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(1) These Regulations may be cited as the National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025.
(2) These Regulations come into force on 1st October 2025.
(3) These Regulations extend to England and Wales and apply in relation to England only .
The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 are amended as follows.
In regulation 2 (interpretation) , in paragraph (1), at the appropriate place insert—
“ NHS CFA ” means the NHS Counter Fraud Authority, established by the NHS Counter Fraud Authority (Establishment, Constitution, and Staff and Other Transfer Provisions) Order 2017 ;
In regulation 33 (refusal of applications for inclusion in a pharmaceutical list on fitness grounds) , in paragraph (2)(c)(i), for “NHS BSA” substitute “NHS CFA” .
In regulation 34 (deferral of consideration of applications for inclusion in a pharmaceutical list on fitness grounds) , in paragraph (1)—
(a) in sub-paragraph (h), for “NHS BSA” substitute “NHS CFA” ; and
(b) in sub-paragraph (i), for “NHS BSA” substitute “NHS CFA” .
In regulation 88 (wider notifications of fitness decisions) , in paragraph (2)(h), for “NHS BSA” substitute “NHS CFA” .
In regulation 106 (LPS proposals: fitness information to be supplied) , in paragraph (2)(l), for “NHS BSA” substitute “NHS CFA” .
(1) Schedule 2 (applications in respect of pharmaceutical lists and the procedures to be followed) is amended as follows.
(2) In Part 1 (information to be included in routine and excepted applications)—
(a) in paragraph 3 (fitness information about individuals: routine and excepted applications for inclusion in a pharmaceutical list) , in sub-paragraph (10), for “NHS BSA” substitute “NHS CFA” ; and
(b) in paragraph 4 (fitness information about corporate bodies: routine and excepted applications for inclusion in a pharmaceutical list) , in sub-paragraph (7), for “NHS BSA” substitute “NHS CFA” .
(3) In Part 4 (determination and deferral of applications), in paragraph 23 (additional matters for consideration in relation to applications for inclusion in a pharmaceutical list) , in sub-paragraph (1)(a), for “NHS BSA” substitute “NHS CFA” .
In Schedule 4 (terms of service of NHS pharmacists), in Part 4 (other terms of service), in paragraph 31 (duty to provide information about fitness matters as they arise) —
(a) in sub-paragraph (1)(k), for “NHS BSA” substitute “NHS CFA” ; and
(b) in sub-paragraph (2)(f), for “NHS BSA” substitute “NHS CFA” .
In Schedule 5 (terms of service of NHS appliance contractors), in paragraph 21 (duty to provide information about fitness matters as they arise) —
(a) in sub-paragraph (1)(k), for “NHS BSA” substitute “NHS CFA” ; and
(b) in sub-paragraph (2)(f), for “NHS BSA” substitute “NHS CFA” .
In Schedule 7 (mandatory terms for LPS schemes), in paragraph 15 (duty to provide information about fitness to practise matters as they arise) , in sub-paragraph (1)(j), for “NHS BSA” substitute “NHS CFA” .
In Schedule 4 (terms of service of NHS pharmacists), in Part 2 (essential services), after paragraph 7 (preliminary matters before providing ordered drugs or appliances) , insert—
Sub-contracting aspects of dispensing under “hub and spoke” arrangements
(7A)
(1) Subject to sub-paragraph (3), an NHS pharmacist (P1) must not sub-contract the performance of any of its core dispensing functions.
(2) For the purposes of this paragraph and paragraph 7B, “ core dispensing functions ” means the assembly or part-assembly of any prescription item (including bagging and the application of dispensing labels) with a view to the supply of that prescription item in accordance with a prescription, a SSP, a LPIV, a PTP or a PTPGD.
(3) Sub-paragraph (1) does not apply to—
(a) a contract for services between P1 and—
(i) a health care professional (for example, a locum) or a provider of locums, or
(ii) a corporate body that is—
(aa) is a subsidiary undertaking of P1, or
(bb) a subsidiary undertaking of a parent undertaking of which P1 is also a subsidiary undertaking,
for the performance by that health care professional, a locum provided by the provider of locums, or the corporate body of core dispensing functions at P1’s pharmacy premises;
(b) arrangements whereby a retail pharmacy business that is not P1 is nevertheless carrying on a retail pharmacy business at P1’s premises as a temporary arrangement related to the purchase of those premises; or
(c) the performance of any of P1’s core dispensing functions under valid hub and spoke arrangements.
(4) For the purposes of this paragraph and paragraphs 7B and 7C, “hub and spoke arrangements” are arrangements between P1 and another retail pharmacy business (P2) which—
(a) are for the purpose of P2 supporting P1with regard to the fulfilment of orders—
(i) submitted to P1 on prescription forms or LPIVs, or
(ii) for the provision of prescription items by P1 in accordance with PTPs or PTPGDs; and
(b) provide for the assembly or part-assembly of those orders (including in accordance with a SSP) at premises of P2 with a view to the supply of the prescription items at or from the pharmacy premises of P1 to or for the use of the patients for whom they were ordered.
(5) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 7B and 7C, P1 must—
(a) have given notice in writing to NHS England of P1’s intention to sub-contract core dispensing functions—
(i) not less than 28 days before the date on which the proposed arrangements are intended to commence, or
(ii) by a date agreed with NHS England before which the proposed arrangements are to commence; and
(b) have taken reasonable steps, before entering into the arrangements, to satisfy itself of P2’s fitness to carry out core dispensing functions on behalf of P1.
(6) A notice under sub-paragraph (5)(a) must include the particulars which have been approved by NHS England for the purposes of making such notifications.
(7) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 7B and 7C, they must have the following features—
(a) they must provide, and ensure, that any prescription item that is assembled or part-assembled under the arrangements is supplied to or for the use of the patient for whom it is dispensed at or from the pharmacy premises of P1 (and so the arrangements must not allow P2 to fulfil the order directly);
(b) in the case of an order for a medicine on a prescription form or LPIV, they must ensure that what is done, in the course of fulfilling the order, is done in a manner that ensures compliance with the requirements that are to be complied with for the supply from P2 to P1 of the medicine to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012 (assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses);
(c) in the case of orders for prescription items that are not orders for medicines on a prescription form or a LPIV (“non-regulation-222A orders”)—
(i) they must relate to fulfilling both orders for medicines on prescription forms and non-regulation-222A orders, and accordingly P1 cannot only sub-contract to P2 core dispensing functions in respect of non-regulation-222A orders, and
(ii) they must ensure that what is done, in the course of fulfilling the non-regulation-222A order, is done in a manner that would ensure compliance with the requirements that would need to be complied with for the supply from P2 to P1 of the prescription item, if it were instead of a medicine ordered on a prescription form or a LPIV, to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012;
(d) they must provide, and ensure, that P2 does not sub-contract any of the core dispensing functions that P2 performs on behalf of P1;
(e) they must provide for the discontinuation of the arrangements, as set out in paragraph 7B (in addition to any patient safety or commercial grounds P1 or P2 may have for discontinuing the arrangements); and
(f) they must not be or have become invalid by virtue of paragraph 7B.
(8) If P1 has hub and spoke arrangements in place, P1 must also have in place, as part of P1’s business continuity plan required by paragraph 29D, business continuity arrangements which ensure that P1 is able to meet all P1’s obligations to provide dispensing services in the event of any temporary or permanent discontinuation or disruption of the hub and spoke arrangements.
(9) P1 must give notice in writing to NHS England of any—
(a) temporary discontinuation of hub and spoke arrangements that amounts to a suspension of those arrangements; or
(b) permanent discontinuation of hub and spoke arrangements,
either before that discontinuation occurs or as soon as is reasonably practicable after it occurs, unless it is in response to a notice of objection from NHS England.
Objection to and discontinuation of hub and spoke arrangements
(7B)
(1) At any stage after receipt of a notice under paragraph 7A(5)(a), NHS England may request from P1 (as defined in paragraph 7A(1)) further information relating to the proposed or commenced hub and spoke arrangements that is relevant to one or more of the objection criteria, and if NHS England makes such a request, P1 must supply the requested information to NHS England promptly.
(2) For the purposes of this paragraph, the objection criteria are—
(a) the proposed or commenced hub and spoke arrangements do not have the features required by paragraph 7A(7), including where they have had them but they have lapsed;
(b) in the case of commenced hub and spoke arrangements, they have the features required by paragraph 7A(7) but there has been a breach of those requirements;
(c) the proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, the safety of any persons to whom P1 provides pharmaceutical services at serious risk;
(d) the proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, NHS England at risk of material financial loss;
(e) in the case of commenced hub and spoke arrangements, those arrangements have led to P1 repeatedly breaching P1’s terms of service, or to P1 breaching its terms of service in circumstances where P1 is likely to continue to do so repeatedly;
(f) P2’s (as defined in paragraph 7A(4)) fitness to carry out core dispensing functions is impaired; or
(g) in the opinion of NHS England, there are reasonable grounds for believing one or more of the objection criteria in paragraphs (a) to (f) are established.
(3) NHS England may, before the commencement of proposed hub and spoke arrangements, issue a notice of objection to the proposed arrangements, based on one or more of the objection criteria and if it does so—
(a) P1 must not commence the arrangements unless or until the notice of objection is withdrawn by NHS England; and
(b) any arrangements that are commenced, in breach of this sub-paragraph, are invalid.
(4) NHS England may, after the commencement of hub and spoke arrangements, issue a notice of objection to the arrangements, based on one or more of the objection criteria, and if it does so—
(a) those arrangements become invalid; and
(b) P1 must discontinue the arrangements promptly.
(5) NHS England may withdraw a notice of objection issued under sub-paragraph (4), which has the effect of the arrangements to which the notice related no longer being invalid.
(6) NHS England must, in a notice of objection, give its reasons for issuing the notice.
(7) Subject to sub-paragraph (9), before issuing a notice under sub-paragraph (4), NHS England must make every reasonable effort to communicate and co-operate with P1 with a view to resolving the matter without the notice being issued.
(8) Where P1 invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (7), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.
(9) Sub-paragraphs (7) and (8) do not apply where NHS England is satisfied—
(a) its concerns relate to a matter that has already been the subject of dispute resolution between NHS England and P1 and there are no new issues of substance to delay issuing the notice; or
(b) that it is appropriate to proceed immediately to issuing a notice—
(i) to protect the safety of any persons to whom P1 may provide pharmaceutical services, or
(ii) to protect NHS England from material financial loss.
(10) After issuing a notice of objection under sub-paragraph (3), or issuing a notice of objection under sub-paragraph (4) which was not delayed by virtue of sub-paragraph (7) or (8), NHS England must, where requested to do so by P1, make every reasonable effort to communicate and co-operate with P1 with a view to resolving the matter in a manner that may lead to the notice of objection being withdrawn.
(11) Where P1 invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (10), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.
(12) Sub-paragraphs (10) and (11) do not apply where NHS England is satisfied its concerns that led to the notice of objection being issued relate to a matter that has already been the subject of dispute resolution between NHS England and P1 and there are no new issues of substance to be resolved.
Hub and spoke arrangements: sharing of “relevant data” between different businesses
(7C)
(1) This paragraph applies to “relevant data”, which is data that relates to a patient and which is shared for the purpose of fulfilling an order under hub and spoke arrangements (as defined in paragraph 7A(4)) which is a non-regulation-222A order (as defined in paragraph 7A(7)(c)).
(2) For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc – health or social care purpose) to, the Data Protection Act 2018 , sub-paragraph (3) applies to the processing of any relevant data—
(a) by P1 or P2 (as defined in paragraph 7A(1) and (4)) which relates to a patient; and
(b) which is necessary for the purposes of—
(i) fulfilling an order of a type mentioned in paragraph 7A(4)(a) under valid hub and spoke arrangements, or
(ii) discharging any related professional obligations to the patient (including obligations relating to the keeping of records).
(3) That processing is—
(a) necessary for the performance of a task carried out in the public interest; and
(b) if the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.
(4) Any person (P3) who—
(a) is employed or engaged by P1 or P2; and
(b) in the course of being so employed or engaged is required to undertake the processing of data described in sub-paragraph (2),
owes a duty of confidentiality in respect of that data (whether or not they would do so but for this sub-paragraph).
(5) The duty in paragraph (4)—
(a) is a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); and
(b) is such that, if the processing is necessary for the purposes described in sub-paragraph (2)(b), P3 is able, lawfully, to process that data by virtue of this paragraph.
(6) For the purposes of sub-paragraph (2)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—
(a) also be an obligation that arises in some other way (for example, arising from a duty of care); or
(b) be done by a person who is not a health care professional.
(7) Sub-paragraphs (2) and (3) do not apply where, in reliance or purported reliance on valid hub and spoke arrangements, a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—
(a) the requirements to be fulfilled if what is done is to be treated as part of valid hub and spoke arrangements; or
(b) a duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in sub-paragraph (5)(a).
(8) Words and expressions used in both—
(a) sub-paragraphs (1) to (7); and
(b) Parts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,
bear the meanings they bear in those provisions of the Data Protection Act 2018.
In Schedule 6 (terms of service of dispensing doctors), after paragraph 4 (preliminary matters before providing ordered drugs or appliances) insert—
Sub-contracting aspects of dispensing under “hub and spoke” arrangements
(4ZA)
(1) For the purposes of—
(a) Part 5 of Schedule 3 to the GMS Regulations (other contractual terms – sub-contracting);
(b) Part 5 of Schedule 2 to the PMS Regulations (other required terms – subcontracting); and
(c) any contractual arrangements with an APMS practice that restrict the sub-contracting of rights or duties under the arrangements in relation to clinical matters,
core dispensing functions are clinical matters (whether or not they would be considered as such but for this sub-paragraph) and accordingly, the specific requirements in this Schedule in respect of sub-contracting those functions are in addition to the general requirements in those Schedules in respect of sub-contracting them.
(2) For the purposes of this paragraph and paragraph 4ZB, “ core dispensing functions ” means the assembly or part-assembly of any prescription item (including bagging and the application of dispensing labels) with a view to the supply of that prescription item in accordance with a prescription, an SSP, a LPIV, a PTP or a PTPGD.
(3) A dispensing doctor (and by extension a provider of primary medical services as mentioned in regulation 47(2)(b), referred to together for the purposes of this paragraph and paragraphs 4ZB and 4ZC as (D)) must not sub-contract the performance of any of its core dispensing functions, but this does not apply to—
(a) a contract for services between D and a health care professional (for example, a locum), or a provider of locums, for performance by that professional, or by locums provided by that provider of locums, personally of core dispensing functions at D’s listed dispensing premises; or
(b) the performance of any of D’s core dispensing functions under valid hub and spoke arrangements.
(4) For the purposes of this paragraph and paragraphs 4ZB and 4ZC, “hub and spoke arrangements” are arrangements between D and a retail pharmacy business (P) which—
(a) are for the purpose of P supporting D with regard to the fulfilment of orders—
(i) submitted to D on prescription forms or LPIVs, or
(ii) for the provision of prescription items by D in accordance with PTPs or PTPGDs; and
(b) provide for the assembly or part-assembly of those orders (including in accordance with an SSP) at premises of P with a view to the supply of the prescription items at or from the listed dispensing premises of D to or for the use of the patients for whom they were ordered.
(5) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 4ZB and 4ZC, any prior notification that D is required to give to NHS England or an ICB before the commencement of arrangements by virtue of which D sub-contracts the core dispensing functions must include the following particulars—
(a) the name, pharmacy premises address and General Pharmaceutical Council premises registration number of P;
(b) the duration of the proposed arrangements;
(c) a description of the core dispensing functions to be covered by arrangements; and
(d) a description of the manner in which P proposes to meet D’s obligations under the terms of service in respect of the core dispensing functions to be covered by the arrangements.
(6) For the hub and spoke arrangements to be valid for purposes of this paragraph and paragraphs 4ZB and 4ZC, if D is not otherwise (apart from by virtue of this sub-paragraph) required to give prior notification to NHS England or an ICB before the commencement of the sub-contracting of clinical services such as core dispensing functions—
(a) it must give that prior notice in the case of hub and spoke arrangements, and in a manner that puts NHS England or the ICB for its location on reasonable notice of the commencement of the arrangements; and
(b) the notification that it does give must include the particulars specified in sub-paragraph (5)((a) to (d).
(7) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 4ZB and 4ZC, they must have the following features—
(a) they must provide, and ensure, that any prescription item that is assembled or part-assembled under the arrangements is supplied to or for the use of the patient for whom it is dispensed at or from the listed dispensing premises of D (and so the arrangements must not allow P to fulfil the order directly);
(b) in the case of an order for a medicine on a prescription form or LPIV, they must ensure that what is done, in the course of fulfilling the order, is done in a manner that ensures compliance with the requirements that are to be complied with for the supply from P to D of the medicine to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012 (assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses);
(c) in the case of orders for prescription items that are not orders for medicines on a prescription form or a LPIV (“non-regulation-222A orders”)—
(i) they must relate to fulfilling both orders for medicines on prescription forms and non-regulation-222A orders, and accordingly D cannot only sub-contract to P core dispensing functions in respect of non-regulation-222A orders, and
(ii) they must ensure that what is done, in the course of fulfilling the non-regulation-222A order, is done in a manner that would ensure compliance with the requirements that would need to be complied with for the supply from P to D of the prescription item, if it were instead of a medicine ordered on a prescription form or a LPIV, to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012;
(d) they must provide, and ensure, that P does not sub-contract any of the core dispensing functions that P performs on behalf of D;
(e) they must provide for the discontinuation of the arrangements, as set out in paragraph 4ZB (in addition to any patient safety or commercial grounds D or P may have for discontinuing the arrangements); and
(f) they must not be or have become invalid by virtue of paragraph 4ZB.
(8) If D has hub and spoke arrangements in place, D must also have in place business continuity arrangements which ensure that D is able to meet all D’s obligations to provide dispensing services in the event of any temporary or permanent discontinuation or disruption of the hub and spoke arrangements.
(9) D must give notice in writing to NHS England of any—
(a) temporary discontinuation of hub and spoke arrangements that amounts to a suspension of those arrangements; or
(b) permanent discontinuation of hub and spoke arrangements,
either before that discontinuation occurs or as soon as is reasonably practicable after it occurs, unless it is in response to a notice of objection from NHS England.
Objection to and termination of hub and spoke arrangements
(4ZB)
(1) NHS England may at any time request from D (as defined in paragraph 4ZA(3)) information relating to hub and spoke arrangements that is relevant to the termination criteria (whether or not the arrangements have commenced), and if NHS England makes such a request, D must supply the requested information to NHS England promptly.
(2) For the purposes of this paragraph, the termination criteria are—
(a) the hub and spoke arrangements do not have the features required by paragraph 4ZA(7), including where they have had them but they have lapsed;
(b) the hub and spoke arrangements have the features required by paragraph 4ZA(7) but there has been a breach of those requirements;
(c) the hub and spoke arrangements put the safety of any persons to whom D provides pharmaceutical services at serious risk;
(d) the hub and spoke arrangements put NHS England at risk of material financial loss;
(e) the hub and spoke arrangements have led to D repeatedly breaching D’s terms of service, or to D breaching its terms of service in circumstances where D is likely to continue to do so repeatedly;
(f) P’s (as defined in paragraph 4ZA(4)) fitness to carry out core dispensing functions is impaired; or
(g) in the opinion of NHS England, there are reasonable grounds for believing one or more of the termination criteria in paragraphs (a) to (f) are established.
(3) NHS England may, after the commencement of hub and spoke arrangements, issue a notice of objection to the arrangements, based on one or more of the termination criteria, and if it does so—
(a) those arrangements become invalid on the termination date specified in the notice of objection; and
(b) D must discontinue the arrangements on or by the date specified in the notice for their termination.
(4) NHS England may withdraw a notice of objection issued under sub-paragraph (3), which has the effect of the arrangements to which the notice related no longer being invalid.
(5) NHS England must, in a notice of objection, give its reasons for issuing the notice.
(6) Subject to sub-paragraph (7), before issuing a notice of objection, NHS England must make every reasonable effort to communicate and co-operate with D with a view to resolving the matter without the notice being issued.
(7) Sub-paragraph (6) does not apply where NHS England is satisfied—
(a) its concerns relate to a matter that has already been the subject of dispute resolution between NHS England and D and there are no new issues of substance to delay issuing the notice; or
(b) that it is appropriate to proceed immediately to issuing a notice—
(i) to protect the safety of any persons to whom D may provide pharmaceutical services, or
(ii) to protect NHS England from material financial loss.
(8) After issuing a notice of objection, unless—
(a) it was delayed by virtue of sub-paragraph (6); or
(b) NHS England is satisfied its concerns related to a matter that has already been the subject of dispute resolution between NHS England and D and there are no new issues of substance to be resolved,
NHS England must, where requested to do so by D, make every reasonable effort to communicate and co-operate with D with a view to resolving the matter in a manner that may lead to the notice of objection being withdrawn.
Hub and spoke arrangements: sharing of “relevant data” between different businesses
(4ZC)
(1) This paragraph applies to “relevant data”, which is data that relates to a patient and which is shared for the purpose of fulfilling an order under hub and spoke arrangements (as defined in paragraph 4ZA(4)) which is a non-regulation-222A order (as defined in paragraph 4ZA(7)(c)).
(2) For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc – health or social care purpose) to, the Data Protection Act 2018 , sub-paragraph (3) applies to the processing of any relevant data—
(a) by D or P (as defined in paragraph 4ZA(3) and (4)) which relates to a patient; and
(b) which is necessary for the purposes of—
(i) fulfilling an order of a type mentioned in paragraph 4ZA(4)(a) under valid hub and spoke arrangements, or
(ii) discharging any related professional obligations to the patient (including obligations relating to the keeping of records).
(3) That processing is—
(a) necessary for the performance of a task carried out in the public interest; and
(b) if the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.
(4) Any person (X) who—
(a) is employed or engaged by D or P; and
(b) in the course of being so employed or engaged is required to undertake the processing of data described in sub-paragraph (2),
owes a duty of confidentiality in respect of that data (whether or not they would do so but for this sub-paragraph).
(5) The duty under paragraph (4)—
(a) is a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); and
(b) is such that, if the processing is necessary for the purposes described in sub-paragraph (2)(b), X is able, lawfully, to process that data by virtue of this paragraph.
(6) For the purposes of sub-paragraph (2)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—
(a) also be an obligation that arises in some other way (for example, arising from a duty of care); or
(b) be done by a person who is not a health care professional.
(7) Sub-paragraphs (2) and (3) do not apply where, in reliance or purported reliance on valid hub and spoke arrangements, a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—
(a) the requirements to be fulfilled if what is done is to be treated as part of valid hub and spoke arrangements; or
(b) a duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in sub-paragraph (5)(a).
(8) Words and expressions used in both—
(a) sub-paragraphs (1) to (7); and
(b) Parts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,
bear the meanings they bear in those provisions of the Data Protection Act 2018.
In Schedule 7 (mandatory terms for LPS schemes), after paragraph 5 (preliminary matters before providing ordered drugs or appliances) insert—
Sub-contracting aspects of dispensing under “hub and spoke” arrangements
(5A)
(1) Subject to sub-paragraph (3), an LPS contractor (C) must not sub-contract the performance of any of its core dispensing functions.
(2) For the purposes of this paragraph and paragraph 5B, “ core dispensing functions ” means the assembly or part-assembly of any prescription item (including bagging and the application of dispensing labels) with a view to the supply of that prescription item in accordance with a prescription, a SSP, a LPIV, a PTP or a PTPGD.
(3) Sub-paragraph (1) does not apply to—
(a) a contract for services between C and—
(i) a health care professional (for example, a locum) or a provider of locums, or
(ii) a corporate body that is—
(aa) a subsidiary undertaking of C, or
(bb) a subsidiary undertaking of a parent undertaking of which C is also a subsidiary undertaking,
for the performance by that health care professional, a locum provided by that provider of locums or the corporate body of core dispensing functions at C’s pharmacy premises;
(b) arrangements whereby a retail pharmacy business that is not C is nevertheless carrying on a retail pharmacy business at C’s premises as a temporary arrangement related to the purchase of those premises; or
(c) the performance of any of C’s core dispensing functions under valid hub and spoke arrangements.
(4) For the purposes of this paragraph and paragraphs 5B and 5C, “hub and spoke arrangements” are arrangements between C and a retail pharmacy business (P) which—
(a) are for the purpose of P supporting C with regard to the fulfilment of orders—
(i) submitted to C on prescription forms or LPIVs, or
(ii) for the provision of prescription items by C in accordance with PTPs or PTPGDs;
(b) provide for the assembly or part-assembly of those orders (including in accordance with an SSP) at premises of P with a view to the supply of the prescription items at or from the scheme premises of C to or for the use of the patients for whom they were ordered.
(5) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 5B and 5C, C must—
(a) have given notice in writing to NHS England of C’s intention to sub-contract core dispensing functions—
(i) not less than 28 days before the date on which the proposed arrangements are intended to commence, or
(ii) by a date agreed with NHS England on which the proposed arrangements are to commence; and
(b) have taken reasonable steps, before entering into the arrangements, to satisfy itself of P’s fitness to carry out core dispensing functions on behalf of C.
(6) A notice under sub-paragraph (5)(a) must include the particulars which have been approved by NHS England for the purposes of making such notifications.
(7) For the hub and spoke arrangements to be valid for the purposes of this paragraph and paragraphs 5B and 5C, they must have the following features—
(a) they must provide, and ensure, that any prescription item that is assembled or part-assembled under the arrangements is supplied to or for the use of the patient for whom it is dispensed at or from the scheme premises of C (and so the arrangements must not allow P to fulfil the order directly);
(b) in the case of an order for a medicine on a prescription form or LPIV, they must ensure that what is done, in the course of fulfilling the order, is done in a manner that ensures compliance with the requirements that are to be complied with for the supply from P to C of the medicine to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012 (assembly or part-assembly as part of “hub and spoke” dispensing arrangements between different businesses);
(c) in the case of orders for prescription items that are not orders for medicines on a prescription form or a LPIV (“non-regulation-222A orders”)—
(i) they must relate to fulfilling both orders for medicines on prescription forms and non-regulation-222A orders, and accordingly C cannot only sub-contract to P core dispensing functions in respect of non-regulation-222A orders, and
(ii) they must ensure that what is done, in the course of fulfilling the non-regulation-222A order, is done in a manner that would ensure compliance with the requirements that would need to be complied with for the supply from P to C of the prescription item, if it were instead of a medicine ordered on a prescription form or a LPIV, to be treated as, or as part of, a retail sale in accordance with regulation 222A(2)(a) of the Human Medicines Regulations 2012;
(d) they must provide, and ensure, that P does not sub-contract any of the core dispensing functions that P performs on behalf of C;
(e) they must provide for the discontinuation of the arrangements, as set out in paragraph 5B (in addition to any patient safety or commercial grounds C or P may have for discontinuing the arrangements); and
(f) they must not be or have become invalid by virtue of paragraph 5B.
(8) If C has hub and spoke arrangements in place, C must also have business continuity arrangements in place which ensure that C is able to meet all C’s obligations to provide dispensing services in the event of any temporary or permanent discontinuation or disruption of the hub and spoke arrangements.
(9) C must give notice in writing to NHS England of any—
(a) temporary discontinuation of hub and spoke arrangements that amounts to a suspension of those arrangements; or
(b) permanent discontinuation of hub and spoke arrangements,
either before that discontinuation occurs or as soon as is reasonably practicable after it occurs, unless it is in response to a notice of objection from NHS England.
Objection to and discontinuation of hub and spoke arrangements
(5B)
(1) At any stage after receipt of a notice under paragraph 5A(5)(a), NHS England may request from C (as defined in paragraph 5A(1)) further information relating to the proposed or commenced hub and spoke arrangements that is relevant to one or more of the objection criteria, and if NHS England makes such a request, C must supply the requested information to NHS England promptly.
(2) For the purposes of this paragraph, the objection criteria are—
(a) the proposed or commenced hub and spoke arrangements do not have the features required by paragraph 5A(7), including where they have had them but they have lapsed;
(b) in the case of commenced hub and spoke arrangements, they have the features required by paragraph 5A(7) but there has been a breach of those requirements;
(c) the proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, the safety of any persons to whom C provides pharmaceutical services at serious risk;
(d) the proposed hub and spoke arrangements would put, or the commenced hub and spoke arrangements put, NHS England at risk of material financial loss;
(e) in the case of commenced hub and spoke arrangements, those arrangements have led to C repeatedly breaching C’s terms of service, or to C breaching its terms of service in circumstances where C is likely to continue to do so repeatedly;
(f) P’s (as defined in paragraph 5A(4)) fitness to carry out core dispensing functions is impaired; or
(g) in the opinion of NHS England, there are reasonable grounds for believing one or more of the objection criteria in paragraphs (a) to (f) are established.
(3) NHS England may, before the commencement of proposed hub and spoke arrangements, issue a notice of objection to the proposed arrangements, based on one or more of the objection criteria and if it does so—
(a) C must not commence the arrangements unless or until the notice of objection is withdrawn by NHS England; and
(b) any arrangements that are commenced, in breach of this sub-paragraph, are invalid.
(4) NHS England may, after the commencement of hub and spoke arrangements, issue a notice of objection to the arrangements, based on one or more of the objection criteria, and if it does so—
(a) those arrangements become invalid; and
(b) C must discontinue the arrangements promptly.
(5) NHS England may withdraw a notice of objection issued under sub-paragraph (4), which has the effect of the arrangements to which the notice related no longer being invalid.
(6) NHS England must, in a notice of objection, give its reasons for issuing the notice.
(7) Subject to sub-paragraph (9), before issuing a notice under sub-paragraph (4), NHS England must make every reasonable effort to communicate and co-operate with C with a view to resolving the matter without the notice being issued.
(8) Where C invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (7), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.
(9) Sub-paragraphs (7) and (8) do not apply where NHS England is satisfied—
(a) its concerns relate to a matter that has already been the subject of dispute resolution between NHS England and C and there are no new issues of substance to delay issuing the notice; or
(b) that it is appropriate to proceed immediately to issuing a notice—
(i) to protect the safety of any persons to whom C may provide pharmaceutical services, or
(ii) to protect NHS England from material financial loss.
(10) After issuing a notice of objection under sub-paragraph (3), or issuing a notice of objection under sub-paragraph (4) which was not delayed by virtue of sub-paragraph (7) or (8), NHS England must, where requested to do so by C, make every reasonable effort to communicate and co-operate with C with a view to resolving the matter in a manner that may lead to the notice of objection being withdrawn.
(11) Where C invites a Local Pharmaceutical Committee to participate in the attempts to resolve the matter referred to in sub-paragraph (10), NHS England must make every reasonable effort to communicate and co-operate with the Committee in its attempts to assist in resolving the matter.
(12) Sub-paragraphs (10) and (11) do not apply where NHS England is satisfied its concerns that led to the notice of objection being issued relate to a matter that has already been the subject of dispute resolution between NHS England and there are no new issues of substance to be resolved.
Hub and spoke arrangements: sharing of “relevant data” between different businesses
(5C)
(1) This paragraph applies to “relevant data”, which is data that relates to a patient and which is shared for the purpose of fulfilling an order under hub and spoke arrangements (as defined in paragraph 5A(4)) which is a non-regulation-222A order (as defined in paragraph 5A(7)(c)).
(2) For the purposes of section 8(c) (lawfulness of processing: public interest etc) of, and paragraph 2(2)(a), (c) and (d) of Schedule 1 (special categories of personal data etc – health or social care purpose) to, the Data Protection Act 2018 , sub-paragraph (3) applies to the processing of any relevant data—
(a) by C or P (as defined in paragraph 5A(1) and (4)) which relates to a patient; and
(b) which is necessary for the purposes of—
(i) fulfilling an order of a type mentioned in paragraph 5A(4)(a) under valid hub and spoke arrangements, or
(ii) discharging any related professional obligations to the patient (including obligations relating to the keeping of records).
(3) That processing is—
(a) necessary for the performance of a task carried out in the public interest; and
(b) if the data is personal data concerning health, necessary for the purposes of preventative medicine, medical diagnosis or for the provision of health care or treatment.
(4) Any person (X) who—
(a) is employed or engaged by C or P; and
(b) in the course of being so employed or engaged is required to undertake the processing of data described in sub-paragraph (2),
owes a duty of confidentiality in respect of that data (whether or not they would do so but for this sub-paragraph).
(5) The duty under paragraph (4)—
(a) is a duty of confidentiality which, if not owed by a health care professional, is owed under an enactment or rule of law for the purposes of section 11(1)(b) of the Data Protection Act 2018 (special categories of personal data etc: supplementary); and
(b) is such that, if the processing is necessary for the purposes described in sub-paragraph (2)(b), X is able, lawfully, to process that data by virtue of this paragraph.
(6) For the purposes of sub-paragraph (2)(b)(ii), a professional obligation to a patient is to be regarded as such notwithstanding that discharging the obligation may—
(a) also be an obligation that arises in some other way (for example, arising from a duty of care); or
(b) be done by a person who is not a health care professional.
(7) Sub-paragraphs (2) and (3) do not apply where, in reliance or purported reliance on valid hub and spoke arrangements, a person processes any data which relates to a patient but, in the course of the doing of anything that relates to the fulfilling of the order to which that data relates, there is a breach of—
(a) the requirements to be fulfilled if what is done is to be treated as part of valid hub and spoke arrangements; or
(b) a duty of confidentiality owed in respect of the data by a health care professional or under an enactment or rule of law as mentioned in sub-paragraph (5)(a).
(8) Words and expressions used in both—
(a) sub-paragraphs (1) to (7); and
(b) Parts 1 and 2 (preliminary and general processing) of, and paragraphs 2(2)(a), (c) and (d) of Schedule 1 to, the Data Protection Act 2018,
bear the meanings they bear in those provisions of the Data Protection Act 2018.
(1) Regulation 2 (interpretation) , paragraph (1) is amended as follows.
(2) In the definition of “distance selling premises”, after “or potential pharmacy premises, at” insert “or from” .
(3) In the definition of “medical practice premises”—
(a) in sub-paragraph (a), after “as the practice premises” insert “at or” ; and
(b) in sub-paragraph (b), after “practice premises” insert “at or” .
(1) Regulation 10 (pharmaceutical lists) , is amended as follows.
(2) In paragraph (1), after “pharmaceutical services”, insert “at or” .
(3) In paragraph (3)—
(a) in sub-paragraph (a), after “in the area of the HWB at” insert “or from” ; and
(b) in sub-paragraph (b), after “and times at which, at” insert “or from” .
(4) In paragraph (7)(a)(ii)—
(a) in sub-paragraph (aa), after “additional premises”, insert “at or” ;
(b) in sub-paragraph (bb), after “and at”, insert “or from” ; and
(c) in sub-paragraph (cc), after “to provide,” insert “at or” .
(1) Regulation 11 (terms of service of NHS chemists: general) is amended as follows.
(2) In paragraph (1)(d)(ii), for “carrying-on of activities on” substitute “carrying-on of activities at or from” .
(3) In paragraph (2)(d)(ii), for “carrying-on of activities on” substitute “carrying-on of activities at or from” .
In regulation 12 (routine applications for inclusion in or amendments to a pharmaceutical list), in paragraph (b)—
(a) in sub-paragraph (i), after “additional premises”, insert “at or” ;
(b) in sub-paragraph (ii), after “and at”, insert “or from” ; and
(c) in sub-paragraph (iii), after “to provide,” insert “at or” .
(1) Regulation 24 (relocations that do not result in significant change to pharmaceutical services provision) is amended as follows.
(2) In paragraph (1)—
(a) in sub-paragraph (a), after “accessing pharmaceutical services at” insert “or from” ; and
(b) in sub-paragraph (d)—
(i) after “provide at”, insert “or from” , and
(ii) after “providing at”, insert “or from” .
(3) In paragraph (2)—
(a) in sub-paragraph (b), after “pharmaceutical services at”, insert “or from” ; and
(b) in sub-paragraph (e)—
(i) after “provide at” insert “or from” , and
(ii) after “providing at” insert “or from” .
(4) In paragraph (3)(b)—
(a) in paragraph (ii), after “at” insert “or from” ; and
(b) in paragraph (iii), after “at” insert “or from” .
(1) Regulation 26 (change of ownership applications) is amended as follows.
(2) In paragraph (1)—
(a) in sub-paragraph (a)—
(i) after “pharmaceutical services at” insert “or from” , and
(ii) in paragraph (ii), after “at” insert “or from” ;
(b) in sub-paragraph (b)—
(i) after “carry on at” insert “or from” , and
(ii) after “providing pharmaceutical services at” insert “or from” ; and
(c) in sub-paragraph (d), after “pharmaceutical services at” insert “or from” .
(3) In paragraph (2)—
(a) in sub-paragraph (a)—
(i) in paragraph (i), after “providing at” insert “or from” , and
(ii) in paragraph (ii)—
(aa) after “provided at” insert “or from” , and
(bb) after “pharmaceutical services at” insert “or from” ;
(b) in sub-paragraph (b), after “pharmaceutical services at” insert “or from” ;
(c) in sub-paragraph (c)—
(i) after “provided at” insert “or from” , and
(ii) after “but at” insert “or from” ; and
(d) in sub-paragraph (e)—
(i) in paragraph (i), after “being provided at” insert “or from” , and
(ii) in paragraph (ii)—
(aa) after “provided at” insert “or from” , and
(bb) after “will commence at” insert “or from” .
In regulation 26A (consolidation onto an existing site) , in paragraph (7)—
(a) in sub-paragraph (a)—
(i) after “carry on at” insert “or from” , and
(ii) after “pharmaceutical services at” insert “or from” ; and
(b) in sub-paragraph (c), after “pharmaceutical services at” insert “or from” .
In regulation 29 (temporary arrangements during emergencies or because of circumstances beyond the control of NHS chemists) —
(a) in paragraph (1)(b), after “pharmaceutical services at” insert “or from” ; and
(b) in paragraph (3)—
(i) for “at P1 at” substitute “at or from P1 at or from” , and
(ii) after “were ordinarily provided at” insert “or from” .
In regulation 31 (refusal: same or adjacent premises) , in paragraph (2)(a), after “(“the existing services”) insert “at or” .
In regulation 40 (applications for new pharmacy premises in controlled localities: refusals because of preliminary matters) , in paragraph (1)(b)(ii), after “additional pharmacy premises” insert “at or” .
In regulation 41(applications for new pharmacy premises in controlled localities: reserved locations) —
(a) in paragraph (1)(b)(ii), after “additional pharmacy premises” insert “at or” ; and
(b) in paragraph (3)(b), after “pharmaceutical services were provided at” insert “or from” .
In regulation 42 (second and subsequent determinations of reserved location status) , in paragraph (5)(b), after “pharmacy business at” insert “or from” .
In regulation 44 (prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location) , in paragraph (1)(b)(ii), after “additional pharmacy premises” insert “at or” .
In regulation 46 (dispensing doctor lists) , in paragraph (1)—
(a) in sub-paragraph (a), after “pharmaceutical services” insert “at or” ; and
(b) in sub-paragraph (b), after “pharmaceutical services” insert “at or” .
In regulation 47 (terms of service of dispensing doctors: general) , in paragraph (1)(d)(ii), for “activities on”, substitute “activities at or from” .
(1) Regulation 48 (arrangements for the provision of pharmaceutical services by doctors: applications by patients) is amended as follows.
(2) In paragraph (3)—
(a) in sub-paragraph (a)(ii), after “for the premises” insert “at or” ; and
(b) in sub-paragraph (b)(iii), after “to the premises” insert “at or” .
(3) In paragraph (5)—
(a) in sub-paragraph (a)—
(i) in paragraph (i), after “applies,” insert “at or” , and
(ii) in paragraph (ii), after “applies,” insert “at or” ; and
(b) in sub-paragraph (b)—
(i) in paragraph (i), after “applies,” insert “at or” , and
(ii) in paragraph (ii), after “applies,” insert “at or” .
In regulation 50 (discontinuation of arrangements for the provision of pharmaceutical services by doctors) , in paragraph (7)(b), after “to obtain services”, insert “at or” .
(1) Regulation 51 (outline consent and premises approval: applications by doctors) is amended as follows.
(2) In paragraph (1)(b), after “medical practice premises” insert “at or” .
(3) In paragraph (2)—
(a) in sub-paragraph (a), after “medical practice premises” insert “at or” ; and
(b) in sub-paragraph (b), after “medical practice premises” insert “at or” .
(1) Regulation 53 (decisions on outline consent and premises approval applications and the taking effect of grants) is amended as follows.
(2) In paragraph (7)—
(a) in sub-paragraph (a)(ii)(bb), after “additional premises” insert “at or” ; and
(b) in sub-paragraph (b)(i), after “of pharmaceutical services” insert “at or” .
(3) in paragraph (11), after “are provided at” insert “or from” .
(4) in paragraph (13)(b)(i), after “being provided at” insert “or from” .
In regulation 54 (premises approval: relocations of practice premises which are not significant before outline consent takes effect) , in paragraph (1), after “to change the premises” insert “at or” .
(1) Regulation 55 (premises approval: relocations of practice premises which are not significant after outline consent has taken effect) is amended as follows.
(2) In paragraph (1)—
(a) in sub-paragraph (a), after “pharmaceutical services” insert “at or” ; and
(b) at the end of the paragraph, after “medical practice premises” insert “at or” .
(3) In paragraph (2)(a), after “pharmaceutical services at” insert “or from” .
In regulation 56 (taking effect of premises approval where there is no related application for outline consent) , in paragraph (3), after “pharmaceutical services are provided at” insert “or from” .
In regulation 57 (gradual introduction of premises approval) , in paragraph (1)—
(a) after “provides pharmaceutical services” insert “at or” ; and
(b) in sub-paragraph (b), after “provide pharmaceutical services” insert “at or” .
In regulation 60 (lapse of outline consent and premises approval) , in paragraph (3)—
(a) in sub-paragraph (b), after “regulation 48 at” insert “or from” ; and
(b) in sub-paragraph (c), after “authority to dispense” insert “at or” .
In regulation 61 (temporary arrangements during emergencies or circumstances beyond the control of a dispensing doctor) —
(a) in paragraph (5), after “dispensing services at” insert “or from” ; and
(b) in paragraph (6)—
(i) for “at P1 at” substitute “at or from P1 at or from” , and
(ii) after “were ordinarily provided at” insert “or from” .
In Regulation 63 (appeals against decisions under Part 8) , in paragraph (1)(b)(ii), after “to obtain services” insert “at or” .
(1) Regulation 65 (core opening hours conditions) is amended as follows.
(2) In paragraph (4)—
(a) in sub-paragraph (a)—
(i) in paragraph (i), after “pharmaceutical services at” insert “or from” ,
(ii) in paragraph (ii), after “are to be provided at” insert “or from” , and
(iii) after “pharmaceutical services at” insert “or from” ; and
(b) in sub-paragraph (b)—
(i) in paragraph (i), after “provide pharmaceutical services at” insert “or from” ,
(ii) in paragraph (ii), after “are to be provided at” insert “or from” , and
(iii) after “is to provide pharmaceutical services at” insert “or from” .
(3) In paragraph (5)—
(a) in sub-paragraph (a), after “provide pharmaceutical services at” insert “or from” ; and
(b) in sub-paragraph (b)(ii)—
(i) in sub-paragraph (aa), after “are to be provided at” insert “or from” ,
(ii) in sub-paragraph (bb), after “are to be provided at” insert “or from” , and
(iii) after “provide pharmaceutical services at” insert “or from” .
(1) Regulation 65A (continuity in respect of opening hours directions) is amended as follows.
(2) In paragraph (3), after “being provided, but at” insert “or from” .
(3) In paragraph (4)(a), after “provide pharmaceutical services, at” insert “or from” .
(1) Regulation 66 (conditions relating to providing directed services) is amended as follows.
(2) In paragraph (1)—
(a) in sub-paragraph (a), after “those directed services at” insert “or from” ; and
(b) in sub-paragraph (b), after “those directed services at” insert “or from” .
(3) In paragraph (2)(b), after “the services be provided at” insert “or from” .
(4) In paragraph (5), after “The condition is that, at” insert “or from” .
In regulation 67 (conditions relating to voluntary closure of premises) , in paragraph (4), after “pharmaceutical services at”, at each place where it occurs (three times), insert “or from” .
In regulation 73 (removal of listings: cases relating to remedial notices and breach notices) , in paragraph (5)(a), after “provide pharmaceutical services at” insert “or from” .
In regulation 74 (removal of listings: cases relating to death, incapacity or cessation of service) , in paragraph (3), after “provided pharmaceutical services at” insert “or from” .
In regulation 75 (voluntary and automatic removal of listings: change of ownership, relocation, temporary provision and voluntary closure) , in paragraph (3), after “suspended NHS chemist at” insert “or from” .
In regulation 99 (designation of areas, premises or descriptions of premises) , in paragraph (2), after “or premises or descriptions of premises at” insert “or from” .
In regulation 101 (cancellation of designations) , in paragraph (2)—
(a) in sub-paragraph (d), after “or to the premises” insert “at or” ; and
(b) in sub-paragraph (e), after “provision of LP services at” insert “or from” .
In regulation 109 (LPS pilot schemes: health service body status) , in paragraph (5), after “must not be provided” insert “at or” .
The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025 (legislation.gov.uk, OGL v3.0). Retrieved via LawPlayer, https://lawplayer.com/uk/act/uksi-2025-989
Contains public sector information licensed under the Open Government Licence v3.0.
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