Legalize / United Kingdom / Statutory-Instrument

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

Type Statutory-Instrument

Publication 2013-02-14

Last updated 2025-10-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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(1) If an NHS chemist is suspended from a pharmaceutical list, in addition to NHS England’s powers to terminate suspensions under section 157(3)(b) of the 2006 Act (review of decisions) on a review, NHS England may terminate the suspension at any time, in appropriate circumstances.

(2) If NHS England terminates a suspension under paragraph (1), it must notify the NHS chemist that it has done so.

Internal handling of fitness information by NHS England or an agent of NHS England

86

(1) NHS England must ensure that the records it maintains relating to the fitness of NHS chemists and LPS chemists to be NHS chemists or LPS chemists are only accessible to persons whom NHS England employs in circumstances where NHS England is satisfied that they—

(a) should have access to the information on a need-to-know basis; and

(b) fully understand the confidential nature of the information and the purposes for which they are being permitted access to it.

(2) Where functions of NHS England relating to the fitness of NHS chemists or LPS chemists are carried out on behalf of NHS England by an agent of NHS England—

(a) the reference in paragraph (1) to persons whom NHS England employs includes reference to persons whom the agent employs to perform functions under the agency arrangement (about whom the agent must be satisfied on NHS England’s behalf as mentioned in sub-paragraphs (a) and (b) of paragraph (1)); and

(b) NHS England must ensure that the terms of the agency arrangement are such that the information the agent holds relating to the fitness of NHS chemists and LPS chemists to be NHS chemists or LPS chemists as a consequence of the arrangement is not further processed by the agent in a manner which is incompatible with the confidential nature of the information and the purposes for which it has been obtained.

Review periods for national disqualifications

87

(1) Section 159(8)(a) of the 2006 Act (national disqualification) is to have effect as if the reference to “two years” were a reference to “five years”, if the First-tier Tribunal determines, when it imposes the national disqualification, that the conduct of the person on whom the national disqualification has been imposed has been such that there is no realistic prospect of a review being successful if held within five years.

(2) Section 159(8)(b) of the 2006 Act is to have effect as if the reference to “one year” were a reference to “three years”, if the First-tier Tribunal determines, on a review, that the conduct of the person on whom the national disqualification has been imposed has been such that there is no realistic prospect of a further review being successful if held within three years.

(3) Section 159(8) of the 2006 Act is to have effect as if the references to “two years” and “one year”—

(a) in a case where—

(i) a national disqualification has been imposed as a consequence of a criminal conviction, and

(ii) on appeal, the conviction has been quashed or the penalty imposed by the court has been reduced; or

(b) in a case where—

(i) a national disqualification has been imposed as a consequence of an adverse decision of a licensing body, and

(ii) on appeal, the decision of the licensing body has been quashed or the penalty imposed by it has been reduced,

were a reference to a period equal to the period between the date on which that appeal was determined and the date on which the national disqualification was imposed or last reviewed.

Wider notifications of fitness decisions

88

(1) Where NHS England—

(a) refuses an application from a person (P) by virtue of regulation 33;

(b) grants an application subject to conditions imposed on P by virtue of regulation 35;

(d) removes P from a pharmaceutical list by virtue of section 151 or 152(3)(b) of the 2006 Act (which relate to disqualification of practitioners and contingent removal);

(e) contingently removes P from a pharmaceutical list by virtue of section 152 of the 2006 Act, or varies or imposes a different condition on P by virtue of that section; or

(f) suspends P under section 154 or 155 of the 2006 Act (which relate to suspension and suspension pending appeal),

NHS England must notify the persons listed in paragraph (2) that it has done so.

(2) Those persons are—

(a) the Secretary of State;

(b) where known to NHS England, any other primary care organisation that—

(i) has included P, or a body corporate of which P is a director or superintendent, in a relevant list, or

(ii) is considering including P, or a body corporate of which P is a director or superintendent, in a relevant list;

(d) the Welsh Ministers;

(e) the Northern Ireland Executive;

(f) the General Pharmaceutical Council;

(g) any Local Pharmaceutical Committee for the area of the relevant HWB (including any Local Pharmaceutical Committee for part of its area or for its area and that of all or part of the area of one or more other HWBs);

(h) in a case that is or may be a fraud case, the NHS CFA; and

(i) any person who may and does request to be notified of an adverse fitness decision as regards P.

(3) A person (Q) comes within paragraph (2)(i) if Q establishes to the satisfaction of NHS England (or before the appointed day the relevant Primary Care Trust) that Q—

(a) has employed or engaged, is employing or engaging or is considering employing or engaging P, or a director or superintendent of P, in a professional capacity; or

(b) is a member of a partnership of which P has been or is a member, or which is considering inviting P to be a member.

(4) A notification under paragraph (1) must include—

(a) where P is an individual or a partnership—

(i) P's, or each member of the partnership's, name, address and date of birth, and

(ii) P's, or each member of the partnership's, registration number in the Register of Pharmacists; and

(b) where P is a body corporate—

(i) P's name, company registration number and the address of P's registered office, and

(ii) the registration number in the Register of Pharmacists of P's superintendent and of any director of P who is a registered pharmacist;

(d) the name of and contact details for a person at NHS England who is in a position to respond to further enquiries.

(5) NHS England must notify P of whom it has notified under paragraph (1) and include, when it does so, the content of that notification.

(6) If, in response to an enquiry from a person notified under paragraph (1), NHS England notifies that person with further documentation (including documentation in an electronic form) that relates to P, NHS England must also notify P with—

(a) that documentation; and

(b) details of the person to whom it has been sent.

(7) If NHS England is notified by the First-tier Tribunal of a national disqualification, or the outcome of the review of a national disqualification, it must notify that information to the persons it notified about its own decision in relation to P under paragraph (2)(b) and (g) to (i).

(8) If—

(a) having notified a person under paragraph (1) of a suspension or a condition (including a condition imposed on contingent removal); or

(b) after a Primary Care Trust notified a person under regulation 88(1) of the 2012 Regulations (wider notifications of fitness decisions) of a suspension or a condition (including a condition imposed on contingent removal),

NHS England terminates the suspension or removes the condition, NHS England must notify that person with the notification given to P of the decision to terminate the suspension or remove the condition.

PART 12 — Remuneration, charges and refunds

The Drug Tariff and section 164: general provisions

89

(1) The Drug Tariff referred to in section 127(4) of the 2006 Act (arrangements for additional pharmaceutical services) is the aggregate of—

(a) the determinations of remuneration made by the Secretary of State, acting as a determining authority, under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services), but not of the remuneration of dispensing doctors;

(b) the determinations of remuneration made by NHS England, acting as a determining authority, pursuant to regulation 91(1); and

(c) any other instruments that the Secretary of State is required by virtue of these Regulations or the 2006 Act to publish, or does publish, together with those determinations,

in the publication known as the Drug Tariff, which the Secretary of State shall publish in such format as the Secretary of State thinks fit.

(2) Determinations under section 164 of the 2006 Act by the Secretary of State or NHS England may be made by reference to—

(a) the drugs and appliances dispensed or expected to be dispensed in accordance with NHS prescriptions during a reference period determined by the Secretary of State;

(b) lists of published prices produced by suppliers of the drugs or appliances that are available from them on NHS prescription;

(c) scales, indices or other data that relate to volume and price that are produced by suppliers of the drugs or appliances that are available from them on NHS prescription; and

(d) any other scales, indices or other data (including formulae) by reference to which the Secretary of State considers it appropriate to make such a determination, and in these circumstances, the Secretary of State may provide that remuneration is to be determined by reference to data which is—

(i) in the form current at the time of the determination; and

(ii) in any subsequent form taking effect after that time.

(3) Amendments may be made to the Drug Tariff at such intervals as the Secretary of State thinks fit, but must be published in a consolidated version of the Drug Tariff that has the amendments included in it.

(4) The consultation that the Secretary of State must undertake under section 165(1) of the 2006 Act (section 164: supplementary) prior to the inclusion of, or change to, a price of a drug or appliance which is to form part of a calculation of remuneration shall be by way of consultation on the process for determining the price to be included or changed, not on the proposed price itself (unless it is impossible to carry out an effective consultation in any other way).

(5) The Drug Tariff is to include the arrangements for the claiming of payments by NHS chemists and the making of payments to NHS chemists under it (whether the amounts are determined by the Secretary of State or NHS England), and—

(a) claims by NHS chemists for payments under the Drug Tariff must be made in accordance with those arrangements;

(b) payments under the Drug Tariff must be made—

(i) by NHS England (or a person exercising its functions), and

(ii) in accordance with those arrangements, subject as appropriate to any deduction that may or must be made in accordance either with those arrangements or with any provision of, or made under, the 2006 Act (including the Drug Tariff); and

Data to be provided to assist Drug Tariff determinations

90

(1) The data which the Secretary of State and NHS England may take into account prior to making a determination under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services) may include information obtained pursuant to paragraph (3) by—

(a) the Secretary of State or a person appointed by the Secretary of State under this paragraph; or

(b) NHS England or a person appointed by NHS England under this paragraph,

and a person appointed under this paragraph is referred to in this regulation as “a nominee”.

(2) Before appointing a person to be a nominee, the Secretary of State or NHS England must consult, as they consider appropriate, organisations representative of the NHS chemists to whose remuneration the possible determination arising out of the data would relate.

(3) An NHS chemist must, within 30 days of a request to do so, provide—

(a) the Secretary of State or a nominee of the Secretary of State with information (for example invoices) which the Secretary of State considers to be relevant to the matters the Secretary of State may take into account prior to making a determination under section 164 of the 2006 Act; or

(b) NHS England or a nominee of NHS England with information (for example invoices) which NHS England considers to be relevant to the matters NHS England may take into account prior to making a determination under section 164 of the 2006 Act.

(4) A nominee may handle and process information obtained under paragraph (3).

(5) The Secretary of State may require—

(a) information obtained by a nominee of the Secretary of State under paragraph (3)(a) to be obtained; and

(b) information processed or handled by a nominee of the Secretary of State under paragraph (4) to be processed or handled,

in such manner as the Secretary of State may reasonably specify.

(6) NHS England may require—

(a) information obtained by a nominee of NHS England under paragraph (3)(b) to be obtained; and

(b) information processed or handled by a nominee of NHS England under paragraph (4) to be processed or handled,

in such manner as NHS England may reasonably specify.

(7) The Secretary of State and NHS England may share with each other information which they or their nominees have obtained under this regulation (for purposes related to the determination of pharmaceutical remuneration).

Remuneration of NHS chemists: instruments of appointment of NHS England

91

(1) NHS England is appointed by the Secretary of State as a determining authority in relation to the following remuneration to be paid to NHS chemists for providing pharmaceutical services—

(a) the remuneration listed in Schedule 8 (which has effect); and

(b) remuneration in respect of advanced services.

(2) Before making determinations as provided for by paragraph (1), NHS England must consult—

(a) the Secretary of State in such manner as the Secretary of State may reasonably request; and

(b) a body appearing to it to be representative of persons to whose remuneration the determination would relate.

(3) In making determinations as provided for by paragraph (1), NHS England must—

(a) co-operate with the Secretary of State over seeking to ensure that resource use in respect of pharmaceutical remuneration is compatible with any objectives agreed between the Secretary of State and NHS England in respect of the total resource to be available for pharmaceutical remuneration;

(b) ensure that those determinations are compatible with the Secretary of State's arrangements for the claiming and making of payments, and making deductions from payments, that are included in the Drug Tariff (which may relate to pharmaceutical remuneration determined by NHS England as well as to pharmaceutical remuneration determined by the Secretary of State);

(c) ensure that those determinations are signed by a member of the senior management of NHS England, and for these purposes a person is a member of the senior management of NHS England if that person plays a significant role in—

(i) the making of decisions about how the whole or a substantial part of its activities are to be managed or organised, or

(ii) the actual managing or organising of the whole or a substantial part of those activities; and

(d) act in a manner that ensures that any amendments which, as a consequence, need to be made to the Drug Tariff, are made in a manner that is compatible with the Secretary of State's arrangements for the publication of the Drug Tariff (or the arrangements of a person publishing the Drug Tariff on the Secretary of State's behalf).

(4) The Secretary of State must, before making a determination which could by virtue of paragraph (1) be made by NHS England, notify NHS England of the Secretary of State's intention to make the determination.

(5) Before determining any remuneration payable in respect of an enhanced service, NHS England must consult—

(a) if the service is to be provided on the basis of a service specification that sets standard conditions nationally (including with regard to remuneration), the body that is, for the time being, the body consulted under section 165(1)(a) of the 2006 Act in respect of pharmaceutical remuneration of NHS pharmacists; or

(b) otherwise, any Local Pharmaceutical Committee for the area in which the service is to be provided.

(6) Where NHS England makes a determination of the remuneration payable in respect of an enhanced service, it must publish the determination in such manner as it thinks appropriate for bringing it to the attention of persons included in the relevant pharmaceutical lists.

(7) The arrangements for claiming and paying any remuneration in respect of an enhanced service thus determined must allow for the making for any deduction that may or must be made from that remuneration by virtue of any provision of, or made under, the 2006 Act (for example, a deduction that may or must be made by virtue of regulations 70 to 72).

Dispensing doctor remuneration

92

(1) As regards the pharmaceutical services provided by dispensing doctors—

(a) if a drug, appliance or related additional service is provided by a dispensing doctor in circumstances where the dispensing doctor could provide it under pharmaceutical services or related arrangements for the provision of primary medical services, the remuneration in respect of providing that drug, appliance or service is to be the remuneration payable in respect of that drug, appliance or service under the related arrangements; and

(b) in all other cases, the remuneration payable to a dispensing doctor in respect of those pharmaceutical services is to be the remuneration payable under a GMS contract to a GMS practice in respect of those services by virtue of directions under section 87 of the 2006 Act (GMS contracts: payments), whether or not the dispensing doctor is a GMS practice.

(2) Claims for remuneration in respect of pharmaceutical services by or on behalf of a dispensing doctor are to be made to the NHS BSA (which calculates the amount of the payment on behalf of NHS England) in such manner as the NHS BSA determines.

(3) The making of payments by NHS England pursuant to a claim made in accordance with paragraph (2) is to be in accordance with the arrangements—

(a) that the dispensing doctor has with NHS England for the provision of primary medical services to the patients to whom the dispensing doctor provides pharmaceutical services; or

(b) if the dispensing doctor has no such arrangements, that NHS England has with a provider of primary medical services for the provision of primary medical services to the patients to whom the dispensing doctor provides pharmaceutical services,

subject as appropriate to any deduction that may or must be made in accordance either with those arrangements or with any provision of, or made under, the 2006 Act (including the determinations mentioned in paragraph (1)).

The taking effect of determinations

93

(1) A determination of remuneration under section 164 of the Act (remuneration for persons providing pharmaceutical services) is to have effect—

(a) in relation to remuneration in respect of a period beginning on or as from a date specified in the determination, on or as from that date; or

(b) if no such date is specified, in relation to remuneration in respect of the period beginning on the date that the determination is published.

(2) A date before the date a determination is published may only be specified under paragraph (1)(a) if, taking the determination as a whole, it is not detrimental to the persons to whose remuneration it relates.

Overpayments

94

(1) Where NHS England considers that a payment has been made to an NHS chemist pursuant to the arrangements mentioned in regulation 89(5) or 91(7) in circumstances where it was not due, it must (except to the extent that the Secretary of State, on the application of NHS England, directs otherwise) draw the overpayment to the attention of the NHS chemist, and—

(a) where the NHS chemist admits the overpayment; or

(b) if the NHS chemist does not admit there has been an overpayment, where the final outcome of an investigation or appeal is that there has been an overpayment,

the amount overpaid shall be recoverable by deduction from other remuneration payable to the NHS chemist in respect of pharmaceutical services or as a civil debt.

(2) Where NHS England considers that a payment has been made to a dispensing doctor or provider of primary medical services pursuant to the arrangements mentioned in regulation 92(2) in circumstances where it was not due, it must (except to the extent that the Secretary of State, on the application of NHS England, directs otherwise) seek to recover that overpayment under those arrangements.

(3) Recovery under this regulation of an overpayment is to be without prejudice to the investigation of any related breach of the relevant NHS chemist's or dispensing doctor's terms of service.

Free supply of drugs, appliances and containers where the drug or appliance is supplied under pharmaceutical services

95

Subject to any provision of regulations made under Part 9 of the 2006 Act (charging) to the contrary and without prejudice to regulation 92(1)(a), any drug, appliance or container supplied under arrangements made by NHS England for the provision of pharmaceutical services must be supplied free of charge (although a prescription charge may be payable).

Refunds of prescription charges

96

(1) Where any person is entitled to repayment of a charge paid under the Charges Regulations presents an NHS pharmacist with a valid claim for the repayment within 3 months of the date on which the charge was paid, the NHS pharmacist must make the repayment.

(2) For the purposes of paragraph (1), a claim for repayment is only valid if duly made—

(a) in such form and manner as the Secretary of State has determined for an application for such a repayment under regulation 18(2)(b) of the Charges Regulations (repayment of charges); or

(b) on an equivalent form issued in Scotland, Wales or Northern Ireland.

Reward scheme

97

(1) An NHS chemist who is presented with or receives an order under paragraph 5(2) or (3) of Schedule 4, or paragraph 4(2) or (3) of Schedule 5, is eligible to claim a payment from NHS England, in accordance with the Drug Tariff, if—

(a) the NHS chemist has refused, in accordance with paragraph 9 of Schedule 4 or paragraph 8 of Schedule 5, to provide a drug or appliance and has informed NHS England of this action as soon as practicable; or

(b) has provided a drug or appliance pursuant to paragraph 5(2) or (3) of Schedule 4, or paragraph 4(2) or (3) of Schedule 5 but has reason to believe (whether or not this was the case at the time that the drug or appliance was dispensed) that the order was not a genuine order on NHS prescription and has informed NHS England of this belief as soon as is practicable,

and in either case has sent the order (or, in the case of an electronic prescription, details of it) to NHS England.

(2) Where NHS England establishes that an order about which it has been notified in accordance with paragraph (1) was not a genuine order, NHS England must make such payment as is due to the NHS chemist under the Drug Tariff.

(3) In this regulation, “order” includes a purported order.

Payments to suspended chemists

98

(1) If an NHS chemist (C) is suspended from a pharmaceutical list, NHS England must make payments to C, in accordance with the determination that is to be made by the Secretary of State under this paragraph in relation to such payments.

(2) A determination under paragraph (1) may be amended from time to time by a further determination under that paragraph.

(3) Before making a determination under paragraph (1), the Secretary of State must consult such organisations as appear to the Secretary of State to be representative of NHS chemists.

(4) A determination under paragraph (1) must be published in the Drug Tariff.

(5) A determination under paragraph (1) may include provision that payments in accordance with the determination are not to exceed a specified amount in a specified period.

(6) If a payment has been made pursuant to a determination under paragraph (1) to C when it was not due, it must (except to the extent that the Secretary of State, on the application of NHS England, directs otherwise) draw the overpayment to the attention of C, and—

(a) where C admits the overpayment; or

(b) if C does not admit there has been an overpayment, where the final outcome of an investigation or appeal is that there has been an overpayment,

the amount overpaid shall be recoverable by deduction from other remuneration payable to C in respect of pharmaceutical services (for example, from subsequent payments under the determination or from payments for pharmaceutical services where C resumes the provision of pharmaceutical services) or as a civil debt.

(7) C may appeal to the Secretary of State against the following decisions by NHS England—

(a) a refusal to make payments to C under the determination under paragraph (1);

(b) the level of any payments made to C under the determination under paragraph (1); or

provided that C notifies the Secretary of State with a valid notice of appeal within 30 days of the date on which C was notified of the decision that is being appealed.

(8) A notice under paragraph (7) is valid only if it includes a concise and reasoned statement of the grounds of appeal.

(9) Schedule 3 has effect in relation to appeals to the Secretary of State under paragraph (7) (as it does in relation to appeals against decisions under Parts 2 to 5, 7, 8 to 10 and Schedule 2).

PART 13 — Local Pharmaceutical Services

Designation of areas, premises or descriptions of premises

99

(1) NHS England may designate relevant areas, premises or descriptions of premises for the purposes of paragraph 2 of Schedule 12 to the 2006 Act (LPS schemes – designation of priority neighbourhoods or premises).

(2) Any designation made is to be of an area in which, or premises or descriptions of premises at or from which, local pharmaceutical services are to be provided under a proposed or approved LPS scheme (referred to in this regulation as the “relevant scheme”), but a designation is not necessary in respect of every such scheme.

(3) Any designation made must—

(a) be made in writing and be dated;

(b) include a map showing the location of the area, premises or description of premises designated; and

(4) NHS England must give notice of the designation to—

(a) the HWB (HWB1) for the area to which the designation relates, or (as the case may be) for the area in which the premises or descriptions of premises are situated;

(b) any Local Pharmaceutical Committee whose area includes the premises, descriptions of premises, or all or part of the area to which the designation relates;

(c) any Local Medical Committee whose area includes the premises, descriptions of premises, or all or part of the area to which the designation relates;

(d) any NHS chemist whose listed chemist premises—

(i) are in the area of HWB1, or

(ii) are in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the designation;

(e) any person who is entitled because of the grant of a routine or excepted application to be included in a pharmaceutical list—

(i) for the area of HWB1, or

(ii) for the area of a neighbouring HWB, if their interests are likely, in the opinion of NHS England, to be affected by the designation,

but who is not (yet) included;

(f) any LPS chemist whose chemist premises—

(i) are in the area of HWB1, or

(ii) are in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the designation;

(g) any dispensing doctor whose listed dispensing premises—

(i) are in the area of HWB1, or

(ii) are in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the designation; and

(h) any Local Healthwatch organisation for the area of HWB1.

(5) A designation under this regulation, and any designation by a Primary Care Trust under regulation 4 of the 2006 Regulations (designation of priority neighbourhoods or premises), may be varied by NHS England where—

(a) if it relates to an area, the LP services to be provided under the relevant scheme are to be provided in or from part only of that area;

(b) if it relates to premises, the LP services to be provided under the relevant scheme are to be provided at or from part only of those premises;

(c) if it relates to a description of premises, the LP services to be provided under the relevant scheme are to be provided at or from parts only of the premises described.

(6) Where a designation is varied under paragraph (5), that designation must—

(a) satisfy the requirements of paragraph (3) (the date of the designation becoming the date on which it is varied); and

(b) be notified in accordance with paragraph (4).

(7) NHS England must—

(a) publish—

(i) all its (current) designations, including designations it has varied, under this regulation, and

(ii) all the (current) designations of Primary Care Trusts, including their varied designations, under regulation 4 of the 2006 Regulations; and

(b) ensure that each HWB has access to those designations which is sufficient to enable the HWB to carry out its functions under these Regulations.

Review of designations

100

(1) NHS England must regularly review—

(a) all its designations, including designations it has varied, under regulation 99; and

(b) all the designations of Primary Care Trusts, including their varied designations, under regulation 4 of the 2006 Regulations (designation of priority neighbourhoods or premises),

and in any event must review each of those designations before the end of 6 months beginning with either the date of the designation or (if later) the date it concluded its last review of the designation.

(2) When conducting a review under paragraph (1), NHS England must take into account any responses it or a Primary Care Trust received when the designation was last notified.

(3) In a case where a designation is not varied or cancelled as a result of a review, NHS England must give notice of the outcome of the review to the persons who would have been notified under regulation 99(6)(b) if the designation had been varied.

Cancellation of designations

101

(1) NHS England may at any time cancel—

(a) any of its designations, including designations it has varied, under regulation 99; and

(b) any of the designations of Primary Care Trusts, including their varied designations, under regulation 4 of the 2006 Regulations (designation of priority neighbourhoods or premises).

(2) NHS England must cancel a designation—

(a) if required to do so by a direction given by the Secretary of State under section 168A of the 2006 Act (exercise of functions);

(b) within 12 months of the date of the decision to make the designation, disregarding any subsequent decision to vary the designation, if in the case of designation for a proposed LPS scheme, no proposal to enter into an LPS scheme has been received by NHS England (or before the appointed day by a Primary Care Trust) for approval;

(c) if, in the case of a designation for a proposed LPS scheme, the only (or only remaining) proposal to enter into an LPS scheme that relates to the designation has been refused;

(d) if there has been a significant change to the area in which, or to the premises at or from which, LP services are to be provided, other than a change which leads to a variation of the designation under regulation 99(5); or

(e) if or when an LPS contractor commences the provision of LP services at or from the designated location.

(3) NHS England must give notice of the cancellation to the persons who would have been notified under regulation 99(6)(b) if the designation had instead been varied.

(4) If a designation has been cancelled under this regulation or regulation 6 of the 2006 Regulations (cancellation of designations by a Primary Care Trust), NHS England may only designate the same area, premises or description of premises under regulation 99 within 6 months of that cancellation if the reason for the cancellation was the refusal by NHS England or a Primary Care Trust of a proposal to enter into an LPS scheme.

Terms of service for LPS schemes: general

102

(1) Each LPS scheme must specify—

(a) the LP services to be provided under the scheme, which must include the dispensing of drugs; and

(b) the address of the premises at or from which those services are to be provided (“the scheme premises”).

(2) If the provider of services under an LPS scheme is a health service body, the scheme must state that it is an NHS contract.

(3) Each LPS scheme must contain the terms, or terms which make provision that has the same effect as the terms, set out in Schedule 7.

LPS schemes: health service body status

103

(1) Subject to paragraph (3), an LPS contractor (C) is to be treated as a health service body for the purposes of section 9 of the 2006 Act (NHS contracts) unless—

(a) as regards an LPS scheme established by a Primary Care Trust before the appointed day, either—

(i) before the LPS scheme was entered into, the proposed provider (or providers) under the scheme objected to that by a notice in writing to the Primary Care Trust, or

(ii) before the appointed day, the LPS scheme was varied under regulation 10(4) of the 2006 Regulations (health service body status), as a consequence of which the scheme ceased to be treated as an NHS contract; or

(b) before the LPS scheme is entered into, the proposed provider (or providers) under the scheme object to that by a notice in writing to NHS England.

(2) Where C is to be treated as a health service body for the purposes of section 9 of the 2006 Act, subject to paragraph (3), any variation of the LPS scheme which changes a party to the scheme does not affect the health service body status of the provider (or providers) of goods and services under the scheme.

(3) C may at any time request a variation of an LPS scheme so as to provide that the scheme is to become, or is to cease to be, an NHS contract, and if C does so—

(a) if—

(i) C is the only other party to the scheme, NHS England must agree to the variation, or

(ii) if all the parties to the scheme other than NHS England are together making the request, NHS England must agree to the variation; and

(b) the procedure in paragraph 26 of Schedule 7 is to apply.

(4) Where, pursuant to paragraph (3), NHS England agrees to a variation of an LPS scheme, C is (as the case may be)—

(a) to be treated as a health service body; or

(b) subject to paragraph (6), to cease to be treated as a health service body,

for the purposes of section 9 of the 2006 Act from the date on which the variation takes effect.

(5) Subject to paragraph (6), a person who has been both a provider under an LPS scheme and treated as a health service body for the purposes of that scheme is to cease to be treated as a health service body for the purposes of that scheme where—

(a) the scheme is varied so that person is no longer a provider under that scheme; or

(b) the scheme, or the agreement that is part of the scheme to which that person is a party, is terminated.

(6) Where a person ceases to be treated as a health service body pursuant to—

(a) paragraph (4)(b), where C or NHS England—

(i) has referred any matter to the NHS dispute resolution procedure before C ceases to be a health service body, or

(ii) refers any matter to the NHS dispute resolution procedure, in accordance with paragraph 21(1)(a) of Schedule 7, after C ceases to be a health service body,

C is to continue to be treated as a health service body (and accordingly the scheme or agreement is to continue to be regarded as an NHS contract) for the purposes of the consideration and determination of the dispute;

(b) paragraph (5)(b), C is to continue to be treated as a health service body for the purposes of the resolution of any dispute that falls to be resolved in accordance with the terms of the terminated agreement or scheme notwithstanding its termination.

Development of LPS schemes

104

(1) NHS England may make payments of financial assistance in respect of the development of LPS schemes.

(2) If a proposal for an LPS scheme is submitted to NHS England, it must consider whether or not to select that proposal for development, unless the proposal is vexatious or frivolous.

Persons permitted to be parties to LPS schemes: fitness criteria

105

(1) NHS England may only be a party to an LPS scheme with the following—

(a) an individual who does not fall within paragraph (2);

(b) a partnership (other than a limited liability partnership) where each partner does not fall within paragraph (2);

(i) the body corporate, and

(ii) any director, chief executive, superintendent or company secretary of the body corporate,

do not fall within paragraph (2).

(2) A person (P) falls within this paragraph if—

(a) P is the subject of a national disqualification;

(b) Subject to paragraph (3), P is disqualified or suspended (other than by an interim suspension order or a direction pending investigation) from practising by a licensing or regulatory body anywhere in the world;

(c) P has, within 5 years of the date on which either P would be due to start participating in the LPS scheme, or (if earlier) commits to participating in the scheme, been refused admission to a relevant list for a reason that amounts to inefficiency, fraud or unsuitability (as understood by reference to the conditions in section 151(2) to (4) of the 2006 Act) (disqualification of practitioners), unless P has subsequently been included in a relevant list;

(d) P has been convicted in the United Kingdom of murder;

(e) P has been convicted in the United Kingdom of a criminal offence other than murder—

(i) which was committed on or after 1st April 2006, and

(ii) for which P has been sentenced to a term of imprisonment of over 6 months;

(f) subject to paragraph (4), P has elsewhere than the United Kingdom been convicted of an offence which, if committed in England or Wales—

(i) would constitute murder, or

(ii) would constitute a criminal offence, and

(aa) which was committed on or after 1st April 2006, and

(bb) for which P has been sentenced to a term of imprisonment of over 6 months;

(g) P has been convicted of an offence referred to in—

(i) Schedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of the Act apply), or

(ii) Schedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply),

which was committed on or after 1st April 2006;

(h) P—

(i) has been made bankrupt and has not been discharged from the bankruptcy,

(ii) is a person in relation to whom a moratorium period under a debt relief order under Part 7A of the Insolvency Act 1986 (debt relief orders) applies,

(iii) is the subject of a bankruptcy restrictions order, an interim bankruptcy restrictions order, a debt relief restrictions order or an interim debt relief restrictions order under Schedule 4A or 4ZB to the Insolvency Act 1986 or Schedule 2A of the Insolvency (Northern Ireland) Order 1989 (which relate to bankruptcy and debt relief restrictions orders and undertakings),

(iv) if P is a body corporate, has been wound up under Part 4 of the Insolvency Act 1986;

(v) has made a composition or arrangement with, or granted a trust deed for, P's creditors and P has not been discharged in respect of it;

(i) in respect of P there is—

(i) an administrator, administrative receiver or receiver appointed, or

(ii) an administration order under Schedule B1 to the Insolvency Act 1986 (administration);

(j) P has, within 5 years of the date on which either P would be due to start participating in the LPS scheme or (if earlier) commits to participating in the scheme, been removed—

(i) from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners, the Charity Commission, the Charity Commission for Northern Ireland or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity—

(aa) for which the person was responsible or to which the person was privy, or

(bb) which the person by their conduct contributed to or facilitated, or

(ii) under—

(aa) section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (powers of Court of Session to deal with management of charities), or

(bb) section 34(5)(e) or (ea) of the Charities and Trustee Investment (Scotland) Act 2005 (powers of the Court of Session),

from being concerned with the management or control of any body;

(k) P has, within 5 years of the date on which either P would be due to start participating in the LPS scheme or (if earlier) commits to participating in the scheme, been subject to—

(i) a disqualification order or disqualification undertaking under the Company Directors Disqualification Act 1986 or the Company Directors Disqualification (Northern Ireland) Order 2002 , or

(ii) an order made under section 429(2) of the Insolvency Act 1986 (disabilities on revocation of a county court administration order); or

(l) P has, in the case of an individual, refused to comply with a request from NHS England for P to be medically examined on the grounds that NHS England is concerned that P is incapable of adequately providing services under the scheme.

(3) A person does not fall within paragraph (2)(b) if NHS England is satisfied that the disqualification or suspension imposed by a licensing or regulatory body outside the United Kingdom does not make P unsuitable to be—

(a) a party to an LPS scheme; or

(b) in the case of an LPS scheme made with a body corporate, a director, chief executive, superintendent or company secretary of a party to an LPS scheme.

(4) A person does not fall within paragraph (2)(f) where NHS England is satisfied that the conviction does not make P unsuitable to be—

(a) a party to an LPS scheme; or

(b) in the case of an LPS scheme with a body corporate, a director, chief executive, superintendent or company secretary of a party to an LPS scheme.

LPS proposals: fitness information to be supplied

106

(1) A person (P) proposing to become a party to an LPS scheme with NHS England must supply to NHS England, with their proposal, the information listed in paragraph (2) about the following relevant persons—

(a) if P is an individual, about P;

(b) if P a partnership, about each partner;

(i) the body corporate, and

(ii) any director, chief executive, superintendent or company secretary of the body corporate.

(2) That information is whether a relevant person (R)—

(a) has any criminal convictions in the United Kingdom;

(b) has accepted a police caution in the United Kingdom;

(c) has been convicted elsewhere than in the United Kingdom of an offence which would, if committed in England or Wales, constitute a criminal offence;

(d) has been subject to an order under section 246(2) or (3) of the Criminal Procedure (Scotland) Act 1995 (admonition and absolute discharge) discharging R absolutely;

(e) has accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal);

(f) has agreed to pay a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution);

(g) is the subject of any proceedings which might lead to a conviction and which have not yet been notified to NHS England;

(h) has been subject to any investigation into R's professional conduct by a licensing or regulatory body, the outcome of which was adverse;

(i) is, to R's knowledge, the subject of an investigation into R's professional conduct by a licensing or regulatory body;

(j) is, to R's knowledge, or where the outcome was adverse has been, the subject of an investigation into R's professional conduct in respect of any current or previous employment;

(k) is, to R's knowledge, the subject of an investigation by another primary care organisation, which might lead to removal from a relevant list;

(l) is, to R's knowledge, or where the outcome was adverse has been, the subject of an investigation by the NHS CFA in relation to fraud;

(m) on fitness grounds—

(i) has had an application for inclusion in a relevant list refused,

(ii) has been conditionally included in a relevant list,

(iii) has been removed or contingently removed from a relevant list,

(iv) is suspended from a relevant list,

and if so, the name of the relevant primary care organisation; or

(n) is or ever has been the subject of a national disqualification,

and if so, P must give details of the relevant investigation or proceedings, including the nature of the investigation or proceedings, where and when (if known) they took place, and any outcome.

(3) If information mentioned in paragraph (2) has already been provided to NHS England on a previous occasion pursuant to regulations under Part 7 of the 2006 Act, P need not provide that information again to NHS England, but if P is relying on this paragraph, P must, when supplying their proposal—

(a) confirm to NHS England that NHS England already has all the information required under paragraph (2); or

(b) if there is any missing information required under that paragraph—

(i) confirm to NHS England what information NHS England already has, and

(ii) provide the missing information.

(4) If NHS England determines that P may not become a party to the LPS scheme by virtue of regulation 105, NHS England must notify P of its determination, the reasons for its determination, and of P's right of appeal under paragraph (5).

(5) P may appeal against a determination mentioned in paragraph (4) to the First-Tier Tribunal, provided P does so within 30 days of the date on which P was notified of the determination.

Notification of proposals

107

If NHS England decides to select a proposal for an LPS scheme for development, it must give notice of that decision and provide such details of the proposed LPS scheme as it considers appropriate to—

(a) the HWB (HWB1) for the area in which are situated the premises at or from which local pharmaceutical services are to be provided under the proposal;

(b) any Local Pharmaceutical Committee for the area in which are situated the premises at or from which local pharmaceutical services are to be provided under the proposal;

(c) any Local Medical Committee for the area in which are situated the premises at or from which local pharmaceutical services are to be provided under the proposal;

(d) any NHS chemist whose listed chemist premises—

(i) are in the area of HWB1, or

(ii) are in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the proposal;

(e) any person who is entitled because of the grant of a routine or excepted application to be included in a pharmaceutical list—

(i) for the area of HWB1, or

(ii) for the area of a neighbouring HWB, if their interests are likely, in the opinion of NHS England, to be affected by the proposal,

but who is not (yet) included;

(f) any LPS chemist whose scheme premises—

(i) are in the area of HWB1, or

(ii) are in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the proposal;

(g) any dispensing doctor whose listed dispensing premises—

(i) are in the area of HWB1, or

(ii) are in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the proposal; and

(h) any Local Healthwatch organisation for the area of HWB1.

Right of return to pharmaceutical lists: LPS contractors

108

(1) Before NHS England becomes a party to an LPS scheme with any person, it must determine whether that person is to be given a right of return to a pharmaceutical list if that person makes an application under regulation 28 and satisfies the conditions for a grant of an application under that regulation.

(2) If an LPS scheme is varied so as to—

(a) relocate the provision of local pharmaceutical services under the scheme to different scheme premises; or

(b) change a party (other than NHS England) to the scheme,

NHS England must review any right of return granted under this regulation or regulation 15 of the 2006 Regulations (right of return to pharmaceutical lists) arising under that scheme in order to determine whether or not the right of return is to be varied or rescinded.

(3) If an LPS scheme is varied as mentioned in paragraph (2)(b), the right of return of the person who is no longer a party to the LPS scheme is extinguished (whether or not the right of return is maintained in respect of the new provider under the LPS scheme).

(4) NHS England may review any right of return granted under this regulation or regulation 15 of the 2006 Regulations (right of return to pharmaceutical lists) in order to determine whether or not the right of return is to be varied or rescinded—

(a) at any time an LPS scheme is varied other than in order to give effect to an amendment to these Regulations (in addition to those occasions on which it is required to review a right of return under paragraph (2)); or

(b) if asked to do so by an LPS contractor.

(5) NHS England must publish the principles by reference to which it makes determinations under this regulation and may amend those principles from time to time.

(6) Where NHS England makes, varies or rescinds a determination under this regulation, it must give notice of that decision to—

(a) the HWB (HWB1) for the area in which are situated the scheme premises for the relevant LPS scheme;

(b) any Local Pharmaceutical Committee for the area in which are situated the scheme premises for the relevant LPS scheme;

(d) any NHS chemist whose listed chemist premises—

(i) are in the area of HWB1, or

(ii) are in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the decision;

(e) any person who is entitled because of the grant of a routine or excepted application to be included in a pharmaceutical list—

(i) for the area of HWB1, or

(ii) for the area of a neighbouring HWB, if their interests are likely, in the opinion of NHS England, to be affected by the decision,

but who is not (yet) included;

(f) any LPS chemist whose scheme premises—

(i) are in the area of HWB1, or

(ii) are in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the decision;

(g) any dispensing doctor whose listed dispensing premises—

(i) are in the area of HWB1, or

(ii) are in the area of a neighbouring HWB and whose interests are likely, in the opinion of NHS England, to be affected by the decision; and

(h) any Local Healthwatch organisation for the area of HWB1.

LPS pilot schemes: health service body status

109

(1) Where a provider (P) of piloted services under an LPS pilot scheme is or has become a health service body for the purposes of section 9 of the 2006 Act (NHS contracts), subject to paragraph (2), any variation of the LPS pilot scheme which changes a party to the scheme does not affect the health service body status of the provider of piloted services under that scheme.

(2) If P is a health service body for the purposes of an LPS pilot scheme, P may at any time request a variation by NHS England of the scheme so as to provide that the scheme is to cease to be an NHS contract, and if P does—

(a) NHS England must agree to the variation; and

(b) subject to paragraph (4), P is to cease to be a health service body for the purposes of section 9 of the 2006 Act from the date on which the variation takes effect.

(3) Subject to paragraph (4), a person who has been both the provider of piloted services under an LPS pilot scheme and a health service body for the purposes of that scheme is to cease to be a health service body for the purposes of that scheme where the scheme—

(a) is varied so that person is no longer the provider of piloted services under that scheme; or

(b) is terminated.

(4) Where a person ceases to be a health service body for the purposes of an LPS pilot scheme agreement pursuant to—

(a) paragraph (2)(b), where P or NHS England—

(i) has referred any matter to the NHS dispute resolution procedure before P ceases to be a health service body, or

(ii) refers any matter to the NHS dispute resolution procedure, in accordance with the terms of the scheme, after it ceases to be a health service body,

P is to continue to be regarded as a health service body (and accordingly the scheme is to continue to be regarded as an NHS contract) for the purposes of the consideration and determination of the dispute;

(b) paragraph (3)(b), P is to continue to be a health service body for the purposes of the resolution of any dispute that falls to be resolved in accordance with the terms of the terminated scheme notwithstanding its termination.

(5) Piloted services and pharmaceutical services must not be provided at or from the same premises.

LPS pilot schemes: termination

110

On the date (D1) on which an LPS pilot scheme terminates because of a term of that scheme provided for in directions under section 138 of, or paragraph 7(1) of Schedule 11 to, the 2006 Act (which relate to terms of LPS pilot schemes) which requires that the scheme is to terminate—

(a) for a reason that relates to the fitness of P to be a provider of piloted services, P does not have a right of return to a pharmaceutical list; or

(b) either—

(i) because listed chemist premises, other than distance selling premises, of an NHS pharmacist have opened less than a kilometre by the nearest practical route available to the public on foot from the premises specified in the LPS pilot scheme,

(ii) for a reason relating to the requisite amount of items dispensed at those premises during a financial year,

(iii) because NHS England (or before it the Primary Care Trust that was party to the scheme) or P has given the other party to the scheme a period of notice of not less than 6 months of their intention to terminate the scheme, or

(iv) because all LPS pilot schemes terminate on that date,

NHS England must include those premises, and if P is not already so included P, in the pharmaceutical list for the area of the HWB in which the premises are situated with effect from D1.

Emergencies requiring the flexible provision of local pharmaceutical services

111

(1) Nothing in these Regulations prevents NHS England from making a temporary amendment to an LPS scheme or an LPS pilot scheme which NHS England is satisfied is necessary or expedient because of an emergency requiring the flexible provision of pharmaceutical services.

(2) In the circumstances described in paragraph (1), NHS England may make a temporary variation to an LPS scheme or an LPS pilot scheme, but—

(a) only for a specified period (which must be no longer than the specified period of the emergency given by the Secretary of State), which NHS England may extend or curtail in appropriate circumstances; and

(b) the provider under the scheme may revert to their overridden arrangements before the end of the period specified by NHS England, on giving NHS England at least 24 hours notice.

(3) There is no right of appeal under these Regulations in respect of a decision to make or not to make, or to extend or curtail the duration of, a temporary amendment under this regulation.

112

Where NHS England has concerns about the fitness of an LPS chemist, or a pharmacist or pharmacy technician employed by an LPS chemist, to provide local pharmaceutical services, it must where appropriate pass on those concerns and any relevant supporting evidence to the General Pharmaceutical Council.

Directions to the First-tier Tribunal relating to local pharmaceutical services

113

(1) The Secretary of State directs the First-tier Tribunal to exercise the functions of the Secretary of State under the terms of an LPS scheme which—

(a) give effect to paragraphs 21, 22 and 29 of Schedule 7; and

(b) relate to the determination of appeals to the Secretary of State, but only in so far as those functions require a determination by the Secretary of State—

(i) as to whether a person falls within paragraph 29(2) of Schedule 7 during the existence of the scheme, or

(ii) in respect of a decision by NHS England under paragraph 29(3) or (4) of Schedule 7.

(2) The Secretary of State directs the First-tier Tribunal to exercise the functions of the Secretary of State under the terms of an LPS pilot scheme that relate to the determination of appeals to the Secretary of State, but only in so far as those functions require a determination by the Secretary of State in respect of the fitness of a provider of piloted services to be a provider of piloted services.

Lists of LPS chemists

114

(1) In respect of the area of each HWB, NHS England must prepare, maintain and publish a list of the LPS chemists (if there are any) who provide local pharmaceutical services at or from premises situated in that area.

(2) The lists must include—

(a) the addresses of the premises at or from which the local pharmaceutical services are provided;

(b) the days on which and times at which, at or from those premises, the LPS chemist is to provide those services;

(3) NHS England must ensure that each HWB has access to the lists of LPS chemists that it holds which is sufficient to enable the HWB to carry out its functions under these Regulations.

PART 14 — Miscellaneous

Notification by the NHSCB of changes to its lists

115

Where, in accordance with the provisions of these Regulations, or the 2012 Regulations or the 2005 Regulations as they continue to have effect by virtue of Schedule 9, or the 2006 Act, NHS England—

(a) removes a person from a pharmaceutical list, dispensing doctor list or list of LPS chemists; or

(b) removes the listing of premises in relation to a person on a pharmaceutical list or dispensing doctor list,

it must notify the person of the change to its list that has taken place.

Authorised persons to apply for services

116

An application to an NHS chemist for pharmaceutical services, or an application to an LPS chemist for local pharmaceutical services, may be made (other than by the chemist concerned)—

(a) on behalf of a child by either parent, or in the absence of both parents, the guardian or other person who has care of the child;

(b) on behalf of any person, other than a child under the age of 18 years of age who is—

(i) in the care of an authority to whose care that person has been committed under the Children Act 1989 , by a person duly authorised by that authority, or

(ii) in the care of a voluntary organisation, by that organisation or a person duly authorised by them;

(c) on behalf of any adult who is incapable of making such an application or authorising such an application to be made on their behalf, by a relative or the primary carer (who may be an adult or an organisation) of that person; or

(d) on behalf of any other person by a duly authorised person.

Functions of the Secretary of State to be exercised by the NHS Litigation Authority

117

(1) The NHS Litigation Authority must exercise the following functions of the Secretary of State—

(a) the functions relating to receiving and determining any appeal in relation to which Schedule 3 has effect, including all of the functions of the Secretary of State under that Schedule (which include determining whether certain persons have rights of appeal);

(b) the functions relating to being contacted about, and providing, information under—

(i) regulation 33(2),

(ii) regulation 86(2), and

(iii) paragraph 23(1)(b) of Schedule 2;

(d) the function of receiving notifications under regulation 88(2)(a);

(e) the functions relating to receiving and determining an appeal under—

(i) paragraph 25(7) to (9) of Schedule 4,

(ii) paragraph 26(9) to (11) of Schedule 4,

(iii) paragraph 15(7) to (9) of Schedule 5, and

(iv) paragraph 16(9) to (11) of Schedule 5;

(f) subject to paragraph (2), the functions under the terms of LPS schemes that give effect to the following provisions—

(i) paragraph 21 of Schedule 7,

(ii) paragraph 22 of Schedule 7, and

(iii) paragraph 23 of Schedule 7;

(g) the functions under the terms of LPS pilot schemes which relate to receiving and determining appeals by providers of piloted services with regard to the determination of premises opening hours;

(h) subject to paragraph (2), the functions under the terms of LPS pilot schemes which relate to dispute resolution; and

(i) the functions relating to—

(i) receiving and determining any appeal which, by virtue of Schedule 9, the Secretary of State is required to determine, and

(ii) dispute resolution which, by virtue of Schedule 9, the Secretary of State is required to perform,

under the 2005 Regulations, the 2012 Regulations or the terms of an LPS scheme, including the incidental functions of the Secretary of State relating to such appeals or dispute resolution (for example, determining whether certain persons have rights of appeal and applying the continuity principles as appropriate).

(2) The NHS Litigation Authority must not, pursuant to paragraph (1)(f) or (h), exercise the Secretary of State's functions that the First-tier Tribunal is required to exercise by virtue of regulation 113.

(3) The NHS Litigation Authority is to exercise the powers of the Secretary of State under section 2 of the 2006 Act (Secretary of State's general power) to do anything that is calculated to facilitate, or is conducive or incidental to, the discharge of any function of the Secretary of State that the NHS Litigation Authority is exercising by virtue of paragraph (1), but only to the extent that it is necessary for the proper exercise of that function.

Proceedings relating to overridden arrangements

118

Where, during an emergency requiring the flexible provision of pharmaceutical services, or a period specified under regulation 29(3), 61(6) or 111(2), arrangements for the provision of pharmaceutical services or local pharmaceutical services are overridden by temporary arrangements—

(a) any proceedings with regard to the overridden arrangements are unaffected by that overriding (although they may need to be stayed during the emergency or the specified period for other reasons); and

(b) if as a result of those proceedings the overridden arrangements require amendment before the end of the temporary arrangements, when the emergency or the specified period ends, the reversion to overridden arrangements is to be to the original overridden arrangements as amended as a result of those proceedings.

Transitional provisions

119

The transitional provisions set out in Schedule 9 have effect.

Amendments and revocations

120

The amendments to and revocations of enactments set out in Schedule 10 have effect.

Review of these Regulations

121

(1) The Secretary of State must, in accordance with paragraphs (2) to (4)—

(a) carry out reviews of these Regulations;

(b) set out the conclusions of each review in a report; and

(2) Each report must in particular—

(a) set out the objectives intended to be achieved by these Regulations;

(b) assess the extent to which those objectives have been achieved;

(d) if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.

(3) The first report under this regulation must be published before the end of 31st March 2018.

(4) Each subsequent report must be published before the end of the period of five years beginning on the day on which the previous report was published.

SCHEDULE 1 — Information to be contained in pharmaceutical needs assessments

Necessary services: current provision

1

A statement of the pharmaceutical services that the HWB has identified as services that are provided—

(a) in the area of the HWB and which are necessary to meet the need for pharmaceutical services in its area; and

(b) outside the area of the HWB but which nevertheless contribute towards meeting the need for pharmaceutical services in its area (if the HWB has identified such services).

Necessary services: gaps in provision

2

A statement of the pharmaceutical services that the HWB has identified (if it has) as services that are not provided in the area of the HWB but which the HWB is satisfied—

(a) need to be provided (whether or not they are located in the area of the HWB) in order to meet a current need for pharmaceutical services, or pharmaceutical services of a specified type, in its area;

(b) will, in specified future circumstances, need to be provided (whether or not they are located in the area of the HWB) in order to meet a future need for pharmaceutical services, or pharmaceutical services of a specified type, in its area.

Other relevant services: current provision

3

A statement of the pharmaceutical services that the HWB has identified (if it has) as services that are provided—

(a) in the area of the HWB and which, although they are not necessary to meet the need for pharmaceutical services in its area, nevertheless have secured improvements, or better access, to pharmaceutical services in its area;

(b) outside the area of the HWB and which, although they do not contribute towards meeting the need for pharmaceutical services in its area, nevertheless have secured improvements, or better access, to pharmaceutical services in its area;

(c) in or outside the area of the HWB and, whilst not being services of the types described in sub-paragraph (a) or (b), or paragraph 1, they nevertheless affect the assessment by the HWB of the need for pharmaceutical services in its area.

Improvements and better access: gaps in provision

4

A statement of the pharmaceutical services that the HWB has identified (if it has) as services that are not provided in the area of the HWB but which the HWB is satisfied—

(a) would, if they were provided (whether or not they were located in the area of the HWB), secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area,

(b) would, if in specified future circumstances they were provided (whether or not they were located in the area of the HWB), secure future improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area.

Other NHS services

5

A statement of any NHS services provided or arranged by a local authority, NHS England, an integrated care board, an NHS trust or an NHS foundation trust to which the HWB has had regard in its assessment, which affect—

(a) the need for pharmaceutical services, or pharmaceutical services of a specified type, in its area; or

(b) whether further provision of pharmaceutical services in its area would secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in its area.

How the assessment was carried out

6

An explanation of how the assessment has been carried out, and in particular—

(a) how it has determined what are the localities in its area;

(b) how it has taken into account (where applicable)—

(i) the different needs of different localities in its area, and

(ii) the different needs of people in its area who share a protected characteristic; and

Map of provision

7

A map that identifies the premises at or from which pharmaceutical services are provided in the area of the HWB.

SCHEDULE 2 — Applications in respect of pharmaceutical lists and the procedures to be followed

PART 1 — Information to be included in routine and excepted applications

Information to be included in all routine and excepted applications

1

(1) The information mentioned below in this paragraph must be included in all routine and excepted applications.

(2) The name of the relevant HWB.

(3) The type of application being made (for example, the application is for inclusion in a pharmaceutical list and a change of ownership application), including a statement of whether the application is a routine or an excepted application.

(4) The name and address of the applicant (A).

(5) If A is an individual or a partnership carrying on a retail pharmacy business, A or each partner's registration number in the GPhC register.

(6) If A is a body corporate carrying on a retail pharmacy business, the name and registration number in the GPhC register of A's superintendent.

(7) If A is seeking the listing of premises not already listed in relation to A (whether or not A is already listed)—

(a) either—

(i) the address of the premises, or

(ii) if the address is not known and it is a routine application, A's best estimate of where the proposed premises will be;

(b) whether the applicant is currently in possession of the premises;

(d) the total proposed opening hours for the premises (having regard to both the proposed core opening hours and any supplementary opening hours).

(8) If A is seeking to provide directed services—

(a) details of the directed services to be provided;

(b) confirmation that A is accredited to provide the services, where that accreditation is a prerequisite for the provision of those services;

(c) confirmation that the premises are accredited in respect of the provision of the services, where that accreditation is a prerequisite for the provision of those services; and

(d) a floor plan showing the consultation area where A proposes to offer directed services (where relevant, unless one cannot be provided for reasons that are good cause).

(9) A is not entitled to ask for a routine application to be considered, in the alternative, as an excepted application, or for an excepted application to be considered, in the alternative, as a routine application.

(10) An estimate of the location of premises is only a “best estimate” for the purposes of sub-paragraph (7)(a)(ii) if NHS England is satisfied that—

(a) it is the best estimate that A can reasonably make at the time of the application of the location of the premises; and

(b) its reasons for granting or refusing the application would be essentially the same if the applicant located, if the application was granted, at any location within the range of possible locations covered by the estimate.

Information to be included in all routine and excepted applications for inclusion in a pharmaceutical list

2

(1) The information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list.

(2) If the applicant (A) is an individual or a partnership—

(a) A's or each partner's full name;

(b) A's or each partner's sex;

(d) A's or each partner's private address and telephone number;

(e) a declaration that A or each partner is a registered pharmacist, if A is seeking entry in the list mentioned in regulation 10(2)(a);

(f) if A is a partnership, a declaration that A is, or is entitled to be, lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act (general provisions), if A is seeking entry in the list mentioned in regulation 10(2)(a); and

(g) if A is already included in Part 3 of the GPhC register in respect of any premises, A's registration number in that Part of the GPhC register, if A is seeking entry in the list mentioned in regulation 10(2)(a).

(3) If A is a body corporate—

(a) A's registered name and any other name under which A trades;

(b) A's company registration number;

(d) the private address and date of birth of A's superintendent (if A is seeking entry in the list mentioned in regulation 10(2)(a));

(e) the name and date of birth of each director of A (who is not A's superintendent), and if any director of A (who is not A's superintendent) is a registered pharmacist, that director's registration number in the GPhC register;

(f) a declaration that A is, or is entitled to be, lawfully conducting a retail pharmacy business in accordance with section 69 of the 1968 Act, if A is seeking entry in the list mentioned in regulation 10(2)(a); and

(g) if A is already included in Part 3 of the GPhC register in respect of any premises, A's registration number in that Part of the GPhC register, if A is seeking entry in the list mentioned in regulation 10(2)(a).

(4) If the services that A undertakes to provide consists of or includes the supply of appliances, the appliances A undertakes to supply.

Fitness information about individuals: routine and excepted applications for inclusion in a pharmaceutical list

3

(1) Subject to paragraph 5, the information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list, as regards any person (P) who is—

(a) the individual who is making the application;

(b) a partner in the partnership that is making the application; or

(c) a director or (if A is seeking entry in the list mentioned in regulation 10(2)(a)) superintendent of the body corporate that is making the application.

(2) Details of whether P—

(a) has been convicted of any criminal offence in the United Kingdom;

(b) has been bound over following a criminal conviction in the United Kingdom;

(d) has, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging P absolutely (without proceeding to conviction); or

(e) has accepted and agreed to pay either a procurator fiscal fine under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal) or a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution).

(3) Details of whether P has at any time been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England (at the time of the application), could lead to a criminal conviction in England.

(4) Details of any criminal proceedings to which P is currently subject—

(a) in the United Kingdom; or

(b) elsewhere than the United Kingdom if the originating events, if they took place in England, could lead to a criminal conviction in England.

(5) If P is, to P's knowledge, or has been subject to any investigation into, or proceedings relating to, P's fitness to practise by a licensing body—

(a) if the investigation or proceedings have not yet reached their final outcome, details of that investigation or proceedings; or

(b) if the investigation or proceedings have reached a final outcome that was adverse, details of the final outcome of that investigation or proceedings.

(6) If P is, to P's knowledge, or has been subject to any investigation into, or proceedings relating to, P's professional conduct by an employer—

(a) if the investigation or proceedings have not yet reached their final outcome, details of that investigation or proceedings; or

(b) if the investigation or proceedings have reached a final outcome that was adverse, details of the final outcome of that investigation or proceedings.

(7) If P is a pharmacist, details of P's—

(a) pharmaceutical qualifications (including where obtained); and

(b) personal work history for the previous 7 years from the date on which the application is submitted, together with a declaration by P (where it can be made, in the case of sub-paragraphs (ii) and (iii)) that—

(i) the details provided are a complete and accurate account of that personal work history,

(ii) P has not been dismissed in that time, and if P cannot make this declaration, the reasons for being unable to do so must be covered in P’s personal work history,

(iii) P has not had a break of more than 6 months from work in that time, and if P cannot make this declaration, the reasons for being unable to do so must be covered in P’s personal work history, and

(iv) if P is an NHS chemist, or is a partner in or a director or superintendent of a NHS chemist, P or the NHS chemist in which P is a partner or of which P is a director or superintendent, has complied with the requirements of paragraph 31 of Schedule 4 and paragraph 21 of Schedule 5 that are applicable to P.

(8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(9) If P is, to P's knowledge, or has been subject to any investigation or proceedings that could lead or could have led to P's removal from a relevant list for a reason relating to unsuitability, fraud or efficiency of service provision, details of that investigation or those proceedings, and of any final outcome to that investigation or those proceedings.

(10) If P is, to P's knowledge, or has been where the outcome was adverse, the subject of any investigation by the NHS CFA (or any body that preceded it which had, or outside England which has, primary responsibility for investigating fraud in the health service) in relation to fraud.

(11) If P has been refused inclusion in, or conditionally included in, or contingently removed or suspended from, any relevant list for a reason relating to unsuitability, fraud or efficiency of service provision, details of same.

(12) If P is in the process of applying to be included in another relevant list and proceedings relating to the application have not yet reached their final outcome (including where an application has been deferred), details of that application and the reasons for—

(a) any deferment of that application; or

(b) refusal or conditional inclusion where the refusal or conditional inclusion has not yet reached its final outcome.

(13) If P—

(a) is the person making the application; and

(b) qualified as a pharmacist in Switzerland or an EEA State other than the United Kingdom,

details that demonstrate that P has the level of knowledge of English which, in the interests of P and the persons making use of the services to which the application relates, is necessary for the provision of those services in the area of the relevant HWB.

Fitness information about corporate bodies: routine and excepted applications for inclusion in a pharmaceutical list

4

(1) Subject to paragraph 5, the information mentioned below in this paragraph must be included in all routine and excepted applications for inclusion in a pharmaceutical list by a body corporate (C1)—

(a) as regards C1; or

(b) as regards any other body corporate (C2) of which a director or superintendent of C1—

(i) is a director or superintendent or has been a director or superintendent in the 6 months prior to the date of the application, or

(ii) has been a director or superintendent for more than 6 months prior to the date of the application, where they were a director or superintendent of C2 at the time of the originating events to which the information relates.

(2) Details of any convictions that C1 or C2 has for offences committed in the United Kingdom that are not spent convictions.

(3) Details of whether C1 or C2 (being corporate bodies registered within the United Kingdom) has at any time been convicted of an offence elsewhere than in the United Kingdom where the originating events, if they took place in England (at the time of the application), could lead to a criminal conviction in England.

(4) Details of any criminal proceedings to which C1 or C2 is currently subject—

(a) in the United Kingdom; or

(b) elsewhere than in the United Kingdom if the originating events, if they took place in England, could lead to a criminal conviction in England.

(5) Details of any investigation to which C1 or C2—

(a) is, to its knowledge, subject by the General Pharmaceutical Council in relation to an entry in Part 3 of the GPhC register; or

(b) has been subject by the General Pharmaceutical Council, the Royal Pharmaceutical Society of Great Britain or the Pharmaceutical Society of Northern Ireland in relation to an entry in the register required to be kept under section 75 of the 1968 Act (registration of premises), the outcome of which was adverse.

(6) If C1 or C2, to its knowledge, is or has been subject to any investigation or proceedings that could lead or could have led to its removal from a relevant list, details of that investigation or those proceedings, and of any final outcome to that investigation or those proceedings.

(7) If C1 or C2 is, to its knowledge, or has been where the outcome was adverse, the subject of any investigation by the NHS CFA (or any body that preceded it which had, or outside England which has, primary responsibility for investigating fraud in the health service) in relation to fraud.

(8) If C1 or C2 has been refused inclusion in, or conditionally included in (other than by reason of a condition imposed under Part 9), a relevant list, details of that refusal or conditional inclusion.

(9) If C1 or C2 is in the process of applying to be included in another relevant list and proceedings relating to the application have not yet reached their final outcome (including where an application has been deferred), details of that application and the reasons for—

(a) any deferment of that application; or

(b) any refusal or conditional inclusion, where the refusal or conditional inclusion has not yet reached its final outcome.

(10) Details of any case in which an application by C1 or C2 has lapsed by virtue of regulation 35(8).

Fitness information that has already been provided under pharmaceutical or local pharmaceutical services

5

(1) If information mentioned in paragraph 3 or 4 has already been provided to NHS England (or a home Primary Care Trust) on a previous occasion pursuant to regulations under Part 7 of the 2006 Act, an applicant need not provide that information again to NHS England in relation to the current application.

(2) An applicant relying on paragraph (1) must, when making its application—

(a) confirm to NHS England that NHS England already has all the information required under paragraphs 3 and 4; or

(b) if there is any missing information required under those paragraphs—

(i) confirm to NHS England what information NHS England already has, and

(ii) provide the missing information.

(3) Unless sub-paragraph (4) applies, information is only to be considered missing for the purposes of sub-paragraph (2)(b) if, having regard to the fact that the fitness of the applicant to be included in a pharmaceutical list has already been established (or if the applicant’s fitness is under investigation, that investigation is being taken forward separately), it is nevertheless material to the consideration of the application.

(4) Information is to be considered missing for the purposes of sub-paragraph (2)(b) if it has previously been provided to NHS England or a Primary Care Trust by the applicant, but more than 7 years prior to the date of the application.

(5) If a declaration that is required to be included in an application has never previously been provided to NHS England or has previously been provided but it is no longer up to date—

(a) an up to date declaration, together with any information that the applicant needs to provide in support of that declaration; or

(b) any information that needs to be provided because the applicant is unable to make that declaration,

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The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

Internal handling of fitness information by NHS England or an agent of NHS England

86

Review periods for national disqualifications

87

Wider notifications of fitness decisions

88

PART 12 — Remuneration, charges and refunds

The Drug Tariff and section 164: general provisions

89

Data to be provided to assist Drug Tariff determinations

90

Remuneration of NHS chemists: instruments of appointment of NHS England

91

Dispensing doctor remuneration

92

The taking effect of determinations

93

Overpayments

94

Free supply of drugs, appliances and containers where the drug or appliance is supplied under pharmaceutical services

95

Refunds of prescription charges

96

Reward scheme

97

Payments to suspended chemists

98

PART 13 — Local Pharmaceutical Services

Designation of areas, premises or descriptions of premises

99

Review of designations

100

Cancellation of designations

101

Terms of service for LPS schemes: general

102

LPS schemes: health service body status

103

Development of LPS schemes

104

Persons permitted to be parties to LPS schemes: fitness criteria

105

LPS proposals: fitness information to be supplied

106

Notification of proposals

107

Right of return to pharmaceutical lists: LPS contractors

108

LPS pilot schemes: health service body status

109

LPS pilot schemes: termination

110

Emergencies requiring the flexible provision of local pharmaceutical services

111

Sharing of information about LPS chemists and their employees with the General Pharmaceutical Council

112

Directions to the First-tier Tribunal relating to local pharmaceutical services

113

Lists of LPS chemists

114

PART 14 — Miscellaneous

Notification by the NHSCB of changes to its lists

115

Authorised persons to apply for services

116

Functions of the Secretary of State to be exercised by the NHS Litigation Authority

117

Proceedings relating to overridden arrangements

118

Transitional provisions

119

Amendments and revocations

120

Review of these Regulations

121

SCHEDULE 1 — Information to be contained in pharmaceutical needs assessments

Necessary services: current provision

1

Necessary services: gaps in provision