The National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012

PART 7 Standing rules: decisions about drugs and other treatments

Interpretation

33.  In this Part—

“health care intervention” includes the use of a medicine or medical device, diagnostic technique, surgical procedure or other therapeutic intervention;

“NICE” means—

(a)

until the coming into force of section 232 of the 2012 Act(1), the National Institute for Health and Clinical Excellence(2); and

(b)

from the coming into force of that section, the National Institute for Health and Care Excellence;

“relevant NICE recommendations” means—

(a)

any directions given by the Secretary of State as to the application of sums paid to a Primary Care Trust under section 228 of the 2006 Act (public funding by Primary Care Trusts) in relation to a health care intervention recommended by NICE; and

(b)

from the coming into force of section 237(8) of the 2012 Act (NICE advice, guidance, information and recommendations), recommendations specified, or recommendations of a description specified, in regulations made under that section where the relevant body—

(i)

is specified in such regulations as required to comply with the recommendation, or

(ii)

is a health and social care body of a description specified in such regulations as a health and social care body that is required to comply with the recommendation.

Duty of a relevant body in respect of the funding and commissioning of drugs and other treatments

34.—(1) A relevant body must have in place arrangements for making decisions and adopting policies on whether a particular health care intervention is to be made available for persons for whom the relevant body has responsibility.

(2) Arrangements under paragraph (1) must—

(a) ensure that the relevant body complies with relevant NICE recommendations; and

(b) include arrangements for the determination of any request for the funding of a health care intervention for a person, where there is no relevant NICE recommendation and the relevant body’s general policy is not to fund that intervention.

Duty to give reasons for decisions

35.—(1) A relevant body must—

(a) publish on its website a written statement of its reasons for any general policy it has on whether a particular healthcare intervention is to be made available for persons for whom it has responsibility; or

(b) where it has not published such a statement, provide a written statement of the reasons for any such policy when any person makes a written request for such a statement.

(2) Where a relevant body—

(a) makes a decision to refuse a request for the funding of a health care intervention for a person; and

(b) its general policy is not to fund that intervention,

the relevant body must provide that person with the reasons for that decision in writing.

Duty to provide written information

36.  Each relevant body must compile information in writing describing the arrangements it has made pursuant to the requirements in regulation 34 and must ensure that that information is—

(a) published on the website of the relevant body; and

(b) available to inspect at the head or main office of the relevant body.

Transitional provisions

37.—(1) For the purposes of this regulation, a relevant body has responsibility for a person in respect of a healthcare intervention only if it has responsibility for that person in relation to services which involve, or would if the intervention was funded involve, the provision of that intervention.

(2) Where, before the relevant date—

(a) a person has made a request for a written statement of the reasons for a Primary Care Trust’s general policy on whether a particular health care intervention is to be funded pursuant to direction 3(1) of the Directions to Primary Care Trusts and NHS trusts concerning decisions about drugs and other treatments 2009 which came into force on 1st April 2009 (“the Decisions Directions”)(3); and

(b) a written statement of reasons has not been provided by the Primary Care Trust to whom that request was made before the relevant date in accordance with that direction,

the relevant body with responsibility for that person must provide a written statement of reasons as soon as reasonably practicable as if the request had been made under regulation 35(1)(b).

(3) Where, before the relevant date, a Primary Care Trust—

(a) has made a decision to refuse a request for the funding of a health care intervention in respect of a person where the Primary Care Trust’s general policy is not to fund that intervention; but

(b) has not provided that person with a written statement of reasons for that decision pursuant to direction 3(3) of the Decisions Directions,

the relevant body with responsibility for that person must provide a written statement of reasons to that person as soon as reasonably practicable as if regulation 35(2) applied.

(4) Where, before the relevant date, a Primary Care Trust—

(a) has made a decision to fund a health care intervention for a person where the Primary Care Trust’s general policy is not to fund that intervention; but

(b) has not notified that person of that decision,

the relevant body with responsibility for that person must notify that person as soon as reasonably practicable of that decision, and fund that intervention.

(5) Where, before the relevant date, a Primary Care Trust has received a request for the funding of a health care intervention but has not yet determined it pursuant to arrangements made under direction 2(3)(a) of the Decisions Directions, the relevant body with responsibility for the person who made the request must—

(a) decide whether or not to fund that intervention; and

(b) if the decision is to refuse to fund that intervention, provide a written statement of reasons to that person as soon as reasonably practicable as if regulation 35(2) applied.

(1)

Section 232 of the 2012 Act establishes a body corporate to be known as the National Institute for Health and Care Excellence.

(2)

The National Institute for Health and Clinical Excellence is a Special Health Authority established by S.I. 1999/220, as amended by S.I. 1999/2219, 2002/1760, 2005/497 and 2012/476. It is abolished by section 248 of the 2012 Act.

(3)

The Directions can be found at www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsLegislation/ DH_096067.