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The National Health Service (Charges for Drugs and Appliances) Regulations 2000 (revoked)

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Point in time view as at 01/04/2008.

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Citation, commencement and extentE+W

1.—(1) These Regulations may be cited as the National Health Service (Charges for Drugs and Appliances) Regulations 2000 and shall come into force on 1st April 2000.

(2) These regulations extend to England only.

InterpretationE+W

2.—(1) In these Regulations, unless the context otherwise requires–

  • “the Act" means the National Health Service Act 1977;

  • [F1“the 2000 Act” means the Electronic Communications Act 2000;]

  • [F2“the 2006 Act” means the National Health Service Act 2006;]

  • [F3“advanced electronic signature” means an electronic signature which is—

    (a)

    uniquely linked to the signatory;

    (b)

    capable of identifying the signatory;

    (c)

    created using means that the signatory can maintain under his sole control; and

    (d)

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

  • “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 he may determine;

  • “appliance" means a listed appliance within the meaning of section 41 of the Act but does not include a contraceptive appliance;

  • [F4“bank holiday” means any day that is specified or proclaimed as a bank holiday in England and Wales pursuant to section 1 of the Banking and Financial Dealings Act 1971;]

  • [F5“batch issue” means a form provided by a Primary Care Trust and issued by a [F6repeatable prescriber] at the same time as a [F7non- electronic repeatable prescription] to enable a chemist to receive payment for the provision of repeat dispensing services, which is in the format specified in Part 2 of Schedule 1 to the GMS Contract Regulations, and which—

    (a)

    is generated by a computer and not signed by a [F6repeatable prescriber];

    (b)

    relates to a particular [F7non- electronic repeatable prescription] and contains the same date as that prescription;

    (c)

    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 [F7non- electronic repeatable prescription] may be provided; and

    (d)

    specifies a number denoting its place in the sequence referred to in paragraph (c);]

  • “chemist" includes any person, other than a doctor, providing pharmaceutical services [F8or local pharmaceutical services];

  • [F9“detainee” means a person who is detained—

    (a)

    under the Immigration Act 1971 or section 62 of the Nationality, Immigration and Asylum Act 2002 (detention by the Secretary of State); and

    (b)

    in a removal centre in which medical, dental, ophthalmic, pharmaceutical or nursing services are provided under the 2006 Act by, or under arrangements made by, a Primary Care Trust otherwise than by virtue of section 21(5) of the 2006 Act (provision of services etc),

    and for the purposes of this definition, “removal centre” has the same meaning as in section 147 of the Immigration and Asylum Act 1999 (interpretation of Part VIII);.]

  • [F10“dispensing services” means services corresponding to pharmaceutical services provided [F11under the terms of a GMS contract which give effect to paragraphs 47 to 51 of Schedule 6 to the GMS Contract Regulations or under the terms of a PMS agreement which give effect to paragraphs 45 to 51 of Schedule 5 to the National Health Service (Personal Medical Services Agreements) Regulations 2004];]

  • “doctor" means a registered medical practitioner;

  • “drugs" includes medicines, but does not include contraceptive substances;

  • [F12“Drug Tariff” means the aggregate of the determinations made by the Secretary of State which are published in accordance with regulation 56(f) (provisions relating to determinations) of the National Health Service (Pharmaceutical Services) Regulations 2005]

  • “elastic hosiery" means anklet, legging, knee-cap, below-knee or thigh stocking;

  • [F1“electronic communication” has the same meaning as in section 15 of the 2000 Act;]

  • [F13“electronic prescription form” means a prescription form which falls within paragraph (b) of the definition of “prescription form”;

  • “electronic repeatable prescription” means a prescription form which falls within paragraph (a)(ii) of the definition of “repeatable prescription”;

  • “ETP service” means the electronic prescription service which forms part of the NHS Care Record Service;]

  • [F1“electronic signature” has the same meaning as in section 7 of the 2000 Act;]

  • “exemption" means any remission granted under these regulations from charges payable under these regulations;

  • “exemption certificate" has the meaning assigned to it by regulation 8(1);

  • [F14“the GMS Contract Regulations” means the National Health Service (General Medical Services Contracts) Regulations 2004;

  • “GMS contract” means a general medical services contract under section 28Q of the Act;]

  • [F15“independent nurse prescriber” means a person—

    (a)

    who is registered in the Nursing and Midwifery Register; and

    (b)

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

  • [F16“local pharmaceutical services” means services that are both—

    (a)

    of a kind which may be provided under section 41 of the Act or by virtue of section 41A of the Act, other than practitioner dispensing services; and

    (b)

    provided under a pilot scheme as defined in section 28(2) of the Health and Social Care Act 2001;]

  • [F17“NHS Care Record” means the records relating to an individual patient held by the NHS Care Record Service;

  • “NHS Care Record Service” means the information technology systems procured by the Department of Health and used by the health service to hold medical records relating to patients;

  • “non-electronic prescription form” means a prescription form which falls within paragraph (a) of the definition of “prescription form”;

  • “non-electronic repeatable prescription” means a prescription which falls within paragraph (a) (i) of the definition of “repeatable prescription”;]

  • F18...

  • [F19“Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001;]

  • [F20“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 between 6.30pm on Friday and 8am on the following Monday; and

    (c)

    Good Friday, Christmas Day and bank holidays;]

  • [F20out of hours services” means services required to be provided in all or part of the out of hours period which would be essential services if provided in core hours,

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

  • F21...

  • “patient" means

    (a)

    [F22any person who is provided with primary medical services under Part 1 of the Act;]

    (b)

    any person who applies to a chemist for the provision of pharmaceutical services [F23or local pharmaceutical services] and includes for the purposes of these Regulations a person acting on behalf of such a person;

    (c)

    any person who seeks information or treatment from a walk-in Centre;

    (d)

    [F24any person who applies to be supplied with a drug in accordance with a Patient Group Direction;]

  • [F25“Patient Group Direction” is to be construed in accordance with regulation 6A(6);]

  • [F26“pharmacist independent prescriber” means a person—

    (a)

    who is registered in [F27Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007] or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976; and

    (b)

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

  • [F28“PMS agreement” means an agreement made under section 28C of the Act;]

  • F29...

  • “pre-payment certificate" has the meaning assigned to it by regulation 9(1);

  • [F30“prescriber” means a doctor, [F31a pharmacist independent prescriber,] an independent nurse prescriber and a supplementary prescriber;]

  • [F32“prescription form” means—

    (a)

    a form provided by an NHS trust, an NHS foundation trust or a Primary Care Trust and issued by a prescriber; or

    (b)

    data that are created in an electronic form, signed with a prescriber’s advanced electronic signature and transmitted as an electronic communication to the ETP service,

    to enable a person to obtain pharmaceutical services or local pharmaceutical services and does not include a repeatable prescription [F33and includes a prescription form provided and issued under equivalent arrangements having effect in Scotland, Wales or Northern Ireland;]]

  • [F34“prison” includes a young offender institution but not a secure training centre or a naval, military or air force prison, and for the purposes of this definition—]

  • [F34“prisoner” means a person who is detained in a prison in which medical, dental, ophthalmic, pharmaceutical or nursing services are provided under the Act by, or under arrangements made by, a Primary Care Trust otherwise than by virtue of section 18A(5) of the Act (provision of services etc.).]

  • [F35“provider of out of hours services” means—

    (a)

    an APMS contractor which provides out of hours services under its APMS contract;

    (b)

    a practice which provides out of hours services;

    (c)

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

    (d)

    an out of hours services sub-contractor of a GMS contractor or PMS contractor,

    and for the purposes of this definition—

  • “APMS contractor” means a person who enters into arrangements with a Primary Care Trust under section 16CC(2)(b) of the Act (primary medical services) for the provision of primary medical services and “APMS contract” shall be construed accordingly;

  • “GMS contractor” means a contractor within the meaning of the National Health Service (General Medical Services Contracts) Regulations 2004;

  • “PMS contractor” means a contractor within the meaning of the National Health Service (Personal Medical Services Agreements) Regulations 2004; and

  • “practice” means a practice established by a Primary Care Trust for the purposes of its provision of primary medical services under section 16CC(2)(a) of the Act;]

  • [F36“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;]

  • [F37“repeatable prescriber” has the same meaning as in the National Health Service (Pharmaceutical Services) Regulations 2005;]

  • [F38“repeatable prescription” means a prescription which—

    (a)

    either—

    (i)

    is contained in a form provided by a Primary Care Trust and issued by a repeatable prescriber which is in the format specified in Part I of Schedule 1 to the GMS Contract Regulations and which is generated by a computer and signed in ink by a repeatable prescriber; or

    (ii)

    data that are created in an electronic form, signed with a repeatable prescriber’s advanced electronic signature and transmitted as an electronic communication to the ETP service;

    (b)

    is issued or created to enable a person to obtain pharmaceutical services or local pharmaceutical services; and

    (c)

    indicates that the drugs or appliances ordered on that prescription may be provided more than once and specifies the number of occasions on which they may be provided;]

  • [F34“secure training centre” means a place in which offenders subject to detention and training orders under section 100 of the Powers of Criminal Courts (Sentencing) Act 2000 (offenders under 18: detention and training orders) may be detained and given training and education and prepared for their release; and]

  • [F39“supplementary prescriber” means a person—

    (a)

    whose name is registered in—

    (i)

    the Nursing and Midwifery Register,

    (ii)

    [F40Part 1 of the Register of Pharmacists maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007;]

    (iii)

    the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976,

    (iv)

    the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—

    (aa)

    chiropodists and podiatrists,

    (bb)

    physiotherapists, or

    (cc)

    diagnostic or therapeutic radiographers, or

    (v)

    the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989; and

    (b)

    against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs and appliances as a supplementary prescriber or, in the case of the Nursing and Midwifery Register, a nurse independent/supplementary prescriber;]

  • “terms of service" means the terms on which F41... F42... general ophthalmic services and pharmaceutical services are provided under the Act;

  • [F43“the Travel Expenses and Remission of Charges Regulations” means the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003;]

  • “treatment" includes examination and diagnosis;

  • “Walk-in Centre" means a centre at which information and treatment for minor conditions is provided to the public under arrangements made by or on behalf of the Secretary of State.

  • [F34“young offender institution” means a place for the detention of offenders sentenced to detention in a young offender institution or to custody for life; and]

F44(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) For the purposes of these Regulations the supply against an order on one prescription form[F45, 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 shall 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, shall be treated as the supply of only one appliance.

[F46(3A) For as long as there are in existence contracts entered into under article 13 of the General Medical Services Transitional and Consequential Provisions Order 2004 (“default contracts”) any reference in these Regulations to a GMS contract shall be read as including a reference to a contract entered into under that article and any reference to a term of a GMS contract shall be read as including a reference to the equivalent term of the default contract.

(3B) For as long as there are in existence transitional agreements as defined in article 1(4) of the General Medical Services and Personal Medical Services Transitional and Consequential Provisions Order 2004, any reference in these Regulations to a personal medical services agreement shall be read as including a reference to a transitional agreement and any reference to a term of a personal medical services agreement shall be read as including a reference to any equivalent term in the transitional agreement.]

(4) Unless the context otherwise requires, any reference in these Regulations to a numbered regulation or Schedule is a reference to the regulation in, or Schedule to, these Regulations which bears that number, and any reference in a regulation to a numbered paragraph is a reference to the paragraph bearing that number in that regulation.

Textual Amendments

F27Words in reg. 2 substituted (coming into force in accordance with art. 1(2)(3) of the amending S.I.) by The Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), Sch. 1 para. 24(a)

F40Words in reg. 2 substituted (coming into force in accordance with art. 1(2)(3) of the amending S.I.) by The Pharmacists and Pharmacy Technicians Order 2007 (S.I. 2007/289), Sch. 1 para. 24(b)

F472A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E+W

Textual Amendments

Supply of drugs and appliances by chemistsE+W

3.—(1) [F48Except as provided in paragraph (1A), a chemist] who provides pharmaceutical services [F49or local pharmaceutical services] to a patient shall, subject to [F50paragraphs (3) and (3A)], make and recover from that patient–

(a)in respect of an item of elastic hosiery a charge of [F51£7.10], that is to say a charge of [F52£14.20], per pair;

(b)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F51£7.10].

[F53(1A) A chemist who provides repeat dispensing services to a patient shall, subject to paragraph (3), make and recover from that patient [F54in respect of—

(a)each batch issue; and

(b)each electronic prescription form—

(i)in respect of an item of elastic hosiery a charge of [F55£7.10], that is to say a charge of [F56£14.20] per pair; and

(ii)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F55£7.10].]]

F57(1B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F58(2) Where a charge is paid under paragraph (1), the person making the payment shall on so doing either—

(a)where a non-electronic prescription form has been issued, sign a declaration in writing on the non-electronic prescription form that the relevant charge has been paid; or

(b)where an electronic prescription form has been created, provide a declaration that the relevant charge has been paid on a form provided by a Primary Care Trust for the purpose of recording patient declarations in respect of electronic prescription forms and issued by a chemist.]

[F59(2A) Where a charge is paid under regulation (1A), the person making the payment shall on so doing either—

(a)in respect of a batch issue, sign a declaration in writing on the batch issue that the relevant charge has been paid; or

(b)in respect of an electronic repeatable prescription, provide a declaration that the relevant charge has been paid on a form provided by a Primary Care Trust for the purpose of recording patient declarations in respect of electronic repeatable prescriptions and issued by a chemist.]

[F60(3) No charges shall be made and recovered under paragraph (1) or paragraph (1A) where—

(a)there is exemption under regulation 7 and a declaration of entitlement to exemption is duly completed by or on behalf of the patient—

(i)in cases [F61involving a batch issue] falling within paragraph (1A), on the batch issue at the time that the drug or appliance is supplied,

[F62in cases involving an electronic repeatable prescription falling within paragraph (1A) on a form provided by a Primary Care Trust for the purpose of recording patient declarations in respect of electronic repeatable prescriptions and issued by a chemist,]

(ii)[F63in cases involving an electronic prescription form, on a form provided by a Primary Care Trust for the purpose of recording patient declarations in respect of electronic prescription forms and issued by a chemist, or]

(iii)in all other cases, on the [F64non-electronic] prescription form;

(b)there is entitlement to remission of the charge under [F65regulation 5 of the Travel Expenses and Remission of Charges Regulations] and a declaration of entitlement to remission is duly completed by or on behalf of the patient either—

(i)in cases [F66involving a batch issue] falling within paragraph (1A), on the batch issue at the time that the drug or appliance is supplied,

[F67in cases involving an electronic repeatable prescription falling within paragraph (1A) on a form provided by a Primary Care Trust for the purpose of recording patient declarations in respect of electronic repeatable prescriptions and issued by a chemist,]

(ii)[F68in cases involving an electronic prescription form, on a form provided by a Primary Care Trust for the purpose of recording patient declarations in respect of electronic prescription forms and issued by a chemist, or]

(iii)in all other cases, on the [F69non-electronic] prescription form; or

(c)the patient is resident in a school or institution the name of which is inserted on the [F70non-electronic] prescription form by a [F71prescriber pursuant to the term of a general medical services contract which gives effect to paragraph 44(2) of Schedule 6 to the GMS Contract Regulations or the equivalent term of a PMS agreement or of other arrangements for the provision of primary medical services made under section 16CC(2) of the Act.]]

[F72(3A) No charges shall be made and recovered under paragraph (1) where there is exemption under regulation 7A(2).]

(4) For the purposes of this regulation, where a drug ordered on a single prescription form is supplied by instalments, the charge of [F73£7.10] payable for that drug shall be payable upon the supply of the first instalment.

(5) A chemist, notwithstanding the provisions of his terms of service [F74on agreement to provide local pharmaceutical services], shall be under no obligation to provide pharmaceutical services [F75or local pharmaceutical services] in respect of an order on a prescription form [F76or repeatable prescription] unless he is first paid by the patient any charge required to be made and recovered by paragraph (1) [F77or paragraph (1A)] in respect of that order.

(6) A chemist who makes and recovers a charge under paragraph (1) [F78or paragraph (1A)] shall, if so required by the patient, give him a receipt for the amount received on the form provided for the purpose which form shall contain forms of declaration in support of an application for repayment and information as to whom an application for repayment shall be made.

(7) Any sum which would otherwise be payable by a [F79Primary Care Trust] to a chemist in respect of the provision by him of pharmaceutical services [F80or local pharmaceutical services] shall be reduced by the amount of any charges which are required to be made and recovered by the preceding provisions of this regulation.

Textual Amendments

Supply of drugs and appliances by doctorsE+W

4.—(1) A doctor who provides pharmaceutical [F81or dispensing] services to a patient shall, subject to paragraph (3), make and recover from that patient–

(a)in respect of an item of elastic hosiery a charge of [F82£7.10], that is to say a charge of [F83£14.20], per pair;

(b)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F82£7.10].

[F84(2) Where a charge is paid under paragraph (1), the person making the payment shall on so doing either—

(a)where a non-electronic prescription form has been issued, sign a declaration in writing on the non-electronic prescription form that the relevant charge has been paid; or

(b)where an electronic prescription form has been created, provide a declaration that the relevant charge has been paid on a form provided by a Primary Care Trust for the purpose of recording patient declarations in respect of electronic prescription forms and issued by a doctor.]

(3) No charge shall be made and recovered under paragraph (1) where–

(a)there is exemption under regulation 7 and a declaration of entitlement to exemption F85... is duly completed by or on behalf of the patient [F86either on the [F87non-electronic] prescription form or, in cases [F88involving an electronic prescription form, on a form provided by a Primary Care Trust for the purpose of recording patient declarations in respect of electronic prescription forms and issued by a doctor;]]

(b)there is entitlement to remission of the charge under [F89regulation 5 of the Travel Expenses and Remission of Charges Regulations] and a declaration of entitlement to remission F90... is duly completed by or on behalf of the patient [F91either on the [F87non-electronic] prescription form or, in cases [F88involving an electronic prescription form, on a form provided by a Primary Care Trust for the purpose of recording patient declarations in respect of electronic prescription forms and issued by a doctor;]]

(c)the drugs or appliances are supplied in respect of two or more persons in a school or institution in which at least 20 persons are normally resident of whom at least 10 are his patients [F92; or]

[F93(d)there is exemption under regulation 7A(2).]

(4) For the purposes of this regulation, where a drug ordered on a single prescription form is supplied by instalments, the charge of [F94£7.10] payable for that drug shall be payable upon the supply of the first instalment.

(5) A doctor shall be under no obligation to provide pharmaceutical [F95or dispensing] services for which a charge is required to be made and recovered by paragraph (1) unless he is first paid the amount of that charge by the patient.

(6) A doctor who makes and recovers a charge under paragraph (1) shall, if so required by the patient, give him a receipt for the amount received on the form provided for the purpose which form shall contain forms of declaration in support of an application for repayment and information as to whom an application for repayment shall be made.

[F96(7) Any sum which would otherwise be payable by a [F97Primary Care Trust] to a [F98contractor under a GMS contract, a PMS agreement or arrangements made under section 16CC(2) of the Act] shall be reduced by the amount of charges which are required to be made and recovered under paragraph (1).]

(8) Nothing in this regulation shall authorise the payment of a charge where the drug or appliance supplied either–

(a)is needed for immediate treatment and no order for the drug or appliance is made on a prescription form; or

(b)is administered or applied to the patient by the doctor personally.

Textual Amendments

[F99Out of hours supply of drugs and appliances by providers of out of hours servicesE+W

4A.—(1) A provider of out of hours services who supplies drugs or appliances to a patient in the course of providing out of hours services shall, subject to paragraphs (3) and (7), make and recover from that patient—

(a)in respect of an item of elastic hosiery a charge of [F100£7.10], that is to say a charge of [F101£14.20] per pair;

(b)in respect of the supply of each appliance and of each quantity of a drug, a charge of [F100£7.10].

(2) Where a charge is paid under paragraph (1), the person making the payment shall on doing so sign a declaration in writing on the supply form that the relevant charge has been paid.

(3) No charge shall be made and recovered under paragraph (1) where—

(a)there is exemption under regulation 7 and a declaration of entitlement to exemption is duly completed by or on behalf of the patient on the supply form;

(b)there is entitlement to remission of the charge under regulation 5 of the Travel Expenses and Remission of Charges Regulations and a declaration of entitlement to remission is duly completed by or on behalf of the patient on the supply form; or

(c)the drugs or appliances are supplied in respect of two or more persons in a school or institution in which at least 20 persons are normally resident provided that the name of the school or institution is inserted on the supply form,

and where, in the cases described in sub-paragraphs (a) and (b), such evidence of entitlement to exemption or remission is provided as the provider of out of hours services may reasonably require.

(4) A provider of out of hours services shall be under no obligation to supply drugs or appliances in the course of out of hours services for which a charge is required to be made and recovered by paragraph (1) unless he is first paid the amount of that charge by the patient.

(5) A provider of out of hours services who makes and recovers a charge under paragraph (1) shall, if so required by the patient, give him a receipt for the amount received on the form provided for the purpose, which form shall contain forms of declaration in support of an application for repayment and information as to whom an application for repayment should be made.

(6) Any sum which would otherwise be payable by a Primary Care Trust to a provider of out of hours services in respect of the provision by him of primary medical services shall be reduced by the amount of charges which are required to be made and recovered under paragraph (1).

(7) Nothing in this regulation shall authorise the payment of a charge where the drug or appliance supplied either—

(a)is needed for immediate treatment and no order for the drug or appliance is made on a supply form; or

(b)is administered or applied to the patient by the provider of out of hours services personally.

(8) In this regulation, “supply form” means a form provided by a Primary Care Trust and completed by or on behalf of a provider of out of hours services for the purpose of recording the provision of drugs or appliances to a patient during the out of hours period.]

Textual Amendments

Supply of drugs and appliances by Health Authorities, NHS trusts and Primary Care TrustsE+W

5.—(1) F102...An NHS trust[F103, an NHS foundation trust] or a Primary Care Trust which supplies to a patient for the purposes of his treatment, drugs, otherwise than for administration at a hospital, or appliances, shall, subject to paragraphs (3)[F104, (3A)] and (4), make and recover from the patient–

(a)in respect of an item of elastic hosiery a charge of [F105£7.10], that is to say a charge of [F106£14.20] per pair;

(b)in respect of an appliance specified in column (1) of Schedule 1, the charge specified in relation to it in column (2) of that Schedule;

(c)in respect of tights, a charge of [F107£14.20];

(d)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F108£7.10].

(2) Where a charge is paid under paragraph (1) the person making the payment shall on doing so sign a declaration in writing that the relevant charge has been paid.

(3) No charge shall be made and recovered under this regulation from a patient who is exempt–

(a)under paragraph 1(1)(a) to (d) of Schedule 12 to the Act,

(b)under regulation 7, or

(c)by reason of being entitled to remission under [F109regulation 5 of the Travel Expenses and Remission of Charges Regulations],

and who, in the case described in paragraph 1(1)(c) of Schedule 12 to the Act and in the cases described in sub-paragraphs (b) and (c), completes a declaration of entitlement to such exemption or remission and provides such evidence of entitlement as theF110... NHS trust[F111, NHS foundation trust] or Primary Care trust may reasonably require.

[F112(3A) No charge shall be made and recovered under this regulation from a patient who is accepted by the person supplying the drug as suffering from tuberculosis in respect of any drug supplied to that patient for the treatment of tuberculosis.]

(4) A partially remitted charge shall be made and recovered under this regulation from a patient who is entitled to partial remission under regulation 7(4) if a declaration in writing is provided that the relevant part of the charge has been paid and a declaration of entitlement and such other evidence of entitlement, to partial remission as may be required, is provided.

(5) For the purposes of this regulation, where a drug ordered on a single written direction is supplied by instalments, the charge of [F113£7.10] payable for that drug shall be payable upon the supply of the first instalment.

(6) [F114An] NHS trust[F115, NHS foundation trust] or Primary Care Trust which makes and recovers a charge under this regulation shall, if so required by the patient, give him a receipt for the amount received on [F116the form provided for the purpose, which form] shall contain forms of declaration in support of an application for repayment and information as to whom an application for repayment shall be made.

Textual Amendments

Supply of drugs and appliances at Walk-in-CentresE+W

6.—(1) F117Where drugs or appliances are supplied to a patient, [F118including during the out of hours period,] for the purposes of his treatment by a [F119prescriber] at a Walk-in-Centre the ... NHS trust[F120, NHS foundation trust], Primary Care Trust or other person responsible for the management of the Centre shall, except in the case of drugs administered or appliances fitted at the Centre and subject to paragraphs (3) and (4), make and recover from the patient–

(a)in respect of an item of elastic hosiery a charge of [F121£7.10], that is to say a charge of [F122£14.20] per pair;

(b)in respect of the supply of each other appliance and each quantity of a drug, a charge of [F121£7.10].

(2) Where a charge is paid under paragraph (1), the person making the payment shall on doing so sign a declaration in writing that the relevant charge has been paid.

(3) No charge shall be made and recovered under this regulation from a patient who is exempt–

(a)under [F123paragraph 1(1)(b) to (d)] of Schedule 12 to the Act,

(b)under regulation 7, or

(c)by reason of being entitled to remission under [F124regulation 5 of the Travel Expenses and Remission of Charges Regulations],

and who, in the case described in paragraph 1(1)(c) of Schedule 12 to the Act and in the cases described in sub-paragraphs (b) and (c), completes a declaration of entitlement to such exemption or remission and provides such evidence of entitlement as the F125... NHS trust[F126, NHS foundation trust] or Primary Care Trust or other person supplying the drug or appliance may reasonably require.

(4) For the purposes of this regulation, where a drug ordered on single written direction is supplied by instalments, the charge of [F127£7.10] payable for that drug shall be payable upon the supply of the first instalment.

(5) [F128An] NHS trust[F129, NHS foundation trust], Primary Care Trust or other person making and recovering a charge under this regulation shall, if so required by a patient, give him a receipt for the amount received on [F130the form provided for the purpose, which form] shall contain forms of declaration in support of an application for repayment and information as to whom an application for repayment shall be made.

Textual Amendments

[F131Supply of drugs under Patient Group DirectionsE+W

6A.—(1) Where drugs are supplied to a patient in accordance with a Patient Group Direction[F132, including during the out of hours period,] the person supplying the drugs shall, subject to paragraphs (3)[F133, (3A)] and (4), make and recover from the patient, in respect of the supply of each quantity, a charge of [F134£7.10].

(2) Where a charge is paid under paragraph (1), the person making the payment shall on doing so sign a declaration in writing that the relevant charge has been paid.

(3) No charge shall be made and recovered under this regulation from a patient who is exempt—

(a)under [F135paragraph 1(1)(b) to (d)] of Schedule 12 to the Act,

(b)under regulation 7, or

(c)by reason of being entitled to remission under [F136regulation 5 of the Travel Expenses and Remission of Charges Regulations],

and who, in the case described in paragraph 1(1)(c) of Schedule 12 of the Act and in the cases described in sub-paragraphs (b) and (c), completes a declaration of entitlement to such exemption or remission and provides such evidence of entitlement as the person supplying the drug may reasonably require.

[F137(3A) No charge shall be made and recovered under this regulation from a patient who is accepted by the person supplying the drug as suffering from tuberculosis in respect of any drug supplied to that patient for the treatment of tuberculosis.]

(4) No charge shall be made and recovered under this regulation where the drug is supplied for personal administration by the person making the supply in accordance with the Patient Group Direction.

(5) A person making and recovering a charge under this regulation shall, if so required by a patient, give him a receipt for the amount received on [F138the form provided for the purpose, which form] shall contain forms of declaration in support of an application for repayment and information as to whom an application for repayment shall be made.

(6) For the purposes of this regulation the reference to the supply of a drug in accordance with a Patient Group Direction is a reference to the supply of a drug for that purpose as provided for in the Medicines (Pharmacy and General Sale—Exemption) Order 1980 or in the Prescription Only Medicines (Human Use) Order 1997.]

Textual Amendments

ExemptionsE+W

7.—(1) Subject to paragraph (3), no charge shall be payable under regulations [F1393, 4, 6 or 6A] by–

(a)a person who is under 16 years of age;

(b)a person who is under 19 years of age and is receiving qualifying full-time education within the meaning of paragraph 7 of Schedule 12 to the Act;

(c)a person who has attained the age of 60 years;

(d)a woman with a valid exemption certificate issued by [F140the Secretary of State] on the ground that she is an expectant mother or has within the last twelve months given birth to a live child or a child registrable as still-born under the Births and Deaths Registration Act 1953 M1 or with a valid exemption certificate issued under equivalent arrangements having effect in Scotland, Wales or Northern Ireland;

(e)a person with a valid exemption certificate issued by [F141the Secretary of State] on the ground that he is suffering from one or more of the following conditions–

(i)permanent fistula (including caecostomy, colostomy, laryngostomy or ileostomy) requiring continuous surgical dressing or an appliance;

(ii)the following disorders–

  • forms of hypoadrenalism (including Addison’s disease) for which specific substitution therapy is essential

  • diabetes insipidus and other forms of hypopituitarism

  • diabetes mellitus—except where treatment is by diet alone

  • hypoparathyroidism

  • myasthenia gravis

  • myxoedema

(iii)epilepsy requiring continuous anti-convulsive therapy;

(iv)a continuing physical disability which prevents the patient from leaving his residence without the help of another person;

or by a person with a valid exemption certificate issued under equivalent arrangements having effect in Scotland, Wales or Northern Ireland;

(f)a person with a valid exemption certificate issued by the Secretary of State in respect of the supply of drugs and appliances for the treatment of accepted disablement, but in either case only in respect of those supplies to which the certificate relates;

(g)a person with a valid pre-payment certificate or with a valid pre-payment certificate granted under equivalent arrangements having effect in Scotland, Wales or Northern Ireland.

(2) Subject to paragraph (3), no charge shall be payable under regulation 5–

(a)in respect of the supply of an appliance specified in column (1) of Schedule 1 by a person of a description specified in paragraph (1)(f);

(b)in respect of the supply of an appliance not so specified or of tights or of drugs, by a person of a description specified in any of sub-paragraphs (c) to (g) of paragraph (1).

(3) [F142Subject to paragraph (3A)] a person who wishes to claim entitlement to exemption under paragraph (1) or (2) shall provide any declaration of entitlement required under regulations 3(3) or 4(3) and any declaration or evidence of entitlement required under regulations [F1435(3), 6(3) or 6A(3)].

[F144(3A) A person who falls within paragraph (1)(a) or (c) shall not be required to provide any declaration of entitlement required under regulations 3(3) or 4(3) where—

(a)an electronic prescription form or an electronic repeatable prescription is issued and the person’s date of birth is recorded on the person’s NHS Care Record and is set out on the electronic prescription form or electronic repeatable prescription; or

(b)a non-electronic prescription form or a non-electronic repeatable prescription is issued and the person’s date of birth is printed by means of computer on the non-electronic prescription form or non-electronic repeatable prescription.]

(4) A charge referred to in column (1) of Schedule 1 shall, in the case of a person referred to in [F145regulation 6 of the Travel Expenses and Remission of Charges Regulations], be remitted to the extent specified in that regulation.

(5) Where a charge is remitted in part under paragraph (4) the person making the part payment shall on doing so sign a declaration in writing that the relevant part of the charge has been paid and complete a declaration of entitlement, and provide such other evidence of entitlement, to partial remission as may be required.

(6) An exemption by reference to age or the validity of an exemption certificate shall be determined by reference to the age or validity on the day on which–

(a)in the case of pharmaceutical services [F146or local pharmaceutical services] provided by a chemist, the order for drugs or appliances is presented for dispensing;

(b)in any other case, the drugs or appliances are supplied.

[F147(7) Where a claim to exemption has been made but is not substantiated, and in consequence of the claim a charge has not been recovered—

(a)if the drugs or appliances were supplied by an NHS Trust [F148or NHS foundation trust], then that NHS Trust [F148or NHS foundation trust] shall recover that charge from the person concerned; or

(b)if the drugs or appliances were supplied by—

(i)a Primary Care Trust,

(ii)a chemist on a Primary Care Trust’s list; or

(iii)a chemist who has entered into an agreement with a Primary Care Trust to provide local pharmaceutical services,

then that Primary Care Trust shall recover that charge from the person concerned.]

Textual Amendments

Marginal Citations

[F149Exemption from charges for prisonersE+W

7A.—[F150(1)] A prisoner shall not be liable to pay any charge under these Regulations.

[F151(2) No charge shall be payable under regulation 3(1) or 4 by a person in respect of the supply of drugs or appliances ordered on a non-electronic prescription form—

(a)where that person was a prisoner at the time that the non-electronic prescription form was issued to him by a prescriber; and

(b)where that non-electronic prescription form has printed upon it—

(i)the letters “HMP”; and

(ii)the name and address of the prison in which the prisoner was issued with that non-electronic prescription form.

(3) For the purposes of paragraph (2), “prisoner” means a person detained in a prison.]]

Textual Amendments

[F152Exemption from charges for detaineesE+W

7B  A detainee shall not be liable to pay any charge under these Regulations.]

Textual Amendments

Certificates of exemption—application and issueE+W

8.—(1) A person who wishes to claim exemption under the provisions of regulation 7(1)(d), (e) or (f) shall apply for a certificate conferring exemption (in these Regulations referred to as an “exemption certificate") to the [F153Secretary of State] in the case of an exemption under sub-paragraph (d) or (e) on a form supplied for that purpose and in the case of an exemption under sub-paragraph (f) to an office of the [F154Ministry of Defence] on a form supplied for that purpose by the Secretary of State.

(2) [F155The Secretary of State], on being satisfied that an applicant is entitled to exemption under paragraph (1)(d), shall issue an exemption certificate which shall be valid [F156from the [F157date one month prior to the date on] which the Secretary of State received the application made under paragraph (1)]–

(a)in the case of an expectant mother until the end of her pregnancy and, where she gives birth to a live child or a child registrable as still-born under the Births and Deaths Registration Act 1953, until the end of the period of twelve months beginning with the expected date of confinement;

(b)in the case of a mother who has given birth to a child, until the end of the period of twelve months beginning with the date of birth of that child.

[F158(3) The Secretary of State, on being satisfied that an applicant, not being a person entitled to exemption under the provisions of regulation 7(1)(a), (b) or (c), is entitled to exemption under regulation 7(1)(e) shall issue to the applicant an exemption certificate which shall be valid—

(a)from the [F159date one month prior to the date on] which the Secretary of State received the application made under paragraph (1); and

(b)for such period as the Secretary of State may determine.]

(4) The Secretary of State, on being satisfied that an applicant is entitled to exemption under regulation 7(1)(f), shall issue to the applicant an exemption certificate which shall be valid for such period as he may determine.

Textual Amendments

Pre-payment certificatesE+W

[F1609.—(1) Subject to paragraph (5), where a person applies to the Secretary of State for a pre-payment certificate and—

(a)pays, or undertakes to pay by means of direct debit in ten monthly instalments, to the Secretary of State the sum payable for the pre-payment certificate as prescribed in paragraph (4); and

(b)provides the Secretary of State with the information the Secretary of State requires to determine that application by—

(i)duly completing and submitting an application for the pre-payment certificate on a form provided for the purpose; or

(ii)providing the Secretary of State with that information in a manner that is acceptable to the Secretary of State,

the Secretary of State shall grant a pre-payment certificate to that person as soon as reasonably practicable after that person has fulfilled the condition set out in paragraph (6).

(2) A pre-payment certificate shall be valid for a period of either 3 months or 12 months and an application for such a certificate shall indicate the period for which it is required to be valid.

(3) A pre-payment certificate which is granted confers on the person to whom it is granted exemption as provided by regulation 7(1)(g) in respect of drugs and appliances supplied during the period for which it is valid.

(4) The sum payable for a pre-payment certificate valid for 3 months shall be [F161£27.85] and for a pre-payment certificate valid for 12 months shall be [F162£102.50]

(5) The Secretary of State may refuse to accept payment for a pre-payment certificate valid for 12 months by means of direct debit in ten monthly instalments, and refuse to grant such a certificate to a person, where that person—

(a)has previously been granted a pre-payment certificate valid for 12 months payable by direct debit in ten monthly instalments;

(b)has failed to pay in full the sum payable for that previously granted pre-payment certificate without good reason; and

(c)has failed to return without good reason that previously granted pre-payment certificate to the Secretary of State within 28 days of the date on which the Secretary of State requested its return.

(6) The condition referred to in paragraph (1) is that the person making an application for the pre-payment certificate in accordance with paragraph (1) has paid the Secretary of State—

(a)in the case of a 3 month pre-payment certificate, [F163£27.85];

(b)in the case of a 12 month pre-payment certificate payable by means of a single instalment, [F164£102.50]; or

(c)in the case of a 12 month pre-payment certificate payable by means of direct debit in ten monthly instalments, the first such instalment amounting to [F165£10.25],

and the payment amount referred to for each type of pre-payment certificate in sub-paragraphs (a) to (c) is referred to in this regulation as “the issuing amount”.

(7) A pre-payment certificate shall be valid—

(a)from a date before the application is made, where that date—

(i)was specified by the applicant when making the application; and

(ii)is no more than one month prior to the date upon which the application was made under paragraph (1); or

(b)from a date after the application is made, where that date—

(i)was specified by the applicant when making the application; and

(ii)is no more than one month after the date upon which the application was made under paragraph (1); or

(c)if the applicant does not specify a date under sub-paragraphs (a)(i) or (b)(i), from the date upon which the application is received.

(8) Where payment of the issuing amount in respect of a pre-payment certificate valid for 3 months or 12 months has been made under this regulation and, not more than one month after the date on which the pre-payment certificate became valid, the person in respect of whom payment was made—

(a)dies; or

(b)becomes resident in hospital and thereafter dies while resident in hospital before the expiry of the pre-payment certificate,

an application for repayment of the entirety of the sum payable for the pre-payment certificate which has already been paid may be made on behalf of that person’s estate in accordance with paragraphs (13) and (14).

(9) Where payment of the issuing amount in respect of a pre-payment certificate valid for 12 months has been made under this regulation and during the period beginning with the date on which the pre-payment certificate became valid and ending with the date of its expiry, the person in respect of whom payment was made—

(a)becomes a person to whom any of the provisions of regulation 7(1)(b) to (f) applies;

(b)becomes a person entitled to remission under regulation 5 of the Travel Expenses and Remission of Charges Regulations; or

(c)becomes resident in hospital and thereafter remains in hospital until the expiry of the pre-payment certificate,

an application for a refund may be made, by or on behalf of that person or his estate, in accordance with paragraphs (13) and (14), and calculated in accordance with paragraph (11), in respect of each complete month following the date on which one of the events listed in sub-paragraphs (a) to (c) above occurred.

(10) Where payment of the issuing amount in respect of a pre-payment certificate valid for 3 months or 12 months has been made under this regulation and during the period beginning one month after the date on which the pre-payment certificate became valid and ending with the date of its expiry, the person in respect of whom payment was made—

(a)dies; or

(b)becomes resident in hospital and thereafter dies while resident in hospital before the expiry of the pre-payment certificate,

an application for a refund may be made on behalf of that person’s estate in accordance with paragraphs (13) and (14), and calculated in accordance with paragraph (11), in respect of each complete month following the date on which the person died or became resident in hospital.

(11) The refund referred to in paragraphs (9) and (10) shall be calculated as follows—

(a)in the case of a pre-payment certificate valid for 3 months, one third of [F166£27.85] for each complete month during which the pre-payment certificate is or was valid following the relevant date;

(b)in the case of a pre-payment certificate valid for 12 months where a person has paid for the pre-payment certificate by means of a single payment, one twelfth of [F167£102.50] for each complete month during which the pre-payment certificate is or was valid following the relevant date;

(c)in the case of a pre-payment certificate valid for 12 months where a person is paying for the pre-payment certificate in ten monthly instalments by means of direct debit either—

(i)where the sum payable for the pre-payment certificate has been paid in full, one twelfth of [F167£102.50] for each complete month during which the pre-payment certificate is or was valid following the relevant date; or

(ii)where the sum payable for the pre-payment certificate has not been paid in full, the amount paid for the pre-payment certificate at the point of refund, minus [F167£102.50], plus one twelfth of [F167£102.50] for each complete month during which the pre-payment certificate is or was valid following the relevant date,

and for the purposes of these calculations, a “complete month” is a month beginning on the monthly anniversary of the date on which the pre-payment certificate became valid and ending on the date immediately preceding that date in the following month, “the relevant date” is the date on which one of the events listed in paragraphs (9)(a) to (c) or (10) (a) and (b) occurred, and if the calculations produce a minus figure for the refund, no refund will be payable.

(12) Where payment of the issuing amount in respect of a pre-payment certificate valid for 3 months has been made under this regulation and not more than one month after the date on which the pre-payment certificate became valid, the person in respect of whom payment was made—

(a)becomes a person to whom any of the provisions of regulation 7(1)(b) to (f) applies;

(b)becomes a person entitled to remission under regulation 5 of the Travel Expenses and Remission of Charges Regulations; or

(c)becomes resident in hospital and remains there until expiry of the pre-payment certificate,

an application for a refund of two thirds of [F168£27.85] may be made by or on behalf of that person or his estate in accordance with paragraphs (13) and (14).

(13) An application for a refund under this regulation shall be made to the Secretary of State and shall be accompanied by the pre-payment certificate (where granted) and a declaration in support of the claim and any repayment shall be made in such manner and subject to such conditions as the Secretary of State may determine.

(14) An application for a refund under this regulation shall be made where the person in respect of whom the payment of the issuing amount was made—

(a)dies or becomes resident in hospital and thereafter dies, within 24 months of the date of his death; or

(b)becomes—

(i)a person to whom any of the provisions of regulation 7(1)(b) to (f) applies; or

(ii)a person entitled to remission under regulation 5 of the Travel Expenses and Remission of Charges Regulations,

within 3 months of the date on which he becomes a person falling within sub-paragraphs (i) or (ii); or

(c)becomes resident in hospital and remains there until the expiry of the pre-payment certificate, within 3 months of the date of expiry.]

Textual Amendments

Repayment of chargesE+W

10.—(1) Where a charge has been paid under these Regulations by or on behalf of a person who was at the time of payment exempt from the requirement to pay that charge, an application for repayment of that charge may be made in accordance with paragraph (2) by or on behalf of that person.

(2) The application for repayment shall–

(a)be made to the person or body specified in the receipt which is given under regulation 3(6), 4(6), [F1695(6), 6(5) or 6A(5)] as being the person or body to whom application for repayment of charges is to be made;

(b)be made in such form and manner as the Secretary of State may determine for the applicant, any class of applicant or applicants generally;

(c)be made within 3 months from the date on which the drug or appliance was supplied to the applicant or within such period as Secretary of State may, for good cause, allow;

(d)be accompanied by the receipt [F170which is given under regulation 3(6), 4(6), 5(6), 6(5) or 6A(5)] for the charge paid and a declaration as to the grounds of exemption.

(3) In the case of a charge under regulation 5 in respect of an appliance specified in column (1) of Schedule 1, the application shall be accompanied by the exemption certificate referred to in regulation 7(1)(f) and, if the patient was referred by a doctor to the F171... NHS trust[F172, NHS foundation trust] or Primary Care Trust for treatment, either–

(a)a certificate from the doctor certifying that the treatment was for accepted disablement; or

(b)a statement that such a certificate was surrendered to the F171... NHS trust[F172, NHS foundation trust] or Primary Care Trust before the supply of the appliance.

(4) The Secretary of State shall make arrangements for the repayment of any charge paid under these Regulations by a person who is entitled to exemption.

Textual Amendments

Arrangements between NHS bodies and Local AuthoritiesE+W

11.  Any arrangements made by virtue of section 31(2)(c) of the Health Act 1999 M2 (arrangements between NHS bodies and local authorities) for or in connection with the exercise by a local authority of any functions of [F173an] NHS trust[F174, NHS foundation trust] or Primary Care Trust shall not affect any power or duty to recover charges in respect of services provided in the exercise of those functions and these Regulations shall apply as if the functions were exercised by the F175... NHS trust[F174, NHS foundation trust] or Primary Care Trust with which the arrangements were made.

Textual Amendments

Marginal Citations

Transitional ProvisionE+W

12.  Where an application under regulation 9 for a pre-payment certificate was received before the coming into force of these Regulations the prescribed sum payable shall be that which applied immediately before the coming into force of these Regulations.

RevocationsE+W

13.  The Regulations specified in column (1) of Schedule 2 are hereby revoked in relation to England to the extent specified in column (3) of that Schedule.

Signed by authority of the Secretary of State for Health

Hunt

Parliamentary Under-Secretary of State,

Department of Health

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