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

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.

These regulations apply in relation to Wales.

In these Regulations, unless the context otherwise requires—

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

• F4“the 2006 Act” (“Deddf 2006”) means the National Health Service (Wales) Act 20063;

• “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 Act2;

• “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—

  1. a

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

  2. b

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

  3. 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

  4. 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 20003;

• “the Charges Regulations 2001” (“Rheoliadau Ffioedd 2001”) means the National Health Service (Charges for Drugs and Appliances) (Wales) Regulations 20014;

• “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;

• F1“Drug Tariff (“Tariff Cyffuriau”) means the aggregate of the determinations made by the National Assembly for Wales which are published in accordance with F44regulation 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 19786, and does not include—

  1. a

     a Welsh prescription form;

  2. b

     a Welsh repeatable prescription; or

  3. 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 20047;

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

• F27“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 F41Health Professions Order 2001;

• F12“independent nurse prescriber” (“nyrs sy'n rhagnodi'n annibynnol”) means a person —

  1. a

     who is registered in the Nursing and Midwifery Register, and

  2. 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;

• F13“independent nurse prescriber” (“nyrs sy'n rhagnodi'n annibynnol”) means a person —

  1. a

     who is registered in the Nursing and Midwifery Register, and

  2. 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 Act8;

• “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 20019;

• F35“paramedic independent prescriber” (“parafeddyg-ragnodydd annibynnol”) means a person—

  1. a

     who is a registered paramedic, and

  2. 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—

  1. a

     any person who is provided with primary medical services under Part 1 of the Act10;

  2. 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;

  3. c

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

  4. 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—

  1. a

     who is a pharmacist, and

  2. 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 pharmacist independent prescriber;

• F23“physiotherapist independent prescriber” (“ffisiotherapydd-ragnodydd annibynnol”) means a person—

  1. a

     who is a physiotherapist, and

  2. 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;

• F23“podiatrist or chiropodist independent prescriber” (“podiatrydd-ragnodydd neu giropodydd-ragnodydd annibynnol”) means a person—

  1. a

     who is a podiatrist or chiropodist, and

  2. 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—

  1. a

     a doctor,

  2. b

     an independent nurse prescriber,

  3. c

     a supplementary prescriber,

  4. d

     a nurse independent prescriber, F24...

  5. e

     a pharmacist independent prescriberF25,

  6. f

     F26a physiotherapist independent prescriber, F28...

  7. g

     a podiatrist or chiropodist independent F29prescriberF34,

  8. h

     F30a therapeutic radiographer independent prescriber,F36and

  9. i

     F37a paramedic independent prescriber,

• F21...

• “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 Act12 by, or under arrangements made by a Local Health Board otherwise than by virtue of section 7(2) of the Health and Medicines Act 198813 (extension of the powers of Secretary of State for financing the Health Service);

• F17...

• F35“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 F45 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);

• F27“registered radiographer” (“radiograffydd cofrestredig”) means a person registered in Part 11 of the Health and Care Professions Council register;

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

  1. a

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

  2. b

     F16in 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.

  3. 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 F42Health Professions Order 200117 relating to—

     1. i

        chiropodists and podiatrists;

     2. ia

        F31dietitians

     3. ib

        F38paramedics;

     4. ii

        physiotherapists; or

     5. iii

        radiographers: diagnostic or therapeutic;

     that register; and

  4. d

     in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 198918;

• “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—

  1. 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

  2. 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

  1. a

     whose name is registered in—

     1. i

        the Nursing and Midwifery Register,

     2. ii

        F14Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007;

     3. iii

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

     4. iv

        the part of the register maintained by the Health Professions Council in pursuance of article 5 of the F43Health Professions Order 2001 relating to—

        1. aa

           chiropodists and podiatrists,

        2. bb

           physiotherapists,

        3. cc

           radiographers: diagnostic or therapeutic, F32...

        4. dd

           F33dietitians, F39...

        5. ee

           F40paramedics, or

     5. v

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

  2. 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 F15, 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;

• F27“therapeutic radiographer independent prescriber” (“radiograffydd therapiwtig-ragnodydd annibynnol”) means a person—

  1. a

     who is a registered radiographer, and

  2. b

     against whose name is recorded in the relevant register—

     1. i

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

     2. 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 198819;

• “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—

  1. a

     a Welsh repeatable prescription;

  2. b

     an equivalent prescription form; or

  3. 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—

  1. a

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

  2. 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.

Where the term “community practitioner nurse prescriber” appears in the F18the 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”.

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 200420 (“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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 F19the Human Medicines Regulations 2012 .

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).

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.

A Local Health Board, on being satisfied that an applicant is entitled to exemption F10under 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.

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.

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.

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;