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These notes refer to the Health and Social Care Bill as brought from the House of Commons on 19th February 2008 [HL Bill 33]
HEALTH AND SOCIAL CARE BILL
1. These explanatory notes relate to the Health and Social Care Bill as brought from the House of Commons on 19th February 2008. They have been prepared by the Department of Health in order to assist the reader of the Bill and to help inform debate on it. They do not form part of the Bill and have not been endorsed by Parliament.
2. The notes need to be read in conjunction with the Bill. They are not, and are not meant to be, a comprehensive description of the Bill. So where a clause or part of a clause does not seem to require any explanation or comment, none is given.
Part 1 - The Care Quality Commission
3. The regulation of health care in England is currently carried out by the Commission for Healthcare Audit and Inspection ('CHAI'), known as the Healthcare Commission. Social care is regulated by the Commission for Social Care Inspection ('CSCI'). CHAI and CSCI were created by the Health and Social Care (Community Health and Standards) Act 2003.
4. The Mental Health Act Commission ('MHAC') is the body currently responsible for monitoring key aspects of the operation of the Mental Health Act 1983 (the 'Mental Health Act') in England and Wales. It has other specific functions as well, notably to appoint registered medical practitioners to give second opinions where this is required by the Mental Health Act, to review decisions to withhold postal packages of patients detained in high security psychiatric hospitals, to visit and interview, in private, patients subject to the Mental Health Act, and to investigate complaints.
5. In the 2005 budget statement, the Chancellor announced plans to reduce the number of public service inspectorates. This included the creation of a single inspectorate for social care and health by merging CHAI and CSCI. The Department of Health had already announced
plans to bring together CHAI and MHAC in 2004 following a review of Arm's Length Bodies 1.
1 Reconfiguring the Department of Health's Arms Length Bodies, published July 2004.
6. The NHS Improvement Plan 2, (published by the Department of Health in 2004) and "Health Reform in England: update and next steps" (published by the Department in 2005) set out the main strands of health reform, which include diversity in provision of services, increased patient choice, and a stronger patient voice and stronger commissioning. These reforms require changes to be made to the regulatory framework.
2 The NHS Improvement Plan: Putting People at the Heart of Public Services, The Stationery Office, published June 2004.
7. The Department of Health commissioned a research study in July 2006 3 to support the development of the policy on regulation of health and adult social care. It followed wide engagement with interested stakeholders as part of the Wider Regulatory Review. It drew on lessons from other sectors, and from other health and social care systems abroad to describe the regulatory functions needed to ensure the effective operation of these systems. It then proposed options for the future regulatory architecture for health and social care, and assessed the advantages and disadvantages of each option.
3 Independent Research Study: the Future of Health and Adult Social Care Regulation, published November 2006.
8. The Department of Health consultation "The future regulation of health and adult social care in England", published in November 2006, built on this initial study and announced the Government's intention to create a new single regulator responsible for regulating health care and adult social care, and monitoring the operation of the Mental Health Act. The consultation ran for three months and the Department consulted widely with a range of stakeholders. In addition to receiving over 100 responses to the consultation, workshops were held for NHS Confederation members, including independent sector affiliates. Two social care workshops, one for social care service users and provider organisations, and one for commissioners of adult social care and Local Government representatives were also held. The Department also worked with the existing regulators throughout the process.
9. Chapter 1 of Part 1 of the Bill establishes a new body called the Care Quality Commission ('the Commission'). The Commission will be responsible for the registration, review and inspection of certain health and social care services in England (but not any care services that are regulated by the Chief Inspector of Education, Children's Services and Skills ('CIECSS')). It will replace CHAI and CSCI, established under the Health and Social Care (Community Health and Standards) Act 2003. The functions currently performed by MHAC will be transferred to the Commission and the Welsh Ministers.
10. Chapter 2 of Part 1 creates a system of registration for providers and, in some cases, managers of health and adult social care. Regulations will set out the health and social care activities (referred to as 'regulated activities'), which a person will not be able to carry on unless that person is registered to do so. The intention is that all providers, including, for the first time, NHS providers, will be brought within the ambit of registration. The new registration system replaces (in England) the current requirement for certain establishments and agencies providing independent health care or adult social care to be registered under the Care Standards Act 2000. The Commission will need to be satisfied that applicants for registration comply with registration requirements, which will be set out in regulations. Once a provider or manager has been registered, the Commission will be responsible for checking continued compliance with these requirements, and will have a range of sanctions so that it can take appropriate action where providers or managers fail to meet the requirements. The Commission will have a wider range of powers than its predecessor organisations, including the power to issue penalty notices for non-compliance with regulatory requirements and the power to suspend registration.
11. Chapter 3 of Part 1 requires the Commission to carry out periodic reviews of care provided by or under arrangements made with Primary Care Trusts ('PCTs') or English local authorities to see how well the bodies reviewed are doing. It also requires the Commission to review health care provided by PCTs, English NHS Trusts and NHS Foundation Trusts. It provides for the Secretary of State to extend the review power to cover care provided by other registered providers by regulations. These reviews will assess performance by reference to indicators of quality that will be set or approved by the Secretary of State. The Commission may also carry out other special reviews and investigations, and must carry out such reviews and investigations if the Secretary of State requests it to do so. Chapter 3 of Part 1 replaces and expands CHAI's and CSCI's review and investigation functions under the Health and Social Care (Community Health and Standards) Act 2003.
12. Chapter 4 of Part 1 transfers to the Commission and the Welsh Ministers various functions under the Mental Health Act. It also makes some changes to those functions.
13. Chapter 5 of Part 1 confers further functions on the Commission, including a requirement for the Commission to provide information and advice to the Secretary of State on the provision of NHS care and adult social services and the carrying on of regulated activities. It also enables the Commission to report on the efficiency and economy of local authority and NHS provision and commissioning. The functions in Chapter 5 replace and expand equivalent functions of CHAI and CSCI under the Health and Social Care (Community Health and Standards) Act 2003.
14. Chapter 6 of Part 1 sets out the powers of entry and inspection which the Commission has for the purposes of carrying out its functions. It also deals with the Commission's interaction with other authorities and makes a number of other provisions relevant to Chapters 1 to 5 of Part 1.
15. There is a statutory framework for the regulation of each of the healthcare professions and for the social care workforce. The Bill's provisions affect the following 11 independent statutory bodies:
16. The main purpose of these regulatory bodies is to provide protection for both patients and the public through the execution of their statutory duties. Each regulator's constitution, functions, and duties are laid out in individual Acts and statutory instruments.
17. In addition, the Council for the Regulation of Health Care Professionals ('CRHP') was established by the National Health Service Reform and Health Care Professions Act 2002 ('the Health Care Professions Act 2002'). Its general functions (as set out in section 25 of that Act) are:
18. Prior to the Health Act 1999 it was only possible to make changes to the Acts relating to the healthcare professions by presenting a Bill to Parliament. Section 60 of the Health Act 1999 allows Her Majesty, by Order in Council, to modify the regulation of the existing regulated healthcare professions, and to bring other healthcare professions into statutory regulation. An Order may repeal or revoke an enactment or instrument, amend it, or replace it (subject to the restrictions in paragraphs 7 and 8 of Schedule 3 to the Health Act 1999). The Government must consult on draft Orders prior to laying them before Parliament. The Orders are subject to the affirmative procedure.
19. The regulation of the social care workforce in England and Wales is governed by Part 4 of the Care Standards Act 2000 which established the GSCC and the CCW. The GSCC and the CCW (referred to collectively as 'the Councils') regulate the training of social workers, maintain registers of social care workers, and produce codes of good practice for social care workers and for employers of such staff. The purpose of regulation is to establish an independent standard of training, conduct and competence for the social care workforce for the protection of the public and for the guidance of employers, with the goal of improving standards in social care work. New powers in the Bill will enable modification of the regulation of the social care workforce. These powers broadly mirror the existing powers in section 60 of the Health Act 1999 which enable modification of the regulation of the healthcare professions.
20. Paragraphs 4.32 to 4.37 of the White Paper "Trust, Assurance and Safety - The Regulation of Health Professionals in the 21st Century" ('Trust, Assurance and Safety', published in February 2007) set out the Government's intention regarding the separation of adjudication of fitness to practise cases from their investigation and prosecution. Part 2 of the Bill provides the legislative underpinning for this through the creation of the Office of the Health Professions Adjudicator ('the OHPA').
21. Paragraphs 1.8 to 1.14 of Trust, Assurance and Safety set out the Government's position regarding the independence and composition of the health profession regulatory bodies, particularly the current proportion of lay membership of the councils of these bodies. Recommendations were made that future lay involvement in the work of the regulators should be expanded generally, but specifically that there should, as a minimum, be parity of lay members with professional members and that a lay majority should also be possible if desired. Part 2 of the Bill provides the legislative underpinning for this through amendments to the Health Act 1999.
22. Paragraphs 4.3 to 4.13 of Trust, Assurance and Safety set out the current inconsistency in respect of the standard of proof used in fitness to practise proceedings by the health profession regulatory bodies. Three regulators (the GMC, the GOC, and the NMC) still use the criminal standard while the other eight use the civil standard. The Government recommended that all the regulators should use the civil standard in fitness to practise proceedings and Part 2 of the Bill provides for this to be incorporated into legislation through amendments to the Health Act 1999. A similar provision is made to use the civil standard in any proceedings which relate to a social care worker's suitability to be or remain registered. This ensures consistency between the regulation of health professionals and the social care workforce in this area.
23. The regulation of pharmacy is shared by two bodies, the RPSGB and the PSNI. The RPSGB's responsibilities cover professional regulation as well as leadership and representation of the profession. It also has an important role regulating and inspecting pharmacy premises and the Government has recently put in place legislation (in England and Wales) to enable it to take on the role of regulating pharmacy technicians. The RPSGB's responsibilities towards pharmacists for professional leadership are potentially in conflict with its role as an independent regulator for the profession itself. The professions are taking on an increased clinical role in the treatment of patients, whereby pharmacists have the autonomy to prescribe potent drugs. Therefore, this dual responsibility does not provide sufficient reassurance to the public that there is effective independent regulation of this role. Separation of the regulatory system from that of professional and clinical leadership will allow each distinct function to focus solely on its core role.
24. Amendments are required to the Health Act 1999 to allow an Order made under section 60 of that Act to remove the statutory function of pharmacy regulation from the RPSGB and the PSNI and transfer these functions to the proposed General Pharmaceutical Council. This new General Pharmaceutical Council will be responsible for the regulation of pharmacists, pharmacy technicians and pharmacy premises. This approach was set out in paragraphs 1.29 to 1.36 of Trust, Assurance and Safety and supported by the Working Party chaired by Lord Carter of Coles. The statutory powers of the RPSGB and the PSNI (subject to a decision by Northern Ireland Ministers to proceed in this way) would be transferred to the new regulatory body.
25. Paragraphs 3.35 to 3.39 of Trust, Assurance and Safety set out the Government's intention for oversight of local elements of revalidation and sharing information on concerns about doctors. Part 2 of the Bill provides the legislative underpinning for this through the establishment of the role of the "responsible officer".
26. Part 2 of the Bill contains changes to the regulation of health professions and the health and social care workforce. This is in line with the Government's response 4 to various inquiries into the actions of specific health professionals 5. Provision is made for:
4 A White Paper: Trust, Assurance and Safety - the Regulation of Health Professionals in the 21st Century, published February 2007; Safeguarding Patients - the Government's response to the Shipman Inquiry's fifth report and the recommendations of the Ayling, Neale and Kerr/Haslam Inquiries; and
27. The Public Health (Control of Disease) Act 1984 ('the Public Health Act 1984') consolidates earlier legislation, much of it dating from the 19th century. Many of its assumptions, both about risks and about how society operates, are now out of date. It makes highly detailed provision on some matters (for example, it is a criminal offence to expose a public library book to plague, or to hold a wake over the body of a person who has died of cholera) but does not address other matters that are now of concern, such as contamination by chemicals or radiation. Part 3 of the Bill updates the Public Health Act 1984 to take account of these points.
28. Most concerns about health threats have, since the 19th century, related to infectious disease (plague, cholera and the like). This is reflected in the way that Part 2 of the Public Health Act 1984 focuses on infectious disease. Recently awareness has grown of the risks that can be posed by contamination, either by chemicals or by radiation. The Bill amends the Public Health Act 1984 to take account of these risks.
29. Internationally the case for taking an "all hazards" approach to dealing with such health threats was taken up by the World Health Organization ('WHO') and reflected in the International Health Regulations 2005 ('IHR'). The IHR are the means by which WHO aims to prevent and control the international spread of disease, by action that is commensurate with and restricted to public health risks, and which avoids unnecessary interference with international traffic and trade. The previous International Health Regulations (1969) were concerned with action at international borders in relation to three specific infectious diseases (cholera, plague and yellow fever), but increasingly were recognised as unable to deal with new threats, such as SARS. The new IHR are concerned with infectious diseases generally, and also with contamination. They also pay more attention than their predecessors to the arrangements needed in-country to deliver an effective response to health risks. The IHR came into effect in June 2007. The Bill amends the Public Health Act 1984 to enable IHR to be implemented, including WHO recommendations issued under them.
30. The health and general well-being of pregnant women in the last months of pregnancy is widely acknowledged to have a correlation with the health and development of a child later in life. Providing pregnant women with additional financial support towards meeting the extra costs at this time, linked to the requirement to seek maternal health advice from a health professional, is intended to help provide them with the knowledge and means to invest in their pregnancy to meet their individual needs.
31. Under the Government's current strategy of financial support, families on low incomes may claim support during pregnancy in the form of the Sure Start Maternity Grant to help with additional costs at the time of the child's birth, and Healthy Start Vouchers to help with the costs of a healthy diet during pregnancy.
32. In the Pre-Budget Report 2006, the Chancellor of the Exchequer announced that additional financial support would be made available to all women in the last months of pregnancy in line with the principle of progressive universalism, delivering support for all pregnant women and more help for those who need it the most.
33. Part 4 creates the Health in Pregnancy Grant. The Health in Pregnancy Grant will sit within the existing financial support system and will make support available to all expectant mothers in the UK in recognition of the importance of a healthy lifestyle, including diet, during the final weeks of pregnancy, and to help women to afford the other additional costs faced at this time. It is a new non-contributory, non-income related benefit payable where a woman has reached a specified stage of her pregnancy and has received the necessary health advice. It will be administered by HM Revenue and Customs. It is not taxable.
34. Part 4 also contains measures regarding the conditions of entitlement, the rate and the administration of the Health in Pregnancy Grant to be provided for in:
Duty of Primary Care Trusts
35. All NHS bodies are currently under a duty under section 45 of the Health and Social Care (Community Health and Standards) Act 2003 to ensure they have arrangements in place for the purpose of monitoring and improving the quality of care.
36. Clause 133 amends the National Health Service Act 2006 ('NHS Act 2006') by inserting a duty on PCTs to make arrangements to secure continuous improvement in the quality of healthcare provided by or for them. This duty replaces the current duty to improve quality in section 45 of the Health and Social Care (Community Health and Standards) Act 2003, requiring on-going improvement activity, and is aligned more closely with the duty imposed on English local authorities by section 3 of the Local Government Act 1999. The duty in section 45 of the 2003 Act will cease to apply in relation to English NHS bodies.
37. There are two different sources of finance which pharmacies receive for providing community-based NHS pharmaceutical services in England. One of these is the funding held centrally by the Department, known as the 'Global Sum'. The other source of finance, which funds the cost of drugs and medicines, is currently included in the sums allocated to PCTs annually to meet the general expenditure incurred in discharging their functions ('the baseline allocations'). The proposed amendment refers to the Global Sum funding only.
38. The Global Sum funding pays fees and allowances for services such as dispensing prescriptions. It also pays for other essential pharmaceutical services such as advice on medicines. It also pays the fees and allowances for appliance contractors who provide medical appliances.
39. The Department proposes that this central funding should be devolved to PCTs and be included in their baseline allocations, and published the consultation document "Modernising financial allocation arrangements for NHS pharmaceutical services 2007" on this proposal in July 2007. However, the Department proposes to continue to set the levels of fees and allowances for nationally agreed services provided by community pharmacies in negotiation with the Pharmaceutical Services Negotiating Committee (PSNC) and in discussion with the NHS. The Department will also continue the current arrangements for appliance contractors. The current funding arrangements are provided for by sections 228 to 231 of, and Schedule 14 to, the NHS Act 2006. Amendments to these parts of the NHS Act 2006 are required in order to move the Global Sum to the baseline allocations of the PCTs in England.
40. The way that funding for the provision of pharmaceutical services in Wales operates mirrors the current system in England. The Welsh Ministers hold centrally the funding that pays fees and allowances for services such as dispensing prescriptions and the provision of advice to patients, which is also referred to as the 'Global Sum'. The Welsh Assembly Government proposes that this centrally held funding should be devolved to Local Health Boards and be included in their baseline allocations. The current funding arrangements are provided for by sections 174 to 177 of, and Schedule 8 to, the National Health Service (Wales) Act 2006 ('NHS (Wales) Act 2006'). Amendments to these parts of the NHS (Wales) Act 2006 are required in order to move the Global Sum to the baseline allocations of the Local Health Boards in Wales.
41. Clause 134 introduces Schedule 12, which contains the changes needed to the NHS Act 2006 to move funding for pharmaceutical services to PCTs and to allocate funding by reference to the PCT of the prescriber. These changes will bring the management of funding for pharmaceutical services in line with funding for other community-based health services. Clause 134, by introducing Schedule 12, also makes the changes necessary to the NHS (Wales) Act 2006 to move the funding for pharmaceutical services to Local Health Boards, and also to introduce the allocation of funding by reference to the Local Health Board of the prescriber.
|© Parliamentary copyright 2008||Prepared: 20 February 2008|