The National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013

Made: 11th February 2013

Laid before Parliament: 13th February 2013

Coming into force: 1st April 2013

The Secretary of State for Health makes the following Regulations in exercise of the powers conferred by sections 235(1) to (3), 237(1) to (3), (5)(b) and (c), and (7) to (9)[^f00001], 238, 239(1), (4) and (5), 240(1) to (3), 242, 268(1) and (2), 269(1), 274(1)(d) and (6) to (8), and 304(1), (9) and (10) of, and paragraph 8(2) of Schedule 16 to, the Health and Social Care Act 2012[^f00002]:

PART 1 — General

Citation, commencement and interpretation

1

• (1) These Regulations may be cited as the National Institute for Health and Care Excellence (Constitution and Functions) and NHS England (Information Functions) Regulations 2013.

• (2) These Regulations come into force on 1st April 2013.

• (3) In these Regulations—

• “the Act” means the Health and Social Care Act 2012;

• “the 2006 Act” means the National Health Service Act 2006[^f00003];

• ...

• “NHS England” means the body corporate established under section 1H of the 2006 Act;

• “relevant date” means 1st April 2013.

PART 2 — The National Institute for Health and Care Excellence

Interpretation of this Part

2

In this Part—

• “carer” means an adult who provides or intends to provide care for another person;

• ...

• “Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use[^f00006];

• “health technology” may include—a medicinal product to which Directive 2001/83/EC applies[^f00007];a medical device;a diagnostic technique;a surgical procedure or other therapeutic technique;a therapeutic technology other than a medicinal product to which Directive 2001/83/EC applies, medical device, diagnostic technique or surgical procedure;a system of care; ora screening tool;

• “highly specialised health technology” means a health technology intended for use in the provision of services for rare and very rare conditions provided for in regulations under section 3B(1)(d) of the 2006 Act[^f00008];

• “highly specialised technology recommendation” means a recommendation made by NICE following an appraisal of the benefits and costs of a highly specialised health technology conducted by NICE in accordance with NICE’s published methods and processes for appraisal of highly specialised health technologies that results in a positive assessment;

• “integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the 2006 Act;

• “the Institute” means the Special Health Authority known as the National Institute for Health and Clinical Excellence[^f00009];

• “life sciences industry” includes the pharmaceutical, medical technology and medical biotechnology industries;

• “NICE” means the National Institute for Health and Care Excellence established under section 232 of the Act;

• “patient” means any person who is receiving treatment as part of the health service[^f00010] in England;

• “technology appraisal recommendation” means a recommendation made by NICE following an appraisal of the benefits and costs of a health technology conducted by NICE in accordance with NICE’s published methods and processes for appraisal of health technologies that results in a positive assessment (but does not include a highly specialised technology recommendation);

• “treatment” means an intervention that is intended to manage a person’s disease, condition or injury and includes prevention, examination and diagnosis.

Procedures for conflicts of interests of members

3

• (1) NICE must publish procedures for dealing with conflicts of interests of members of NICE or members of a committee or sub-committee of NICE.

• (2) The procedures must address conflicts or potential conflicts arising in connection with a pecuniary or other personal interest.

• (3) The procedures may provide amongst other things for—

• (a) arrangements regarding the divestment, or declaration of, or disability in proceedings by reason of, a pecuniary or other personal interest; or

• (b) the settlement of disputes regarding a pecuniary or other personal interest.

Supply of quality standards to devolved authorities or other persons

4

• (1) NICE may supply a quality standard[^f00011] to a devolved authority[^f00012] or other person (whether or not in the United Kingdom), and for that purpose NICE has power to make such adjustments to the quality standard as NICE considers appropriate.

• (2) Adjustments may, in particular, relate to—

• (a) the organisation of health or social care services in the territory—

• (i) of the devolved authority, or

• (ii) in which the person exercises functions, undertakes activity or is established; or

• (b) a language used in the territory of a devolved authority or by the person to whom a quality standard is supplied.

• (3) NICE may impose a charge for or in connection with the supply of a quality standard to a devolved authority or other person.

• (4) Subject to paragraph (5), a charge imposed pursuant to paragraph (3) may be calculated as NICE considers—

• (a) appropriate to enable NICE to recover the cost of making an adjustment to the quality standard or supplying the quality standard; or

• (b) to be the appropriate commercial basis.

• (5) NICE may impose a charge on a devolved authority under paragraph (3) only if the charge is calculated so as to enable NICE to recover no more than the cost of making an adjustment to the quality standard or supplying the quality standard.

Advice, guidance, information and recommendations

5

• (1) NICE has the functions of giving advice or guidance, providing information or making recommendations about any matter concerning or connected with the provision of—

• (a) NHS services[^f00013],

• (b) public health services[^f00014], or

• (c) social care[^f00015] in England.

• (2) In the case of a function conferred under paragraph (1)(a), the function—

• (a) is only exercisable on the direction of the Secretary of State or NHS England;

• (b) is subject to directions given by the Secretary of State or (as the case may be) NHS England about NICE’s exercise of the function.

• (3) In the case of a function conferred under paragraph (1)(b) or (c), the function—

• (a) is only exercisable on the direction of the Secretary of State;

• (b) is subject to directions given by the Secretary of State about NICE’s exercise of the function.

• (4) NICE must establish procedures for the giving of advice or guidance, the provision of information or the making of recommendations as NICE considers appropriate.

• (5) NICE must consult such persons as it considers appropriate in establishing a procedure under paragraph (4).

• (6) NICE must publish or disseminate any advice or guidance it gives or information it provides or a recommendation it makes—

• (a) to such health or social care bodies[^f00016] as NICE considers appropriate, and

• (b) in such form and manner and at such time as NICE considers appropriate.

• (7) The Secretary of State must consult NHS England before giving a direction under paragraph (2).

• (8) The Secretary of State must not give a direction under paragraph (2)(b) or (3)(b) about the substance of advice, guidance or recommendations of NICE.

• (9) NHS England must not give a direction under paragraph (2)(b) about the substance of advice, guidance or recommendations of NICE.

• (10) NICE must keep under review and may revise as it considers appropriate any advice or guidance it gives, information it provides or recommendation it makes.

• (11) For the purposes of this regulation, a “recommendation” does not include a technology appraisal recommendation or a highly specialised technology ... recommendation.

Charges for NICE advice, guidance, information or recommendations

6

• (1) NICE may impose a charge for or in connection with the giving of advice or guidance, provision of information or making of a recommendation in exercise of the functions conferred by regulation 5(1) on persons other than—

• (a) the Secretary of State, or

• (b) a person identified in a direction to NICE given by the Secretary of State under paragraph (2).

• (2) The Secretary of State may direct NICE in writing not to impose a charge in relation to—

• (a) advice, guidance, information or a recommendation specified in the direction, or

• (b) advice, guidance, information or a recommendation of a description specified in the direction.

• (3) Subject to paragraph (4), a charge imposed pursuant to paragraph (1) may be calculated as NICE considers—

• (a) appropriate to enable NICE to recover the cost of providing the service; or

• (b) to be the appropriate commercial basis.

• (4) NICE may impose a charge on a devolved authority under paragraph (1) only if the charge is calculated so as to enable NICE to recover no more than the cost of providing the service.

• (5) Charges imposed by NICE under paragraph (1) are recoverable as a civil debt.

• (6) NICE must pay monies received by it by virtue of paragraph (1) to the Secretary of State except to the extent that the Secretary of State directs in writing that it may retain those monies.

NICE technology appraisal recommendations

7

• (1) NICE may make a technology appraisal recommendation—

• (a) in relation to a health technology identified in a direction given by the Secretary of State;

• (b) that recommends that relevant health bodies provide funding within a specified period to ensure that the health technology be made available for the purposes of treatment of patients.

• (1A) The Secretary of State may direct NICE as to the applicable cost-effectiveness threshold to apply to a health technology undergoing appraisal.

• (2) NICE must specify in a technology appraisal recommendation the period within which the recommendation in paragraph (1)(b) should be complied with.

• (3) The period in paragraph (2) must be a period that begins on the date the recommendation is published by NICE and ends on the date 3 months from that date, unless paragraph (4) applies.

• (4) In the circumstances described in paragraph (5), if NICE considers it appropriate, NICE must specify a longer period.

• (5) The circumstances referred to in paragraphs (4) and (11) are—

• (a) the health technology cannot be appropriately administered until—

• (i) training is,

• (ii) certain health service infrastructure requirements including goods, materials or other facilities are, or

• (iii) other appropriate health services resources, including staff, are,

in place; or

• (b) the health technology is not yet available in England.

• (6) A relevant health body must comply with a technology appraisal recommendation.

• (7) A relevant health body for the purposes of this regulation is—

• (a) NHS England in the case of a technology appraisal recommendation that applies to the exercise of NHS England's s functions of arranging for the provision of services for the purposes of the health service in England[^f00017], in particular—

• (i) its functions under sections 4 (high security psychiatric services)[^f00018], 83 (primary medical services)[^f00019], 99 (primary dental services)[^f00020], 115 (primary ophthalmic services)[^f00021], and 126 (arrangements for pharmaceutical services)[^f00022] of the 2006 Act;

• (ii) its functions under regulations under section 3B(1) of that Act (Secretary of State’s power to require NHS England to commission services)[^f00023];

• (iii) functions exercisable by NHS England pursuant to arrangements under section 7A of that Act (exercise of Secretary of State’s public health functions)[^f00024]; and

• (iv) its functions by virtue of regulations under section 117(2E) of the Mental Health Act 1983 (after-care)[^f00025];

• (b) a CCG in the case of a technology appraisal recommendation that applies to the exercise of the CCG’s functions of arranging for the provision of services for the purposes of the health service in England[^f00026], in particular—

• (i) its functions under sections 3 (duties of integrated care boards as to commissioning certain health services)[^f00027] and 3A (power of integrated care boards to commission certain health services)[^f00028] of, and paragraph 9 of Schedule 1 (provision of vehicles for disabled persons)[^f00029] to, the 2006 Act;

• (ii) functions exercisable by a CCG pursuant to arrangements under section 7A of that Act[^f00030];

• (iii) its functions under section 117(2), or by virtue of regulations under section 117(2E), of the Mental Health Act 1983[^f00031]; or

• (c) a local authority in the case of a technology appraisal recommendation that applies to the provision of public health services which the local authority must arrange—

• (i) for the purpose of the exercise of its functions under or by virtue of section 2B (functions of local authorities and Secretary of State as to improvement of public health)[^f00032], 6C(1) or (3) (regulations as to the exercise by local authorities of certain public health functions)[^f00033] and 111 (dental public health)[^f00034] of, and Schedule 1 (further provision about the Secretary of State and services under this Act)[^f00035] to, the 2006 Act; or

• (ii) in pursuance of arrangements under section 7A of that Act.

• (8) The duty of a relevant health body in paragraph (6) must be taken to require that—

• (a) where NHS England is a relevant health body, NHS England must apply such amounts of the sums paid to it under section 223B(1) of the 2006 Act (funding of NHS England)[^f00036] as may be required to enable NHS England to comply with the recommendation;

• (b) where a CCG is a relevant health body, the CCG must apply such amounts of the sums paid to it under section 223G(1) of the 2006 Act (means of meeting expenditure of integrated care boards out of public funds)[^f00037] as may be required to enable the CCG to comply with the recommendation; or

• (c) where a local authority is a relevant health body, the local authority must apply such amounts of the sums paid to it under section 31 of the Local Government Act 2003[^f00038] (power to pay grant) for the purpose of funding the performance of its functions under section 2B or 111 of, or paragraphs 1 to 7B or 13 of Schedule 1 to, that Act, as may be required to enable the local authority to comply with the recommendation.

• (9) Subject to paragraph (9A), NICE must establish a procedure for the appraisal of health technologies, and must consult such persons as it considers appropriate in establishing the procedure.

• (9A) The obligation to consult does not apply to a change to procedures that are necessary to give effect to a direction given by the Secretary of State made under paragraph (1A).

• (10) The procedure must include arrangements for NICE to consult such persons with an interest in the appraisal of a health technology that is the subject of a direction referred to in paragraph (1)(a) as it considers appropriate.

• (11) In the circumstances described in paragraph (5)—

• (a) pursuant to paragraph (4), the consultation referred to in paragraph (10) must include consultation about the appropriate period that may be specified in a technology appraisal recommendation; and

• (b) the Secretary of State and NHS England must be consulted as to the appropriate period.

• (12) NICE must publish a technology appraisal recommendation in such form and manner and at such time as NICE considers appropriate.

• (13) NICE must keep under review and may revise as it considers appropriate a technology appraisal recommendation.

• (14) The Secretary of State must not give a direction under paragraph (1)(a) about the substance of a technology appraisal recommendation.

• (15) In this regulation and regulation 8—

• “cost-effectiveness threshold” means the value, whether expressed as a single figure or a range, against which NICE evaluates the cost-effectiveness or value for money of a health technology or highly specialised health technology.

NICE highly specialised technology recommendations

8

• (1) NICE may make a highly specialised technology recommendation—

• (a) in relation to a highly specialised health technology identified in a direction given by the Secretary of State;

• (b) that recommends that NHS England, in the exercise of NHS England's function to arrange for the provision as part of the health service of services specified in regulations made under section 3B of the 2006 Act[^f00039], provide funding within a specified period to ensure that the highly specialised health technology can be made available for the purposes of treatment of patients.

• (1A) The Secretary of State may direct NICE as to the applicable cost-effectiveness threshold to apply to a highly specialised health technology undergoing appraisal.

• (2) NICE must specify in a highly specialised technology recommendation the period within which NHS England must comply with the recommendation in paragraph (1)(b).

• (3) The period in paragraph (2) must be a period that begins on the date the recommendation is published by NICE and ends on a date 3 months from that date, unless paragraph (4) applies.

• (4) In the circumstances described in paragraph (5), if NICE considers it appropriate, NICE must specify a longer period.

• (5) The circumstances referred to in paragraphs (4) and (10) are—

• (a) the highly specialised health technology cannot be appropriately administered until—