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The National Health Service (Charges for Drugs and Appliances) Regulations 2015

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InterpretationE+W

This section has no associated Explanatory Memorandum

2.—(1) In these Regulations—

the 2000 Act” means the Electronic Communications Act 2000 M1;

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

accepted disablement” means physical or mental injury or disease which is accepted by the Secretary of State as attributable to, or aggravated by, service in the armed forces of the Crown or such other service as the Secretary of State may determine;

advanced electronic signature” means an electronic signature which is—

(a)

uniquely linked to the signatory;

(b)

capable of identifying the signatory;

(c)

[F1created using electronic signature creation data that the signatory can, with a high level of confidence, use under the signatory's sole control]; and

(d)

linked to the data to which it relates in such a manner that any subsequent change of data is detectable;

another primary care organisation” means—

(a)

as regards Wales, a Local Health Board;

(b)

as regards Scotland, a Health Board constituted under section 2 of the National Health (Scotland) Act 1978 M2 (Health Boards);

(c)

as regards Northern Ireland, the Regional Health and Social Care Board established under section 7 of the Health and Social Care (Reform) Act (Northern Ireland) 2009 M3 (Regional Health and Social Care Board); and

(d)

as regards England, in relation to any time prior to 1st April 2013, a Primary Care Trust;

F2...

“appliance”, unless the context otherwise requires, means an appliance included in a list approved by the Secretary of State for the purposes of section 126 of the 2006 Act M4 (arrangements for pharmaceutical services), but does not include a contraceptive appliance;

approved”, in relation to forms, means approved by the Secretary of State;

armed forces of the Crown” means the forces that are “regular forces” or “reserve forces” within the meanings given in section 374 of the Armed Forces Act 2006 M5 (definitions applying for the purposes of the whole Act);

arrangements for recharging” means arrangements under paragraph 3 of Schedule 12A to the 2006 Act M6 (pharmaceutical remuneration – other pharmaceutical remuneration) under which the Board requires a person to reimburse it for any pharmaceutical remuneration to which that paragraph applies;

bank holiday” means any day that is, by virtue of section 1 of, or Schedule 1 to, the Banking and Financial Dealings Act 1971 M7 (which relate to bank holidays), a bank holiday in England;

batch issue” means an approved form, in the format required by the Board (or person exercising its functions), which—

(a)

is issued by a prescriber at the same time as a non-electronic repeatable prescription to enable a chemist or a dispensing doctor to receive payment for the provision of repeat dispensing services;

(b)

relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;

(c)

is generated by a computer and not signed by a prescriber;

(d)

is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs or appliances ordered on the non-electronic repeatable prescription may be provided; and

(e)

has included on it a number denoting its place in the sequence referred to in sub-paragraph (d);

CCG” means a clinical commissioning group;

chemist” means an LPS chemist or a person included in a pharmaceutical list of the type referred to in regulation 10(2)(a) or (b) of the Pharmaceutical and Local Pharmaceutical Services Regulations (pharmaceutical lists and EPS lists);

chiropodist or podiatrist independent prescriber” means a chiropodist or podiatrist who is registered in Part 2 of the register maintained under article 5 of the [F3Health Professions Order 2001] (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that the chiropodist or podiatrist is qualified to order drugs and appliances as a chiropodist or podiatrist independent prescriber;

community treatment order” means an order under section 17A(1) of the Mental Health Act 1983 M8 (community treatment orders);

directed services” means additional pharmaceutical services provided in accordance with directions under section 127 of the 2006 Act M9 (arrangements for additional pharmaceutical services);

dispensing doctor” is to be construed in accordance with regulation 46(1) of the Pharmaceutical and Local Pharmaceutical Services Regulations (dispensing doctor lists);

dispensing services” means the provision of drugs or appliances that may be provided as pharmaceutical services by a medical practitioner in accordance with arrangements made under sections 126 and 132 of the 2006 Act M10 (arrangements for pharmaceutical services, and persons authorised to provide pharmaceutical services);

doctor” means a registered medical practitioner;

drugs” includes medicines, but does not include contraceptive substances;

elastic hosiery” means anklet, legging, knee-cap, below-knee or thigh stocking;

electronic communication” has the same meaning as in section 15(1) of the 2000 Act M11 (general interpretation);

electronic prescription form” means data created in an electronic form for the purpose of ordering a drug or appliance, which—

(a)

is compatible with the systems used by the Board (or a person exercising its functions) for—

(i)

the remuneration of persons providing pharmaceutical services or local pharmaceutical services, and

(ii)

any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless the chemist or dispensing doctor dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;

(b)

is signed with a prescriber's advanced electronic signature;

(c)

is transmitted as an electronic communication to a nominated dispensing contractor [F4or via an information hub] by the Electronic Prescription Service; and

(d)

does not indicate that the drug or appliance ordered may be provided more than once;

electronic repeatable prescription” means data created in an electronic form, which—

(a)

is signed with a prescriber's advanced electronic signature;

(b)

is transmitted as an electronic communication to a nominated dispensing contractor [F5or via an information hub] by the Electronic Prescription Service;

(c)

indicates that the drug or appliance ordered may be provided more than once; and

(d)

specifies the number of occasions on which they may be provided;

Electronic Prescription Service” means the service of that name which is managed by the Information Centre;

electronic signature” has the same meaning as in section 7 of the 2000 Act (electronic signatures and related certificates);

[F6electronic signature creation data” means unique data which is used by the signatory to create an electronic signature;]

enhanced services” means the directed services which the Board is authorised (as opposed to required) to arrange by virtue of directions under section 127 of the 2006 Act;

“exemption certificate”, unless the context otherwise requires, has the meaning assigned to it by regulation 15(1);

GMS contract” means a general medical services contract, and “GMS contractor” is to be construed accordingly;

independent nurse prescriber” means a person—

(a)

who is registered in the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001 M12 (establishment and maintenance of register); and

(b)

against whose name in that register is recorded an annotation signifying that they are qualified to order drugs and appliances as a community practitioner nurse prescriber, a nurse independent prescriber or a nurse independent/supplementary prescriber;

Information Centre” means the Health and Social Care Information Centre established under section 252 of the Health and Social Care Act 2012 M13 (the Health and Social Care Information Centre);

[F7“integrated care provider contract” has the meaning given in Schedule 3A to the National Health Service (General Medical Services Contracts) Regulations 2015;]

LPS chemist” means a party to an LPS scheme other than the commissioning body;

mental disorder” has the same meaning as in section 1 of the Mental Health Act 1983 M14 (application of Act: “mental disorder”);

[F8“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;]

NHS services” means services provided as part of the health service (including services provided as part of the health service in pursuance of the public health functions of the Secretary of State or local authorities);

nominated dispensing contractor” means a chemist or a dispensing doctor who has been nominated in a particular patient's PDS patient details to dispense the electronic prescriptions of that patient;

non-electronic prescription form” means an approved form for ordering a drug or appliance which—

(a)

is compatible with the systems used by the Board (or person exercising its functions) for—

(i)

the remuneration of persons providing pharmaceutical services and local pharmaceutical services, and

(ii)

any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless the chemist or dispensing doctor dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;

(b)

has been provided for use by a prescriber by—

(i)

the Board,

(ii)

another primary care organisation,

(iii)

a local authority, under arrangements for providing NHS services which include, with the consent of the Board, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,

(iv)

the Secretary of State,

(v)

a CCG, under arrangements for providing NHS services which include, with the consent of the Board, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,

(vi)

an NHS trust, or

(vii)

an NHS foundation trust;

(c)

has been issued by a prescriber; and

(d)

does not indicate that the drug or appliance ordered may be provided more than once;

non-electronic repeatable prescription” means a repeatable prescription which is not an electronic repeatable prescription;

optometrist independent prescriber” means a person—

(a)

who is registered in the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989 M15 (register of opticians); and

(b)

against whose name in that register is recorded an annotation that the person is qualified to order drugs and appliances as an optometrist independent prescriber;

out of hours period” means—

(a)

the period beginning at 6.30pm on any day from Monday to Thursday and ending at 8am on the following day;

(b)

the period beginning at 6.30pm on Friday and ending at 8am on the following Monday; and

(c)

Good Friday, Christmas Day and bank holidays;

out of hours services” means the services commissioned in respect of all, or part of, the out of hours period to enable the registered patients of a GMS, PMS or [F9section 83(2)] contractor to receive primary medical services outside core hours, and in this definition—

(a)

core hours” means the period beginning at 8am and ending at 6.30pm on any day from Monday to Friday except Good Friday, Christmas Day and bank holidays; and

(b)

“part” of an out of hours period means any part of one or more of the periods described in paragraphs (a) to (c) of the definition of “out of hours period”;

[F10“paramedic independent prescriber” means a person—

(a)

who is registered in Part 8 of the register maintained under article 5 of the [F11Health Professions Order 2001] (establishment and maintenance of register); and

(b)

against whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines or appliances as a paramedic independent prescriber;]

PDS patient details” means the information held about a patient in the Patient Demographics Service managed by the Information Centre;

the Pharmaceutical and Local Pharmaceutical Services Regulations” means the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 M16;

pharmacist independent prescriber” means a registered pharmacist—

(a)

against whose name in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 M17 (establishment, maintenance of and access to the register) or in the register maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 M18 (which relates to the registers and the registrar) is recorded an annotation signifying that the pharmacist is qualified to order drugs and appliances as a pharmacist independent prescriber; and

(b)

who is prescribing under arrangements for the provision of NHS services, but for these purposes those arrangements must not be arrangements for the provision of—

(i)

pharmaceutical services, unless they are arrangements for the provision of enhanced services, or

(ii)

local pharmaceutical services, unless they are arrangements that have been made by the Board with an LPS chemist for the provision of services that are equivalent to services provided as enhanced services;

physiotherapist independent prescriber” means a physiotherapist who is registered in Part 9 of the register maintained under article 5 of the [F12Health Professions Order 2001], and against whose name in that register is recorded an annotation signifying that the physiotherapist is qualified to order drugs and appliances as a physiotherapist independent prescriber;

PMS agreement” means an agreement made under section 92 of the 2006 Act M19 (arrangements by the Board for the provision of primary medical services);

PMS contractor” means a contractor within the meaning of [F13the National Health Service (Personal Medical Services Agreements) Regulations 2015];

“pre-payment certificate”, unless the context otherwise requires, is to be construed in accordance with regulation 16;

prescriber” means a doctor, a dental practitioner, a pharmacist independent prescriber, a supplementary prescriber, a chiropodist or podiatrist independent prescriber, a physiotherapist independent prescriber, an independent nurse prescriber [F14, an optometrist independent prescriber [F15, a paramedic independent prescriber] or a therapeutic radiographer independent prescriber];

“prescription form”, except in the context of the expression “electronic prescription form” or “non-electronic prescription form”, means an electronic prescription form or a non-electronic prescription form;

provider of NHS services” means a person or a body which provides services under the 2006 Act pursuant to arrangements made with—

(a)

the Board;

(aa)

[F16a person responsible for providing services under an integrated care provider contract;]

(b)

a CCG;

(c)

an NHS trust;

(d)

an NHS foundation trust;

(e)

a local authority in the exercise of its public health functions—

(i)

under section 2B of the 2006 Act M20 (functions of local authorities and Secretary of State as to improvement of public health),

(ii)

under section 111 of the 2006 Act M21 (dental public health),

(iii)

under paragraphs 1 to 7B and 13 of Schedule 1 to the 2006 Act M22 (further provision about the Secretary of State and services under the Act), or

(iv)

pursuant to regulations made under section 6C of the 2006 Act M23 (regulations as to the exercise by local authorities of certain public health functions); or

(f)

the Secretary of State when exercising the public health functions of the Secretary of State (as defined in section 1H(5)(a) of the 2006 Act M24 (the Board and its commissioning functions));

provider of out of hours services” means—

(a)

[F17a section 83(2)] contractor or a PMS contractor which provides out of hours services under [F17its section 83(2)] contract or PMS agreement;

(b)

a GMS contractor which provides out of hours services under its GMS contract; or

(c)

an out of hours services sub-contractor of a GMS contractor, PMS contractor or [F18section 83(2)] contractor;

registered pharmacist” means a person who is registered in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010 or in the register maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976;

[F19“relevant body” means—

(a)

a health service body or local authority, pursuant to arrangements with which a provider of NHS services provides NHS services; or

(b)

the NHS BSA;]

repeat dispensing services” means pharmaceutical services or local pharmaceutical services which involve the provision of drugs or appliances by a chemist in accordance with a repeatable prescription;

repeatable prescription” means an electronic repeatable prescription or an approved form for ordering drugs or appliances which—

(a)

is compatible with the systems used by the Board (or a person exercising its functions) for—

(i)

the remuneration of persons providing pharmaceutical services or local pharmaceutical services, and

(ii)

any apportionment of, or any arrangements for recharging in respect of, that remuneration,

unless the chemist or dispensing doctor dispensing the prescription is to receive no pharmaceutical remuneration of any kind in respect of any drug or appliance ordered on the form;

(b)

has been provided for use by a prescriber by—

(i)

the Board,

(ii)

another primary care organisation,

(iii)

a local authority, under arrangements for providing NHS services which include, with the consent of the Board, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,

(iv)

the Secretary of State,

(v)

a CCG, under arrangements for providing NHS services which include, with the consent of the Board, the dispensing of prescriptions as part of pharmaceutical or local pharmaceutical services,

(vi)

an NHS trust, or

(vii)

an NHS foundation trust;

(c)

has been issued by a prescriber;

(d)

indicates that the drugs or appliances ordered may be provided more than once; and

(e)

specifies the number of occasions on which they may be provided;

[F7“section 83(2) contractor” means a person that provides primary medical services under contractual arrangements under section 83(2) of the 2006 Act (primary medical services), including in circumstances where those contractual arrangements are part of wider contractual arrangements for the provision of NHS services, and “section 83(2) contract” is to be construed accordingly;]

[F20“serious shortage protocol” means—

(a)

in the case of a prescription only medicine, a serious shortage protocol for the purposes of regulation 226A of the Human Medicines Regulations 2012 (sale etc. by a pharmacist in accordance with a serious shortage protocol); or

(b)

in the case of any other drug or appliance, a written protocol that—

(i)

is issued by the Secretary of State in circumstances where England or any part of England is, in the opinion of the Secretary of State, experiencing or may experience a serious shortage of—

(aa)

a specified drug or appliance, or

(bb)

drugs or appliances of a specified description,

(ii)

provides for the supply by a provider of pharmaceutical or local pharmaceutical services, where there is an order on a prescription form or a repeatable prescription for—

(aa)

the specified drug or appliance, or

(bb)

a drug or appliance of the specified description,

of a different product or quantity of product to the product or quantity of product ordered, subject to such conditions as may be specified in the protocol, and

(iii)

specifies the period for which, and the parts of England (which may be all of England) in which, the protocol is to have effect;]

[F21signatory” means a natural person who creates an electronic signature;]

[F20“SSP” means a serious shortage protocol;]

the Standing Rules Regulations” means the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 M25;

supplementary prescriber” means—

(a)

a registered pharmacist against whose name in the register (“register” has the same meaning here as in the definition of “registered pharmacist”), is recorded an annotation signifying that they are qualified to order drugs and appliances as a supplementary prescriber;

(b)

a person—

(i)

who is registered in a part of the register under article 5 of the [F22Health Professions Order 2001] which relates to chiropodists and podiatrists, [F23dietitians,] physiotherapists or radiographers, and

(ii)

against whose name in that register is recorded an annotation signifying that they are qualified to order drugs and appliances as a supplementary prescriber; or

(c)

an optometrist against whose name in the register of optometrists maintained under section 7 of the Opticians Act 1989 is recorded an annotation signifying that the optometrist is qualified to order drugs and appliances as a supplementary prescriber;

the Board” means the National Health Service Commissioning Board M26;

[F24“therapeutic radiographer independent prescriber” means a radiographer—

(a)

who is registered in Part 11 of the register maintained under article 5 of the [F25Health Professions Order 2001]; and

(b)

against whose name in that register is recorded—

(i)

an entitlement to use the title “therapeutic radiographer”, and

(ii)

an annotation signifying that the radiographer is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;]

the Travel Expenses and Remission of Charges Regulations” means the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003 M27;

treatment” includes examination and diagnosis; and

walk-in centre” means a centre at which information and treatment for minor conditions is provided to the public under arrangements made by the Board or a CCG.

(2) For the purposes of these Regulations, the supply against an order on one prescription form, or on one repeatable prescription (but only where the supply is against one batch issue relating to that repeatable prescription)—

(a)of quantities of the same drug in more than one container is to be treated as the supply of only one quantity of a drug;

(b)of more than one appliance of the same type, except in the case of elastic hosiery and tights, or of two or more component parts of the same appliance, is to be treated as the supply of only one appliance.

Textual Amendments

F2Words in reg. 2(1) omitted (1.4.2019) by virtue of The Amendments Relating to the Provision of Integrated Care Regulations 2019 (S.I. 2019/248), regs. 1(1), 26(3)

F7Words in reg. 2(1) inserted (1.4.2019) by The Amendments Relating to the Provision of Integrated Care Regulations 2019 (S.I. 2019/248), regs. 1(1), 26(2)

F9Words in reg. 2(1) substituted (1.4.2019) by The Amendments Relating to the Provision of Integrated Care Regulations 2019 (S.I. 2019/248), regs. 1(1), 26(4)

F16Words in reg. 2(1) inserted (1.4.2019) by The Amendments Relating to the Provision of Integrated Care Regulations 2019 (S.I. 2019/248), regs. 1(1), 26(5)

F17Words in reg. 2(1) substituted (1.4.2019) by The Amendments Relating to the Provision of Integrated Care Regulations 2019 (S.I. 2019/248), regs. 1(1), 26(6)(a)

F18Words in reg. 2(1) substituted (1.4.2019) by The Amendments Relating to the Provision of Integrated Care Regulations 2019 (S.I. 2019/248), regs. 1(1), 26(6)(b)

Marginal Citations

M4Section 126 has been amended by the Health and Social Care Act 2012, sections 213(7)(k) and 220(7), and Schedule 4, paragraph 63. See section 126(9), which provides a definition of “listed” that includes the power for the Secretary of State to approve lists for the purposes of section 126.

M6Schedule 12A was inserted by the Health and Social Care Act 2012 (c. 7), Schedule 3.

M81983 c. 20. Section 17A(1) was inserted by the Mental Health Act 2007 (c. 12), section 32(1) and (2).

M9Section 127 has been amended by the Health and Social Care Act 2012, Schedule 4, paragraph 65.

M10Section 132 has been amended by the Health and Social Care Act 2012, Schedule 4, paragraph 69, the Protection of Freedoms Act 2012 (c. 9), Schedule 9, paragraphs 120 and 122, and by S.I. 2007/289 and 2010/22 and 231.

M11The definition of “electronic communication” has been amended by the Communications Act 2003 (c. 21), Schedule 17, paragraph 158.

M12S.I. 2002/253. Article 5 was amended by S.I. 2009/1182.

M14Section 1 has been amended by the Mental Health Act 2007 (c. 12), sections 1, 2 and 3, and Schedule 11, Part 1.

M151989 c. 44. Section 7 has been amended by S.I. 2005/484.

M19Section 92 has been amended by the Health and Social Care Act 2012 (c. 7), Schedule 4, paragraph 36.

M20Section 2B was inserted by the Health and Social Care Act 2012 (c. 7), section 12.

M21Section 111 has been amended by the Health and Social Care Act 2012, section 29.

M22Relevant amendments have been made to Schedule 1 by the Health and Social Care Act 2012, sections 17 and 143(1), and Schedule 14, paragraph 6, and by S.I. 2010/1158.

M23Section 6C was inserted by the Health and Social Care Act 2012, section 18(1).

M24Section 1H was inserted by the Health and Social Care Act 2012, section 9(1).

M26The National Health Service Commissioning Board is established by section 1H of the National Health Service Act 2006. Section 1H is inserted by section 9 of the Health and Social Care Act 2012 (c. 7).

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