National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007

Title, commencement and application E+W

1.—(1) The title of these Regulations is the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007 and they come into force on 1 April 2007.

(2) These regulations apply in relation to Wales.

Commencement Information

I1 Reg. 1 in force at 1.4.2007, see reg. 1(1)

Interpretation E+W

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

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

[F1 “the 2006 Act” (“Deddf 2006”) means the National Health Service (Wales) Act 2006(2);]

“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;

“accredited course” (“cwrs a achredwyd”) means a course accredited by the Nursing and Midwifery Council;

“appliance” (“cyfarpar”) means a listed appliance within the meaning of section 41 of the Act(1);

“batch issue” (“swp-ddyroddiad”) means a form provided by a Local Health Board and issued by a repeatable prescriber at the same time as a repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services, which is in the format specified in Part 2 of Schedule 1 to the GMS Contract Regulations, and which—

(a)

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

(b)

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

(c)

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

(d)

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

“the Charges Regulations 2000” (“Rheoliadau Ffioedd 2000”) means the National Health Service (Charges for Drugs and Appliances) Regulations 2000(2);

“the Charges Regulations 2001” (“Rheoliadau Ffioedd 2001”) means the National Health Service (Charges for Drugs and Appliances) (Wales) Regulations 2001(3);

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

“dispensing services” (“gwasanaethau gweinyddu”) means services corresponding to pharmaceutical services under the terms of a GMS contract which give effect to paragraphs 47 to 51 of Schedule 6 to the GMS Contract Regulations;

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

[F2 “Drug Tariff (“Tariff Cyffuriau”) means the aggregate of the determinations made by the National Assembly for Wales which are published in accordance with [F3 regulation 55 of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (the Drug Tariff and remuneration of NHS pharmacists and NHS appliance contractors)];]

“drugs” (“cyffuriau”) includes medicines;

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

“entitlement card” (“cerdyn hawl”) has the meaning assigned to it by regulation 11(1);

“equivalent batch issue” (“swp-ddyroddiad cyfatebol”) means a form provided under equivalent arrangements having effect in England, Scotland and Northern Ireland which is issued by a repeatable prescriber at the same time as an equivalent repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services;

“equivalent prescription form” (“ffurflen brescripsiwn gyfatebol”) means a form provided and issued under equivalent arrangements having effect in England, Scotland or Northern Ireland to enable a person to obtain pharmaceutical services or local pharmaceutical services, or in Scotland pharmaceutical care services provided under Part 1 of the National Health Service (Scotland) Act 1978(4), and does not include—

(a)

a Welsh prescription form;

(b)

a Welsh repeatable prescription; or

(c)

an equivalent repeatable prescription;

“equivalent repeatable prescription” (“presgripsiwn amlroddadwy cyfatebol”) means a prescription contained in a form and issued in accordance with arrangements having effect in England, Scotland and Northern Ireland to enable a person to obtain equivalent repeat dispensing services to those provided within Wales;

“exemption” (“esemptiad”) means any exemption provided for in regulation 8;

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

“the GMS Contract Regulations” (“Rheoliadau Contract GMS”) means the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004(5);

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

[F4 “the Health and Care Professions Council register” (“cofrestr y Cyngor Proffesiynau Iechyd a Gofal”) means the register established and maintained by the Health and Care Professions Council under article 5 of the [F5 Health Professions Order 2001];]

[F6 “independent nurse prescriber” (“nyrs sy'n rhagnodi'n annibynnol”) means a person —

(a)

who is registered in the Nursing and Midwifery Register, and

(b)

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

[F7 “independent nurse prescriber” (“nyrs sy'n rhagnodi'n annibynnol”) means a person —

(a)

who is registered in the Nursing and Midwifery Register, and

(b)

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

“Local Health Board” (“Bwrdd Iechyd Lleol”) has the meaning assigned to it by section 16BA of the Act(6);

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

“Nursing and Midwifery Register” (“Cofrestr Nyrsio a Bydwreigiaeth”) means the register maintained by the Nursing and Midwifery Council under the Nursing and Midwifery Order 2001(7);

[F8 “paramedic independent prescriber” (“parafeddyg-ragnodydd annibynnol”) means a person—

(a)

who is a registered paramedic, and

(b)

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

“patient” (“claf”) means—

(a)

any person who is provided with primary medical services under Part 1 of the Act(8);

(b)

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

(c)

any person who seeks information or treatment from a Walk-in centre;

(d)

any person who applies to be supplied with a drug in accordance with a Patient Group Direction;

“Patient Group Direction” (“Cyfarwyddyd Grwp Cleifion”) is to be construed in accordance with regulation 7(2);

“pharmacist independent prescriber” (“fferyllydd-ragnodydd annibynnol”) means a person—

(c)

who is a pharmacist, and

(d)

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

[F9 “physiotherapist independent prescriber” (“ffisiotherapydd-ragnodydd annibynnol”) means a person—

(a)

who is a physiotherapist, and

(b)

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

[F9 “podiatrist or chiropodist independent prescriber” (“podiatrydd-ragnodydd neu giropodydd-ragnodydd annibynnol”) means a person—

(a)

who is a podiatrist or chiropodist, and

(b)

against whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a podiatrist or chiropodist independent prescriber;]

“prescriber” (“rhagnodydd”) means—

(a)

a doctor,

(b)

an independent nurse prescriber,

(c)

a supplementary prescriber,

(d)

a nurse independent prescriber, F10 ...

(e)

a pharmacist independent prescriber[F11 ,]

(f)

[F12 a physiotherapist independent prescriber, F13 ...

(g)

a podiatrist or chiropodist independent [F14 prescriber[F15 ,]]]

(h)

[F16 a therapeutic radiographer independent prescriber,] [F17 and]

(i)

[F18 a paramedic independent prescriber,]

F19 ...

“prison” (“carchar”) includes a young offender institution but not a secure training centre or a naval, military or air force prison, and for the purposes of this definition—

“prisoner” (“carcharor”) means a person who is detained in a prison in which medical, dental, ophthalmic, pharmaceutical or nursing services are provided under the Act(9) by, or under arrangements made by a Local Health Board otherwise than by virtue of section 7(2) of the Health and Medicines Act 1988(10) (extension of the powers of Secretary of State for financing the Health Service);

F20 ...

[F8 “registered paramedic” (“parafeddyg cofrestredig”) means a person registered in Part 8 of the Health and Care Professions Council register;]

“secure training centre” (“canolfan hyfforddi diogel”) means a place in which offenders subject to detention and training orders [F21 within the meaning given by section 233 of the Sentencing Code] may be detained and given training and education and prepared for their release; and

“young offender institution” (“sefydliad tramgwyddwyr ifanc”) means a place for the detention of offenders sentenced to detention in a young offender institution or to custody for life;

“qualifying patient” (“claf cymwys”) has the meaning assigned to it by regulation 11(3);

[F4 “registered radiographer” (“radiograffydd cofrestredig”) means a person registered in Part 11 of the Health and Care Professions Council register;]

“relevant register” (“cofrestr berthnasol”) means—

(a)

in relation to a nurse or a midwife, the Nursing and Midwifery Register;

(b)

[F22 in relation to a pharmacist, the register maintained under article 19 of the Pharmacy Order 2010 or the register maintained under Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976.]

(c)

in relation to a person whose name is registered in the part of the register maintained by the Health Professions Council in pursuance of article 5 of the [F23 Health Professions Order 2001] (11) relating to—

(i)

chiropodists and podiatrists;

(ia)

[F24 dietitians]

(ib)

[F25 paramedics;]

(ii)

physiotherapists; or

(iii)

radiographers: diagnostic or therapeutic;

that register; and

(d)

in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989(12);

“repeat dispensing services” (“gwasanaethau amlweinyddu”) means pharmaceutical services which involve the provision of drugs or appliances by a chemist in accordance with a repeatable prescription;

“repeatable prescriber” (“rhagnodydd amlroddadwy”) means a prescriber who is—

(a)

a GMS contractor who provides repeatable prescribing services under the terms of its contract which give effect to paragraph 40 of Schedule 6 to the GMS Contract Regulations; or

(b)

employed or engaged by a GMS contractor who provides repeatable prescribing services under the terms of a contract which give effect to paragraph 40 of Schedule 6 to the GMS Contract Regulations;

“supplementary prescriber” (“rhagnodydd atodol”) means a person

(a)

whose name is registered in—

(i)

the Nursing and Midwifery Register,

(ii)

[F26 Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007;]

(iii)

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

(iv)

the part of the register maintained by the Health Professions Council in pursuance of article 5 of the [F27 Health Professions Order 2001] relating to—

(aa)

chiropodists and podiatrists,

(bb)

physiotherapists,

(cc)

radiographers: diagnostic or therapeutic, F28 ...

(dd)

[F29 dietitians, F30 ...]

(ee)

[F31 paramedics, or]

(v)

the register of optometrists maintained by the General Optical Council in pursuance of section 7(a) of the Opticians Act 1989, and

(b)

against whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs, medicines and appliances as a supplementary prescriber [F32 , save in the case of the Nursing and Midwifery Register, where the annotation or entry signifies qualification as a nurse independent/supplementary prescriber;];

“terms of service” (“telerau gwasanaeth”) means the terms on which general ophthalmic services and pharmaceutical services are provided under the Act;

[F4 “therapeutic radiographer independent prescriber” (“radiograffydd therapiwtig-ragnodydd annibynnol”) means a person—

(a)

who is a registered radiographer, and

(b)

against whose name is recorded in the relevant register—

(i)

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

(ii)

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

“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(13);

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

“valid entitlement card” (“cerdyn hawl dilys”) means an entitlement card which is in force and applies to the patient named on an equivalent prescription form;

“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;

“Welsh prescription form” (“ffurflen brescripsiwn Gymreig”) means a form provided by a Local Health Board or a Welsh NHS Trust and issued by a prescriber or a dentist to enable a person to obtain pharmaceutical services and does not include—

(a)

a Welsh repeatable prescription;

(b)

an equivalent prescription form; or

(c)

an equivalent repeatable prescription,

and for the purposes of this definition—

“a Welsh NHS Trust” (“un o Ymddiriedolaethau'r GIG yng Nghymru”) means an NHS Trust all or most of whose hospitals, establishments and facilities are situated in Wales;

“Welsh repeatable prescription” (“presgripsiwn amolroddadwy Cymreig”) means a prescription contained in a form provided by a Local Health Board and issued by a repeatable prescriber to enable a person to obtain pharmaceutical services, which is in the format specified in Part 1 of Schedule 1 to the GMS Contract Regulations and which—

(a)

is generated by a computer but signed by a repeatable prescriber; and

(b)

indicates that the drugs or appliances ordered on that form may be provided more than once, and specifies the number of occasions on which they may be provided.

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

(a) of quantities of the same drug in more than one container 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.

[F33 (2A) Where the term “community practitioner nurse prescriber” appears in the [F34 the Human Medicines Regulations 2012] or the Nursing and Midwifery Register it is to be construed for the purposes of these Regulations as a reference to an “independent nurse prescriber”.]

(3) For as long as there are in existence contracts entered into under article 13 of the General Medical Services Transitional and Consequential Provisions (Wales) Order 2004(14) (“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.

(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

F1 Words in reg. 2 inserted (20.10.2009) by The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2009 (S.I. 2009/2607), regs. 1(1), 2

F2 Words in reg. 2(1) substituted (1.4.2007) by The National Health Service (Pharmaceutical Services) (Remuneration for Persons providing Pharmaceutical Services) (Amendment) (Wales) Regulations 2007 (S.I. 2007/1112), regs. 1(2), 11

F3 Words in reg. 2(1) substituted (1.10.2020) by The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020 (S.I. 2020/1073), reg. 1(2), Sch. 8 para. 5

F4 Words in reg. 2(1) inserted (9.1.2017) by The National Health Service (Therapeutic Radiographer Independent Prescriber and Dietitian Supplementary Prescriber) (Miscellaneous Amendments) (Wales) Regulations 2016 (S.I. 2016/1221), regs. 1, 4(2)

F5 Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 22(2)(a); S.I. 2019/1436, reg. 2(b)

F6 Words in reg. 2(1) substituted (19.7.2010) by The National Health Service (Miscellaneous Amendments Relating to Independent Prescribing) (Wales) Regulations 2010 (S.I. 2010/1647), regs. 1(1), 4(2)(a) (with reg. 5)

F7 Words in reg. 2(1) substituted (19.7.2010) by The National Health Service (Miscellaneous Amendments Relating to Independent Prescribing) (Wales) Regulations 2010 (S.I. 2010/1647), regs. 1(1), 4(2)(b) (with reg. 5)

F8 Words in reg. 2(1) inserted (22.2.2019) by The National Health Service (Paramedic Independent Prescriber and Paramedic Supplementary Prescriber) (Wales) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/149), regs. 1(1), 3(2)(a)

F9 Words in reg. 2(1) inserted (24.9.2014) by The National Health Service (Physiotherapist, Podiatrist or Chiropodist Independent Prescribers) (Miscellaneous Amendments) (Wales) Regulations 2014 (S.I. 2014/2291), regs. 1(1), 4(2)

F10 Word in reg. 2(1) omitted (24.9.2014) by virtue of The National Health Service (Physiotherapist, Podiatrist or Chiropodist Independent Prescribers) (Miscellaneous Amendments) (Wales) Regulations 2014 (S.I. 2014/2291), regs. 1(1), 4(3)(i)

F11 Word in reg. 2(1) substituted (24.9.2014) by The National Health Service (Physiotherapist, Podiatrist or Chiropodist Independent Prescribers) (Miscellaneous Amendments) (Wales) Regulations 2014 (S.I. 2014/2291), regs. 1(1), 4(3)(ii)

F12 Words in reg. 2(1) inserted (24.9.2014) by The National Health Service (Physiotherapist, Podiatrist or Chiropodist Independent Prescribers) (Miscellaneous Amendments) (Wales) Regulations 2014 (S.I. 2014/2291), regs. 1(1), 4(3)(ii)

F13 Word in reg. 2(1) omitted (9.1.2017) by virtue of The National Health Service (Therapeutic Radiographer Independent Prescriber and Dietitian Supplementary Prescriber) (Miscellaneous Amendments) (Wales) Regulations 2016 (S.I. 2016/1221), regs. 1, 4(3)(a)(i)

F14 Words in reg. 2(1) inserted (9.1.2017) by The National Health Service (Therapeutic Radiographer Independent Prescriber and Dietitian Supplementary Prescriber) (Miscellaneous Amendments) (Wales) Regulations 2016 (S.I. 2016/1221), regs. 1, 4(3)(a)(ii)

F15 Reg. 2(1): comma substituted for word (22.2.2019) by virtue of The National Health Service (Paramedic Independent Prescriber and Paramedic Supplementary Prescriber) (Wales) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/149), regs. 1(1), 3(2)(b)(i)

F16 Words in reg. 2(1) inserted (9.1.2017) by The National Health Service (Therapeutic Radiographer Independent Prescriber and Dietitian Supplementary Prescriber) (Miscellaneous Amendments) (Wales) Regulations 2016 (S.I. 2016/1221), regs. 1, 4(3)(a)(iii)

F17 Word in reg. 2(1) inserted (22.2.2019) by The National Health Service (Paramedic Independent Prescriber and Paramedic Supplementary Prescriber) (Wales) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/149), regs. 1(1), 3(2)(b)(ii)

F18 Words in reg. 2(1) inserted (22.2.2019) by The National Health Service (Paramedic Independent Prescriber and Paramedic Supplementary Prescriber) (Wales) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/149), regs. 1(1), 3(2)(b)(iii)

F19 Words in reg. 2(1) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 104(2)

F20 Words in reg. 2(1) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 91(2) (with Sch. 32)

F21 Words in reg. 2(1) substituted (1.12.2020) by Sentencing Act 2020 (c. 17), s. 416(1), Sch. 24 para. 358(1) (with Sch. 27); S.I. 2020/1236, reg. 2

F22 Words in reg. 2(1) substituted (27.9.2010) by The Pharmacy Order 2010 (S.I. 2010/231), art. 1(5), Sch. 4 para. 55 (with Sch. 5); S.I. 2010/1621, art. 2(1), Sch.

F23 Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 22(2)(b); S.I. 2019/1436, reg. 2(b)

F24 Words in reg. 2(1) inserted (9.1.2017) by The National Health Service (Therapeutic Radiographer Independent Prescriber and Dietitian Supplementary Prescriber) (Miscellaneous Amendments) (Wales) Regulations 2016 (S.I. 2016/1221), regs. 1, 4(3)(b)

F25 Words in reg. 2(1) inserted (22.2.2019) by The National Health Service (Paramedic Independent Prescriber and Paramedic Supplementary Prescriber) (Wales) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/149), regs. 1(1), 3(2)(c)

F26 Words in reg. 2(1) substituted (19.7.2010) by The National Health Service (Miscellaneous Amendments Relating to Independent Prescribing) (Wales) Regulations 2010 (S.I. 2010/1647), regs. 1(1), 4(2)(d)(i) (with reg. 5)

F27 Words in reg. 2(1) substituted (2.12.2019) by The Children and Social Work Act 2017 (Consequential Amendments) (Social Workers) Regulations 2019 (S.I. 2019/1094), reg. 1, Sch. 2 para. 22(2)(c); S.I. 2019/1436, reg. 2(b)

F28 Word in reg. 2(1) omitted (9.1.2017) by virtue of The National Health Service (Therapeutic Radiographer Independent Prescriber and Dietitian Supplementary Prescriber) (Miscellaneous Amendments) (Wales) Regulations 2016 (S.I. 2016/1221), regs. 1, 4(3)(c)(i)

F29 Words in reg. 2(1) inserted (9.1.2017) by The National Health Service (Therapeutic Radiographer Independent Prescriber and Dietitian Supplementary Prescriber) (Miscellaneous Amendments) (Wales) Regulations 2016 (S.I. 2016/1221), regs. 1, 4(3)(c)(ii)

F30 Word in reg. 2(1) omitted (22.2.2019) by virtue of The National Health Service (Paramedic Independent Prescriber and Paramedic Supplementary Prescriber) (Wales) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/149), regs. 1(1), 3(2)(d)(i)

F31 Words in reg. 2(1) inserted (22.2.2019) by The National Health Service (Paramedic Independent Prescriber and Paramedic Supplementary Prescriber) (Wales) (Miscellaneous Amendments) Regulations 2019 (S.I. 2019/149), regs. 1(1), 3(2)(d)(ii)

F32 Words in reg. 2(1) inserted (19.7.2010) by The National Health Service (Miscellaneous Amendments Relating to Independent Prescribing) (Wales) Regulations 2010 (S.I. 2010/1647), regs. 1(1), 4(2)(d)(ii) (with reg. 5)

F33 Reg. 2(2A) inserted (19.7.2010) by The National Health Service (Miscellaneous Amendments Relating to Independent Prescribing) (Wales) Regulations 2010 (S.I. 2010/1647), regs. 1(1), 4(3) (with reg. 5)

F34 Words in reg. 2(2A) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 91(3) (with Sch. 32)

Commencement Information

I2 Reg. 2 in force at 1.4.2007, see reg. 1(1)

Supply of drugs and appliances by chemists E+W

3.—(1) A chemist who provides pharmaceutical services to a patient must not make or recover a charge for any drugs or appliances supplied as part of those services in the following circumstances—

(a) where the patient presents a Welsh prescription form; or

(b) where the patient presents both an equivalent prescription form and a valid entitlement card.

(2) Save where the circumstances in paragraph (1) (a) or (b) above are satisfied, a chemist who provides pharmaceutical services to a patient, must, subject to paragraph (3), make and recover from that patient,—

(a) in respect of an item of elastic hosiery the charge that is specified in regulation 3(1)(a) of the Charges Regulations 2000,

(b) in respect of the supply of each other appliance and each quantity of a drug, the charge that is specified in regulation 3(1)(b) of the Charges Regulations 2000.

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

(4) A chemist who provides repeat dispensing services to a patient must not make or recover a charge for any drugs or appliances supplied as part of those services in the following circumstances—

(a) where a batch issue applies to the supply of any appliance or quantity of drug dispensed by the chemist to that patient; or

(b) where an equivalent batch issue applies to the supply of any appliance or quantity of drug dispensed by the chemist to that patient and where the patient presents a valid entitlement card.

(5) Save where the circumstances in paragraph (4) (a) or (b) above are satisfied, a chemist who provides repeat dispensing services to a patient must, subject to paragraph (6), make and recover from that patient—

(a) in respect of an item of elastic hosiery, the charge specified in regulation 3(1A)(b)(i) of the Charges Regulations 2000,

(b) in respect of the supply of each other appliance and of each quantity of a drug, the charge that is specified in regulation 3(1A)(b)(ii) of the Charges Regulations 2000.

(6) Where a charge is paid under paragraph (5), the person making the payment must on doing so sign a declaration in writing on the equivalent batch issue that the relevant charge has been paid.

(7) For the purposes of paragraph (2) where a drug ordered on a single equivalent prescription form is supplied by instalments, the charge specified in regulation 3(4) of the Charges Regulations 2000 must be paid upon the supply of the first instalment.

(8) No charges may be made and recovered under paragraphs (2) or (5) where—

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

(i) in cases where an equivalent prescription form is presented, on the equivalent prescription form,

(ii) in cases falling within paragraph (5) on the equivalent batch issue relating to the equivalent repeatable prescription, at the time the drug or appliance is supplied;

(b) the patient is resident in a school or institution the name of which is inserted on the equivalent prescription form by a prescriber pursuant to the term of a GMS Contract which gives effect to paragraph 44(2) of Schedule 6 to the GMS Contract Regulations or of other arrangements for the provision of primary medical services made under section 16CC(2) of the Act(15);

(c) 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 is duly completed by or on behalf of the patient in accordance with regulation 7 of those Regulations.

(9) A chemist, notwithstanding his or her terms of service, is under no obligation to provide pharmaceutical services in respect of an order on—

(a) an equivalent prescription form,

(b) an equivalent repeatable prescription,

unless he or she is first paid by the patient any charge required to be made and recovered by paragraph (2) or (5), as the case may be, in respect of that order.

[F35 (10) A chemist who makes and recovers a charge—

(a) under paragraph (2) from or on behalf of a patient who is a person described in regulation 11A(1) must, if so required by the patient or the patient’s representative, provide a receipt for the amount received in the form approved by the Welsh Ministers;

(b) under paragraph (2) or (5) from or on behalf of a patient who is not a person described in regulation 11A (1) must, if so required by the patient or the patient’s representative, provide a receipt for the amount received on the form provided for the purpose, which form must contain forms of declaration in support of an application for repayment and information as to whom an application for repayment should be made.]

(11) Any sum which would otherwise be payable by a Local Health Board to a chemist in respect of the provision by the chemist of pharmaceutical services will 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

F35 Reg. 3(10) substituted (20.10.2009) by The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2009 (S.I. 2009/2607), regs. 1(1), 3(2)

Commencement Information

I3 Reg. 3 in force at 1.4.2007, see reg. 1(1)

Supply of drugs and appliances by doctors E+W

4.—(1) A doctor who provides pharmaceutical services to a patient must not make or recover a charge for any drugs or appliances supplied as part of those services in the following circumstances—

(a) where the patient presents a Welsh prescription form; or

(b) where the patient presents both an equivalent prescription form and a valid entitlement card.

(2) Save where the circumstances in paragraph (1)(a) and (b) above are satisfied, a doctor who provides pharmaceutical services to a patient, must, subject to paragraph (3), make and recover from that patient,—

(a) in respect of an item of elastic hosiery the charge that is specified in regulation 4(1)(a) of the Charges Regulations 2000,

(b) in respect of the supply of each other appliance and each quantity of a drug, the charge that is specified in regulation 4(1)(b) of the Charges Regulations 2000.

(3) No charge may be made and recovered under paragraph (2) where—

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

(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 is duly completed by or on behalf of the patient in accordance with regulation 7 of those Regulations.

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

(5) For the purposes of paragraph (2) where a drug ordered on a single equivalent prescription form is supplied by instalments, the charge specified in regulation 4(4) of the Charges Regulations 2000 payable for that drug must be paid upon the supply of the first instalment.

(6) A doctor is under no obligation to provide pharmaceutical services for which a charge is required to be made and recovered by paragraph (2) unless he or she is first paid the amount of that charge by the patient.

[F36 (7) A doctor who makes and recovers a charge under paragraph (2)—

(a) from or on behalf of a patient who is a person described in regulation 11A(1) must, if so required by the patient or the patient’s representative, provide a receipt for the amount received in the form approved by the Welsh Ministers;

(b) from or on behalf of a patient who is not a person described in regulation 11A(1) must, if so required by the patient or the patient’s representative, provide a receipt for the amount received on the form provided for the purpose, which form must contain forms of declaration in support of an application for repayment and information as to whom an application for repayment should be made.]

(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 an equivalent prescription form; or

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

Textual Amendments

F36 Reg. 4(7) substituted (20.10.2009) by The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2009 (S.I. 2009/2607), regs. 1(1), 4(2)

Commencement Information

I4 Reg. 4 in force at 1.4.2007, see reg. 1(1)

Supply of drugs and appliances by Local Health Boards and NHS trusts E+W

5.  A patient is not liable to pay charges to a Local Health Board or an NHS trust which supplies to that patient for the purposes of his or her treatment, drugs, or appliances.

Commencement Information

I5 Reg. 5 in force at 1.4.2007, see reg. 1(1)

Supply of drugs and appliances at Walk-in centres E+W

6.  A patient is not liable to pay charges for drugs or appliances supplied for the purposes of his or her treatment by a prescriber at a Walk-in Centre or for drugs administered or appliance fitted at the Centre.

Commencement Information

I6 Reg. 6 in force at 1.4.2007, see reg. 1(1)

Supply of drugs under Patient Group Directions E+W

7.—(1) A patient is not liable to pay charges for drugs supplied in accordance with a Patient Group Direction or for drugs supplied for personal administration by any person making the supply in accordance with the Patient Group Direction.

(2) 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 [F37 the Human Medicines Regulations 2012 ].

Textual Amendments

F37 Words in reg. 7(2) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 91(4) (with Sch. 32)

Commencement Information

I7 Reg. 7 in force at 1.4.2007, see reg. 1(1)

[F38 7A.   (Supply of drugs in the event of a pandemic) E+W

“(1) No charges may be made or recovered under these Regulations in respect of a supply of drugs which is—

(a) made—

(i) while a disease is pandemic, or

(ii) in anticipation of a disease being imminently pandemic,

and is 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 [F39 regulation 247 of the Human Medicines Regulations 2012] .]

Textual Amendments

F38 Reg. 7A inserted (8.5.2009) by The National Health Service (Charges) (Amendments Relating to Pandemic Influenza) (Wales) Regulations 2009 (S.I. 2009/1175), regs. 1(1), 2(2)

F39 Words in reg. 7A(1)(b) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 91(5) (with Sch. 32)

Exemptions E+W

8.—(1) Subject to paragraph (3), no charge will be payable under paragraphs (2) or (5) of regulation 3 or paragraph (2) of regulation 4 by

(a) a person who is exempt under paragraph 1(1) (a) to (d) of Schedule 12 to the Act(16);

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

(c) a woman with a valid exemption certificate issued by arrangements in England, Scotland or Northern Ireland 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(17);

(d) a person with a valid exemption certificate issued under arrangements for exemptions from charges for drugs and appliances in England, Scotland or Northern Ireland on the ground that he or she is suffering from one of 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 or her residence without the help of another person;

(e) a person with a valid exemption certificate issued under arrangements for exemptions from charges for drugs and appliances in England, Scotland or Northern Ireland in respect of the supply of drugs and appliances for the treatment of accepted disablement;

[F40 (ea) a person with a valid exemption certificate issued by a Local Health Board 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 1 November 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 England, Scotland or Northern Ireland where the certificate is used in respect of drugs or appliances which are supplied on or after 1 November 2009.]

(f) a person with a valid pre-payment certificate issued under arrangements for exemptions from charges for drugs and appliances in England, Scotland or Northern Ireland.

(2) Subject to paragraph (3) a person who wishes to claim entitlement to exemption under paragraph (1) must provide any declaration of entitlement required under regulations 3(8) or 4(3).

(3) A person who is exempt under paragraph 1(1)(c) of Schedule 12 to the Act or under paragraph (1)(b) of this regulation is not required to provide any declaration of entitlement required by regulations 3(8) or 4(3) where—

(a) an equivalent prescription form; or

(b) an equivalent repeatable prescription,

is issued and the person’s date of birth is printed by means of a computer on the relevant form.

(4) An exemption by reference to age or the validity of an exemption certificate is to 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.

(5) 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 Local Health Board or, where the drugs or appliances were supplied by an NHS trust, that NHS trust must recover such charge from the person concerned.

Textual Amendments

F40 Reg. 8(1)(ea)(eb) inserted (20.10.2009) by The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2009 (S.I. 2009/2607), regs. 1(1), 5

Commencement Information

I8 Reg. 8 in force at 1.4.2007, see reg. 1(1)

Certificates of exemption — application and issue E+W

9.—(1) Notwithstanding the provisions of regulations 3(1) and (4), 4(1), 5, 6 and 7(1), a person who wishes to claim exemption on the ground that

(a) 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;

(b) he or she is suffering from one or more of the conditions set out in paragraph (i) to (iv) of regulation 8(1)(d);

(c) he or she requires the supply of drugs and/or appliances for the treatment of accepted disablement[F41 ;

(d) he or she is a person undergoing treatment as specified in regulation 8(1)(ea)]

may apply for a certificate conferring exemption (to be known as an “exemption certificate”) to the Local Health Board in the case of an exemption [F42 , substitute “under sub-paragraph (a), (b) or (d)] on a form supplied for that purpose and in the case of an exemption under sub-paragraph (c) to an office of the Department of Social Security on a form supplied for that purpose by the National Assembly.

(2) A Local Health Board, on being satisfied that an applicant is entitled to exemption under paragraph (1)(a), must issue an exemption certificate which will 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 Local Health Board, on being satisfied that an applicant is entitled to exemption [F43 under paragraph (1)(b) or (1)(d)] must issue to the applicant an exemption certificate which will be valid for such period as it may determine.

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

Textual Amendments

F41 Reg. 9(1)(d) and semi colon inserted (20.10.2009) by The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2009 (S.I. 2009/2607), regs. 1(1), 6(2)(a)

F42 Words in reg. 9(1) substituted (20.10.2009) by The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2009 (S.I. 2009/2607), regs. 1(1), 6(2)(b)

F43 Words in reg. 9(3) substituted (20.10.2009) by The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2009 (S.I. 2009/2607), regs. 1(1), 6(3)

Commencement Information

I9 Reg. 9 in force at 1.4.2007, see reg. 1(1)

Exemption from charges for prisoners E+W

10.  A prisoner is not liable to pay any charges under these Regulations.

Commencement Information

I10 Reg. 10 in force at 1.4.2007, see reg. 1(1)

Entitlement cards E+W

11.—(1) A Local Health Board, on being satisfied that a person is a qualifying patient, must issue to that person a card (in these Regulations referred to as an “entitlement card”) which will be valid for such period as the Local Health Board may determine.

(2) An entitlement card which is issued confers on the qualifying patient the right to obtain drugs and appliances free of charge under paragraphs (1)(b) and (4)(b)(i) of regulation 3 and paragraph 1(b) of regulation 4;

(3) For the purposes of these Regulations “a qualifying patient” means a person who—

(a) is resident in Wales; and

(b) receives primary medical services under Part 1 of the Act from a provider who is contracted to provide such services with [F44 NHS England]; and

includes a person acting on behalf of such a person.

Textual Amendments

F44 Words in reg. 11(3)(b) substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), regs. 1(1), 23(2)

Commencement Information

I11 Reg. 11 in force at 1.4.2007, see reg. 1(1)

[F45 Repayment of certain charges paid under the Charges Regulations 2000 E+W

11A.— (1) Where a charge has been paid under the Charges Regulations 2000, whether or not in accordance with these Regulations, by or on behalf of a person who is, at the time the charge was paid, a person who—

(a) is resident in Wales; and

(b) receives primary medical services under Part 4 of the 2006 Act from a provider who is contracted to provide such services with a Local Health Board,

an application for the repayment of that charge may be made in accordance with paragraph (2).

(2) An application for repayment made by or on behalf of a person described in paragraph (1) must—

(a) be made in such form and manner as the Welsh Ministers may determine;

(b) be made within 3 months from the date on which the charge was paid, or within such period as the Welsh Ministers may, for good cause, allow; and

(c) be accompanied by the receipt for the charge paid and a declaration that the person was, at the time the charge was paid, a person described in paragraph (1).]

Textual Amendments

F45 Reg. 11A inserted (20.10.2009) by The National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2009 (S.I. 2009/2607), regs. 1(1), 7(1)

Transitional Provisions E+W

12.  The transitional provisions in Schedule 1 take effect.

Commencement Information

I12 Reg. 12 in force at 1.4.2007, see reg. 1(1)

Minor and Consequential Amendments E+W

13.  The provisions listed in Schedule 2 are amended as therein specified.

Commencement Information

I13 Reg. 13 in force at 1.4.2007, see reg. 1(1)

Revocations E+W

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

Commencement Information

I14 Reg. 14 in force at 1.4.2007, see reg. 1(1)

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998(18)

D. Elis-Thomas

The Presiding Officer of the National Assembly

23 January 2007