The Branded Health Service Medicines (Costs) Regulations 2018

Document Number:2018 No. 345
Coming into force:Coming into force on the 01/04/2018
 
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Statutory Instruments

National Health Service, England And Wales

National Health Service, Scotland

Health And Personal Social Services, Northern Ireland

Made

8 th March 2018

Laid before Parliament

9 th March 2018

Coming into force

1 st April 2018

The Secretary of State for Health and Social Care makes the following Regulations in exercise of the powers in sections 263(1) , (2) , (4) , (5 A) and (6) , 264 A(2) , (5) and (7) , 265(1) , (3) , (4) , (5) and (5 A) , 266(1) and (2) and 272(7) and (8) of the National Health Service Act 2006(1) and in accordance with sections 266(3) , (4) and (4 A) of that Act.

The Secretary of State has consulted in accordance with sections 263(1) , 263(1 A) , 264 C(1) and 265(9) of the National Health Service Act 2006.

Citation, commencement and interpretation

  1. —(1) These Regulations may be cited as the Branded Health Service Medicines (Costs) Regulations 2018 and come into force on 1 st April 2018.

    (2) In these Regulations—

    “the 1978 Act” means the National Health Service (Scotland) Act 1978(2);

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

    “the 2006 Wales Act” means the National Health Service (Wales) Act 2006(3);

    “the 2008 Regulations” means the Health Service Branded Medicines (Control of Prices and Supply of Information)(No.2) Regulations 2008(4);

    “the 2012 Regulations” means the Human Medicines Regulations 2012(5);

    “accounting reference date” has the meaning given to it under section 391 of the Companies Act 2006(6);

    “accounting reference period” has the meaning given to it under section 391 of the Companies Act 2006;

    “audited sales report” means a sales report audited in accordance with regulation 23(1);

    “branded medicine” means a medicinal product to which a brand name has been applied that enables the medicine to be identified without reference to the common name;

    “common name” in respect of a medicinal product means the non-proprietary name or if one does not exist, the usual common name;

    “contracting authority” in relation to a contract based on a framework agreement has the meaning given to it by regulation 3 of the Public Contracts Regulations 2006(7) , regulation 3 of the Public Contracts (Scotland) Regulations 2012(8) , regulation 2 of the Public Contracts Regulations 2015(9) or regulation 2 of the Public Contracts (Scotland) Regulations 2015(10) under which the relevant framework agreement was concluded;

    “duration of supplementary certificate” is to be construed in accordance with article 13 of Regulation (EC) 469/2009 of the European Parliament and of the Council of 6 th May 2009 concerning the supplementary protection certificate for medicinal products(11);

    “final quarter” means the last quarter in a financial year;

    “financial year” has the meaning given to it under section 390 of the Companies Act 2006;

    “framework agreement” has the meaning given to it by regulation 2 of the Public Contracts Regulations 2006 , regulation 2 of the Public Contracts (Scotland) Regulations 2012 , regulation 33(2) of the Public Contracts Regulations 2015 or regulation 2 of the Public Contracts (Scotland) Regulations 2015 under which the framework agreement was concluded;

    “gross sales income” means income from sales, excluding value added taxes, and before deduction of all trade and other discounts (howsoever named) including settlement discounts, rebates or deduction of any payments, including penalties, made under these Regulations;

    “group” has the meaning given to it under section 474(1) of the Companies Act 2006;

    “health service use” means used to any extent for the purposes of—

    the health service continued under section 1(1) of the 2006 Act;

    health care provided by virtue of Health and Social Care (Reform) Act (Northern Ireland) 2009(12);

    the health service within the meaning of the 1978 Act; or

    the health service continued under section 1(1) of the 2006 Wales Act;

    “individual accounts” means accounts of the manufacturer or supplier prepared in accordance with section 394 of the Companies Act 2006;

    “invented name” is a name which is not the common name and is not liable to be confused with the common name;

    “low cost presentation” means a presentation which has a maximum price, as determined by regulation 8 , for each item of presentation of less than £2.00;

    “marketing authorisation” has the meaning given by regulation 8(1) of the 2012 Regulations;

    “marketing authorisation holder” means a manufacturer or supplier that holds a marketing authorisation;

    “net sales income” means income from sales, excluding value added taxes, and after deduction of all trade and other discounts (howsoever named) including settlement discounts and rebates but before deduction of any payments, including penalties, made under these Regulations;

    “new manufacturer or supplier” means a manufacturer or supplier that is within its first accounting reference period;

    “NHS BSA” means the NHS Business Services Authority established by the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) (Establishment and Constitution) Order 2005(13);

    “NHS chemist” means any person who—

    provides pharmaceutical or local pharmaceutical services under Part 7 of the 2006 Act or as mentioned in section 264 A(9) of that Act(14); and

    is not also a primary medical services provider;

    “non-proprietary name” means a name which is, or which is a permitted variation of—

    an International Non-proprietary Name (INN);

    an International Non-proprietary Name Modified (INNM);

    a British Approved Name (BAN);

    a British Approved Name Modified (BANM); or

    an approved name,

    and for this purpose these names (and their permitted variations) have the same meanings as in a list of names(15) which has been prepared and published under regulation 318 of the 2012 Regulations (list of names) and which is in force;

    “parallel distributed presentation” means a presentation in respect of which a parallel distribution notice(16) with the United Kingdom as the Member State of destination has been given;

    “patent protection period” means the total period of the term of patent and if a supplementary protection certificate has been granted, the duration of the supplementary protection certificate;

    “prescription only medicine” is to be construed in accordance with regulation 5 of the 2012 Regulations;

    “presentation” means a particular form of a relevant medicine which may be distinguished from other forms of the medicine by reference to its active ingredients, strength and excipients, pack size, method of administration or formulation;

    “presentation report” is to be construed in accordance with the requirements of regulation 22;

    “primary medical services provider” means any person who provides primary medical services (who may be a provider of pharmaceutical services as well as primary medical services) under—

    Part 4 of the 2006 Act;

    Part 4 of the 2006 Wales Act;

    section 2 C of the 1978 Act(17) , a contract under section 17 J of the 1978 Act(18) or an agreement under section 17 C of the 1978 Act(19); or

    Part 2 or 6 of the Health and Personal Social Services (Northern Ireland) Order 1972(20);

    “public contract” has the meaning given to it by regulation 2 of the Public Contracts Regulations 2006 , regulation 2 of the Public Contracts (Scotland) Regulations 2012 , regulation 2 of the Public Contracts Regulations 2015(21) or regulation 2 of the Public Contracts (Scotland) Regulations 2015 under which the relevant contract was awarded;

    “quarter” means, in relation to a financial year which is of at least three months duration, the three month period beginning on the first day of the financial year, and every subsequent three month period in that year even if there are more than four such periods in that financial year;

    “relevant medicine” means a health service medicine—

    which is a branded medicine;

    which is a medicine in respect of which a marketing authorisation has been granted;

    which is a prescription only medicine; and

    which is not—

    in relation to England, listed in Schedule 1 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004(22) ,

    in relation to Scotland, specified in any directions given by the Scottish Ministers under section 17 N(6) (other mandatory contract terms) of the 1978 Act(23) as being drugs, medicines or other substances which may not be ordered by a contractor made under section 17 J for patients in the provision of primary medical services under a general medical services contract made under section 17 J (health boards power to enter into general medical services contracts) of the 1978 Act(24) in relation to Scotland,

    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(25) , or

    in relation to Wales, listed in Schedule 1 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004(26);

    “relevant NHS BSA online gateway” means the service provided for on the NHS BSA website for receiving information for the purpose in question(27);

    “relevant UK hospital” means—

    a UK health service hospital; or

    any other body (not being a public authority) that is responsible, under the arrangements for managing a hospital that supplies UK health service products to patients, for purchasing those health service products;

    “remaining period” means—

    in relation to a financial year which is of less than three months’ duration, the entire financial year(28);

    in relation to a financial year which is of more than three months’ duration, any part of that financial year, which cannot be more than three months, falling after the final quarter;

    “sales report” is to be construed in accordance with the requirements of regulation 21(1);

    “small manufacturer or supplier” is to be construed in accordance with Schedule 2;

    “statutory audited accounts” means—

    in relation to individual...

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