The Health Service Medicines (Information Relating to Sales of Branded Medicines etc.) Regulations 2007

Interpretation

2.—(1) In these Regulations—

“the 1978 Act” means the National Health Service (Scotland) Act 1978(1);

“the 2006 Act” means the National Health Service Act 2006;

“the 2006 Wales Act” means the National Health Service (Wales) Act 2006(2);

“the 1972 Order” means the Health and Personal Social Services (Northern Ireland) Order 1972(3);

“Annual Financial Return” means the Annual Financial Return that must be submitted by a scheme member under the PPRS;

“branded health service medicine” means a health service medicine which—

(a)

is identifiable by and traded under a specific name given to it by the manufacturer, supplier or holder of a marketing authorisation relating to it;

(b)

is a medicinal product in respect of which a marketing authorisation has been granted; and

(c)

is not—

(i)

in relation to England, listed in Schedule 1 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004(4);

(ii)

in relation to Scotland, specified in any directions given by the Scottish Ministers under section 17N(6) (other mandatory contract terms)(5) of the 1978 Act as being drugs, medicines or other substances which may not be ordered by a GMS contractor for patients in the provision of primary medical services under a general medical services contract made under section 17J (health boards power to enter into general medical services contracts)(6) of the 1978 Act in relation to Scotland; or

(iii)

in relation to Northern Ireland, listed in Schedule 1 to the Health and Personal Social Services (General Medical Services Contracts) (Prescription of Drugs Etc.) Regulations (Northern Ireland) 2004(7);

“dispensing doctor” means a registered medical practitioner who provides pharmaceutical services;

“GMS contractor” means a person providing primary medical services under a general medical services contract made under—

(a)

section 84 (general medical services contracts: introductory) of the 2006 Act in relation to England;

(b)

section 42 (general medical services contracts: introductory) of the 2006 Wales Act in relation to Wales;

(c)

section 17J (health boards power to enter into general medical services contracts) of the 1978 Act in relation to Scotland; or

(d)

article 57 of the 1972 Order in relation to Northern Ireland;

“health service hospital” means a hospital owned or managed by a health service body;

“health service body” means—

(a)

a Strategic Health Authority, Special Health Authority, Primary Care Trust, National Health Service Trust or NHS foundation trust established or continued under the 2006 Act;

(b)

a Local Health Board established or continued under the 2006 Wales Act;

(c)

a Health Board or Special Health Board constituted under section 2 (Health Boards and Special Health Boards)(8) of the 1978 Act;

(d)

a Health and Social Services Board established under the 1972 Order;

(e)

a special health and social services agency established under the Health and Personal Social Services (Special Agencies) (Northern Ireland) Order 1990(9);

(f)

the Common Services Agency for the Scottish Health Service constituted under section 10 (Common Services Agency)(10) of the 1978 Act;

(g)

the Northern Ireland Central Services Agency for the Health and Social Services established under the 1972 Order; or

(h)

a Health and Social Services trust established under the Health and Personal Social Services (Northern Ireland) Order 1991(11);

“marketing authorisation” means a marketing authorisation for a medicinal product for human use granted—

(a)

by the competent authority of the United Kingdom in accordance with Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(12); or

(b)

by the European Commission in accordance with Regulation (EC) No. 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency(13);

“pharmaceutical services” means pharmaceutical services within the meaning of—

(a)

section 126 (arrangements for pharmaceutical services) of the 2006 Act in England;

(b)

section 80 (arrangements for pharmaceutical services) of the 2006 Wales Act in Wales;

(c)

section 27 (arrangements for provision of pharmaceutical services)(14) of the 1978 Act in Scotland; or

(d)

article 63 (arrangements for pharmaceutical services) of the 1972 Order in Northern Ireland;

“PMS contractor” means a person providing primary medical services under—

(a)

a personal medical services agreement made under section 92 (arrangements by Strategic Health Authorities for the provision of primary medical services) in relation to England;

(b)

an agreement made under section 50 (arrangements by Local Health Boards for the provision of primary medical services) of the 2006 Wales Act in relation to Wales;

(c)

an agreement made under section 17C (personal medical or dental services)(15) of the 1978 Act in relation to Scotland; or

(d)

a personal medical services agreement made under article 15B (provision of primary medical services or personal dental services) of the 1972 Order in relation to Northern Ireland;

“PPRS” means the Pharmaceutical Price Regulation Scheme(16);

“quarter” means the period—

(a)

1st January to 31st March;

(b)

1st April to 30th June;

(c)

1st July to 30th September; or

(d)

1st October to 31st December;

“relevant scheme member” means a scheme member who falls within regulation 3(1) but who does not fall within regulation 3(2) (unless regulation 3(3) applies);

“retail pharmacist” means a person lawfully conducting a retail pharmacy business in accordance with section 69 (general provisions) of the Medicines Act 1968(17) who provides pharmaceutical services;

“sales income” means income from sales after deduction of all trade and other discounts (howsoever named) including settlement discounts, rebates and sales taxes;

“supply” means supply by way of sale; and

“wholesaler” means a person who—

(a)

is a holder of a wholesale dealer’s licence within the meaning of subsection (3) and (3A) of section 8 (provisions as to manufacture and wholesale dealing)(18) of the Medicines Act 1968; and

(b)

is not a retail pharmacist, dispensing doctor, GMS contractor or PMS contractor nor is a health service hospital.

(2) A health service medicine is supplied on the date on which a contract for its sale for health service use is concluded.

(1)

1978 c. 29.

(2)

2006 c. 42.

(3)

S.I. 1972/1265 (N.I. 14).

(4)

S.I. 2004/629.

(5)

Section 17N was inserted by section 4 of the Primary Medical Services (Scotland) Act 2004 (asp 1).

(6)

Section 17J was inserted by section 4 of the Primary Medical Services (Scotland) Act 2004 (asp 1).

(7)

S.R. 2004/142.

(8)

Section 2 was amended by section 28 of and Schedules 9 and 10 to the National Health Service and Community Care Act 1990 (c.19) (“the 1990 Act”), paragraph 1 of Schedule 1 to the National Health Service Reform (Scotland) Act 2004 (asp 7) (“the 2004 Act”) and paragraph 2 of Schedule 2 to the Smoking, Health and Social Care (Scotland) Act 2005 (asp 13) (“the 2005 Act”).

(9)

S.I. 1990/247 (N.I. 3).

(10)

Section 10 was amended by Schedule 10 to the 1990 Act, section 65 of and paragraph 44 of Schedule 4 to the Health Act 1999 (c.8), Schedule 2 to the 2004 Act and paragraph 2 of Schedule 2 to the 2005 Act.

(11)

S.I. 1991/194 (N.I. 1).

(12)

OJ No. L311, 28.11.2001; Directive 2001/83/EC was amended by Directive 2002/98/EC of the European Parliament and of the Council (OJ No. L33, 8.2.2003, p.30), by Commission Directive 2003/63/EC (OJ No. L159, 27.6.2003, p.46), by Directive 2004/24/EC of the European Parliament and of the Council (OJ No. L136, 30.4.2004, p.85) and by Directive 2004/27/EC of the European Parliament and of the Council (OJ No. L136, 30.4.2004, p.34).

(13)

OJ No. L136, 30.4.2004, p.1.

(14)

Section 27 was amended by section 20(2) of the Health Services Act 1980 (c. 53), section 3(3) of the National Health Service (Amendment) Act 1986 (c. 66), S.I. 1987/2202, paragraph 19(7) of Schedule 9 to the 1990 Act, section 3 of the Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28) and paragraph 44 of Schedule 2 to the National Health Service (Primary Care) Act 1997 (c.46) (“the 1997 Act”).

(15)

Section 17C was inserted by sections 21(2) and 41(3) of the 1997 Act and amended by section 2(2)(a), (b), (c), (d) and (e) of the Primary Medical Services (Scotland) Act 2004 (asp 1) and paragraph 12 of Schedule 3 to the National Health Service Reform and Health Care Professions Act 2002 (c. 17). Section 17C retains its original heading of “personal medical or dental services” although the section now relates to primary medical services and personal dental services.

(16)

Current version first published: November 2004. The Pharmaceutical Price Regulation Scheme is available on the Department of Health’s website at: http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAnd Guidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4093228&chk=qW14At.

(17)

1968 c. 67. Section 69 was amended by section 1 of and paragraph 5 of the Schedule to the Pharmacists (Fitness to Practise) Act 1997 (c. 19), the Statute Law Repeals Act 1993 (c. 50) and Article 26(b) of and paragraph 4 of Schedule 5 to S.I. 1976/1213.

(18)

Section 8(3) was substituted by S.I. 1977/1050 and amended by S.I. 1992/604, 1993/834, 2004/1031 and 2006/2407. Section 8(3A) was inserted by S.I. 1993/384 and amended by S.I. 2002/236 and 2004/1031.