out “order”

Member’s explanatory statement

This amendment is to correct the drafting.

Amendments 3 to 8 agreed.

Motion

Moved by

Lord Bethell Portrait Lord Bethell
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That the Bill do now pass.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the Bill before us is quite different from the one we started with, but it is no doubt much better. That is entirely because of the huge value of your Lordships’ challenge and scrutiny. We have held over 50 meetings and considered 249 amendments, and the result is a tribute to the care and patience of noble Lords, for which I give profound thanks. It is also, if I may say so, a tribute to the workings of the hybrid House, which have kept legislation moving under difficult circumstances.

We would not have reached this position without the thoughtful, collaborative and constructive input of noble Lords, to whom, I pay tribute—in particular, to the noble Baronesses, Lady Thornton and Lady Wheeler, on the Opposition Front Bench, together with the noble Lord, Lord Hunt, and the noble Baronesses, Lady Jolly and Lady Walmsley, and the noble Lord, Lord Sharkey, on the Liberal Democrat Benches. I also thank, from the Cross Benches, the noble Lords, Lord Patel and Lord Alton, and the noble Baroness, Lady Finlay. They have all brought their immense experience and wisdom to our debates, to improve this legislation. And when it comes to wisdom and experience, I must also pay tribute to those from these Benches, especially my noble friend Lord Lansley, my predecessor, my noble friend Lord O’Shaughnessy, and my noble and learned friend Lord Mackay of Clashfern, who have all been of enormous help in enabling us to arrive at a consensus across the House. My noble friend Lord Howe has been a generous mentor, and my noble friend Lady Penn is a superlative Whip, both shepherding the process charmingly, discreetly and effectively.

I thank most emphatically my noble friend Lady Cumberlege. She has spoken of the importance of compassion, of the voices she has listened to, and of the paramount importance of patient safety. I have heard her, and I support her endeavour. She has the support of the House in her efforts, and we have collectively made significant progress towards her admirable goal.

I also thank officials on the Bill team, particularly Alice Clouter, and those in my private office, particularly Tilly McEwan. They have all worked tirelessly and expertly. I cannot give thanks to all the other champions in the House who have made influential interventions, but I am definitely very grateful to them.

I cannot hide my excitement about the future. While the Bill process is near its conclusion, we are at the end of the beginning of an exciting new regulatory system—a system that protects patients and enables innovation. It is with that vision of the future, as well as my gratitude to all, that I beg to move.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, at this stage of the Bill, we take a few moments to congratulate ourselves and thank those who have made it possible to get this far. First, I thank my own Bill team, who have worked so hard, particularly Rhian Copple in the Lords Opposition office, and my noble friends Lady Wheeler and Lord Hunt—and, indeed, my noble friend Lady Andrews and others, who popped up here and there to support us.

We should all congratulate ourselves because, despite the conditions in which we have worked this autumn and winter, we have managed to build effective communications which have made it possible to make considerable progress in improving the Bill in many ways, as the Minister said. I think we can say that we did our job, as the revising Chamber.

The fact that we ended up with only three Divisions on Report is a testimony to way in which the Minister, the noble Lord, Lord Bethell, his Whip, the noble Baroness, Lady Penn, and his adviser, the noble Earl, Lord Howe, and the very hard-working Bill team led by Alice Clouter, handled the Bill. They listened, they discussed, they considered and they revised, which is really all that one can ask. This is the Minister’s first Bill, and I congratulate him on leading his team and handling what is always a baptism of fire for any Minister.

I am delighted to agree with the Minister and say that we are sending back a very different, and much improved, Bill. We have managed to address many of the big-ticket items, ranging from data sharing to human tissue, and, ultimately, patient safety. I thank participants across the House. Like the Minister, I mention in particular the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, the noble Lords, Lord Freyberg and Lord Clement-Jones, and the noble Baroness, Lady Cumberlege. I also thank everybody else who has taken part in the many discussions and given us the benefit of their wisdom, particularly the noble Lords, Lord Lansley and Lord O’Shaughnessy.

First Do No Harm paved the way for the creation of an independent patient safety commissioner, and I think that changed the way in which the Bill was handled, because it is now, as it should be, a patient safety Bill. For that, I really wish to congratulate the noble Baroness, Lady Cumberlege.

Finally, I want to thank the organisations who have given us their support and expertise, which is particularly important for those of us in opposition. I am very grateful to the DPRR and Constitution Committees for their insightful scrutiny, which sometimes is painful for the Government but is almost always helpful to us; the Lords Library; and, for us, the University of Birmingham, the British Dietetic Association, Advanced Accelerator Applications, the Association of British HealthTech Industries, Cancer Research UK and, in particular, the BMA. I am very grateful for the expert briefs that they have given us.

Stakeholder engagement will remain key for many years to come, for while the Bill will soon pass—as the Minister said—the task of creating a post-Brexit medicines and medical devices regulatory regime is far from finished. I look forward to working with stakeholders and the Minister to make sure that we move forward in the best possible fashion. We have given ourselves a good start.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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My Lords, Bills come and go. This Bill started its life as one to tidy up regulatory issues to do with the new post-EU world. In 10 years’ time, the Medicines and Medical Devices Bill is one I may not list as one of the most important I have worked on; I hope that the forthcoming mental health Bill will fit that spot. If remembered at all, it will be for the introduction of a commissioner for patient safety, born out of the First Do No Harm report by the noble Baroness, Lady Cumberlege.

There will need to be changes in the House of Commons to make the Bill really fit for purpose. The Minister has indicated the Government’s intention to lay amendments, and I am grateful to him for involving Peers in that process. When does he anticipate Second Reading in the Commons?

As the Minister and the noble Baroness, Lady Thornton, said, many people make a Bill, and they do not all sit in the Chamber. In particular, I thank both the Minister and the noble Baroness, Lady Penn, for giving us time to talk to the Bill team and allow them to explain new government amendments. Of course, I should not forget the noble Baroness, Lady Thornton, and her team; the noble Lord, Lord Patel; my noble friend Lord Sharkey; staff in opposition offices; and others who certainly made the Bill better, turning it into a workable piece of primary legislation.

Baroness Cumberlege Portrait Baroness Cumberlege (Con) [V]
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My Lords, I could not let this opportunity pass without expressing my gratitude to all those who have played such a vital part in drafting, scrutinising and improving this important Bill. I know that it will now return to the other place. I wish it a fair wind and hope that we will soon see it enacted.

Throughout, noble Lords from all sides of the House have, quite rightly, focused on using the Bill to strengthen patient safety. Safety is now threaded throughout the Bill. I do so welcome that; it is something that the noble Baronesses, Lady Thornton and Lady Jolly, have both just mentioned. We have enshrined a very important safety recommendation in the Bill: we will now have a proper database to record the medical devices that are used and on which we and patients will be able to track their outcomes and detect safety more quickly. I cannot overstate just how important that is. Without this data, the healthcare system has been flying blind.

I have been very touched by the kind and thoughtful expressions of support from so many noble Lords in general debates and, in particular, for my amendments, which were triggered by the recommendations in First Do No Harm. The report enshrined in me that, at every opportunity, we must be reminded that the NHS is run for the people and is paid for by the people. Right now, the NHS is demonstrating a total commitment to saving lives and defeating this deadly virus—a virus that, as it sweeps around the world, devastates lives, livelihoods, education, personal budgets and a national aspiration for a better world.

In the dark days of the Second World War, Beveridge was preparing for a better Britain. In these dark days, there is a need to make plans—not just to return to what was there before but to look forward to something better. I believe that the patient safety commissioner will provide something better and will improve patient safety and healthcare as a whole. I was thrilled that so many of your Lordships lent me their support in calling for this; I know that their voices made all the difference. I thank the Minister and the noble Baronesses, Lady Thornton and Lady Jolly, for their generous remarks today.

The new commissioner will certainly have a challenging task. We continue to get a flow of calls, letters and emails recounting lives devastated by hormone pregnancy tests, the risks of sodium valproate taken by pregnant women and the insertion of surgical mesh. Only this week, a woman wrote to me saying: “I was left devastated that I was never given the truth by my consultant. I have suffered incredible, irreparable harm since 2010 and have lost my loving intimacy with my husband. I suffer constant pain and am unable to walk too far. I am not able to enjoy the interaction with nine grand- children and, most of all, I do not feel like a female at all”. The patient safety commissioner will have to respond to these sorts of concerns rapidly—more rapidly than we found during our review. In doing so, the commissioner will prevent avoidable harm and, I am sure, save lives.

In my last amendment, concerning redress for patients unavoidably harmed, I was heartened by the Minister’s response. The Minster told us:

“We are moved by the stories; I am totally and utterly sympathetic to the situation that the patients affected by these conditions find themselves in on a day-to-day basis. They are still living through it today. I would like to regard myself as a compassionate person”.

We recognise that. He went on to say that

“it is not appropriate to make policy on this kind of matter through primary legislation”;—[Official Report, 14/1/21; col. 963.]

perhaps he is right on that. He also went on to tell us that work is under way. I just ask: what work? When will it be delivered? These injured women and their families need answers. They deserve justice and some redress—and, what is more, they need it now.

Although my amendment was not carried, my noble friend knows that I am not one to give up easily. Indeed, we have established a powerful all-party parliamentary group. Its purpose is to see the remaining recommendations in my report implemented. On Tuesday, the First Do No Harm APPG will meet to hear the Minister for Safety, Nadine Dorries, address the group. Of course, everybody is welcome to join.

In summing up, I reserve special thanks for my noble friends the Minister, Lady Penn and Lord Howe. They have been a formidable trio, guiding the Bill through and designing and tabling a lot of government amendments. I know that steering through important legislation and improving it with a pandemic raging all around has been a most demanding task. The Minister has risen to that challenge. He has chosen and shown endless patience with me personally; he has listened; and, above all, he has acted. I also know that he has been truly moved by the suffering he has heard about, as he said today, and that this has motivated him to act. I thank him very much.

I also thank the officials who, behind the scenes, have worked so very hard on the Bill, with endless meetings, conversations and negotiations—not least in bringing forward a whole range of government amendments. They are warned: no doubt we shall meet again for the raft of statutory instruments that will be before the House. But, actually, I look forward to that.

I consider this Bill a reforming Bill—perhaps a small step, not a great stride, but we must look on the bright side. I congratulate all noble Lords who put forward the other important amendments on medicines and medical devices that have been accepted by the Government, as we have just witnessed. With an independent patient safety commissioner, who will listen, especially to the patient groups and campaigners, put all patients first and fight for their causes, a significant change may arise. Out of Covid darkness, with the astonishing example set by NHS staff, I believe a better system will emerge.

In a time of war, Beveridge realised the aspirations of people had changed. In the time of Covid, they are changing now, and we have to acknowledge that patients and the public voice must be heard. If private enterprise can bring forward a vaccine in under a year, Ministers, parliamentarians, the department and the healthcare system should rise to the challenge of reform towards a totally patient-oriented service. That is what I believe is essential for the future of our country and our future health and well-being.

Baroness McIntosh of Pickering Portrait Baroness McIntosh of Pickering (Con) [V]
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My Lords, I am delighted to follow my noble friend Lady Cumberlege; I pay fulsome tribute to her and the team that, through her leadership, produced the report, First Do No Harm, from which we see this Bill. I would like to join her and others in paying tribute to my noble friends Lord Bethell, Lady Penn and Lord Howe, who I had the honour to work with, as a humble bag carrier, in the other place.

In recalling my interest with the Dispensing Doctors’ Association, I would like to make one plea to the Minister as this Bill proceeds to the other place. For clinical trials and patient safety, which is the focus of the Bill, which I wholeheartedly support, we need to rely on patients making their data available and giving consent for it to be used for clinical purposes. During the passage of the Bill, I raised what has now been seen in Denmark—a huge reaction against patient data having been abused and used for commercial purposes against the wishes, and without the consent, of patients. Were that to happen here, it would detract from the fundamental good of this Bill and the wider public benefit to the NHS and future patients of sharing the clinical data that permeates this Bill. I urge the Minister, therefore, to look seriously at the practical question that remains of how patient consent will be obtained and confidentiality respected, particularly in meeting the requirements of clinical need. But I am delighted to have played even a small part in the passage of this Bill, and we look forward to its passage through the other place.

Lord Patel Portrait Lord Patel (CB) [V]
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My Lords, I am delighted to have this opportunity to express my thanks to the Minister—the noble Lord, Lord Bethell—the noble Baroness, Lady Penn, and all the other noble Lords who have been taking part in this legislation, in particular those who spoke to and supported my amendments from all sides of the House.

Much has already been said about what we have achieved. I know that time is running short, so I will try and be brief. Of course I congratulate, first and foremost, the noble Baroness, Lady Cumberlege, for achieving what I had tried before—getting patient safety on statute. I did not have her tenacity or clout. So, many congratulations to her and, I believe, the commissioner for patient safety, who will make patient safety stronger in the whole of the health service.

I am very grateful to the Minister, the noble Lord, Lord Bethell, to the noble Baroness, Lady Penn, and to the noble Earl, Lord Howe, for the many meetings they arranged with us to hear our concerns and find solutions. I know it is a privilege for me to speak in person, but I hope all my colleagues on the Cross Benches—more than 12 of them—who took part in the Bill will feel I can speak on their behalf to thank Ministers and all other noble Lords.

I am also grateful to members of the Bill team, who were very helpful at the many meetings that the Minister arranged. And I am grateful to outsiders, in particular the University of Birmingham faculty of law, which worked very hard to produce the details of the legislation. Thank you all.

Lord O'Shaughnessy Portrait Lord O’Shaughnessy (Con) [V]
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My Lords, there is not much more to say that has not already been said by other noble Lords. I just wanted to use this opportunity to thank and pay tribute to particular groups. The Bill team and private office, which have worked so hard to produce this legislation, are amazing in what they do and often unsung. It is important we recognise them.

Secondly, I thank those patients and patient groups who have provided so much moving information and testimony that has informed our work. After all, we serve them, and I hope and believe that we have served them through improving this Bill in this House in the way we have.

Thirdly, I pay particular tribute to my noble friend Lady Cumberlege. When I was in government and we commissioned her report, I could not have dreamed that she would have done such a thorough job and carried it with her customary tenacity, to the point where we have, on statute, the commitment to a patient safety commissioner. It is such an important step forward and it will make a massive difference to the lives of hundreds of thousands of people in this country. For that, we should all be proud of this step—and she in particular should be.

Finally, I thank the Minister—my noble friend Lord Bethell—the noble Baroness, Lady Penn, and the noble Earl, Lord Howe, but particularly the Minister; he has performed with absolute aplomb in the difficult 10 months since he became a Minister. He has so much on his plate, yet throughout this process he has listened, engaged and acted in a way that does him enormous credit, and I really want to pay tribute to him for everything he has done.

I share the Minister’s optimism that, having produced this Bill, we can produce a regulatory system for the UK outside Europe that is the envy of the world, that makes sure that every company, every charity and every researcher who wants to bring a transformative therapy into a health system will come to us because of what we are able to do and how we are able to bring them through into mainstream treatment, just as we are doing with vaccines and have done with the recovery trial. That is the template, and I look forward to working with my noble friends and other noble Lords to make that happen in the months to come.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am extremely touched by the kind words of noble Lords and pay tribute once again to the hard work of all those concerned. I look forward to the future—to, as my noble friend Lord O’Shaughnessy said, the opportunity for patient safety and innovation to be enhanced by this Bill. In that spirit, I beg to move.

Bill passed and returned to the Commons with amendments.

Sitting suspended.

Medicines and Medical Devices Bill

(Report: 2nd sitting (Hansard))
(Report: 2nd sitting (Hansard): House of Lords)
Thursday 14th January 2021

(1 month, 3 weeks ago)

Lords Chamber

Read Hansard Text
Department of Health and Social Care

Report (2nd Day)

Relevant documents: 19th and 33rd Reports from the Delegated Powers Committee, 10th Report from the Constitution Committee

Amendment 16

Moved by

16: After Clause 6, insert the following new Clause—

“Strategy for tackling vaccination disinformation

(1) Within one month of the day on which this Act is passed, the Secretary of State must prepare and publish a strategy outlining plans to prevent the promotion of disinformation related to human vaccines.(2) The overarching objective of the strategy must be safe- guarding public health.(3) The strategy must be laid before Parliament.(4) In formulating the strategy under subsection (1), the Secretary of State must include proposals to—(a) build public trust and encourage uptake of vaccines;(b) require social media companies to promptly remove disinformation related to vaccines that has been reported to them by an appropriate authority, employees or other social media users, including financial and criminal penalties if they fail to act; and(c) prohibit social media users or companies from directly profiting from vaccine disinformation through advertising revenue.”Member’s explanatory statement

This amendment requires the Secretary of State to publish a strategy for tackling anti-vaccination disinformation within one month of the Bill passing.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, this amendment requires the Secretary of State to publish a strategy for tackling anti-vax disinformation within one month of the Bill passing, to safeguard public health. The strategy should include proposals to build public trust and encourage uptake of vaccines, require social media platforms and companies to promptly remove anti-vax disinformation, and prevent profiting from vaccine disinformation through advertising revenue. The context to this amendment is the problem that lies designed to erode trust in vaccines and persuade people not to protect themselves and their families are being broadcast to millions of people online every day.

Covid-19 has been a “growth opportunity” for anti-vaxxers, according to research by the Centre for Countering Digital Hate, which estimates that the largest English-language social media accounts promoting vaccine scepticism have increased their followers by nearly a fifth over the past year. Intelligence assessments suggest that while the majority of anti-vax propaganda seen by UK internet users comes from within Britain, a small proportion of it is being amplified or initiated by hostile states, notably Russia.

Whereas the normal vaccine debate is largely limited to the parents of young children and teenagers, the Covid-19 pandemic is a rare instance where the entirety of a society has to choose whether they wish to be vaccinated. The spread of disinformation online presents a “real and present danger” to vaccination efforts. This is why action must urgently be taken to tackle anti-vax campaigns and build public confidence to save lives.

Disinformation is distinct from legitimate scientific questions and scrutiny, although valid concerns can be and often are manipulated. Disinformation encompasses the full spectrum of—

Baroness Penn Portrait Baroness Penn (Con)
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My Lords, we appear to have lost the connection to the noble Baroness, Lady Thornton, so I suggest that we adjourn for five minutes.

Sitting suspended.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, I think I am back now. I apologise: I have no idea what happened then, but the trusty old iPad is coming in useful. I think that when I lost my link I was talking about media companies, so I will pick up with that.

Despite the Government’s and social media companies’ announcement last week of new measures to tackle the issue, dedicated anti-vaccine groups with hundreds of thousands of members on social media are still churning out disinformation—100,000 Facebook users and 180,000 on TikTok. Although the Government have talked about online harms for a long time, it is unlikely that that legislation will have Royal Assent in time to help with this.

Finally, the situation was made clear in the Question in the House yesterday from my noble friend Lady Lawrence about the BAME community and the vaccine being rolled out. She said:

“I have heard messages from the black community about their mistrust of and lack of confidence in the vaccine. I ask Her Majesty’s Government: what proportion of those taking part in the vaccine trials were black, Asian or from ethnic minorities before the rollout?”—[Official Report, 13/1/21; col. 725.]

That was amplified by the noble Baroness, Lady Warsi, who made the point that, although BAME communities were initially less likely to accept a Covid vaccine than white communities, when they had the opportunity to discuss their concerns with healthcare professionals, they were more likely than white communities to be persuaded to have the vaccine. Is the noble Lord familiar with that polling, and will he follow it up? I beg to move.

Baroness Altmann Portrait Baroness Altmann (Con) [V]
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My Lords, first, I apologise to the House because this is the first time I have spoken on this Bill, so I will not detain the House long. However, I support the aims of the amendment. This is something I have felt strongly about for some years.

Tackling anti-vax disinformation can be life-saving, and continuing to promote anti-vax messaging can be so damaging to public health as well as individual health. As the noble Baroness, Lady Thornton, rightly said in her excellent introduction—I am grateful to her for tabling the amendment—the online anti-vax messaging problem is growing. It is not just from a tiny minority in any one country; there could be systemic efforts to damage public health in our country and others. Given that those minority views can be spread, potentially to the severe detriment of the public and those who perhaps tend to support those views, believe them or be convinced by them, I should be very grateful if my noble friend would explain to the House the Government’s position. What do they believe they can do to combat the anti-vax messaging, not least as we are in the middle of this dreadful pandemic, for which the way out seems to me and many others to be to vaccinate as much of the population as we can, as soon as we can, to enhance their protection? Therefore, this is a very important and live issue, given the dreadful consequences that the pandemic is having not only on health through the virus itself, but on other aspects of public health and the country’s wider ability to support our beloved NHS.

Baroness Masham of Ilton Portrait Baroness Masham of Ilton (CB) [V]
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My Lords, I am speaking on the telephone, as something went wrong with my iPad.

I support Amendment 16, which is tackles anti-vaccination disinformation. For some years, this has created a problem. For example, there has been an epidemic of measles in many countries because many people, including the growing number of vegans, mistrust vaccines. Clear messages should go out about the benefits of vaccines and how they work. Some vaccines are very complicated and difficult to develop, but they are desperately needed for diseases such as HIV, TB and malaria.

Regarding these important coronavirus vaccines, I hope that the Government will be very careful that disinformation is not going out to the public about the Pfizer vaccine. Many health workers and elderly vulnerable people have had one dose, and the second dose should be given in three weeks’ time. People have signed up to that, as there are written instructions to do so, but the Government are trying to delay the second dose by up to three months, which is not recommended by Pfizer-BioNTech or the regulator.

There is a risk that with only one dose, people may become carriers and the virus may become resistant to the vaccine. The Doctors’ Association is not happy about the Government’s idea of a three-month delay. More careful monitoring and research is needed, but these mixed messages are extremely unhelpful. I hope that the Government will realise that people need to trust the information they receive.

Baroness Cumberlege Portrait Baroness Cumberlege (Con) [V]
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My Lords, I congratulate the noble Baroness, Lady Thornton, on her comprehensive introduction, expressing the urgency of the situation, which was also stressed by the noble Baroness, Lady Masham, in another interesting contribution for which I thank her. This is a difficult and hugely important issue, and it needs serious consideration on two counts. We have to look beyond the present situation with anti-vaccine campaigners and decide very carefully what is information and how we should combat damaging information being spread. Secondly, how do we reserve the right of the individual to use social media to express their personal views?

I spent six years on the Press Council, dealing with complaints. It was taxing, but today the print media is regulated to a greater extent. Even then, accountability for what should be published and what should not lay with not only the journalist who had written the article but with the editor and, in some newspapers, the owner.

However, social media is not regulated. A Private Member’s Bill by the noble Lord, Lord McNally, was introduced and had its First Reading exactly a year ago today, 14 January 2020. It never received a Second Reading or reached further stages in either the Lords or Commons. He was prescient. Perhaps if we had enacted that Bill we would be in a better place than we are today.

Not all is lost, however. As I understand it, a government Bill is to be introduced in the next Session of Parliament. There is an ongoing debate as to whether there should be pre-legislative scrutiny. I hope that there will be. The Government have also produced their response to the consultation carried out on the dilemmas we face. They clearly understand how difficult it is to get this right.

Social media has democratised communication, and that is a good thing. News and opinions are not the sole province of those who are well educated or articulate but are for any individual who wishes to express views or opinions. Some are, of course, deeply harmful—for example, children who are bullied by others and so on. Some are simply irritating. Others express views of great value. What do we do about social media?

It was interesting that the noble Baroness, Lady Masham, raised the issue of measles. I was a Health Minister and responsible for infectious diseases. When I left that post in 1997, there were no cases of home-grown measles. That was before Andrew Wakefield started his anti-vax campaign, which was hugely damaging. Today, not only do we have many cases of measles but in 2019 there were 810 cases. We also have had deaths.

I therefore share the sentiments of the noble Baroness, Lady Thornton, but we are into the debate we had on Tuesday. This is about benefits versus risks and whether we should uphold the freedom of the press in all its different forms, or whether it should be controlled. That needs a lot of thought. We need legislation and that will take time. The problem is urgent and I accept that but, much as I would like to support the amendment, it is difficult to find a quick solution. The risk of agreeing to it in the Bill is that we are in danger of doing more harm than good because this is a big issue that needs a lot of clever minds and thought in deciding how we go forward.

We should not rush on this. We have to get it right. However, I am disappointed, not only not to be able to support the noble Baroness, Lady Thornton, because she has been so generous in supporting my amendments, but because this subject is truly difficult. We need to concentrate minds and the amendment is a way to do that. It is a good initiative but we have to be careful to ensure that the Government give their proposed Bill priority, which they say they will do in the next Session. We should do all we can to ensure that that happens.

Baroness Bennett of Manor Castle Portrait Baroness Bennett of Manor Castle (GP) [V]
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My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege, and I join her and other speakers in thanking the noble Baroness, Lady Thornton, for tabling the amendment, which I think is largely intended to start a debate and get some focus on this terribly important issue.

My approach to the whole issue of disinformation about harmful content on the internet is slightly different from those of some of the other speakers. We need to take the same approach as we do with the vaccine, which is to think about vaccination being better than treatment—prevention being better than cure. Ensuring good public communication, information and education about Covid and many other issues is the best possible way in which to take on misinformation, rather than after the fact—after the infection—and then trying to treat it. As soon as one starts trying to combat such messages, it is difficult to avoid repeating them. As any communications professional will tell you, you are then trapped in a difficult cycle of raising the issue up the agenda and raising it up the hashtags.

When we are talking about problems on the internet more generally, we need much broader education on media literacy and critical thinking throughout our education system. That will not help us in the immediate future but, when we are talking about Covid, we can think about the nature of the Government’s communications and public information campaigns that will, in effect, inoculate people against the disinformation so prevalent in cyberspace. We need calm, factual, often quite detailed information that will educate the public about what is going on.

It is telling that we have seen a great deal of hunger among the public for briefings involving senior scientific officers and advisers. Some of them now have their own fan clubs and T-shirts. There is a real hunger for that kind of quality of information with clear scientific facts. That needs to come from all levels of the Government, including the politicians, not just the technical people. Let us trust the public with more information, data and facts, and with more of the difficulties and uncertainties, than we do now.

If one looks at the messaging in countries such as New Zealand and Germany, one can see that the level of detail and facts, and the quality of the information, given to their publics is much better than ours. Nearly every time there is a major government announcement or bit of advice, I see good technical people, senior professors and consultants on social media screaming in frustration about the quality of the presentation, data and messaging. I am talking not just about the shape of the graphs being wrong or whatever; we need to get the whole of government communications much better. That is the best way in which to tackle all these issues.

We all, even those of us with a scientific background, have learned a great deal more about IgG versus IgM versus IgA antibodies. A huge amount of information is out there, as is a hunger among people to find it. We must make sure that the good sources are there. That is the best way to tackle this problem when it comes to Covid and, indeed, much more broadly.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, this is an interesting debate and I am grateful to my noble friend Lady Thornton. We know that there is a problem with vaccine uptake, which is linked to anti-vaccine sentiment—though not necessarily always.

Looking back over the past few months, I note that there was in November a survey by Savanta ComRes on behalf of ITV News that found that almost 70% of people in the UK would like to receive a vaccination. More recently, in December, the Royal Society for Public Health published a poll showing that 76% of people would take the vaccine but, significantly, that only 57% of people from BAME backgrounds would do so. There was also a lower response among lower-income groups.

No doubt the Minister will give us figures, but my understanding is that the initial results on vaccine uptake are encouraging. However, we cannot be complacent in the face of the pernicious anti-vaccine sentiment around. Even before the pandemic, vaccine hesitancy was described by the WHO as one of the top 10 threats to global health.

We are interested in what the Government are doing. Last month, we debated this issue and the noble Baroness, Lady Evans, the Leader of the House, referred to the work of a central government unit on it. I should like to hear from the Minister about what is happening. We clearly need strong pro-vaccination campaigns, and the majority of people who may be described as vaccine hesitant are not necessarily anti-vaccine. Most people who are hesitant can be persuaded by good public health messages.

However, as my noble friend and other noble Lords have said, there has been a huge amount of misinformation across social media in the past few months. This is obviously cited by survey respondents as an area of concern when it comes to levels of trust in those delivering public health messages. As Scientists for Labour pointed out, since the recovery from the false findings around the MMR vaccine and autism from Mr Andrew Wakefield, the UK overall now ought to be in a good place when it comes to routine vaccine uptake. For example, the HPV vaccine has a consistent uptake of between 80% and 85%, which is an excellent return for a vaccine that is not part of early childhood schedules.

We do not have too much in the way of well-organised anti-vaccine groups, unlike the USA or, indeed, even the Republic of Ireland, so the likelihood is that the UK population will show less hesitancy about recently introduced vaccines compared with other countries. But the level of misinformation out there is high and we have to learn lessons from other recent vaccine scares. Clearly the Government have a huge challenge in making sure that the uptake of the vaccine is as high as possible—which is why I welcome this debate and the amendment, and very much look forward to the Minister’s response.

Lord Naseby Portrait Lord Naseby (Con) [V]
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My Lords, I declare an interest in that I am married to a retired general practitioner.

I congratulate the noble Baroness on her proposed new clause. Whether the detail is correct is another matter, but the principle that she is promoting is absolutely right. I make my observations as someone who, before he came into politics, was a senior director in the fifth-largest advertising agency in the world. I was actually handling the UK Government’s COI account—that is, the general one for specific purposes.

I have four observations. First, all misinformation must be refuted immediately, wherever it occurs—whether it is in the main media or other media. That is not just social media; it includes radio, TV, print, posters, et cetera. Secondly, every medical professional body must make it unequivocally clear that disinformation must be refuted. Thirdly, I suggest that all medical outlets should provide a clear statement, in poster format, for hospitals, surgeries, clinics and pharmacies. Fourthly, consideration should be given to how best to communicate with schools, universities and colleges.

In conclusion, we must all remember the terrible harm that was done to the MMR—measles, mumps and rubella—programme, largely by one pioneering rogue doctor. Against that background, I plead with the Minister to ensure that we have a robust new clause and a plan, worked on now so that it can be communicated instantly, if possible.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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My Lords, I support this amendment to require

“the Secretary of State to publish a strategy for tackling antivaccination disinformation within one month of the Bill passing.”

The noble Baroness, Lady Thornton, has picked a fascinating, current topic, and the noble Baroness, Lady Bennett of Manor Castle, posed some pointed questions about the quality and effectiveness of the messages. I look forward to the Minister summing up on these points.

Misinformation is not new. I remember websites being used many years ago to persuade parents to ensure that their children had their childhood vaccinations at the appropriate time, and it is paramount that the Government take a robust stance against anti-vaccination disinformation. Research from Oxford University suggests that 12% of the UK population is “strongly hesitant” about taking the vaccine, with a further 16% unsure. Together, that makes 28%, a very significant proportion of the population—over a quarter. We are putting all our efforts into stopping the spread of this virus. This means that if the 28% avoid vaccination, they will run the real and severe risk of catching the virus; not only that, we will run the risk of catching it from them, so undoing all the benefits of the programme.

When I was doing my research, I was astounded by the volume of anti-vax propaganda undermining public trust. Social media of course carries a large amount of the extreme views. While not the majority, the minority is not insignificant, and with the Government putting their efforts into the rollout of the vaccine as their strategy for exiting the crisis, strong action is needed to counter the threat of anti-vax disinformation. The Government were quick to adopt our mobile phones as a tool to fight the virus. Are they as willing to counter this misinformation via those phones that have the Covid-19 app installed? In summing up, will the Minister tell us whether there is a plan to do this?

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, what a helpful and instructive debate, and I thank all noble Lords who were involved.

In December 2020, we witnessed a landmark moment in our battle against Covid: the launch of an effective and safe vaccination programme, which has yielded great results. Thankfully, confidence in vaccines remains very high across the UK. None the less, some citizens have questions and there is a prevalence of misinformation. It is therefore absolutely and entirely right that we should answer those questions in the spirit of constructive dialogue, which is exactly what we seek to do.

I completely share the aspiration of the noble Baroness, Lady Bennett, for Covid to be an inflection point in a business model moving away from late-stage acute medicine toward prevention. Vaccines play an absolutely critical role in that, and this could be a profound legacy of this awful disease.

Despite all this, I completely recognise that we have also seen a range of baseless and sometimes absurd narratives being shared, particularly through social media platforms. It is completely unacceptable that a minority of people seek to exploit legitimate questions about vaccines and spread dangerous lies about vaccines for their own malicious reasons and profit.

Noble Lords will agree that it is vital that both misinformation and disinformation about vaccines are tackled. Before I address the Government’s response on how we will handle these two challenges, I pay tribute to the cross-party alignment on this issue and the spirit in which the noble Baroness, Lady Thornton, moved her amendment. Noble Lords from all sides of the House have shown a strong commitment to tackling anti-vax conspiracies and I express profound thanks for this tremendous collective effort, of which we can all be proud.

Throughout this pandemic, we have remained committed to transparency around the vaccine and to ensuring that people have access to accurate information about the virus and vaccines. DHSC is leading extensive cross-government communications activity, providing advice and information to anyone who has questions about the vaccine.

I do not think it would be helpful for me to run through our efforts in this area in detail, but I reassure noble Lords that we have worked, and continue to work, extremely hard to rebut false information online. In March 2020, we stood up the Counter Disinformation Unit, bringing together cross-government monitoring and analysis capabilities to tackle misinformation and disinformation. The Government have worked tirelessly to act wherever false and harmful content appears on social media platforms, either by flagging the content to the platforms or through direct rebuttal on social media via our Rapid Response Unit.

We are particularly committed to dialogue with and the protection of communities that might be particularly susceptible to disinformation and which, coincidentally, are particularly vulnerable to the virus. I thank all those involved in those efforts, including ministerial colleagues and noble Lords. I note the reference by the noble Baroness, Lady Thornton, to my noble friend Lady Warsi’s optimistic update in this area.

I turn to the point the noble Baroness’s amendment makes about requiring social media platforms to remove and demonetise anti-vaccination content. My noble friend Lady Cumberlege’s points on this are extremely valid. The Government have already secured commitments from platforms such as Facebook, Twitter and Google to the principle that no company should profit from or promote anti-vaccine misinformation and disinformation, and to respond to that content much more swiftly. We are holding platforms to these commitments and have set a series of policy forums in motion, bringing together platforms, academia and civil society organisations to better develop responses to online misinformation and disinformation. These forums are chaired by my ministerial colleagues in DCMS, to whom I give thanks. I attend them and can report back that they have a constructive and thorough approach.

I understand the concern that noble Lords have about anti-vaccination content and the harm it causes. I stress that the Government are totally committed to working with the platforms and other key stakeholders to combat that content and to build public trust in our vaccination programme. I point noble Lords to the continued high rates of Covid-19 vaccine uptake that we see, which have been achieved in part by our effective approach to tackling vaccine misinformation and disinformation. We are not complacent; we are on the case. Therefore, for that reason, I hope that the noble Baroness, Lady Thornton, sees the Government’s efforts in this area and feels able to withdraw her amendment.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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I thank the Minister for that comprehensive answer. I particularly thank what I can describe only as a bouquet of Baronesses—the noble Baronesses, Lady Altmann, Lady Bennett, Lady Masham and Lady Cumberlege—for their support. I say to the noble Baroness, Lady Cumberlege, fear not: if I had intended to have a Division on this I would have given her pre-warning, do not worry. I also thank my noble friend Lord Hunt for his pertinent questions and the noble Lord, Lord Naseby, for his four action points, which were instructive and useful.

This has been a useful debate that has been worth having, because we have so few opportunities to knock around issues that we all agree on and really want to support the Government to get right. That is why I tabled the amendment. I am very happy with the response to it and I beg leave to withdraw the amendment.

Amendment 16 withdrawn.

Lord Faulkner of Worcester Portrait The Deputy Speaker (Lord Faulkner of Worcester) (Lab)
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We now come to the group beginning with Amendment 17. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in the group to a Division must make that clear in debate.

Clause 7: Disclosure of information in accordance with international agreements

Amendment 17

Moved by

17: Clause 7, page 4, line 36, after “a” insert “relevant”

Member’s explanatory statement

This amendment and the amendment in the Minister’s name to add a definition of “relevant person” to Clause 7 restrict the persons to whom information may be disclosed in reliance on Clause 7(2).

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, in moving Amendment 17 I will speak also to Amendments 19, 22, 23, 25, 35, 37, 38, 55, 56 and 58 to 62. All amendments in the group deal with the sharing of information outside the UK where this is required to give effect to an international agreement or arrangement.

I have listened to the concerns raised by noble Lords as to further safeguards that could be provided in relation to Clauses 7, 12 and 37(5), and the amendments made in Grand Committee. I am enormously grateful to noble Lords who have met and spoken to me and my team over the weeks between Grand Committee and Christmas. Their further explanations and collaborative spirit have been enormously valuable. I can say confidently that this collaboration has definitely improved the drafting of the Bill.

It is worth saying first that the Bill introduces powers for international information sharing only where it is pursuant to international agreements or arrangements concerning the regulation of human medicines, medical devices or veterinary medicines. As such, we are starting from a place where it is in the public interest for data to be shared to support the safety of human medicines, medical devices and veterinary medicines in the UK and globally.

As I explained in earlier debates, information sharing with other regulators plays an absolutely critical role in the work of the MHRA and the VMD to protect patient safety and to support international collaboration. For example, in medical device safety investigations, international information sharing allows for better signal detection and gathering of evidence to support the safety of medical devices available on the UK market. It is worth saying that failure to share that data has been one of the contributing factors to many patient safety issues. However, it is right that we ensure that when the MHRA and the VMD share information they do so with the appropriate persons. These amendments will ensure that.

Nevertheless, I have heard the concerns about the use of the term “persons” and whether this may be subject to broad interpretation. Noble Lords will agree that including in the Bill an exhaustive list of named organisations we share data with is not practical. Therefore, we have amended Clauses 7, 12 and 37 to include a definition of “relevant person”. These amendments clarify the types of persons outside the UK that information may be shared with. In short, they make it clear that these clauses do not offer a “blank cheque”.

We also heard concerns from noble Lords in Committee about the sharing of patient-identifiable information internationally. Clauses 7 and 37 already include safeguards to protect personal and commercially sensitive information, and there are additional safeguards in data protection legislation. However, we are keen to provide additional reassurance. That is why we have tabled further amendments that ensure that patient-identifiable information can be shared only if patients have provided consent.

In the vast majority of cases patient information is anonymised before being shared. These amendments account for the rare instances where it is necessary to share patient-identifiable data internationally to support our commitment to uphold patient safety; for example, in sharing patients’ concerns with an international regulator about a clinical trial they are taking part in in another country.

Finally, Amendments 22, 37 and 59 seek to clarify that the information-sharing powers in the Bill do not limit the circumstances in which information can be shared under any other enactment or rule of law. Such housekeeping amendments can be found as standard in many Acts and will ensure that the powers in the Bill cannot be construed as replacing existing statutory, prerogative or common laws of disclosure, which is not the intention. In introducing these amendments we seek simply to remove any potential confusion over what the powers in the Bill are intended to deliver.

I say again that I am enormously grateful to all noble Lords for their constructive challenge and thoughtful contributions on this subject. International information sharing is fundamental to the effective functioning of the MHRA and the VMD, but it is of vital importance that data is shared with care and that the appropriate safeguards are in place. I believe that our amendments deliver this balance. I beg to move.

Lord Patel Portrait Lord Patel (CB) [V]
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My Lords, before I address the amendment from the noble Baroness, Lady Thornton, I reciprocate by thanking the Minister enormously for the many meetings he and his colleagues have had with all of us who are trying better to understand what the Government are trying to do with the Bill, particularly with these amendments. I agree that there are times, including in clinical trials—I have done this—when there is a need to share information with people involved in trials not only in the United Kingdom but overseas. I will come back to that in a minute.

I will start by saying that I support the amendments tabled by the noble Baroness, Lady Thornton, which address the broadly drafted government amendments that were introduced in Committee. Those amendments allow information held in connection with medicines and medical devices to be shared with relevant persons outside the UK, to give effect to international agreements in relation to the regulation of medicines and medical devices.

The original wording of these clauses was worrying due to the use of vague terms. It was not clear, for example, whether any information held by the relevant authority could cover all information contained in patient records relating to medicines and medical devices, including any information in medical records relating to the use of medicines for patients. As highlighted in Committee debates, there was also no definition of

“persons outside the United Kingdom”,

which left it open to broad interpretation, placing no limits on the category of persons to whom information may be disclosed.

The purposes of information disclosure are also broad, relating to the fulfilment of the requirements of any potential international agreement concerning the regulation of medicines and medical devices. In fact, a letter which the Minister sent to us all explaining these amendments in Committee argued that any such information disclosure would be related to the purposes of promoting public safety. There was and still is no mention of public safety in the purposes of information disclosure in the Government’s amendments, although I accept that, in presenting his amendments, the Minister did mention it in his introductory remarks.

The purposes are left to be determined by any international agreement, and thus this power is exceptionally broad. The Government’s own amendments to these clauses are welcome. They narrow the powers slightly by providing a definition of “relevant persons” to whom such information may be disclosed, and add new subsections requiring that no patient information be disclosed without consent. However, it is not clear to me what mechanism or form of consent is required.

Some may well remember that the care.data scandal evolved from the lack of a requirement for opt-in consent to the use of medical and healthcare data. The amendment tabled by the noble Baroness, Lady Thornton, addresses this issue by requiring that consent be “opt-in” in these situations. This is a sensible addition to ensure greater safeguards for patients. It is also worth highlighting that patient information is defined in government Amendment 22, in a new subsection relating to

“physical and mental … diagnosis … care or treatment”,

and information that

“identifies the individual or enables the individual to be identified (whether by itself or in combination with other information)”.

This means that information pertaining to patients can be shared where it has been rendered non-identifiable. This is in line with current data protection principles.

The amendment tabled by the noble Baroness, Lady Thornton, strengthens this protection further, through the addition of the word “could”, so that any information which might lead to reidentification is also captured in this definition. These protections are necessary as aggregate data can reveal patterns which may allow for reidentification, especially for small patient clusters, such as in rare diseases and conditions, and even in cancers, and where patients with common diseases are stratified for particular medicines.

Regardless of the need for consent to disclose patient data, consent is not required where data has been anonymised. Decisions on the use of public health data represent a substantive area of policy that should be subject to scrutiny and debate, and not relegated to the discretion of the Government alone. Data can be of high commercial value, so this power would essentially be used to allow the sharing of such data with interested parties as part of their trade deals. It has “international agreements” within the meaning of this clause, and the Minister may wish to comment on whether trade deals are included in international agreements.

This comes back to the issue of scrutiny at the heart of the Bill. It may be that information sharing and disclosure is necessary to allow smooth functioning and support internationally on pharmacovigilance and medical device monitoring, but there is an issue that patient/NHS data could also be bought as part of commercial interests in trade deals which the operation of information disclosure clauses may still allow for. The clauses as they stand, and as the Government now intend to amend them, still potentially allow for sharing of anonymised data with commercial partners for undefined—and therefore unknown—purposes, to be settled as part of an international agreement or trade deal that would probably not be scrutinised by Parliament.

While it may be conceded that international agreements may require the sharing of information to allow for proper international co-operation for pharmacovigilance and monitoring of safety, as the Minister himself mentioned, in their current form the government amendments may allow sharing for broader purposes that we are currently unable to scrutinise. The amendment tabled by the noble Baroness, Lady Thornton, requiring that any information disclosure to relevant persons outside the UK be permissible only to aid pharmacovigilance and device safety, and for purposes that are in the public interest, represents an acceptable compromise in narrowing the purposes for which information can be shared. The public interest principle at least requires consideration by the Government of substantial ethical issues in sharing information, yet it still allows significant flexibility when contemplating future agreements post Brexit.

There can surely be no objection to this minimal protection being required when contemplating the broad power being taken by the Government in decisions on the international sharing of valuable public data.

Lord Clement-Jones Portrait Lord Clement-Jones (LD) [V]
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My Lords, it is a pleasure to follow the noble Lord, Lord Patel. I support and will speak to Amendments 18, 36 and 57, which have been so well introduced and explained by him, and which I have signed, and will speak to my own Amendment 20.

We have had discussions on this Bill and the Trade Bill about health data and trade issues. The two Bills are intimately connected, and this amendment is very complementary to Amendment 11, passed on Report of the Trade Bill on 7 December. There was no debate or discussion about the new Clauses 7 and 12 and the new subsection in Clause 37 when they were introduced in Grand Committee. On both counts it is therefore vital that we get to grips with them today. I welcome the Minister’s new amendments, which he has spoken to and which take us a step further in terms of patient consent, definition of information and relevant persons. But I have signed, and these Benches support, the additional amendments to those clauses and subsection put forward by the noble Baroness, Lady Thornton, to ensure that we further tighten these provisions. Specifically, we want to tie this to international co-operation on pharmacovigilance or in monitoring the performance and safety of medical devices, and a public interest test put around the disclosure of health data, for all the reasons put forward by the noble Lord, Lord Patel.

As I said when the House debated these issues on Report of the Trade Bill and later passed the amendment, NHS data is a precious commodity, especially given the many transactions between technology, telecoms and pharma companies concerned with NHS data. I cited a recent report in which EY estimated that the value of NHS data could be around £10 billion a year in the benefit delivered, and the fact that the Department of Health and Social Care is preparing to publish its national health and care data strategy shortly, in which it is expected to prioritise the

“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes.”

I mentioned too that, while acknowledging that the UK is a leading player in the fields of life sciences and biosciences, health professionals have strongly argued that free trade deals risk compromising the safe storage and processing of NHS data in much the way that the noble Lord, Lord Patel, has mentioned.

Through the amendment to the Trade Bill from the noble Baroness, Lady Thornton, and likewise this amendment, the objective is to ensure that it is the NHS, not US big tech companies and drug giants, that reaps the benefit of all this data. This is especially important given what the Ada Lovelace Institute called in its report, The Data Will See You Now, the “datafication” of health, which, it says, has profound consequences for who can access data about health, how we practically and legally define health data, and our relationship with our own well-being and the healthcare system. Health information can now be inferred from non-health data, and data about health can be used for purposes beyond healthcare. Harnessing the value of healthcare data must therefore be allied with ensuring that adequate protections are put in place in trade agreements, if that value is not to be given or traded away.

At the time, I raised questions about the provisions of the UK-Japan trade agreement, and there is no doubt that these questions will linger unless an amendment of this kind, to both this Bill and the Trade Bill, goes forward.

There have been many shortcomings in the sharing of data between various parts of the health service, care sector and Civil Service. The development of the Covid-19 app and the way that the Government have procured contracts for data management with the private sector have not improved public trust in their approach to data use. That is why clear safeguards are needed to ensure that, in trade deals and international agreements, our publicly held data is safe from exploitation where it is not for public benefit.

On Tuesday, the Minister heavily emphasised the public interest test that he wanted to see applied to the sharing and use of Clause 3 information. The data covered by Clauses 7, 12 and 37 is even more important. He used the same language today and in correspondence, so I hope he can accept these amendments. As the noble Lord, Lord Patel, has said, we also want to see the aspect of patient consent clarified.

I turn briefly to Amendment 20. I welcome the Minister’s Amendment 19, but Amendment 20 is designed to get the Minister to further clarify what is meant by “consent” in Clause 7. Informed consent is very much a familiar concept in healthcare, especially in treatment and trials, and, indeed, that is effectively the definition on the NHS website. It depends on capacity, explanation, understanding and it being voluntary. That is why my amendment would insert the word “informed”, to make it abundantly clear that, at the very least, that is what is intended here. I look forward to the Minister’s reply.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, it is a great pleasure to follow the noble Lord, Lord Clement-Jones, and I welcome the opportunity to debate this important group of amendments. I welcome the government amendments, but feel that my noble friend Lady Thornton’s amendment is very important, as indeed are some of the others in this group.

I have always been strongly in favour of using patient information. It is a rich source of data for scientists to pursue in the search for medical advances. We all benefit, and I am sure that the great majority of the public see this and are agreeable to information being shared. But we must have appropriate safeguards, and that is why the government amendments to restrict the persons to whom information may be disclosed, and the addition of a definition of patient information and the need for individual patient consent, are all very welcome.

My understanding, however, is that information pertaining to patients can be shared where it has been rendered non-identifiable. As the University of Birmingham has commented, this may be in line with current data protection principles but there is still a danger of a care.data-type problem, in that the provisions might allow the Government to share with “relevant persons”—as they are now called—outside the UK information they hold on patient data through NHS bodies without consent when anonymised. The noble Lord, Lord Patel, referred to some of the issues with care.data. The stricter definition of patient information may address some of the concerns that the definition of patient data—being restricted to identifiable data—left anonymised data open for use or barter as part of international agreements. Part of this broader concern is that aggregate data can reveal patterns that may allow for re-identification, especially for small patient clusters in respect of rare diseases and conditions.

The points that the noble Lord, Lord Clement-Jones, made about the interrelationship between this Bill and the Trade Bill are therefore hugely important. We know that data can be of high commercial value, and the power could in essence be used to allow the sharing of such data to interested parties as part of trade deals and international agreements, which certainly has implications for concerns about consent.

I just say to the Minister that the NHS has form in giving away data to American companies without enough care being taken over the conditions under which the data can be used, and certainly without adequate resource compensation. This makes it all the more important to ensure that we beef up the safeguards. The amendments from my noble friend Lady Thornton and those from the noble Lords, Lord Clement-Jones and Lord Patel, all deserve support for seeking to do that.

Lord Freyberg Portrait Lord Freyberg (CB)
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My Lords, I was privileged to speak at some length about the provisions of this Bill in Grand Committee, and I thank those who supported the amendments in my name, which concerned the role of cutting-edge, data-driven medical devices. The Minister has since reassured me of his intention to further explore their implications in the course of a consultation exercise about their definition and regulation over the coming year. Like the noble Lord, Lord Patel, I want to put on record my gratitude for the way that he has facilitated these discussions.

The amendments that I rise to support today seek to protect patient information, including what is properly “special category data” in the Data Protection Act 2018, which is crucial in the development of new pharmaceutical products and medical devices.

Of course, it goes without saying that efforts to facilitate the flow of data in the context of the ongoing health emergency are vitally important. These are extraordinary circumstances in which we find ourselves. Today, however, we must take steps with an eye to the long term; steps that will introduce legal provisions to prevent a situation that might give rise to undue concern or restrict scrutiny of matters pertaining to patient safety in the future, both at home and overseas.

I am certain that the Minister is well aware of public sentiment concerning privacy and data protection, which are, of course, not limited to the healthcare domain. Maintaining the trustworthiness of organisations that function as stewards of the nation’s healthcare data is paramount, and a carefully considered approach to patient safety is needed to preserve that trustworthiness, as the Government move to improve upon and forge new international arrangements.

The Minister’s amendments make it mandatory for consent to be provided where patient information is being shared with territories outside the United Kingdom. The noble Baroness, Lady Thornton, has tabled clarifying amendments to ensure that the purpose for which patient information is being shared is limited to patient safety and its scrutiny. For these reasons, I support Amendments 18, 36 and 57, to which I have added my name.

Lord Lansley Portrait Lord Lansley (Con) [V]
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My Lords, I am very glad to follow the noble Lord, Lord Freyberg, who has made some very cogent points, both in that speech and when we discussed these clauses in Grand Committee.

I want to make two points. The first is about the structure of Amendment 18. I am not entirely sure that I understand why pharmacovigilance has been singled out in the amendment as a reason why disclosure should be made, as distinct from, for example, public health co-operation or the pursuit of research. Indeed, the Minister referred to the sharing of information in relation to international clinical trials as a very good example. If one were to legislate in this form, it would be inevitable that the reference to pharmacovigilance would be regarded as having additional weight, and the absence of reference to other purposes for which information would be shared would be regarded as less important. I am not sure that that would be at all helpful to have in statute.

My other point is in relation to Clause 7(5). Government Amendment 22 refers to and introduces a provision that assists in understanding the relationship between this legislation and other enactments concerning the disclosure of information. Clause 7(5) states:

“Nothing in this section authorises a disclosure of information which … contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section)”.

Noble Lords may recall the Trade Bill and, in particular, the debate we had on the Trade (Disclosure of Information) Act just before Christmas and new year. We passed legislation the purpose of which was, among other things, to ensure that we clarified the relationship between that enactment and others that authorise disclosures of information or, in some circumstances, prohibit such disclosures. The particular basis for the structure of that Bill was to clarify a situation where there is a statutory gateway and other enactments that put constraints on the disclosure of information.

In subsection (5) it is clear that if someone is considering a disclosure that might contravene the data protection legislation, that legislation must be considered alongside the powers in this legislation. That enables them to satisfy the test in the Christian Institute and others v The Lord Advocate 2016 Supreme Court decision, as referred to in my noble friend Lord Grimstone’s letter to us about the Trade Bill. In the Trade Bill, though, as is the case in this Bill, we have reference both to the data protection legislation and to the Investigatory Powers Act. In the Trade Bill, amendments were introduced on Report to ensure that the saving reference—that is, when determining whether a disclosure would contravene the legislation, it takes into account the powers in this section—was applied to both the data protection legislation and the Investigatory Powers Act. However, in this legislation—Clause 7(5)(b) —the saving reference is applied to the data protection legislation but not to the Investigatory Powers Act.

My question, which I am sorry I have not had an opportunity to give the Minister notice of, as I have started working through these issues only very recently, is this. Having dealt with this matter on the Trade Bill, I would have thought that both these subsections should have the saving reference that allows the question of the contravention of those Acts to be considered, including reference to the powers in this Bill. I wonder if he would agree.

Baroness McIntosh of Pickering Portrait Baroness McIntosh of Pickering (Con) [V]
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My Lords, I am delighted to follow my noble friend, who speaks with such great authority both as a former Secretary of State for Health and as someone who has followed the Trade Bill and the Trade (Disclosure of Information) Act so closely.

At the risk of dancing on the head of a pin, the amendments in this group are quite close, and the Minister set out every reason why we should support his Amendment 17. He said that information would be shared only in the circumstances where there is perceived to be a public need. The amendments and explanatory statement of the noble Baroness, Lady Thornton, refine that by saying that, in the context of giving effect to an international agreement or arrangement concerning the regulation of human medicines, it should be disclosed only provided that it is in the public interest to do so. A number of noble Lords have spoken with great eloquence and passion on these issues, including the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, and my noble friend Lord Lansley. I have to say that I personally would draw the line at disclosing information for a commercial need as opposed to a public one.

I have a particular question about Amendment 19, which clearly states that patient information cannot be disclosed where the patient could be identified and that that information cannot be given without their consent. I remember that I was once asked to participate in a study; I signed the form and was delighted to do so, and never heard any more about it. I would just like to know how Amendment 19 would work in practice. At what point, and by whom, would the patient be contacted if that information was about to be disclosed and their consent sought?

I have reservations about this group. I remember the important debate that we had on the Trade Bill in this regard, and I am delighted to see that those issues are being considered in the context of this Bill as well. I have two concerns that I hope can be allayed. The first is that public need should not be deemed to collude with commercial need where it might not be in the interests of the patient. The second is about informed consent: how will the patient be consulted within the provisions of Amendment 19?

Baroness Cumberlege Portrait Baroness Cumberlege (Con) [V]
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My Lords, this has been an interesting and well-informed debate, and I am quite reluctant to enter into it. I support government Amendment 19 and particularly Amendment 20 tabled by the noble Lord, Lord Clement-Jones. I hope I have got this right, although I am very happy to be put right if I have not. As I understand it, Amendments 19 to 25 concern consent, relating very specifically to the disclosure of information in accordance with international agreements. This is information that I think a relevant authority such as the MHRA holds in connection with human medicines.

As I listened to the noble Lord, Lord Freyberg, he raised a question in my mind about devices. We know that pharmaceuticals are much more closely regulated than devices have been, so can the Minister tell us a bit more about instances where there is a comparable agreement, and perhaps an amendment, for medical devices? I want to know whether they are on all fours with pharmaceuticals. I suspect not. Having listened to the noble Lord, Lord Freyberg, I think that there is more to hear on this.

The Minister’s Amendment 19 makes it very clear that:

“Nothing in this section authorises a disclosure of … information”

that would include patient-identifiable information without the patient’s consent. I warmly welcome that, but Amendment 20 in the name of the noble Lord, Lord Clement-Jones, goes further. It seeks to ensure that such consent is informed. As the noble Lord, Lord Hunt, and others, including the noble Lord, Lord Clement-Jones, said, informed consent is very well recognised within the NHS but sadly not always adhered to. To me, Amendment 20 in the name of the noble Lord, Lord Clement-Jones, is preferable to Amendment 21, which states that

“‘consent’ means that an individual has given notice of their willingness for an appropriate authority to disclose patient information”

by explicitly opting in. That is not good enough.

I fully support Amendment 20, with the proviso that gaining informed consent can never be just a tick-box exercise. The information, of course, pertains to patients and their state of health, the diagnosis they have received, the treatments they have had and the outcomes from those interventions. That information, rightly, belongs to the patient. The noble Lord, Lord Hunt, mentioned care.data, and we know what a terrible debacle that was, when not enough care was given to the rights of patients over their information.

We know from the reams of evidence that we received during our review that “informed consent”, albeit usually in the context of a patient/clinician consultation, was often anything but informed. However, as I understand it, this debate is not about that; it is about the information that will be passed on through international agreements. I hope I have that right.

If we are to change how the healthcare system manages, interprets and responds to informed consent, we must ensure that it does not just pay lip service. Whenever informed consent matters, we should ensure, through this Bill and elsewhere, that it really does matter and is fully protected.

I support these amendments but ask the Minister to give an assurance that, in relying on informed consent, where disclosure of information can enable a patient to be identified, the relevant authority will have evidence on four issues: first, that consent was indeed properly informed; secondly, that the patient concerned understood how their information might be used; thirdly, that any specific concerns they might have had had been addressed; and, lastly, that the patient was made fully aware that they could withdraw consent at any time. I should perhaps add to that last point that they could withdraw either via an intermediary or directly. There must be a mechanism in place to ensure that the relevant authority is made aware of this change—that the patient has withdrawn consent—and that the authority can be seen to have acted on it.

There is much in all these amendments. It has been a good debate and I look forward to the Minister’s reply.

Lord Naseby Portrait Lord Naseby (Con) [V]
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It is a pleasure to follow my noble friend Lady Cumberlege, who has gone into great detail on these amendments. As far as I can see, these are mainly government amendments, plus some from other parties, and they are all broadly to be welcomed. The question I ask myself is: where are the boundaries to be set?

Very helpfully, the Minister, in his opening statement, explained in some detail the extent of information-sharing outside the UK and gave the example of the safety of medical devices. Having listened to my noble friend and the others who have contributed, I am still not quite sure about Amendments 18 and 20. I can see where they are coming from and can understand what is behind them but on this occasion I will have to listen to the Minister. These are sensitive areas and certainly we in the upper House should listen. I am also not entirely clear from the Minister’s statement at the beginning what the implications of Amendment 22 are. There has already been a good deal of coverage and I will not add to it further.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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These amendments relate to the use of data and information sharing. The noble Baroness, Lady Thornton, my noble friend Lord Clement- Jones and the noble Lord, Lord Patel, have put their names to some of them. The noble Lord, Lord Freyberg, outlined clearly in the context of trade and health the power and value of data. Data is a hugely rich source for research but also a hugely valuable commodity, so we need safeguards.

Concern was raised in Committee about the level of protection in the Bill for patient information, as regulations are able to make provision about the disclosure of such information. I am grateful to the Minister for being so willing to look at this again.

The Government have responded in two main ways: with the introduction of a definition of “relevant person”, thereby narrowing the definition of whom data can be shared with, and by defining what is meant by patient information. As the noble Lord, Lord Patel, explained, Amendment 24 in the name of the noble Baroness, Lady Thornton, strengthens the definition of patient information to protect information that could identify a patient, rather than just information that does.

Amendments 18, 36 and 57, led by the noble Baroness, Lady Thornton, and supported by my noble friend Lord Clement-Jones and others, would allow a relevant authority to disclose information to a person outside the UK only where required for the purpose of giving effect to an international agreement or an arrangement concerning the regulation of human medicine, provided it was within the public interest so to do. Those three amendments all pass the test put forward by the noble Baroness, Lady McIntosh of Pickering, concerning public good.

Amendment 20, from my noble friend Lord Clement-Jones, would take the Government’s amendment on patient consent further by ensuring that consent given in relation to identifiable information was informed consent. The noble Baroness, Lady Cumberlege, has just raised the issue. We should not need this. Informed consent should be the default but, as it clearly is not, I support my noble friend’s Amendment 20.

Similarly, Amendment 21, in the name of the noble Baroness, Lady Thornton, would ensure that patient information could be shared by an appropriate authority only if the individual to whom it related had given their explicit consent.

These amendments strengthen the Bill and therefore patient outcomes. I will listen to the Minister to see what plans the Government have to satisfy noble Lords on this group.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, I thank all noble Lords who have taken part in this debate. I will speak to the amendments in my name, and give notice that I will test the opinion of the House on Amendment 18, along with Amendments 36 and 57, all of which are supported by the noble Lords, Lord Patel, Lord Freyberg and Lord Clement-Jones. This is unless—of course, I always live in hope—they are agreed to by the Minister.

Turning to the other amendments in my name in this group, I just want to put on record how grateful we are on our Benches for the way that the Minister and the Bill team have worked on these important issues, and how much we support the amendments that he has tabled. We do not see these amendments as in opposition; we see them as amplification and clarification.

Amendment 24 is a probing test for whether aggregate data could identify individuals through de-identification or de-anonymisation practices. The Government’s amendments define patient information as data that

“identifies the individual or enables the individual to be identified (whether by itself or in combination with other information)”.

This represents a welcome tightening up of the definition to include scenarios where contextual information might allow de-identified data to become identifiable. This is very important given that aggregate data can reveal patterns which allow for reidentification, especially for small patient clusters as in rare diseases and conditions. Given the rapid development of sophisticated technology, my Amendment 24 probes the test for whether anonymised aggregate data could identify individuals through this. I hope the Minister will be able to assure the House that the appropriate safeguards and checks are in place.

Amendment 21 would ensure that patient information

“can only be shared by an appropriate authority if the individual to whom it relates has given their explicit (‘opt-in’) consent.”

We welcome the Government’s requirement for consent to share patient information. However, they have not specified how this consent mechanism will work in practice. This amendment in my name would ensure that important distinction, which has been mentioned by many noble Lords across the House. Other noble Lords have also mentioned care.data, which, because of a lack of clarity about the use of data, did not work. I hope the Government will be able to assure us that explicitly informed consent will be sought and secured.

Under Amendment 18, followed by Amendments 36 and 57, data would be disclosed to persons under international agreements or arrangements only for pharmacovigilance or if “in the public interest”. I hope the public interest bit answers the question from the noble Lord, Lord Lansley. I thank the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, my noble friend Lord Hunt and other noble Lords for their support for this suite of amendments.

Overall, the government amendments narrow discretion and set out in more detail the purposes for the information-sharing powers. However, in our view they still potentially allow for the disclosure of patient data without consent to commercial partners for undefined, and therefore unknown, purposes to be settled as part of international agreements or trade deals. That is why the helpful read-across to the Trade Bill by the noble Lords, Lord Freyberg, Lord Clement-Jones and Lord Patel, is so important. We recognise that information-sharing and disclosure may be necessary to allow smooth functioning and support internationally on pharmacovigilance, for example, but remain concerned that NHS data—which has been described as a treasure trove, worth perhaps £9.6 billion—could be bartered as part of commercial interests in trade deals.

Amendment 18, along with Amendments 36 and 57 in my name, would allow the Secretary of State to disclose NHS data only under the terms of an international agreement or trade deal for pharmacovigilance, of if it is otherwise in the public interest. We believe “the public interest” is a legitimate test that would offer reassurance that substantive and ethical issues relating to the sharing of data would at least be considered. I hope the Minister will recognise the value of this amendment; otherwise, as I say, I would like to test the opinion of the House.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, we are enormously grateful to the noble Baroness, Lady Thornton, and the noble Lord, Lord Clement-Jones, for their Amendments 20 and 24 to one of my own amendments to Clause 7. These amendments seek to ensure that patient information can be shared by an appropriate authority only if the individual has given their explicit or informed consent, respectively. I completely recognise the commendable intent behind both amendments to safeguard and protect patient safety. Their intentions are benign but they are absolutely not necessary.

My lived experience for the past year has been completely aligned with the words of the noble Lords, Lord Clement-Jones and Lord Freyberg. Data is absolutely key. I have spent my time outside the Chamber working on little else: clearing the path for patient recruitment to clinical trials, so that therapies can be designed to save lives; getting data on long Covid patients from primary care to those researchers and clinicians who are trying to help them, which is an extremely complex and onerous task; getting central tracing data to local infections teams, which means transferring it between various jurisdictions; getting people to record the tests they take, which is a legal requirement but legally and technically difficult to implement; and getting test results from those who have taken them into their GP records. Most bizarrely, to me at least, I have been getting data-sharing agreements in place so that local authorities, which are crying out for the data—as their representatives here in this very Chamber cry out to me at the Dispatch Box for it—can access the dashboards with those legal agreements; or getting the data on those who may need support isolating into the hands of those charities and local authorities which are keen to support them.

Every step of the way, there has been an onerous set of legal, ethical and bureaucratic barriers. Speaking on the back of that experience, I wonder whether scientific deduction and patient safety are sometimes sidelined by other considerations. I therefore warn about measures that are driven by prejudice or secondary principles, rather than the priorities of trying to save lives and pursue science. Their unintended consequences can have a profound, stifling effect on patient safety, medical research and innovation, and on the effective running of a modern healthcare system. I can think of so many incidents where the need for data-sharing agreements, legally obtuse patient consents and all sorts of rarefied ethical reviews have caused major life-threatening obstacles and troubling issues in our response to Covid.

I know that the measures in these amendments are well intended, but I assure noble Lords that they are not necessary. For instance, Clause 7 accounts for the rare instances where it is necessary for the MHRA to share identifiable patient information internationally to support our commitment to upholding patient safety. I take this opportunity to assure noble Lords not only that this will be done only with the informed consent of the patient but that the practical implementation of some of the very measures in this Bill, such as the medical information system, will require these kinds of measures. It seems counterproductive for us to be undoing the benefits of our own information system.

Amendment 21 in the name of the noble Baroness, Lady Thornton, seeks to broaden the definition of patient information to include information that could enable identification. I reassure the noble Baroness that the MHRA absolutely follows the Information Commissioner’s gold standard practices on patient data anonymisation. In order to be truly anonymised under GDPR, sufficient personal data is always stripped out so that, not only can the individual not be identified, but reasonably available means could also not enable the recipient to re-identify the individual. As such, if patient information to be shared still enables the patient to be identified, for example due to the unique nature of their condition, the amendment in my name will provide sufficient protection by requiring that patient’s consent be sought before sharing their information. The MHRA keep anonymisation processes under review in line with the ICO’s guidelines and continue to monitor advances in data technology.

We have heard from the noble Baroness, Lady Thornton, and the noble Lords, Lord Patel and Lord Clement-Jones, on their Amendments 18, 36 and 57, which seek to limit the purpose for which information can be shared internationally under the powers. It is important to highlight that we could only disclose information under this power where disclosure is required in order to give effect to an international agreement or arrangement concerning the regulation of human medicines, medical devices or veterinary medicines. In that regard, the clause already allows disclosure only for a particular purpose. As international co-operation in this area is important and a good, even necessary, thing, such agreements or arrangements would be in the public interest by default. The UK meeting its international obligations under these agreements and arrangements would be even more so. Furthermore, the MHRA and VMD do not share information for commercial gain—on that point I want to be absolutely categoric. Therefore, I am persuaded that these amendments are accordingly unnecessary.

We have introduced a number of amendments to these powers to clarify the types of person with whom information can be shared and, for those instances when it is necessary to share identifiable patient data internationally, introduced a lock that ensures that data can be shared only with consent. These amendments are, of course, in addition to existing data protection legislation and ICO guidance. I can assure the noble Lords that we are not complacent when it comes to the safe and appropriate use of patient data. We understand that, as technology advances, we will need to continually review the way in which we anonymise data to ensure that it remains just that.

I hope this provides noble Lords with assurance that the Bill and the additional amendments in my name provide robust safeguards to protect patient information, alongside long-standing data protection legislation already in place, and that they will not press their amendments.

Amendment 17 agreed.

Amendment 18

Moved by

18: Clause 7, page 4, line 38, at end insert—

“( ) Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—(a) it is required as part of international cooperation for pharmacovigilance; or(b) it is in the public interest.”Member’s explanatory statement

This amendment would allow a relevant authority to disclose information to a person outside the UK where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicine provided it is within the public interest to do so.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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I beg to move, and I wish to test the opinion of the House.

Amendment 19

Moved by

19: Clause 7, page 5, line 8, at end insert—

“(4A) Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.”Member’s explanatory statement

This amendment and the amendment in the Minister’s name to add a definition of “patient information” to Clause 7 prevent Clause 7 authorising the disclosure of information from which patients can be identified without their consent.

Lord Russell of Liverpool Portrait The Deputy Speaker (Lord Russell of Liverpool) (CB)
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Does the noble Lord, Lord Clement-Jones, wish to move Amendment 20, as an amendment to Amendment 19?

Lord Clement-Jones Portrait Lord Clement-Jones (LD) [V]
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[Inaudible]—very much about informed consent, but, nevertheless, I will not move the amendment.

Amendment 20 (to Amendment 19) not moved.

Amendment 21 (to Amendment 19) not moved.

Amendment 19 agreed.

Amendment 22

Moved by

22: Clause 7, page 5, line 14, at end insert—

“(5A) This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”Member’s explanatory statement

This amendment provides that Clause 7 does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.

Amendment 22 agreed.

Amendment 23

Moved by

23: Clause 7, page 5, line 21, at end insert—

““patient information” means information (however recorded) which—(a) relates to—(i) the physical or mental health or condition of an individual, (ii) the diagnosis of an individual’s condition, or(iii) an individual’s care or treatment,or is (to any extent) derived directly or indirectly from information relating to any of those matters, and(b) identifies the individual or enables the individual to be identified (whether by itself or in combination with other information);”Member’s explanatory statement

See the explanatory statement for the amendment in the Minister’s name adding a new subsection (4A) to Clause 7.

Amendment 24 (to Amendment 23) not moved.

Amendment 23 agreed.

Amendment 25

Moved by

25: Clause 7, page 5, line 24, at end insert—

““relevant person” means—(a) the government of a country or territory outside the United Kingdom;(b) a person who exercises functions on behalf of such a government;(c) any other person who exercises functions or provides services relating to human medicines in a country or territory outside the United Kingdom;(d) an international organisation that exercises functions or provides services relating to human medicines.”Member’s explanatory statement

See the explanatory statement to the first amendment to Clause 7 in the Minister’s name.

Amendment 25 agreed.

Lord Russell of Liverpool Portrait The Deputy Speaker (Lord Russell of Liverpool) (CB)
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Does the noble Lord, Lord Patel, wish to move Amendment 26?

Lord Russell of Liverpool Portrait The Deputy Speaker (Lord Russell of Liverpool) (CB)
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Does the noble Baroness, Lady Thornton, wish to move Amendment 27?

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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I thought these amendments were part of the group that was passed on Tuesday?

Baroness Penn Portrait Baroness Penn (Con)
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The noble Baroness is correct that Amendment 27 is consequential to an amendment agreed on day 1 of Report, so she may wish to move it.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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I think Amendment 26 is similar, possibly. We may need some guidance from the clerk. Was Amendment 26 also related to the group of amendments that were agreed on Tuesday? I apologise; it is always difficult to do these things when you are not actually in the Chamber.

Baroness Penn Portrait Baroness Penn (Con)
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My understanding is that Amendment 26 is also consequential to amendments passed on day 1 of Report, so we may wish to ask the noble Lord, Lord Patel, whether he wishes to move his amendment, which is consequential to previous amendments agreed.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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That is what I thought

Lord Russell of Liverpool Portrait The Deputy Speaker (Lord Russell of Liverpool) (CB)
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I will go back to Amendment 26. Does the noble Lord, Lord Patel, wish to move Amendment 26?

Lord Patel Portrait Lord Patel (CB) [V]
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I do not wish to move the amendment.

Lord Russell of Liverpool Portrait The Deputy Speaker (Lord Russell of Liverpool) (CB)
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Does the noble Baroness, Lady Thornton, wish to move that amendment?

Moved by

26: After Clause 7, insert the following new Clause—

“Requirement for draft consolidated legislation: human medicines

The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to human medicines.”Member’s explanatory statement

This new Clause, and the other consolidation amendments in the name of Lord Patel, would require the Secretary of State to publish draft consolidated legislation within three years to streamline the existing regulatory framework. These amendments are linked to the amendment providing for a three year sunset provision in the name of Baroness Thornton.

Amendment 26 agreed.

Clause 9: Power to make regulations about veterinary medicines

Amendment 27

Moved by

27: Clause 9, page 6, line 21, 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 2 of the Bill requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 1 and 3 of the Bill, and the amendments in the name of Lord Patel requiring consolidated legislation.

Amendment 27 agreed.

Amendment 28

Moved by

28: Clause 9, page 6, line 21, at end insert—

“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”

Amendment 28 agreed.

Amendments 29 to 32

Moved by

29: Clause 9, page 6, line 22, leave out from beginning to “promote” on line 23 and insert “In making regulations under subsection (1), the appropriate authority’s overarching objective must be to”

Member’s explanatory statement

This amendment provides that the appropriate authority’s overarching objective in making regulations under Clause 9 must be to promote one or more of the following: the health and welfare of animals; the health and safety of the public; the protection of the environment.

30: Clause 9, page 6, line 27, leave out “they would” and insert “regulations under subsection (1) would contribute to this objective”

Member’s explanatory statement

This amendment is consequential on the amendment to Clause 9(2) in the Minister’s name.

31: Clause 9, page 6, line 32, leave out “an attractive or” and insert “a”

Member’s explanatory statement

This amendment omits the word “attractive” from Clause 9(3)(c).

32: Clause 9, page 6, line 32, leave out “develop or supply veterinary medicines” and insert “—

(i) develop veterinary medicines, or(ii) manufacture or supply veterinary medicines.”Member’s explanatory statement

This amendment clarifies the meaning of Clause 9(3)(c).

Amendments 29 to 32 agreed.

Amendment 33

Moved by

33: Clause 9, page 6, line 33, at end insert—

“(3A) Where regulations under subsection (1) may have an impact on the safety of veterinary medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”Member’s explanatory statement

This amendment provides that the appropriate authority may make regulations that may have an impact on the safety of veterinary medicines only if the authority considers that the benefits of doing so outweigh the risks.

Amendment 34, as an amendment to Amendment 33, not moved.

Amendment 33 agreed.

Clause 12: Disclosure of information in accordance with international agreements

Amendment 35

Moved by

35: Clause 12, page 8, line 19, after “a” insert “relevant”

Member’s explanatory statement

This amendment and the other amendment to clause 12 in the Minister’s name restrict the persons to whom information may be disclosed in reliance on Clause 12(2).

Amendment 35 agreed.

Amendment 36

Moved by

36: Clause 12, page 8, line 21, at end insert—

“( ) Where information is disclosed in accordance with subsection (2) such disclosure will only be permitted where—(a) it is required as part of international cooperation for pharmacovigilance; or(b) it is in the public interest.”Member’s explanatory statement

This amendment would allow a relevant authority to disclose information to a person outside the UK where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicine provided it is within the public interest to do so.

Amendment 36 agreed.

Amendments 37 and 38

Moved by

37: Clause 12, page 8, line 39, at end insert—

“(5A) This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”Member’s explanatory statement

This amendment provides that Clause 12 does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.

38: Clause 12, page 9, line 6, at end insert—

““relevant person” means—(a) the government of a country or territory outside the United Kingdom;(b) a person who exercises functions on behalf of such a government;(c) any other person who exercises functions or provides services relating to veterinary medicines in a country or territory outside the United Kingdom;(d) an international organisation that exercises functions or provides services relating to veterinary medicines.”Member’s explanatory statement

See the explanatory statement to the other amendment to Clause 12 in the Minister’s name.

Amendments 37 and 38 agreed.

Amendment 39

Moved by

39: After Clause 12, insert the following new Clause—

“Requirement for draft consolidated legislation: veterinary medicines

The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to veterinary medicines.”Member’s explanatory statement

This new Clause, and the other consolidation amendments in the name of Lord Patel, would require the Secretary of State to publish draft consolidated legislation within three years to streamline the existing regulatory framework. These amendments are linked to the amendment providing for a three year sunset provision in the name of Baroness Thornton.

Amendment 39 agreed.

Clause 14: Power to make regulations about medical devices

Amendment 40

Moved by

40: Clause 14, page 9, line 32, 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 3 of the Bill requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 1 and 2 of the Bill, and the amendments in the name of Lord Patel requiring consolidated legislation.

Amendment 40 agreed.

Amendment 41

Moved by

41: Clause 14, page 9, line 32, at end insert—

“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”

Amendment 41 agreed.

Lord Russell of Liverpool Portrait The Deputy Speaker (Lord Russell of Liverpool) (CB)
- Hansard - - - Excerpts

My Lords, I should inform the House that, if Amendment 45 is agreed to, I shall not be able to call Amendment 46 by reason of pre-emption, and that the debate on the group beginning with Amendment 46 will be postponed and take place on Amendment 66.

Amendments 42 to 45

Moved by

42: Clause 14, page 9, line 33, leave out subsection (2) and insert—

“(2) In making regulations under subsection (1), the Secretary of State’s overarching objective must be safeguarding public health.”Member’s explanatory statement

This amendment provides that the Secretary of State’s overarching objective in making regulations under Clause 14 must be safeguarding public health.

43: Clause 14, page 9, line 35, leave out “they would” and insert “regulations under subsection (1) would contribute to this objective”

Member’s explanatory statement

This amendment is consequential on the amendment in the Minister’s name substituting Clause 14(2).

44: Clause 14, page 9, line 39, leave out “an attractive or” and insert “a”

Member’s explanatory statement

This amendment omits the word “attractive” from Clause 14(3)(c).

45: Clause 14, page 9, line 40, leave out “develop or supply medical devices” and insert “—

(i) carry out research relating to medical devices,(ii) develop medical devices, or(iii) manufacture or supply medical devices.”Member’s explanatory statement

This amendment clarifies the meaning of Clause 14(3)(c).

Amendments 42 to 45 agreed.

Amendment 46 not moved.

Amendment 47

Moved by

47: Clause 14, page 9, line 40, at end insert—

“(4) Where regulations under subsection (1) may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if the Secretary of State considers that the benefits of doing so outweigh the risks.”Member’s explanatory statement

This amendment provides that the Secretary of State may make regulations that may have an impact on the safety of medical devices only if the Secretary of State considers that the benefits of doing so outweigh the risks.

Amendment 48, as an amendment to Amendment 47, not moved.

Amendment 47 agreed.

Clause 18: Information systems

Amendment 49

Moved by

49: Clause 18, page 11, line 40, at end insert—

“( ) Regulations made under subsection (1) that introduce significant new policy or significant changes to existing policy are subject, in relation to regulations made by the Secretary of State, to the super-affirmative procedure set out in section (Super-affirmative procedure), in relation to regulations made by a Northern Ireland department, to section (Super-affirmative procedure: Northern Ireland), and, in relation to regulations of the Secretary of State and a Northern Ireland department acting jointly, to both.”

Amendment 49 agreed.

Lord Russell of Liverpool Portrait The Deputy Speaker (Lord Russell of Liverpool) (CB)
- Hansard - - - Excerpts

We now come to the group beginning with Amendment 50. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in this group to a Division must make that clear in debate.

Amendment 50

Moved by

50: After Clause 18, insert the following new Clause—

“Advisory committee

(1) The Secretary of State may by regulations establish, and make other provision about, a committee to advise the Secretary of State on such matters relating to medical devices as the regulations may specify.(2) The regulations may (among other things) make provision about—(a) the membership of the committee;(b) the establishment by the committee of sub-committees;(c) matters to which the committee may, or must, have regard;(d) cooperation between the committee and the Commission on Human Medicines, and other bodies with expertise in relation to medical devices.(3) The provision mentioned in subsection (2)(a) may include—(a) provision about the number of members, their appointment, and the circumstances in which a person ceases to be a member;(b) requirements as to the independence of members from the Secretary of State;(c) provision about the payment of remuneration and allowances to members.”Member’s explanatory statement

This new Clause would enable regulations to be made creating a statutory committee to provide advice to the Secretary of State in relation to medical devices.

Lord Bethell Portrait Lord Bethell (Con)
- Hansard - - - Excerpts

My Lords, in moving Amendment 50, I shall speak also to Amendments 64 and 96. We have spoken extensively about the critical importance of patient safety and the need to improve medical device safety in bold new regulations going forwards. The need for medical device scrutiny to the highest standards was expressed by noble Lords throughout Grand Committee and, of course, in the report of my noble friend Lady Cumberlege. We recognise that improved and strengthened post-market surveillance and vigilance is essential. Equally, it is critical that we take further steps to strengthen oversight and increase transparency behind regulatory decision-making. Amendment 50 would support those efforts.

This new clause provides the Government with the power to create a statutory committee for independent expert advice on matters relating to medical devices. Historically, systems for post-market surveillance for medicines and medical devices have evolved differently. However, given scientific and technological advances and the kinds of innovative products and treatments becoming available, whether classed as medicines or medical devices, there is now need for greater assurance of equally high standards of surveillance, to ensure the upmost protection of patients.

The Commission on Human Medicines, which has a statutory basis in the human medicines regulations, provides an expert independent view to the MHRA on human medicines. It is visible and is underpinned by a statutory footing in the Human Medicines Regulations 2012. There is a parallel set of experts for medical devices. The Devices Expert Advisory Committee, or DEAC, advises the MHRA on medical devices but does not have an equivalent statutory footing.

Amendment 50 would change this. Subsection (1) provides a delegated power to establish a committee to advise on matters relating to medical devices. The aim is to strengthen the vigilance system for medical devices. A statutory committee for medical devices will support structured decision-making and formal accountability, allowing for clear roles and responsibilities for independent expert advice. This will strengthen the MHRA’s ability to manage safety issues which are identified in clinical use even more effectively, ensuring that timely decisions are made and appropriate action taken to protect patients.

Proposed new subsection (2) provides that regulations may include, among other things, provision about membership, matters which the committee may or must consider, and establishment of sub-committees. This subsection also allows for provision to be made regarding co-operation with other bodies with medical devices expertise and the Commission on Human Medicines, allowing for join-up and best use of our experts.

Proposed new subsection (3) lists matters that regulations under proposed new subsection (2)(a) in relation to membership may cover. This includes the number of members, their appointment, the circumstances in which they cease to be members, and requirements as to independence from the Secretary of State. Proposed new subsection 3(c) allows for provisions to be made about payment of remuneration and allowances to committee members.

The amendment also amends Clause 41, enabling regulations relating to the advisory committee to make consequential provisions. Pursuant to Clause 45, regulations are to be made by statutory instrument and subject to the affirmative procedure. We consider it appropriate that Parliament has the opportunity to scrutinise regulations made under this power, given that the placing of this committee on a statutory footing will be a key element of enhancing the safety of medical devices. These regulations will be subject to all the requirements in Clause 45: public consultation and use of the affirmative procedure; and allowing patients, and other stakeholders, to comment before regulations are made to establish the Committee.

Those regulations will set out clearly, and transparently, how the statutory committee would provide advice where the regulator identifies that there is a need for scientific, technical or clinical advice. They will set out requirements to engage patients in the advisory system; for timeframes for advice on safety concerns to be issued; and requirements to communicate publicly about new and emerging risks. Rightly, the public want more transparency and accountability in regulatory decision-making. They want clearer, greater communication and explanation relating to the performance of healthcare products in clinical use. Patients deserve clear and up-to-date information on the safety of healthcare products from credible and authoritative sources. This statutory committee will meet that need. A statutory devices advisory committee will give confidence to patients, as well as clinicians and the public, that the regulator will take account of expert views on medical devices in a fast-moving area of life sciences. It will create an equilibrium in the level of external advice informing regulatory decisions across all healthcare products.

There are two other amendments in my name in this group and I do not intend to dwell on them, as they are only minor and technical. Amendment 96 provides for consequential changes to allow the DEAC to be commenced. Amendment 64 makes a technical amendment in relation to the time limits for bringing prosecutions for an offence. Time limits already exist but, as part of the clarification of the enforcement regime in Part 3, changes were made to break the link between consumer protection legislation and medical devices, and to streamline the enforcement regime. Due to an oversight, the current time limit was removed but not then reinstated by the Bill into the medical device regulations. Without this change, the system would not function correctly. I beg to move.

Amendment 51 (to Amendment 50)

Moved by

51: After Clause 18, in subsection (1), leave out “may” and insert “must”

Member’s explanatory statement

This would require the Secretary of State to make regulations to creating a statutory committee to provide advice in relation to medical devices.

Baroness Wheeler Portrait Baroness Wheeler (Lab)
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My Lords, I thank the Minister for moving Amendment 50 enabling regulations to be made to establish the medical devices advisory committee to advise the Secretary of State and to place the existing Devices Expert Advisory Committee on a statutory footing. We welcome this proposed new clause to the information system requirements as an important step towards bringing more transparency to the devices system and ensuring that the regulator seeks independent expert advice on the safety of devices.

As will be seen from Amendments 51, 52, and 53, however—I am moving Amendment 51 on behalf of my noble friend Lady Thornton—we want the requirement on the Secretary of State to establish the MDAC as a “must do” commitment, rather than the “may” in proposed new subsections (1), (2) and (3) of the amendment in relation to: the need for the regulations; providing advice; and making key provisions, such as how independent members should be from the Secretary of State. I know that numerous debates have been held during the course of legislation going through this House about the differences between “must” and “may”. However, “must” is surely the necessary language to require the Secretary of State to establish the committee and ensure its independence.

The Government’s briefings on the amendment—and the Minister today—as well as referring to the committee providing independent expert advice, emphasise that this will include “the views of patients”, complementing the work of the patient safety commissioner and giving patients a voice within the system of regulating medical devices. Through every stage of the Bill, noble Lords have underlined the importance of consultation with patients and end-users of medicines and medical devices. Can the Minister explain the thinking behind not including a subsection in the amendment which underlines the importance of the patient’s voice and perspective? I would also be grateful if he could tell the House what he considers will be the impact on the advisory role and scope of the change to a statutory footing for the committee.

We acknowledge the need for the two technical government Amendments 64 and 96. On Amendment 64, I note the explanation from the Minister today, and in his briefing letter to Peers of 5 January, of the need to reinstate provisions in the Medical Devices Regulations 2002 extending time limits for bringing proceedings in relation to medical devices offences. Amendment 96 is a necessary consequential amendment in relation to the added clause on the MDAC under Clause 18, bringing the whole clause into force two months after the Bill is passed.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, I am glad to be able to take part in this debate, which allows the House to have a preliminary discussion about the future of medical devices regulation. I certainly welcome the establishment of an advisory committee, but I also welcome my noble friend’s amendment which makes sure that the rather tentative “may” is replaced by “must”. The Minister’s amendment is rather open-ended. It does not specify what matters it will advise the Secretary of State on, nor does it give any indication of the likely balance of membership. This is important because, as I have said, there has been some concern over quite a few years that the regulation of medical devices is not up to the mark, nor sufficiently protective of patient safety. The report by the noble Baroness, Lady Cumberlege, has identified some weaknesses. In that regard, I declare my interest as president of GS1 UK, the bar-coding association.

We received a very helpful briefing from Professor Muireann Quigley and colleagues at the University of Birmingham, pointing to the rather confused state that medical devices regulation is in. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 came into force at the end of the EU exit transition period. These amend the Medical Devices Regulations 2002 to mirror key elements contained in EU regulations 2017/745, on medical devices, and 2017/746 on in vitro diagnostic medical devices. The aim of that was to make sure that there was good regulatory alignment between the UK and EU, as well as between different parts of the UK’s own regulatory framework. This Bill, when enacted, will provide an opportunity to mandate a more streamlined legislative approach. That would benefit all stakeholders, including industry, businesses and patients.

At present, the MHRA has no involvement in the pre-market phase of medical device development and there is a question as to whether it ought to have. Birmingham University colleagues are certainly proposing a proactive regulatory role for devices that is more akin to that for medicines. This would be clinically focused and, as they say, at least as stringent as the new EU medical devices regulations. Under that proposal, manufacturers could be required to apply to the MHRA before marketing their device. The MHRA could also assess the application in a way that is proportionate to the risks. It is proposed to take account of relevant factors, such as evidence-based supply, approvals in other jurisdictions and post-marketing surveillance plans. I know that that view may not necessarily be shared by industry, which would, perhaps, be concerned about the cost and delay in achieving licensing. However, we can expect a pretty intense debate about medical device regulation in the future.

There is also a need to reflect an industry fear that, for instance, once it becomes mandatory to use a UK process for the British market, suppliers may choose either to deprioritise Britain as a whole or else not to produce products here at all. One of the challenges is therefore to ensure that the UK remains attractive and that new sovereign regulation does not become merely duplicative and costly. Given the innovation in our own sector, this is very important indeed. The global reputation of the MHRA is clearly in our favour, as is the trend to the harmonisation of standards globally. However, we will also need to think about innovative regulation in areas such as digital healthcare, artificial intelligence and deep learning. I therefore assume and hope that the advisory committee will be very much involved in all that. That means that its membership must have a broad range of interests, including patients and users as well as industry. I hope that in winding the Minister may be able to say something about that.

The amendments in the name of my noble friend Lady Wheeler seek to create greater certainty by substituting “must” for “may”. Surely that is right, and I certainly support her on that.

Lord Lansley Portrait Lord Lansley (Con) [V]
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My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who asked some relevant and useful questions about this while welcoming the new clause and the advisory committee on medical devices as a statutory body. I join him in that and think it is a very welcome move on the Government’s part. The analogy with the Commission on Human Medicines is helpful. As regards translating the Devices Expert Advisory Committee into a statutory role, in effect, in the process, as the noble Lord, Lord Hunt, suggested, there is considerable scope to think about how the Government’s new and expanded roles in the regulation of medical devices can be supported by the advisory committee.

I have a number of points. The first reflects the point made by the noble Lord, Lord Hunt, which is that the MHRA has an enviable reputation as a regulatory authority for the approval of medical devices. If I recall correctly, among the European regulatory bodies something like 40% of the most important or significant medical devices were authorised by the MHRA. Other regulatory authorities in other countries will seek to supplant that. However, our reputation should enable us to establish an international position, and I hope that the advisory committee will not be confined to expertise from within the United Kingdom. There is a lot to be said for positioning the MHRA as a body providing internationally recognised authorisations for medical devices, and its scientific evaluation in that respect should be something that others look to. I therefore hope that that will assist if we have some international participation in the advisory committee structure.

Secondly, I recall, not least in the context of the vexed experience of the PIP breast implant issues back in 2010-11, that the role of notified bodies is very important. Hitherto they have, in essence, been regulated by the European Commission, not by the UK Government, but they fall to be UK-regulated in future. There are not many of them, but there is considerable benefit in there being an advisory committee sub-committee which is focused on the work of the notified bodies. That was the weak link that probably led to the PIP breast implant problems. The regulation is all very well but we have to have bodies that we are confident are able to deliver on these things. The few notified bodies we have in this country are highly respected but we want to make sure that that is maintained even as further notified bodies are authorised.

Thirdly, I recognise that the Devices Expert Advisory Committee has leading clinicians from Scotland and Wales in its membership. However, this must be a UK advisory function, as the MHRA is. I wonder whether it would be appropriate for there to be in addition a Northern Ireland representative on the committee and for there to be perhaps some specific mechanisms to ensure that Scotland, Wales and Northern Ireland are represented in the regulations that establish the advisory committee.

I have one further point, which is that I hope that the various categories of medical devices are very carefully examined and the relevant expertise is available in relation to those. So, for example, on digital devices it is important that we have not only the clinical expertise to deal with the safety of medical devices we have at the moment but the technical expertise in the advisory committee to understand how digital devices will work in the future. That must also be the case in the special interests section related to in vitro diagnostic devices. I hope that that also will have its own special advisory committee function.

Baroness Masham of Ilton Portrait Baroness Masham of Ilton (CB) [V]
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My Lords, I am pleased to follow the noble Lord, Lord Lansley. I support Amendments 51 to 53 because it is important that the new clause will read “must” instead of “may”, so that the advice on medical devices will be clear and should be followed. “May” means it can be optional and makes the regulations weaker, and people might miss important aspects of care. There is no doubt that clear, correct information is the way to better patient safety. In many ways, communication within the National Health Service should be improved.

Baroness McIntosh of Pickering Portrait Baroness McIntosh of Pickering (Con) [V]
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My Lords, I am delighted to follow the noble Baroness, Lady Masham, and earlier speakers in welcoming this group of amendments. I support government Amendments 50, 64 and 96 and welcome the placing of the advisory committee on a statutory footing, and particularly that the affirmative procedure will be used.

My question goes to the nub of Amendment 50—in which regard, if this is correct, Amendments 51 and others in this group will not be needed. Is it for the Secretary of State to decide what goes in the regulations on which presumably Parliament will be consulted under the affirmative procedure?

I can quite understand that the use of “may” appears to be discretionary, leaving open what should be included. Having got this far, it would be helpful to understand the thinking behind the use of “may” in Amendment 50, which indicates that this may be discretionary, whereas clearly it appears to be the will of the House that this is mandatory.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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My Lords, we support these amendments from the Government and from the noble Baroness, Lady Thornton, which relate to the creation of a statutory committee to provide advice to the Secretary of State. Government Amendment 50 would allow the creation of such a committee in relation to medical devices, and the amendments in the name of the noble Baroness, Lady Thornton, in this group would require the Secretary of State to create the committee in Amendment 50, as the Government’s amendment states only that the Government “may” create the committee, not that they must.

No Secretary of State should be above independent advice. Amendment 50 is no bad thing, and of course any advisory committee on a statutory footing should consist of patients as well as experts. I understand that there might be kickback on the amendments in the name of the noble Baroness, Lady Thornton, but a Secretary of State will rarely have expertise in medical devices, so an ad hoc independent committee to inform, advise and warn would be very valuable. A lot of thought will need to be given to working out its terms of reference. We therefore support Amendments 51 to 53. As the noble Lord, Lord Lansley, said, it will also be critical to ensure how this committee will work alongside the MHRA.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am enormously thankful for that constructive debate. This change to the Devices Expert Advisory Committee should be welcomed. It provides for if not equivalence then equality between the medicines and medical devices regimes. It provides for transparency, which we value enormously, and it indicates our direction of travel, the step change and the commitment to patient safety that the MHRA will enshrine.

As has been noted, the committee already exists. It currently meets, and it has an impact and an effect, but these measures mean that it will be strengthened. This change is put forward not solely by the Government; it was a recommendation in the review authored by my noble friend Lady Cumberlege. It adds to the collective picture of improvements that we are making, from future regulation of devices to the medical devices information system. I reassure my noble friend Lord Lansley that we have a profound commitment to creating a regulator in the MHRA that has international influence. I say to the noble Lord, Lord Hunt, that patient representatives are already on the DEAC. As Dr June Raine made clear in her briefing to noble Lords, she and the MHRA are massively committed to the patient safety agenda and to mobilising the patient safety voice through instruments such as the DEAC but not solely through it.

It is a delegated power, but one that I hope noble Lords agree is contained. It will allow us to ensure that the structure and focus of the committee can be kept under review to make best use of its impact, and the regulations will be subject to public consultation and all the steps therein.

The noble Baroness, Lady Thornton, has tabled Amendments 51 to 53 to the government amendment, which would change the nature of the regulations such that they “must” rather than “may” be made. However, as I have set out, the committee already exists; it functions now. It will be strengthened by the regulations. We are committed to a more structured decision-making process that improves transparency. There is no equivocation or doubt; these regulations will be made.

The powers provided by Amendment 50 in my name will enable movement towards a more transparent, proactive, whole-life cycle approach to vigilance. Fundamentally, they will make a difference in the oversight of medical devices to the benefit of patients and patient safety.

I am grateful to noble Lords who have continued to shine a light on the importance of device safety. I hope that this additional tool in the arsenal demonstrates continued commitment and that I have provided sufficient reassurances for the noble Baroness to feel able to withdraw the amendment.

Baroness Wheeler Portrait Baroness Wheeler (Lab)
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I thank the Minister for his response and all noble Lords and noble Baronesses who have taken part in this useful debate. The points made by my noble friend Lord Hunt and the noble Lord, Lord Lansley, about the future role of regulation were particularly pertinent, and we look forward to seeing how it develops.

I understand the Minister’s response in relation to “may” or “must” and heard loudly his reassurance that there is no doubt that the committee will be established or be upgraded. That being the case, I am happy to withdraw the amendment.

Amendment 51 (to Amendment 50) withdrawn.

Amendments 52 and 53 (to Amendment 50) not moved.

Amendment 50 agreed.

Amendment 54

Moved by

54: Before Schedule 1, insert the following new Schedule—

“SCHEDULE A1 FURTHER PROVISION ABOUT THE COMMISSIONER FOR PATIENT SAFETYPrinciples relating to core duties

1_(1) The Commissioner must prepare and publish a set of principles to govern the way in which the Commissioner will carry out the Commissioner’s core duties.(2) The Commissioner—(a) may revise the principles, and(b) must publish any revised version.(3) The Commissioner must carry out a public consultation in preparing or revising the principles.Involvement of patients

2_(1) The Commissioner must take reasonable steps to involve patients in the discharge of the Commissioner’s core duties.(2) The Commissioner must in particular take reasonable steps to— (a) ensure that patients are aware of the Commissioner’s core duties and of how they may communicate with the Commissioner, and(b) consult patients, or persons who appear to the Commissioner to represent the interests of patients, on matters which the Commissioner proposes to consider in the discharge of the core duties.Supplementary functions and information

3_(1) For the purposes of carrying out the core duties, the Commissioner may—(a) make a report or recommendation to a relevant person;(b) consult or receive information from patients or any other person the Commissioner thinks appropriate;(c) request information from a relevant person;(d) share information with a relevant person.(2) A relevant person to whom a report or recommendation is made under sub-paragraph (1)(a) must provide a response to that report or recommendation within such period as the Commissioner may reasonably require.(3) A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner to provide information within such period as the Commissioner may reasonably require.(4) Nothing in this Schedule authorises a disclosure of information which contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this Schedule).(5) In this paragraph—“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;“health care” means all forms of health care provided for individuals, whether relating to physical or mental health, and including ancillary care;“relevant person” means—(a) a person who exercises functions of a public nature, relating to medicines or medical devices, so far as those functions are exercisable in relation to England;(b) any other person who, in the course of providing health care, provides services relating to medicines or medical devices in relation to England.Individual cases

4_(1) The Commissioner may not exercise functions in relation to an individual case.(2) But sub-paragraph (1) does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue.Amendments to primary legislation

5_(1) In Part 1 of the Table at the end of paragraph 3 of Schedule 1 to the Public Records Act 1958 (definition of public records), at the appropriate place insert—“Commissioner for Patient Safety.”(2) In Part 3 of Schedule 1 to the House of Commons Disqualification Act 1975 (offices disqualifying for membership), at the appropriate place insert—“Commissioner for Patient Safety.”(3) In Part 6 of Schedule 1 to the Freedom of Information Act 2000 (other public bodies and offices: general), at the appropriate place insert—“The Commissioner for Patient Safety.”(4) In section 71 of the National Health Service Act 2006 (schemes for meeting losses and liabilities etc of certain health service bodies), in subsection (2), before paragraph (h) insert—“(ga) the Commissioner for Patient Safety,”. (5) In Part 1 of Schedule 19 to the Equality Act 2010 (authorities subject to the public sector equality duty), in the group of entries under the heading “Health, social care and social security”, at the appropriate place insert—“The Commissioner for Patient Safety.”Regulations about appointment and operation

6_(1) The Secretary of State may by regulations make such provision as the Secretary of State considers appropriate with regard to the appointment and operation of the Commissioner.(2) Regulations under sub-paragraph (1) may (among other things) contain provision for and about—(a) the Commissioner’s terms of office;(b) remuneration or other benefits;(c) the provision of financial or other assistance, including staff, accommodation, equipment or other facilities, for the Commissioner;(d) requirements to prepare business plans;(e) requirements to prepare reports;(f) requirements to lay documents before Parliament;(g) requirements to provide documents to the Secretary of State or other persons specified in the regulations;(h) the conferring of functions on other persons in relation to the Commissioner;(i) the appointment of a board to provide advice to the Commissioner.”Member’s explanatory statement

This amendment makes further provision about the Commissioner for Patient Safety established by the amendment in the Minister’s name to insert a new Part before Part 1.

Amendment 54 agreed.

Clause 37: Disclosure of information

Amendments 55 and 56

Moved by

55: Clause 37, page 22, line 1, after “a” insert “relevant”

Member’s explanatory statement

This amendment and the amendment to clause 37 in the Minister’s name adding a definition of “relevant person” restrict the persons to whom information may be disclosed in reliance on Clause 37(5).

56: Clause 37, page 22, line 3, at end insert—

“(5A) But subsection (5) does not authorise a disclosure of patient information without the consent of the individual to whom that information relates.”Member’s explanatory statement

This amendment and the amendment in the Minister’s name to add a definition of “patient information” to Clause 37 prevent Clause 37(5) authorising the disclosure of information from which patients can be identified without their consent.

Amendments 55 and 56 agreed.

Amendment 57

Moved by

57: Clause 37, page 22, line 3, at end insert—

“( ) Where information is disclosed in accordance with subsection (5) such disclosure will only be permitted where—(a) it is required as part of international cooperation in monitoring the performance and safety of medical devices; or(b) it is in the public interest.” Member’s explanatory statement

This amendment would allow a relevant authority to disclose information to a person outside the UK where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicine provided it is within the public interest to do so.

Amendment 57 agreed.

Amendments 58 to 62

Moved by

58: Clause 37, page 22, line 4, leave out “But”

Member’s explanatory statement

This amendment is consequential on the amendment in the Minister’s name adding a new subsection (5A) to Clause 37.

59: Clause 37, page 22, line 27, at end insert—

“(9A) This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”Member’s explanatory statement

This amendment provides that Clause 37 does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.

60: Clause 37, page 22, leave out line 32

Member’s explanatory statement

This amendment omits an unnecessary definition.

61: Clause 37, page 22, line 32, at end insert—

““patient information” means information (however recorded) which—(a) relates to—(i) the physical or mental health or condition of an individual,(ii) the diagnosis of an individual’s condition, or(iii) an individual’s care or treatment,or is (to any extent) derived directly or indirectly from information relating to any of those matters, and(b) identifies the individual or enables the individual to be identified (whether by itself or in combination with other information);”Member’s explanatory statement

See the explanatory statement for the amendment in the Minister’s name adding a new subsection (5A) to Clause 37.

62: Clause 37, page 22, line 32, at end insert—

““relevant person” means—(a) the government of a country or territory outside the United Kingdom;(b) a person who exercises functions on behalf of such a government;(c) any other person who exercises functions or provides services relating to medical devices in a country or territory outside the United Kingdom;(d) an international organisation that exercises functions or provides services relating to medical devices.”Member’s explanatory statement

See the explanatory statement to the first amendment to Clause 37 in the Minister’s name.

Amendments 58 to 62 agreed.

Lord Faulkner of Worcester Portrait The Deputy Speaker (Lord Faulkner of Worcester) (Lab)
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Does the noble Lord, Lord Patel, wish to move to move his Amendment 63? Lord Patel? We cannot hear the noble Lord.

Baroness Penn Portrait Baroness Penn (Con)
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The noble Lord may wish to know that the amendment is consequential on an amendment passed earlier on Report, so he or a fellow signatory may wish to move it.

Amendment 63

Moved by

63: After Clause 39, insert the following new Clause—

“Requirement for draft consolidated legislation: medical devices

The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to medical devices.”Member’s explanatory statement

This new Clause, and the other consolidation amendments in the name of Lord Patel, would require the Secretary of State to publish draft consolidated legislation within three years to streamline the existing regulatory framework. These amendments are linked to the amendment providing for a three year sunset provision in the name of Baroness Thornton.

Amendment 63 agreed.

Schedule 2: Offence of breaching provisions in the Medical Devices Regulations 2002

Amendment 64

Moved by

64: Schedule 2, page 39, line 39, at end insert—

“(2A) In respect of an offence under this regulation—(a) a magistrates’ court in England and Wales may try an information laid before the earlier of—(i) the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and(ii) the end of the period of three years beginning with the day on which the offence was committed;(b) a magistrates’ court in Northern Ireland may hear and determine any complaint made before the earlier of—(i) the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and(ii) the end of the period of three years beginning with the day on which the offence was committed;(c) in Scotland, summary proceedings for the offence may be commenced before the earlier of—(i) the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and(ii) the end of the period of three years beginning with the day on which the offence was committed.(2B) For the purposes of paragraph (2A)(a)(i), (b)(i) and (c)(i)—(a) a certificate signed by or on behalf of the prosecutor and stating the date on which such evidence came to the prosecutor’s knowledge is conclusive evidence of that fact, and(b) a certificate stating that matter and purporting to be so signed is to be treated as so signed until the contrary is proved.” Member’s explanatory statement

This amendment ensures that prosecutions for an offence under new regulation 60A of the Medical Devices Regulations 2002 can be brought before the earlier of one year from the prosecutor thinking there was sufficient evidence to justify a prosecution or three years of the commission of the offence, as is currently the case with regard to equivalent offences under section 12 of the Consumer Protection Act 1987.

Amendment 64 agreed.

Amendment 65 not moved.

Lord Faulkner of Worcester Portrait The Deputy Speaker (Lord Faulkner of Worcester) (Lab)
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We now come to Amendment 66. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press the amendment to a Division must make that clear in debate.

Amendment 66

Moved by

66: After Clause 40, insert the following new Clause—

“Availability of medicines and medical devices for human use on the National Health Service

(1) The National Institute for Health and Care Excellence must have regard to the need—(a) to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices,(b) to support early patient access to effective new medicines and medical devices, including by accepting a greater degree of uncertainty and risk in recommending their use,(c) to ensure patients with rare diseases have access to medicines and medical devices that they need, and(d) to support the use of curative therapies involving medicines and medical devices.(2) The Secretary of State must lay a report and impact assessment before both Houses of Parliament setting out how the National Institute for Health and Care Excellence has implemented its duty under subsection (1), in particular in its manual on process and methods for developing NICE guidelines.”Member’s explanatory statement

This new Clause would require the National Institute for Health and Care Excellence to ensure that its recommendations support the NHS in the ways described in subsection (1).

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, before I start, perhaps I may make the point to the clerks that the noble Baroness, Lady Thornton, needs to be unmuted every time the Deputy Speaker goes through the amendments so that she can move them or not. It is very frustrating; we can see it happening, and it is impossible for us to come in on this situation. That is why there is such a hiatus.

My Amendment 66 concerns NICE’s current view of its methods and processes as part of the agreement on the voluntary scheme for branded medicines pricing and access, happily known as VPAS. If NICE is to maintain its global relevance, it is critical that the methods review delivers tangible changes to ensure that it can fairly and effectively assess the true value of innovative medicines.

The UK life sciences sector is at a crossroads. Without meaningful intervention from the Government, exiting the EU obviously presents significant threats to the attractiveness of the UK. We know that global boardrooms take a holistic approach when considering where to place their investment, including the attractiveness and speed of the commercial environment—we have debated these earlier in the Bill. The ability quickly to launch medicines and technologies into our market and to get medicines quickly to the patients who need them is one of the main factors that shape boardroom sentiment on future investment, alongside the quality of scientific research and the possibility of collaboration. It was the Labour Government who set up NICE to do that: to get innovative new medicines and devices to the NHS and implemented as quickly as possible.

But the UK risks missing out on a wave of breakthrough therapies, with the potential to transform outcomes, if the NICE review does not lead to meaningful change in the way it does its business. Not only do we risk losing our reputation as a leader at the cutting edge of medical science but, more importantly, patients will not be able to assess the most innovative treatments available elsewhere. So NICE’s approach to appraising value must take into account the strategic benefits of the NHS remaining at the forefront of medical innovation and demonstrate that the UK Government are committed to supporting a thriving, world-leading life science sector post Brexit.

In relation to my amendment, I would like to raise issues of barriers to new innovative technologies, such as gene therapy. Gene therapy is a prime example of a medical technology that the UK should embrace, and, indeed, the Government have rightfully lauded the UK’s efforts in this regard. But a procedure called the discount rate, used by NICE to adjust for future costs and health benefits when valuing treatments, discriminates against one-time therapies that offer potential long-term health benefits over many years, such as gene therapies. NICE almost always uses a 3.5% rate. It can apply a lower 1.5% rate for therapies that offer longer-term health benefits, but it has chosen to do this only on exceptionally rare occasions. I wonder whether the Minister will commit to working with NICE to review the circumstances in which the policy solution can be applied to unlock the potential of such innovations.

The VPAS was negotiated with the aim to secure a triple win for patients, government and industry. But NHS England’s current bespoke commercial agreements significantly undervalue innovation, and this is something global boardrooms look at for evidence in the NICE review—that speedy access to new medicines will be improved.

Why should the Government commit to doing an impact assessment of the changes? Well, warm words and promises from Ministers are not enough; we need a clear commitment from them that they will place the emphasis on NICE to ensure meaningful action. In Committee, the Minister argued that my amendment was not necessary, and that the issues I raised were already dealt with in existing legislation and were outside the remit of the Bill. She went on to say:

“NICE, like the rest of the health system, is constantly keeping methods under review to ensure they are appropriate and support the speed of innovation in the life sciences sector,”

and she agreed about the need to get new innovations into the hands of patients quickly. In so doing, she referred to the methods and process manual produced by NICE

“in consultation with a range of stakeholders, including industry and academics.”

She said:

“NICE will publish a revised manual and related impact assessment when that process is completed.”—[Official Report, 26/10/20; col. GC 52.]

Is that sufficient?

The Ethical Medicines Industry Group has identified that medicines and medical devices often face challenges when being assessed by NICE, due the rigid focus on cost-effectiveness. Failing to consider other factors, such as the benefits of treatment in reducing health inequalities or the wider impacts on quality of life, often hinders patients’ ability to access innovative life-saving treatments. The EMIG argues that introducing a health inequalities modifier would be critical to demonstrate that NICE recognises the importance of reducing the high levels of unmet medical needs in the population and to benefit the most disadvantaged and underserved patient groups. There is strong support for the introduction of this modifier among experts involved in the development of the consultation, with a document noting that there is evidence that people are willing to generate less health overall if the health is generated in disadvantaged groups, particularly for socioeconomic disadvantage.

My amendment seeks to build on expert support to ensure equitable access to innovative treatments for conditions that are not adequately treated, to drive down health inequalities and benefit the most marginalised patients. I argue that NICE must also review its appraisal system for rare disease treatments to ensure that the system in place enables patient access. Inherently, rare disease treatments serve small patient populations, and generating sufficient data to meet NICE’s cost-effectiveness requirements is often challenging.

I have received a briefing from another organisation, Global Blood Therapeutics, on sickle cell disease. It argues that, in relation to the UK’s most prevalent genetic disorder, SCD treatments are currently limited to managing the condition rather than addressing the underlying causes. But there is hope that a new range of therapies may change this.

On occasion, NICE has also considered treatments which may not meet its traditional cost-effectiveness thresholds but which would have a significant impact on health inequalities. But consideration of health inequalities remains rare, and I think that this needs to be revisited. If NICE is truly committed to designing an appraisal process which reduces health inequalities and provides equitable access for the most disadvantaged patients, the introduction of a health inequalities modifier, as set out in my amendment, is vital.

The UK life science sector faces a great challenge. It is a huge asset. We have to ensure that organisations such as NICE play their part in making sure that the NHS and the UK are attractive for major investment in the future. In a nutshell, that is the crunch point of my amendment. We have as well to make sure that its methodology deals with health inequalities sufficiently. I beg to move.

Baroness Finlay of Llandaff Portrait Baroness Finlay of Llandaff (CB) [V]
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My Lords, I declare that I am vice chair of the NICE review committee. Amendment 66, moved by the noble Lord, Lord Hunt of Kings Heath, aims to ensure early access for NHS patients to medicines and medical devices. This must also involve ensuring that results of safety and efficacy from devices in real-time use—as well as in trials—are registered, published and then considered again in real time, a process that I hope will be helped and promoted by the patient safety commissioner role.

Noble Lords will remember that in Committee I tabled, along with the noble Lord, Lord Hunt of Kings Heath, an amendment to ensure provision for the development of a new rapid provisional two-year licensing procedure. The intention behind that amendment was to ensure that patients could more quickly access potentially life-saving medicines and medical devices.

I sincerely thank the Minister and his team for meeting with me on this, and for the other meetings they facilitated. I am reassured that the approval processes from the MHRA over device development are due to be revised completely over the coming year, with improved and streamlined processes, and I hope that today the Minister can confirm this, even with a timeframe, so that we can move forward quickly.

We have a unique opportunity to develop devices and roll them out to the NHS, but it is important that approval processes do not slow down or block patient access to improvements in treatment and management over a wide range of conditions, particularly rare disorders. Evidence from real-time use is crucial, and development and improvement can become a virtuous circle when that is rapidly fed back—so we become the intellectual innovation hothouse for our future prosperity, while also benefiting our patients. The UK can then be seen as a favourable place to develop, approve and supply medicines and medical devices.

Speeding up and widening approval processes, including two-year provisional licensing that I have been advocating with the Royal College of Physicians, would ensure that developing a new device from beginning to end—taking an idea from conception to supply—all in the UK is seen as an attractive prospect. Otherwise, we continue to risk new devices beginning their innovation journey in the UK, then being taken abroad part-way through the development process and marketed back to the UK. Keeping the entire process in the UK, with different models of fast-track approvals and provisional approvals, will allow better oversight of the safety and efficacy of devices during early access, with ongoing monitoring in real-time use. That would then facilitate moving into appropriately costed long-term approval processes.

We can innovate in the UK and stop intellectual capacity being outsourced. We can protect the safety of patients while getting them access to the latest treatments. It is patients who will suffer if we do not get this right, which is why the proposals in this amendment are so important.

Baroness McIntosh of Pickering Portrait Baroness McIntosh of Pickering (Con) [V]
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My Lords, I am delighted to follow the noble Baroness, Lady Finlay, and speak on this group of amendments. I can see that the noble Lord, Lord Hunt, speaks with passion and some considerable knowledge and experience of NICE. But I am concerned and would just like to understand, as we have established that patient safety absolutely has to be paramount, that patient safety could not be compromised through either of the two amendments—Amendments 46 and 66—in this group.

The noble Baroness, Lady Finlay, set out in the earlier amendment in Committee a two-year licensing procedure and, now that we have obtained an assurance that the approval processes are to be revised, I would imagine that the same procedure as set out under Amendment 66 should be considered as part of that review and revision of the processes. I would also like to further understand how a role for NICE as set out in Amendment 66 actually fits in with the Bill before us today and, in particular, the role as set out, and just agreed, of what the advisory committee should be.

My concern is absolutely that patient safety has to be paramount—first, foremost and bottom line. In my view, what is sought to be set out in these two amendments in this little group should be best done as part of an overall review of the processes to which the Government, as I understand, are already committed.

Baroness Masham of Ilton Portrait Baroness Masham of Ilton (CB) [V]
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My Lords, I am grateful to my noble friend Lady Finlay of Llandaff for alerting me to the fact that government Amendment 45 pre-empted our Amendment 46. They were grouped on different days, but I am pleased that others were thinking on the same wavelength.

I am very happy to support Amendment 66 in the name of the noble Lord, Lord Hunt of King’s Heath. The availability of medicines and medical devices is top of my priority list. In fact, antibiotics have saved my life on several occasions. It is important that NICE adheres to health equality: everyone who needs medicines or medical devices should be treated equally and there should be no delay. Unfortunately, with this devious coronavirus, this has not happened, but we hope for better days.

Having experienced a member of my family dying, I know that sometimes it seems worth trying anything that might help and that is in the research process. There are many really rare diseases which need orphan drugs; they can be a lifeline to the individual. I hope that NICE will consider them without delay and realise their importance and value to these small patient groups. It is so frustrating when patients in Scotland and other European countries can get medicines and medical devices, when those in England cannot; patients here have to wait—unless the public come to their rescue by crowd funding.

Many users of devices also need instruction on their use, and staff and patients need training. Personal medicine is so important and patient safety is absolutely paramount.

Lord Lansley Portrait Lord Lansley (Con) [V]
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My Lords, I am most grateful to the noble Lord, Lord Hunt of King’s Heath, for his amendment and for the way he introduced it. It very helpfully allows us, at this very important moment, to take stock of how we secure the availability of medicines—although the legislation does not relate to NICE, and I am sure it will not surprise the noble Lord, Lord Hunt, that I do not think it is appropriate for us to legislate to tell NICE how to do its work, given its independent statutory constitution. None the less, the Bill is about the availability of medicines, and it is really important for us to identify how the NICE processes can assist in ensuring that we get medicines to those who need them.

I shall say a few words about the NICE processes. First, let me address the objective, from my point of view. When I was Secretary of State, I advocated a process called “value-based pricing”, which was to try to understand that not only were there quantitative factors measured in quality-adjusted life years—QALYs —which, if one were able to secure them, gave one a quantitative basis for understanding the value of a new medicine, but that in addition there were other qualitative aspects, which I described as the societal benefits and the innovation benefits. I still think that this is the right approach.

In the international context, many countries are trying to escape the potential downward spiral of reference pricing, where everybody is trying to pay less than the average. The net result, if we carry on down that path and if the American Administration pursue that path, will be that we end up with inadequate support for the industry for the development of new and innovative medicines.

What we need to do is to value innovation and support the industry for the value it delivers. However, we do not measure it precisely in those terms. When we look at our current structure in this country, we need to understand that there is an opportunity created by what is known as VPAS—the voluntary pricing and access scheme. If it is genuinely the case, and we have argued that it should be, that the industry has accepted a constraint on the overall growth of the medicines budget in the NHS, and if it is clear that, if that growth is exceeded, there will be a rebate and that rebate does indeed return to benefit patients, through the NHS or the innovative medicines fund, so promoting access to new medicines, then we will arrive at the point where both NICE and NHS England should be working together to try to secure the best value from that drugs budget. I think they should be working together to ensure that, where there is a mandate for a new medicine, it is one which is supported by, not imposed upon, NHS England. That is increasingly where we should be aiming to arrive: at a combined thought.

What goes into value-based pricing matters enormously as well. The noble Lord, Lord Hunt, referred to some of the important aspects. First, it is about societal values. For example, if we can deliver a health gain among the parts of our population where health outcomes are poorest, then we should ascribe additional value to that health gain. A modifier for health inequalities is consistent, for example, with the statutory responsibilities of the NHS to seek to address and reduce health inequalities.

Unmet medical need makes a difference. Incremental effectiveness of medicines is important, but to have a medicine available for those who thought that there was no opportunity for treatment available to them from the NHS can make an enormous difference, and I think we should ascribe additional value to that. Medicines which deliver innovative benefits—for example, which have a whole new mode of action—can lead to subsequent treatments, and we should have a method of qualitatively understanding where those innovations, even if they may not have dramatic incremental benefits, none the less give us long-term potential. We should reflect that in the price that we are prepared to pay.

Indeed, as the noble Lord, Lord Hunt, said, we should not apply a discount rate to quality-adjusted life years that is directly comparable with the discount rates that are applied to revenues over time. I think people's time preference for quality-adjusted life years is not so dramatically higher for gain now as opposed to gain in the future; there is a much greater degree of equivalence between health gain now and health gain that people will derive in future. That would certainly assist in promoting medicines that slow the progression of disease and help us to manage longer-term morbidity in our older population, which would be immensely helpful.

There is a whole range of such matters and there are many more one could talk about, but it is really important to distinguish between NICE’s job in undertaking a health technology assessment, which I think should be moved from the purely quantitative to the qualitative. It should include, for example, relying not only on randomised control trial data but understanding observational data and the data we receive from the use of the innovative medicines fund to see how well medicines work and what benefits and outcomes they can deliver—sometimes in relatively small populations for rare diseases—understanding that in practice and incorporating it in its assessment.

We need to support NICE in delivering what is regarded internationally, I hope, as a gold standard of health technology assessment. We need to understand that that is separate and distinct from the business of what price the NHS should pay and on what basis the industry and we, as payers for new medicines, should agree, understanding that our objective must always be to ensure that safe, effective and high-quality medicines are available to the NHS and patients.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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My Lords, these amendments relate to NHS access to medical devices, and Amendment 46 from the noble Baroness, Lady Finlay, would ensure early access for NHS patients to medical devices and allow monitoring of safety and efficacy in real-time use. This amendment is pre-empted rather by the Government’s amendment, which removes the concept of attractiveness.

Amendment 66 from the noble Lord, Lord Hunt of Kings Heath, would require NICE to ensure that its recommendations support the NHS in the ways outlined in subsection (1) of the proposed new clause. This includes ensuring access to new medicines and medical devices for patients with rare diseases. Those of us who have been involved in rare diseases will be all too well aware of the problems of access to appropriate treatments for so few patients.

The interesting thing about this debate is that two of the House’s big health thinkers have been speaking, and both the noble Lord, Lord Hunt of Kings Heath, and the noble Lord, Lord Lansley, have given us a really good big-picture look which takes us slightly above legislation.

The noble Lord, Lord Lansley, spoke of social and innovation benefits and the need to value innovation, but with innovation does not always come success: we may have to try again. He spoke about the innovative medicines fund and the necessity for NICE and NHS England to work together. When it is put like that, it sounds very straightforward: why is that not normally happening? He talked about the importance of value-based pricing and getting the best value from the drugs budget—which, after all, is finite. He also talked about the health technology assessment, which is of course qualitative, not quantitative. I valued the contribution of this debate on the fourth group of amendments, and I will read it again with great interest.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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The noble Baroness, Lady Jolly, is quite right: two of our health big thinkers have laid out the issues here. My noble friend Lord Hunt gave a wonderful introduction to Amendment 66, which covered the reasons why it is important and what it will do. The noble Lord, Lord Lansley, took us on a journey through how health inequalities can be addressed. The point, and the reason the amendment is on the Marshalled List today, is that it does not always work like that. Implementation is key. As the noble Baroness, Lady Jolly, said, requiring NICE to support NHS access to new medicines and medical devices seems kind of obvious. The challenge for the Minister here is how to use this legislation and this discussion to make what we think is obvious work better.

Baroness Penn Portrait Baroness Penn (Con)
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My Lords, I know the noble Lord, Lord Hunt of Kings Heath has a long-term interest in and commitment to the work of NICE and, as such, will know that NICE’s remit is set out in other legislation. I do not intend to rehearse the arguments on why we do not see that as strictly for this Bill. Instead, I hope to provide some reassurance on the issues he raises with his amendment.

The noble Lord will be aware that NICE’s methods and processes for assessing the cost-effectiveness of medical technologies are internationally respected and have been developed over almost 20 years through periodic review, including extensive engagement with stakeholders, and the latest iteration of that process of periodic review of its methods is ongoing. NICE finished the first phase of its consultation on the case for change to its methods on 18 December 2020. There will be a second consultation on the case for change to its processes in the spring. The result of those will inform the final consultation on the updated methods manual in summer 2021. I hope that the noble Lord is reassured by the consultative nature of that process in considering the issues he raised.

Subsection (1)(a) of the new clause proposed in his amendment would require NICE to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices. Subsection (1)(b) would require NICE to accept a greater degree of uncertainty and risk in recommending their use. I reassure the noble Lord that NICE is already considering both of those as part of its review, and they were both consulted on as part of the consultation on the case for change that ran from 6 November to 18 December 2020.

In that consultation, NICE noted that there may be a case for a modifier that considers health inequalities. However, further work is needed to explore how this could be defined and implemented in a health technology evaluation, and under which circumstances. This will be done in NICE’s second consultation running from February to March. Such a modifier could consider the types and sources of inequality, as well as how a modifier should be applied—qualitative or quantitative. It could also consider whether such a modifier covers technologies that directly reduce inequalities—for example, by specifically targeting or providing additional benefits for a disadvantaged group; or whether indirect effects might also be considered—for example, if a technology has uniform benefits across groups, but the condition disproportionally affects a disadvantaged group. At this stage, it is not clear that there is sufficient evidence for a health inequalities modifier, but it is being explored, and will be explored further in the second stage.

I hope that level of detail on the consideration that NICE is undertaking helps to reassure the noble Lord, but of course it would not be appropriate to pre-empt that review, and we want to encourage all stakeholders to respond to it.

In addition, I remind the noble Lord that a requirement to have regard to reducing health inequalities is already imposed on NICE under Section 1C of the National Health Service Act 2006. This applies to NICE as a non-departmental public body of the Department of Health and Social Care.

Proposed new subsection 1(c) would require NICE to have regard to the need

“to ensure patients with rare diseases have access to medicines and medical devices”.

The noble Baroness, Lady Wheeler, noted some concern during Grand Committee as to why NICE did not propose a rarity modifier in its methods review. A rarity modifier was considered by NICE prior to publication of the consultation document. However, stakeholders noted that rare diseases would be covered by the proposed severity modifier, which more accurately reflects society’s values. Although there is of course overlap between severity and rarity, not all rare conditions are severe and some severe conditions are more common. Of course, the consultation was an opportunity for all stakeholders to express their views on this point. As noted previously, NICE is also consulting on changes, such as a more accepting attitude towards uncertainty in some situations, which should benefit medicines for rare diseases.

Where there is uncertain evidence relating to a medical technology—I appreciate this can be a challenge for rare diseases—NICE and NHSE&I have developed managed access agreements. NICE has already recommended six topics for use subject to a managed access agreement outside of cancer. NHSE&I continues to use its sophisticated commercial capabilities to negotiate deals with industry that enable patients to access the most innovative new medicines and ensure that the NHS gets good value.

Proposed new subsection 1(d) would require NICE to have regard to supporting

“the use of curative therapies involving medicines and medical devices.”

The word “curative” should be used with caution, as there is no standard definition of what might be meant by it. For example, in some cases it may mean a significant amelioration in symptoms, in others that the treatment pathway is different or more tolerable.

While I appreciate that recently launched advanced therapy medicinal products hold great promise by targeting the specific cell or genetic defect, the data on long-term effectiveness is often immature at the time of marketing approval. Further, we need flexibility to respond quickly and effectively to developments in life sciences. We want to avert a situation whereby an effective therapy is not guaranteed funding because it did not meet the legal definition of a “curative therapy”. However, I think that the noble Lord was more trying to get at our support for some of these innovative approaches. Again, this is being looked at in the review of NICE’s methods.

NICE’s working group has explored whether there is a case for changing the approach to discounting, which the noble Lord asked about, in particular the impact on technologies with long-term benefits such as one-time gene therapies. This is a complex area that needs to take into account the policy-level need to support particular types of technologies or circumstances, the limitations of the current criteria for non-reference case discounting, and the effects and any accompanying policy and affordability challenges of any change. This will be covered by the second stage of the NICE methods review. Again, while we would not want to pre-empt that review, all stakeholders are encouraged to respond to it.

Briefly, proposed new subsection (2) would require the Secretary of State to lay a report and impact assessment before both Houses of Parliament, setting out how NICE has implemented its duty under proposed new subsection (1). As I said in Grand Committee, NICE will publish its revised methods and process manual, including its impact assessment, on its website for all to access, including parliamentarians, once the process has been completed. That is the correct forum.

I will briefly address Amendment 46 in the name of the noble Baroness, Lady Finlay, which touches on similar issues—the importance of access to medical technologies, the future medical devices regulatory regime, and the critical nature of medical device safety. I pay tribute to the noble Baroness’s work through her engagement with Ministers and our officials in developing government Amendment 45, which provides greater clarity on the types of activity we would intend to encourage through appropriate regulation. That includes, in respect of medical devices, carrying out research, developing medical devices, or manufacturing and supplying medical devices.

The Government support the agenda for early access to medical devices for NHS patients, as demonstrated through other mechanisms such as the rapid uptake products programme, managed by Accelerated Access Collaborative, and the medtech funding mandate, due to launch in April.

The second stated purpose of the noble Baroness’s amendment—to allow monitoring of the safety and efficacy of medical devices in real-time use—is already achieved by regulations that may be made under Clause 15(1)(i) and (j), so the mechanism to deliver this is already in place. In addition, Clause 18 empowers the Secretary of State to make regulations for the establishment of a medical device information system by NHS Digital, which will support the monitoring of patient outcomes and patient safety.

The noble Baroness also asked about the timeframe for future devices regulation made under the Bill. I assure her we will consult on this issue this year.

I hope the reassurances I have provided, here and during Committee, are of comfort to noble Lords and that the noble Lord, Lord Hunt of Kings Heath, feels able to withdraw his amendment.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, I wanted to stimulate a debate on the NICE review and it certainly succeeded, because we had a very high-quality debate. I am very grateful to the Minister for what was a comprehensive and encouraging response, in a number of ways.

I will start with the noble Baroness, Lady Finlay, because she made a powerful speech and argued very convincingly for the speeding up of approval processes, alongside speeding up the introduction to the National Health Service of proven, innovative new medicines and treatments. The noble Baroness, Lady McIntosh, asked about patient safety, but my amendment and, I believe, that of the noble Baroness, Lady Finlay, would do nothing to undermine patient safety. In the first place, the Minister has already tabled an amendment to Clause 1, which we debated on the first day of Report, which gives priority to considerations of patient safety. It is clear from the explanation given for Amendment 46 from the noble Baroness, Lady Finlay, that her proposals for a preliminary licence would allow for monitoring of safety and efficacy in real time. That could be a real bonus indeed.

I thought that the noble Baroness, Lady Masham, asked the fundamental question: why are we so slow to introduce new medicines and devices? Why are we behind so many other developed countries?

The noble Lord, Lord Lansley, gave a very thoughtful contribution. He is absolutely right to argue that we need more support for innovative medicine. The tragedy is this. We have the excellent VPAS agreement whereby, essentially, industry accepts that if the cost of medicines goes above a certain agreed level it will pay a rebate back to the Government, or ideally the National Health Service. If this worked properly the resource going back would be used for innovation, but for reasons that I have never quite understood the money does not seem to go back directly in an identifiable form to the NHS. We have the bizarre situation where, locally, the NHS worries about its drug costs. When it goes above a certain level there is a rebate, but unfortunately that rebate does not seem to find its way back in a tangible, transparent form, to the NHS. We have not created out of the agreement the kind of win-win situation that surely was envisaged when the previous voluntary agreement was first developed.

The noble Lord, Lord Lansley, mentioned one of the big issues: the need for NICE and NHS England to work together. I do not get the impression that they do work together that well, because NHS England regards most innovation as costly and therefore tries to dampen it down. I agree with the noble Lord, Lord Lansley: we need a much better partnership where we build in value for innovation and dealing with inequalities—one where NHS England would actually be on board.

The noble Baroness, Lady Jolly, and my noble friend Lady Thornton talked about this being a big-picture debate. Of course, this is not something that can be solved by an amendment to a medicines Bill, but Parliament ought to debate these important issues and, at the very least, raise some issues that the review should undertake to address.

The noble Baroness, Lady Penn, gave us a very comprehensive response in relation to the review. I was encouraged by that. I see, from what she was saying, that many of the arguments put forward today by noble Lords will be considered. She also said that NICE has an internationally respected reputation; I agree. This is not so much about NICE’s reputation or the quality of its work; it is just that, at the moment, the end product is depriving NHS patients of innovation. That is what we need to turn around.

I am very grateful to noble Lords and I beg leave to withdraw my amendment.

Amendment 66 withdrawn.

Lord Faulkner of Worcester Portrait The Deputy Speaker (Lord Faulkner of Worcester) (Lab)
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We now come to the group consisting of Amendment 67. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this amendment to a Division must make that clear in the debate.

Amendment 67

Moved by

67: After Clause 40, insert the following new Clause—

“Medicines and Medical Devices Redress Agency

The Secretary of State must, by the end of the period of 12 months beginning with the day on which this Act is passed, bring proposals before Parliament to establish a Redress Agency for those harmed by medicines and medical devices.”

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, I want to come back to the debate on clinical negligence and the recommendation made by the noble Baroness, Lady Cumberlege, in her report for a redress agency. I declare my interest as a member of the GMC board.

We have reached a very serious position, with an exponential rise in clinical negligence costs. Twenty years ago, contingent liability was £3.9 billion; it is now £83 billion. Even allowing for inflation, I hardly think that we have become 20 times more negligent over that period. Indeed, the Minister, Nadine Dorries, told the House of Commons in a Written Answer last November:

“The continued rises in clinical negligence costs are eating into resources available for front-line care”.

It is not delivering for patients and their families, either. There are huge delays in getting cases settled and huge lawyers’ fees, in a quite remarkable situation where the NHS ends up paying damages in 80% of litigated clinical negligence claims. There is something wrong in the way we deal with these cases.

There have been endless reviews over the past 20 years, but precious little has happened. Seventeen years ago, an NHS redress scheme was unveiled by the then Chief Medical Officer, Sir Liam Donaldson. Legislation followed in 2006 but, 14 years later, it has yet to be implemented—and I doubt it ever will be. Since then, there has been much debate about the sustainability of Section 2(4) of the 1948 Law Reform (Personal Injuries) Act, which essentially promotes increased costs because it provides that

“there shall be disregarded, in determining the reasonableness of any expenses, the possibility of avoiding those expenses or part of them by taking advantage of facilities available under”

the NHS. In other words, the NHS tends to pay twice.

In 2017, the department and the Ministry of Justice commissioned the independent Civil Justice Council to draw up a new claims handling process for clinical negligence claims of up to £25,000, together with proposals for fixed recoverable costs for these cases. The report was published, with recommendations, in October 2019. Since then, there has been silence.

In that context, the noble Baroness, Lady Cumberlege, argued in her report First Do No Harm for a redress agency to be set up on an avoidable harm basis, which looks to systematic failings rather than blaming individuals. This, she thought, would encourage reporting and provide faster resolution for claimants. She argued that this

“would provide a standing structure to administer decisions using a non-adversarial process. This model is simple for patients to access as there is one point of contact. This structure enables flexibility to adapt and respond to situations as they arise.”

The proposed scheme of the noble Baroness, Lady Cumberlege, is well intentioned and has popular appeal. I recognise that details need to be spelled out in relation to eligibility, qualifying criteria or conditions of entitlement for her proposed redress scheme. Of course, causality is at the heart of any consideration of patient safety remedy. Causation is at the heart of tort. The Vaccine Damage Payments Act 1979 is limited to persons disabled as a result of vaccination. Even the NHS Redress Act 2006, to which have just referred, is concerned with arrangements for redress in relation to liability in tort. The noble Baroness’s approach is of course quite different from that.

The noble Baroness the Minister in Committee was not enthusiastic. In the past 48 hours we have heard the Government’s response that they have,

“no current plans to establish a redress agency”,

as set out in the recommendations of the noble Baroness, Lady Cumberlege. The reply went on to say:

“The government and industry have previously established redress schemes without the need for an additional agency.”

Well, that is a rather disappointing dismissal and misses the point, because the noble Baroness was essentially calling for a wholesale reform of the current clinical negligence system. I urge the Minister to reconsider this matter.

Can we really go on with the exponential rise in costs to the NHS—a system in which it loses 80% of cases that reach the courts, and where huge delays take place in patients getting access to an outcome? The system is completely bust. We need a new one and I hope that the Minister will, with his colleagues, consider what action needs to be taken to improve the current situation. I beg to move.

Baroness Cumberlege Portrait Baroness Cumberlege (Con) [V]
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My Lords, I warmly thank the noble Lord, Lord Hunt. His determination is awe-inspiring. I am so pleased that he has not left this issue mouldering on the Committee Floor but has picked it up again.

I understand what the noble Lord said about the Government not being enthusiastic. However, I have known other issues on which the Government have been less than enthusiastic. It is the way in which we put forward persuasive arguments—although setting up this agency will take a lot of work, with a lot of detail to be considered. However, other schemes have been successful. I think about the one in my area—thalidomide. That trust is still running and getting redress for people who need it. So I strongly support the amendment of the noble Lord, Lord Hunt.

In our review, we tried to achieve a very simple and accessible structure for patients through the proposed redress agency. In an update on our recommendations, the Minister in the House of Commons, Nadine Dorries, said that the Department of Health and Social Care had delivered ex-gratia payments with individual schemes without the need for a redress agency. Indeed it has.

There are four or five schemes for infected blood alone, with eligibility based on whether the patient was a haemophiliac with HIV; a haemophiliac with hepatitis C; a non-haemophiliac with HIV; or a non-haemophiliac with hepatitis C. These different schemes addressed what type of payment should be awarded according to the patient’s need. What we—I am talking about my team and I—were advocating is a single point of contact for avoidably harmed patients. We felt very strongly that they had suffered enough without the necessity of finding out how to access the schemes that are relevant to them. The noble Lord, Lord Hunt, has said that something is wrong. He is right: it is wrong. This is not the way to help people who have been seriously harmed.

The problem is that, without a redress agency, each ex gratia scheme starts from scratch, which we felt was grossly inefficient. We need a standing administrative structure, funded by contributions from manufacturers and the state—both have a responsibility. At the moment, litigation is the only route, as the noble Lord, Lord Hunt, has said, for injured people to get serious compensation. We know that the process is very damaging to people. They do not like going to court, they do not like having to put forward all the information that is absolutely necessary—and sometimes not so necessary—and they do not like the fact that it is an adversarial system. We felt that the redress agency could remove the need for adversarial litigation that focuses on blaming individual doctors and nurses. The agency would be non-adversarial and would look at the systems failings that led to avoidable harm. This would help develop an open culture in healthcare and facilitate learning—we are not good at that. We know that the same mistakes happen over and again, and we felt that this was another tool to ensure that there would be much less of that.

Gathering information in one place—the agency—would make it so much easier to learn from the data that is collected and would strengthen the ability of the healthcare system to learn from the mistakes made. We have only to look at the cost of litigation of some £83 billion a year—I was very interested in what the noble Lord, Lord Hunt, said. We know that, often, the majority of those costs go to the law firms, not the individuals who have suffered so grievously. We felt that it would be much better if those huge sums of money, which are much needed by the NHS, should be used with a redress agency, which would have other advantages, as I have just outlined. A stand-alone agency, with a single entry point, would be a much better and more cost-effective way to award redress to those who suffer such avoidable harm—and many of them suffer for decades.

Baroness Bennett of Manor Castle Portrait Baroness Bennett of Manor Castle (GP) [V]
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My Lords, it is again my great pleasure to follow the noble Baroness, Lady Cumberlege, and the noble Lord, Lord Hunt of Kings Heath. I am pleased to attach my name to Amendment 67 in the name of the noble Lord.

I do not think the noble Baroness, Lady Cumberlege, will mind if I explain why I am coming in on Amendments 67 and 68 in particular. It is because I was in a meeting and asked her what her next priority would be after the broad achievement of the patient safety commissioner. She said that the redress agency was in her mind as the next priority, which is why I have chosen to make it a priority in this Bill, in which I have become considerably more involved than I was originally expecting.

Like the noble Lord, Lord Hunt, did, I have to describe the Government’s response to the noble Baroness’s review as very disappointing. Simply very curtly saying:

“The Government and industry have previously established redress schemes without the need for an additional agency”

really does not engage with the arguments put by the noble Baroness in her report or reflect the strong support seen in the British Medical Journal editorial on 20 August, which expressed growing support for the entire review but particularly for the idea of a redress agency.

It is worth setting out some of the context for this. On one level, in an ideal society a redress agency would not be necessary, or certainly not needed as urgently as it is now. Anyone suffering from illness or disability, whatever the cause, should be supported, given the resources that they need to live a full life as healthily as possible and given the chance to make a full contribution to society to the absolute top of their human potential. In such a society—with a universal basic income, adequate funding for health and social care, full access to public transport and access in every building—perhaps we would not need a redress agency in the same way as we do now. There would still be an argument for compensation for avoidable suffering but not, as we are seeing in the case of children who suffer avoidable injury at birth, the need for many millions of pounds to be paid to cover the costs of support through life. However, I hardly need to add, that is not the world that we live in now.

To quote the noble Baroness’s report:

“We have heard from individuals who have described how they have struggled to access the benefits that they are entitled to … Benefits assessments are not straightforward and can be daunting and hugely stressful for individuals with complex issues.”

One thing that a redress agency might include in the current environment is support to help people to access the benefits that they need for their particular set of circumstances.

As the noble Baroness has said, although I shall put it more strongly than she did, families and patients do not like going to court. I would say that we all know that going to court is immensely stressful, difficult and—I hope the noble and learned Lords in your Lordships’ House will forgive me for saying this—sometimes something of a lottery. The result depends on the evidence presented on the day, in the moment, and very often on the quality of the legal representation available to people.

The noble Baroness’s report said that

“litigation has not proved useful to the majority of the affected individuals we have heard from.”

Again, while I am not aiming to set up a dispute with the noble and learned Lords in the House, there are conditions and circumstances in which a competitive contest is not the best way to achieve a just outcome in a dispute. That is something that has been accepted broadly by society when it comes to divorce. A reparation process is not a combative process but one that seeks to take the time necessary to consider the evidence, ask for clarification and arrive at the right level of compensation and payment. That is not without stress, but there is probably considerably less. Obviously, Windrush shows us that that is not a panacea, but it is certainly better than having to go to court.

I want to make another argument from a broad social perspective. Before I make it, I need to declare my position on the All-Party Parliamentary Group on Legal Aid. We have heavily overstretched courts around the land and heavily overstretched practitioners of legal aid, a service that is increasingly unavailable in many parts of the country. We have to ask why for medical errors we are putting extra weight on the courts when there is a better alternative approach.

I have one final thought. If I cannot win the Government over with arguments about justice—about the fact, as the noble Lord, Lord Hunt, said, that the current system is “completely bust”—then surely there is an argument here for cost effectiveness. The cost of people having to go to court to get redress for medical errors, mistakes and faults is enormous. Surely the cost of a redress agency would be much less.

Lord Lansley Portrait Lord Lansley (Con) [V]
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My Lords, I am very glad to follow the noble Baroness, Lady Bennett of Manor Castle, and prior to her the movers of Amendment 67. I welcome the fact that we have this opportunity to say something about redress. Amendment 68 is to follow in the next group, and I think it important to distinguish between the need to establish a scheme of redress where the NHS or government have been responsible for something which subsequently turns out to have damaged or harmed people, and the need to establish a scheme to provide proper support to those who have been harmed. That has been done on an ex gratia basis but, if the Government sought to do so, I think it would be possible to commence the NHS Redress Act 2006 and to establish such redress schemes under a statutory footing. It is not necessary to pass legislation to make that happen.

Those are different and distinct from the process of recognising that those harmed as a result of clinical negligence or failures in treatment processes should be able to secure a remedy and redress. I say remedy advisedly because often, in my experience of talking to people who have been harmed as a result of clinical negligence—these are often cases involving harm to babies during birth—it is as important to understand what happened, to accept where responsibility lies and to understand that others will not suffer in the same way, as it is to secure redress, compensation and support, which is often support for the child throughout their life. We need to understand that that is what we are talking about, not just the question of compensation.

I am slightly surprised by Amendment 67. I wonder what we think NHS Resolution is, if not an agency within the NHS with responsibility for securing redress for those who have been harmed as a result of clinical negligence. We need to recognise the need for, and I hope the Minister will tell us that the Government have not abandoned thought of, further reform. Certainly, when we were in opposition, we argued during the passage of the NHS Redress Bill that there should be a fact-finding phase. We argued that, rather than having an adversarial process with expert witnesses and all the associated costs, we should have a phase during which a claim is brought and the facts are established on an independent basis. That could lead to arbitration procedures and a settlement, rather than court-based proceedings, and we might escape some of the burden of cost. We should remember that nearly half the total cost of compensation in the clinical negligence process through NHS Resolution is actually legal fees. If we can escape some of that through an independent fact-finding phase, an arbitration process and financial settlements which recognise the support that the NHS and taxpayers give to those who have been harmed and have enduring problems and disabilities as a result, we might escape some of the burden of cost.

As the noble Lord, Lord Hunt, said, the potential contingent liability—not on an annual basis, but in the future—has risen to £83 billion. It is an enormous sum. The amounts paid by way of premiums to NHS Resolution are a significant aspect of the cost of NHS providers. There continues to be a good argument that the Government should consider this area still in need of reform.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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This amendment from the noble Lord, Lord Hunt of Kings Heath, supported by the noble Baronesses, Lady Cumberlege and Lady Bennett, would require the Secretary of State to introduce proposals for a redress agency for those harmed by medicines and medical devices. As the noble Lord, Lord Hunt of Kings Heath, said, the concept of a redress agency for those harmed in such a manner has been around for many years but has not been realised. However, in the light of the Cumberlege report, which has been a great catalyst for innovation, the Government must see that now is the time. This is a really practical and common-sense move that would provide support and relief for patients while also avoiding the need for costly litigation on both sides, saving the NHS a considerable amount of money which could be better spent.

The NHS has a duty to give proper support to those in its care who have been harmed. As the noble Lord, Lord Lansley, said, there needs to be independent fact-finding, leading to a resolution process. He cited the NHS Redress Act 2006. I ask the Minister to reflect on this debate and to speak to his right honourable friend the Secretary of State, perhaps using his charm to persuade him to think again.

One advantage of being at home for this debate, in front of your own computer in your own study, is the opportunity quickly to look online to see how easy it is to find the relevant website. It took me a couple of searches before I came up with NHS Resolution, but it was not hugely helpful or intuitive. Therefore, would the Minister also feed that back to the Secretary of State and the people who manage these schemes?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the noble Lord, Lord Hunt of Kings Heath, raises matters in Amendment 67 that he raised in Grand Committee. I completely recognise that they are of enormous concern right across the House. One could say that it is the £83 billion question. I know he is an advocate, as indeed are many noble Lords, of the conclusions of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege, and I commend him and other former Health Ministers in this place.

In Committee, we had a very helpful, substantial and informative discussion on the concept and merits of a redress agency. I know that the noble Lord indicated that he would return to these matters if it seemed likely that we were unable to give an update on the way in which the department is responding to the review. I understand that he seeks further assurances and I shall attempt to give them.

As I set out in Committee, we are determined to ensure the safety of medicines and devices so that harm is less likely to happen in the first place, and, when things do go wrong, we are committed to fair redress arrangements that work for all. However, for the reasons that I set out in Committee, we do not believe it is necessary to create a new body for the purpose of providing redress for medicines and devices.

First, routes already exist if patients believe they were harmed by medicines or medical devices. They can bring a legal claim in the courts either against the manufacturer on the basis of product liability or against the actions of an NHS provider or clinician.

Secondly, the Government and manufacturers already have the ability to set up redress schemes when necessary, and in fact they have done so already, where appropriate, without ever establishing an additional agency. Setting up an overarching redress agency could become an unnecessary addition to an already complex landscape.

Thirdly, we do not believe that a redress agency in this country would necessarily make products safer or drive the right incentives for industries which are usually directed from a global level. It is a fact of life that any extra costs to firms could impact the attractiveness of the UK as a place to market and manufacture products —something that we are committed to supporting.

The noble Lord, Lord Hunt, asked what, in the absence of wholesale changes, we are doing to improve things. Since its strategy, Delivering Fair Resolution and Learning From Harm, was launched in 2017, NHS Resolution has successfully reduced the number of cases going to litigation. In its 2019-20 accounts, it reported that 71% of claims are now resolved without court hearings, which is extremely encouraging.

This has been accompanied by a significant increase in the use of ADR—alternative dispute resolution, referred to by my noble friend Lord Lansley—with over 1,000 mediations undertaken by 31 March 2020, with a success rate of around 80%. This is again encouraging. As a result of the strategies employed on ADR and early resolution, overall time to resolution of cases had reduced since the NAO report by an average of 26 days. The new early notification scheme for obstetric cerebral palsy has ensured that many early admissions of liability and interim payments can be made to families within months. In answer to my noble friend Lord Lansley, we keep the whole arrangement under review and assess options all the time.

None of this is to say that redress reform is not important. I reassure the House that we continue to explore recommendation 4 on redress schemes for sodium valproate, mesh and HPTs, and further work is being carried out to allow a response to that recommendation. I hope my noble friend Lady Cumberlege takes some reassurance from that.

However, for the reasons set out, and as announced yesterday in the Written Ministerial Statement on the review, we currently have no plans to establish a redress agency. As the noble Lord, Lord Hunt of Kings Heath, is aware, and as the noble Baroness, Lady Bennett, might like to remember, the Government will respond to the issues raised in the amendment, in full, as part of our formal response to the independent medicines and medical devices safety review. I therefore hope the noble Lord has heard enough, so that he is reassured and able to withdraw Amendment 67.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, again, this has been an interesting debate. As was said by the noble Baroness, Lady Cumberlege, there are persuasive arguments to change the current approach to redress and criminal negligence more widely. I agree with the noble Baroness, Lady Bennett, that the Government’s response was short and not really sweet.

The noble Lord, Lord Lansley, is right to draw a distinction between schemes of redress and wider clinical negligence issues. The noble Baroness, Lady Cumberlege, has a later amendment dealing with specific recommendations on redress for the patient groups that she examined in her report. I took her argument for a redress agency to have much wider implications and considerations. The noble Lord, Lord Lansley, expressed surprise at the wording of my Amendment 67. I simply sought to bring this back, so that we could have a wider discussion, as well as deal with the issues raised around the three patient groups in the noble Baroness’s report.

I have never understood why the redress Act was put on the statute book but never implemented. It is clear from talking to experts that it is regarded as flawed, but it is interesting that no Government have picked this up. Equally, we all accept that redress schemes for individual patient groups are an appropriate way forward. However, we are left with a system for criminal negligence that I simply do not believe works.

I heard what the Minister said about improvements for NHS Resolution, but the fundamental argument is that the system is getting more and more expensive—the £80 billion-plus question, as the Minister said. For patients and their relatives, it can be a daunting process, even though, as he said, more can be dealt with prior to going to court. But when the cases do go to court, NHS Resolution tends to lose them. We go back to the size of awards, where the issue, in essence, is that the NHS has to pay twice because of the way that the 1948 legislation was drafted.

At the end of the day, surely we need a thorough review of the whole issue of redress and clinical negligence. I can see that the Government do not yet accept the recommendations of the noble Baroness, Lady Cumberlege. In the end, we have to start with a clean sheet of paper to see if we can do better by patients, the NHS and all the individuals affected. Having said that, I beg leave to withdraw my amendment.

Amendment 67 withdrawn.

Lord Russell of Liverpool Portrait The Deputy Speaker (Lord Russell of Liverpool) (CB)
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We now come to the group consisting of Amendment 68. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this amendment to a Division must make that clear in debate.

Amendment 68

Moved by

68: After Clause 40, insert the following new Clause—

“Redress schemes

The Secretary of State must, by the end of the period of three months beginning with the day on which this Act is passed, bring proposals before Parliament to establish redress schemes for those avoidably harmed by—(a) hormone pregnancy tests,(b) sodium valproate, and(c) pelvic mesh.” Member’s explanatory statement

This new Clause would require the Secretary of State to create redress schemes for those who have already suffered avoidable harm related to the medicines and medical devices specified in the new Clause, and would thus implement one of the recommendations made in the report of the Independent Medicines and Medical Devices Safety Review.

Baroness Cumberlege Portrait Baroness Cumberlege (Con) [V]
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My Lords, it is interesting that these two amendments reflect each other, but I wanted them to be separate. The debate that we have had on the agency has been really interesting.

The noble Lord, Lord Hunt, has just talked about a further review of the whole system, which probably needs doing, but I am dealing all the time—through emails, letters and phone calls—with people who are suffering now. Rather than wait for a really good scheme, which I hope a redress agency would be, I feel that we should be compassionate and really understand how people are suffering today. They will suffer tomorrow. They have suffered for decades. It is time that they had some redress to help them in the very difficult and complicated lives that they lead, with huge suffering. It is not just the individual: it is the family and it is the children, especially with sodium valproate. One must think of the home. It is therefore important for society that we as a Government understand and are happy to supply some redress now.

I thank my noble friend Lord O’Shaughnessy, the noble Lord, Lord Hunt, and the noble Baroness, Lady Bennett, who have put their names to this amendment. I look forward very much to hearing what they have to say.

In the two and a half years that we spent travelling the country, listening to tragic stories from women and their families, there was absolutely no doubt in our minds that avoidable harm had been inflicted on those who openly, honestly and with great dignity told us their life stories. I have frequently mentioned what they and their families have told us, but I will spare your Lordships on this occasion because I do not need to reiterate it. Your Lordships know what we found. It is all in our report, First Do No Harm, if you want to dig a bit deeper. Hormone pregnancy tests, sodium valproate and surgical mesh are three interventions that have caused avoidable psychological harm in some patients. It is also clear that surgical mesh has caused significant physical harm and that sodium valproate has caused physical and neurodevelopmental harm.

Having listened to these ruined lives, we believe that the state and manufacturers have an ethical responsibility to provide discretionary payments to those who have experienced avoidable damage in these three interventions. Each of them should have its own scheme and tailored eligibility criteria. When we have, as I hope we will, a redress agency, these schemes can be subsumed into the agency.

I make it clear that these payments are not intended to cover the costs of services that are already available free of charge. I am thinking of healthcare and social security payments, and in some cases education for children. This is rather for other needs, which could include things such as travel to medical appointments—we have heard a lot about the costs of that—respite breaks or emergency payments, when a parent has had to stop working to cover the care needed for that child or members of the family.

Patients have waited far too long for redress, some for decades, and any scheme must be set up promptly, as soon as possible. However, it should be structured so that it can be incorporated into the redress agency in future. Individuals who obtain compensation through litigation or out-of-court settlements—and we have heard of some, particularly from Johnson & Johnson and the Scottish pelvic mesh settlement—will not need recourse to these schemes. It is over and above what is already supplied by the state or is totally inadequate. So we are not setting a precedent: ex gratia payments have made by the Government to those suffering from infected blood, for example, as I mentioned in the last debate, as well as variant CJD and other areas, where treatments have caused avoidable damage.

In responding to the report’s recommendations, the Patient Safety Minister, Nadine Dorries, said that our recommendation that these schemes should be established is still under consideration. I am very heartened by her words, which give me—and, much more importantly, those who are suffering—cause for hope that the Government will do the right thing.

I ask my compassionate and noble friend the Minister if he could give us more information on this. If it has not been ruled out of court, can he tell us what plans are made to ensure that these schemes become a reality, and very soon, because they are much needed? I beg to move.

Baroness Bennett of Manor Castle Portrait Baroness Bennett of Manor Castle (GP) [V]
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My Lords, I shall be brief, since I am following the powerful case put by the noble Baroness, Lady Cumberlege, for Amendment 68, to which I am pleased to attach my name, along with the noble Lords, Lord O’Shaughnessy and Lord Hunt. This is not a lesser amendment than Amendment 67 but a more limited one. As the noble Baroness said, agreeing Amendment 68 would not stop Amendment 67 from happening in future. The scheme for each individual could be rolled into a broader redress agency. I join her in welcoming the initial response to her report from the Government, which says that proposals such as that in Amendment 68 remain under consideration.

The case has been made—and I am not sure that I am allowed to do this post Brexit, but I note that in France the Government already pay into a fund for valproate damage. There are other cases around the world which reflect what already happens in other instances of medical disasters that have been acknowledged.

I commend the amendment to your Lordships’ House. I do not think that we will be pressing it to a vote tonight, but I hope that the consideration that the Government continue to give will turn into action very soon.

Lord O'Shaughnessy Portrait Lord O'Shaughnessy (Con) [V]
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My Lords, it is a privilege to be able to support and put my name to the amendment in the name of my noble friend Lady Cumberlege. As has so often been the case in this Bill, where she leads, others follow, and I entirely endorse everything that she and the noble Baroness, Lady Bennett, have said. My reason for supporting the amendment is simple: as my noble friend made clear today, there are tens of thousands of women, men and their families who are suffering from the impact of licensed medicines and medical devices that have been wrongly used.

My noble friend’s landmark review gives voice to so many people who have been ignored for too long; that is what gives it such moral power and makes the force of its arguments so irresistible. Within the final report of her review is a clear recommendation for ex gratia redress schemes to be established for those affected by the HPT, mesh and valproate scandals. To my mind, this recommendation is neither radical nor extraordinary: such schemes have been set up in the past—for the victims of thalidomide and contaminated blood. Indeed, this is a common-sense proposal, and it is urgent—because the suffering of so many continues to this day, as my noble friend pointed out.

I have spoken in the past of two women—Janet Williams and Emma Murphy—whose lives, and whose children’s lives, have been changed for ever by in utero exposure to sodium valproate. They were interviewed as part of a recent Channel 4 documentary on the challenges they face in day-to-day life, the guilt they have been made to feel and their struggle to be heard. Janet and Emma’s honesty and tenacity have been an inspiration to me since I met them, and I defy anyone to watch that programme and not be moved to tears.

I was also contacted recently by another lady, who has been harmed by mesh. Her name is Susan Morgan, and, with her permission, I convey her story. She described to me being on,

“a hideous journey that was thrust upon me without consent”,

suffering grievous, painful and irreparable damage due to a mesh that can now never be removed. Sadly, she has lost nearly everything in dealing with the consequences of this terrible, avoidable injury, and she asks only that

“the burden of fear and worry be removed so that I can find some peace”.

Therefore, I ask my noble friend the Minister: are the redress schemes proposed in the review of the noble Baroness, Lady Cumberlege, under serious consideration, as my honourable friend Nadine Dorries said in the other place earlier this week? I hope so. If so, when will they be introduced? Only a robust answer will be enough to satisfy those supporting this amendment. I close by imploring my noble friend to move quickly: these victims cannot wait any longer—their pain is real, and their need is urgent. Of course, a redress scheme will not change or right every wrong that has been done to Susan, Janet, Emma and thousands like them, but perhaps it might bring them some peace.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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Amendment 68, in the name of the noble Baroness, Lady Cumberlege, requires the Secretary of State

“to create redress schemes for those who have already suffered avoidable harm”

related to hormone pregnancy tests, sodium valproate and pelvic mesh. The Minister has told us that there will be no redress agency. The noble Lord spoke passionately about suffering without redress. A significant amount will need to be paid through NHS Resolution to the women affected by these three interventions. Who will ensure that the women affected receive proper recompense? As the noble Baroness, Lady Cumberlege, has said, they have had to pay out for travel for treatment and payment for carers, and they are seriously out of pocket for what they originally thought was standard, straightforward NHS treatment.

I fear that, if there is no scheme, the NHS will have to pay more than it would through a properly managed redress scheme. This and the previous amendment are powerful signals to the Government that they must act on this issue of redress. I hope that, in summing up, the Minister will be able to share the Government’s plans with us. If they have no plans, what would he suggest that these women should do? The noble Lord, Lord O’Shaughnessy, put the case very powerfully.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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I very much agree with the noble Baroness, Lady Jolly, that this afternoon we have given a powerful signal to the Government. Certainly, from these Benches, we very much support her amendment and her efforts to get redress for people who were grievously damaged by procedures undertaken in the National Health Service.

The noble Lord, Lord O’Shaughnessy, talked about one woman’s experience of the impact of surgical mesh, and the huge pain and damage inflicted. I was very grateful to him when I had a Question on surgical mesh, which he answered, as watching it from the Gallery were a group of women from Sling the Mesh, who I had brought in. He gave a lot of time to them afterwards; perhaps it paved the way to the inquiry established under the chairmanship of the noble Baroness, Lady Cumberlege. Like him, meeting those women and talking to them about what they had suffered made me absolutely determined to do anything I could to raise the issue.

We were very fortunate that the noble Baroness, Lady Cumberlege, accepted the chairmanship of this inquiry, given the quality of her team and the extraordinary lengths to which she went to produce its very fine report. Anyone who has met the people involved and listened to the suffering that they have undertaken is left with a feeling that it is awful. Something must be done for them and I very much hope that the Minister will be sympathetic.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, what a moving and heartrending set of speeches on a very important amendment, which I take extremely seriously. It raises the issue of establishing a specific redress scheme for those medicines and medical devices considered by the review: sodium valproate, the use of pelvic mesh and hormone pregnancy tests. The stories in the review, which have been told here this afternoon, are extremely moving on every single level. I cannot but pay testimony to those who have conducted the campaign and given evidence about their own personal suffering—and who, quite reasonably, look for some form of redress.

I completely understand why my noble friend Lady Cumberlege has raised this issue and why she and other noble Lords have asked for progress on her review. I also completely understand the importance that she and her team attach to this recommendation. They rightly spent considerable time drawing on a wide range of complex evidence before reaching their recommendations. The Government feel it is only right that we also give that incredibly helpful report our full consideration before responding to its recommendations. I remind noble Lords about the timeline for a response to these kinds of reviews, which we have gone over before. I think we are well within the normal response time for such reviews, Covid notwithstanding.

In order to determine whether redress schemes should be established, the Government have a duty to ensure that the final decision is fair for patients and for citizens more generally—not just the patients and citizens affected by the three treatments that my noble friend Lady Cumberlege alluded to, but all citizens and patients; you cannot favour someone over another. This requires extremely careful consideration of any proposed scheme but also the precedent that any decision sets for future policy-making. We spoke in the previous debate about the £83 billion problem. That kind of financial impact has a profound bearing on this kind of discussion.

My noble friend Lady Cumberlege asked when the Government will respond to her review. The Written Ministerial Statement of 11 January sets out the Government’s interim response. I emphasise to anyone who may be confused that it is just an interim response to the report of the IMMDS review. We currently plan to respond to the report later this year; that is a commitment made by my honourable friend Nadine Dorries, the Minister in the other place. The report took over two years to compile and we therefore consider it absolutely vital for the sake of patients, especially those who have suffered greatly, to give this recommendation the full consideration it deserves.

The noble Baroness, Lady Bennett, asked why the Government have established redress schemes in the past but are unwilling to commit to the schemes proposed in this amendment. I think that one is too early to call. It is right and proper for the Government to carefully consider proposals for redress schemes on their own merits to ensure a fair outcome for patients, and citizens more generally.

The noble Lord, Lord Hunt, asked why it is taking so long to consider the recommendations. The report took over two years to compile, so we need to consider it very carefully. I do not want to use the Covid pandemic as a catch-all excuse, but the reality is that our hospitals are overwhelmed; the Department of Health has doubled in size in the last six months and even with that it is overworked and overstretched. The resources and capacity to respond to this kind of report are, I am afraid, distracted on other matters of national health crisis. However, I reassure the noble Baroness, Lady Cumberlege, and other noble Lords who have spoken that work is under way and we will set out the Government’s response to this report later this year.

I could not help but be enormously moved by the testimony of the noble Lord, Lord O’Shaughnessy. In essence, he asked why the Government do not recognise that the patients highlighted in the report of the medicines and medical devices review suffered unavoidable harm, particularly those who took hormone pregnancy tests. The Government absolutely do regard their suffering most seriously indeed and are considering the contents of the report. I am restricted in what I can see regarding hormone pregnancy tests in particular, given the live litigation, but I want to make clear the Government’s position regarding a causal association between HPTs and adverse outcomes in pregnancy. The scientific evidence has been reviewed on a number of occasions, most notably by the Commission on Human Medicines expert working group on HPTs, which, as noble Lords will know, reporting its findings in November 2017. The EWG concluded that the scientific evidence did not support a causal association and that remains the Government’s position.

Just as Covid-19 impacted the publication of the report, it has also had an impact on the timing of our response. I know, and recognise, that that is enormously frustrating. The Government are committed to responding and I assure the noble Baroness, Lady Cumberlege, that work is under way. Our upcoming full response will address recommendation number four. We are moved by the stories; I am totally and utterly sympathetic to the situation that the patients affected by these conditions find themselves in on a day-to-day basis. They are still living through it today. I would like to regard myself as a compassionate person, but it is not appropriate to make policy on this kind of matter through primary legislation. For that reason, I ask my noble friend to withdraw her amendment and await the Government’s full response to her report.

Baroness Cumberlege Portrait Baroness Cumberlege (Con) [V]
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My Lords, I am so grateful to noble Lords who have taken part in this debate. It has been quite short, but it is very important. As the noble Baroness, Lady Bennett, said in the previous debate on the agency, she has been involved with this Bill in a way that she did not anticipate. She has been such a stalwart, coming to my rescue on occasions, and supporting so much of what has been in the Bill from other sources. I thank her for all of that. The noble Lord, Lord O’Shaughnessy, made a powerful speech about the individuals he has met. We know Susan Morgan well; we have worked with Janet and Emma and many others who have led their own organisations. We think of patient groups as being a few people who got together—when we did not have lockdown—to have coffee and just discuss life generally. That is not the case.

One of the groups I know has 8,500 members—from all over the world, in fact. Other groups have an equal number of members, or numbers of that order. So these are important organisations. They know what it is to have real research. They come up with not just experiences; they beaver away at all our institutions, they look at what they are producing and they challenge. They are so valuable. In the way they work, when they are people who are in considerable pain—very often, they have complicated and difficult lives, having to deal with constant pain—they are thinking of others all the time. That really is so uplifting.

I thank the noble Lord, Lord Hunt, so much for, again, a very interesting debate and for talking about the powerful signal that the Government should have got from the debate. I was very interested in his full and comprehensive points on the agency. Eventually, the two will be linked, I think, but at the moment, here and now, we should be ameliorating the terrible difficulties that these damaged people must endure.

I say this to my noble friend Lord Bethell: this Bill has actually been quite extraordinary, in a way. I congratulate him on the way in which he has dealt with it and on the number of amendments that he has put forward. I know that they often need a lot of negotiating, not only with the department but beyond it as well. I thank him for that, for listening to us, for his patience, for his consideration, for his views and for the work that he has to carry out, which we do not always see. He is also right to mention coronavirus. Many times, I have put the House of Lords on on the television and seen the noble Lord again at the Dispatch Box. It is not just about his compassion; it is about the resilience that he has had to have to carry out his duty. I thank him very much for that.

Finally, I would like to hear some dates. I have run a company. I know what it is like when you have to deliver. You have to deliver; otherwise, you go out of business. You have serious competition—you have to keep your eye on them—but you absolutely must meet deadlines. A bit of that rigour in government would be very welcome. There are tremendous tragedies that have to be dealt with, of course. There are huge concerns, especially with the virus. I understand that. I accept that having to make decisions on all sorts of very difficult issues takes a huge amount of energy and thought. However, as I said earlier, in this case, these people have been suffering for decades. It is time that they got justice. A bit of justice in terms of ameliorating the terrible suffering that they endure through some finance would be terribly important, especially for us as a Government to show that we are not only resilient but compassionate. It is time that we did that.

I thank noble Lords for this debate and beg leave to withdraw the amendment.

Amendment 68 withdrawn.

Baroness Barker Portrait The Deputy Speaker (Baroness Barker) (LD)
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My Lords, we now come to the group beginning with Amendment 69. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in this group to a Division must make that clear in debate.

Amendment 69

Moved by

69: After Clause 40, insert the following new Clause—

“Northern Ireland and regulatory divergence

(1) The Secretary of State must make an annual report to Parliament on areas of regulatory divergence between Northern Ireland and the rest of the United Kingdom in matters covered by this Act.(2) Where the Secretary of State has identified areas of potential regulatory divergence between Northern Ireland and the rest of the United Kingdom, the Secretary of State must set out plans to mitigate the adverse effects of such divergence in the annual report.” Member’s explanatory statement

This new Clause would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK.

Baroness Wheeler Portrait Baroness Wheeler (Lab)
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My Lords, I am moving the amendment in the name of my noble friend Lady Thornton, which revisits the issue of regulatory divergence between Northern Ireland and the rest of the UK in matters covered by the Bill, and the need for an annual report to Parliament on this matter. The amendment also places an obligation on the Secretary of State specifically to report on plans to mitigate its adverse effects.

The Government will know that there is huge concern on this issue, strongly reflected in our Committee debates through our amendment and an amendment from the noble Lord, Lord Patel, calling for an annual report. The issue was also raised in consideration of the medicines and medical devices statutory instruments before Christmas and in the deliberations on the Northern Ireland protocol and the Trade Bill.

However, I welcome the Government’s amendments in this group to Clause 44, which extend reporting obligations to apply in respect of regulations made by a Northern Ireland department and to regulations under Clause 18 on the health and social care information systems. In particular, Amendment 85 specifies a Northern Ireland department and the Northern Ireland Assembly as an appropriate legislature and relevant authority in relation to regulations made under the Act.

We also welcome the Government’s acceptance of the arguments put forward by noble Lords and the Delegated Powers and Regulatory Reform Committee on the need for parliamentary scrutiny before and after delegated powers are exercised, and the introduction of a two-yearly reporting requirement in large parts of the Bill. I note that government briefings commit to the reports containing a summary of how the regulations have operated over the period under consideration, including any concerns from stakeholders and the Secretary of State’s response, as well as outlining plans for further changes.

I am speaking also on Amendment 78, in the name of my noble friend Lady Thornton, supported by the noble Baroness, Lady Jolly, which in Committee we submitted for inclusion in the provisions under the previous Clause 41 on consultation but which now amends the reporting requirements in Clause 44. Our amendment specifies cohorts that must be consulted in preparation of a report to Parliament, including patients and their representatives, and other key industry stakeholders from healthcare, pharmaceuticals, veterinary and medical research organisations, and healthcare providers and regulators.

Once again, we come back to the importance of ensuring that patients and end users are part of and involved in consultation and reporting relating to existing and potential new medicines, veterinary medicines and medical devices. The stark lessons from the Cumberlege review, the Ockenden review and many other reviews that we have had are that patients’ voices must be heard.

For the record, we feel that the Government’s reporting requirements amendment falls short of providing the reassurances that we sought in Committee, because the relevant authority still has ultimate discretion over whom it consults. This could mean that any report could be skewed or biased by those chosen at the discretion of the Government. That is why our Amendment 78 details the key stakeholders that should be consulted.

In response to that amendment, I am sure that the Minister will come back to the often stock response to the inclusion of specific stakeholders in the Bill, namely that this would be too rigid and burdensome, and would inadvertently rule out contributions from those accidentally not listed. However, in the context of a very complex Bill and the history of often poor communications with stakeholders, I urge the Minister, if she is not happy with our list, to consider a broader amendment at Third Reading that would provide the reassurance that is clearly needed.

I come back to the key issue of regulatory divergence between Northern Ireland and the UK and reporting on this matter. Marketing, authorisation and trading processes on medicines and medical devices between Northern Ireland, the EU and the UK are complex issues, and many remain unclear. The Northern Ireland protocol and the provision for ongoing discussions to resolve key issues mean continued uncertainty for businesses, health services and patients. In this context, an annual rather than a two-yearly report to Parliament would have been more appropriate, particularly highlighting the problems arising from regulatory divergence, and the plans and progress on addressing them.

This is not the time or occasion to go into detail on the issues covered in Committee. However, in Committee the noble Lord, Lord Patel, highlighted many key matters and concerns arising from the MHRA’s guidance on regulating medical devices from 1 January 2021, issued in September 2020, before Committee. I know that the MHRA has been pretty busy of late with the vital Covid-19 vaccination authorisation, but can the Minister tell us when it is envisaged that the MHRA guidance will be updated and reissued?

We have sought and been given reassurances from the Minister that the MHRA’s staffing, resourcing and capacity have been substantially increased to meet its new obligations. It is a much-respected body, but, as we have said, it faces huge challenges under its new role, and we suspect that the £13 million additional funding provided to it by the Government up to the end of March 2021 will be just a pump-priming starter in the light of all that needs to be done. The Minister’s reassurances over the MHRA’s strategic development plans and the Government’s commitment to further funding are welcome, but this is something that we will need to keep a close watch on. I beg to move.

Lord Patel Portrait Lord Patel (CB) [V]
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My Lords, from the outset it has been clear that there was a potential for regulatory divergence in Northern Ireland from the rest of the UK for medicines and veterinary medicines, since they are referred to separately in the Bill as reserved matters in Northern Ireland. However, it has been made clear in the last quarter of 2020 that interaction with the Northern Ireland protocol makes that divergence inevitable for medical devices as well.

Guidance published by the MHRA in October, which I referred to previously, and statutory instruments laid before Parliament in the final months of 2020, set out two different systems of market authorisation and registration, among other issues, and distinguished between the Northern Ireland and Great Britain markets for medical devices and medicines alike. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland, while CE marks will cease to be recognised in the Great Britain market from July 2023 unless the products in question are from manufacturers based in Northern Ireland.

There are essentially two paths for manufacturers based in Northern Ireland to bring a medical device product into the Great Britain and Northern Ireland markets. The first is to go through UK-based approved bodies for their assessment and market authorisation, which will be approved for both the Great Britain and Northern Ireland markets but will not be recognised in the EU. The second is to submit an application to approved or notified bodies in the EEA to gain a CE mark and thus access to the markets of Great Britain, Northern Ireland and the EU without further needing to apply to a UK body for approvals for the Great Britain market.

By contrast, manufacturers based in Great Britain will need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland, but will need to undertake the separate task of setting up an EU-based responsible person and apply separately for a CE mark in the EU. It appears that the recognition of a CE mark on a medicine or device coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. What is not clear is the extent to which this dual system between Northern Ireland and the rest of the UK will diverge in substance.

For these reasons and many others, the Government should clarify the position. The amendment would provide greater transparency on potential regulatory divergence, with a commitment to mitigate it where possible. Of course, I will not be surprised if the Minister does not accept the amendment, and neither do I think the noble Baroness will divide the House on it, but whether we agree with it or not, I hope the Minister will agree that somebody has to have some way to recognise what this divergence will do. Who will that be? Would she agree that this will be needed in due course?

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, it is a great pleasure to follow the noble Lord, Lord Patel.

What does one say to the people of Northern Ireland? They voted to remain in the EU, their vote was ignored by the DUP, and they have been duped by the Government, who continue to deny that there is a border in the North Sea—when today we are debating ample evidence of such a border. As the noble Lord, Lord Patel, identified, the distinction the MHRA is now having to make between the EU market, the British market and the market for Northern Ireland, as well as the bureaucracy involved and the cost for British-based companies, is undeniable.

These two very modest amendments seek to ensure that Parliament gets a regular report on how this is working in relation to medicines and medical devices regulations, and that various bodies should be consulted. However, over and above that, the Minister owes the House some explanation of how we have ended up in this bizarre situation, where Northern Ireland, which wanted to be in the EU and wanted to be listened to, has ended up in this rather parallel existence, with a border down the North Sea, food shortages in its supermarkets, and in a right mess. I hope the Minister can answer that.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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My Lords, the amendments in this group relate to reporting requirements and consultation. The noble Lord, Lord Hunt of Kings Heath, has just put the political case very clearly; the noble Lord, Lord Patel, looked at the technical and regulatory issues; I will look at the practical issues around health services on the island of Ireland.

Amendment 69 from the noble Baroness, Lady Thornton, would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK. Can the Minister tell us when the first report would be published, whether the Republic would be part of this consultation, and if not, why not? The noble Baroness, Lady Thornton, and I tabled this amendment to require the relevant authority to consult with patients and healthcare and industry stakeholders when preparing a report under Clause 44.

Divergence is inevitable. The situation for healthcare on the island of Ireland could become extremely complicated. In the past, patients have travelled north or south to receive treatment wherever the appropriate treatment is available. Will citizens from Northern Ireland and the Republic have to use the new GHIC, or do the Government have an agreement with the Republic so that business as usual will be the new norm—no change?

Government Amendments 75 to 77 and 79 to 85 extend the reporting requirements under Clause 44 so that they apply to regulations made by a Northern Ireland department and in respect of regulations under Clause 18. However, we cannot ignore the Republic when we talk about health in Ireland.

Baroness Penn Portrait Baroness Penn (Con)
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My Lords, we now turn to the way in which reports are prepared and made on the exercise of the regulatory-making powers in the Bill.

Amendment 69 in the name of the noble Baroness, Lady Thornton, would make changes to the existing requirement to report, introduced in Grand Committee. It proposes that an additional report be made by the Secretary of State to Parliament, this time on regulatory divergence with Northern Ireland introduced as a consequence of future regulations. I understand the noble Baroness’s intent. I heard the concerns raised in Grand Committee about the potential impact of regulatory divergence. The Government take that seriously. However, I will explain why this amendment is not necessary to address it.

As a reminder, the amendments made in Grand Committee provided for a reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 9(1) and 14(1)—one that was both forward- and backward-looking. Those reports must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. It will necessarily draw Parliament’s attention to regulations that have been made.

Parts 1 and 2 of the Bill relating to human and veterinary medicines are matters transferred to Northern Ireland. As such, legislative consent was secured for the Bill earlier in its passage, but as amendments were made during Grand Committee, further legislative consent was sought. At Northern Ireland’s request, government Amendments 75, 76, 79, 80, 81, 82 and 85 in this group replicate the existing reporting obligation for Northern Ireland. This means there will be a report laid in Parliament every two years on what new regulations have been made and any plans to make further related regulations. A separate report will be laid before Northern Ireland. Between our report and the report laid before the Northern Ireland Assembly, any areas of regulatory divergence between the UK and Northern Ireland regulatory regimes will be made clear. Therefore, it would be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for human and veterinary medicines and medical devices.

In addition, where there are concerns about the implementation of the protocol and its impact on patients and animals in Northern Ireland, there are formal channels in place. Officials meet regularly in the Ireland/Northern Ireland Specialised Committee. The Specialised Committee reports to the Withdrawal Agreement Joint Committee and provides advice on decisions to be taken by the Joint Committee under the protocol.

Before the end of the transition period, we raised with the EU through its specialised committee the issue of the falsified medicines directive and regulatory importation requirements for medicines moving from Great Britain to Northern Ireland after 1 January. We agreed with the EU a pragmatic one-year, time-limited approach to implementing these regulations that ensures no disruption to the flow of medicines to Northern Ireland. I say this to reassure noble Lords as to the effectiveness of those mechanisms under the protocol.

Noble Lords made a number of comments on the issue of regulatory divergence and I thought I would dwell on it briefly. The noble Lord, Lord Patel, gave a good description of future provisions regulating devices between Northern Ireland and Great Britain. He is wrong to say that the Bill lays out Northern Ireland separately because of this. It does so because medicines and veterinary medicines in Northern Ireland are the responsibility of the Northern Ireland Assembly and are therefore devolved. However, divergence may be an issue for the future, not least because the EU may change its own regulatory regime under the protocol that Northern Ireland will follow, and the UK may make changes here as well.

To reassure noble Lords, we have agreed a standstill period of two years for medicines and veterinary medicines and two and a half years for devices, during which we will continue to recognise EU regulations in these areas. This means that there is time for adequate consultation on regulations made under this Bill, for consultation on any future changes and for these mechanisms to operate properly. Divergence may be a matter for the future, but we have reporting to Parliament and public consultations on any regulations made under this Bill to address those questions.

The noble Lord, Lord Hunt, asked how we ended up here. I think that question is slightly wider than the purview of this Bill. I have quite a lot of lived experience of how we ended up here and I do not intend to recount that now.

I hope the amendments I have referred to in the name of my noble friend Lord Bethell, coupled with these other, existing arrangements, make the amendment tabled by the noble Baroness unnecessary.

Government Amendments 77, 83 and 84, also in the name of my noble friend, are made in the same light of expanding reporting obligations. In the interests of transparency and scrutiny, amendments have been made to extend the obligation to include regulations made under Clause 18—the regulation-making power in relation to the medical devices information system. We have made this change to make clear our absolute commitment to transparency, to giving Parliament continued visibility, to understanding the assessment made of any proposals or concerns raised as to how the regulations have been working, and to ensure that the regulation-making powers specifically containing provisions that may ensure or affect device safety and post-market surveillance are treated equally.

The noble Baroness, Lady Thornton, again seeks to test us on the preparation of the reports with Amendment 78, which would add a list of stakeholders to be consulted under the obligation. Again, this is unnecessary. If her concern is that the stakeholders listed may be ignored, I reassure her that the reports must summarise concerns raised, or proposals for change made, in relation to regulations enforced during the reporting period. That information will come from engagement with relevant stakeholders. Therefore, I do not think it necessary or proportionate to add a list of specific stakeholders to be consulted for each report, which will be a summary of public consultation that will already have been responded to.

I must say to the noble Baronesses, Lady Jolly and Lady Wheeler, that the Government will not return to this issue at Third Reading, so if they wish to press it, now is the moment. However, with the number of avenues already available, I hope that they are reassured that their amendment is not needed and will not wish to press it.

Baroness Wheeler Portrait Baroness Wheeler (Lab)
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I thank the Minister for her response. I shall not go into details now, but we know that there will be significant issues of regulatory divergence, as the noble Lord, Lord Patel, my noble friend Lord Hunt and the noble Baroness, Lady Jolly, have stressed. We know that it is an issue about which we will have to be very watchful. In the circumstances we currently face, an annual report would have aided the process of working through the issues and encouraged understanding of the plans to address them and the progress being made.

On Amendment 78, the Minister is obviously not going to oblige me with a tidying-up amendment at Third Reading to underline the importance of the patient voice. I think that is a mistake; it would have been helpful. However, I beg leave to withdraw Amendment 69.

Amendment 69 withdrawn.

Clause 41: Power to make consequential etc provision

Amendments 70 and 71

Moved by

70: Clause 41, page 25, line 43, at end insert—

“(1) This section applies to regulations under a power in Part A1, 1, 2 or 3, apart from regulations under paragraph 9 of Schedule 1.”Member’s explanatory statement

This amendment is consequential on the Minister’s amendments to insert a new Part before Part 1 and a new Clause after Clause 18, and would enable regulations under powers in those provisions to make consequential and other connected provision.

71: Clause 41, page 25, line 44, leave out “Regulations under sections 1(1), 9(1), 14(1) and 18(1)” and insert “The regulations”

Member’s explanatory statement

See the explanatory statement for the other amendment to Clause 41 in the Minister’s name.

Amendments 70 and 71 agreed.

Clause 43: Consultation

Amendments 72 to 74

Moved by

72: Clause 43, page 26, line 13, after “Part” insert “A1,”

Member’s explanatory statement

This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety. It requires the Secretary of State to carry out a public consultation before making regulations about the Commissioner.

73: Clause 43, page 26, line 22, leave out “1(2) and (3), 9(2) and (3) or 14(2) and (3)” and insert “1, 9 or 14”

Member’s explanatory statement

This amendment would require a consultation in relation to regulations under Clause 1, 9 or 14 to include a summary of the assessment of the person making the regulations of all matters mentioned in Clause 1, 9 or 14 (as the case may be), including new subsections (3A), (3A) and (4) inserted by amendments in the Minister’s name into Clauses 1, 9 and 14 respectively (overall assessment of risk-benefit analysis).

74: Clause 43, page 26, line 39, leave out from “to” to “, the” on line 40 and insert “any other regulations”

Member’s explanatory statement

This amendment provides for the definition of “relevant authority” to apply in relation to regulations under new Part A1 (the Commissioner for Patient Safety) and the new Clause tabled in the Minister’s name to appear after Clause 18 (advisory committee), as well as in relation to other regulations under Part 1, 2 or 3.

Amendments 72 to 74 agreed.

Clause 44: Reporting requirements

Amendments 75 to 77

Moved by

75: Clause 44, page 26, line 43, leave out “Secretary of State must lay before Parliament” and insert “relevant authority must lay before the appropriate legislature”

Member’s explanatory statement

This amendment and the other amendments to Clause 44 in the Minister’s name extend reporting obligations under Clause 44 so they apply in respect of regulations made by a Northern Ireland department and in respect of regulations under Clause 18.

76: Clause 44, page 27, line 1, leave out “Secretary of State” and insert “relevant authority”

Member’s explanatory statement

See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

77: Clause 44, page 27, line 1, leave out “and 14(1)” and insert “, 14(1) and 18(1)”

Member’s explanatory statement

See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

Amendments 75 to 77 agreed.

Amendment 78 not moved.

Amendments 79 to 85

Moved by

79: Clause 44, page 27, line 3, leave out “Secretary of State” and insert “relevant authority”

Member’s explanatory statement

See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

80: Clause 44, page 27, line 4, leave out “Secretary of State” and insert “relevant authority”

Member’s explanatory statement

See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

81: Clause 44, page 27, line 8, leave out “Secretary of State’s” and insert “relevant authority’s”

Member’s explanatory statement

See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

82: Clause 44, page 27, line 9, leave out “Secretary of State” and insert “relevant authority”

Member’s explanatory statement

See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

83: Clause 44, page 27, line 10, leave out “or 14(1)” and insert “, 14(1) or 18(1)”

Member’s explanatory statement

See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

84: Clause 44, page 27, line 13, leave out “or 14(1)” and insert “, 14(1) or 18(1)”

Member’s explanatory statement

See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

85: Clause 44, page 27, line 14, at end insert—

“(5) In this section—“appropriate legislature” means—(a) in relation to a report of the Secretary of State, Parliament;(b) in relation to a report of a Northern Ireland department, the Northern Ireland Assembly;“relevant authority” means—(a) in relation to regulations made under section 1(1) or 9(1) by the Secretary of State (whether acting alone or jointly with a Northern Ireland department), the Secretary of State; (b) in relation to regulations made under section 1(1) or 9(1) by a Northern Ireland department (whether acting alone or jointly with the Secretary of State), the Northern Ireland department;(c) in relation to regulations made under section 14(1) or 18(1), the Secretary of State.”Member’s explanatory statement

See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

Amendments 79 to 85 agreed.

Clause 45: Procedure

Amendments 86 and 87

Moved by

86: Clause 45, page 27, line 16, after “Part” insert “A1,”

Member’s explanatory statement

This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety.

87: Clause 45, page 27, line 24, after “Part” insert “A1,”

Member’s explanatory statement

This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety.

Amendments 86 and 87 agreed.

Amendments 88 to 90

Moved by

88: Clause 45, page 27, line 39, column 2, leave out paragraph (b)

89: Clause 45, page 28, line 10, column 2, leave out paragraph (b)

90: Clause 45, page 28, leave out line 12

Amendments 88 to 90 agreed.

Amendment 91

Moved by

91: Clause 45, page 28, line 12, after “Part” insert “A1,”

Member’s explanatory statement

This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety. It provides for regulations about the Commissioner to be subject to the draft affirmative procedure.

Amendment 91 agreed.

Amendments 92 and 93

Moved by

92: After Clause 45, insert the following new Clause—

“Super-affirmative procedure

(1) For the purposes of section 1(1), section 9(1), section 14(1) and section 18(1), the “super-affirmative procedure” is as follows.(2) The Secretary of State must lay before Parliament—(a) a draft of the regulations, and(b) a document which explains the draft regulations.(3) Where a draft of the regulations is laid before Parliament under subsection (2), no statutory instrument containing the regulations is to be laid before Parliament until after the expiry of the 30-day period. (4) The Secretary of State must request a committee of either House whose remit includes health, science or technology to report on the draft regulations within the 30-day period.(5) In preparing a draft statutory instrument containing the regulations, the Secretary of State must take account of—(a) any representations,(b) any resolution of either House of Parliament, and(c) any recommendations of a committee under subsection (4), made within the 30-day period with regard to the draft regulations.(6) If, after the 30-day period, the Secretary of State wishes to make regulations in the terms of the draft or a revised draft, he or she must lay before Parliament a statement—(a) stating whether any representations, resolutions or recommendations were made under subsection (5);(b) giving details of any representations, resolutions or recommendations so made; and(c) explaining any changes made in any revised draft of the regulations.(7) The Secretary of State may make a statutory instrument containing the regulations (whether or not revised) if, after the laying of the statement required under subsection (6), a draft of the instrument has been laid before and approved by a resolution of each House of Parliament.(8) In this section, reference to “the 30-day period” in relation to any draft regulations is to the period of 30 days beginning with the day on which the original draft regulations were laid before Parliament.(9) For the purposes of subsection (8) no account is to be taken of any time during which Parliament is dissolved or prorogued or during which either House is adjourned for more than four days.”

93: After Clause 45, insert the following new Clause—

“Super-affirmative procedure: Northern Ireland

(1) For the purposes of section 1(1), section 9(1), section 14(1) and section 18(1), the “super-affirmative resolution procedure” in the Northern Ireland Assembly is as follows.(2) The Department must request a committee of the Assembly whose remit includes health, science or technology to report on the draft order within the 30-day period.(3) A Northern Ireland Department must take account of—(a) any representations,(b) any resolution of the Assembly, and(c) any recommendations of a committee under subsection (2), made within the 30-day period.(4) If, after the 30-day period, the Department wishes to make an order in the terms of the draft, it must lay before the Assembly a statement—(a) stating whether any representations were made under subsection (3)(a); and(b) if any representations were so made, giving details of them.(5) The Department may after the laying of such a statement lay before the Assembly for approval by affirmative resolution the draft order in its initial form, or a revised draft order together with an explanation of the changes made.(6) In this section, reference to the “30-day period” in relation to any draft order is to the period of 30 days beginning with the day on which the original draft order was laid before the Assembly.(7) For the purposes of subsection (6) no account is to be taken of any time during which the Assembly is dissolved or adjourned for more than four days.”

Amendments 92 and 93 agreed.

Clause 47: Commencement

Amendments 94 to 96

Moved by

94: Clause 47, page 30, line 2, at end insert—

“(ba) section 5(4),”Member’s explanatory statement

This amendment would commence the definition of “human medicines provision” from the day on which the Bill is passed.

95: Clause 47, page 30, line 10, at end insert—

“(za) Part A1,”Member’s explanatory statement

This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety. It provides for those amendments to come into force two months after the Act is passed.

96: Clause 47, page 30, line 14, leave out “section 18” and insert “Chapter 2 of Part 3”

Member’s explanatory statement

This amendment is consequential on the Minister’s amendment to insert a new clause after clause 18, in Chapter 2 of Part 3, and provides for the new clause to come into force two months after the Bill is passed.

Amendments 94 to 96 agreed.

In the Title

Amendment 97

Moved by

97: In the Title, line 1, at beginning insert “Make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices;”

Member’s explanatory statement

This amendment would add a limb to the long title in relation to the new provisions tabled in the Minister’s name for the purpose of establishing a Commissioner for Patient Safety.

Amendment 97 agreed.

Medicines and Medical Devices Bill

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

(1 month, 3 weeks ago)

Lords Chamber

Read Hansard Text
Department of Health and Social Care

Report (1st Day)

Relevant documents: 19th and 33rd Reports from the Delegated Powers Committee, 10th Report from the Constitution Committee

Amendment 1

Moved by

1: Before Clause 1, insert the following new Clause—

“PART A1THE COMMISSIONER FOR PATIENT SAFETYEstablishment and core duties etc

(1) The Secretary of State must appoint a Commissioner for Patient Safety (referred to in this Part as “the Commissioner”) to exercise the functions set out in this Part in relation to England.(2) The Commissioner’s core duties are to—(a) promote the safety of patients with regard to the use of medicines and medical devices, and(b) promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.(3) The Commissioner is not to be regarded as the servant or agent of the Crown or as enjoying any status, immunity or privilege of the Crown.(4) Schedule (Further provision about the Commissioner for Patient Safety) makes further provision about the Commissioner.”Member’s explanatory statement

This amendment inserts a new Clause which provides for the creation and core duties of a Commissioner for Patient Safety in relation to medicines and medical devices in England. The new Clause and the Schedule which it introduces would form a new Part, to appear before Part 1.

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell)
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My Lords, patient safety is very much at the heart of the Bill, and while we have an enormous amount to get through this afternoon, I beg the Chamber’s forbearance if I talk in some detail about this extremely important amendment. Patient safety is the golden thread that runs through this entire Bill. Safety has been our guiding force in amendments that have made it to the Bill, from the changes to decision-making on regulatory change and the new safety lock amendment—which we will debate later—to the enforcement powers for medical devices to make clearer what the MHRA can do to take action, through to the medical devices information system.

The Government have heard the calls, including the strong cross-party support, to establish an independent patient safety commissioner for the health service in England. Of course, this was the centrepiece recommendation of the Independent Medicines and Medical Devices Safety Review helmed by my noble friend Lady Cumberlege, to whom I pay profound tribute for her tireless championing on behalf of patients. I am delighted that Amendment 1 in my name—with which it is convenient to debate Amendments 54, 65, 70 to 72, 74, 86, 87, 91, 95 and 97—delivered upon that recommendation. These amendments provide for an independent advocate to champion the safety of patients. The patient safety commissioner will promote their interests and those of other members of the public in relation to the safety of medicines and medical devices.

We acknowledge that the patient’s voice can advance safe care and system improvements but that it needs to be strengthened, as explained in my noble friend’s review published six months ago. Listening to patients is central to preventing the kinds of issues which that review brought so clearly into focus. If we do not strive to listen to patients, their families and to staff, we limit our ability to learn from mistakes, be innovative and continually improve. I pay testament to the extensive listening and the passionate advocating by my noble friend, her supporters and all patient groups.

Patient safety is a system-wide concern. It cannot be tackled by a single individual but needs to be rooted in all the branches of our health system. Good progress has been made: for example, we are improving system-wide learning through measures such as the Healthcare Safety Investigation Branch and the implementation of the 2019 NHS Patient Safety Strategy with our National Director of Patient Safety, Dr Aidan Fowler, in charge. That strategy has been listening to patients.

Staff are also encouraged and protected to speak up if they have concerns about anything they believe is harming the services their organisations deliver or commission. They are supported by the NHS People Plan, which envisages a health service that is compassionate and inclusive, not hierarchical, and where staff are listened to. The Government’s emphasis on patient safety will also be reinforced by the establishment of a new patient safety programme board. The board will take an overview—with pace and rigour—of measures and actions across the health system to improve patient safety.

The Government fully support sharpening our focus on the safety of NHS-funded services to patients and the public. We accept that the patient safety system needs to get better at identifying issues and listening to patients’ experiences of avoidable harm. Better co-ordination across and between regulators and other oversight bodies is also needed.

A patient safety commissioner will help us to champion the views of people who have been harmed by treatments provided by the health service. He or she would reinforce a culture of humility, openness and learning. The role is essentially about prioritising the insights of patients as a vital source of learning.

The Government’s amendment puts this new part of the Bill first. Amendment 1 provides for the appointment by the Secretary of State of a patient safety commissioner who is an independent statutory officeholder funded by the Department of Health and Social Care. It sets out the commissioner’s core duties, which are to promote both the safety of patients and the importance of ensuring that they are heard.

Patient engagement will be integral to the role of the commissioner. Proposed new Schedule A1 outlines the ways in which the commissioner must inform, consult and involve patients. This will ensure that patients’ concerns are being heard and that the work of the commissioner has focus and relevance for the people he or she is being set up to serve.

We have reflected carefully on the patient safety commissioner model set out by my noble friend’s comprehensive report. We agree on the importance of the commissioner’s role; it is a critical new part of the map of patient safety. But there are other areas of significant importance to the Government. The commissioner is one part of the whole system—the fundamental change that it required to tackle unsafe care and empower patients. A step change is required in how the health service transforms itself in a joined-up way to put patient safety at its core. Significantly, the introduction of the commissioner should not create overlap or confusion within that health service architecture, thereby reducing the potential to deliver patient safety improvements for patients. Indeed, my noble friend’s report rightly made it clear that the duplication of the roles of other regulatory bodies should be avoided.

In view of this, the patient safety commissioner will not act as an ombudsman. He or she will not carry out functions in pursuit of specific cases. But they can consider individual cases in their role as an overarching advocate for all patients and of making thematic and systemic recommendations. These areas are where we believe the commissioner can have greatest impact.

We have also given the patient safety commissioner deliberately intrusive powers, as called for by my noble friend Lady Cumberlege. He or she will be empowered to request and share information from relevant public authorities or a “relevant person”, meaning anyone providing health care, in relation to medicines and medical devices in England. The commissioner’s ambit will cover both the public and the independent sector.

Where my noble friend and I differ is on the process of the appointment and sponsorship of the commissioner. The patient safety commissioner will be appointed by the Secretary of State for Health and Social Care and funded by the Department of Health and Social Care. It is absolutely right that this should be the case. For example, the Secretary of State is able to initiate action on reports and understands, and has strategic oversight of, the system the commissioner is looking at.

Some noble Lords have expressed concerns about how such a commissioner might maintain their independence, but I believe that such concerns are unfounded. I am encouraged by the precedent of the Office of the Children’s Commissioner, which drew praise from several noble Lords in Grand Committee for its independence. As noble Lords know, the Children’s Commissioner is sponsored by the Department for Education and guards its independence very well. The Victims’ Commissioner does exactly the same and is sponsored by the Ministry of Justice.

It is critical—that is agreed—that the patient safety commissioner is able to speak out without fear or favour. He or she must have the powers and functions to act independently to maximise their impact and confidence. That is absolutely the case here. It is also critical that the right calibre individual with a strong voice for patients is appointed to the role. I do not think any such person would accept such a role if they felt they would in any way be constrained in that role. Nor do I think they would remain silent. Furthermore, we would expect the Secretary of State to work with the commissioner to establish how they will safe- guard and secure the commissioner’s independence. Independence is not static but an active objective, which we would expect the patient safety commissioner to be prepared to approach continuously.

The commissioner will have the power to make reports to both the public sector and independent sector, and to the Department of Health and Social Care if they so wish. Those reports are entirely independent. There is no intention—and indeed no restriction—that would allow for the Secretary of State to edit those reports. As an independent public appointee, the commissioner will also be subject to the scrutiny of Parliament, including through the Health and Social Care Select Committee.

The powers in the Bill are accompanied by a regulation-making power about the terms of office of the patient safety commissioner, the appointment of staff, and other operational matters. But while this power is exercised by the Secretary of State, we are not proposing that the Secretary of State would have any power over the commissioner regarding the fulfilment of his or her functions. However, it is right that the detail is left to regulations so that we can publicly consult on this, as we are obliged to do so under Clause 45. It is important that we get the details right. That is also why the regulations will be subject to the draft affirmative procedure.

Other amendments make minor changes to ensure that the patient safety commissioner clauses work well with the rest of the Bill.

From the First Do No Harm report by my noble friend Lady Cumberlege, to earlier, well-known inquiries and investigations, we have heard numerous harrowing stories with terrible examples of how patients have been let down badly by our most loved institutions. As noble Lords have said, now is the time to act. The Government have listened to the impassioned and compelling arguments from all sides, and I thank my esteemed colleagues for their help in shaping this amendment.

We have no doubt that restoring patient trust will be at the heart of the patient safety commissioner’s role and that he or she will advance patient safety. Our commitment to amplifying and acting on the voices of patients in our health service is paramount. To that end, I beg to move.

Baroness Cumberlege Portrait Baroness Cumberlege (Con) [V]
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My Lords, I thank the Minister for his huge support throughout this whole process—all the times we have had to meet and I have met with his officials. I also thank him for the way in which he has so comprehensively introduced his amendment today. To be honest—“O ye of little faith!”—there were times when I thought the patient safety commissioner would not see the light of day. However, I underestimated my noble friend and thank him for agreeing to the concept and for bringing it to fruition with his officials.

I am very much aware of the long hours and prodigious amount of work that has gone into this amendment. I and many others are truly grateful, not least of course to my fellow parliamentarians, who have been stalwart in their support, but perhaps more importantly to all the patients and their families, who have endured the most appalling experiences over very many decades, and who have fought hard to see this day dawn.

In the report of my review, I and my small team recognised that we did not need another regulator. Many of those parts of the NHS and the healthcare system have regulators, but we did not want another regulator—we have those in plenty. We wanted something —or rather someone—new, who would be pivotal to improving patients’ safety and to prevent avoidable harm in the future. My noble friend really understands that. We need a listener, an advocate and a person of standing, who would call the healthcare system to account when needed.

In my letter to the Secretary of State, I said that the new patient safety commissioner would be the golden thread that would tie our disjointed healthcare system together for the benefit of those who matter most—the patients. I know, having listened to the Minister on many occasions and this morning, that he fully understands that. I am therefore delighted and grateful, and I thank the Government for having listened and agreed with me and my team. This new clause and the new schedule are so wonderful to see. I cannot thank my noble friend enough for his personal commitment to making this all happen. As I have said, I know a whole team has worked very hard alongside him, including other Ministers and of course his officials. I thank all of them from the bottom of my heart.

The Government’s amendments reflect crucial elements set out in our report: for example, the need for the patient safety commissioner to be independent. I hear what the Minister has said today, but we still need some reassurance on that. The patient safety commissioner cannot work or be effective if he or she is not independent. We are also very pleased that the patient safety principles underpin the commissioner’s work—that has been set out very clearly today and on other occasions—and of course, always, that patients will be closely involved in all that work. There is also an obligation on the system to respond to and co-operate with the commissioner. That is absolutely critical and is now in statute, and I thank those who enabled that to happen.

Having met so many people who have suffered avoidable harm and listened to their concerns, I know that the creation of a patient safety commissioner will mean a huge amount to them. One thing we heard so often from many them was the phrase, “Please don’t let this happen to anyone else”, a selfless plea that we should act to stop harm happening to other people in the future. Today, we are doing that. The patient safety commissioner him or herself will do just that, and I hope that will at least bring some peace of mind to those who are suffering now.

As my noble friend is aware, I have three points on which I would welcome some further reassurance. First, the importance of the role dictates that we must act as swiftly as possible to establish this role and this person in their job. The Government must of course have a credible selection process. I understand and welcome that; however, I know that my noble friend appreciates the urgency and there will be considerable pressure from patient groups and parliamentarians if we do not act at speed. This is not the time to dally. We must not risk losing the trust placed in us to get this person in post, up and running.

It is unclear to me whether the appointment of the patient safety commissioner will be independent of, and separate from, the much broader and lengthier public consultation and making of regulations. These regulations may determine some of the commissioner’s terms of office and how that person should operate. In my view, it is imperative that the two are kept separate—not least because this will facilitate the early appointment of the commissioner, who can then properly influence and shape those regulations. There is a precedent for this with the appointment of the designate domestic abuse commissioner. I see no reason for delay and would welcome my noble friend’s assurance that this appointment will be made with express urgency. I am sure the Minister will agree that we want a high-speed train, not a rumbling steam engine.

My second point concerns the definition of “relevant persons”. As I understand it, “relevant persons” will include healthcare providers in England and bodies exercising public functions relating to medicines and medical devices, but I am concerned that that does not go far enough. Other public bodies may have relevant information that could and should usefully inform the commissioner’s signal detection activities—opportunities to look wider than the norm and to scan the horizon. I include in this group, for example, the coroners’ courts, where cause of death may be found to be attributable to a medicine or medical device. I should be grateful if my noble friend could clarify whether the phrase “relevant persons” may include any public body that has information relevant to the duties of the patient safety commissioner.

I am also concerned about information of relevance to the commissioner that is held by manufacturers of medicines and medical devices. I know from my review that not all information from clinical trials, in particular, is published and shared with regulators. I should be grateful if my noble friend could reassure me that manufacturers will be required to share information and co-operate with the commissioner. Does he agree that it would be appropriate to place a duty to co-operate with the commissioner on manufacturers as a condition of selling to the UK market?

In evidence to the review, Professor Carl Heneghan repeated a question:

“Is the whole system commercially conflicted? Yes it is”,

he replied. In last week’s BMJ, Sir Cyril Chantler, vice-chairman to the review, recalled that a

“constant voice across the country was of patients telling us they felt the mesh had been commercially promoted and doctors were receiving benefits from companies prescribing it.”

Does the Minister agree that it would be appropriate to place a duty to co-operate with the commissioner on manufacturers, as a condition of selling to the UK market?

My third point concerns the following phrase in paragraph 3(3) of the Schedule:

“A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner to provide information within such period as the Commissioner may reasonably require.”

It is those five words—

“so far as reasonably practicable”—

that provide the reluctant person or organisation a get-out, not to co-operate with the commissioner. I am concerned that the words

“so far as reasonably practicable”

provide too much wriggle-room to the organisation from which the patient safety commissioner has requested information. The Freedom of Information Act requires the holder of the information to reply within 20 working days. I am not requesting anything so specific, but simply that we should not give the holder of information an opportunity to evade their responsibility when the words of the schedule require the commissioner to be reasonable in his or her request. There should be parity on that.

The commissioner must be in control. As currently drafted, it rests on the commissioner to have to challenge the relevant person’s reason for noncompliance. This could be a crucial waste of time if the information could prevent serious harm. I appreciate that the phrase exists elsewhere in legislation and its use here is not considered unusual. It is said that the commissioner should go to the lengths of naming and shaming. I do not think naming and shaming is a good solution. It is a distraction, a further waste of time and requires publicity and input from the media, which be against the commissioner’s whole raison d’être and what he or she is trying to do.

I add finally on this that those of us who were, or are employers, marvel at the fertile imagination of individuals and organisations intent on hiding some inconvenient truth, and we came across a lot of that in our review. Timely information is so important. It is crucial, because information is power, and we should not encourage a get-out in the schedule for those who still wish to hide things. It is a very small ask, but I should be grateful if my noble friend would consider omitting just those five words from the schedule prior to Third Reading.

In conclusion, it strikes me that one of the qualities of good government and good leadership, as in so many walks of life, is the willingness to listen. As we found during the review, that is not something that the healthcare system does well. When we listened to the women, they said, without fail, “Thank you for listening. You are the first people who really have listened”. This time, the Government have listened and, above all, acted. They have been inordinately patient with me and have listened to me and to my team and, more importantly, to so many people who have suffered and who want there to be a patient safety commissioner. I am truly grateful.

Lord Patel Portrait Lord Patel (CB) [V]
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My Lords, I shall be extremely brief. It was a pleasure to support the noble Baroness, Lady Cumberlege, and I congratulate her on achieving a remarkable feat of getting patient safety in statute for the first time in the United Kingdom. Her tenacity was such that she was never going to give up. I also congratulate the Minister. He obviously listened and understood all the arguments that were made. He has produced the establishment of an independent patient safety commissioner. Having been concerned with patient safety for many years, it is good to know that for the first time it is in statute. The noble Baroness made a few important points that were well argued as to why words may be misinterpreted. I hope that the Minister has listened and will respond positively. Again, I congratulate her—it was a pleasure to support her.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, I, too, welcome the Government’s amendment establishing the patient safety commissioner. This is highly significant and a great tribute to the noble Baroness, Lady Cumberlege, and her team. I should also declare an interest I must declare an interest as a member of the GMC board.

The noble Baroness’s report, First Do No Harm, is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I go back to her report because she found that the healthcare system, in which she included the NHS, private providers, regulators, professional bodies, and pharmaceutical and device manufacturers, was disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’être. Those are telling points, which led the noble Baroness to recommend the appointment of a patient safety commissioner, an independent and proactive public leader with a statutory responsibility to champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety. That is welcome and it will be essential that the person who is appointed is robust, fearless and commands wide respect. Their independence needs to be assured. I hope also that the appointment will be subject to Select Committee scrutiny and I should be glad if the Minister can comment on that.

Picking up on a point that the noble Baroness made, I should also be grateful if I could have a little more explanation about what is meant by relevant bodies, as defined in the schedule. It is clearly important that bodies with responsibilities in relation to patient safety are expected to respond to a report or recommendation made by the commissioner. Can the Minister give a broad indication of the relevant bodies? Also, in relation to the private health sector, my reading is that this is covered by the Bill and that the schedule provides for that. Can the Minister respond?

Overall, however, I commend the Minister on the Government’s response to this significant recommendation by the noble Baroness, Lady Cumberlege.

Baroness Finlay of Llandaff Portrait Baroness Finlay of Llandaff (CB) [V]
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My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in driving up better outcomes.

I hope that in the response to these proposals it will be helpful to have reassurance that the new post will be adequately resourced, the timeframe for fulfilling the appointment is rapid, and, subsequently, regulatory requirements can be defined and relevant statutory instruments drawn up. The independence of the post-holder is crucial. The person must be able to work across all the different and varied organisations and structures that have responsibility for patients, directly or indirectly. That will require promotion to all organisations that they have a duty to co-operate and collaborate with the commissioner to ensure that early warning signals are picked up and heeded through processes that are light on bureaucracy yet rapidly responsive in order to pick up signals. We cannot have years of accumulation of distressed patients. When things start not to be right, those amber warning lights must start flashing.

I urge the Minister to ensure that the remit of the commissioner is as wide as possible. For example, the coroners’ reports that the noble Baroness, Lady Cumberlege, referred to have not had adequate enforcement by others sometimes. The reports made powerful recommendations but it was found that those responsible for enforcing them have been so slow to act that the proposals have effectively gathered dust.

In previous debates, I raised the need for the yellow card scheme to be updated—opened for easy use by patients themselves, who may wish to report adverse outcomes. The wording of the Bill that I found most helpful and welcome is the part stating that the role

“does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue”.

Can the Minister make sure that the reporting mechanisms are open to patients and do not hit a hurdle when they try to report to a clinician who does not recognise the full import of they are saying?

To conclude, I reiterate my congratulations to all, particularly the noble Baroness, Lady Cumberlege, and her team, and look forward to the next phase of working with her and others as this important development moves forwards.

Lord O'Shaughnessy Portrait Lord O'Shaughnessy (Con)
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My Lords, I join other noble Lords in expressing my sincere thanks to my noble friend the Minister for the progress that we have made. In all fairness to him, he said that since Second Reading he was listening, but we all know that it is sometimes possible to listen and not hear, let alone act. On this occasion, he heard and acted. I join other noble Lords in expressing my sincere gratitude for that.

I also pay tribute to my noble friend Lady Cumberlege. No one doubted her tenacity but it has been on display in bucketloads, and she has made the progress that her superb report deserves. More than anyone, I pay thanks to the army of campaigners; many of us have met them, and they could not help but move us with their stories. This legislation is ultimately for them and a tribute to them.

I had a close look at my noble friend the Minister’s amendment and compared it to that of my noble friend Lady Cumberlege. Clearly, there is a specific issue about where the organisation, the commissioner, should sit, but there is a precedent for doing that in the way in which the Minister suggested. I take confidence from his determination to give proper independence to the role. A lot will depend on the kind of person recruited, how they are recruited and to whom they are accountable. I should like him to say a little more about how he envisages that happening.

We also need to hear more detail on the timetable. The Minister will know that when one makes big commitments of this kind, they are staging posts—never the destination. There is still some way to go in making sure that we get there quickly. That is important, as my noble friend pointed out. However, the powers in the amendment are important to recognise. On the ability to demand information from relevant persons, as other noble Lords have said, we need to hear a little more about who they are and the consequences of non-compliance. However, they are powerful ways in which the commissioner can act and create change in the system. I have no doubt that they will be effective.

In conclusion, I make a couple of comments provided by the ABPI’s briefing. They relate to further questions around the nature of the relationship between the commissioner and the MHRA and other bodies, how the four nations of the UK will act together on patient safety, given that we are a single market, and ensuring diversity of patient voice.

I would also add one more thing to that. Patient safety is not just about finding out when medicines and devices go wrong; it is also about access to them. Will the patient commissioner have a remit to investigate these kinds of issues?

However, these questions are for tomorrow. Today, we want to recognise the progress that has been made and the amendments put down in the name of my noble friend. I thank him sincerely for them and I thank my noble friend Lady Cumberlege for her dedication to this particular cause.

Baroness McIntosh of Pickering Portrait Baroness McIntosh of Pickering (Con) [V]
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My Lords, I, too, add my congratulations to my noble friend the Minister and pay particular tribute to the tireless work of my noble friend Lady Cumberlege in bringing us this far. I welcome government Amendments 1 and 54.

I want to take this opportunity to mention two specific issues that we focused on in Committee and seek confirmation on where we are in this regard. I want in particular to look at the right of patients to report directly on their own experience, rather than waiting for the patient safety commissioner to investigate. I would welcome hearing that my noble friend the Minister imagines that the commissioner should have this power. If not, would he consider introducing such a measure at the first available opportunity? It is so important that the voice of patients is heard. I remember the accounts that my noble friend Lady Cumberlege gave in Committee of her work and that of her team in producing the report, First Do No Harm; that will be a lasting legacy. Allowing patients the right to report directly, without necessarily waiting to be asked, would cut through many of the difficulties with medicines and medical devices, and would enable the patient safety commissioner to report directly to the Government in this regard.

The only other point that I wish to make at this stage is that of the regulations that my noble friend envisages in the government amendments in this group. Can he confirm that these will be discussed and agreed with the devolved Administrations at the earliest possible stage? Can my noble friend assure us that if the devolved Administrations raise any significant issues or highlight any problems that they have with the draft regulations, these will be acted on before the regulations are adopted and sent to each House of Parliament?

We are in a very good place. I congratulate my noble friend Lady Cumberlege and her team on bringing us here, and I pay special tribute to my noble friend the Minister for listening to the concerns of so many people, over so many years, to bring us to where we are today. I wish the amendments godspeed.

Baroness Bennett of Manor Castle Portrait Baroness Bennett of Manor Castle (GP) [V]
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My Lords, I join the universal commendations for the Government for accepting the recommendation to introduce a patient safety commissioner. It demonstrates that campaigning can work for everybody, from school pupils to Premiership footballers to Members of the House of Lords—in this case supported by patients, many of them suffering from continuing illness and disability.

I want briefly to pick up three points made by the noble Baroness, Lady Cumberlege. The first is the importance of the commissioner being a person of standing. As the noble Baroness’s report clearly explains, there is a strong gender aspect to the fact that far too many patients have not been listened to, have been ignored and have been mistreated by the system. It is really important that the patient safety commissioner is well equipped to understand that and make themself accessible to all patients. As the noble Baroness said, it is clear that the patient safety commissioner should be a person of standing and the kind of person who should shape the role that they will ultimately fulfil.

That brings me to my second point, which the noble Baroness and many others have stressed: the urgency of this appointment. As has already been pointed out, the Domestic Abuse Commissioner has been appointed before we have even passed the Domestic Abuse Bill. That is very much a model. I have a direct question for the Minister. It should not be beyond the capacity of the department to advertise this role within, say, one month. If he does not think that this timetable is reasonable, can he suggest what he thinks a reasonable timetable is? The noble Lord, Lord O’Shaughnessy, also asked this. I also echo the point made by the noble Lord, Lord Hunt of Kings Heath, that it is crucial that this appointment has Select Committee scrutiny.

Thirdly, I very much agree with the noble Baroness, Lady Cumberlege, that naming and shaming is not the way forward. The commissioner needs to be able to get urgent action; that certainly has not worked very well with the enforcement of minimum wage legislation. The commissioner needs to be able to swing into action.

Finally, I want to pick up a point made by the Minister in his introduction. He made a comparison to the Children’s Commissioner, saying that that commissioner is also appointed by the Secretary of State and funded by the department. There is a fundamental difference between the Children’s Commissioner and a patient safety commissioner. The Children’s Commissioner has a very broad remit, of course, and has done excellent work on everything from immigration law to poverty and inequality—things that the department itself might well want to see action on, as part of bringing its entire weight to assisting children suffering so many disadvantages to get an education. But that is not quite parallel to the patient safety commissioner operating in the health department and within the NHS framework. That is where such a comparison does not quite work.

Baroness Ritchie of Downpatrick Portrait Baroness Ritchie of Downpatrick (Non-Afl) [V]
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My Lords, I am delighted to follow the noble Baroness, Lady Bennett of Manor Castle.

At this stage, let me congratulate the noble Baroness, Lady Cumberlege, on her thought-provoking report, First Do No Harm, which really led to the position we are in today. I also thank the Minister—the noble Lord, Lord Bethell—for bringing forward on Report this amendment regarding the patient safety commissioner and putting it on a statutory basis. Led by the noble Baronesses, Lady Cumberlege and Lady Thornton, we have had several meetings with the Minister on this particular issue. He gave commitments in this respect, for which I, for one, am particularly grateful.

Naturally, as with everything, I have some questions, to which I and others would like some answers. On the nature of the patient safety commissioner’s appointment, how independent will they be? They will be accountable to the Secretary of State for Health and the department, but what does that level of accountability mean? What will the nature of the regulations circumscribing the appointment be? When will the appointment actually take place? What is the timeframe? Will there be adequate resources on an ongoing annual basis to fund this position, to ensure that the patient safety commissioner can act as an advocate on behalf of patients?

We have heard what the Minister had to say: that patient safety is the golden thread holding this Bill together. That is particularly important, but the patient safety commissioner will be the person who will have to provide direction and leadership. This was one of the principal aims and outcomes of the report by the noble Baroness, Lady Cumberlege, First Do No Harm. Patients who have been unwell and feel that they have been slighted or undermined in their dealings with medical practitioners want to feel safe and have confidence that they are being listened to. I hope that, whenever the regulations are published and enacted, this appointment can take place at very short notice. And, of course, the commissioner must be someone who commands respect and is a person of standing.

It is vital that the commissioner leads, with full patient group engagement and involvement, on the development of a set of principles for better patient safety that governs the way the commissioner fulfils his or her remit. I am delighted to support the government amendment. It goes without saying that I also support Amendment 65 in the name of the noble Baroness, Lady Cumberlege. There are issues with who the person is accountable to—the Department of Health, in this instance. I know that the noble Baroness was looking for the Cabinet Office, but that is just a detail. We have arrived at an important stage today, and I welcome that.

Finally, I have been talking to the Minister at the meetings organised by the department with the noble Baroness, Lady Cumberlege, to give an update on Northern Ireland, where there are several ongoing inquiries. The Minister and his officials were very helpful and are having discussions with the Minister for Health in Northern Ireland. Maybe today the Minister could provide me and your Lordships’ House with an update on the position within the Northern Ireland Executive and Department of Health.

Lord Lansley Portrait Lord Lansley (Con) [V]
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My Lords, I am pleased to follow the noble Baroness, Lady Ritchie of Downpatrick, who asked some good questions. Indeed, many noble Lords have asked good questions about the functioning of a patient safety commissioner. All are agreed that we have come very far, very quickly, and the Minister and my noble friend Lady Cumberlege are to be congratulated on having brought this proposal from her excellent report to primary legislation so rapidly. Knowing how difficult it is, I commend the Minister and his team for securing collective agreement to such a significant policy innovation so rapidly, to the point that we can put it into the Bill on Report.

I want to make two points. First, as I know from the past, independence can be instrumental to the functioning of an organisation, but the NHS can, if one is not careful, see independence as something outside the system. It is somewhat discounted because of that. We must always think of the patient safety commissioner in two important respects. First, it should be not only independent but influential. A number of noble Lords have spoken about how that might best be achieved. That influence is terrifically important.

Secondly, patient safety is central across the NHS and is regarded as such. As the Minister and the noble Lord, Lord Patel, evidenced, we have come a long way with safety in the NHS—for example, in the reduction in healthcare-acquired infections. I was responsible for introducing never events and a range of other factors. Mainstreaming safety to become a central concern of commissioners and providers across the NHS has been a recurring feature of the work of this Government and their predecessors, and of my successors, Jeremy Hunt in particular.

I stress that that work on safety inside the NHS is clinically led and data-driven. The patient safety commissioner has a remit focused on hearing from, understanding and working with patients. That distinction is tremendously important and must be made clear to all those working across the health and care systems, from the outset. There is something new and distinctive about the patient safety commissioner, and it is not simply another accretion to the many organisations that those who work in the health system feel impede their lives. On the contrary, this is a representative of patients who, by virtue of that, attracts special attention from their point of view and brings a distinctive and unique voice into the NHS systems. I am pleased to have had this opportunity to say those few things and to support the government amendment in the name of the Minister.

Baroness Masham of Ilton Portrait Baroness Masham of Ilton (CB) [V]
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My Lords, I agree with the noble Lord, Lord Lansley. It is very good news that there is to be a patient safety commissioner. I congratulate everyone who has worked so hard to create this amendment, especially the noble Baroness, Lady Cumberlege. It is so good that the Government have listened. Patient safety is vital, especially now when the NHS is under so much stress and demand. Over the years, some tragic incidents could have been avoided if patients had been listened to and there had not been cover-ups.

The noble Baroness feels that the words

“so far as reasonably practicable”

should be removed. She may feel that they would weaken the amendment; is this the case? This is important, because patients need clear information about how they are to communicate with the patient commissioner, so that they trust the system.

Baroness Watkins of Tavistock Portrait Baroness Watkins of Tavistock (CB) [V]
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My Lords, I am delighted to follow my noble friend Lady Masham of Ilton. I reiterate my support given in Grand Committee for the appointment of a patient safety commissioner, and I thank both the Minister and the noble Baroness, Lady Cumberlege, for the work they have done together to get to this point.

To reflect on the speed since the report of the noble Baroness, Lady Cumberlege, I remind noble Lords of the report, in the early 1970s, called Sans Everything, about the terrible atrocities and lack of safety in some in-patient mental health services. It took nearly a decade for that to be taken seriously, so we warmly welcome the speed with which we are dealing with this situation now.

I am delighted that Amendment 54, which will be moved by the noble Lord, Lord Bethell, on behalf of the Government, will identify the principles relating to core duties, involvement of patients and amendment to primary legislation, together with regulations for appointment and operation of the office for the commissioner. I too have concerns about paragraph 3(3) of the proposed new Schedule A1, concerning the statement:

“A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner”.

This means that a reluctant organisation—we need to remember that some very small organisations deliver healthcare on behalf of the NHS—or individual is potentially provided with an excuse not to co-operate with the commissioner on a reasonable request. I ask the Minister: could the words

“so far as reasonably practicable”

be removed?

Clarity over roles and responsibilities will be key to maximising patient safety, as will the independence of such a commissioner. It may well be that, as we work forward, we can be clear about the level of independence to ensure that, as they revise the principles of better patient safety, they consider not only patients in hospitals and mainstream community care but patients further afield, particularly in areas provided by the independent and charitable sector.

As other noble Lords have acknowledged, it will be necessary in any development of the commissioner for patient safety’s office to clarify roles and accountability in relation to the MHRA, and to negotiate the most appropriate approach across the four nations of the UK in relation to the commissioner.

Finally, in several briefings received on this matter it has been stressed that it will be important to ensure that the office of the commissioner, and any other associated committees or boards, reflects the diversity of our population and a range of patient experiences involving mental health and learning difficulties, as well as the physical health problems so sadly outlined in the report by the noble Baroness, Lady Cumberlege. I hope that we will also ensure that we embrace all chronological ages of our society that are served by our healthcare services. Can the Minister inform us whether these important issues of representation will be carefully considered?

Lord Mackay of Clashfern Portrait Lord Mackay of Clashfern (Con) [V]
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My Lords, I would like to join in the praise that has been very well entitled from the many people who have spoken today, and at other times, in thanking the noble Baroness, Lady Cumberlege, and her team for the excellent report, which lies at the beginning of this development. I thank my noble friend Lord Bethell and his team for the way they have taken this forward, because I am conscious—I have tried to think about it quite a bit —of how difficult this has been. I feel that, apart from some questions that have been raised—which I do not seek to mention again as it would be useless repetition—the scheme that is involved in these amendments is very good indeed. I shall say one thing about it in a few minutes.

It is quite clear to me that safety in the NHS and in other services is an extremely important matter. When you see the amount of money that the Health Foundation pays out in respect of claims against the health service, it is fairly plain that it is a very serious problem, in fact, and one which has been found to be extremely difficult to reduce substantially. The money that goes out for these claims is a very substantial proportion of the total amount spent on the health service, so this is certainly a very important area, and it is important that it should be attended to in this way as soon as possible.

When I read the report originally, I felt that it revealed a very urgent and important problem in the health service, and that it was vital that patients should have a voice when damage emerged from a particular source, particularly where that source was in some general use. There can be no question but that this is a difficult problem and that it will take all the skill and command of the Government to produce a satisfactory and workable answer.

The report emphasises the need for principles to guide the commissioner and the wisdom of seeking the help of the public to enunciate them. I am very pleased that the Government have taken this on and that the Scottish Government have also indicated their hand to tackle this problem. Although health is devolved, it is important that, if it is at all possible, the answer to this question is agreed across the whole of the United Kingdom.

The title of the report is First Do No Harm. However, the report indicates harm having been done in a number of cases. Many treatments start with an incision and, sadly, some patients pass away on the operating table. In none of these cases do any of the practitioners involved intend to do harm. Surely this shows the calibre of the person required to take on this essential role. To enunciate the principles involved in patient care I consider to be an extremely important labour and a task demanding a person of tremendous responsibility.

I strongly support these amendments, subject to the questions that have been raised, and I am happy that they have been put forward so fully at this stage by the Government.

Baroness Jolly Portrait Baroness Jolly (LD) [V]
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My Lords, the amendments in this group relate to the introduction of a commissioner for patient safety. We have supported this proposal right from the publication of the review, First Do No Harm.

At Second Reading and in Committee we supported the amendments tabled by the noble Baroness, Lady Cumberlege, to put the patient safety commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review. I was pleased to add my name to Amendment 65, tabled by the noble Baroness, Lady Cumberlege, that we are debating. Along with all the government amendments, it will enable the progress of the commissioner’s appointment. I join others in congratulating the noble Baroness, Lady Cumberlege, and the Minister, the noble Lord, Lord Bethell, for getting the patient safety commissioner accepted so quickly by the establishment.

The critical issue is to be independent, and to be seen to be independent by example. As the noble Baroness, Lady Finlay, mentioned, both the children’s and the victims’ commissioner have remained independent, and I am sure would be useful allies and candid friends in the world of commissioners—who, as the noble Baroness, Lady Cumberlege, underlined, are not regulators.

I look forward to the time when in every NHS healthcare setting there will be easily accessible information on the role of the patient safety commissioner, and the way to contact them. We welcome the department’s commitment to working at pace, and there are many parliamentarians here today who will be keen to ensure that it does just that.

As the noble Baroness, Lady Cumberlege, said, there is a time pressure to appoint the commissioner. I join the noble Lord, Lord O’Shaughnessy, the noble Baroness, Lady Bennett, and others, in their concern for the pace of the appointment. What body will have oversight of setting up the office of the patient commissioner? I wonder whether the Minister could tell the House when he would expect the office to be up and running—in a year, in two, or more?

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I can only join in with the congratulations that everybody has expressed in this debate today. I congratulate of course the noble Baroness, Lady Cumberlege, and support her—as we have from these Benches throughout. I also congratulate and thank the Minister, the noble Baroness, Lady Penn, and also somebody who I do not think has been mentioned but I do remember sitting giving his wisdom in the many discussions we have had, who is of course the noble Earl, Lord Howe. I think the team were very wise indeed to have him sitting with them.

I am not going to say very much because I think we are there with this. Most of the questions that needed to be asked have been asked: on speed, independence, resourcing and powers, and on the issue of “relevant person”, which several noble Lords mentioned. These are the key issues.

One issue that has not been mentioned—here I thank the PSA for its brief—is the need to ensure that there is no reduction in public protection in any other areas of government policy, and that the remit of the role should link closely with the work of the other bodies involved in patient safety.

Finally, I have to say that I agree with the noble and learned Lord, Lord Mackay of Clashfern, that there has to be a four-country element in this. As the role is intended to cover only England, there should be consideration of how the link with equivalent or complementary mechanisms will work in the other countries of the UK. Otherwise, we might find ourselves with a dissonance here, which will not be in patients’ interests.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I will save my Hollywood thank-yous for the end of the process, but profound thanks will need to be said. I want to say specific thanks to those who have spoken in the debate on these amendments. There have been a large number of very thoughtful comments. The noble Baroness, Lady Thornton, and my noble and learned friend Lord Mackay both mentioned four nations and devolution. The noble Baroness, Lady Bennett, spoke on gender, my noble friend Lord O’Shaughnessy on industry advocacy, and the noble Baroness, Lady Ritchie, on Northern Ireland. It is a very long list, and I cannot address every contribution. What I will do instead is address what I think have been the key points in the debate on these very important amendments.

Amendment 65 was tabled by my noble friend Lady Cumberlege before the Government’s own. I am extremely grateful to her and her team, who have written to me expressing their thoughts. The government amendment would not have been possible without her continued engagement and that of other noble Lords whose experience and knowledge have been essential in shaping the Government’s thinking. Although there are differences between our amendments, we are agreed on the fundamental point that we must create a patient safety commissioner in order to give the voice of patients its rightful prominence. My noble friend Lord O’Shaughnessy has made that point extremely clearly and effectively.

More broadly, I hope that the amendment in my name assures my noble friend Lady Cumberlege and the House of the seriousness with which the Government takes the report First Do No Harm. The Government will continue to review this report. We made a Written Ministerial Statement on the report and its recommendations yesterday, and will respond to the whole report shortly.

A patient safety commissioner, as proposed in Amendment 65, would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. The Government entirely agree that listening to patients is essential to preventing the sorts of issues highlighted in the report. On this, our visions for the patient safety commissioner are as one.

However, Amendment 65 in the name of my noble friend Lady Cumberlege differs in specific ways. Her proposed new subsection (2) provides that the Cabinet Office would host and fund the patient safety commissioner. My noble friend has argued here and in Committee—and, indeed, in her report—that this would be necessary to safeguard the independence of the commissioner. I simply do not agree. It is common practice for commissioners to be sponsored by the government department with relevant policy responsibility, and it is entirely unclear to me what the benefit of sponsorship elsewhere would be. The process of public appointments is set out clearly; there is no question of undue influence by the sponsoring Secretary of State. The process is there—in fact, it is public. Nor does the identity of the sponsoring department amend or change the powers and functions of the commissioner; it is simply how the body is supported.

There are also differences in the way in which my noble friend’s intention is executed. In her report, she was clear that working with other bodies was necessary and, as I would hope, obvious as part of any commissioner’s remit. However, Amendment 65 is unclear as to how the commissioner would interact with other regulatory bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and any other persons, including regulators and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants. These bodies also have their own routes for reporting. For example, as we know from the vaccines rollout, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme.

Without differentiation between taking receipt of direct reports to further a broader investigation and acting as an ombudsman, Amendment 65 might create a body overwhelmed by patient reporting and investigating individual cases. The noble Lords, Lord Patel and Lord Hunt, both referred to past agencies here, but where the best route to resolution sits elsewhere. The report itself said that the commissioner should not investigate individual cases, yet this boundary is absent from the amendment.

Proposed new subsection (7) enables the commissioner to require information from public bodies and others for the purposes of producing and laying before Parliament reports regarding patient safety, but “other” would extend to private individuals—a very expansive group indeed. The amendment tabled by my noble friend provides for the commissioner to make reports only to the Secretary of State and Parliament, and not to a range of bodies as in the government amendment. Nor does my noble friend’s amendment provide for what would happen if these individuals did not respond.

“Relevant person” is a broad definition. I am confident that it will enable the commissioner to engage with the organisations necessary to fulfil their functions effectively. In addition, proposed new paragraph 3(1)(b) of Schedule A1 would enable the commissioner to receive information from and consult

“any other person the Commissioner thinks appropriate”.

This provides the commissioner with all the relevant tools necessary. A vital difference between my amendment and the proposals of my noble friend is that, in mine, provisions are made for the patient safety commissioner to make reports and recommendations to relevant public authorities or persons, and for that authority or person to have a duty to respond to these; I think that is vital.

We have listened, and made substantial changes in this area since Second Reading, so I signal to my noble friend that I do not anticipate debating any amendments at Third Reading.

My noble friend has raised the issue as to whether the words “reasonably practicable” are a fetter on the commissioner, saying that they might prevent the commissioner obtaining information. To this I would say that the language used in our amendment is exactly—or almost exactly—as it is for the Children’s Commissioner and the Domestic Abuse Commissioner. They are no different. “So far as reasonably practicable” provides for circumstances where a body is asked for information it simply does not hold, or, say, information is requested to be sent via email when the information held cannot be transferred from one IT system to another. Without the words “so far as reasonably practicable” there is no means to be compliant. It is fair to have that language in there. Such language reflects that the commissioner may ask for the impossible or the undeliverable, but it is not a shut door. We would expect that a refusal on the basis that it is not reasonably practicable to comply would open up a dialogue on what was practicable.

However, the commissioner is armed with tools for additional action if met with non-compliance. The commissioner could, for example, bring that non-compliance to the attention of the body’s regulator, the Secretary of State or Parliament. In a system that can sometimes seem crowded, it is essential that each organisation is able to work in a way that is complementary, so that the system becomes greater than the sum of its parts.

I hope my noble friend can acknowledge that we differ here on very few matters. We discussed this in Committee and had conversations after that. The Government’s position on this has not changed and our view will not change between now and Third Reading. I therefore hope that my noble friend will not feel that she has to push her amendment. If she wishes to test the opinion of the House, she should do so now.

Lord McNicol of West Kilbride Portrait The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)
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I have received one request to ask a short question. I call the noble Baroness, Lady Cumberlege, to ask a short question for elucidation.