Clause 85 - Medicine information systems

Health and Care Bill – in a Public Bill Committee at 10:30 am on 19th October 2021.

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Photo of Philippa Whitford Philippa Whitford Shadow SNP Spokesperson (Health and Social Care), Shadow SNP Spokesperson (Europe) 10:30 am, 19th October 2021

I beg to move amendment 65, page 77, line 3, at beginning insert “Subject to subsection (3A),”

This amendment, together with Amendment 66, would allow specified people and organisations who are required to provide information for a registry or information system to provide information to NHS Digital in pseudonymised form.

Photo of Peter Bone Peter Bone Conservative, Wellingborough

With this, it will be convenient to discuss the following:

Amendment 66, page 77, line 12, at end insert—

“(3A) The provision mentioned in subsection (2)(b) must enable those required to provide information to provide information in pseudonymised form.”

See explanatory statement to Amendment 65.

Amendment 64, in clause 85, page 77, line 33, at end insert—

“(5A) The Scottish Ministers may exempt persons to whom subsection (5) applies and who are in Scotland from any requirements imposed by regulations under this section.”

This amendment would allow Scottish Ministers to exempt providers in Scotland from participating in any particular registry or medical devices information system.

Amendment 61, in clause 85, page 77, line 34, at beginning insert “Subject to subsection (6A),”

Amendment 62, in clause 85, page 77, line 47, at end insert—

“(6A) Provision under subsection (6)(c) and (d) may only provide for the disclosure, use or (as the case may be) further disclosure of information for purposes of public health analysis, and must prohibit disclosure, use or further disclosure of information for commercial use.”

This amendment would require that the disclosure of information will only be for the purposes of public health analysis and not for commercial use.

Amendment 63, in clause 85, page 78, line 1, leave out

“includes power to vary or revoke the directions by a subsequent direction” and insert “—

(a) includes power to vary or revoke the directions by a subsequent direction, and

(b) is subject to the consent of—

(i) the Scottish Ministers insofar as the direction makes provision for any matter which falls within the legislative competence of the Scottish Parliament,

(ii) the Welsh Ministers insofar as the direction makes provision for any matter which falls within the legislative competence of Senedd Cymru, and

(iii) the Northern Ireland Ministers insofar as the direction makes provision for any matter which falls within the legislative competence of the Northern Ireland Assembly.”

This amendment would require the appropriate authority to obtain the legislative consent of the devolved governments before powers under this clause are exercised.

Amendment 60, in clause 85, page 78, line 9, at end insert—

“(8A) Regulations under subsection (1) may not be made without the consent of the Scottish Ministers, the Welsh Ministers and the Northern Ireland Ministers.”

This amendment would require the Secretary of State for Health and Social Care to obtain the legislative consent of the devolved governments before powers in this clause are exercised.

Amendment 67, in clause 85, page 79, line 8, at end insert—

“(4) Provision under subsection (3) which changes the territorial extent of provisions of Chapter 2 of Part 9 of the Health and Social Care Act 2012 (constitution and functions etc of the Health and Social Care Information Centre) and—

(a) relates to Scotland may only be made with the consent of the Scottish Ministers,

(b) relates to Wales may only be made with the consent of the Welsh Ministers, and

(c) relates to Northern Ireland may only be made with the consent of the Northern Ireland Ministers.”

This amendment would require the Secretary of State for Health and Social Care to obtain the legislative consent of the devolved governments before regulations under this provision are made.

Photo of Philippa Whitford Philippa Whitford Shadow SNP Spokesperson (Health and Social Care), Shadow SNP Spokesperson (Europe)

I should like to speak to the whole group of amendments because they all relate to one another—amendments 65, 66 and 64 are very much about the form of data, which I discussed earlier.

The principle of the clause relates to the powers that are going to be given to the Health and Social Care Information Centre. It is given a power to require, so it can demand data. As a Scottish MP I am aware that data handling under NHS Scotland is different. Our data systems are different. We have a real concern that there is no mention of consultation, let alone legislative consent. For the public across the UK, the way in which their data is handled, who owns and controls their data and what is done with it are critical. We did not take part in the project or Google DeepMind. There has not been any attempt within NHS Scotland to commercialise data, but we have very innovative working from Public Health Scotland and the academic universities. We do not want to see that undermined.

It is disappointing that there is no recognition in the clause that there should be both consultation and consent from the devolved Health Ministers. Proposed new section 7A(2) and 7A(4) give the power to require, and amendments 61 and 62 relate to proposed new section 7A(6) on how data is used and to whom it is disclosed, which we discussed earlier.

On proposed new section 7A(3) relating to the form of data, I totally support registries, particularly of devices. We are all aware of vaginal meshes. I remember wading through case sheets at the time of the PIP breast implant scandal, even though I knew we had never used them, because the only way to prove that none of my patients had had them was to go through literally every single operation note and sign it off.

Amendments 65, 66 and 64 relate to the form of data and specify that the Health and Social Care Information Centre would have power to decide what kind of information would be included in individual patient information. Amendments 61 and 62 relate to what we talked about earlier: disclosure to third parties, which is of public concern.

Amendments 63, 60 and 67 relate to proposed new section 7B(5)(b), which is the power to change the territorial extent. Although most of these provisions talk about getting data on social care from local government in England, it is completely within this Bill that the information centre would be able to demand data from devolved health centres and that the Bill’s territorial extent could be changed later by regulation, and without consultation, let alone legislative consent. All my amendments relate to the same basic principle: the four health services run separately, use different data systems and have different principles for sharing, using and analysing data, and whether they feel that sharing that with commercial companies is actually in the best interests of research, of patients and of clinical communication.

It is not necessary for pharmaceutical companies to have access to pseudonymised or individual data to study the functioning of their drugs. They require analysed, anonymised data that has been handled by trusted academics and researchers, whether from Public Health England or working in collaboration with universities. The amendments call for both consultation and legislative consent, without which the devolved health services and their principles of keeping data within the NHS and the public health system will be undermined. The Government need to talk to the devolved nations about that. They saw this Bill the day before it was launched. That is not consultation. That is not collaboration. That is not involvement.

It may well be that Ministers feel that a central registry of individual, identifiable details makes sense, or they may feel that it should be pseudonymised and brokered by the individual health services, because it will be those services that will have to contact patients if devices are found to be unsafe or need reviewing or if people need further surgery. This is about the lack even of consultation. As we have talked about all morning, data is so important to the public and to patients that legislative consent should be put into all those clauses of the Bill. I am disappointed that none of the devolved Ministers got to see the Bill when it was being put together, and as we heard from the Welsh Health Minister during the evidence sessions, her concerns are exactly the same as those of the Scottish Cabinet Secretary for Health and Social Care.

That is what I call for the Government to do, and I look forward to the Minister’s comments.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care) 10:45 am, 19th October 2021

I congratulate the hon. Member for Central Ayrshire on her amendments and the case she made for them. I remember with fondness that during proceedings on the Medicines and Medical Devices Act 2021 we were able to offer constructive ways in which information regarding medical devices could be collected and used. We managed to move the Government on that. I hope we have similar success on these proposals too, because those were arguments well made.

Amendments 65 and 66 get to the heart of building confidence regarding data among the general public. There is widespread understanding about anonymised data and about datasets so big that individuals cannot be recognised, but we know that sometimes, if we want more detail, and particularly around rarer conditions or in rural and more isolated communities, we risk identification. Giving our information leaders the tools with which to protect individuals while still delivering the desired outcome is a sound principle and is part of hearing the message that was sent from our constituents, so we can start to rebuild trust. Providing such extra tools would be proportionate.

Turning to amendment 64, devolution is at its best when the four nations can exercise the advantage of local knowledge and leadership but collectively harness separate oversight to tackle collective challenges. That is important, particularly for the use of data. I strongly believe it will be in the interests of people across the United Kingdom for all four nations to have similar systems of standards and alignment on data. I am conscious that the challenges in north Nottingham will be similar to the challenges in north Cardiff, but devolution may well mean that services in Cardiff are different from those in Nottingham; that is part of the process. It can also mean that the outcomes are different, and we may want to know that, so that one community can, if it wants to, change to replicate what another is doing. I am not arguing against common usage; I think it is important, but we do not want a situation where the Secretary of State seeks to act with overbearing control as a first among equals. The mutual benefits of sharing data are so clear to all parties that they ought to be able to be agreed on a good-faith and negotiated basis. It should not need compulsion from the Secretary of State; in fact, that would be a significant failure. Therefore, the opt-out specified would be proportionate in this case.

Amendments 61 and 62 are crucial. The general practice data for planning and research process fell over because a significant part of the population did not trust the Government to handle their data appropriately. There is widespread concern about the Government’s relationship with big commercial entities, whether in the planning process, political donations or covid contracts. They are not scare stories or political fluff; they are real issues, they are in the public consciousness, and there is a sense that that relationship and the balance with the commercial sector is not one where the calibration is right.

On data, we must at every opportunity send the loudest possible signal that there are irremovable firewalls between people’s data and commercial usage. That works on two levels. First, as mentioned there is a lack of trust that the data will not be handed over to big commercial companies. We know that the mega-giants in social media have an insatiable desire for our data, and the old adage that social media is only free because our data is the product rings true. The NHS is not like a social media platform, though; it is free at the point of use, but we have paid for it through our taxes. It is not a free service we get in return for sharing our data, and there is no mandate to simply pass on the information collected as a result of our healthcare.

Let us be honest: what confidence would we have in sending the Government to negotiate with these companies? We have seen the painstaking process involved in just getting them to pay tax in this country; I would not, with full confidence, send a Prime Minister to negotiate a fee for our data, because I suspect we would end up paying the companies. This is an opportunity to be absolutely, immovably and irreversibly clear that we do not think that they should be near this data.

Secondly, it is worth reiterating that it is not as simple as just not handing data over. Even through legitimate and beneficial use of data, we are still at risk of getting a bad deal. For example, we no doubt want to use population-level healthcare to work out what conditions we may need new treatments for in the future. For that reason, we want researchers to use this data, and from that new treatments and drugs will emerge. Big pharmaceutical companies stand to gain from this, so how is it to be accounted for? We have a stake and have played a part in that process, so we ought to have a share of the benefits. How will the premium that we pay for the new treatments reflect the contribution that we have made—bluntly, where is our dividend? Those are the reasons that the GPDPR process fell apart, and why there is so much suspicion about the Government’s handling of data more generally. If we keep repeating the same approaches we will get the same outcomes. This is a moment to change that and to send a signal that our data will be protected from commercial interests; I hope the Minister will meet this moment.

Finally, on amendments 60 to 63 and 67, I will not rehearse the arguments I have previously made. I can conceive of times when NHS bodies, local authorities, community and voluntary sector providers or private sector providers might fall short of the expectations we have of them on data sharing, and exceptions where the Secretary of State may need to step in. That is why the Opposition have supported earlier clauses in part 2. That is a reasonable and proportionate way of ensuring that the data sharing regime is an enabling regime. I cannot think that applies to the devolved nations. All four nations are partners in the common pursuit of improving health outcomes; we may diverge in approach, but the common goal is the same. I cannot conceive that there will be such a divergence on data that it would be legitimate and wise to resolve it by working without shared consent. I hope, in the light of the arguments made, that the Minister will revisit that point.

Photo of Edward Argar Edward Argar Minister of State (Department of Health and Social Care)

To the point made by the hon. Member for Central Ayrshire about the relationship with Edinburgh, while it is correct that a number of these clauses, and a large part of the Bill, were not finalised in their drafting until a day or two before publication, it is important to say that since the beginning of this year Scottish Government officials have had sight of the intentions and have been discussing with UK Government officials the wording and content of these clauses. I appreciate that this is not necessarily the same as a Minister seeing the exact wording, but that relationship and transparency has been there at that level.

I also put on record my gratitude to Humza Yousaf, the Cabinet Secretary for Health and Social Care. I spoke to him a week or two ago, and with tragic timing, in that conversation he asked me to pass on his best wishes to James Brokenshire for his recovery. I know that they got on well, and I hope that I have a similar relationship with Humza, who is pragmatic, and I appreciate the work that he is doing on this. We continue to talk, because I am keen that we have that healthy relationship and it is my intention that we respect the Sewel convention and work together to come to an agreed position. It is challenging because there are genuine differences of principle on how things should be interpreted, but I am committed to working with him, as he is with me, to find a way to reach a common position that respects everyone’s principles and approach.

The medicine information systems clauses give us an important opportunity to ensure we have the highest quality evidence on which to base critical regulatory decisions. If we get this right, there is real potential, which has been alluded to by all Members, to take a step forward in the way medicines are monitored, risks are identified and action is taken to protect patients. We need to provide for the most effective operation of this system to realise the full benefits for patients across the UK.

The detailed operation of the system will need to be carefully considered further as we develop the regulations under the clause. It will probably be important that the systems are able to receive information that is fully identifiable to ensure accurate linkage and deduplication of data. That is necessary to ensure that the information system is able to capture a comprehensive picture of a patient’s treatment to generate robust evidence, and that if a patient moves from one area of the UK to another, they are not lost from the registry.

Robust decision making on patient safety must be made using accurate data, which can only be achieved by processing identifiable data from the four nations to create the UK-wide information system. That necessitates precise data linkage due to the nature and potential rarity of harmful events based on multiple identifiable data points. It is proportionate to use identifiable data to understand potentially adverse patterns early.

Patient-identifiable information is also necessary where inclusion in a registry is to be used as a risk minimisation tool, where a patient needs to be identifiable in the registry to their healthcare providers, or if information systems are linked with wider safety monitoring mechanisms already in place, such as the yellow card scheme, through which the public and healthcare professionals can report adverse incidents experienced with a medicine to MHRA, to further strengthen the data it collates.

It is not necessary to make provision in the Bill, because the powers in clause 85 give the ability to follow the most appropriate approach on the collection and disclosure of data, following discussion with stakeholders on the detail of the future regulations. The confidentiality and security of patient data and the reassurance that offers to patients is paramount. I hope I can assure the hon. Member for Central Ayrshire and other Members that all data held in a medicines information system will be processed in compliance with data protection legislation, which places crucial safeguards on the use of that information. That includes data principles such as lawfulness, fairness and transparency, purpose limitation and data minimisation—meaning that the minimum necessary information will be collected to meet the required purpose.

I recognise the importance of ensuring the appropriate and proportionate use and access to information in a medicine information system. As part of our consultation on the regulations to establish and operate a medicine information system, we will engage with patient groups and other stakeholders across the UK, as well as the devolved Administrations, on the content and scope of the system to ensure we do what is right for patients.

On amendment 64, at official level we have been in discussions with the devolved Administrations since February about the provisions in the Bill, particularly those for which at an early stage we identified a shared agreement that legislative consent was required. Clause 85 is one of those. I would like to put on record my gratitude to those officials—we often talk at ministerial level, but they worked very hard for some time in the spirit of finding a way forward that works for everyone. Let me say the same in respect of the devolved Administrations, who have spent considerable time working with us.

Without going into too many details, because those discussions are continuing, I have had constructive discussions with the Cabinet Secretary for Health and Social Care in Edinburgh. I am keen, as he is, to do what we can to move those discussions forward. I hope we will be able to provide further reassurance over any outstanding areas of concern to the DAs, and where necessary and agreed, to table amendments ahead of Report. I hope that gives the hon. Lady some reassurance that I am directly engaged with the Cabinet Secretary and I will continue to be so. I am due to have another conversation with him in the coming days, and I have in my bundle another draft letter I am due to send him addressing some of the details of the granular points we are now looking at. I hope we will be able to make progress.

For medicine information systems to be truly effective as a tool, they need to cover all patients using the medicine across the UK. The regulatory decisions taken on the basis of the data collected will apply to the licensing of that medicine across the whole of the UK. My concern about Scottish Ministers choosing whether Scottish providers should or should not participate in the information system is that it could risk a fragmented approach, which is why we are having those discussions at policy level.

The amendment would apply only to medicine information systems. However, I note that the hon. Lady also refers to the medical devices information system. My memory may fail me, but I recall that the regulation enabling the medical devices information system was introduced in the Medicines and Medical Devices Act 2021, which was passed by both Houses and was subject to a legislative consent motion, agreed by the Scottish Parliament at the time.

The amendments in the Bill related to the medical device information system are technical in nature. We believe that, having got where we are, it would not be appropriate to revisit those substantive points, which were debated fully and voted on in the context of that previous piece of legislation. I again commit to working as closely as I can with the devolved Administrations to find a way forward.

Turning to amendments 61 and 62, as we have debated in other clauses, the Government are committed to championing the safe, effective use of data, enabling it to flow in a lawful, secure and appropriate way to improve outcomes for citizens. NHS Digital allows information to be used for purposes connected to health and care by organisations that have a legal basis and legitimate need to use the data. That approach enables data to be made available for a range of purposes that improve health and care. In some instances, such a use may have a commercial aspect, for example when informing the commissioning of tertiary services, such as paediatric services for children adversely affected by medicines taken in pregnancy, or when supporting research by organisations at the earlier stages of developing new treatments.

I recognise that individuals, regardless of where they live in the UK, will rightly want to be reassured that their information will be used in a trustworthy and appropriate manner. NHS Digital does not approve requests for data where the purpose is for marketing, insurance or similar purposes. That would extend to systems established under this clause. We would also continue to build on the safeguards in place to ensure that information will be appropriately protected and to ensure transparency about how it is used and by whom. The Government will work closely with the devolved Administrations to ensure that differences in approach to the use and disclosure of information across the UK are taken into consideration in developing the medicines information system.

Finally, I turn to amendments 63, 60 and 67. Amendment 60 would require consent to be obtained from all the devolved Administration Ministers in each case where the regulation-making power in clause 85 relating to medicines and information systems is exercised. Similarly, amendment 63 would require consent to be obtained from the devolved Administrations before the power in clause 85 to give a direction can be used. Amendment 67 would require consent to be obtained from the devolved Ministers before the power in clause 85(5) relating to territorial extent of the Health and Social Care Act 2012 could be exercised.

Clause 85 would enable the capture of data on the use of specific medicines throughout the UK to support high-quality evidence on their use, benefits and risks, and will be a significant step forward in improving the monitoring of medicines. As I have said, we are seeking to implement a system that works for the whole of the UK and ensures the safety of all patients. I reiterate that I am committed to working with the devolved Administrations to see if we can do just that.

The crux of what the hon. Member for Central Ayrshire is getting at is “consult or consent”, and the difference of interpretation on which is the more appropriate. Without going into too much detail, those are exactly the conversations I am having with her colleague, the Cabinet Secretary for Health and Social Care. Those discussions are ongoing, but I hope we will be able to make further progress. My previous conversations with him have been typically well informed and positive, and I hope we continue to make further progress.

It is important to be clear that clause 85(5), which would be affected by amendment 67, is a technical provision. Regulations made in relation to medicines and medical device information systems will introduce more substantial functions for NHS Digital in relation to Scotland, Wales and Northern Ireland. To ensure that NHS Digital can effectively undertake its UK-wide function in relation to the medicines and medical devices information systems, it is appropriate that certain provisions relating to the Health and Social Care Act 2012 can form part of the law for the whole of the UK. That is achieved through the power in clause 85(5).

That power can be exercised only as part of the regulations that deliver either the medicines or the medical devices information systems. The power applies only to certain provisions in the Health and Social Care Act 2012 that relate to the functions and constitution of NHS Digital. Therefore, use of the power is appropriately limited, and is also subject to the same public consultation requirement before any changes can be introduced through those regulations. It is not the intent to impact the range of other elements of the 2012 Act outside of the context of NHS Digital’s functions under the Medicines and Medical Devices Act 2021.

The Government are committed to ensuring that all patient data are captured efficiently, stored safely and used effectively, including those from patients within the devolved Administrations. To reiterate one more time, I commit to continuing to work closely with the devolved Administrations in discussions on this. I cannot promise what the outcome of those discussions will be; that would be wrong while they are going on. However, I commit to continuing to engage in good faith with the devolved Administrations to see whether we can make further progress. On that basis, I hope that the hon. Member for Central Ayrshire might consider withdrawing her amendment, but obviously that is her choice.

Photo of Philippa Whitford Philippa Whitford Shadow SNP Spokesperson (Health and Social Care), Shadow SNP Spokesperson (Europe) 11:00 am, 19th October 2021

I welcome the Minister’s constructive comments. Obviously, I am not party to the consultations that are going on. I am still disappointed that there was not provision for both consultation and, where necessary, legislative consent. As the Minister clarified, those registries will absolutely contain individual patient data. As a surgeon, of course I support the principle of registries and how they are put together, but the responsibility for data in NHS Scotland and in the other devolved nations lies with the Health Ministers of those nations. It is disappointing that there was nothing put in these provisions.

I hope that the consultation goes forward. I will therefore not push the amendments. Obviously, I reserve the right to table amendments at a later stage. However, it is important that the Government recognise that the same concerns that we have heard around GP data in England would then apply in Scotland, where we have not taken any kind of commercial approach in the past, and that there will be a recognition of the role of those health Ministers. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

Photo of Edward Argar Edward Argar Minister of State (Department of Health and Social Care)

As we have discussed in the context of the various amendments, clause 85 inserts a new chapter, 1A, into the Medicines and Medical Devices Act 2021. It introduces a new power to make regulations that would provide for one or more medicines information systems to be established and operated by NHS Digital. The power may be exercised only for the specified purposes set out in the provision: namely, purposes relating to the safety, quality and efficacy of human medicines and the improvement of clinical decision making in relation to human medicines. The clause sets out the types of provisions that could be made by the regulations and, to ensure full engagement, includes a mandatory public consultation requirement that must be fulfilled before any regulations are made.

Medicines information systems will enhance the capture and collation of information on the uses and effects of specific medicines across all four nations, including medicines prescribed to patients by the NHS and private healthcare providers. That information will be used by the Medicines and Healthcare Products Regulatory Agency to enhance post-market surveillance of medicines by enabling the development of comprehensive UK-wide medicines registries, which will be used to drive improvements to patient safety. The evidence generated through medicines registries can be used to inform regulatory decision making, support local clinical practice and provide prescribers with the evidence needed to make better-informed decisions. For example, where safety concerns have led to the introduction of measures to minimise risk to patients, comprehensive medicines registries will enable early identification and investigation of cases where those measures are not being followed, so that additional action can be taken to improve safety at national, local or individual patient level.

The clause also ensures that we have the right powers to promptly modify what data is collected by NHS Digital as the need for new or different information about a medicine emerges in the light of changing or developing public health needs. That will provide the ability to rapidly respond to emerging risks to patient safety if and when they develop.

Given the overarching aims of the clause, it makes sense that the provisions will ultimately sit within the Medicines and Medical Devices Act 2021, which has a similar power for establishing information systems for medical devices in section 19. To ensure the effective operation of both the medicines information systems and the medical devices information systems, the clause also introduces necessary technical amendments to the MMD Act.

The clause drives forward improvements to the safety measures that protect patients in the UK against avoidable harm from medicines, and supports the need for the establishment of registries as recommended in the independent medicines and medical devices safety review, published last year. The clause directly supports putting patient safety at the heart of regulatory decision making. It will ensure that we have robust and comprehensive evidence to address public health concerns, and enable mechanisms to track the use and effects of medicines, based on public health needs. I therefore commend the clause to the Committee.

Photo of Alex Norris Alex Norris Shadow Minister (Health and Social Care)

I had intended to go the entire period that I am in this place, however long that might be, at least trying to be a young Member, if not a new Member, but clause 85 amends a piece of legislation that I was on the Bill Committee for previously, so I feel that I cannot do that now. That is really startling. Nevertheless, as I said earlier, I and the hon. Member for Central Ayrshire argued strongly for this in Committee on that Bill, and I certainly would want to see this used properly and developed. With all the daily treatments that there are—and certainly when it comes to the medical devices that are inserted into people on any given day and on every day of the year every year—we really ought to know what those things are and, when there is a problem, be able to deal with it quite quickly.

I will make one final point. The Minister references, quite rightly, the independent review—the Cumberlege review. We will be revisiting the matter in the new clauses, because the Government have not done the job properly on that review. Although there are elements in this clause that make good on some of the commitments, there are very significant things that have been left out and that the Government do not intend to do, and they have really let down the families by not doing them, so we will be returning to that point, and I hope to find the Government in listening mode when we do.

Photo of Edward Argar Edward Argar Minister of State (Department of Health and Social Care)

I have nothing further to add to what we have said, save that I am always in listening mode when the shadow Minister is making his points.

Question put and agreed to.

Clause 85 accordingly ordered to stand part of the Bill.

Ordered, That further consideration be now adjourned. —(Steve Double.)

Adjourned till this day at Two o’clock.