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

Interpretation of this Part

2.  In this Part—

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

“CCG” means a clinical commissioning group(1);

“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(2);

“health technology” may include—

(a)

a medicinal product to which Directive 2001/83/EC applies(3);

(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;

“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(4);

“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 Excellence(5);

“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(6) 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.

(1)

A clinical commissioning group (“CCG”) is a body established under section 14D of the 2006 Act. Section 14D is inserted by section 25(1) of the Act. See also section 1I of the 2006 Act, inserted by section 10 of the Act.

(2)

OJ No L 311, 28.11.2001, p.67. Directive 2001/83/EC was last amended by Directive 2012/26/EU (OJ No L 299, 27.10.2012, p. 1 to 4).

(3)

See Articles 1(2), 2(1) and 3 of Directive 2001/83/EC.

(4)

See regulations 7, 10 and 11 of, and Schedule 4 to, the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012, S.I. 2012/2996.

(5)

The National Institute for Health and Clinical Excellence was established by article 2 of the National Institute for Clinical Excellence (Establishment and Constitution) Order 1999, S.I. 1999/220, as amended by S.I. 1999/2219, 2002/1750, 2005/497 and 2012/476 and abolished by section 248 of the Act, which is to come into force on 1st April 2013 (see the Health and Social Care Act 2012 (Commencement No. 4, Transitional, Savings and Transitory Provisions) Order 2013, S.I. 2013/160 (C. 9).

(6)

“The health service” is defined in section 247 of the Act.