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The National Health Service (General Medical Services Contracts) (Scotland) Regulations 2018

Type Scottish-Statutory-Instrument

Publication 2018-02-15

Last updated 2026-03-14

State In force

Jurisdiction Scotland

Department King's Printer for Scotland

Source legislation.gov.uk

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(2) Within a period of 28 days beginning with the date of receipt of the notification referred to in sub‑paragraph (1), the Health Board must enter into discussions with the contractor concerning the support which the Health Board may give the contractor, or other changes which the Health Board or the contractor may make, which would enable the contractor to keep its list of patients open.

(3) In the discussions referred to in sub‑paragraph (2), both parties must use reasonable endeavours to achieve the aim of keeping the contractor’s list of patients open.

(4) The discussions mentioned in sub‑paragraph (2) must be completed within a period of 3 months beginning with the date of the Health Board’s receipt of the notification referred to in sub‑paragraph (1), or within such longer period as the parties may agree.

(5) Notwithstanding the requirements mentioned in sub-paragraphs (2) and (4), the contractor may issue a closure notice to the Health Board which the Health Board must approve in accordance with sub-paragraph (13) if—

(a) the period of 28 days mentioned in sub-paragraph (2) has expired and the Health Board has not begun discussions with the contractor in accordance with sub-paragraph (2); or

(b) the 3 month period or such longer period as has been agreed in accordance with sub-paragraph (4) has expired and the Health Board has failed to complete the discussions mentioned in sub-paragraph (2).

(6) If, following the discussions mentioned in sub‑paragraph (2), the Health Board and the contractor reach agreement that the contractor’s list of patients should remain open, the Health Board must send full details of the agreement in writing to the contractor within a period of two weeks beginning with the date the agreement was reached.

(7) The Health Board and the contractor must comply with the terms of an agreement reached as mentioned in sub‑paragraph (6).

(8) If, following the discussions mentioned in sub‑paragraph (2)—

(a) the Health Board and the contractor reach agreement that the contractor’s list of patients should close; or

(b) the Health Board and the contractor fail to reach agreement and the contractor still wishes to close the contractor’s list of patients,

the contractor must send a closure notice to the Health Board.

(9) A closure notice mentioned in sub-paragraphs (5) or (8) must be submitted in the form specified in schedule 7, and must include the following details which (in a case falling within sub‑paragraph (8)(a)) have been agreed between the parties or (in a case falling within sub‑paragraph (8)(b)) are proposed by the contractor—

(a) the period of time (which may not exceed twelve months) for which the contractor’s list of patients will be closed;

(b) the current number of the contractor’s registered patients;

(c) the number of registered patients (lower than the current number of such patients, and expressed either in absolute terms or as a percentage of the number of such patients specified pursuant to paragraph (b)) which, if that number were reached, would trigger the re‑opening of the contractor’s list of patients;

(d) the number of registered patients (expressed either in absolute terms or as a percentage of the number of such patients specified pursuant to paragraph (b)) which, if that number were reached, would trigger the re‑closure of the contractor’s list of patients; and

(e) any withdrawal or reduction in provision of any additional or enhanced services which had previously been provided under the contract.

(10) The Health Board must, without delay, acknowledge receipt of the closure notice mentioned in sub-paragraphs (5) or (8) in writing to the contractor.

(11) Before the Health Board reaches a decision as to whether to approve or reject the closure notice mentioned in sub-paragraph (8) under sub‑paragraph (14), the Health Board and the contractor may enter into further discussions concerning the details of the closure notice as specified in sub‑paragraph (9), with a view to reaching agreement; and, in particular, if the parties are unable to reach agreement regarding the period of time for which the contractor’s list of patients will be closed, that period will be twelve months.

(12) A contractor may not withdraw a closure notice mentioned in sub-paragraphs (5) or (8) for a period of three months beginning with the date on which the Health Board has received the notice, unless the Health Board has agreed otherwise in writing.

(13) Within a period of 14 days beginning with the date of the receipt of the closure notice mentioned in sub-paragraph (5), the Health Board must approve the closure notice and notify the contractor in writing as soon as possible.

(14) Within a period of 14 days beginning with the date of receipt of the closure notice mentioned in sub-paragraph (8), the Health Board must—

(a) approve the closure notice; or

(b) reject the closure notice,

and must notify the contractor of its decision in writing as soon as possible.

(15) Approval of a closure notice includes—

(a) where it is a closure notice mentioned in sub-paragraph (5), approval of the details specified in accordance with sub‑paragraph (9); or

(b) where it is a closure notice mentioned in sub-paragraph (8) and approved under sub-paragraph (14)(a), approval of the details specified in accordance with sub-paragraph (9)(or, where those details are revised following discussions under sub‑paragraph (11), approval of those details as so revised).

Approval of closure notice by the Health Board

27

(1) If the Health Board approves the closure notice in accordance with paragraph 26(13) or paragraph 26(14)(a), the contractor must close its list of patients—

(a) with effect from a date agreed between the Health Board and the contractor; or

(b) if no such agreement has been reached, with effect from the date on which the contractor receives notification of the Health Board’s decision to approve the closure notice.

(2) Subject to sub-paragraph (3), the contractor’s list of patients is to remain closed for the period specified in the closure notice in accordance with paragraph 26(9)(a) (or, where a period of twelve months has been fixed in accordance with paragraph 26(11), for that period).

(3) The contractor’s list of patients is to re‑open before the expiry of the period mentioned in sub‑paragraph (2) if—

(a) the number of the contractor’s registered patients falls to the number specified in the closure notice in accordance with paragraph 26(9)(c); or

(b) the Health Board and the contractor agree that the list of patients should re‑open.

(4) If the contractor’s list of patients has re-opened pursuant to sub-paragraph (3)(a), it will nevertheless close again if, during the period specified in the closure notice in accordance with paragraph 26(9)(a) (or, where the period of twelve months specified in paragraph 26(11) applies, during that period) the number of the contractor’s registered patients rises to the number specified in the closure notice in accordance with paragraph 26(9)(d).

(5) Except in cases where the contractor’s list of patients is already open pursuant to sub‑paragraph (3), the Health Board must notify the contractor in writing between 7 and 14 days before the expiry of the period of closure specified in sub-paragraph (2), confirming the date on which the contractor’s list of patients will re-open.

(6) Where the details specified in the closure notice mentioned in paragraph 26(8) in accordance with paragraph 26(9) have been revised following discussions under paragraph 26(11), references in this paragraph to details specified in the closure notice are references to those details as so revised.

Rejection of closure notice by the Health Board

28

(1) This regulation applies where the Health Board rejects the closure notice in accordance with paragraph 26(14)(b).

(2) The contractor and the Health Board may not refer the matter for determination in accordance with the NHS dispute resolution procedure (or, where applicable, commence court proceedings) until the assessment panel has given its determination in accordance with the following sub‑paragraphs.

(3) The Health Board must ensure that an assessment panel is appointed by another Health Board as soon as is practicable to consider and determine whether the contractor should be permitted to close its list of patients, and if so, the terms on which the contractor should be permitted to do so.

(4) The Health Board must provide the assessment panel with such information as the assessment panel may reasonably require to enable the panel to reach a determination and must include in such information any written observations received from the contractor.

(5) At least one member of the assessment panel must visit the contractor before reaching a determination under sub‑paragraph (6).

(6) Within the period of 28 days beginning with the date on which the Health Board rejected the closure notice, the assessment panel must—

(a) approve the list closure; or

(b) reject the list closure,

and must notify the Health Board and the contractor of its determination in writing as soon as possible.

(7) Where the assessment panel determines in accordance with sub‑paragraph (6)(a) that the contractor’s list of patients should close, it must specify—

(a) a date from which the closure is to take effect, which must be within a period of 7 days beginning with the date of the assessment panel’s determination; and

(b) those details specified in paragraph 26(9).

(8) Subject to sub-paragraph(9), the contractor’s list of patients is to remain closed for the period specified by the assessment panel in accordance with sub-paragraph(7)(b).

(9) The contractor’s list of patients is to re-open before the expiry of the period mentioned in sub-paragraph (8) if—

(a) the number of the contractor’s registered patients falls to the number specified by the assessment panel in accordance with sub-paragraph (7)(b) as the number of registered patients which, if that number were reached, would trigger the re-opening of the contractor’s list of patients; or

(b) the Health Board and the contractor agree that the list of patients should re-open.

(10) If the contractor’s list of patients has re-opened pursuant to sub-paragraph (9)(a), it will nevertheless close again if, during the period specified by the assessment panel as the period for which the list should remain closed, the number of the contractor’s registered patients rise to the number specified by the assessment panel in accordance with sub-paragraph (7)(b) as the number of registered patients which, if that number were reached, would trigger the re-closure of the contractor’s list of patients.

(11) Except in cases where the contractor’s list of patients is already open pursuant to sub-paragraph (9), the Health Board must notify the contractor in writing between 7 and 14 days before the expiry of the closure period specified in sub-paragraph (8), confirming the date on which the contractor’s list of patients will re-open.

(12) Where the assessment panel rejects the list closure in accordance with sub‑paragraph (6)(b), that list must remain open, and the Health Board and the contractor must enter into discussions with a view to ensuring that the contractor receives support from the Health Board which will enable the contractor to continue to provide services safely and effectively.

(13) An assessment panel which rejects the list closure in accordance with sub-paragraph (6)(b) must specify the number of registered patients (expressed either in absolute terms or as a percentage of the number of such patients specified as the current number of the contractor’s registered patients), which if that number were reached, would trigger the closure of the contractor’s list of patients.

(14) Where a list closure is triggered in accordance with sub-paragraph (13), a contractor must notify the Health Board to confirm the date the list closure was triggered and the details specified in paragraph 26(9).

(15) Where the assessment panel rejects the list closure in accordance with sub‑paragraph (6)(b), the contractor may not submit a further closure notice as described in paragraph 26 until—

(a) the expiry of a period of six months beginning with the date of the assessment panel’s determination; or

(b) (if applicable) the final determination of the NHS dispute resolution procedure (or any court proceedings),

whichever is the later unless there has been a change in the circumstances of the contractor which affects its ability to deliver services under the contract.

(16) Any decision or determination by the assessment panel for the purposes of this paragraph may be reached by a majority.

Assignment of patients to lists: open lists

29

(1) A Health Board may, subject to paragraph 31, assign a new patient to a contractor whose list of patients is open.

(2) In this paragraph and in paragraphs 30 and 32 to 34, a “new” patient means a person who—

(a) is resident (whether or not temporarily) within the area of the Health Board;

(b) has been refused inclusion in a list of patients of, or has not been accepted as a temporary resident by, a contractor whose premises are within such an area; and

Assignment of patients to lists: closed lists

30

(1) A Health Board may not assign a new patient to a contractor which has closed its list of patients except in the circumstances specified in sub‑paragraph (2).

(2) A Health Board may, subject to paragraph 31, assign a new patient to a contractor whose practice premises are within the Health Board’s area and which has closed its list of patients, if—

(a) most or all of the providers of essential services (or their equivalent) whose practice premises are within the Health Board’s area have closed their lists of patients;

(b) the assessment panel has determined under paragraph 32(7) that patients may be assigned to the contractor in question, and that determination has not been overturned either by a determination of the Scottish Ministers or the adjudicator under the NHS dispute resolution procedure as modified by paragraph 33(3) or (where applicable) by a court; and

(c) the Health Board has entered into discussions with the contractor in question regarding the assignment of a patient if such discussions are required under paragraph 34.

Factors relevant to assignments

31

In making an assignment to a contractor under paragraph 29 or 30, the Health Board is to have regard to—

(a) the wishes and circumstances of the patient to be assigned;

(b) the distance between the patient’s place of residence and the contractor’s practice premises;

(c) whether, during the six months ending on the date on which the application for assignment is received by the Health Board, the patient’s name has been removed from the list of patients of any contractor in the area of the Health Board under paragraph 17 or its equivalent provision in relation to a section 17C provider in the area of the Health Board;

(d) whether the patient’s name has been removed from the list of patients of any contractor in the area of the Health Board under paragraph 18 or its equivalent provision in relation to a section 17C provider in the area of the Health Board and, if so, whether the contractor has appropriate facilities to deal with such a patient; and

(e) such other matters as the Health Board considers to be relevant.

Assignments to closed lists: determinations of the assessment panel

32

(1) This paragraph applies where most or all of the providers of essential services (or their equivalent) whose practice premises are within the area of a Health Board have closed their lists of patients.

(2) If the Health Board wishes to assign new patients to contractors which have closed their lists of patients, it must prepare a proposal to be considered by the assessment panel, and the proposal must include details of those contractors to which the Health Board wishes to assign patients.

(3) The Health Board must ensure that an assessment panel is appointed by another Health Board to consider and determine its proposal made under sub‑paragraph (2).

(4) The Health Board must notify in writing—

(a) contractors or section 17C providers whose practice premises are within the Health Board’s area which—

(i) have closed their list of patients; and

(ii) may, in the opinion of the Health Board, be affected by the determination of the assessment panel; and

(b) the area medical committee (if any) for the area of the Health Board,

that it has referred the matter to the assessment panel.

(5) In reaching its determination, the assessment panel must have regard to relevant factors including—

(a) whether the Health Board has attempted to secure the provision of essential services (or their equivalent) for new patients other than by means of their assignment to contractors with closed lists of patients; and

(b) the workload of those contractors likely to be affected by any decision to assign such patients to their list of patients.

(6) The assessment panel must reach a determination within the period of 28 days beginning with the date on which the panel was appointed.

(7) The assessment panel must determine whether the Health Board may assign patients to contractors which have closed their lists of patients; and if it determines that the Health Board may make such assignments, it must also determine those contractors to which patients may be assigned.

(8) The assessment panel may determine that the Health Board may assign patients to contractors other than those contractors specified by the Health Board in its proposal under sub‑paragraph (2), as long as the contractors were notified under sub‑paragraph (4)(a).

(9) The assessment panel’s determination must include its comments on the matters specified in sub‑paragraph (5), and must be notified in writing to those contractors which were notified under sub‑paragraph (4)(a).

(10) Any decision or determination by the assessment panel for the purposes of this paragraph may be reached by a majority.

Assignments to closed lists: NHS dispute resolution procedure relating to determinations of the assessment panel

33

(1) Where an assessment panel makes a determination under paragraph 32(7) that the Health Board may assign new patients to contractors which have closed their lists of patients, any contractor specified in that determination may refer the matter to the Scottish Ministers to review the determination of the assessment panel.

(2) Where more than one contractor specified in the determination in accordance with paragraph 32(7) wishes to refer the matter for dispute resolution, those contractors may, if they all agree, refer the matter jointly, and in that case the Scottish Ministers must review the matter in relation to those contractors together.

(3) Where a matter is referred to the Scottish Ministers under sub‑paragraph (1) or (2), it will be determined in accordance with the NHS dispute resolution procedure as modified as follows—

(a) in paragraph 91(3), for “a dispute as mentioned in sub-paragraph (1)” substitute “the matter as mentioned in paragraph 33(1)”;

(b) for paragraph 91(4) substitute—

(4) The contractor (or contractors) wishing to refer the matter as mentioned in paragraph 33(1) or (2) must send the request to the Scottish Ministers within the period of 7 days beginning with the date of the determination by the assessment panel in accordance with paragraph 32(7).

(13) In this paragraph, “specified period” means such period as the Scottish Ministers specify in the request sent under sub-paragraphs (6) or (8), being not less than one, nor more than two, weeks beginning with the date on which the request is given, but the adjudicator may, if the period for determination of the dispute has been extended in accordance with sub-paragraph (19), extend any such period (even after it has expired) and, where the adjudicator does so, a reference in this paragraph to the specified period is to the period as so extended.

(d) after paragraph 91(15), insert—

(16) Subject to sub-paragraph (19), within the period of 21 days beginning with the date on which the matter was referred to the Scottish Ministers, the adjudicator must determine whether the Health Board may assign patients to contractors which have closed their lists of patients; and if the adjudicator determines that the Health Board may make such assignments, the adjudicator must also determine those contractors to which patients may be assigned. (17) The adjudicator may not determine that patients may be assigned to a contractor which was not specified in the determination of the assessment panel under paragraph 32(7). (18) In the case of a matter referred jointly by contractors in accordance with paragraph 33(2), the adjudicator may determine that patients may be assigned to one, some or all of the contractors which referred the matter. (19) The period of 21 days referred to in sub-paragraph (16) may be extended (even after it has expired) by a further specified number of days if an agreement to that effect is reached by— (a) the adjudicator; (b) the Health Board; and (c) the contractor (or contractors) which referred the matter to dispute resolution.

; and

(e) paragraph 92(2) does not apply.

Assignments to closed lists: assignments of patients by a Health Board

34

(1) Before the Health Board may assign a new patient to a contractor, it must, subject to sub-paragraph (3), enter into discussions with that contractor regarding additional support that the Health Board can offer the contractor, and the Health Board must use its best endeavours to provide appropriate support.

(2) In the discussions referred to in sub-paragraph (1), both parties must use reasonable endeavours to reach agreement.

(3) The requirement in sub-paragraph (1) to enter into discussions applies—

(a) to the first assignment of a patient to a particular contractor; and

(b) to any subsequent assignment to that contractor to the extent that it is reasonable and appropriate having regard to the numbers of patients who have been or may be assigned to it and the period of time since the last discussions under sub-paragraph (1) took place.

Assignments of patients to lists at request of contractor

35

(1) A Health Board may, subject to sub-paragraph (3), at the request of a contractor, assign a patient on that contractor’s list of patients to a receiving contractor’s list of patients.

(2) A request under sub-paragraph (1) must be notified in writing to the Health Board and confirm that—

(a) the patient has given written consent to the assignment; and

(b) the requesting and receiving contractors have agreed to the assignment.

(3) An assignment under this paragraph may only be made where either the requesting contractor or receiving contractor have varied their practice area in accordance with paragraph 36.

(4) In this paragraph, “a receiving contractor” may include a contractor who has closed its list of patients.

Application for variation of a practice area

36

(1) A contractor may request a variation of their practice area by notifying the Health Board in writing of its variation request.

(2) The Health Board must—

(a) enter into discussions with the contractor regarding the variation request mentioned in sub-paragraph (1) within a period of 1 month beginning with the date of receipt of the notification referred to in that sub-paragraph; and

(b) have concluded such discussions within a period of 3 months beginning with the date of the receipt of the notification mentioned in sub-paragraph (1).

(3) Following the discussions mentioned in sub-paragraph (2), the Health Board must—

(a) consult with the Area Medical Committee regarding the contractor’s variation request;

(b) consider the effect of the variation request mentioned in sub-paragraph (1) on the practice areas of other contractors within its Health Board area; and

(c) taking account of the discussions mentioned in sub-paragraph (2) and the factors at sub-head (a) and (b), approve or reject the contractor’s variation request.

(4) The Health Board must notify the contractor in writing as soon as possible of its decision to approve or reject the variation request in accordance with sub-paragraph (3).

(5) A notification of approval mentioned in sub-paragraph (4) must confirm the date the variation is to take effect.

Rejection of a practice area variation request

37

(1) This paragraph applies where the Health Board rejects the variation request in accordance with paragraph 36(3).

(2) The contractor and the Health Board may not refer the matter for determination in accordance with the NHS dispute resolution procedure (or, where applicable, commence court proceedings) until the assessment panel has given its determination in accordance with the following sub-paragraphs.

(3) The Health Board must ensure that an assessment panel is appointed by another Health Board as soon as is practicable to consider and determine whether the contractor should be permitted to vary its practice area.

(4) The Health Board must provide the assessment panel with such information as the assessment panel may reasonably require to enable the panel to reach a determination and must include in such information any written observations received from the contractor.

(5) Within a period of three months beginning with the date on which the Health Board rejected the variation request, the assessment panel must—

(a) approve the variation request; or

(b) reject the variation request,

and must notify the Health Board and the contractor of its determination in writing as soon as possible.

(6) Where the assessment panel approves a variation request in accordance with sub-paragraph (5)(a), it must specify the date from which the variation of the practice area takes effect.

(7) Where the assessment panel rejects the variation request in accordance with sub-paragraph (5)(b), the contractor may not request a further practice area variation under paragraph 36 until whichever is the later of the following dates—

(a) the expiry of a period of one year beginning with the date of the assessment panel’s determination; or

(b) (if applicable) the final determination of the NHS dispute resolution procedure (or any court proceedings).

(8) Any decision or determination by the assessment panel for the purposes of this paragraph may be reached by a majority.

PART 3 — PRESCRIBING AND DISPENSING

Prescribing

38

The contractor is to ensure that any prescription form for drugs, medicines or appliances issued or created by a prescriber complies as appropriate with the requirements in paragraphs 39 to 41.

Prescribing

39

(1) Subject to paragraphs 40 and 41 a prescriber is to order any drugs, medicines or appliances which are needed for the treatment of any patient who is receiving treatment under the contract by—

(a) issuing to that patient a non-electronic prescription form; or

(b) creating and transmitting an electronic prescription form,

and such a non-electronic prescription form or electronic prescription form must not be used in any other circumstances.

(2) In issuing any non-electronic prescription form, the prescriber must sign the prescription form in ink with the prescriber’s initials, or forenames, and surname in the prescriber’s own handwriting and not by means of a stamp and must so sign only after particulars of the order have been inserted in the prescription form.

(3) A prescription form must not refer to any previous prescription form.

(4) A separate prescription form must be used for each patient.

(5) In a case of urgency a prescriber may request a pharmacist to dispense a drug or medicine before a prescription form is issued or created, only if —

(a) that drug or medicine is not a Scheduled drug;

(b) that drug is not a controlled drug within the meaning of the Misuse of Drugs Act 1971¹⁰² other than a drug which is for the time being specified in schedules 4 or 5 of the Misuse of Drugs Regulations 2001¹⁰³; and

(c) the prescriber undertakes to furnish the pharmacist, within 72 hours, with a prescription form completed in accordance with sub‑paragraph (2) or with an electronic prescription form.

(6) In a case of urgency a prescriber may request a pharmacist to dispense an appliance before a prescription form is issued or created only if—

(a) that appliance does not contain a Scheduled drug or a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in schedule 5 of the Misuse of Drugs Regulations 2001;

(b) in the case of a restricted availability appliance, the patient is a person, or it is for a purpose, specified in the Drug Tariff; and

(c) the prescriber undertakes to furnish the pharmacist, within 72 hours, with a prescription form completed in accordance with sub‑paragraph (2) or with an electronic prescription form.

(7) A prescriber may only order drugs, medicines or appliances by means of an electronic prescription form if the prescription is not for a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in schedule 4 or 5 of the Misuse of Drugs Regulations 2001.

(8) A prescriber who orders drugs, medicines or appliances by means of an electronic prescription form must issue the patient with a written record of the prescription which has been created.

Restrictions on prescribing by medical practitioners

40

(1) In the course of treating a patient to whom a medical practitioner is providing treatment under the contract, the medical practitioner must not order on a prescription form a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act (Other mandatory contract terms)¹⁰⁴ as being drugs, medicines or other substances which may not be ordered for patients in the provision of medical services under the contract but may, subject to regulation 28(2)(b), prescribe such a drug or other substance for that patient in the course of that treatment under a private arrangement.

(2) In the course of treating a patient to whom a medical practitioner is providing treatment under the contract, the medical practitioner must not order on a prescription form a drug, medicine or other substance specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes unless—

(a) that patient is a person of the specified description;

(b) that drug, medicine or other substance is prescribed for that patient only for the specified purpose; and

but may, subject to regulation 28(2)(b), prescribe such a drug, medicine or other substance for that patient in the course of that treatment under a private arrangement.

(3) In the course of treating a patient to whom a medical practitioner is providing treatment under the contract, the medical practitioner must not order on a prescription form a restricted availability appliance unless—

(a) the patient is a person, or it is for a purpose, specified in the Drug Tariff; and

(b) the practitioner includes on the prescription form the reference “SLS”,

but may, subject to regulation 28(2)(b), prescribe such an appliance for that patient in the course of that treatment under a private arrangement.

Restrictions on prescribing by supplementary prescribers

41

(1) The contractor must have arrangements in place to secure that a supplementary prescriber will—

(a) issue or create a prescription for a prescription only medicine;

(b) administer a prescription only medicine for parenteral administration; or

as a supplementary prescriber, under the conditions set out in sub‑paragraph (2).

(2) The conditions referred to in sub‑paragraph (1) are that—

(a) the supplementary prescriber satisfies the applicable conditions set out in regulation 215 of the Human Medicines Regulations 2012 (prescribing and administration by supplementary prescribers)¹⁰⁵, unless those conditions do not apply by virtue of any of the exemptions set out in the subsequent provisions of those Regulations;

(b) the drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract;

(c) the drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes unless—

(i) the patient is a person of the specified description;

(ii) the medicine is prescribed for that patient only for the specified purposes; and

(iii) if the supplementary prescriber is issuing or creating the prescription form, the supplementary prescriber includes on the prescription form the reference “SLS”.

(3) Where the functions of a supplementary prescriber include prescribing, the contractor must have arrangements in place to secure that that person will only issue or create a prescription for—

(a) an appliance; or

(b) a medicine which is not a prescription only medicine,

as a supplementary prescriber under the conditions set out in sub‑paragraph (4).

(4) The conditions referred to in sub‑paragraph (3) are that—

(a) the supplementary prescriber acts in accordance with a clinical management plan which is in effect at the time the supplementary prescriber acts and which contains the following particulars—

(i) the name of the patient to whom the plan relates;

(ii) the illness or conditions which may be treated by the supplementary prescriber;

(iii) the date on which the plan is to take effect, and when it is to be reviewed by the medical practitioner or dentist who is a party to the plan;

(iv) reference to the class or description of medicines or types of appliances which may be prescribed or administered under the plan;

(v) any restrictions or limitations as to the strength or dose of any medicine which may be prescribed or administered under the plan, and any period of administration or use of any medicine or appliance which may be prescribed or administered under the plan;

(vi) relevant warnings about known sensitivities of the patient to, or known difficulties of the patient with, particular medicines or appliances;

(vii) the arrangements for notification of—

(aa) suspected or known adverse reactions to any medicine which may be prescribed or administered under the plan, and suspected or known adverse reactions to any other medicine taken at the same time as any medicine prescribed or administered under the plan;

(bb) incidents occurring with the appliance which might lead, might have led or has led to the death or serious deterioration of state of the health of the patient, and

(viii) the circumstances in which the supplementary prescriber should refer to, or seek the advice of, the medical practitioner or dentist who is a party to the plan;

(b) the supplementary prescriber has access to the health records of the patient to whom the plan relates which are used by any medical practitioner or dentist who is a party to the plan;

(c) if it is a prescription for a drug, medicine or other substance, that drug, medicine or other substance is not specified in any directions given by the Scottish Ministers under section 17N(6) of the Act as being a drug, medicine or other substance which may not be ordered for patients in the provision of primary medical services under a general medical services contract;

(d) if it is a prescription for an appliance, the appliance is listed in Parts 2 to 6 or 8 to 10 of the Drug Tariff; and

(e) if it is a prescription for a restricted availability appliance—

(i) the patient is a person of a description mentioned in the entry in Part 3 of the Drug Tariff in respect of that appliance;

(ii) the appliance is prescribed only for the purposes specified in respect of that person in that entry; and

(iii) when issuing or creating the prescription form, the supplementary prescriber includes on the prescription form the reference “SLS”.

(5) In sub‑paragraph (4)(a), “clinical management plan” means a plan (which may be amended from time to time) relating to the treatment of an individual patient agreed by—

(a) the patient to whom the plan relates;

(b) the medical practitioner or dentist who is a party to the plan; and

Interpretation of paragraphs 38 to 41

42

For the purposes of paragraphs 38 to 41, in their application to a contractor whose contract includes the provision of contraceptive services, drugs includes contraceptive substances and appliances includes contraceptive appliances.

Excessive prescribing

43

(1) The contractor must not prescribe drugs, medicines or appliances whose cost or quantity, in relation to any patient, is, by reason of the character of the drug, medicine or appliance in question in excess of that which was reasonably necessary for the proper treatment of that patient.

(2) In considering whether a contractor has breached its obligations under sub‑paragraph (1), the Health Board must seek the views of the area medical committee for its area.

Provision of dispensing services

44

(1) A contractor may secure the provision of dispensing services to its registered patients only if it is authorised or required to do so by the Health Board in accordance with this paragraph.

(2) Where the Health Board, is satisfied, after consultation with the area pharmaceutical committee, that a person, by reason of—

(a) distance;

(b) inadequacy of means of communication; or

will have serious difficulty in obtaining from a pharmacist any drugs, medicines or appliances, other than Scheduled drugs, required for that person’s treatment, the Health Board may require or authorise the contractor with whom the person is a registered patient to supply such drugs, medicines and appliances to that person until further notice.

(3) Notwithstanding anything contained in sub-paragraph (2)—

(a) a contractor will not be required to undertake the supply of drugs, medicines, and appliances under sub‑paragraph (2) if the contractor satisfies the Health Board that the contractor is not in the habit of dispensing drugs, medicines, and appliances for the contractor’s patients;

(b) a contractor must receive reasonable notice from the Health Board that the contractor is required to undertake the supply of drugs, medicines and appliances under sub‑paragraph (2) or that such supply is to be discontinued.

(4) A contractor must receive the support of an appropriately qualified pharmacist independent prescriber provided by the Health Board, where the Health Board considers that the health outcomes of patients are likely to be improved by the contractor and pharmacist independent prescriber working together with the aim of ensuring that the patient gets the best clinical benefit from their prescribed medicines.

(5) Subject to sub‑paragraph (7), a contractor, who is required by the Health Board to supply drugs, medicines and appliances under sub-paragraph (2) to a patient, in the course of treating that patient under these Regulations—

(a) must, subject to sub-paragraph (7), record on a prescription form completed in accordance with paragraph 39, an order for supply of any drugs, medicines or appliances which are needed for the treatment of that patient, but is not required to issue that form to that patient;

(b) is to supply those drugs, medicines or appliances for that patient under sub‑paragraph (2) but—

(i) must not supply under sub‑paragraph (2) for that patient any Scheduled drug specified as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract,except that, where the contractor has ordered a drug which has an appropriate non‑proprietary name either by that name or by its formula, the contractor may supply a drug which has the same specification notwithstanding that it is such a Scheduled drug (but, in the case of a drug which combines more than one drug, only if the combination has an appropriate non‑proprietary name);

(ii) will supply under sub‑paragraph (2) for that patient any Scheduled drug specified as being a drug, medicine or other substance which may only be ordered for specific patients and purposes only where—

(aa) that patient is a person of the specified description; and

(bb) that drug, medicine or other substance is supplied to that patient only for the specified purpose;

(iii) will supply under sub‑paragraph (2) for that patient a restricted availability appliance only if it is for a patient in a category of person or a purpose specified in the Drug Tariff;

(c) may supply for that patient with the contractor’s consent, in respect of that treatment but otherwise than under sub‑paragraph (2), any Scheduled drug.

(6) A contractor must comply with any arrangements made by the Scottish Ministers, or made by the Health Board after consultation with the area medical committee (if any) and the area pharmaceutical committee and approved by the Scottish Ministers, under which the contractor may obtain and have available any drugs, medicines or appliances which the contractor is required or entitled to supply in terms of this paragraph.

(7) Sub‑paragraph (5) does not apply to drugs, medicines or appliances ordered on a prescription form by a supplementary prescriber, or an independent prescriber.

(8) Where a patient presents an order on a non-electronic prescription form for listed drugs or medicines, or appliances, signed by a supplementary prescriber, or an independent prescriber, to a contractor who is required under sub‑paragraph (2) to provide drugs or appliances to that patient or a contractor who is required under sub-paragraph (2) to provide drugs or appliances to a patient receives from the ePharmacy service an electronic prescription form which contains an order for listed drugs or medicines, or appliances in respect of that patient, signed by a supplementary prescriber, or an independent prescriber, the contractor may provide to the patient such drugs, medicines or appliances so ordered as the contractor supplies in the normal course of the contractor’s practice.

(9) A drug supplied by a contractor unless administered in person must be supplied in a suitable container.

(10) Nothing in this paragraph prevents a contractor providing a Scheduled drug or a restricted availability appliance in the course of treating a patient under a private arrangement.

(11) A contractor who is required or authorised by the Health Board to supply drugs, medicines and appliances under sub-paragraph (2) may do so in accordance with a Scottish SSP.

Provision of drugs, medicines and appliances for immediate treatment or personal administration

45

(1) Subject to sub‑paragraph (2), a contractor—

(a) is to provide to a patient any drug, medicine or appliance, not being a Scheduled drug, where such provision is needed for the immediate treatment of that patient before provision can otherwise be obtained; and

(b) may provide to a patient any drug, medicine or appliance, not being a Scheduled drug, which the contractor personally administers or applies to that patient,

but may, in either case, provide a restricted availability appliance only if it is for a person or a purpose specified in the Drug Tariff.

(2) Nothing in sub‑paragraph (1) authorises a person to supply any drug or medicine to a patient otherwise than in accordance with Part 3 of the Medicines Act 1968¹⁰⁶ or any regulations or orders made thereunder.

PART 4 — PERSONS WHO PERFORM SERVICES

Qualifications of performers

46

(1) Subject to sub-paragraph (2), no medical practitioner may perform medical services under the contract unless the practitioner is—

(a) included in the primary medical services performers’ list for the Health Board which is under a duty to provide or secure the provision of the service to be performed;

(b) not suspended from that list or from the Medical Register; and

(2) Sub-paragraph (1)(a) does not apply in the case of—

(a) a medical practitioner employed in Scotland, by a Health Board, in England and Wales, by an NHS trust, an NHS foundation trust, or, in Northern Ireland, by a Health and Social Care trust who is providing services other than primary medical services at the practice premises;

(b) a person who is provisionally registered under section 15 (provisional registration), 15A (provisional registration for EEA nationals) or 21 (provisional registration of EEA nationals with certain overseas qualifications) of the Medical Act 1983¹⁰⁸ acting in the course of the person’s employment in a resident medical capacity in an approved practice setting within the meaning of section 44D of the Medical Act 1983 (approved practice settings)¹⁰⁹; or

(c) a GP Registrar who has applied to the Health Board to have the GP Registrar’s name included in the primary medical services performers list of the Health Board, until the first of the following events arises—

(i) the Health Board notifies the GP Registrar of the Board’s decision on that application;

(ii) the end of a period of 2 months, starting with the date on which the GP Registrar’s vocational training scheme begins.

(3) In this paragraph, “vocational training scheme” has the meaning given in regulation 2 (interpretation) of the National Health Service (Primary Medical Services Performers Lists) (Scotland) Regulations 2004¹¹⁰.

Qualifications of performers

47

No health care professional other than one to whom paragraph 46 applies may perform clinical services under the contract unless the health care professional is appropriately registered with the health care professional’s relevant professional body and the health care professional’s registration is not currently suspended.

Qualifications of performers

48

Where the registration of a health care professional or, in the case of a medical practitioner, the practitioner’s inclusion in a list, is subject to conditions, the contractor must ensure compliance with those conditions insofar as they are relevant to the contract.

Qualifications of performers

49

No health care professional may perform any clinical services unless the health care professional has such clinical experience and training as are necessary to enable the health care professional properly to perform such services.

Conditions for employment and engagement

50

(1) Subject to sub‑paragraphs (2) and (3), a contractor must not employ or engage a medical practitioner (other than one falling within paragraph 46(2)) unless—

(a) that practitioner has provided it with the name and address of the Health Board on whose primary medical services performers list the practitioner appears; and

(b) the contractor has checked that the practitioner meets the requirements in paragraph 46.

(2) Where the employment or engagement of a medical practitioner is urgently needed and it is not possible for the contractor to check the matters referred to in paragraph 46 in accordance with sub‑paragraph (1)(b) before employing or engaging the practitioner, the practitioner may be employed or engaged on a temporary basis for a single period of up to 7 days whilst such checks are undertaken.

(3) Where the prospective employee is a GP Registrar, the requirements set out in sub‑paragraph (1) apply with the modifications that—

(a) the name and address provided under sub‑paragraph (1) may be the name and address of the Health Board on whose primary medical services performers list the GP Registrar has applied for inclusion; and

(b) confirmation that the GP Registrar’s name appears on that list will not be required until the end of the first two months of the GP Registrar’s training period.

Conditions for employment and engagement

51

(1) A contractor must not employ or engage—

(a) a health care professional (other than one to whom paragraph 46 applies) unless the contractor has checked that the health care professional meets the requirements in paragraph 47; or

(b) a health care professional to perform clinical services unless the contractor has taken reasonable steps to satisfy itself that the health care professional meets the requirements in paragraph 49.

(2) Where the employment or engagement of a health care professional is urgently needed and it is not possible to check the matters referred to in paragraph 47 in accordance with sub‑paragraph (1) before employing or engaging that person, the health care professional may be employed or engaged on a temporary basis for a single period of up to 7 days whilst such checks are undertaken.

(3) When considering a health care professional’s experience and training for the purposes of sub‑paragraph (1)(b), the contractor must have regard in particular to—

(a) any post‑graduate or post‑registration qualification held by the health care professional; and

(b) any relevant training undertaken by the health care professional and any relevant clinical experience gained by the health care professional.

Conditions for employment and engagement

52

(1) The contractor must not employ or engage a health care professional to perform medical services under the contract unless—

(a) that person has provided two clinical references, relating to two recent posts (which may include any current post) as a health care professional which lasted for three months without a significant break, or where this is not possible, a full explanation and alternative referees; and

(b) the contractor has checked and is satisfied with the references.

(2) Where the employment or engagement of a medical practitioner is urgently needed and it is not possible to obtain and check the references in accordance with sub‑paragraph (1)(b) before employing or engaging the practitioner, the practitioner may be employed or engaged on a temporary basis for a single period of up to 14 days whilst the practitioner’s references are checked and considered, and for an additional single period of a further 7 days if the contractor believes the person supplying those references is ill, on holiday or otherwise temporarily unavailable.

(3) Where the contractor employs or engages the same person on more than one occasion within a period of three months, it may rely on the references provided on the first occasion, provided that those references are not more than twelve months old.

Conditions for employment and engagement

53

(1) Before employing or engaging any person to assist it in the provision of services under the contract, the contractor must take reasonable care to satisfy itself that the person in question is both suitably qualified and competent to discharge the duties for which the person is to be employed or engaged.

(2) The duty imposed by sub‑paragraph (1) is in addition to the duties imposed by paragraphs 50 to 52.

(3) When considering the competence and suitability of any person for the purpose of sub‑paragraph (1), the contractor must have regard, in particular, to—

(a) that person’s academic and vocational qualifications;

(b) that person’s education and training; and

Training

54

(1) Subject to sub-paragraph (2) the contractor must ensure that for any health care professional who is—

(a) performing clinical services under the contract; or

(b) employed or engaged to assist in the performance of such services,

there are in place arrangements for the purpose of maintaining and updating the health care professional’s skills and knowledge in relation to the services which the health care professional is performing or assisting in performing.

(2) Sub-paragraph (1) does not apply in respect of a health care professional who is—

(a) employed by the Health Board, and

(b) performing clinical services under the contract solely as part of the support which the Health Board is required to provide under paragraph 1(1) of schedule 2B (community treatment and care services) or paragraph 1(1) of schedule 2C (pharmacotherapy services).

Training

55

The contractor must afford to each employee reasonable opportunities to undertake appropriate training with a view to maintaining that employee’s competence.

Terms and conditions

56

The contractor may only offer employment to a general medical practitioner on terms and conditions which are no less favourable than those contained in the “Model terms and conditions of service for a salaried general practitioner employed by a GMS practice” published by the British Medical Association and the NHS Confederation as item 1.2 of the supplementary documents to the GMS contract 2003¹¹¹.

Arrangements for GP Registrars

57

(1) The contractor may only employ or engage a GP Registrar subject to the conditions in sub‑paragraph (2).

(2) The conditions referred to in sub‑paragraph (1) are that the contractor must not, by reason only of having employed or engaged a GP Registrar, reduce the total number of hours for which other medical practitioners perform primary medical services under the contract or for which other staff assist them in the performance of those services.

(3) A contractor which employs or engages a GP Registrar is to—

(a) offer the GP Registrar terms of employment in accordance with the rates and subject to the conditions contained in any directions given by the Scottish Ministers to NHS Education for Scotland¹¹² concerning the grants, fees, travelling and other allowances payable to GP Registrars; and

(b) take into account any guidance issued by the Scottish Ministers in relation to the GP Registrar Scheme¹¹³.

Independent prescribers and supplementary prescribers

58

(1) Where—

(a) a contractor employs or engages a person who is an independent prescriber or a supplementary prescriber whose functions will include prescribing;

(b) a contractor is a partnership or limited liability partnership and one of the partners or members as the case may be is an independent prescriber or a supplementary prescriber whose functions will include prescribing;

(c) a contractor is a company and one of the members is an independent prescriber or a supplementary prescriber whose functions will include prescribing; or

(d) the functions of a person who is an independent prescriber or a supplementary prescriber whom the contractor already employs or has already engaged are extended to include prescribing,

the contractor must notify the Health Board in writing within the period of 7 days beginning with the date on which the contractor employed or engaged the person, the person became a partner or member as the case may be of the partnership, limited liability partnership or company that is a party to the contract (unless, immediately before becoming such a partner or member of that partnership, limited liability partnership or company that is such a party, the person fell under sub-paragraph (1)(a)) or the person’s functions were extended as the case may be.

(2) Where—

(a) the contractor ceases to employ or engage a person who is an independent prescriber or a supplementary prescriber whose functions included prescribing;

(b) the partner or member, as the case may be, in a partnership or limited liability partnership who is an independent prescriber or a supplementary prescriber whose functions include prescribing, ceases to be a partner or member of the partnership or limited liability partnership;

(c) the member of a company who is an independent prescriber or a supplementary prescriber whose functions include prescribing, ceases to be a member of the company;

(d) the functions of a person who is an independent prescriber or a supplementary prescriber whom the contractor employs or engages in its practice are changed so that they no longer include prescribing; or

(e) the contractor becomes aware that a person who is an independent prescriber or a supplementary prescriber whom the contractor employs or engages has been removed or suspended from the relevant register,

the contractor must notify the Health Board in writing by the end of the second working day after the day when the event occurred.

(3) The contractor must provide the following information when it notifies the Health Board in accordance with sub‑paragraph (1)—

(a) the person’s full name;

(b) the person’s professional qualifications;

(d) the date on which the person’s entry in the relevant register was annotated to the effect that the person was qualified to order drugs, medicines and appliances for patients;

(e) the date on which—

(i) the person was employed or engaged, if applicable;

(ii) the person became a partner or member, as the case may be in the partnership or limited liability partnership, if applicable;

(iii) the person became a member of the company, if applicable; or

(iv) one of the person’s functions became prescribing in its practice.

(4) The contractor must provide the following information when it notifies the Health Board in accordance with sub‑paragraph (2)—

(a) the person’s full name;

(b) the person’s professional qualifications;

(d) the date on which—

(i) the person ceased to be employed or engaged in its practice;

(ii) the person ceased to be a partner or member, as the case may be in the partnership or limited liability partnership;

(iii) the person ceased to be a member of the company;

(iv) the person’s functions changed so as no longer to include prescribing; or

(v) the person was removed or suspended from the relevant register.

Signing of documents

59

(1) In addition to any other requirements relating to such documents whether in these Regulations or otherwise, the contractor must ensure that the documents specified in sub‑paragraph (2) include—

(a) the clinical profession of the health care professional who signed the document; and

(b) the name of the contractor on whose behalf it is signed.

(2) The documents referred to in sub‑paragraph (1) are—

(a) certificates issued in accordance with regulation 25, unless regulations relating to particular certificates provide otherwise;

(b) prescription forms; and

Level of skill

60

The contractor must carry out its obligations under the contract with reasonable skill and care.

Appraisal and assessment

61

(1) The contractor must ensure that any medical practitioner performing services under the contract—

(a) participates in the appraisal system provided by the Health Board unless the practitioner participates in an appropriate appraisal system provided by another health service body or is an armed forces GP; and

(b) co‑operates with any assessment process which the Health Board operates in relation to poorly performing doctors, as set out in NHS circular PCA(M)(2001)17¹¹⁴.

(2) The Health Board must provide an appraisal system for the purposes of sub‑paragraph (1)(a) after consultation with the area medical committee and such other persons as appear to the Health Board to be appropriate.

(3) In sub‑paragraph (1)—

“armed forces GP” means a medical practitioner who is employed on a contract of service by the Ministry of Defence, whether or not as a member of the United Kingdom Armed Forces of Her Majesty; and

“health service body” does not include any person who is to be regarded as a health service body in accordance with regulation 13.

Sub‑contracting of clinical matters

62

(1) Subject to sub‑paragraph (2), the contractor may not sub‑contract any of its rights or duties under the contract in relation to clinical matters unless—

(a) in all cases, it has taken reasonable steps to satisfy itself that—

(i) it is reasonable in all the circumstances; and

(ii) the proposed sub-contractor person is qualified and competent to provide the service; and

(b) it has notified the Health Board of its intention to sub‑contract as soon as reasonably practicable before the date on which the proposed sub‑contract is intended to come into force.

(2) Sub‑paragraph (1)(b) does not apply to a contract for services with a health care professional for the provision by that person of clinical services.

(3) The notification referred to in sub‑paragraph (1)(b) must include—

(a) the name and address of the proposed sub‑contractor;

(b) the duration of the proposed sub‑contract;

(d) the address of any premises to be used for the provision of services ; and

(e) whether the sub-contractor, if that sub-contractor were a contractor, would have sufficient involvement in patient care in terms of section 17L(3) and (4) of the Act¹¹⁵.

(4) Following receipt of a notice in accordance with sub‑paragraph (1)(b), the Health Board may request such further information relating to the proposed sub‑contract as appears to it to be reasonable and the contractor must supply such information promptly.

(5) The contractor will not proceed with the sub‑contract or, if it has already taken effect, must take appropriate steps to terminate it, where, within 28 days of receipt of the notice referred to in sub‑paragraph (1)(b), the Health Board has served notice of objection to the sub‑contract on the grounds that—

(a) the sub‑contract would—

(i) put at serious risk the safety of the contractor’s patients; or

(ii) put the Board at risk of material financial loss;

(b) the sub‑contractor would be unable to meet the contractor’s obligations under the contract; or

(c) the sub-contractor would not have sufficient involvement in patient care in terms of section 17L(3) and (4) of the Act, if that sub-contractor were a contractor.

(6) Where the Health Board objects to a proposed sub‑contract in accordance with sub‑paragraph (5), it must include with the notice of objection a statement in writing of the reasons for its objections.

(7) Sub‑paragraphs (1) and (3) to (6) also apply in relation to any renewal or material variation of a sub‑contract in relation to clinical matters.

(8) Where a Health Board does not object to a proposed sub‑contract under sub-paragraph (5), the parties to the contract will be deemed to have agreed a variation of the contract which has the effect of adding to the list of practice premises any premises whose address was notified to it under sub‑paragraph (3)(d) and paragraph 94 (1) does not apply.

(9) A contract with a sub‑contractor must prohibit the sub‑contractor from sub‑contracting the clinical services it has agreed with the contractor to provide.

(10) The contractor may not sub contract any of its rights or duties under the contract in relation to the provision of essential services to a company, partnership or limited liability partnership—

(a) owned wholly or partly by the contractor, or by any former or current employee of, or partner or member of the contractor;

(b) formed by or on behalf of the contractor, or from which it derives or may derive a pecuniary benefit; or

(c) formed by or on behalf of a former or current employee of, or partner ... or member of the contractor, or from which such a person derives or may derive a pecuniary benefit,

where that company, partnership or limited liability partnership is or was formed wholly or partly for the purpose of avoiding the restrictions on the sale of goodwill of a medical practice in section 35 of the Act¹¹⁶ or any regulations made wholly or partly under that section.

PART 5 — DATA PROTECTION, RECORDS, INFORMATION, NOTIFICATIONS AND RIGHTS OF ENTRY

Interpretation – general

63

(1) For the purposes of this Part—

“electronic patient records” means records of the contractor’s attendance on its patients created by way of data entries on a computer and electronically held and controlled by the contractor;

“patient records” means records of the contractor’s attendance on and treatment of its patients created by way of electronic patient records or on forms supplied by the Health Board to the contractor;

“practice data” means data about a contractor’s practice and which may include any information or data about employees, sub-contractors, remuneration, finances, workloads, and contracts other than personal data within patient records.

(2) No provision of this Part is to be construed as creating a duty, obligation or right which is contrary to any duty, obligation or right created by —

(a) the data protection legislation, or

(b) any directly applicable EU legislation which is not part of the data protection legislation but which relates to data protection.

Meaning of data controller etc.

64

(1) The meaning of “data controller”, “personal data”, “processing” and “supervisory authority” is to be construed in accordance with the 1998 Act.

(2) The meaning of “data controller”, “data protection officer”, “personal data”, “processing” and “supervisory authority” is to be construed in accordance with the GDPR[^f00125].

(3) Sub-paragraph (1) ceases to have effect on 25th May 2018.

Roles, responsibilities and obligations – general

65

(1) The Health Board and the contractor, when processing any data under this Part, must comply with any relevant direction, or guidance issued by the Scottish Ministers.

(2) The Health Board and the contractor must include within the contract—

(a) terms which have the effect of the obligations mentioned in paragraphs 66 and 67 ; and

(b) a term that requires the Health Board and the contractor to act jointly as controllers in relation to the processing of patient records.

Contractor’s obligations – records etc.

66

The contractor must—

(a) take all reasonable steps to ensure the accuracy of patient records;

(b) verify the accuracy of any templates and notices provided to it by the Health Board in accordance with paragraph 67(b), and once verified, use such templates and notices;

(c) comply with the Health Board’s current policies concerning data security, personal data or IT security notified by the Health Board to the contractor under paragraph 67(c);

(d) maintain a record of all of the contractor’s processing activities carried out in performance of the contract and make the records available to the Health Board on request; and

(e) ensure that any person under its direction who has access to patient records has undergone adequate data protection training.

Health Board Obligations – records etc.

67

The Health Board must—

(a) take all reasonable steps to confirm the accuracy of patient records provided to or accessed by it;

(b) provide to the contractor, guidance, templates, and privacy notices, relating to the contractor’s processing of personal data and the contractor’s maintenance of a record in accordance with sub-paragraph 66(d);

(c) notify the contractor timeously of its current policies regarding data security, personal data security and IT security processes;

(d) maintain a record of its processing activities carried out in relation to a contractor’s patient records;

(e) ensure that any of its employees who have access to the contractor’s patient records and practice data has undergone adequate data protection training; and

(f) make available appropriate data protection training to the contractor and its employees.

Records

68

(1) The contractor must keep adequate patient records of its attendance on and treatment of its patients and must do so—

(a) on forms to be supplied to it for that purpose by the Health Board;

(b) with the written consent of the Health Board, by way of electronic patient records; or

(2) The contractor must include in patient records referred to in sub-paragraph (1) clinical reports sent in accordance with paragraph 6 of schedule 6 or from any other health care professional who has provided clinical services to a person on its list of patients.

(3) The consent of the Health Board required by sub-paragraph (1)(b) must not be withheld or withdrawn provided the Health Board is satisfied, and continues to be satisfied, that—

(a) the contractor ensures that the computer system upon which the contractor proposes to keep the electronic patient records is accredited by the Scottish Ministers or another person on their behalf as suitable for that purpose in accordance with a relevant standard issued by the Scottish Ministers;

(b) the security measures, audit and system management functions incorporated into the computer system as accredited in accordance with sub-paragraph (a) have been enabled; and

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