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STATUTORY INSTRUMENTS

2007 No. 121 (W.11)
NATIONAL HEALTH SERVICE, WALES
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[1] hereby makes the following Regulations:—

Title, commencement and application
     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.

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

y Ddeddf

anabledd wedi'i dderbyn

cwrs a achredwyd

"appliance" ("cyfarpar") means a listed appliance within the meaning of section 41 of the Act[

2

swp-ddyroddiad

Rheoliadau Ffioedd 2000

3

Rheoliadau Ffioedd 2001

4

fferyllydd

gwasanaethau gweinyddu

meddyg

Tariff Cyffuriau

5

cyffuriau

hosan elastig

cerdyn hawl

swp-ddyroddiad cyfatebol

ffurflen brescripsiwn gyfatebol

6

presgripsiwn amlroddadwy cyfatebol

esemptiad

tystysgrif esemptio

Rheoliadau Contract GMS

7

contract GMS

nyrs sy'n rhagnodi'n annibynnol

is also recorded in that register;

Bwrdd Iechyd Lleol

8

Cynulliad Cenedlaethol

nyrs-ragnodydd annibynnol

Cofrestr Nyrsio a Bydwreigiaeth

9

claf

10

Cyfarwyddyd Grwp Cleifion

fferyllydd-ragnodydd annibynnol

rhagnodydd

Ymddiriedolaeth Gofal Sylfaenol

11

carchar

carcharor

12

13

canolfan hyfforddi diogel

14

sefydliad tramgwyddwyr ifanc

claf cymwys

cofrestr berthnasol

15

16

17

that register; and

(d) in relation to a registered optometrist, the register of optometrists maintained under section 7(a) of the Opticians Act 1989[18];

gwasanaethau amlweinyddu

rhagnodydd amlroddadwy

rhagnodydd atodol

(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;

telerau gwasanaeth

y Rheoliadau Treuliau Teithio a Pheidio â Chodi Tâl

19

triniaeth

cerdyn hawl dilys

Canolfan cerdded i mewn

ffurflen brescripsiwn Gymreig

and for the purposes of this definition—

un o Ymddiriedolaethau'r GIG yng Nghymru

presgripsiwn amolroddadwy Cymreig

(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)—

    (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[20] ("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
     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—

(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[21];

(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—

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.

    (10) A chemist who makes and recovers a charge under paragraph (2) or (5) must, if so required by the patient, give the patient 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.

Supply of drugs and appliances by doctors
     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.

    (7) A doctor who makes and recovers a charge under paragraph (2) must, if so required by the patient, give the patient 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.

Supply of drugs and appliances by Local Health Boards and NHS trusts
     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.

Supply of drugs and appliances at Walk-in centres
     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.

Supply of drugs under Patient Group Directions
     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 the Medicines (Pharmacy and General Sale — Exemption) Order 1980[22] or in the Prescription Only Medicines (Human Use) Order 1997[23].

Exemptions
     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[

24

25

(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;

(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—

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—

(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.

Certificates of exemption — application and issue
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

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 under sub-paragraph (a) or (b) 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 under paragraph (1)(b) 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.

Exemption from charges for prisoners
     10. A prisoner is not liable to pay any charges under these Regulations.

Entitlement cards
     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 a Primary Care Trust; and

includes a person acting on behalf of such a person.

Transitional Provisions
     12. The transitional provisions in Schedule 1 take effect.

Minor and Consequential Amendments
     13. The provisions listed in Schedule 2 are amended as therein specified.

Revocations
     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.

Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998[26]

D. Elis-Thomas
The Presiding Officer of the National Assembly

23 January 2007

SCHEDULE 1Regulation 12

Transitional Provisions

Repayment of charges
1. —(1) Where a charge has been paid under the Charges Regulations 2001 by or on behalf of a person who was at the time of payment exempt from the requirement to pay that charge under regulation 8 of those Regulations, 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 must —

    (3) In the case of a charge under regulation 5 in respect of an appliance specified in column (1) of Schedule 1 to the Charges Regulations 2001, regulation 11(3) of the Charges Regulations 2001 applies.

    (4) Arrangements made by the National Assembly for the repayment of any charge paid under regulation 11(4) of the Charges Regulations 2001 by a person who is entitled to exemption continue to have effect for the purposes of paragraph 1.

Pre payment Certificates
     2. —(1) Where a person has obtained a pre-payment certificate by virtue of making any payment in accordance with regulation 10 of the Charges Regulations 2001, and the relevant period as defined by paragraph (3) is unexpired, an application for a refund may be made, by or on behalf of that person or his or her estate, in accordance with paragraph (4) in respect of each complete month following 1 April 2007.

    (2) The refund referred to in paragraph (1) is calculable as follows—

and for the purposes of these calculations "complete month" means a month beginning on the monthly anniversary of the date upon which the pre-payment certificate became valid and ending on the date immediately preceding that date in the following month.

(3) In paragraph (1) "the relevant period" means the period of validity of the pre-payment certificate excluding the month in respect of which an application for repayment under paragraph (1) may be made.

(4) Applications under this regulation must be made to the Local Health Board that received the prescribed sum under regulation 10 of the Charges Regulations 2001 and must be accompanied by the certificate (where granted) and a declaration in support of the claim, and the claim and any repayment must be made in such manner and subject to such conditions as the National Assembly may determine.

SCHEDULE 2Regulation 13

Minor and Consequential Amendments

The National Health Service (Pharmaceutical Services) Regulations 1992
1. —(1) The National Health Service (Pharmaceutical Services) Regulations 1992 are amended as provided in this paragraph.

(2) In regulation 2(1) (interpretation) substitute the definition of "the Charges Regulations" with the following—

" "the Charges Regulations" means the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007".

(3) In paragraph (7) of Part 2 (Essential Services) of Schedule 2 delete the term "or (1A)".

The National Health Service (Travelling Expenses and Remission of Charges) (Wales) Regulations 1988
2. Substitute the entirety of paragraph (1)(b) of regulation 7 of the National Health Service (Travelling Expenses and Remission of Charges) (Wales) Regulations 1988 with the following—

The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
3. —(1) The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004 are amended as provided in this paragraph.

(2) In paragraph 11A of Part 1 of Schedule 6 (Other Contractual Terms)—

" "the Charges Regulations" means the National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007".

SCHEDULE 3Regulation 14

REGULATIONS REVOKED

(1)	(2)	(3)
Regulations revoked	Reference	Extent of revocation
National Health Service (Charges for Drugs and Appliances) (Wales) Regulations 2001	SI 2001/1358 (W.86)	The whole Regulations except regulation 11(3) and (4).Regulation 11(3) and 11(4) with effect from 1 July 2007.
National Health Service (Charges for Drugs and Appliances) (Amendment) (Wales) Regulations 2001	SI 2001/1359 (W.196)	The whole Regulations
National Health Service (Amendments concerning Supplementary and Independent Nurse Prescribing) (Wales) Regulations 2003	SI 2003/2624 (W.252)	Regulation 4
National Health Service (Pharmaceutical Services etc) (Repeatable Prescriptions) (Amendment) (Wales) Regulations 2004	SI 2004/1018 (W.115)	Regulations 1(4), 7 and 8
National Health Service (Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2004	SI 2004/1605 (W.164)	The whole Regulations
Health Act 1999 (Consequential Amendments) (Nursing and Midwifery) Order 2004	SI 2004/1771	Paragraph 29 of Part 2 of Schedule 2
General Medical Services Transitional and Consequential Provisions (Wales) (No.2) Order 2004	SI 2004/1016 (W.113)	Paragraph 24 of Schedule 1
National Health Service (Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2005	SI 2005/427 (W.44)	The whole Regulations
National Health Service (Charges for Drugs and Appliances) (Wales) (Amendment) (No.2) Regulations 2005	SI 2005/1915 (W.158)	The whole Regulations
National Health Service (Charges for Drugs and Appliances) (Wales) (Amendment) Regulations 2006	SI 2006/943 (W.92)	The whole Regulations
General Dental Services and Personal Dental Services Transitional and Consequential Provisions (Wales) Order 2006	SI 2006/946 (W.95)	Paragraph 4 of Schedule 1
National Health Service (Charges for Drugs and Appliances) (Wales) (Amendment) (No.2) Regulations 2006	SI 2006/1792 (W.188)	The whole Regulations

EXPLANATORY NOTE

(This note is not part of the Regulations)

     1. These Regulations revoke and replace, with amendments, the National Health Service (Charges for Drugs and Appliances) Regulations 2001[27] as amended.

     2. Accordingly, these Regulations abolish charges in respect of drugs and appliances supplied to patients registered with GPs in Wales, or registered with GPs in England but holding valid entitlement cards, where such drugs and appliances are supplied by chemists providing pharmaceutical services (regulation 3), by doctors providing pharmaceutical services (regulation 4), by Local Health Boards 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). Regulations 3 and 4 further provide for charges for drugs and appliances to any patients other than patients registered with GPs in Wales or registered with GPs in England but holding valid entitlement cards.

     3. Save in the circumstances outlined in paragraph 2 above, these Regulations provide for the making and recovery of charges for drugs and appliances supplied under the National Health Service Act 1977[28]. Provision for dental charges and optical charges is made separately.

     4. The Regulations provide for exemptions from payment of charges for drugs and appliances which will apply to patients other than those registered with GPs in Wales or registered with GPs in England but holding valid entitlement cards (regulation 8) and further provide for patients registered with GPs in Wales or registered with GPs in England but holding valid entitlement cards to apply for exemption certificates (regulation 9).

     5. Regulation 11 provides for the issuing of entitlement cards enabling Welsh residents registered with GPs in England to obtain drugs and appliances free of charge where the same are dispensed by chemists or doctors within Wales.

     6. The Regulations also provide for exemption from charges for prisoners (regulation 10).

     7. A regulatory appraisal has been prepared in respect of these Regulations and placed in the library of the National Assembly for Wales.

Notes:

[1] 1977 c.49.back

[2] Section 41 of the Act is replaced by section 80 of the National Health Service (Wales) Act 2006 (c.42) with effect from 1 March 2007.back

[3] S.I. 2000/620, as last amended by S.I. 2006/675.back

[4] S.I. 2001/1358 (W.86), as last amended by S.I. 2006/1792 (W.188).back

[5] S.I. 1992/662, as last amended in relation to Wales by S.I. 2005/1013 (W.67).back

[6] 1978 c.29.back

[7] S.I. 2004/478 (W.48) as last amended by S.I. 2006/945 (W.94).back

[8] Section 16BA of the Act is replaced by section 11 of the National Health Service (Wales) Act 2006 with effect from 1 March 2007.back

[9] S.I. 2001/253.back

[10] Primary medical services are provided under Part 4 of the National Health Service (Wales) Act 2006 with effect from 1 March 2007.back

[11] Section 16A of the Act is replaced by section 18 of the National Health Service Act 2006 (c.41) with effect from 1 March 2007.back

[12] Medical, dental, ophthalmic and pharmaceutical services are provided under Parts 4, 5, 6, and 7 of the National Health Service (Wales) Act 2006 respectively with effect from 1 March 2007.back