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

In these Regulations—

• “the 1978 Act” means the National Health Service (Scotland) Act 1978 M1;

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

• “the 2006 Wales Act” means the National Health Service (Wales) Act 2006 M2;

• “the 2008 Regulations” means the Health Service Branded Medicines (Control of Prices and Supply of Information)(No.2) Regulations 2008 M3;

• “the 2012 Regulations” means the Human Medicines Regulations 2012 M4;

• “accounting reference date” has the meaning given to it under section 391 of the Companies Act 2006 M5;

• “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);

• F1“biological medicinal product” has the meaning given to it by regulation 8(1) of the 2012 Regulations;

• “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 M6, regulation 3 of the Public Contracts (Scotland) Regulations 2012 M7, regulation 2 of the Public Contracts Regulations 2015 M8 or regulation 2 of the Public Contracts (Scotland) Regulations 2015 M9 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 6th May 2009 concerning the supplementary protection certificate for medicinal products M10;

• “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—

  1. a

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

  2. b

     health care provided by virtue of Health and Social Care (Reform) Act (Northern Ireland) 2009 M11;

  3. c

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

  4. d

     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 M12;

• “NHS chemist” means any person who—

  1. a

     provides pharmaceutical or local pharmaceutical services under Part 7 of the 2006 Act or as mentioned in section 264A(9) of that Act M13; and

  2. b

     is not also a primary medical services provider;

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

  1. a

     an International Non-proprietary Name (INN);

  2. b

     an International Non-proprietary Name Modified (INNM);

  3. c

     a British Approved Name (BAN);

  4. d

     a British Approved Name Modified (BANM); or

  5. e

     an approved name,

  and for this purpose these names (and their permitted variations) have the same meanings as in a list of names M14 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 M15 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—

  1. a

     Part 4 of the 2006 Act;

  2. b

     Part 4 of the 2006 Wales Act;

  3. c

     section 2C of the 1978 Act M16, a contract under section 17J of the 1978 Act M17 or an agreement under section 17C of the 1978 Act M18; or

  4. d

     Part 2 or 6 of the Health and Personal Social Services (Northern Ireland) Order 1972 M19;

• “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 M20 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—

  1. a

     which is a branded medicine F2or a biological medicinal product (whether or not it is a branded medicine);

  2. b

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

  3. c

     which is a prescription only medicine; and

  4. d

     which is not—

     1. i

        in relation to England, listed in Schedule 1 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 M21,

     2. ii

        in relation to Scotland, specified in any directions given by the Scottish Ministers under section 17N(6) (other mandatory contract terms) of the 1978 Act M22 as being drugs, medicines or other substances which may not be ordered by a contractor made under section 17J 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) of the 1978 Act M23 in relation to Scotland,

     3. 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 M24, or

     4. iv

        in relation to Wales, listed in Schedule 1 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004 M25;

• “relevant NHS BSA online gateway” means the service provided for on the NHS BSA website for receiving information for the purpose in question M26;

• “relevant UK hospital” means—

  1. a

     a UK health service hospital; or

  2. b

     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—

  1. a

     in relation to a financial year which is of less than three months' duration, the entire financial year M27;

  2. b

     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—

  1. a

     in relation to individual accounts of the manufacturer or supplier required to be audited in accordance with Part 16 of the Companies Act 2006, the individual accounts audited in accordance with Part 16 of that Act;

  2. b

     in relation to individual accounts of the manufacturer or supplier exempt from audit under Part 16 of the Companies Act 2006 in accordance with section 477 of that Act, the individual accounts of the manufacturer or supplier;

  3. c

     in relation to individual accounts of the manufacturer or supplier exempt from audit under Part 16 of the Companies Act 2006 in accordance with section 479A of that Act, the consolidated accounts of the parent undertaking in the same group as the manufacturer or supplier as referred to in subsection (2)(c) of that section;

• “supplementary protection certificate” F3has the meaning given by section 128B(2) of the Patents Act 1977;

• “supply” means supply by way of sale unless the context otherwise requires;

• “term of patent” is to be construed in accordance with section 25 of the Patents Act 1977 M28;

• “unbranded generic health service medicine” means a health service medicine the labelling of which includes the common name of the medicinal product but does not include an invented name;

• “UK health service hospital” means a body which —

  1. a

     is mentioned in Part 3 of Schedule 1 to the Freedom of Information Act 2000 M29 and is responsible, under the arrangements for managing a hospital that supplies UK health service products to patients, for purchasing those health service products; or

  2. b

     is mentioned in Part 4 of Schedule 1 to the Freedom of Information (Scotland) Act 2002 M30 and is responsible, under the arrangements for managing a hospital that supplies UK health service products to patients, for purchasing those health service products;

• “voluntary scheme” means a scheme referred to in section 261(1) of the 2006 Act M31;

• “voluntary scheme presentation” means a presentation covered by a voluntary scheme at the time of supply of that presentation;

• “wholesale dealer's licence” is to be construed in accordance with regulation 18 (wholesale dealing in medicinal products) of the 2012 Regulations; and

• “wholesaler” means a person who—

  1. a

     is a holder of a wholesale dealer's licence; and

  2. b

     is not a primary medical services provider, NHS chemist or UK health service hospital.