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These notes refer to the Health Bill as introduced in the House of Commons on 27 October 2005 [Bill 69] HEALTH BILLEXPLANATORY NOTESINTRODUCTION 1. These explanatory notes relate to the Health Bill as introduced in the House of Commons on 27 October 2005. They have been prepared by the Department of Health in order to assist the reader of the Bill and 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. 3. Different parts of the Bill apply to different territorial areas. The application of each is set out in the paragraphs below. SUMMARY AND BACKGROUND 4. The Bill would make a number of changes intended to protect the health of the public as well as improve the running of the NHS. The Bill covers smoke-free public places and workplaces; prevention and control of health care associated infections; management of controlled drugs in the NHS; improved provision of pharmacy and ophthalmic services; countering NHS fraud; and replacing the NHS Appointments Commission with a new body with a wider role. In addition the Bill contains changes relating to administration of the Social Care Bursary scheme; the audit of special health authorities; injury cost recovery in the NHS; and transfer of criminal liability in the NHS. OVERVIEW OF THE STRUCTURE OF THE BILL 5. The Bill is in 7 parts: [Bill 69-EN] 54/1 Part 1 6. Part 1 of the Bill includes provisions to make enclosed public places and workplaces smoke-free. This follows the publication of the White Paper, Choosing Health: Making healthy choices easier 1 in November 2004 which set out proposals to shift the balance significantly in favour of smoke-free environments. The Bill will also give the Secretary of State for Health the power to make regulations specifying places or specified areas within them that do not have to be smoke-free. These will include licensed premises as well as premises where a person has his home or is living either permanently or temporarily, for example: hotels, care homes and prisons, membership clubs and all licensed premises that do not prepare and serve food. 1 http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4094550&chk=aN5Cor7. This part of the Bill extends to England and Wales. Part 2 8. Part 2 of the Bill introduces new provisions which are concerned with the prevention and control of health care associated infections. The Bill gives the Secretary of State the power to issue a code of practice containing a range of actions to reduce the levels of health care associated infections in connection with health care that is provided or commissioned by the NHS. The NHS bodies to which the code applies, which may include any English NHS body (except Strategic Health Authorities) and any cross-border Special Health Authority ("cross-border SHA"), must observe it in discharging their duty of quality in health care under the Health and Social Care (Community Health and Standards) Act 2003 ("the 2003 Act"). 9. The Bill also places duties on the Commission for Healthcare Audit and Inspection ("the CHAI"), which is referred to in these notes as "the Healthcare Commission", to consider observance of the code when it carries out reviews and investigations of health care under Chapter 3 Part 2 of the 2003 Act. Where the code is not being observed, the provisions in the Bill gives the Healthcare Commission the power to serve an improvement notice, and places a duty on the Commission to report significant failings to the Secretary of State or the regulator of NHS foundation trusts ("the regulator") with a view to remedying the situation. 10. This Part of the Bill extends to England and Wales. Part 3 11. Part 3 of the Bill has two chapters: 12. Chapter 1 responds to recommendations in the Fourth Report of the Shipman Inquiry 2. It would enable a duty to be imposed on specified organisations in the health sector to appoint an Accountable Officer to ensure the safe use of controlled drugs within the organisation's sphere of responsibility. It also enables a duty to be imposed on specified organisations concerned with controlled drugs issues in the health sector to share information about controlled drug use by health and social care professionals and to agree joint action as needed. The provisions also create a right of entry and inspection into NHS hospitals, GP practices, community pharmacies and other organisations contracted to provide services to the NHS. 2 See http://www.the-shipman-inquiry.org.uk/. Government's response to the fourth report at http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4097904&chk=isA3Eo13. This part of the Bill extends to the whole of the United Kingdom. 14. Chapter 2 provides for the amendment of provisions of the Medicines Act 1968, and the Health Act 1999, relating to pharmacies, pharmacists and the sale and supply of medicines. In particular, it includes changes to the requirement in the Medicines Act 1968 for a pharmacist to be in personal control of the retail sale and supply of medicines at each retail pharmacy, and changes to the provisions of the Act relating to supervision by pharmacists of the preparation, dispensing, sale and supply of medicines. This part of the Bill extends to the entire UK. Part 4 15. Part 4 of the Bill has four chapters: 16. Chapter 1 makes changes to the National Health Service Act 1977 ("the 1977 Act") to enable charges to be levied on applications to provide NHS pharmaceutical services. The changes are in response to recommendations made in a report from The Office of Fair Trading (OFT) report: The control of entry regulations and retail pharmacy services in the UK published on 17 January 2003 3. These charges may either be determined by the Secretary of State or by Primary Care Trusts (PCTs) under directions from the Secretary of State. The Chapter also makes changes to enable PCTs to consider in their assessment of applications from pharmacists to provide NHS services, what improvements they would bring to local provision of, or access to, over-the counter medicines and other healthcare products. The Chapter also makes changes in relation to the requirement that a person who enters arrangements to provide pharmaceutical services must undertake that medicines are dispensed by, or under the supervision of a pharmacist. This part of the Bill extends to England and Wales. 3 http://www.oft.gov.uk/business/market+studies/pharmacies.htm17. Chapter 2 proposes changes to the 1977 Act which will remove current restrictions on who PCTs may contract with to provide general ophthalmic services. The changes will create a legal framework which is closer to that of other parts of primary care. The Bill is intended to strengthen the protection of public funds through improved controls over who may redeem optical vouchers. The provisions extend to England and Wales. They apply in England only. 18. Chapter 3 provides for a power to require the production of documents, records and data in connection with the appropriate national authority's NHS counter fraud or security management functions. This will give NHS counter fraud organisations the same powers as other regulators and auditing organisations. This measure is in response to the Department of Health consultation document entitled, Access to Relevant Documents, Records and Data to Counter NHS Fraud: A Paper for Consultation, launched in October 2004 4. The response to the consultation was published on 27 May 2005. The provisions extend to England and Wales. 4 see consultation document and summary of responses at: http://www.dh.gov.uk/Consultations/ResponsesToConsultations/ResponsesToConsultationsDocumentSummary/fs/en?CONTENT_ID=4112148&chk=T68WA519. Chapter 4 makes provision for the auditing of the accounts of certain NHS bodies in England and Wales. Part 5 20. Part 5 of the Bill covers provisions to replace the NHS Appointments Commission with a new organisation called the Appointments Commission. This is in line with the Government's response to the Public Administration Select Committee (June 2003) 5, which indicated that some Departments could benefit from using the services of the NHS Appointments Commission to support their sponsor teams in making appointments but that statutory authority would be needed to achieve this. The Bill will establish the Appointments Commission as a Non-Departmental Public Body and give it powers to exercise, if directed to do so, the appointment functions of the Secretary of State for Health and the Privy Council in relation to the appointment of chairmen and non executive members to NHS and other health and social care bodies and health professional regulatory bodies and certain appointment powers of the National Assembly for Wales. The Appointments Commission may also assist, if requested to do so, the Boards of NHS Foundation Trusts with their similar powers of appointment and also assist, if requested to do so English ministers with their similar powers of appointment to other public bodies 5 http://www.publications.parliament.uk/pa/cm200203/cmselect/cmpubadm/165/16502.htmPart 6 21. Part 6 of the Bill makes changes in three areas:
Part 7 22. Part 7 of the Bill deals with various matters of general application, including provisions relating to orders and regulations, interpretation, commencement and extent. TERRITORIAL EXTENT 23. The territorial extent of the Bill is set out in the summaries of each provision. The table below summarises this information.
TERRITORIAL APPLICATION: WALES 24. There are two provisions that affect Wales differently. 25. The Protection of NHS from Fraud and other Unlawful Activities clauses in Part 4 Chapter 3 provide for powers to require the production of documents for counter fraud and security management purposes. The powers provided for counter fraud purposes are given to the Secretary of State and the National Assembly for Wales. The powers for security management purposes are limited to the Secretary of State and are not provided for the National Assembly for Wales. 26. The Appointments Commission clauses in Part 5 of the Bill provide for the Secretary of State to direct the Appointments Commission to exercise his appointments functions that are exercisable jointly or concurrently with the National Assembly for Wales after consultation with the Assembly. Other provisions enable the National Assembly for Wales to direct the Appointments Commission to exercise its appointments functions relating to the appointment of members to the Healthcare Commission and the Health Protection Agency and provides for the Assembly to make payments to the Commission in respect of the appointments functions it is directed to undertake. COMMENTARY ON CLAUSES PART 1 SMOKE-FREE WORKPLACES 27. Part 1 of the Bill contains provisions that will make the vast majority of enclosed places to which the public have access and enclosed workplaces smoke-free. The White Paper, Choosing Health: Making healthy choices easier published in November 2004 sets out proposals that will shift the balance significantly in favour of smoke-free environments, and in June 2005, a consultation document put forward further details on the policy outlined in the White Paper. The proposals would make over 99% of enclosed public places and workplaces smoke-free. 28. The Bill will ensure that all enclosed public places and workplaces (other than for example membership clubs, all licensed premises that do not prepare and serve food and a limited number of other exempt premises - predominantly places occupied as residential premises or as living accommodation) will be smoke-free. 29. It is proposed to implement these provisions so as to ban smoking in all enclosed public places and workplaces, (apart from the above exemptions), from Summer 2007. 30. The provisions extend to England and Wales. Clause 1: Introduction 31. Clause 1, subsection (1), explains that Part 1 contains prohibitions on smoking in certain premises, places and vehicles. Subsection (2) defines "smoking" for Part 1. The definition covers being in possession of tobacco, substances that include tobacco or other substances which are alight. Clause 2: Smoke-free premises 32. Clause 2 makes provision for enclosed or substantially enclosed premises to be smoke-free. By subsection (1) all premises to which the public have access will be smoke-free unless specifically exempted by regulations under Clause 3. However, private premises, for example, stately homes which are open to the public for one day a year and are not a person's workplace, will only need to be smoke-free for the period when the public may be present. This only applies where they are not a workplace. 33. Subsection (2) sets out that premises used as a place of work by more than one person, irrespective of whether they work there at the same time, and premises where members of the public go to give or receive goods or a service, including for example a solicitor's office or a dressmaker's shop, will be smoke-free at all times. 34. Subsection (3) covers cases of premises which are, for example, someone's home as well as their workplace. When members of the public come to them to give or receive goods or a service, only the parts of the premises, which are used for work purposes, will be smoke-free. Those parts might include the waiting room and the area in which they receive the service. 35. Clause 2 applies only to premises, which are enclosed or substantially enclosed (subsection (4)) and the appropriate national authority will be able to specify in regulations what enclosed and substantially enclosed means (subsection (5)). By clause 75(1) the appropriate national authority in relation to England is the Secretary of State and in relation to Wales is the National Assembly for Wales. Subsection (6) is a reference to exemptions that may be made by regulations under clause 3. For example, an exemption may apply to premises where designated smoking rooms will be allowed, such as in residential care homes and psychiatric hospitals and units. 36. Subsection (7) provides that premises are open to the public if a section of the public has access to them. It includes premises to which a section of the public has free access and premises to which a section of the public has access on the payment of a fee. The word "work" also constitutes voluntary work (subsection (8)), so even if a village hall was being used to hold an event, which required volunteers, such as a scout meeting, it would still have to be smoke-free. The hall would be both a workplace and a public place. Clause 3: Exemptions 37. Clause 3 enables regulations to be made which specify the premises in which smoking will be permitted. 38. Subsection (2) gives examples of the type of exempted premises currently envisaged. These include premises which act as an individual's dwelling or are clearly private space, whether this is on a permanent or temporary basis. This would include bedrooms in a hotel, bed and breakfast or hostel, which are designated for the use of a particular person or groups of persons by the proprietor. In premises such as prisons and care homes, which are a person's full time place of residence for an extended period, designated smoking rooms/areas may be allowed as it may be impossible for smoking to take place outside for either safety or health reasons. 39. Also included in exemptions in the examples are membership clubs and licensed premises. 40. The power in subsection (3) enables regulations to provide that premises may in certain circumstances or at specified times be smoke-free and that in other circumstances or at other times smoking may be permitted. Subsection (4) makes provision for the regulations to contain conditions. Paragraph (a) applies to the conditions that may be made for licensed premises, such as public houses. In such premises the conditions may include restrictions on what may be sold, offered for consumption or consumed there. These restrictions are intended, for example, to restrict the food that may be prepared and served. Paragraph (b) applies to all premises. It enables the regulations to provide for the designation of smoking areas by proprietors. Clause 4: Additional smoke-free places 41. Clause 4 enables regulations to be made that designate additional smoke-free places. These will be places which are not covered by Clause 2. However, they will be places/areas where the appropriate national authority consider that there is risk of harm from second-hand smoke due to, for example, the inevitable close grouping of people (subsection (3)). Examples might be sports stadia and other outdoor areas such as entrances or exits to public buildings or workplaces, as well as bus shelters. The regulations will provide details of the circumstances in which such places will be smoke-free. Clause 5: Vehicles 42. Clause 5 covers vehicles, vessels, aircraft, and other means of transport. It enables regulations to be made to provide smoke-free business and public transport. The regulations will set out all the descriptions of the vehicles that are to be smoke-free and the circumstances and specified areas in which they are to be smoke-free. The regulations may also exempt classes of vehicles, such as private vehicles. Clause 6: No-smoking signs 43. Clause 6 creates a duty to display no-smoking signs and sets out whose duty it is, as well as the signage requirements, the offence provision and the defences, which may apply. 44. No-smoking signs will designate smoke-free areas and vehicles etc. Subsection (1) states that it is the duty of the person who occupies or is concerned in the management of smoke-free premises to make sure that the no-smoking signs are displayed that conform to the requirements as set out in regulations. There is also power to make requirements for the signs that must be displayed in the additional smoke-free premises mentioned in Clause 4, and smoke-free vehicles mentioned in Clause 5 (subsection (2)). The regulations will set out how and where the signs are to be displayed. For example, they may allow special provision to be made in relation to the display of signage in listed buildings (subsection (3)). Subsection (4) states that regulations will specify the content, size, design, colour or wording of the signs. For example, it may be appropriate to have smaller signs in motor cars than in buildings or different language requirements in England and Wales. 45. By subsection (5) anyone who occupies or who is concerned in the management of smoke-free premises who does not comply with the requirements for no-smoking signs, as set out in regulations, will be guilty of an offence. Subsection (6) goes on to explain that there is however a defence which may arise where a defendant produces evidence to show that he or she was not aware, and could not reasonably be expected to have been aware, that the premises were smoke-free. This defence would be relevant where there is a dispute about the extent to which premises are enclosed. There is also a defence where the defendant produces evidence to show that he or she was not aware, and could not reasonably be expected to have been aware, that signs complying with requirements had not been displayed. For example, this defence may be relevant where vandals have removed signs. Finally, there is a defence where on other grounds it was reasonable for a defendant not to comply with the duty in subsection (1). For example, this defence might apply to a period which begins when a defendant becomes aware that a required sign has been removed by vandals and ends when he has had a reasonable period in which to display a replacement sign. 46. By subsection (7), where a defendant wishes to rely on any of these defences, he or she must provide evidence that supports the defence on which they wish to rely. Where a defendant does that, the defence should be taken to be proved unless the prosecution establishes beyond reasonable doubt that the defence does not apply. For example, a defendant might call evidence to show that a sign had been defaced as a basis for relying on the defence in subsection (6)(b) but the prosecution may establish that even before the sign was defaced it did not comply with the requirements as set out in regulations. Clause 7: Offence of smoking in smoke-free place 47. Clause 7 sets out the offence of smoking in a smoke-free place. Smoke-free places comprise enclosed or substantially enclosed premises covered in Clause 2, additional smoke-free places covered in Clause 4, and vehicles etc covered in Clause 5. 48. By subsection (2), a person who smokes in any of these places may be guilty of an offence. 49. Subsection (3) sets out that it is a defence for a person charged with smoking in a no-smoking area to show that he or she was not aware, and could not have reasonably been expected to have been aware, that the place was smoke-free. For example, this defence may arise where no-smoking signs have been removed or are obscured. 50. Where a defendant who is charged with smoking in smoke-free premises wishes to rely on that defence, he or she must provide evidence that supports it. (subsection (4)). A person who is found guilty under this Clause will be liable to a fine as specified in regulations (subsection (5)). Clause 8: Fixed penalties for offence of smoking in smoke-free place 51. A person who smokes in smoke-free premises, an additional smoke-free place or a vehicle may be given a penalty notice by an authorised officer of an enforcement authority who believes that the smoker has contravened clause 7 in his area. If the person pays the penalty, he will not be prosecuted for an offence. Schedule 1 contains the fixed penalty provisions.
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