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Arrangement of Clauses (Contents)
These notes refer to the Health Bill as brought from the House of Commons on 15th February 2006 [HL Bill 76]
1. These explanatory notes relate to the Health Bill as brought from the House of Commons on 15th February 2006. 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; power to amend the minimum age of sale of tobacco; 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authorities; injury cost recovery in the NHS; transfer of criminal liability in the NHS; and provisions to remove out-of-date references to Welsh health authorities.
OVERVIEW OF THE STRUCTURE OF THE BILL
5. The Bill is in 7 parts:
6. Chapter 1 of 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 premises where a person has his home or is living either permanently or temporarily, for example: hotels, long-term adult care homes and prisons.
7. Chapter 2 of Part 1 of the Bill contains provisions to give the Secretary of State a power to change the minimum age of sale of tobacco products through secondary legislation. The Bill specifies that the minimum age of sale of tobacco products may not be lower than 16 years.
8. This part of the Bill extends to England and Wales except for the smoke-free provisions for ships which extend to the UK.
9. 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").
10. 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 give 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.
11. This Part of the Bill extends to England and Wales.
12. Part 3 of the Bill has two chapters:
13. 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=isA3Eo
14. This part of the Bill extends to the whole of the United Kingdom.
15. 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.
16. Part 4 of the Bill has four chapters:
17. 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 17th 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. In the case of Wales, the charges may be determined by the National Assembly for Wales or by Local Health Boards under directions from the Assembly. 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 and also, as respects certain arrangements relating to dispensing medicines, to Scotland.
18. 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.
19. 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 27th 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=T68WA5
20. Chapter 4 makes provision for the auditing of the accounts of certain NHS bodies in England and Wales.
21. 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
22. Part 6 of the Bill makes changes in four areas:
23. Part 7 of the Bill deals with various matters of general application, including provisions relating to orders and regulations, interpretation, commencement and extent.
24. The territorial extent of the Bill is set out in the summaries of each provision. The table below summarises this information
TERRITORIAL APPLICATION: WALES
25. There are two provisions that affect Wales differently.
26. 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.
27. 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 - SMOKING
CHAPTER 1 - SMOKE-FREE PREMISES, PLACES AND VEHICLES
28. 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.
29. The Bill will ensure that all enclosed public places and workplaces (other than a limited number of exempt premises which will be exempted in regulations made under clause 3 of the Bill) will be smoke-free.
30. It is proposed to implement smoke-free legislation in all enclosed and substantially enclosed public places and workplaces (apart from exempted premises) from Summer 2007.
31. Chapter 2 of Part 1 of the Bill contains provisions to give the Secretary of State a power to change the minimum age of sale of tobacco products through secondary legislation. The Bill specifies that the minimum age of sale of tobacco products may not be lower than 16 years. The Government has announced plans to launch a public consultation on the age of sale of tobacco products in the near future
32. The provisions extend to England and Wales, with the exception of ships covered under the Merchant Shipping Act 1995, where amendments to that enactment made by this Bill will extend throughout the United Kingdom.
Clause 1: Introduction
33. Clause 1, subsection (1), explains that Part 1 Chapter 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 that are alight and in a form that could be smoked.
Clause 2: Smoke-free premises
34. 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. In the case of private premises, that are open to the public for one day a year and are not a person's workplace, for example stately homes, the premises will only need to be smoke-free for the period when members of the public may be present. However, such arrangements would only apply where a premises is not also a workplace.
35. Subsection (2) sets out that premises used as a place of work by more than one person, irrespective of whether the persons 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.
36. Subsection (3) covers cases of premises that are only in part open to the public or used as a workplace, for example, someone's home that in part includes a workplace. In such circumstances only the parts of the premises that are used for work purposes will be smoke-free. These parts might include, for example, a waiting room or an area where people receive goods or services.
37. Clause 2 applies only to premises that are enclosed or substantially enclosed as set out in subsection (4) and the appropriate national authority will be able to specify in regulations what enclosed and substantially enclosed means (subsection (5)). By clause 81(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) states that exemptions from smoke-free provisions may be made in regulations made under clause 3.
38. 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 or premises to which a section of the public has access, including on the payment of a fee. The word "work" in subsection (2) 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 be required to be smoke-free. The hall would, therefore, be smoke-free by virtue of being both a workplace and a public place.
Clause 3: Smoke-free premises: exemptions
39. Clause 3 enables regulations to be made by the appropriate national authority that specify the premises to where smoke-free provisions of the Bill will not extend.
40. Subsection (2) gives examples of the type of exempted premises currently envisaged. They are 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 long-term adult 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 safety, health or practical reasons.
41. Subsection (3) specifically excludes licensed premises operating under a premises license (including hotels, pubs, bars, discos and nightclubs) and premises operating under a club premises certificate, both as specified in the licensing Act 2003, from being provided with an exemption under Clause 3, meaning that the public and work areas of these premises will be required to be smoke-free. However, subsection (4) allows for exemptions to be made in parts of licensed premises that are considered to be an individual's dwelling or are clearly private space, whether this is on a permanent or temporary basis. Such an arrangement will ensure that a hotel room which is located within a licensed premises ie, so a mini-bar service could be provided) can still be exempted from smoke-free provisions.
42. The power in subsection (5) enables regulations to provide that exempted premises may, in certain circumstances or at certain times, allow smoking to take place. Subsection (6) enables the regulations to provide for the designation of smoking areas within a premises by proprietors.
Clause 4: Additional smoke-free places
43. Clause 4 enables regulations to be made that designate additional smoke-free places. These will be places that are not covered by Clause 2. However, they will be places or 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 of such places might include, if need be, sports stadia and other outdoor areas, such as public transport facilities that are not covered within clause 2, or entrances or exits to public buildings or workplaces if need be.
Clause 5: Vehicles
44. Clause 5 covers vehicles, vessels, aircraft, and other means of transport, and the clause enables regulations to be made for vehicles to be smoke-free. Regulations will make provision for the description of vehicles to be smoke-free, the circumstances in which they will be smoke-free (including limitations to specified areas of the vehicle only, where necessary) and any exemptions from these provisions. Regulations made under this section would ensure that vehicles that are used for work purposes or are available for public transportation, are covered by smoke-free provisions in a fashion that is equivalent to those made for premises. Meanwhile, regulations may exempt certain classes of vehicles, such as private vehicles.
45. Clause 5 is intended to cover vehicles, trains, aircraft, vessels, hovercraft and other means of transport. However, under subsections (3) and (4), the power to make regulations under this section are not exercisable in relation to ships or hovercraft that are specified under the Merchant Shipping Act 1995 or the Hovercraft Act 1968. Smoke-free provisions with respect to these craft will be exercisable under section 85 of the Merchant Shipping Act 1995, including the appointment by the Secretary of State (as specified under the Merchant Shipping Act 1995) of persons to enforce smoke-free provisions in a manner corresponding to arrangements provided for under clause 10 of the Bill.
Clause 6: No-smoking signs
46. Clause 6 creates a duty on any person who occupies, or is concerned in the management of smoke-free premises (and designated persons or descriptions of persons to be specified in regulations in relation to additional smoke-free places and vehicles), to display no-smoking signage in a way that complies with requirements set out in the Bill. The clause also sets out requirements for the display of actual signs together with the offences that might apply for non-compliance.
47. No-smoking signs will designate the areas of premises, places and vehicles that are smoke-free. 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 that 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) provides for regulations to specify requirements of signage, for example, requirements surrounding the content, size, design, colour and wording. For example, it may be appropriate to have smaller signs in vehicles than in premises, and signage might be required in different languages.
48. 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 that 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, for example, 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 that 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.
49. 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. A person who is found guilty under this Clause will be liable to a fine up to a level as specified in regulations (subsection (8)).
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