Addendum to the memorandum for the House of Lords Delegated Powers and Regulatory Reform Committee on the Health and Social Care Bill 2011 1. This document is an addendum to the memorandum prepared by the Department of Health for the House of Lords Delegated Powers and Regulatory Reform Committee on the Health and Social Care Bill 2011. 2. The main memorandum describes the purpose and content of the Health and Social Care Bill, identifies the provisions of the Bill that confer powers to make delegated legislation, and explains in each case why the power has been taken and the nature of, and reasons for, the procedure selected. The main memorandum is available on the Department of Health website at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publication sLegislation/DH_123593. 3. This addendum identifies which of the Government amendments tabled on 1 February 2012 for consideration at Lords Report would make changes to the provisions of the Bill that confer powers to make delegated legislation. It describes the effect of the amendments and explains in each case why the Government wishes to amend these powers and the nature of, and reasons for, the procedure selected for the power as amended. 4. The addendum also describes the effect on the Bill’s delegated powers provisions of two non-Government amendments, tabled by Lord Ribeiro, which the Government supports. 5. In addition, the addendum provides a description of 20 amendments which the Government has tabled in response to the recommendations of the Delegated Powers and Regulatory Reform Committee (the DPRRC). The DPRRC reported on the Bill on 14 October 2011 and recommended a series of amendments to the level of scrutiny afforded to various of the Bill’s delegated powers. The Government accepted all of the DPRRC’s recommendations and these amendments fulfil that commitment. Clause 69: Failure to perform functions Power conferred on: Secretary of State Power exercised by: Directions Parliamentary procedure: None (unless given by regulations – see clause 300(13) – in which case negative) Amendment: Clause 69, page 93, line 38, after “Monitor’s” insert – “, other than a function it has by virtue of section 70 or 71,” Background: 6. Clause 69 confers powers on the Secretary of State to direct Monitor if it fails to carry out one or more of its functions and the failure is significant. However, it does not allow him to intervene in individual cases. Effect of amendment: 7. This amendment provides that this power to direct Monitor does not apply in relation to the functions that Monitor would have under the Competition Act 1998 and Part 4 of the Enterprise Act 2002 as a result of clauses 70 and 71. The purpose of the amendment is to prevent the Secretary of State intervening and exercising these powers, which would involve consideration of individual cases under those Acts. If Monitor failed to exercise its functions under the Competition Act or Part 4 of the Enterprise Act there would not be a regulatory gap, since the Office of Fair Trading could consider any healthcare cases under those Acts, using the powers that it would have concurrently with Monitor. Reason for delegating the power: 8. The existing delegated power was created in order to provide the necessary flexibility for the Secretary of State to respond appropriately and at speed to any failure by Monitor. The amendment does not affect the rationale for delegation of the power. Reason for the selected procedure: 9. The amendment does not alter the selected procedure, which was chosen in order that the most appropriate format for the directions could be decided based on the type of intervention that was necessary. Clauses 118, 120, 121 and 126: Consultation on proposals for the national tariff Power conferred on: Secretary of State Power exercised by: Regulations Parliamentary procedure: Negative Amendments: Clause 118, page 125, line 18, leave out “licence holder” and insert “relevant provider”. Clause 118, page 127, line 9, at end insert— “(13A) In this section, a “relevant provider” is— (a) a licence holder, or (b) such other person, of such description as may be prescribed, a provides health care services for the purposes of the NHS.” Clause 118, page 127, line 10, leave out subsection (14). Clause 120, page 127, line 38, leave out “licence holders” and insert “relevant providers”. Clause 120, page 128, line 1, leave out “licence holders” and insert “relevant providers”. Clause 120, page 128, line 7, leave out “licence holders” and insert “relevant providers”. Clause 120, page 128, line 10, leave out “licence holders” and insert “relevant providers”. Clause 120, page 128, line 21, leave out “licence holder’s” and insert “relevant provider’s”. Clause 120, page 128, line 22, at end insert— “( ) In this section and section 121 and Schedule 12, “relevant provider” has the meaning given in section 118(13A).” Clause 120, page 128, line 23, leave out subsection (7). Clause 121, page 128, line 32, leave out “licence holders” and insert “relevant providers”. Clause 121, page 129, line 20, leave out “licence holders” and insert “relevant providers”. Clause 126, page 132, line 16, leave out “licence holder” and insert “relevant provider”. Clause 126, page 132, line 25, at end insert— “( ) In this section, “relevant provider” has the meaning given in section 118(13A).” Background: 10. Subsection 3 of clause 120 provides for the Secretary of State to prescribe, through regulations, an objection percentage and a share of supply percentage for relevant providers of NHS services in relation to consultation on the methodologies used for setting prices for the purposes of the national tariff. If the number of objections reach such percentages this could trigger independent adjudication of the methodologies. Effect of amendments: 11. These amendments provide that ‘relevant providers’ shall mean licence holders, or such other persons of such description as the Secretary of State may prescribe by regulations. This establishes a new regulationmaking power which would enable the Secretary of State to change which providers will be consulted about and able to trigger independent adjudication of Monitor’s pricing methodologies. 12. This power is intended to allow the Secretary of State in the future to require consultation with providers who are not licence holders, for example because they are exempted from holding a licence by exemption regulations made under clause 84. Reason for delegating the power: 13. Delegating the power provides flexibility to adjust to changing circumstances, for example to extend the range of providers who must be consulted, or to reflect changes to the exemptions from the requirement to hold a licence. Reason for the selected procedure: 14. The intention is that the Secretary of State would exercise the power to ensure that all those providers that it would be appropriate for Monitor to consult on the national pricing tariff will be consulted about Monitor’s proposals and have an opportunity to trigger independent review of them. Hence, the Government does not envisage that the proposals would be controversial and considers the negative procedure appropriate. Clause 180: Healthwatch England Power conferred on: Secretary of State Power exercised by: Regulations Parliamentary procedure: Negative Amendment: Clause 180, Page 176, leave out lines 26 to 29 Clause 180, page 176, line 30, leave out subsection (3) and insert “(3) After sub-paragraph (5) insert “(5A) Regulations under sub-paragraph (1A) must make provision requiring a person who has power to appoint a member of the Healthwatch England committee to secure that a majority of the members of the committee are not members of the Commission. (5B) Regulations under sub-paragraph (1A) may specify other results which a person who has power to appoint a member of the committee must secure. (5C) Regulations under sub-paragraph (1A) may, in particular, make provision as to (a) eligibility for appointment; (b) procedures for selecting or proposing persons for appointment. (5D) Regulations under sub-paragraph (1A) may, in particular, make provision as to (a) the removal or suspension of members of the committee; (b) the payment of remuneration and allowances to members.”” Background: 15. Clause 180, subsection (2) inserts new sub-paragraph (1A) into paragraph 6 of Schedule 1 of the Health and Social Care Act 2008, to provide that a committee of the Care Quality Commission known as “the Healthwatch England committee” is to be appointed in accordance with regulations. It also inserts sub-paragraph (1C), which provides that the regulations may include provisions as to the removal or suspension of members of Healthwatch England and the payment of remuneration and allowances to members. Effect of amendment: 16. This amendment would require the regulations on appointment of Healthwatch England members, made under sub-paragraph (1A), to require the person who appoints the members to ensure that the majority of Healthwatch England members are not from the Care Quality Commission. The amendment also provides that the regulations may specify other results to be secured by the person who appoints members. It enables the regulations, in particular, to make provision about eligibility for appointment as a member, and about procedures for selecting or proposing persons to be appointed as members. It also makes minor and consequential amendments to subsections (2) and (14) of clause 180. Reason for delegating the power: 17. The reason for the existing delegated power is to ensure flexibility for changes to be made to the membership of Healthwatch England in line with changing circumstances and operational experience. The reason for this amendment in relation to the power is to respond to concerns about the location of Healthwatch England within the Care Quality Commission, and its ability to act independently on behalf of service users and the public. The amendment seeks to ensure that the membership of Healthwatch England is such that the majority voice is that of persons who are not members of the Commission. The intention is to ensure greater independence of the members of Healthwatch England from the Care Quality Commission. Reason for the selected procedure: 18. The amendment does not change the procedure currently provided for the delegated power in the Bill, which is in line with the procedure for other bodies such as the Care Quality Commission, of which Healthwatch England is a committee. Clause 236: NICE advice, guidance, information and recommendations Power conferred on: Secretary of State Power exercised by: Regulations Parliamentary procedure: Negative Amendments: LORD RIBEIRO Clause 236, page 236, line 29, at end insert “( ) But provision made under subsection (8) may impose a requirement on a local authority, or a description of local authorities, only if the requirement relates to (a) the exercise by an authority of any of its functions under section 2B or 111 of, or paragraphs 1 to 7B or 13 of Schedule 1 to, the National Health Service Act 2006; (b) the exercise by an authority of any of its functions by virtue of section 6C(1) or (3) of that Act; (c) anything done by an authority in pursuance of arrangements under section 7A of that Act.” LORD RIBEIRO Clause 236, page 236, line 31, leave out “other than a local authority” Background: 19. Clause 236(1) provides a regulation-making power allowing for regulations to confer functions on NICE in relation to the giving of advice or guidance, provision of information or making of recommendations concerning or connected with the provision of NHS services, social care or public health services. Subsection (8) makes provision for the regulations to require specified health or social care bodies to have regard to NICE’s advice, guidance or information or to comply with NICE’s recommendations. The intention is to rely on this provision to replicate the effect of the existing funding direction to PCTs and NHS trusts that requires NHS commissioners (PCTs) to make funding normally available for NICEapproved drugs and treatments. Effect of amendments: 20. As currently drafted, subsection (10) of the clause excludes local authorities from its scope. However, subject to legislation, local authorities will be responsible for funding public health services that may include NICE-approved drugs and treatments, and it would therefore be appropriate for the regulations to be capable of applying also to them. The Government therefore supports this amendment, tabled by Lord Ribeiro, to enable the regulations to impose a requirement on prescribed local authorities and remove the provision which excludes local authorities. Reason for delegating the power: 21. The amendment does not affect the original reason for delegating the power as described in subsection (8), which was to preserve the flexibility that is currently provided for by the Secretary of State’s power to give directions to NHS Authorities in an area which sees constantly evolving developments in medicines, diagnostics, technologies, and the health and social care environments. Reason for the selected procedure: 22. The negative resolution procedure was originally selected for this power in order to provide for a higher level of transparency than may currently be applied to directions given to NHS Authorities – this remains unaffected by the amendment. Clauses 253 to 259: Powers to direct Information Centre to establish information systems Powers conferred on: Secretary of State or the NHS Commissioning Board Powers exercised by: Directions Parliamentary procedure: None (unless a direction by the Secretary of State is given in regulations – in which case, negative) Amendments: Clause 253, page 243, line 26, leave out second “and” and insert “or” Clause 253, page 243, line 30, leave out from beginning to second “it” and insert “the Secretary of State considers that the information which could be obtained by complying with the direction is information which” Clause 253, page 243, line 38, leave out from “if” to “it” in line 39 and insert “the Board considers that the information which could be obtained by complying with the direction is information which” After Clause 254, insert the following new Clause - “Requests for collection under section 254: confidential information (1) A request under section 254 is a confidential collection request if it is a request for the Information Centre to establish and operate a system for the collection of information which is in a form which— (a) identifies any individual to whom the information relates who is not an individual who provides health care or adult social care, or (b) enables the identity of such an individual to be ascertained. (2) A person may make a confidential collection request under section 254 only if the request— (a) is a mandatory request, (b) relates to information which the person making the request (“R”) may require to be disclosed to R or to the Information Centre by the person holding it, or (c) relates to information which may otherwise be lawfully disclosed to the Information Centre or to R by the person holding it.” Clause 258, page 246, line 32, leave out “collects pursuant to” and insert “obtains by complying with” Clause 258, page 247, line 9, leave out “collected pursuant to” and insert “obtained by complying with” Clause 258, page 247, line 10, leave out “collects pursuant to” and insert “obtains by complying with” Clause 259, page 247, line 39, leave out “collects pursuant to” and insert “obtains by complying with” Clause 259, page 248, line 11, at end insert— “(3A) The Information Centre may also disseminate, in such form and manner and at such times as it considers appropriate, any information which it collects pursuant to a direction under section 253 or a request under section 254 (whether or not it falls within subsection (2)) to any person to whom the information could have been lawfully disclosed by the person from whom the Centre collected the information. (3B) The Information Centre may also disclose information which it obtains by complying with a direction under section 253 or a request under section 254 (whether or not it falls within subsection (2)) if— (a) the information has previously been lawfully disclosed to the public, (b) the disclosure is made in accordance with any court order, (c) the disclosure is necessary or expedient for the purposes of protecting the welfare of any individual, (d) the disclosure is made to any person in circumstances where it is necessary or expedient for the person to have the information for the purpose of exercising functions of that person conferred under or by virtue of any provision of this or any other Act, (e) the disclosure is made in connection with the investigation of a criminal offence (whether or not in the United Kingdom), or (f) the disclosure is made for the purpose of criminal proceedings (whether or not in the United Kingdom). (3C) Paragraphs (a), (b) and (f) of subsection (3B) have effect notwithstanding any rule of common law which would otherwise prohibit or restrict the disclosure.” Clause 259, page 248, line 12, leave out subsections (4) and (5) After clause 259, insert the following new Clause— “Other dissemination: directions under section 253 and requests under section 254 (1) A direction under section 253 may require the Information Centre to disseminate information which it obtains by complying with the direction if the information falls within subsection (2). (2) Information falls within this subsection if— (a) the information is required to be published under section 258; (b) the information is in a form which identifies any relevant person to whom the information relates or enables the identity of such a relevant person to be ascertained and— (i) the relevant person has consented to the dissemination, or (ii) the person giving the direction, after taking into account the public interest as well as the interests of the relevant person, considers that it is appropriate for the information to be disseminated; (c) the information is in a form which identifies any individual to whom the information relates who is not a relevant person or enables the identity of such an individual to be ascertained and the individual has consented to the dissemination; (d) the Centre is prohibited from publishing the information only by virtue of it falling within section 258(2)(c) and the person giving the direction considers it would be in the public interest for the information to be disseminated. (3) A direction under section 253 may require the Information Centre to exercise— (a) the power conferred by section 259(3A) in relation to information which it collects pursuant to the direction, or (b) any other power it has under or by virtue of any other provision of this Act (other than section 259(1) or (3B)) or any other Act to disseminate information which it obtains by complying with the direction. (4) A request under section 254 may request the Information Centre to exercise— (a) the power conferred by section 259(1) or (3A) in relation to information which it obtains by complying with the request, or (b) any other power it has to disseminate such information under or by virtue of any other provision of this or any other Act. (5) A direction under section 253 may require, and a request under section 254 may request, the Information Centre not to exercise the power conferred by section 259(1) or (3A) in relation to information which it obtains by complying with the direction or request. (6) Section 254(3) does not apply in relation to anything included in a mandatory request by virtue of subsection (4) or (5). (7) A requirement imposed on, or a request made to, the Information Centre in accordance with this section to disseminate information may include a requirement or request about the persons to whom the information is to be disseminated and the form, manner and timing of dissemination.” Background: 23. Clause 253 is the primary direction-giving power in Part 9, Chapter 2 of the Bill. It provides the Secretary of State or the NHS Commissioning Board with a power to direct the Information Centre to establish a system for the collection or analysis of certain information. In the case of the Secretary of State, the information must be in connection with the provision of health services or adult social care or where otherwise considered by the Secretary of State to be in the interests of the health service or recipients of adult social care. In respect of the NHS Commissioning Board, the information must be in connection with the provision of NHS services. Effect of amendments: 24. The amendments clarify how the Information Centre is to treat information derived from information it has collected (i.e. the information generated through analysing and linking information). To this effect, the amendments ensure that, where appropriate, direction-giving powers relating to publication or dissemination apply to derived information as well as to collected information. 25. The amendments otherwise clarify what information a direction may require the Information Centre to disseminate, and what other requirements relating to dissemination may be included in a direction. They align direction-giving powers relating to dissemination with the amendments for confidential collection requests by clarifying to whom information that the Information Centre has collected may be disseminated pursuant to a direction. 26. The amendments also clarify that the Secretary of State or the NHS Commissioning Board may direct the Information Centre to exercise (or not) any power it has under or by virtue of the Bill (other than clause 259(1) or (3B)) or any other Act to disseminate information it obtains by complying with the direction. They remove the powers of a principal body to require the Centre to exercise or not to exercise a power it has to disseminate. Reason for delegating the power: 27. The reason for delegating the powers remains unchanged from the rationale set out in the main memorandum. That is, the information requirements in relation to collection, analysis, publication or other dissemination will be technical and require more detail to describe than is usually included in primary legislation. Reason for the selected procedure: 28. The reason for the choice of directions which are not subject to a Parliamentary procedure remains unchanged from that set out in the main memorandum. That is, the directions would set out detailed and technical matters that do not merit a Parliamentary procedure. The Secretary of State is, however, able to give his directions by regulations subject to the negative resolution procedure. Recommendations of the Delegated Powers and Regulatory Reform Committee 29. The Government accepted all of the recommendations that the DPRRC made on the Bill in its report on 14 October 2011. The following list provides descriptions of the amendments made to fulfil these recommendations. These descriptions are also included in the briefing notes which the Government published on its amendments for Lords Report, which are published on the Department of Health website at http://healthandcare.dh.gov.uk/bill-amends/ Commissioning responsibility Amendment: Clause 12, page 7, line 22, at end insert “( ) In section 272 of that Act (orders, regulations, rules and directions), in subsection (6) before paragraph (za) insert – “(zza) regulations under section 3(1D),”.” Description: 30. Section 3 of the NHS Act 2006, as amended by the Bill, states that CCGs have responsibility for persons provided with primary medical services by a member of the group, and persons usually resident in the group’s area, who are not provided with primary medical services by a member of any CCG. Regulations under subsection (1D) enable the Secretary of State to specify that this would not apply for persons of a prescribed description, or in prescribed circumstances – for example, for persons registered with an English GP, who were resident in Scotland. Under the current drafting, these regulations would be subject to the negative procedure in Parliament; following the recommendation of the DPRRC, this amendment would make the regulations subject to the affirmative procedure. Establishment of clinical commissioning groups Amendments: Clause 24, page 29, line 16, leave out “in writing by” and insert “by order of” Schedule 4, page 321, line 18, at end insert “, and (b) before paragraph (a) insert “(za) section 14A(1),”.” Description: 31. Section 14A(1) of the 2006 Act, inserted by clause 24 of the Bill, requires the NHS Commissioning Board to exercise its functions to ensure that at any time after a day specified by the Secretary of State in writing, every provider of primary medical services, within the meaning of this section, is a member of a CCG. The DPRRC recommended that the Secretary of State should specify this date in a Statutory Instrument, rather than simply in writing, but that this instrument need not be subject to Parliamentary procedure. These amendments would therefore amend the Bill to require the Secretary of State to specify this date by an order that is not subject to Parliamentary procedure. Licensing – Amendments 136, 137 Amendments: Clause 300, page 269, line 24, at end insert “( ) the first regulations under section 84 (licensing requirement: exemption regulations);” Clause 300, page 269, line 24, at end insert “( ) the first order under section 87 (approval by Secretary of State of licensing criteria);” Description: 32. Following the recommendation of the DPRRC, these amendments would make the first set of exemption regulations and the first approval of the licensing criteria by the Secretary of State subject to the affirmative procedure, and subsequent revisions of the licensing criteria by the Secretary of State order subject to the negative procedure. Fluoridation Amendments: Clause 35, page 66, line 11, at end insert “( ) The duty in subsection (3) does not apply in relation to the proposal if the Secretary of State so directs by an instrument in writing.” Clause 35, page 66, leave out lines 14 to 17 Clause 35, page 66, line 39, at end insert “( ) The duty in subsection (2) does not apply in relation to the proposal if the Secretary of State so directs by an instrument in writing.” Clause 35, page 66, leave out lines 42 to 45 Clause 35, page 67, line 34, at end insert “( ) The duty in subsection (2) does not apply in relation to the proposal if the Secretary of State so directs by an instrument in writing.” Clause 35, page 67, leave out lines 37 to 40 Description: 33. The Secretary of State has regulation-making powers to specify the circumstances when various consultation or other procedural requirements in the Bill relating to proposals for termination of fluoridation arrangements do not apply. The Secretary of State may also use direction-making powers to exempt local authorities from those requirements in relation to their proposals for termination. The intention was that these powers could be used if the supply of fluoridation needed to be terminated quickly (e.g. because of safety concerns). The DPRRC made a number of recommendations in relation to the direction-making powers. 34. Having considered its report, the Government agrees with the DPRRC’s recommendation that the power to direct given by new sections 88K(5), 88L(4) and 88M(4) of the Water Industry Act 1991 should be confined to termination proposals in individual cases, leaving any general exemptions to be dealt with in the regulations. These amendments would achieve this by replacing the current provisions, which allow the direction-making powers to be exercised generally as well as in relation to a particular scheme. Mandate to the NHS Commissioning Board Amendments: Clause 22, page 17, line 9, at end insert “( ) Requirements included in the mandate have effect only if regulations so provide.” Clause 22, page 17, line 21, at end insert “( ) Revisions to the mandate which consist of adding, omitting or modifying requirements have effect only if regulations so provide.” Description: 35. The Secretary of State will set objectives and requirements for the health service through the mandate to the NHS Commissioning Board. The DPRRC recommended that where the mandate sets out requirements, these should be given effect through regulations subject to the negative resolution procedure. These amendments would bring about this change. Special Health Authorities Amendments: Clause 20, page 15, line 10, at end insert “( ) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations.” Clause 20, page 15, line 22, at end insert “(6) In section 273 of that Act (further provision about orders and directions), in subsection (4)(b) (a) before paragraph (i) insert “(zi) section 7 about a function of a person other than the Secretary of State,” and (b) in paragraph (i) after “a function” insert “of the Secretary of State”.” Clause 48, page 80, line 10, at end insert “( ) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations.” Clause 48, page 81, line 6, at end insert “( ) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations.” Clause 48, page 81, line 16, at end insert “( ) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations.” Clause 48, page 82, line 10, at end insert “( ) Subsection (1) does not apply to any function of the Secretary of State of making an order or regulations.” Schedule 6, page 356, line 13, at end insert “() The amendment made by section 20(6) does not affect (a) the validity of any direction made by an instrument in writing which continues to have effect by virtue of sub-paragraph (2), (b) any power to vary such a direction otherwise than for the purpose of directing the Special Health Authority concerned to exercise an additional function, or (c) any power to revoke such a direction.” Description: 36. The Government is proposing amendments to clause 20 so as to prevent the Secretary of State from delegating the function of making orders or regulations to Special Health Authorities and have therefore tabled the first of these amendments. 37. As part of this, the Government is also proposing further amendments to clause 48. These would make it clear that the Secretary of State is not able to delegate his function of making orders or regulations specifically relating to the provision of primary medical, dental, or ophthalmic services and any functions relating to local or other pharmaceutical services to the NHS Commissioning Board, a CCG, a Special Health Authority or to such other persons or bodies as may be prescribed. 38. However, the Secretary of State is currently able to delegate his other functions to Special Health Authorities, through directions in writing, should he wish to do so. In the new system, the Secretary of State will also be able to delegate the functions of others to Special Health Authorities. The DPRRC recommended that in this case, delegation should be through directions in regulations that are subject to the negative resolution procedure and the second amendment to clause 20 makes the necessary changes to ensure this is the case. 39. Where there are existing directions from the Secretary of State to Special Health Authorities that will continue in the future system, these will remain in force. Some functions that will continue to be exercised by Special Health Authorities will not be functions of the Secretary of State in the new system. The second amendment to clause 20 would have the effect that where functions are not Secretary of State functions, they must be conferred on a Special Health Authority by regulations. The amendment to Schedule 6 would ensure that where such functions are referred to in existing directions, it would not be necessary to re-issue the existing directions as regulations.