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

Made: 23 January 2007

Coming into force: 1 April 2007

The National Assembly for Wales in exercise of the powers conferred by sections 77, 83, 83A and 126(4) of, and paragraph 1 of Schedule 12 to, the National Health Service Act 1977[^f00001] hereby makes the following Regulations:—

Title, commencement and application

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• (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.

Interpretation

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

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

• “the 2006 Act” (“Deddf 2006”) means the National Health Service (Wales) Act 2006[^f00003];

• “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[^f00002];

• “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—is generated by a computer and not signed by a repeatable prescriber;relates to a particular repeatable prescription and contains the same date as that prescription;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; andspecifies 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[^f00003];

• “the Charges Regulations 2001” (“Rheoliadau Ffioedd 2001”) means the National Health Service (Charges for Drugs and Appliances) (Wales) Regulations 2001[^f00004];

• “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;

• “Drug Tariff (“Tariff Cyffuriau”) means the aggregate of the determinations made by the National Assembly for Wales which are published in accordance with 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[^f00006], and does not include—a Welsh prescription form;a Welsh repeatable prescription; oran 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[^f00007];

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

• “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 Health Professions Order 2001;

• “independent nurse prescriber” (“nyrs sy'n rhagnodi'n annibynnol”) means a person —who is registered in the Nursing and Midwifery Register, andagainst 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;

• “independent nurse prescriber” (“nyrs sy'n rhagnodi'n annibynnol”) means a person —who is registered in the Nursing and Midwifery Register, andagainst 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[^f00008];

• “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[^f00009];

• “paramedic independent prescriber” (“parafeddyg-ragnodydd annibynnol”) means a person—who is a registered paramedic, andagainst 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—any person who is provided with primary medical services under Part 1 of the Act[^f00010];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;any person who seeks information or treatment from a Walk-in centre;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—who is a pharmacist, andagainst 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;

• “physiotherapist independent prescriber” (“ffisiotherapydd-ragnodydd annibynnol”) means a person—who is a physiotherapist, andagainst 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;

• “podiatrist or chiropodist independent prescriber” (“podiatrydd-ragnodydd neu giropodydd-ragnodydd annibynnol”) means a person—who is a podiatrist or chiropodist, andagainst 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 doctor,an independent nurse prescriber,a supplementary prescriber,a nurse independent prescriber, ...a pharmacist independent prescriber,a physiotherapist independent prescriber, ...a podiatrist or chiropodist independent prescriber, a therapeutic radiographer independent prescriber, and a paramedic independent prescriber,

• ...

• “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[^f00012] 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[^f00013] (extension of the powers of Secretary of State for financing the Health Service);

• ...

• “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 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);

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

• “relevant register” (“cofrestr berthnasol”) means—in relation to a nurse or a midwife, the Nursing and Midwifery Register; 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. 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 Health Professions Order 2001 [^f00017] relating to—chiropodists and podiatrists; dietitians paramedics; physiotherapists; orradiographers: diagnostic or therapeutic;that register; andin relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989[^f00018];

• “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 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; oremployed 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 personwhose name is registered in—the Nursing and Midwifery Register, Part 1 of the register maintained under article 10(1) of the Pharmacists and Pharmacy Technicians Order 2007; the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976,the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to—chiropodists and podiatrists,physiotherapists,radiographers: diagnostic or therapeutic, ... dietitians, ... paramedics, or the register of optometrists maintained by the General Optical Council in pursuance of section 7(a) of the Opticians Act 1989, andagainst 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 , 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;

• “therapeutic radiographer independent prescriber” (“radiograffydd therapiwtig-ragnodydd annibynnol”) means a person—who is a registered radiographer, andagainst whose name is recorded in the relevant register—an entitlement to use the title “therapeutic radiographer”; andan 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[^f00019];

• “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 Welsh repeatable prescription;an equivalent prescription form; oran 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—is generated by a computer but signed by a repeatable prescriber; andindicates 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.

• (2A) Where the term “community practitioner nurse prescriber” appears in the 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[^f00020] (“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.

Supply of drugs and appliances by chemists

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• (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