Medicines and Medical Devices Bill

Lord Bethell Excerpts

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

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?

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

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 (Lab) [V]]

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.

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Moved by

[Lord Bethell]

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).

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[Lord Bethell (Con)]

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 (CB) [V]]

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.

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[Lord Bethell (Con)]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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).

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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 (Con)]

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

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[Baroness Jolly (LD) [V]]

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 (Con)]

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 (Lab)]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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).

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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[Baroness Jolly (LD) [V]]

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 (Con)]

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.

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[Lord Hunt of Kings Heath (Lab) [V]]

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 (Con)]

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 (Con) [V]]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.

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Moved by

[Lord Bethell]

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.