Clause 9:     Offence of failing to prevent smoking in smoke-free place

52.     Any person who controls or is concerned in the management of smoke-free premises (and designated persons in relation to additional smoke-free places, vehicles etc) has a duty to prevent smoking in the premises. They may be guilty of an offence if they fail to comply with that duty.

53.     Subsection (4) sets out that it is a defence to the offence for a defendant to show that he or she

a.     took reasonable steps to stop a person smoking in a smoke-free area, such as requesting a person to stop smoking and taking steps to have the smoker evicted;

b.     did not know, and could not reasonably be expected to know, that the contravention was occurring, such as where a person is given false information by his employees; or

c.     has other grounds that show that it was reasonable for him or her not to comply with the duty, for example during a period when priority had to be given priority to some other legal duty, such as preventing disorderly conduct.

54.     Subsection (5), provides that where a defendant wishes to rely on that, defence, he or she must provide evidence that supports it. A person who is found guilty under this Clause will be liable to a fine as specified in regulations (subsection (6)).

Clause 10:     Enforcement

55.     The enforcement authorities will be designated by the Secretary of State for England and by the National Assembly for Wales for Wales (subsection (1)). Regulations will set out descriptions of places where an enforcement authority has enforcement functions and provision will be made for the transfer of investigations and prosecutions between designated enforcement bodies (subsection (2)). The enforcement authority has a duty to enforce all of the smoke-free provisions in the areas in which they have enforcement functions as set out in regulations (subsection (3)). The Secretary of State in relation to England and the National Assembly for Wales in relation to Wales may exercise enforcement functions themselves (subsection 4). Provision is made for the authorisation of officers by enforcement authorities (subsection (5)) and for regulations to provide for the qualifications which authorised officers must possess (subsection (6)). Subsection (7) introduces Schedule 2 which makes provision in relation to powers of entry, etc

Schedule 2

Covers powers of entry for enforcement. The Schedule sets out the powers of an officer who has been authorised by an enforcement authority. He/she may enter premises (other than premises used as a private dwelling), require and take possession of substances, and request information. The provision is also made for a justice of the peace to issue warrants where admission is likely to be refused etc.

56.     It is intended that regulations made under subsection (1) will provide that local authorities will be enforcement authorities. It is thought that the enforcement officers of those authorities are likely to be environmental health officers. In addition the power in subsection (1) may be exercised so that health and safety officials can act as enforcement officers in specified situations. It may be that the areas of two enforcement bodies overlap (e.g. Local Authority and Health and Safety Executive).

Clause 11:     Obstruction etc of officers

57.     Clause 11 sets out the offence which may be committed where an authorised officer of an enforcement authority is obstructed and related provisions. The offence may be committed, for example, where a person fails to give assistance or information to the authorised officer in order for him or her to carry out the functions of his job, or where a person knowingly or recklessly gives false or misleading information. A person who obstructs an authorised officer may be liable on summary conviction to a fine not exceeding level 3 on the standard scale, as set out in regulations. The same provisions would apply to the obstruction of an enforcement officer who is acting on behalf of the Secretary of State or the National Assembly for Wales, if they take over enforcement functions.

Clause 12:     Interpretation and territorial sea

58.     Subsection (1) contains definitions that apply to Part 1, other than the definition of "smoking" which is in Clause 1. Subsection (2) enables the definition of premises in subsection (1) to be amended as regards offshore installations. This is needed because the reference to offshore installations in the definition of premises is to a set of regulations that might be amended or revoked. Subsections (3) and (4) provide that Part 1 has effect in relation to the territorial sea which is adjacent to England and Wales.

PART 2

PREVENTION AND CONTROL OF HEALTH CARE ASSOCIATED INFECTIONS

Clause 13: Code of practice relating to health care associated infections

59.     This clause inserts three new sections into Part 2 of the 2003 Act.

60.     The first is new section 47A (code of practice relating to health care associated infections). This gives the Secretary of State the power to issue a code of practice ("the code") on the prevention and control of health care associated infections. The code will set out the measures which he considers are an important part of best practice in reducing those infections which are related to health care that is provided by, or commissioned for, the NHS bodies to which the code applies.

61.     Health care associated infections are defined in subsection (8). A health care associated infection is any infection to which an individual may be exposed where the risk of exposure is directly or indirectly attributable to the provision of the health care. The individual who may be at risk does not have to be the individual receiving the health care.

62.     "Health care" has the same meaning as in section 45(2) of the 2003 Act. It means services provided to individuals for or in connection with the prevention, diagnosis or treatment of illness and the promotion and protection of public health.

63.     The code may be applied to all English NHS bodies (other than Strategic Health Authorities) and to cross-border SHAs (subsection (2)). These bodies are defined in section 148 of the 2003 Act. English NHS bodies include an NHS trust all or most of whose hospitals, establishments and facilities are situated in England, an NHS foundation trust and a Primary Care Trust ("PCT"). The code may specify which of its provisions apply to which bodies, and it may do so by description or by naming them (subsection (3)).

64.     Subsection (4)(a) makes it clear that the code may include measures designed to protect people who are not themselves receiving health care, but who may nonetheless be at risk from health care associated infections, such as staff and visitors. Subsection (4)(b) makes it clear that the code may place obligations on those NHS bodies to which the code applies in connection with the health care that they commission.

65.     It is envisaged that the provisions of the code will need to operate by reference to the content of other documents, whether published by the Secretary of State or other relevant sources. Subsection (5) allows the code to incorporate other documents (in whole or part), and to take effect by reference to a document as revised from time to time. Where the code refers to a document in this way, the code will be automatically changed each time the document that it refers to is revised.

66.     The code may make different provision for different cases or circumstances (subsection (5)(c)). This allows the code to reflect the fact that NHS bodies have different functions.

67.     The Secretary of State must keep the code under review, and may revise all or any part of it (subsection (7)).

68.     Clause 13 also inserts new section 47B (consultation etc.) into the 2003 Act.

69.     Subsections (1) and (2) of the new section 47B provide that where the Secretary of State proposes to issue a code or to issue a revised code which he thinks would result in a substantial change in the code, he must prepare a draft of it and consult such persons as he thinks appropriate about the draft.

70.     Subsections (4) and (5) are concerned with a situation where any provision of the code operates by reference to another document as revised from time to time. Before the Secretary of State revises any document published by him in relation to his health functions, he must consult appropriate persons about any change which would, in his view, lead to a substantial change in the code (subsection (4)). In the case of revisions to other such documents, where the Secretary of State thinks that the code has been substantially altered as a consequence, subsection (5) places a duty on him to consult appropriate persons about whether the code should be revised.

71.     Subsection (6) allows for the consultation for the purposes of this section to take place before the Act is passed.

72.     Lastly, clause 13 also inserts new section 47C (effect of code under section 47A). It places a duty on those NHS bodies to which provisions of the code apply to observe them in discharging their duty of quality under section 45 of the 2003 Act (subsection (1)). Section 45 places a duty on each NHS body to ensure that appropriate arrangements are in place with a view to monitoring and improving the quality of health care that they provide or commission.

73.     A failure to observe any provision of the code does not, of itself, make a person liable to criminal or civil proceedings, but the code is admissible in evidence in such proceedings, for example in a negligence action (subsections (2) and (3)).

Clause 14: Code of practice: effects on existing functions of Commission for Healthcare Audit and Inspection

74.     This clause amends the 2003 Act to provide for new functions of the Healthcare Commission in relation to the code.

75.     Subsection (2) amends section 50 of the 2003 Act (annual reviews) so that the Healthcare Commission must take the code into account when it conducts an annual review of health care under this section. It places a duty on the Healthcare Commission to consider the extent (if any) to which a body is observing any provisions of the code that apply to it.

76.     The Healthcare Commission also has the function of conducting reviews of NHS health care across England and Wales under section 51 of the 2003 Act (reviews: England and Wales). Subsection (3) amends section 51(4)(a) so that the Healthcare Commission must also take account of the code when reviewing health care provided by or for an English NHS body or cross-border SHA in the context of a review under this section.

77.     This clause also amends section 52 of the 2003 Act (reviews and investigations: England) so that the Healthcare Commission must take the code into account when conducting a review or investigation under this section (subsection (5)). Subsection (5A) provides that when the Healthcare Commission undertakes a review of the arrangements made by a particular English NHS body or cross-border SHA for the purpose of discharging their duty of quality in health care, the Healthcare Commission must consider the extent (if any) to which the body in question is observing any applicable provisions of the code (see section 52(3) of the 2003 Act (as amended by subsection (4)).

78.     Subsection (6) amends section 54(2) of the 2003 Act so that it refers to the code and allows for the Healthcare Commission to give advice to the Secretary of State on changes that it thinks should be made to the code in order to secure improvements in the quality of NHS health care.

Clause 15: Code of practice: improvement notices

79.     This clause inserts two further new sections, sections 53A (failings in connection with code under Section 47A: improvement notices) and 53B (code of practice: action by the Healthcare Commission following service of an improvement notice), into the 2003 Act.

80.     New section 53A(1) gives the Healthcare Commission the power to serve an improvement notice in relation to the code. The power applies where, following a review or investigation (as the case may be) under section 50, 51 or 52 of the 2003 Act, the Healthcare Commission is of the view that any provisions of the code applying to an English NHS body or a cross-border SHA are not being observed in any material respect in relation to the provision of health care by or for that body.

81.     The Healthcare Commission may issue an improvement notice where it considers that this is the most appropriate course for it to take with a view to securing that the failure in question is remedied (subsection (2)).

82.     It is considered that a failure to observe the code in any material respect would include any failure to observe the code that, in the Healthcare Commission's view, could compromise the body's ability to ensure health care associated infections are appropriately tackled.

83.     However, the Healthcare Commission may only issue a notice if, having regard to all the circumstances, it is not required to make a report to the Secretary of State under section 53(2) of the 2003 Act and to the regulator under section 53(6), where the body in question is an NHS foundation trust (subsection (1)(b)).

84.     Section 53 of the 2003 Act (failings) requires the Healthcare Commission to make such a report where it is of the view that there are significant failings in relation to the provision of health care by or for an English NHS body or cross-border SHA, in the running of such a body, or in the running of any body or the practice of any individual providing health care for an English NHS body or cross-border SHA. Such a report may include a recommendation that the recipient take special measures with a view to remedying the failing in question (see below). It is considered that significant failings related to the code could be the subject of reporting under this section.

85.     A significant failing is not defined in the 2003 Act. It is considered that a significant failing is one that, in the view of the Healthcare Commission, is serious enough to be drawn to the immediate attention of the Secretary of State or the regulator with a view to a decision being taken about whether special measures are required. Whether the failing is significant is a mixed question of fact and law. It is considered that the Healthcare Commission's decision would be informed by its overall conclusions following the review or investigation. This could include an assessment of (amongst other things) any action that the NHS body is taking to resolve the issue, the nature of and reason for the failure, and any impact on the health care provided by or for the body. It is considered that significant failings could, therefore, include (but are not limited to) a failure related to the provision of health care or the running of the body that endangers the lives of patients or the viability of the body.

86.     Special measures are not defined in the 2003 Act, but they may include practical assistance or organisational support. For example, the Secretary of State could invite a Director of Infection Prevention and Control from another NHS Trust to act as an advisor to an NHS Trust who require advice on how to implement the code.

87.     A report under section 53 may lead to intervention in relation to the NHS body by the Secretary of State using his direction-making or intervention powers under the 1977 Act (c. 49) or by the regulator under section 23 of the 2003 Act (significant failings) in the case of an NHS foundation trust. For example, if an NHS foundation trust or an NHS trust proved unable to provide adequate training on infection control for its existing staff, it could be required to take particular measures to put adequate training in place.

88.     Subsection (3) sets out what the Healthcare Commission must include in an improvement notice. In particular, the notice must specify the period by which the body in question must remedy the failure. The notice may also (but need not) include a recommendation by the Healthcare Commission about how the failure should be remedied (subsection 4)). This would be advisory only, but the body would be expected to take the Healthcare Commission's views into account. More than one failure to observe the code may be included in a single notice, in which case the Healthcare Commission may specify different periods for compliance for different failures (subsection 5)), and may make several recommendations in a single notice.

89.     Where the Healthcare Commission serves an improvement notice, it must notify the Secretary of State, the regulator, in the case of a NHS foundation trust, and any relevant Strategic Health Authority, in the case of a NHS trust or PCT (subsection (6)). The "relevant Strategic Health Authority" is defined in subsection (7).

90.     Subsections (8) and (9) prohibit the Healthcare Commission from responding to any failure by the body to comply with an improvement notice served on it by serving another improvement notice concerning the same failure, but allows the Healthcare Commission to serve another notice where, on reviewing compliance with the notice, it identifies a different failure to observe the code.

91.     New section 53B is concerned with the action by the Healthcare Commission after it has served an improvement notice on an NHS body.

92.     Subsection (2) provides that the Healthcare Commission may, at the request of the body in question and by notice, extend the length of time that the body has been given to rectify the non-observance of the code specified in the improvement notice. Time can only be extended where the Healthcare Commission believe that this is justified by exceptional circumstances. The length of time may be extended more than once as long as the conditions in subsection (2) are met on each occasion.

93.     Subsection (4) places a duty on the Healthcare Commission to undertake a review into whether the body has complied with the improvement notice. That review will be carried out under section 52(3) of the 2003 Act. The review will take place at the end of the period specified in the improvement notice unless the body informs the Healthcare Commission that it has complied with the improvement notice before this time, in which case it can take place sooner.

94.     Having conducted the review, the Healthcare Commission must then report to the Secretary of State and to the regulator if the body is a NHS foundation trust in accordance with subsection (5) or (6).

95.     If the Healthcare Commission remains of the view that the body is not observing the code in material respects and, having regard to all the circumstances, considers that it must report to the Secretary of State or the regulator under section 53 of the 2003 Act at this stage, then subsection (5) makes it clear that the Healthcare Commission must make such a report. In deciding whether to make such a report, the Healthcare Commission must take the overall situation into account. This would include the fact of, and the reasons for, the body's failure to comply with the improvement notice, and any effect on the quality and effectiveness of the health care.

96.     Where the Healthcare Commission does not report significant failings as described above, then it must report to the Secretary of State and to the regulator (as the case may be) setting out particular matters. Those matters are specified in subsections (7) and (8).

97.     If the Healthcare Commission considers that the body has complied with the improvement notice and is observing the provisions of the code which resulted in the notice being served, then the Healthcare Commission must state this fact and give its reasons for this view (subsection (7)). If, however, the Healthcare Commission continues to believe that the body is not observing those provisions, subsection (8) provides that the Healthcare Commission's report must set out:-

98.     Subsection (9) provides that the Healthcare Commission must send a copy of any report to the relevant Strategic Health Authority, as defined in new section 53(A)(7) where the body in question is a PCT or a NHS Trust.

PART 3

PART 3 CHAPTER 1

SUPERVISION OF MANAGEMENT AND USE OF CONTROLLED DRUGS

99.     Part 3 of the Bill contains provisions intended to strengthen the arrangements for the safe management of controlled drugs in healthcare settings. It provides the legislative underpinning to the programme of action set out in Safer management of controlled drugs, the government's response to the Fourth Report of the Shipman Inquiry. The key elements are:

100.     The relevant authority regarding the regulation making powers within this chapter are the Secretary of State in respect of England and Scotland, the National Assembly for Wales in respect of Wales and the Department of Health, Social Services and Public Safety in respect of Northern Ireland.

Clause 16:     Accountable officers and their responsibilities as to controlled drugs

101.     Clause 16 allows the relevant authority by regulations to determine the organisations which are to be required to appoint an accountable officer, the functions of the accountable officer, and the criteria to be satisfied in making appointments. The intention is that all NHS hospital trusts and primary care trusts, and the larger private sector healthcare organisations such as independent hospitals, should appoint accountable officers.

102.     Subsection (1) sets out the general power to make regulations under which certain organisations ("designated bodies") are required to appoint accountable officers with specified responsibilities. The responsibilities are to relate to the management and use of controlled drugs in connection with activities carried on by or on behalf of the organisation (eg a hospital trust) or by third parties under arrangements with the organisation (eg a primary care trust). Subsection (2) introduces the term "accountable officer". Subsections (3) and (4) define more closely the types of organisations which may be required to appoint an accountable officer, ie those which are directly or indirectly involved in providing healthcare or other activities which may involve the supply or administration of a controlled drug. Subsections (5) and (6) give examples of the detailed requirements which may be laid down in regulations, including criteria for appointment, funding, the requirement to follow best practice guidance, and responsibilities of the accountable officer. The regulations may also create offences or other procedures for enforcing any provisions of the regulations. Subsections (7) and (8) ensure that requirements set out in regulations can have application to a wide variety of settings in which controlled drugs may be supplied or administered, including care provided by third parties under contract to a designated body (eg a primary care trust). Subsection (10) allows regulations to cover issues not listed in (5) or (6).

Clause 17:     Co-operation between health bodies and other organisations

103.     Clause 17 allows the relevant authority to make regulations to require organisations described in the regulations to co-operate, by sharing intelligence and coordinating action, in order to ensure the safe management of controlled drugs and to safeguard patients from harm. The intention is that the duty to cooperate would be applied to all bodies required to appoint an accountable officer under clause 16, to police forces, to social care authorities, and to regulatory bodies with inspection rights such as the Royal Pharmaceutical Society of Great Britain, the Healthcare Commission and the Commission for Social Care Inspection.

104.     Subsection (1) sets out the power to make regulations for requiring organisations described in the regulations to co-operate and describes in broad terms the areas to be covered by the duty of co-operation. Subsections (2) to (4) specify the types of body to which the duty would apply eg. bodies that are concerned with the provision of healthcare, or carry on activities that involve the supply or administration of controlled drugs. Subsections (5) to (7) give examples of the requirements as to co-operation that may be included in the regulations, including the circumstances in which the duty to disclose information to other organisations could be triggered (subsection (5)(a)) and imposing duties on the accountable officer of the bodies concerned to make recommendations for action (subsection (6)) including recommendations relating to disciplinary action (subsection (7)).