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Statutory Instruments

2000 No. 620

NATIONAL HEALTH SERVICE, ENGLAND

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

Made

9th March 2000

Laid before Parliament

10th March 2000

Coming into force

1st April 2000

The Secretary of State for Health, in exercise of powers conferred by sections 77, 83, 83A and 126(4) of, and paragraph 1 of Schedule 12 to, the National Health Service Act 1977M1 and of all other powers enabling him in that behalf, hereby makes the following Regulations:–

Marginal Citations

M11977 c. 49; see section 128(1) as amended by the National Health Service and Community Care Act 1990 (c. 19) (“the 1990 Act"), section 26(2)(g) and (i), for the definitions of “prescribed" and “ regulations". Section 83 was amended by the Health Authorities Act 1995 (c. 17) (“the 1995 Act"), Schedule 1, paragraph 39 and by the Health and Social Security Act 1984 (c. 48), Schedule 8, Part 1. Section 83A was amended by the Health and Medicines Act 1988 (c. 49), Schedule 2, paragraph 6; by the 1990 Act, Schedule 9, paragraph 18(5); by the 1995 Act, Schedule 1, paragraph 40 and by article 2 of S.I. 1998/2385. Section 126(4) was amended by the 1990 Act, section 65(2) and by the Health Act 1999 (c. 8) (“the 1999 Act"), Schedule 4, paragraph 37(6). As regards Wales, the functions of the Secretary of State under the above mentioned powers are transferred to the National Assembly for Wales under article 2(a) of the National Assembly for Wales (Transfer of Functions) Order 1999/672 as amended by section 66(5) of the 1999 Act; these Regulations therefore extend only to England.

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–

F72(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) For the purposes of these Regulations the supply against an order on one prescription form[F73, 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.

[F74(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

F752A.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E+W

Textual Amendments

Supply of drugs and appliances by chemistsE+W

3.—(1) [F76Except as provided in paragraph (1A), a chemist] who provides pharmaceutical services [F77or local pharmaceutical services] to a patient shall, subject to [F78paragraphs (3) and (3A)], make and recover from that patient–

(a)in respect of an item of elastic hosiery a charge of [F79£8.05], that is to say a charge of [F80£16.10], per pair;

(b)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F81£8.05].

[F82(1A) A chemist who provides repeat dispensing services to a patient shall, subject to paragraph (3), make and recover from that patient [F83in respect of—

(a)each batch issue; and

(b)each electronic prescription form—

(i)in respect of an item of elastic hosiery a charge of [F84£8.05], that is to say a charge of [F85£16.10] per pair; and

(ii)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F86£8.05].]]

F87(1B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F88(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 [F89the Board and approved by the Secretary of State] for the purpose of recording patient declarations in respect of electronic prescription forms and issued by a chemist.]

[F90(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 [F91the Board and approved by the Secretary of State] for the purpose of recording patient declarations in respect of electronic repeatable prescriptions and issued by a chemist.]

[F92(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 [F93involving a batch issue] falling within paragraph (1A), on the batch issue at the time that the drug or appliance is supplied,

(ia)[F94in cases involving an electronic repeatable prescription falling within paragraph (1A) on a form provided by [F95the Board and approved by the Secretary of State] for the purpose of recording patient declarations in respect of electronic repeatable prescriptions and issued by a chemist,]

(ii)[F96in cases involving an electronic prescription form, on a form provided by [F97the Board and approved by the Secretary of State] 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 [F98non-electronic] prescription form;

(b)there is entitlement to remission of the charge under [F99regulation 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 [F100involving a batch issue] falling within paragraph (1A), on the batch issue at the time that the drug or appliance is supplied,

(ib)[F101in cases involving an electronic repeatable prescription falling within paragraph (1A) on a form provided by [F102the Board and approved by the Secretary of State] for the purpose of recording patient declarations in respect of electronic repeatable prescriptions and issued by a chemist,]

(ii)[F103in cases involving an electronic prescription form, on a form provided by [F104the Board and approved by the Secretary of State] 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 [F105non-electronic] prescription form; or

(c)the patient is resident in a school or institution the name of which is inserted on the [F106non-electronic] prescription form by a [F107prescriber 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 [F108section 83(2) of the 2006 Act (primary medical services)].]]

[F109(3A) No charges shall be made and recovered under paragraph (1) where there is exemption under [F110regulations 7A(2) or 7D].]

(4) For the purposes of this regulation, where a drug ordered on a single prescription form is supplied by instalments, the charge of [F111£8.05] 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 [F112on agreement to provide local pharmaceutical services], shall be under no obligation to provide pharmaceutical services [F113or local pharmaceutical services] in respect of an order on a prescription form [F114or repeatable prescription] unless he is first paid by the patient any charge required to be made and recovered by paragraph (1) [F115or paragraph (1A)] in respect of that order.

(6) A chemist who makes and recovers a charge under paragraph (1) [F116or paragraph (1A)] shall, if so required by the patient, give him a receipt for the amount received on the form [F117approved by the Secretary of State and] 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 [F118the Board] to a chemist in respect of the provision by him of pharmaceutical services [F119or 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 [F120or 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 [F121£8.05], that is to say a charge of [F122£16.10], per pair;

(b)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F123£8.05].

[F124(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 [F125the Board and approved by the Secretary of State] 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 F126... is duly completed by or on behalf of the patient [F127either on the [F128non-electronic] prescription form or, in cases [F129involving an electronic prescription form, on a form provided by [F130the Board and approved by the Secretary of State] 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 [F131regulation 5 of the Travel Expenses and Remission of Charges Regulations] and a declaration of entitlement to remission F132... is duly completed by or on behalf of the patient [F133either on the [F128non-electronic] prescription form or, in cases [F129involving an electronic prescription form, on a form provided by [F134the Board and approved by the Secretary of State] 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 [F135; or]

[F136(d)there is exemption under [F137regulations 7A(2) or 7D].]

(4) For the purposes of this regulation, where a drug ordered on a single prescription form is supplied by instalments, the charge of [F138£8.05] 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 [F139or 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 [F140approved by the Secretary of State and] 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.

[F141(7) Any sum which would otherwise be payable by [F142the Board] to a [F143contractor under a GMS contract, a PMS agreement or arrangements made under [F144section 83(2) of the 2006 Act (primary medical services), including under arrangements made under Part 8 of the Pharmaceutical Services Regulations (dispensing doctors),]] 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

[F145Out 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 [F146£8.05], that is to say a charge of [F147£16.10] per pair;

(b)in respect of the supply of each appliance and of each quantity of a drug, a charge of [F148£8.05].

(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 [F149the Board] 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 [F150the Board, approved by the Secretary of State] 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

[F151Supply of drugs and appliances by NHS trusts and NHS foundation trusts] E+W

5.—(1) F152...An NHS trust [F153or an NHS foundation trust] which supplies to a patient for the purposes of his treatment, drugs [F154or appliances, except in the case of drugs administered or appliances fitted at the hospital or other establishment or facility which forms part of the NHS trust or NHS foundation trust,] shall, subject to paragraphs (3)[F155, (3A)] [F156, (3B)] and (4), make and recover from the patient–

(a)in respect of an item of elastic hosiery a charge of [F157£8.05], that is to say a charge of [F158£16.10] 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 [F159£16.10];

(d)in respect of the supply of each other appliance and of each quantity of a drug, a charge of [F160£8.05].

(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 [F161regulation 7(2)], or

(c)by reason of being entitled to remission under [F162regulation 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 theF163... NHS trust [F164or NHS foundation trust] may reasonably require.

[F165(3A) No charge shall be made and recovered under this regulation from a patient who is accepted by the person supplying the drug as—

(a)suffering from tuberculosis, in respect of any drug supplied to that patient for the treatment of tuberculosis; or

(b)being subject to a community treatment order, in respect of any drug supplied to that patient for the treatment of mental disorder.]

[F166(3B) No charge shall be made and recovered under this regulation in respect of a supply which is—

(a)made—

(i)while a disease is, or

(ii)in anticipation of a disease being imminently,

pandemic and a serious risk, or potentially a serious risk, to human health; and

(b)in accordance with a protocol relating to that disease as provided for in [F167regulation 247 (exemption for supply in the event or anticipation of pandemic disease) of the Human Medicines Regulations 2012].]

(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 [F168£8.05] payable for that drug shall be payable upon the supply of the first instalment.

(6) [F169An] NHS trust [F170or an NHS foundation 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 [F171the form [F172approved by the Secretary of State and] 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

F167Words in reg. 5(3B)(b) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 73(a) (with Sch. 32)

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

6.—(1) F173Where drugs or appliances are supplied to a patient, [F174including during the out of hours period,] for the purposes of his treatment by a [F175prescriber] at a Walk-in-Centre the ... NHS trust[F176, NHS foundation trust]F177... 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 [F178£8.05], that is to say a charge of [F179£16.10] per pair;

(b)in respect of the supply of each other appliance and each quantity of a drug, a charge of [F180£8.05].

(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 [F181paragraph 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 [F182regulation 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 F183... NHS trust[F184, NHS foundation trust] F185... 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 [F186£8.05] payable for that drug shall be payable upon the supply of the first instalment.

(5) [F187An] NHS trust[F188, NHS foundation trust]F189... 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 [F190the form [F191approved by the Secretary of State and] 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

[F192Supply of drugs under Patient Group DirectionsE+W

6A.—(1) Where drugs are supplied to a patient in accordance with a Patient Group Direction[F193, including during the out of hours period,] the person supplying the drugs shall, subject to paragraphs (3)[F194, (3A)] and (4), make and recover from the patient, in respect of the supply of each quantity, a charge of [F195£8.05].

(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 [F196paragraph 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 [F197regulation 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.

[F198(3A) No charge shall be made and recovered under this regulation from a patient who is accepted by the person supplying the drug as—

(a)suffering from tuberculosis, in respect of any drug supplied to that patient for the treatment of tuberculosis; or

(b)being subject to a community treatment order, in respect of any drug supplied to that patient for the treatment of mental disorder.]

(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 [F199the form [F200approved by the Secretary of State and] 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 [F201the Human Medicines Regulations 2012].]

Textual Amendments

[F202Supply of drugs and appliances by other providers of NHS servicesE+W

6B.—(1) A provider of NHS services who, otherwise than under regulations 3 to 6A, supplies drugs or appliances to a patient for the purposes of treatment must, subject to paragraphs (3) to (8), make and recover from the patient—

(a)in respect of an item of elastic hosiery a charge of [F203£8.05], that is to say a charge of [F204£16.10] 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 [F205£16.10]; and

(d)in respect of the supply of each other appliance and each quantity of a drug, a charge of [F206£8.05].

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

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

(a)under section 173(1) of the 2006 Act;

(b)under regulation 7(2); or

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

and who, in the cases described in section 173(1)(c) of the 2006 Act and sub-paragraphs (b) and (c), completes a declaration of entitlement to such exemption or remission and provides such evidence of entitlement as the provider of NHS services who supplies the drugs or appliances to that patient may reasonably require.

(4) No charge is to be made and recovered under this regulation from a patient where the drugs supplied to the patient are administered, or the appliances supplied to the patient are fitted, at the hospital or other establishment or facility from which the provider of NHS services provides such services.

(5) No charge is to be made and recovered under this regulation where the drug or appliance supplied is administered or applied to the patient personally by a person employed by, or contracted to provide services for, a provider of NHS services.

(6) No charge is to be made and recovered under this regulation from a patient who is accepted by the person supplying the drug as—

(a)suffering from tuberculosis, in respect of any drug supplied to that patient for the treatment of tuberculosis; or

(b)being subject to a community treatment order, in respect of any drug supplied to that patient for the treatment of a mental disorder.

(7) No charge is to be made and recovered under this regulation in respect of a supply which is—

(a)made—

(i)while a disease is, or

(ii)in anticipation of a disease being imminently,

pandemic and a serious risk, or potentially a serious risk, to human health; and

(b)in accordance with a protocol relating to that disease as provided for in regulation 247 of the Human Medicines Regulations 2012(exemption for supply in the event or anticipation of pandemic disease).

(8) A partially remitted charge must 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.

(9) For the purposes of this regulation, where a drug ordered on a single written direction is supplied by instalments, the charge of [F207£8.05] payable for that drug is payable upon the supply of the first instalment.

(10) A provider of NHS services which makes and recovers a charge under this regulation must, if so required by the patient, give the patient a receipt for the amount received on the form approved by the Secretary of State and provided for the purpose, which form is to contain forms of declaration in support of an application for repayment and information as to whom an application for repayment is to be made.]

Textual Amendments

ExemptionsE+W

7.—(1) Subject to paragraph (3), no charge shall be payable under regulations [F2083, 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 [F209the 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 M2 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 [F210the 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–

(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;

[F211(ea)a person with a valid exemption certificate issued by the Secretary of State on the ground that the person is undergoing treatment for—

(i)cancer;

(ii)the effects of cancer, or

(iii)the effects of cancer treatment,

where the certificate is used in respect of drugs or appliances which are supplied on or after 1st April 2009;

(eb)a person with a valid exemption certificate issued on any of the grounds in sub-paragraph (ea) under equivalent arrangements which have effect in Scotland, Wales or Northern Ireland where the certificate is used in respect of drugs or appliances which are supplied on or after 1st April 2009;]

(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 [F212or 6B]–

(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 [F213sub-paragraphs (a) to (g)] of paragraph (1).

(3) [F214Subject 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 [F2155(3), 6(3)[F216, 6A(3) or 6B(3)]] .

[F217(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 [F218PDS patient details] 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 [F219regulation 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 [F220or 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.

[F221(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 a chemist pursuant to regulation 3 or by a doctor pursuant to regulation 4, then the Board must recover that charge from the person concerned;

(b)if the drugs or appliances were supplied by an NHS trust or an NHS foundation trust pursuant to regulation 5, then that NHS trust or NHS foundation trust must recover that charge from the person concerned;

(c)if the drugs or appliances were supplied under regulations 4A, 6, 6A or 6B, then the body which made the arrangements for the provision of services under the 2006 Act with the person or body which supplied the drugs or appliances must recover that charge from the person concerned.]

Textual Amendments

Marginal Citations

[F222Exemption from charges for prisonersE+W

7A.—[F223(1)] A prisoner [F224or a person detained in other secure accommodation] shall not be liable to pay any charge under these Regulations.

[F225(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 [F226or a person detained in other secure accommodation] 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

[F227(ii)the name and address of the—

(aa)prison in which the prisoner, or

(bb)other secure accommodation in which the person detained in other secure accommodation,

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

[F228Exemption from charges for detaineesE+W

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

Textual Amendments

[F229Exemption from charges in respect of listed [F230or emergency] medicinesE+W

7C.—(1) No patient shall be liable to pay a charge under these Regulations in respect of the following medicines—

(a)oseltamivir (marketed as Tamiflu);

(b)zanamivir (marketed as Relenza),

[F231(c)medicines for the prevention or treatment of a condition arising from an emergency that threatens, is causing or has caused serious damage to public health in England or any part of England,]

in the circumstances set out in paragraph (2).

(2) Those circumstances are that—

(a)the Secretary of State has made arrangements for supplying the medicine to patients free of charge; or

(b)the NHS body that is responsible for the arrangements under which the medicine is supplied has made arrangements, with the approval of the Secretary of State, for supplying the medicine to patients free of charge,

and the patient is supplied with the medicine under those arrangements.]

Textual Amendments

[F232Exemption for prescriptions provided or issued in Northern IrelandE+W

7D.  No charge shall be payable under regulation 3 or 4 in respect of any pharmaceutical services, local pharmaceutical services or dispensing services which are obtained on the presentation of a prescription form which is provided and issued in Northern Ireland.]

Textual Amendments

Certificates of exemption—application and issueE+W

8.—[F233(1) A person who wishes to claim exemption under the provisions of regulation 7(1)(d), (e), (ea) or (f) shall apply for a certificate conferring exemption (in these Regulations referred to as an “exemption certificate”) as follows—

(a)a claim for an exemption under regulation 7(1)(d) shall be made to the Secretary of State on a form supplied by the Secretary of State;

(b)a claim for an exemption under regulation 7(1)(e) or (ea) shall be made to the Secretary of State on form “FP92A – 1 January 2009” supplied by the Secretary of State; and

(c)a claim for an exemption under regulation 7(1)(f) shall be made to an office of the Ministry of Defence on a form supplied by the Secretary of State.]

(2) [F234The 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 [F235from the [F236date 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.

[F237(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 [F238date 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.]

[F239(3A) Where Secretary of State is satisfied that an applicant is not a person entitled to exemption under the provisions of regulation 7(1)(a), (b), (c) or (e) but is a person entitled to exemption under the provisions of regulation 7(1) (ea)—

(a)the Secretary of State shall issue to the applicant an exemption certificate which shall be valid from 1st April 2009 or, if the application made under paragraph (1) is received after 1st May 2009, the date one month prior to the date on which the Secretary of State received the application; and

(b)such a certificate shall be valid for such period which begins on or after 1st April 2009 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

[F2409.—(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 [F241£29.10] and for a pre-payment certificate valid for 12 months shall be [F242£104.00].

(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, [F243£29.10];

(b)in the case of a 12 month pre-payment certificate payable by means of a single instalment, [F244£104.00]; 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 [F245£10.40],

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 [F246£29.10] 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 [F247£104.00] 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 [F248£104.00] 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 [F248£104.00], plus one twelfth of £98.70 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 [F249£29.10] 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), [F2505(6), 6(5)[F251, 6A(5) or 6B(10)]] 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 [F252which is given under regulation 3(6), 4(6), 5(6), 6(5)[F253, 6A(5) or 6B(10)]] for the charge paid and a declaration as to the grounds of exemption.

(3) In the case of a charge under [F254regulations 5 or 6B] 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 F255... NHS trust[F256, NHS foundation trust] or [F257other provider of NHS services] 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 F255... NHS trust[F256, NHS foundation trust] or [F257other provider of NHS services] 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 M3 (arrangements between NHS bodies and local authorities) for or in connection with the exercise by a local authority of any functions of [F258an] NHS trust [F259or NHS foundation 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 F260... NHS trust [F259or NHS foundation 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

Regulation 5(1)

SCHEDULE 1E+W CHARGES FOR FABRIC SUPPORTS AND WIGS

(1)(2)
Specified ApplianceSpecified Charge
Surgical Brassiere [F261£27.05]
Abdominal or Spinal Support [F262£40.85]
Stock Modacrylic Wig [F263£66.70]
Partial Human Hair Wig [F264£176.65]
Full Bespoke Human Hair Wig [F265£258.35]

Textual Amendments

Regulation 13

SCHEDULE 2E+W Regulations Revoked

(1)(2)(3)
Regulations revokedReferenceExtent of revocation
The National Health Service (Charges for Drugs and Appliances) Regulations 1989S.I. 1989/419The whole Regulations
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 1990S.I. 1990/537The whole Regulations
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 1991S.I. 1991/579The whole Regulations
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 1992S.I. 1992/365The whole Regulations
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 1993S.I. 1993/420The whole Regulations
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 1994S.I. 1994/690The whole Regulations
The National Health Service (Pharmaceutical Services and Charges for Drugs and Appliances) Amendment Regulations 1994S.I. 1994/2402regulation 3
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 1995S.I. 1995/643The whole Regulations
The National Health Service (Charges for Drugs and Appliances) Amendment (No. 2) Regulations 1995S.I. 1995/2737The whole Regulations
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 1996S.I. 1996/583The whole Regulations
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 1997S.I. 1997/559The whole Regulations
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 1998S.I. 1998/491The whole Regulations
The National Health Service (Pilot Schemes: Miscellaneous Provisions and Consequential Amendments) Regulations 1998S.I. 1998/646regulation 9
The National Health Service (Pilot Schemes for Personal Dental Services: Miscellaneous Provisions and Consequential Amendments) Regulations 1998S.I. 1998/2224regulation 5
The National Health Service (Charges for Drugs and Appliances and Travelling Expenses and Remission of Charges) Amendment Regulations 1999S.I. 1999/767regulations 2 and 3 and the Schedule
The National Health Service (Charges for Drugs and Appliances) Amendment Regulations 2000S.I. 2000/122The whole Regulations

Explanatory Note

(This note is not part of the Regulations)

M4These Regulations revoke and replace, with amendments, the National Health Service (Charges for Drugs and Appliances) Regulations 1989 as amended. They provide for the making and recovery of charges for drugs and appliances supplied under the National Health Service Act 1977. Provision for dental charges and optical charges is made separately .

Accordingly, these Regulations provide for charges for drugs and appliances supplied by doctors and chemists providing pharmaceutical services (regulations 3 and 4) and by Health Authorities, NHS trusts and Primary Care Trusts (regulation 5) and at walk-in centres (regulation 6). Provision is also made in relation to cases where a local authority acts in partnership arrangements with an NHS body (regulation 11). The Regulations also provide for exemption and remission from charges in certain cases (regulation 7), for the issue of exemption certificates (regulation 8), for the issue of pre-payment certificates (regulation 9) and for repayment of charges in certain cases (regulation 10).

The main changes made by these Regulations are to increase charges (by approximately 2%) and to include provision in relation to Primary Care Trusts established under section 16A of the National Health Services Act 1977 (as amended by the Health Act 1999).