PART 1 Introductory

Citation, commencement and interpretation

1. —(1) These Regulations may be cited as the National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018 and come into force on 26th November 2018.

(2) In these Regulations—

“the Charges Regulations” means the National Health Service (Charges for Drugs and Appliances) Regulations 2015( 2 );

“the GMS Contracts Regulations” means the National Health Service (General Medical Services Contracts) Regulations 2015( 3 );

“the PLPS Regulations” means the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013( 4 ); and

“the PMS Agreements Regulations” means the National Health Service (Personal Medical Services Agreements) Regulations 2015( 5 ).

PART 2 Amendments to the PLPS Regulations

Amendment of regulation 2 of the PLPS Regulations

2. —(1)Regulation 2(1) of the PLPS Regulations( 6 ) (interpretation) is amended as follows.

(2) At the appropriate place in the alphabetical order insert—

“ “EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—

(3) At the appropriate place in the alphabetical order insert—

“ “paramedic independent prescriber” means a person—

(4) In sub-paragraph (c) of the definition of “electronic prescription form”, after “nominated dispensing contractor” insert “or via an information hub”.

(5) In sub-paragraph (b) of the definition of “electronic repeatable prescription”, after “nominated dispensing contractor” insert “or via an information hub”.

(6) In the definition of “prescriber”, after “optometrist independent prescriber” insert “, a paramedic independent prescriber”.

Amendment of regulation 69 of the PLPS Regulations

3. —(1)Regulation 69 of the PLPS Regulations (local dispute resolution before serving remedial notices or breach notices) is amended as follows.

(2) In paragraph (3)(b)(i), after “good cause” insert “, the NHSCB having made reasonable efforts to communicate with C with a view to establishing what the cause was”.

Amendment of regulation 70 of the PLPS Regulations

4. —(1)Regulation 70 of the PLPS Regulations (breaches of terms of service: remedial notices) is amended as follows.

(2) After paragraph (7), insert the following paragraph—

“ (8) The NHSCB may rescind a remedial notice at any time. ” .

Amendment of regulation 71 of the PLPS Regulations

5. —(1)Regulation 71 of the PLPS Regulations (breaches of terms of service: breach notices) is amended as follows.

(2) After paragraph (4), insert the following paragraph—

“ (5) The NHSCB may rescind a breach notice at any time. ” .

Amendment of Schedule 3 to the PLPS Regulations

6. —(1) Schedule 3 to the PLPS Regulations( 8 ) (appeals to the Secretary of State) is amended as follows.

(2) In paragraph 8 (oral hearings), in sub-paragraph (2)(a), omit from “, which—” to “at the oral hearing”.

Amendment of Schedule 4 to the PLPS Regulations

7. —(1) Schedule 4 to the PLPS Regulations (terms of service of NHS pharmacists) is amended as follows.

(2) In paragraph 5( 9 ) (dispensing of drugs and appliances)—

(a) in sub-paragraph (2)—

(i) omit “or” at the end of paragraph (a),

(ii) in paragraph (b), after “P receives” insert “as a nominated dispensing contractor”,

(iii) insert “; or” at the end of paragraph (b), and

(iv) after paragraph (b), insert the following paragraph—

“ (c) any person—

(i) presents P with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic prescription form, ” ; and

(b) in sub-paragraph (3)—

(i) omit “or” at the end of paragraph (a),

(ii) in paragraph (b), after “P receives” insert “as a nominated dispensing contractor”,

(iii) insert “; or” at the end of paragraph (b), and

(iv) after paragraph (b), insert the following paragraph—

“ (c) any person—

(i) presents P with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic repeatable prescription, ” .

(3) In paragraph 7( 10 ) (preliminary matters before providing ordered drugs or appliances)—

(a) in sub-paragraph (3), for “a declaration” substitute “or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription”;

(b) after sub-paragraph (3), insert the following sub-paragraph—

“ (3ZA) For the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, 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 the Charges Regulations. ” ; and

(c) in sub-paragraph (5), for “transmit to the Electronic Prescription Service” substitute “ensure that the following information is duly entered into the records managed by the Information Centre that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (3))”.

(4) In paragraph 9 (refusal to provide drugs or appliances ordered), after sub-paragraph (2) insert the following sub-paragraph—

“ (2A) P may refuse to provide a drug or appliance ordered on an electronic prescription if the access that P has to the Electronic Prescription Service is not such as to enable P to dispense that prescription promptly (or at all). ” .

(5) In paragraph 11 (additional requirements in relation to electronic prescribing)—

(a) in sub-paragraph (2)(a), for “the dispensing contractor chosen by that person” substitute “a nominated dispensing contractor”; and

(b) after sub-paragraph (5), insert the following sub-paragraph—

“ (6) If P dispenses an electronic prescription or makes an urgent supply without a prescription, P must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b) or (c), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA. ” .

Amendment of Schedule 5 to the PLPS Regulations

8. —(1) Schedule 5 to the PLPS Regulations (terms of service of NHS appliance contractors) is amended as follows.

(2) In paragraph 4 (dispensing of appliances)—

(a) in sub-paragraph (2)—

(i) omit “or” at the end of paragraph (a),

(ii) in paragraph (b), after “C receives” insert “as a nominated dispensing contractor”,

(iii) insert “; or” at the end of paragraph (b), and

(iv) after paragraph (b), insert the following paragraph—

“ (c) any person—

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) or (ii), and

(ii) requests the provision of an appliance in accordance with the related electronic prescription form, ” ; and

(b) in sub-paragraph (3)—

(i) omit “or” at the end of paragraph (a),

(ii) in paragraph (b), after “C receives” insert “as a nominated dispensing contractor”,

(iii) insert “; or” at the end of paragraph (b), and

(iv) after paragraph (b), insert the following paragraph—

“ (c) any person—

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) or (ii), and

(ii) requests the provision of appliances in accordance with the related electronic repeatable prescription, ” .

(3) In paragraph 6( 11 ) (preliminary matters before providing appliances)—

(a) in sub-paragraph (3)(a), for “a declaration” substitute “or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription”;

(b) in sub-paragraph (3)(c), for “transmit to the Electronic Prescription Service” substitute “ensure that the following information is duly entered into the records managed by the Information Centre that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (a))”; and

(c) after sub-paragraph (3), insert the following sub-paragraph—

“ (3A) For the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, 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 the Charges Regulations. ” .

(4) In paragraph 8 (refusal to provide appliances ordered), after sub-paragraph (1) insert the following sub-paragraph—

“ (1A) C may refuse to provide an appliance ordered on an electronic prescription if the access that C has to the Electronic Prescription Service is not such as to enable C to dispense that prescription promptly (or at all). ” .

(5) In paragraph 10 (additional requirements in relation to electronic prescribing)—

(a) in sub-paragraph (2)(a), for “the dispensing contractor chosen by that person” substitute “a nominated dispensing contractor”; and

(b) after sub-paragraph (5), insert the following sub-paragraph—

“ (6) If C dispenses an electronic prescription or makes an urgent supply without a prescription, C must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA. ” .

Amendment of Schedule 6 to the PLPS Regulations

9. —(1) Schedule 6 to the PLPS Regulations (terms of service of dispensing doctors) is amended as follows.

(2) In paragraph 2( 12 ) (dispensing of drugs and appliances ordered by another prescriber)—

(a) in sub-paragraph (2)—

(i) omit “or” at the end of paragraph (a),

(ii) in paragraph (b), after “D receives” insert “as a nominated dispensing contractor”,

(iii) insert “; or” at the end of paragraph (b), and

(iv) after paragraph (b), insert the following paragraph—

“ (c) any person—

(i) presents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic prescription form, ” ; and

(b) in sub-paragraph (3)—

(i) omit “or” at the end of paragraph (a),

(ii) in paragraph (b), after “D receives” insert “as a nominated dispensing contractor”,

(iii) insert “; or” at the end of paragraph (b), and

(iv) after paragraph (b), insert the following paragraph—

“ (c) any person—

(i) presents D with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

(ii) requests the provision of drugs or appliances in accordance with the related electronic repeatable prescription, ” .

(3) In paragraph 4( 13 ) (preliminary matters before providing ordered drugs or appliances)—

(a) in sub-paragraph (a), for “a declaration” substitute “or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription”; and

(b) in sub-paragraph (c), for “transmit to the Electronic Prescription Service” substitute “ensure that the following information is duly entered into the records managed by the Information Centre that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (a))”.

(4) After paragraph 4, insert the following paragraph—

“ Charge exemption and remission of charges: declarations and checks

4A. —(1) For the purposes of paragraph 4, satisfactory evidence includes evidence derived from a check, known as a real time exemption check, 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 the Charges Regulations.

(2) If D dispenses an electronic prescription, D must send the form duly completed by or on behalf of the patient, if one is required under regulation 4(2)(b) or (3A) of the Charges Regulations in respect of that electronic prescription (which may be the associated EPS token), to the NHS BSA. ” .

(5) In paragraph 6 (refusal to provide drugs or appliances ordered), after sub-paragraph (1) insert the following sub-paragraph—

“ (1A) D may refuse to provide a drug or appliance ordered on an electronic prescription if the access that D has to the Electronic Prescription Service is not such as to enable D to dispense that prescription promptly (or at all). ” .

Amendment of Schedule 7 to the PLPS Regulations

10. —(1) Schedule 7 to the PLPS Regulations (mandatory terms for LPS schemes) is amended as follows.

(2) In paragraph 3( 14 ) (dispensing)—

(a) in sub-paragraph (1)—

(i) omit “or” at the end of paragraph (a),

(ii) in paragraph (b), after “C receives” insert “as a nominated dispensing contractor”,

(iii) in paragraph (b)(i), after “a drug” insert “or appliance”,

(iv) insert “; or” at the end of paragraph (b), and

(v) after paragraph (b), insert the following paragraph—

“ (c) any person—

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iii), and

(ii) requests the provision of a drug or appliance in accordance with the related electronic prescription form, ” ; and

(b) in sub-paragraph (2)—

(i) omit “or” at the end of paragraph (a),

(ii) in paragraph (b), after “C receives” insert “as a nominated dispensing contractor”,

(iii) insert “; or” at the end of paragraph (b), and

(iv) after paragraph (b), insert the following paragraph—

“ (c) any person—

(i) presents C with an EPS token that relates to an order of a kind specified in paragraph (a)(i) to (iv), and

(ii) requests the provision of a drug or appliance in accordance with the related electronic repeatable prescription, ” .

(3) In paragraph 5( 15 ) (preliminary matters before providing ordered drugs or appliances)—

(a) in sub-paragraph (3), for “a declaration” substitute “or duly completes a declaration as or on behalf of the person named on the prescription form or repeatable prescription”;

(b) after sub-paragraph (3), insert the following sub-paragraph—

“ (3ZA) For the purposes of sub-paragraph (3), satisfactory evidence includes evidence derived from a check, known as a real time exemption check, 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 the Charges Regulations. ” ; and

(c) in sub-paragraph (5), for “transmit to the Electronic Prescription Service” substitute “ensure that the following information is duly entered into the records managed by the Information Centre that are accessible as part of the Electronic Prescription Service (if either it is not already recorded in those records or a check, known as a real time exemption check, has not produced satisfactory evidence as mentioned in sub-paragraph (3))”.

(4) In paragraph 7 (refusal to provide drugs or appliances ordered), after sub-paragraph (2) insert the following sub-paragraph—

“ (2A) C may refuse to provide a drug or appliance ordered on an electronic prescription if the access that C has to the Electronic Prescription Service is not such as to enable C to dispense that prescription promptly (or at all). ” .

(5) In paragraph 9 (additional requirements in relation to electronic prescribing)—

(a) in sub-paragraph (2)(a), for “the dispensing contractor chosen by that person” substitute “a nominated dispensing contractor”; and

(b) after sub-paragraph (4), insert the following sub-paragraph—

“ (5) If C dispenses an electronic prescription or makes an urgent supply without a prescription, C must send the form duly completed by or on behalf of the patient, if one is required under regulation 3(3)(b) or (c), (5C) or (5E) of the Charges Regulations in respect of that prescription (which may be the associated EPS token), to the NHS BSA. ” .

PART 3 Amendments to the Charges Regulations

Amendment of regulation 2 of the Charges Regulations

11. —(1)Regulation 2(1) of the Charges Regulations( 16 ) (interpretation) is amended as follows.

(2) In sub-paragraph (c) of the definition of “electronic prescription form”, after “nominated dispensing contractor” insert “or via an information hub”.

(3) In sub-paragraph (b) of the definition of “electronic repeatable prescription”, after “nominated dispensing contractor” insert “or via an information hub”.

(4) At the appropriate place in the alphabetical order insert—

“ “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 ( 17 ) ; ” .

(5) At the appropriate place in the alphabetical order insert—

“ “paramedic independent prescriber” means a person—

(6) In the definition of “prescriber”, after “optometrist independent prescriber” insert “, a paramedic independent prescriber”.

(7) At the appropriate place in the alphabetical order insert—

“ “relevant body” means—

Amendment of regulation 3 of the Charges Regulations

12. —(1)Regulation 3 of the Charges Regulations( 19 ) (supply of drugs and appliances by chemists) is amended as follows.

(2) In paragraph (3)(b), after “by a chemist” insert “or the prescriber”.

(3) In paragraph (4)(b), after “by a chemist” insert “or the prescriber”.

(4) In paragraph (5), omit sub-paragraphs (a) and (b).

(5) After paragraph (5), insert the following paragraphs—

“ (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 ( 20 ) (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 the Information Centre 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 the Board 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 the Board for recording patient declarations in respect of supplies in accordance with regulation 225 of the Human Medicines Regulations 2012 ( 21 ) (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. ” .

Amendment of Regulation 4 of the Charges Regulations

13. —(1)Regulation 4 of the Charges Regulations( 22 ) (supply of drugs and appliances by doctors) is amended as follows.

(2) In paragraph (2)(b), after “by a doctor” insert “or the prescriber”.

(3) In paragraph (3), for sub-paragraphs (a) and (b) substitute—

“ (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 the Information Centre 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); ” .

(4) After paragraph (3) insert the following paragraphs—

“ (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 the Board 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). ” .

Amendment of regulation 10 of the Charges Regulations

14. —(1)Regulation 10 of the Charges Regulations (exemptions: general) is amended as follows.

(2) In paragraph (4), for “or 4(3),” substitute “to (5E) or 4(3) to (3B),”.

(3) In paragraph (5), for “and 4(3)” substitute “to (5E) and 4(3) to (3B)”.

New regulation 18A of the Charges Regulations

15. After regulation 18 of the Charges Regulations (repayment of charges), insert the following regulation—

“ Sharing 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 ( 23 ) ,

bear the meanings they bear in those provisions of the Data Protection Act 2018. ” .

PART 4 Amendments to the GMS Contracts Regulations

Amendment of regulation 3 of the GMS Contracts Regulations

16. —(1)Regulation 3 of the GMS Contracts Regulations( 24 ) (interpretation) is amended as follows.

(2) In paragraph (b)(ii) of the definition of “prescription form”, for “nominated dispensing contractor” substitute “nominated dispenser or via an information hub”.

(3) In paragraph (c)(ii) of the definition of “repeatable prescription”, for “nominated dispensing contractor” substitute “nominated dispenser or via an information hub”.

(4) At the appropriate place in the alphabetical order insert—

“ “authorised person”, in relation to a patient, is a person who is entitled to make an application for pharmaceutical services on behalf of the patient by virtue of regulation 116(a) to (c) of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (authorised persons to apply for services); ” .

(5) At the appropriate place in the alphabetical order insert—

“ “contractor’s EPS phase 4 date” means the date, encoded within the Electronic Prescription Service software, which is the date that a contractor has agreed is to be the date on and after which the contractor’s prescribers are to use the Electronic Prescription Service for all eligible prescriptions; ” .

(6) At the appropriate place in the alphabetical order insert—

“ “EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—

Amendment of regulation 56 of the GMS Contracts Regulations

17. —(1)Regulation 56 of the GMS Contracts Regulations (orders for drugs, medicines or appliances) is amended as follows.

(2) In paragraph (1), for “paragraphs (2) and (3)” substitute “paragraphs (1A), (2) and (3)”.

(3) After paragraph (1), insert the following paragraphs—

“ (1A) If, on a particular occasion when a drug, medicine or appliance is needed as mentioned in paragraph (1)—

(a) the prescriber is able, without delay, to order the drug, medicine or appliance by means of an electronic prescription;

(b) the Electronic Prescription Service software that the prescriber would use for that purpose provides for the creation and transmission of electronic prescriptions without the need for a nominated dispenser; and

(c) none of the reasons for issuing a non-electronic prescription form or a non- electronic repeatable prescription given in paragraph (1B) apply,

the prescriber must create and transmit an electronic prescription for that drug, medicine or appliance.

(1B) The reasons given in this paragraph are—

(a) although the prescriber is able to use the Electronic Prescription Service, the prescriber is not satisfied that—

(i) the access that the prescriber has to the Electronic Prescription Service is reliable, or

(ii) the Electronic Prescription Service is functioning reliably;

(b) the patient, or where appropriate the patient’s authorised person, informs the prescriber that the patient wants the option of having the prescription dispensed elsewhere than in England;

(c) the patient, or where appropriate the patient’s authorised person, insists on the patient being issued with a non-electronic prescription form or a non-electronic repeatable prescription for a particular prescription and in the professional judgment of the prescriber the welfare of the patient is likely to be in jeopardy unless a non-electronic prescription form or a non-electronic repeatable prescription is issued;

(d) the prescription is to be issued before the contractor’s EPS phase 4 date or the contractor has no such date. ” .

Amendment of regulation 57 of the GMS Contracts Regulations

18. —(1)Regulation 57 of the GMS Contracts Regulations (electronic prescriptions) is amended as follows.

(2) In paragraph (1), omit sub-paragraphs (a) and (b).

(3) After paragraph (1), insert the following paragraphs—

“ (1A) If a prescriber orders a drug, medicine or appliance by means of an electronic prescription, the prescriber must issue the patient with—

(a) subject to paragraph (1C), an EPS token; and

(b) if the patient, or where appropriate an authorised person, so requests, a written record of the prescription that has been created.

(1B) On and after the contractor’s EPS phase 4 date, if the order is eligible for Electronic Prescription Service use, the prescriber must ascertain if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser.

(1C) The prescriber must not issue the patient with an EPS token if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser. ” .

(4) Omit paragraphs (3) and (4).

Amendment of regulation 58 of the GMS Contracts Regulations

19. —(1)Regulation 58 of the GMS Contracts Regulations (nomination of dispensers for the purposes of electronic prescriptions) is amended as follows.

(2) In paragraph (1)—

(a) in the opening words, after “its patients must”, insert “, if a patient, or where appropriate the patient’s authorised person, so requests,”; and

(b) in sub-paragraph (a), after “chosen by the patient”, insert “, or where appropriate the patient’s authorised person”.

(3) Omit paragraph (3).

(4) In paragraph (4)—

(a) in sub-paragraph (a), after “a patient” insert “or a patient’s authorised person”; and

(b) in sub-paragraph (b)—

(i) after “by a patient”, insert “or a patient’s authorised person”,

(ii) after “whom the patient”, insert “or the patient’s authorised person”, and

(iii) after “provide the patient”, insert “or, as the case may be, the patient’s authorised person”.

PART 5 Amendments to the PMS Agreements Regulations

Amendment of regulation 3 of the PMS Agreements Regulations

20. —(1)Regulation 3 of the PMS Agreements Regulations( 25 ) (interpretation) is amended as follows.

(2) In paragraph (b)(ii) of the definition of “prescription form”, for “nominated dispensing contractor” substitute “nominated dispenser or via an information hub”.

(3) In paragraph (b)(ii) of the definition of “repeatable prescription”, for “nominated dispensing contractor” substitute “nominated dispenser or via an information hub”.

(4) At the appropriate place in the alphabetical order insert—

“ “authorised person”, in relation to a patient, is a person who is entitled to make an application for pharmaceutical services on behalf of the patient by virtue of regulation 116(a) to (c) of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (authorised persons to apply for services); ” .

(5) At the appropriate place in the alphabetical order insert—

“ “contractor’s EPS phase 4 date” means the date, encoded within the Electronic Prescription Service software, which is the date that a contractor has agreed is to be the date on and after which the contractor’s prescribers are to use the Electronic Prescription Service for all eligible prescriptions; ” .

(6) At the appropriate place in the alphabetical order insert—

“ “EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—

Amendment of regulation 49 of the PMS Agreements Regulations

21. —(1)Regulation 49 of the PMS Agreements Regulations (orders for drugs, medicines or appliances) is amended as follows.

(2) In paragraph (1), for “paragraphs (2) and (3)” substitute “paragraphs (1A), (2) and (3)”.

(3) After paragraph (1), insert the following paragraphs—

“ (1A) If, on a particular occasion when a drug, medicine or appliance is needed as mentioned in paragraph (1)—

(a) the prescriber is able, without delay, to order the drug, medicine or appliance by means of an electronic prescription;

(b) the Electronic Prescription Service software that the prescriber would use for that purpose provides for the creation and transmission of electronic prescriptions without the need for a nominated dispenser; and

(c) none of the reasons for issuing a non-electronic prescription form or a non- electronic repeatable prescription given in paragraph (1B) apply,

the prescriber must create and transmit an electronic prescription for that drug, medicine or appliance.

(1B) The reasons given in this paragraph are—

(a) although the prescriber is able to use the Electronic Prescription Service, the prescriber is not satisfied that—

(i) the access that the prescriber has to the Electronic Prescription Service is reliable, or

(ii) the Electronic Prescription Service is functioning reliably;

(b) the patient, or where appropriate the patient’s authorised person, informs the prescriber that the patient wants the option of having the prescription dispensed elsewhere than in England;

(c) the patient, or where appropriate the patient’s authorised person, insists on the patient being issued with a non-electronic prescription form or a non-electronic repeatable prescription for a particular prescription and in the professional judgment of the prescriber the welfare of the patient is likely to be in jeopardy unless a non-electronic prescription form or a non-electronic repeatable prescription is issued;

(d) the prescription is to be issued before the contractor’s EPS phase 4 date or the contractor has no such date. ” .

Amendment of regulation 50 of the PMS Agreements Regulations

22. —(1)Regulation 50 of the PMS Agreements Regulations (electronic prescriptions) is amended as follows.

(2) In paragraph (1), omit sub-paragraphs (a) and (b).

(3) After paragraph (1), insert the following paragraphs—

“ (1A) If a prescriber orders a drug, medicine or appliance by means of an electronic prescription, the prescriber must issue the patient with—

(a) subject to paragraph (1C), an EPS token; and

(b) if the patient, or where appropriate an authorised person, so requests, a written record of the prescription that has been created.

(1B) On and after the contractor’s EPS phase 4 date, if the order is eligible for Electronic Prescription Service use, the prescriber must ascertain if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser.

(1C) The prescriber must not issue the patient with an EPS token if the patient, or where appropriate the patient’s authorised person, wants to have the electronic prescription dispensed by a nominated dispenser. ” .

(4) Omit paragraphs (3) and (4).

Amendment of regulation 51 of the PMS Agreements Regulations

23. —(1)Regulation 51 of the PMS Agreements Regulations (nomination of dispensers for the purposes of electronic prescriptions) is amended as follows.

(2) In paragraph (1)—

(a) in the opening words, after “its patients must”, insert “, if a patient, or where appropriate the patient’s authorised person, so requests,”; and

(b) in sub-paragraph (a), after “chosen by the patient”, insert “or where appropriate the patient’s authorised person”.

(3) Omit paragraph (3).

(4) In paragraph (4)—

(a) in sub-paragraph (a), after “the patient” insert “or the patient’s authorised person”; and

(b) in sub-paragraph (b)—

(i) after “by the patient”, insert “or the patient’s authorised person”,

(ii) after “whom the patient”, insert “or the patient’s authorised person”, and

(iii) after “provide the patient”, insert “or, as the case may be, the patient’s authorised person”.