Select Committee on Delegated Powers and Regulatory Reform Sixth Report


APPENDIX 1: HEALTH AND SOCIAL CARE BILL


Memorandum by the Department of Health

Introduction

1.  This Memorandum describes the purpose and content of the Health and Social Care Bill and identifies the provisions of the Bill which confer powers to make delegated legislation. It also explains in each case why the power has been taken and the nature of, and reason for, the procedure selected.

Background and Purpose of the Bill

2.  The Health and Social Care Bill was announced as part of the Government's draft Third Session Legislative Programme on 11 July 2007 and in The Queen's Speech on 6 November 2007. As a portmanteau Bill, the Bill covers a wide range of areas.

3.  The main purposes of the Health and Social Care Bill are to:

  • create a new integrated regulator for health and adult social care, the Care Quality Commission, bringing together existing health and social care regulators into one regulatory body
  • reform professional regulation to enhance public and professional confidence and strengthen clinical governance as part of the Government's response to the Shipman Inquiry
  • reform public health protection to help prevent the spread of disease from infection or contamination
  • include provisions to make a one off payment to expectant mothers in the final weeks of pregnancy

4.  The four main areas of the Bill are set out below in more detail.

The Creation of the Care Quality Commission

5.  The largest measure in the Health and Social Care Bill is to establish a new integrated health and adult social care regulator for England, the Care Quality Commission, from existing regulators.

6.  The Bill will define the functions of the new regulator in the areas of safety and quality assurance, information and performance assessment and safeguarding the rights of patients subject to the Mental Health Act 1983, and will update the system of registration that applies to providers of health and social care services and enable this to cover all providers of health and social care, including NHS providers, without duplicating the functions of other public bodies.

Regulation of Health Professions and Health and Social Care Workforce

7.  The second largest part of the Health and Social Care Bill is a package of measures to reform the system of professional regulation. Specifically, the Bill will, among other measures for professional regulation:

  • introduce legislation to impose the civil, rather than criminal standard of proof in proceedings relating to fitness to practice proceedings concerning health care professionals and in proceedings concerning the suitability of a social care worker to be or remain registered in England and Wales
  • create an independent adjudicator to undertake independent and objective formal adjudication for the healthcare professional regulatory bodies
  • ensure that all specified healthcare organisations employing or contracting with doctors appoint a 'responsible officer' with personal responsibility to work with the General Medical Council (GMC) to identify and handle cases of poor professional performance by doctors
  • take new powers to enable modification of the regulation of social care workers

8.  These measures will help to implement, following the inquiry into the case of Harold Shipman, the manifesto commitment to strengthen clinical governance, and will ensure professional activity is more accountable to the public.

Measures to Enhance Public Health Protection

9.  The third largest measure in the Health and Social Care Bill is the modernisation of the Public Health (Control of Disease) Act 1984, to help prevent the incidence or spread of infection or contamination.

10.  By modernising legislation to take into account new scientific understanding, these measures provide for a more flexible and proportionate response to outbreaks of infectious disease or contamination, and reflect the International Health Regulations 2005, issued by the World Health Organisation.

11.  The legislation includes safeguards, taking into account human rights, designed to ensure that the powers are used only when it is appropriate to do so.

The Creation of a Health in Pregnancy Grant

12.  The last of the larger measures in the Health and Social Care Bill is the creation of a Health in Pregnancy Grant, which will be a one-off payment to expectant mothers ordinarily resident in the UK, who have received the necessary health advice, to help with the costs of a healthy lifestyle, including diet, in the later stages of pregnancy and other additional costs at this time. The payment is designed to support the expectant mother's individual health needs during the pregnancy in order to give her children the best start in life.

Other measures in the Health and Social Care Bill

13.  The Bill also includes other smaller measures aimed at modernising health & social care provisions:

  • the transfer of the Global Sum for Pharmaceutical Services
  • the power to extend membership of NHS indemnity schemes
  • the extension of Direct Payments
  • amendments to the National Assistance Act
  • the creation of a power for the Secretary of State to give financial assistance to social enterprises
  • the creation of the National Information Governance Board for Health and Social Care
  • the abolition of the National Biological Standards Board and the transfer of its functions to the Health Protection Agency
  • Legislative cover for performance management and feedback to parents as part of the National Child Measurement Programme

Provisions for Delegated Legislation

14.  The Bill contains 165 clauses and 15 schedules.

15.  In considering whether matters should be specified on the face of the Bill or allocated to delegated legislation, the Department has carefully considered the need to:

  • avoid too much technical and administrative detail on the face of the Bill
  • ensure flexibility in responding to changing circumstances, for example scientific developments, so that the legislation can be brought up to date without requiring further primary legislation
  • allow detailed administrative arrangements to be set up and kept up to date within the basic structures and principles set out in the primary legislation, subject to Parliament's right to challenge inappropriate use of powers.

16.  This document also includes, as an annex, a Statement of Intent for NHS Indemnity, to more fully demonstrate how the measure, including the delegated powers examined within the main text of this document, is intended to be used by the Department.

Part 1: The creation of the Care Quality Commission

17.  The Care Quality Commission (the Commission) will be established as a new regulator for health and social care (other than care regulated by OFSTED) in England in place of three existing statutory bodies, namely (a) the Commission for Healthcare Audit and Inspection (CHAI); (b) the Commission for Social Care Inspection (CSCI); and (c) the Mental Health Act Commission (MHAC). The Care Quality Commission inherits the functions of CHAI, CSCI and MHAC. The Bill will allow for the Care Quality Commission to be responsible, in England, for the review and regulation of health and social care services whether publicly or privately provided or funded. The precise scope will be subject to consultation. It will not duplicate the functions of other public bodies with functions in respect of health and social care such as OFSTED, the Human Fertilisation and Embryology Authority, and the Human Tissue Authority.

Clause 1: The Care Quality Commission

Powers conferred on: no powers are conferred directly by this section

Power exercised by: not applicable

Parliamentary procedure: not applicable

18.  Clause 1 creates a new body called "the Care Quality Commission". No delegated powers are conferred on the Secretary of State by this clause. However, subsection (3) provides that Schedule 1 shall have effect. The delegated powers in Schedule 1 are addressed by reference to Schedule 1.

Clause 2: The Commission's functions

Powers conferred on: Secretary of State

Power exercised by: directions

Parliamentary procedure: none

19.  Clause 2 sets out the general purpose of the Commission. It also provides for matters that the Commission must have regard to in performing those functions.

20.  Subsection (4) provides that the Secretary of State may direct the Commission to have regard to aspects of government policy in performing its functions.

21.  The Secretary of State may want the Commission to take account of broad aspects of government policy as these change over time, so that these are given priority in the regulation of health and adult social care services. For instance, improving care pathways across services for people with long-term conditions or the needs of vulnerable older people. This power allows him to direct the Commission to do so. These requests may change over time so it would not be appropriate to set these out on the face of the Bill.

22.  This power will need to be exercised at short notice and it does not therefore seem appropriate for any Parliamentary procedure to apply. A direction making power currently applies to the precursors to this clause, sections 130 and 131 of the Health and Social Care (Community and Standards) Act 2003 (2003 Act).

Clause 3: Transfers of property, rights and liabilities

Powers conferred on: no powers are conferred directly by this section

Power exercised by: not applicable

Parliamentary procedure: not applicable

23.  Clause 3 relates to Schedule 2 (which makes provision for the transfer of property, rights and liabilities).

24.  No delegated powers are conferred on the Secretary of State by this clause. However, this clause provides that Schedule 2 shall have effect. The delegated powers in Schedule 2 are addressed by reference to Schedule 2.

Clause 4: Regulated activity

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: affirmative resolution

25.  Clause 4 provides for the definition of "regulated activity" for the purposes of Part 1 of the Bill. Subsection (1) enables the Secretary of State to make regulations prescribing what a regulated activity is.

26.  A wide range of services need to be regulated by the Commission. It would not be practicable to define all of these in primary legislation because new types of services will evolve over time - a regulation making power will enable the legislation to take this into account. The description of regulated activity is also expected to change as new service models evolve. The Secretary of State may also decide in the future that other services should also be regulated by the Commission. This power therefore allows for these details to be set in secondary legislation where they can be amended more easily.

27.  These regulations will determine the activities which will be regulated by the Commission. The affirmative procedure would therefore seem to be appropriate in this case. Given the impact on services to be brought into (or removed from) the scope of registration, any changes to these regulations would also be subject to a public consultation.

Clause 6: Requirement to register as a service provider

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

28.  Clause 6 establishes that it is an offence for a person to carry on a regulated activity without being registered and provides for sanctions in respect of that offence.

29.  Subsection (2) provides that the Secretary of State may make regulations in relation to a regulated activity carried on by two or more persons acting in different capacities, determining which of those persons is to be regarded as the person carrying on the activity.

30.  The change from "undertaking" in the Care Standards Act 2000 (the Care Standards Act) to "activity" in this Bill means that it may be more difficult to identify the person who carries on the activity. One can more readily regard employees as "carrying on" the activity in which their employer is engaged than as carrying on his undertaking. Subsection (2) therefore enables regulations to determine which of two or more persons is to be regarded as carrying on an activity. This power enables the Secretary of State expressly to exclude employees etc and to resolve any uncertainties. It would not be possible to do this in the Bill as regulated activities themselves will be determined in secondary legislation.

31.  These regulations will deal with clarifying administrative details associated with the applications to register and the negative procedure is therefore appropriate.

Clause 9: Condition requiring registered manager

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

32.  Clause 9 makes provision for the imposition of a condition requiring a registered manager.

33.  Subsection (1) enables the Secretary of State by regulations to prescribe cases in which a person's registration as a service provider must be subject to a registered manager condition.

34.  Subsection (2) enables the Secretary of State to make regulations requiring the Commission to have regard to prescribed matters when deciding whether to impose a registered manager condition under clause 8(3) or (5) (b), in a case where subsection (1) does not require such a condition to be to be imposed.

35.  The purpose behind both regulation-making powers is to ensure that for cases where there needs to be an individual with day-to-day responsibility for the provision of care who is accountable for that care in addition to the person with overall responsibility for carrying on the care, then the Commission will make the registration of a manager an additional condition of registration. Activities that will require registration with the Commission will be set out in regulations and may change over time so it will not be possible to set out when a registered manager will be required on the face of the Bill.

36.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure.

Clause 12: Regulations about registration

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

37.  Clause 12 enables the Secretary of State to make regulations providing for keeping of registers by the Commission, the registration process, applications for registration and notifying the Commission of addresses for service of documents.

38.  This clause enables regulations to prescribe requirements relating to the registration process, such as requirements for interviewing applicants, or situations when the Commission should be notified about a change in circumstances following an application to register (for example, to ensure that the Commission can be kept abreast of changes of address which will be required should the Commission need to serve warning notices or other documents as in clause 89). These requirements may differ for different regulated activities and circumstances where a registered manager is required, all of which will be dealt with by regulations. It is therefore necessary to deal with these details through secondary legislation.

39.  These regulations will deal with administrative details associated with the applications to register and the negative procedure is therefore appropriate. The negative procedure is used in the precursor to this clause in section 16 of the Care Standards Act, which applies to independent healthcare and social care services regulated under this Act. We therefore think the negative procedure is also appropriate in this case.

Clause 13: Cancellation of Registration

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

40.  Clause 13 sets out the circumstances in which the Commission may cancel registration of a regulated activity as a service provider or manager.

41.  Subsection (1)(e) provides that these may include grounds specified by the Secretary of State in regulations.

42.  The Secretary of State may decide that additional matters should be grounds for cancellation that might not covered by (1)(a)-(d). Setting out additional grounds for cancellation in regulations will provide flexibility to ensure they are kept up to date.

43.  The negative procedure applies to the precursor to this clause in section 14 of the Care Standards Act and seems appropriate here also.

44.  Subsection (2)(d) provides that the offences that the Commission may take into account under subsection (1) include such other offences as may be prescribed.

45.  This power is necessary to ensure that relevant offences that might be created in other legislation can be included as grounds for cancellation.

46.  This power does not allow offences to be created. It only allows for provision to be made for other offences to be taken into account when making a decision regarding the cancellation of registration so the negative procedure seems to be the most appropriate in this case.

Clause 16: Regulation of regulated activities

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

47.  Clause 16(1) provides that the Secretary of State may by regulations impose such requirements in relation to regulated activities as the Secretary of State thinks fit for the purposes of Chapter 2.

48.  Subsections (2) to (5) set out what, in particular, regulations made under (1) will cover. Subsection (2) provides that those regulations may make provision with a view to: (a) securing that any service provided is of appropriate quality and (b) securing the health, safety and welfare of persons for who any service is provided.

49.  Subsection (3) to (5) relate to particular provision which the Secretary of State has power to make. In particular, subsection (4) provides that they may cover the use of restraint.

50.  Subsection (5) provides that the regulations may also make provision for the prevention and control of health and associated infections (HCAI).

51.  This power enables the Secretary of State to prescribe essential requirements around safety, quality and general probity and governance for ensuring the fitness for purpose of registered activities and those who apply to be registered to provide or manage such activities. It is important that these requirements can be changed as necessary based on advice from the Commission or to respond to changes in service provision to ensure that adequate requirement apply. A regulation making power therefore seems appropriate. The Commission will develop criteria under clause 19 to use in assessing whether registered services are complying with these regulations. The Secretary of State may also issue a Code of Practice under clause 17 about compliance with regulations that relate to the prevention and control of HCAIs.

52.  A regulation making power is particularly appropriate as it may be necessary for the Secretary of State to amend the regulations at short notice to ensure they provide adequate protection for people using registered services.

53.  The negative procedure applies to the precursor to this clause in section 22 of the Care Standards Act. We therefore think the negative procedure is also appropriate in this case.

Clause 17: Code of practice relating to health care associated infections

Powers conferred on: Secretary of State

Power exercised by: not applicable

Parliamentary procedure: none

54.  Clause 17 gives the Secretary of State the power to issue a code of practice about compliance with requirements of regulations under Clause 16 which relate to the prevention and control of healthcare associated infection (HCAI).

55.  This clause takes forward the power given by the Health Act 2006 to the Secretary of State to issue a code of practice for the prevention and control of HCAIs. The purpose of that code of practice is to help NHS bodies plan and implement how they can prevent and control HCAI. The new code will be capable of applying to all registered providers of health and social care. It will describe the ways in which managers of NHS organisations and other health and social care providers should ensure that patients and service users are cared for in a clean environment, where the risk of HCAI is kept as low as possible.

56.  The code of practice must be consulted upon (under clause 18) and it will be based on an accumulating body of evidence that takes account of current clinical practices - as such, it is considered that no Parliamentary procedure is necessary.

Clause 19: Guidance as to compliance with requirements

Powers conferred on: The Commission

Power exercised by: not applicable

Parliamentary procedure: none

57.  Clause 19 obliges the Commission to produce guidance about compliance with the requirements of regulations under clause 16, other than requirements relating to the prevention and control of HCAIs. The guidance may relate to compliance with requirements in any other legislation for the purposes of Chapter 2.

58.  The guidance can make different provision for different circumstances or cases and can operate by reference to provisions in other documents.

59.  Regulations under clause 16 are intended to be applicable to all regulated activities. As such it is important that providers, managers, and indeed users of those activities understand what they are expected to do by way of compliance. The Commission will be better placed than the Secretary of State to produce guidance on this.

60.  The guidance will need to be kept up to date and revised as necessary and may need to be amended as new service models develop. It therefore seems appropriate for no parliamentary procedure to apply.

Clause 26: Urgent procedure for cancellation

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

61.  The Commission may apply to a justice of the peace for an order cancelling a registration. Under subsection (3) notice of the application must, in specified circumstances, be given to Strategic Health Authorities (SHAs) or the Independent Regulator of NHS Foundation Trusts (Monitor) and may be given to such other people as the Commission considers appropriate. Which SHA must be given notice may be determined by regulations. Notice must also be given to Primary Care Trusts (PCTs) and Local Authorities (LAs) as may be determined by regulations.

62.  It is important that PCTs and LAs are notified so that they can comply with their statutory duties, for example, in the case of LAs, to provide or arrange alternative care for service users in accordance with their duties under section 47(1) of the National Health Service and Community Care Act 1990. The relevant bodies will need to make alternative provision for services. A number of different PCTs or LAs may commission services from a particular service provider. As the activities that will require registration will be set out in regulations it is therefore necessary to take a regulation making power to set how the Commission will determine what bodies it should notify in different circumstances.

63.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure.

Clause 31: Contravention of regulations

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: this depends on the procedure applicable to regulations under Part 1, Chapter 2 which make use of this power

64.  Clause 31 provides that the Secretary of State may make regulations providing that a contravention or failure to comply with a specified provision of regulations under Chapter 2 of Part 1 of the Bill is to be an offence. Offences relating to regulations under clause 16 could attract a maximum fine of up to £50,000 and other offences a maximum fine of up to level 4 on the standard scale (£2,500).

65.  Some of the regulation-making powers in the Bill, particularly those under clause 16, will impose requirements on registered services that will deal with matters that are important for ensuring the fitness for purpose of those services. For this reason, it is important that the Secretary of State should be able to make it an offence to fail to comply with some of those requirements. This clause allows for that possibility and for different fines to apply depending on the severity of the offence.

66.  This power relates to regulations that may be made under other clauses in this Chapter of the Bill and the relevant parliamentary procedure will be the procedure applicable to those regulations.

Clause 34: Provision of copies of registers

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

67.  Clause 34 (3) enables the Secretary of State to make regulations in relation to circumstances and parts of a register which subsections (1) and (2) do not apply to i.e. which parts or in what circumstances the register is not to be available for inspection and copying.

68.  It may not be acceptable to release some information contained in registers (for example, particular information in relation to services for certain offenders who have been released at the end of their sentences or other sensitive services registered with the Commission in a given area). This clause enables regulations to be made providing that the register may not be inspected, or copies of the register or extracts are not to be made available, in such circumstances as the appropriate Minister may prescribe. These details may need to vary for different regulated activities or to enable varying levels of access to different categories of people. The level of detail and need for flexibility mean it is more appropriate to deal with this in regulations.

69.  A charge may be made except where prescribed in regulations or where the Commission decides it should be provided free of charge. Subsection (4)(a) enables the Secretary of State to make regulations about the circumstances in which a fee determined by the Commission is not payable for a copy of the register. This will allow for certain people or bodies to access necessary information in particular circumstances. Given the level of detail required and need for flexibility it is more appropriate to deal with this in secondary legislation.

70.  These powers take forward section 36 of the Care Standards Act specifically for care registered with the Care Quality Commission. For reasons of parity with the Care Standards Act, which will remain in force for children's services registered with Ofsted, and for services registered in Wales, the negative procedure remains appropriate.

Clause 35: Bodies required to be notified of certain matters

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

71.  Clause 35(1) enables the Secretary of State to make regulations determining the PCT, LA or SHA to whom specified notices must be given.

72.  It is important that PCTs, LAs or SHAs are notified where the Commission takes action against a registered person of the kind listed in subsection (2). As with notices under clause 26, which deals with urgent cancellations, the relevant bodies may need to make alternative provision for services. The failure to which any enforcement action relates may represent a breach of contract with a person commissioning health or social care or simply be of such concern to prompt them to seek better provision from another provider. A number of different PCTs or LAs may commission services from a particular provider. Rather than set out complex details for determining what PCTs or LAs are relevant in different circumstances on the face of the Bill , subsection (1)(a) provides a regulation making power to do this in secondary legislation.

73.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure.

74.  In some cases, notices relating to matters covered in subsection (2) may be given by the Commission for procedural reasons - such as a change of manager, in which cases no one else need be sent a copy. Rather than set out the detail about circumstances when notifications are not required on the face of the Bill, subsection (4) creates a regulation making power to set out when notices need not be sent.

75.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure.

Clause 36: Periodic returns

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

76.  Clause 36(1) enables the Secretary of State to make regulations requiring the person carrying on a regulated activity to make a return to the Commission at such intervals as may be prescribed.

77.  The kind of information supplied might include, for care homes, details of the number of beds occupied and the number and type of staff currently employed.

78.  The level of detail required in the return means it is better to set the requirement out in regulations rather than in the Bill. The negative procedure applies to existing power under section 33 of the Care Standards Act and therefore seems appropriate in this case.

Clause 37: Liquidators etc.

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

79.  Clause 37(1) enables the Secretary of State to make regulations that;

a)  require any person to whom this section applies to give notice of the person's appointment to the Commission;

b)  require any person to whom this section applies to appoint a person to manage the regulated activity in question.

80.  The Commission will need to know if another individual has taken over the running of a regulated activity because of financial difficulty. Regulations will set out the procedural details for how this should work and provide for the appointment of a suitable manager to ensure the regulated activity complies with the relevant requirements. Given the detail required and the need to ensure flexibility to amend the requirements as required where changes are made to the activities regulated by the Commission it seems most appropriate to deal with this in secondary legislation.

81.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure. The negative procedure applies to the existing power under section 34 of the Care Standards Act and therefore seems appropriate in this case.

Clause 38: Death of registered person

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

82.  Clause 38 enables the Secretary of State to make regulations that:

a)  provide for the provisions of this Chapter to apply with prescribed modifications in cases where the only person registered under this Chapter in respect of a regulated activity as a service provider has died;

b)  require the personal representatives of a deceased person who was registered in respect of a regulated activity as a service provider to notify the Commission of the person's death.

83.  Clause 38(2) sets out that regulations under subsection (1)(a) may, in particular, provide for a registered activity to be carried on by a person who is not registered in respect of it and for the Commission to extend the time which this can continue for.

84.  The Commission will need to know if a registered service provider dies. In this situation it will clearly be important that there is some continuity of service provision, at least in the short term, but equally that they are provided by somebody with the appropriate skills. This will be particularly important where the service provider is also managing the services. Regulations under this clause will set out the procedure for notifying the Commission of the death of a service provider and allow for someone else to provide the services for a limited period without the proper registration. These regulations may need to make different provision for different circumstances which will depend on what activities the Commission regulates. The level of detail makes this an appropriate matter to be dealt with in regulations

85.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure. The negative procedure applies to the existing power under section 35 of the Care Standards Act and therefore seems appropriate in this case.

Clause 39: Power to modify Chapter in relation to newly regulated activities

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: affirmative resolution

86.  Clause 39 enables the Secretary of State to make regulations modifying this Chapter in its application to newly regulated activities of a prescribed description.

87.  The registration provisions are designed to work for care which is already subject to regulation and to cover care directly provided by NHS bodies. When other forms of care are eventually brought within the ambit of the registration regime, there may be unforeseeable issues which necessitate modification of the registration procedures. This power allows for that eventuality. The power to modify the provisions of Chapter 2 of Part 1 under this clause would not apply to the registration of NHS bodies and other providers registered with the Commission from the outset.

88.  This is not dissimilar to a Henry VIII power and it therefore seems appropriate that the affirmative procedure should apply.

Clause 41: Standards set by Secretary of State

Powers conferred on: Secretary of State

Power exercised by: directions

Parliamentary procedure: none

89.  Clause 41 enables the Secretary of State to prepare and publish standards in relation to the provision of NHS care. The Secretary of State may direct any person to prepare a draft statement of those standards, submit it to the Secretary of State for approval, and keep the standards under review.

90.  This power is necessary so that the Secretary of State can delegate these functions to make use of professional expertise on the matters covered by standards in a way that represents best value. The standards will require the Secretary of State's approval before being published so that the Secretary of State can ensure they are appropriate benchmarks of expected behaviour. There is also a requirement to consult on standards before they are issued or approved.

91.  A direction making power has been taken so that flexibility is provided for the Secretary of State to direct different people to develop standards or keep them under review.

Clause 42: Periodic reviews

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument and directions

Parliamentary procedure: negative resolution as regards the regulations; none as regards the directions

92.  Clause 42(1) provides that the Commission must conduct periodic reviews of the provision of health care by the PCT and by other persons pursuant to arrangements made by the PCT.

93.  Subsection (2) provides that the Commission must conduct periodic reviews of the provision of health care by an English NHS provider. Subsection (3) provides for reviews of adult social services provided by local authorities.

94.  Subsection (5) provides that the Secretary of State may direct the Commission to devise indicators for the purpose of assessing the performance of those bodies.

95.  This power is necessary so that the Secretary of State can delegate the function of setting performance assessment criteria to the Commission in relation to some bodies. The setting of criteria is primarily a responsibility for the Secretary of State so as to ensure that they reflect the priorities of the public and encourage health and adult social care services to work towards outcomes that are shared priorities across the public sector. However, the Secretary of State may decide that the Commission is best placed to set the detailed criteria in relation to some services and this power would enable the function to be delegated to it where appropriate.

96.  The Commission must prepare a statement describing the method it proposes to use to assess and evaluate a body's performance and publish a report of its assessment following such reviews.

97.  Subsection (9) provides that the Secretary of State may, after consulting the Commission, make regulations to provide for the procedure to be followed in respect of making representations to the Commission before the publication of a report under this clause.

98.  This power enables the Secretary of State to prescribe what processes should apply to ensure that there is a fair system for allowing services to make representations before the findings of reviews under this clause are made public. It is important that bodies that are subject to review by the Commission should have the chance to respond if they think that there are mitigating factors, errors or other circumstances that might have affected the Commission's findings which they do not think have been taken into account. It is in everyone's interest to ensure that the results of reviews by the Commission present an accurate picture of the quality of the services they cover.

99.  These regulations will deal with administrative details associated with the making of representations to the Commission which it seems more appropriate to deal with in regulations. The negative procedure currently applies to regulations under the precursors to this clause, sections 79(9) and 50(6) in the 2003 Act dealing with annual reviews and seems appropriate here.

Clause 44: Special reviews and investigations

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

100.  Clause 44 provides that the Commission may conduct special reviews and investigations and must conduct such special reviews and investigations as the Secretary of State may request.

101.  Where the Commission conducts such a review or investigation it must publish a report. Subsection (5) provides that the Secretary of State may, after consulting the Commission, make regulations providing for the procedure to be followed in respect of the making of any representations to the Commission before publication of such a report.

102.  This power enables the Secretary of State to prescribe what processes should apply to ensure that there is a fair system for allowing bodies to make representations before the findings of reviews under this clause are made public. It is important that bodies that are subject to review by the Commission should have the chance to respond if they think that there are mitigating factors, errors or other circumstances that might have affected the Commission's findings which they do not think have been taken into account. It is in everyone's interest to ensure that the results of reviews by the Commission present an accurate picture of the quality of the services they cover.

103.  These regulations will deal with administrative details associated with the making of representations to the Commission which it seems more appropriate to deal with in regulations. The negative procedure currently applies to regulations under the precursors to this clause, sections 52(8) and 80(8) in the 2003 Act, and this seems to still be appropriate.

Clause 45: Power to extend periodic review function

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

104.  Clause 45 enables the Secretary of State to make regulations extending the requirement for the Commission to conduct periodic reviews so that the Commission could be required to review any regulated activity carried on by a registered service provider. These reviews would be additional to those already required under clause 42. In relation to regulated activities carried on by a PCT, English NHS provider or an English local authority, to the extent that those activities are already covered by periodic reviews to be carried out under clause 42, subsection (1) does not apply. But regulations under subsection (1) could be made requiring the Commission to conduct periodic reviews of a particular aspect of those activities. The Commission will be required to either publish reports of reviews carried out under these regulations or to assess the performance of the service provider and publish the results of its assessment.

105.  The Secretary of State may decide that it is important that performance information on particular regulated activities, for instance hospitals or care homes, is available to the public to enable them to make informed choices. Where services are providing publicly funded care this is also important in terms of providing public accountability that services represent good value for money. It may not be appropriate for every type of regulated activity to be subject to performance review as some may be very small services providing care to small numbers of people. This power therefore enables the Secretary of State to provide in secondary legislation which types of regulated activity should be covered. This power is needed so that additional activities can be specified for review once the scope of registration has been determined following consultation. It will also allow flexibility if there are changes to the scope of registration in the future.

106.  It is intended that any proposal to extend the range of services that are covered by reviews will be subject to consultation. Given that such an extension will result in a greater (rather than lesser) amount of comparative information about services provided, such an extension is unlikely to be controversial. We therefore, consider the negative procedure is therefore appropriate.

Clause 48: Transfer and amendment of functions under Mental Health Act 1983

Powers conferred on: not applicable

Power exercised by: not applicable

Parliamentary procedure: not applicable

107.  No delegated powers are conferred by clause 48. However, subsection (5) provides that Schedule 3 shall have effect. The delegation of powers under provisions set out in Schedule 3 is addressed by reference to that Schedule.

Clause 51: Publication of results of studies under Section 50

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

108.  Clause 50 provides that the Commission may undertake or promote comparative or other studies as to economy and efficiency in the provision of health services by English NHS bodies and in the provision of adult social services by English local authorities and the making of arrangements by PCTs and LAs for healthcare and adult social services to be provided.

109.  Clause 51(1) provides that the Commission must publish any recommendations made under section 50(1) and the results of any studies undertaken or promoted under that section.

110.  Clause 51(2) enables the Secretary of State to make regulations, after consulting the Commission, as to the procedure to be followed in respect of the making of representations to the Commission before any publication under subsection (1).

111.  This power enables the Secretary of State to prescribe what processes should apply to ensure that there is a fair system for allowing services to make representations before the findings of reviews under this clause are made public. It is important that bodies that are subject to review by the Commission should have the chance to respond if they think that there are mitigating factors, errors or other circumstances that might have affected the Commission's findings which they do not think have been taken into account. It is in everyone's interest to ensure that the results of reviews by the Commission present an accurate picture of the quality of the services they cover.

112.  These regulations are needed to deal with administrative details associated with the making of representations to the Commission and the negative procedure therefore seems appropriate. The negative procedure currently applies to regulations under the precursors to this clause, sections 82(5) and 57(5) in the 2003 Act.

Clause 55: Additional functions

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

113.  Clause 55 enables the Secretary of State to make regulations providing that the Commission is to have additional functions of a kind related to its functions specified in the Bill. The Secretary of State must consult Monitor before making any regulations which extend the functions of the Commission in relation to NHS Foundation Trusts.

114.  The sectors that will be regulated by the Commission are constantly changing, which might necessitate giving additional functions to the Commission which have not yet been identified and therefore cannot be dealt with on the face of the Bill itself. The purpose of this power therefore is to ensure that sufficient flexibility is retained to ensure that the Commission can be given additional functions by means of secondary legislation, where this would be desirable, in order to enable it to be responsive to changing trends in health and adult social care provision or in its approach to monitoring the application of the Mental Health Act 1983 (the Mental Health Act).

115.  The negative procedure applies to the precursors to this clause in the 2003 Act (sections 58 and 84). We therefore think the negative procedure is appropriate in this case.

Clause 57: Inspections carried out for registration purposes

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

116.  The power in subsection (1) enables the Secretary of State to prescribe how often the Commission carries out inspections to assess compliance with requirements of the registration system under Chapter 2, who should carry them out and how they should be carried out. Different approaches to inspection may be required for different types of services or for different types of issue. In particular, the Secretary of State may want inspections into requirements around the control of infections to be carried out in a particular way and by people with particular skills. The Secretary of State may want to make different provision in respect of particular registration requirements or other relevant requirements, or in respect of particular regulated activities and it therefore necessary to deal with circumstances when inspection is required in secondary legislation.

117.  These regulations will deal with procedural details of the inspection process and the negative procedure is therefore appropriate.

118.  The power in subsection (4) enables the Secretary of State to prescribe what processes should apply to ensure that there is a fair system for allowing services to make representations before the findings of reviews under this clause are made public. It is important that bodies that are inspected by the Commission should have the chance to respond before reports of inspections are made public if they think that there are mitigating factors, errors or other circumstances that might have affected the Commission's findings which they do not think have been taken into account. These regulations will set out details about what procedures should apply which it would seem more appropriate to deal with in regulations rather than in the Bill. The same regulations may cover procedure for making representations in relation to a number of clauses.

119.  These regulations will deal with procedural details of the inspection process and the negative procedure is therefore appropriate.

Clause 61: Power to require explanation

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

120.  This clause gives the Secretary of State the power to make regulations to prescribe individuals who can be obliged by the Commission to explain documents or other information obtained by the Commission or persons authorised by it to act on its behalf. The regulations may also prescribe the circumstances (e.g. times and places) under which explanations may be given.

121.  The power to require an explanation of the information obtained by it is an important tool for the Commission. It will enable it to question those in positions of responsibility about perceived discrepancies in the data it has received or about instances where information it has obtained provides evidence of failings in the provision of services.

122.  Subsection (4) provides that any person who fails to comply with any requirement imposed by virtue of this clause will be guilty of a criminal offence. It is thus very important that the individuals whom the Commission may call upon are properly defined, as are the circumstances under which they may be called.

123.  The regulations will be used to specify types of person who must give an explanation and the times and places where explanations must be given. They may make different provision for different cases. Provisions covering areas such as these will be highly detailed and are more appropriate to secondary legislation than the face of the Bill. The provisions may also need to change in order to be responsive to the changing ways in which services are organised.

124.  Regulations under this clause are subject to the negative procedure. The primary legislation gives the Secretary of State the power to require persons to provide an explanation of documents or other information. The secondary legislation will set out who is required to provide these explanations and deal with procedural matters. For example, the Commission for Social Care Inspection (Explanation and Co-operation) Regulations 2004 (2004/555) give CSCI the power to require explanations both in person and in writing from a number of prescribed persons including Local Authorities and service providers. The negative procedure applies to the powers that currently apply under sections 69 and 91 of the 2003 Act and this continues to seem appropriate.

Clause 62: Interaction with other authorities

Powers conferred on: no powers are conferred directly by this clause

Power exercised by: not applicable

Parliamentary procedure: none

125.  No delegated powers are conferred by this clause, which provides that Schedule 4 shall have effect. The delegated powers provided for by Schedule 4 are addressed by reference to that Schedule.

Clause 64: Avoidance of unreasonable burdens in exercise of regulatory powers

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

126.  Clause 64(2) gives the Secretary of State power to make regulations prescribing regulatory authorities (in addition to the Commission) who are to be required to have regard to guidance published by the Secretary of State, about steps that may be taken to avoid imposing unreasonable burdens on health and social care organisations when carrying out inspections or collecting information.

127.  Regulatory authorities should operate to avoid unreasonable burdens being imposed on organisations where possible. The purpose of this clause is to allow the Secretary of State to issue guidance to help regulatory authorities to avoid these burdens. Specifying the regulatory authorities in regulations will allow the list of regulatory authorities to be determined when the scope of registration has been consulted on. If there are changes to the scope of registration, the list of regulatory authorities will be able to be more easily updated if necessary than if the regulatory authorities were specified on the face of the Bill.

128.  The negative procedure applies as these regulations will deal with the administrative detail of guidance issued by the Secretary of State in reducing the burdens of regulation.

Clause 69: Arrangements with Ministers

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

129.  Clause 69(1)(a) provides that the Commission and a Minister of the Crown may make arrangements for the Commission to perform any of its functions in relation to a prescribed health or social care scheme for which the Minister has responsibility.

130.  Other Ministers may have responsibility for health services that are not subject to regulation by the Commission. The purpose of this clause is to allow other Ministers to benefit from the experience and expertise that the Commission will be able to lend in managing such schemes. Attempting to define these schemes on the face of the Bill could risk limiting the scope for the Commission to do this as new schemes may be created in the future. It is therefore necessary to take a power to define the relevant schemes in regulations.

131.  The negative procedure applies to the precursors to this clause in the 2003 Act (sections 124(1) and 125(1). We therefore think the negative procedure is also appropriate in this case.

Clause 71: Inquiries

Powers conferred on: Secretary of State

Power exercised by: directions

Parliamentary procedure: none

132.  Clause 71 provides that the Secretary of State may cause an inquiry to be held into any matter connected with the exercise by the Commission of any of its functions.

133.  Subsection (2) provides that the Secretary of State may give a direction that it is held in private.

134.  Where he decides to call an inquiry the Secretary of State may determine that it is appropriate that it be held in private, for instance to protect patient confidentiality.

135.  This power will need to be exercised at short notice and it does not therefore seem appropriate for any Parliamentary procedure to apply. A direction making power currently applies to the precursors to this clause, sections 134(3) and 135(2) in the 2003 Act.

Clause 76: Code of practice on confidential personal information

Powers conferred on: the Commission

Power exercised by: not applicable

Parliamentary procedure: none

136.  Clause 76 requires the Commission to prepare and publish a code in respect of the practice it proposes to follow in relation to confidential personal information. Before publishing this code, the new regulator must consult with the National Information Governance Board (also being established by this Bill - clauses 149 and 150).

137.  This power has been taken to ensure that service users know how confidential information held by the Commission will be handled.

138.  The Code will need to be kept up to date and will reflect the Commission's own policy. It therefore seems appropriate that no Parliamentary procedures should apply. No Parliamentary procedure applies to the Codes of Practice that CHAI and CSCI are currently required to produce under sections 140 and 141 of the 2003 Act.

Clause 77: Publication of programme of reviews etc.

Powers conferred on: Secretary of State

Power exercised by: order made by statutory instrument

Parliamentary procedure: negative resolution

139.  This clause requires the Commission to publish a document setting out what plans it has to carry out special reviews and investigations under clause 44, studies under clause 50 and reviews under clause 53.

140.  Subsection (1) provides that the Commission must prepare such a document at such times as the Secretary of State may specify by order.

141.  This document will relate closely to the inspection programmes and frameworks that the Commission will be required to publish under Schedule 4. The Secretary of State may therefore want to ensure that the publication of a document under this clause coincides with the development of its inspection programmes or frameworks, or that it is produced at a certain time of the year. This may need to change at different times. An order-making power will allow for that.

142.  The negative procedure is appropriate since the power is limited to a procedural matter and as such is not a matter that Parliament would necessarily want to debate.

143.  Subsection (2) requires the Commission to consult the Secretary of State and any other person or body the Secretary of State may specify by order.

144.  The Secretary of State may want the Commission to consult other relevant public authorities who have remits that are relevant to the health and adult social care services that will be regulated by the Commission, or which are created in the future to ensure their plans in this regard are co-ordinated and avoid areas of overlap or duplication. The power to specify by order is required to allow flexibility to change the list of persons or bodies that the Commission must consult, for example when new bodies are created.

145.  The negative procedure is appropriate since the power is limited to a procedural matter.

Clause 78: Failure by the Care Quality Commission in discharge of its functions

Powers conferred on: Secretary of State

Power exercised by: direction

Parliamentary procedure: none

146.  Clause 78 provides that the Secretary of State may give a direction to the Commission if it considers that the Commission is, to a significant extent, failing to:

  • discharge any its functions
  • properly discharge any of its functions

147.  This power is necessary so that the Secretary of State can take action should the Commission fail to carry out its function properly. Should such a situation occur it would jeopardise the safety and quality of services regulated by the Commission and public confidence in those services and the Commission's ability to regulate them. In that event it is appropriate that the Secretary of State should have a mechanism to give it direction in respect of a particular issue, or should the problem be serious, to make alternative arrangements for functions to be carried out.

148.  Such circumstances might be outside the Commission's control, for instance an issue that affected its staff or the premises it uses, but might require that alternative arrangements can be made to ensure the Commission's functions are still carried out effectively. Such action is likely to need to be made quickly and may well apply for a limited period. The power to direct (with "no procedure"), follows the precedent set for CHAI and CSCI under s132 and s133 of the 2003 Act and, therefore, seems most appropriate.

Clause 79: Reports for each financial year etc

Powers conferred on: Secretary of State

Power exercised by: direction

Parliamentary procedure: none

149.  Clause 79 provides that the Commission must make annual reports.

150.  Subsection (3) provides that the Secretary of State may direct the Commission to include separate reports as to:

a)  the way in which it has exercised its functions during the year,

b)  the provision of health care by and on behalf of registrable persons during the year,

c)  the provision of adult social care by and on behalf of registrable persons during the year.

151.  The Commission will have to produce one or more reports on the way it has exercised its functions, the provision of health care and the provision of adult social care. For example, if the Secretary of State feels a function is of particular importance or is concerned that the Commission did not previously, or may not, cover one of its functions adequately or clearly enough, a direction could be given to it to deal separately with the way it has exercised this function when it produces a report under this clause.

Clause 81: Fees

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

152.  Clause 81 enables the Commission, from time to time, to make and publish provision for the payment of fees in respect of an application under chapter 2, including an application under 15(1), the grant or subsistence of any such registration. It also enables the Commission to charge fees to English NHS bodies, English local authorities, people registered under Chapter 2 and other prescribed people in relation to the exercise by the Commission of such of its other functions under Part 1 of the Bill as may be prescribed.

153.  Subsection (5) enables the Secretary of State to make regulations providing for the manner in which the Commission is to make and publish provision for fees and the matters to be taken into account before making provision in that respect.

154.  Specifying matters in regulations that the Commission must take into account and the manner in which they must do so will ensure that the Commission will make and publish provision for the payment of fees on an appropriate basis and in a way that ensures transparency for those subject to the fees. For instance, the Commission could be required to publish certain types of information to explain the amount of fees charged. To include these matters on the face of the Bill would not provide the flexibility to amend matters the Commission must take into account in the future, or the manner in which they must make provision, should that be necessary or desirable.

155.  The negative procedure applies to the precursor to this clause in the 2003 Act (sections 62(1) and 86(1)). We therefore think the negative procedure is also appropriate in this case.

156.  Subsection (6) enables the Secretary of State to make regulations making alternative provision determining the amount of any fee payable under this clause and the time at which it is payable.

157.  The Government has set a limit on the operating costs in relation to the Commission as part of its policy to reduce the cost of public sector regulation. This will be made up of income generated from fees and grant in aid from the Government. The Commission will have the power to determine what fees it will charge, how they are calculated and when they should be paid. It is therefore also important that the Secretary of State is able to make alternative provision if the Commission does not strike a reasonable balance in making provision on fees or attempts to set fees at a level that would exceed the cost limit it will be tasked with operating within.

158.  The Secretary of State is required to consult the Commission and other appropriate persons before making regulations under this clause. The negative procedure applied to the precursor to this power in section 113A of the Care Standards Act and therefore also seems appropriate.

Clause 82: Penalty notices

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

159.  Payment of a penalty notice prevents the Commission from taking further action in relation to the offence in question. Subsection (2) provides for regulations to prescribe what offences under Part 1 this applies to.

160.  The penalty notice is intended to be a way for the Commission to take action against registered managers and service providers where there is admission that an offence has been committed but the Commission does not feel further action is necessary. However, penalty notices are not appropriate in all cases, for example where the offence involves significant issues of intent. New offences may be created by virtue of clause 31. The power in subsection (2) is therefore needed to ensure that the Secretary of State can specify those offences in respect of which it is appropriate for the penalty notice procedure to apply.

161.  It is necessary to set these out in regulations as new offences may be created in regulations or under the powers to modify chapter 2 or give the Commission additional functions.

162.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure.

163.   In subsection (4), where a person is given a penalty notice, proceedings for the offence to which the notice relates may not be instituted before the end of such period as may be prescribed.

164.  There needs to be a period following the serving of a notice to allow the person to consider and respond. However, the Commission must not be prevented from taking further action if no response is forthcoming. The regulations are intended to address the administrative detail of how long a person is given to decide what to do.

165.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure.

Clause 83: Penalty notices: supplementary provision

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

166.  This clause enables the Secretary of State to make regulations about penalty notices, and in particular:

  • the form and content of penalty notices
  • the amount of the penalty
  • action to be taken if it is not paid
  • such other matters as the Secretary of State thinks expedient

167.  Penalty notices will provide an alternative to prosecution for an offence under this Chapter where the registered service admits liability and the Commission determines this to be an appropriate punishment. It is important that a clear and legally robust procedure exists to set out the procedures that will apply to the serving of a penalty notice. Whilst the upper limit of the penalty is established in subsection (2)(b), it will be more appropriate to set out the details in secondary legislation and we therefore propose to use a regulation making power. The regulations will need to make different provision for different offences. As offences can be created in regulations it is necessary to make provision under this clause in secondary legislation as well.

168.  These regulations will deal with administrative details associated with the serving of penalty notices and the negative procedure is therefore appropriate.

Clause 84: Guidance by the Commission in relation to enforcement action

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

169.  Subsection (4) requires the Commission to consult such people as may be prescribed before issuing guidance in relation to enforcement action.

170.  The Commission's enforcement powers have the potential to have a big impact on a registered person. The Secretary of State may want the Commission to consult other relevant public authorities who have remits that are relevant to the health and adult social care services that will be regulated by the Commission, or which are created in the future to ensure that they are aware of the way the Commission intends to approach its enforcement powers, that their views are taken into account and that the Commission takes account of the way they approach any enforcement powers they may have. It is necessary to deal with this in regulations so that the list of prescribed people can be amended to account for future changes to the Commission's powers or the powers of other existing bodies or any new ones that are created.

171.  These regulations will deal with administrative details associated with the preparation of guidance and the negative procedure is therefore appropriate.

Clause 85: Publication of information relating to enforcement action etc.

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

172.  Clause 85(1) gives the Secretary of State the power to make regulations which may enable or require the Commission to publish prescribed information relating to enforcement action taken by the Commission and prescribing the time and manner in which information should be published. If the regulations require information to be published in relation to warning notices under (1)(e) the Commission is obliged to provide people with an opportunity to make representations to it before it does so and the regulations will set out the procedure that should apply.

173.  It will be important that members of the public are made aware of what enforcement action the Commission has taken in order to be fully informed about the quality of provision PCTs and LAs are commissioning on their behalf and for them to exercise an informed choice about what services to use. Because changes to conditions of registration and other actions covered by this clause may not always occur as a result of enforcement action a regulation making power has been taken so that the details about when such information should be published can be addressed in secondary legislation.

174.  There is also no right of appeal in respect of warning notices so we feel it is important that some procedure for making representations should apply. The procedure for similar provision for making representations is also dealt with in secondary legislation.

175.  These regulations will set out procedural details about how the circumstances in which information can or must be published and how the procedure for making representations should work so the negative procedure therefore seems appropriate.

Schedule 1: The Care Quality Commission

Paragraph 3: Chair and other members

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

176.  Paragraph 3 provides that the Commission is to consist of a chair and other members.

177.  Sub-paragraph (2) provides that the Secretary of State may remove the chair or a member in the circumstances specified. The Secretary of State may make regulations in respect of the manner of removal.

178.  Sub-paragraph (3) enables the Secretary of State to make regulations providing for:

  • appointment of the chair and other members
  • the tenure of office
  • circumstances in which a person shall cease to holds office, and
  • disqualification and suspension.

179.  It is important that Parliament is assured that proper procedures apply in respect of the terms of employment of the Chair and Board of the Commission. This power will enable the Secretary of State to set out procedural details in this regard. Given the level of detail required it seems more appropriate to deal with by secondary legislation rather than in the Bill.

180.  The negative procedure currently applies to regulations under the precursors to these provisions in Schedules 6 and 7 of the 2003 Act.

Paragraph 6: Procedure

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

181.  Paragraph 6(1) provides that the Commission must appoint an advisory committee for the purpose of giving advice or information to it about the exercise of its functions.

182.  Sub-paragraph (5) provides that the advisory committee must include persons of a prescribed description. The Secretary of State may make regulations in that respect.

183.  The purpose of the advisory group is to ensure that the Commission takes account of the views of users and providers of registered services and others with an interest when deciding how it exercises its functions. This power will enable the Secretary of State to ensure that a range of stakeholder views are adequately reflected on the advisory group. The type of stakeholders that would be relevant will depend on what activities the Commission will regulate. These will be set out in regulations and may change over time so it therefore seems appropriate to set out who should be on the advisory committee in secondary legislation.

184.  The regulations will set out the type of person who should be included on an advisory group. These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure.

Schedule 2: Transfers of property and staff etc.

Paragraph 1: Transfer schemes

Powers conferred on: Secretary of State

Power exercised by: transfer scheme

Parliamentary procedure: none

185.  Paragraph 1 of Schedule 2 enables the Secretary of State to make one or more transfer schemes for the transfer of property, rights and liabilities. This will enable the administrative details to be set out regarding the property, rights and liabilities that, for example, may be transferred from CHAI, CSCI and MHAC to the Commission. It also allows for transfers from CHAI and CSCI to the Crown, from the Crown to the CQC and, in the case of MHAC, for transfers to Welsh Ministers. This power, and the procedure to be followed, match that in Schedule 8 to the Health and Social Care (Community Health and Standards) Act 2003, which provided for similar transfer schemes when property, rights and liabilities were transferred to the existing regulators. The same procedure is therefore regarded as appropriate here.

Schedule 3: Amendments of the Mental Health Act 1983

Paragraph 9: Section 120 A to C of the Mental Health Act

186.  Paragraph 9 of Schedule 3 inserts sections 120A to D into the Mental Health Act. Sections 120A to C contain regulation making powers.

Section 120A

Powers conferred on: Secretary of State and the Welsh Ministers

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

187.  Section 120A provides that the regulatory authority (in England this is the Commission, in Wales it is Welsh Ministers) may publish a report on an investigation or review carried out under section 120(1) of the Mental Health Act (as substituted by paragraph 8 of Schedule 3 to the Bill) concerning the exercise of the powers and the discharge of duties under the Mental Health Act.

188.  Subsection (2) of section 120A provides that the Secretary of State may by regulations make provision as to the procedure to be followed in respect of representations to the Commission before the publication of any report under subsection (1). Subsection (4) gives Welsh Ministers similar power in relation to Wales.

189.  These powers enable the Secretary of State and the Welsh Ministers to prescribe the procedure that should be followed in making representations. This is required to ensure that there is a transparent and fair system that allows service providers to make representations before the findings of reviews and investigations made under section 120(1) are made public. It is important that people who are subject to review and investigation should have the chance to comment before a report is published. They may think that there are mitigating factors, that there have been errors or that there are other circumstances that might have affected the findings which have not been adequately taken into account. It is in everyone's interests to ensure that the reports of reviews and investigations present an accurate picture. These regulations will set out details about what procedures should apply which it would seem more appropriate to deal with in regulations rather than in the Bill.

190.  These regulations will be subject to the negative procedure in Parliament and in the National Assembly for Wales (as appropriate) by virtue of section 143 of the Mental Health Act. That procedure is appropriate because the regulations will deal with administrative details associated with the making of representations to the Commission and the Welsh Ministers. This power is equivalent to other powers in Part 1 of the Bill concerning the procedure for making representations before publication of reports - see, for example, the powers in clauses 42 (periodic reviews) and 44 (special reviews and investigations.) Those powers are also to be subject to the negative procedure.

Section 120B

Powers conferred on: Secretary of State and Welsh Ministers

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

191.  Section 120 B (1) and (2) provides that the regulatory authority (again, the Commission in relation to England and the Welsh Ministers in relation to Wales) may direct the managers of an NHS or independent hospital or local social services authorities to publish a statement about the action they propose to take as a result of a review or investigation under section 120(1) of the Mental Health Act.

192.  Section 120B(2)(c) provides that the Secretary of State and the Welsh Ministers, in relation to England and Wales respectively, may make regulations extending the list of people who may be required to publish such a statement.

193.  The Mental Health Act confers powers and duties on a variety of people, including individual professionals and both statutory and private sector bodies. For the most part, the people to whom these powers and duties fall are either responsible for hospitals (known as hospital managers in the Act) which care for patients subject to the Mental Health Act or are local social services authorities, or are individuals working within such hospitals or on behalf of such authorities.

194.  However, it is not only hospital managers and social services authorities and their staff who exercise relevant functions under the Mental Health Act and contribute to the operation of the Mental Health Act. There may, therefore, be circumstances in which reviews or investigations make recommendations that are addressed (in whole or in part) to others. In these cases, it would make sense for the people concerned to be asked directly to publish a report of the action they propose to take as a result. This might include, for example, other NHS bodies that are responsible for providing or commissioning services for patients subject to the Mental Health Act.

195.  The power to extend the powers of direction in section 120B to such people by means of regulations will enable the list of relevant people to be subject to a process of consultation following the passage of the Bill and to be revised expeditiously, as necessary, in the light of experience.

196.  Such regulations will be subject to the negative procedure in Parliament and in the National Assembly for Wales (respectively), again by virtue of section 143 of the Mental Health Act. That procedure is appropriate because the additional obligations that may be imposed on people by any such regulations will be of a limited nature, relating only to matters concerning the operation of the Mental Health Act.

197.  Section 120B(3) provides that the Secretary of State (in relation to England) and Welsh Ministers (in relation to Wales) may use regulations to make further provision about the content and publication of statements made under this section. Such regulations could, for example, specify the time limit within which a report must be published or require the hospital managers or other people required to publish such a report to obtain the consent of another person before including particular information in a report.

198.  Such regulations will again be subject to the negative procedure in Parliament and in the National Assembly for Wales, again by virtue of section 143 of the Mental Health Act. The use of regulations and of the negative procedure is appropriate in this case because the regulations will only be dealing with questions of detail concerning the content and publication of reports.

Section 120C

Powers conferred on: Secretary of State and Welsh Ministers

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

199.  Section 120C provides that the persons specified in subsection (1) must provide the Commission (in relation to England) and the Welsh Ministers (in relation to Wales) with such information as they may reasonably request for or in connection with their functions under section 120 of the Mental Health Act (as substituted by paragraph 8 of Schedule 3 to the Bill). For these purposes, information includes records and documents. The same duty applies to information requested by people authorised by the Commission or the Welsh Ministers to carry out functions under section 120.

200.  Subsection (1) provides that the people who must provide information on request include the managers of an NHS or independent hospital, a local social services authority and any person prescribed in regulations.

201.  It is important that the Commission and the Welsh Ministers (and any people whom they authorise to act on their behalf) should have access to the information that they need to carry out effective reviews and investigations under section 120 in order to help safeguard the rights of patients subject to the Mental Health Act.

202.  Under subsection (7) of the new section 120, people authorised by the Commission and by the Welsh Ministers will have the right to inspect records relating to individual patients. However, for an effective review or investigation to be carried out, it may also be important for them to be able to access records and information that relate to patients generally, rather than to individual patients. This might, for example, include statistical information about the demographic characteristics of patients treated for mental disorder in a particular area or hospital.

203.  Such information is likely to be held in the main by bodies who act as hospital managers or by local social services authorities. However, information relevant to reviews and investigations may be held by other bodies and people involved in the care and treatment of patients who are subject to the provisions of the Mental Health Act.

204.  Regulations under subsection (1)(c) will therefore be used, as appropriate, to extend the powers of the Commission and the Welsh Ministers to cover other people from whom they may reasonably require information. This might, for example, include other NHS bodies (e.g. PCTs or local health boards who do not themselves manage hospitals) or independent providers who provide services for patients outside hospital on behalf of PCTs, local social services authorities or independent hospitals. Again, a power to do this by means of regulations will enable the list of such people to be subject to a process of consultation following the passage of the Bill. It will also enable the list to be revised expeditiously, as necessary, in the light of experience.

205.  The regulations will be subject to the negative procedure in Parliament and in the National Assembly for Wales, again by virtue of section 143 of the Mental Health Act. This procedure is appropriate because the additional obligations that may be imposed by such regulations will be of a limited nature, relating only to matters concerning the operation of the Mental Health Act.

Paragraph 12: section 134A of the Mental Health Act

Powers conferred on: Secretary of State and Welsh Ministers

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

206.  Section 134 provides for the withholding of postal packets in specified circumstances. Paragraph 12 of Schedule 3 inserts section 134A into the Mental Health Act to make further provision in relation to the withholding of postal packets.

207.  Section 134A(1) provides that the Commission (in relation to England) and Welsh Ministers (in relation to Wales) must review any decision to withhold a postal packet or anything contained in it on application by a specified person.

208.  Subsection (5) provides that the Secretary of State may, by regulations, make provision in connection with applications to the Commission and the determination of any such application. This includes provision for the production to the Commission of any postal packet in question. Subsection (6) gives Welsh Ministers a similar power to make regulations about the making of applications to them.

209.  These provisions are the equivalent of powers that already exist in section 121 of the Mental Health Act in relation to the review by the Mental Health Act Commission of decisions to withhold postal packets under section 134 of the Mental Health Act. Section 121 will cease to have effect as a result of subsection (4) of clause 48, as MHAC is to be abolished.

210.  Subsections (5) and (6) of the new section 134A are, in effect, a restatement of the power to make regulations in subsection (9) of section 121 of the Mental Health Act as it stands now. The provision made under that power is currently to be found in Regulation 18 of the Mental Health (Hospital, Guardianship and Consent to Treatment) Regulations 1983 (SI 1983/893). Regulation 18 provides, in particular, that an application for a review of a decision to withhold a postal packet may be made to MHAC in any form that the Commission accepts as sufficient in the circumstances, and need not be in writing. Applicants must let the Commission have a copy of the notice of withholding provided by the relevant hospital. Regulation 18 also empowers the Commission to direct people to produce any documents, information or other evidence it reasonably requires for its review of the decision.

211.  The powers in subsection (5) of the new section 134A will be used to make similar regulations in relation to England once the functions of MHAC have been transferred to the Commission. It is likely that Welsh Ministers will make similar provision in relation to Wales.

212.  As now, the regulations under this provision will be subject to the negative procedure in Parliament and in the National Assembly for Wales, by virtue of section 143 of the Mental Health Act. The right to require the production of the relevant postal packet is expressly provided for in the enabling provision (new section 134A(5) and (6)) and otherwise the regulations will be of a procedural nature. The negative procedure is therefore appropriate.

Schedule 4: Interaction with other authorities

Part 2 - Exercise of Functions

Paragraph 5: Inspection programmes and inspection frameworks

Powers conferred on: Secretary of State

Power exercised by: order made by statutory instrument

Parliamentary procedure: negative resolution

213.  Paragraph 5(1) provides that the Commission must from time to time, or at such times as the Secretary of State may specify by order, prepare inspection programmes and inspection frameworks.

214.  The preparation of inspection programmes and frameworks will be an important element of how the Commission will work with the other inspection authorities to co-ordinate its inspection activity. The order making power in subsection (1) will enable Secretary of State to specify when the Commission should produce these to ensure they are produced at such times as to enable such co-ordination.

215.  The negative procedure is appropriate since the power is limited to a procedural matter.

216.  Sub-paragraph (2)(c) requires the Commission to consult the Secretary of State and any other person or body the Secretary of State may specify by order.

217.  The Secretary of State may want the Commission to consult other relevant public authorities who have remits that are relevant to the health and adult social care services that will be regulated by the Commission, or which are created in the future to ensure their plans in this regard are co-ordinated and avoid areas of overlap or duplication.

218.  The negative procedure is appropriate since the power is limited to a procedural matter.

219.  Sub-paragraph (3) further provides that the Secretary of State may by order specify the form of any inspection programme or framework.

220.  Again, it will be important that the Commission's inspection programmes and frameworks contain the information necessary to enable it to co-ordinate its inspection activity with the other inspection authorities. The information contained in them may change over time. This power will enable the Secretary of State to ensure that any programme or framework prepared by the Commission will be in a form that corresponds with that adopted by other inspection authorities (so far as is appropriate). It will also ensure that providers and users of services regulated by the Commission can make best use of the information.

221.  An order under this clause will deal with procedural details associated with the preparation of inspection programmes and frameworks by the Commission and the negative procedure is therefore appropriate.

Paragraph 6: Inspections by other inspectors of registrable undertakings

Powers conferred on: Secretary of State

Power exercised by: order made by statutory instrument

Parliamentary procedure: negative resolution

222.  Paragraph 6 provides for inspections by other inspectors of specified organisations.

223.  Sub-paragraph (1) provides that the Commission, where the Commission is notified of a proposed inspection by a specified inspector and considers that it would impose an unreasonable burden on a specified person, or would do so if carried out in a particular way, may notify the inspector that the inspection is not to be carried out.

224.  Sub-paragraph (2) provides for the definition of a "specified inspector". It includes an inspection authority and, at paragraph (b), provides that the Secretary of State may specify that it also includes any other person specified by order.

225.  This power is being taken so that this clause can be applied to other people who, in future, may carry out relevant inspections. This power will ensure the list of relevant inspectors is kept up to date.

226.  Sub-paragraph (3) provides that a "specified organisation", for the purpose of paragraph 6, means a person specified by the Secretary of State by order. This power is being taken to provide for flexibility in relation to those organisations that may be regulated by the Commission. Sub-paragraphs (4) and (5) provide that such an order may limit inspection of a specified organisation to particular functions or activities carried out by that organisation.

227.  Any such order would operate in the context of remits of the other inspection authorities as set in secondary legislation. The power therefore allows for the remits of the respective inspection authorities to be agreed across government. This would not seem to be a matter that Parliament would want to debate and the negative procedure therefore seems appropriate.

228.  Sub-paragraph (6) provides that the Secretary of State may by order specify the cases or circumstances in respect of which a notice under sub-paragraph (1) need not be given.

229.  Sub-paragraph (9) provides that the Secretary of State may by order make supplementary provision in respect of this paragraph.

230.  The power in sub-paragraph (6) is being taken because there may be some circumstances in which the Secretary of State feels it would not be appropriate for the Commission to exercise the power under this paragraph, for example where it would prevent another body from carrying out its statutory functions. As the definition of 'specified inspector' may change over time it is not possible to provide all the circumstances in which a notice may not be required on the face of the Bill.

231.  The power in sub-paragraph (9) is being taken so that the Secretary of State can set out procedural details about how notices under this clause are to operate in secondary legislation. This is to avoid including excessive detail on the face of the Bill and to ensure that the requirements can be amended if necessary.

232.  Orders under this clause will deal with procedural details associated with the serving of notices by the Commission and the negative procedure is therefore appropriate.

Paragraph 7: Co-operation

Powers conferred on: Secretary of State

Power exercised by: order made by statutory instrument

Parliamentary procedure: negative resolution

233.  Paragraph 7 provides that the Commission must cooperate with:

  • the inspection authorities -

(a) Her Majesty's Chief Inspector of Prisons,

(b) Her Majesty's Inspectors of Constabulary,

(c) Her Majesty's Chief Inspector of the Crown Prosecution Service,

(d) Her Majesty's Inspectorate of the National Probation Service for England and Wales,

(e) Her Majesty's Inspectorate of Court Administration,

(f) Her Majesty's Chief Inspector of Education, Children's Services and Skills, and

(g) the Audit Commission for Local Authorities and the National Health Service in England, and

  • any other public authority specified by the Secretary of State by order

where it is appropriate to do so for the efficient and effective exercise of the Commission's functions.

234.  There are a number of other public authorities who have remits that are relevant to the health and adult social care services that will be regulated by the Commission. New ones may also be created in the future. This power will enable the Secretary of State to specify that the Commission must co-operate with any other public authorities that are relevant bodies.

235.  The negative procedure will apply as this essentially deals with procedures of the Commission.

Paragraph 10: Inspections carried out under arrangements

Powers conferred on: Secretary of State

Power exercised by: order made by statutory instrument

Parliamentary procedure: negative

236.  Under paragraph 10 the Commission may make arrangements to carry out inspections for other inspection authorities. Those authorities are listed in paragraph 1 of Schedule 4.

237.  Paragraph 10(1)(b) enables the Secretary of State to specify by order other public authorities for the purposes of this paragraph. There are a number of other public authorities who have remits that are relevant to the health and adult social care services that will be regulated by the Commission. New ones may also be created in the future. This will allow for the Commission to be given authority to carry out inspections on their behalf if appropriate.

238.  The negative procedure will apply as this is essentially a deregulatory matter, helping to reduce the number of inspections carried out by different inspection authorities.

Schedule 5: Further amendments relating to Part 1

Paragraph 25: Penalty Notices

Powers conferred on: Welsh Ministers

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

239.  Payment of a penalty notice prevents the Welsh Ministers from taking further action in relation to the offence in question. Subsection (2) provides for regulations to prescribe which offences this applies to.

240.  The penalty notice is intended to be a way for the Welsh Ministers to take action against registered persons where there is admission that an offence has been committed but the Welsh Ministers do not feel further action is necessary. However, penalty notices are not appropriate in all cases, for example where the offence involves significant issues of intent. The power in subsection (2) is therefore needed to ensure that the Welsh Ministers can provide for those offences in respect of which it is appropriate for the penalty notice procedure to apply.

241.  It is necessary to set these out in regulations as new offences may be created in regulations or under the powers to extend the application of Part II of the Care Standards Act 2000.

242.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure.

243.  In subsection (5), where a person is given a penalty notice, proceedings for the offence to which the notice relates may not be instituted before the end of such period as may be prescribed.

244.  There needs to be a period following the serving of a notice to allow the person to consider and respond. However, the Welsh Ministers must not be prevented from taking further action if no response is forthcoming. The regulations are intended to address the administrative detail of how long a person is given to decide what to do.

245.  These regulations will include a relatively uncontroversial level of detail which would justify the negative procedure.

Penalty notices: supplementary provision

Powers conferred on: Welsh Ministers

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

246.  This enables the Welsh Ministers to make regulations about penalty notices, and in particular:

  • the form and content of penalty notices
  • the amount of the penalty
  • action to be taken if it is not paid
  • such other matters as the Welsh Ministers think expedient

247.  Penalty notices will provide an alternative to prosecution for an offence under the Care Standards Act where the registered person admits liability and the Welsh Ministers determine this to be an appropriate punishment. It is important that a clear and legally robust procedure exists to set out the procedures that will apply to the serving of a penalty notice. Whilst the upper limit of the penalty is established in subsection (2)(b), it will be more appropriate to set out the details in secondary legislation and we therefore propose to use a regulation making power. The regulations will need to make different provision for different offences. As offences can be created in regulations it is necessary to make provision under this clause in secondary legislation as well.

248.  These regulations will deal with administrative details associated with the serving of penalty notices and the negative procedure is therefore appropriate.

Part 2: Professional Regulation

Clause 95: Fitness to practise panels

Power conferred on: Office of the Health Professions Adjudicator

Power exercisable by: rules, subject to approval by order of the Privy Council (see clause 104)

Parliamentary procedure: none, but orders of the Privy Council are subject to negative resolution

249.  This clause sets out the structure and composition of the panels by which the Office of the Health Professions Adjudicator (OHPA) will operate in the adjudication of fitness to practise cases. The members are to be drawn from lists held by OHPA and must consist of at least 3 persons - a chair, a lay member and a professionally qualified member. The chair may be a lay person, a professionally qualified member or a legally qualified person but must be on the list of persons eligible to serve as a chair.

250.  The appointment of other lay or professionally qualified members may be required by rules made by OHPA. Subsection (3) provides for further provision about the selection of fitness to practise panels also to be made through rules made by OHPA. The rules might, for example, provide that professional panel members must be of the same profession as the practitioner whose fitness to practise is being considered.

251.  Sub-section (4) allows OHPA to make particular provision in its rules about the selection of a legally qualified chair in specified circumstances. If OHPA decides to run a pilot scheme for legal chairs, the rules can make provision for the selection of cases to be chaired by a legally qualified person.

252.  It is the intention that OHPA will draft and consult widely on its rules before they are made to ensure that the views of all parties are taken into consideration. There is a statutory requirement for OHPA to carry out such a consultation under clause 104(3).

253.  Clause 104(4) provides that rules made by OHPA will not come into force until they have been approved by order of the Privy Council. Clause 153 provides that orders of the Privy Council are to be made by statutory instrument and under clause 154 this kind of statutory instrument will be subject to annulment in pursuance of a resolution of either House of Parliament. The Privy Council will be able to approve the rules as they stand, or subject to any changes they think necessary. Where the Privy Council intend to approve the rules subject to certain changes, the clause requires them to notify OHPA and consider any observations which OHPA may make on their changes.

254.  Currently, the Medical Act 1983 and the Opticians Act 1989 make provision for the GMC and General Optical Council (GOC) respectively to make rules relating to fitness to practise proceedings, subject to approval of those rules by order of the Privy Council. Orders made by the Privy Council are subject to the negative resolution procedure. There are therefore precedents for the use of this kind of power. Similar powers are to be found in legislation relating to the regulation of other health professions, so this clause will help to ensure continuing consistency amongst all of the regulatory bodies.

255.  This use of delegated powers is considered to be appropriate because the purpose of the rules which OHPA is empowered to make is to add technical and procedural detail to the statutory framework for adjudication of fitness to practise cases. As the adjudicator, OHPA will be best placed to know what is required in this respect. The powers conferred on OHPA will also provide flexibility where it becomes apparent that procedural changes are needed.

Clause 96: Lists of persons eligible for membership of fitness to practise panels

Power conferred on: OHPA

Power exercisable by: rules, subject to approval by order of the Privy Council (see clause 104)

Parliamentary procedure: none, but orders of the Privy Council are subject to negative resolution

256.  This clause requires OHPA to appoint people to lists of persons eligible to sit on fitness to practise panels and to chair the panels. It makes provision for rules to be made by OHPA regarding such lists including provision about the division of a list into parts and the information which is to appear on a list about a person appointed to it. It also empowers OHPA to prescribe the requirements for appointment to a list in its rules.

257.  It is the intention that OHPA will draft and consult widely on its rules before they are made, to ensure that the views of all parties are taken into consideration. There is a statutory requirement for OHPA to carry out such a consultation under clause 104(3).

258.  Clause 104(4) provides that rules made by OHPA will not come into force until they have been approved by the Privy Council. Clause 153 provides that orders of the Privy Council are to be made by statutory instrument and under clause 154 this kind of statutory instrument will be subject to annulment in pursuance of a resolution of either House of Parliament. The Privy Council will be able to approve the rules as they stand, or subject to any changes they think necessary. Where the Privy Council intend to approve the rules subject to certain changes, the clause requires them to notify OHPA and consider any observations which OHPA may make on their changes.

259.  Currently, the Medical Act 1983 and the Opticians Act 1989 make provision for the GMC and GOC respectively to make rules relating to fitness to practise proceedings, subject to approval of those rules by order of the Privy Council. Orders made by the Privy Council are subject to the negative resolution procedure. There are therefore precedents for the use of this kind of power. Similar powers are to be found in legislation relating to the regulation of other health professions, so this clause will help to ensure continuing consistency amongst all of the regulatory bodies.

260.  This use of delegated powers is considered to be appropriate in this context because the purpose of the rules which OHPA is empowered to make is to add technical and procedural detail to the statutory framework for adjudication of fitness to practise cases. As the adjudicator, OHPA will be best placed to know what is required in this respect. The powers conferred on OHPA will also provide flexibility where it becomes apparent that procedural changes are needed.

Clause 98: Legal assessors

Power conferred on: OHPA

Power exercisable by: rules, subject to approval by order of the Privy Council (see clause 104)

Parliamentary procedure: none, but orders of the Privy Council are subject to negative resolution

261.  This clause requires OHPA to appoint or arrange for the appointment of legal assessors to give their fitness to practise panels advice on questions of law. It gives OHPA the power to make provision in its rules about the qualifications which a person must have, and other conditions which must be satisfied, in order to be eligible for appointment as a legal assessor. OHPA may also make provision about the functions of these legal assessors in its rules. The rules may also provide that a legal assessor not be appointed when the panel is chaired by a legally qualified person.

262.  Clause 104(4) provides that rules made by OHPA will not come into force until they have been approved by the Privy Council. Clause 153 provides that orders of the Privy Council are to be made by statutory instrument and under clause 154 this kind of statutory instrument will be subject to annulment in pursuance of a resolution of either House of Parliament. The Privy Council will be able to approve the rules as they stand, or subject to any changes they think necessary. Where the Privy Council intend to approve the rules subject to certain changes, the clause requires them to notify OHPA and consider any observations which OHPA may make on their changes.

263.  Currently, the Medical Act 1983 and the Opticians Act 1989 make provision for the GMC and GOC respectively to make rules relating to fitness to practise proceedings, subject to approval of those rules by order of the Privy Council. Orders made by the Privy Council are subject to the negative resolution procedure. There are therefore precedents for the use of this kind of power. Similar powers are to be found in legislation relating to the regulation of other health professions, so this clause will help to ensure continuing consistency amongst all of the regulatory bodies.

264.  This use of delegated powers is considered to be appropriate in this context because the purpose of the rules which OHPA is empowered to make is to add technical and procedural detail to the statutory framework for adjudication of fitness to practise cases. As the adjudicator, OHPA will be best placed to know what is required in this respect. The powers conferred on OHPA will also provide flexibility where it becomes apparent that procedural changes are needed.

Clause 99: Clinical and other specialist advisers

Power conferred on: OHPA

Power exercisable by: rules, subject to approval by order of the Privy Council (see clause 104)

Parliamentary procedure: none, but orders of the Privy Council are subject to negative resolution

265.  This clause empowers OHPA to appoint or arrange for the appointment of clinical advisors to give their fitness to practise panels advice on issues relating to health. It also allows OHPA to appoint other specialist advisers to give advice to their fitness to practise panels on issues where OHPA considers specialist knowledge is required.

266.  For both clinical and other specialist advisers, the clause gives OHPA the power to set out in rules the qualifications a person must have and any other conditions a person must fulfil in order to be eligible for appointment. It also allows OHPA to make provisions about the functions of these advisers in its rules.

267.  Current provision in the Opticians Act 1989 and rules made by the GMC and approved by the Privy Council allow for the appointment of such persons. The purpose of this clause is to enable OHPA to assume similar functions as are currently exercised by the regulators for which it will adjudicate. It expands on the existing powers in that it now enables OHPA to make rules specifically about qualifications and functions. Existing powers are being expanded to provide flexibility to make necessary changes to the functions or expertise of such advisers.

268.  It is the intention that OHPA will draft and consult widely on its rules before they are made, to ensure that the views of all parties are taken into consideration. There is a statutory requirement for OHPA to carry out such a consultation under clause 104(3).

269.  Clause 104(4) provides that rules made by OHPA will not come into force until they have been approved by order of the Privy Council. Clause 153 provides that orders of the Privy Council are to be made by statutory instrument and under clause 154 this kind of statutory instrument will be subject to annulment in pursuance of a resolution of either House of Parliament. The Privy Council will be able to approve the rules as they stand, or subject to any changes they think necessary. Where the Privy Council intend to approve the rules subject to certain changes, the clause requires them to notify OHPA and consider any observations which OHPA may make on their changes.

270.  Currently, the Medical Act 1983 and the Opticians Act 1989 make provision for the GMC and GOC respectively to make rules relating to fitness to practise proceedings, subject to approval of those rules by order of the Privy Council, Orders made by the Privy Council are subject to the negative resolution procedure. There are therefore precedents for the use of this kind of power. Similar powers are to be found in legislation relating to the regulation of other health professions, so this clause will help to ensure continuing consistency amongst all of the regulatory bodies.

271.  This use of delegated powers is considered to be appropriate in this context because the purpose of the rules which OHPA is empowered to make is to add technical and procedural detail to the statutory framework for adjudication of fitness to practise cases. As the adjudicator, OHPA will be best placed to know what is required in this respect. The powers conferred on OHPA will also provide flexibility where it becomes apparent that procedural changes are needed.

Clause 100: Procedural Rules

Power conferred on: OHPA

Power exercisable by: rules, subject to approval by order of the Privy Council (see clause 104)

Parliamentary procedure: none, but orders of the Privy Council are subject to negative resolution

272.  This clause sets out the requirement for OHPA to make rules about procedures. The rules will make provision about the procedure to be followed in making referrals to OHPA under the Medical Act 1983 and the Opticians Act 1989 and the procedure to be followed, and the rules of evidence to be observed, in proceedings before OHPA's fitness to practise panels.

273.  The rules may make provision for matters relating to preliminary hearings, the giving of directions to parties as to the conduct of proceedings and the consequences of failure to comply with such directions. OHPA may also make provision in its rules about a fitness to practise panel taking account of undertakings given by the person to whom the proceedings relate and about voting by fitness to practise panels, including the taking of decisions by majority and the conferral of a casting vote on the chair. OHPA's rules may also make provision about the award and assessment of costs and expenses, and the review by fitness to practise panels of their own decisions.

274.  Rules about the award and assessment of costs and expenses may require that regard be had to a person's ability to pay; include provision for a legal representative's costs or expenses to be disallowed because of their conduct of the proceedings and provide for a costs award to be recoverable as if it had been made by court order.

275.  The rules must make provision for securing that notice of proceedings and notice of decisions of a fitness to practise panel are given to appropriate persons. They must also make provision which allows each party to proceedings to have the opportunity to put their case at a hearing, with an entitlement to legal representation. They must also include provision securing that proceedings are held in public except and to the extent that the rules provide otherwise.

276.  It is the intention that OHPA will draft and consult widely on its rules before they are made, to ensure that the views of all parties are taken into consideration. There is a statutory requirement for OHPA to carry out such a consultation under clause 104(3).

277.  Clause 104(4) provides that rules made by OHPA will not come into force until they have been approved by order of the Privy Council. Clause 153 provides that orders of the Privy Council are to be made by statutory instrument and under clause 154 this kind of statutory instrument will be subject to annulment in pursuance of a resolution of either House of Parliament. The Privy Council will be able to approve the rules as they stand, or subject to any changes they think necessary. Where the Privy Council intend to approve the rules subject to certain changes, the clause requires them to notify OHPA and consider any observations which OHPA may make on their changes.

278.  Currently, the Medical Act 1983 and the Opticians Act 1989 make provision for the GMC and GOC respectively to make rules relating to fitness to practise proceedings, subject to approval of those rules by order of the Privy Council. Orders made by the Privy Council are subject to the negative resolution procedure. There are therefore precedents for the use of this kind of power. Similar powers are to be found in legislation relating to the regulation of other health professions, so this clause will help to ensure continuing consistency amongst all of the regulatory bodies.

279.  This use of delegated powers is considered to be appropriate in this context because the purpose of the rules which OHPA is empowered to make is to add technical and procedural detail to the statutory framework for adjudication of fitness to practise cases. As the adjudicator, OHPA will be best placed to know what is required in this respect. The powers conferred on OHPA will also provide flexibility where it becomes apparent that procedural changes are needed.

Clause 102: Duty to inform the public

Power conferred on: OHPA

Power exercisable by: rules, subject to approval by order of the Privy Council (see clause 104)

Parliamentary procedure: none, but orders of the Privy Council are subject to negative resolution

280.  This clause provides that OHPA will be under a general duty to publish information about the exercise of its functions, including the decisions of its fitness to practise panels. But subsection (3) enables OHPA to make rules allowing it to withhold certain information.

281.  It is the intention that OHPA will draft and consult widely on its rules before they are made, to ensure that the views of all parties are taken into consideration. There is a statutory requirement for OHPA to carry out such a consultation under clause 104(3).

282.  Clause 104(4) provides that rules made by OHPA will not come into force until they have been approved by order of the Privy Council. Clause 153 provides that orders of the Privy Council are to be made by statutory instrument and under clause 154 this kind of statutory instrument will be subject to annulment in pursuance of a resolution of either House of Parliament. The Privy Council will be able to approve the rules as they stand, or subject to any changes they think necessary. Where the Privy Council intend to approve the rules subject to certain changes, the clause requires them to notify OHPA and consider any observations which OHPA may make on their changes.

283.  Currently, the Medical Act 1983 and the Opticians Act 1989 make provision for the GMC and GOC respectively to make rules relating to fitness to practise proceedings, subject to approval of those rules by order of the Privy Council. Orders made by the Privy Council are subject to the negative resolution procedure. There are therefore precedents for the use of this kind of power. Similar powers are to be found in legislation relating to the regulation of other health professions, so this clause will help to ensure continuing consistency amongst all of the regulatory bodies.

284.  This use of delegated powers is considered to be appropriate in this context because the purpose of the rules which OHPA is empowered to make is to add technical and procedural detail to the statutory framework for adjudication of fitness to practise cases. As the adjudicator, OHPA will be best placed to know what is required in this respect. The powers conferred on OHPA will also provide flexibility where it becomes apparent that procedural changes are needed

Clause 104: OHPA rules: supplementary

Power conferred on: the Privy Council

Power exercisable by: order of the Privy Council

Parliamentary procedure: negative resolution

285.  Clause 104 requires all rules made by the OHPA under clauses 95, 96, 98, 99, 100 and 102 to be approved by an order of the Privy Council before they are able to come into force.

286.  The Privy Council will be able to approve the rules as they stand, or approve them subject to any changes they think necessary. Where the Privy Council intend to approve the rules subject to certain changes, the clause requires them to notify OHPA and consider any observations which OHPA may make on their changes.

287.  It is the intention that OHPA will draft and consult widely on its rules before they are made, to ensure that the views of all parties are taken into consideration. There is a statutory requirement for OHPA to carry out such a consultation under sub-section (3).

288.  Negative resolution is the Parliamentary procedure which currently applies to Orders of the Privy Council approving rules made under the Medical Act 1983 and the Optical Act 1989. It has been selected to ensure consistency with the rule making powers of all the regulatory bodies.

Clause 105: Fees payable by the General Medical Council and General Optical Council

Power conferred on: the Secretary of State

Power exercisable by: regulation made by statutory instrument

Parliamentary procedure: negative resolution

289.  Clause 105 introduces a fees regime from which OHPA will secure the majority of its funding from the relevant regulatory bodies (initially the GMC and later the GOC) for the adjudication services which it provides.

290.  Under subsection (2), the regulations will provide that OHPA must follow the procedures set out in the regulations. The regulations might for instance require OHPA to agree detailed procedures with the relevant regulators and to publish them. It might also require OHPA to review the procedures from time to time.

291.  The regulations would provide for a formula to be devised which would enable a calculation to be made taking into account OHPA's estimate of the costs of its hearings in the current financial year and the relevant regulators' estimates of volume and complexity. The estimate of OHPA's costs could be on the basis of a "day rate" to be applied to the above formula.

292.  Under subsection (3), the regulations must require OHPA to ensure that its fees are set at a level that will cover its forecast of "chargeable costs". The regulations will need to provide which costs are not chargeable costs. The non-chargeable costs will be funded by the Secretary of State (or the relevant Northern Ireland department). It is expected that the non-chargeable costs will relate to set up and transitional costs, High Court referrals and other exceptional costs.

293.  Subsection (4) enables regulations to set the date from which the chargeable costs would fall to be met by the fees paid by the relevant regulatory bodies. Regulations under this subsection can also exclude costs incurred for specified purposes from being chargeable costs.

294.  The regulations made under subsection (5) will provide for the relevant regulatory bodies to be fully engaged in the setting of the fee. As a result of applying the formula OHPA will be able to calculate the amount of chargeable costs that it needs to fund its budget for the following financial year. The regulations will provide for this amount to be apportioned between the relevant regulatory bodies to reflect their estimates, which they will have provided at the start of the fee setting cycle. OHPA will make a formal determination of these amounts and notify the relevant regulatory bodies along with an explanation of the calculation in such detail as will be prescribed in the regulations. This will allow the relevant regulatory bodies to make informed representations about the determination.

295.  The regulations will provide that representations must be made within a specified timescale and that any representations made within these time limits must be considered. The regulations will require OHPA to set out the administrative arrangements for this process, including the process for considering representations made on the determination. OHPA will notify the relevant regulatory bodies of the final determination. These amounts will then become payable at such times as may be specified in the regulations by virtue of subsection (7).

296.   The Bill has reserved a power under subsection (6) for the Treasury to approve the fee. The regulations will set out the arrangements for approval to be obtained.

297.  It is anticipated that the making of a determination will be on an annual basis and this will be provided for in regulations under subsection (7). The regulations will make provision for situations where it becomes clear that the fee level has not been set at the correct level to ensure that OHPA will not be in surplus or deficit beyond set parameters. In these circumstances, the determination may be varied, replaced or revoked.

298.  Subsection (8) requires the Secretary of State to consult the relevant regulatory bodies and others who he considers are appropriate, such as bodies representing the interests of the professions, before making regulations under this clause.

299.  The power to make regulations about OHPA's ability to raise fees is left to delegated legislation as it concerns administrative procedures. It will also enable amendments to be made in the light of practical experience. The more detailed financial and management arrangements will be set out in a Management Statement or Financial Memorandum.

300.  Negative resolution is the Parliamentary procedure which currently applies to Orders of the Privy Council approving rules made under the Medical Act 1983 and the Optical Act 1989.

Clause 109: Constitution etc of Council

Power conferred on: Secretary of State

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

301.  Clause 108 changes the name of the Council for the Regulation of Health Care Professionals to the 'Council for Healthcare Regulatory Excellence' (the Council). Clause 109 makes changes to the constitution of the Council and subsection (3) amends the enabling powers in paragraph 6 of Schedule 7 to the National Health Service Reform and Health Care Professions Act 2002 as a consequence of these changes. Paragraph 6 of that Schedule as amended enables the Secretary of State to provide by regulations for:

  • the conditions which must be fulfilled for appointment of the chair and other members of the Council
  • the tenure of office of the chair and non-executive members of the Council
  • the appointment of a member as deputy chair and the circumstances in which that member ceases to hold office or may be removed from office as deputy chair.
  • the appointment of, constitution of and exercise of functions by committees and sub-committees of the Council.

302.  It is intended that regulations will be made to provide for the appointment of the Chair, Deputy Chair and other non-executive members of the Council. The regulations will specify, amongst other things, the types of people who would not be eligible to be a non-executive member of the Council, e.g. those with certain criminal convictions. Schedule 10 includes provision for the delegation of the Privy Council's and the Secretary of State's appointments process to the Appointments Commission.

303.  The regulations will also set out the conditions to be fulfilled by the Chair, Deputy Chair and the non-executive members, as well as grounds for disqualification from holding office and grounds for removal from office. The regulations will also cover the appointment of Council Committees, sub-committees and their membership.

304.  It is intended that the regulations will allow some flexibility to meet changing circumstances such as the need to set up committees at short notice by enabling the Council to appoint committees. It will also allow the conditions to be amended if necessary to take into account future circumstances without the need for primary legislation.

305.  It is appropriate for such procedural and technical matters to be dealt with by regulations, rather than be on the face of the Bill. The regulations will be subject to the negative Parliamentary procedure because it is appropriate to retain the existing Parliamentary procedure provided for the conditions for the appointment of the Chair and members and tenure etc. It is our intention to consult on draft regulations which will replace the SI 2002/ 2376 The Council for the Regulation of Health Care Professionals (Appointment etc.) Regulations 2002.

Clause 111 - Powers of Secretary of State and devolved administrations

Power conferred on Secretary of State

Power exercisable by: directions

Parliamentary procedure: None

306.  Clause 111 inserts a new section 26A into the National Health Service Reform and Health Care Professions Act 2002. New section 26A(3) and (4) enables the Secretary of State to give directions to the Council as to the manner in which the Council exercises its functions. The power is only exercisable after the Secretary of State has consulted Ministers of the devolved administrations and the Council itself.

307.  Directions are not subject to any parliamentary procedure. The power to direct is appropriate as it will enable the Secretary of State to respond quickly to different circumstances as they arise, such as a need to direct CHRE to prioritise areas of its workload.

Clause 114: Responsible officers and their duties relating to medical profession

Powers conferred on: Secretary of State in relation to England and Wales and Scotland and, in relation to Northern Ireland, the Department of Health, Social Services and Public Safety in Northern Ireland

Power exercised by: regulations by statutory instrument (England and Wales and Scotland) or by statutory rule (Northern Ireland)

Parliamentary procedure: negative resolution

308.  Clause 114 inserts a new Part 5A (responsible officers) into the Medical Act 1983, containing new sections 45A to 45F. The new section 45A confers on the Secretary of State in relation to England, Wales, and Scotland and the Department of Health, Social Services and Public Safety in Northern Ireland in relation to Northern Ireland, power to make regulations to designate bodies which shall be required to nominate or appoint persons, to be known as "responsible officers", with responsibilities in relation to the professional regulation of medical practitioners (i.e. doctors) who are employed by such bodies, provide services to them or have a prescribed connection to them.

309.  The types of bodies which can be designated for these purposes are those which appear to the Secretary of State to provide, or arrange for the provision of, health care, or to employ or contract with medical practitioners. Further provision about what may be included in such regulations is made by the new sections 45A to 45C, including a power to require designated bodies or responsible officers to have regard to any guidance given from time to time by the Secretary of State or the Department of Health, Social Services and Public Safety in Northern Ireland (as the case may be).

310.  This is a new power and is linked to the requirement (not yet in force) for doctors to be required to hold a licence to practice and to be subject to re-licensing under Part 3A of the Medical Act 1983. All medical practitioners will be linked to a responsible officer and it is intended that part of the re-licensing process will be the collection and evaluation of information relating to fitness to practice of practitioners by such officers, who will submit recommendations to the GMC. Responsible officers will also be responsible for monitoring and liaising with the GMC on the performance and fitness to practice of doctors.

311.  It is considered appropriate for the detailed provisions needed, such as specifying which healthcare organisations are to be designated bodies and the qualifications and responsibilities of responsible officers, to be dealt with by regulations and guidance will assist persons in carrying out their responsibilities. A power to do this by means of regulations will also ensure that those bodies designated and the detailed responsibilities of responsible officers can be amended as necessary in the light of experience.

312.  The new section 45C(1) provides a power to create offences or to create other procedures for enforcement of the regulations. This will enable provisions to be adopted for enforcing the regulations should any problems with compliance arise.

313.  The negative resolution procedure is in line with the procedure for regulations made under Part 3 of the Health Act 2006, section 17 of which provides for the designation of bodies who are to nominate or appoint accountable officers with prescribed responsibilities in relation to the supervision of management and use of controlled drugs. The proposed guidance is intended to assist designated bodies and responsible officers in performing their obligations and functions and will need to be kept up to date and revised as necessary; it therefore seems appropriate for no Parliamentary procedure to apply to it.

Clause 115: Additional responsibilities of responsible officers: England and Wales and Northern Ireland

Powers conferred on: Secretary of State in relation to England, the Welsh Ministers in relation to Wales and, in relation to Northern Ireland, the Department of Health, Social Services and Public Safety in Northern Ireland

Power exercised by: regulations by statutory instrument (England and Wales) or by statutory rule (Northern Ireland)

Parliamentary procedure: negative resolution

314.  Clause 115 provides the Secretary of State, in relation to England, the Welsh Ministers, in relation to Wales, and the Department of Health, Social Services and Public Safety in Northern Ireland in relation to Northern Ireland with power to confer additional responsibilities on responsible officers nominated or appointed under section 45A of the Medical Act 1983 (as inserted in that Act by clause 114). Such additional responsibilities will relate to ensuring that medical practitioners employed by, or contracted with, the designated body have appropriate skills and experience; for monitoring the conduct and performance of medical practitioners; and, ensuring that appropriate action is taken in response to concerns about such conduct or performance (short of concerns about fitness to practice).

315.  As with regulations made under section 45A of the Medical Act 1983, it is appropriate for the detailed responsibilities to be set down in regulations. Guidance may also be given to designated bodies and responsible officers in relation to the performance of such additional responsibilities.

316.  The negative resolution procedure is in line with the proposed procedure for regulations under section 45A of the Medical Act 1983. Similarly, it does not seem appropriate for the guidance to be subject to any Parliamentary procedure.

Clause 116: Co-operation between prescribed bodies

Powers conferred on: Secretary of State in relation to England and the Welsh Ministers in relation to Wales

Power exercised by: regulations by statutory instrument

Parliamentary procedure: negative resolution

317.  Clause 116 provides the Secretary of State, in relation to England, and the Welsh Ministers, in relation to Wales, with power to designate bodies which are to co-operate with each other in connection with sharing information about the conduct or performance of any health care worker. Such bodies shall also be under a duty to co-operate in considering any issues which arise from such shared information and in taking any steps which the regulations require to be taken following such consideration. It also provides a power to create punishable offences for failure to comply with regulations.

318.  The regulations may require designated bodies to have regard to guidance given by the appropriate authority. The types of bodies which can be designated for these purposes are those which appear to the Secretary of State to provide, or arrange for the provision of, health care, or to employ or contract with medical practitioners, as well as any other body specified for the purposes of this clause.

319.  This is a new power aimed at strengthening the responsibilities and powers of healthcare organisations to collaborate in handling information which might point to a possible serious risk to patients. One recurrent theme in the Shipman and Ayling cases was the failure of healthcare organisations to "join up" the information that was available to them, singly and collectively, and to realise that it was pointing to the possibility of such a risk.

320.  It is considered appropriate to designate bodies by regulations as the bodies to which this duty to co-operate needs to apply, as well as the steps that need to be taken where a possible risk to patients is identified, may change over time.

321.  The negative resolution procedure is in line with the procedure for regulations made under section 18 of the Health Act 2006, which provide for bodies specified by regulations to co-operate with each other in identifying cases where action may need to be taken in respect of matters arising in relation to management and use of controlled drugs. The proposed guidance is intended to assist designated bodies in co-operating with each other and will need to be kept up to date and revised; it therefore does not seem appropriate for this to be subject to any Parliamentary procedure.

Clause 118 - Regulation of social care workers

Powers conferred on: Secretary of State in relation to England and Welsh Ministers in relation to Wales

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: affirmative resolution

322.  Clause 118 confers on the Secretary of State, in relation to England, and Welsh Ministers, in relation to Wales, the power to make regulations to modify the regulation of social care workers in England (social care workers are defined by reference to the definition in section 55 of the Care Standards Act). This modification may include repealing or amending any provision (other than section 55) of the Care Standards Act, and any other enactment or other instrument or document. The power is therefore a "Henry VIII" power. It is the Care Standards Act that provides for the regulation of the social care workforce by establishing a General Social Care Council (GSCC) for England, and a Care Council for Wales (CCW) (referred to collectively as "the Councils"). The Councils regulate the training of social workers and raise standards in social care through codes of conduct and practice, and by other means.

323.  Schedule 9 supplements clause 118. Paragraph 2 of Schedule 9 provides an illustration of the matters about which regulations may make provision. These include the functions of the Councils, the keeping of registers of social care workers, education and training, privileges of registered persons, removal or suspension from the register, and codes of practice or guidance for persons employing or seeking to employ social care workers.

324.  The provisions providing for the regulation of the social care workforce (currently to be found in the Care Standards Act) may only be changed by means of primary legislation unlike the healthcare professional regulators whose legislation may be changed by an Order under section 60 of the Health Act. The Government considers that there is a need for a similar mechanism to enable legislation governing the social care workforce to be kept up to date.

325.  The regulation-making power would enable the Government to be more responsive to changing public expectations of the social care workforce and the social care workforce's own views about the development of their regulation.

326.  The power in clause 118 broadly mirrors the equivalent power enabling changes to the regulation of the healthcare professions which is contained in section 60 of the Health Act 1999. This power has proved to be effective, allowing the introduction of a number of changes to improve patient safety such as modernising fitness to practise procedures and the widening of regulation to include new professional groups.

327.  The power in section 60 is a power to make an Order in Council as the Privy Council has traditionally been concerned with matters of professional regulation. However, under Schedule 1 to the Care Standards Act, the Privy Council has no functions in relation to the Councils. It is the Secretary of State who appoints members of the GSCC (paragraph 5 of Schedule 1 to the Care Standards Act) and has the power to make regulations about appointments, tenure of office, committees of the GSCC, and procedure (paragraph 6 of Schedule 1 to the Care Standards Act). The power in clause 114 has therefore been conferred on the Secretary of State in relation to the GSCC and on the Welsh Ministers in relation to the CCW.

328.  The regulation-making power will enable new responsibilities and powers to be given to the Councils. For example, the GSCC have proposed changes to allow conditions to be imposed on registration and new powers to require the production of documents at proceedings. These changes will require amendments to the Care Standards Act. It is anticipated that, like Orders under section 60 of the Health Act 1999, the majority of changes made under clause 118 will be at the request of the GSCC. Prior to the drafting of regulations under clause 118, it is also intended that there will be full consultation with the social care workforce and other interested bodies such as the British Association of Social Workers.

329.  In order to make the kind of changes proposed, the regulation-making power needs to be of sufficient scope. However, Schedule 9 sets some important limits on the power:

  • paragraph 7 places limits on the ability of the power to create criminal offences to those where the maximum punishment on summary conviction is a fine at level 5 on the standard scale. This is commensurate with the existing penalty in section 61 of the Care Standards Act;
  • paragraph 8(1) provides that regulations may not abolish the GSCC or CCW; and
  • paragraph 8(2) provides that where the four core functions associated with the regulation of the social care workforce, listed in paragraph 8(3), are exercised by the GSCC or the CCW, or any of its committees or officers, regulations may not provide for them to be exercised by anyone other than the GSCC or the CCW (as the case may be).

330.  A further limit on the power is set by subsection (4) of clause 119 which provides that regulations under clause 118 may not amend or make any provision which is inconsistent with the requirement (in clause 119) that the standard of proof in proceedings relating to registration of social care workers is the civil standard.

331.  Paragraph 4 of the Schedule enables regulations to make provision for the delegation of functions, including the power to make, confirm or approve subordinate legislation. The Care Standards Act confers powers on the Councils to make subordinate legislation. For example, section 60 of the Care Standards Act enables the GSCC to make rules about registration. This paragraph enables regulations to confer the power to make rules on the GSCC. It also enables regulations to make provision for the approval of such rules (rules currently made by the GSCC are required to be approved by the Secretary of State; see section 71(4) of the Care Standards Act).

332.  Paragraph 6 enables functions to be conferred on Ministers of the Crown. This will enable regulations to make provision for a Minister to pay grants to a body.

333.  Paragraph 9 of Schedule 9 provides that, once regulations have been drafted, the draft regulations must be published at least three months in advance of the draft regulations being laid before Parliament. Following publication the Secretary of State must consult representatives of the social care workforce on the draft regulations. Other interested parties, including persons representing those provided with services by social care workers (e.g. service user groups) must also be consulted.

334.  After the consultation period, the draft regulations, with any modifications the Secretary of State considers appropriate in the light of the consultation, may be laid before Parliament. The Secretary of State must also lay before Parliament a report about the consultation; this report is intended to set out the results of the consultation.

335.  Clause 154(3) provides that the draft regulations must be subject to the affirmative procedure. The arrangements for consultation and the level of Parliamentary scrutiny match that for the equivalent power in section 60 of the Health Act 1999.

Clause 120 - Education and Training of Approved Mental Health Professionals

Powers conferred on: Secretary of State, in relation to England, and the Welsh Ministers, in relation to Wales

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: affirmative resolution

336.  Clause 120(1) enables the appropriate Minister by regulations to make provision modifying the functions of the Councils in relation to the education and training of persons who are, or wish to become approved mental health professionals (AMHPs). This includes repealing, amending or applying (with or without modifications) any provision of any enactment or other instrument or document. The appropriate Minister, in relation to the GSCC, is the Secretary of State and, in relation to the CCW, is the Welsh Ministers.

337.  The Mental Health Act 1983[3] provides for the approval of persons to act as AMHPs and confers functions on the Council in relation to the education and training of social workers when acting as AMHPs. When the relevant provisions come into force, AMHPs will take on the functions previously exercised by approved social workers, including the function of making applications for a patient's admission and detention in hospital under Part 2 of the Mental Health Act. As well as social workers, a wider group of professionals, for example nurses, occupational therapists and psychologists, will potentially be eligible for approval as AMHPs as long as individuals have the right skills, experience and training.

338.  Since the functions of the Councils in relation to AMHPs may only be changed by means of primary legislation, the regulation-making power in clause 120 is to be capable of being used to modify the regulation of AMHPs in so far as the Care Standards Act is applied to them (namely in relation to the education and training of such persons). The rationale for taking these powers is the same as that for taking the powers in relation to the regulation of social care workers, namely that it allows the Councils to update their functions in relation to AMHPs in a timely manner.

339.  Clause 120(3) applies the provisions of paragraphs 4, 5, 6, 9 and 10 of Schedule 9 to the making of regulations relating to the education and training of AMHPs. This means that draft regulations must be published at least three months in advance of the draft regulations being laid before Parliament, and that following publication the Secretary of State must consult fully with AMHPs and other interested bodies.

340.  After the consultation period, the draft regulations, with any modifications the Secretary of State considers appropriate in the light of the consultation, may be laid before Parliament. The Secretary of State must also lay before Parliament a report about the consultation; this report is intended to set out the results of the consultation.

341.  The draft regulations must be subject to the affirmative procedure. The arrangements for consultation and the level of Parliamentary scrutiny match that for the equivalent power in section 60 of the Health Act 1999.

Schedule 6: The Office of the Health Professions Adjudicator

Paragraph 5

Power conferred on: Privy Council

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

342.  Paragraph 5 gives to the Privy Council power by regulation to prescribe requirements for appointment to membership of OHPA. The Privy Council may prescribe requirements for the appointment of the Chair and other members. The regulations might specify, amongst other things, the types of people who would not be eligible to be the Chair or member of the Council, e.g. those with certain criminal convictions.

343.  The regulations made by the Privy Council are subject to negative resolution (see clause 154(1)(c)). The regulation making power will enable the Privy Council to add detailed requirements to the statutory framework for the membership of OHPA for which Schedule 6 provides. The Privy Council is well placed to co-ordinate the views of the Health Departments, the professions and other interested parties as to the person specifications for these appointments and then to delegate the responsibility for recruiting the members through the Appointments Commission. These powers will provide flexibility as the OHPA extends its remit to other professions and it becomes apparent that changes to the numbers of non-executive and executive members would be beneficial to the performance of OHPA's functions.

Paragraph 7

Power conferred on: Privy Council

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

344.  Paragraph 7 gives to the Privy Council power by regulation to prescribe the number of executive and non-executive members of OHPA. Paragraph 7(2) states that the regulations must specify the number of executive and non-executive members (between one and three in each case) and paragraph 7(3) that the number of executives cannot exceed the number of non-executives.

345.  The regulations made by the Privy Council are subject to negative resolution (see clause 154(1)(c)). The regulation making power will enable the Privy Council to add detailed requirements to the statutory framework for the membership of OHPA for which Schedule 6 provides. These powers will provide flexibility as the OHPA extends its remit to other professions and it becomes apparent that changes to the numbers of non-executive and executive members would be beneficial to the performance of OHPA's functions.

Schedule 8: Extension of powers under Section 60 of Health Act 1999

Power conferred on: Her Majesty in Council

Power exercisable by: Order in Council

Parliamentary procedure: affirmative resolution

Background

346.  This clause extends the scope of section 60 of the Health Act 1999.

347.   Section 60 was introduced in the Health Act 1999 to enable changes to be made to the regulation of health professions in an efficient and timely manner. Before the introduction of the section 60 procedure, the enactments that regulated the health professions made detailed provisions which, with very few exceptions, could only be changed by means of primary legislation. Section 60 allows changes to such provisions without the need for an Act of Parliament, whilst strengthening the arrangements for consultation of interested parties and maintaining an appropriate level of Parliamentary scrutiny.

348.  This power has proved to be effective, allowing the introduction of a number of changes to improve patient safety, such as modernising fitness to practise procedures and the widening of regulation to include new professional groups.

349.  The changes in the Bill will, in particular, amend section 60 of and the associated Schedule 3 to, the Health Act 1999 to:

1.  include the new OHPA within the scope of section 60. This will enable the use of section 60 order making powers to change the scope of the functions of the new regulator, and will, in particular allow responsibility for adjudication of fitness to practice cases in respect of further health professions to be transferred to it in due course (should such a course of action be considered appropriate and be agreed with the professional regulatory bodies in question)

2.  make provision that a new professional regulatory body for pharmacy (the proposed General Pharmaceutical Council) may be created by means of a section 60 order and that the regulatory functions of the Royal Pharmaceutical Society of Great Britain (RPSGB) and Pharmaceutical Society of Northern Ireland (PSNI) (subject to a decision by Northern Ireland Ministers to proceed in this way) may be transferred to that body

3.  make provision for lay majorities. This will help establish and sustain confidence in the independence of the regulators. Under the current provisions, a section 60 order cannot be used to impose a lay majority on a health professions regulatory body. This provision will allow councils of health professions bodies to have a lay majority, should they wish. It will be used as and when such councils request such a change

4.  remove a restriction that has prevented Orders under section 60 from being used to make provisions allowing functions conferred on the Privy Council in relation to some of the regulated professions to be exercised by another person. The professions affected are pharmacists, doctors, optometrists, osteopaths, chiropractors, dentists and the other professions regulated, or to be regulated, under the Dentists Act 1984. Of those professions currently regulated, the restriction already does not apply to nurses, midwives, pharmacy technicians and the thirteen professions currently regulated under the Health Professions Order 2001. Removing the restriction as regards the affected professions will allow new legislation to be introduced to transfer functions of the Privy Council as regards them to other bodies, where this is merited. In practice, it is anticipated that this extended power will generally be used to transfer functions from the Privy Council to the regulatory bodies for the affected professions rather than to third parties.

350.  Orders under section 60 have been used successfully over a number of years to enable professional regulation to keep pace with the changing needs of the health professionals, without unnecessary delays due to limits on Parliamentary time. This includes for the pharmacy profession the Pharmacists and Pharmacy Technicians Order 2007.

351.  There is precedent for using this power to set up a new regulatory body. Both the Nursing and Midwifery Council and the Health Professions Council were successfully established by means of section 60 Orders.

Changes in Respect of Pharmacy

352.  The Schedule contains a number of amendments, which will extend the scope of section 60 to cover the regulation of pharmacy in Northern Ireland and update references to pharmacy legislation in Great Britain. This will enable the transfer of the RPSGB's and PSNI's functions in respect of the regulation of pharmacy professionals to the planned new General Pharmaceutical Council, which the Department will be creating via an order under section 60. The transfer of the regulatory functions of PSNI will be subject to a decision by Northern Ireland Ministers to proceed in this way.

353.  The Schedule also extends the scope of section 60 to enable the transfer of the RPSGB's regulatory functions (and those where undertaken by the PSNI) relating to the registration and regulation of pharmacy premises and other inspection and enforcement functions under the Medicines Act; compliance with those provisions of the Poisons Act 1972 and the Poisons (Northern Ireland) Order 1976, which relate to pharmacists and those carrying on a retail pharmacy business; and the grant of authorisation under s28 of the Regulation of Investigatory Powers Act 2000 concerning directed surveillance. Currently with limited exceptions, section 60 applies to the regulation of individual pharmacy professionals and not to premises.

354.  Paragraph 4(2) makes a consequential change so that the proposed new General Pharmaceutical Council cannot be abolished by an order under section 60.

Lay Majorities

355.  Paragraph 4(3) removes the restriction preventing an Order in Council from imposing a lay majority. This means the councils of health professions regulatory bodies will be able to be composed of a lay majority, should they wish. Parity of membership can already be made by an order under section 60.

OHPA

356.  In paragraph 5(3), the insertion of sub-paragraph (2A) extends the restriction on transferring the functions set out in paragraph 8(2) of Schedule 3 of the Health Act 1999 to the OHPA.

357.  The insertion of (2A) is a consequential amendment to bring the OHPA into the scope of this particular restriction on Section 60.

358.  Paragraph 6(2) makes changes to clarify that where an Order under section 60 deals with more than one profession, for example pharmacists and pharmacy technicians, representations on the published draft Order should be invited from persons appearing appropriate to represent any profession covered by the Order. Similarly those persons appearing appropriate to represent those provided with services by any profession to be regulated should be consulted on the draft Order.

Procedure

359.  An order under section 60 allows affected health professions to be closely involved with development of the legislation, including through the requirement to formally consult on section 60 orders in draft. As a section 60 order is subject to the affirmative resolution procedure, this allows for an appropriate level of Parliamentary scrutiny. This is entirely appropriate given the significant nature of the changes which may be made by an order under section 60, and the fact that section 60 orders may amend primary legislation. The Department considers that this procedure works well at present, as has been successfully demonstrated on a number of occasions.

360.  Orders made under section 60, as amended by the Bill, will continue to be made in the same way as section 60 orders are presently made, that is by an Order in Council subject to the affirmative resolution procedure.

Schedule 10 - Further amendments relating to Part 2

Paragraph 16

Power conferred on: Privy Council

Power exercisable by: directions

Parliamentary procedure: None

361.  Paragraph 16 makes consequential amendments to the enabling power in section 60 of the Health Act 2006 as a result of the changes to the constitution of the Council and the establishment of OHPA.

362.  As amended, the Privy Council is able to make directions delegating its function relating to the appointment of the Chair of the Council and members of OHPA to the Appointments Commission.

363.  It is intended to make directions relating to the process of appointment and the criteria to be applied.

364.  The existing Parliamentary procedure enables the delegation of the appointments process to the Appointments Commission which has built up expertise in health professional regulatory body appointments. The Department therefore considers it appropriate to retain the existing Parliamentary procedure for delegating the appointments process to the Appointments Commission.

Part 3: Public Health Protection

Background

365.  The Public Health (Control of Disease) Act 1984 consolidates earlier legislation, much of it dating back to the 19th century. Many of its assumptions, both about risks and about how society operates, are now out of date. It makes highly detailed provision on some matters (for example, it is a criminal offence to expose a public library book to plague, or to hold a wake over the body of a person who has died of cholera) but does not address others that now seem more relevant, such as contamination by chemicals or radiation. It provides for only a limited range of actions (for example, detaining a person in hospital), when other actions (such as requiring him to stay in his own home, with appropriate health support) could be as effective in terms of protecting public health and therefore more available as they may also interfere less with the person's human rights.

366.  There has been an increased recognition, both domestically and internationally, of the case for taking an "all hazards" approach to dealing with such health threats. Within the UK, the Health Protection Agency (HPA) has been created to provide support and advice in relation to radiation, toxicology, and infectious disease, topics that were previously handled by separate bodies.

367.  Internationally, in May 2005 the World Health Organization (WHO) adopted new International Health Regulations (IHR) which, unlike their predecessors, are concerned with contamination as well as infectious disease. The IHR came into effect in June last year, further strengthening the case for updating the Public Health (Control of Disease) Act 1984. The Department needs to ensure that the appropriate Minister is able to take, where he considers it appropriate, the sort of actions that WHO have indicated they might recommend under the IHR in response to specific threats.

368.  The new legislation will create flexible, proportionate and comprehensive powers to deal swiftly with a significant threat to public health brought about through the incidence or spread of infection or contamination. The Department intends to consult fully on all non urgent regulations under each of the powers in accordance with Cabinet Office guidance.

Clause 123 (Section 45B): Public health protection

Health protection regulations: international travel etc.

Power conferred on: the appropriate Minister, defined as the Secretary of State for England and the Welsh Ministers for Wales

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution (unless amending primary legislation, in which case will be subject to affirmative resolution)

369.  New section 45B gives the appropriate Minister power to make regulations to prevent danger to public health from conveyances arriving at any place. It also enables regulations to prevent the spread of infection or contamination by conveyances leaving any place, or from the articles or persons on board (or attempting to board) those conveyances. Airports, shipping ports and international train terminals are places where large numbers of people and articles enter and leave England and Wales. When people arrive from abroad they may have been exposed to and be carriers of health risks that are not prevalent in the UK. Borders are therefore particularly vulnerable places in relation to the incidence or spread of disease.

370.  With the increase in international travel, airports, train terminals and ports are extremely busy and an interruption to conveyance timetables can have a substantial impact on a large number of people. Therefore, any action to protect public health needs to be taken swiftly and be proportionate to avoid unnecessary interference with international traffic and trade.

371.  The Department believes secondary legislation is the most appropriate way to address public health threats at borders because threats can change and evolve, means of transport and travel can develop, requiring different approaches, and new international recommendations can be passed requiring a swift response. For example, this year the Department updated the Public Health (Ships) Regulations 1979, (S.I. 1979/1435) to adopt the IHR ship sanitation certificates in time for the coming into force of the IHR in June 2007.

372.  The Public Health (Aircraft) Regulations 1979 (S.I. 1979/1434), the Public Health (Ships) Regulations 1979, and the Public Health (International Trains) Regulations 1994 (S.I. 1994/311) were made under section 13 of the Public Health (Control of Disease) Act 1984. They deal with particular measures that a local authority or port health authority may need to take at an international border to prevent the spread of infectious disease but for the most part reflect the circumstances of nearly thirty years ago, when movement across borders was less common and less rapid than it is now.

373.  The Association of Port Health Authorities has provided examples of how they would wish to be able to use these powers in future. They mentioned a case where an aircraft had a consignment of giant African Land snails, which resulted in liquor at the bottom of the aircraft container bins. These snails are known to sometimes have parasites that can cause meningitis. The powers could ensure that regulations enable a port health authority to require that, before the aircraft container bins could be put back into use (e.g. for transporting goods which could be foodstuffs) the airline disinfect the container bins.

374.  In England, the Department intends to use the powers in section 45B to update the existing regulations to ensure they take account of modern circumstances, including the new IHR and recognition of the risks posed by contamination as well as infectious disease. The Department will also recast the provisions so that they dovetail with the new broader and more flexible 'in-country' powers afforded to a justice of the peace. For example, the Department may introduce requirements for port health authorities and local authorities to cooperate when an individual at a point of entry has been found to be in need of continued health monitoring.

375.  The Department intends that local authorities and port health authorities should continue to have powers with regard to conveyances arriving at or leaving any place that would under the new provisions otherwise be afforded to a justice of the peace. Due to the volume of activity at borders and given the need to avoid disruption to trade and travel, it would not be practical to involve justices of the peace at points of entry. For example, the intention is that local authorities will, as now (although currently the powers are limited to infectious disease), have the power to require an individual arriving in England who is thought to be infected or contaminated to undergo a medical examination. Article 23 of the IHR prohibits the regulations from allowing any measure that is not the least intrusive that would achieve the public health aim. It must also be a non-invasive measure.

376.  The IHR and other international agreements such as the Universal Declaration of Human Rights provide safeguards for human rights in the application of measures at points of entry. The Department believes that rights under the European Convention on Human Rights are fully covered by the IHR which means that where regulations under section 45B give effect to the IHR there should be no greater need for scrutiny with the new regulations for Convention compliance purposes than there has been in the past.

377.  The Department has agreed to work with Scotland, Wales and Northern Ireland to secure that regulations under section 45B are compatible with legislation in those countries, for the convenience of conveyance operators across the UK. The regulations are to be subject to the negative resolution procedure. The existing powers are subject to the negative resolution procedure. To the Department's knowledge, no provisions under them have been challenged since 1979.

378.  The regulation making powers in section 45B also enable regulations to be made for giving effect to any international agreement or arrangement relating to the spread of infection or contamination. An example might be the resolution calling for voluntary early implementation of measures relevant to avian flu with pandemic potential, passed unanimously on 26 May 2005 by the World Health Assembly, Global Health Security Initiative and Group of 8.

379.  The Department has worded the provision in section 45B(1)(c) so as to enable the Government to choose how to give effect to international agreements or arrangements. It may be that the Government does not want to adopt a recommendation wholesale, or the Government might in some cases want to go slightly further than the recommendation requires. Secondary legislation is the most appropriate vehicle for enabling the adoption of such recommendations because it allows a rapid and flexible response and it is not possible to know now what agreements, arrangements or recommendations there will be in the future that the Government may wish to give effect to. Consistently with the precursor power in section 13 of the Act, the negative procedure is appropriate to give effect to an international agreement which has already undergone debate in international fora.

380.  However, the Department realises that in order to facilitate some of these recommendations it may at times be necessary to amend domestic legislation. Section 45F(3) would enable this. Where this is necessary the regulations would be subject to the fullest Parliamentary scrutiny through an affirmative resolution procedure (section 45Q(2)(b) and (4)). In cases of urgency however, the need to act swiftly may override the immediate need for full Parliamentary scrutiny, and section 45R allows for this. Such regulations however (i) must contain a statement by the appropriate Minister making them that the Minister is of the opinion that it is necessary by reason of urgency for the regulations to be made without undergoing the affirmative resolution procedure described in section 45Q(4) (see section 45R(2)), (ii) the regulations must be agreed by a resolution of each House of Parliament (or in Wales by the National Assembly for Wales) within 28 days in order to continue in force (section 45R(4)) and (iii) if at any point during the 28 days, a debate under section 45R(5) ends with a vote rejecting the regulations, the regulations will cease to have force at the end of that day. These safeguards should help ensure that the power is not abused.

Clause 123 (Section 45C): Public health protection

Health protection regulations: Domestic

Power conferred on: the appropriate Minister, defined as the Secretary of State for England and the Welsh Ministers for Wales

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: affirmative resolution, unless the regulations contain a declaration that the person making them is of the opinion that the instrument does not contain any provision made by virtue of section 45C(3)(c) which imposes or enables the imposition of a special restriction or requirement or any other restriction or requirement which has or would have a significant effect on a person's rights, in which case, subject to negative resolution

381.  New section 45C provides powers for the appropriate Minister to make provision by regulations for the purpose of preventing, protecting against, controlling or providing a public health response to the incidence or spread of infection or contamination. The wording "prevent, protect against, control or provide a public health response to" is intended to cover the range of potential responses to public health threats arising from infection or contamination. By section 45A(3), the infection or contamination is one which presents or could present significant harm to human health.

382.  This general regulation making power is intended to be used for two purposes:

  • to create standing regulations regarding permanent preparedness; and
  • to create regulations providing additional safeguards for particular situations allowing the Secretary of State (or the Welsh Ministers) to respond swiftly to a serious and imminent threat to public health where it is not already covered by the preparedness provisions.

383.  The examples below set out how the Department intends to use the powers.

Standing Preparedness

384.  Examples of the standing preparedness provisions the Government intends to make include:

  • regulations requiring information on cases of infection or contamination (previously called notifiable diseases);
  • regulations providing local authorities with certain powers, including the power under section 45C(4)(a) for infected children to be kept away from school for the protection of other children and teachers.

Information regulations

385.  The Department envisages that regulations under section 45C(3)(a) will update the standing national information requirements imposed on registered medical practitioners to notify the local authority of cases or suspected cases of specified diseases or disease syndromes. The regulations are likely to formalise the arrangements whereby local authorities will continue, as they do now, to pass the information on to the HPA (and see the proposed regulations enabling notices to be given electronically under new section 60A of the Public Health (Control of Disease) Act 1984). The Department intends that the regulations will also create new standing national information requirements imposed on laboratories to notify the local authority and HPA of the causative agents of specified diseases or disease syndromes. The power is also intended to be used to require laboratories that test food samples to notify the local authority and the Food Standards Agency of the detection of specified pathogens that may be harmful to human health. The diseases, disease syndromes and their causative agents will be those that require urgent investigation and action to protect public health. It is envisaged that further urgent investigation and action may be carried out in specified circumstances by the local authority under regulations made under section 45C(3)(c).

386.  The power in section 45C(3)(b) is needed to enable statutory underpinning in future of the current voluntary laboratory surveillance regime whereby laboratories provide information to the HPA over long timescales to enable the HPA to monitor trends, identify unusual disease patterns, identify and evaluate interventions and inform healthcare planning.

387.  The current regime splits notifiable diseases between section 11 of the Public Health (Control of Disease) Act 1984, and the Public Health (Infectious Diseases) Regulations 1988 (S.I. 1988/1546) (the Infectious Diseases Regulations). The Infectious Diseases Regulations then apply different primary legislative measures to different diseases requiring the practitioner, local authority or member of the public to refer to both the secondary and the primary legislation to see what they could or should be doing in relation to any particular disease.

388.  The Department believes that placing all the notification requirements in secondary legislation will ensure that those concerned (registered medical practitioners, laboratories and local authorities) will have one clear document stating what they must do by way of notification. Delegated legislation is appropriate to enable the lists of specified diseases or disease syndromes to be amended to keep up to date with changes in epidemiology and the emergence of new health risks.

389.  Regulations under section 45C(3)(a) or (b) (if not with other provision subject to the affirmative resolution procedure in section 45Q(4)) would contain a declaration that the person making them was of the opinion that the instrument does not contain any provision made by virtue of section 45C(3)(c) which imposes or enables the imposition of a special restriction or requirement or any other restriction or requirement which has or would have a significant effect on a person's rights in accordance with section 45Q(3). The regulations would be subject to the negative resolution procedure under section 45Q(1). The negative resolution procedure is appropriate for such technical details. At present the standing notification requirements in the Infectious Diseases Regulations are subject to the negative resolution procedure. The new regulations are not intended to be any more intrusive.

Local authority powers

390.  The Public Health (Control of Disease) Act 1984 contains specific powers enabling local authorities to take action without application to a justice of the peace. The Department intends to provide in regulations under section 45C for some of these powers which the Department believes are still relevant to preventing the incidence or spread of infection or contamination (but not for others such as the prohibition against a person infected with plague returning a library book). For example, under section 21 of the Public Health (Control of Disease) Act 1984 a local authority can require a child to stay away from school in certain circumstances. The Department does not believe that requiring a child to stay away from school should require an application to a justice of the peace. In most cases, parents will voluntarily cooperate to keep their child from infecting others.

391.  The HPA reports that local authorities rarely have to use the existing provision. The threat of using the provision is usually enough to gain cooperation. However for the threat to be effective, a legislative provision is needed. Section 45D restricts use of the powers to make regulations under section 45C so that regulations under section 45C(3)(c) and (4)(a) enabling a local authority to require a child to be kept away from school would need to impose on a local authority the proportionality test in section 45D(2). The regulations would need to provide that a decision under the provision may only be taken if the person taking the decision considers, when taking it, that keeping a child away from school is proportionate to what is to be achieved by imposing the requirement. Provision enabling a local authority to require a child to be kept away from school under section 45C(3)(c) and 45(4)(a) would normally apply for a short time only, and the Department of Health and the Department for Children, Schools and Families have a protocol to ensure that children who are ill receive appropriate education even when they are kept away from school[4] so the provision is likely to be proportionate. Having a delegated power will enable the regulations to specify the circumstances in which a child should be kept away from school, and to ensure that the provisions are commensurate with scientific knowledge in relation to the spread of infection amongst children.

392.  The likelihood is that such provision would be included in the first set of regulations made under section 45C(3)(c) so would be with other provision subject to the affirmative resolution procedure. However it is possible that subsequent regulations amending the provision would contain a declaration that the person making them was of the opinion that the instrument does not contain any provision made by virtue of section 45C(3)(c) which imposes or enables the imposition of a special restriction or requirement or any other restriction or requirement which has or would have a significant effect on a person's rights and would be subject to the negative resolution procedure under section 45Q(1) for the reasons indicated in the declaration.

393.  Regulations under section 45C(1) and 45F(2)(a) may be exercised to enable a local authority to offer disinfection or decontamination services. Delegated legislative power enables provision for such services to reflect new techniques or limitations in relation to the use of particular products and to be kept up-to-date. The proportionality test in section 45D(1) or (2) would not be relevant as the regulations would not impose or enable the imposition of any restriction or requirement. Therefore the regulations, if not with other provision subject to the affirmative resolution procedure, would contain a declaration that the person making them was of the opinion that the instrument does not contain any provision made by virtue of section 45C(3)(c) which imposes or enables the imposition of a special restriction or requirement or any other restriction or requirement which has or would have a significant effect on a person's rights. Appropriately for regulations on technical matters that are not intrusive, the regulations would be subject to the negative resolution procedure under section 45Q(1).

394.   Another potential use of the powers is to impose in regulations a requirement that a local authority in prescribed circumstances investigate an outbreak, for example of a particular airborne infectious disease in its area by requiring information from the owners of premises with air conditioning units or other types of relevant establishments. The information to be required may consist of names and contact details of persons who had attended those types of premises within a prescribed period of detection of the outbreak. Delegated legislation is appropriate as the diseases that may need to be investigated as well as scientific knowledge of the aetiology of the disease may change.

395.  Under section 45D(1) the appropriate Minister would need to consider when making the regulations whether the requirement to investigate to be imposed on the local authority was proportionate to what was sought to be achieved by it. Under section 45D(2) the regulations would need to provide that the local authority could only require the owner of relevant premises to provide information if the person taking the decision on behalf of the local authority considered, when taking the decision, that the requirement was proportionate to what was sought to be achieved by imposing it. As enabling the imposition of a requirement to provide information consisting of the names and contact details of a customer or other third party could engage the right to respect for private and family life of a person the person making the regulations would not be able to come to the view that the regulations would not have a significant effect on a person's rights so as to enable the regulations to contain the declaration set out at section 45Q(3). The regulations would be subject to the affirmative resolution procedure under section 45Q(4) by virtue of section 45Q(2). Affirmative resolution procedure is appropriate, amongst other reasons as the measures used to investigate the outbreak may affect a person's rights.

396.  The Department intends that regulations under section 45C(1) and 45F(2)(g) will enable local authorities to meet or contribute to the costs that individuals incur, whether the individuals incur such costs on a voluntary basis or under a requirement set out in regulations, to prevent the spread of disease. Delegated powers enable the provision to be tailored to circumstances where the provision is appropriate. Regulations containing such provision, if not with other provision subject to the affirmative resolution procedure, would contain a declaration that the person making them was of the opinion that the instrument did not contain any provision made by virtue of section 45C(3)(c) which imposes or enables the imposition of a special restriction or requirement or any other restriction or requirement which has or would have a significant effect on a person's rights. The regulations would be subject to the negative resolution procedure under section 45Q(1) for the reasons indicated in the declaration.

Additional safeguards

397.  Regulations providing additional safeguards for particular situations would be made as and when they were required, under sections 45C(1), 45C(3)(c) and 45C(4). They would often be temporary to deal with a specific set of circumstances. Section 45C(1) makes it clear that the regulations may only be made for the purpose of preventing, protecting against, controlling, or providing a public health response to the incidence or spread of infection or contamination. Delegated powers are appropriate to deal with future unpredictable circumstances including incidents such as the polonium 210 poisoning in London and new diseases such as SARS, to enable the provisions to be tailored to the circumstances. However the Department does not intend to burden the statute book with regulations for situations that are unlikely to arise in practice, so the examples given are not intended to do more than demonstrate how the powers and legislative procedures work.

398.  Regulations under section 45C(1) and 45C(3)(c) might, but by way of a hypothetical example only of an additional safeguard, require local authorities to post in prominent places the symptoms of a specific disease, so that anyone who suspects they may be infected or contaminated could seek medical attention. Such provision could not be included in regulations unless the appropriate Minister considered when making the regulations that the requirement was proportionate to what was to be achieved by imposing it in accordance with section 45D(1). As the regulations would not have a significant effect on a person's rights the regulations would contain the declaration in section 45Q(3) and accordingly be subject to the negative resolution procedure under section 45Q(1).

399.  Any additional safeguard regulations which imposed, or enabled a local authority or other person to impose a restriction or requirement under section 45C(3)(c) would be subject to the proportionality tests in section 45D(1) or (2) (as are standing regulations under section 45C(3)(c)). By section 45D(1) the appropriate Minister would not be able to impose such a restriction or requirement unless the appropriate Minister considered when making the regulations that the restriction or requirement was proportionate to what was sought to be achieved by imposing it. Under section 45D(2) the regulations would not be able to include provision enabling the imposition of a restriction or requirement unless the regulations containing it provided that a decision under the provision may only be taken if the person taking the decision considers, when taking it, that the restriction or requirement is proportionate to what is to be achieved by imposing it.

400.  Many of the actions that might be imposed by way of additional safeguards would be similar to the measures that could be required by a justice of the peace. If the person making the regulations cannot say that regulations do not contain any provision which imposes or enables the imposition of a restriction or requirement which has or would have a significant effect on a person's rights, then the regulations would be subject to the affirmative resolution procedure by virtue of section 45Q(2). It is appropriate that provision for such measures should be subject to the additional Parliamentary scrutiny provided by an affirmative resolution procedure. The Department believes that most 'additional safeguard' regulations made under section 45C(3)(c) are likely to be subject to the affirmative resolution procedure.

401.  Under section 45C(3)(c), (4)(d), and 45D(3) the appropriate Minister may by regulations impose a special restriction or requirement that a justice of the peace could impose for example a requirement to wear protective clothing in prescribed circumstances, provided that it is not a measure requiring or restricting medical examination, removal to or detention in hospital or another establishment or the quarantine or isolation of persons. A "special restriction or requirement" is defined in section 45C(6). The appropriate Minister may impose such a restriction or requirement even in the absence of a serious and imminent threat. This is to allow for regulations needed to ensure preparedness and protection before a threat becomes serious and imminent. However, the provisions might not be for standing preparedness, as they might involve one off actions to protect against a particular threat, such as the risk of avian flu mutating into pandemic flu. The power is in delegated legislation to enable a flexible and tailored response to a future threat.

402.  By section 45D(1) the appropriate Minister would not be able to impose the measure unless the appropriate Minister considered when making the regulations that the restriction or requirement was proportionate to what was sought to be achieved by imposing it. As the regulations would contain a special restriction or requirement so could not contain the declaration in section 45Q(3) they would be subject to full debate in each House of Parliament (or in Wales by the National Assembly for Wales) by virtue of section 45Q(2)(a) under the affirmative resolution procedure in section 45Q(4), so that Parliament would decide whether the measure was appropriate.

403.  Section 45D(4)(a) and (b) restrict the use of powers under section 45C(3)(c) and 45C(4)(d) that enable a local authority or other person to impose a restriction or requirement that a justice of the peace could impose under sections 45G(2), 45H(2) or 45I(2) (other than those at section 45C(4)(a), (b) or (c)), known as a "special restriction or requirement" by virtue of section 45C(6). Regulations may not enable the imposition of a special restriction or requirement except in response to or contingent on there being a serious or imminent threat to public health.

404.  If the regulations required a local authority or other person to impose the special restriction or requirement, under section 45D(1) the appropriate Minister would need to consider when making the regulations whether the requirement was proportionate to what was sought to be achieved by it. As the regulations would enable the local authority or other person to impose the measure, under section 45D(2) the regulations would need to provide that the restriction or requirement could only be imposed if, at the time the decision to impose it is taken, the person taking the decision considers that the restriction or requirement is proportionate to what is sought to be achieved by imposing it. As the restriction or requirement the decision maker is able to impose would be a special restriction or requirement, under section 45D(4)(a) the regulations would need to be made in response to a serious and imminent threat. Alternatively under section 45D(4)(b) they could be made in advance but the regulations would need to provide that the decision to impose the measure could not be taken except in the event of a serious and imminent threat to public health. As the decision would be one by which a special restriction or requirement was imposed on or in relation to a person, thing or premises the regulations would need to include provision for a right of appeal to a magistrates' court under section 45F(6) and, if the special restriction or requirement were to continue, provision also for a right of periodic review under section 45F(7). The regulations could not contain the declaration set out at section 45Q(3) as they would contain a special restriction or requirement. The regulations would be subject to the affirmative resolution procedure under section 45Q(4) by virtue of section 45Q(2)(a).

405.  Such regulations could be made in advance subject to the affirmative resolution procedure to allow provisions to be in place in anticipation of a serious and imminent threat. The measures in the regulations could be adapted and updated following incidents, based on lessons learned. For these reasons of flexibility amongst others it is appropriate for such matters to be dealt with in delegated legislation. The affirmative resolution procedure ensures that Parliament (and in Wales the National Assembly for Wales) can decide whether the imposition of the measures would be appropriate.

406.  New section 45R will allow regulations under section 45C declared by the appropriate Minister as necessary by reason of urgency (section 45R(2)) to be made that can come into effect immediately. In certain circumstances, the need to act swiftly may override the immediate need for full Parliamentary scrutiny. But such regulations must be agreed by a resolution of each House (or in Wales by the National Assembly for Wales) within 28 days in order to continue in force (section 45R(4)). However, section 45R(5) provides the security that at any point during the 28 days, if a debate ends with a vote rejecting the regulations, the regulations will cease to have force at the end of that day.

407.  A measure that is urgent will not necessarily be highly intrusive. For example, the measure might be a requirement that a person visiting another with a particular disease in hospital wear a mask. It may therefore not be a high priority for debate in the Houses of Parliament. The Department believes 28 days will allow enough time to arrange a debate in each House even where the requirement passed by regulations is a relatively minor yet urgent one, where debating whether the measure stays in force may not take priority over more pressing Parliamentary business.

Clause 123(Sections 45G(7), 45H(7) and 45I(7)): Public health protection

Regulations making provisions about the evidence that should be available to a justice of the peace

Power conferred on: the appropriate Minister, defined as the Secretary of State for England and the Welsh Ministers for Wales

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: the first set of regulations under section 45G(7) are to be subject to affirmative resolution, subsequent regulations subject to negative resolution; and regulations under section 45H(7) or 45(I)(7) subject to negative resolution unless in an instrument which also contains provisions mentioned in section 45Q(2), in particular the first set of regulations under section 45G(7), in which case, subject to affirmative resolution

408.  A justice of the peace may make orders at the request of the local authority to impose restrictions or requirements on a person, or in relation to things or premises or in relation to a group of persons, things or premises (known as a Part 2A order). The regulation making power in section 45G(7) requires the appropriate Minister to set out what evidence must be presented to the justice of the peace before the justice can be satisfied that it is necessary to make an order in relation to a person, including an order to require a person to provide information about the identity of a related party. The evidence might relate to the nature of infection or contamination or the efficacy of the measures that might be imposed under an order. The requirement to make regulations under section 45G(7) will assist to ensure that evidence presented to a justice of the peace in relation to requirements or restrictions to be placed on persons is of a consistent standard. For example the regulations may require a recommendation from a registered medical practitioner with particular expertise before an order may be made to detain or quarantine someone who is or may be infected or contaminated with a particular disease. As infections or contaminations may change, and scientific knowledge about the nature of particular infections or contaminations and the efficacy of measures is likely to change over time, the matters are appropriate for delegated legislation.

409.  The first set of regulations under section 45G(7) would be subject to an affirmative resolution procedure allowing Parliament (and the National Assembly for Wales) to fully scrutinise the parameters of the evidence to be put before justices of the peace to assist them to decide whether an order in relation to a person is necessary. Subsequent amending legislation is likely to be used mostly to keep the provisions up to date with current scientific knowledge so is appropriately subject to the negative resolution procedure.

410.  Similarly the appropriate Minister may make regulations under the powers in sections 45H(7) and 45I(7) in relation to evidence which must be produced when applying to a justice of the peace for a Part 2A order regarding things or premises, or information about related contacts of things or premises. It may not be necessary to specify such requirements where, for example premises are not private, or things are believed to have been abandoned. As the evidence is likely to be routine though specialist in nature, it is appropriate that provision in regulations for evidence in relation to things or premises should be subject to delegated legislation and to the negative resolution procedure.

Clause 123 (Section 45L(4)): Public health protection

Regulations prescribing the maximum period of any extension by order of a justice of the peace under section 45L(2) in relation to restrictions or requirements mentioned in section 45G(2)(c) or (d) that are imposed in a Part 2A order or the maximum period for which any restriction or requirement other than under section 45G(2)(c) or (d) may be imposed in a Part 2A order or the maximum period of any extension of such restriction or requirement

Power conferred on: the appropriate Minister, defined as the Secretary of State for England and the Welsh Ministers for Wales

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution, unless in an instrument which also contains provisions mentioned in section 45Q(2), in particular, the first set of regulations under section 45G(7), in which case, subject to affirmative resolution

411.  A Part 2A order is required by section 45L(1) to specify the period for which any restriction or requirement imposed by or under the order is to remain in force. A restriction or requirement mentioned in section 45G(2)(c) or (d) consisting of detention in hospital or other suitable establishment or quarantine or isolation must not exceed 28 days, but a period in respect of any restriction or requirement may be extended by a further order of the justice of the peace. The regulation making power in section 45L(4) enables the appropriate Minister to make provision for the maximum period of an extension of a detention, or other maximum periods in respect of other restrictions or requirements or extensions of them. A regulation making power is needed to be able to ensure consistency in the periods to which persons affected by orders are subject to measures, and for the guidance of justices of the peace in this technical area. It is appropriate for such provision to be in delegated legislation for flexibility in dealing with changing or as yet unknown infections or contaminations, the aetiology of each disease including when the disease is no longer able to spread, or circumstances relating to measures to address a disease such as the length of time a course of training or advice sessions might run. The negative resolution procedure is appropriate to deal with technical and varied matters such as lengths of infectiousness or time between exposure and expression of different diseases or periods measures should be in force to be effective.

Clause 123 (Section 45M(5)(e), (6)(c), (7)(c) and (8)): Public health protection

Regulations prescribing persons who are affected persons for the purpose of applying for variation or revocation of a Part 2A order

Power conferred on: the appropriate Minister, defined as the Secretary of State for England and the Welsh Minister for Wales

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution unless in an instrument which also contains provisions mentioned in section 45Q(2), in particular the first set of regulations under section 45G(7), in which case, subject to affirmative resolution

412.  A Part 2A order may be varied or revoked by a justice of the peace on the application of an affected person (amongst others) under section 45M(4). The regulation making powers in section 45M(5)(e), (6)(c), (7)(c) and (8) enable the appropriate Minister to make provision for who may be an affected person in the case of a Part 2A order under each of sections 45G, 45H(2), 45I(2) or section 45H(4) or 45I(4) respectively. Regulation making powers are needed to be able to ensure consistency in magistrates' courts throughout England or Wales respectively as to who may apply for such orders and for the guidance of justices of the peace in this technical area. Delegated legislation under the negative resolution procedure is appropriate to deal with such technical administrative matters.

Clause 123 (Section 45N)): Public health protection

Regulations about the taking of measures pursuant to Part 2A orders

Power conferred on: the appropriate Minister, defined as the Secretary of State for England and the Welsh Ministers for Wales

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution unless in an instrument which also contains provisions mentioned in section 45Q(2), in particular the first set of regulations under section 45G(7), in which case, subject to affirmative resolution

413.  Regulations under the power in section 45N may make provision about the taking of measures and help to set the parameters within which measures imposed under orders of a justice of the peace under sections 45G, 45H and 45I may operate. Section 45N(2) lists the types of provision that may be included. The provisions that might be made in regulations include how and by whom measures in orders could be carried out. The appropriate Minister may wish to stipulate, or restrict, which organisations may assist the local authority in the monitoring of quarantine orders, to ensure that only appropriately qualified staff is involved. The powers allow the appropriate Minister to make regulations regarding who is liable for the costs or compensation payable in relation to measures imposed under justice of the peace orders. For example, the appropriate Minister may wish to limit local authority powers to recover costs from individuals in receipt of income support.

414.  These matters are appropriately addressed in secondary legislation to keep them up to date so that, for example, if private health firms hire individuals with the appropriate qualifications to enforce quarantine, the regulations can include them as possible enforcers. Alternatively if it becomes apparent that an enforcement regime is not appropriate it can be prohibited. While the powers provided to a justice of the peace under sections 45G, 45H and 45I sit well with the existing role of a justice of the peace, and simply extend the role already afforded to justices under the Public Health (Control of Disease) Act 1984, the regulations are intended to ensure that the orders have a national consistency. These are technical and administrative matters and as such are suitable for delegated legislation subject to the negative resolution procedure.

Schedule 11: Public health protection: further amendments

Paragraph 15: Electronic communications

Power conferred on: the appropriate Minister, defined as the Secretary of State for England and the Welsh Ministers for Wales

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

415.  Schedule 11, paragraph 15 introduces a new section 60A. This section enables the appropriate Minister through regulations to enable notices, orders and other documents to be given or served electronically where the recipient has stated in writing that they are willing to receive it in this way. The power is expected to be most relevant in enabling provision for registered medical practitioners and laboratories to email the local authority and HPA with recorded cases of infection or contamination under regulations made under section 45C(3)(a).

416.  Delegated powers are needed so that the provisions can be extended to cover any new notices, orders or documents that may be created through regulation making powers in sections 45B or 45C. It may not always be desirable to allow a notice, order or document to be provided solely in electronic format, which is why the provision was not appropriate for primary legislation covering all documents. The regulations will deal with administrative and technical matters and therefore the negative resolution procedure is appropriate.

Schedule 11: Public health protection: further amendments

Paragraph 25: Default Powers

Power conferred on: the appropriate Minister, defined as the Secretary of State for England and the Welsh Ministers for Wales

Powers exercisable by: orders made by statutory instrument

Parliamentary procedure: none

417.  Schedule 11, paragraph 25 replaces old section 71 with a new section 71. This enables the appropriate Minister to make an order. The purpose of the order is to indicate that the appropriate Minister considers the relevant health protection authority named in the order to have failed to discharge its functions and to direct the authority as to how the function should be discharged. The provision also allows the appropriate Minister to enforce the order by a further mandatory order or to make a further order to provide for the functions of the authority in default to be transferred to the appropriate Minister or another public authority.

418.  Provision to deal with default by an authority is appropriate for delegated legislation as the circumstances in which an authority might be in default under the Act cannot be anticipated and provided for on the face of the legislation. The order making procedure is sufficiently formal to ensure transparency and clarity. The orders do not require Parliamentary scrutiny. This will enable an order to be made without delay when public health may be at risk because a local authority is not carrying out their functions effectively.

Part 4: Health in Pregnancy Grants

419.  The Health in Pregnancy Grant clauses set out the scope of this new policy, for which we propose to cover the bulk of the detail in regulations. These will be made by HM Treasury and the Commissioners for Her Majesty's Revenue and Customs and will, in general, be subject to the negative resolution procedure. On the whole this approach is consistent with that followed for other social security benefits and is appropriate because the matters in regulations need to have in built flexibility to enable the grant to respond to changing requirements and to allow changes to be reflected quickly. For example defining a "health professional" in regulations rather than in primary legislation will allow for changes to be made where there are changes in definition or additional health professionals are to be included.

420.  As a result, the grant will be able to respond to the changing needs of expectant mothers, in order that during this relatively short period of time, there is flexibility to ensure that as many entitled women as possible are able to gain the maximum benefit from any potential changes.

421.  There are provisions that will be subject to a mix of both negative and affirmative resolution by both Houses of Parliament. These regulations concern decisions and appeals and are made under the Social Security Act 1998 as inserted by clauses 126 and 127, and the Northern Ireland equivalents clauses 129 and 130. This is appropriate because it is important that the House will have the opportunity to readily apply closer scrutiny to the matter of decisions and appeals. However, we still require a degree of flexibility and therefore propose that the provisions are detailed in regulations and not on the face of the Bill. Again, this is consistent with overall approach followed for decision and appeal provisions in respect of other social security benefits.

Clause 125: Entitlement: Great Britain

Power conferred on: HM Treasury

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

422.  Clause 125 inserts a new section 140A(1) into the Social Security Contributions and Benefits Act 1992. This section provides for general conditions of entitlement to the grant in relation to a pregnancy. We believe that the degree of detail required for the entitlement provisions means it is better to set the requirement out in regulations rather than in the Bill. This will allow for greater flexibility should the provisions require amending at a future date in order to respond to changes in the delivery of maternity care.

423.  Regulations of this type are routinely used to define eligibility throughout the Social Security legislation, for example in Child Benefit, and it is therefore considered that the negative procedure is appropriate.

424.  Section 140A(2) provides for conditions in relation to a pregnancy under subsection (1) in order to be entitled to the grant. This power is necessary to set out basic conditions in respect of a woman who is pregnant and to accommodate those cases where a woman has given birth before a claim could otherwise be made.

425.  In order that we might adapt to necessary changes in entitlement quickly, prescribing conditions relating to a pregnancy in secondary regulations rather than in primary legislation will provide greater flexibility.

426.  Section 140A(4) provides for HM Treasury to prescribe for the purposes of subsection (3)(b), circumstances in which a woman is treated as being or not being, in Great Britain. As a consequence of the requirement under subsection (3)(b), a pregnant woman must be resident in Great Britain at the time she makes a claim.

427.  Section 140A(4) is therefore necessary to ensure that we do not exclude from entitlement those who are absent from Great Britain in specific circumstances, such as the partners of crown servants posted overseas, or the children of crown servants posted overseas providing they are living with them. This is not a contentious issue and precedent can also be found in relation to other benefits including Child Benefit. The negative resolution procedure is therefore appropriate in this case.

428.  Section 140A(5) provides the definition of a health professional for the purpose sub-section (3)(a). The definition of a "health professional" may change as definitions and health professions evolve. This power therefore allows for these details to be set in secondary legislation where they can be amended more easily. Any changes to definition or health professions will not be regulated by Her Majesty's Revenue and Customs but will need to be implemented for the purposes of the grant quickly to ensure minimum disruption to claimants. The negative procedure is therefore appropriate in this case.

429.  Clause 125, section 140B(1) enables HM Treasury to prescribe in regulations the amount of the grant. Prescribing rates for benefits in regulations is commonplace although, as a rule, such regulations require affirmative resolution. However, we believe that given the short time window for applying for the grant, the negative resolution procedure, which is followed in respect of changes to the rate of the Sure Start Maternity Grant, is appropriate in this instance. This will enable HM Treasury to make changes in the rates as quickly as possible in order that they have the maximum impact.

430.  Section 140B(2) enables regulations to be made to provide for different rates to be payable in different circumstances. HM Treasury will not presently be exercising this power. However there may be circumstances in the future in which the Government should wish to alter the amount to be paid in different cases as a result of desired changes to the financial support provided to parents.

431.  Clause 128 introduces the same provisions into the equivalent Northern Ireland legislation by inserting a new Part 8A into the Social Security Contributions and Benefits (Northern Ireland) Act 1992.

Clause 126: Administration: Great Britain

Power conferred on: the Commissioners for Her Majesty's Revenue and Customs

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution, except for some regulations made under subsection (6) (see explanation below)

Manner and time of claim

432.  Clause 126, subsection (1) amends section 5, subsection (2) of the Social Security Administration Act 1992, by inserting reference to the Health in Pregnancy Grant. Subsection (2) provides the power for the Commissioners for Her Majesty's Revenue and Customs to exercise the powers provided under section 5 of the Social Security Administration Act to prescribe in regulations matters regarding the claiming and payment of the Health in Pregnancy Grant.

433.  Section 5 of the Social Security Administration Act provides in respect of most social security benefits, powers to prescribe in regulations the details concerning the making of claims and payment of benefits. Bringing the Health in Pregnancy Grant within the scope of this measure ensures consistency with other social security benefits and will deliver a flexible system. Regulations made under these powers will permit claims to be made in a variety of ways in the future, for such documents and information to be provided by claimants as may be required, and to allow for another person to claim the grant on behalf of the pregnant woman, when for particular reasons she is unable to act on her own behalf. This provision deals with the clarification of administrative details associated with applications to the grant and the negative procedure is therefore appropriate.

434.  Clause 129 inserts the same provision into the equivalent Northern Ireland legislation by amending section 5 of the Social Security Administration (Northern Ireland) Act 1992.

Proof of Identity: Requirement to have a National Insurance Number

435.  Clause 126 subsection (3) inserts a new section 12A to the Social Security Administration Act 1992 making entitlement to Health in Pregnancy Grant conditional on the production of proof of identity. As with other benefits, all women claiming Health in Pregnancy Grant will be required either to state their national insurance number if they have one, to give proof that it is theirs, or to provide sufficient information that would enable them to be allocated a national insurance number. Paragraph 5 of section 12A enables regulations to be made to exempt certain categories of people from the requirement of producing a national insurance number.

436.  In consideration of the degree of detail necessary to provide for the exemptions, and to enable it to react quickly to future changes, the Department views secondary legislation as being more suitable. This provision is found in other benefits, including Child Benefit and does not seem to be a contentious issue and therefore the negative procedure is appropriate.

437.  Clause 129 introduces the same provision into the equivalent Northern Ireland legislation by inserting a new section 10A into the Social Security Administration (Northern Ireland) Act 1992.

Recovery of overpayments

438.  Clause 126 subsection (4) amends section 71(11) of the Social Security Administration Act 1992 (c.5) to insert paragraph (ea) in order that Her Majesty's Revenue and Customs are able to recover overpayments that arise as a direct result of the misrepresentation of, or failure to disclose material information by a claimant.

439.  Section 71 of the Administration Act provides the basis on which questions of whether overpaid social security benefits are recoverable are determined. The section contains regulation making powers. It is envisaged that we will make regulations as necessary to provide for the recovery of overpayments of the Health in Pregnancy Grant that are consistent with the general approach adopted in respect of other benefits. The detail of such provisions will be introduced by secondary legislation to enable any changes to the provisions to be implemented as required. The recovery of overpayments in relation to other Social Security Benefits is subject to the negative resolution procedure and we consider that an equivalent arrangement would therefore be suitable for the Health in Pregnancy Grant.

440.  Clause 129 makes the same amendment to the equivalent Northern Ireland legislation by amending section 69 of the Social Security Administration (Northern Ireland) Act 1992.

Decision making and appeals

441.  Clause 126 subsection (7) provides for the Health in Pregnancy Grant to be treated as a relevant benefit for the purposes of the Social Security Act 1998 in relation to all matters relating to decision making and appeals, including which decisions may be appealed and the appeal process. This will ensure that Health in Pregnancy Grant appellants will have similar rights of appeal as appellants in other social security appeal cases and that appeals will be dealt with in the same manner. Regulations made under these provisions are subject to a mix of both negative and affirmative resolution in order that the House can automatically apply closer scrutiny to these matters whilst a degree of flexibility is still maintained by providing for these provisions in regulations rather than in the Bill.

442.  Clause 129 introduces the same provision into the equivalent Northern Ireland legislation by inserting a new section 10A into the Social Security (Northern Ireland) Order 1998.

Clause 127: Penalty: Great Britain

Power conferred on: the Commissioners for Her Majesty's Revenue and Customs

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative and affirmative resolution

443.  Clause 127 subsection (2) inserts Schedule 3A into the Social Security Administration Act 1992, providing for a penalty to be imposed where a person fraudulently or negligently makes an incorrect statement in connection with a claim to the Health in Pregnancy Grant. Paragraph 2(1) of Schedule 3A provides a right of appeal against a determination that a penalty should be imposed and paragraph 2(6) provides the power to make regulations under the provisions contained in the Social Security Act 1998 in relation to all matters relating to decision making and appeals in relation to the imposition of a penalty. This approach ensures that where a person is given notice of a determination imposing a penalty, they will have the same appeal rights as other social security appellants and that their appeal will be handled in the same manner as social security appeals in general. Regulations made under these provisions are subject to a mix of both negative and affirmative resolution.

444.  Clause 130 introduces the same provisions into the equivalent Northern Ireland legislation by inserting a new Schedule 3A into the Social Security (Northern Ireland) Act 1992.

Clause 132: General and supplementary

Power conferred on: HM Treasury

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

445.  Clause 132 subsection (1) amends section 115 of the Immigration and Asylum Act 1999 by inserting a reference to the Health in Pregnancy Grant thereby excluding persons subject to immigration control from entitlement to such benefits. Sub-section (2) of Clause 132 amends subsection (5) of that section of that Act by inserting reference to the Health in Pregnancy Grant.

446.  This provision provides the power to make regulations allowing exceptions to the exclusion from entitlement for persons with certain immigration status. Provision will be made in secondary legislation to provide entitlement to such persons. This will enable regulations to be amended as necessary in the future and parallels the structure that exists elsewhere in benefits including Child Benefit. It is therefore appropriate that the negative procedure be used.

Part 5: Miscellaneous

NHS Indemnity

Clause 135: Indemnity schemes in connection with provision of health services

Power conferred on: Secretary of State, with the consent of the Treasury

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

447.  Clause 135 inserts into subsection (2) of section 71 of the National Health Service Act 2006 additional bodies and persons that can become members of schemes for meeting losses and liabilities of certain bodies; the detail of the various schemes that already exist under section 71 is set out in regulations made under section 71(1) of that Act. The amended power will allow extension of the membership of such schemes to include non-NHS bodies and individuals that may provide health services for the NHS as well as allowing the Secretary of State to be a member of the scheme. The Secretary of State can limit the class or description of bodies which, or other persons who, are eligible to participate in any of the schemes by regulations. Regulations under section 71 can only be made with the consent of the Treasury.

448.  The clause also substitutes subsection (5) of section 71 of the National Health Service Act 2006. The Secretary of State currently has power under section 71(4) to direct eligible bodies to participate in the scheme. The existing subsection (5) exempts NHS foundation trusts from this power of direction and subsection (5) is being substituted to ensure that non-NHS bodies are also exempt from this power of direction.

449.  It is envisaged that the existing regulations establishing the Clinical Negligence Scheme for Trusts (CNST) will be amended to allow non-NHS bodies that provide certain health services for the NHS to be members of CNST. This is to ensure that the same indemnity arrangements can be put in place for certain health services that are now being provided for the NHS by non-NHS bodies or individuals.

450.  Section 71 provides a framework power with the detail of schemes set out in secondary legislation. This provides the flexibility for schemes to be able to respond to the evolving health service environment. Regulations made under section 71 are subject to the negative resolution procedure; the Department does not consider that that the proposed amendments to the power necessitate any change to the negative resolution procedure that currently applies. The regulations will still require the consent of the Treasury.

451.  A Statement of Intent, which is annexed to this document, gives more detail about how the Department intends to use these provisions.

Weighing and measuring of children

Clause 136: Weighing and measuring of children: England

Power conferred on: Secretary of State

Power exercisable by: regulations made by the Secretary of State

Parliamentary procedure: negative resolution

452.  This power enables the making of regulations that lay down detailed provisions for the weighing and measuring of children. It is intended that the weighing and measuring will be conducted initially as part of the National Child Measurement Programme, although it is not restricted to this.

453.  It is intended that the Regulations will provide for weighing and measuring of children to take place in a room or screened area where their privacy will be respected.

454.  The regulations will also cover the conditions which must be satisfied where weighing and measuring take place under the regulations. The first set of regulations under the power will contain provisions which are intended to ensure that weighing and measuring under the regulations complies with the European Convention on Human Rights and data protection legislation by including:

  • a requirement that reasonable steps must be taken to enable parents to withdraw their children from the programme if they wish (opt out);
  • a requirement that where parents indicate that they do not wish to receive information on the height and weight of their children, that reasonable steps are taken to ensure the information will not be sent to them;
  • provisions specifying how the information obtained under the regulations may be processed: the first set of regulations will provide for information to be sent to parents and, after personal identifiers are removed, for it to be processed for management and research purposes.

455.  Parliamentary scrutiny under the affirmative resolution procedure is not considered necessary for the detailed provision which may be made under the regulation making power. That is because:

  • provision for the medical examinations of pupils already appears in primary legislation (Schedule 1 to the National Health Service Act 2006) and the power to weigh and measure will be included within that Schedule; and the information which it is proposed to gather under the new powers will be of low sensitivity as it will comprise purely weight and height information, information which in other contexts is not health information at all;
  • there is a policy commitment that no weighing or measuring will take place if a child's parent "opts" a child out of the programme or where a child refuses to take part.

Clause 137: Weighing and measuring children: Wales

Power conferred on: the Welsh Ministers

Power exercisable by: regulations made by the Welsh Ministers

Procedure: negative resolution

456.  The power enables the making of regulations that lay down detailed provisions for the weighing and measuring children. In particular the regulations will provide for:

  • the selection of children for a weighing and measuring programme;
  • the conditions which must be satisfied where weighing and measuring take place under the regulations.

457.  Scrutiny under the affirmative resolution procedure is not considered necessary for the detailed provision which may be made under the regulation making power.

458.  This is because provision for the medical examinations of pupils already appears in primary legislation (Schedule 1 to the National Health Service (Wales) Act 2006) and the power to weigh and measure will be included within that Schedule. In addition, the information which it is proposed to gather under the new powers will be of low sensitivity as it will comprise purely weight and height information, information which in other contexts is not health information at all.

Direct Payments

Clause 138: Direct payments in lieu of provision of care services

Power conferred on: Secretary of State and Welsh Ministers

Power exercisable by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

459.  Clause 138 inserts new subsections, and makes amendments, to section 57 of the Health and Social Care Act 2001 ("the 2001 Act"). Section 57 provides that regulations can be made in connection with enabling individuals to receive money from social services, in the form of a direct payment, to secure the provision of certain community care services. Currently, section 57 provides that direct payments can only be made to individuals who can consent to receive the payment. Clause 138 amends section 57 of the 2001 Act, extending the direct payments scheme to allow a designated 'suitable person' to receive and manage a direct payment on behalf of an individual who lacks capacity.

460.  The delegated powers arising from clause 138 can be found in subsections (1A), (3), (5B) and (5C) of section 57 (as amended by the clause) and in subsection (8) of the clause which amends section 64 of the 2001 Act.

Section 57(1A) and (3) of the 2001 Act

461.  Subsection (1A) provides that the Secretary of State may, through regulations, make provision for and in connection with requiring or authorising local authorities to make direct payments to designated 'suitable persons' on behalf of individuals who lack capacity to receive and manage the payments themselves.

462.  Subsection (3) lists the type of provision that regulations under section 57 may make and has therefore been amended to ensure that the type of provision that can be made by regulations caters for direct payments to suitable persons on behalf of individuals lacking the relevant capacity. In particular, paragraphs (j), (k) and (l) have been inserted into subsection (3) which together provide that regulations made under section 57 may specify matters to which local authorities must or may have regard when taking any decision under regulations made under subsection (1) or (1A). It also sets out that regulations may specify the steps that local authorities must (or may) take before or after making such decisions and that regulations may make provision for persons with fluctuating capacity and how they are to be treated for the purposes of section 57.

463.  The power under subsection (1A) (as supplemented by the amended subsection (3)) will be used to set out the detail of the extended direct payments scheme and it is envisaged that the power will be used to amend the Community Care, Services for Carers and Children's Services (Direct payments) (England) Regulations 2003 (S.I 2003/762) which sets out the detail of the current direct payments scheme.

464.  By creating a delegated power under subsection (1A) of section 57 our intention is to mirror, as far as possible, the provisions set out under subsection (1) of the 2001 Act. It would not be proportionate to set out on the face of the Bill the detailed provisions in connection with making direct payments in respect of individuals who lack capacity, particularly when the same provisions in relation to people who do have capacity are set out in delegated legislation. In addition, the delegated power allows flexibility to amend the detail of the operation of the direct payments scheme in the future, should the need arise, without having to revisit primary legislation.

465.  The provisions under subsection (1) of the 2001 Act are subject to the negative resolution procedure: the Department does not consider that the proposed amendments necessitate any change to the use of the negative resolution procedure that currently applies to regulations under section 57.

Section 57(5B) of the 2001 Act

466.  Subsection (5B) provides for regulations to set out those individuals who will fall into the category of 'representative', as defined in the new subsection (1C) of section 57. Representatives are those individuals who, by virtue of a qualification which will be set out in regulations, are considered 'automatically' suitable to receive and manage a direct payment for a person who lacks capacity[5]. Where a 'representative' exists, it is envisaged that the local authority will consider this person to manage the direct payment in the first instance.

467.  Initially, it is envisaged that the power will be used to limit 'representatives' to those individuals who are donees of a Lasting Power of Attorney or who are deputies appointed by the Court of Protection (i.e. those individuals who are recognised in law as being suitable to make decisions on behalf of another person). However, once the extended scheme is up and running, it may prove practicable and sensible to expand the list of 'representatives' to include other groups of individuals, for example, those individuals who are donees of an enduring power of attorney. The delegated power provides the flexibility to expand the list of 'representatives' without the need for further primary legislation. Given the limits of this delegated power, the Department considers that the negative resolution procedure is the appropriate procedure.

Section 57(5C) of the 2001 Act

468.  Subsection (5C) defines the term 'surrogate' as a deputy appointed for the person lacking capacity by the Court of Protection pursuant to the Mental Capacity Act 2005 or a donee of a lasting power of attorney created by that individual, who has such powers as are prescribed in regulation. This will enable regulations to limit the role of 'surrogates' under the section to those 'surrogates' whose authority extends to matters relating to securing the provision of community care services.

469.  It is envisaged that the power will be used to limit the category of 'surrogate' to those deputies/donees whose authority can be interpreted as extending to making decisions incorporating those matters covered by the direct payments.

470.  The provisions in the Mental Capacity Act 2005 relating to lasting powers of attorney and the new Court of Protection came into force on October 1 2007. At this early stage it is difficult to predict how people will choose to construct lasting powers of attorney, or what orders the Court of Protection will make conferring authority on deputies to make decisions. Therefore, it would seem sensible to take a delegated power in respect of prescribing the authority of 'surrogates' in order to avoid setting something out on the face of the Bill that may not work in practice. This prescription of authority is primarily a technical matter and it would therefore seem appropriate for this delegated power to be subject to annulment by negative resolution.

Territorial extent

471.  Clause 138 extends to England and Wales. As section 57 of the 2001 Act currently extends to England and Wales and clause 138 simply creates new provisions and amends existing ones, then it would seem appropriate to mirror the territorial extent of the 2001 Act.

472.  Subsection (8) amends section 64 of the 2001 Act to make provision for the making of regulations under section 57 by Welsh Ministers. Since the implementation of the Government of Wales Act 2006, Acts of Parliament that create new enabling powers for Welsh Ministers to make subordinate legislation must also specify the Assembly procedures that will apply. If it is appropriate for the negative procedure to apply to the making of regulations by a Minister of the Crown, then the same procedure should be adopted for the making of regulations by the Welsh Ministers.

Financial assistance related to provision of health or social care services

Clause 141: Power of Secretary of State to give financial assistance

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

473.  Clause 141(2) allows the Secretary of State to provide financial assistance to people for the purpose of them setting up qualifying bodies, delivering health and social care or related services. The conditions for being a qualifying body are set out in clause 142. The intention is to enable funding for the setting up of social enterprises in health and social care.

474.  Under clause 141(2), qualifying bodies will need to satisfy certain conditions set out in regulations if their founders are to be eligible for funding under the clause. Setting additional conditions in regulations allows flexibility to reflect the developmental nature of the emerging models and enables the Department to specify in greater detail what the requirements are for funding, in addition to the primary conditions under clause 142 (community benefit, restrictions on profits and carrying on as a business). Flexibility on additional conditions is particularly necessary in cases where the qualifying body has yet to be set up, as a range of different organisations are likely to apply for financial assistance.

475.  The Parliamentary procedure adopted will be negative resolution as regulations will deal with technical matters, such as specific features of business models and legal forms used by social enterprises.

Clause 142: Qualifying bodies

Powers conferred on: Secretary of State

Power exercised by: regulations made by statutory instrument

Parliamentary procedure: negative resolution

476.  Clause 142 sets out the conditions for being a qualifying body. Under clause 141 the Secretary of State can only give financial assistance to:

  • bodies which are qualifying bodies; or to
  • persons in order for them to set up qualifying bodies

477.  Subsection (1)(b) provides that a body is only a qualifying body if it satisfies conditions prescribed in regulations relating to the distribution of profits. It also allows an exception for bodies of a kind set out in regulations. Different legal forms used by social enterprises have different restrictions or arrangements for the distribution of profits. The power to prescribe conditions on the distribution of profits will allow us to reflect this range in more detail, and allow for flexibility, as the sector matures.

478.  Subsection (1)(b) includes a power to specify in regulations the kinds of bodies which will not be required to meet conditions relating to the distribution of profits. The current proposal is that this will be exercised only in relation to Community Interest Companies (CIC), although this power is necessary in order to extend the exemption to other models which may develop in the future. A CIC is a new legal form that is increasingly being used by social enterprises, as this form has important features for a social enterprise; balancing the needs of business with social objectives and restrictions on the distribution of profits. For example, a CIC limited by shares can obtain equity finance but there are limits on the return that may be paid to investors.

479.  Subsection (1)(d) provides that regulations may set out other conditions that must be satisfied for an organisation to be a qualifying body. As explained above, the power to impose additional conditions will allow both flexibility and a greater level of detail, enabling us to target a range of organisations. For example, different legal forms have very different features in relation to the distribution of profits and access to equity finance. The additional conditions will enable us to clarify the range within which bodies will qualify for funding.

480.  Subsection (2)(a) allows regulations to provide that an organisation can only be a qualifying body if it is a body of a kind set out in regulations. This will allow for restrictions on the type of body than can qualify, e.g. a CIC is likely to be qualifying body. This, again, is a level of detail that is more appropriate for regulations.

481.  Subsection (2)(b) allows regulations to set out which activities are to be treated as being carried on for the benefit of the community and which activities are not to be treated as such. For example, regulations may state that political activities will not be treated as for the benefit of the community. A list of such activities will provide greater clarity but is a level of detail that would not be appropriate for primary legislation.

482.  These regulations will deal with technical matters such as conditions relating to restrictions on profits, so the negative resolution procedure is appropriate.

Clause 145: Directions to certain NHS bodies

Powers conferred on: Secretary of State

Power exercised by: directions given by an instrument in writing

Parliamentary procedure: not applicable

483.  Clause 145(1) allows the Secretary of State make directions to certain NHS trusts, PCTs, Strategic Health Authorities and Special Health Authorities. These directions would authorise them to exercise the Secretary of State's powers to provide financial assistance to certain qualifying bodies; as well as people wanting to set up qualifying bodies.

484.  Local authorities are excluded from this power as provision for this is set out elsewhere in legislation.

485.  In addition, where the Secretary of State has given directions under clause 145(1), clause 145(2) allows the Secretary of State to give directions about how those functions are to be exercised. These would include directions as to the written financial procedures which must be followed, e.g. a requirement in certain cases to submit a business case for the proposed investment. The intention is to ensure that appropriate safeguards are in place to protect public monies.

486.  Such directions will not be subject to any Parliamentary procedure and will be given by an instrument in writing. These directions would deal with matters of administrative and technical detail, and adopt the same procedure as set out in section 273 of the National Health Service Act 2006 for directions given to NHS bodies under that Act.

The Creation of the National Information Governance Board for Health and Social Care

Clause 149: National Information Governance Board for Health and Social Care

487.  This clause contains delegated powers to make:

a)  directions under a power in a new section 250A which the clause will insert into the National Health Service Act 2006; and

b)  regulations under a power in a new section 250C which the clause will insert into that Act.

(a) The powers to make directions:

Powers conferred on: Secretary of State

Powers exercisable by: directions made by the Secretary of State

Parliamentary procedure: none

488.  The power enables the Secretary of State for Health to designate, by a direction in writing, the bodies which the National Information Governance Board for Health and Social Care (NIGB) will keep informed about the practice being followed by relevant bodies in relation to the processing of patient information and other information which is obtained or generated either during the provision of the health service or during the delivery of adult social services functions by local social services authorities. Also, but separately, the matters relating to the processing of this information on which the NIGB can offer advice directly to the persons who are processing the information. It is intended that this will allow the Secretary of State for Health to:

  • ensure that new bodies which are established, for example Special Health Authorities or regulatory bodies, or existing bodies which have their remit modified, which have a requirement for information on the practices being followed by relevant bodies in relation to the processing of patient information and other information which is obtained or generated during either the provision of the health service or the delivery of adult social services functions by local social services authorities can be provided with this information. It will also allow the NIGB to cease to provide information to bodies when it is no longer appropriate
  • direct the NIGB as to the matters on which it may advise persons who process relevant information. The need for direct advice could result from changes in information processing practices in health and social care or from new information governance issues, including those that the NIGB would not normally consider, for example because of adverse publicity.

489.  These powers of direction relate to administrative matters. The first powers, in the proposed section 250A(2)(b), enable provision to be made for the efficient distribution of information. The second power, in the proposed section 250A(2)(e), enables the making of provision under which the NIGB may give advice directly to persons who process relevant information. It is not considered that Parliamentary scrutiny of the exercise of either of these administrative powers is warranted.

(b) The powers to make regulations:

Power conferred on: Secretary of State

Power exercisable by: regulations made by the Secretary of State

Parliamentary procedure: negative resolution

490.  The power enables the Secretary of State to make regulations relating to the constitution and administration of the NIGB. The regulations may make provision for the appointment, payment and payment of expenses of the Chair and members of the NIGB and its sub-committees. They may also enable the NIGB to establish committees and sub-committees to support its activities.

491.  It is intended that the NIGB will have flexibility in relation to its committee and sub-committee arrangements, but it is envisaged that:

  • the committees will have specific functions in their own right
  • the sub-committee groups will be assembled to undertake specific pieces of work on behalf of the NIGB. They will cease to exist when their work is complete.

492.  Information governance requires a wide range of skills. It is not practical for experts in every field to attend NIGB meetings. Meetings would become too large to function effectively. Moreover, requiring the attendance of a wide range of experts at large meetings would be an inappropriate use of their skills. Adopting the proposed approach allows the NIGB to be both more efficient and more effective.

493.  Parliamentary scrutiny under the affirmative procedure is not considered necessary for this procedural provision. The NIGB is an advisory body and will produce an annual report. How resources are deployed to formulate advice is largely an internal administrative matter. Whilst the committees or sub-committees will have an important role in the way the new NIGB carries out its role, the NIGB itself will remain responsible for any advice which they give on its behalf.

494.  Moreover, subsection (5) of the proposed section 250C limits the power to make regulations so that it cannot be exercised to amend any provision in primary legislation.

Functions of the Health Protection Agency in relation to biological substances

Clause 151: Functions of Health Protection Agency in relation to biological substances

Powers conferred on: the Secretary of State and the Department of Health, Social Services and Public Safety in Northern Ireland, acting jointly

Power exercised by: directions to be given in regulations by statutory instrument and a scheme for the transfer of property rights and liabilities

Parliamentary procedure: the directions to be given in regulations are subject to the negative resolution procedure and a scheme is not subject to any Parliamentary procedure

495.  Clause 151 makes a number of amendments to the Health Protection Agency Act 2004 (the 2004 Act) to give the HPA functions in relation to biological substances currently performed by the National Biological Standards Board (the NBSB). The NBSB is abolished and the Biological Standards Act 1975 (the 1975 Act) under which it was established, is repealed.

496.  The Secretary of State and the Department of Health, Social Services and Public Safety in Northern Ireland, acting jointly, are given power to direct the HPA to carry out functions in relation to biological substances (new section 2A(1) of the 2004 Act). This power mirrors the power contained in the 1975 Act to direct the NBSB to carry out such functions. In line with the similar power under the 1975 Act, directions are to be given by regulations by statutory instrument and to be subject to the negative resolution procedure. By virtue of the new section 2A(3) of the 2004 Act, the HPA is deemed to have the same functions as the NBSB was previously directed to carry out by the National Biological Standards Board (Functions) Order 1976.

497.  The new section 8(4A) of the 2004 Act gives the Secretary of State and the Department of Health, Social Services and Public Safety in Northern Ireland, acting jointly, power to make a scheme for the transfer of the property rights and liabilities of the NBSB to the HPA. In line with powers to make similar schemes under section 8 of the 2004 Act, and normal practice in respect of such schemes, any such scheme is not subject to any Parliamentary procedure.

Part 6: General

498.  This Part lays down general provisions in respect of the regulations, orders and directions that will be made or given under powers conferred by or under the Bill. It gives order-making powers to the Secretary of State and Welsh Ministers to make transitional or transitory provisions and savings, in connection with the coming into force of any provision of the Bill, and to the Secretary of State to make supplementary, incidental or consequential provisions. Such orders may modify any enactment.

Clause 159: Power to make transitional and consequential provision etc

Powers conferred on: Secretary of State and the Welsh Ministers

Power exercised by: order made by statutory instrument

Parliamentary procedure: affirmative if amending or repealing any provision of an Act of Parliament, otherwise negative

499.  Clause 159 confers on the Secretary of State and Welsh Ministers the power to make by order transitional or transitory provisions and savings in connection with the commencement of any provision made by or under the Bill. It also confers on the Secretary of State the power to make by order such supplementary, incidental or consequential provision as considered appropriate for the purposes of, in consequence of, or for giving full effect to any provision of the Bill. Such orders may amend, repeal, revoke or otherwise modify any enactment (including Acts of Parliament, Acts of the Scottish Parliament, Measures or Acts of the National Assembly for Wales, and Northern Ireland legislation). These powers are additional and without prejudice to any other provision of the Bill.

500.  This power is necessary to ensure that necessary or expedient transitional arrangements can be made as the Bill is commenced without creating any difficulty or unfairness. This means that it will be possible to modify the application of the Bill to existing situations and to ensure a smooth transition from the old law and procedures to the new.

501.  A number of transitional provisions will be needed in relation to the establishment of the Commission and the assumption by it of the functions of CHAI, CSCI and MHAC. The Commission will assume the different functions of the three existing regulators over a period of time and will take on some earlier than others. A particular example of where transitional provision will be needed is in relation to the transition from the registration provisions of Part 2 of the Care Standards Act to the new regime under Chapter 2 of Part 1 of the Bill.

502.  Transitional provision will also need to be made in relation to some of the provisions in Part 2 (regulation of health professions and health and social care workforce) of the Bill. This will be the case, for example, in connection with the establishment of the Council and the winding down of the present Council for the Regulation of Health Care Professionals in its current form (clauses 108 to 113). Transitional provision will also have to be made in connection with: (a) preserving existing regulations, or parts of them, under the Public Health (Control of Disease) Act 1984 (Part 3 of the Bill); and, (b) the abolition of the NBSB and the assumption of identical functions by the HPA (clause 151).

503.  The power to make supplemental, incidental or consequential provision is essential to ensure that the changes made to the law by the Bill are reflected in other legislation which refers to or is dependent on provisions repealed or amended by the Bill. In particular, whilst Schedules 3 and 5 make amendments to the Mental Health Act, the Care Standards Act, and the 2003 Act in connection with Part 1 of the Bill, amendments will need to be made to other legislation which contain references to CHAI, CSCI and MHAC.

504.  The Parliamentary procedure to be followed depends on the content of the order. If the order amends or repeals any provision of an Act of Parliament, it may not be made unless a draft has been laid before and approved by each House of Parliament under clause 154(3)(d). In any other case, the negative resolution procedure applies. This combination of procedures seems to the Department to strike an appropriate balance between the need to secure a quick and smooth transition between an old and a new regime and to ensure that changes made by this Bill are reflected in other legislation, and the need to respect Parliamentary involvement where an Act of Parliament is to be amended.

Clause 162: Commencement

Powers conferred on: the "appropriate authority" (as defined by clause 163: Secretary of State, the Department of Health, Social Services and Public Safety in Northern Ireland, the Welsh Ministers, or the Treasury)

Power exercised by: order made by statutory instrument

Parliamentary procedure: none

505.  Clause 162(1) makes provision for certain provisions of the Bill to come into force on the day that the Bill receives Royal Assent. Subject to those specific provisions, clause 162(2) provides for the "appropriate authority" to appoint, by order, the day on which the provisions of the Bill will come into force. Clause 163 provides that the appropriate authority is the Secretary of State (subject to duties of consultation set down in clause 164), except that it will be the Department of Health, Social Services and Public Safety in Northern Ireland in relation to clauses 114, 115 and 117 (responsible officers) so far as they relate to Northern Ireland, the Welsh Ministers in relation to specified provisions in so far as they apply to Wales, and the Treasury in relation to Part 4 (health in pregnancy grant). Consistent with the usual practice, commencement orders under this clause are not subject to any Parliamentary procedure.


3   As amended by the Mental Health Act 2007;  Back

4   Section 19 of the Education Act 1996 (c. 56) requires a local education authority to arrange for provision of suitable education for children who by reason of illness, exclusion from school or otherwise, may not for any period receive suitable education unless such suitable arrangements are made for them.  Back

5   Although in the explanation of (1C) above we state people who are 'representatives' will be considered 'automatically' suitable to manage the direct payment, this simply means that local authorities will automatically look to these individuals to receive and manage the payment in the first instance. Ultimate responsibility for deciding whether a third person is 'suitable' to manage a direct payment on behalf of another person will rest with the local authority, in the same way that local authorities currently determine whether an individual with capacity is suitable to receive and manage a direct payment.  Back


 
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