2006 Chapter 28

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These notes refer to the Health Act 2006 (c.28) which received Royal Assent on 19 July 2006

HEALTH ACT 2006

EXPLANATORY NOTES

INTRODUCTION

1.     These explanatory notes relate to the Health Act 2006 which received Royal Assent on 19 July 2006. They have been prepared by the Department of Health in order to assist the reader in understanding the Act. They do not form part of the Act and have not been endorsed by Parliament.

2.     The notes need to be read in conjunction with the Act. They are not, and are not meant to be, a comprehensive description of the Act. So where a section or part of a section does not seem to require any explanation or comment, none is given.

3.     Different parts of the Act apply to different territorial areas. The application of each is set out in the paragraphs below.

SUMMARY AND BACKGROUND

4.     The Act makes a number of changes intended to protect the health of the public and to improve the running of the NHS. The Act 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; 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 Act contains changes relating to administration of the Social Care Bursary scheme; the audit of special health authorities; injury cost recovery in the NHS; the transfer of the criminal liabilities of NHS bodies; and provisions to remove out-of-date references to Welsh health authorities.

OVERVIEW OF THE STRUCTURE OF THE ACT

5.     The Act is in 7 parts:

Part 1

6.     Chapter 1 of Part 1 of the Act makes provision for enclosed and substantially enclosed public places and shared workplaces to be smoke-free. This follows the publication of the White Paper, Choosing Health: Making healthy choices easier ¹ in November 2004 which set out the Government's proposals to shift the balance significantly in favour of smoke-free environments. The Act will also give the appropriate national authority (Secretary of State in the case of England and the National Assembly for Wales in the case of Wales) powers to make regulations to exempt premises or parts of premises from smoke-free legislation, although, in general, no exemptions can be made for premises operating under a premises licence or club premises certificate (as specified in the Licensing Act 2003). The Act also provides powers for the appropriate national authority to make regulations to specify additional places as smoke-free and to require specified types of vehicles to be smoke-free.

¹ http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4094550&chk=aN5Cor

7.     Chapter 2 of Part 1 of the Act provides power for the Secretary of State to change the minimum age of sale of tobacco products through secondary legislation. The Act provides that the age specified under such secondary legislation may not be lower than 16 years or higher than 18 years.

8.     This part of the Act extends to England and Wales. The Act also amends the Merchant Shipping Act 1995 to include provisions for smoke-free ships. The Merchant Shipping Act extends throughout the United Kingdom and so do the amendments.

Part 2

9.     Part 2 of the Act introduces new provisions which are concerned with the prevention and control of health care associated infections. The Act 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 the code 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 Act 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 of Part 2 of the 2003 Act. Where the code is not being observed, the provisions in the Act give the Healthcare Commission the power to serve an improvement notice, and place 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 Act extends to England and Wales.

Part 3

12.     Part 3 of the Act 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 premises used in connection with the provision of health care or the supply or administration of controlled drugs.

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 Act 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 Medicines Act relating to supervision by pharmacists of the preparation, dispensing, sale and supply of medicines. This part of the Health Act extends to the whole of the United Kingdom.

Part 4

16.     Part 4 of the Act 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 and to introduce a new criterion for determining competing applications from chemists in respect of the same neighbourhood. The changes form part of the Government's response for England to recommendations made in The Office of Fair Trading (OFT) report: The control of entry regulations and retail pharmacy services in the UK published on 17 January 2003. This is available at http://www.oft.gov.uk/business/market+studies/pharmacies.htm. The National Assembly for Wales has separately decided to introduce the same changes in Wales.

18.     The Chapter provides that, in England, charges may be determined either 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 (LHBs) under directions from the Assembly. The Chapter also makes changes to enable PCTs, or LHBs as appropriate, to consider in their assessment of competing applications from pharmacists to provide NHS services what improvements such applications would bring to local provision of, or access to, over-the counter medicines and other healthcare products and advice related to such provision. This new criterion will only come into play where certain conditions are met. These conditions are described in more detail in the commentary on sections below. The Chapter also makes changes in relation to the current 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 Act extends to England and Wales and also, as respects certain arrangements relating to dispensing medicines, to Scotland.

19.     Chapter 2 makes 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 which applies to "high street" medical and dental services. This Chapter also include provisions which are intended to strengthen the protection of public funds through improved controls over who may redeem optical vouchers. The provisions in this Chapter extend to England and Wales. They apply in England only.

20.     Chapter 3 provides for a power to require the production of documents in connection with the appropriate national authority's NHS counter fraud functions and the Secretary of State's security management functions. This will give NHS counter fraud organisations powers comparable to those of 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 ³. The response to the consultation was published on 27 May 2005. The provisions extend to England and Wales.

³ see consultation document and summary of responses at: http://www.dh.gov.uk/Consultations/ResponsesToConsultations/ResponsesToConsultationsDocumentSummary/fs/en?CONTENT_ID=4112148&chk=T68WA5

21.     Chapter 4 makes provision for the auditing of the accounts of certain NHS bodies in England and Wales.

Part 5

22.     Part 5 of the Act contains provisions for replacing 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) ⁴, 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 Act 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 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 also 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.

⁴ http://www.publications.parliament.uk/pa/cm200203/cmselect/cmpubadm/165/16502.htm

Part 6

23.     Part 6 of the Act makes changes in four areas:

• it amends the Care Standards Act 2000 to enable the Secretary of State for Health to direct a special health authority to administer the Social Care Student Bursary Scheme.

• it amends the 2003 Act to allow for contributory negligence to be taken into account in a wider range of cases when the NHS recovers hospital treatment and/or ambulance costs where people receive compensation for injuries. The 2003 Act establishes the legal framework to allow the expansion of the current costs recovery scheme for road traffic accident cases (as set out in the Road Traffic (NHS Charges) Act 1999). This provision extends to England and Wales and also to Scotland by virtue of the provisions of section 84(4) of the Act.

• it amends the 1977 Act, the National Health Service and Community Care Act 1990 ("the 1990 Act") and the 2003 Act to give the Secretary of State for Health, or in the case of Wales, the National Assembly for Wales, the power to transfer criminal liabilities of NHS bodies on their dissolution or abolition to other specified NHS bodies.

• it gives the Secretary of State and the National Assembly for Wales power to make orders to deal with out-of-date references in legislation to Welsh health authorities.

Part 7

24.     Part 7 of the Act deals with various matters of general application, including provisions relating to orders and regulations, interpretation, commencement and extent.

TERRITORIAL EXTENT

25.     The table below summarises the territorial extent of the various provisions of the Act.

TERRITORIAL APPLICATION: WALES

26.     There are two sets of provisions that affect Wales differently.

27.     The sections in Chapter 3 of Part 4 which relate to the protection of NHS from fraud and other unlawful activities 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 given to the National Assembly for Wales.

28.     The sections in Part 5 relating to the Appointments Commission 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 the Assembly's appointments functions relating to the appointment of members to the Healthcare Commission and the Health Protection Agency and provide for the Assembly to make payments to the Commission in respect of the appointments functions it is directed to undertake.

COMMENTARY ON SECTIONS

PART 1 - SMOKING

CHAPTER 1 - SMOKE-FREE PREMISES, PLACES AND VEHICLES

29.     Chapter 1 of Part 1 of the Act contains provisions that will make virtually all enclosed and substantially enclosed public places and shared workplaces smoke-free. The White Paper Choosing Health: Making healthy choices easier, published in November 2004, set out proposals to shift the balance significantly in favour of smoke-free environments, and in June 2005 the Department of Health published a consultation document with proposals for smoke-free legislation.

30.     The Act requires that enclosed public places and shared workplaces be smoke-free, unless exempted by regulations to made under section 3 of the Act. Regulations can also provide for vehicles to be smoke-free in certain circumstances and for additional places not covered by section 2 of the Act to be smoke-free.

31.     Health Ministers intend that the smoke-free provisions within the Act will come into force in England in Summer 2007.

32.     Chapter 2 of Part 1 of the Act provides the Secretary of State with power to amend the minimum age of sale of tobacco products through secondary legislation. The Act specifies that when amending the age of sale through such secondary legislation the age specified may not be lower than 16 years or higher than 18 years. The Department of Health published a 12-week public consultation on amending the age of sale of tobacco products in July 2006.

33.     The provisions in Part 1 of the Act extend to England and Wales. The Act also amends the Merchant Shipping Act 1995 to include provisions for smoke-free ships. The Merchant Shipping Act extends throughout the United Kingdom, and the amendments to that Act also do so.

Section 1:     Introduction

34.     Section 1 introduces the smoke-free premises, places and vehicles provisions within the Act. Subsection (1) explains that Chapter 1 of Part 1 makes provision prohibiting smoking in certain premises, places and vehicles. Subsection (2) defines "smoking" for the purposes of Chapter 1 of Part 1 and provides that "smoking" refers to smoking tobacco, or anything which contains tobacco, or smoking any other substance, and includes being in possession of lit tobacco, or anything lit which contains tobacco, or being in possession of any other lit substance in a form which could be smoked. "Smoking" therefore includes the smoking of cigarettes, pipes, cigars, herbal cigarettes and waterpipes (often known as hookah or shisha pipes) etc.

Section 2:     Smoke-free premises

35.     Section 2 makes provision for enclosed or substantially enclosed premises which are open to the public, and shared workplaces, to be smoke-free.

36.     Subsection (1) provides that premises that are open to the public are to be smoke-free when they are open to the public. However, unless such premises also fall within the provisions of subsection (2), they are smoke-free only when open to the public.

37.     Subsection (2) provides that if premises are used as a place of work by more than one person, irrespective of whether such people work there at the same time, or if they are used a place of work where the public might attend to seek or receive goods or services, then they are to be smoke-free all the time. Subsection (3) provides that if only part of any premises are open to the public or used as a place of work, then the premises are only smoke-free to that extent.

38.     Subsection (4) provides that only enclosed or substantially enclosed premises are smoke-free under section 2. The appropriate national authority (the Secretary of State in the case of England and the National Assembly in the case of Wales) may define in regulations under subsection (5) the meaning of "enclosed" or "substantially enclosed".

39.      Subsection (6) is a signpost to section 3, which provides that premises that would otherwise be smoke-free under section 2 may be exempted from that requirement by regulations made under section 3.

40.     Subsections (7) and (8) make provision as to what is covered by the terms "open to the public" and "work".

Section 3:     Smoke-free premises: exemptions

41.     Section 3 enables regulations to be made by the appropriate national authority to specify descriptions of premises, or specified areas within such premises, which are not to be smoke-free where they would otherwise be covered by the provisions of Section 2.

42.     Subsection (2) gives examples of the types of premises that might specified under such regulations. These might include, in particular, premises where someone has their home or where they are living, whether permanently or temporarily. Such premises might include places such as rooms in a hotel, bed and breakfast accommodation, a hostel or a care home. They could also include a place where a person is detained, such as a prison. .

43.     Subsection (3) provides that such regulations may not exempt from the smoke-free requirement premises where the sale of alcohol is permitted under a premises licence under the Licensing Act 2003 (which could include places such as pubs, bars, discos and nightclubs) or premises which operate under a club premises certificate under the Licensing Act. However, by virtue of subsection (4), if someone has their home, or is living either temporarily or permanently, in some area within such premises, the regulations may specify that particular living area as being exempt from the smoke-free requirement. This could permit, for example, a publican's living accommodation above a pub to be exempt from the smoke-free requirement that applies to the pub itself.

44.     Subsection (5) provides that such regulations may make provision for those taking part in performances, so as to permit smoking by such performers if artistic integrity so requires. Performances may, by virtue of subsection (8), include the performance of a play or a performance in connection with a film or television production (including rehearsals in each case but only if the regulations so provide). This would, for example, enable provision to be made enabling those participating in an artistic performance to smoke (where the artistic integrity of the performance made it appropriate) where that performance takes place on licensed premises.

45.     Subsection (6) makes provision in respect of the matters such regulations may deal with, including the circumstances and conditions under which, and the times at which, premises may be exempt from the smoke-free requirement. Subsection (7) provides that regulations may also make provision for the designation of rooms in which smoking may be permitted. This would enable provision to be made for designated smoking rooms, for example, in premises such as hotels, prisons or long term adult care homes or in other premises where it may be impossible for smoking to take place outside for safety, health or practical reasons, such as oil rigs.

Section 4:     Additional smoke-free places

46.     Section 4 enables regulations to be made that designate additional smoke-free places. These will be places that are not already covered by section 2 of the Act. Such places will not need to be enclosed or substantially enclosed. The appropriate national authority may designate a place under this section only if, in the authority's opinion, there is significant risk that, without designation, persons present in the place would be exposed to significant quantities of smoke. Examples of such places that might possibly be covered by regulations made under this section are sports stadia, bus shelters or entrances to buildings that are not covered within section 2 of the Act. Regulations made under this section may provide for additional places to be smoke-free only in certain circumstances, at certain times, if certain conditions are satisfied or in certain areas (or any combination of those).

Section 5:     Vehicles

47.     Section 5 provides powers for the appropriate national authority to make regulations providing for vehicles to be smoke-free. These regulations may make provision for the types of vehicles that are to be smoke-free, the circumstances in which the vehicles are to be smoke-free, any limitations to specified areas of the vehicle which is to be smoke-free and any exemptions. Subsection (5) defines vehicle as meaning every type of vehicle, including train, vessel, aircraft and hovercraft.

48.     By subsection (3), the power to make regulations to provide for smoke-free vehicles is not exercisable in relation to ships or hovercraft (or any persons on any such ship or hovercraft) for which regulations could be made under section 85 of the Merchant Shipping Act 1995. Subsection (4) amends section 85 of the Merchant Shipping Act to enable safety regulations made under that Act to provide for smoke-free provision for ships and hovercraft which corresponds with provisions in the Health Act.