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

• (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.

Providing ordered drugs or appliances

Refusal to provide drugs or appliances ordered

Further activities to be carried out in connection with the provision of dispensing services

Additional requirements in relation to electronic prescribing

Further activities in connection with repeat dispensing

Home delivery service while a disease is or in anticipation of a disease being imminently pandemic etc.

Home delivery of notified items while a disease is or in anticipation of a disease being imminently pandemic etc.

Information to be provided for NHS England’s lists

Clinical governance

Professional Standards

Accessing summary care records

Electronic Prescription Service access

Contact via NHS.net Connect and the Central Alerting System

Inducements etc

Duty to provide information about fitness to practise matters as they arise

Co-operation with NHS England

Charges for drugs, appliances and containers, and ownership of containers

Refunds of prescription charges

Remuneration, overpayments etc

Local resolution of disputes

Dispute resolution: non-NHS contracts

NHS dispute resolution procedure

Determination of dispute

Disputes: supplemental

Complaints

Variation of LPS schemes

Termination by agreement

Termination by serving notice

Termination of arrangements by NHS England on grounds of suitability etc

Termination by NHS England: patient safety and material financial loss

Termination and the NHS dispute resolution procedure

Third party rights