Medicines and Medical Devices Bill

Baroness Fookes Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Lord Bethell (Con)]

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.

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 are 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.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

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.

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

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.

[Lord Bethell (Con)]

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.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I have not received any further requests to speak, so I call the noble Baroness, Lady Wheeler.

[Baroness Wheeler (Lab)]

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.

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Clauses 17 to 34 agreed.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

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.

Clause 35: Disclosure of information

Amendment 108

Moved by

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[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I understand that the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so the next speaker will be the noble Lord, Lord O’Shaughnessy.

[Lord O'Shaughnessy (Con)]

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.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I next call the noble Baroness, Lady Jolly, and I dare say that there will be a little pause before she speaks.

[Baroness Jolly (LD) [V]]

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?

[Baroness Thornton (Lab)]

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.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I understand that there was an error, and the noble Baroness, Lady Bennett, was not called, so I call her now.

[Baroness Bennett of Manor Castle (GP) [V]]

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?

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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 are therefore necessary or appropriate. I therefore hope that the noble Lord, Lord Patel, feels able to withdraw his amendment.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I have received a request to speak after the Minister, so I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

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?

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[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

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.

Amendment 117

Moved by

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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.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

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.

[Lord Patel (CB) [V]]

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.

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 prosthesis. 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.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

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.

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

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.

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.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

My Lords, I suggest that the Committee adjourn for 15 minutes.