Health and Care Bill (Thirteenth sitting)

Philippa Whitford Excerpts

Committee stage
Tuesday 19th October 2021 Public Bill Committees

The clause will help by allowing organisations to demand such information of each other. That is probably second-best; it would be better for information to be readily shareable. That is why Labour are proposing this amendment. We have heard that the public will not differentiate between the different processes, and I cannot quite understand why the Government propose to make them.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

It is important that we recognise the different types of data. The clause is talking about anonymised data, from which we are looking at performance standards, outcome standards and the percentage of patients who had a certain treatment. It is not talking specifically about identifiable data. We also have fully identifiable data with patient details, and in between those we have what is called pseudonymised data, which is like a blurry picture. However, the public are also concerned about that data because they fear that when it is triangulated with other sources somebody can be identified.

It is important that clinical data—the basis of communication between a GP, a breast surgeon like me and an oncologist in a centre—moves around and can be used. However, we must recognise that, as the hon. Member for Nottingham North clarified with the survey that he quoted, the public are concerned about their data. Beyond someone’s biological self, the most important thing that relates to them is their personal data, and after the care.data scandal of seven years ago and Google DeepMind, the public do not trust programmes that suddenly appear with little discussion and consultation and that talk about taking data. There is a huge public education process to be carried out, but equally, in the end, confidence is undermined by the talk about sharing data, whether identifiable or pseudonymised, with commercial companies.

Anonymised data is not an issue. For example, of the patients who took a drug, 10% got a side effect and, of those, 3% had previous heart disease. That is useful information; it does not identify patients. The public’s concern is that commercial companies, including pharmaceutical companies, could access pseudonymised or full data that would identify them. It is important that the Government explain the three types of data and how they are used for utterly different things. The public have no issue with Public Health England or academics working to recognise what is happening with heart disease or cancer in the UK and learning from data. However, they are concerned about the potential commercial use and potential revelation of their personal data.

The Government have a long job to do to convince the public. The danger is that the baby goes out with the bathwater and we lose not just research but integrated functioning in NHS England. It is important to recognise that the data held in the devolved health services is completely separate. I will come to that on clause 85.

[Karin Smyth (Bristol South) (Lab)]

Unfortunately, Mr Bone, you missed our last sitting, in which I relayed to other Members my long career in the NHS and my experience on these matters, but I will start in the spirit in which I left off. Having worked at a clinical commissioning group at the time of the care.data episode, I absolutely concur with the comments made by the Labour and SNP Front Benchers, my hon. Friend the Member for Nottingham North and the hon. Member for Central Ayrshire.

We have had a lost decade, which is a great shame because the use of such data—we have learned much more about data and science during the pandemic—can save lives. My hon. Friend the Member for Nottingham North mentioned meeting a patient who could perhaps have been helped better. At the end of the day, that is what we want to make happen.

My experience inside the health service will not be everybody’s, but on information governance the attitude to data is very well developed and sophisticated, and people take it incredibly seriously. When we started on the care.data episode, the value of that really seemed self-evident in the system.

We need to bear in mind, as we look at the issue as legislators, that the people who deal with it day to day to effect what they see as positive change may be operating on one track and be completely taken by surprise by the public reaction. I remember trying to understand it myself; I am not a data specialist, but I tried to understand the different channels of what was being tried at the time. I explained to more senior managers that it did not sit right with me—I did not understand where it was going or what it meant for me. If I did not understand it, I knew that if it were not explained carefully, as the hon. Member for Central Ayrshire says, the general public would not either.

There is a missed opportunity. I ask the Minister to consider our very helpful Opposition amendment, not just in his role as a political leader in the Government, but by thinking about the rest of the system and how we can support it to do what it needs to. We absolutely need to bring the general public with us. Because of the mistakes of the past, I would argue that that we now require quite a mammoth exercise: not just differentiating between types of data, but considering who owns it, how we give it and what powers we will have in future.

As my hon. Friend the Member for Nottingham North said, the opt-out was really quite an incredible exercise over the summer. I think that has gone below the political radar in terms of the numbers of people who have taken that really quite difficult step. Part of this, as we will come to later, is about trust in GPs and GP data, which is where so much of our individual source data goes. The role of GPs also has to be brought very carefully along the path, because that data is of course very valuable for them.

The commercialisation concerns people, but beyond that, this is about our very essence—our trust in the system and the clinicians we see, who most of the time are our GPs. The Government need to step back—although not for too long, because they have already stepped back for a decade—and consider what is the best public exercise that they could embark on to resolve this problem, as the system and all of us really need.

Accepting our amendment in the spirit in which it was moved would be a step in the right direction. If the Government do not accept it, at the very least we should understand what they propose in its place.

--- Later in debate ---

[Edward Argar]

I am happy to bear in mind those sensible points as we look to the formulation of regulations. I am grateful to the shadow Minister.

Question put and agreed to.

Clause 84 ordered to stand part of the Bill.

Clause 85

Medicine information systems

[Dr Whitford]

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.

[The Chair]

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.

[Dr Whitford]

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 care.data 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.

--- Later in debate ---

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.

[Dr Whitford]

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.

[Edward Argar]

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.