Wednesday 9th February 2022
(4 years, 6 months ago)
Lords ChamberHealth and Care Act 2022 View all Health and Care Act 2022 Debates Read Hansard Text Amendment Paper: HL Bill 71-IX Ninth marshalled list for Committee - (7 Feb 2022)
Baroness Jones of Whitchurch (Lab)
My Lords, I intend to be brief because we do not believe that these two amendments are either necessary or appropriate in the context of the Health and Care Bill. If the Equality and Human Rights Commission is conducting a wider review into single-sex services then we should consider those issues at that time, but not in the context of this Bill.
I agree with the noble Baroness, Lady Brinton, that the Equality Act 2010 and the 2019 NHS guidance Delivering Same-Sex Accommodation already provide an effective mechanism for inclusion in the context of single-sex wards. The two amendments seek to cut across long-standing provisions in both the Act and the guidance. There is no substantial evidence to suggest that the status quo is not working and that NHS professionals are unable to use the existing guidance, which clearly sets out the principles and practice to be followed.
We also consider that the amendments could do harm if implemented, because they would create a blanket rule requiring trans women to be treated on men’s wards and trans men to be treated on women’s wards. At best, that would create an environment contrary to the dignity and well-being of the patients. At worst, it would leave trans patients at the risk of harm and abuse by outing them in a public context at a time when they are particularly vulnerable.
Like other noble Lords, we have received a detailed briefing from Stonewall imploring us to oppose these amendments. Given that we do not consider that the Bill is the right place for the consideration of these issues, we will not be lending our support to the amendments.
Lord Kamall (Con)
My Lords, I am grateful to my noble friend Lord Blencathra for bringing this discussion before the Committee and to my noble friend Lady Nicholson for taking the time to meet to discuss this issue, on which she is a strong advocate.
It clearly arouses strong feelings, but it is really important that we remember two principles: dignity and respect. There are people who feel they were born in the wrong body, and we should respect their rights as trans men or trans women; at the same time, there will be some women in wards who, on seeing someone who, to them, seems like a man, may feel slightly vulnerable at a particularly vulnerable time—in hospital. It is right that we get the right balance.
I hope noble Lords will be aware that NHS England is currently reviewing the Delivering Same-Sex Accommodation guidance to ensure that it remains focused on privacy, safety and dignity for all patients. The NHS is committed to meeting its duties under the Equality Act and, as such, needs to give due regard to both those whose gender identity is the same as their biological sex at birth and those whose gender identity is not. This means that the rights and needs of women and trans women are equal in law.
Following the review, the new content of the guidance will be informed by engagement with a wide range of stakeholders and by the statutory duties of the NHS outlined in the Equality Act 2010, including the public sector equality duty. NHS England is currently under- taking this review and is fully aware of its importance. The guidance, which will be updated if appropriate, is due to be published later this year. I call on noble Lords not to pre-empt the outcome of the guidance review. Any guidance will—indeed, must—be compatible with the requirements and duties placed on NHS bodies by the Equality Act 2010.
I am aware that concerns have been raised about the safety of women in single-sex wards. We, as a Government, believe that violence of any kind has no place in NHS facilities. We expect that hospital staff will act in the best interests of all patients and can, if necessary, call on security staff and law enforcement to ensure that everyone is safe. I repeat my request to my noble friend Lady Nicholson for evidence of such cases, whether it be women who feel uncomfortable or patients or staff who have raised concerns and been accused of being transphobic. If that is the case, I ask her to bring these cases to my attention and we can look at them further.
However, given that NHS England is currently reviewing the guidance, I hope noble Lords can appreciate the need to allow it time to review it in full. I ask the noble Baroness to withdraw her amendment.
Baroness Nicholson of Winterbourne (Con)
I thank the Minister very much for his immensely helpful statement, while reminding him that the rights of another group do not supersede the rights of the group that is already there. In other words, it is not really worth listening to the simple comment, “Women and trans women are equal”. We are all equal under the law; we all have dignity and equal rights. My contention is that the dignity, privacy and safety of women patients, which have been fought over for several decades in both Houses, are now being diminished significantly and their health and recovery from illness significantly undermined by the imposition of new rights of others on top of women’s rights. It amuses me that no one is suggesting they should be on top of men’s rights.
This is, I am afraid, a matter of great concern to all women. I know that Members of other Benches have demanded evidence. I can guarantee that, within 24 hours, if you wish it, I can get 20,000 to 40,000 letters in front of the Minister claiming that women need privacy, safety and dignity, and that they are not receiving it with these new impositions. If noble Lords want evidence, feel free.
Lord Kamall
(i) would be within the legislative competence of the Northern Ireland Assembly if contained in an Act of that Assembly, and(ii) would not, if contained in a Bill for an Act of the Northern Ireland Assembly, result in the Bill requiring the consent of the Secretary of State under section 8 of the Northern Ireland Act 1998.”Member’s explanatory statement
This amendment makes a drafting change to reflect the fact that consent of the Secretary of State under section 8 of the Northern Ireland Act 1998 is given in relation to an Assembly Bill rather than an Assembly Act.
Lord Kamall
“Information about payments etc to persons in the health care sector
(1) The Secretary of State may by regulations require manufacturers or commercial suppliers of health care products, or connected persons, to—(a) publish information about payments or other benefits provided by them to relevant persons, or(b) provide such information to the Secretary of State.(2) The regulations may make further provision about when and how the information is to be published or provided.(3) The information may, in particular, include information about—(a) a payment or other benefit,(b) the person who provided it, or(c) the person who received it.(4) The regulations may make provision permitting or requiring the further sharing, publication or use of the information.(5) The regulations may impose requirements on manufacturers or commercial suppliers of health care products, or connected persons, about the retention of information relating to payments or other benefits provided by them to relevant persons.(6) The regulations may—(a) authorise the Secretary of State to designate as a “relevant scheme” any scheme under which information about payments or other benefits to relevant persons is collected or published by a person other than the Secretary of State, if the Secretary of State considers that the provision of information under the scheme would render compliance with some or all of the requirements imposed by the regulations unnecessary;(b) create exceptions from requirements to publish or provide information imposed by virtue of subsection (1) where information is provided under a relevant scheme;(c) if such exceptions are created—(i) require a person who holds information mentioned in subsection (1) in connection with the operation of a relevant scheme to provide the information to the Secretary of State;(ii) permit or require the Secretary of State to publish the information.(7) The regulations may impose requirements on a person mentioned in subsection (6)(c)(i) about the retention of information mentioned there.(8) The provision for exceptions that may be made by the regulations includes provision authorising the Secretary of State to grant an exception from a requirement imposed by the regulations in a particular case, on grounds specified in the regulations. (9) The regulations may provide that the disclosure of information under the regulations does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed), other than a restriction imposed by the data protection legislation.(10) Provision made by the regulations may, in particular, be framed by reference to manufacturers or commercial suppliers with a specified connection to the United Kingdom or a part of it.(11) In this section—(a) “connected person”, in relation to a manufacturer or commercial supplier, means a person who has a connection, of a description specified in regulations made by the Secretary of State, with the manufacturer or commercial supplier;(b) “relevant person” means—(i) a person who provides health care in the United Kingdom or a part of it, whether or not under arrangements made by another person, or(ii) another person who carries on activities connected with health care provided in the United Kingdom or a part of it and is of a description specified in regulations made by the Secretary of State.(12) In this section—“commercial supplier”, in relation to a health care product, means a person who supplies the product otherwise than in the course of providing health care;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;“health care” means all forms of health care provided for individuals, whether relating to physical or mental health;“health care product” means a medicine, medical device or other product which is supplied or prescribed in the course of the provision of health care;“manufacturer”, in relation to a health care product, means a person who manufactures or assembles the product;“payments or other benefits” includes any payment or other benefit—(a) wherever it is provided,(b) whether or not it is of a financial nature,(c) whether it is provided under a contract or otherwise, and(d) whether it is provided directly or through a third party.”Member’s explanatory statement
This New Clause would enable regulations to require the reporting and publication of information about payments and other benefits provided to persons in the health care sector by manufacturers and suppliers of health care products.
Baroness Jones of Whitchurch (Lab)
My Lords, I will respond to the debate, but my comments apply equally to the next group, so I hope that the noble Baroness, Lady McIntosh, will forgive me if I do not respond to that group separately. We have heard some very thoughtful and persuasive contributions to the debate on these amendments this evening, and once again my noble friend Lord Hunt and the noble Lord, Lord Clement-Jones, have very eloquently led the charge. I congratulate them on their contributions and the constructive detail of their proposals. Issues such as this require some specific proposals to have any meaning and their amendments very much do that: they spell out some solutions to the challenges we face. I also welcome the specific proposal from the noble Baroness, Lady Tyler, who made the case well for a single identifier for children.
The underlying issues around the use of information collected by the NHS are not new. As we know and have heard, the NHS is almost unique in being a single player in this field, at least for some purposes. It can and often does lead the world in its ability to collect and aggregate patient data to drive improvement and for other non-profit-making purposes.
Since the organisational changes of the 1990s, data collection and use have been well developed, and information and analysis—for example, from the Secondary Uses Service and some GP sources—have been extensively used by academics and researchers, as well as operational managers, to huge public benefit. But we have struggled, as we have heard. Despite hugely expensive meanders into, for example, the National Programme for IT, we are far from the goal of integrated data sharing, even in a single hospital, let alone all hospitals, let alone for all care. Clearly, technical, legal and cultural barriers need to be overcome before we can maximise the use of all the data collected.
As noble Lords have pointed out, the groundswell of opposition to data collection and the related concerns about who gets to use it and for what purposes runs along these barriers. We know that the NHS often has dismal communications—for example, around CareCo and the recent changes to the use of GP data, which we have heard about this evening.
Although we do not own our data, there is a very powerful set of legal protections over what data can be collected and stored about us and what it can be used for. If the public had absolute confidence in the systems and usage rules, there would be far fewer objections to their information being used to drive improved healthcare, innovative drugs research or better preventive or public health information programmes. But the reality is that concerns are widespread—about data breaches, about NHS data reaching people who do not need to see it and, more recently, as we have heard, about data being used by a number of unethical organisations and private companies to drive profitability rather than for the improvement of public health.
Many patients would wish to be able to refuse to allow data collected about them to be used simply to drive a better marketing campaign for slimming or cosmetic aids but would allow their data to be aggregated so that better drugs could be developed and treatments improved to save lives; that would be an altogether different matter. Amendment 305A, in the name of my noble friend Lord Hunt, on establishing a sovereign health fund to invest in data-driven healthcare assets to generate long-term income for health and care makes that point, and I am sure it would have public support.
The key principle should be that all data collected for the purposes of care should be held and controlled by the public sector and its use protected. It should be subject to ethical guidelines and independently verified by an expert oversight group. These amendments would strengthen these rights in those regards.
Anyone who visited a hospital 20 years ago and walked around would probably have come across a trolley stacked with files that could easily have been removed or read. However, IT and the ability to aggregate vast amounts of data, allowing serious data breaches, is a modern and valid concern. My noble friend Lord Davies illustrated this with specific concerns about smart programmes which can identify individual people from a very small amount of data about their lives.
So we do feel that these amendments would be a very helpful way to address the underlying and fundamental problems of the lack of patient and public confidence in how their data is going to be used and shared. I hope the Minister, the noble Baroness—no, it is the noble Lord—agrees that these proposals offer a helpful way forward in addressing these concerns. While we will not press the amendments to a vote this evening, I hope he is able to offer some reassurance that some of these practical proposals will be taken forward by the Government.
Lord Kamall (Con)
Let me assure the noble Baroness that I was not trying to opt out of my duty to respond.
I thank all noble Lords for their contributions to this important debate. I reassure many noble Lords across the House that when I first became a Minister, I had many of these questions myself—and I continue to have them, if I am perfectly honest.
I will turn first to the amendments before deciding how to go forward, as it were. In response to Amendment 298, Clause 81 explicitly mentions NHS England as a body to which mandatory information standards can be applied. As set out in this clause, the exact procedure for publishing information standards, as well as any procedure for granting waivers in respect of compliance with these standards, will be set out in regulations subject to parliamentary scrutiny under the affirmative procedure. The regulations may set out limits on the circumstances in which a waiver may be granted. For example, a temporary waiver might be considered where an organisation does not have funding in place to implement the required changes.
The noble Lord, Lord Hunt, also referred to accredited data access environments and rightly acknowledges that their function is not just to support research but for analysis to support service planning, as well as other essential activity. I believe that we are fulfilling our promises to the profession and the public at the moment, but clearly more could be done. We have made clear that data collection for General Practice Data for Planning and Research will now begin only when: first, we have in place the ability to delete data if patients choose to opt out of sharing their GP data with NHS Digital; secondly, a trusted research environment is available, where approved researchers can work securely on deidentified patient data; and, lastly, a campaign of engagement and communication has increased public awareness, explaining how data is used and patient choices.
In addition, the Government have committed to developing, this year, rules for such data environments in the NHS, including technical specifications and a framework for accreditation. However, while we expect secure data environments to be appropriate for the vast majority of uses, there are likely to be exceptions. For example, where patient consent has been given for data to be made available to an external researcher or organisation, or where there is a court order requiring data, it may have to leave the secure data environment. I assure the noble Lord that we will continue to examine how secure data environments operate and are governed, to make sure that they are fit for the future.
Lord Warner (CB)
I am sorry to interrupt the Minister at this time of night, but I think he has no idea how many Ministers have stood in this place over the last 10 to 15 years making very similar speeches to this. We now have “deep dives”, but the idea of Whitehall co-operating on this issue is always dead in the water after these deep dives, if I may mix my metaphors. What we really need is at least an assurance that some kind of pilot scheme will actually emerge from this deep diving and be put in place so that something actually happens, with all the agencies co-operating.
Lord Kamall (Con)
I thank the noble Lord, first for his earlier confidence in my abilities and now for questioning my abilities, as it were, and rightly so. I am very interested in this, and noble Lords will remember that, in the meeting, I discussed what I saw as technical solutions to this. If there are different primary keys, it does not take a complicated bit of code to give equivalence or, in fact, restricted views, as it were, as appropriate. However, once again, those views would have to be agreed across government: while it might seem appropriate for the Department of Health number or the NHS number to be used, that could give access that is not considered appropriate, and we have to get the right balance. I ask the noble Lord, Lord Warner, to revert back to his earlier confidence in my abilities to do something —assuming I am here for some time.
In the coming months, the Department for Education will be providing an update to the existing information-sharing guidance. We believe that provides a real opportunity. One thing I have been quite clear about—for example, in the life sciences vision—is that I want to work with my counterparts and have been working with my counterparts in other departments; in BEIS, in DIT but also with the adviser in No. 10. I fully recognise the Committee’s interest in promoting data protection, ensuring that patients’ data is used appropriately. We have all been on a learning curve over the years as people share their data on such things as Facebook and now realise what happens to that data, how it is used and sold. I alhso refer to the ownership of data: at the end of the day, the data has to be the patient’s data. They have to be quite clear about that ownership and what happens to it.
All processing and sharing of information under Clauses 81 to 87 will meet the requirements of data protection law, including the UK GDPR. An individual’s personal information will be shared only in specific circumstances: where the individual consents to the use of the data, where there is a legal requirement to share or where sharing such data is necessary. I recognise as well that noble Lords, if we get through this, will be having a meeting tomorrow on confidential data and I hope that we can have some more, deeper conversations, not only tomorrow but in future. I have committed previously to meetings: there is a particular issue with one of the meetings and I will explain that to the noble Lords I spoke to previously about it, but I hope that for now, noble Lords will have some reassurance, although perhaps not complete reassurance, and will feel able to withdraw their amendments at this stage.
Lord Hunt of Kings Heath (Lab)
My Lords, I am very grateful to the Minister. I am conscious of what my noble friend Lord Davies said about the time we have to debate these complex and important matters. Clearly, we would like to reflect on the Minister’s reply, which was constructive and helpful, although I cannot help recalling meetings that I held as a DoH Minister with the Department for Education Ministers in about 2002, where we were discussing this very issue. My noble friend Lady Hughes—Beverley Hughes—was the Education Minister and, alas, nearly 20 years later, here we are still talking about these issues, which is why we are a little pessimistic about the dive that the noble Lord is about to make.
In the end, this is all about public confidence and the balance between the needs of our health and care system and the benefit that accrues from the exchange of, and access to, information. I am alarmed by the figure for opt-outs—a million—and it puts at risk the integrity of having the shared information system. That is a reflection of the challenge that the NHS in particular faces and I still doubt whether it really recognises just what it needs to do. Making opt-out easier is one way in which we build confidence in the system, and it might mean that fewer people opt out in the future. The current system of making it as hard as possible for people to opt out is not the way to grow confidence. That is probably the most important point that I want to make.
Having said that, I thank the Minister for his constructive response, and we look forward to these further meetings. I beg leave to withdraw the amendment.
Lord Clement-Jones (LD)
My Lords, I rise very briefly to speak to this amendment. I have considerable doubts about it. In relation to patient data, it looks like a possible thin end of a wedge—in fact, it might even be the thick end of a wedge.
I take this opportunity to come back to the Minister to add a query about the data governance regime which he has described this evening and into which we dipped our toe with the last group of amendments. My noble friend anticipated me in discussing the White Paper, which, in turn, follows from the Data Saves Lives draft strategy. I hope we will have the opportunity to meet the Minister to discuss this further because it is a very complex area.
I want to add to that conversation the fact that we variously have IGARD, CAG and the National Data Guardian for Health and Care—as well as NHS Digital, which we hope will remain separate, but we will come to that shortly. We have all these different bodies, but we need a simple regime which helps us understand, for instance, whether the Minister will say, “Yes, it’s already happening”, to the noble Baroness, Lady McIntosh, or, “No, it’s not going to happen.” I could not tell you the answer to that question in my current state of knowledge about the ability to transfer information across the health service and internationally.
There is a balance to be struck between the established protections and new provisions which might expedite the development of access to new and improved treatments and technologies—but it must be done in a safe way. I hope that, between Committee and Report, the Minister will take the opportunity to ensure that we have all the information we need on plans to perform a so-called reset of or new direction for—or however he might like to describe it—the NHS’s use of our health data.
Lord Kamall (Con)
I am grateful to the noble Baroness, Lady McIntosh, for bringing this discussion before the Committee. I also thank the noble Lord, Lord Clement-Jones, for his contribution. The information collected by the future medicine information systems has the potential to be used appropriately to support relevant research and improve the way in which we monitor medicines across the UK. However, once again, referring to the previous debate, we must be quite clear about whose data that is and the right to opt out.
Exchanging information with both national and international institutions is already integral to the MHRA’s post-market surveillance activities. Appropriate sharing of data from medicine information systems and medicine registries could also help support wider research to directly inform regulatory decision-making and to further support patient safety. Once again, we must respect patients’ concerns and their right to opt out.
The clause already provides the necessary power, by inserting new subsection (7A)(2)(c), enabling regulations to be made about the use and disclosure of information held within medicine information systems.
In regard to the noble Baroness’s admirable desire to ensure international co-operation with other bodies for post-market surveillance, medicines information systems will be established to support the MHRA developing medicine registries. As the regulatory authority, it is the MHRA’s international collaboration, rather than the information centres’, that will be key to supporting post-market surveillance. To ensure that this can continue, there are already specific powers in the Medicines and Medical Devices Act which enable the Secretary of State, and by extension the MHRA, to appropriately share information with international partners. Once again, going back to a previous debate, it is about what is an appropriate sharing of data.
As with medicines information systems, we already have sufficient legal powers to appropriately share. On the second element of this amendment, the existing provisions in Section 19, specifically Section 19(2)(c), enable regulations to address the use and disclosure of information held within medical devices information systems, providing an ability to appropriately share information within a future system. There will need to be careful consideration and consultation on the sharing and use of information, as we have previously said. However, there is a beneficial impact that the system could have in research and post-market surveillance.
In response to the specific question, I recognise the desire to see a system set up under the regulation-making powers in place, but given the importance of this matter, it is crucial—I hope that the noble Baroness reflects on the previous debate—that we take the time to get this right. Any regulations made under Section 19 and the wider system will need to be informed by extensive engagement and consultation, working closely with our partners in the devolved Administrations, so that they can deliver their full potential for patients and clinicians across the UK, taking account of the very real concerns raised about patient data. Once again, we are trying to get that balance right: better healthcare and better research feeding into health, but at the same time patients having the right to opt out.
NHS Digital is well placed to deliver and operate the medical devices information system. Alongside key partners, such as the devolved Administrations, we will consider how we can establish this system in a controlled, staged manner that builds on the confidence and momentum behind this issue.
Finally, I will be moving Amendment 306AA in my name. The amendment is supported by the Scottish Government; it is simply a clarification in wording. It makes clear that any powers or duties conferred on Scottish Ministers in relation to their role in collecting information for medicines information systems can be treated in the same way as other NHS powers or duties in Scotland and be delegated to health boards in Scotland. It is my sincere intent not only to respect the devolved settlement but to create the best possible system, one that will work UK-wide. This amendment supports that aim. It is for that reason that I ask noble Lords to support this amendment and invite my noble friend to withdraw hers.
Baroness McIntosh of Pickering (Con)
My Lords, I am grateful to my noble friend the Minister and the noble Lord, Lord Clement-Jones, for their contributions. I quite understand that my noble friend feels that there has to be a proper consultation, mindful of the sensitivity of patient data. I remember that being discussed during the passage of the Medicines and Medical Devices Bill in this place. It would be helpful to have an idea of what the timetable is for the consultation period and the introduction of the regulations. I do not know if my noble friend is able to put a timetable on that. Perhaps he could do that when we meet at the round table; it would be extremely helpful.
I am grateful for the reassurance he has given and for the opportunity to have aired the issues this evening. At this stage, I beg leave to withdraw the amendment.
Lord Kamall
“(b) provide for powers or duties conferred on the Scottish Ministers to be treated for the purposes of section 2 of the National Health Service (Scotland) Act 1978 as functions relating to the health service (within the meaning of that Act).”Member’s explanatory statement
This amendment enables the Scottish Ministers to delegate functions conferred on them under medicine information systems regulations to certain health bodies in Scotland.
Lord Kamall (Con)
My Lords, as many other noble Lords have said, this group contains a range of amendments in relation to the power to transfer the functions of the arm’s-length bodies. Because some of the bodies within the scope of this power perform functions in areas of devolved competence, Clauses 88 to 94 engage the legislative consent process. To ensure that we can proceed on a UK-wide basis, the Government have agreed to make a number of amendments, while recognising the comments of the noble Baroness about support for those amendments. Following the recent conclusion of our negotiations with the devolved Governments, I am pleased that they have now recommended to their respective legislatures that legislative consent Motions be granted provided that these amendments are accepted.
Amendments 231A and 231B will remove devolved Ministers, the Northern Ireland Department of Health and Welsh NHS trusts from the list of appropriate persons to whom property rights and liabilities can be transferred through a transfer scheme, following a transfer of functions. Following a request by the devolved Governments, we determined that it would not be necessary for such a transfer to those entities to occur.
Proposed Amendment 231C creates a requirement for the Government to obtain the consent of the devolved Governments for any transfer of functions that are within the competence of their legislatures or that modify functions exercised by Welsh Ministers, Scottish Ministers or a Northern Ireland department. While the majority of the functions within the scope of the power relate to reserved matters or apply in England only, certain bodies have functions that meet the criteria laid out above. This requirement to obtain the consent of devolved Ministers replaces the requirement to consult them. The Secretary of State will still be required to consult any body to which the regulations relate and can consult such other bodies as the Secretary of State deems appropriate. A memorandum of understanding is currently being finalised that sets out how the devolved Governments will be engaged from an early stage of policy formulation.
Amendments 231D to 231G are consequential on the changes to Clause 94 made by Amendment 231C. We have also agreed with the Welsh Government to make Amendment 227A, which clarifies that the powers in Part 3 of the Bill apply only in relation to England-only and cross-border special health Authorities and not Wales-only special health authorities. It has never been the Government’s intention for references in Part 3 of the Bill to special health authorities to include Wales-only ones. This amendment simply makes that explicitly clear.
I would also like to provide some reassurance to the devolved Governments about Clause 91(6), which sets out that the consequential provision that may be made when making regulations to transfer functions includes consequential changes to devolved legislation. The reason this is necessary is that there are references to the relevant arm’s-length bodies in devolved legislation that may need to be amended to reflect a transfer of functions or the renaming of a body. Amendments to devolved legislation under this power may be made only if they genuinely flow from a transfer of functions. This is not a broad power to make sweeping substantive changes to devolved legislation.
In a similar vein, we want to provide assurance to the devolved Governments about Clause 149, which is a wider power to enable the UK Government to make consequential amendments that may be necessary following the passage of the Bill. This type of power is quite common in a Bill as large as the Health and Care Bill and there are many examples of similar powers in legislation already on the statute book. Amendments, including amendments to devolved legislation, under this power may be made only if they are genuinely consequential upon provisions within the Bill. Like Clause 91(6), this is not a broad power to make sweeping substantive changes to devolved legislation.
I now turn to Amendments 229 and 230 relating to Clause 91 that have been spoken to by the noble Lord, Lord Patel. Clause 91 does not create powers in and of itself. Rather, it sets out certain types of provision that may be made when the Secretary of State uses the power to make consequential provision where making regulations under the Bill—Clause 150—alongside the power to make regulations under Clauses 89 or 90 transferring or delegating functions. Anything done under the powers to which this clause relates, therefore, would need to be genuinely consequential, supplementary or incidental to a transfer or delegation of functions.
It is impossible to predict every consequential provision that may arise from a transfer of powers and functions. Therefore, it is appropriate that the list in Clause 91(1) should be non-exhaustive, and include provision for abolishing and changing functions, as well as conferring them. Any changes would be made under the affirmative procedure, allowing Parliament to scrutinise them, and I hope the noble Lord will feel that he does not need to press his amendments.
I turn now to Amendment 227 and 228, tabled by the noble Lord, Lord Hunt, and spoken to by the noble Lord, Lord Clement-Jones. The merger of NHS Digital and NHS England was a recommendation of the Wade-Gery review. The aim is to give NHS England overall accountability for leading the transformation of digital services in the NHS, which includes how we use data effectively and securely.
Years ago, when I did my master’s in information systems management, one of the things we found out about companies or push-back companies was that digital and technology should not be separate or a bolt-on. They should be an integral part of the strategy and NHS Transformation tells me how integral technology is to transformation. If you consider it a bolt-on, it will not be integral to the overall strategy. To quote from Putting Data, Digital and Tech at the Heart of Transforming the NHS:
“data and analytics must become a core capability for NHSEI and the wider healthcare system going forward … Currently, this capability is split across NHSEI, NHSX and NHSD and, as a result, is being underutilised with duplicated activities, investments and capabilities.”
The report makes clear the benefits of these proposed changes.
There is also no question of diluting the current patient data protections. The planned merger will largely be achieved through a transfer of functions, staff, services and platforms from NHS Digital to NHS England. The Government will continue to hold NHS England to account for delivery of these functions, just as it currently holds NHS Digital to account. None of the changes we are making will remove the protections in respect of patient data.
I thank the noble Lord, Lord Warner, and the noble Baroness, Lady Walmsley, for for moving their amendment into this group. Placing these kinds of constraints on the Government’s power to commence legislation would be both unusual and counterproductive; we believe that our elective recovery delivery plan, which was announced yesterday, is better suited to solving the issues in this debate. We have committed an additional £2 billion this year, plus a further £8 billion, and laid out how we expect to tackle the backlog. As the noble Baroness, Lady Merron, rightly said, there was a backlog before, and we would have been tackling it earlier had it not been for Covid. We intend to deliver on our proposals, and those in the 2019 NHS Long Term Plan.
Lord Kamall
“Special Health Authority” means a Special Health Authority established under section 28 of the National Health Service Act 2006.”Member’s explanatory statement
This amendment makes it clearer that the powers in Part 3 of the Bill apply only in relation to England-only and cross-border Special Health Authorities (and not Wales-only Special Health Authorities).
Baroness Walmsley (LD)
My Lords, the 2012 Act removed certain powers from the Secretary of State, and Jeremy Hunt, the former and longest-serving Secretary of State, says that he never felt the lack of them. He had all the levers he needed to carry out his role of ensuring that the mandate and the five-year forward view were carried out and responsible to Parliament. However, Part 3 of the Bill puts a whole lot back—and more. These powers appear all over the Bill but particularly in Part 3, and we have spent the last five weeks pushing back against most of them.
There is a real danger that, if the Secretary of State were to use these powers, it could threaten the stability, proper management and operational independence of key parts of the NHS. The Constitution Committee raised serious concerns about the range of Secretary of State powers and concluded that the new powers
“could alter the balance between the Government’s constitutional responsibility for the provision of health care and providers’ ability to … respond effectively to local needs.”
I make no apology for the fact that I have quoted this section of the committee’s report before. It applies to so much of the “We know best” power grab that it bears repeating.
If the Minister wishes to abolish, change or transfer functions between arm’s-length bodies to this extent, it should be scrutinised by Parliament. Should it be necessary and appropriate in the future to make these changes, the Secretary of State should find another piece of primary legislation in which to do it. But to take these overreaching powers with no indication of how they will be used—or why—is going too far.
Lord Kamall (Con)
I thank both noble Baronesses for bringing this debate before the Committee. The proposal is to remove Part 3 of the Bill entirely. I understand that the noble Baronesses are principally concerned to prevent Health Education England, NHS Digital, the Health Research Authority and the Human Fertilisation and Embryology Authority from being abolished as a consequence of this power.
I clearly understand the concerns in this debate, but I stress that this is not a power to take away services currently being performed by arm’s-length bodies. The power is to enable the transfer of functions between arm’s-length bodies, and the delegation of the Secretary of State’s functions to arm’s-length bodies, to improve consistency and coherence in the arm’s-length body landscape. There is no free-standing power simply to abolish an arm’s-length body contained in this clause, and it is not the Government’s primary intention to use this power to abolish bodies. The only circumstances where a body may be abolished under this power is where it is, as the result of transfers of its functions to other bodies, effectively rendered redundant. To not have the power to abolish such bodies in these circumstances would effectively leave shell arm’s-length bodies with no significant functions, which would weaken the efficiencies we are seeking to create.
I reassure the noble Baronesses that all proposals will be considered through a full and extensive engagement and consultation process. Regulations providing for transfers under this power will be subject to the affirmative procedure. This ensures that Parliament can scrutinise the use of this power, including any necessary amendments made to primary legislation. This would follow on from a consultation with the relevant parties.
The Secretary of State must, at a minimum, consult the arm’s-length bodies and devolved Governments to which the transfer relates. Additional stakeholders whom it may be appropriate to consult will vary depending on the nature of the transfer of functions contemplated. The Bill therefore provides that such other persons as the Secretary of State considers appropriate should also be consulted, which is in line with the department’s and the Government’s commitment to engaging with stakeholders.
We have set out the principles of engagement and consultation with the devolved Governments through a memorandum of understanding, which has been negotiated and is close to agreement. This will sit along- side the legislation and provide the opportunity for the devolved Governments to be involved at a formative stage of policy development. In addition, the principle of Amendment 231C, which we have just discussed, is a requirement for the relevant devolved Governments’ consent to be given to transfer any functions that are within their legislative competence or that modify functions exercised by the devolved Government.
Although the majority of the arm’s-length bodies and functions within the scope of the power relate to reserved matters or apply in England only, certain bodies have functions that meet the criteria laid out above. We all know that the arm’s-length body landscape is complex, and this power will ensure that there is a transparent process throughout, including formal consultation, so that any relevant arm’s-length bodies and devolved Governments, and Parliament, will have the opportunity to scrutinise any plans for its use. I hope that that has given some assurance, and for these reasons I ask the noble Baroness to withdraw her opposition to the clause standing part.
Baroness Merron (Lab)
I thank the Minister for his reply and the reference to parliamentary scrutiny. He will know that, in discussions in this Committee, the call for transparency and scrutiny has often been repeated. I am interested in the reassurances that the Minister has given and will consider his points further. I am sure that he understands that there is a feeling that these powers are still not necessary—not now—but I will certainly consider his points. With that, I beg leave to withdraw my opposition to Clause 88 standing part.
Lord Kamall
Member’s explanatory statement
This amendment removes the Scottish Ministers, a Northern Ireland department and the Welsh Ministers from the list of persons to whom property etc can be transferred under Clause 92.
Lord Kamall
“(1) Before making regulations under section 89 or 90, the Secretary of State must—(a) obtain the consent of the Scottish Ministers in relation to any provision—(i) which would be within the legislative competence of the Scottish Parliament, if contained in an Act of that Parliament, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or(ii) which modifies the functions of the Scottish Ministers;(b) obtain the consent of the Welsh Ministers in relation to any provision—(i) which would be within the legislative competence of Senedd Cymru, if contained in an Act of the Senedd, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or(ii) which modifies the functions of the Welsh Ministers;(c) obtain the consent of a Northern Ireland department in relation to any provision—(i) which would be within the legislative competence of the Northern Ireland Assembly, if contained in an Act of that Assembly, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or(ii) which modifies the functions of a Northern Ireland department.”Member’s explanatory statement
This amendment requires the Secretary of State to obtain consent of, rather than consulting with, the Scottish Ministers, the Welsh Ministers or a Northern Ireland department (as appropriate) before making provision within devolved legislative or executive competence in regulations under Clause 89 or 90.
Lord Kamall
Member’s explanatory statement
This amendment adds the new England and Wales offences relating to hymenoplasty to section 65A of the Police and Criminal Evidence Act 1984 (qualifying offences for the purposes of Part 5 of that Act).
Lord Kamall
“STORAGE OF GAMETES AND EMBRYOSPART 1AMENDMENTS TO HUMAN FERTILISATION AND EMBRYOLOGY ACT 1990Introductory
1_ The Human Fertilisation and Embryology Act 1990 is amended as follows.Maximum storage periods
2_(1) Section 14 (conditions of storage licences) is amended as follows.(2) In subsection (1), for paragraph (c) substitute—“(c) that the requirements of subsection (3) (maximum storage periods) are met,”.(3) For subsections (3) to (5) substitute— “(3) The requirements referred to in subsection (1)(c) are as follows—(a) gametes must not be kept in storage for longer than such period not exceeding 55 years beginning with the day on which they are first placed in storage as the licence may specify;(b) an embryo must not be kept in storage for treatment purposes for longer than such period not exceeding 55 years beginning with the day on which it is first so kept as the licence may specify;(c) an embryo that is kept in storage for the research or training purpose but not for treatment purposes must not be so kept for longer than such period not exceeding 10 years beginning with the day on which consent was given under Schedule 3 to the storage of the embryo for that purpose as the licence may specify;(d) a human admixed embryo must not be kept in storage for longer than such period not exceeding 10 years beginning with the day on which it is first placed in storage as the licence may specify.(4) Where under Schedule 3 consent is given to the storage of an embryo for the training or research purpose by different persons on different days, the reference in subsection (3)(c) to the day on which consent was given is to be taken as a reference to the last of those days.(5) For the purposes of this section—(a) “treatment purposes” are purposes referred to in paragraph 2(1)(a) or (b) of Schedule 3;(b) the “training purpose” is the purpose referred to in paragraph 2(1)(ba) of that Schedule;(c) the “research purpose” is the purpose referred to in paragraph 2(1)(c) of that Schedule.”3_ In section 47 (index), omit the entry for the “Statutory storage period”.4_ In Schedule 3 (consents), in paragraph 2(2)(a), for “statutory storage period” substitute “period for which, by virtue of section 14(3), the gametes, embryo or human admixed embryo may be stored under the licence”.Disposal of material
5_ In section 14 (conditions of storage licences), in subsection (1), after paragraph (c) insert—“(ca) that any gametes, embryos or human admixed embryos that have been kept in storage pursuant to the licence must, once they may no longer lawfully be so kept, be removed from storage and disposed of, and”.6_ In section 17 (the person responsible), in subsection (1)(c), for “allowed to perish” substitute “removed from storage”.Consent to storage
7_(1) Schedule 3 (consents) is amended as follows.(2) In paragraph 1—(a) in sub-paragraph (1), before the first “and” insert “any renewal of consent,”;(b) in sub-paragraph (2), before the first “and” insert “any renewal of consent by a person unable to sign,”;(c) in sub-paragraph (3)—(i) the words from ““effective consent” to the end become paragraph (a);(ii) after that paragraph insert—“(b) references to renewal of consent are to renewal of consent to the storage of any gametes or embryo under paragraph 11A or 11C.”(3) In paragraph 3, in sub-paragraph (1), after “gives” insert “or renews”. (4) After paragraph 11 insert—“Renewal of consent to storage of gametes11A_(1) This paragraph applies where—(a) the gametes of a person (“P”) are in storage,(b) P’s consent to the storage of the gametes is required under paragraph 8(1),(c) there is effective consent from P to the storage of the gametes, and(d) the gametes are being kept for use for the purposes of providing treatment services to—(i) P, or(ii) P and another person together.(2) The person keeping the gametes in storage (“K”) must, in each consent period, request P to renew consent to storage of the gametes within the renewal period.For the meaning of “consent period” and “renewal period”, see paragraph 11B.(3) A request under sub-paragraph (2) must be given in writing before the start of the renewal period.(4) The duty in sub-paragraph (2) ceases to apply if K is notified that P has died.(5) The duty in sub-paragraph (2) does not apply in relation to any consent period if—(a) K has at any time been informed in writing that P has been certified as lacking capacity to renew consent to storage of the gametes, and(b) K has not subsequently been informed in writing, before the start of the renewal period which relates to that consent period, that P has been certified as having capacity to renew consent to storage of the gametes.(6) P renews consent by informing K in writing that P consents to the storage of the gametes.(7) If P’s consent is not renewed under sub-paragraph (6) before the end of the consent period, K must, as soon as possible after the end of that period, give a notice to P stating that if P does not renew consent before the end of the renewal period, the gametes will be removed from storage and disposed of.(8) P’s consent to the storage of the gametes is to be taken as having been withdrawn at the end of a renewal period that relates to a consent period if—(a) K has complied with the requirements of sub-paragraphs (2) and (7) in relation to that consent period, and(b) P’s consent is not renewed under sub-paragraph (6) before the end of the renewal period.But this is subject to sub-paragraphs (9) and (10).(9) If, in a case referred to in sub-paragraph (8)(a) and (b), P dies before the end of the renewal period—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P died there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.(10) If, in a case referred to in sub-paragraph (8)(a) and (b), before the end of the renewal period P is certified as lacking capacity to renew consent—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P was so certified there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time. (11) But P’s consent is not to be taken as withdrawn under sub-paragraph (10)(b) if, before the time it would be taken to be withdrawn under that sub-paragraph—(a) P is certified as having capacity to renew consent to storage of the gametes, and(b) P renews consent to storage of the gametes by informing K in writing that P consents to their storage.(12) In a case where P renews consent under sub-paragraph (11)(b), this paragraph applies subsequently as if references to a consent period were to—(a) the period of 10 years beginning with the day on which P so renewed consent, and(b) each successive period of 10 years.11B_(1) For the purposes of paragraph 11A, each of the following is a “consent period”—(a) the period of 10 years beginning with the relevant day, and(b) each successive period of 10 years.(2) In sub-paragraph (1)(a) “relevant day” means—(a) the day on which the gametes are first placed in storage, or(b) in a case where sub-paragraph (3) or (5) applies, the day on which P gives consent to the storage of the gametes.(3) This sub-paragraph applies where the gametes are taken from or provided by P before P attains the age of 18 years and, at the time the gametes are first stored—(a) P has not attained the age of 16 years and is not competent to deal with the issue of consent to storage of the gametes, or(b) P has attained that age but, although not lacking capacity to consent to the storage of the gametes, is not competent to deal with the issue of consent to their storage.(4) In relation to Scotland, sub-paragraph (3) is to be read as if, for paragraphs (a) and (b), there were substituted “P does not have capacity (within the meaning of section 2(4) of the Age of Legal Capacity (Scotland) Act 1991) to consent to storage of the gametes”.(5) This sub-paragraph applies where the gametes are taken from or provided by P after P attains the age of 16 years and, at the time the gametes are first stored, P lacks capacity to consent to their storage.(6) In paragraph 11A “the renewal period”, in relation to a consent period, means the period which—(a) begins 12 months before the end of the consent period, and(b) ends 6 months after the end of the consent period.(7) In paragraph 11A “certified” means certified in writing by a registered medical practitioner.(8) In paragraph 11A and this paragraph, in relation to Scotland, references to a person lacking or having capacity to consent or renew consent are to be read as references to the person being or not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of consenting or renewing consent.Renewal of consent to storage of embryos11C_(1) This paragraph applies where—(a) an embryo, the creation of which was brought about in vitro, is in storage,(b) the embryo is being kept for use for the purposes of providing treatment services to— (i) a person (“P”) whose gametes or human cells were used to bring about the creation of the embryo, or(ii) P and another person together,(c) P’s consent to the storage of the embryo is required under paragraph 8(2), and(d) there is effective consent from P to the storage of the embryo.(2) The person keeping the embryo in storage (“K”) must, in each consent period, request P to renew consent to storage of the embryo within the renewal period.For the meaning of “consent period” and “renewal period”, see paragraph 11D.(3) A request under sub-paragraph (2) must be given in writing before the start of the renewal period.(4) The duty in sub-paragraph (2) ceases to apply if—(a) K is notified that P has died, or(b) K is notified under paragraph 4A(1)(c) of the withdrawal of a person’s consent to storage of the embryo.(5) The duty in sub-paragraph (2) does not apply in relation to any consent period if—(a) K has at any time been informed in writing that P has been certified as lacking capacity to renew consent to storage of the embryo, and(b) K has not subsequently been informed in writing, before the start of the renewal period which relates to that consent period, that P has been certified as having capacity to renew consent to storage of the embryo.(6) P renews consent by informing K in writing that P consents to the storage of the embryo.(7) If P’s consent is not renewed under sub-paragraph (6) before the end of the consent period, K must, as soon as possible after the end of that period, give a notice to P stating that if P does not renew consent before the end of the renewal period, the embryo will be removed from storage and disposed of.(8) P’s consent to the storage of the embryo is to be taken as having been withdrawn at the end of a renewal period that relates to a consent period if—(a) K has complied with the requirements of sub-paragraphs (2) and (7) in relation to that consent period, and(b) P’s consent is not renewed under sub-paragraph (6) before the end of the renewal period.But this is subject to sub-paragraphs (9) and (10).(9) If, in a case referred to in sub-paragraph (8)(a) and (b), P dies before the end of the renewal period—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P died there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.(10) If, in a case referred to in sub-paragraph (8)(a) and (b), before the end of the renewal period P is certified as lacking capacity to renew consent—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P was so certified there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.(11) But P’s consent is not to be taken as withdrawn under sub-paragraph (10)(b) if, before the time it would be taken to be withdrawn under that sub-paragraph— (a) P is certified as having capacity to renew consent to storage of the embryo, and(b) P renews consent to storage of the embryo by informing K in writing that P consents to its storage.(12) In a case where P has renewed consent under sub-paragraph (11)(b), this paragraph applies subsequently as if references to the consent period were to—(a) the period of 10 years beginning with the day on which P so renewed consent, and(b) each successive period of 10 years.(13) Where P’s consent is taken as withdrawn under this paragraph, K must, as soon as possible, take all reasonable steps to give notice of the withdrawal to each person whose gametes or human cells were used to bring about its creation.(14) Storage of the embryo remains lawful until—(a) the end of the period of 6 months beginning with the day on which P’s consent is taken as withdrawn under this paragraph, or(b) if, before the end of that period, K receives a notice from each person notified under sub-paragraph (13) stating that the person consents to the disposal of the embryo, the time at which the last of those notices was received.11D_(1) For the purposes of paragraph 11C , each of the following is a “consent period”—(a) the period of 10 years beginning with the day on which the embryo is first placed in storage, and(b) each successive period of 10 years.(2) In paragraph 11C “the renewal period”, in relation to a consent period, means the period which—(a) begins 12 months before the end of the consent period, and(b) ends 6 months after the end of the consent period.(3) In paragraph 11C “certified” means certified in writing by a registered medical practitioner.(4) In paragraph 11C , in relation to Scotland, references to a person lacking or having capacity to renew consent are to be read as references to the person being or not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of renewing consent.”PART 2TRANSITIONAL PROVISIONInterpretation
8_(1) In this Part of this Schedule—“the commencement day” means 1 July 2022;“the transitional period” means the period beginning with the commencement day and ending with 30 June 2024.(2) In this Part of this Schedule—“the 1990 Act” means the Human Fertilisation and Embryology Act 1990;“the 2009 Regulations” means the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009 (S.I. 2009/1582);“the 2020 Regulations” means the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) (Coronavirus) Regulations 2020 (S.I. 2020/566).(3) In this Part of this Schedule—“gamete storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of gametes; “embryo storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of embryos;“storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of gametes, embryos or human admixed embryos;“pre-commencement”, in relation to a storage licence, or a storage licence of any description, means granted before the commencement day and “post-commencement” means granted on or after that day.(4) In this Part of this Schedule—“statutory storage period” has the same meaning as in the 1990 Act immediately before the commencement day;references to gametes, embryos and human admixed embryos have the same meaning as in that Act;“the training purpose”, “the research purpose” and “treatment purposes” have the same meanings as in section 14(3)(c) of that Act.Application of Part 1 to material already in storage
9_(1) The amendments in paragraphs 2 to 6 of this Schedule have effect in relation to pre-commencement storage licences under which gametes, embryos or human admixed embryos are kept in storage on or after the commencement day (as well as having effect in relation to post-commencement storage licences).This is subject to sub-paragraphs (2) and (3).(2) In the case of a pre-commencement embryo storage licence, the condition imposed by section 14(3)(c) of the 1990 Act (as substituted by paragraph 2 of this Schedule) does not apply in relation to an embryo which, on the commencement day, is kept in storage for the training or research purpose but not for treatment purposes.(3) In the case of any pre-commencement storage licence, the condition imposed by section 14(1)(ca) of the 1990 Act (as substituted by paragraph 5 of this Schedule) applies only in relation to times on or after the commencement day.10_ The amendments made by paragraph 7 of this Schedule have effect in relation to the storage of gametes and embryos under a pre-commencement gamete or embryo storage licence, where the gametes or embryos are kept in storage on or after the commencement day (as well as having effect in relation to the storage of gametes and embryos under a post-commencement gamete or embryo storage licence).Date of first storage
11_(1) This paragraph applies if the person storing gametes or an embyro under a pre-commencement gamete or embryo storage licence—(a) has, before the end of the transitional period, taken all reasonable steps to establish the date on which the gametes were or embryo was first placed in storage, but(b) is unable to establish that date.(2) The person may give a notice to each person whose consent to the storage is required under Schedule 3 to the 1990 Act specifying a date on which the gametes are or embryo is to be regarded as having been first placed in storage.(3) Where notice is given under sub-paragraph (2), the gametes are or embryo is to be regarded, for all purposes of the 1990 Act and this Part of this Schedule, as having been first placed in storage on the date specified in the notice.Storage periods specified in pre-commencement storage licences
12_(1) For the purposes of section 14(3)(a) of the 1990 Act (as substituted by paragraph 2 of this Schedule), a pre-commencement gamete storage licence under which, on and after the commencement day, gametes are kept in storage is to be regarded as specifying the period of 55 years beginning with the day on which the gametes were first placed in storage.(2) For the purposes of section 14(3)(b) of the 1990 Act (as substituted by paragraph 2 of this Schedule), a pre- commencement embryo storage licence under which, on and after the commencement day, an embryo is kept in storage for treatment purposes is to be regarded as specifying for those purposes the period of 55 years beginning with the day on which the embryo was first so kept.Storage after expiry of pre-commencement consent
13_(1) If a pre-commencement consent to the storage of gametes or an embryo expires at any time in the transitional period, the storage of the gametes or embryo for the remainder of that period is not unlawful merely because of that fact.(2) In sub-paragraph (1)—(a) “pre-commencement consent” means consent given under Schedule 3 to the 1990 Act before the commencement day;(b) the reference to expiry of consent does not include withdrawal.Storage with no effective consent prior to commencement
14_(1) This paragraph applies in relation to the storage of gametes or an embryo under a pre-commencement gamete or embryo storage licence where, immediately before the commencement day, there is no effective consent to the storage by a relevant person.(2) The person keeping the gametes or embryo in storage must request the relevant person to give consent to the storage under Schedule 3 to the 1990 Act.(3) A request under sub-paragraph (2) must be given before 1 July 2023 in writing.(4) The storage of the gametes or embryo at any time before the end of the transitional period is not unlawful merely because there is no effective consent to the storage by the relevant person.(5) In this paragraph—“effective consent” means consent under Schedule 3 to the 1990 Act which has not been withdrawn;“relevant person” means a person whose consent is required under Schedule 3 to the 1990 Act to storage of the gametes or embryo.Time for first renewal of consent
15_(1) This paragraph applies in relation to the storage of gametes under a pre- commencement gamete storage licence where the statutory storage period applicable immediately before the commencement day was provided for by—(a) regulation 4, 4A, 7 or 8 of the 2009 Regulations, or(b) regulation 4 of the 2020 Regulations.(2) For the purposes of paragraph 11A of Schedule 3 to the 1990 Act (as inserted by paragraph 7 of this Schedule), paragraph 11B(1)(a) of that Schedule has effect as if the reference to the period of 10 years beginning with the relevant day were a reference to the period which—(a) begins with the relevant day, and(b) ends at the end of the statutory storage period referred to in sub-paragraph (1).16_(1) This paragraph applies in relation to the storage of an embryo under a pre-commencement embryo storage licence where the statutory storage period applicable immediately before the commencement day was provided for by—(a) regulation 3, 3A, 5 or 6 of the 2009 Regulations, or(b) regulation 3 of the 2020 Regulations.(2) For the purposes of paragraph 11C of Schedule 3 to the 1990 Act (as inserted by paragraph 7 of this Schedule), paragraph 11D(1)(a) of that Schedule has effect as if the reference to the period of 10 years beginning with the day on which the embryo was first placed in storage were a reference to the period which—(a) begins with the day on which the embryo was first so placed, and(b) ends at the end of the statutory storage period referred to in sub-paragraph (1).Renewals falling due in the transitional period
17_(1) This paragraph applies in relation to the storage of gametes under a pre-commencement gamete storage licence in a case where—(a) paragraph 11A of Schedule 3 to the 1990 Act applies in relation to the storage, and(b) for the purposes of that paragraph, the first consent period (see paragraph 11B(1)(a) of that Schedule) ends in the transitional period.(2) Where this paragraph applies, paragraph 11A of Schedule 3 to the 1990 Act has effect in relation to that first consent period as if—(a) for sub-paragraphs (2) and (3) there were substituted—“(2) The person keeping the gametes in storage (“K”) must request P to renew consent to storage of the gametes before 1 July 2024.(3) A request under sub-paragraph (2) must—(a) be given in writing before 1 July 2023;(b) state that if P does not renew consent before 1 July 2024, the gametes will be removed from storage and disposed of.”;(b) in sub-paragraph (5)(b), for “the start of the renewal period which relates to that consent period” there were substituted “1 July 2023”;(c) sub-paragraph (7) were omitted;(d) for sub-paragraph (8) there were substituted—“(8) P’s consent to the storage of the gametes is to be taken as having been withdrawn at the beginning of 1 July 2024 if—(a) K has complied with sub-paragraph (2), and(b) P’s consent is not renewed under sub-paragraph (6) before 1 July 2024.But this is subject to sub-paragraphs (9) and (10).”;(e) in sub-paragraphs (9) and (10), references to the end of the renewal period were to 1 July 2024.18_(1) This paragraph applies in relation to the storage of an embryo under a pre-commencement embryo storage licence in a case where—(a) paragraph 11C of Schedule 3 to the 1990 Act applies in relation to the storage, and(b) for the purposes of that paragraph, the first consent period (see paragraph 11D(1)(a) of that Schedule) ends in the transitional period.(2) Where this paragraph applies, paragraph 11C of Schedule 3 to the 1990 Act has effect in relation to that first consent period as if—(a) for sub-paragraphs (2) and (3) there were substituted—“(2) The person keeping the embryo in storage (“K”) must request P to renew consent to storage of the embryo before 1 July 2024.(3) A request under sub-paragraph (2) must—(a) be given in writing before 1 July 2023;(b) state that if P does not renew consent before 1 July 2024, the embryo will be removed from storage and disposed of.”;(b) in sub-paragraph (5)(b), for “the start of the renewal period which relates to that consent period” there were substituted “1 July 2023”; (c) sub-paragraph (7) were omitted;(d) for sub-paragraph (8) there were substituted—“(8) P’s consent to the storage of the embryo is to be taken as having been withdrawn at the beginning of 1 July 2024 if—(a) K has complied with sub-paragraph (2), and(b) P’s consent is not renewed under sub-paragraph (6) before 1 July 2024.But this is subject to sub-paragraphs (9) and (10).”;(e) in sub-paragraphs (9) and (10), references to the end of the renewal period were to 1 July 2024.”Member’s explanatory statement
Part 1 of this new Schedule makes provision for the maximum period for which gametes and embryos may be stored, for what happens at the end of that period, and for a requirement that consents to storage be renewed periodically. Part 2 contains transitional provision.
Lord Kamall
“(1A) A power to make regulations under section (Information about payments etc to persons in the health care sector), 89 or 90 includes power to make different provision for England, Wales, Scotland or Northern Ireland.”Member’s explanatory statement
This amendment provides for regulations under Part 3 of the Bill, and regulations relating to the reporting and publication of information about payments and other benefits provided to persons in the health care sector, to be able to make different provision for different parts of the UK.
Lord Kamall
“(aa) in Part 2, sections (Information about payments etc to persons in the health care sector), (Regulations under section (Information about payments etc to persons in the health care sector): enforcement) and (Regulations under section (Information about payments etc to persons in the health care sector): consent) (information about payments etc to persons in the health care sector);”Member’s explanatory statement
This amendment provides for the powers relating to the reporting and publication of information about payments and other benefits provided to persons in the health care sector to extend to the whole of the United Kingdom.
Lord Kamall
“(2A) Section (Storage of gametes and embryos) and Schedule (Storage of gametes and embryos) (storage of gametes and embryos) come into force on 1 July 2022.”Member’s explanatory statement
This amendment provides for the new Clause and Schedule relating to the storage of gametes and embryos to come into force on 1 July 2022.