Health And Care Act 2022

Policy Background

Merging NHS England, Monitor and NHS Trust Development Authority

6. Section 1H of the NHS Act 2006, as inserted by Part 1 of the 2012 Act, established a Non-Departmental Public Body (NDPB) called the National Health Service Commissioning Board. The NHS Commissioning Board was given broad duties, in conjunction with the Secretary of State, to promote a comprehensive health service and to arrange and secure the provision of services for the purposes of the health service. The NHS Commissioning Board is accountable to the Secretary of State and operated under the name NHS England.
7. Monitor was established in 2004 by the Health and Social Care (Community Health and Standards) Act 2003 as an executive NDPB of the Department of Health and Social Care (DHSC). It was responsible for regulating NHS Foundation Trusts and in 2012, section 61 of the 2012 Act changed its name to Monitor. Part 3 of the 2012 Act conferred additional functions on Monitor, establishing it as the "sector regulator" for healthcare. Monitor’s overriding duty was to protect and promote the interests of patients by promoting economy, efficiency and effectiveness in the provision of healthcare, while maintaining or improving quality.
8. The NHS Trust Development Authority (TDA) was a Special Health Authority established by the Secretary of State by order under section 28 of the NHS Act 2006 (see the National Health Service Trust Development Authority (Establishment and Constitution) Order 2012 (SI 2012/901)). The TDA was established to exercise such functions as the Secretary of State may direct in connection with the management of the performance and development of English NHS trusts and other functions as directed by the Secretary of State. The detailed functions of the TDA (which, apart from the patient safety function, are all Secretary of State functions) are set out in directions made by the Secretary of State under section 8 of the NHS Act 2006.
9. In 2016, the TDA was directed to work collaboratively with Monitor under a single leadership and operating model to ensure improvement in the quality of care, patient safety and financial sustainability across the health service. As such, Monitor and the TDA came together to operate as a single organisation known as NHS Improvement. NHS Improvement is not itself a statutory body and has no distinct functions of its own.
10. Prior to the Act, NHS England and NHS Improvement had already been working closely together with a view to acting as a single organisation with a single operating model, with an aligned board and committee arrangements and joint senior executive appointments (the Joint Working Programme). There were limits on the extent to which NHS England and NHS Improvement could collaborate under that statutory framework. For instance, NHS England and NHS Improvement were assigned distinctive and non-shareable functions, and required separate boards including separate chairs, CEOs and non-executive directors for the two organisations.
11. The Act enables the functions of the previous three national statutory bodies responsible for the NHS - the NHS Commissioning Board, Monitor and the TDA ––– to be moved into a single body. The formation of the new NHS England will provide national leadership which speaks with one voice to providers, commissioners and local health systems; will remove potential duplication; and use collective resources more efficiently and effectively to support local health systems and ultimately make effective use of public money.
12. The Act transfers the functions of Monitor and the TDA to NHS England and abolishes Monitor and the TDA.

Mental Health Financial Reporting

13. Ensuring public clarity about mental health funding, particularly the proportion of overall health services funding being spent on mental health services, is seen as an important way to measure "parity of esteem"– valuing mental health equally to physical health.
14. The Act therefore seeks to strengthen the accountability and transparency on spending relating to mental health. The Act will place a requirement to publish before the start of each financial year whether NHS mental health expenditure is expected to increase in the amount and proportion as compared to the previous year. It is expected that this expenditure will include integrated care boards’ baseline spend within scope of the Mental Health Investment Standard, which covers all spending on mental health from an integrated care board’s core allocations; NHS England service development fund spending on mental health; and specialised commissioning spending on mental health. NHS England and integrated care boards will then have to report back on their performance against this expectation as part of their respective annual reporting.

Mandate and financial directions to NHS England

15. Under Section 13A of the NHS Act 2006, the Secretary of State has a duty to lay in Parliament and publish a mandate to NHS England before the beginning of each new financial year. The mandate must include objectives that NHS England has a duty to seek to meet and must also specify the limits on capital and revenue resource use that the Secretary of State has set for the purposes of section 223D of the NHS Act 2006.
16. The mandate may also set out the matters the Secretary of State will take into account when assessing progress against the objectives and may include requirements that NHS England must comply with in order to meet the objectives. Requirements in the mandate only have effect if regulations provide for them to do so.
17. NHS England has a legal duty, under section 13T of NHS Act 2006, to set out in its business plan how it intends to meet objectives in the mandate. The Secretary of State also has a duty to keep NHS England’s performance against the mandate under review. Having considered NHS England’s own annual report, under section 13U of the NHS Act 2006, the Secretary of State must then lay in Parliament and publish an annual assessment of its overall performance during the financial year – including performance against the mandate.
18. The mandate remains the primary statutory mechanism for government to set objectives and requirements for the new NHS England. However, this Act makes the mandate duty more flexible, so that a mandate can be revised at any time, ensuring there is always a mandate in place, and will remain in force until it is revised by a new mandate. This flexibility strengthens the ability of the mandate to set longer-term direction for the NHS, where appropriate, and ensure that each mandate can fully reflect the most up to date strategic priorities and associated government funding commitments for the NHS even where it is impractical for these to be determined in line with the annual financial cycle. Within this context, however, the mandate will continuously include objectives on cancer that are expressed in terms of outcomes, and these objectives will have a priority over other objectives in the mandate that relate specifically to cancer. There continues to be a legal duty, under section 13A(8) of the NHS Act 2006, for the Secretary of State to consult NHS England, Healthwatch England (representing patients) and any other persons that the Secretary of State considers appropriate before setting objectives in a mandate. Every mandate will also continue to be laid in Parliament. NHS England will not be required to revise its own business plan should the mandate be revised during the period the plan applies but will need to set out in its annual report the extent to which, in that year, it met any objectives or requirements specified in the mandate for the relevant year.
19. The Secretary of State will continue, under section 13U of the NHS Act 2006, to have a duty to keep performance against the mandate under review and continue to lay in Parliament and publish an assessment of NHS England’s overall performance against any mandate in force on an annual basis.
20. As a consequence of removing the statutory link between the mandate and the annual financial cycle, NHS England’s annual limits on capital and revenue resource use can be set through financial directions from the Secretary of State. Such directions will be published and laid in Parliament to ensure continued transparency to Parliament for the financial allocations within which NHS England is expected to deliver mandate objectives and requirements, as well as its wider functions. The Act requires NHS England to exercise its functions with a view to ensuring that, in respect of each financial year, it does not exceed such limits specified in a direction by the Secretary of State.

Funding for service integration

21. The Better Care Fund (BCF) is the national policy driving forward the integration of health and social care in England. The BCF requires integrated care boards (formerly NHS Clinical Commissioning Groups (CCGs)) and local authorities to make joint plans and pool budgets for the purposes of integrated care, providing a context in which they can work together, as partners, towards shared objectives.
22. The Act puts in place stand-alone powers for directions to be given to NHS England and to integrated care boards to use a specified sum of their financial allocation for the purposes of service integration, known as the BCF, which does not rely on the NHS mandate.
23. Previously, the legal basis for the allocation of the BCF relied on ministers setting a requirement each year in the NHS mandate to ringfence funding from commissioners’ budgets.
24. A stand-alone power ensures that the BCF continues to function as it previously did should mandates be set on anything other than a financial year basis. It is a technical change and will not have any impact on the operation or policy intention of the BCF.

Integrated Care Boards and Integrated Care Partnerships

25. Prior to this Act, CCGs were responsible for the planning and commissioning of health services in local areas. Since 2016, health and care organisations increasingly worked together in every part of England to coordinate services and to plan in a way that improves population health and reduces inequalities between different groups. The formation of non-statutory integrated care systems accelerated this change.
26. The Act provides for the establishment of statutory integrated care boards and statutory integrated care partnerships.
27. The integrated care board takes on the commissioning functions of CCGs as well as some of NHS England’s commissioning functions. However, an integrated care board is not simply a larger CCG but is expected to work differently in practice – its governance model reflects the need for integration and collaboration across the system. It has the ability to exercise its functions through place-based committees (while remaining accountable for them) and is directly accountable for NHS spend and performance within the system.
28. The integrated care board, as a minimum, includes a Chair, Chief Executive Officer, and representatives from NHS Trusts and NHS Foundation Trusts, general practice, and Local Authorities. Beyond that, local areas will have the flexibility to determine any further representation in their area. Integrated care boards will also need to ensure they have appropriate clinical advice when making decisions and that at least one ordinary member has knowledge and experience in connection with services relating to mental illness.
29. Each integrated care board and its partner Local Authorities will be required to establish an integrated care partnerships. The integrated care partnership can bring together health, social care, public health and representatives from the wider public space where appropriate, such as social care providers or housing providers.
30. An integrated care partnership is tasked with developing a strategy to address the needs assessed by Health and Wellbeing Boards under section 116 of the Local Government and Public Involvement in Health Act 2007 in respect of the relevant integrated care board area. The integrated care board, NHS England and local authorities will have to have regard to that plan when making decisions.

Collaborative Commissioning

31. Previous NHS legislative mechanisms made it difficult for the health and care system to work collaboratively and flexibly across different geographical footprints, forcing some local systems to adopt complex workarounds to be able to align their decisions and pool budgets. In practice, these arrangements were potentially cumbersome and difficult to manage and risked slow decision-making processes.
32. The Act makes a number of technical legislative changes to remove barriers and bureaucracy which could get in the way of delivering high-quality care to patients.
33. The Act makes it easier for integrated care boards to commission services collaboratively with other integrated care boards and other system partners by permitting a wider set of arrangements for joint commissioning, pooling of budgets and delegation of functions.

Triple Aim

34. The Act introduces a new duty on NHS organisations to consider the effects of their decisions on the better health and wellbeing of the people in England, the quality of care for all patients, and the sustainable use of NHS resources - the policy referred to in the White Paper "Working together to improve health and social care for all" as the "Triple Aim". This duty should facilitate the tackling of inequalities, and it is made clear in the Act that the duty requires inequalities in health and wellbeing and the benefits from services to be part of the considered.
35. The previous legislative framework potentially led organisations to work primarily in the best interest of their own organisations and their own immediate patients - but did not support the delivery of integrated, patient-centred care.
36. This new duty requires organisations to think about the interests of the wider system and will provide common, system-wide goals that need to be achieved through collaboration, which includes NHS organisations’ role in tackling disparities in health.

Duty to Cooperate

37. The Act introduces a new power that allows the Secretary of State to issue guidance on cooperation between NHS bodies, and between NHS bodies and local authorities.
38. New guidance will give organisations greater clarity about what the duties to cooperate mean in practice, helping build on the innovation, working relationships and positive behaviours that had been seen during the covid pandemic period in particular.

CQC Reviews of Integrated Care Systems

39. The Act introduces a new duty on the Care Quality Commission (CQC) to conduct reviews of the integrated care system (integrated care boards, local authorities and their system partners working collectively).
40. These reviews assess the provision of NHS care, public health, and adult social care within the integrated care board area. They consider how well the integrated care boards, local authorities, and CQC registered providers discharge their functions in relation to the provision of care as well as the functioning of the system as a whole, which will include the role of the integrated care partnership. The CQC is required to publish a report, providing an independent assessment of the health and care in integrated care systems.
41. The Act requires the Secretary of State to set the priorities and objectives of these reviews, with a requirement that priorities are set relating to leadership, integration, and quality and safety, and the CQC to determine the indicators of quality, methods, period, and frequency for these reviews with Secretary of State approval.

Secretary of State’s duty to report on workforce systems

42. Section 1 of the NHS Act 2006 gives the Secretary of State a duty to promote a comprehensive health service in England. Section 1F of the NHS Act 2006 gives the Secretary of State a further duty to secure an effective system for the planning and delivery of education and training to individuals who are employed or are considering becoming employed as healthcare workers. This duty is delegated to Health Education England (HEE) through Section 97(1) of the Care Act 2014. However, other bodies (currently including the NHS Commissioning Board, the TDA and individual employers, and, following changes made by the Act, the newly merged NHS England and integrated care boards) also have responsibilities for workforce planning and supply.
43. However, no one document exists or captures how the workforce planning and supply system operates at national, regional and local level. The Act places a duty on the Secretary of State to publish, at least once every five years, a report describing the system in place for assessing and meeting the workforce needs of the health service in England. It will also place a duty on HEE and NHS England to assist in the preparation of the report, if asked to do so by the Secretary of State.
44. The scope of the report will include workforce planning and supply for healthcare workers, including those working in the NHS, public health, regulated healthcare professions working in social care (e.g. nurses and occupational therapists).
45. The report will provide clarity and transparency as to how the workforce planning and supply system operates, by describing the workforce planning and supply roles of relevant national bodies – including DHSC, HEE and NHS England, integrated care boards and individual employers - and how they work together in practice at national, regional and local levels. It will not set out workforce targets or give any bodies new functions.
46. The report will be published at a minimum of every five years but can be reviewed by the Secretary of State before then, if the Secretary of State considers appropriate.

Power of Direction – Secretary of State public health functions

47. Section 7A of the NHS Act 2006 enables the making of arrangements for the delegated exercise of the Secretary of State’s public health functions by agreement.
48. NHS England currently commissions a range of services, including national immunisation and screening programmes, under such a delegation as set out in an NHS Public Health Functions Agreement with the Secretary of State.
49. However, the Secretary of State could not require NHS England, or any other NHS body, to take on a delegated public health function. This potentially could have exposed the Secretary of State to a position where they were to effectively deliver an aspect of his or her public health duties. The Act creates a power for the Secretary of State to require, via directions, NHS England (or an integrated care board) to discharge public health functions delegated by the Secretary of State.
50. This is intended to provide for greater speed, agility, certainty and clarity to keep in step with challenges presented to public health, and to strengthen the Secretary of State’s ability to play the role in the system that Parliament expects.
51. It is expected that the delegation of public health functions will continue to be on the basis of agreement in most circumstances. However, consistent with other changes in the Act, this bolsters the Secretary of State’s ability, via the flexibility of a direction making power, to ensure the system can respond rapidly to emerging issues as they arise, or where the additional clarity and certainty of directions is otherwise desirable. Power to give directions to NHS England as to the exercise of public health functions, once delegated, will be covered by the more general power of direction in new section 13ZC.
52. To ensure transparency, the Secretary of State will need to publish any directions as soon as is practicable.

Secretary of State power to direct NHS England

53. The Secretary of State had responsibility for ensuring that NHS England, Monitor and the TDA were effectively carrying out their functions and retained ultimate responsibility for securing provision of services through the exercise of their functions, through powers such as those to set objectives for commissioners (for example by setting the mandate under section 13A of the NHS Act 2006), and to intervene in the event of significant failure (under section 13Z2 of the NHS Act 2006).
54. As explained above, the Act abolishes Monitor and the TDA and transfers their functions to NHS England. In recognition of the expanded powers and responsibilities of NHS England, the Act introduces an additional accountability mechanism to support the Secretary of State in his or her democratic oversight of NHS England.
55. The Act amends the NHS Act 2006 by inserting new sections 13ZC, 13ZD, 13ZE, and 13ZF which provide the Secretary of State with powers to give directions to NHS England in relation to its functions. Such directions apply only to functions of NHS England and sit alongside the pre-existing accountability mechanisms and processes for ensuring NHS England fulfil its duties to promote a comprehensive health service. The Secretary of State will be able to use these powers to ensure that NHS England continues to work effectively with other parts of the system for which the Secretary of State has responsibility including social care and public health, to support integration and tackle broader priorities such as health inequalities.
56. NHS England will remain an Arm’s Length Body and will therefore continue to exercise the majority of its functions as it does now. The Mandate will remain the primary mechanism through which the Secretary of State will set out the priorities that NHS England should be seeking to achieve. The Framework Agreement between DHSC and NHS England will continue to set the parameters within which NHS England should operate and how DHSC and NHS England will interact with each other. The power supplements these mechanisms by giving the Secretary of State the ability, where he or she deems it appropriate, to set direction and to intervene in relation to NHS England’s functions. Directions could be issued on specific matters or on a standing basis. This will be done in a transparent way. Any directions made by the Secretary of State on NHS England’s functions under section 13ZC must be made in the public interest, in writing, and published.

Reconfigurations

57. Reconfiguration is the term used to describe the management of service change in the NHS that has an impact on patients. The scale of possible change is broad, ranging from the small-scale closure of a GP surgery to a more significant replacement of a number of stroke units with a centralised hyper acute stroke unit.
58. Unless there is a need for urgent temporary reconfiguration of services, which is usually for reasons of patient safety, most service changes happen locally with consultation. Planned reconfigurations are developed at local or regional levels by commissioners. The Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) Regulations 2013 imposes requirements on relevant persons to consult the local authority where a substantial development of the health service or substantial variation in the provision of health services is proposed. This regime is intended to continue so that the day to day interactions between NHS commissioners, NHS providers and local authorities do not change. Local NHS commissioners will continue to be accountable to NHS England for the discharge of their functions in these matters, including planning, consulting and delivering on service change proposals.
59. The Secretary of State, pre-Act, was only able to intervene in reconfigurations upon receiving a local authority referral relating to the adequacy of consultation, or whether the proposal was in the interest of the health service. Following a referral, the Secretary of State had a discretionary power to take certain decisions based on the grounds of the referral. The Secretary of State typically asked the Independent Reconfiguration Panel (IRP) to provide expert advice and recommendations. The Secretary of State considered all of the available evidence, the expert advice of the IRP and the impacts of the proposal before making a decision on the matter, which could include giving a direction to NHS England. While this approach was able to help with difficult cases, referrals often came very late in the process meaning Ministers had to account for service changes in Parliament without having been meaningfully engaged on them themselves.
60. The Act adds a new discretionary power to the NHS Act 2006 for the Secretary of State to call in and make a decision on a reconfiguration proposal. The Secretary of State will be able to use this call-in power at any stage of the reconfiguration process.
61. This power is intended to be used in cases which are complex, a significant cause for public concern, or where Ministers can see a critical benefit to taking a particular course of action. Cases such as these can lead to difficult debate and lengthy processes.
62. To support this intervention power, the Local Authority referral power, which is set out in regulations made under enabling powers in section 244 of the NHS Act 2006, will be amended to reflect the new process. There is no intention to remove the local Health Oversight and Scrutiny Committee (HOSC) role or the requirement to involve them in reconfigurations.
63. Where a reconfiguration has been called in by the Secretary of State using the powers in the Act, there is a duty on NHS England, integrated care boards or NHS trusts and NHS foundation trusts to provide any information or assistance that the Secretary of State requires. This may include any representations that a HOSC, stakeholder, patient group or any other interested party have made, if applicable.
64. NHS England, an integrated care board or an NHS trust or NHS foundation trust must provide all relevant information and take no further action in progressing the reconfiguration without the Secretary of State’s agreement. They will be able to make representations to the Secretary of State in support of their preferred option at this stage.
65. The Secretary of State will seek appropriate advice in advance of their decision to meet the legal duties placed on them - including in relation to value for money, reducing inequalities, and continuous improvement in the quality of health services - and subsequently publish their decision in a transparent manner.
66. The Secretary of State will publish guidance for NHS England, integrated care boards, NHS trusts and NHS foundation trusts about how they should be exercising their functions under this new process, as well as how the Secretary of State may exercise their functions during this new process. These NHS bodies must have regard to such guidance provided by the Secretary of State.
67. It is intended that guidance will also provide detail for NHS bodies on exercising their duty to notify the Secretary of State of reconfigurations and clarify how the Secretary of State may use expert advice, including advice from the Independent Reconfiguration Panel.
68. The Secretary of State will be able to exercise the call-in power at any stage of a reconfiguration process, and will also be able to be the catalyst for a reconfiguration where he or she thinks appropriate. This might occur before NHS England, integrated care boards, NHS trusts or NHS Foundation Trusts have notified the Secretary of State of a proposed reconfiguration but where the Secretary of State is aware of an emerging issue after stakeholders have raised the issue with the Secretary of State or information has been supplied from within DHSC.

New NHS Trusts

69. When the 2012 Act was passed, it was expected that all NHS Trusts would develop Foundation Trust status and, once there were no NHS Trusts left, NHS Trusts could be abolished along with the ability to create new NHS Trusts. However, NHS Trusts remain an important part of the provider landscape in the NHS, making up around a third of providers. DHSC does not expect the provider landscape to drastically change and, to ensure flexibility in that landscape, the Act provides for the repeal of the provisions for the abolition of NHS Trusts and the continuation of the legislative provisions governing such Trusts, including the power to establish new Trusts.
70. DHSC expects new Trusts to be established following an application from an integrated care board to the Secretary of State, with further guidance to be published in due course. The Act allows for transfer schemes to be made to allow NHS Trusts and Foundation Trusts to transfer assets, property and liabilities between themselves.

Capital spending limits over Foundation Trusts

71. The Department for Health and Social Care is allocated a capital funding budget by Parliament and the Treasury, which amongst other capital spending covers capital spending in, in respect of the NHS (e.g. buildings, equipment and IT).
72. From 1 April 2020, a major part of the NHS capital budget had been allocated to voluntary partnerships of NHS commissioners, providers and local authorities known as Sustainability and Transformation Partnerships (STPs) and integrated care systems, in system-wide envelopes. These envelopes were derived directly from the NHS’ share of DHSC’s total departmental capital budget. They were set for all NHS provider organisations within an integrated care system footprint for their annual business as usual operational investments (e.g. routine maintenance and replacing equipment), distinct from the specific nationally led programmes such as major new hospital builds.
73. Under the new framework of this Act, it is the role of the integrated care board to ensure system capital expenditure is affordable within such envelopes and to prioritise its spending plans in accordance with the system wide health needs between each of the system providers. The Act establishes a joint duty between the integrated care board and its partner Trusts and Foundation Trusts to prepare a plan setting out their use of planned capital resources.
74. NHS Trusts were previously set statutory annual capital expenditure limits by the TDA in accordance with their capital expenditure plans. Capital expenditure limits are now set by NHS England following its merger with the TDA and Monitor under the Act. Previously there was no limit set on NHS Foundation Trusts, which also have additional freedoms to borrow from commercial lenders and spend their own surpluses to fund capital projects. Capital expenditure by Foundation Trusts counts against the integrated care system capital envelope and DHSC’s overall capital departmental expenditure limit (CDEL). Under previous statutory powers, there was a risk that a Foundation Trust may go ahead with an individual scheme or schemes using its own cash to invest in capital without considering the overall impact on the local system integrated care system capital envelope, or on the national capital budget. This created an issue of equity as well as proper financial management. Uncertainty about Foundation Trust capital spending plans, and the risk of breaching the capital limit, could lead to capital spending in one or more NHS providers having to be reduced to ensure the NHS lives within its allotted capital resources.
75. The Act gives a new power to allow NHS England to set capital spending limits for Foundation Trusts. The Foundation Trust limit would be set on an individual basis in respect of a named Foundation Trust for a single financial year (or part of it) and the limit would automatically cease at the end of that financial year. The power is intended to be used where there is a clear risk of a system breaching its system capital envelope as a result of actions of a Foundation Trust, and the issue has not been resolved more informally.
76. NHS England will produce guidance on the use of the power which will set out the circumstances in which it is likely to make an order to set a capital limit and the method it will use to determine the capital expenditure limit. The power will be used proportionately and it is envisaged in a limited way. The guidance will outline the process before a limit is set, including notifications and consideration of views from the Foundation Trust and the integrated care board. The guidance will also set out the publication of the order so there is transparency in the process.
77. The limit applies solely to capital expenditure (e.g. investment in new building and equipment etc.) and not to revenue expenditure (e.g. staff costs and consumables). Foundation Trusts will continue to operate as autonomous organisations, legally responsible for maintaining their estates and providing healthcare services, with their boards continuing to decide what investments they make. They will retain their freedoms around commercial borrowing or reinvesting their surpluses.

Joint Committees

78. Legislation did not previously allow NHS providers (NHS Trusts and Foundation Trusts) and CCGs to come together to formally take joint decisions. The Act puts in place an express mechanism to allow integrated care boards and NHS providers to form joint committees, or indeed two or more providers, and to make joint arrangements and pool funds. This can be used to facilitate greater integration.
79. These joint committees could take advice from other organisations such as primary care networks, GP practices, community health providers, local authorities or from the voluntary sector.

Joint Appointments

80. This Act introduces the ability for NHS England to issue guidance on joint appointments between NHS bodies; NHS bodies and local authorities; and NHS bodies and Combined Authorities. Joint appointments have already been made to great effect, allowing organisations to explore innovative new workforce models and deploy staff in the most effective way possible. Given the increased integration facilitated under the Act, joint appointments will continue to be beneficial. The new statutory guidance-making power for NHS England, which NHS bodies are required to have regard to, will help to ensure joint appointments are used effectively, and prevent conflicts of interest.
81. Ahead of publishing any guidance, NHS England would consult with appropriate organisations.

The NHS Payment Scheme

82. The Act replaces the National Tariff with a new NHS payment scheme which gives the NHS more flexibility in how prices and rules are set, to help support the delivery of more integrated care at local levels.
83. The scheme will be published by NHS England, who will consult with integrated care boards as the new commissioners of most NHS services, as well as relevant providers (both NHS providers and those from the independent or voluntary sector). The NHS payment scheme will set rules around how commissioners establish prices to pay providers for healthcare services for the purposes of the NHS, or public health services commissioned by an integrated care board or NHS England, on behalf of the Secretary of State (known as section 7A and section 7B services, in reference to the relevant powers in the NHS Act 2006, as inserted by this Act).

Patient Choice

84. Section 75 of the 2012 Act provided for regulations to be made in relation to patient choice. Section 75 also covers procurement and is being repealed as part of this Act, which means the regulations covering patient choice would also be revoked. However, so that patients’ rights to choice will continue to be protected, the Act will add similar powers including those relating to guidance and enforcement to the NHS Act 2006. The power to make guidance and powers in relation to the enforcement of patient choice will be held by NHS England, following the planned merger with Monitor, under this Act. NHS England will have powers to resolve any breaches of patient choice.
85. There are a wide range of choices that people should expect to be offered in the NHS services they use; for example, choosing a GP and GP practice and choosing where to go for an appointment as an outpatient (with some exceptions). The Act will allow for these, and other aspects of patient choice, to be preserved through regulations made under new powers.
86. The intention is to preserve the existing requirements for patient choice, which are a tool for improving waiting times and people’s experience of care.

Procurement of clinical healthcare services

87. The procurement reforms within the Act will enable the removal of the current procurement rules which apply for NHS and public health service commissioners when arranging clinical healthcare services e.g. hospital or community services. The Act provides a power to create, via regulations, separate procurement measures for these services. It is our intention to use these powers to remove the procurement of health care services for the purposes of the health service from scope of the Public Contracts Regulations 2015. The Act provisions also repeal Section 75 of the 2012 Act and the National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013.
88. The Act enables the development of new measures for NHS and public health procurement, informed by public consultation, to reduce bureaucracy on commissioners and providers alike, and give decision makers the flexibility to use competitive tendering where it adds value.
89. These reforms will generally only apply to the procurement of clinical healthcare services. The procurement of non-clinical services, such as professional services or clinical consumables, will remain subject to wider rules governing public procurement. The power does, however, provide an ability to make provision for mixed procurements in the regime, where a contract involves a mixture of health care services and other services or goods – for example, if a health care service is being commissioned but in the interests of providing joined up care some social care services are also commissioned as part of a mixed procurement.
90. NHS England have previously consulted on the proposal to replace the current legislation with a new provider selection regime, and over 70% of respondents either agreed or strongly agreed with this proposal. The Department of Health and Social Care launched a further consultation on the details of the policy on 21 February 2022.

Modern Slavery and Supply Chains

91. Modern slavery encompasses the offences of slavery, servitude, forced and compulsory labour and human trafficking. The NHS has a significant role to play in combatting it, including through taking steps to ensure that NHS supply chains and business activities are free from ethical and labour standards abuses. Government relies on its suppliers for the delivery of many important public services and we expect the highest standards of business ethics from our suppliers and their agents.
92. The Act introduces a duty on the Secretary of State to carry out a review into the risk of slavery and human trafficking taking place in NHS supply chains, and to lay a report before Parliament on its outcomes.
93. The Act also requires the Secretary of State to make regulations setting out such provision as he thinks appropriate with a view to eradicating the use in the NHS in England of goods or services that are tainted by slavery or human trafficking. The regulations can, in particular, include steps that the NHS should be taking to assess the level of risk associated with their supply chains; provision in relation to procurement processes, including the basis on which the NHS should exclude suppliers from a tendering process; and measures that should be included in contracts.

Competition

94. The 2012 Act gave Monitor (now operating as NHS Improvement) and the Competition and Markets Authority ("the CMA") formal roles to provide regulatory oversight of competition issues within the NHS. Monitor was given a concurrent duty to promote competition in the NHS, while it was clarified that the CMA had specific functions to investigate mergers between NHS Foundation Trusts. The CMA was also given a role in investigating contested licence conditions should significant numbers of providers object to them.
95. The NHS Long Term Plan 2019 called for a stronger emphasis on collaboration between organisations and a less central role for competition in the system.
96. The Act removes Monitor’s competition functions rather than moving them to NHS England as part of the merger, to allow NHS England to focus more on improvement in the quality of care and use of NHS resources, and on the development of integrated care.
97. The Act also removes the CMA’s ability to review NHS foundation trust mergers. Instead, NHS England, as the national body responsible for the NHS, will review mergers of NHS providers to ensure they are in the best interests of patients and the taxpayer.
98. The Act removes Monitor’s ability to refer contested licence conditions and tariff prices to the CMA. Instead, NHS England will make its own decisions on how to operate the licensing regime and the NHS Payment Scheme, in consultation with local leaders.
99. The CMA will retain its other functions in relation to regulating competition, such as within the private healthcare market, and within General Practice.

Special Health Authority Time Limits

100. The 2012 Act amended the 2006 Act to require that, where Special Health Authorities (SpHAs) are set up after 2012, their establishment orders must provide for their expiry within three years of their establishment. Variations could be made to that expiry date, but only to extend it for a maximum of three years at a time. The Act removes the three-year time limit for all SpHAs.
101. This time limit is deemed no longer necessary, as ministers intend the functions of all SpHAs to be enduring. The amendment also ensures that SpHAs established after 2012 (only the NHS Counter Fraud Authority at the point of these provisions coming into force), and those established before that date, are no longer in different positions. By removing this time limit, all SpHAs will be treated equally in legislation.

Abolition of LETBs

102. Local Education and Training Boards (LETBs) were established as statutory sub-committees of HEE under Chapter 1 of Part 3 of the Care Act 2014. They were set up to exercise HEE’s functions at local level to plan and commission education and training, quality assure the education and training commissioned for their areas, and act as a forum for local workforce development in the NHS and public health system.
103. The Act abolishes LETBs as statutory sub-committees to enable HEE to develop and adapt its own flexible regional operating model to best deliver its objectives over time.

Mandatory reporting of industry payments to the healthcare sector

104. The Independent Medicines and Medical Devices Safety Review (the "IMMDS Review"), chaired by Baroness Cumberlege, reported in July 2020 on three medical interventions: Primodos (which is a brand of hormone pregnancy test used from the 1950s to 1970s), sodium valproate (a drug used to treat epilepsy) and pelvic mesh (a medical device used to support pelvic prolapse and urinary incontinence).
105. Recommendation number 8 of the report on the review (page 188) provided the following: "there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians".
106. This recommendation was made because of concerns about perceived and real conflicts of interest in the provision of healthcare and treatment, particularly when doctors have financial and other links with pharmaceutical and medical device companies. The report emphasised that responsibility for transparency in this regard should not only lie with the medical profession, but also with the pharmaceutical and medical devices industries.
107. Although there are existing reporting initiatives, participation is voluntary. The IMMDS Review (at paragraphs 2.53 to 2.57) identified a perception amongst patient groups that payments to clinicians could influence their practice, and that a voluntary scheme is not adequate to ensure transparency. Patient groups subsequently continued to make strong demands for a mandatory scheme.
108. The Government accepted the recommendation in principle and agreed to develop options "including making reporting mandatory through legislation". Sections 92 to 94 of the Act respond to this recommendation by creating powers that will enable regulations to require that payments and other benefits provided by pharmaceutical, medical device and other businesses to the healthcare sector are put into the public domain.
109. The sections allow regulations to place a requirement on manufacturers or commercial suppliers of health care products (or persons connected to them) to publish or provide to the Secretary of State information about payments they make or other benefits they provide to persons providing healthcare or persons who carry on activities connected with healthcare. This includes organisations who may not directly provide healthcare but who may influence it, for example through the education of healthcare professionals.
110. There are some circumstances in which the publication of information relating to a payment or other benefit may impact on delivering value of money in the healthcare sector or the attractiveness of the United Kingdom as a research destination, and it therefore may not be appropriate to require this information to be made publicly available. For example, where the NHS negotiates a confidential discount on medicines, it is not the intention that relevant companies will be required to publish or provide information about this payment given the impact this would have on the NHS’s ability to achieve the best value for money. Therefore, section 92 provides that the Secretary of State has the ability to make provision in the regulations for exceptions to the requirement to publish or provide information, for example, to support the attractiveness of the United Kingdom’s life sciences sector.
111. Section 92 enables the Secretary of State to exempt businesses from these requirements if the equivalent information is published elsewhere via an alternative reporting scheme which the Secretary of State considers renders compliance with the requirements imposed by the regulations unnecessary.
112. While the value of this policy is to enhance transparency and improve the data available to the public, this can only be realised if businesses comply. The Secretary of State will therefore be able to make regulations about enforcement of requirements in the regulations, including imposing financial penalties.
113. We consider there is benefit to introducing UK-wide regulations. This is consistent with the approach taken in medicines and medical devices regulations and would place consistent obligations on businesses, reduce potential loopholes and ensure we can achieve comprehensive coverage to the benefit of patients. In order to ensure regulations work for the whole of the United Kingdom the sections provide that the Secretary of State must seek the consent of the Scottish Ministers, Welsh Ministers or Department of Health in Northern Ireland before regulations are laid, where the regulations are within the legislative competence of the devolved legislatures.
114. Taken together, sections 92 to 94 enable the Secretary of State to make regulations which will deliver increased transparency of the relationship between businesses and the healthcare sector, provide patients with information on the relationships which may impact their healthcare and provide the public with information to enhance their trust in the health care system.

Adult social care information

115. Adult social care is governed by a national regulatory framework but is generally delivered at a local level by local authorities. Under normal circumstances, aggregated adult social care data is collected from local authorities once a year and is published by NHS Digital. Prior to this Act, there was no mechanism to collect data from private social care providers and, due to the frequency with which data is collected from public providers and local authorities, it is not always complete, accurate or up to date. This has resulted in gaps in the information available to inform policy decisions or to identify and respond to emerging issues and risks.
116. The provisions in the Act reflect a view that data relating to care received by individuals is more useful than aggregate data in enabling the linking and use of data across health and adult social care to improve services and to monitor people’s care through the whole care system. The provisions also aim to ensure consistency of data whether care is publicly arranged or arranged privately by individuals.
117. Alongside client data, being able to collect information from, and about, providers in a consistent way will enable effective oversight and management of the social care market by improving the understanding of capacity and risk in the system, enabling identification of when and how to target direct support to providers and enabling identification of and responses to social care workforce needs including recruitment, retention, and equality policies. This information would continue to be subject to restrictions under the Data Protection Act 2018, the UK GDPR and the common law duty of confidentiality (although the provision of the information to DHSC would not itself breach the common law duty of confidentiality).

Information standards

118. For the health and social care system to work efficiently and effectively, data needs to flow through the system in a standardised way, so that when it is accessed by or provided to an organisation for any purpose it can be read by, be meaningful to, and be easily understood by the recipient and/or user of the data. This relies on data being collected, processed, and shared in a consistent way.
119. Information standards set standards relating to processing information, including standards about how information is shared, and which make it easier to compare data, across the publicly funded health and social care system. They are prepared and published by the Secretary of State (in relation to health services and adult social care) and by NHS England in relation to NHS services. They apply to the Secretary of State and NHS England as well as to bodies involved in the provision of publicly arranged health or adult social care services in England.
120. The changes in this Act arise from a desire to further improve the consistency with which information systems used by health and adult social care providers adopt a standardised approach to the collection, storage and processing of data. The aim is to enable the Secretary of State DHSC and NHS England to publish mandatory standards. Providers of health or adult social care to whom such standards apply will have to comply with them rather than just have regard to them. It is also intended to extend the potential application of information standards to include private providers of health and adult social care.

Improving sharing of information

121. There is a need to ensure greater certainty among health and social care organisations about what information they can share and when, so that information is shared appropriately for the benefit of the health and adult social care sector and those using services.
122. The processing of personal data (that is, information which identifies an individual or enables them to be identified) is subject to UK data protection legislation. The legislation does not impose restrictions on the sharing of information that is not personal data. If the information does not relate to identified or identifiable individuals, it may be shared without the need for rigorous safeguards to ensure privacy and confidentiality.
123. The Act introduces a power for relevant health or social care bodies in England to require the sharing of information other than personal information for purposes related to their functions in connection with the provision of health services or adult social care in England. The requirement will only apply to information that is in a form that does not identify any individual or enable the identity of any individual to be ascertained, i.e. it is anonymous. This information is not subject to the retained version of the General Data Protection Regulation (EU 2016/679) (UK GDPR), the Data Protection Act 2018 or the common law duty of confidentiality. This means that pseudonymised or de-identified data, which enables individuals to be identified, does not fall under the power. In addition, the Act provides powers to make regulations that will enable the introduction of exceptions to the power, which would allow further safeguards to be introduced, for example, where the information requested is publicly available, or to ensure that the duty does not apply to commercially sensitive information.
124. The duty to share anonymous information complements the existing duty on certain health or social care organisations to share information about an individual with certain persons where this is likely to facilitate the provision to the individual of health services or adult social care and is in the individual’s best interests (section 251B of the 2012 Act). The objective is to increase the sharing of anonymous data for the benefit of the health and adult social care sector.
125. The intention is to require organisations to share anonymous information they already hold if required to do so by a relevant organisation; organisations are not required to undertake any process of anonymisation for the purpose of complying with the requirement.
126. Requiring, enabling, facilitating and encouraging more effective use of data will support other key provisions in the Act, for example provisions strengthening the duty to cooperate across the health and care system, including integrated care boards, requiring them to have regard to the effects of their decisions on the health and well-being of the people of England, the quality of services and efficiency and sustainability in relation to the use of resources.

The Health and Social Care Information Centre

127. The Health and Social Care Information Centre, known as NHS Digital, was established and given functions under the 2012 Act. It is the national information and technology partner to the health and social care system in England. There is a need to ensure that it has the right powers and duties to enable it to collect, share and otherwise process data proportionately, appropriately and with due regard to protecting privacy, to benefit the health and social care system and the individuals served by it.

Information

128. The data provisions in the Act are intended to work, collectively, to enable increased sharing and more effective use of data across the health and adult social care system. The provisions are informed by extensive work done by DHSC and its partners to identify barriers to - and solutions to ensure - the secure, appropriate, and proportionate use of data to benefit individuals, populations, and the health and social care system.
129. Key to this has been learning from the Government’s response to COVID-19 which has shown how data can be used effectively and securely to improve the services individuals receive and the operation of the health and care system.

Transfer of functions between Arm’s Length Bodies

130. Arm’s Length Bodies (ALBs) are bodies that have a role in the processes of national Government, but are not a part of it, and accordingly operate to a greater or lesser extent at Arm’s Length from ministers. The health and social care ALB landscape is made up of a mix of Executive Agencies (EAs) which are legally part of DHSC; Special Health Authorities (SpHAs), which are created by secondary legislation and are subject to direction by the Secretary of State; Executive Non-Departmental Public Bodies (NDPBs), which operate at arm’s length and are legally separate from DHSC and ministers, though a minister will be responsible to Parliament for them; and Advisory NDPBs , which are not separate legal identities and consist of external experts operating in a personal capacity. Although not strictly ALBs, DHSC also has Expert Committees operating as part of DHSC, and sponsors one Non-Ministerial Department, the Food Standards Agency, which is fully independent and accountable to Parliament.
131. This configuration of ALBs has remained largely unchanged since the 2012 Act reforms. As the challenges facing the health system have changed over the last decade, the statutory nature of this configuration has made it harder for ALBs to change their role.
132. These powers will allow the transfer, by regulations, of functions from one of a list of relevant NDPBs to another. It will also enable the Secretary of State, by regulations, to provide for the Secretary of State’s functions to be exercised by any of the listed NDPBs. These powers will not allow the Secretary of State’s functions to be transferred to a NDPB, merely the exercise of those functions. Responsibility will remain with the Secretary of State.
133. There will be a full and transparent process when making regulations to transfer or provide for the exercise of functions. A formal consultation will take place, which will include the ALBs involved, and approval will need to be secured from both Houses of Parliament as the regulations are subject to the affirmative procedure.
134. Additionally, consent must be obtained from the Devolved Governments for any transfer within their legislative competence or that modifies the functions of the Welsh or Scottish Ministers, or a Northern Ireland Department.
135. The Executive Agencies are legally indistinguishable from the Secretary of State and, as such, there is no need for them to be separately included in these powers.
136. The NDPBs to remain out of scope, given their particular, technical, regulatory functions, are the Care Quality Commission, the National Institute for Health and Care Excellence, and the Health Service Safety Investigations Body (once it is created as a NDPB through this Act).

Health Services Safety Investigations Body

137. The existing Healthcare Safety Investigation Branch ("the Investigation Branch") was set up on 1 April 2017. The Investigation Branch is currently operational under Secretary of State Directions as an organisational arm of the TDA. The Act establishes a new statutory body which will largely replace the Investigation Branch. There will be transitional arrangements to transfer the Investigation Branch’s function to NHS England for an interim period following the abolition of the TDA and prior to the establishment of the Health Services Safety Investigations Body (HSSIB).
138. The HSSIB is a new Executive NDPB, with powers and independence to conduct investigations into "qualifying incidents". These are incidents that occur in England during the provision of health care services which have, or may have, implications for the safety of patients. Independence is fundamental to the HSSIB as it will help ensure that patients, families and staff have trust in its processes and judgements.
139. Establishing the HSSIB as a new independent body aligns with the Department’s drive to improve patient safety and reflects the commitment given when the Investigation Branch was established.
140. The Act creates a "safe space" within which participants can provide information to the HSSIB for the purposes of an investigation without fear that it will be disclosed to others. It prevents the HSSIB, or any individual connected with the HSSIB, from disclosing "protected material" held by the HSSIB in connection with its investigatory function. In this context, protected material includes any information, document, equipment or other item which is held by the HSSIB (or a connected individual) for the purposes of the HSSIB’s investigation function. Information held in safe space will only be disclosed by the HSSIB in certain limited circumstances. The policy to establish the "safe space" provision is comparable to similar legal provisions for bodies that investigate air, rail and marine accidents. These investigation branches look to use "safe space" principles to improve safety, by promoting learning and not attributing blame, and this is a founding principle behind establishing a "safe space" for investigating qualifying incidents.
141. The HSSIB will look to encourage the spread of a culture of learning within the NHS through promoting better standards for local investigations and improving their quality and effectiveness. To this end, the HSSIB may provide advice, guidance and training to organisations in connection with an investigation upon request.
142. HSSIB’s remit will cover healthcare provided in and by the independent sector as well as by the NHS.
143. This policy aligns with the recommendations in the report Learning not blaming: the Government response to the Freedom to Speak Up consultation, the Public Administration Select Committee report ‘Investigating Clinical Incidents in the NHS’ and the Morecambe Bay Investigation (July 2015). 1

Virginity Testing

144. Virginity testing, also known as a hymen test or "two-finger" test, is defined by the World Health Organisation (WHO) as a gynaecological examination conducted under the belief that it determines whether a woman or girl has had vaginal intercourse.2 The process involves placing two fingers or a medical instrument inside the vagina to check for an intact hymen (tissue at the vaginal opening). This can be a physical or a visual examination. There is no consensus around this definition as virginity testing can also be defined as checking for vaginal laxity (looseness) and examining the size of the vagina which could suggest vaginal intercourse. It must be noted that this definition is not widely used.
145. Virginity testing is widely regarded as a form of violence and abuse against women and girls which stems from a patriarchal and repressive attitude towards women, with women and girls being often coerced and forced into having a virginity test against their will. In early 2021, the then Secretary of State for Health and Social Care and the Home Secretary commissioned an intensive Departmental review into virginity testing.
146. The review concluded that virginity testing is not a medical procedure, but a vaginal examination with no scientific or clinical merit. Women and girls are often coerced or forced into virginity testing against their will. Virginity tests are carried out for cultural reasons and may be done before a young woman or girl gets married as proof of her "virginity" and so called "honour". Virginity testing can also be carried out in other circumstances, for example if a teenage girl is seen with a boy and there is a perceived need to "prove" that she is still a virgin. All stakeholders outlined that women and girls are often coerced or forced into having the "test" by their family members or their intended husband’s family. It is most prevalent in highly conservative communities. It is widely accepted as a form of violence against women and girls that can have short- and long-term impacts. Virginity testing can be physically harmful, in some cases causing damage to the hymen, bleeding and infection. Stakeholders have explained that virginity testing can also lead to anxiety, depression and post-traumatic stress disorder and suicide, especially if performed without the patient’s consent. There is anecdotal evidence that suggests girls as young as 13 are being subjected to virginity testing.
147. The review’s finding and recommendations were published in the Violence Against Women and Girls strategy in July 2021, which states that virginity testing can have detrimental physical and psychological impacts on women and girls. In light of this decision, this Act therefore provides for the criminalisation of "virginity testing". Provisions in the Health and Care Act 2022 making it illegal to carry out, offer or aid and abet virginity testing in any part of the UK came into effect on 1 July 2022.

Hymenoplasty

148. Hymenoplasty is a procedure undertaken to reconstruct a hymen. This is done by suturing hymenal remnants together at the vaginal opening, or surgically reconstructing the hymen with the purpose of making a woman bleed the next time she has intercourse (but is not guaranteed to do so), in order to give the impression that she has no history of vaginal intercourse. The hymen, once broken, does not disappear but leaves papillary projections. In a hymenoplasty these are trimmed and picked up with a stitch and then tied like a purse string. This will ultimately form some scar tissue. There is no guarantee that this will fully reform the hymen or cause bleeding when penetration is attempted. It can sometimes be advertised as "virginity surgery".
149. The hymen is a thin piece of skin that partially covers the vagina. It usually breaks during sex, but not always, and can be broken through using tampons, activities such as horse riding and other sports. This means that having a broken hymen cannot be used as an indication that a woman has had vaginal intercourse. Equally, an intact hymen also does not mean that sexual intercourse has not occurred, as a hymen can stretch to accommodate penile penetration. It is entirely normal for hymenal remnants to remain even after childbirth. The World Health Organisation is clear that the appearance of a hymen is not a reliable indication of absence of intercourse. The hymen also has very few blood vessels and therefore an absence of blood when having sexual intercourse for the first time is also not an indication that a woman has had previous sexual intercourse.
150. Following widespread concerns that women and girls were being forced and coerced into undergoing virginity testing and hymenoplasty, in early 2021 the then Secretary of State for Health and Social Care and the Home Secretary commissioned urgent policy work to determine if any government intervention, including legislation, is required, and if so, what the right legislative vehicle might be. The review’s recommendations included the proposal to criminalise virginity testing, but not to legislate to ban hymenoplasty at the same time. The arguments for a ban were at the time not so clear cut, and the government committed to establishing an expert panel to review the procedure in more detail.
151. The Panel’s report was published on 23 December 2021 alongside a background paper Expert panel on hymenoplasty - GOV.UK (www.gov.uk) which summarises the evidence gathered during the intensive review and other several other sources of evidence. This evidence includes an extensive literature review, position statements from Royal Colleges, recent campaigns and personal experience case studies. This also includes the conversation and positions put forward by the Moral and Ethical Advisory Group (MEAG) who were consulted prior to the establishment of the panel.
152. The Panel found that hymenoplasty is inextricably linked to virginity testing. Hymenoplasty is often undertaken by the same private clinics that offer virginity testing. If a woman or girl "fails" a virginity test, hymen repair surgery might be the logical next step. The continuing availability of hymenoplasty could serve as an incentive for families to seek virginity testing of women and girls. A failure to prohibit hymenoplasty would undermine the Government’s commitment to address the violence against women and girls by criminalising virginity testing. It is a harmful practice that creates and exacerbates social, cultural and political beliefs that a women’s value is based on whether or not she is a virgin before marriage.
153. There is no clinical benefit to hymenoplasty, nor any other procedure under a different name that seeks to reconstruct the hymen. The Royal College of Obstetricians and Gynaecologists (RCOG) does not provide any training or clinical guidelines on how to undertake this procedure, and the clinical risks of undertaking it are unknown, with no evidence to prove it has no adverse effects.
154. The Panel describes the physical and psychological risks of HP as including:
     • Infection
     • Acute bleeding during the procedure
     • Scarring and narrowing of vaginal opening
     • Reduced sensation/ increased sensation (pain rather than pleasure)
     • Sexual difficulties
     • Depression
     • Anxiety
     • Post-Traumatic Stress Disorder
     • Reduced or no libido
     • Suicide

155. The expert panel have confirmed that there is never a medical or clinical need to repair or reconstruct the hymen. In some very limited circumstances (not least because clinicians have other, non-surgical treatments available), there are procedures that are clinically necessary to remove hymenal remnants caused by external trauma or child birth. This would involve removing any remaining parts of the hymen to prevent bleeding, infection or discomfort to a woman. Such a procedure does not involve any reconstruction of the hymen but rather removes any remaining traces of the skin.
156. The government agreed with the panel’s main recommendation and announced its intention to ban hymenoplasty when Parliamentary time allowed in the Women’s Health Strategy Vision Document published on 23rd December 2021. The Health and Care Act 2022 has provided the earliest legislative vehicle to ban hymenoplasty.
157. As a cosmetic surgical procedure, hymenoplasty would not have otherwise been an offence if carried out with the patient’s consent. The ban is therefore achieved through the creation of a new criminal offence. No other legislation would serve to prevent hymenoplasty. Sexual offences are not relevant because the surgery is not sexual in nature. The prohibition on female genital mutilation would not cover the surgery, because this only applies to mutilation of certain of the specific external genitalia. Professional regulation was considered by the expert panel, who concluded that this was insufficient to protect women from the risks of hymenoplasty. And in relation to offences against the person, while consent to the surgery may not be in place due to the pressure placed on women to undergo it, this would not necessarily always be the case.
158. Provisions in the Health and Care Act 2022 making it illegal to carry out, offer or aid and abet hymenoplasty in any part of the UK came into effect on 1 July 2022.

Pharmacy Reimbursements

159. The typical process by which Community pharmacies obtain medicines can be summarised as follows: wholesalers purchase stock from manufacturers, which they sell to pharmacies who in turn supply it to patients. This could be in accordance with a prescription, a serious shortage protocol, a patient group direction or a pandemic treatment protocol. The pharmacy then claims reimbursement from the NHS for the product supplied. This is according to the arrangements set out in determinations by either the Secretary of State, Welsh ministers or NHS England which are published monthly in the Drug Tariff. The legal basis for these arrangements is set out in section 164 of the NHS Act 2006 and section 88 of the National Health Service (Wales) Act 2006. The Drug Tariff sets out a total payment package for the service provider that includes an amount that is referable to the cost of the product supplied and an amount that is referable to the service cost, for example doing the clinical check, advising the patient etc. Payments linked to the supply of products are termed reimbursement and in connection with service fees termed remuneration.
160. The assumption is that even if the service provider received the product for free, they will be reimbursed something for dispensing it. This precludes an arrangement whereby the Government or NHS centrally procures products and then requires community pharmacies to source them from the central supplier at no cost to the community pharmacy. Regardless of the fact that the community pharmacy has paid nothing for the product, the scheme of the Act is such that there is an obligation for them to be reimbursed for it, unless there is a statutory exemption that applies, which is now being added to.
161. We encounter problems with the system when not using a conventional supply chain, and this led to the unlicensed "specials" medicine amendments made to section 164 of the NHS Act 2006 and section 88 of the NHS (Wales) Act 2006 in 2017. Due to a lack of competition in the market for unlicensed medicines, and arrangements that meant that suppliers’ list prices were paid (a factor that has been partially dealt with in other ways), there was no incentive for pharmacy contractors to seek value for money. Therefore, the Government has included provisions to allow the Secretary of State or Welsh ministers to make regulations to the effect that pharmacy contractors do not need to be reimbursed for unlicensed "specials" medicines that are centrally supplied free of charge to them, for example by the NHS or DHSC.
162. This provision seeks to add, in a limited way, further exemptions from the general obligation that community pharmacies needed to be reimbursed for the products supplied as part of pharmaceutical services in England and Wales, and as a corollary to that, to facilitate central purchasing. There are various reasons why the Department of Health and Social Care may now seek to centrally procure vaccines, immunisations or products used to treat a pandemic. For example, in a global health emergency, when pressures from global demand mean that central purchasing and direct supply to community pharmacies are critical to maintain continuity of supply for UK patients in England or Wales, Ministers may wish to use central procurement without the risks of wholesalers increasing prices or exporting the stock. The Government wishes to have the option to be able to supply the product "directly" free of charge to pharmacies, without needing to sell into the supply chain in order to allow the ordinary reimbursement arrangements to function. In these circumstances, the Department would not want to reimburse pharmacies as well as purchasing the stock, otherwise the Government would be paying twice for the product.
163. The additions made by the provision are restricted to vaccinations and immunisations, medicinal products used for the prevention or treatment of disease in a pandemic, and associated products such as diluents and syringes. This provision aims to strengthen the legal basis for these central purchasing scenarios while aiming to not radically change established NHS pharmaceutical service provision or payment mechanisms.

International Healthcare

164. International healthcare is a small and important element of general healthcare policy in the UK. Reciprocal Healthcare agreements can support people from the UK to obtain access to healthcare in other countries (and vice versa for people from other countries who visit the UK).
165. In 2019 Parliament enacted the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019 ("HEEASAA") to establish a legal basis for the Secretary of State to fund and implement reciprocal healthcare, and share necessary data, after the UK left the European Union (EU). In anticipation of a possible no deal scenario, the Act contained powers to implement new bilateral agreements with individual Member States and to establish detailed unilateral arrangements to support certain people to access healthcare in the European Economic Area (EEA) or Switzerland if no bilateral arrangements were in place.
166. On 20 December 2020 the UK signed the Trade and Cooperation Agreement (TCA) with the EU. The TCA contains a Protocol on Social Security Coordination which provides UK Nationals with access to a range of social security benefits, including reciprocal healthcare cover when they are in the EU and Switzerland.
167. The Government is now looking to strengthen the UK’s relationships with countries across the globe and improve international healthcare cooperation. The Reciprocal Healthcare provisions in this Act amend HEEASAA to enable the Secretary of State to also implement comprehensive reciprocal healthcare agreements with countries outside the EEA and Switzerland.
168. Prior to the provisions in this Act, the Secretary of State only had powers under HEEASAA to implement comprehensive reciprocal healthcare agreements within the EEA and Switzerland. The limited geographical scope of the powers in HEEASAA meant that the Secretary of State did not have the necessary powers to implement reciprocal healthcare agreements with countries outside of the EEA and Switzerland, including, for example, British Overseas Territories and Crown Dependencies, other than the ability to exempt individuals from charges for relevant NHS services.
169. As a result, although the UK entered into a number of reciprocal healthcare agreements with countries outside the EEA and Switzerland, such as with Australia and New Zealand, they were limited in scope because of the absence of financial reimbursement or data sharing powers. For example, under the terms of reciprocal healthcare agreements the UK entered into with countries outside the EEA and Switzerland, UK nationals could access emergency treatment should they require it, however, access to haemodialysis for kidney patients was restricted or not included within the scope of these agreements..
170. The provisions expanding HEEASAA to countries outside the EEA and Switzerland enable the Secretary of State to make regulations for the purpose of giving effect to healthcare agreements, including provision for the reimbursement of healthcare costs. The provisions also provide the devolved authorities (Scottish Ministers, Welsh Ministers and a Northern Ireland department) with a concurrent regulation making power to give effect to healthcare agreements in devolved areas of competence.
171. Further, the amendments to HEEASAA will enable the Secretary of State to make discretionary payments, in exceptional circumstances, but only in countries with which the UK has a reciprocal healthcare agreement. This remains a necessary power which will allow the Secretary of State to support UK nationals abroad where due to exceptional circumstances they require to access healthcare abroad but fall outside the scope of a reciprocal healthcare agreement.
172. They will extend the existing data sharing provisions in section 4 HEEASAA to Rest of World countries to provide a legal basis for facilitating data processing to support the making of payments and giving effect to healthcare agreements. This data sharing will be fully in line with UK GDPR.
173. Now the Government has a reciprocal healthcare agreement with the EU, this section also removes the power in HEEASAA to establish detailed unilateral healthcare arrangements as these are no longer needed.
174. No reciprocal healthcare arrangements are made or changed as a direct result of this legislation.

Adult Social Care Assurance

175. Part I of the Care Act 2014 sets out a wide range of care and support responsibilities and functions (functions relate to the processes, activities or broader responsibilities that local authorities perform), for which local authorities are responsible. These include the direct provision or commissioning of adult social care services.
176. The Act will introduce a new legal duty for the CQC to review and make an assessment of the performance of local authorities in discharging their "regulated care functions" under Part 1 of the Care Act 2014. These are the specific adult social care functions, which will be set out in secondary legislation, that will be subject to review by the CQC, with the aim of assessing the effectiveness of services put in place to achieve high quality care outcomes for local populations.
177. The CQC must publish the findings of their reviews with the intention of helping people see and understand how their local authority is performing in the delivery of its adult social care duties, and thus support transparency and local accountability. This will support local authorities to understand what they are doing well and help them to identify what they could do better. It will also help DHSC understand what is happening in the provision of adult social care at a local level as well as forming an overarching national picture, gaining insight into issues such as regional variation. This will provide a platform from which DHSC and Government partners can work with local authorities to promote best practice, provide support, and act to secure improvement in the event of substantial issues being identified.
178. The CQC is the regulator of health and social care in England and has a statutory duty to undertake a variety of functions, including conducting reviews and performance assessments of adult social care providers, as set out under section 46 of the Health and Social Care Act 2008. Under section 48 of the Health and Social Care Act 2008, the CQC has undertaken local strategic reviews of how well health and care systems work together to care for people.
179. The exact functions in Part 1 of the Care Act 2014 in scope for review under the new duty will be set out in secondary legislation. The reviews undertaken by the CQC under the new section 46A will be by reference to objectives and priorities set for the CQC by the Secretary of State. This will help focus reviews of regulated care functions on areas of particular concern or in alignment with future key priorities for adult social care policy. Review by the CQC will also be by reference to a set of quality indicators determined by the CQC and approved by the Secretary of State.
180. The CQC must devise a methodology for assessing and evaluating local authorities including the frequency by which it will undertake its performance reviews, which it must then set out in a statement to be approved by the Secretary of State. For example, in developing the methodology for assessment, the CQC may wish to undertake reviews at different intervals or make a case for alternative methodologies depending on the specific case presented. The CQC may also consider that it wishes to review local authorities that perform above a certain threshold less frequently.
181. The new duty for the CQC will sit alongside their existing powers and duties to undertake special reviews or investigations under section 48 of the Health and Social Care Act 2008. Section 48 of the Health and Social Care Act 2008 provides that the CQC may, or must when requested by the Secretary of State, conduct a "special review" or investigation into a range of matters, including the provision of adult social care services. The CQC must first gain the approval of the Secretary of State before undertaking a review of how local authorities arrange for the provision of adult social services. Section 48 is amended by this Act so that there is a clear distinction between these "special reviews" or investigations, and the reviews to be carried out by the CQC under the new section 46A of the Health and Social Care Act 2008.
182. Section 50 of the Health and Social Care Act 2008 sets out the steps which the CQC may or must take following a review under section 46 (or a special review or investigation under section 48) of the Health and Social Care Act 2008, where it is considered that a local authority is failing to discharge its adult social services functions. Section 50 is amended by this Act to also apply to reviews conducted by the CQC under the new section 46A.
183. Section 60 of the Health and Social Care Act 2008 enables the CQC to conduct inspections for the purposes of its regulatory functions, including functions carried out under sections 46, 48 and 50. Section 60 is amended by this Act so that the CQC may carry out inspections for the purposes of its reviews under new section 46A.

Adult Social Care Intervention

184. Part 1 of the Care Act 2014 sets out a wide range of care and support duties and functions (functions relate to the processes, activities or broader responsibilities that local authorities perform), for which local authorities are responsible. These include the direct provision or commissioning of adult social care services.
185. Section 164 of this Act inserts a new section 72A into the Care Act 2014. Section 72A contains powers for the Secretary of State to issue directions to local authorities where the Secretary of State is satisfied that they are failing or have failed to discharge their functions under Part 1 of the Care Act 2014 to an acceptable standard.
186. These powers are part of the approach to oversight and support of the adult social care sector, underpinned by other Act provisions to provide for data collection and routine CQC assurance of local authority performance. These new powers enable Secretary of State to intervene to secure improvement where necessary.
187. In light of these new intervention powers, two pieces of existing legislation will be amended:
     1. Section 165 makes amendments to section 50 of the Health and Social Care Act 2008, so that in every case where the CQC considers that a local authority is failing to discharge its functions to an acceptable standard, it must inform the Secretary of State and must recommend any special measures it considers that the Secretary of State should take.
     2. Section 164 makes amendments to section 7D of the Local Authority Social Services Act 1970, taking local authority duties under Part 1 of the Care Act 2014 out of scope of the powers conferred by section 7D.

Cap on Care Costs

188. The Care Act 2014 (the "2014 Act") contains provisions relating to adult care, support and health. Part 1 of the 2014 Act is intended to provide duties and responsibilities to local authorities in meeting the care needs of their population. Part 1 also includes powers for a local authority to charge for the cost of care and provisions to implement the changes put forward by the Commission on the Funding of Care and Support.
189. Section 15 of the 2014 Act establishes a cap on the amount that adults can be required to pay towards eligible care costs over their lifetime. These costs are either specified in a personal budget (under section 26) where the local authority is meeting the person’s needs, or, once commenced, in an independent personal budget (under section 28) where the local authority is not.
190. The amendments made in this Act were introduced in order to enable the introduction of a cap on the amount anyone in England will need to spend on their personal care over their lifetime. While the power to set a cap was already legislated for in the 2014 Act, the decision was made that the cap, and the way people meter (accrue costs) towards it, should operate differently to how the Government envisaged in 2014.
191. Prior to the amendments made by this Act, section 15 of the 2014 Act stated that people who receive financial support from the local authority will meter to the cap at the cost of care specified in their personal budget; this cost is met through a combination of local authority and individual contributions.
192. The Act provides that only the amount that the individual contributes towards these costs will count towards the cap on care costs, and so individuals will not reach the cap at a faster rate than their personal contributions.
193. The Act also makes technical changes to the 2014 Act to ensure the policy intentions for Personal Budgets and Independent Personal Budgets are reflected in legislation.
194. The legislation specifies the information which must be included when creating a Personal Budget, to ensure that all contributions made by the individual which ought to count towards the cap at the local authority determined rate are recorded in the Personal Budget – to bring it in line with the policy intention. This is aimed to ensure that Personal Budgets and Independent Personal Budgets work as they were originally intended when being used in conjunction with the cap.

Hospital Discharge

195. This section revokes the procedural requirements in the Care Act 2014 which require local authorities to carry out social care needs assessments, in relevant circumstances, before a patient is discharged from hospital. It does not change existing legal obligations on NHS bodies to meet health needs, and local authorities are still required to assess and meet people’s needs for adult social care.
196. This section introduces flexibility for local areas to adopt the discharge model that best meets local needs, including an approach known in England as "discharge to assess" – a model which allows individuals to recover in an environment that is familiar to them, while they receive care and reablement support in the community. Individuals are then assessed at a point of recovery, where it is possible to make an accurate evaluation of their long-term needs.
197. Since the Care Act 2014 came into force, the requirement to carry out assessments before discharge has resulted in some individuals experiencing delayed hospital discharge as they wait for their assessment to be carried out, meaning the appropriate transfer of care cannot take place when a patient is ready to leave a hospital. Delayed discharges can result in poorer patient outcomes, such as loss of independence or functional decline such as muscle deterioration in patients who are elderly or have dementia; additional expense to the NHS as patients occupy beds without a clinical need; pressure on hospital beds so it is harder to give in-patients the healthcare they may need; and more complex or higher levels of care on discharge due to the loss of function described above.
198. Discharging patients as soon as they no longer meet the criteria to reside in hospital – and therefore no longer need acute hospital care – is increasingly recognised as the most effective way to support patient outcomes.
199. This section also introduces a new duty for trusts and foundation trusts to, where appropriate, involve carers at the earliest opportunity in discharge planning for adult patients who are likely to need care and support after their hospital discharge. The section states that carers should be involved as soon as it is feasible after the trust begins making any plans relating to the patient’s discharge. This section defines a carer as an individual who provides or intends to provide care for an adult, otherwise than by virtue of a contract or as voluntary work. It applies to carers of all ages, including young carers.

Medicine Information Systems

200. The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of DHSC. It acts on behalf of the UK’s licensing authority 3 , and is responsible for overseeing the regulatory regime for human medicines in the UK as set out in the Human Medicines Regulations 2012. The regime provides a comprehensive scheme for regulating human medicines that covers licensing, manufacture, importing, brokering, labelling, distribution, advertising, and pharmacovigilance.
201. The MHRA’s pharmacovigilance activities are a key way that the safety of medicines on the market is monitored. This includes assessing the risk and benefits of medicines so that necessary steps may be taken to improve their safe use, monitoring the everyday use of medicines to identify new, or changes in existing, patterns of adverse events and providing information to healthcare practitioners and patients to promote safe and effective use of medicines.
202. Comprehensive UK-wide registries have the potential to be an important tool in improving post marketing surveillance of the use of medicines, and in turn improving patient safety, as they are a valuable source of evidence on the use, safety, and effectiveness of medicines. Registries consolidating prescribing data for specific medicines and linking it with data from clinical care and other social administrative databases with additional bespoke patient-focused data capture, enable the exploration of trends in prescribing and associated patient experiences and the identification of issues that may impact on patient safety. The establishment of registries was recommended in the Independent Medicines and Medical Devices Safety (IMMDS) Review published on 8 July 2020.
203. The evidence generated through medicines registries can be used to inform regulatory decision making, support local clinical practice and provide patients and prescribers with the evidence they need to make better informed decisions.
204. UK-wide obligations to capture data, potentially through a registry, can already be placed on companies or other legal entities that have the authorisation to market a medicine (also known as Marketing Authorisation Holders) in the UK by the MHRA, through post-authorisation commitments detailed in a medicine’s approved Risk Management Plan. However, Marketing Authorisation Holders cannot oblige healthcare providers to share information with them, which in many circumstances leads to the incomplete capture of evidence. These types of registries have not consistently delivered the required evidence in reasonable timeframes, partly due to a lack of trust from clinicians and patients but also partly due to the way in which they are set up, placing burdens on healthcare providers for additional data entry, meaning that they have often failed to recruit sufficient patients to meet the required objectives.
205. To improve the existing monitoring of the use, benefits and risks of medicines and to improve patient safety, the Act creates powers through which one or more medicines information systems can be established and operated to allow for the creation of centrally held UK-wide medicine registries. The core of these registries would be made up of existing routinely collected data which would be supplemented with bespoke data extracts from other systems to minimise the burden on healthcare professionals to input additional information.
206. The central vehicle through which the health service in England collects and disseminates health service information and data is the Health and Social Care Information Centre, known as NHS Digital. NHS Digital is a statutory corporation established under section 252 of the 2012 Act. The 2012 Act sets out the general functions of NHS Digital, such as collecting, analysing and presenting national health and social care data, setting up and managing national IT systems as well as publishing rules around the handling and management of personal confidential information of patients.
207. The Act provides a power to make regulations which will enable NHS Digital to collect a range of information about the use of medicines and their effects in the UK and to hold this data in one or more information systems. The MHRA would be able to then use the information held in an information system to establish and maintain comprehensive UK-wide medicines registries. This would improve post-market surveillance on the use of medicines. For example, where a safety issue has led to the introduction of measures to minimise risk to patients, registries would facilitate the early identification and investigation of potential non-compliance so that additional action can be taken by regulators in conjunction with health service providers at a national, local, or individual patient level.
208. It is not the intention to create a registry for every medicine used in the UK. A registry will only be established where there is a clear public health need and after the Commission on Human Medicines (CHM), the independent expert advisory body to the MHRA, has made a formal registry-specific recommendation. A similar power to establish and operate one or more information systems for medical devices is found in the Medicines and Medical Devices Act 2021 (c.3) (section 19). This Act amends that Act; this will ensure both powers are set out in the same piece of legislation.

Children and Young People

209. The transition to integrated care boards and integrated care partnerships provides an opportunity to improve the planning and provision of services to make sure they are more joined up and better meet the needs of babies, children, young people and families.
210. To ensure that the integrated care board specifically considers the needs of babies, children and young people, the Act requires the integrated care board to set out any steps it proposes to take to address the particular needs of children and young people under the age of 25, in the annual joint forward plan with its partner NHS Trusts and Foundation Trusts.
211. NHS England has committed that statutory guidance to integrated care boards will contain provisions for an integrated care board executive lead to be appointed to act as a "children and young people’s lead", with responsibility for championing the needs of children and young people. To ensure child safeguarding and SEND duties receive sufficient focus in the integrated care board, NHS England statutory guidance will contain provision for the delegation of responsibility for these duties to an integrated care board executive lead. NHS England statutory guidance will also clarify that the integrated care board annual report should set out how the integrated care board has discharged their duties in relation to child safeguarding.
212. The Government has committed that statutory guidance will contain provisions for the integrated care partnership’s integrated care strategy to consider child health and wellbeing outcomes and the integration of children’s services.
213. The Act also requires the Secretary of State to publish a report by July 2023 that will describe the Government’s policy on information sharing, by or with public authorities, in relation to the safeguarding of children. It will include an explanation of the government’s policy on a consistent identifier for children. It will also include the government’s approach and actions to implement the policy set out in the report.

Provision of Social Care Services: financial assistance

214. The Health and Social Care Act 2008 (the 2008 Act) allows the Secretary of State to provide financial assistance to "qualifying bodies" who are providing health and social care services, or to those providing related services to providers of health and social care services.
215. Section 150 of the 2008 Act and the Health and Social Care (Financial Assistance) Regulations 2009 (S.I. 2009/649) prescribe conditions for a "qualifying body", and this excludes providers who operate for profit. Social care in England is largely delivered by private providers operating on a profit-making basis as an ordinary business. As such, the Secretary of State is unable to make direct payments under this existing statutory power to much of the social care provider sector. Regular funding for social care is funded via integrated care boards or local authorities.
216. Section 67167 seeks to address this by making changes to sections 149-156 of the 2008 Act, expanding existing powers so that payments can be made to providers delivering social care services or delivering services relating to that provision of social care.
217. These provisions do not amend the powers in these sections of the 2008 Act regarding the ability of the Secretary of State to make payments to health service providers. The type of payment that can be made, and any terms on which a payment is made, to health service providers is also not changed.

Professional Regulation

218. The powers provided through this Act form part of a wider programme aiming to create a more flexible and proportionate professional regulatory framework that is better able to protect patients and the public.
219. Section 60 of the Health Act 1999 provides powers to make changes to the professional regulatory landscape through secondary legislation. This enables the regulation of new professions, the establishment of new regulatory bodies and the amendment of legislation in relation to nine health and care regulatory bodies which operate across the UK.
220. This section extends the scope of the existing powers in section 60 of the Health Act 1999 regulating health and social care professions by means of Orders in Council to make further changes to the professional regulation system. Any use of the extended powers will be in collaboration with the devolved administrations. Orders may require the approval of the Scottish Parliament (where they concern professions brought into regulation after the Scotland Act 1998) or the Welsh Assembly (where the order concerns social care workers). The regulation of healthcare professions is a transferred matter in Northern Ireland (NI). UK Government will continue, as it does now, to seek the agreement of the Northern Ireland Executive when legislating on matters that effect regulation in its territory. These additional powers will widen the scope of section 60 and enable the Secretary of State to make additional changes.
221. The new powers will enable:
     1. the abolition of an individual health and care professional regulatory body where the professions concerned have been deregulated or are being regulated by another body;
     2. the removal of a profession from regulation where regulation is no longer required for the protection of the public;
     3. the delegation of previously restricted functions to other regulatory bodies through legislation; and
     4. the regulation of groups of workers concerned with health and care, whether or not they are generally regarded as a profession e.g. senior managers and leaders.
222. Secondary legislation made using the new powers would be subject to the existing provision in Schedule 3 and section 62 of the Health Act 1999, namely, consultation and the affirmative parliamentary procedure.
223. In 2017, the UK Government and the devolved administrations consulted on high-level principles for reform of professional regulation and set out their five objectives, to:
     1. improve the protection of the public from the risk of harm from poor professional practice;
     2. support the development of a flexible workforce that is better able to meet the challenges of delivering healthcare in the future;
     3. deal with concerns about the performance of professionals in a more proportionate and responsive fashion;
     4. provide greater support to regulated professionals in delivering high quality care; and
     5. increase the efficiency of the system.
224. The 2017 consultation Promoting professionalism, reforming regulation included questions relating to the provisions in the Act.4 The Government response set out the proposals that were welcomed by key stakeholders, including professional organisations, regulatory bodies and employers. 5
225. The consultation response also highlighted the case for broader changes to the regulatory landscape including reducing the number of regulatory bodies. The Secretary of State further committed to reviewing the number of health and care professional regulatory bodies in the November 2020 Busting Bureaucracy policy paper.6 An independent review of the current make-up of the regulatory landscape, to review how it might be simplified to provide better public protection in a more efficient way, was carried out in 2021.
226. In March 2021, the UK Government published a consultation Regulating healthcare professionals, protecting the public that sets out proposed reforms to the legislation for professional regulators in four key areas: Governance and Operating Framework; Education and Training; Registration; and Fitness to Practise. The reforms will start with legislation that will bring physician associates and anaesthesia associates into regulation under the General Medical Council7.
227. In 2022, the UK Government published a further consultation Healthcare regulation: deciding when statutory regulation is appropriate 8 on the criteria on deciding which professions are subject to statutory regulation.
228. This work, which builds on the work of the Law Commissions in their review of UK law relating to the regulation of healthcare professionals9 paves the way for reforms that deliver a flexible and modern system of regulation for health and care professionals across the UK.

Medical Examiners

229. The Act amends the Coroners and Justice Act 2009 in England and Wales to set out a power for English and Welsh NHS bodies to appoint Medical Examiners. A duty is also imposed upon the Secretary of State and Welsh Ministers to ensure that enough medical examiners are appointed in the healthcare system in England and Wales respectively, that enough funds and resources are made available to medical examiners to enable them to carry out their functions of scrutiny to identify and deter poor practice, and to ensure that their performance is monitored.
230. The purpose of the amendment is to enable the introduction of a statutory scheme of medical examiners within the NHS rather than Local Authorities in England, and a range of Welsh NHS bodies rather than only local health boards in Wales. It is intended that, following a death that is not being referred to a coroner, medical examiners, who will be registered medical practitioners, will scrutinise the cause of death stated by the attending medical practitioner on the Medical Certificate of Cause of Death and hold discussions with families.
231. Medical examiners will introduce an additional level of scrutiny to those deaths not reviewed by a coroner, improve engagement with the bereaved in the process of death certification and offer them an opportunity to raise any concerns as well as improving the quality and accuracy of Medical Certificates of Cause of Death. Independent scrutiny of deaths will reduce the potential for malpractice by doctors to go unchecked. The level of scrutiny will be proportionate so as not to impose undue delays on the bereaved or undue burdens on medical practitioners and others involved in the process.

Organ Tourism

232. Where it takes place, the purchase and sale of organs almost invariably leads to the exploitation of the organ donor. Existing legislation prevents commercial dealings in human material for transplantation in the UK, and overseas when a substantial part of the offence takes place in the UK. It also covers cases where a UK national arranges or facilitates the travel of the organ donor who is exploited in any part of the world. However, there was concern that legislation did not cover all scenarios in which a person from the UK might engage in the purchase and sale of organs, as there may be commercial dealings which involve UK nationals or residents but where no part of that dealing takes place here and where the UK national is not involved in the travel of the donor.
233. Section 170 provides for the criminalisation of the purchase or sale of organs outside the United Kingdom by extending the jurisdiction of offences described in section 32(1) of the Human Tissue Act 2004 and section 20(1) of the Human Tissue (Scotland) Act 2006 when they relate to human organs. These offences cover the purchase of organs, the supply of organs in exchange for payment, and the initiation or negotiation of any such arrangement.
234. The Human Tissue Act 2004 makes it a criminal offence to remove or store, for the purposes of transplantation, or to transplant, an organ without appropriate consent (section 5, read with section 1 and Schedule 1). It also makes it an offence to pay, or offer to pay, for an organ and to make arrangements for organ purchases (section 32(1)). Section 33 prohibits the removal and use of transplantable material from a living donor unless the requirements of regulations made under that section are met. These offences apply to those who carry out illicit removals and transplants (section 5) and those who make the arrangements for payment (section 32). They do not target the recipient of the transplanted material as such.
235. For England and Wales, the Modern Slavery Act 2015 covers cases where a UK citizen arranges or facilitates the travel of the organ donor who is exploited, in any part of the world. Section 2 prohibits UK nationals from arranging or facilitating the travel of a donor, with a view to their being exploited (which includes the commission, by him or her or another person, of what would be an offence in this country under section 32 or 33 of the Human Tissue Act 2004), while knowing, or being in a position where they ought to have known, that another person is likely to exploit the donor. The Human Trafficking and Exploitation (Scotland) Act 2015 and the Human Trafficking and Exploitation (Criminal Justice and Support for Victims) (Northern Ireland) Act 2015 make similar provision for those territories.

Human Fertilisation and Embryology: Storage of Gametes and Embryos

236. Fertility preservation is increasingly possible through the freezing of gametes (eggs and sperm) and embryos. This allows fertility patients to keep their gametes or embryos in storage until they are ready to undergo treatment at a later date. The Human Fertilisation and Embryology Act 1990 (the "1990 Act"), as amended by the Human Fertilisation and Embryology Act 2008 (the "2008 Act"), sets the maximum storage limit for frozen gametes and embryos, which prior to the changes made by this Act was set at 10 years. In exceptional circumstances, those who are deemed to be "prematurely infertile", could store their gametes and embryos for longer – up to a maximum of 55 years. This was permitted through the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009 (the "2009 Regulations"). The provisions governing storage are set out in section 14 of the 1990 Act, and the requirements in relation to consent to storage are set out in Schedule 3 to that Act.
237. In February 2020 the Government launched a public consultation to test whether there was a case for changing the above storage limits, as fertility patients, the fertility sector, and fertility charities argued the current limit no longer functions to serve modern society. Such groups argued the maximum storage limit should be increased from the current 10 year limit to maximise reproductive choice for all, including for those who wish to freeze their gametes or embryos for social (non-medical) reasons, for example because they wish to start a family later in life.
238. The consultation ran from the 11 February 2020 until the 5 May 2020. In September 2021, following careful analysis of all submissions, the Government published its response to the consultation. The Government announced that the maximum storage limit for gametes and embryos would be increased from the current 10-year limit, to 10-year renewable periods up to a maximum of 55 years for all, regardless of medical need. The policy announcement by the Government on the 6 September 2021 was welcomed by key stakeholders, including fertility patients, charities, professional organisations, and the Human Fertilisation and Embryology Authority, the sector regulator.
239. These sections amend the 1990 Act to implement the above policy and increase the maximum storage period to 55 years for all. Patients will be required to renew their consent to storage every ten years. These changes will allow everyone, irrespective of medical need, to store their gametes or embryos for longer and therefore to make unpressurised decisions about when to start a family.
240. Embryos that are to be stored for the purposes of research and training will be limited to a maximum of 10 years, as is the case currently. This is because a 10-year storage period was judged to be sufficient for researchers to get approval for their proposals, to secure their research licences from the regulator, and for the projects using human embryos to be completed. The 1990 Act limits the length of time that human embryos can be used in research to a maximum of 14 days beginning the day on which the process of creating the embryo began or until appearance of the primitive streak, whichever comes first.
241. The sections also amend the 1990 Act to specify a scheme for the storage of donated gametes, embryos created from donated gamete(s), and donated embryos. In all these instances the donor(s) will be able stipulate the length of time that their donated materials can be stored and used for, up to the maximum of 55 years. Donors will not need to be contacted every 10-years to renew their consent in instances where they specify a storage limit longer than 10-years, however they will be able to contact the facility storing their material(s) and can withdraw their consent at any time, until the point of treatment. This is to enable donors to consider and set out how long their gametes or embryos are stored and used for; if they wish to avoid large age gaps between themselves and any donor-conceived children, they can do so.
242. The sections will also amend the 1990 Act to extend the provisions in relation to posthumous storage of gametes and embryos, where a person wishes to enable their partner to use their gametes or embryos made with their gametes after the person’s death. Under the 1990 Act, posthumous storage is already possible where a gamete provider gives consent to this. The consent requirement will remain. In addition, where a person who has given consent to posthumous use of their gametes or embryos dies, their storage period will automatically be renewed for a further 10 years from the date of their death. The living partner will need to provide a death certificate to the clinic to validate the extension; however, the death certificate does not need to be provided immediately and the extension can be applied retrospectively from the date of death by facilities. This change aims to provide the living partner with sufficient time to grieve, undertake counselling, and make unpressurised decisions about whether to undergo fertility treatment or not.
243. The sections in Part 2 also set out the transitional arrangements. The new provisions came into force on the 1 July 2022. The fertility sector, the regulator, and patients will have 2 years, until the 1 July 2024, to comply with the new requirements and to settle the status of any doubtful storage cases.

Advertising of less healthy food and drink

244. Obesity is one of the greatest long-term health challenges this country faces. Around two-thirds (63%) of adults are above a healthy weight and of these, half are living with obesity. The latest NCMP data from 2020/21 showed that around 40% of children leaving primary school in England were living with overweight or obesity, with 1 in 4 living with obesity 10 . Obesity is associated with reduced life expectancy and is a risk factor for a range of chronic diseases, including cardiovascular disease, type 2 diabetes, cancer and respiratory disease. It can also impact mental health.
245. In July 2020, the Government published its obesity strategy, Tackling obesity: empowering adults and children to live healthier lives. This was in response to emerging evidence that people who are overweight or living with obesity are at greater risk of long-term health conditions and being seriously ill and dying from COVID-19.
246. The intention of this Act is to reduce children’s exposure to the advertising of less healthy food and drink products on TV and online. This Act introduces a 9pm watershed for less healthy food or drink advertising on TV and a prohibition of paid-for less healthy food or drink advertising online, simultaneously, from 1 January 2023. The Secretary of State has the power to delay the implementation date for the restrictions, should this be deemed necessary. All On Demand Programme Services (ODPS) under the jurisdiction of the UK, and therefore regulated by OFCOM, are included in the TV watershed. Other ODPS will be subject to the online prohibition because they are not defined in the Communications Act 2003, so are considered as "internet services".
247. This Act amends the Communications Act 2003 11 to enable OFCOM to introduce restrictions prohibiting advertising of less healthy food or drink between the hours of 5.30 a.m. and 9 p.m. on broadcast TV, and on ODPS12 that are subject to Part 4A of the Communications Act 2003. This Act also introduces a prohibition of paid-for high fat, sugar and salt (HFSS) advertising online by inserting a new section into the Communications Act 2003 after Part 4B.
248. TV Broadcasters and ODPS defined in the Communications Act 2003 will be liable for breaches of the TV watershed. Advertisers will be liable for breaches of the paid-for online prohibition. For ODPS not subject to UK regulation, the advertiser will be liable for breaches of the paid-for online prohibition on these platforms.
249. OFCOM will be appointed as the appropriate regulatory authority. OFCOM will receive , design statutory guidance and request information to help draft the guidance. The frontline regulator will use informal powers (e.g. reputational sanction, such as naming and shaming) and takedown requests in the first instance. For serious breaches or where these sanctions have had no effect, the frontline regulator can refer the relevant liable party to the backstop regulator (OFCOM), design statutory guidance and request information to help draft the guidance. The frontline regulator will use informal powers (e.g. reputational sanction, such as naming and shaming) and takedown requests in the first instance. For serious breaches or where these sanctions have had no effect, the frontline regulator can refer the relevant liable party to the backstop regulator (OFCOM) to appoint a day-to-day regulator to carry out frontline regulation, design statutory guidance and request information to help draft the guidance. The frontline regulator will use informal powers (e.g. reputational sanction, such as naming and shaming) and takedown requests in the first instance. For serious breaches or where these sanctions have had no effect, the frontline regulator can refer the relevant liable party to the backstop regulator (OFCOM).
250. The responsibility for monitoring and regulating broadcast advertising is co-regulated by the Advertising Standards Authority (ASA) and OFCOM. The content and standards for broadcast advertising on TV and ODPS are set out in the Communications Act 2003.
251. Prior to this Act, advertising on the internet was not subject to statutory regulation.

Hospital Food Standards

252. In the summer of 2019, the Secretary of State for Health announced a "root and branch" review of food served and sold in hospitals. The scope of the review included the safety, nutrition, quality and production methods of food for patients, staff and visitors in NHS hospitals.
253. The Independent Review of NHS Hospital Food 13 - published on 26 October 2020 – made a series of recommendations across a range of areas to improve standards for food served to patients and staff, including:
     • Catering staff support
     • Nutrition and hydration
     • Food safety
     • Facilities
     • Technology
     • Enforcing standards
     • Sustainability and waste

254. As well as recommendations on the above areas, the Hospital Food Review recommended improved NHS food and drink standards for patients, staff and visitors to be put on a statutory footing to ensure a level playing field and compliance across the sector so far as nutritional standards in hospitals are concerned.
255. This Act amends section 20 of the Health and Social Care Act 2008 to provide the Secretary of State for Health and Social Care with powers to make regulations imposing requirements relating to food or drink provided or sold to patients, staff, visitors or anyone else on hospital premises in England. Such requirements include the power to specify nutritional standards, or other nutritional requirements, such as to specify descriptions of food or drink that are not to be provided or made available.
256. This is in line with the recommendations of the Independent Review of NHS Hospital Food.
257. Any regulations made under the provisions of this Act will be enforced by the Care Quality Commission (CQC) pursuant to their existing statutory powers of enforcement under the Health and Social Care Act 2008. The CQC may consider compliance with any regulations made under this power when undertaking routine inspections of hospitals. The CQC only has the power to inspect hospital premises which are providers of regulated activities as defined in Section 8 of the Health and Social Care Act 2008. The section will not therefore apply to premises that are not within its regulatory remit.

Food information for consumers: power to amend retained EU law

258. Existing EU regulations were converted into domestic law by the European Union (Withdrawal) Act 2018. This Act enables technical changes to be made to food labelling and presentation requirements to reflect the United Kingdom’s withdrawal from the EU.
259. The retained Regulation (EU) No. 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers ("Regulation (EU) No. 1169/2011") was incorporated into domestic law, carried forward and modified according to the European Union (Withdrawal) Act 2018. It sets out requirements on the provision of food information to consumers which includes the labelling of prepacked food and drink in the UK. Due to its status as retained direct principal EU legislation, primary legislation is often required to amend or otherwise modify the provisions contained within Regulation (EU) No. 1169/2011. The Act provides the Secretary of State and Ministers of Scotland and Wales with powers to amend and modify retained Regulation (EU) No. 1169/2011 using secondary legislation, via an affirmative process. This section therefore allows the Government (and/or, where appropriate, a devolved authority) to make regulations to implement any new policies regarding food information and labelling.
260. The intention of the power is to broaden the reach of any modifications to Regulation (EU) No. 1169/2011 to those matters that fall within the scope of section 16(1)(e) of the Food Safety Act 1990. This section allows the Secretary of State and Ministers in Scotland and Wales to implement new policies regarding food information and labelling applicable to their relevant territories.
261. For example, the Government’s obesity strategy "Tackling obesity: empowering adults and children to live healthier lives" included a commitment to consult on front of pack nutrition labelling and whether to mandate alcohol calorie labelling to help support consumers to make healthier choices. If consultations indicate that changes to food and drink labelling and/or presentation are required, this provision will enable Ministers to introduce these policies, while retaining a level of scrutiny on any proposed changes. It will also support the alignment of labelling policies across the three nations, by allowing each nation to make changes applicable to their relevant territories.

Water Fluoridation

262. Research shows that water fluoridation is an effective public health intervention to improve oral health for both children and adults and reduces oral health inequalities. Around 10% of the population of England currently receive fluoridated water. If all 5-year-olds with drinking water with less than 0.2 milligrams per litre of fluoride instead received at least 0.7 milligrams of fluoride per litre then the number experiencing caries would reduce by up to 28% and the number of hospital admissions for tooth extractions in children and young people would reduce by up to 68%.
263. Since 2013 local authorities have had the power, through the Water Industry Act 1991, to propose, and consult on, new fluoridation schemes and variations or terminations to existing schemes. Local authorities, and the NHS who had responsibility for water fluoridation schemes before them, have faced difficulties with implementing water fluoridation schemes, including most recently the fact that local authority boundaries are not coterminous with water flows, which requires the involvement of several authorities in these schemes, in a way which is complex and burdensome.
264. In light of these challenges, the purpose of the sections within the Act that relate to water fluoridation is to give the Secretary of State for Health and Social Care the power to directly introduce, vary or terminate water fluoridation schemes. This removes the burden from local authorities and will allow DHSC to streamline processes and take responsibility for proposing any new fluoridation schemes, which will be subject to consultation and funding being agreed.

Children’s Palliative Care

265. Where there are disagreements about a child’s treatment between those with parental responsibility and treating clinicians, or between different doctors, the court is asked to decide based on the child’s best interests. Making such a declaration would be under the court’s inherent jurisdiction, or the Children Act 1989. The views of the parents will be very important, but it is the child’s best interests that are paramount, not the rights of those with parental responsibility.
266. Cases where there is a dispute between parents and clinicians over a child’s care are extremely distressing for all involved. Getting the process right from the start through good communication and careful handling is the most important way to avoid or manage disputes.
267. The Act requires the Secretary of State to carry out a review of the causes of disputes between persons with parental responsibility for a critically ill child and the persons responsible for that child’s treatment and care. This independent review will provide the Government with strong, evidence-based recommendations to support the creation of healthcare environments that foster good, collaborative relationships between parents and healthcare staff.

Permitted locations for abortion treatment

268. Section 178 amends the Abortion Act 1967 to make provision for early medical termination of pregnancy and applies to both England and Wales.
269. The amendment provides for the medication for early medical abortion to be taken in the home of the pregnant woman where the pregnancy has not exceeded 10 weeks, and permits registered medical practitioners to prescribe the medication for early medical abortion from their homes.
270. The amendment maintains the provision made by the temporary approval for at-home early medical abortion following a telephone or video consultation with a clinician, which was adopted in March 2020 in response to the COVID-19 pandemic.

Cosmetic Regulation

271. The current regulatory framework places few restrictions on who may perform non-surgical cosmetic interventions. There is also a lack of nationally recognised requirements or standards covering the education, training and qualifications required for the administration of these treatments. There is also no assurance that the premises in which non-surgical cosmetic interventions are carried out meet hygiene standards, or that individuals carrying out procedures have appropriate indemnity and insurance arrangements in place.
272. This amendment to the Health and Care Act will grant the Secretary of State a delegated power to introduce a licensing scheme for non-surgical cosmetic procedures and prohibit carrying out these procedures without a licence or outside of licensed premises. Regulations made using these powers will be subject to the affirmative parliamentary procedure.
273. Both the personal licence and the premises licence will be issued by Local Authorities, which may also attach conditions to such licences.
274. The regulations may create offences related to: (i) a breach of the prohibition in the section (ii)a breach of conditions related to the personal licence or the premises licence, and (iii) the provision of false or misleading information to a local authority in connection with these licences. Such an offence would be punishable on summary conviction with a fine.
275. The details and scope of these regulations (including what specific procedures require a licence and the size of any fines) will be the product of an extensive engagement exercise and the section requires the regulations to be subject to a public consultation.

Mandatory training for learning disabilities and autism

276. The Learning from lives and deaths – People with a learning disability and autistic people (LeDeR) programme continues to find that people with learning disabilities and autistic people experience inequalities in access to health services. The second annual LeDeR report (2017), found that for a significant proportion of the deaths reviewed, the individual’s health was affected by factors that were avoidable, with a lack of awareness of the needs of people with learning disabilities and autism among health and social care providers. The report recommended the introduction of mandatory training for all staff, delivered in conjunction with people with lived experience of learning disabilities.
277. In "Right to be heard" published in 2019, the government set out its intention to amend the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 ("the 2014 Regulations"), to require all NHS and social care providers who carry out regulated activities to ensure that their staff have achieved the learning outcomes in respect of learning disabilities and autism relevant to their role. The CQC is responsible for monitoring compliance with the 2014 Regulations.
278. The policy intention of the Department of Health and Social Care is to make an explicit requirement in legislation for all health and social care employees who perform CQC regulated activities to undertake training on learning disability and autism appropriate to their role.
279. The Act introduces a duty in the Health and Social Care Act 2008 (HSCA 2008) on the Secretary of State to make regulations to require all health and social care providers who carry out regulated activities to ensure that their staff, who are employed for the provision of a regulated activity, receive specific training appropriate to their role on learning disability and autism.
280. The Act also introduces a duty on the Secretary of State to produce a Code of Practice (CoP) which will provide guidance about the nature of the training including the content, delivery and the ongoing evaluation of the training. The Government must consult on the CoP and lay a copy of the draft code before Parliament prior to publication.
281. The Act includes a provision which means that from commencement of the section, the 2014 Regulations and HSCA 2008 are to be read as including a requirement for all health and social care providers who carry out regulated activities to ensure that their staff receive specific training on learning disabilities and autism appropriate to their role.
282. The amendments are designed to operate within the existing framework of the HSCA 2008. Section 20 (1) of the HSCA 2008 requires the Secretary of State, by way of regulations, to secure that services provided through regulated activities cause no avoidable harm to recipients. Section 20(2) provides that the Secretary of State may use regulations to impose any other requirement in relation to such regulated activities, particularly to ensure service quality and to secure the health, safety and welfare of service recipients. Section 20(3) provides a non-exhaustive list of what may be addressed by those regulations, including provision about the management and training of staff undertaking regulated activities.
283. Section 21 contains a specific provision relating to infections acquired in health care settings. If regulations are made under section 20 which contain requirements relating to the prevention or control of health care associated infections, the Secretary of State must produce a CoP about compliance with these requirements. The Act adds a new section 21A which sets out provision for a CoP relating to mandatory learning disability and autism training. Section 22 contains provisions which outline the consultation requirements for the CoP required under section 21. The Act will expand section 22 to cover both CoPs.
284. Section 23 provides that the CQC must issue guidance about the requirements of regulations made under section 20, other than requirements which relate to the prevention or control of health care associated infections (these are covered by the CoP provisions in section 21). Section 24 contains provisions outlining the consultation procedures for the guidance produced under section 23.
285. Section 25 sets out the circumstances in which the CoP under section 21 and guidance under section 23 may be taken into account in relation to decisions or orders under the HSCA 2008.
286. The 2014 Regulations are the regulations made under (amongst others) section 20 of the HSCA 2008 and set out the list of activities which are regulated by the CQC and the requirements which apply in relation to the way these activities are carried out.
287. Regulation 18 of the 2014 Regulations currently provides that "Persons employed by the service provider in the provision of a regulated activity must receive such appropriate support, training, professional development, supervision and appraisal as is necessary to enable them to carry out the duties they are employed to perform…".
288. Regulation 21 provides a general overarching guidance provision which requires regulated persons to take into account any guidance when complying with requirements in regulations, and in the case of regulation 12 (as it applies to health care associated infections), take into account the CoP issued by the Secretary of State under section 21 of the 2008 Act.