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.
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;]
“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;
“chemist" includes any person, other than a doctor, providing pharmaceutical services [F2or local pharmaceutical services];
[F3“dispensing services” means services corresponding to pharmaceutical services provided under a pilot scheme;]
“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;
[F1“electronic communication” has the same meaning as in section 15 of the 2000 Act;]
[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);
[F4“local pharmaceutical services” means services that are both—
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
provided under a pilot scheme as defined in section 28(2) of the Health and Social Care Act 2001;]
“medical list" means the list, prepared under section 29 of the Act, of medical practitioners who have undertaken to provide general medical services;
[F5“nurse prescriber” means a person who is registered in Parts 1, 3, 5, 8, 10, 11, 12, 13, 14 or 15 of the register maintained by the Nursing and Midwifery Council pursuant to paragraph 10 of Schedule 2 to the Nursing and Midwifery Order 2001 and against whose name is recorded in that register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients;]
“patient" means
any person for whose treatment a doctor is responsible under his terms of service or in connection with a pilot scheme;
any person who applies to a chemist for the provision of pharmaceutical services [F6or local pharmaceutical services] and includes for the purposes of these Regulations a person acting on behalf of such a person;
any person who seeks information or treatment from a walk-in Centre;
[F7any person who applies to be supplied with a drug in accordance with a Patient Group Direction;]
[F8“Patient Group Direction” is to be construed in accordance with regulation 6A(6);]
“pilot scheme" shall be construed in accordance with section 1(1) of the National Health Service (Primary Care) Act 1997 M1;
“pre-payment certificate" has the meaning assigned to it by regulation 9(1);
“prescription form" means[F9, subject to regulation 2A,] a form provided by F10... an NHS trust or a Primary Care Trust and issued by a doctor, dentist or nurse prescriber to enable a person to obtain pharmaceutical services [F11or local pharmaceutical services] and includes a prescription form provided and issued under equivalent arrangements having effect in Scotland, Wales or Northern Ireland;
“terms of service" means the terms on which general medical services, general dental services, general ophthalmic services and pharmaceutical services are provided under the Act;
“the Travelling Expenses and Remission of Charges Regulations" means the National Health Service (Travelling Expenses and Remission of Charges) Regulations 1988 M2;
“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.
F12(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(3) For the purposes of these Regulations the supply against an order on one prescription form–
(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.
(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
F1Words in reg. 2(1) inserted (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 2(2)(a)
F2Words in reg. 2(1) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 2(a)
F3Words in reg. 2 inserted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 2(2)(a)
F4Words in reg. 2(1) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 2(b)
F5Words in reg. 2 substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 2(2)(b)
F6Words in reg. 2(1) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 2(c)
F7Words in reg. 2(1) added (11.12.2000) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 2) Regulations 2000 (S.I. 2000/3189), regs. 1(1), 2(a)
F8Words in reg. 2(1) inserted (11.12.2000) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 2) Regulations 2000 (S.I. 2000/3189), regs. 1(1), 2(b)
F9Words in reg. 2(1) inserted (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 2(2)(b)
F10Words in reg. 2(1) omitted (1.10.2002) by virtue of The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 2(d)(i)
F11Words in reg. 2(1) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 2(d)(ii)
F12Reg. 2(2) repealed (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 2(3)
Marginal Citations
M2S.I. 1988/551 as amended by S.I. 1989/394, 517 and 614, 1990/548, 918 and 1661, 1991/557, 1992/1104, 1993/608, 1995/642 and 3252, 1996/410, 1346 and 2362, 1997/748 and 2393, 1998/2417, and 1999/767 and 2507 and 2000/621.
[F132A.—(1) In these Regulations, where the conditions set out in paragraph (2) are met, the term “prescription form” includes data that—E+W
(a)are created in an electronic form and signed with an electronic signature and are transmitted as an electronic communication;
(b)are created in an electronic form and signed with an electronic signature, where both the data and the signature are entered on the prescription form in a non-legible manner;
(c)are created in writing and signed with an electronic signature which is entered on the prescription form in a non-legible manner; or
(d)are created in an electronic form and entered on the prescription form in a non-legible manner, and signed in ink.
(2) The conditions are:—
(a)that the prescription is an order for a drug or appliance and is issued by a doctor in connection with the provision of general medical services or personal medical services;
(b)that the order is not for an oxygen concentrator; and
(c)that the Secretary of State is satisfied that—
(i)the use of electronic means in order to create, sign and transmit prescriptions (or whichever of those purposes is applicable) is appropriate for the purposes of a pilot scheme on the use of electronic prescribing in relation to the doctor and, where relevant, the chemist and the premises at which the prescription is dispensed; and
(ii)the particular electronic means used by the doctor and, where relevant, the chemist concerned are suitable for the purposes of such a pilot scheme.]
Textual Amendments
F13Reg. 2A inserted (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 2(3)
3.—(1) A chemist who provides pharmaceutical services [F14or local pharmaceutical 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 [F15£6.20], that is to say a charge of [F16£12.40], per pair;
(b)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F15£6.20].
(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 prescription form that the relevant charge has been paid [F17or, in cases falling within regulation 2A above, provide such a declaration in such other written or alternative form as the Secretary of State is satisfied is suitable for the purposes of a pilot scheme on the use of electronic prescribing.]
(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 F18... is duly completed by or on behalf of the patient [F19either on the prescription form or, in cases falling within regulation 2A above, in such other written or alternative form as the Secretary of State is satisfied is suitable for the purposes of a pilot scheme on the use of electronic prescribing;]
(b)there is entitlement to remission of the charge under regulation 3 of the Travelling Expenses and Remission of Charges Regulations and a declaration of entitlement to remission F20... is duly completed by or on behalf of the patient [F21either on the prescription form or, in cases falling within regulation 2A above, in such other written or alternative form as the Secretary of State is satisfied is suitable for the purposes of a pilot scheme on the use of electronic prescribing;]
(c)the patient is resident in a school or institution the name of which is inserted on the prescription form by a doctor under his terms of service or in connection with a pilot scheme.
(4) For the purposes of this regulation, where a drug ordered on a single prescription form is supplied by instalments, the charge of [F22£6.20] 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 [F23on agreement to provide local pharmaceutical services], shall be under no obligation to provide pharmaceutical services [F24or local pharmaceutical services] in respect of an order on a prescription form unless he is first paid by the patient any charge required to be made and recovered by paragraph (1) in respect of that order.
(6) A chemist 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.
(7) Any sum which would otherwise be payable by a [F25Primary Care Trust] to a chemist in respect of the provision by him of pharmaceutical services [F26or 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
F14Words in reg. 3(1) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 3(a)
F15Sum in Reg. 3(1) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 3(2)
F16Sum in Reg. 3(1)(a) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 3(3)
F17Words in reg. 3(2) added (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 3(a)
F18Words in reg. 3(3)(a) revoked (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 3(b)
F19Words in reg. 3(3)(a) added (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 3(b)
F20Words in reg. 3(3)(b) revoked (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 3(b)
F21Words in reg. 3(3)(b) added (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 3(b)
F22Sum in Reg. 3(4) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 3(2)
F23Words in reg. 3(5) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 3(b)(i)
F24Words in reg. 3(5) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 3(b)(ii)
F25Words in reg. 3(7) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 3(c)(i)
F26Words in reg. 3(7) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 3(c)(ii)
4.—(1) A doctor who provides pharmaceutical [F27or 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 [F28£6.20], that is to say a charge of [F29£12.40], per pair;
(b)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F30£6.20].
(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 prescription form that the relevant charge has been paid [F31or, in cases falling within regulation 2A above, provide such a declaration in such other written or alternative form as the Secretary of State is satisfied is suitable for the purposes of a pilot scheme on the use of electronic prescribing.]
(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 F32... is duly completed by or on behalf of the patient [F33either on the prescription form or, in cases falling within regulation 2A above, in such other written or alternative form as the Secretary of State is satisfied is suitable for the purposes of a pilot scheme on the use of electronic prescribing;]
(b)there is entitlement to remission of the charge under regulation 3 of the Travelling Expenses and Remission of Charges Regulations and a declaration of entitlement to remission F34... is duly completed by or on behalf of the patient [F35either on the prescription form or, in cases falling within regulation 2A above, in such other written or alternative form as the Secretary of State is satisfied is suitable for the purposes of a pilot scheme on the use of electronic prescribing;]
(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.
(4) For the purposes of this regulation, where a drug ordered on a single prescription form is supplied by instalments, the charge of [F36£6.20] 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 [F37or 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.
[F38(7) Any sum which would otherwise be payable by a [F39Primary Care Trust] to a doctor in respect of the provision by him of general medical services or personal medical services in connection with a pilot scheme 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
F27Words in reg. 4(1) inserted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 4(2)
F28Sum in Reg. 4(1)(a) substituted (21.5.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 2) Regulations 2002 (S.I. 2002/1386), regs. 1(1), 2
F29Sum in Reg. 4(1)(a) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 4(3)
F30Sum in Reg. 4(1)(b) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 4(4)
F31Words in reg. 4(2) added (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 4(a)
F32Words in reg. 4(3)(a) revoked (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 4(b)
F33Words in reg. 4(3)(a) added (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 4(b)
F34Words in reg. 4(3)(b) revoked (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 4(b)
F35Words in reg. 4(3)(b) added (11.9.2001) by The National Health Service (Charges for Drugs and Appliances) (Electronic Communications) Order 2001 (S.I. 2001/2887), arts. 1(1), 4(b)
F36Sum in Reg. 4(4) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 4(4)
F37Words in reg. 4(5) inserted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 4(2)
F38Reg. 4(7) substituted (1.10.2000) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2000 (S.I. 2000/2393), regs. 1(1), 2
F39Words in reg. 4(7) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 4
5.—(1) F40...An NHS 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) and (4), make and recover from the patient–
(a)in respect of an item of elastic hosiery a charge of [F41£6.20], that is to say a charge of [F42£12.40] 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 [F43£12.40];
(d)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F44£6.20].
(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 regulation 3 of the Travelling 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 theF45... NHS trust or Primary Care trust may reasonably require.
(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 [F46£6.20] payable for that drug shall be payable upon the supply of the first instalment.
(6) [F47An] NHS 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 a form which 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
F40Words in reg. 5(1) omitted (1.10.2002) by virtue of The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 5(a)
F41Sum in Reg. 5(1)(a) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 5(2)
F42Sum in Reg. 5(1)(a) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 5(3)
F43Sum in Reg. 5(1)(c) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 5(3)
F44Sum in Reg. 5(1)(d) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 5(2)
F45Words in reg. 5(3) omitted (1.10.2002) by virtue of The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 5(b)
F46Sum in Reg. 5(5) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 5(2)
F47Word in reg. 5(6) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 5(c)
6.—(1) Where drugs or appliances are supplied to a patient, for the purposes of his treatment by a doctor or nurse prescriber at a Walk-in-Centre the F48... NHS 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 [F49£6.20], that is to say a charge of [F50£12.40] per pair;
(b)in respect of the supply of each other appliance and each quantity of a drug, a charge of [F51£6.20].
(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 regulation 3 of the Travelling 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 F52... NHS 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 [F53£6.20] payable for that drug shall be payable upon the supply of the first instalment.
(5) [F54An] NHS 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 a form which 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
F48Words in reg. 6(1) omitted (1.10.2002) by virtue of The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 6(a)
F49Sum in Reg. 6(1)(a) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 6(2)
F50Sum in Reg. 6(1)(a) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 6(3)
F51Sum in Reg. 6(1)(b) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 6(2)
F52Words in reg. 6(3) omitted (1.10.2002) by virtue of The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 6(b)
F53Sum in Reg. 6(4) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 6(2)
F54Word in reg. 6(5) substituted for words (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 6(c)
6A.—(1) Where drugs are supplied to a patient in accordance with a Patient Group Direction the person supplying the drugs shall, subject to paragraphs (3) and (4), make and recover from the patient, in respect of the supply of each quantity, a charge of [F56£6.20].
(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 regulation 3 of the Travelling 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.
(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 a form which 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
F55Reg. 6A inserted (11.12.2000) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 2) Regulations 2000 (S.I. 2000/3189), regs. 1(1), 3
F56Sum in Reg. 6A substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 7
7.—(1) Subject to paragraph (3), no charge shall be payable under regulations [F573, 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 [F58the 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 M3 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 [F59the 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) 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 [F605(3), 6(3) or 6A(3)].
(4) A charge referred to in column (1) of Schedule 1 shall, in the case of a person referred to in regulation 5 of the Travelling 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 [F61or 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.
[F62(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, then that NHS 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
F57Words in reg. 7(1) substituted (11.12.2000) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 2) Regulations 2000 (S.I. 2000/3189), regs. 1(1), 4(a)
F58Words in reg. 7(1)(d) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 7(a)
F59Words in reg. 7(1)(e) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 7(a)
F60Words in reg. 7(3) substituted (11.12.2000) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 2) Regulations 2000 (S.I. 2000/3189), regs. 1(1), 4(b)
F61Words in reg. 7(6)(a) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 7(b)
F62Reg. 7(7) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 7(c)
Marginal Citations
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 [F63Secretary 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 [F64Ministry of Defence] on a form supplied for that purpose by the Secretary of State.
(2) [F65The 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 [F66from the first day of the month in 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.
[F67(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 first day of the month in 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
F63Words in reg. 8(1) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 8(a)(i)
F64Words in reg. 8(1) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 8(a)(ii)
F65Words in reg. 8(2) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 8(b)(i)
F66Words in reg. 8(2) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 8(b)(ii)
F67Reg. 8(3) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 8(c)
9.—(1) Subject to the following provisions of this regulation, [F68the Secretary of State] on payment of the relevant sum prescribed by paragraph (5) shall as soon as reasonably practicable grant a certificate (in these regulations referred to as a “pre-payment certificate") to any person [F69who provides the Secretary of State with all the information the Secretary of State requires to determine an application, by—
(a)duly completing and submitting an application for it on a form provided for the purpose; or
(b)providing the Secretary of State with that information in a manner that is acceptable to the Secretary of State].
(2) A pre-payment certificate shall be valid for a period of either four months or twelve 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.
[F70(4) 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) and (b)(i), from the date upon which the application is received.]
(5) For the purposes of this regulation the prescribed sum shall be [F71£32.40]for a pre-payment certificate valid for 4 months and [F71£89.00]for a pre-payment certificate valid for 12 months.
(6) Where payment of a prescribed sum has been made under this regulation and, not more than one month after the date on which his 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)or becomes a person entitled to remission under regulation 3 of the Travelling Expenses and Remission of Charges Regulations; or
(c)dies; or
(d)becomes resident in a hospital and thereafter either–
(i)dies while resident in hospital before the expiry of the pre-payment certificate; or
(ii)remains in hospital until the expiry of the pre-payment certificate,
an application for repayment of that sum may be made, by or on behalf of that person or his estate, in accordance with [F72paragraphs (13) to (15)].
[F73(7) Where payment of a prescribed sum has been made and where on or after 1st April 2001 the person in respect of whom the payment was made dies or becomes resident in a hospital and thereafter dies during the relevant period as defined in paragraph (9) an application for a refund may be made, by or on behalf of that person or his estate, in accordance with paragraphs (13) to (15) in respect of each complete month following the date on which the person died or became resident in a hospital.
(8) The refund referred to in paragraph (7) shall be calculated as follows—
(a)in the case of a pre-payment certificate valid for 4 months, one quarter of the prescribed sum paid for each complete month during which the pre-payment certificate is or was valid;
(b)in the case of a pre-payment certificate valid for 12 months, one twelfth of the prescribed sum paid for each complete month during which the pre-payment certificate is or was valid;
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.
(9) [F74In paragraph (7) “the relevant period” means the period beginning one month after the date on which the pre-payment certificate became valid and ending with the date of its expiry.]
(10) Where payment of a prescribed sum in respect of a pre-payment certificate valid for 12 months has been made and where on or after 1st April 2001 and during the relevant period defined in paragraph (12), the person in respect of whom the payment was made—
(a)becomes a person to whom any of the provisions of regulation 7(1)(b) to (f) applies; or
(b)becomes a person entitled to remission under regulation 3 of the Travelling Expenses and Remission of Charges Regulations,
an application for a refund may be made, by or on behalf of that person or his estate in accordance with paragraphs (13) to (15).
(11) The refund referred to in paragraph (10) shall be for the sum which is the difference between the prescribed sum paid and the sum which was prescribed for a pre-payment certificate valid for four months on the date that the prescribed sum was paid.
(12) [F75In paragraph (10) “the relevant period” means the period of three months beginning one month after the date on which the pre-payment certificate became valid.]
(13) Applications under this regulation shall be made to the [F76Secretary of State] and shall be accompanied by the 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) Subject to paragraph (15) an application under this regulation shall be made where the person in respect of whom the payment of the prescribed sum was made—
(a)dies or becomes resident in a hospital and thereafter dies, within 24 months of the date of his death; or
(b)has a pre-payment certificate valid for 4 months and becomes a person;
(i)to whom any of the provisions of regulation 7(1)(b) to (f) apply, or
(ii)entitled to remission under regulation 3 of the Travelling Expenses and Remission of Charges Regulations,
within four months of the date on which the pre-payment certificate became valid; or
(c)has a pre-payment certificate valid for 12 months and becomes a person;
(i)to whom any of the provisions of regulation 7(1)(b) to (f) apply; or
(ii)entitled to remission under regulation 3 of the Travelling Expenses and Remission of Charges Regulations,
within seven months of the date on which the pre-payment certificate became valid; or
(d)becomes resident in hospital and remains there until the expiry of the pre-payment certificate within 3 months of the date of expiry.
(15) Where an application under this regulation is made outside the time limits specified in paragraph (14) in respect of a death which occurs on or after 1st April 2001 or in respect of a person who becomes a person to whom paragraph 14(b) to (d) applies on or after 1st April 2001, the [F77Secretary of State shall accept it if] satisfied that the delay was for good cause.]
Textual Amendments
F68Words in reg. 9(1) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 9(a)(i)
F69Words in reg. 9(1) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 9(a)(ii)
F70Reg. 9(4) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 9(b)
F71Sums in Reg. 9(5) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 8(2)
F72Words in reg. 9(6) substituted (1.4.2001) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2001 (S.I. 2001/746), regs. 1(1), 7(2)
F73Reg. 9(7)-(15) substituted for reg. 9(7)(8) (1.4.2001) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2001 (S.I. 2001/746), regs. 1(1), 7(3)
F74Reg. 9(9) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 8(3)
F75Reg. 9(12) substituted (1.4.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2002 (S.I. 2002/548), regs. 1(1), 8(4)
F76Words in reg. 9(13) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 9(c)
F77Words in reg. 9(15) substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 9(d)
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), [F785(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 [F79which 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 F80... NHS 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 F80... NHS 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
F78Words in reg. 10(2)(a) substituted (11.12.2000) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 2) Regulations 2000 (S.I. 2000/3189), regs. 1(1), 5
F79Words in reg. 10(2)(d) inserted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 10(a)
F80Words in reg. 10(3) omitted (1.10.2002) by virtue of The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 10(b)
11. Any arrangements made by virtue of section 31(2)(c) of the Health Act 1999 M4 (arrangements between NHS bodies and local authorities) for or in connection with the exercise by a local authority of any functions of [F81an] NHS 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 F82... NHS trust or Primary Care Trust with which the arrangements were made.
Textual Amendments
F81Word in reg. 11 substituted (1.10.2002) by The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 11(a)
F82Words in reg. 11 omitted (1.10.2002) by virtue of The National Health Service (Charges for Drugs and Appliances) Amendment (No. 3) Regulations 2002 (S.I. 2002/2352), regs. 1(1), 11(b)
Marginal Citations
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.
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