PART 2The National Institute for Health and Care Excellence
Interpretation of this Part2
In this Part—
“carer” means an adult who provides or intends to provide care for another person;
“CCG” means a clinical commissioning group5;
“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 use6;
“health technology” may include—
- a
a medicinal product to which Directive 2001/83/EC applies7;
- b
a medical device;
- c
a diagnostic technique;
- d
a surgical procedure or other therapeutic technique;
- e
a therapeutic technology other than a medicinal product to which Directive 2001/83/EC applies, medical device, diagnostic technique or surgical procedure;
- f
a system of care; or
- g
a screening tool;
- a
“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 Act8;
“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;
“the Institute” means the Special Health Authority known as the National Institute for Health and Clinical Excellence9;
“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 service10 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 members3
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 persons4
1
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 recommendations5
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 services13,
b
public health services14, or
c
social care15 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 the Board;
b
is subject to directions given by the Secretary of State or (as the case may be) the Board 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 bodies16 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 the Board 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
The Board 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 appraisal recommendation.
Charges for NICE advice, guidance, information or recommendations6
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.
NICE technology appraisal recommendations7
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.
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
the Board in the case of a technology appraisal recommendation that applies to the exercise of the Board’s functions of arranging for the provision of services for the purposes of the health service in England17, in particular—
i
ii
its functions under regulations under section 3B(1) of that Act (Secretary of State’s power to require Board to commission services)23;
iii
functions exercisable by the Board pursuant to arrangements under section 7A of that Act (exercise of Secretary of State’s public health functions)24; and
iv
its functions by virtue of regulations under section 117(2E) of the Mental Health Act 1983 (after-care)25;
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 England26, in particular—
i
its functions under sections 3 (duties of clinical commissioning groups as to commissioning certain health services)27 and 3A (power of clinical commissioning groups to commission certain health services)28 of, and paragraph 9 of Schedule 1 (provision of vehicles for disabled persons)29 to, the 2006 Act;
ii
functions exercisable by a CCG pursuant to arrangements under section 7A of that Act30;
iii
its functions under section 117(2), or by virtue of regulations under section 117(2E), of the Mental Health Act 198331; 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)32, 6C(1) or (3) (regulations as to the exercise by local authorities of certain public health functions)33 and 111 (dental public health)34 of, and Schedule 1 (further provision about the Secretary of State and services under this Act)35 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 the Board is a relevant health body, the Board must apply such amounts of the sums paid to it under section 223B(1) of the 2006 Act (funding of the Board)36 as may be required to enable the Board 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 clinical commissioning groups out of public funds)37 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 200338 (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
NICE must establish a procedure for the appraisal of health technologies, and must consult such persons as it considers appropriate in establishing the procedure.
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 the Board 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.
NICE highly specialised technology recommendations8
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 the Board, in the exercise of the Board’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 Act39, 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.
2
NICE must specify in a highly specialised technology recommendation the period within which the Board 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—
i
training is,
ii
certain health services infrastructure requirements including goods, materials or other facilities are, or
iii
other appropriate health services resources, including staff, are,
in place; or
b
the highly specialised health technology is not yet available in England.
6
The Board must comply with a highly specialised technology recommendation.
7
The duty of the Board in paragraph (6) must be taken to require that the Board apply such amounts of the sums paid to it under section 223B(1) of the 2006 Act as may be required to enable the Board to comply with the paragraph (1)(b) recommendation.
8
NICE must establish a procedure for the appraisal of highly specialised health technologies, and must consult such persons as it considers appropriate in establishing the procedure.
9
The procedure must include arrangements—
a
for NICE to consult such persons with an interest in the appraisal of a highly specialised health technology that is the subject of a direction referred to in paragraph (1)(a) as it considers appropriate; and
b
for the Board to be consulted as such a person.
10
In the circumstances described in paragraph (5)—
a
pursuant to paragraph (4), the consultation referred to in paragraph (9)(a) must include consultation about the appropriate period that may be specified in a highly specialised technology recommendation; and
b
the Secretary of State and the Board must be consulted as to the appropriate period.
11
NICE must publish a highly specialised technology recommendation in such form and manner and at such time as NICE considers appropriate.
12
NICE must keep under review and may revise as it considers appropriate a highly specialised technology recommendation.
13
The Secretary of State must not give a direction under paragraph (1)(a) about the substance of a highly specialised technology recommendation.
NICE recommendations: appeals9
1
A person aggrieved by a recommendation described in paragraph (2) may bring an appeal against the recommendation on grounds described in paragraph (3).
2
A recommendation against which an appeal may be brought is—
a
a technology appraisal recommendation, or
b
a highly specialised technology recommendation.
3
The grounds on which an appeal may be brought are that—
a
in making the assessment that preceded the recommendation, NICE—
i
failed to act fairly, or
ii
exceeded its powers; or
b
the recommendation is unreasonable in the light of the evidence submitted to NICE.
NICE recommendations: appeal panel10
1
The appeal panel by which an appeal brought under regulation 9 is to be heard must—
a
consist of members appointed by NICE whose appointment has been agreed by the Secretary of State;
b
contain a majority of members who are not members or employees of NICE; and
c
include—
i
a member who has experience in the life sciences industry;
ii
a member who is a patient or carer or member of an organisation that represents patients or carers; and
iii
a member who is engaged in the provision of health care40 in the health services.
2
A chair of the appeal panel must be appointed by NICE—
a
from amongst the members who are not members or employees of NICE; and
b
only if the appointment as a chair has been agreed by the Secretary of State.
Arrangements for holding appeals11
1
NICE must make arrangements for the holding of appeals.
2
The arrangements must include procedures for dealing with conflicts of interests or potential conflicts of interests of members or potential members of an appeal panel.
Training12
1
NICE has the function of providing, or facilitating the provision of, training in connection with any matter concerning or connected with the provision of—
a
NHS services;
b
public health services; or
c
social care in England.
2
NICE has power to impose a charge for or in connection with the provision, or the facilitation of the provision, of training.
3
A charge imposed pursuant to paragraph (2) 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.
Advisory services13
1
NICE may give advice to persons (whether or not in the United Kingdom) in relation to any matter concerning or connected with—
a
the provision of health care;
b
the protection or improvement of public health; or
c
the provision of social care.
2
The persons mentioned in paragraph (1) include—
a
persons concerned or connected with the life sciences industry;
b
persons otherwise concerned or connected with a health technology or a highly specialised health technology;
c
a devolved authority;
d
a foreign government; or
e
an international body or organisation.
3
NICE may impose a charge for or in connection with the giving of advice pursuant to paragraph (1).
4
NICE must calculate a charge imposed on a devolved authority so as to enable NICE to recover no more than the cost of providing the advice.
5
NICE may calculate a charge imposed on any other person on the basis NICE considers to be the appropriate commercial basis.
NICE’s charter14
1
NICE must publish the charter41 before 1st July 2013.
2
NICE may include in the charter such information as it considers appropriate but must include information on—
a
the procedures it establishes for carrying out its functions; and
b
the consultation it undertakes in the establishment of its procedures and in the carrying out of its functions.
3
NICE may revise the charter when it considers it appropriate to do so but must review the charter to consider whether it should be revised at least once in any review period.
4
A review period referred to in paragraph (3) is—
a
the period of 3 years beginning with the day on which the charter is published, and
b
each subsequent period of 3 years.
Transitional provision – directions: recommendations, guidelines and information15
1
Paragraph (3) applies where, before the relevant date, the Institute, in connection with the promotion of clinical excellence and the effective use of available resources in the health service, has been directed by the Secretary of State42 to—
a
develop guidelines providing advice on good practice in the management of such diseases and conditions as may be notified by the Secretary of State;
b
provide such information on the implementation of the Institute’s recommendations and guidelines to persons employed in activities connected with the health service as may be conducive to their efficiency in relation to that employment;
c
include in its recommendations and guidelines guidance on clinical audit criteria;
d
disseminate through an appropriate range of media its recommendations and guidelines to the health service and general public;
e
look into and consider, for the purpose of advising the Secretary of State with regard to possible improvements in the provision of health services and in the effective use of available resources, such matters as were notified to it by the Secretary of State;
f
consider all interventional procedures notified to it;
g
identify any interventional procedure notified to it for which an assessment by the Institute as to whether it is safe and efficacious for use in the health service is unnecessary;
h
identify any interventional procedure notified to it otherwise than by the Secretary of State for which a comprehensive review of the evidence is required to enable the Institute to evaluate the procedure for the purposes of its recommendations or guidelines; and to evaluate its safety and efficacy for the purposes of use in the health service, and issue guidance to the health service on the use of the procedure;
i
assess the extent to which any interventional procedure notified to the Institute, other than one for which an assessment by the Institute is unnecessary, is safe and efficacious for use in the health service, and issue guidance to the health service on the use of the procedure;
j
subject to the approval of the Secretary of State, consider, and, as appropriate, endorse guidance prepared by other bodies concerning the clinical benefits of health care interventions43 and good practice in the management of diseases and other conditions affecting health; or
k
exercise any similar function of the Secretary of State relating to the health service, other than a function referred to in paragraph (3) or regulations 16 to 23.
2
Paragraph (3) applies where, before the relevant date, the Institute, in connection with the promotion of excellence in public health provision and promotion and the effective use of resources available in the health service and other available public funds, has been directed by the Secretary of State44 to—
a
develop, maintain and disseminate an evidence-base for effective public health action on health improvement and the reduction of inequalities in health;
b
provide guidance on the development and setting of standards for public health and health promotion programmes and practice and support their implementation;
c
provide guidance on the means for improving the capability and capacity of organisations, systems and the wider public health workforce to deliver health improvement and reduce inequalities in health; or
d
disseminate through an appropriate range of media, the guidance described in sub-paragraphs (b) and (c).
3
Where this paragraph applies, on and after the relevant date, NICE must treat the direction as if the direction had been given by the Secretary of State—
a
in the case of a matter concerning or connected with the provision of NHS services, under regulation 5(2); or
b
in the case of a matter concerning or connected with the provision of public health services, under regulation 5(3).
Transitional provision – directions: technology appraisal guidance16
1
Where, before the relevant date, the Institute, in connection with the promotion of clinical excellence and the effective use of available resources in the health service, has been directed by the Secretary of State to appraise the clinical benefits and costs of such health care interventions as may have been notified by the Secretary of State, and to make recommendations45, paragraph (2) applies.
2
Where this paragraph applies, on and after the relevant date, NICE must treat the direction as a direction given by the Secretary of State under regulation 7(1)(a).
Transitional provision – Appeal Panels17
1
Where the Institute has made arrangements for an appeal, on the application of a person aggrieved by a recommendation made by the Institute on the grounds that the Institute—
a
failed to act fairly,
b
exceeded its powers, or
c
formulated guidance which cannot reasonably be justified in the light of the evidence submitted46,
but has not determined the application before the relevant date, paragraph (2) applies.
2
Where this paragraph applies, on and after the relevant date—
a
any Appeal Panel that has been appointed by the Institute to determine the application of a person aggrieved is to be treated as an appeal panel constituted in accordance with regulation 10; and
b
NICE must make arrangements in accordance with regulation 11 for the determination of the application.
Transitional provision – directions: instruction18
1
Where, before the relevant date, the Institute has been directed to provide the instruction described in paragraphs (2) and (3), on and after the relevant date, NICE must provide the instruction as if it were training that NICE has the function of providing or facilitating the provision of under regulation 12(1)(a).
2
The instruction referred to in paragraph (1) is the provision by the Institute of education, training and development to support the safe and effective use of medicines47.
3
The education, training and development referred to in paragraph (2) includes—
a
instruction on the implementation of the Institute’s recommendations and guidelines to persons employed in activities connected with the health service;
b
supporting the implementation of good practice guidance;
c
developing educational resources and materials; and
d
organising and delivering a national education and training event programme.
4
Regulation 12(2) and (3) does not apply in the case of training provided pursuant to paragraph (1).
Transitional provision – procedures: recommendations, guidelines, information or instruction19
1
Anything done by the Institute before the relevant date, in pursuance of a direction given by the Secretary of State described in regulation 15(1) or (2), is to be treated, on and after the relevant date, as having been done by NICE in pursuance of a direction given by the Secretary of State—
a
in the case of a matter concerning or connected with the provision of NHS services, under regulation 5(2); or
b
in the case of a matter concerning or connected with the provision of public health services, under regulation 5(3).
2
A procedure established or published by the Institute for the giving of advice or guidance, the provision of information or the making of recommendations by the Institute before the relevant date, is to be treated, on and after the relevant date, as if it were a procedure established or published by NICE in accordance with regulation 5(4).
3
Consultation with any person undertaken by the Institute for the establishment of a procedure for the giving of advice or guidance, the provision of information or the making of recommendations before the relevant date, is to be treated, on and after the relevant date, as if it were consultation for the establishment of a procedure carried out by NICE in accordance with regulation 5(5).
4
The publication or dissemination by the Institute of advice, guidance, information or recommendations given, provided or made by the Institute, including through its website under the title, “NHS Evidence”48, before the relevant date, is to be treated, on and after the relevant date, as publication or dissemination by NICE in accordance with regulation 5(6).
5
In this regulation, “recommendations” does not include a recommendation made by the Institute in relation to a health care intervention in a Technology Appraisal Guidance issued by the Institute as described in regulation 20(1).
Transitional provision – procedures: health care interventions20
1
A recommendation made by the Institute in relation to a health care intervention in a Technology Appraisal Guidance issued by the Institute before the relevant date, is to be treated, on and after the relevant date, as if it were a technology appraisal recommendation made by NICE pursuant to regulation 7(1).
2
A procedure for the appraisal by the Institute of the clinical benefits and costs of a health care intervention, in connection with the promotion of clinical excellence and the effective use of available resources in the health service, established by the Institute before the relevant date, is to be treated, on and after the relevant date, as a procedure for the appraisal of a health technology pursuant to regulation 7(9).
3
Anything done by the Institute by way of appraisal of the clinical benefits and costs of a health care intervention, in connection with the promotion of clinical excellence and the effective use of available resources in the health service, before the relevant date, is to be treated, on and after the relevant date, as done in accordance with a procedure established by NICE pursuant to regulation 7(9).
4
Consultation undertaken by the Institute for the appraisal by the Institute of the clinical benefits and costs of a health care intervention, in connection with the promotion of clinical excellence and the effective use of available resources in the health service, before the relevant date, is to be treated, on and after the relevant date, as consultation undertaken by NICE in accordance with arrangements included in the procedure established pursuant to regulation 7(9) as set out in regulation 7(10).
5
The issuance by the Institute of a Technology Appraisal Guidance to the health service on the use of a health care intervention before the relevant date, is to be treated, on and after the relevant date, as publication of a technology appraisal recommendation by NICE in accordance with regulation 7(12).
Transitional provision – appeal arrangements21
Arrangements for holding appeals made by the Institute before the relevant date, are to be treated, on and after the relevant date, as arrangements for the holding of appeals made pursuant to regulation 11.
Transitional provision – procedures: instruction22
Anything done by the Institute before the relevant date, in pursuance of a direction given by the Secretary of State referred to in regulation 18(1), is to be treated, on and after the relevant date, as having been done by NICE under regulation 12(1)(a), but regulation 12(2) and (3) does not apply in the case of training provided pursuant to regulation 18(1).
Transitional provision - charter23
Preparation of a charter by the Institute before the relevant date, is to be treated, on and after the relevant date, as if it were preparation by NICE for the purposes of publishing the charter pursuant to regulation 14(1).