The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025

14 Amendment to Schedule 7

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. .