A participants’ list for today’s proceedings has been published by the Government Whips’ Office, as have lists of Members who have put their names to the amendments or expressed an interest in speaking on each group. I will call Members to speak in the order listed. Members are not permitted to intervene spontaneously; the Chair calls each speaker. Interventions during speeches or “before the noble Lord sits down” are not permitted.
During the debate on each group, I will invite Members, including those in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will call the Minister to reply each time. The groupings are binding, and it will not be possible to degroup an amendment for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate. Leave should be given to withdraw amendments.
When putting the Question, I will collect voices in the Grand Committee Room only. I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an amendment is negatived, and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group. We will now begin.
95: Clause 16, page 9, line 18, leave out “may” and insert “must”
Member’s explanatory statement
This amendment is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill, setting up the new information system envisaged by Clause 16.
My Lords, this is a large group of amendments relating to expert registries. I have Amendments 95, 99, 100 and 101 and support the others in this group.
First, I welcome Clause 16, which the Government added during the Bill’s passage in the other place. The clause is a clear step in the right direction. Amendment 95, like Amendment 96, would build on this to ensure efficacy by tracking the use, and the outcomes from the use, of all medical devices rather than just a select few. We must not forget the conclusions of the Cumberlege review that registries are too
“few and far between and all too often prompted by catastrophe”.
The Bill provides a prime opportunity to move away from that position. Without tracking all devices, we will allow another scandal, involving an as-yet-unknown device, to emerge undetected until many have been affected. A proper warning system is essential.
Amendment 99 seeks to make the list of objectives for regulations listed under Clause 16(2) mandatory rather than permissive. These should be minimum standards against which to hold any regulations the Government publish, not just aspirations.
Amendments 100 and 101 then seek to add to that list of standards. In doing this in Grand Committee, I would welcome some commitments from the Minister, setting out where the Government share the objectives in those amendments. In essence, the difference between the Government’s approach and mine is that the Government foresee a future in which some medical devices continue not to be tracked, hoping that their outcomes will be audited. I strongly believe that this is a mistake.
Registries, which track patient outcomes through proper monitoring and audit, are an essential component of post-market surveillance and a prerequisite for patient safety. They should be the rule, not the exception. This is a principle that the Royal College of Surgeons of England strongly supports too. Indeed, its former president, Professor Derek Alderson, made this clear in his evidence to the review of the noble Baroness, Lady Cumberlege. As he put it
My Lords, I thank the noble Baroness, Lady Finlay, for introducing this group. As a surgeon, I will focus on the registries and, in particular, the National Joint Registry—the NJR—and the Breast and Cosmetic Implant Registry. The noble Lord, Lord Hunt, was Parliamentary Under-Secretary of State when the NJR was introduced in 2003, with the aim to
“improve surgery through learning from best practice, and … improve the quality of care to patients.”
The NJR is the largest of its kind in the world, with data from 3 million hip, shoulder, knee, elbow and ankle replacements. In the last year before Covid-19, nearly 200,000 hip and knee replacements were recorded. By analysing this information, surgeons are supported in choosing the best artificial joints for their patients. It helps surgeons decide whether their patients need to return to hospital by flagging up problems with a particular type of implant. I was lucky enough to have bilateral metal-on-ceramic hip implants. Had I received a metal-on-metal implant, I would be concerned, as the NJR in 2010 identified higher than expected revision rates for metal-on-metal implants, with metal debris damaging patients’ soft tissue and causing pain and loss of function. Without the NJR’s comprehensive registry, hospitals would be unable to track their patients’ progress and identify problems early. Similarly, the Breast and Cosmetic Implant Registry records implants used in patients, along with the surgeon and organisation responsible for the procedure, allowing patients to be traced in the event of a safety concern or product recall.
As we were informed in the Minister’s useful briefing this morning, the NJR is able to capture details on patients, procedures, place or site, and the device with its product identification and unique identifier, thus allowing comparison with other devices that are underperforming. Amendment 100 adds four new paragraphs to Clause 16(2). They are subject to the patient’s consent and require that information about any medical device implanted in the human body is registered and retained in the information system outlined in Clause 16. The information system should be subject to expert review and, more importantly, patients should be empowered to enter reports of their experiences, following the use of medical devices in their treatment. The noble Baroness, Lady Cumberlege, identified this in her review and she will doubtless comment further.
In conclusion, I also support Amendment 101 in the name of the noble Baronesses, Lady Finlay and Lady Bennett. These amendments will give patients a voice and ensure that they consent to the information used about their care.
My Lords, I am very glad to have the opportunity to follow my noble friend Lord Ribeiro and to speak to my Amendment 104. I am grateful to the noble Baroness, Lady Finlay of Llandaff, for bringing forward her amendments as well. They highlight some useful points and—particularly Amendment 101—focus on the necessity for patients to be provided with information and for patient experience to have its place in the information systems to be created under Clause 16. My noble friend Lord Ribeiro very helpfully illustrated that the benefit of the joint registry and similar information systems is not simply to promote safety but also to improve outcomes. We can certainly look forward to seeing both happening in the future.
My Amendment 104, to which the noble Baroness, Lady Finlay, and the noble and learned Lord, Lord Woolf have added their names, requires that the regulations made under Clause 16 include specific reference to the Caldicott principles. Noble Lords will recall the establishment of those principles back in 1997. They say that an organisation should:
“Justify the purpose for using confidential information”
and that the NHS should not
“use confidential data unless absolutely necessary”.
The NHS should:
“Use the minimum necessary personal confidential data”,
while
“Access to personal confidential data should be on a strict need-to-know basis … Everyone with access to personal confidential data should be aware of their responsibilities”
and, when using data, NHS personnel should “comply with the law”. In 2003, a seventh principle was added:
“The duty to share information can be as important as the duty to protect patient confidentiality.”
In a sense, a balancing principle was added as number seven. The amendment refers to those two reports, which have given rise to those principles. I am interested generally in the proposition of how certain we are that the Caldicott principles are being applied in every case. I think in these regulations it would be to the benefit if they were restated, given the importance of this as an information system.
This string of amendments all talk about recording information, and I broadly agree with all of them. I particularly mention Amendment 104, in the name of the noble Lord, Lord Lansley, because of the mention of the Caldicott principles. Many people, particularly noble Lords in the Liberal Democrat party, jealously guard our right to privacy—hence the promissory tone of Amendment 100 in the name of my noble friend Lady Jolly.
The purpose of the proposed new clause in Amendment 107, to which I have put my name, is slightly different from that of the other clauses because it seeks to ensure that a proper systematic analysis is made of the effectiveness of mesh implants through registers. The Cumberlege review notes that registries are
“few and far between and all too often prompted by catastrophe”
in relation to transvaginal mesh and PIPs. This is obviously a good phrase because the noble Baroness, Lady Finlay, has already picked it out of the report.
This clause proposes a register. It requires the Secretary of State to report on progress towards creating databases relating to other devices. I appreciate that there are many databases out there—far more than I anticipated when first became involved in this Bill. The idea of the registries is to draw all this information together. As the Cumberlege report says,
“a ‘registry’ … would act as a repository for more complex patient related information datasets enabling research and investigation into patient outcomes.”
This would be more holistic and far more useful than just a database, enabling any adverse outcomes to be spotted early and not allowed to fester, literally, for years before defaults are spotted.
Patient groups must be consulted on devising the register. Time and time again, victims reported that they had not been listened to, despite the fact that the mesh felt “like razor blades” inside them. Never again must a patient feel patronised, unheard or left to suffer in silence. Of course, those healthcare professionals at the coal face, as it were, of the issues must have their say. We know that some registries exist today, but this database would bring everything together, instead of the piecemeal system we have at the moment.
My Lords, first, I apologise for not being able to participate at earlier stages of the Bill because of the clash with speaking in the Chamber. I congratulate the noble Baroness, Lady Finlay, on introducing these amendments and, especially, my noble friend Lady Cumberlege for all her work in preparing her report in advance of this. I also thank the Minister, my noble friend Lord Bethell, for briefing us this morning. I will particularly speak in favour of Amendments 100 and 101.
I hope that my noble friend the Minister will look favourably on patients being able to report directly to the register. The testimony that my noble friend Lady Cumberlege and others heard in the context of her report was very moving. As my noble friend Lord Ribeiro said, it is absolutely essential that the voice of patients is heard. This absolutely goes to the heart of medical and surgical treatment. We must ensure that, whether they have had a good or a bad experience, patients are able to place their experiences on the record. Amendments 100 and 101 go some way to achieving that. Were my noble friend not to like those amendments, I hope that the Government would come forward with a similar provision to put our minds at rest. I thank the noble Baroness, Lady Finlay, for these amendments, and I lend my support to them.
Baroness Masham of Ilton (CB) [V]
My Lords, Amendments 100 and 101 make clear that there should be means by which patients can report into registries directly so that they can be heard even if there is divergence of opinion with their clinician. Patients need to be protected. I support all the amendments in this group and thank those who tabled them, giving extra thanks to my noble friend Lady Finlay, who works so hard.
This is exceedingly important for many patients who have rare and complicated conditions. I speak from experience, as a high-lesion paraplegic. Many GPs and general doctors or surgeons may not be familiar with several of the peculiarities and may not understand the patient’s needs. For people with spinal injuries, for example, the three Bs are very important: bowels, bladders and bedsores. If not treated by specialists, patients can get into serious problems. Severely disabled people use all sorts of complicated devices that need to be kept on a register and to be easy to track if they go wrong. Suitable mechanisms should be found for the variety of needs, which can be inside and outside the body. This is particularly difficult in this time of Covid-19.
The NHS is so big, and there are so many different bodies, that it is vital that patients should have a direct route to report their experiences into any information system with a clear remit. Plain English should be used and there should be clear translations into other languages, so that patients understand and are understood. Patients need to feel that they are having their voices heard, so that improvements can be made and mistakes will not happen to other patients.
I endorse the recommendations from the noble Baroness, Lady Cumberlege, in her report FirstDo No Harm. It is important that MHRA works closely with NICE, but I hope that it will also work with patients. Patients should be trusted: it is their life, and their hope for the future. The overriding need for better patient safety is, I hope, what this Bill will advance.
My Lords, I particularly welcomed the remarks of my noble friend Lady Burt, as they took me back to the days in the 1990s when I taught IT. I taught A-level students the differences between databases, tables and registers. I totally support these amendments about registries and databases relating to medical devices. They form one of the key recommendations of the review of the noble Baroness, Lady Cumberlege, in light of the scandals relating to, for example, vaginal mesh.
A huge number of patients have been affected by these incidents, and introducing registries allowing the use of implantable devices to be tracked, and allowing patients to view information relating to the data stored, would make a huge difference. Amendment 95, from the noble Baroness, Lady Finlay, changing “may” to “must”, is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill setting up the new information system envisaged by Clause 16.
Amendment 96, in the name of the noble Baroness, Lady Thornton, is a probing amendment seeking clarity about whether the Government intend to track all medical devices used in the UK, rather than a selection. Amendment 99, in the name of the noble Baroness, Lady Finlay, seeks to make mandatory the list of specified issues for regulations to cover. Her Amendment 100, to which I have added my name, would allow for the creation of a system of information regarding implants, with appropriate consents and oversights. It would also allow a patient’s experiences to be reported and stored; they should be subject to oversight. The noble Baroness, Lady Finlay, has also included the point about patient experience in her Amendment 101.
Amendment 104, in the name of the noble Lord, Lord Lansley, would require regulations under this section to have regard to the Caldicott principles. It was just over 20 years ago, when I was a non-exec director in a local NHS trust, that these principles were first introduced. I can remember the way that clinicians—in particular, senior clinicians—really welcomed the new measures. They certainly changed the way that clinicians thought about information and data. We are now moving through a different step change.
My Lords, this group concerns the need to set up information systems—registries—which will serve the purpose of tracking medical devices. I thank the Minister and the Bill team for their very enlightening and useful presentation this morning. The noble Baroness, Lady Finlay, and other noble Lords have already explained to the Committee how these registries and databases might work. The key point, which was made by the noble Baroness, is that they should be mandatory rather than permitted. Changing “may” to “must” so that the Secretary of State has to produce the information system envisaged by Clause 16 is a small but vital change. The Minister will need to explain to the Committee why, at this stage and after the experiences expressed and covered in the report of the noble Baroness, Lady Cumberlege, there should be any discretion in this matter.
The other amendments seek to ensure that patients have a direct route to report their experience to any information system established. Again, after the dismissal of so much patient experience over so many years in the cases outlined in First Do No Harm, it would seem to be the only way to guarantee that patient experience can be heard and registered.
Amendment 96 in my name is a probing amendment which seeks clarity about whether the Government intend to track all medical devices used in the UK, or just some of them. As other noble Lords have pointed out in the course of this Committee, if supermarkets have the technology and wherewithal to track the provenance of every single food product from anywhere in the world, we would need to understand why this would not be possible for medical devices.
Amendment 107 specifically addresses the issue of surgical meshes, and requires the production of a registry for patient safety. I hope that the Committee will be seeking to discuss registries and how they are linked. On Amendment 104 on the Caldicott principles, I do not see how anybody could possibly object to that.
My Lords, we had an excellent debate last week on the subject of medical device information systems at Clause 16, which is critical for how we will go forward on these points. The noble Baroness, Lady Finlay, seeks in Amendment 95 to confirm that the Government will make regulations to establish the system, not that they might. We will introduce this system; the noble Baroness provides no timescale attached to the obligation she introduces. It is essential that the regulations are informed by consultation. The discretion that “may” provides allows for this consultation to be conducted. We want the regulations to be right, not rushed.
I spoke last week on Amendment 96, in the name of the noble Baroness, Lady Thornton. Devices have varying levels of risk profile; it is our intention in the first instance to use the power in Clause 16 to require all implanted devices to be recorded in information systems. Implanted devices pose the greatest risk to patients and it is right that these should be prioritised. Consultation will help us to determine which devices ought to be captured by the information system.
On Amendment 99 in the name of the noble Baroness, Lady Finlay, we recognise the importance of all the issues in Clause 16(2): that is why they were explicitly referred to. However, there may be occasions where the inclusion of provisions in regulations on all four of the issues listed here is not appropriate or necessary. For example, in future we might wish to update the types of information in Clause 16(2)(a) to include, perhaps, a new way of recording a procedure or a device. We might have no immediate need for further provision under 16(2)(b) to 16(2)(d). Without the flexibility afforded by the current drafting, we would be prevented from making proportionate regulation limited to what was necessary.
On Amendment 100 in the name of the noble Baroness, Lady Finlay, the drafting of Clause 16(2) is sufficiently broad as to say, “among other things”. Regulation is not limited to the four suggested areas for provision at subsection (2)(a) to (d).
I commend the spirit of Amendment 107, but it is unnecessary. It seeks to establish a registry of those patients who undergo procedures to insert surgical mesh in order to research and audit patient outcomes and device safety. The amendment would also require a report to be laid before Parliament within six months. I stand by all remarks that I have made to date on the importance of my noble friend Lady Cumberlege’s report, which dealt with the specific issue of vaginal mesh. I appreciate that, as she stated earlier in the proceedings, this did not cover other uses of mesh, but the consequences set out in her report for some patients can be similar. I take these concerns very seriously. That is why work is already under way under a direction from the Secretary of State to NHS Digital, the Surgical Devices and Implants Directions of 15 July 2020, to develop a national database for pelvic floor procedures involving mesh. Work is also under way to determine how the information collected could best be clinically assessed to identify potential issues at the earliest point. NHS Digital is also working with the devolved Administrations on this project.
As the noble Baroness, Lady Finlay, put very well, existing clinical registries have been established through various mechanisms in the past, from direct action taken by the sector in the creation of the National Joint Registry through to commissioning by DHSC and NHS England and NHS Improvement. The geographical scope of each registry is different. Some work across the whole of the UK while others are nation-specific.
Amendment 107, however, would require the establishment under the Bill of a clinical registry for the monitoring of all procedures that use surgical mesh. I do not think it appropriate to single out one clinical area for inclusion in this Bill. Other clinical registries operate without being established under legislation. The National Joint Registry demonstrates that the best basis on which to create a registry is a decision based on clinical need. Clinical needs may change over time, potentially rendering some registries obsolete as procedures change and technology develops. We recognise that further clinical registries will be necessary. Work is under way with existing registries to identify areas of best practice and establish any pitfalls to avoid in the future. The intention is to create a best-practice model that is flexible enough to respond to different clinical specialties’ needs while retaining core similarities to ensure that the registries operate effectively to deliver maximum benefit to patients.
Further on Amendment 107, we are committed to full consultation on the regulations under Clause 16. It may take longer than six months to develop and lay those regulations before Parliament. I think the best way to update Parliament on our progress is by taking the steps to establish the system.
I hope that the noble Baroness, Lady Finlay, feels able to withdraw her amendment and that others do not press theirs.
No, that is a mistake. Somebody else involved with the conversation that I have been having thought that I wanted to come in on this occasion. I thought that I would give noble Lords a rest—they hear enough from me, so on this occasion I did not want to come in.
I thank the noble Baroness, Lady Cumberlege—that is very gracious. On that basis, we have nobody else to come in after the Minister at this point so I come directly to the noble Baroness, Lady Finlay of Llandaff.
My Lords, I thank all noble Lords who not only spoke in support of the amendments in this group but expanded on them and provided additional information.
I understand the Minister saying that it is important to get this right and not rush, and that the consultation will inform the SIs. I also understand him pointing out the rigidity of primary legislation. I accept his points and am glad for the assurances he was able to give.
I stress the importance of looking at all implantable devices, even those that look as though they are in such common use that we do not need to worry about them. An example happened just a couple of weeks ago when a guide wire for a pacemaker snapped inside a patient. Completely unknown previously, these things can happen. They need to be picked up and recorded.
We also need to update the way in which we record information and use the new artificial intelligence computer systems to analyse it. The reason I asked for expert oversight is that there is no point in putting information into any kind of database unless the right information is extracted from it, and expertise is needed to set that up. I accept, however, that this is a hub, not a decision tool in itself.
The yellow card system that the Minister spoke about needs to be publicised much more widely. I hope that, as we go forward, there will be a positive move across the whole of healthcare, in particular to make sure that patients are aware of this scheme so that they can use it appropriately and early. It is an amazing scheme; I pay tribute to Professor Phil Routledge, who instigated it many years ago—decades ago, I think—as a way of collecting adverse reactions.
I appreciate the Minister’s assurance about working with the devolved nations, particularly in the light of the unfortunate remarks made recently about devolution. It is important to have compatible information systems and oversight that allows the free movement of information. That happens in the UK Foundation Programme Office and the UK medical and dental recruitment offices, where four-nation oversight works well. I know that those types of medical practice are outside the Bill’s remit but we have examples of good working, which needs to be built on to cement the sharing of information across the different healthcare systems.
I should alert the Committee to the fact that the House may divide during the next debate. I will adjourn our proceedings accordingly. We now come to the group beginning with Amendment 105. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
105: After Clause 16, insert the following new Clause—
“Requirement for consultation with devolved authorities
(1) Before making regulations under section 16 that contain provision which is within the legislative competence of a devolved legislature, the Secretary of State must consult the relevant devolved authority on that provision and have regard to the views of that devolved authority.(2) In this section—“devolved authority” means the Scottish Ministers, the Welsh Ministers, Northern Ireland ministers or a Northern Ireland department; and“devolved legislature” means the Scottish Parliament, Senedd Cymru or the Northern Ireland Assembly.(3) A provision is within the legislative competence of a devolved legislature if—(a) it would be within the legislative competence of the Scottish Parliament if it were contained in an Act of the Scottish Parliament;(b) it would be within the legislative competence of Senedd Cymru if it were contained in an Act of Senedd Cymru (including any provision that could only be made with the consent of a Minister of the Crown); or(c) the provision, if it were contained in an Act of the Northern Ireland Assembly—(i) would be within the legislative competence of the Assembly, and(ii) would not require the consent of the Secretary of State.”Member’s explanatory statement
This new Clause would require the Secretary of State to consult the devolved administrations before making regulations concerning UK-wide information systems.
My Lords, I am moving Amendment 105 on behalf of my noble friend Lady Thornton; it leads the group of amendments following Clause 16, which provides the legal framework for the medical devices information system. I will also speak to our other amendments in this group—Amendments 128, 130 and 132—and on the remaining amendments, including government Amendment 126.
The number of amendments in this group shows the strength of feeling on this issue. Key issues raised last week and in debate on Clause 16 earlier today are also relevant here. As we have all stressed, First Do No Harm, the landmark report by the noble Baroness, Lady Cumberlege, very much places the importance of the MDIS system centre stage. The complete lack of safety data and record-keeping on pelvic mesh implants in thousands of women—including basic details about the patient’s name, medical history and health problems, and manufacture and supply information for these devices after implantation, which would have enabled patients to be traced and treated—reinforces the need for MDIS and its future role as both an information and tracing system.
Amendment 105 would add a new clause after Clause 16 to place a statutory requirement in the Bill that the devolved Administrations in Scotland, Wales and Northern Ireland must be consulted before regulations on the MDIS are laid and that the Secretary of State must have regard to the views of the devolved authority. Government Amendment 126 and Amendments 105, 127, 128, 129 and 132 all aim to strengthen consultation provisions, including public consultation before making regulations under any provision of Parts 1, 2 or 3 of the Bill or under Clause 16(1).
This focus on the importance of consultation and ensuring that NHS Digital—with its existing remit and expertise limited to England—fully engages in meaningful and active collaboration with the devolved authorities is absolutely crucial for the UK-wide development of MDIS. If the system is to be fit for purpose, the work to deliver it must be informed by and responsive to the local requirements and realities across the devolved Administrations. The devolved nations must be fully involved in the system’s design and modelling, have equal access to MDIS data analysis and sharing, have a governance structure for MDIS that includes representatives from all the devolved authorities’ institutions, and have parity of funding across the four nations.
Clause 41 is very scant in detail, so our Amendment 128 specifies cohorts that must be consulted under the clause—healthcare, pharmaceuticals, veterinary, medical research and patient representative organisations, and other such persons considered appropriate. Amendment 129, in the name of the noble Lord, Lord Sharkey, covers similar ground and gives welcome clarity on the consultation details, including the terms, start date and length of consultations.
Amendment 127, in the name of the noble Lord, Lord Patel, quite rightly brings the focus back to listening to the voices of patients directly affected by the regulations. Can the Minister tell the Committee what structure and formal processes will be in place to ensure that the knowledge and expertise from health organisations, patients and staff across health and social care impacted by MDIS is drawn on in the system’s development and operation?
I have a few questions for the Minister on the various letters to Peers and to the noble Baroness, Lady Finlay, and from NHS Digital, to which I referred earlier. If he does not have the answers to hand, I am happy for him to write to me. First, on NHS Digital’s reference in its letter of 4 November to the need for further detailed discussions with the devolved authorities to design and plan the MDIS solution and proposal to formally review where further input is needed with further workshops and consultation, can the Minister update the Committee on the programme of work that has occurred so far and what regular engagement is planned regarding both the content of the regulations on MDIS under Clause 16 and its future operation?
Secondly, NHS Digital refers to engagement with stakeholders, including clinicians, patients, devolved authorities, private providers, MHRA, the CQC and NICE, as the key to delivering “a full interoperable UK-wide system”. This is, of course, welcome. We are told that there are active discussions with the devolved authorities and how they can best be supported in their engagements with stakeholders within their own nations. Can the Minister tell the Committee what work is being undertaken and how that is progressing?
Thirdly, the letter of 9 November from the noble Lord, Lord Bethell, also reminds us of the involvement of the private provider sector in MDIS, which we have not really looked at yet. Can the Minister say what discussions have been held and what work has taken place with private providers and how it is envisaged that they will participate in MDIS?
Fourthly, in that same letter, the Minister refers to reassurances given by NHS Digital, NHSX—which has responsibility for setting national policy and developing best practice for NHS technology, data and digital—and the Department of Health and Social Care teams responsible for developing the regulations that they will engage with the devolved Administrations “to ensure there is an effective system across the UK”. How will this three-way relationship be overseen and co-ordinated?
Finally, the Minister’s letter of 9 November updates on the ongoing process of consultation on Clause 16 with the devolved authorities. The Scottish Health and Sport Committee has agreed to recommend consent to the clause to the Scottish Parliament, and Northern Ireland officials have laid a legislative consent memorandum at the Assembly business office for scrutiny. However, in Wales there are “residual concerns”. Can the Minister tell us what these are and what has been done to address them? As a result of the overall consultation, does the Minister envisage changes to the Bill on Report and, if so, will he undertake to ensure that any such amendments are circulated to Peers in advance of their submission to the Marshalled List? I beg to move.
My Lords, in speaking to my Amendment 127, I also speak in support of the amendments referred to by the noble Baroness, Lady Wheeler, on consultation with the devolved Administrations. While Scotland is devolved in terms of healthcare, the regulations on medicines and medical devices, particularly market authorisation, are not. I support the comments on consulting the devolved Administrations and I have no doubt that the Minister will respond.
I am extremely grateful to my friend, the noble and learned Lord, Lord Mackay of Clashfern, for adding his name to my Amendment 127. I am pleased to see that he might speak to it later. The amendment would add to line 9, page 24 of the Bill, the words
“patients and end users directly affected by the regulations”.
It would strengthen the consultation provision by requiring that patients and end users be part of any consultation relating to potential new regulation on medicines, veterinary medicines and medical devices.
Clause 41 creates a duty to consult the relevant authorities when using the delegated powers to make provisions for medicines, veterinary medicines and medical devices. However, this duty refers only to who the authority thinks it should consult, giving a wide area of discretion and providing no guidance or guarantee on consulting patients and end users of medicines and medical devices.
The Cumberlege review found widespread failure to listen to patients’ voices. It recommended that the regulatory framework underpinning the MHRA, and medicines and medical devices in general, be reformed to better take into account patients’ perspectives in the future. In addition, the review recommended that the MHRA regulatory framework should have a requirement to demonstrate how patient views have been taken into account and influenced regulatory design. With this in mind, it is surely crucial that any duty to consult on the exercise of powers should also include reference to the need to consult patients and end users of medicines and medical devices where that is considered reasonable.
My Lords, all the amendments in this group deal with the very important question of consultation. As the DPRRC has pointed out in its report on the Bill, consultations are not a substitute for proper parliamentary scrutiny, which the Bill so obviously fails to provide, but in the absence of any real parliamentary mechanisms for real scrutiny, consultations take on an added importance.
Clause 41 is slightly improved by the Government’s Amendment 126. The obligation to consult the devolved Administrations is obviously critical, although it would be helpful if the Minister could explain why in Northern Ireland it is the Department of Health that must be consulted rather than Ministers.
The Minister may also be able to reassure the Committee that the government amendment does not provide only one overriding consultation; the text seems to suggest that when it refers to carrying out “a public consultation”. Can we assume that there will be not portmanteau consultations but individual consultations on each proposed significant policy introduction, change or amendment?
The introduction of a new obligation in proposed new subsection (1B) to include a summary in the consultation document, with the relevant authority’s assessment of the matters addressed by the proposed regulations, is welcome, as far as it goes. But quite what depth or rigour should these assessments have? Can the Minister assure the Committee that the assessments will have the same reach, depth and rigour as the standard impact assessments produced for SIs?
Apart from naming the devolved Administrations, it is notable that the government amendment does not specify, or even hint at, who should be consulted in any of these consultations. The Bill is entirely silent on the matter. This leaves open the possibility of narrowly drawn consultations and the omission of important interested groups, not to mention short consultations over holiday or very busy periods. I am particularly concerned that the voice of the medical research charities be clearly heard in all the appropriate consultations. I remind the Committee of my interests as chair of the Association of Medical Research Charities, whose 150 members spent £1.9 billion on research last year—the same amount as was spent by the Government. Despite this enormous contribution, the Government have form in overlooking the medical research charities sector. It took an amendment moved in your Lordships’ House to persuade the Government to agree that the board of UKRI should include a person with experience of the sector. We do not want to see the same omission here.
I have been made aware that a Division may happen in the course of the next contribution. I apologise in advance to the noble Baroness, Lady Bennett of Manor Castle, should we have to suspend the Committee. I now call the noble Baroness, Lady Bennett.
It is a pleasure to follow the noble Lord, Lord Sharkey. I share his concerns about the quality, depth and effectiveness of far too many consultations. As he was speaking, I was looking at an editorial article in the British Medical Journal, which says:
“The medical-political complex tends towards suppression of science to aggrandise and enrich those in power.”
That is a powerful message.
I will speak specifically to Amendments 105 and 132, in the name of the noble Baroness, Lady Thornton, to which I have attached my name and which have been ably introduced by the noble Baroness, Lady Wheeler. I do not feel the need to speak at great length—maybe I will manage to beat the bells, but we shall see. However, I want to reflect on the fact that both Amendment 105, in addressing information systems, and Amendment 132, in addressing regulations, specify full consultation with the devolved Administrations. As the noble Baroness, Lady Finlay, noted in her summing up on the previous group, the Government’s attitude towards devolution is a little uncertain. It would seem that the Prime Minister’s view changes from one hour to the next, according to recent reports, but it is terribly important that we see in the Bill an absolute commitment and requirement to consult the devolved Administrations.
In his comments on the initial group, the Minister noted that data needs to be consistent. Speaking as someone who has occasionally been forced to manipulate databases and work with Excel spreadsheets, although that is certainly not my favourite thing, I think we all know the problem with inconsistent data and the kind of outcomes that it can produce. It is crucial—
My Lords, we are now reconvening the Grand Committee and I call upon the noble Baroness, Lady Bennett of Manor Castle, to perhaps recapitulate her speech and continue thereafter.
Thank you. I will not go back to the beginning but I was speaking about the need for consistent data, which the Minister referred to in his earlier summing up. We have, of course, diverging systems and that is the point of devolution: it is for the devolved nations and Administrations to be able to go their own way and end up with quality, easily comparable data. It is obvious that there will need to be very tight consultation and working together. Amendments 105 and 132 would put this into the Bill, Amendment 105 being particularly important in terms of data.
I will also refer briefly to the other amendments in this group. As the noble Baroness, Lady Wheeler, said, government Amendment 126 is an improvement. Any kind of strengthening of consultation, as in the references to the public and devolved Administrations, is good but it is only partial. I can only commend Amendments 127 to 130 for pushing further on these issues. We know from the report of the noble Baroness, Lady Cumberlege, that so much needs to be done better. Transparency, openness and consultation are clearly key to all of that.
Lord Mackay of Clashfern (Con) [V]
My Lords, I join my noble friend Lady McIntosh of Pickering in apologising for having my name to amendments here while I have found myself in proceedings on another Bill which were fairly encompassing in the sense that it required a good deal of attention to understand what was going on. We were not able to achieve the result that the noble Baroness, Lady Finlay, managed of being in both places at once. However, I am glad to be here on this occasion and I am particularly interested in Amendment 117, which we may reach later.
In this group, I particularly support Amendment 127, which the noble Lord, Lord Patel, has carefully referred to already. I generally support all that has been said by others before me on this group of amendments, especially the reference of the noble Lord, Lord Sharkey, to the need to keep in mind the medical charities. I think particularly of Cancer Research, but it applies equally, as he said, to all of them.
I wondered whether the government amendment made unnecessary some of our amendments, but I really wonder about that, because a public consultation is not specifically targeted, and I think the groups that we have represented—particularly in relation to Amendment 127—require to be consulted more directly. I do not know how your Lordships feel about consultations, but I often found that I did not know that there was a consultation at all until the time allowed for it was well passed. That is no doubt due to my lack of efficiency, but I suspect that a lot of patients will not know that a public consultation is happening unless it is drawn specifically to their attention. It is important that the consultation, public as it is, has direction as well. Therefore, I think that Amendment 127 and the other specific amendments are well worth considering in relation to the new government amendment.
I am also extremely anxious that the devolved Administrations should be properly consulted. Of course, devolution and independence are different things, and we are talking about devolved institutions at present. This group of amendments is important, and I agree with most of what has been said about them. Therefore, I do not need to say any more on this occasion.
My Lords, it is a great pleasure to follow the noble and learned Lord. I have added my name to that of my noble friend Lady Thornton on Amendment 128, which was introduced by my noble friend Lady Wheeler. This regards the organisations to be consulted—other noble Lords have already referred to this—and concerns the provisions of Clause 41 for consultation on Parts 1, 2 and 3 of the Bill. As noble Lords have said, at the moment, it is entirely up to the Secretary of State who is consulted, other than the clarification the Government have brought in relation to the devolved Administrations.
The context of this amendment is the extensive power given to Ministers under the Bill. We have debated this before, but it is worth reminding the Committee that the Delegated Powers Committee in its report on the Bill was highly critical of Ministers for failing to provide sufficient justification for parts of the Bill adopting a skeletal approach. As the committee said, the Bill gives Ministers wide powers to almost completely rewrite the existing regulatory regime for medicines and medical devices.
It is also worth reminding the Committee that the Constitution Committee described the Bill as
“a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made using the powers.”
It went on to say:
“The Government has not provided the exceptional justification required for this skeleton approach.”
The case for a sunset clause is readily apparent, but in its absence, the way in which consultations are done assumes more importance than normal. It is very surprising that the duty to consult is open-ended and simply leaves it to Ministers to decide whom to consult. The Minister may say that he does not like lists of organisations to be consulted, but legislation is littered with lists of organisations because it is important to reflect the range of bodies that ought to be consulted. Discretion is always given to Ministers to add to those lists of organisations.
My Lords, I support in particular Amendments 105 and 127 in this group, but I shall speak briefly to Amendment 105 and thank the noble Baroness, Lady Wheeler, for introducing this short debate on it. In the context of the proposal for a requirement to consult the devolved Assemblies, I share the concern expressed by my noble and learned friend Lord Mackay of Clashfern: it is essential that we keep all the devolved Assemblies in tune with Westminster thinking as the Bill and the regulations under it progress.
Will my noble friend the Minister please explain what form of consultation he imagines will take place in preparation for the regulations under the Bill? What timeframe will be allowed for the consultation? What regard will the Government and his department have to the result of the consultation? Also, will the responses to the consultation be published? In my experience, every consultation from the Government solicits many responses, particularly on controversial issues. I think this will excite a lot of interest as well. Are the Government now out of the habit of publishing responses to consultations, rather than their brief resumé of them? Are they inclined to revert to the former practice of publishing all the results, which I think is enormously helpful?
With those few words, I support the sentiments behind Amendments 105 and 127, but I am concerned that there should be proper consultation over a 12-week period, and that the results of and responses to the consultation will be published for us all to read.
My Lords, these amendments relate to consultation. My noble friend Lord Sharkey’s Amendment 129, to which I have added my name, specifies some people or classes of people who should be involved but who have in the past been omitted—patients or representatives of patient groups, medical research bodies, the pharmaceutical industry and academic researchers.
My noble friend asked a good question of the Minister about why the consultation in Northern Ireland is with the department and not the Minister. The Select Committee on which I sit has engaged with the Northern Ireland Government on various areas of policy. They often do things well, but they do it their way.
The amendment also calls for details about consultation timings, consultees and proposed publication details. The point the noble and learned Lord, Lord Mackay of Clashfern, made about contacting patients was a really good one. His remarks follow on from those of the noble Lord, Lord Hunt of Kings Heath. Many consultations involve patients, but they are often with what I might call professional patients. This is not a derogatory statement, but sometimes they are the usual suspects and the story does not change. That can lead to a loss of a total patient view.
Government Amendment 126
“requires a relevant authority to carry out a public consultation before making regulations under any provision of Part 1, 2 or 3, and to set out the authority’s assessment of any matter to which the authority must have regard in making the regulations”.
It also requires the Secretary of State
“to consult the devolved administrations in relation to regulations under clause 16 (1).”
In this morning’s useful meeting—I join others in thanking the Minister for hosting such a fascinating session—we touched briefly on Scotland, Wales and Northern Ireland. Would the Minister confirm that the devolved nations are being consulted on their involvement in their use of our registries, and maybe ours of theirs?
My Lords, Amendment 105, tabled by the noble Baroness, Lady Thornton, would mandate consultation with the devolved Administrations before making regulations under Clause 16. This question has been raised by a very large number of those who have contributed. Amendment 132, also tabled by the noble Baroness, would insert after Clause 41 a separate obligation to consult on regulations made under the Bill that relate to matters within devolved competence.
Both amendments are unnecessary. It goes without saying that we will consult the relevant Northern Ireland departments where it may be possible to make regulations jointly under Parts 1 and 2 of the Bill for the benefit of the whole of the UK. I reassure the noble Baronesses, Lady Jolly and Lady Masham, and all others who mentioned consultation with the devolved Assemblies that we are in very regular contact. There are fortnightly four-nations calls. These include NHS Digital where necessary. We intend to maintain this level of engagement. It has proved constructive and has contributed enormously to our plans for broad consultation on the mechanics of the Bill.
While medical device regulation relates to reserved matters, the provision of healthcare services, including the healthcare data collected, is devolved. As the regulations about the establishment and operation of the information systems encompass both areas of responsibility, it is right and proper that the Secretary of State is required to consult the devolved Administrations before making regulations under Clause 16(1).
The noble Baroness’s amendment appears on the list before my own, but Amendment 126 in my name, which I will come to shortly, is appropriate for this situation. It makes it very clear that the devolved Administrations will be consulted on regulations to be made under Clause 16. This reflects that provisions in those regulations may relate to devolved as well as reserved matters.
Amendment 127, in the name of the noble Lord, Lord Patel, is unnecessary. My Amendment 126, which I will come on to shortly, would apply a statutory duty to carry out a public consultation precisely because we know how important it is for patients and other stakeholders to be involved. The intent of Amendment 127 is already achieved by Clause 41 and is further clarified by the government amendment.
I have received a request to speak after the Minister from the noble Lord, Lord Hunt of Kings Heath. I am not clear whether the noble Lord, Lord Patel, also wishes to do so. Perhaps that could be clarified.
I thank the Minister for his extensive response. Essentially, he has relied on the well-known departmental argument that, by listing certain categories of organisation, you exclude others. However, legislation that has been passed in the last few years has often contained extensive lists of organisations to be consulted. Amendment 128, which I support, would give Ministers the power to consult any other persons that the authority considered appropriate. I wonder whether the Minister will just answer this. He would surely accept that this Bill is highly unusual in giving a huge amount of powers to Ministers essentially to change primary legislation through regulation and extensively to alter the regulatory framework for medicines and medical devices. Given that, we should be careful about similarly open-ended regulations on consultation. The amendment would provide reassurance to the key sectors that they will be consulted, but it would also give discretionary power to Ministers to add to that on the occasions when greater flexibility was needed.
My Lords, I acknowledge the noble Lord’s point that the Bill puts huge emphasis on the effective and impactful nature of our consultation arrangements. That is very much our approach. He is entirely right that these consultations are key. That is why we have sought, as I have this afternoon, to give reassurances about our approach to consultation.
On the noble Lord’s point about the listing of groups, we have in mind two considerations. The first is that, by listing one group and not another, you assign a degree of legislative weight on one group and not the other. That is an unfortunate result of a listing process such as he describes. Secondly, as I have said, not all the groups that you could list in one part of the Bill would be relevant for all parts of the Bill. For that reason, we are reluctant to provide lists of groups that technically have to be consulted on every aspect of the Bill.
I take the noble Lord’s point that broad, effective and deep consultation is critical to the effective implementation of the Bill and to the drafting of thoughtful and effective regulations. All those involved in the Bill, including the department and me, very much agree with that point. That is why I tabled the amendment.
I thank the Minister for his extensive and helpful response, particularly on the comments made by my noble friend Lord Hunt about the groups that are consulted. This has been an excellent debate and I have little to add, as noble Lords put forward the issues so ably, in particular on the importance of listening to patients and patient representatives so that the consultation is meaningful and well thought through, given the enormous powers that are in the Bill and will be set out in the regulations. It is timely for my noble friend to remind us of the context of the DPRRC and Constitution Committee reports. I asked the Minister to consider whether Clause 41 should specifically include reference to consultation with the devolved authorities. If he could come back to me on that, that would be helpful. I also asked some questions about his correspondence, which I hope he will agree to follow up.
On the question of why the government amendment is being made to Clause 41 rather than Clause 16, which I think is what the noble Baroness is asking about, Clause 41 is concerned with consultation. It is important that consultation requirements are provided for in one place, as that assists with clarity and understanding. The legal effect is the same, irrespective of where in the Bill the obligation to consult the devolved Administrations when making regulations under Clause 16 is found.
We now come to the group beginning with Amendment 108. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
108: Clause 35, page 19, line 22, at end insert—
“( ) The Secretary of State must disclose information for the purpose of warning the public about concerns relating to a medical device where there is a clear threat to public safety.”Member’s explanatory statement
This amendment places a duty on the Secretary of State to disclose the information where there is a clear threat to public safety.
My Lords, in moving Amendment 108, I will also speak to Amendment 114. I am immensely grateful to my friend, the noble and learned Lord, Lord Mackay of Clashfern, for his support. I beg noble Lords’ indulgence because I intend to explore these two amendments in some depth as I have some concerns about them.
Amendment 108 places a duty on the Secretary of State to disclose information
“where there is a clear threat to public safety.”
Clause 35 provides that the Secretary of State
“may disclose information for the purpose of warning members of the public about concerns that the Secretary of State has in relation to the safety of a medical device.”
This is welcome, but the power is discretionary. There is no duty to disclose information in these circumstances. It is not clear why there should not be an unambiguous duty to disclose information to the public where their safety is an issue. The Government have repeatedly committed themselves in their guidance and policy documents to patient safety as their primary concern, and have given reassurances about it in the other place. However, this clause is yet another example of where there is no explicit legal commitment to patient safety. For this reason, an amendment to this clause is suggested to create a duty to disclose information where there is a threat to medical device safety.
In addition, it must be queried what is meant by a “threat to public safety” and how any such threat is to be judged or even detected. The Cumberlege review reviewed the failure of medical professionals and the system in general to listen to patients’ own reports of pain and the seriously adverse effects of their implants. The duty to disclose a threat is only as meaningful and effective as the processes behind it that monitor and capture the information relating to patients’ adverse events. A safety issue will not be recognised if patients are not being taken seriously.
Part of the findings of the Cumberlege review related to the ineffectiveness of the current yellow card system for self-reporting adverse events. There is a lack of a clear and well-publicised route for patients to report their experiences. Clear and effective processes need to be in place to capture the information relevant to identifying potential threats to public safety. This duty to disclose should be supported by such processes.
Lord Mackay of Clashfern (Con) [V]
My Lords, I warmly support the noble Lord, Lord Patel, in both these amendments. First, in relation to safety, the idea that the Secretary of State “may” disclose information in relation to concerns about patient safety strikes me as extraordinary. If I knew that something was dangerous and that somebody was just about to take it, I think I might be in very grave difficulty if I did not warn the person. The idea that the Secretary of State can have information that suggests a danger to people, and yet is allowed to keep it to himself in the exercise of his discretion, strikes me as extraordinary. It may require some explanation from the Minister as to why that should be. There is a tendency to provide for discretion rather than compulsion. We have seen a bit of that already this afternoon. In the area of safety, discretion should certainly give way to compulsion where it is a matter of risk to a person who is involved.
Amendment 114 concerns confidentiality. Patient confidentiality is one of the most important aspects of the law on medical treatment. It requires to be taken into account very carefully because people have a great concern about the confidentiality of their medical situation—some people more than others because it depends on the origin of the difficulties of the medical history. The general principle of confidentiality in relation to patients is, in my opinion, extremely important and I cannot understand why this little provision has been included that interferes, in my mind, with a very important principle, without much explanation. I support both these amendments.
I put my name to Amendment 108 and, when listening again to the noble Lord, Lord Patel, and my noble and learned friend Lord Mackay of Clashfern, it was so good to hear this tremendous commitment to the safety of patients. The public must be paramount and know where there are issues, conflicts and risks. It seemed to me that if there really are concerns that a medical device, for instance, may pose a threat to safety, surely the public have a right to know.
We should have the right to make informed decisions about our healthcare, our treatment options and the medicines and medical devices available to us. Too often—we have heard this and written about it in the report, First Do No Harm—the healthcare system has shown itself to be unwilling, or even unable, to be transparent. There are too many examples of cases where people have had treatments or medical devices inserted without really being aware of the known safety concerns surrounding them. That is quite unacceptable.
My hope and expectation is that, once we have an independent patient safety commissioner—of course, we are coming on to that in the next amendment—these safety concerns will be more swiftly and thoroughly identified and communicated so that patients and the public know what is going on. I fully support the amendment. It would provide another layer of transparency and assurance, which is why I am very happy to support my noble and learned friend and the noble Lord, Lord Patel, who I consider my noble friend, on this amendment.
My Lords, I will speak to Amendment 108. In doing so, I remind noble Lords of my interests as listed on the register and my membership of the First Do No Harm All-Party Group, set up by my noble friend Lady Cumberlege. It seems that the debate and discussion on this issue revolve around the use of “may” or “must”, as is often the case in legislation —we are all familiar with this. I fully understand why the Bill uses the word “may” in relation to concerns as set out currently in the clause because, as described, they involve ambiguity. That is implicit in the way the clause is framed. It therefore requires judgment about the balance of risks, which is difficult to prejudge.
It seems that Amendment 108 is a build, as they say, on this and an elegant solution to the existence of a higher-risk category of the kind that the noble Lord, Lord Patel, my noble and learned friend Lord Mackay and my noble friend Lady Cumberlege have talked about. It would leave “may” in place for when ambiguity exists, but would introduce “must” when, in their words,
“there is a clear threat to public safety”,
which is the highest category of risk. It seems unconscionable to think that, when there is knowledge of such risks, they should not be communicated; indeed, there should be, if there is not already, an obligation to do so. Consequently, I feel that this amendment improves on the Bill. It seems perfectly logical and rational to me, and I hope my noble friend the Minister will be sympathetic.
I support Amendment 108, led by the noble Lord, Lord Patel, which would place a duty on the Secretary of State to disclose information they hold
“relating to a medical device where there is a clear threat to public safety.”
Amendment 114, also in the name of the noble Lord, Lord Patel, would retain Regulation 3B of the Medical Devices Regulations 2002, which was inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, among other things, requires the 2002 regulations to comply with the Data Protection Act 2018.
I support these amendments but wonder what might be the process to contact patients in the event of a fitted medical device fault, which might lead to a threat to public safety if it was more than just one. Would it be the same sort of process as that for recalling certain faulty domestic appliances, which, by law, also need to be recorded? Noble Lords may chuckle, but there is a system there. Where the patient has a medical device implanted, who is responsible for taking patient contact information?
More importantly, how does the patient ensure that their contact data is up to date? Will it link, using the unique patient reference number: their 10-digit NHS number? It would need the patient to ensure that their personal data is kept up to date via the website or app. Many do use the NHS app, but, given the patient demographic, I would not be that confident in relying on that mechanism. I am not sure that the general public are ready for that requirement or, in many cases, have the capacity or devices to fulfil it. Could the Minister clarify this for me?
I am very grateful to the noble Lord, Lord Patel, and the noble and learned Lord, Lord Mackay of Clashfern, for bringing these amendments to the Committee. They are quite different, although linked. On Amendment 108, which would place a duty on the Secretary of State to
“disclose information … about concerns relating to a medical device where there is a clear threat to public safety”,
the noble Lord, Lord O’Shaughnessy, absolutely got it when he said that this is not a “may” but really is a “must”. The thing about this that would interest me most, because it is an important duty, is how it could happen: what would trigger such a disclosure, where would it come from and how would it be handled?
The only thing I would ask about this issue is whether a Secretary of State is the right person to do that. I have in mind someone who is now a respected noble Lord of this House, who fed his daughter a burger to show us that beef was safe during the BSE outbreak, which led to the creation of the Food Standards Agency as an independent organisation that would say, “This food is actually unsafe”, to the Government. It quite rightly has the powers to bring about a closure or recall. This is exactly the right place to be on patient safety. The only question I would pose is: is that the right person to do it?
Amendment 114, on Regulation 3B, worries me enormously. I would need to have an explanation from the Minister as to why he would remove confidentiality and seemingly protect commercial interests. It is very worrying, and the Committee needs to know the justification for that because it looks to me like it probably needs to remain in place.
Thank you, Madam Deputy Chairman; I resisted the urge to leap in. My contribution, anyway, will be brief. I want to build on my remarks in the previous group and, in particular, to address Amendment 108 in the name of the noble Lord, Lord Patel. I referred then to the article in the British Medical Journal about the medical-political complex. We have seen over the decades, again and again, in respect of medicines, pesticides and herbicides, situations where there has been growing concern about a particular chemical. Critics have come under tremendous pressure, including critics often from Governments—critics in official positions—from very large, powerful commercial interests to remain silent.
The noble and learned Lord, Lord Mackay of Clashfern, asked how anyone could not speak out in a situation where they saw that there was a danger or a serious cause for concern. We have seen again and again, however, situations where people, including Ministers in Governments, have come under tremendous pressure. Does the Minister not think that an amendment such as that proposed by the noble Lord, Lord Patel, would protect the Government, the individual and the public if she or one of her successors were in a situation where there was grave cause for concern but also very powerful multinational company forces at play?
My Lords, I thank the noble Lord, Lord Patel, for his amendment, designed to ensure that the public are always warned about concerns relating to a medical device where there is a clear threat to public safety. The Government agree that sharing information with the public—as well as the healthcare system—is important. Safety information is provided already to relevant special interest groups and through social media channels to ensure that messages are accessible and reach those affected who need to be aware or take action. This can include patients, healthcare professionals and members of the public. For example, MHRA recently urged users of Safe and Sound Infrared Ear Thermometers to check their product code and lot number due to a voluntary recall of specific lots because of a two-degree temperature overreading fault. This is a safety concern for members of the public who are monitoring their temperature, particularly in view of the pandemic. However, noble Lords are correct that it is critical that we do more to improve transparency and share more safety information to support patient safety. This has been made even more apparent in the findings of the report by my noble friend Lady Cumberlege.
Clause 35, along with Clause 13(1)(h)(iii), is designed to ensure that in future we can share information with key parts of the healthcare system, academia and the public in a considered and effective way. Under the current medical device legislation, MHRA does not have a clear legal basis to report all incidents involving medical devices occurring in the UK. By contrast, this has been common practice in the USA, via the FDA’s MAUDE database, and in Australia, via its DAEN database. Medicines legislation already enables MHRA to provide its interactive drug analysis prints, or iDAPs. It is therefore right that, via the information-sharing powers in this Bill, we are able to disclose in an appropriate manner all medical-device serious incidents. This will provide greatly improved transparency about the safety of medical devices in the UK.
Amendment 108 would place a legal requirement on the MHRA to disclose information to the public to warn them about concerns relating to a medical device where a clear threat to public safety had been determined. The amendment is unnecessary, as the MHRA would always share safety information with the public where it was necessary to do so. However, issuing warnings and safety information to the public needs careful management, a good understanding of the situation, full verification of the data and consideration of wider complexities. There is a high risk that mandating the disclosure of clear threats to public safety would commit MHRA to regular disproportionate direct communication to the public about safety issues that the public cannot act on.
Clause 35(2) will ensure that the public are warned of concerns about the safety of devices in the most appropriate and effective way. We can proactively warn the public when there are actions that they can take to protect their own or others’ safety. In addition, we will be able to ensure that the public have access to wider information about the safety of devices, passively through the MHRA website. All adverse incidents with medical devices, for example, are published on the MHRA website.
Amendment 108 would risk the MHRA being forced to put out information that may cause harm. We must ensure that patients receive safety information in a proportionate manner, and that they will be in a position to engage with the information when serious safety warnings are given that affect them.
In response to the question about who makes the decisions on issuing such safety warnings and what that process is, I undertake to write to noble Lords with more detail.
Amendment 114 from the noble Lord, Lord Patel, would retain Regulation 3B of the Medical Devices Regulations 2002, as amended by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. This imposes certain confidentiality requirements on those operating the regulatory system for medical devices. I believe that the noble Lord’s intent is to ensure that confidentiality requirements apply when information is shared under Clause 35. I reassure the noble Lord that subsections (5) and (8) already take into consideration the disclosure of commercially sensitive information and personal data, as described under Regulation 3B of the Medical Devices Regulations 2002, and provide safeguards to ensure that commercially sensitive information will not be disclosed unless necessary and proportionate and that any disclosure of information will not contravene data protection legislation.
Keeping in place Regulation 3B of the Medical Devices Regulations 2002 would create two conflicting provisions: Regulation 3B, which would, on its face, restrict the regulator operating under those regulations; and what is currently Clause 35, which, with certain restrictions and limitations, would allow the regulator to disclose some information to which that restriction in Regulation 3B might apply. The Government seek to use the powers within this Bill to improve transparency around medical devices and want to be as clear as possible in law about what they can and cannot disclose and the circumstances in which that disclosure could take place. By leaving Regulation 3B in place, there would be contradictory and overlapping provisions concerning confidentiality and disclosure of information that would be unnecessarily confusing.
I reassure noble Lords that the provisions relating to confidentiality that we are talking about in respect of these clauses is the confidentiality of manufacturers and not patient confidentiality. While respecting manufacturers’ confidentiality, the measures that we are taking in this Bill will allow us once we have left the EU at the end of the transition period to share more information with a view to patient safety than is currently allowed under EU regulations. The steps that we are taking are about being able to do more on patient safety than we currently can under the EU and do not contravene any of the measures on patient confidentiality that noble Lords have expressed concerns about.
I hope that I have reassured noble Lords that Clause 35 provides for an appropriate level of transparency while providing appropriate safeguards, and that neither of these well-intentioned amendments is therefore necessary or appropriate. I therefore hope that the noble Lord, Lord Patel, feels able to withdraw his amendment.
My Lords, I thank the Minister for her explanation in response to Amendment 114. My desire to explore the issue slightly more is partly a result of what the noble Baroness, Lady Cumberlege, and others have said. It is also partly a result of the very helpful discussions this morning about the time that it is going to take to get the protection on devices in place. If we have another mesh situation, will that be able to emerge in this period of time? If so, who will be responsible for saying that it is not a safe device?
I believe that responsibility will continue to lie with the MHRA. We have existing systems, such as the yellow card reporting system. The report by my noble friend Lady Cumberlege will have made an important difference; as we discussed earlier and in other sittings, not just the systems but the culture will need to change. That culture change has begun already.
We must get the systems right so that they operate as intended and deliver the results that we all want, but the noble Baroness, Lady Thornton, is right: in the space that there will be while we implement these changes, we need to be extra vigilant about these potential issues.
As I have already said, adverse incidents involving medical devices are published on the MHRA website. The job is to take all that information and make sure that it is not just dispersed but that people can build the bigger picture. That is what we are working towards.
My Lords, before I start, let me thank my noble friend Lady Cumberlege enormously for putting her name to Amendment 108. I apologise for not alluding to that earlier.
The noble Lord, Lord O’Shaughnessy, got it: my amendment leaves it to the discretion of the Secretary of State that there might be times when disclosure is not required.
To my friend the Minister, I say: good try, but I am not convinced. I do not see why my amendment cannot be accepted—it provides discretion but just removes “may”.
As far as Amendment 114 is concerned, the point is exactly this. The Minister may recollect the journalist’s report on the regulation of devices in the EU, which raised concerns about manufacturers not agreeing to provide safety information that they may have had when they were testing the devices. Removing that requirement for manufacturers does not help patient safety—hence my amendment asking to leave Regulation 3B as it is.
I have listened. In the meantime, I beg leave to withdraw the amendment.
109: Clause 35, page 19, line 33, at end insert—
“(4A) The Secretary of State may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of medical devices.”Member’s explanatory statement
This amendment makes clear that information held by the Secretary of State in connection with medical devices can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.
110: Clause 35, page 19, line 35, leave out “or (4)” and insert “, (4) or (4A)”
Member’s explanatory statement
This amendment is consequential on amendment in the Minister’s name inserting a new subsection into Clause 35.
111: Clause 35, page 19, line 37, leave out “or (4)” and insert “, (4) or (4A)”
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name inserting a new subsection into Clause 35.
Amendments 109 to 111 agreed.
Clause 35, as amended, agreed.
Clause 36 agreed.
Clause 37: Consequential and supplementary provision
We now come to the group consisting of Amendment 117. Once again, I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
117: After Clause 38, insert the following new Clause—
“Independent Patient Safety Commissioner
(1) An independent Patient Safety Commissioner is established.(2) The Office of Patient Safety is to be hosted and funded by the Cabinet Office.(3) The Patient Safety Commissioner must publish a business plan, reviewed annually, which sets out, in relation to the discharge of the Commissioner’s functions—(a) the Commissioner’s proposed main activities for the period covered by the plan (including the matters he or she intends to consider or investigate), and(b) the Commissioner’s proposed strategic priorities for that period.(4) The Patient Safety Commissioner must appoint an advisory board to provide the Commissioner with advice and assistance relating to the discharge of his or her functions, consisting of persons who (taken together) represent a broad range of interests which are relevant to the Patient Safety Commissioner’s functions, and must from time to time publish a report on the procedure followed and the criteria used when making appointments to the advisory board.(5) The Commissioner’s functions are to—(a) promote and improve patient safety with respect to the use of medicines and medical devices;(b) promote the views and interests of patients and other members of the public in relation to the safety of medicines and medical devices;(c) make recommendations to the Secretary of State;(d) establish and, when deemed appropriate, revise Principles of Better Patient Safety;(e) receive direct reports from patients and other members of the public, any other persons (whether natural or corporate), and the Secretary of State and, when the Commissioner deems appropriate, share those reports with relevant organisations and the Secretary of State;(f) produce and lay before Parliament for the attention of any committees of either House whose remit covers medicines and medical devices—(i) an Annual Report and Accounts, and(ii) any other reports regarding patient safety, which may include recommendations to improve patient safety with respect to the use of medicines and medical devices.(6) For the purposes of subsection (5)(d), the Principles of Better Patient Safety must—(a) describe expected patient safety outcomes relating to the safety of medicines and medical devices; and(b) be drafted in consultation with the public.(7) For the purposes of subsection (5)(f), the Commissioner may require a public body and other persons (whether natural or corporate) to provide such information as is reasonable in order to fulfil that function relating to the safety of medicines and medical devices.(8) In fulfilling his or her functions, the Commissioner may do anything which appears to be necessary or expedient for the purpose of, or in connection with, the performance of his or her functions.(9) The Commissioner has the duty to involve and inform patients and other members of the public in carrying out his or her functions.(10) The Commissioner may make recommendations to the Minister for the Cabinet Office for any additional powers which the Commissioner considers may be necessary to fulfil the duties and functions under this section.(11) The Minister for the Cabinet Office may by regulations make any other provision relating to the establishment of the Commissioner, including—(a) the appointment of a Commissioner,(b) the terms of office,(c) remuneration and financial and other assistance,(d) staff, and(e) any other matters the Minister for the Cabinet Office considers appropriate.(12) A statutory instrument containing regulations under this section may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament.”Member’s explanatory statement
This new clause would establish the Patient Safety Commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review.
My Lords, this proposed new clause, which would implement one of the most important recommendations in our report, First Do No Harm, is about the independent patient safety commissioner. I am conscious that you cannot change history, but you can plan for the future; that is what we seek to do through the independent commissioner.
I thank noble Lords from all sides of the House who have put their names to this amendment, particularly the noble Baroness, Lady Jolly, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel. I also thank the noble Lords who spoke in favour of the commissioner at Second Reading and have done so often since then.
Many people outside Parliament have also voiced their support. It really gladdens my heart, when we live in such troubled times, to have a rock-solid consensus. Of course, I await the response from my noble friend the Minister but I really do hope that he will choose not to stand apart but to be instrumental in improving safety and the lives of thousands of people by supporting this amendment, even if it requires a bit of redrafting.
I think that noble Lords will be grateful that I will not go through the amendment subsection by subsection, paragraph by paragraph, because that would take all night and it is all there for noble Lords to see. First, though, let me put a question. Why do we need this independent patient safety commissioner? It is quite simple: because there is no one person whose task it is to listen to the voices of patients, to stop the trends and patterns that give rise to safety concerns, and to encourage or require the healthcare system to act on those concerns when they are not being recognised and realised.
The healthcare system has failed to listen to patients’ concerns. Our review vividly and tragically illustrated that. Thousands of people have suffered. Lives have been ruined. I am absolutely convinced that, had we had a patient safety commissioner—that is, if that person had existed—much of the harm done could have been prevented.
When as a review team we worked together in July, in the early days when we first met, we heard from patients the enormity of their suffering, and we said, “Come on, we must act now.” But we were only a review team and could only recommend. Sir Cyril Chantler, my vice-chairman, and I went to talk to NHS England, to Professor Keith Willett and to the department’s then Chief Medical Officer, Dame Sally Davies. We asked them for these mesh operations to be paused until six safety measures were introduced. I have to say that those individuals were amazing and, to their credit, agreed to halt operations immediately. Today, more than two years later, those safety measures still have not been delivered.
I have heard some people say that we could nest a patient safety commissioner inside an existing body in the healthcare system. Quite frankly, that troubles me. The commissioner needs to be independent of the system—a person who is outside the system looking in, not somebody being in and looking out. We want someone who is independent, outside the system looking in. The commissioner must have an uncluttered and single-minded focus on patients and patients’ needs, and that person needs to hold their trust. The notion that such an important and major role should be nested within something else is practically flawed. Rather than being subsumed by an existing body, it would amount to a reverse takeover.
Similarly, the answer is not to set up another regulator within the system. We do not need another regulator; the space is too crowded already, as it is. No, we need a new voice, one which will talk and act from the patients’ perspective and encourage the system to do what needs to be done and hold it to account. Crucially, the commissioner must have statutory powers; he or she must have their powers established in legislation, which is why I am proposing this amendment today.
We have looked at other commissioners—certainly the Children’s Commissioner, who has proved herself so effective. She speaks for children. When I looked at her job description, I thought, “Yes, that’s what we want from the patient safety commissioner.” I was really interested to hear her on Radio 4 when there was a lot of controversy about children going to school or not. Parents were worried, as were the trade unions and the teachers—as were the children, to some extent. The Children’s Commissioner said, “Stop your squabbling. These children need to get back to school.” And I thought, “That’s great—that’s what we want from our patient safety commissioner.”
We need a person of standing, independent, accountable to Parliament and with the Cabinet Office as their sponsor, within government but avoiding conflicts of interest with other departments. This new voice will continue the work we started in our review, pressing the healthcare system to take timely action, where action is needed to minimise harm.
The remit of the patient safety commissioner as set out in the proposed new clause extends to medicines and medical devices. I have been asked whether the remit should not be wider, to cover all forms of treatment or even all patient experiences, not just those linked to safety. My answer is this: let us get to first base. The remit could be extended in future beyond medicines and devices, but this is where I believe the need is most urgent and we should address it.
Our healthcare system is very good. It is full of wonderful people, working hard to treat illness and to help people live healthy lives. But we discovered in our review that something is missing. We need something—no, we need someone—to be the patients’ port of call, their listener and their advocate. We need a person who holds the system to account, monitors trends and requires it to act. We need this person to be the golden thread tying this disjointed system together in the interests of those who matter most: the patients. Quite simply, we need an independent patient safety commissioner. I beg to move.
Before I call the next speaker, I must tell the Committee that we normally have a break about now but it has been suggested that we delay it until there is the vote in the Chamber, expected very soon, and that we then take 15 minutes. In the meantime, I call the noble Lord, Lord Patel.
My Lords, first, it was a privilege to put my name to the amendment moved by my noble friend Lady Cumberlege. It is a pleasure to follow her powerful speech, which made the case for an independent patient safety commissioner so powerfully that I am tempted to say that no more needs to be said about the amendment except for the Minister to accept it. But of course I cannot do that. I will try to make a case for why now is the time to accept what the noble Baroness is asking for. The time for her amendment has come.
I strongly support the amendment. It was one of the key recommendations of the noble Baroness’s report First Do No Harm to establish an independent commissioner for patient safety and to do this through legislation. The need to address patient safety as an important aspect of healthcare was identified in England following the publication of the report An Organisation with a Memory. This was the watershed moment in the history of patient safety development. In 2001, a report was produced, Building a Safer NHS for Patients, which led to the establishment of the National Patient Safety Agency for England; a national reporting and learning system was to be developed as part of it. In 2006, Safety First, a report for patients, clinicians and healthcare managers, was published, with the objective of recasting the functions of the National Patient Safety Agency. It was after that that I took the chair of it.
The National Patient Safety Agency did develop several good and respected methodologies and publications, and introduced some fundamental patient safety protocols, but it lacked the power and authority of an organisation established in statute. Functioning as an arm’s-length body of the Department of Health, and at its behest, was not the way to establish patient safety. In my view, it weakened its ability to deliver patient safety across the NHS.
As chair, I remember having to try to persuade management at NHS Confederation meetings that alert notices related to patient safety needed to be implemented. This lack of statutory authority meant that hospital trusts were not required to follow any guidance or alert notices. On Friday 1 June 2012, the functions of the NPSA were transferred to the special commissioning board as the NPSA fell victim to the cull of quangos. So what has happened since? Regulatory organisations have come and gone. NHS structures have changed and continue to do so. The NHS is a bit of a political football; I remember that, when I suggested that the political parties stop using it as one, the noble Lord, Lord Hunt, laughed at my comment. Change is a constant feature.
I understand that there may be a delay in the vote taking place in the House for technical reasons. I do not think that we can go on here indefinitely so I suggest that I call the noble Lords, Lord Hunt of Kings Heath, and we break then regardless.
My Lords, it is a great pleasure to follow the noble Lord, Lord Patel. No doubt we will have further debates about the role of politics in the National Health Service. I would just say to him that I think the failure of NHS England is, in many ways, an example of how we end up with a quango that seems unaccountable to Parliament but Ministers wash their hands of many of the decisions that they make. The problem is that you can end up with the worst of all worlds.
That perhaps reflects some of the issues relating to patient safety because, thanks to the Minister, we all enjoyed meeting the person responsible for patient safety in NHS England. The problem is that NHS England has many other responsibilities, including financial and target responsibilities. Patient safety does not really seem to be that body’s top concern.
This seems to be the very point that the noble Baroness, Lady Cumberlege, makes. Her report’s conclusion is really rather shocking in many ways. She made a general conclusion from the three areas that she investigated. She said that the healthcare system
“is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially.”
That is a devastating critique, particularly in relation to patient safety.
I forgot to declare an interest as a member of the GMC board, but I must make it clear that I am not speaking on behalf of the GMC.
The noble Baroness’s recommendation of a patient safety commission is so powerful because she proposes that somebody sits outside the current system, accountable to Parliament and not to Ministers or the devolved NHS management system. She argues for the commissioner to have the necessary authority and standing to talk about, report on, influence and cajole where necessary without fear or favour on matters related to patient safety.
My Lords, I suggest that the Committee adjourn for 15 minutes.
Sitting suspended.
Lord Mackay of Clashfern (Con) [V]
My Lords, the Bill will confer a power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices. I respectfully submit that a power to create a system to protect the public in relation to all three, but particularly two of them, is well within the scope of the Bill.
When I first read the report of my noble friend Lady Cumberlege, I was extremely upset by what it disclosed. When the noble Lord, Lord Hunt, followed me last time, he said that doing so was a privilege. I want to say that following him is a tremendous privilege because he knows much more about the internal structures of the health service and its related services than I do.
I was privileged to represent the Medical and Dental Defence Union of Scotland for a good number of years before I joined the public service. The work was concerned primarily with mistakes of one kind or another that doctors or dentists had been involved in, but the need for safety was absolutely clear in most of the cases I was involved in. The first time I ever came to the House of Lords was on the instruction of the Medical and Dental Defence Union of Scotland, but of course, that was long ago. The case concerned the safety of a patient.
The message that cries out from the report of the committee chaired by my noble friend Lady Cumberlege is that people are suffering considerable harm as a result of treatments given in the health service, but they have no one to turn to. There is no direct public voice for patients to come to and discuss the matter. It is essential to have someone to whom patients can bring their concerns, which may not always be complaints. It may start as something much less than a complaint—a concern that becomes a complaint if not attended to in any way.
It is essential that somebody with authority and complete independence of the health service be put in place now who is able to listen to what any patient may want to say in connection with the treatment he or she has received. There is a huge deficiency, as has been exposed clearly by the examples given in the report. Therefore, there is an urgent need for Her Majesty’s Government to deal with that immediately. It is all very well to say that it is not this or that, but the truth is that this is urgent, because people are suffering and have suffered from the absence of anybody to whom they can turn in situations such as those described in the report. The Government would be heavily at fault if treatments and difficulties of this kind emerged in the future without them having done anything about it.
The setting up of a patient safety commissioner seems to require in the first instance the appointment of a completely independent person who would be a voice for patients, with a knowledge of the service but independent of it. He or she could bring a patient’s question or trouble to the attention of the part of the service that was intimately concerned with it and do something about it. The report makes it clear that the full powers that a patient safety commissioner should have is a matter for detailed work by a taskforce, but in the meantime statutory authority should be given to an independent person to listen to those suffering in some way from a difficulty in relation to the health service so that it can be brought to people who understand the nature of the subject. The independent person could bring it to the appropriate authority. It is a serious matter that should be dealt with straightaway.
My Lords, it is a pleasure to follow my noble and learned friend Lord Mackay of Clashfern in talking to my noble friend Lady Cumberlege’s important amendment. It is impossible to match the passion and forensic skill with which she introduced her amendment—no one can make the case better and I will not try—but I offer her my deepest support for what she is trying to achieve through it.
The review that my noble friend carried out is quite simply one of the most remarkable of its kind, detailing as it does the extraordinary harm done to patients, mostly women, because of an inadequate safety regime that was too lax on products coming into the market, not capable of fully monitoring the adverse effects of products while they were used in the health system, and unwilling to heed the voices of those crying out in agony because of the harm being done to them and their families.
The First Do No Harm report is full of arresting facts: the 11-year delay between the first statistically significant evidence of the links between hormone pregnancy tests and malformations in babies; the lack of clinical evaluation of the use of mesh—a supposedly inert and harmless device—in the treatment of pelvic organ prolapse in tens of thousands of people; and the 20,000 people exposed in utero to sodium valproate in the UK, around half of whom have been affected physically or mentally, often very severely. But its true power comes from the testimony of those women whose lives were turned upside down by the adverse effects of these tests, pelvic mesh, sodium valproate and other medical scandals.
It was a privilege to hear this testimony at first hand when I was a Minister in the department, and I pay tribute to those brave women who led delegations to bring their message of pain and sorrow, and of being patronised by those who claimed to care for them, to us. Marie Lyon, Kath Sansom, Emma Murphy, Janet Williams—women like them are the reason why Ministers, and ultimately the then Prime Minister, asked my noble friend to carry out her review. It is to tens of thousands of women like them and their families that we owe a duty to implement the findings of that review.
First, I declare a tangential interest in the sense that I am patron of the Society of Occupational Medicine and, together with the faculty, it obviously has a real interest in this area, as well as its broader remit. I apologise to the noble Baroness, Lady Cumberlege, and the Committee for not being in my place at the beginning of her incredibly powerful speech, and I endorse what people have said already about not only the speech but the incredible work and reflections in the report.
The history that the noble Lord, Lord Patel, gave us, indicates very clearly the challenges that have been faced in this area. I am the first Member to speak who, as a former Member of Parliament, had people at my surgery bewildered, frustrated and not in a position, as they were in America, to go down the litigious route to get any satisfaction. But, of course, down the road and down the line is, as the report of the noble Baroness, Lady Cumberlege, indicates, is too late. Having someone who can intervene to prevent misery, hurt and, for many, terrible trauma for life is really important.
When you have the noble and learned Lord, Lord Mackay, and a former Health Minister, the noble Lord, Lord O’Shaughnessy, on your side, you are on a winner, and I hope that the noble Lord, Lord Bethell, will be able to indicate that he is prepared to go back to what we used to call the Legislative Committee—difficult as that is, because there is enormous resistance in government, as the noble Lord, Lord O’Shaughnessy, will remember and my noble friend Lord Hunt will be painfully aware, to having substantial amendments to Bills and to conceding that measures were not thought of first within the department. But I hope that on this occasion it will be possible to do so.
Reference has been made to other commissioners, and I endorse what the noble Lord, Lord O’Shaughnessy, said about the noble Baroness, Lady Newlove, and the powerful work that she did. I respect her greatly, as I do Anne Longfield, the Children’s Commissioner. I say to my good friend and noble friend Lord Hunt that I like to think that some of us in the political arena played a bit of a part in getting the schools reopened as well as the commissioner, but she did a phenomenal independent job in that area. I hope that the commissioner recommended by the noble Baroness, Lady Cumberlege, would be able to do the same in this sometimes forgotten area.
My Lords, it is a great pleasure to follow the noble Lord, Lord Blunkett, on this group. I pay tribute to the noble Baroness, Lady Cumberlege, for her report and for introducing this proposed new clause, which I feel the Minister should accept.
I apologise for not participating on previous days but I was involved in debates in the Chamber, so I ask your Lordships to accept my apologies.
I fully accept the need for this new clause. At Second Reading, I indicated that the recommendation of an independent patient safety commissioner, on a statutory basis—one of the central recommendations in the report of the noble Baroness, Lady Cumberlege, and her team—should be given legislative effect. The provision of high-quality healthcare in which all citizens can have confidence defines any nation. For me, that is why this Bill is so important and why it should be amended to include this proposed new clause, among others. Our ethical practices are of the highest standard, and any medical product available in the UK, or indeed anywhere, must be rigorously tested and be shown to be safe and effective. That also goes for the Covid vaccines which are currently under investigation and awaiting licence.
I have long campaigned to get justice for pelvic mesh sufferers who have been left with internal damage and intense, chronic pain. They were failed by an appalling culture of mismanagement, ignorance and apathy within the health system. These victims deserve better justice and we must ensure that this sort of systemic failure never happens again. I remember, as a Member of the other place, meeting many constituents —in the main, women—who had a pelvic mesh inserted and suffered immeasurable pain. They were trying their very best to have it removed.
The recent report by the noble Baroness, Lady Cumberlege, First Do No Harm, on surgical mesh and other medical interventions, was scathing in its assessment of the failure of a disjointed and defensive health system to listen to and address patient concerns. Much of the suffering, it concluded, was entirely avoidable. As I said, I met victims of this appalling mismanagement when I was a Member in the other place. I learned at first hand of the pain they had been forced to endure and the impact that it had on the quality of their lives and those of their families. Therefore, I am pleased that the report was commissioned and I am happy to support the recommendation for an independent patient safety commissioner, as per the proposed new clause. It should be placed on the face of the Bill. I believe that, if the Government are serious about that report and about the Bill, this recommendation should be given legislative effect, and I urge the Minister to accept the amendment.
Lord Sheikh (Con) [V]
My Lords, I commend my noble friend Lady Cumberlege on putting forward this important amendment, which has my full support.
I referred to this issue when I spoke at Second Reading. At the outset, I congratulate my noble friend on her thorough and excellent review, including the bravery of its participants. The Cumberlege review was clear that there is an urgent need for action. I welcome this Bill, which aims to put patient safety first.
We need to listen to the review’s recommendations and create an independent patient safety commissioner through the enactment of this amendment. This commissioner would be a trusted voice for patient safety and would ensure that the Primodos, valproate and mesh scandals, or any other previous scandals, are not repeated. As the Cumberlege review shows, the harm caused should have been avoided—and could have been, if patients’ concerns had been properly listened to and acted on.
Furthermore, Sir Cyril Chantler, one of the review’s panel members, rightly said that if such a commissioner had existed before, there would have been no need for this latest inquiry as the Primodos, valproate and mesh scandals would have been dealt with at an early stage, thus preventing the high number of patient incidents that were allowed to occur. Instead, thousands of patients and their families suffered for many years. Many of them were not listened to even though they were right. If this Bill is to succeed in its goal of promoting patient safety, we must accept this amendment.
Patients should not have to fight to be heard. They should not be made to feel that they are in the wrong. Patients and their families need to be consulted, listened to and given a voice. Through this amendment, the patient safety commissioner would be that voice. As is stated in the amendment, the commissioner would
“promote the views and interests of patients”
and would be able to
“receive direct reports from patients and other members of the public”.
This way, all concerns will be listened to and properly acted on. The amendment also states that the commissioner will be able to produce
“reports regarding patient safety … with respect to the use of medicines and medical devices.”
This information will be essential in making patients aware of any potential risks or harms so that they can make fully informed decisions about their treatment. I am glad to see that the commissioner would be independent so that the public know that any information is accurate and unbiased.
My Lords, the Grand Committee will reconvene again, and I call upon the noble Lord, Lord Sheikh, to finish his contribution.
Lord Sheikh (Con) [V]
Thank you. My Lords, I have nearly finished. I conclude by saying that a patient safety commissioner will be a champion to mobilise changes and deliver necessary improvements. This is vital for creating a healthier system that works for everyone because it can listen to everyone. We must ensure that historical or recent scandals are not repeated, and we must therefore accept this amendment.
Baroness Masham of Ilton (CB) [V]
My Lords, I would support an independent patient safety commissioner, as its aim would be to
“promote and improve patient safety with respect to the use of medicines and medical devices,”
which is vital. In the past years there have been some tragic cases: patients have been left in long-term pain after operations with medical mesh; pregnant women have taken medicines that have caused disabilities in their children; and people have died due to the wrong dose of morphine or potassium chloride by the wrong button being pressed on the infusion pump.
I hope that, if established, the patient safety commissioner would be able to help patients from the private health sector as well. There have been some unfortunate incidents in plastic surgery, for example.
I would like to ask a few questions, but I do not know whether it is the noble Baroness, Lady Cumberlege, or the Minister who can answer them. The NHS is so huge and has so many different bodies and groups. Many people get confused about who does what. Would the patient safety commissioner co-operate with the Healthcare Safety Investigation Branch and the Citizens’ Partnership, which will work with HSIB on healthcare safety investigations?
AvMA—Action against Medical Accidents—which works for patient safety and justice, would be happy to work with an independent patient safety commissioner. Would that be helpful? Many all-party groups take evidence from patients and experts on safety issues. Would the safety commissioner be interested in collecting the data and promoting what is appropriate? A great deal of time, energy and experience goes into producing these reports.
There are still cover-ups and fears about reporting safety issues. Patients and their supporters need to feel that their voices are heard and will be acted on independently, and that they will stay safe and not be victimised for reporting patient safety matters. I thank the noble Baroness, Lady Cumberlege, for her report and for bringing this subject up the agenda to where it should stay, with the lead of a patient safety commissioner.
My Lords, I can only begin this contribution, as I did at Second Reading, by paying tribute to the power and importance of the report by the noble Baroness, Lady Cumberlege, as so many other noble Lords have. I also note that the length of the list of Peers speaking to this amendment reflects the fact that this is perhaps the most important element of her recommendations, or certainly the most easily and directly deliverable through legislation.
When thinking about how I could contribute within this long list of speakers in a positive way, I decided to go back to the noble Baroness’s report and to the patients who spoke to her. If I were delivering this as a public speech, I would at this point deliver a trigger warning: what I am about to say is very disturbing. That needs to be said now.
I will quote three of the patients quoted in the noble Baroness’s report. The first is identified as a mesh-affected patient who said:
“I have had a constant battle to get the help and treatment I needed with my mesh complications. ‘Gaslighting’ and a ‘fobbing off’ culture appears to be rife”.
The second quote is from a former GP and mesh-affected patient:
“I do … believe there is a huge unconscious negative bias among you all towards middle aged females in chronic pain.”
Finally, the third quote is from Teresa Hughes, from Meshies United:
“They would tell you there is nothing wrong with you and that you are just a hysterical woman”.
It is worth reflecting briefly on the history of medicine and the medical profession. The idea of a wandering womb—with strange afflictions supposedly affecting women, particularly those of reproductive age—goes back to the ancient Greeks. We have something here that has been embedded for literally millennia. If we look to more recent history, it was the book on hysteria by Edward Jorden in 1603 that really pinned down in English something that became medical doctrine for centuries. This treatment of female patients has a very long and embedded history.
My Lords, Amendment 117 would establish the independent patient safety commissioner on a statutory basis, as recommended in First Do No Harm, the report of the Independent Medicines and Medical Devices Safety Review. As the noble Baroness, Lady Cumberlege, said, it is a future-facing amendment towards a proposed organisation. It has not been a surprise that all noble Lords who have spoken have been hugely supportive of her report. This recommendation from the Cumberlege review was overwhelmingly supported by the House at Second Reading and is vital to ensure that the interests of patients are represented, to try to prevent scandals such as that regarding mesh implants from recurring. We support it wholeheartedly, and I was delighted to add my name to the amendment.
At present, there is no one to listen to the voice of patients, act on concerns, gather data and put together a clear picture to report back to the department. Commissioners can bring a fresh pair of eyes to an area but also a strong voice for patients. Of course, as the noble and learned Lord, Lord Mackay of Clashfern, said, they bring independence too. In addition, they will have unique statutory powers and responsibilities, such as powers to get access to data, and investigatory powers, with power of entry if necessary. Of course, patients’ voices would need to be heard, so in all probability, there would be a helpline, as well as email access and access via a website and by letter.
The noble Baroness, Lady Cumberlege, spoke of the Children’s Commissioner, and she was not alone. It has been a great success. The commissioner knows her remit and, as the noble Lord, Lord Hunt of Kings Heath, said, she speaks with no vested interest except in children, and she stays within it. She champions children and, as has already been said, this has given her authority. As a consequence, the organisation is hugely respected.
I have heard the criticism of the cost of such a body as the patient safety commission, and I feel sure that the noble Baroness would have squared off the funding for a commissioner and their office with the Cabinet Office, which would be the funding vehicle. However, compared with similar commissions, it would amount to less than £1 per head of population per year—less than tuppence per person per week. I defy anyone to claim that that is excessive. This is indeed of value, and patients of course deserve it.
The last remark of the noble Baroness, Lady Jolly, was very pertinent indeed.
After this debate, I probably need to say only that, from these Benches, we support the noble Baroness, Lady Cumberlege, in her proposal to establish a patient safety commissioner on a statutory basis. We have heard powerful contributions from the noble Baroness, Lady Cumberlege, herself, the noble Lord, Lord Patel, and my noble friend Lord Hunt. I always thought, when I was a Minister and since, that you should always listen when the noble and learned Lord, Lord Mackay of Clashfern, says that, in his “respectful submission”, something is a good idea; it is always a good idea for the Minister to take note of that.
The scale and severity of avoidable harm that resulted from the three interventions over a period of several decades is shocking, as noble Lords have said. As the noble Baroness says, such experiences resulted in
“relationships destroyed, careers broken, and as a result financial ruin, with no income, many lost their homes, and faced their children being taken into care”.
The report also strongly states that patients and their families should not be left to
“join up the dots of patient safety”
for themselves.
Over the 20 years that I have been in your Lordships’ House, there have been at least three reports about patient safety—some as a result of scandals—yet the systematic causes of unsafe care persist. I recall Liam Donaldson’s report in 2000, An Organisation with a Memory, a report of an expert group on learning from adverse events in the NHS, and Ian Kennedy’s heart-wrenching 2002 report on the public inquiry into children’s heart surgery at the Bristol Royal Infirmary, Learning from Bristol. Of course, I was the Minister who, from the Dispatch Box, had to deal with the Report of the MidStaffordshire NHS Foundation Trust Public Inquiry, or Francis report, which was as harrowing in what it said as the report of the noble Baroness. And yet we have still not learned how to ensure that patient safety is at the heart of our work in the NHS and that patients have a voice. That is what is at the heart of this amendment.
The amendment also deals with health inequalities. The interventions focused on in the report were all taken and used by women, and its findings highlight consistent themes around sexist attitudes to patients’ concerns. That is yet another reason why having an independent patient voice is so important.
I hope that the Minister supports this amendment and, if he cannot, that he will commit to bringing an amendment back on Report which recognises the patient voice and influence within the NHS, and that a new patient safety commissioner would strengthen that voice and the NHS enormously by bringing a focused perspective to improving patient safety.
My Lords, I start by profoundly thanking my noble friend Lady Cumberlege. It has not escaped the notice of anyone in this Grand Committee that her amendment has the support of a very large number of noble Lords, including the noble Lords, Lord Patel and Lord Hunt, and the noble Baronesses, Lady Jolly and Lady Thornton. Many Members spoke in favour of her report’s recommendation at Second Reading, and I expected that we would spend time on these matters now.
Let me say at the outset that the Government take very seriously the report of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege. We are absolutely determined to learn from it. We are taking time to carefully consider the report and all its recommendations before we respond, which is reasonable. Given the important issues it raises, it is only right that the report gets due consideration. It is right that, on a report of this length and breadth, we take the time to do this properly.
At the heart of the review are harrowing stories of hundreds of people and their families. It is right that the Government have made an unqualified apology on behalf of the health system to all the individuals affected by this report.
I shall say a word about the pause in the use of vaginal mesh in the treatment of prolapse and incontinence which was introduced in mid-2018. As my noble friend Lady Cumberlege rightly observed, the pause introduced a period of high vigilance, restricted practice to ensure that NICE guidance was followed. A blanket ban on the relevant procedures was not recommended as there needed to be some exceptions within the pause. I am aware of the six conditions that must be met before the pause can be lifted. The majority of the six measures are in hand. NHSE is working closely with providers to set up specialist mesh removal centres and is working in partnership with the British Association of Urological Surgeons and the British Society of Urogynaecology to ensure that there is a consistent approach to informed consent and shared decision-making in these centres with clear and accessible information available for patients. I am aware that a data solution is yet to be fully implemented, but I reassure noble Lords that I understand that NHS Digital, working with NHSX, has put together a programme of work to establish an information system to collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures, and that this work is in the pilot stage with a view to establishing a medical device information system.
The Government want to ensure that patients in England are not let down by our most loved institution, which was set up to protect each and every one of us. There is no doubt that the report by my noble friend Lady Cumberlege gives the Government and everyone in healthcare a lot to think about. My noble friend has done a great service by highlighting the importance of listening to patients and we are considering carefully her recommendation to establish a patient safety commissioner.
Whatever structures we put in place, the reality is that patient safety is a combination of culture, behaviours and underlying conditions. Patients should be able to trust that their concerns will be listened to without feeling that they must resort to a third party to be heard. It is ultimately about the way we work with, and behave towards, each other, and towards patients and their families. Any approach to add a further layer to an already complex health system architecture should aim to mitigate the potential for issues to get lost, confused or duplicated. It definitely should not hamper the effectiveness of existing patient safety bodies. It is absolutely right that we put the patient at the heart of the system and improve the system around them.
I am very grateful to my noble friend Lady Cumberlege, to the noble Lords, Lord Patel and Lord Hunt, and to the noble Baroness, Lady Jolly, for tabling their amendment. However, with the utmost respect to them, the Government are unable to accept it for the reasons I have outlined. I therefore hope the noble Baroness feels able to withdraw her amendment.
I am grateful to the Minister for that detailed answer, but as far as I can see, it underlined the point about the fragmentation of patient safety. He is undoubtedly right about the need to change culture. Will the Minister look at this again, because I mentioned the three inquiries in the past 20 years that I knew about very well, and every one of them said very similar things to what the Minister has said? None of them has produced the kind of support that one would want for patients or been the catalyst required here from the patient safety commissioner. Will the Minister go back and think about this again?
I take the encouragement of the noble Baroness to heart. I would be very happy to think further on it. She makes a very good point: we know about the terrible incidents of the past and the very substantial responses that they had. I share with her the frustration that these problems continue to arise. For that reason, as I said, we are looking for a really thoughtful, considered response to the review overall. As I said in my earlier remarks, the case for a patient safety commissioner is one that we are looking at. I listened to absolutely everyone who has spoken in its advocacy, but we do not regard it as a silver bullet or a single point of catalysis, which I do not think the noble Baroness was alluding to. We are looking for a broad response to the review that would ultimately take on all the different points that my noble Friend Lady Cumberlege and the Baroness and her review team have made.
My Lords, I will come to the Minister’s summing up at the end, but I thank all noble Lords who have taken part in this debate. I have not heard anything really contrary or disturbing against a patient safety commissioner. It has been supported, and I am very grateful for that.
I first thank the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Jolly. I know that the noble Lord, Lord Patel, has been a champion of safety both in Scotland and in this country. I share his impatience. He considered some of the interesting reports that have been produced and we hope that they all have made a little difference—but not enough. He is so right to say that we are searching for independence, as other noble Lords have mentioned. The person who we appoint to this position is so important. We do not want a patsy or someone who is just going to do what the department and Ministers want. We want an independent voice. I thank all those who also talked about a patient safety commissioner and the Children’s Commissioner, who, as we all said, has been outstanding. I also thank the noble Lord, Lord Patel, for his revealing statistics, which were interesting.
I understand the cynicism of the noble Lord, Lord Hunt of Kings Heath, about NHS England. I say just one thing about it, but I should have declared my interest at the start of the debate because I am employed by NHS England in the context of maternity services. The chief executive took our report, Better Births, and said, “I am giving you five years to implement it”. He gave us the people, resources and everything else. We were making real progress until March. The virus has really knocked us back—we did not expect it. However, in the four years that we have completed, we have changed much of the culture within maternity services and improved the lot of many women. We have not had that response from the Government on this report. They have not said, “We will give you five years and some resources. See what you can do”. No, they have been silent. Today, the Minister told us a bit about what he has been doing. However, none of that was news to us. We know all that already.
I thank the noble Baroness, Lady Ritchie of Downpatrick, for her strong support and what she said about the different stories she had heard. It is shocking that they have been avoidable. Perhaps I could pick up just one. Throughout the report, there are a lot of quotes but this one really struck me. This is a woman who had mesh, and she says:
“This device took everything from me my health my life my job my dignity my marriage my freedom. There are a lot of us suffering.”
That is the impact that some of this has had on thousands of individuals. That is our nation’s tragedy.
I thank the noble Lord, Lord Sheikh, very much for his report. We were working as a very small team and met very often; through Cyril Chantler and others, we were thinking about the patient. We said, “Where is the patient?”. The patient is the pilot, while the clinician is the navigator. We said that often what happens is that the clinician is the pilot and the patient is the passenger. We want to change that. Who is this service run for? It is run for the patients. Who pays for it? The public, who are patients. We were really thinking a lot about that. Of course, we want to trust patients and to have someone who is going to help them and join the dots, as the noble Lord, Lord Sheikh, said.
I thank the noble Baroness, Lady Masham. As I have said, she was on the button with the private health sector. We always have to include it, and we have, when we talk about the healthcare system as a whole. She mentioned charities, which are also terribly important. We essentially worked with 15 charities and with hundreds and hundreds of individuals. I still have a postbag full of their worries and requests, such as “What is happening to your report? Why isn’t it implemented? What are the Government doing?”—I get all those questions all the time.
I thank the noble Baroness, Lady Bennett of Manor Castle. She is so correct—go back always to the patients’ quotes. That is what this is all about. We have certainly talked a lot about Anne Longfield and the patient safety commissioner. People have spoken glowingly of her, and perhaps we ought to canonise her—I do not know.
I thank the noble Baroness, Lady Thornton, for all her support and the encouragement she has given me. She was also so right to talk about three reports on patient safety, complete with Mid Staffs. The problem with Mid Staffs was that it had so many recommendations; I think it was about 160, but I cannot remember the exact number. That is why we had only nine, but these nine are key. One of them was about an apology, which we asked for and which was given by the Secretary of State, so we have eight. But those eight are key to ensuring that in the future we have a much better system that is totally influenced by patients and their experiences. That is really important and this Bill brings a lot of it in. I am very grateful for that.
I thank my noble friend the Minister for his summing up. He warned me beforehand that it was likely to be long. It was very thorough but for us, there was no news. We know all about special centres, and we have been working with the people there to establish them. Of course, we have worked with the British Society of Urogynaecology. We have talked a lot about consent and how that should operate. Of course, a lot of work has gone on with NHS Digital and NHSX. We have talked to their leaders and listened to what they have to say. As the Minister knows, we asked certain questions of them and we had the replies.
Of course we must listen to patients, but we need to do much more than that. We need some sort of mechanism. We need something that makes this a reality. We do not want warm words; we want action. We have thought about this for two and a half years. What would make a real difference? The eight recommendations would, but the most important, and the one that needs legislation, is that of an independent patient safety commissioner.
I say to my noble friend the Minister that of course we know about the HSIB, the duty of candour, “speak up” guardians, the MHRA, the CQC and all that. We are trying to promote something and someone different—someone who is not part of the system and is not going to have a vested interest in how it works. We want someone independent. I know that scares the pants off the department of health and Ministers. They do not like independence but, my goodness, it is so important, as we have learned with the patient safety commissioner.
I understand my noble friend talking about the fact that it is a big report and the Government will have to think a lot about it. I have done a lot of reports in my time. The first was to ensure that nurses could prescribe. It took me 20 years to get that to happen. I have not got 20 years. The people suffering now do not have two years or 18 months. Suffering cannot wait. This is important and it is critical that we move quickly because our people are in a terrible state and are suffering. I will talk later about redress and things like that, but that is another amendment.
I thank my noble friend for his summing up. I am disappointed but I am delighted that he said, in answer to questions from the noble Baroness, Lady Thornton, that he will think further. We know that we have something important here. Nobody has countered this in the Lords, the Commons or anywhere else. They have all agreed with it. I have talked to Aidan Fowler, who is newly appointed and has his strategy, and he told me that if we have a patient safety commissioner he would work with him or her.
We need somebody. Perhaps all of us here, with all our contacts, should be thinking about who would be a good person to take on this role. I am not going to be on the appointments commission, but we should be moving this forward. We cannot just sit on it because there are too many people suffering now and who will continue to suffer unless we really get to grips with this.
Finally, on sodium valproate, surgical mesh and Primodos, a lot of these people are very sick. They have nevertheless given their lives to help others and to take forward what they know needs to be done. We have had no opposition at all from those people. On the contrary, we have had a lot of support.
At a time of great difficulty for this country, when we know that it is divided, here is something consensual that we can be proud of as a nation. Yes, we have been managing the coronavirus and that will be part of our legacy, but what a tragedy if that alone is our legacy. We want something more than that. We could go down in history as having made a real difference to the population, to people who would have suffered if we had not made a stand.
I say to my noble friend the Minister: do not be worried about disturbing the pond. I can see that he is worried that this will upset some people, but they have not come to me about being upset. This is the time when we should all be on the side of the angels. I beg leave to withdraw the amendment.
We now come to the group beginning with Amendment 119. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
119: After Clause 38, insert the following new Clause—
“Northern Ireland and regulatory divergence
(1) The Secretary of State must work together with the appropriate authority in Northern Ireland to minimise the potential for and mitigate against regulatory divergence in relation to human medicines, veterinary medicines and medical devices. (2) Where the Secretary of State has identified areas of regulatory divergence in relation to human medicines, veterinary medicines and medical devices between Northern Ireland and the rest of the UK, the Secretary of State must lay a report before both Houses of Parliament setting out how the divergence will impact—(a) the UK; and(b) Northern Ireland.(3) The report must set out the steps the appropriate authorities have taken to mitigate against such divergence.”Member’s explanatory statement
This Clause would require the Secretary of State to work with the appropriate authority in Northern Ireland to minimise the potential for regulatory divergence relating to medicines and devices, and report any areas of regulatory divergence to Parliament, including the impact they will have, and report on actions to mitigate against adverse consequences arising from divergence.
My Lords, on behalf of my noble friend Lady Thornton, I am moving Amendment 119 on the important issue of regulatory divergence with Northern Ireland and reporting to Parliament. I am grateful for the support of the noble Baroness, Lady Ritchie, who raised this key issue at Second Reading, as did the noble Lord, Lord Patel, whose Amendment 120 is grouped with this amendment. I look forward to their contributions and to those of other noble Lords.
Amendment 119 would add a new clause to the Bill on the interpretation of Part 3, “Medical Devices”. It would require the Government to work with the appropriate authority in Northern Ireland to
“minimise the potential for and mitigate against regulatory divergence in relation to human medicines, veterinary medicines and medical devices.”
Where an area of divergence is identified, the Secretary of State would be required to lay a report before Parliament on the impact it will have and the steps being taken to mitigate it.
Human and veterinary medicines are transferred matters in Northern Ireland. For this reason, Clauses 1 and 8 lay out in black and white the possibility of regulatory divergence, as they give separate powers to Northern Ireland departments to make regulations relating to Northern Ireland. However, despite this being in the Bill, the rest of the legislation as drafted is completely silent on the implications this may have, or on any mechanism for dealing with them. This means Northern Ireland could end up passing different legislation.
As well as those powers in the Bill, there is the wider context of the Northern Ireland protocol, under which Northern Ireland will continue to apply certain European Union standards that will no longer automatically be part of the law governing Great Britain. For example, in the Government’s own guidance on regulating medical devices from 1 January 2021, it is stated that, unlike in Great Britain, the EU medical device regulations and the EU in vitro diagnostic medical device regulations will apply in Northern Ireland from May 2021 and May 2022 respectively.
On the issue of reporting to Parliament, Amendment 120, in the name of the noble Lord, Lord Patel, which we support, calls for an
“annual report to Parliament on potential areas of regulatory divergence between Northern Ireland and the rest of the United Kingdom in matters covered by this Act.”
Can the Minister tell the Committee what preparatory work is being done, specifically in response to this Bill, to minimise and mitigate against any adverse consequences of possible divergence between Great Britain and Northern Ireland in the medium and longer term? What structures will be put in place to address this issue? Who will have responsibility for identifying possible areas of divergence? How will Parliament be kept informed?
There is deep concern about this issue and what happens if Northern Ireland and Great Britain end up with increasingly different legislation covering medicines and medical devices. I look forward to the debate and the Minister’s response.
My Lords, I will speak to Amendment 120 and, again, I am very grateful to my friend the noble and learned Lord, Lord Mackay of Clashfern, for joining me on this amendment. I beg noble Lords’ indulgence because, when I read the legislation and the Bill related to this and then looked at the advice or guidance issued by MHRA, I got more and more confused about what the divergence is going to be, how much of it there will be and how clear the Bill is. I am sorry, but I will be labouring the point at length to get some answers.
My proposed new clause would require the Secretary of State to report on
“regulatory divergence between Northern Ireland and the rest of the United Kingdom”.
This amendment would address the issues of potential regulatory divergence between Northern Ireland and the rest of the United Kingdom. In relation to medicines and veterinary medicines, Northern Ireland is referred to separately from the rest of the UK. This means that, as set out in Clause 1(4)(b) and Clause 8(4)(b), the power to make regulations in respect of Northern Ireland lies with the Department of Health in Northern Ireland or both the department and the Secretary of State, when acting together.
Clause 40 limits the capacity of the Department of Health in Northern Ireland to act alone, only allowing it to do so when it would be
“within the legislative competence of the Assembly, and … would not require the consent of the Secretary of State.”
It is not clear in the Bill which areas would be in the sole competence of the Northern Ireland Assembly. Will the Minister clarify that?
Furthermore, while powers on medical devices are not reserved, the guidance most recently published by the MHRA paints a picture of two different systems—market authorisation and registration, among other issues—and distinguishes between the “Northern Ireland market” and the “Great Britain market”. This implies that regulation different from that in the rest of the UK may be intended for Northern Ireland in respect of medical devices.
My Lords, I am delighted to follow the noble Baroness, Lady Wheeler, and the noble Lord, Lord Patel, on these amendments dealing with regulatory divergence and Northern Ireland. I am a signatory to Amendment 119 in the name of the noble Baroness, Lady Thornton.
During Second Reading, I stated that there is the issue of potential regulatory divergence in relation to Northern Ireland, as medicines are a devolved power but medical devices are not. The Bill raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK, and that matter requires clarification, hence my support for Amendment 119. Both amendments seek to ensure greater accountability and transparency, to which the noble Lord, Lord Patel, referred, in that Parliament should receive reports on regulatory divergence as a means of oversight and accountability—with which I totally agree.
In some areas, this also relates back to the Northern Ireland protocol. There is no doubt that we must ensure the highest level of standards in relation to veterinary medicines, human medicines and medical devices. In his response at Second Reading, the Minister indicated to me that the Government intended to implement the Northern Ireland protocol, but I ask how that squares with the UK internal market Bill, this Bill and the need to ensure that we have the highest standards for medicines, medical devices and veterinary medicines—how does this all square?
I note that the NHS Confederation will continue to follow developments, analyse the implications for the health sector in the UK and push for as much clarity as possible on the implementation of the Northern Ireland protocol from 1 January 2021. It has also been stated that Northern Ireland will remain part of the UK customs arrangements constitutionally, so HMRC—not EU officials—and the UK’s Medicines and Healthcare products Regulatory Agency should administer the necessary controls. The MHRA remains responsible for placing the goods on the market and monitoring products once sold, but they will have to be approved through the European procedures because Northern Ireland will be treated as a member state in terms of regulatory decisions.
My Lords, we have unfortunately come to the end of our allotted time for this Grand Committee. I am afraid that I will need to adjourn our debate for today.
That concludes the work of the Committee this afternoon. I remind Members to sanitise their desks and chairs before leaving the Room.
Committee adjourned at 7.30 pm.
“a registry of its own right does not create patient safety; it’s just a list. The registry must contain information that can be audited”.
Essentially, as the Cumberlege review acknowledges, a registry is a registry only if it contains patient outcomes, which are then subject to expert oversight. To that end, Amendment 100, which is at the core of this group of amendments, sets out the following principles.
First, the use of all implantable devices should be recorded in a registry. That goes to the heart of the issues explored by the Cumberlege review and is surely the central lesson that must be learned from the unnecessary—and unnecessarily long—suffering of thousands of women whose experiences with mesh were horrific.
Secondly, other devices used in the course of operations should similarly be subject to outcomes tracking. I raise this in particular because it is not just devices left inside people that can later cause problems. We know, for example, that machines used in the heating and cooling of blood during open heart surgery can cause a Mycobacterium chimaera infection. The NHS now warns people of this risk, but it seems clear that the Bill should put in place measures to ensure that the use of particular machines is tracked, and that where infections develop later, a flag can be raised against that machine. To be clear, the machines involved do not actually make contact with the patient or their blood. The heater-cooler units contain two water tanks and tubing. One water tank uses warm water, which, through indirect thermal transfer, keeps the patient warm during the surgical procedure, often through the use of a warming blanket. The second water tank contains cold water, used, again indirectly, to cool the cardioplegic solution that slows or stops the patient’s heart to allow the surgical procedure to proceed. It is thought that where Mycobacterium chimaera develops in these machines, it can escape as aerosol—a fine spray—into the surgical area and thus cause infection from there. I raise the example simply to illustrate that medical devices are not only about what is left inside people, or even what comes into contact with people. The new provisions for information systems need to be flexible in recognising that.
The third provision of Amendment 100 is that information systems must be subject to expert oversight. That is to deal with the central point raised by the Royal College of Surgeons of England, which is that without this oversight a registry is just a list—not really a registry at all. A good example of a registry in action is the National Joint Registry, which is overseen by a steering committee of experts. The expert committee monitors outcomes achieved in joint replacement surgery, analysing procedures by brand of prosthesis, hospital and surgeon. Instances where performance falls below expected levels are highlighted to ensure appropriate investigation and follow-up. This is a standard we need to see replicated across surgical specialities and across the NHS.
Fourthly, and perhaps most critically, the amendment seeks assurances from the Minister that information systems set up under the Bill will provide a direct route for patients to report their own outcomes. Clinicians, of course, want to assume the best about the treatment they have commissioned and undertaken for a patient. It is a natural and not ignoble instinct to try to reassure a patient who presents with a problem following a procedure. There is human nature in a clinical transaction. When a problem emerges, patients are often reassured that they “need to give it more time” or “things will settle down”. Each GP may see only one or two patients who have been subject to a particular device or procedure. With follow-up appointments decreasing, these patients with problems can become invisible to secondary care. Yet the patients know that they feel worse, feel that they are not being properly listened to and speak to others in online communities, discovering a specific pattern of concerns.
The yellow-card notification scheme is greatly underused, and patients do not know how to self-report on it. For that reason, we need two ways for information to reach a registry. We hope that a majority will be tracked from patients, through clinicians. Where there are multiple instances of concerning outcomes, these should be flagged through expert monitoring, but there must be a failsafe for patients to approach the holders of the registry directly to have their outcome reported and considered in its monitoring. The fourth limb of Amendment 100 seeks to achieve this objective and Amendment 101 reflects the same principle. Together, the measures in Amendments 100 and 101 seek to implement this key conclusion of the Cumberlege review:
“A central patient-identifiable database should be created … This can then be linked to specifically created registers to research and audit the outcomes in terms of both the device safety and patient reported outcomes measures.”
That surely is the goal to which we must all aspire.
I want finally to address Amendment 104, to which I have added my name. The noble Lord, Lord Lansley, draws attention to the balances we have to get right in collecting all this data in the name of patient safety. As I said on a previous group of amendments, I hope and expect that dealing with consent to recording this data could and should be dealt with as part of shared decision-making between the clinician and the patient at the point of agreeing to a procedure. Of course, it should be open to a patient to have a procedure without the data being recorded, but they would have to be made aware of the increased risk to their own health if problems with a device used in the operation were later to arise.
I have sought to reflect this point in Amendment 100 by making clear that collecting data should be subject to patient consent. None the less, the noble Lord, Lord Lansley, offers another way to deal with the issue by putting in the Bill that regulations under Clause 16 should have regard to the Caldicott principles. I do not see how the Minister could argue with that and I hope he will be able to give a positive response.
This group of amendments is designed to assist the Government and to catalyse faster movement on their part. I understand that Ministers see tracking and auditing the outcomes from the use of all medical devices as the right direction of travel, but as yet we do not have a destination or an estimated time of arrival. We need to hear both from the Minister this afternoon. I beg to move.
I will ask three questions of my noble friend. First, can he assure us that the regulations themselves will make specific reference to the Caldicott principles? This would mean that we did not need to put it in the Bill. Secondly, in establishing these information systems, can we be assured that Caldicott Guardians will be appointed specifically in relation to each of the information systems that are to be established? Thirdly, can my noble friend tell us any more about the National Data Guardian’s consultation, which opened in June and closed in September, on an eighth principle:
“Inform the expectations of patients and service users about how their confidential information is to be used”?
This ties very directly into Amendment 101 in the name of the noble Baroness, Lady Finlay of Llandaff.
If it is endorsed by the National Data Guardian, that principle would give rise to an additional principle being reflected in the regulations. I freely confess that this is a good reason not to put my amendment in the Bill, because the nature of the Caldicott principles might well change in the immediate future, so it is not very helpful to entrench it in its current form. If we get the assurance that we are looking for from my noble friend, I hope the regulations, when they are made, will be able fully to reflect the Caldicott principles.
I will go back to the lady whose poignant testimony I quoted at Second Reading, whom I called Jane. Jane had an estimated five pieces of mesh inside her, although the health professionals treating her maintained that there were only two. How can this be? I leave noble Lords to speculate but, in my view, this is a sharp indictment of the state of the service our health service gives to patients in this area. Unless we have a proper register of everything that is inside a patient, when it was inserted and what its performance record is, how are we going to enable them to be given the appropriate treatment when problems arise? The Royal College of Surgeons endorses this view—it wants all medical device implants overseen by registries.
Finally, I express my gratitude to the noble Lord, Lord Bethell, for the briefing this morning. I was very heartened to learn of the hard work going on in this area and the aspiration that a register for vaginal mesh implants could be up and running in only a year. I wish the Bill well.
Finally, my noble friend’s Amendment 107 would require the introduction of a registry for patients who have had surgical mesh implanted. Though I appreciate that this looks retrospective, there should be data held in hospital databases that could be imported into the new registry. It would then give a complete overview of surgical mesh implantations. It would require the Secretary of State to report on progress towards creating databases relating to other devices or implants and how they would lead to the creation of registries.
Like other noble Lords, we favour registries as opposed to databases because, according to the Cumberlege review, registries act as a repository for more complex patient-related information datasets, enabling research and investigation into patient outcomes. A database is really just a three-dimensional table held in store, but a registry is a richer, more useful resource than a database. However, often a database is required before a registry can be created, which is why our amendment is framed in that particular way.
The noble Baroness suggests mandating recording of information on any medical device implanted into the human body and the information related to any other medical device as considered necessary for patient safety. Clause 16(2)(a) is sufficient for both these matters. While they are clearly important, the addition is unnecessary.
The noble Baroness adds a requirement of patient consent for the information to be recorded in the information system. I hope that the assurances that I provided to my noble friend Lady Cumberlege last week gave her some comfort on this point. I am happy to write further on this, but the noble Baroness will know that the information systems are conditional on regulations, on which we must consult.
The noble Baroness adds in her amendment expert oversight of any information system established under Clause 16(1). I do not think this is necessary. The information system acts as a database. Where expert oversight is needed is in the assessment of patient outcomes, where information is reviewed by clinical registries operated by experts in their field.
I understand the intent behind Amendment 101. I pay tribute to the noble Baroness, Lady Masham, and my noble friend Lady McIntosh, who put it very well. The patient voice is very important in the assessment of the efficacy and safety of medical devices, but I do not wish to confuse the purpose of the information system. It is a hub; it is not a decision-making tool. There are existing routes to raise specific concerns and experience of devices.
The yellow card scheme allows patients to complete and submit reports themselves. This gives a single, clear route for patients to avoid confusion about who to tell and how, and to ensure that all necessary parties receive all data relating to patient concerns. However, data used for analysis needs to be consistent in format and terminology to ensure that comparisons can be drawn and to maximise the ability to spot common themes and issues.
Amendment 101A in the name of the noble Baroness, Lady Finlay, is unnecessary. Even though the overarching objective of the information system is medical device safety, and therefore a reserved matter, I have made it clear that I am committed to ensuring early and ongoing consultation and engagement with colleagues in Scotland, Wales and Northern Ireland as we look to develop a UK-wide system. I say for the record that it is of great importance to us all that we work together to improve the safe use of medical devices across the four nations. I strongly agree that there is a need for a centralised approach to address the existing gaps in the traceability of medical devices placed on the market. The Government have already introduced Amendment 126 to Clause 41. Therefore, it is neither necessary nor appropriate to set out the engagement or working arrangements between the four nations in regulations.
I understand that the aim of Amendment 104 in the name of my noble friend Lord Lansley is to ensure that organisations protect any information that could identify a patient, such as their name and their records. I reassure him and others who have spoken to the amendment that this information is used and shared only when it is appropriate to do so.
On the Caldicott principles and guardians, I am sure that these matters will be brought forward by others in consultation. That is the forum for addressing these points. Adherence to the Caldicott principles is expected of all NHS organisations, including—some would say most of all—NHS Digital. The Caldicott principles have been developed into the national data guardian principles that apply in England. GDPR also requires that personal information be treated in this way. All data collected by the information system will be subject to GDPR. The intention is that the medical device information system should hold patient-identifiable information. Information that is de-identified will be shared with the relevant organisations to ensure the protection of that patient. It is unlikely that there would be any requirement to share patient-identifiable information with other organisations. MDIS would be programmed to know, when provided with notices by MHRA or others, that action needed to be taken and which patients it applied to.
Parliament oversees data protection legislation. The standards are very high, and we have no intention of lowering them. I do not think, therefore, that having regard to the Caldicott principles is necessary or would add anything material to the legal constraints that would apply to this information. Of course, we have no intention of doing anything contrary to those principles through this legislation. Regulations under Clause 16 will be subject to public consultation. Under GDPR, they are also subject to the requirement to consult the Information Commissioner’s Office. We have already begun discussions with the Information Commissioner’s Office on this basis.
With that and with all the points made, which I hope will thoroughly inform the statutory instruments as they are developed, I beg leave to withdraw the amendment.
I am very grateful for the helpful correspondence of 9 November from the Minister to the noble Baroness, Lady Finlay, regarding MDIS and working with the devolved Administrations. It was shared with Members, together with the 4 November letter from NHS Digital setting out its intended “collaborative approach”. These letters contain a number of assurances on both the current work being undertaken and how the future four-way relationship needs to be taken forward to develop the UK-wide system.
The remaining amendments in this group, including the government amendment, refer to the general duty under Clause 41 to consult before making regulations. Our Amendment 132 would insert a new clause on the duty to consult the devolved Administrations and “have regard” to their views. I hope the Minister will agree that that is not an unreasonable requirement.
Government Amendment 126 would amend Clause 41 to ensure consultation with the devolved authorities under Clause 16, headed “Information systems”. Although the inclusion of this statutory duty to consult as far as Clause 16 goes is a step forward, other key parts of the Bill have an impact on the devolved authorities. We want to see a general duty in Clause 41 to consult the devolved Administrations, as is common practice in a number of Bills—not just limited to consultation in relation to Clause 16. I hope that the Minister will undertake to review the Bill after Committee and consider this key point in relation to Clause 41.
In his 13 October letter to noble Lords, the Minister refers to the Government’s amendments as providing “certainty” that the Government will ensure that the devolved authorities’ views are heard throughout the development of the regulations and in their implementation. The certainty given, however, is in relation only to Clause 16 and not to the rest of the Bill, as we would like to see.
Amendment 130 is a probing amendment that would remove the permissive provision in Clause 41(3) that consultation carried out before the Act was passed could satisfy the duty to consult. This clause is very open-ended. Can the Minister provide details of the purpose and intended use of this provision? There is no explanation in the Explanatory Notes. Will there be a time limit on how up to date a consultation needs to be for it to be considered done and dusted?
I have been deliberately brief because this proposal is so obvious that I do not, I hope, need to speak at length. I am sure that the Minister recognises this, and I look forward to his response.
Our Amendment 129 is very similar to Amendment 128 in the name of the noble Baroness, Lady Thornton, which we are happy to support. Both amendments list who must be included in any consultation. The lists should not be contentious or surprising. We include
“representatives of the relevant patient groups … medical research charities”
and pharma as statutory consultees, along with academic researchers. We leave it open to the relevant authorities to add others to that list.
Our amendment also addresses the problems that could be caused by short and short-notice consultations, perhaps over holiday periods among a less than comprehensive range of consultees. It simply requires the relevant authorities to publish on their websites the terms, start dates and lengths of the consultations, along with the proposed consultees and
“date and method of the publication of … results”.
I rather hope that the Minister will tell us that this part of our amendment is not necessary. I hope that he will see our amendment as an opportunity to give firm assurances to the Committee that the groups we name will be consultees, and about the form and detail of each consultation, as we propose. I hope the Minister will feel able to oblige us.
I hope that the Minister will be prepared to take this back because in the end, certainly in the absence of a sunset clause, we have to beef up the provisions on consultation.
Amendments 125, 127 to 130 and 132 all relate to consultation when making regulations, including, but not limited to, the devolved Administrations, patient groups, various healthcare organisations and academics. Consultation is key to all this, with clinicians, who will give you one set of information, but even more so with patients, who will give you a different, richer, more detailed dataset.
Amendments 128 and 129, tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Sharkey, would commit the appropriate authority to consult all those listed before making regulations under the Bill. We all wish to ensure that a range of views is adequately captured. However, we do not wish to inadvertently rule out contributions from those accidentally not listed. Those listed in the amendments would not necessarily be directly affected by each regulation. For example, regulations relating to human medicines prescribing would not affect veterinary medicines. I reassure the noble Lord and the noble Baroness that the consultations will have depth and reach, and that medical research charities will be fully involved. Requiring consultation with all those listed would be unduly burdensome and seemingly add little value to the making of regulations.
On Amendment 130 in the name of the noble Baroness, Lady Thornton, I completely understand that there are perhaps some concerns with the extent of consultation, or, indeed, its duration, or that the Government might seek to consult on proposed regulations without sufficient notice to those wishing to comment. This is simply not the case, but limiting us in this way may hinder the delivery of important regulations coming into force. If the Bill were to be significantly delayed, it would mean that we could not make an efficient start on consulting stakeholders on key policy areas, such as on a future regulatory system for medical devices.
Whether consultation is conducted prior to the Bill achieving Royal Assent or afterwards, we will make it clear to stakeholders when the consultation processes will start and end. Consultations will be targeted, form part of a process of engagement and last for a proportionate amount of time. For my part, I cannot wait for the process to begin. It is very exciting.
I know that noble Lords want to know our plans for consultation, as do I, and when precisely that will begin. I reassure my noble friend Lady McIntosh that we will publish responses to consultation. We will follow the Cabinet Office guidance, which is extremely stringent. I am incredibly enthusiastic to reach that next step and to begin to make changes to the regulatory regime to deliver a comprehensive, stand-alone and first-class medical devices system, as well as to consult and have the benefit of informed views, like those of the noble Lords, Lord Kakkar and Lord Patel, among others, when we discussed provisional rapid licensing.
I want to make changes to the clinical trials regulations and to consult on how we can make improvements and update definitions. Also, of course, I want to bring in the medical devices information system regulations so that we can establish a world-leading medical devices safety regime. I indicated the intention to consult in the first quarter of 2021 on the innovative medicines fund. We intend to start public consultation on the medical devices information system in May 2021. We also hope to take forward the medical devices regulations consultation over the summer of 2021. There is obviously sequencing to do on all the other measures that we will want to bring in. I will update the House on our consultation plans in due course. The dates are dependent on getting the Bill done, of course.
As to Amendment 126 in my name, I heard the noble Lord, Lord Blencathra, ask at Second Reading how Parliament could be consulted on regulatory changes. Others reflected on the importance of consulting patients on the regulatory changes that impacted or mattered to them. I know that there has been concern about whether the relationship to the pharmaceutical and medical device industries is such that they might be unduly weighted in consultation, but I assure noble Lords that that is not the case.
To provide reassurance, Amendment 126 changes the obligation in Clause 41 to public consultation. The effect of the amendment would not be to prevent the appropriate authority from inviting responses from certain stakeholders or groups as the authority might consider appropriate. Engagement and close working will continue, but Amendment 126 will ensure greater transparency and enable even more people to become involved in the consultation.
The duty to consult the devolved nations on Clause 16 has been the subject of ongoing conversations and correspondence between Ministers in the devolved nations and me. I spoke earlier about the nature of these regulations relating to both reserved and devolved matters. Specific considerations will need to be taken into account in relation to how the devolved healthcare systems function and we want to ensure that any information system that we create is as effective as it can be. The information system will provide an important tool for improving the safety of medical devices for patients throughout the four nations of the United Kingdom. It has always been our intention to consult fully the devolved Administrations on the development of the regulations. I am making this change to provide greater reassurance and confidence, both to the devolved nations and to Peers who have raised the significance of ensuring interoperability between any such information system and devolved healthcare systems.
The final change made to Clause 41 by Amendment 126 will mean that participants engaging with the consultation can understand how the considerations have been taken into account so far. This additional transparency will, I hope, provide noble Lords with assurances that we have taken the criticisms on board and have provided a method for Parliament, the public and stakeholders to know how our thinking progresses throughout the development of regulations made under the Bill.
The combination of these changes strengthens the consultation requirement in the Bill. I hope that, taken together with amendments that I have made elsewhere in the Bill, it goes some way to meeting your Lordships’ concerns and that the noble Baroness will feel able to withdraw her amendment. I commend my Amendment 126.
Clause 16 gives the power to create an information system, and a later amendment introduced by the noble Baroness, Lady Cumberlege, on the setting up of a patient safety commissioner, could form part of the processes needed to ensure that the experiences of patients and the reporting of adverse events are effectively monitored, recorded and evaluated. However, effective self-reporting processes and clear routes for patients to self-report need to be established. Clarification of how such reporting is to be integrated into effective communication across the NHS and the medicines and medical device regulatory framework as a whole is needed.
As the Bill stands, so much is left unsaid and what has been laid out for Parliament to discuss was drafted and conceived before the findings of the Cumberlege review were published. Any patient safety commissioner would need to be properly resourced if they were to work in practice—equally there should be more consideration by the Government of processes for patient reporting and communication across the system. That ought to be put before Parliament.
Amendment 114 would mean that Regulation 3B on the requirement for confidentiality in the Medical Devices Regulations 2002 would remain in place. It is suggested in the Bill that this is removed. Clause 37 provides for “Consequential and supplementary provision”. Subsections (3) to (7) of Clause 37 variously amend the Medical Devices Regulations 2002. In particular, subsection (5) removes Regulation 3B from the 2002 regulations. This was only recently inserted into the law by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. Regulation 3B requires that
“all parties involved in the application of these Regulations must respect the confidentiality of information and data obtained in carrying out their tasks in order to protect … (a) personal data in accordance with the Data Protection Act 2018; (b) commercially confidential information … (c) the effective operation of … inspections, investigations or audits.”
It is not clear why the requirement for confidentiality has been removed so soon after it was created. While Clause 35 provides that commercially sensitive data cannot be disclosed except where necessary for the Secretary of State to warn of serious harm in civil proceedings or criminal proceedings, no other clauses in the Bill reflect the similar requirements that have now been removed by Clause 37. It is concerning that in removing the requirement for confidentiality, the Bill seems to emphasise protection for commercial interests more than those of patients and users.
The Government should provide clarity on why they wish to remove this condition to respect patient confidentiality in operating the Medical Device Regulations. This not notwithstanding, Clause 37(5) should be removed.
The great majority of MHRA’s medical device safety alerts require healthcare workers, not members of the public, to take action to remove a public health threat. For example, MHRA’s national patient safety alert of 23 September 2020, addressing a clear threat to public health, instructed all hospital trusts and other healthcare providers on actions to be taken to avoid potential unexpected shutdown, leading to a complete loss of ventilation, when using the Philips Respironics V60 ventilator. Such messages should not be targeted and promoted to the public but should be made available passively to the public; for example, via access to a website. Otherwise, this would likely create unwarranted anxiety in the public about safety issues that they themselves could address because they required the intervention and clinical support of healthcare professionals.
It is not only what we found in our review that proves the need for this. Think of the recent Paterson inquiry. Its findings echoed ours, with patients voicing concern but their voices not being heard and avoidable harm going undetected. Sadly, we all know that there is a long line of similar examples; indeed, Essure, a contraceptive device that has caused many women terrible suffering, was reported on by the BBC last weekend.
We know our own bodies. We know when something is not right. We know when a treatment is causing a problem. We are the first to know, yet patient voices and experiences are all too often simply referred to as anecdotes and written off. They are not; they are serious research. We think that a patient safety commissioner would put an end to that—an end to anecdotes simply being written off.
There have been suggestions that existing organisations are already responsible for patient safety so we do not need another one. I want to tackle that fallacy head on. If it is true that organisations in the healthcare system are performing this task and doing it effectively, why has so much avoidable harm occurred?
The system simply is not working. Yes, the organisations within the healthcare system are doing their job; people are working very hard as individuals, and in the organisation, but they are disjointed and siloed, and patient safety is not their overriding purpose. They did not prevent the avoidable harm that we discovered. While some organisations have elements of safety within their remit, not one has patient safety as their total focus, and not one considers that they have the responsibility to listen, spot trends, raise concerns and get the system to act.
Patient safety documents and policies from 2000 to the present day all sound alarmingly familiar: progress is slow and incremental, even at present. An NAO report criticised the pace of change as regards patient safety, saying that it was too slow and that those who manage trusts focused more on financial budgets than patient safety. One result was the Mid Staffs crisis: we all remember how devastating that report was, particularly in what it had to say about the major patient safety failings.
We now have another devastating report, First Do No Harm. It is the second, and I hope the last, call for us to establish patient safety through legislation and on behalf of patients. The Government’s response to the Francis report defines the current patient safety system. Patient safety became an important aspect of government policy, with several initiatives and three global ministerial meetings, et cetera, but the processes are the same. Have things changed? In my view, not much, especially in terms of a clear demonstration of reducing patient harm. The patient safety organisations that exist are still part of and accountable to NHS departments, not to patients.
The noble Baroness focused her amendment on the safety of medicines and medical devices. Of the top five areas of patient safety errors, harm related to medicines and medical devices rank second and fourth. She is right to focus on these two areas as the first task of the commissioner for patient safety. A 2018 review of errors related to medicine estimated that 237 million errors occur every year in England. The national reporting and learning system had 204,000 incident reports related to medicine, while 712 deaths are attributed yearly to medicine-related harm, costing annually something like £70 million.
Data in relation to the harm associated with medical devices is not as readily available, except when investigated as part of a report such as First Do No Harm. However, figures from the USA can be used as a proxy, as its larger population may give some indication of the scale and types of devices implicated. A recent report in the USA showed the following as examples: 60,000 cases related to the use of surgical mesh; a similar number in relation to defibrillators; and 104,000 cases related to hip prostheses. There were many more. These data clearly show not just the level of safety issues in relation to medicines and medical devices but the need to address them.
It is time to give patient safety the legal status it needs, as the noble Baroness, Lady Cumberlege, said. It is time for a bolder and more ambitious vision to make patient care safer. I believe that her amendment does this and I strongly support it.
In pointing to the Children’s Commissioner, the noble Baroness, Lady Cumberlege, has really put her finger on it. This gives us an idea of the sort of person we need—someone who, like the Children’s Commissioner, challenges the positions of Governments, schools, unions and local authorities. As the noble Baroness said, I am certain that it was the Children’s Commissioner’s comments that led to the reopening of schools. I do not believe that somebody in a government department or a quango could have done that. She did it because, personally, she is a very admirable person, but structurally, because she is wholly independent.
The noble Baroness made some very telling points when she anticipated a potential criticism of her report. The core of it is that many organisations already have some responsibility for patient safety in their remit. That is true, and they all do good work, but she is right because none of them really has patient safety as a systematic approach to the NHS as their sole remit. Until we have some independent agency or person with patient safety as their sole remit, I am afraid that I do not think that we will make progress. We must accept that, if patient safety is one of many objectives of an organisation, compromises inevitably have to be made.
There is a tension between funding, throughput, targets and patient safety—not always, but sometimes. Here, I turn back to my experience as a foundation trust chair. The trust boards hold a huge amount of tension within them. Of course they are concerned with patient safety and quality, but they are also under the cosh from NHS England and the regulator, NHS Improvement, for their overall performance, whether financial or in throughput. I certainly accept the argument that many of the best organisations where everything runs well include patient safety, but to deny that there is a tension between these other objectives and patient safety is disingenuous.
That is why we look forward to the Minister making a strong statement. If he simply says that this is outside the Bill’s scope, as we have been told consistently, it will not cut the mustard, because we could easily start expanding and extending the Bill as we get other legislation and when the Government finally respond to the report of the noble Baroness, Lady Cumberlege. In my view, the Bill will not leave this House unamended unless the Government can make it clear that they are determined to implement the noble Baroness’s central recommendation.
I am very impressed by the example of the Children’s Commissioner, which has been referred to. In the recent discussion about whether to keep schools open, the Children’s Commissioner could not be said to be an organ of the Government, of the trade unions, or particularly of children; she stood independently in a relationship that considered all three parties. That gave her tremendous authority in a very difficult situation, which remains difficult. She was able as an independent person authoritatively to say that children should come back to school. Of course, it was necessary to take effective steps to protect them, but I believe that she was influential in bringing that about. In Scotland also, that has been an important area in delivering people from the stringency of the lockdowns.
So that is a very good illustration of what an independent person can do. I strongly hope that the Government will put forward an amendment to deal with this matter in the simplest possible terms at present, but with the possibility of enlargement as time goes on. Indeed, I suggested some time ago to the Department of Health that it would be useful for it to consider an amendment that would give effect to the report—but I gather that nothing has happened in that direction so far. So we might have to think about amendments to try to deal with some of those matters, as well as the present one. But I strongly support the essence of the present amendment, and I strongly support it happening now.
There are many excellent proposals in the report, and it is my sincere wish that my noble friend Lord Bethell and his colleagues at the department will implement its recommendations as soon as possible. However, one recommendation stands out: the proposal for a patient safety commissioner, which is the subject of the amendment. Having served in government, I know that there is often internal resistance when a review proposes a new arm’s-length body or something of that kind, so I will explain why I believe that this one is so important and why there is a strong precedent for a Conservative Government introducing one.
As my right honourable friend Jeremy Hunt said when he first launched the medicine and medical device safety review in February 2018, it is the responsibility of the Government to listen, hear and act with compassion, speed and proportionality when things are going wrong. As the exhaustive findings of my noble friend’s review show, this did not happen, time and again, over many decades—and it must.
Whose responsibility, then, should it be? I, like other noble Lords, have great confidence in the NHS, the MHRA, the DHSC and other bodies, but we must be honest that none of them has consistently lived up to the maxim propounded by the former Secretary of State. More importantly, too many patients have had negative experiences interacting with these organisations when they were seeking help, so confidence in their ability to act in patients’ interests is not robust.
As the review continued, it became clear to me, as it did to my noble friend Lady Cumberlege, that there was a need for an entirely independent body that could act as the patient’s friend on safety in the system, a gateway and a support mechanism where those who were not being listened to could go—if you like, a conscience for the system. This would benefit the health system too, providing aggregated access to new information on safety issues and a potential to spot emerging concerns. Nothing that currently exists could perform both these essential functions in a way that carries the support of patients.
These are precisely the roles that the patient safety commissioner is proposed to play. There are different ways it could be implemented, of course, but it must be independent of the department and the NHS, as other noble Lords have said, and it must be patient-facing in all it does. We already have examples of how this could and should work. Many noble Lords have referred to the excellent work of the Children’s Commissioner. I also point to the Victims’ Commissioner, a role fulfilled until recently with great expertise by my noble friend Lady Newlove, and the new independent office of the Domestic Abuse Commissioner. It is absolutely right that these new positions have come into being, and I am proud that it was a Conservative Government who created them.
So once again I throw my weight behind the proposals of my noble friend Lady Cumberlege. I am sure that my noble friend the Minister is highly sympathetic to this cause. For the sake of all those women—and the men and children who have also been harmed—I hope that we can work together to make it happen.
I am not sure that she will thank me for this, but perhaps the noble Baroness will accept that there may be a connection with the Health and Safety Executive, because the research and testing facilities it has may have a relevance here, and some connection with the commissioner that she has recommended may be sensible. My noble friend Lord Hunt and I shared an interest in this when we were both at the Department for Work and Pensions and the HSE reported to us. We had a number of ideas which, because we had both moved on, did not come to fruition. But here we are, all those years later, with an opportunity to do something that would be of great benefit to many people—mainly, as the noble Lord, Lord O’Shaughnessy, said, women—who have suffered so grievously and did not need to.
It would be vital for the commissioner to lead with full patient group engagement, and be accountable to Parliament. Patient groups should also be involved in developing a set of better patient safety principles that would govern the way the commissioner fulfilled her or his remit.
As other noble Lords have referred to, we now have experience of the work of various commissioners. I can speak about those that exist in Northern Ireland. There is now a Veterans Commissioner, a Children’s Commissioner and a victims’ commissioner. They all do good work, acting as advocates for people in their specific fields, and bring forward recommendations to the devolved Administrations. In this particular instance, there is absolutely nothing to suggest that this commissioner, if established through this legislation, would not do likewise. They would be a listening ear and would seek to improve existing health service regulations and practice, particularly in the area of medical devices.
Therefore, I am very happy to support this proposed new clause, and I urge the Minister to accept it.
Our healthcare system is one of our greatest assets. I would like to state my gratitude for all the marvellous work that the NHS has done and continues to do. As we have seen during this pandemic, NHS staff have done sterling work and work effectively as a team. Unfortunately, some key workers have paid the ultimate price and we are forever grateful to them.
The NHS is a very large organisation that does many great things but it cannot do everything right. Sometimes it is better when activities are undertaken by outside bodies that have specific duties and expertise. This is where a patient safety commissioner will play an important role in overseeing the whole system. Furthermore, as in this amendment, an advisory board will support the commissioner in their work, using its wide range of experience.
Our current complaints system is too complex and there have been issues with reports being misplaced and poor co-ordination between the different departments and actors. As the commissioner would be constantly reviewing patient safety and be completely aware of any potential issues, they would be able to keep the Minister and the Cabinet Office informed, for the benefit of patients. The commissioner will be able to join the dots in our big healthcare system so that nobody gets lost, and will provide a more straightforward direction.
I am also supportive of this amendment because it requires the commissioner to publish an annual business plan. As a businessman, I know how important this is in creating a clear strategy to bring together different stakeholders and respond to current issues. This annual plan, alongside establishing and updating the principle of patient safety, will help guide the whole healthcare system. I am also glad to see that subsection (6) of the proposed new clause means that these principles must
“be drafted in consultation with the public.”
This will make them more accurate, and help build public trust.
Unfortunately, the Primodos, valproate and mesh scandals are not the only cases of a lack of patient safety and we must learn from previous historic mistakes. In 1958, Distaval was licensed in the UK. It was sold as a wonder drug for insomnia, coughs, colds and headaches. It also gave many women relief from morning sickness symptoms, but this drug contained thalidomide and had not been tested on pregnant women.
In November 1961, it was withdrawn from sale and, in May 1962, the Government released an official warning against its use by pregnant women. Thalidomide harmed the development of unborn babies, causing serious life-threatening birth defects, and affected 10,000 babies worldwide, and many more are thought to have died before birth. The drug led to the arms or legs of the babies being very short or incompletely formed, as well as causing deformed eyes, ears and hearts. In the UK, more than 400 adults are still living with these consequences.
In 1968, the UK producer Distillers paid 62 families of thalidomide-affected babies compensation amounting to 40% of assessed damages. A similar amount was paid to a further 367 children in 1973. However, it later became clear that these settlements were not large enough to support those affected in their day-to-day lives. Only in the last 10 or 15 years since the scandal have significant settlements been made and provided by Distillers, now part of Diageo, as well as by the UK Government.
Although there have been many improvements in drug testing since the thalidomide scandal, the delays in dealing with potential risks and proper compensation were totally unacceptable. I comment again that, if there had been a patient safety commissioner, the scale of harm would have been limited, action could have been taken more quickly and compensation may have been paid earlier.
It is imperative that we learn from these historic scandals and the more recent scandals related to Primodos, valproate and mesh. Therefore, we must have a patient safety commissioner. We have to support this amendment, and I welcome its objective to lay reports before Parliament and committees. It is important to take quick and appropriate action against any harmful medicines or medical devices before they become a scandal. It also means that the correct bodies and people can be held to account so that the right improvements can be made.
Independent commissioners have been incredibly valuable in certain areas; for example, the Children’s Commissioner, which was established in 2004. Since the start of the pandemic, 14 different reports and policy briefs have been produced by the Children’s Commissioner. They have provided key information on how children are affected, different vulnerabilities and how the Government—
If we look back at the 1960s and 1970s, up until that point in time the culture of medicine was very much one of paternalism. The doctor, who was most often a male, knew best; the patient was told what they should do and how they should be treated. The doctor knew what was best for them and the patient had very little say or control. We can credit the women’s movement as an important part of the forces driving for change in the medical profession. We have seen change, but medical habitus does not change quickly in its practices and culture. It is clear from those quotes I just read out that there is still a long way to go. There is a strong gender aspect to this, but many male and child patients were affected by it as well.
A patient safety commissioner could be someone to go to: someone who knows the system and has sufficient technical support to understand the issues, and to see where systematic breakdowns are happening and act on them. The Children’s Commissioner is a wonderful example—the noble Baroness, Lady Cumberlege, referred to it—and by chance I was referring to that commissioner approvingly in this very same Room yesterday.
We have already seen action on the recommendation for a patient safety commissioner in Scotland, and I am proud that the England and Wales sister party, the Scottish Greens, was very strong in supporting that. With this amendment, your Lordship’s House has a real chance, as we have been doing with so many Bills lately, to insert an important and key improvement.
I hope that, if not today then sometime very soon, the Government might see the sense of following the Scottish lead and the recommendations of the report of the noble Baroness, Lady Cumberlege. However, if that is not the case, I can certainly offer the Green group’s very strong support for pushing this further—as far as it needs to be pushed—to deliver this vital figure.
We recognise that Amendment 117 stems from the centrepiece recommendation of that bold and far-reaching report to establish an independent patient safety commissioner. He or she would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. We recognise that the role would be to help patients navigate the healthcare system architecture and to troubleshoot problems and that, as my noble friend put it in her report, the commissioner could be a golden thread tying our complex health system together in the interests of patients and the public. We recognise the significance of the intention of this amendment. We wholeheartedly accept that listening to patients is a key step to preventing the sort of issues that the report by my noble friend Lady Cumberlege has highlighted.
We accept that policymakers, the NHS, private providers, regulators, professional bodies, pharmaceutical and device manufacturers need to do more to engage patients and families, and to recognise and use their insights as a vital source of learning. It is only by listening to patients, their families and staff that we can learn from mistakes and continually improve. On this point, it has been imperative that we listen, and I am listening very carefully today to the points made by colleagues about the arguments for a commissioner and how this might sit within the wider system. I will continue to listen.
However, before I turn to Amendment 117, allow me to explain why patient safety is an unwavering commitment for the Government and the measures we are taking to embed patient safety throughout the NHS. These include putting a positive learning culture at the heart of the NHS and ensuring that providers are listening to those who raise concerns at the time they are raised, whether by patients, their families or staff, and that they show empathy and sensitivity when they respond. This is a culture where patients are listened to in the first place and not one where they feel they must resort to a third party in order to be heard.
Following the tragedy of Mid Staffs, which the noble Baroness, Lady Thornton, referred to, and some other very concerning cases, we have overhauled the infrastructure underpinning safety and quality in the past decade. That includes taking steps to help staff speak up when they see things going wrong. A culture that listens and responds to concerns in the first place is crucial if the right lessons are to be learned and errors are to be minimised. Our measures include establishing: the Healthcare Safety Investigation Branch to examine the most serious patient safety incidents and promote system-wide learning; medical examiners to provide much-needed support for bereaved families and to improve patient safety; a duty of candour so that hospitals tell patients if their safety has been compromised and apologise; and protections for whistleblowers and “freedom to speak up” guardians across all trusts, supported by a national guardian.
In addition, the NHS people plan for 2020-21 sets out our vision for a health service that is compassionate and inclusive, that is not hierarchical and where people are listened to. We know that implementing change can be a slow and complex process for many organisations and individuals. Healthcare will always involve risks, but they can be reduced by analysing and tackling the root causes of patient safety incidents.
However robust our regulatory and oversight system is, ultimately, improving patient safety requires those at the executive level of our health service to act just as much as individuals involved in patient care. It is why in 2019 we commissioned the NHS national director of patient safety, Dr Aidan Fowler, to publish a new NHS patient safety strategy. Substantial programmes are planned which include: a framework to support patients to contribute to their own safety by having patients or their advocates on all safety-related clinical governance committees in NHS organisations; a requirement for all NHS organisations to identify a specialist to lead on patient safety; the first ever system-wide patient safety syllabus and training for all staff so that they have the knowledge to make care safer themselves; a new patient safety incident response framework to improve the handling of patient safety investigations in the NHS; a successor to the national reporting and learning system to support safety improvement and help the NHS when things go wrong; and a national patient safety improvement programme to prioritise the most important safety issues in the NHS, including medicines safety.
Implementation of the 10-year NHS patient safety strategy is being led by a team that is more than 50 strong. At its core, the strategy seeks to significantly improve the way the NHS learns, treats its staff and involves patients. The strategy seeks to ensure that all healthcare organisations in England adopt a different focus for patient safety that is based on culture and systems. NHS England and NHS Improvement have assessed that getting patient safety right could save 1,000 lives and £100 million in care costs each year from 2023, with the potential to reduce claims provision by around £750 million a year by 2025. The NHS patient safety strategy will be refreshed each year to support our ambition of cementing patient safety into the everyday fabric of the NHS and encouraging a safety and learning culture. NHS safety bodies are doing more to involve patients to better understand issues that give rise to patient safety concerns. Let me give a couple of examples.
The Healthcare Safety Investigation Branch has established a citizen partnership panel to bring in patient insights and ideas for referrals or improvements in HSIB’s investigations. The experiences of patients and their families are central to the regulatory approach of the CQC and its future direction. The MHRA has begun a substantial programme of work to drive forward change in its culture, where a key priority is listening and responding to patients.
Lest we forget, the healthcare system architecture is complex. This means that patient safety regulation is prone to overlaps of remit and gaps between oversight bodies. It is why our consideration of the recommendations by my noble friend Lady Cumberlege includes how a patient safety commissioner would interact with other bodies across the healthcare landscape, ensuring that they could make a difference without creating duplication or confusion.
With this in mind, although Amendment 117 from my noble friend Lady Cumberlege, the noble Lords, Lord Patel and Lord Hunt, and the noble Baroness, Lady Jolly, would give the patient safety commissioner considerable latitude about how he or she would operate, it is without detail about how the commissioner would interact with other bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among many others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants whatever the cause of the complaint may be. These bodies also have their own routes for reporting. For example, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme. Proposed new subsection (5)(e) does not address how a new route for patients to report safety concerns would mitigate the risk of drawing patients away from reporting these incidents to the MHRA or of causing a delay in the MHRA receiving this vital information or receiving it at all.
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. Although this power does not, as we might expect, extend to requiring information for the purposes of fulfilling the commissioner’s other functions, it is otherwise broad, because it would apply to both public and private bodies, and individuals, and could involve requests for sensitive personal data and confidential commercial information that these bodies may not agree are reasonable for the purposes of the commissioner’s public reports.
Moving on, I refer to what the noble Lord, Lord Hunt of Kings Heath, said about the tension within boards. I chaired the Brighton health authority board when the Grand Hotel was bombed. It was a tragedy—lives were lost—but when one looked at the whole system, it worked. Why was that? It was because we had a good leader in A&E who conducted a rehearsal three weeks before the bombing. That rehearsal paid off. Preparation is extremely important. The noble Lord was of course right about the financial problems that must be weighed up within trusts.
We are so lucky to have in our House my noble and learned friend Lord Mackay of Clashfern, a previous Lord Advocate and Lord Chancellor. I remember working with him on debates about the family and all sorts of matters. If you want somebody with true wisdom, understanding and foresight, you go to him. He has done it all, knows about it and always has such integrity. I thank him very much for his support and his impatience, which I share. We know today that babies are being born deformed. One in two has a chance of having a disabled child if they are on sodium valproate, and they do not know about it. We are impatient. We do not want to see more of that. We want to see safety become a reality.
My noble friend Lord O’Shaughnessy has, of course, been a Minister in the House and he knows the tensions and difficulties. One of the things that I know about him is that he listens to patients: he takes time out to do that. He appreciates, almost more than all of us, how people have waited for decades in terrible conditions, suffering terribly. I know that he has done a lot with sodium valproate and the patient groups there, and I thank him for that. What he was telling us about Jeremy Hunt and the way that this review was first commissioned was really helpful, because Jeremy Hunt set the parameters. He was invited to take on three different areas by the Prime Minister, Theresa May. It was really her initiative first, and then Jeremy worked extremely well. I am of course delighted that he appointed me to chair the team.
I want to say a word about the noble Lord, Lord Blunkett. I am very pleased that he is taking part in this Committee; he apologised for not being at Second Reading. Whenever he comes in on a debate, we welcome him. Again, with him having been a really strong leader in his own area and then in the Commons, it is really good to have had him join us today. He talked about the Health and Safety Executive and how we have to work with it. He is of course right.
The Minister, in his summing up, asked who this patient safety commissioner is going to work with. We do not know exactly—of course not. He can read the amendment, which sets out quite a lot. He can read the report and see there what we were thinking about, but of course this needs more work. In fact, one of the members of our team said to us, “Do not lose out on the coroners’ courts; you learn a lot from them”. Her husband is a judge, so she knows a bit about it. We are saying that you have to map the whole horizon and see where things are not quite right. Why is something going wrong? That is something we ought to look at more carefully.
It is about listening to patients but, much more than that, it is about working with all the different healthcare systems. My noble friend Lord Sheikh and others talked about the NHS. We are thinking much more broadly than the NHS. We are thinking about it, of course, and we know it has done a fantastic job with the coronavirus, but we are also thinking about private providers. I was very interested that the noble Baroness, Lady Masham, brought in private providers. We need to think about other public bodies and certainly about the royal colleges, the pharmaceutical and devices industries, the manufacturers and of course the policymakers—the politicians. I appreciate that it is a broad area but that is the problem with it at the moment: it is disjointed and siloed, it is unresponsive and defensive. We need some person who is going to get into all of that and call all the organisations to account—encourage them but call them to account when things are not working right.
The risks of divergence have been raised by Members in both Houses, including the risk that what may on the face of it seem to be only minor or technical differences could create a butterfly effect, leading to much larger legal and operational problems. The Bill does not itself create divergence and nor for that matter does the Northern Ireland protocol, but both permit it or create a situation in which it may arise. It is therefore vital that the implications of this are part of discussions on the Bill.
The MHRA published guidance on medicines and medical devices based upon the potential situation at the end of the transition period, days before this House was due to sit for the Second Reading of the Bill. This advice implies that a dual system would be operating in respect of Northern Ireland for both medicines and medical devices due to the operation of the Northern Ireland protocol, to which the noble Baroness, Lady Wheeler, referred. This assumes that the Government will actually honour that agreement. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland.
The MHRA guidance makes a distinction between the EU market, the market of Great Britain and the market of Northern Ireland. It sets out that CE marks will cease to be recognised in the market of Great Britain from July 2023, unless the products in question are from manufacturers based in Northern Ireland. There are essentially two different baskets envisaged in the guidance for manufacturers that are based in Northern Ireland to bring a medicinal or medical product to the markets of Great Britain and Northern Ireland.
The first is to go through UK-based approved bodies for their assessments and market authorisations, which would be approval for the Great Britain or Great Britain and Northern Ireland markets, but it would not be recognised in the EU. The second is to submit their application to approval or notified bodies in the EEA, gaining 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. Noble Lords will see how confusing the whole system sounds.
In contrast, manufacturers based in Great Britain would need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland but would need to undertake the separate task of getting an EU-based responsible person and applying separately for a CE mark in the EU if they were to bring their product to the EU market.
Further, from 30 June 2023, CE-marked devices originating from the EU market but not manufactured in Northern Ireland will no longer be able to flow to Great Britain. This regulatory set-up in Northern Ireland could therefore be an incentive for EU manufacturers to base their European operations in Northern Ireland to have unfettered access to both markets. Discussions about whether this constitutes state aid and would distort the EU single market are still ongoing.
On the face of the MHRA guidance, it appears that the recognition of the CE mark on medicines and devices coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. It certainly suggests a dual system applying between Northern Ireland and the UK, but the extent to which those systems will diverge in substance in future is not clear. It is not clear how systems of pharmacovigilance or the monitoring of medical devices will be co-ordinated for products available in the Great Britain market that are manufactured in Northern Ireland and subject to EU regulations and monitoring. If monitoring systems and databases are to be fit for purpose in the EU, surely it is essential that the UK has access to EU databases. In the absence of this access, how can the Government guarantee, or claim to be prioritising, the safety of patients?
What is clear, because the guidance states it, is that draft regulations with reference to medicines and medical devices exist but have not yet been introduced to Parliament. These draft regulations are what the guidance claims to be based on. If these regulations exist to the extent that the MHRA is publishing guidance based on them on issues of significant policy in these areas, why has this House not had sight of them? Why have they not been included as part of the substance of the Bill where they would receive proper scrutiny and provide much-needed clarity to all stakeholders for medicines and medical devices?
The situation regarding regulatory alignment or divergence between Northern Ireland and the rest of the UK is politically charged and should be dealt with explicitly. Given the potential for some aspects of medicine and veterinary medicine to be subject to the distinct competence of the Northern Ireland Assembly, there is potential for the requirement to have regard to “attractiveness” to have different interpretations in Northern Ireland and the rest of the UK. Further, the ambiguity surrounding the Northern Ireland protocol and its implications raises the potential for divergence, even where the United Kingdom Government have competence to regulate in respect of medical devices. For these reasons—I hope that I have made this point at length—the Government should clarify the position. This amendment would provide greater transparency about the potential regulatory divergence with a commitment to mitigate where possible.
There is also concern that there will be delays in the import and export of medicines and medical devices, which need to continue to reach patients as quickly as possible, and we must ensure that any such delays are minimised, particularly during a pandemic. Avoiding delays caused by tariffs and regulatory barriers requires the UK and the EU to reach agreement on shared standards, such as manufacturing and inspections, so that goods can be licensed for rapid release into the UK market, or vice versa. With potential new checks and the lack of clarity on how the regulatory framework will apply, this could create unnecessary delays and impact on individual patients but also on medical practitioners.
There is also a need, as the Northern Ireland Affairs Committee said, for the Government to commit to covering all costs to businesses for complying with the protocol, which includes the whole area of medicines. I ask the Minister, the noble Baroness, Lady Penn, what discussions she and the noble Lord, Lord Bethell, have had with Minister Swann in the Northern Ireland Executive, as the Minister responsible for the Department of Health, about these issues, particularly in relation to the measures to minimise and mitigate the impact of divergence and how that will be achieved. We want to ensure the least impact from regulatory divergence on the availability and accessibility of medical devices and any other forms of medicine, whether for humans or for animals.