Citation, commencement and application

1.—(1) These Regulations may be cited as the National Health Service (Charges for Drugs and Appliances) (Wales) Regulations 2001, and shall come into force on 1st April 2001.

(2) These regulations apply to Wales only.

Interpretation

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

“the Act” (“y Ddeddf”) means the National Health Service Act 1977;

“accepted disablement” (“anabledd wedi'i dderbyn”) means physical or mental injury or disease which is accepted by the National Assembly as attributable to or aggravated by service in the armed forces of the Crown or such other service as it may determine;

“appliance” (“cyfarpar”) means a listed appliance within the meaning of section 41 of the Act but does not include a contraceptive appliance;

“chemist” (“fferyllydd”) includes any person, other than a doctor, providing pharmaceutical services;

“doctor” (“meddyg”) means a registered medical practitioner;

“drugs” (“cyffuriau”) includes medicines, but does not include contraceptive substances;

“elastic hosiery” (“hosan elastig”) means anklet, legging, knee-cap, below-knee or thigh stocking;

“exemption” (“esemptiad”) means any remission granted under these regulations from charges payable under these regulations;

“exemption certificate” (“tystysgrif esemptio”) has the meaning assigned to it by regulation 9(1);

“medical list” (“rhestr feddygol”) means the list, prepared under section 29 of the Act, of medical practitioners who have undertaken to provide general medical services;

“National Assembly” (“Cynulliad Cenedlaethol”) means the National Assembly for Wales;

“nurse prescriber” (“nyrs sy'n rhagnodi”) means a nurse or health visitor of a description specified in paragraph (2);

“patient” (“claf”) means—

“Patient Group Direction” (“Cyfarwyddyd Grw p Cleifion”) is to be construed in accordance with regulation 7(6);

“pilot scheme” (“cynllun peilot”) shall be construed in accordance with section 1(1) of the National Health Service (Primary Care) Act 1997(2);

“pre-payment certificate” (“tystysgrif ragdalu”) has the meaning assigned to it by regulation 10(1);

“prescription form” (“ffurflen bresgripsiwn”) means a form provided by a Health Authority, an NHS trust and issued by a doctor, dentist or nurse prescriber to enable a person to obtain pharmaceutical services and includes a prescription form provided and issued under equivalent arrangements having effect in England, Scotland, or Northern Ireland;

“terms of service” (“telerau gwasanaeth”) 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” (“y Rheoliadau Treuliau Teithio a Pheidio â Chodi Tâl”) means the National Health Service (Travelling Expenses and Remission of Charges) Regulations 1988(3);

“treatment” (“triniaeth”) includes examination and diagnosis;

“Walk-in centre” (“Canolfan cerdded i mewn”) 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 National Assembly

(2) The specified description of a nurse or health visitor mentioned in the definition of “nurse prescriber” in paragraph (1) is—

(a)a person who is registered in Part 1 or 12 of the register maintained under the Nurses, Midwives and Health Visitors Act 1997(4) (referred to below in this paragraph as “the professional register”), has a district nursing qualification additionally recorded in the professional register maintained under rule 11 of the Nurses, Midwives and Health Visitors Rule 1983(5), and is, at the time of ordering the listed drug or medicine or listed appliance—

(i)employed as a district nurse by a Health Authority, an NHS trust or by a local authority in connection with arrangements under section 31(2)(c) of the Health Act 1999(6);

(ii)employed as a nurse by a doctor whose name is included in a medical list or who, at that time, is assisting in the performance of personal medical services under a pilot scheme; or

(iii)assisting, in the capacity of a nurse, in the provision of services walk in centre;

(b)a person who is registered in Part 11 of the professional register as a health visitor and is, at the time of ordering the listed drug or medicine or listed appliance—

(i)employed as a nurse by a Health Authority, an NHS trust or by a local authority in connection with arrangements under section 31(2)(c) of the Health Act 1999;

(ii)employed as a nurse by a doctor whose name is included in a medical list or who, at that time, is assisting in the performance of personal medical services under pilot scheme;

(iii)assisting, in the capacity of a nurse,in the provision of services at a Walk-in centre;

against whose name (in each case) is recorded in the professional register an annotation signifying that he is qualified to order drugs, medicines and appliances for patients.

(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.

Supply of drugs and appliances by chemists

3.—(1) A chemist who provides 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 £6.00, that is to say a charge of £12.00, per pair;

(b)in respect of the supply of each other appliance and of each quantity of a drug, a charge of £6.00.

(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.

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

(a)there is exemption under regulation 8 and a declaration of entitlement to exemption on the prescription form is duly completed by or on behalf of the patient;

(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 on the prescription form is duly completed by or on behalf of the patient;

(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 £6.00 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, shall be under no obligation to provide 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[dmb1] 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 Health Authority to a chemist in respect of the provision by him of 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.

Supply of drugs and appliances by doctors

4.—(1) A doctor who provides 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 £6.00, that is to say a charge of £12.00, per pair;

(b)in respect of the supply of each other appliance and of each quantity of a drug, a charge of £6.00.

(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.

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

(a)there is exemption under regulation 8 and a declaration of entitlement to exemption on the prescription form is duly completed by or on behalf of the patient;

(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 on the prescription form is duly completed by or on behalf of the patient;

(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 £6.00 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 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.

(7) Any sum which would otherwise be payable by a Health Authority 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.

Supply of drugs and appliances by Health Authorities and NHS trusts

5.—(1) A Health Authority or an NHS 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 £6.00, that is to say a charge of £12.00 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 £12.00;

(d)in respect of the supply of each other appliance and of each quantity of a drug, a charge of £6.00.

(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 8, 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 Health Authority or NHS 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 8(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 £6.00 payable for that drug shall be payable upon the supply of the first instalment.

(6) A Health Authority or NHS 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.

Supply of drugs and appliances at Walk-in centres

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 Health Authority or NHS 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 £6.00, that is to say a charge of £12.00 per pair;

(b)in respect of the supply of each other appliance and each quantity of a drug, a charge of £6.00.

(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 8, 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 Health Authority or NHS 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 £6.00 payable for that drug shall be payable upon the supply of the first instalment.

(5) A Health Authority or NHS 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.

Supply of drugs under Patient Group Directions

7.—(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 £6.00.

(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 8, 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(7) or in the Prescription Only Medicines (Human Use) Order 1997(8).

Exemptions

8.—(1) Subject to paragraph (3), no charge shall be payable under regulations 3, 4, 6 or 7 by—

(a)a person who is under 25 years of age;

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

(c)a woman with a valid exemption certificate issued by a Health Authority 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(9) or with a valid exemption certificate issued under equivalent arrangements having effect in England, Scotland or Northern Ireland;

(d)a person with a valid exemption certificate issued by a Health Authority on the ground that he or she 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 England, Scotland or Northern Ireland;

(e)a person with a valid exemption certificate issued by the National Assembly 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;

(f)a person with a valid pre-payment certificate or with a valid pre-payment certificate granted under equivalent arrangements having effect in England, Scotland 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)(e);

(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 (b) to (f) 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 5(3), 6(3) or 7(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 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.

(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, the Health Authority or, where the drugs or appliances were supplied by an NHS trust, that NHS trust shall recover such charge from the person concerned.

Certificates of exemption – application and issue

9.—(1) A person who wishes to claim exemption under the provisions of regulation 8(1)(c), (d) or (e) shall apply for a certificate conferring exemption (in these Regulations referred to as an “exemption certificate”) to the Health Authority in the case of an exemption under sub-paragraph (c) or (d) on a form supplied for that purpose and in the case of an exemption under sub-paragraph (e) to an office of the Department of Social Security on a form supplied for that purpose by the National Assembly.

(2) A Health Authority, on being satisfied that an applicant is entitled to exemption under paragraph (1)(c), shall issue an exemption certificate which shall be valid—

(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.

(3) A Health Authority, on being satisfied that an applicant, not being a person entitled to exemption under the provisions of regulation 8(1)(a) or (b) is entitled to exemption under regulation 8(1)(d) shall issue to the applicant an exemption certificate which shall be valid for such period as it may determine.

(4) The National Assembly, on being satisfied that an applicant is entitled to exemption under regulation 8(1)(e), shall issue to the applicant an exemption certificate which shall be valid for such period as it may determine.

Pre-payment certificates

10.—(1) Subject to the following provisions of this regulation, a Health Authority 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 who duly completes and submits an application for it on a form provided for the purpose.

(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 8(1)(f) in respect of drugs and appliances supplied during the period for which it is valid.

(4) No pre-payment certificate shall be granted unless the application made for it is received less than one month before the date on which its period of validity is to begin.

(5) For the purposes of this regulation the prescribed sum shall be £31.40 for a pre-payment certificate valid for 4 months and £86.20 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 8(1)(b) to (e) 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 or her estate, in accordance with paragraphs (7) and (8).

(7) An application under paragraph (6) shall be made to the Health Authority that granted the certificate and shall be accompanied by the certificate (where granted) and a declaration in support of the claim, and the claim and any repayment shall be made in such manner and subject to such conditions as the National Assembly may determine.

(8) An application under paragraph (6) shall be made—

(a)in a case falling within paragraph (6)(a), (b) or (c), not more than four months after the date on which the pre-payment certificate became valid;

(b)in a case falling within paragraph (6)(d)(i), not more than three months after the date of death; or

(c)in a case falling within paragraph (6)(d)(ii), not more than three months after the date on which the pre-payment certificate expired.

Repayment of charges

11.—(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), 5(6), 6(5) or 7(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 National Assembly 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 the National Assembly may, for good cause, allow;

(d)be accompanied by the receipt 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 8(1)(e) and, if the patient was referred by a doctor to the Health Authority or NHS 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 Health Authority or NHS trust before the supply of the appliance.

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

Arrangements between NHS bodies and Local Authorities

12.  Any arrangements made by virtue of section 31(2)(c) of the Health Act 1999 (arrangements between NHS bodies and local authorities) for or in connection with the exercise by a local authority of any functions of a Health Authority or NHS 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 Health Authority or NHS trust with which the arrangements were made.

Revocations

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

Regulation5(1)

SCHEDULE 1

Regulation 13

SCHEDULE 2REGULATIONS REVOKED

Explanatory Note

(This note does not form part of the Regulations)

These 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 and NHS trusts (regulation 5) and at walk-in centres (regulation 6) and when they are supplied in accordance with patient group directions (regulation 7). Provision is also made in relation to cases where a local authority acts in partnership arrangements with an NHS body (regulation 12).

The Regulations also provide for exemption and remission from charges in certain cases (regulation 8), for the issue of exemption certificates (regulation 9), for the issue of pre-payment certificates (regulation 10) and for repayment of charges in certain cases (regulation 11).