Moved by Lord Bethell
17: Clause 7, page 4, line 36, after “a” insert “relevant”Member’s explanatory statementThis amendment and the amendment in the Minister’s name to add a definition of “relevant person” to Clause 7 restrict the persons to whom information may be disclosed in reliance on Clause 7(2).
My Lords, in moving Amendment 17 I will speak also to Amendments 19, 22, 23, 25, 35, 37, 38, 55, 56 and 58 to 62. All amendments in the group deal with the sharing of information outside the UK where this is required to give effect to an international agreement or arrangement.
I have listened to the concerns raised by noble Lords as to further safeguards that could be provided in relation to Clauses 7, 12 and 37(5), and the amendments made in Grand Committee. I am enormously grateful to noble Lords who have met and spoken to me and my team over the weeks between Grand Committee and Christmas. Their further explanations and collaborative spirit have been enormously valuable. I can say confidently that this collaboration has definitely improved the drafting of the Bill.
It is worth saying first that the Bill introduces powers for international information sharing only where it is pursuant to international agreements or arrangements concerning the regulation of human medicines, medical devices or veterinary medicines. As such, we are starting from a place where it is in the public interest for data to be shared to support the safety of human medicines, medical devices and veterinary medicines in the UK and globally.
As I explained in earlier debates, information sharing with other regulators plays an absolutely critical role in the work of the MHRA and the VMD to protect patient safety and to support international collaboration. For example, in medical device safety investigations, international information sharing allows for better signal detection and gathering of evidence to support the safety of medical devices available on the UK market. It is worth saying that failure to share that data has been one of the contributing factors to many patient safety issues. However, it is right that we ensure that when the MHRA and the VMD share information they do so with the appropriate persons. These amendments will ensure that.
Nevertheless, I have heard the concerns about the use of the term “persons” and whether this may be subject to broad interpretation. Noble Lords will agree that including in the Bill an exhaustive list of named organisations we share data with is not practical. Therefore, we have amended Clauses 7, 12 and 37 to include a definition of “relevant person”. These amendments clarify the types of persons outside the UK that information may be shared with. In short, they make it clear that these clauses do not offer a “blank cheque”.
We also heard concerns from noble Lords in Committee about the sharing of patient-identifiable information internationally. Clauses 7 and 37 already include safeguards to protect personal and commercially sensitive information, and there are additional safeguards in data protection legislation. However, we are keen to provide additional reassurance. That is why we have tabled further amendments that ensure that patient-identifiable information can be shared only if patients have provided consent.
In the vast majority of cases patient information is anonymised before being shared. These amendments account for the rare instances where it is necessary to share patient-identifiable data internationally to support our commitment to uphold patient safety; for example, in sharing patients’ concerns with an international regulator about a clinical trial they are taking part in in another country.
Finally, Amendments 22, 37 and 59 seek to clarify that the information-sharing powers in the Bill do not limit the circumstances in which information can be shared under any other enactment or rule of law. Such housekeeping amendments can be found as standard in many Acts and will ensure that the powers in the Bill cannot be construed as replacing existing statutory, prerogative or common laws of disclosure, which is not the intention. In introducing these amendments we seek simply to remove any potential confusion over what the powers in the Bill are intended to deliver.
I say again that I am enormously grateful to all noble Lords for their constructive challenge and thoughtful contributions on this subject. International information sharing is fundamental to the effective functioning of the MHRA and the VMD, but it is of vital importance that data is shared with care and that the appropriate safeguards are in place. I believe that our amendments deliver this balance. I beg to move.
My Lords, before I address the amendment from the noble Baroness, Lady Thornton, I reciprocate by thanking the Minister enormously for the many meetings he and his colleagues have had with all of us who are trying better to understand what the Government are trying to do with the Bill, particularly with these amendments. I agree that there are times, including in clinical trials—I have done this—when there is a need to share information with people involved in trials not only in the United Kingdom but overseas. I will come back to that in a minute.
I will start by saying that I support the amendments tabled by the noble Baroness, Lady Thornton, which address the broadly drafted government amendments that were introduced in Committee. Those amendments allow information held in connection with medicines and medical devices to be shared with relevant persons outside the UK, to give effect to international agreements in relation to the regulation of medicines and medical devices.
The original wording of these clauses was worrying due to the use of vague terms. It was not clear, for example, whether any information held by the relevant authority could cover all information contained in patient records relating to medicines and medical devices, including any information in medical records relating to the use of medicines for patients. As highlighted in Committee debates, there was also no definition of
“persons outside the United Kingdom”,
which left it open to broad interpretation, placing no limits on the category of persons to whom information may be disclosed.
The purposes of information disclosure are also broad, relating to the fulfilment of the requirements of any potential international agreement concerning the regulation of medicines and medical devices. In fact, a letter which the Minister sent to us all explaining these amendments in Committee argued that any such information disclosure would be related to the purposes of promoting public safety. There was and still is no mention of public safety in the purposes of information disclosure in the Government’s amendments, although I accept that, in presenting his amendments, the Minister did mention it in his introductory remarks.
The purposes are left to be determined by any international agreement, and thus this power is exceptionally broad. The Government’s own amendments to these clauses are welcome. They narrow the powers slightly by providing a definition of “relevant persons” to whom such information may be disclosed, and add new subsections requiring that no patient information be disclosed without consent. However, it is not clear to me what mechanism or form of consent is required.
Some may well remember that the care.data scandal evolved from the lack of a requirement for opt-in consent to the use of medical and healthcare data. The amendment tabled by the noble Baroness, Lady Thornton, addresses this issue by requiring that consent be “opt-in” in these situations. This is a sensible addition to ensure greater safeguards for patients. It is also worth highlighting that patient information is defined in government Amendment 22, in a new subsection relating to
“physical and mental … diagnosis … care or treatment”,
and information that
“identifies the individual or enables the individual to be identified (whether by itself or in combination with other information)”.
This means that information pertaining to patients can be shared where it has been rendered non-identifiable. This is in line with current data protection principles.
The amendment tabled by the noble Baroness, Lady Thornton, strengthens this protection further, through the addition of the word “could”, so that any information which might lead to reidentification is also captured in this definition. These protections are necessary as aggregate data can reveal patterns which may allow for reidentification, especially for small patient clusters, such as in rare diseases and conditions, and even in cancers, and where patients with common diseases are stratified for particular medicines.
Regardless of the need for consent to disclose patient data, consent is not required where data has been anonymised. Decisions on the use of public health data represent a substantive area of policy that should be subject to scrutiny and debate, and not relegated to the discretion of the Government alone. Data can be of high commercial value, so this power would essentially be used to allow the sharing of such data with interested parties as part of their trade deals. It has “international agreements” within the meaning of this clause, and the Minister may wish to comment on whether trade deals are included in international agreements.
This comes back to the issue of scrutiny at the heart of the Bill. It may be that information sharing and disclosure is necessary to allow smooth functioning and support internationally on pharmacovigilance and medical device monitoring, but there is an issue that patient/NHS data could also be bought as part of commercial interests in trade deals which the operation of information disclosure clauses may still allow for. The clauses as they stand, and as the Government now intend to amend them, still potentially allow for sharing of anonymised data with commercial partners for undefined—and therefore unknown—purposes, to be settled as part of an international agreement or trade deal that would probably not be scrutinised by Parliament.
While it may be conceded that international agreements may require the sharing of information to allow for proper international co-operation for pharmacovigilance and monitoring of safety, as the Minister himself mentioned, in their current form the government amendments may allow sharing for broader purposes that we are currently unable to scrutinise. The amendment tabled by the noble Baroness, Lady Thornton, requiring that any information disclosure to relevant persons outside the UK be permissible only to aid pharmacovigilance and device safety, and for purposes that are in the public interest, represents an acceptable compromise in narrowing the purposes for which information can be shared. The public interest principle at least requires consideration by the Government of substantial ethical issues in sharing information, yet it still allows significant flexibility when contemplating future agreements post Brexit.
There can surely be no objection to this minimal protection being required when contemplating the broad power being taken by the Government in decisions on the international sharing of valuable public data.
My Lords, it is a pleasure to follow the noble Lord, Lord Patel. I support and will speak to Amendments 18, 36 and 57, which have been so well introduced and explained by him, and which I have signed, and will speak to my own Amendment 20.
We have had discussions on this Bill and the Trade Bill about health data and trade issues. The two Bills are intimately connected, and this amendment is very complementary to Amendment 11, passed on Report of the Trade Bill on
As I said when the House debated these issues on Report of the Trade Bill and later passed the amendment, NHS data is a precious commodity, especially given the many transactions between technology, telecoms and pharma companies concerned with NHS data. I cited a recent report in which EY estimated that the value of NHS data could be around £10 billion a year in the benefit delivered, and the fact that the Department of Health and Social Care is preparing to publish its national health and care data strategy shortly, in which it is expected to prioritise the
“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes.”
I mentioned too that, while acknowledging that the UK is a leading player in the fields of life sciences and biosciences, health professionals have strongly argued that free trade deals risk compromising the safe storage and processing of NHS data in much the way that the noble Lord, Lord Patel, has mentioned.
Through the amendment to the Trade Bill from the noble Baroness, Lady Thornton, and likewise this amendment, the objective is to ensure that it is the NHS, not US big tech companies and drug giants, that reaps the benefit of all this data. This is especially important given what the Ada Lovelace Institute called in its report, The Data Will See You Now, the “datafication” of health, which, it says, has profound consequences for who can access data about health, how we practically and legally define health data, and our relationship with our own well-being and the healthcare system. Health information can now be inferred from non-health data, and data about health can be used for purposes beyond healthcare. Harnessing the value of healthcare data must therefore be allied with ensuring that adequate protections are put in place in trade agreements, if that value is not to be given or traded away.
At the time, I raised questions about the provisions of the UK-Japan trade agreement, and there is no doubt that these questions will linger unless an amendment of this kind, to both this Bill and the Trade Bill, goes forward.
There have been many shortcomings in the sharing of data between various parts of the health service, care sector and Civil Service. The development of the Covid-19 app and the way that the Government have procured contracts for data management with the private sector have not improved public trust in their approach to data use. That is why clear safeguards are needed to ensure that, in trade deals and international agreements, our publicly held data is safe from exploitation where it is not for public benefit.
On Tuesday, the Minister heavily emphasised the public interest test that he wanted to see applied to the sharing and use of Clause 3 information. The data covered by Clauses 7, 12 and 37 is even more important. He used the same language today and in correspondence, so I hope he can accept these amendments. As the noble Lord, Lord Patel, has said, we also want to see the aspect of patient consent clarified.
I turn briefly to Amendment 20. I welcome the Minister’s Amendment 19, but Amendment 20 is designed to get the Minister to further clarify what is meant by “consent” in Clause 7. Informed consent is very much a familiar concept in healthcare, especially in treatment and trials, and, indeed, that is effectively the definition on the NHS website. It depends on capacity, explanation, understanding and it being voluntary. That is why my amendment would insert the word “informed”, to make it abundantly clear that, at the very least, that is what is intended here. I look forward to the Minister’s reply.
My Lords, it is a great pleasure to follow the noble Lord, Lord Clement-Jones, and I welcome the opportunity to debate this important group of amendments. I welcome the government amendments, but feel that my noble friend Lady Thornton’s amendment is very important, as indeed are some of the others in this group.
I have always been strongly in favour of using patient information. It is a rich source of data for scientists to pursue in the search for medical advances. We all benefit, and I am sure that the great majority of the public see this and are agreeable to information being shared. But we must have appropriate safeguards, and that is why the government amendments to restrict the persons to whom information may be disclosed, and the addition of a definition of patient information and the need for individual patient consent, are all very welcome.
My understanding, however, is that information pertaining to patients can be shared where it has been rendered non-identifiable. As the University of Birmingham has commented, this may be in line with current data protection principles but there is still a danger of a care.data-type problem, in that the provisions might allow the Government to share with “relevant persons”—as they are now called—outside the UK information they hold on patient data through NHS bodies without consent when anonymised. The noble Lord, Lord Patel, referred to some of the issues with care.data. The stricter definition of patient information may address some of the concerns that the definition of patient data—being restricted to identifiable data—left anonymised data open for use or barter as part of international agreements. Part of this broader concern is that aggregate data can reveal patterns that may allow for re-identification, especially for small patient clusters in respect of rare diseases and conditions.
The points that the noble Lord, Lord Clement-Jones, made about the interrelationship between this Bill and the Trade Bill are therefore hugely important. We know that data can be of high commercial value, and the power could in essence be used to allow the sharing of such data to interested parties as part of trade deals and international agreements, which certainly has implications for concerns about consent.
I just say to the Minister that the NHS has form in giving away data to American companies without enough care being taken over the conditions under which the data can be used, and certainly without adequate resource compensation. This makes it all the more important to ensure that we beef up the safeguards. The amendments from my noble friend Lady Thornton and those from the noble Lords, Lord Clement-Jones and Lord Patel, all deserve support for seeking to do that.
My Lords, I was privileged to speak at some length about the provisions of this Bill in Grand Committee, and I thank those who supported the amendments in my name, which concerned the role of cutting-edge, data-driven medical devices. The Minister has since reassured me of his intention to further explore their implications in the course of a consultation exercise about their definition and regulation over the coming year. Like the noble Lord, Lord Patel, I want to put on record my gratitude for the way that he has facilitated these discussions.
The amendments that I rise to support today seek to protect patient information, including what is properly “special category data” in the Data Protection Act 2018, which is crucial in the development of new pharmaceutical products and medical devices.
Of course, it goes without saying that efforts to facilitate the flow of data in the context of the ongoing health emergency are vitally important. These are extraordinary circumstances in which we find ourselves. Today, however, we must take steps with an eye to the long term; steps that will introduce legal provisions to prevent a situation that might give rise to undue concern or restrict scrutiny of matters pertaining to patient safety in the future, both at home and overseas.
I am certain that the Minister is well aware of public sentiment concerning privacy and data protection, which are, of course, not limited to the healthcare domain. Maintaining the trustworthiness of organisations that function as stewards of the nation’s healthcare data is paramount, and a carefully considered approach to patient safety is needed to preserve that trustworthiness, as the Government move to improve upon and forge new international arrangements.
The Minister’s amendments make it mandatory for consent to be provided where patient information is being shared with territories outside the United Kingdom. The noble Baroness, Lady Thornton, has tabled clarifying amendments to ensure that the purpose for which patient information is being shared is limited to patient safety and its scrutiny. For these reasons, I support Amendments 18, 36 and 57, to which I have added my name.
I want to make two points. The first is about the structure of Amendment 18. I am not entirely sure that I understand why pharmacovigilance has been singled out in the amendment as a reason why disclosure should be made, as distinct from, for example, public health co-operation or the pursuit of research. Indeed, the Minister referred to the sharing of information in relation to international clinical trials as a very good example. If one were to legislate in this form, it would be inevitable that the reference to pharmacovigilance would be regarded as having additional weight, and the absence of reference to other purposes for which information would be shared would be regarded as less important. I am not sure that that would be at all helpful to have in statute.
My other point is in relation to Clause 7(5). Government Amendment 22 refers to and introduces a provision that assists in understanding the relationship between this legislation and other enactments concerning the disclosure of information. Clause 7(5) states:
“Nothing in this section authorises a disclosure of information which … contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section)”.
Noble Lords may recall the Trade Bill and, in particular, the debate we had on the Trade (Disclosure of Information) Act just before Christmas and new year. We passed legislation the purpose of which was, among other things, to ensure that we clarified the relationship between that enactment and others that authorise disclosures of information or, in some circumstances, prohibit such disclosures. The particular basis for the structure of that Bill was to clarify a situation where there is a statutory gateway and other enactments that put constraints on the disclosure of information.
In subsection (5) it is clear that if someone is considering a disclosure that might contravene the data protection legislation, that legislation must be considered alongside the powers in this legislation. That enables them to satisfy the test in the Christian Institute and others v The Lord Advocate 2016 Supreme Court decision, as referred to in my noble friend Lord Grimstone’s letter to us about the Trade Bill. In the Trade Bill, though, as is the case in this Bill, we have reference both to the data protection legislation and to the Investigatory Powers Act. In the Trade Bill, amendments were introduced on Report to ensure that the saving reference—that is, when determining whether a disclosure would contravene the legislation, it takes into account the powers in this section—was applied to both the data protection legislation and the Investigatory Powers Act. However, in this legislation—Clause 7(5)(b) —the saving reference is applied to the data protection legislation but not to the Investigatory Powers Act.
My question, which I am sorry I have not had an opportunity to give the Minister notice of, as I have started working through these issues only very recently, is this. Having dealt with this matter on the Trade Bill, I would have thought that both these subsections should have the saving reference that allows the question of the contravention of those Acts to be considered, including reference to the powers in this Bill. I wonder if he would agree.
My Lords, I am delighted to follow my noble friend, who speaks with such great authority both as a former Secretary of State for Health and as someone who has followed the Trade Bill and the Trade (Disclosure of Information) Act so closely.
At the risk of dancing on the head of a pin, the amendments in this group are quite close, and the Minister set out every reason why we should support his Amendment 17. He said that information would be shared only in the circumstances where there is perceived to be a public need. The amendments and explanatory statement of the noble Baroness, Lady Thornton, refine that by saying that, in the context of giving effect to an international agreement or arrangement concerning the regulation of human medicines, it should be disclosed only provided that it is in the public interest to do so. A number of noble Lords have spoken with great eloquence and passion on these issues, including the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, and my noble friend Lord Lansley. I have to say that I personally would draw the line at disclosing information for a commercial need as opposed to a public one.
I have a particular question about Amendment 19, which clearly states that patient information cannot be disclosed where the patient could be identified and that that information cannot be given without their consent. I remember that I was once asked to participate in a study; I signed the form and was delighted to do so, and never heard any more about it. I would just like to know how Amendment 19 would work in practice. At what point, and by whom, would the patient be contacted if that information was about to be disclosed and their consent sought?
I have reservations about this group. I remember the important debate that we had on the Trade Bill in this regard, and I am delighted to see that those issues are being considered in the context of this Bill as well. I have two concerns that I hope can be allayed. The first is that public need should not be deemed to collude with commercial need where it might not be in the interests of the patient. The second is about informed consent: how will the patient be consulted within the provisions of Amendment 19?
My Lords, this has been an interesting and well-informed debate, and I am quite reluctant to enter into it. I support government Amendment 19 and particularly Amendment 20 tabled by the noble Lord, Lord Clement-Jones. I hope I have got this right, although I am very happy to be put right if I have not. As I understand it, Amendments 19 to 25 concern consent, relating very specifically to the disclosure of information in accordance with international agreements. This is information that I think a relevant authority such as the MHRA holds in connection with human medicines.
As I listened to the noble Lord, Lord Freyberg, he raised a question in my mind about devices. We know that pharmaceuticals are much more closely regulated than devices have been, so can the Minister tell us a bit more about instances where there is a comparable agreement, and perhaps an amendment, for medical devices? I want to know whether they are on all fours with pharmaceuticals. I suspect not. Having listened to the noble Lord, Lord Freyberg, I think that there is more to hear on this.
The Minister’s Amendment 19 makes it very clear that:
“Nothing in this section authorises a disclosure of … information” that would include patient-identifiable information without the patient’s consent. I warmly welcome that, but Amendment 20 in the name of the noble Lord, Lord Clement-Jones, goes further. It seeks to ensure that such consent is informed. As the noble Lord, Lord Hunt, and others, including the noble Lord, Lord Clement-Jones, said, informed consent is very well recognised within the NHS but sadly not always adhered to. To me, Amendment 20 in the name of the noble Lord, Lord Clement-Jones, is preferable to Amendment 21, which states that
“‘consent’ means that an individual has given notice of their willingness for an appropriate authority to disclose patient information” by explicitly opting in. That is not good enough.
I fully support Amendment 20, with the proviso that gaining informed consent can never be just a tick-box exercise. The information, of course, pertains to patients and their state of health, the diagnosis they have received, the treatments they have had and the outcomes from those interventions. That information, rightly, belongs to the patient. The noble Lord, Lord Hunt, mentioned care.data, and we know what a terrible debacle that was, when not enough care was given to the rights of patients over their information.
We know from the reams of evidence that we received during our review that “informed consent”, albeit usually in the context of a patient/clinician consultation, was often anything but informed. However, as I understand it, this debate is not about that; it is about the information that will be passed on through international agreements. I hope I have that right.
If we are to change how the healthcare system manages, interprets and responds to informed consent, we must ensure that it does not just pay lip service. Whenever informed consent matters, we should ensure, through this Bill and elsewhere, that it really does matter and is fully protected.
I support these amendments but ask the Minister to give an assurance that, in relying on informed consent, where disclosure of information can enable a patient to be identified, the relevant authority will have evidence on four issues: first, that consent was indeed properly informed; secondly, that the patient concerned understood how their information might be used; thirdly, that any specific concerns they might have had had been addressed; and, lastly, that the patient was made fully aware that they could withdraw consent at any time. I should perhaps add to that last point that they could withdraw either via an intermediary or directly. There must be a mechanism in place to ensure that the relevant authority is made aware of this change—that the patient has withdrawn consent—and that the authority can be seen to have acted on it.
There is much in all these amendments. It has been a good debate and I look forward to the Minister’s reply.
It is a pleasure to follow my noble friend Lady Cumberlege, who has gone into great detail on these amendments. As far as I can see, these are mainly government amendments, plus some from other parties, and they are all broadly to be welcomed. The question I ask myself is: where are the boundaries to be set?
Very helpfully, the Minister, in his opening statement, explained in some detail the extent of information-sharing outside the UK and gave the example of the safety of medical devices. Having listened to my noble friend and the others who have contributed, I am still not quite sure about Amendments 18 and 20. I can see where they are coming from and can understand what is behind them but on this occasion I will have to listen to the Minister. These are sensitive areas and certainly we in the upper House should listen. I am also not entirely clear from the Minister’s statement at the beginning what the implications of Amendment 22 are. There has already been a good deal of coverage and I will not add to it further.
These amendments relate to the use of data and information sharing. The noble Baroness, Lady Thornton, my noble friend Lord Clement- Jones and the noble Lord, Lord Patel, have put their names to some of them. The noble Lord, Lord Freyberg, outlined clearly in the context of trade and health the power and value of data. Data is a hugely rich source for research but also a hugely valuable commodity, so we need safeguards.
Concern was raised in Committee about the level of protection in the Bill for patient information, as regulations are able to make provision about the disclosure of such information. I am grateful to the Minister for being so willing to look at this again.
The Government have responded in two main ways: with the introduction of a definition of “relevant person”, thereby narrowing the definition of whom data can be shared with, and by defining what is meant by patient information. As the noble Lord, Lord Patel, explained, Amendment 24 in the name of the noble Baroness, Lady Thornton, strengthens the definition of patient information to protect information that could identify a patient, rather than just information that does.
Amendments 18, 36 and 57, led by the noble Baroness, Lady Thornton, and supported by my noble friend Lord Clement-Jones and others, would allow a relevant authority to disclose information to a person outside the UK only where required for the purpose of giving effect to an international agreement or an arrangement concerning the regulation of human medicine, provided it was within the public interest so to do. Those three amendments all pass the test put forward by the noble Baroness, Lady McIntosh of Pickering, concerning public good.
Amendment 20, from my noble friend Lord Clement-Jones, would take the Government’s amendment on patient consent further by ensuring that consent given in relation to identifiable information was informed consent. The noble Baroness, Lady Cumberlege, has just raised the issue. We should not need this. Informed consent should be the default but, as it clearly is not, I support my noble friend’s Amendment 20.
Similarly, Amendment 21, in the name of the noble Baroness, Lady Thornton, would ensure that patient information could be shared by an appropriate authority only if the individual to whom it related had given their explicit consent.
These amendments strengthen the Bill and therefore patient outcomes. I will listen to the Minister to see what plans the Government have to satisfy noble Lords on this group.
My Lords, I thank all noble Lords who have taken part in this debate. I will speak to the amendments in my name, and give notice that I will test the opinion of the House on Amendment 18, along with Amendments 36 and 57, all of which are supported by the noble Lords, Lord Patel, Lord Freyberg and Lord Clement-Jones. This is unless—of course, I always live in hope—they are agreed to by the Minister.
Turning to the other amendments in my name in this group, I just want to put on record how grateful we are on our Benches for the way that the Minister and the Bill team have worked on these important issues, and how much we support the amendments that he has tabled. We do not see these amendments as in opposition; we see them as amplification and clarification.
Amendment 24 is a probing test for whether aggregate data could identify individuals through de-identification or de-anonymisation practices. The Government’s amendments define patient information as data that
“identifies the individual or enables the individual to be identified (whether by itself or in combination with other information)”.
This represents a welcome tightening up of the definition to include scenarios where contextual information might allow de-identified data to become identifiable. This is very important given that aggregate data can reveal patterns which allow for reidentification, especially for small patient clusters as in rare diseases and conditions. Given the rapid development of sophisticated technology, my Amendment 24 probes the test for whether anonymised aggregate data could identify individuals through this. I hope the Minister will be able to assure the House that the appropriate safeguards and checks are in place.
Amendment 21 would ensure that patient information
“can only be shared by an appropriate authority if the individual to whom it relates has given their explicit (‘opt-in’) consent.”
We welcome the Government’s requirement for consent to share patient information. However, they have not specified how this consent mechanism will work in practice. This amendment in my name would ensure that important distinction, which has been mentioned by many noble Lords across the House. Other noble Lords have also mentioned care.data, which, because of a lack of clarity about the use of data, did not work. I hope the Government will be able to assure us that explicitly informed consent will be sought and secured.
Under Amendment 18, followed by Amendments 36 and 57, data would be disclosed to persons under international agreements or arrangements only for pharmacovigilance or if “in the public interest”. I hope the public interest bit answers the question from the noble Lord, Lord Lansley. I thank the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, my noble friend Lord Hunt and other noble Lords for their support for this suite of amendments.
Overall, the government amendments narrow discretion and set out in more detail the purposes for the information-sharing powers. However, in our view they still potentially allow for the disclosure of patient data without consent to commercial partners for undefined, and therefore unknown, purposes to be settled as part of international agreements or trade deals. That is why the helpful read-across to the Trade Bill by the noble Lords, Lord Freyberg, Lord Clement-Jones and Lord Patel, is so important. We recognise that information-sharing and disclosure may be necessary to allow smooth functioning and support internationally on pharmacovigilance, for example, but remain concerned that NHS data—which has been described as a treasure trove, worth perhaps £9.6 billion—could be bartered as part of commercial interests in trade deals.
Amendment 18, along with Amendments 36 and 57 in my name, would allow the Secretary of State to disclose NHS data only under the terms of an international agreement or trade deal for pharmacovigilance, of if it is otherwise in the public interest. We believe “the public interest” is a legitimate test that would offer reassurance that substantive and ethical issues relating to the sharing of data would at least be considered. I hope the Minister will recognise the value of this amendment; otherwise, as I say, I would like to test the opinion of the House.
My Lords, we are enormously grateful to the noble Baroness, Lady Thornton, and the noble Lord, Lord Clement-Jones, for their Amendments 20 and 24 to one of my own amendments to Clause 7. These amendments seek to ensure that patient information can be shared by an appropriate authority only if the individual has given their explicit or informed consent, respectively. I completely recognise the commendable intent behind both amendments to safeguard and protect patient safety. Their intentions are benign but they are absolutely not necessary.
My lived experience for the past year has been completely aligned with the words of the noble Lords, Lord Clement-Jones and Lord Freyberg. Data is absolutely key. I have spent my time outside the Chamber working on little else: clearing the path for patient recruitment to clinical trials, so that therapies can be designed to save lives; getting data on long Covid patients from primary care to those researchers and clinicians who are trying to help them, which is an extremely complex and onerous task; getting central tracing data to local infections teams, which means transferring it between various jurisdictions; getting people to record the tests they take, which is a legal requirement but legally and technically difficult to implement; and getting test results from those who have taken them into their GP records. Most bizarrely, to me at least, I have been getting data-sharing agreements in place so that local authorities, which are crying out for the data—as their representatives here in this very Chamber cry out to me at the Dispatch Box for it—can access the dashboards with those legal agreements; or getting the data on those who may need support isolating into the hands of those charities and local authorities which are keen to support them.
Every step of the way, there has been an onerous set of legal, ethical and bureaucratic barriers. Speaking on the back of that experience, I wonder whether scientific deduction and patient safety are sometimes sidelined by other considerations. I therefore warn about measures that are driven by prejudice or secondary principles, rather than the priorities of trying to save lives and pursue science. Their unintended consequences can have a profound, stifling effect on patient safety, medical research and innovation, and on the effective running of a modern healthcare system. I can think of so many incidents where the need for data-sharing agreements, legally obtuse patient consents and all sorts of rarefied ethical reviews have caused major life-threatening obstacles and troubling issues in our response to Covid.
I know that the measures in these amendments are well intended, but I assure noble Lords that they are not necessary. For instance, Clause 7 accounts for the rare instances where it is necessary for the MHRA to share identifiable patient information internationally to support our commitment to upholding patient safety. I take this opportunity to assure noble Lords not only that this will be done only with the informed consent of the patient but that the practical implementation of some of the very measures in this Bill, such as the medical information system, will require these kinds of measures. It seems counterproductive for us to be undoing the benefits of our own information system.
Amendment 21 in the name of the noble Baroness, Lady Thornton, seeks to broaden the definition of patient information to include information that could enable identification. I reassure the noble Baroness that the MHRA absolutely follows the Information Commissioner’s gold standard practices on patient data anonymisation. In order to be truly anonymised under GDPR, sufficient personal data is always stripped out so that, not only can the individual not be identified, but reasonably available means could also not enable the recipient to re-identify the individual. As such, if patient information to be shared still enables the patient to be identified, for example due to the unique nature of their condition, the amendment in my name will provide sufficient protection by requiring that patient’s consent be sought before sharing their information. The MHRA keep anonymisation processes under review in line with the ICO’s guidelines and continue to monitor advances in data technology.
We have heard from the noble Baroness, Lady Thornton, and the noble Lords, Lord Patel and Lord Clement-Jones, on their Amendments 18, 36 and 57, which seek to limit the purpose for which information can be shared internationally under the powers. It is important to highlight that we could only disclose information under this power where disclosure is required in order to give effect to an international agreement or arrangement concerning the regulation of human medicines, medical devices or veterinary medicines. In that regard, the clause already allows disclosure only for a particular purpose. As international co-operation in this area is important and a good, even necessary, thing, such agreements or arrangements would be in the public interest by default. The UK meeting its international obligations under these agreements and arrangements would be even more so. Furthermore, the MHRA and VMD do not share information for commercial gain—on that point I want to be absolutely categoric. Therefore, I am persuaded that these amendments are accordingly unnecessary.
We have introduced a number of amendments to these powers to clarify the types of person with whom information can be shared and, for those instances when it is necessary to share identifiable patient data internationally, introduced a lock that ensures that data can be shared only with consent. These amendments are, of course, in addition to existing data protection legislation and ICO guidance. I can assure the noble Lords that we are not complacent when it comes to the safe and appropriate use of patient data. We understand that, as technology advances, we will need to continually review the way in which we anonymise data to ensure that it remains just that.
I hope this provides noble Lords with assurance that the Bill and the additional amendments in my name provide robust safeguards to protect patient information, alongside long-standing data protection legislation already in place, and that they will not press their amendments.
Amendment 17 agreed.