Citation and commencement

1. These Regulations may be cited as the National Health Service (Charges for Drugs and Appliances) Regulations 2015 and come into force on 1st April 2015.

Interpretation

2.—(1) In these Regulations—

^M2 “ the 2000 Act ” means the Electronic Communications Act 2000 ;

“ the 2006 Act ” means the National Health Service Act 2006 ;

“ accepted disablement ” means physical or mental injury or disease which is accepted by the Secretary of State as attributable to, or aggravated by, service in the armed forces of the Crown or such other service as the Secretary of State may determine;

“ advanced electronic signature ” means an electronic signature which is—

“ another primary care organisation ” means—

^F2...

^M5 “appliance”, unless the context otherwise requires, means an appliance included in a list approved by the Secretary of State for the purposes of section 126 of the 2006 Act (arrangements for pharmaceutical services), but does not include a contraceptive appliance;

“ approved ”, in relation to forms, means approved by the Secretary of State;

^M6 “ armed forces of the Crown ” means the forces that are “regular forces” or “reserve forces” within the meanings given in section 374 of the Armed Forces Act 2006 (definitions applying for the purposes of the whole Act) ;

^M7 “ arrangements for recharging ” means arrangements under paragraph 3 of Schedule 12A to the 2006 Act (pharmaceutical remuneration – other pharmaceutical remuneration) under which [^F3 NHS England ^F3] requires a person to reimburse it for any pharmaceutical remuneration to which that paragraph applies;

^M8 “ bank holiday ” means any day that is, by virtue of section 1 of, or Schedule 1 to, the Banking and Financial Dealings Act 1971 (which relate to bank holidays) , a bank holiday in England;

“ batch issue ” means an approved form, in the format required by [^F3 NHS England ^F3] (or person exercising its functions), which—

^F4...

“ chemist ” means an LPS chemist or a person included in a pharmaceutical list of the type referred to in regulation 10(2)(a) or (b) of the Pharmaceutical and Local Pharmaceutical Services Regulations (pharmaceutical lists and EPS lists);

“ chiropodist or podiatrist independent prescriber ” means a chiropodist or podiatrist who is registered in Part 2 of the register maintained under article 5 of the [^F5 Health Professions Order 2001 ^F5] (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that the chiropodist or podiatrist is qualified to order drugs and appliances as a chiropodist or podiatrist independent prescriber;

^M9 “ community treatment order ” means an order under section 17A(1) of the Mental Health Act 1983 (community treatment orders) ;

^M10 “ directed services ” means additional pharmaceutical services provided in accordance with directions under section 127 of the 2006 Act (arrangements for additional pharmaceutical services);

“ dispensing doctor ” is to be construed in accordance with regulation 46(1) of the Pharmaceutical and Local Pharmaceutical Services Regulations (dispensing doctor lists);

^M11 “ dispensing services ” means the provision of drugs or appliances that may be provided as pharmaceutical services by a medical practitioner in accordance with arrangements made under sections 126 and 132 of the 2006 Act (arrangements for pharmaceutical services, and persons authorised to provide pharmaceutical services);

“ doctor ” means a registered medical practitioner;

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

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

^M12 “ electronic communication ” has the same meaning as in section 15(1) of the 2000 Act (general interpretation);

“ electronic prescription form ” means data created in an electronic form for the purpose of ordering a drug or appliance, which—

“ electronic repeatable prescription ” means data created in an electronic form, which—

“ Electronic Prescription Service ” means the service of that name which is managed by [^F8 NHS England ^F8] ;

“ electronic signature ” has the same meaning as in section 7 of the 2000 Act (electronic signatures and related certificates);

[^F9 “ electronic signature creation data ” means unique data which is used by the signatory to create an electronic signature; ^F9]

“ enhanced services ” means the directed services which [^F3 NHS England ^F3] is authorised (as opposed to required) to arrange by virtue of directions under section 127 of the 2006 Act;

“exemption certificate”, unless the context otherwise requires, has the meaning assigned to it by regulation 15(1);

[^F10 “ exemption certificate ” means a certificate conferring exemption that is to be applied for in accordance with regulation 15(1); ^F10]

“ GMS contract ” means a general medical services contract, and “ GMS contractor ” is to be construed accordingly;

[^F10 “ health care professional ” means a person who is a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 (the Professional Standards Authority for Health and Social Care) ; ^F10]

[^F11 “ HRT only PPC ” has the meaning given in regulation 17A(1)(a); ^F11]

“ independent nurse prescriber ” means a person—

^F12...

[^F13 “ integrated care board ” means an integrated care board established under Chapter A3 of Part 2 of the 2006 Act; ^F13]

[^F14 “integrated care provider contract” has the meaning given in Schedule 3A to the National Health Service (General Medical Services Contracts) Regulations 2015 ; ^F14]

[^F11 “ listed HRT prescription item ” is to be construed in accordance with regulation 17A(1)(a), read with regulation 17A(7); ^F11]

“ LPS chemist ” means a party to an LPS scheme other than the commissioning body;

^M14 “ mental disorder ” has the same meaning as in section 1 of the Mental Health Act 1983 (application of Act: “mental disorder”);

[^F15 “NHS BSA” means the NHS Business Services Authority established by the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) (Establishment and Constitution) Order 2005; ^F15]

[^F16 “ NHS England ” means the body corporate established under section 1H of the 2006 Act; ^F16]

“ NHS services ” means services provided as part of the health service (including services provided as part of the health service in pursuance of the public health functions of the Secretary of State or local authorities);

“ nominated dispensing contractor ” means a chemist or a dispensing doctor who has been nominated in a particular patient's PDS patient details to dispense the electronic prescriptions of that patient;

“ non-electronic prescription form ” means an approved form for ordering a drug or appliance which—

“ non-electronic repeatable prescription ” means a repeatable prescription which is not an electronic repeatable prescription;

“ optometrist independent prescriber ” means a person—

“ out of hours period ” means—

“ out of hours services ” means the services commissioned in respect of all, or part of, the out of hours period to enable the registered patients of a GMS, PMS or [^F18 section 83(2) ^F18] contractor to receive primary medical services outside core hours, and in this definition—

[^F19 “paramedic independent prescriber” means a person—

“ PDS patient details ” means the information held about a patient in the Patient Demographics Service managed by [^F8 NHS England ^F8] ;

^M16 “ the Pharmaceutical and Local Pharmaceutical Services Regulations ” means the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 ;

“ pharmacist independent prescriber ” means a registered pharmacist—

“ physiotherapist independent prescriber ” means a physiotherapist who is registered in Part 9 of the register maintained under article 5 of the [^F21 Health Professions Order 2001 ^F21] , and against whose name in that register is recorded an annotation signifying that the physiotherapist is qualified to order drugs and appliances as a physiotherapist independent prescriber;

^M19 “ PMS agreement ” means an agreement made under section 92 of the 2006 Act (arrangements by [^F3 NHS England ^F3] for the provision of primary medical services);

“ PMS contractor ” means a contractor within the meaning of [^F22 the National Health Service (Personal Medical Services Agreements) Regulations 2015 ^F22] ;

“pre-payment certificate”, unless the context otherwise requires, is to be construed in accordance with regulation 16;

“ prescriber ” means a doctor, a dental practitioner, a pharmacist independent prescriber, a supplementary prescriber, a chiropodist or podiatrist independent prescriber, a physiotherapist independent prescriber, an independent nurse prescriber[^F23 , an optometrist independent prescriber [^F24 , a paramedic independent prescriber ^F24] or a therapeutic radiographer independent prescriber ^F23] ;

“prescription form”, except in the context of the expression “electronic prescription form” or “non-electronic prescription form”, means an electronic prescription form or a non-electronic prescription form;

[^F25 “prescription item” means an item available on prescription, whether or not it is supplied in pursuance of a prescription or another basis for supply (for example a serious shortage protocol or a patient group direction); ^F25]

[^F26 “ prescription only medicine ” has the same meaning as in regulation 5(3) of the Human Medicines Regulations 2012 (classification of medicinal products) ; ^F26]

“ provider of NHS services ” means a person or a body which provides services under the 2006 Act pursuant to arrangements made with—

“ provider of out of hours services ” means—

“ registered pharmacist ” means a person who is registered in Part 1 or 4 of the register maintained under article 19 of the Pharmacy Order 2010 or in the register maintained under articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976 ;

[^F30 “relevant body” means—

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

“ repeatable prescription ” means an electronic repeatable prescription or an approved form for ordering drugs or appliances which—

[^F14 “section 83(2) contractor” means a person that provides primary medical services under contractual arrangements under section 83(2) of the 2006 Act (primary medical services), including in circumstances where those contractual arrangements are part of wider contractual arrangements for the provision of NHS services, and “section 83(2) contract” is to be construed accordingly; ^F14]

[^F31 “serious shortage protocol” means—

[^F32 “ signatory ” means a natural person who creates an electronic signature; ^F32]

[^F31 “SSP” means a serious shortage protocol; ^F31]

^M25 “ the Standing Rules Regulations ” means the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 ;

“ supplementary prescriber ” means—

^F35...

[^F36 “therapeutic radiographer independent prescriber” means a radiographer—

^M26 “ the Travel Expenses and Remission of Charges Regulations ” means the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003 ;

“ treatment ” includes examination and diagnosis; and

“ walk-in centre ” means a centre at which information and treatment for minor conditions is provided to the public under arrangements made by [^F3 NHS England ^F3] or [^F17 an integrated care board ^F17] .

(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 is to 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, is to be treated as the supply of only one appliance.

Supply of drugs and appliances by chemists

3.—(1) Except as provided in paragraph (2), a chemist who provides pharmaceutical services or local pharmaceutical services to a patient must, subject to paragraphs (5) to (7), make and recover from that patient for the supply of—

(a)an item of elastic hosiery, a charge of [^F38£9.90^F38] or [^F39£19.80^F39] per pair;

(b)each other appliance, a charge of [^F40£9.90^F40] ;

(c)each quantity of a drug, a charge of [^F41£9.90^F41] .

(2) A chemist who provides repeat dispensing services to a patient must, subject to paragraphs (5) to (7), make and recover from that patient in respect of each batch issue and each electronic prescription form for the supply of—

(a)an item of elastic hosiery, a charge of [^F42£9.90^F42] or [^F43£19.80^F43] per pair;

(b)each other appliance, a charge of [^F44£9.90^F44] ;

(c)each quantity of a drug, a charge of [^F45£9.90^F45] .

^F46(3) Where a charge is paid under paragraph (1), the person paying the charge must on doing so ...—

(a)^F47where a non-electronic prescription form has been issued, sign a declaration in writing on the non-electronic prescription form that the relevant charge has been paid; ...

(b)where an electronic prescription form has been created, provide a declaration that the relevant charge has been paid on an approved form provided by [^F3NHS England^F3] for recording patient declarations in respect of electronic prescription forms and issued by a chemist[^F48 or the prescriber^F48][^F49 ; or^F49]

[^F50 (c)where the person has been supplied with a drug—

(i)in accordance with regulation 225 of the Human Medicines Regulations 2012 (emergency sale etc by pharmacist: at patient’s request), and

(ii)pursuant to arrangements made in accordance with directions given by the Secretary of State under section 127 of the 2006 Act (arrangements for additional pharmaceutical services) or, if the drug is supplied under arrangements for the provision of local pharmaceutical services, equivalent arrangements to arrangements made in accordance with such directions,

provide a declaration that the relevant charge has been paid on an approved form provided by [^F3 NHS England^F3] for recording patient declarations in respect of supplies in accordance with regulation 225 of the Human Medicines Regulations 2012 and issued by a chemist.^F50]

(4) Where a charge is paid under paragraph (2), the person paying the charge must on doing so either—

(a)in respect of a batch issue, sign a declaration in writing on the batch issue that the relevant charge has been paid; or

(b)in respect of an electronic repeatable prescription, provide a declaration that the relevant charge has been paid on an approved form provided by [^F3NHS England^F3] for recording patient declarations in respect of electronic repeatable prescriptions and issued by a chemist[^F51 or the prescriber^F51] .

(5) No charge is to be made and recovered under paragraph (1) or paragraph (2) where—

^F52(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

^F52(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c)^M27the patient is resident in a school or institution, the name of which is inserted on the non-electronic prescription form by a prescriber under the term of an arrangement to provide primary medical services under section 83(2) of the 2006 Act (primary medical services).

[^F53 (5A) In cases involving an non-electronic prescription form other than one to which paragraph (5) applies, or a non-electronic repeatable prescription, no charge is to be made and recovered under paragraph (1) or (2) where—

(a)there is an exemption by virtue of regulation 10(1) or entitlement to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations (entitlement to full remission and payment); and

(b)subject to regulation 10(5)(b), a declaration of entitlement to an exemption or remission is duly completed by or on behalf of the patient on the non-electronic prescription form or the batch issue.

(5B) In cases involving an electronic prescription form or an electronic repeatable prescription, no charge is to be made and recovered under paragraph (1) or (2) where—

(a)there is an exemption by virtue of regulation 10(1) or entitlement to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations; and

(b)subject to regulation 10(5)(a), entitlement to that exemption or remission has been declared to the chemist by or on behalf of the patient and the chemist has duly entered into the records managed by [^F54 NHS England^F54] that are accessible as part of the Electronic Prescription Service a record of that entitlement (if that entitlement is not already recorded in those records).

(5C) Where a declaration is made under paragraph (5B)(b), subject to paragraph (5D), the patient or a person acting on the patient’s behalf must duly complete a record of that declaration on an approved form provided by [^F3 NHS England^F3] for recording such declarations and issued by the chemist or the prescriber.

(5D) The record referred to in paragraph (5C) is not required where a check, known as a real time exemption check, by the chemist of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under these Regulations has confirmed that no charge is to be made and recovered under paragraph (1) or (2).

(5E) In cases involving a relevant emergency supply of a drug, no charge is to be made and recovered under paragraph (1) or (2) where—

(a)there is an exemption by virtue of regulation 10(1) or entitlement to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations; and

(b)a declaration of entitlement to an exemption or remission is duly completed by or on behalf of the patient on an approved form provided by [^F3 NHS England^F3] for recording patient declarations in respect of supplies in accordance with regulation 225 of the Human Medicines Regulations 2012 (emergency sale etc. by pharmacist: at patient’s request) and issued by a chemist.

(5F) For the purposes of paragraph (5E), a supply of a drug is a relevant emergency supply of a drug if it is made—

(a)in accordance with regulation 225 of the Human Medicines Regulations 2012; and

(b)pursuant to arrangements made in accordance with directions given by the Secretary of State under section 127 of the 2006 Act (arrangements for additional pharmaceutical services) or, if the drug is supplied under arrangements for the provision of local pharmaceutical services, equivalent arrangements to arrangements made in accordance with such directions.^F53]

^M28(6) No charge is to be made and recovered under paragraph (1) or (2) where there is an exemption by virtue of section 173(1)(d) of the 2006 Act (exemptions from general charging) or regulation 10(2), 11, 12, 13 [^F55, 13A^F55] or 14.

(7) For the purposes of this regulation, where a drug ordered on a single prescription form is supplied by instalments, the charge of [^F56£9.90^F56] payable for that drug is payable on the supply of the first instalment.

(8) A chemist is under no obligation to supply drugs or appliances in the course of providing pharmaceutical services or local pharmaceutical services where a charge is required to be made and recovered under paragraphs (1) or (2) unless the patient first pays that charge (notwithstanding any provisions in the chemist's terms of service).

(9) Where a patient requests a receipt for a charge made and recovered under paragraph (1) or (2), the chemist must give the patient a receipt for the amount received on the relevant approved form.

(10) Any sum which would otherwise be payable by [^F3NHS England^F3] to a chemist in respect of the provision by that chemist of pharmaceutical services or local pharmaceutical services is to be reduced by the amount of any charges which must be made and recovered under paragraph (1) or (2).

(11) In paragraph (8), “ terms of service ” means the terms on which pharmaceutical services or local pharmaceutical services are provided under the 2006 Act.

[^F57 (12) Where, instead of supplying a drug or appliance in accordance with a prescription form or an associated batch issue, a chemist provides a drug or appliance in accordance with a SSP, for the purposes of this regulation, the relevant form for recording an exemption or entitlement to remission of a charge is treated as being the prescription for product reimbursement purposes, as mentioned in (as the case may be)—

(a)paragraph 5A(4)(a) of Schedule 4 to the Pharmaceutical and Local Pharmaceutical Services Regulations (terms of service of NHS pharmacists – supply in accordance with a SSP);

(b)paragraph 4A(4)(a) of Schedule 5 to those Regulations (terms of service of NHS appliance contractors – supply in accordance with a SSP); or

(c)paragraph 3A(4)(a) of Schedule 7 to those Regulations (mandatory terms of LPS schemes – supply in accordance with a SSP),

but for these purposes, those provisions are to be read with regulation 119A(2)(a) of those Regulations (transitional provisions in respect of drugs and appliances supplied in accordance with SSPs), so the relevant form may instead be a dispensing token that records the supply of the product (“dispensing token” having the meaning given in regulation 119A(1)(b) of those Regulations). ^F57]

Supply of drugs and appliances by doctors

4.—(1) A doctor who provides dispensing services to a patient must, subject to paragraphs (3), (4) and (8), make and recover from that patient for the supply of—

(a)an item of elastic hosiery, a charge of [^F58£9.90^F58] or [^F59£19.80^F59] per pair;

(b)each other appliance, a charge of [^F60£9.90^F60] ;

(c)each quantity of a drug, a charge of [^F61£9.90^F61] .

(2) Where a charge is paid under paragraph (1), the person paying the charge must on doing so either—

(a)where a non-electronic prescription form has been issued, sign a declaration in writing on the non-electronic prescription form that the relevant charge has been paid; or

(b)where an electronic prescription form has been created, provide a declaration that the relevant charge has been paid on an approved form provided by [^F3NHS England^F3] for recording patient declarations in respect of electronic prescription forms and issued by a doctor[^F62 or the prescriber^F62] .

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

[^F63 (a)in cases involving a non-electronic prescription form, there is—

(i)an exemption by virtue of regulation 10(1) or entitlement to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations (entitlement to full remission and payment), and

(ii)subject to regulation 10(5)(b), a declaration of entitlement to an exemption or remission is duly completed by or on behalf of the patient on the non-electronic prescription form;

(b)in cases involving an electronic prescription form, there is—

(i)an exemption by virtue of regulation 10(1) or entitlement to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations, and

(ii)subject to regulation 10(5)(a), entitlement to that exemption or remission has been declared to the doctor by or on behalf of the patient and the doctor has duly entered into the records managed by [^F64 NHS England^F64] that are accessible as part of the Electronic Prescription Service a record of that entitlement (if that entitlement is not already recorded in those records);^F63]

(c)the drugs or appliances are supplied in respect of two or more persons in a school or institution in which 20 persons are normally resident, of whom at least 10 are that doctor's patients; or

(d)^M29there is an exemption by virtue of section 173(1)(d) of the 2006 Act (exemptions from general charging) or regulation 10(2), 11(1), 12, [^F65, 13 or 13A^F65] .

[^F66 (3A) Where a declaration is made under paragraph (3)(b)(ii), subject to paragraph (3B), the patient or a person acting on the patient’s behalf must duly complete a record of that declaration on an approved form provided by [^F3 NHS England^F3] for recording such declarations and issued by the doctor or the prescriber.

(3B) The record referred to in paragraph (3A) is not required where a check, known as a real time exemption check, by the doctor of electronic records that are managed by the NHS BSA for the purposes (amongst other purposes) of providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under these Regulations has confirmed that no charge is to be made and recovered under paragraph (1).^F66]

(4) For the purposes of this regulation, where a drug ordered on a single prescription form is supplied by instalments, the charge of [^F67£9.90^F67] payable for that drug is payable on the supply of the first instalment.

(5) A doctor is under no obligation to supply drugs or appliances in the course of providing dispensing services where a charge is required to be made and recovered under paragraph (1) unless the patient first pays that charge (notwithstanding any provisions in the relevant GMS contract, PMS agreement or [^F68section 83(2)^F68] contract).

(6) Where a patient requests a receipt for a charge made and recovered under paragraph (1), the doctor must give the patient a receipt for the amount received on the relevant approved form.

(7) Any sum which would otherwise be payable by [^F3NHS England^F3] to a contractor under a GMS contract, a PMS agreement or [^F69a section 83(2)^F69] contract that includes terms of service by virtue of regulation 47 of the Pharmaceutical Services and Local Pharmaceutical Services Regulations (terms of service of dispensing doctors: general) is to be reduced by the amount of any charges which must be made and recovered under paragraph (1).

(8) Nothing in this regulation authorises the payment of a charge where the drug or appliance supplied is either—

(a)needed for immediate treatment and no order for the drug or appliance is made on a prescription form; or

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

[^F70 (9) Where, instead of supplying a drug or appliance in accordance with a prescription form or an associated batch issue, a doctor provides a drug or appliance in accordance with a SSP, for the purposes of this regulation, the relevant form for recording an exemption or entitlement to remission of a charge is treated as being the prescription for product reimbursement purposes, as mentioned in paragraph 3A(2)(b) of Schedule 6 to the Pharmaceutical and Local Pharmaceutical Services Regulations (terms of service of dispensing doctors – supply in accordance with a SSP).

(10) For these purposes, paragraph 3A(2)(b) of Schedule 6 to the Pharmaceutical and Local Pharmaceutical Services Regulations is to be read with regulation 119A(2)(a) of those Regulations (transitional provisions in respect of drugs and appliances supplied in accordance with SSPs), so the relevant form may instead be a dispensing token that records the supply of the product (“dispensing token” having the meaning given in regulation 119A(1)(b) of those Regulations). ^F70]

Out of hours supply of drugs and appliances by providers of out of hours services

5.—(1) A provider of out of hours services which are not dispensing services who supplies drugs or appliances to a patient in the course of providing out of hours services must, subject to paragraphs (3), (4) and (8), make and recover from that patient for the supply of—

(a)an item of elastic hosiery, a charge of [^F71£9.90^F71] or [^F72£19.80^F72] per pair;

(b)each other appliance, a charge of [^F73£9.90^F73] ;

(c)each quantity of a drug, a charge of [^F74£9.90^F74] .

(2) Any person paying a charge under paragraph (1) must on doing so sign a declaration in writing on the approved form that the relevant charge has been paid.

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

(a)there is an exemption by virtue of regulation 10(1) and a declaration of entitlement to an exemption is duly completed by or on behalf of the patient on the approved form;

(b)^M30there is entitlement to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations (entitlement to full remission and payment) and a declaration of entitlement to remission is duly completed by or on behalf of the patient on the approved form;

(c)the drugs or appliances are supplied in respect of two or more persons in a school or institution in which at least 20 persons are normally resident provided that the name of the school or institution is inserted on the approved form; and

(d)in the cases described in sub-paragraphs (a) and (b), such evidence of entitlement to an exemption or remission is provided as the provider of out of hours services may reasonably require.

^M31(4) No charge is to be made and recovered under paragraph (1) where there is an exemption by virtue of section 173(1)(d) of the 2006 Act (exemptions from general charging) or regulation 10(2), 11(1), 12 or 13.

(5) A provider of out of hours services is under no obligation to supply drugs or appliances in the course of providing out of hours services where a charge is required to be made and recovered under paragraph (1) unless the patient first pays that charge (notwithstanding any provisions in the relevant agreement to provide out of hours services).

(6) Where a patient requests a receipt for a charge made and recovered under paragraph (1), the provider of out of hours services must give the patient a receipt for the amount received on the relevant approved form.

(7) Any sum which would otherwise be payable by [^F3NHS England^F3] to a provider of out of hours services in respect of the provision of primary medical services is to be reduced by the amount of any charges which must be made and recovered under paragraph (1).

(8) Nothing in this regulation authorises the payment of a charge where the drug or appliance supplied is either—

(a)needed for immediate treatment and no order for the drug or appliance is made on an approved form; or

(b)administered or applied to the patient by the provider of out of hours services personally.

Supply of drugs and appliances by NHS trusts and NHS foundation trusts

6.—(1) Where an NHS trust or an NHS foundation trust supplies a drug or appliance to a patient for the purpose of treatment, the NHS trust or the NHS foundation trust (as the case may be) must, subject to paragraphs (3) to (6), make and recover from the patient for the supply of—

(a)an item of elastic hosiery, a charge of [^F75£9.90^F75] or [^F76£19.80^F76] per pair;

(b)an item specified in column (1) of Schedule 1 (which has effect), the charge specified in relation to it in column (2) of that Schedule;

(c)tights, a charge of [^F77£19.80^F77] ;

(d)each other appliance, a charge of [^F78£9.90^F78] ;

(e)each quantity of a drug, a charge of [^F79£9.90^F79] .

(2) Any person paying a charge under paragraph (1) must on doing so sign a declaration in writing that the relevant charge has been paid.

(3) No charge is to be made and recovered under this regulation for the supply of drugs administered or appliances fitted or put into service at the hospital or other establishment or facility which forms part of the NHS trust or NHS foundation trust which supplies the drugs or appliances.

(4) No charge is to be made and recovered under this regulation from a patient who is exempt—

(a)^M32by virtue of section 173(1)(a), (c) or (d) of the 2006 Act (exemptions from general charging) or regulation 10(2), 11(1), 12 or 13;

(b)by virtue of regulation 10(3); or

(c)^M33by reason of being entitled to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations (entitlement to full remission and payment),

and who, in the case described in section 173(1)(c) of the 2006 Act (aged under 16 or aged under 19 and in full-time education) and in the cases described in sub-paragraph (b) and (c), completes a declaration of entitlement to such exemption or remission and provides any other evidence of entitlement as the NHS trust or NHS foundation trust may reasonably require.

(5) No charge is to be made and recovered under this regulation from a patient who is accepted by the person supplying the drug as—

(a)suffering from tuberculosis, in respect of any drug supplied to that patient for the treatment of tuberculosis; or

(b)being subject to a community treatment order, in respect of any drug supplied to that patient for the treatment of a mental disorder.

(6) A partially remitted charge must be made and recovered under this regulation from a patient who is entitled to partial remission by virtue of regulation 10(6) if a declaration in writing is provided that the relevant part of the charge has been paid and a declaration of entitlement, and any other evidence of entitlement to partial remission, as may be required, is provided.

(7) Where a patient requests a receipt for a charge made and recovered under paragraph (1), the NHS trust or an NHS foundation trust must give the patient a receipt for the amount received on the relevant approved form.

Supply of drugs and appliances at walk-in centres

7.—(1) Where drugs or appliances are supplied to a patient, including during the out of hours period, for the purpose of treating that patient, by a prescriber at a walk-in centre, the NHS trust, NHS foundation trust or other person responsible for the management of the centre, must, subject to paragraphs (3) to (5), make and recover from that patient for the supply of—

(a)an item of elastic hosiery, a charge of [^F80£9.90^F80] or [^F81£19.80^F81] per pair;

(b)each other appliance, a charge of [^F82£9.90^F82] ;

(c)each quantity of a drug, a charge of [^F83£9.90^F83] .

(2) Any person paying a charge under paragraph (1), must on doing so, sign a declaration in writing that the relevant charge has been paid.

(3) No charge is to be made and recovered under this regulation for the supply of drugs administered or appliances fitted or put into service at the walk-in centre.

(4) No charge is to be made and recovered under this regulation from a patient who is exempt—

(a)^M34by virtue of section 173(1)(d) of the 2006 Act (exemptions from general charging) or regulation 10(2), 11(1), 12 or 13;

(b)by virtue of regulation 10(1); or

(c)^M35by reason of being entitled to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations (entitlement to full remission and payment),

and in the cases described in sub-paragraphs (b) and (c), completes a declaration of entitlement to such exemption or remission and provides any other evidence of entitlement as the NHS trust, NHS foundation trust or other person responsible for the management of the walk-in centre supplying the drug or appliance may reasonably require.

(5) For the purpose of this regulation, where a drug ordered is supplied by instalments, the charge of [^F84£9.90^F84] payable for that drug is payable on the supply of the first instalment.

(6) Where a patient requests a receipt for a charge made and recovered under paragraph (1), the person making and recovering the charge must give the patient a receipt for the amount received on the relevant approved form.

Supply of drugs under Patient Group Directions

8.—(1) Where, in the course of providing NHS services, drugs are supplied to a patient in accordance with a Patient Group Direction, including during the out of hours period, the person supplying the drugs must, subject to paragraphs (3) to (5), make and recover from the patient for the supply of each quantity of a drug, a charge of [^F85£9.90^F85] .

^F86(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) No charge is to be made and recovered under this regulation from a patient who is exempt—

(a)^M36by virtue of section 173(1)(a) of the 2006 Act (exemptions from general charging) or regulation 10(2), 11(1), 12 or 13;

(b)by virtue of regulation 10(1); or

(c)^M37by reason of being entitled to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations (entitlement to full remission and payment),

and who, in the cases described in sub-paragraphs (b) and (c), completes a declaration of entitlement to such exemption or remission and provides any other evidence of entitlement as the person supplying the drug may reasonably require.

(4) No charge is to be made and recovered under this regulation from a patient who is accepted by the person supplying the drug as—

(a)suffering from tuberculosis, in respect of any drug supplied to that patient for the treatment of tuberculosis; or

(b)being subject to a community treatment order, in respect of any drug supplied to that patient for the treatment of a mental disorder.

(5) No charge is to be made and recovered under this regulation where the drug is supplied for personal administration by the person making the supply in accordance with the Patient Group Direction.

(6) Where a patient requests a receipt for a charge made and recovered under paragraph (1), the person making that charge must give the patient a receipt for the amount received on the relevant approved form.

^M38(7) For the purpose 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 Human Medicines Regulations 2012 .

Supply of drugs and appliances by other providers of NHS services

9.—(1) A provider of NHS services who, otherwise than as mentioned in regulations 3 to 8, supplies drugs or appliances to a patient for the purpose of treatment must, subject to paragraphs (3) to (8), make and recover from the patient for the supply of—

(a)an item of elastic hosiery, a charge of [^F87£9.90^F87] or [^F88£19.80^F88] per pair;

(b)tights, a charge of [^F89£19.80^F89] ;

(c)an item specified in column (1) of Schedule 1, the charge specified in relation to it in column (2) of that Schedule;

(d)each other appliance, a charge of [^F90£9.90^F90] ;

(e)each quantity of a drug, a charge of [^F91£9.90^F91] .

(2) Any person paying a charge under paragraph (1) must on doing so sign a declaration in writing that the relevant charge has been paid.

[^F92 (2A) Paragraph (2) does not apply if the person paying the charge is paying it in respect of a medicine, other than a prescription only medicine, supplied as part of an additional pharmaceutical service.^F92]

(3) No charge is to be made and recovered under this regulation from a patient who is exempt—

(a)^M39by virtue of section 173(1)(a), (c) or (d) of the 2006 Act (exemptions from general charging) or regulation 10(2), 11(1), 12 or 13;

(b)by virtue of regulation 10(3); or

(c)^M40by reason of being entitled to remission of the charge by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations (entitlement to full remission and payment),

and who, in the cases described in section 173(1)(c) of the 2006 Act and in the cases described in sub-paragraphs (b) and (c), completes a declaration of entitlement to such exemption or remission and provides any other evidence of entitlement as the provider of NHS services may reasonably require.

(4) No charge is to be made and recovered under this regulation from a patient where the drugs supplied to the patient are administered, or the appliances supplied to the patient are fitted or put into service, at the hospital or other establishment or facility from which the provider of NHS services provides such services.

(5) No charge is to be made and recovered under this regulation where the drug or appliance supplied is administered or applied to the patient personally by a person employed by, or contracted to provide services for, a provider of NHS services.

(6) No charge is to be made and recovered under this regulation from a patient who is accepted by the person supplying the drug as—

(a)suffering from tuberculosis, in respect of any drug supplied to that patient for the treatment of tuberculosis; or

(b)being subject to a community treatment order, in respect of any drug supplied to that patient for the treatment of a mental disorder.

(7) A partially remitted charge must be made and recovered under this regulation from a patient who is entitled to partial remission by virtue of regulation 10(6) if a declaration in writing is provided that the relevant part of the charge has been paid and a declaration of entitlement, and any other evidence of entitlement to partial remission, as may be required, is provided.

(8) For the purpose of this regulation, where a drug ordered on a single written direction is supplied by instalments, the charge of [^F93£9.90^F93] is payable for that drug on the supply of the first instalment.

(9) Where a patient requests a receipt for a charge made and recovered under paragraph (1), the provider of NHS services must give the patient a receipt for the amount received on the relevant approved form.

Exemptions: general

10.—(1) Subject to paragraph (4), no charge is payable under regulations 3, 4, 5, 7 or 8 by a person who—

(a)is under 16 years of age;

(b)is under 19 years of age and is receiving qualifying full-time education within the meaning of section 173(2) and (3) of the 2006 Act (exemptions from general charging);

(c)is 60 years of age or older;

(d)has a valid exemption certificate on the grounds that they—

(i)are expecting a child, or

(ii)^M41have within the last twelve months given birth to a child (including a child whose death was registrable under the special provisions as to the registration of still-births in the Births and Deaths Registration Act 1953 ),

or has a valid exemption certificate issued under equivalent arrangements (to regulation 15) having effect in Scotland, Wales or Northern Ireland;

(e)has a valid exemption certificate on the grounds that they are suffering from one or more of the following conditions—

(i)permanent fistula (including caecostomy, colostomy, laryngostomy or ileostomy) requiring continuous surgical dressing or an appliance,

(ii)the following disorders—

• forms of hypoadrenalism (including Addison's disease) for which specific substitution therapy is essential,

• diabetes insipidus and other forms of hypopituitarism,

• diabetes mellitus – except where treatment is by diet alone,

• hypoparathyroidism,

• myasthenia gravis, or

• myxoedema,

(iii)epilepsy requiring continuous anti-convulsive therapy, or

(iv)a continuing physical disability which prevents the person from leaving the person's residence without the help of another person;

(f)has a valid exemption certificate on the grounds that the person is undergoing treatment for—

(i)cancer,

(ii)the effects of cancer, or

(iii)the effects of cancer treatment;

(g)has a valid exemption certificate issued on any of the grounds in sub-paragraph (e) or (f) under equivalent arrangements which have effect in Scotland, Wales or Northern Ireland;

(h)^F94has a valid exemption certificate in respect of the supply of drugs and appliances for the treatment of accepted disablement, but in either case only in respect of those supplies to which the certificate relates; ...

(i)has a valid pre-payment certificate granted under regulation 16 or a valid pre-payment certificate granted under equivalent arrangements (to regulation 16) having effect in Scotland, Wales or Northern Ireland [^F95; or^F95]

[^F96 (j)has a valid HRT only PPC, but only in respect of a prescription item that is a listed HRT prescription item.^F96]

^M42(2) No charge is payable under these Regulations in respect of the supply of any drug for the treatment of a sexually transmitted disease within the meaning of section 173(1)(b) of the 2006 Act .

(3) Subject to paragraph (4), no charge is payable under regulation 6 or 9—

(a)by a person of a description specified in paragraph (1)(h) in respect of the supply of an item specified in column (1) of Schedule 1; or

(b)by a person of any description specified in paragraph (1) in respect of the supply of an appliance not specified in column (1) of Schedule 1, or of tights or of drugs.

(4) Subject to paragraph (5), a person who wishes to claim entitlement to exemption by virtue of paragraph (1) or (3) must provide any declaration of entitlement required under regulation 3(5) [^F97to (5E) or 4(3) to (3B),^F97] or any declaration and evidence of entitlement required under regulation 5(3), 6(4), 7(4), 8(3) or 9(3).

(5) A person of a description specified in paragraph (1)(a) or (c) is not required to provide any declaration of entitlement required under regulations 3(5) [^F98to (5E) and 4(3) to (3B)^F98] where—

(a)an electronic prescription form or an electronic repeatable prescription is created and the person's date of birth is recorded on the person's PDS patient details and is set out on the electronic prescription form or electronic repeatable prescription; or

(b)a non-electronic prescription form or a non-electronic repeatable prescription is issued and the person's date of birth is printed by means of a computer on the non-electronic prescription form or non-electronic repeatable prescription.

^M43(6) A charge referred to in column (2) of Schedule (1) must, in the case of a person referred to in regulation 6 of the Travel Expenses and Remission of Charges Regulations (entitlement to partial remission and payment), be remitted to the extent specified in that regulation.

(7) Where a charge is remitted in part under paragraph (6), the person making the part payment must, on doing so, sign a declaration in writing that the relevant part of the charge has been paid, complete a declaration of entitlement and provide such other evidence of entitlement to partial remission as may be required by the person supplying the drug or appliance.

(8) An exemption by reference to age or the validity of an exemption certificate must be determined by reference to the age or validity on the day on which—

(a)in the case of pharmaceutical services or local pharmaceutical services provided by a chemist, the order for drugs or appliances is presented for dispensing; and

(b)in any other case, the drugs or appliances are supplied.

(9) Where a claim to an exemption has been made but is not substantiated, and in consequence of the claim a charge has not been recovered, if—

(a)the drugs or appliances were supplied by a chemist as mentioned in regulation 3 or by a doctor as mentioned in regulation 4, then [^F3NHS England^F3] must recover that charge from the person concerned;

(b)the drugs or appliances were supplied by an NHS trust or an NHS foundation trust as mentioned in regulation 6, then that NHS trust or NHS foundation trust must recover that charge from the person concerned; or

(c)the drugs or appliances were supplied as mentioned in regulations 5, 7, 8 or 9, then the body which made the arrangements for the provision of NHS services with the person or body that supplied the drugs or appliances must recover that charge from the person concerned.

[^F99Declarations, signatures and evidence of entitlement or of payment during a pandemic etc.

10A.—(1) Where, by virtue of these Regulations, a person is required to make, provide, complete or sign any declaration, or provide any evidence (including by way of completing a form or providing a certificate), but as a consequence of a disease being, or in anticipation of a disease being imminently—

(a)pandemic; and

(b)a serious risk or potentially a serious risk to human health,

the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, for the period specified in the announcement, that requirement is to be waived or modified in the manner specified in the announcement, that requirement is waived or is as modified in the specified manner for the specified period.

(2) Modifications under paragraph (1) may include modifications imposing requirements on a person other than the person who, but for the announcement, would be required to make, provide, complete or sign any declaration, or provide any evidence.

(3) An announcement under paragraph (1) may be withdrawn or amended at any time.^F99]

Exemption from charges for prisoners and persons detained in other secure accommodation

11.—(1) A prisoner or person detained in other secure accommodation is not liable to pay any charge under these Regulations.

^F100(2) No charge is payable under regulation 3(1), 3(2), or 4 by a person where the charge is for drugs or appliances ordered on a ... prescription form, and—

(a)^F100that person was a prisoner or a person detained in other secure accommodation at the time that the ... prescription form was issued; and

(b)^F100that ... prescription form has [^F101included within^F101] it—

(i) [^F102 in the case of a non-electronic prescription form, ^F102] the letters “HMP”, and

(ii)^F100the name and address of the prison or other secure accommodation in which the person was detained at the time the ... prescription form was issued.

(3) In this regulation—

“ other secure accommodation ” means—

^M46 “ person detained in other secure accommodation ” means a person who is detained in other secure accommodation in which medical, dental, ophthalmic, pharmaceutical or nursing services are provided under the 2006 Act under arrangements made by [^F3 NHS England ^F3] pursuant to Parts 4 to 7 of the 2006 Act or regulation 10 of the Standing Rules Regulations (services for prisoners and other detainees);

“ prison ” includes a young offenders institution but not a naval, military or air force prison; and

“ prisoner ” means a person who is detained in a prison in which medical, dental, ophthalmic, pharmaceutical or nursing services are provided under the 2006 Act under arrangements made by [^F3 NHS England ^F3] pursuant to Parts 4 to 7 of the 2006 Act or regulation 10 of the Standing Rules Regulations.

Exemption from charges for detainees

12.—(1) A detainee is not liable to pay any charge under these Regulations.

(2) In this regulation—

“ detainee ” means a person who is detained—

^M50 “ removal centre ” has the same meaning as in section 147 of the Immigration and Asylum Act 1999 (interpretation of Part 8).

Exemption from charges: risks to public health

13.—(1) In the circumstances set out in paragraph (2), the following [^F106prescription items^F106] are exempt from any charge under these Regulations—

(a)[^F106 prescription items^F106] for the prevention or treatment of a condition or disease arising from an emergency that threatens, is causing or has caused serious damage or risk to public health in England or any part of England; and

(b)^M51[^F106 prescription items^F106] , the supply of which is for, or is in anticipation of, a pandemic disease where the supply is in accordance with [^F107a prescription ^F108..., a patient group direction, a serious shortage protocol or a protocol^F107] relating to that disease as provided for in regulation 247 of the Human Medicines Regulations 2012 (exemption for supply in the event or anticipation of pandemic disease).

(2) Those circumstances are where—

(a)the Secretary of State has made arrangements for supplying the [^F109prescription item^F109] to patients free of charge; or

(b)^M52the NHS body that is responsible for the arrangements under which the [^F109prescription item^F109] is supplied has made arrangements, with the approval of the Secretary of State, for supplying the [^F109prescription item^F109] to patients free of charge,

and the patient is supplied with the [^F109prescription item^F109] under those arrangements.

[^F110Exemption from charges: supplies in accordance with a SSP

13A.—(1) No charge is payable under regulation 3(1) or (2) or 4(1) in respect of the supply of a drug or appliance in accordance with a SSP if, as a consequence of the supply being in accordance with a SSP instead of being in accordance with a prescription form or an associated batch issue, the patient receives a smaller quantity of the drug or fewer appliances than the quantity originally ordered.

(2) If, as a consequence of the supply of a drug or appliance being in accordance with a SSP instead of being in accordance with a prescription form or an associated batch issue—

(a)more than one charge would (but for this sub-paragraph) become payable under regulation 3(1) or (2) or 4(1) in respect of what is supplied in accordance with the SSP instead of only one charge being payable, then only one charge is payable in respect of what is supplied in accordance with that SSP; or

(b)a charge would (but for this sub-paragraph) become payable under regulation 3(1) or (2) or 4(1) in respect of what is supplied in accordance with the SSP instead of no charge being payable, then no charge is payable in respect of what is supplied in accordance with that SSP.^F110]

[^F111Coronavirus and influenza vaccinations and immunisations

13B.—(1) No charge is payable under these Regulations in respect of the supply or administration to an eligible person of a medicinal product used for vaccination or immunisation against coronavirus or influenza virus.

(2) In this regulation—

“coronavirus” has the meaning given in section 1(1) of the Coronavirus Act 2020 ; and

“eligible person” means a person who is of a class or description that means they would be entitled to be supplied with the medicinal product, or have it administered to them, in accordance with—

whether or not the medicinal product is supplied or administered to that person in accordance with such a patient group direction or protocol.^F111]

Exemption for prescriptions provided or issued in Northern Ireland

14. No charge is payable under regulation 3 in respect of any pharmaceutical services or local pharmaceutical services which are obtained on the presentation of a prescription form which was provided or issued in Northern Ireland.

Certificates of exemption: application and issue

15. [^F112 —(1) A person who wishes to claim exemption from charges payable under these Regulations (“an applicant”) by virtue of—

(a)regulation 10(1)(d), (e) or (f), or a health care professional making such an application on an applicant’s behalf, must apply for a certificate conferring exemption on an approved form provided by the Secretary of State; or

(b)regulation 10(1)(h), must apply for a certificate conferring exemption to the Ministry of Defence on an approved form provided by the Secretary of State.^F112]

(2) The Secretary of State, on being satisfied that an applicant is entitled to exemption by virtue of regulation 10(1)(d), must issue an exemption certificate which is to be valid from the date which is one month before the date on which the Secretary of State received the application made under paragraph (1) until, in the case of an expectant mother, the end of [^F113the period of twelve months beginning with the expected date of confinement, or in respect of applications received after an applicant has given birth^F113] —

(a)^M53to a child whose death is registrable under the special provisions as to the registration of still-births in the Births and Deaths Registration Act 1953 , thereafter until the end of the period of twelve months beginning with the expected date of confinement [^F114or the date of birth (depending on which is requested)^F114] ; or

(b)to a live child (who is not registrable as still-born), thereafter until the end of the period of twelve months beginning with the date of birth of that child.

[^F115 (2A) Where an exemption certificate is issued to an applicant who is an expectant mother the period of the validity of the certificate may be extended so that the twelve months is calculated from the child’s date of birth if—

(a)that date is later than the expected date of confinement; and

(b)the mother requests such an extension following the birth of a child as mentioned in paragraph (2)(a) or (b).^F115]

(3) The Secretary of State, on being satisfied that an applicant, not being a person entitled to exemption by virtue of regulation 10(1)(a), (b) or (c), is entitled to exemption by virtue of regulation 10(1)(e), must issue to the applicant an exemption certificate which is to be valid—

(a)from the date one month prior to the date on which the Secretary of State received the application made under paragraph (1); and

(b)for such period as the Secretary of State may determine.

(4) The Secretary of State, on being satisfied that an applicant, not being a person entitled to exemption by virtue of regulation 10(1)(a), (b), (c), or (e) is entitled to exemption by virtue of regulation 10(1)(f), must issue to the applicant an exemption certificate which is to be valid—

(a)from the date one month prior to the date on which the Secretary of State received the application under paragraph (1); and

(b)for such period as the Secretary of State may determine.

(5) The Secretary of State, on being satisfied that an applicant is entitled to exemption by virtue of regulation 10(1)(h), must issue to the applicant an exemption certificate which is to be valid for such period as the Secretary of State may determine.

[^F116 (6) The Secretary of State, on being satisfied that an exemption certificate has been issued in error or because of fraud, may revoke that certificate.^F116]

[^F117Sharing of data relating to applications for medical and maternity exemption certificates

15A.—(1) As regards any application made for an exemption certificate mentioned in regulation 15(1)(a) (either by the applicant or by a health care professional making an application on the applicant’s behalf), paragraph (2) applies to the data (which may be electronic data) arising from—

(a)the completion of the application form (by whosoever completes it);

(b)the processing of the application form for the purposes of assessing whether or not an applicant meets the entitlement criteria for the exemption certificate;

(c)the issuing of an exemption certificate to an applicant where it is appropriate to do so; and

(d)the management of these processes to ensure that they are performed effectively, efficiently and economically.

(2) Where paragraph (3) applies, the processing of data which is or is part of data described in paragraph (1) is—

(a)necessary for the performance of a task carried out in the public interest;

(b)the exercise of a function conferred on a person by an enactment (whether or not it would be so but for this sub-paragraph); and

(c)if the data is personal data concerning health, necessary for the management of health care systems or services.

(3) This paragraph applies where the processing—

(a)is by or on behalf of a relevant body or a provider of NHS services, including by another body on behalf of the relevant body or the provider of NHS services; and

(b)is for the purposes of performing, or facilitating the performance of, the functions mentioned in paragraph (1).

(4) A person who—

(a)is employed or engaged by a relevant body or provider of NHS services, or by a body processing data on their behalf as mentioned in paragraph (3)(a); and

(b)in the course of being so employed or engaged is required, for the purposes of performing, or facilitating the performance of, the functions mentioned in paragraph (1), to undertake the processing of data which is or is part of data described in that paragraph,

owes a duty of confidentiality in respect of that data (whether or not that person would do so but for this paragraph), but that duty is such that the person is able for those purposes, lawfully, to process that data by virtue of this regulation.

(5) Words and expressions used in both—

(a)paragraphs (2) to (4); and

(b)Parts 1 and 2 (preliminary and general processing) of, and paragraph 2(2)(f) of Schedule 1 (special categories of personal data and criminal convictions etc data – health or social care purposes) to, the Data Protection Act 2018,

bear the meanings they bear in those provisions of the Data Protection Act 2018.^F117]

Pre-payment certificates: application and grant

16. —(1) A person [^F118 (“a patient”) ^F118] applying to the Secretary of State for a pre-payment certificate [^F119 for themselves, or someone acting on their behalf, (either of them potentially being, for the purposes of this regulation, ^F119] “ the applicant ”) must—

(a)pay, or undertake to pay by means of a direct debit in ten monthly instalments, to the Secretary of State, the sum payable for the pre-payment certificate as set out in paragraph (3); and

(b)provide the Secretary of State with the information required to determine that application by—

(i)duly completing and submitting an application for the pre-payment certificate on an approved form provided for the purpose, or

(ii)providing the Secretary of State with that information in a manner that is acceptable to the Secretary of State.

(2) A pre-payment certificate is valid for a period of either 3 months or 12 months and an application for such a certificate must indicate the period for which it is required to be valid.

(3) The applicant must pay to the Secretary of State—

(a)in the case of a 3 month pre-payment certificate, [^F120£32.05^F120] ;

(b)in the case of a 12 month pre-payment certificate payable by means of a single instalment, [^F121£114.50^F121] ; or

(c)in the case of a 12 month pre-payment certificate payable by means of a direct debit in ten monthly instalments, instalments amounting to [^F122£11.45^F122] ,

and the payment amount referred to for each type of pre-payment certificate is referred to in this regulation and regulation 17 as “the issuing amount”.

(4) Subject to paragraph (6), the Secretary of State must grant a pre-payment certificate to the [^F123patient^F123] as soon as reasonably practicable after the applicant has fulfilled the requirements set out in paragraph (1).

(5) The Secretary of State may refuse to accept payment for a pre-payment certificate valid for 12 months by means of direct debit in ten monthly instalments, and refuse to grant such a certificate to [^F124a patient^F124] , where the applicant has—

(a)previously been granted a pre-payment certificate valid for 12 months payable by direct debit in ten monthly instalments; [^F125and^F125]

(b)^F126failed to pay in full the amount payable for that previously granted prepayment certificate without good reason; ...

^F126(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) A pre-payment certificate is valid—

(a)from a date before the application is made, where that date—

(i)was specified by the applicant when making the application, and

(ii)is no more than one month prior to the date when the application was made under paragraph (1); or

(b)from a date after the application is made, where that date—

(i)was specified by the applicant when making the application, and

(ii)is not more than one month after the date when the application was made under paragraph (1); or

(c)if the applicant does not specify a date in accordance with sub-paragraphs (a)(i) or (b)(i), from the date when the application is received.

(7) Pre-payment certificates granted under this regulation are not valid in respect of the items specified in column (1) of Schedule 1.

[^F127Sharing of data relating to applications for pre-payment certificates

16A.—(1) As regards any application made for a pre-payment certificate mentioned in regulation 16(1) (either by the patient or someone making an application on their behalf), paragraph (2) applies to the data (which may be electronic data) arising from—

(a)the completion of the application form (by whosoever completes it);

(b)the processing of the application form for the purposes of assessing whether or not a patient meets the entitlement criteria for the pre-payment certificate;

(c)the issuing of a pre-payment certificate to a patient where it is appropriate to do so; and

(d)the management of these processes to ensure that they are performed effectively, efficiently and economically.

(2) Where paragraph (3) applies, the processing of data which is or is part of data described in paragraph (1) is—

(a)necessary for the performance of a task carried out in the public interest;

(b)the exercise of a function conferred on a person by an enactment (whether or not it would be so but for this sub-paragraph); and

(c)if the data is personal data concerning health, necessary for the management of health care systems or services.

(3) This paragraph applies where the processing is for the purposes of performing, or facilitating the performance of, the functions mentioned in paragraph (1).

(4) A person who is required, for the purposes of performing, or facilitating the performance of, the functions mentioned in paragraph (1), to undertake the processing of data which is or is part of data described in that paragraph, owes a duty of confidentiality in respect of that data (whether or not that person would do so but for this paragraph), but that duty is such that the person is able for those purposes, lawfully, to process that data by virtue of this regulation.

(5) Words and expressions used in both—

(a)paragraphs (2) to (4); and

(b)Parts 1 and 2 (preliminary and general processing) of, and paragraph 2(2)(f) of Schedule 1 (special categories of personal data and criminal convictions etc data – health or social care purposes) to, the Data Protection Act 2018,

bear the meanings they bear in those provisions of the Data Protection Act 2018.^F127]

Pre-payment certificates: repayment

17.—(1) Where the issuing amount in respect of a pre-payment certificate has been paid and, not more than one month after the date when the pre-payment certificate became valid, the relevant person—

(a)dies; or

(b)becomes resident in a hospital and thereafter dies while resident in hospital before the expiry of the pre-payment certificate,

an application for repayment of the entirety of the issuing amount which has already been paid may be made on behalf of that person's estate in accordance with paragraph (6) and (7).

(2) Where the issuing amount in respect of a pre-payment certificate valid for 12 months has been paid and during the period beginning on the date when the pre-payment certificate became valid and ending on the date of its expiry, the relevant person becomes—

(a)entitled to exemption by virtue of regulation 10(1)(b) to (h);

(b)^M54entitled to remission by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations (entitlement to full remission and payment); or

(c)resident in hospital and thereafter remains in hospital until the expiry of the pre-payment certificate,

an application for a refund may be made, by or on behalf of that person or that person's estate, in accordance with paragraph (6) and (7), and is to be calculated in accordance with paragraph (4), in respect of each complete month following the date on which one of the events listed in sub-paragraph (a) to (c) occurred.

(3) Where the issuing amount in respect of a pre-payment certificate has been paid and during the period beginning one month after the date when the pre-payment certificate became valid and ending with the date of its expiry, the relevant person—

(a)dies; or

(b)becomes resident in hospital and thereafter dies while resident in hospital before the expiry of the pre-payment certificate,

an application for a refund may be made on behalf of that person's estate in accordance with paragraph (6) and (7), and is to be calculated in accordance with paragraph (4), in respect of each complete month following the date when the person died or became resident in hospital.

[^F128 (3A) Where the issuing amount in respect of a pre-payment certificate has been paid and, not more than one month after the date when the pre-payment certificate became valid, the relevant person becomes entitled to exemption by virtue of regulation 10(1)(d) or 10(1)(e), the Secretary of State must—

(a)cancel the pre-payment certificate; and

(b)refund to the relevant person the entirety of the issuing amount (without an application for a refund needing to be made).

(3B) Where the issuing amount in respect of a pre-payment certificate has been paid, and during the period beginning one month after the date when the pre-payment certificate became valid and ending with the date of its expiry, the relevant person becomes entitled to exemption by virtue of regulation 10(1)(d) or 10(1)(e), the Secretary of State must—

(a)cancel the pre-payment certificate; and

(b)refund to the relevant person an amount that is to be calculated in accordance with paragraph (4) in respect of each complete month following the date on which the relevant person became entitled to an exemption (without an application for a refund needing to be made).^F128]

(4) The refund referred to in [^F129paragraph (2), (3) and (3B)^F129] is to be calculated as follows—

(a)in the case of a pre-payment certificate valid for 3 months, one third of [^F130£31.25^F130] for each complete month during which the pre-payment certificate is or was valid following the relevant date;

(b)in the case of a pre-payment certificate valid for 12 months where a person has paid for the pre-payment certificate by means of a single payment, one twelfth of [^F131£111.60^F131] for each complete month during which the pre-payment certificate is or was valid following the relevant date; or

(c)in the case of a pre-payment certificate valid for 12 months where a person is or was paying for the pre-payment certificate in ten monthly instalments by means of direct debit either—

(i)where the sum payable for the pre-payment certificate has been paid in full, one twelfth of [^F132£111.60^F132] for each complete month during which the pre-payment certificate is or was valid following the relevant date, or

(ii)where the sum payable for the pre-payment certificate has not been paid in full, the amount paid for the pre-payment certificate at the point of refund, minus £104.00, plus one twelfth of [^F133£111.60^F133] for each complete month during which the pre-payment certificate is or was valid following the relevant date,

and for the purposes of these calculations, a “complete month” is a month beginning on the monthly anniversary of the date on which the pre-payment certificate became valid and ending on the date immediately preceding that date in the following month, “the relevant date” is the date on which one of the events listed in [^F134 paragraph (2), (3) or (3B) ^F134] occurred, and if a calculation produces a minus figure for the refund, no refund is payable.

(5) Where the issuing amount in respect of a pre-payment certificate valid for 3 months has been paid and not more than one month after the date on which the pre-payment certificate became valid, the relevant person becomes—

(a)entitled to exemption by virtue of regulation 10(1)(b) to (h);

(b)entitled to remission by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations; or

(c)resident in a hospital and remains there until expiry of the pre-payment certificate,

an application for a refund of two thirds of [^F135£31.25^F135] may be made by or on behalf of that person in accordance with paragraph (6) and (7).

^F136(6) An application for a refund under this regulation is to be made to the Secretary of State and must be accompanied by ... a declaration in support of the claim.

(7) An application for a refund under this regulation is to be made—

(a)where the relevant person dies or becomes resident in hospital and thereafter dies, within 24 months of the date of that death;

(b)where the relevant person becomes—

(i)entitled to exemption by virtue of regulation 10(1)(b) to (h), or

(ii)entitled to remission by virtue of regulation 5 of the Travel Expenses and Remission of Charges Regulations,

within 3 months of the date on which the event specified in paragraph (i) or (ii) occurred; or

(c)where the relevant person becomes resident in hospital and remains there until the expiry of the pre-payment certificate, within 3 months of the date of expiry.

(8) Any repayment is to be made in such manner and subject to such conditions as the Secretary of State may determine.

(9) Where the calculation of an amount under this regulation produces a sum which is not a whole number, the amount must be rounded up to the nearest penny.

(10) In this regulation, “ the relevant person ” means the person in respect of whom an issuing amount was paid.

[^F137 (11) This regulation does not apply to a HRT only PPC.^F137]

[^F138HRT only pre-payment certificates

17A.—(1) The Secretary of State may make arrangements for the grant of pre-payment certificates solely in respect of prescription items that are used for hormone replacement therapy (HRT) treatment, in particular by—

(a) publishing in the Drug Tariff a list of the drugs and appliances (“listed HRT prescription items”) in respect of which no charge is payable by a person on whom exemption from charging in respect of the listed HRT prescription items is conferred by the granting of such a certificate (referred to in these Regulations as a “ HRT only PPC ”); and

(b)specifying how applications for the grant of HRT only PPCs are to be made.

(2) Any such arrangements must provide that a patient may apply for a HRT only PPC whether or not the listed HRT prescription items are prescribed for them for use for HRT treatment or for some other purpose.

(3) The list mentioned in paragraph (1)(a) is only to include those of the prescription items used for HRT treatment that the Secretary of State wishes to include in the arrangements mentioned in paragraph (1), not all the prescription items that may be used for HRT treatment.

(4) In order to benefit from any arrangements as mentioned in paragraph (1), a patient or someone acting on their behalf (an “applicant”) may apply for a HRT only PPC, but if an applicant does so, the applicant must—

(a)pay to the Secretary of State the sum payable for the HRT only PPC, which is [^F139 £19.80^F139] (and an application is not valid if that amount has not been received by the Secretary of State); and

(b)provide the Secretary of State with the information required to determine that application by—

(i)duly completing and submitting an application for a HRT only PPC on a form approved by the Secretary of State and provided for that purpose, or

(ii)providing the Secretary of State with that information in a manner that is otherwise acceptable to the Secretary of State.

(5) A HRT only PPC is valid for a period of 12 months and an application for a HRT only PPC must include the date from which the patient wishes it to be valid.

(6) A HRT only PPC is valid from the date included in the application pursuant to paragraph (5), where the applicant has specified a date that is—

(a)before the application is made and that date is no more than one month prior to the date on which the application is made (so if the application is made on 1st May, the start date may be no earlier than 1st April);

(b)the date on which the application is made; or

(c)after the application is made and that date is no more than one month after the date on which the application is made (so if the application is made on 1st April, the start date may be no later than 1st May),

but otherwise, the HRT only PPC is valid from the date on which the application is received.

(7) A HRT only PPC is only valid in respect of a prescription item that is a listed HRT prescription item at the time of the supply of the prescription item, unless—

(a)the prescription item was a listed HRT prescription item before that time but it has since been removed from the list in the Drug Tariff; and

(b)it was a listed HRT prescription item at the time the prescription in pursuance of which the product is supplied was issued (whether the product is supplied in accordance with that prescription or a serious shortage protocol),

in which case, the HRT only PPC is also valid in respect of that product.

(8) As regards any HRT only PPCs that are to be valid during the first month for which any arrangements as mentioned in paragraph (1) are made—

(a)the date to be included by the applicant in the application pursuant to paragraph (5) must be a date no earlier than the date on which the arrangements start; and

(b)if an earlier start date for the HRT only PPC is included but the application is otherwise valid, the HRT only PPC is valid from the date on which the arrangements start.^F138]

Repayment of charges

18.—(1) Where a charge has been paid under these Regulations by or on behalf of a person who was at the time of payment exempt from the requirement to pay that charge, an application for repayment may be made in accordance with paragraph (2) by or on behalf of that person.

(2) An application for repayment must be—

(a)made to the person or body specified in the receipt which is given under regulation 3(9), 4(6), 5(6), 6(7), 7(6), 8(6) or 9(9) as being the person or body to whom application for repayment of charges may be made;

(b)made in such form and manner as the Secretary of State may determine for the applicant, any class of applicant or applicants generally;

(c)made within 3 months from the date on which the drug or appliance was supplied to the applicant or within such longer period as the Secretary of State may allow; and

(d)accompanied by the receipt which is given pursuant to regulation 3(9), 4(6), 5(6), 6(7), 7(6), 8(6) or 9(9) for the charge paid and a declaration as to the grounds of exemption.

(3) In the case of a charge under regulation 6 or 9 in respect of an item specified in column (1) of Schedule 1, the application must be accompanied by the exemption certificate referred to in regulation 10(1)(h) and, if the patient was referred by a doctor to the NHS trust, NHS foundation trust or other provider of NHS services for treatment—

(a)a certificate from the doctor certifying that the treatment was for an accepted disablement; or

(b)a statement that such a certificate was surrendered to the NHS trust, NHS foundation trust or other provider of NHS services before the supply of the item.

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

[^F140Sharing of prescription and charging data

18A.—(1) As regards any order for a drug or an appliance in respect of which—

(a)a charge is payable under these Regulations (whether or not it is partially remitted); or

(b)a charge would be payable under these Regulations, but for an exemption by virtue of these Regulations,

paragraph (3) applies to the data relating to that order which is described in paragraph (2) (which may be electronic data).

(2) The data relating to that order described in this paragraph is—

(a)data used for ordering the drug or appliance (which may be in the form of a prescription form), if the data, in the form in which it is used for ordering the drug or appliance, is also used for the purposes of claiming a payment by way of—

(i)reimbursement for the cost of the supply of the drug or appliance, or

(ii)remuneration for the service provided in the course of which the drug or appliance was supplied;

(b)data derived from the data used for ordering the drug or appliance (which may have been in the form of a prescription form), which is to be or has been provided to a health service body by a provider of NHS services for the purposes of claiming a payment by way of—

(i)reimbursement for the cost of the supply of the drug or appliance, or

(ii)remuneration for the service provided in the course of which the drug or appliance was supplied; and

(c)data relating to whether a charge is payable by a patient under these Regulations in respect of the order.

(3) The processing of data which relates to a patient and which is or is part of data described in paragraph (2) is—

(a)necessary for the performance of a task carried out in the public interest;

(b)the exercise of a function conferred on a person by an enactment (whether or not it would be so but for this sub-paragraph); and

(c)if the data is personal data concerning health, necessary for the management of health care systems or services,

where the processing is by or on behalf of a relevant body or a provider of NHS services (including by another body on behalf of the relevant body or the provider of NHS services) and is for the purposes of performing, or facilitating the performance of, the functions listed in paragraph (4).

(4) Those functions are—

(a)reimbursement for the cost of the supply of that drug or appliance (taking account, as appropriate, of any charge payable under these Regulations);

(b)remuneration for providing the service in the course of which that drug or appliance was supplied (taking account, as appropriate, of any charge payable under these Regulations);

(c)ascertaining whether a charge is payable under these Regulations;

(d)providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under these Regulations;

(e)recovery of unpaid charges payable under these Regulations, and the making and recovery of penalty charges;

(f)repayment or partial repayment of amounts paid as a charge under these Regulations where no amount or only part of the amount was payable; and

(g)management functions of a relevant body relating to ensuring that the functions mentioned in sub-paragraphs (a) to (f) are performed effectively, efficiently and economically.

(5) A person who—

(a)is employed or engaged by a relevant body or provider of NHS services, or by a body processing data on their behalf as mentioned in paragraph (3); and

(b)in the course of being so employed or engaged is required, for the purposes mentioned in paragraph (3), to undertake the processing of data described in paragraph (2),

owes a duty of confidentiality in respect of that data (whether or not that person would do so but for this paragraph), but that duty is such that, if the processing is for the purposes mentioned in paragraph (3), that person is able, lawfully, to process that data by virtue of this regulation.

(6) Words and expressions used in both—

(a)paragraphs (3) and (5); and

(b)Parts 1 and 2 (preliminary and general processing) of, and paragraph 2(2)(f) of Schedule 1 (special categories of personal data and criminal convictions etc data) to, the Data Protection Act 2018,

bear the meanings they bear in those provisions of the Data Protection Act 2018.^F140]

Transitional provision

^M5519. Where, on or after 1st April 2015, an item specified in column (1) of the table in Schedule 1 is supplied pursuant to an order made before that date, the National Health Service (Charges for Drugs and Appliances) Regulations 2000 are to have effect in relation to the supply of that appliance as if these Regulations had not come into force (and so those Regulations had not been revoked).

Consequential amendments

20. The amendments set out in Schedule 2 have effect.

Revocations

21. The Regulations and Orders specified in column (1) of Schedule 3 are hereby revoked in relation to England to the extent specified in column (3) of that Schedule.

Regulation 6(1)

SCHEDULE 1 Charges for fabric supports and wigs

Regulation 20

SCHEDULE 2 Consequential amendments

Amendments to the National Health Service (Travel Expenses and Remission of Charges) Regulations 2003

^M561.—(1) The National Health Service (Travel Expenses and Remission of Charges) Regulations 2003 are amended as follows.

(2) In regulation 2 (interpretation), for the definition of “the Charges Regulations” substitute the following definition—

(3) In regulation 5(2)(e) (entitlement to full remission and payment), for “regulation 3(1)(b)” substitute “ regulation 3(1)(b) or (c) ”.

(4) In regulation 12(1)(a)(ia) (repayments), for “regulation 6B” substitute “ regulation 9 ”.

Amendment to the National Health Service (General Medical Services Contracts) Regulations 2004

^M572. In regulation 2(1) of the National Health Service (General Medical Services Contracts) Regulations 2004 (interpretation), for the definition of “listed medicines” substitute the following definition—

Amendment to the National Health Service (Personal Medical Services Agreements) Regulations 2004

^M583. In regulation 2(1) of the National Health Service (Personal Medical Services Agreements) Regulations 2004 (interpretation), for the definition of “listed medicines” substitute the following definition—

Amendment to the Primary Ophthalmic Services Regulations 2008

^M594. In regulation 3(2)(c) of the Primary Ophthalmic Services Regulations 2008 (sight tests –eligibility), for “National Health Service (Charges for Drugs and Appliances) Regulations 2000” substitute “ National Health Service (Charges for Drugs and Appliances) Regulations 2015 ”.

Amendments to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

^M605.—(1) The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 are amended as follows.

(2) In regulation 2 (interpretation), for the definition of “Charges Regulations” substitute the following definition—

(3) In regulation 96(2)(a) (refunds of prescription charges), for “regulation 10(2)(b)” substitute “ regulation 18(2)(b) ”.

(4) In Schedule 4 (terms of service of NHS pharmacists), in paragraph 7 (preliminary matters before providing ordered drugs or appliances)—

(a)in sub-paragraph (3), for “or (1A)” substitute “ or (2) ”; and

(b)for “regulation 7(1)”, at each place where it occurs, substitute “ regulation 10(1) ”.

(5) In Schedule 5 (terms of service of NHS appliance contractors), in paragraph 6 (preliminary matters before providing appliances)—

(a)in sub-paragraph (3), for “or (1A)” substitute “ or (2) ”; and

(b)for “regulation 7(1)”, at each place where it occurs, substitute “ regulation 10(1) ”.

(6) In Schedule 6 (terms of service of dispensing doctors), in paragraph 4 (preliminary matters before providing ordered drugs or appliances)—

(a)in sub-paragraph (a), for “regulation 7(1)” substitute “ regulation 10(1) ”, and for “regulation 7” substitute “ regulation 10 ”; and

(b)in sub-paragraph (c)(i)(aa), for “regulation 7(1)” substitute “ regulation 10(1) ”.

(7) In Schedule 7 (mandatory terms for LPS schemes)—

(a)in paragraph 5 (preliminary matters before providing ordered drugs or appliances)—

(i)in sub-paragraph (3), for “or (1A)” substitute “ or (2) ”, and

(ii)for “regulation 7(1)”, at each place where it occurs, substitute “ regulation 10(1) ”; and

(b)in paragraph 18(2)(a) (refunds of prescription charges), for “regulation 10(2)(b)” substitute “ regulation 18(2)(b) ”.

Amendment to the National Health Service (Optical Charges and Payments) Regulations 2013

^M616. In regulation 8(3)(b) of the National Health Service (Optical Charges and Payments) Regulations 2013 (eligibility for a voucher – supply of optical appliances), for “the National Health Service (Charges for Drugs and Appliances) Regulations 2000” substitute “ the National Health Service (Charges for Drugs and Appliances) Regulations 2015 ”.

Amendment to the Social Security (Information-sharing) (NHS Payments and Remission of Charges etc.) (England) Regulations 2015

^M627. In regulation 2 of the Social Security (Information-sharing) (NHS Payments and Remission of Charges etc.) (England) Regulations 2015 (interpretation), for the definition of “the CDA Regulations” substitute the following definition—

Amendment to the Delegation of Additional Functions to the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) Regulations 2015

^M638. In regulation 2 of the Delegation of Additional Functions to the NHS Business Services Authority (Awdurdod Gwasanaethau Busnes y GIG) Regulations 2015 (functions of the National Health Service Commissioning Board to be exercised by the NHS Business Services Authority), for “regulation 7(7)(a) of the National Health Service (Charges for Drugs and Appliances) Regulations 2000” substitute “ regulation 10(9)(a) of the National Health Service (Charges for Drugs and Appliances) Regulations 2015 ”.

Regulation 21

SCHEDULE 3 Revocations