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The National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004

Type Scottish-Statutory-Instrument

Publication 2004-03-10

State In force

Jurisdiction Scotland

Department Queen's Printer for Scotland

Source legislation.gov.uk

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(9) Sub-paragraphs (6) to (24) of paragraph 3 shall apply to an out of hours opt out as they apply to a permanent opt out and as if the reference to “A day” was a reference to “OOH day” and the reference in paragraph 3(18) to a “permanent opt out notice” was a reference to “an out of hours opt out notice”.

Out of hours opt out where opt out notice is served before 1st October 2004

5

(1) This paragraph shall apply where a contractor wishes to serve or serves an out of hours opt out notice before 1st October 2004.

(2) In this paragraph—

“OOH day” is the day specified by the Health Board for the commencement of the out of hours opt out in its decision under sub-paragraph (5);

“OOHB day” is the day six months after the date of service of the out of hours opt out notice; and

“OOHC day” is the day specified by the Health Board in its decision under sub-paragraph (11) or (13) (which must be nine months after the date of service of the out of hours opt out notice or before 2nd January 2005).

(3) A contractor which wishes to terminate its obligation to provide out of hours services which was included in the contract pursuant to regulation 30 shall notify the Health Board in writing to that effect (“an out of hours opt out notice”).

(4) An out of hours opt out notice shall state the date on which the contractor would like the opt out to take effect, which must be either three or six months after the date of service of the out of hours opt out notice.

(5) As soon as is reasonably practicable and in any event within 28 days of receiving the out of hours opt out notice, the Health Board shall approve the notice and specify in accordance with sub-paragraphs (6) and (7) the date on which the out of hours opt out is to commence (“OOH day”) and the Health Board shall notify the contractor in writing of its decision as soon as possible, including reasons for its decision.

(6) Subject to sub-paragraph (7), OOH day shall be—

(a) the date specified in the out of hours opt out notice; or

(b) any other date before 2nd January 2005.

(7) A Health Board may not specify under sub-paragraph (5) a date earlier than the date specified in the out of hours opt out notice.

(8) A contractor may not withdraw an out of hours opt out notice once it has been approved by a Health Board under sub-paragraph (5) without the Health Board’s agreement.

(9) Following receipt of the out of hours opt out notice, the Health Board must use its reasonable endeavours to make arrangements for the contractor’s registered patients to receive the out of hours services from an alternative provider from OOH day.

(10) The contractor’s duty to provide the out of hours services shall terminate on OOH day unless the Health Board—

(a) serves notice under sub-paragraph (11) (extending OOH day to OOHB day or OOHC day); or

(b) makes an application under sub-paragraph (14) (seeking the approval of the assessment panel to a decision to refuse an opt out or to delay the taking of effect of an opt out until after OOH day).

(11) If the Health Board is not successful in finding an alternative provider to take on the provision of the out of hours services from OOH day, then it shall notify the contractor in writing of this fact no later than one month before OOH day, and—

(a) in a case where OOH day is three months after service of the out of hours opt out notice, the contractor shall continue to provide the out of hours services until OOHB day unless at least one month before OOHB day the contractor receives a notice in writing from the Health Board under sub-paragraph (13) that despite using its reasonable endeavours, the Board has failed to find an alternative provider to take on the provision of the out of hours services from OOHB day;

(b) in a case where OOH day is after the day three months after the service of the out of hours opt out notice, the contractor shall continue to provide the out of hours services until OOHC day (which shall be specified by the Health Board in accordance with sub-paragraph (12) and included in its notice to the contractor under this sub-paragraph) unless at least one month before OOHC day the contractor receives a notice from the Health Board under sub-paragraph (16) that it has made an application to the assessment panel under sub-paragraph (14) seeking the panel’s approval to a decision to refuse an opt out or to delay the commencement of the opt out until after OOHC day.

(12) OOHC day shall be any day before 2nd January 2005 or the day nine months after the service of the out of hours opt out notice.

(13) Where in accordance with sub-paragraph (11)(a) the out of hours opt out is to commence on OOHB day and the Health Board, despite using its reasonable endeavours has failed to find an alternative provider to take on the provision of the out of hours services from that day, it shall notify the contractor in writing of this fact at least one month before OOHB day, in which case the contractor shall continue to provide the out of hours service until OOHC day (which shall be specified by the Health Board in accordance with sub-paragraph (12) and included in its notice to the contractor under this sub-paragraph) unless at least one month before OOHC day the contractor receives a notice from the Health Board under sub-paragraph (16) that it has applied to the assessment panel under sub-paragraph (14) seeking the approval of the assessment panel to a decision to refuse an opt out or to postpone the commencement of an opt out until after OOHC day.

(14) The Health Board may, if it considers there are exceptional circumstances, make an application to the assessment panel for approval of a decision to—

(a) refuse an opt out; or

(b) postpone the commencement of an opt out until after—

(i) OOHC day, or

(ii) OOH day where OOH day is 1st January 2005 and 1st January 2005 is nine months or more after the date of the out of hours opt out notice.

(15) Where OOH day is 1st January 2005, and 1st January 2005 is nine months or more after the date of the out of hours opt out notice, an application under sub-paragraph (14) shall be made at least one month before OOH day.

(16) As soon as practicable after making an application under sub-paragraph (14) to the assessment panel, the Health Board shall notify the contractor in writing that it has made such an application.

(17) Sub-paragraphs (12) to (24) of paragraph 3 shall apply to an out of hours opt out as they apply to a permanent opt out and as if the reference to “C day” was a reference to OOHC day or OOH day where OOH day is 1st January 2005 and 1st January 2005 is nine months or more after the date of the out of hours opt out notice.

Informing patients of opt-outs

6

(1) Prior to any opt out taking effect, the Health Board and the contractor shall discuss how to inform patients of the proposed opt out.

(2) The contractor shall, if requested by the Health Board inform the contractor’s registered patients of an opt out and the arrangements made for them to receive the additional service or out of hours services by—

(a) placing a notice in the practice’s waiting room; or

(b) including the information in the practice leaflet.

(3) In this paragraph “opt out” means an out of hours opt out, a permanent opt out or a temporary opt out.

SCHEDULE 3 — LIST OF PRESCRIBED MEDICAL CERTIFICATES

1

To support a claim or to obtain payment either personally or by proxy; to prove incapacity to work or for self-support for the purposes of an award by the Secretary of State; or to enable proxy to draw pensions etc.

2

To establish pregnancy for the purpose of obtaining welfare foods.

3

To secure registration of still-birth.

4

To enable payment to be made to an institution or other person in case of mental disorder of persons entitled to payment from public funds.

5

To establish unfitness for jury service.

6

To support late application for reinstatement in civil employment or notification of non-availability to take up employment owing to sickness.

7

To enable a person to be registered as an absent voter on grounds of physical incapacity.

8

To support applications for certificates conferring exemption from charges in respect of drugs, medicines and appliances.

9

To support a claim by or on behalf of a severely mentally impaired person for exemption from liability to pay the Council Tax or eligibility for a discount in respect of the amount of Council Tax payable.

SCHEDULE 4 — FEES AND CHARGES

1

The contractor may demand or accept a fee or other remuneration—

(a) from any statutory body for services rendered for the purposes of that body’s statutory functions;

(b) from any body, employer or school for a routine medical examination of persons for whose welfare the body, employer or school is responsible, or an examination of such persons for the purpose of advising the body, employer or school of any administrative action they might take;

(c) for treatment which is not primary medical services or otherwise required to be provided under the contract and which is given—

(i) pursuant to the provisions of section 57 of the Act[^f00075] (accommodation and services for private patients), or

(ii) in accommodation provided by a care home service which is not providing services under the Act,

if, in either case, the person providing the treatment is serving on the staff of a hospital providing services under the Act as a specialist providing treatment of the kind the patient requires and if, within 7 days of giving the treatment, the contractor or the person providing the treatment supplies the Health Board, on a form provided by it for the purpose, with such information about the treatment as it may require;

(d) under section 158 of the Road Traffic Act 1988 (payment for emergency treatment of traffic casualties)[^f00076];

(e) when the contractor treats a patient under regulation 24(3), in which case the contractor shall be entitled to demand and accept a reasonable fee (recoverable in certain circumstances under regulation 24(4)) for any treatment given, if the contractor gives the patient a receipt;

(f) for attending and examining (but not otherwise treating) a patient—

(i) at the patient’s request at a police station in connection with possible criminal proceedings against the patient,

(ii) at the request of a commercial, educational or not-for-profit organisation for the purpose of creating a medical report or certificate,

(iii) for the purpose of creating a medical report required in connection with an actual or potential claim for compensation by the patient;

(g) for treatment consisting of an immunisation for which no remuneration is payable by the Health Board and which is requested in connection with travel abroad;

(h) for prescribing or providing drugs, medicines or appliances (including a collection of such drugs, medicines and appliances in the form of a travel kit) which a patient requires to have in his possession solely in anticipation of the onset of an ailment or occurrence of an injury while he is outside the United Kingdom but for which he is not requiring treatment when the medicine is prescribed;

(i) for a medical examination—

(i) to enable a decision to be made whether or not it is inadvisable on medical grounds for a person to wear a seat belt, or

(ii) for the purpose of creating a report—

(aa) relating to a road traffic accident or criminal assault, or

(bb) that offers an opinion as to whether a patient is fit to travel;

(j) for testing the sight of a person to whom none of the paragraphs (a), (b) or (c) of section 26(1) of the Act[^f00077] (arrangements for general ophthalmic services) applies (including by reason of regulations under section 26(1E)[^f00078]) of the Act;

(k) where the contractor is authorised or required by a Health Board under the contract in accordance with paragraph 44 of Schedule 5 to provide drugs, medicines or appliances to a patient and provides for that patient, otherwise than by way of pharmaceutical services, any Scheduled drug; and

(l) for prescribing or providing drugs or medicines for malaria chemoprophylaxis.

SCHEDULE 5 — OTHER CONTRACTUAL TERMS

PART 1 — Provision of Services

Premises

1

Subject to any plan which is included in the contract pursuant to regulation 18(3), the contractor shall ensure that the premises used for the provision of services under the contract are—

(a) suitable for the delivery of those services; and

(b) sufficient to meet the reasonable needs of the contractor’s patients.

Attendance at practice premises

2

(1) The contractor shall take steps to ensure that any patient who—

(a) has not previously made an appointment; and

(b) attends at the practice premises during the normal hours for essential services,

is provided with such services by an appropriate health care professional during that surgery period except in the circumstances specified in sub-paragraph (2).

(2) The circumstances referred to in sub-paragraph (1) are that—

(a) it is more appropriate for the patient to be referred elsewhere for services under the Act; or

(b) the patient is then offered an appointment to attend again within a time which is appropriate and reasonable having regard to all the circumstances and the patient’s health would not thereby be jeopardised.

Attendance outside practice premises

3

(1) In the case of a patient whose medical condition is such that in the reasonable opinion of the contractor—

(a) attendance on the patient is required; and

(b) it would be inappropriate for the patient to attend at the practice premises,

the contractor shall provide services to that patient at whichever in its judgement is the most appropriate of the places set out in sub-paragraph (2).

(2) The places referred to in sub-paragraph (1) are—

(a) the place recorded in the patient’s medical records as being the patient’s last home address;

(b) such other place as the contractor has informed the patient and the Health Board is the place where the contractor has agreed to visit and treat the patient; or

(3) Nothing in this paragraph prevents the contractor from—

(a) arranging for the referral of a patient without first seeing the patient, in a case where the medical condition of that patient makes that course of action appropriate; or

(b) visiting the patient in circumstances where this paragraph does not place it under an obligation to do so.

Newly registered patients

4

(1) Where a patient has been—

(a) accepted on a contractor’s list of patients under paragraph 15; or

(b) assigned to that list by the Health Board,

the contractor shall, in addition to and without prejudice to its other obligations in respect of that patient under the contract, invite the patient to participate in a consultation either at the contractor’s practice premises or, if the medical condition of the patient so warrants, at one of the places referred to in paragraph 3(2).

(2) An invitation under sub-paragraph (1) shall be issued within six months of the date of the acceptance of the patient on, or their assignment to, the contractor’s list.

(3) Where a patient (or, where appropriate, in the case of a patient who is a child, the child’s parent) agrees to participate in a consultation mentioned in sub-paragraph (1) the contractor shall, in the course of that consultation make such inquiries and undertake such examinations as appear to it to be appropriate in all the circumstances.

Patients not seen within 3 years

5

(1) Where a registered patient who—

(a) has attained the age of 16 years but has not attained the age of 75 years; and

(b) has attended neither a consultation with, nor a clinic provided by, the contractor within the preceding 3 years prior to the date of the patient’s request,

requests a consultation the contractor shall, in addition and without prejudice to the contractor’s other obligations in respect of that patient under the contract, provide such a consultation in the course of which the contractor shall make such inquiries and undertake such examinations as appear to the contractor to be appropriate in all the circumstances.

Patients aged 75 years and over

6

(1) Where a registered patient who—

(a) has attained the age of 75 years; and

(b) has not participated in a consultation under this paragraph within the period of twelve months prior to the date of the patient’s request,

requests a consultation, the contractor shall, in addition and without prejudice to its other obligations in respect of that patient under the contract, provide such a consultation in the course of which it shall make such inquiries and undertake such examinations as appear to it to be appropriate in all the circumstances.

(2) A consultation under sub-paragraph (1) shall take place in the home of the patient where, in the reasonable opinion of the contractor, it would be inappropriate, as a result of the patient’s medical condition, for the patient to attend at the practice premises.

Clinical reports

7

(1) Where the contractor provides any clinical services, other than under a private arrangement, to a patient who is not on the contractor’s list of patients, the contractor shall, as soon as reasonably practicable, provide a clinical report relating to the consultation, and any treatment provided, to the Health Board.

(2) The Health Board shall send any report received under sub-paragraph (1)—

(a) to the person with whom the patient is registered for the provision of essential services or their equivalent; or

(b) if the person referred to in paragraph (a) is not known to it, to the Health Board in whose area the patient is resident.

Storage of vaccines

8

The contractor shall ensure that—

(a) all vaccines are stored in accordance with the manufacturer’s instructions; and

(b) all refrigerators in which vaccines are stored have a maximum/minimum thermometer and that readings are taken on all working days.

Infection control

9

The contractor shall ensure that it has appropriate arrangements for infection control and decontamination.

Criteria for out of hours services

10

A contractor whose contract includes the provision of out of hours services shall only be required to provide such services if, in the reasonable opinion of the contractor in the light of the patient’s medical condition, it would not be reasonable in all the circumstances for the patient to wait for the services required until the next time at which the patient could obtain such services during core hours.

Standards for out of hours services

11

From 1st January 2005, a contractor which provides out of hours services must, in the provision of such services, meet the quality standards set out from time to time in guidance which has been issued to Health Boards by NHS Quality Improvement Scotland and notified in writing to the contractor by the Health Board.

Duty of co-operation in relation to additional, enhanced and out of hours services

12

(1) A contractor which does not provide to its registered patients or to persons whom it has accepted as temporary residents—

(a) a particular additional service;

(b) a particular enhanced service; or

shall comply with the requirements specified in sub-paragraph (2).

(2) The requirements referred to in sub-paragraph (1) are that the contractor shall—

(a) co-operate, insofar as it is reasonable, with any person responsible for the provision of that service or those services;

(b) comply in core hours with any reasonable request for information from such a person or from the Health Board relating to the provision of that service or those services; and

(c) in the case of out of hours services, take reasonable steps to ensure that any patient who contacts the practice premises during the out of hours period is provided with information about how to obtain services during that period.

(3) Nothing in this paragraph shall require a contractor whose contract does not include the provision of out of hours services to make itself available during the out of hours period.

Duty of co-operation in relation to additional, enhanced and out of hours services

13

Where a contractor is to cease to be required to provide to its patients—

(a) a particular additional service;

(b) a particular enhanced service; or

it shall comply with any reasonable request for information relating to the provision of that service or those services made by the Health Board or by any person with whom the Board intends to enter into a contract for the provision of such services.

PART 2 — Patients

List of patients

14

The Health Board shall prepare and keep up to date a list of the patients—

(a) who have been accepted by the contractor for inclusion in its list of patients under paragraph 15 and who have not subsequently been removed from that list under paragraphs 19 to 27; and

(b) who have been assigned to the contractor under paragraph 32 or 33 and whose assignment has not subsequently been rescinded.

Application for inclusion in a list of patients

15

(1) The contractor may, if its list of patients is open, accept an application for inclusion in its list of patients made by or on behalf of any person whether or not resident in its practice area or included, at the time of that application, in the list of patients of another contractor or provider of primary medical services.

(2) The contractor may, if its list of patients is closed, only accept an application for inclusion in its list of patients from a person who is an immediate family member of a registered patient whether or not resident in its practice area or included, at the time of that application, in the list of patients of another contractor or provider of primary medical services.

(3) Subject to sub-paragraph (4), an application for inclusion in a contractor’s list of patients shall be made by delivering to the practice premises a medical card or an application signed (in either case) by the applicant or a person authorised by the applicant to sign on the applicant’s behalf.

(4) An application may be made—

(a) on behalf of any child—

(i) by either parent, or in the absence of both parents, the guardian or other adult person who has care of the child,

(ii) by a person duly authorised by a local authority, where the child is in the care of a local authority under the Children (Scotland) Act 1995[^f00079]; or

(iii) by a person duly authorised by a voluntary organisation, by which the child is being accommodated under the provisions of that Act; or

(b) on behalf of any adult who is incapable of making such an application, or authorising such an application to be made on their behalf, by the primary carer of that person or by the person authorised under the Adults with Incapacity (Scotland) Act 2000[^f00080] to act on the patient’s behalf.

(5) A contractor which accepts an application for inclusion in its list of patients shall notify the Health Board in writing as soon as possible.

(6) On receipt of a notice under sub-paragraph (5), the Health Board shall-

(a) include that person in the contractor’s list of patients from the date on which the notice is received; and

(b) notify the applicant (or, in the case of a child or incapable adult, the person making the application on their behalf) of the acceptance.

Temporary residents

16

(1) The contractor may, if its list of patients is open, accept a person as a temporary resident provided it is satisfied that the person is—

(a) temporarily resident away from the person’s normal place of residence and is not being provided with essential services (or their equivalent) under any other arrangement in the locality where the person is temporarily residing; or

(b) moving from place to place and not for the time being resident in any place.

(2) For the purposes of sub-paragraph (1), a person shall be regarded as temporarily resident in a place if, when the person arrives in that place, the person intends to stay there for more than 24 hours but not more than three months.

(3) A contractor which wishes to terminate its responsibility for a person accepted as a temporary resident before the end of—

(a) three months; or

(b) such shorter period for which it agreed to accept the person as a patient,

shall notify the person either orally or in writing and its responsibility for that patient shall cease 7 days after the date on which the notification was given.

(4) At the end of three months, or on such earlier date as its responsibility for the temporary resident has come to an end, the contractor shall notify the Health Board in writing of any person whom it accepted as a temporary resident.

Refusal of application for inclusion in the list of patients or for acceptance as a temporary resident

17

(1) The contractor shall only refuse an application made under paragraph 15 or 16 if it has reasonable grounds for doing so which do not relate to the applicant’s race, gender, social class, age, religion, sexual orientation, appearance, disability or medical condition.

(2) The reasonable grounds referred to in paragraph (1) shall, in the case of applications made under paragraph 15, include the ground that the applicant does not live in the contractor’s practice area.

(3) A contractor which refuses an application made under paragraph 15 or 16 shall, within 14 days of its decision, notify the applicant (or, in the case of a child or incapable adult, the person making the application on their behalf) in writing of the refusal and the reason for it.

(4) The contractor shall keep a written record of refusals of applications made under paragraph 15 and of the reasons for them and shall make this record available to the Health Board on request.

Patient preference of practitioner

18

(1) Where the contractor has accepted an application for inclusion in its list of patients, it shall—

(a) notify the patient (or, in the case of a child or incapable adult, the person who made the application on their behalf) of the patient’s right to express a preference to receive services from a particular performer or class of performer either generally or in relation to any particular condition; and

(b) record in writing any such preference expressed by or on behalf of the patient.

(2) The contractor shall endeavour to comply with any reasonable preference expressed under sub-paragraph (1) but need not do so if the preferred performer—

(a) has reasonable grounds for refusing to provide services to the patient; or

(b) does not routinely perform the service in question within the practice.

Removal from the list at the request of the patient

19

(1) The contractor shall notify the Health Board in writing of any request for removal from its list of patients received from a registered patient.

(2) Where the Health Board—

(a) receives notification from the contractor under sub-paragraph (1); or

(b) receives a request from the patient to be removed from the contractor’s list of patients,

it shall remove that person from the contractor’s list of patients.

(3) A removal in accordance with sub-paragraph (2) shall take effect—

(a) on the date on which the Health Board received notification of the registration of the person with another provider of essential services (or their equivalent); or

(b) 14 days after the date on which the notification or request made under sub-paragraph (1) or (2) respectively is received by the Health Board,

whichever is the sooner.

(4) The Health Board shall, as soon as practicable, notify in writing—

(a) the patient; and

(b) the contractor,

that the patient’s name will be or has been removed from the contractor’s list of patients on the date referred to in sub-paragraph (3).

(5) In this paragraph and in paragraphs 20(1)(b) and (10), 21(6) and (7), 23 and 26, a reference to a request received from or advice, information or notification required to be given to a patient shall include a request received from or advice, information or notification required to be given to—

(a) in the case of a patient who is a child, a parent or other person referred to in paragraph 15(4)(a); or

(b) in the case of an adult patient who is incapable of making the relevant request or receiving the relevant advice, information or notification, a relative or the primary carer of the patient.

Removal from the list at the request of the contractor

20

(1) Subject to paragraph 21, a contractor which has reasonable grounds for wishing a patient to be removed from its list of patients which do not relate to the applicant’s race, gender, social class, age, religion, sexual orientation, appearance, disability or medical condition shall—

(a) notify the Health Board in writing that it wishes to have the patient removed; and

(b) subject to sub-paragraph (2), notify the patient of its specific reasons for requesting removal.

(2) Where, in the reasonable opinion of the contractor—

(a) the circumstances of the removal are such that it is not appropriate for a more specific reason to be given; and

(b) there has been an irrevocable breakdown in the relationship between the patient and the contractor,

the reason given under sub-paragraph (1) may consist of a statement that there has been such a breakdown.

(3) Except in the circumstances described in sub-paragraph (4), a contractor may only request a removal under sub-paragraph (1) if, within the period of twelve months prior to the date of its request to the Health Board, it has warned the patient that the patient is at risk of removal and explained to him the reasons for this.

(4) The circumstances referred to in sub-paragraph (3) are that—

(a) the reason for the removal relates to a change of address;

(b) the contractor has reasonable grounds for believing that the issue of such a warning would—

(i) be harmful to the physical or mental health of the patient; or

(ii) put at risk the safety of the persons specified in sub-paragraph (5); or

(5) The persons referred to in sub-paragraph (4) are—

(a) in the case of a contract with an individual medical practitioner, that practitioner;

(b) in the case of a contract with a partnership, a partner in that partnership;

(d) a member of the contractor’s staff;

(e) a person engaged by the contractor to perform or assist in the performance of services under the contract; or

(f) any other person present—

(i) on the practice premises, or

(ii) in the place where services are being provided to the patient under the contract.

(6) The contractor shall record in writing—

(a) the date of any warning given in accordance with sub-paragraph (3) and the reasons for giving such a warning as explained to the patient; or

(b) the reason why no such warning was given.

(7) The contractor shall keep a written record of removals under this paragraph which shall include—

(a) the reason for removal given to the patient;

(b) the circumstances of the removal; and

and shall make this record available to the Health Board on request.

(8) A removal requested in accordance with sub-paragraph (1) shall, subject to sub-paragraph (9) take effect from—

(a) the date on which the Health Board receives notification of the registration of the person with another provider of essential services (or their equivalent); or

(b) the eighth day after the Health Board receives the notice referred to in sub-paragraph (1)(a),

whichever is the sooner.

(9) Where, on the date on which the removal would take effect under sub-paragraph (8), the contractor is treating the patient at intervals of less than 7 days, the contractor shall notify the Health Board in writing of the fact and the removal shall take effect—

(a) on the eighth day after the Health Board receives notification from the contractor that the person no longer needs such treatment; or

(b) on the date on which the Health Board receives notification of the registration of the person with another provider of essential services (or their equivalent),

whichever is the sooner.

(10) The Health Board shall notify in writing—

(a) the patient; and

(b) the contractor,

that the patient’s name has been or will be removed from the contractor’s list of patients on the date referred to in sub-paragraph (8) or (9).

Removal from the list of patients who are violent

21

(1) A contractor which wishes a patient to be removed from its list of patients with immediate effect on the grounds that—

(a) the patient has committed an act of violence against any of the persons specified in sub-paragraph (2) or behaved in such a way that any such person has feared for that person’s own safety; and

(b) the contractor has reported the incident to the police or the Procurator Fiscal,

shall notify the Health Board in accordance with sub-paragraph (3).

(2) The persons referred to in sub-paragraph (1) are—

(a) in the case of a contract with an individual medical practitioner, that practitioner;

(b) in the case of a contract with a partnership, a partner in that partnership;

(d) a member of the contractor’s staff;

(e) a person engaged by the contractor to perform or assist in the performance of services under the contract; or

(f) any other person present—

(i) on the practice premises or

(ii) in the place where services were provided to the patient under the contract.

(3) Notification under sub-paragraph (1) may be given by any means including telephone or fax but if not given in writing shall subsequently be confirmed in writing within 7 days (and for this purpose a faxed notification or transmission by electronic means is not a written one).

(4) The Health Board shall acknowledge in writing receipt of a request from the contractor under sub-paragraph (1).

(5) A removal requested in accordance with sub-paragraph (1) shall take effect at the time that the contractor—

(a) makes the telephone call to the Health Board; or

(b) sends or delivers the notification to the Health Board.

(6) Where, pursuant to this paragraph, the contractor has notified the Health Board that it wishes to have a patient removed from the contractor’s list of patients with immediate effect, it shall inform the patient concerned unless—

(a) it is not reasonably practicable for it to do so; or

(b) it has reasonable grounds for believing that to do so would—

(i) be harmful to the physical or mental health of the patient; or

(ii) put at risk the safety of one or more of the persons specified in sub-paragraph (2).

(7) Where the Health Board has removed a patient from the contractor’s list of patients in accordance with sub-paragraph (5), it shall give written notice of the removal to that patient.

(8) Where a patient is removed from the contractor’s list of patients in accordance with this paragraph, the contractor shall record in the patient’s medical records that the patient has been removed under this paragraph and the circumstances leading to the patient’s removal.

Removals from the list of patients registered elsewhere

22

(1) The Health Board shall remove a patient from the contractor’s list of patients if—

(a) the patient has subsequently been registered with another provider of essential services (or their equivalent) in the area of the Health Board; or

(b) it has received notice from another Health Board, Primary Care trust, Local Health Board, or a Health and Social Services Board that the patient has subsequently been registered with a provider of essential services (or their equivalent) outside the area of the Health Board.

(2) A removal in accordance with sub-paragraph (1) shall take effect—

(a) on the date on which the Health Board receives notification of the registration of the person with the new provider; or

(b) with the consent of the Health Board, on such other date as has been agreed between the contractor and the new provider.

(3) The Health Board shall notify the contractor in writing of patients removed from its list of patients under sub-paragraph (1).

Removals from the list of patients who have moved

23

(1) Subject to sub-paragraph (2), where the Health Board is satisfied that a person on the contractor’s list of patients has moved and no longer resides in that contractor’s practice area, the Board shall—

(a) inform that patient and the contractor that the contractor is no longer obliged to visit and treat the person;

(b) advise the patient in writing either to obtain the contractor’s agreement to the continued inclusion of the person on its list of patients or to apply for registration with another provider of essential services (or their equivalent); and

(c) inform the patient that if, after the expiration of 30 days from the date of the letter of advice mentioned in paragraph (b), the patient has not acted in accordance with the advice and informed the Board accordingly, the Health Board will remove the patient from the contractor’s list of patients.

(2) If, at the expiration of the period of 30 days referred to in sub-paragraph (1)(c), the Health Board has not been notified of the action taken, it shall remove the patient from the contractor’s list of patients and inform the patient and the contractor accordingly.

Removals from the list of patients who have moved

24

Where the address of a patient who is on the contractor’s list of patients is no longer known to the Health Board, the Health Board shall—

(a) give to the contractor notice in writing that it intends, at the end of the period of six months commencing with the date of the notice, to remove the patient from the contractor’s list of patients; and

(b) at the end of that period, remove the patient from the contractor’s list of patients unless, within that period, the contractor satisfies the Health Board that it is still responsible for providing essential services to that patient.

Removals from the list of patients absent from the United Kingdom etc.

25

(1) The Health Board shall remove a patient from the contractor’s list of patients where it receives notification that that patient—

(a) intends to be away from the United Kingdom for a period of at least three months;

(b) is in Her Majesty’s Forces;

(d) has died.

(2) A removal in accordance with sub-paragraph (1) shall take effect—

(a) in the cases referred to in sub-paragraph (1)(a) and (b) from the date of the departure or enlistment or the date on which the Health Board first receives notification of the departure or enlistment, whichever is the later; or

(b) in the cases referred to in sub-paragraph (1) (c) and (d) from the date on which the Health Board first receives notification of the absence or death.

(3) The Health Board shall notify the contractor in writing of patients removed from its list of patients under sub-paragraph (1).

Removals from the list of patients accepted elsewhere as temporary residents

26

(1) The Health Board shall remove from the contractor’s list of patients a patient who has been accepted as a temporary resident by another contractor or other provider of essential services (or their equivalent) where it is satisfied, after due inquiry—

(a) that the person’s stay in the place of temporary residence has exceeded three months; and

(b) that the patient has not returned to the patient’s normal place of residence or any other place within the contractor’s practice area.

(2) The Health Board shall notify in writing of a removal under sub-paragraph (1)—

(a) the contractor; and

(b) where practicable, the patient.

(3) A notification to the patient under sub-paragraph (2)(b) shall inform the patient of—

(a) the patient’s entitlement to make arrangements for the provision to the patient of essential services (or their equivalent), including by the contractor by which the patient has been treated as a temporary resident; and

(b) the name and address of the Health Board in whose area the patient is resident.

Removals from the list of pupils etc. of a school

27

(1) Where the contractor provides essential services under the contract to persons on the grounds that they are pupils at or staff or residents of a school, the Health Board shall remove from the contractor’s list of patients any such persons who do not appear on particulars of persons who are pupils at or staff or residents of that school provided by that school.

(2) Where the Health Board has made a request to a school to provide the particulars mentioned in sub-paragraph (1) and has not received them, it shall consult the contractor as to whether it should remove from its list of patients any persons appearing on that list as pupils at, or staff or residents of, that school.

(3) The Health Board shall notify the contractor in writing of patients removed from its list of patients under sub-paragraph (1).

Termination of responsibility for patients not registered with the contractor

28

(1) Where a contractor—

(a) has received an application for the provision of medical services other than essential services—

(i) from a person who is not included in its list of patients, or

(ii) from a person whom the contractor has not accepted as a temporary resident, or

(iii) on behalf of a person mentioned in (i) or (ii) above, from one of the persons specified in paragraph 15(4); and

(b) has accepted that person as a patient for the provision of the service in question,

its responsibility for that patient shall be terminated in one of the circumstances referred to in sub-paragraph (2).

(2) The circumstances referred to in sub-paragraph (1) are—

(a) the patient informs the contractor that the patient no longer wishes it to be responsible for provision of the service in question;

(b) in cases where the contractor has reasonable grounds for terminating its responsibility which do not relate to the person’s race, gender, social class, age, religion, sexual orientation, appearance, disability or medical condition, the contractor informs the patient that it no longer wishes to be responsible for providing the patient with the service in question; or

(i) no longer resides in the area for which the contractor has agreed to provide the service in question; or

(ii) is no longer included in the list of patients of another contractor to whose registered patients the contractor has agreed to provide that service.

(3) A contractor which wishes to terminate its responsibility for a patient under sub-paragraph (2)(b) shall notify the patient of the termination and the reason for it.

(4) The contractor shall keep a written record of terminations under this paragraph and of the reasons for them and shall make this record available to the Health Board on request.

(5) A termination under sub-paragraph (2)(b) shall take effect—

(a) from the date on which the notice is given where the grounds for termination are those specified in paragraph 21(1); or

(b) in all other cases, 14 days from the date on which the notice is given.

Closure of lists of patients

29

(1) A contractor which wishes to close its list of patients shall notify the Health Board in writing to that effect.

(2) Within a period of 7 days beginning with the date of receipt of the notification referred to in sub-paragraph (1), or, if that is not reasonably practicable, as soon as is practicable thereafter, the Health Board shall 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 shall use reasonable endeavours to achieve the aim of keeping the contractor’s list of patients open.

(4) The discussions mentioned in sub-paragraph (2) shall be completed within a period of 28 days 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) 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 shall send full details of the agreement in writing to the contractor.

(6) The Health Board and the contractor shall comply with the terms of an agreement reached as mentioned in sub-paragraph (5).

(7) 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 shall send a closure notice to the Health Board.

(8) A closure notice shall be submitted in the form specified in Schedule 7, and shall include the following details which (in a case falling within sub-paragraph (7)(a)) have been agreed between the parties or (in a case falling within sub-paragraph (7)(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.

(9) The Health Board shall forthwith acknowledge receipt of the closure notice in writing to the contractor.

(10) Before the Health Board reaches a decision as to whether to approve or reject the closure notice under sub-paragraph (12), the Health Board and the contractor may enter into further discussions concerning the details of the closure notice as specified in sub-paragraph (8), 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 shall be twelve months.

(11) A contractor may not withdraw a closure notice 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.

(12) Within a period of 14 days beginning with the date of receipt of the closure notice, the Health Board shall—

(a) approve the closure notice; or

(b) reject the closure notice,

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

(13) Approval of the closure notice under sub-paragraph (12)(a) includes approval of the details specified in accordance with sub-paragraph (8) (or, where those details are revised following discussions under sub-paragraph (10), approval of those details as so revised).

Approval of closure notice by the Health Board

30

(1) If the Health Board approves the closure notice in accordance with paragraph 29(12)(a), the contractor shall 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 shall remain closed for the period specified in the closure notice in accordance with paragraph 29(8)(a) (or, where a period of twelve months has been fixed in accordance with paragraph 29(10), for that period).

(3) The contractor’s list of patients shall 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 29(8)(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 shall nevertheless close again if, during the period specified in the closure notice in accordance with paragraph 29(8)(a) (or, where the period of twelve months specified in paragraph 29(10) 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 29(8)(d).

(5) Except in cases where the contractor’s list of patients is already open pursuant to sub-paragraph (3), the Health Board shall 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 in accordance with paragraph 29(8) have been revised following discussions under paragraph 29(10), 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

31

(1) This regulation applies where the Health Board rejects the closure notice in accordance with paragraph 29(12)(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 shall provide the assessment panel with such information as the assessment panel may reasonably require to enable the panel to reach a determination and shall include in such information any written observations received from the contractor.

(5) At least one member of the assessment panel shall 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 shall—

(a) approve the list closure; or

(b) reject the list closure,

and shall 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 shall specify—

(a) a date from which the closure shall 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 29(8).

(8) Where the assessment panel rejects the list closure in accordance with sub-paragraph (6)(b), that list shall remain open, and the Health Board and the contractor shall 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.

(9) 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 29 until—

(a) the expiry of a period of three 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.

(10) 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

32

(1) A Health Board may, subject to paragraph 34, assign a new patient to a contractor whose list of patients is open.

(2) In this paragraph and in paragraphs 33 and 35 to 37, 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

33

(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 34, 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 35(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 36(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 37.

Factors relevant to assignments

34

In making an assignment to a contractor under paragraph 32 or 33, the Health Board shall 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 20 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 21 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;

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

Assignments to closed lists: determinations of the assessment panel

35

(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 shall 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 shall 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 shall reach a determination within the period of 28 days beginning with the date on which the panel was appointed.

(7) The assessment panel shall 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 shall 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 shall include its comments on the matters specified in sub-paragraph (5), and shall 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

36

(1) Where an assessment panel makes a determination under paragraph 35(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 35(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 shall 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 shall 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 36(1)”;

(b) for paragraph 91(4) substitute—

(4) The contractor (or contractors) wishing to refer the matter as mentioned in paragraph 36(1) 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 35(7).

(13) In this paragraph, “specified period” means such period as the Scottish Ministers shall 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 it 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), there shall be inserted the following sub-paragraphs—

(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 shall 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 shall 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 35(7). (18) In the case of a matter referred jointly by contractors in accordance with paragraph 36(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 (15) 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) shall not apply.

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

37

(1) Before the Health Board may assign a new patient to a contractor, it shall, 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 shall use its best endeavours to provide appropriate support.

(2) In the discussions referred to in sub-paragraph (1), both parties shall 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.

PART 3 — Prescribing and Dispensing

Prescribing

38

The contractor shall ensure that any prescription form for drugs, medicines or appliances issued 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 shall order any drugs, medicines or appliances which are needed for the treatment of any patient who is receiving treatment under the contract by issuing to that patient a prescription form and such a prescription form shall not be used in any other circumstances.

(2) In issuing any such prescription form, the prescriber shall 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 shall so sign only after particulars of the order have been inserted in the prescription form, and:

(a) the prescription form shall not refer to any previous prescription form ; and

(b) a separate prescription form shall be used for each patient.

(3) In a case of urgency a prescriber may request a pharmacist to dispense a drug or medicine before a prescription form is issued, 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 1971[^f00081] other than a drug which is for the time being specified in Schedules 4 or 5 to the Misuse of Drugs Regulations 2001[^f00082]; and

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

(4) In a case of urgency a prescriber may request a pharmacist to dispense an appliance before a prescription form is issued 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 to 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).

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 shall 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)[^f00083] 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 24(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 shall 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 24(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 shall 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 endorses the face of the form with the reference “SLS”,

but may, subject to regulation 24(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 shall have arrangements in place to secure that a supplementary prescriber will—

(a) give 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 article 3B(3) of the POM Order (prescribing and administration by supplementary prescribers)[^f00084], unless those conditions do not apply by virtue of any of the exemptions set out in the subsequent provisions of that Order;

(b) the medicine is not a controlled drug within the meaning of the Misuse of Drugs Act 1971;

(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 may not be ordered for patients in the provision of medical services under the contract;

(d) 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 giving a prescription, the supplementary prescriber endorses the face of the form with the reference “SLS”.

(3) Where the functions of a supplementary prescriber include prescribing, the contractor shall have arrangements in place to secure that that person will only give 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 medicine, the medicine is not a controlled drug within the meaning of the Misuse of Drugs Act 1971;

(d) 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 medical services under the contract;

(e) 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 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) when giving the prescription, the supplementary prescriber endorses the face of the form with the reference “SLS”;

(f) if it is a prescription for a medicine—

(i) the medicine is the subject of a product licence, a marketing authorisation or a homeopathic certificate of registration granted by the licensing authority or the European Commission, or

(ii) subject to paragraph (6), the use of the medicine is for the purposes of a clinical trial, and

(aa) that trial is the subject of a clinical trial certificate issued in accordance with the Medicines Act 1968[^f00085], or

(bb) a clinical trial certificate is not needed in respect of that trial by virtue of any exemption conferred by or under that Act;

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

(h) 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 giving the prescription, the supplementary prescriber endorses the face of the form with 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

(6) In relation to any time from the coming into force of any regulations made by the Secretary of State under section 2(2) of the European Communities Act 1972 (general implementation of treaties)[^f00086] to implement Directive 2001/83/EC on the Community code relating to medicinal products for human use[^f00087], sub-paragraph (4)(f)(ii) shall be read as if it referred to a clinical trial which has been authorised, or is treated as having been authorised by the licensing authority for the purposes of those Regulations.

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 shall 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 shall 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 shall 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 shall 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 shall be entitled to 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) Subject to sub-paragraph (6), 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) shall, 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 shall not be required to issue that form to that patient;

(b) shall supply those drugs, medicines or appliances for that patient under sub-paragraph (2) but—

(i) shall 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) shall 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) shall 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.

(5) A contractor shall 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.

(6) Sub-paragraph (4) does not apply to drugs, medicines or appliances ordered on a prescription form by a supplementary prescriber or an independent nurse prescriber.

(7) Where a patient presents an order on a prescription form for listed drugs or medicines, or appliances, signed by a supplementary prescriber or an independent nurse prescriber, to a contractor who is required under sub-paragraph (2) to provide drugs or appliances to that patient, 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.

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

(9) Before supplying the drugs, medicines or appliances recorded on a prescription form in accordance with sub-paragraph (4) or providing the drugs or medicines or appliances ordered on a prescription form signed by a supplementary prescriber or an independent nurse prescriber in accordance with sub paragraph (7) a contractor who is required by the Health Board under sub-paragraph (2) to provide drugs, medicines or appliances to a patient shall request any person who makes a declaration on the prescription form claiming either charge exemption under regulation 7 of the National Health Service (Charges for Drugs and Appliances) (Scotland) Regulations 2001[^f00088] (“the 2001 Regulations”) or charge remission under the National Health Service (Travelling Expenses and Remission of Charges) (Scotland) (No 2) Regulations 2003[^f00089] to provide evidence of the patient’s entitlement to such exemption or remission.

(10) Sub-paragraph (9) shall not apply in respect of claims for exemption under regulation 7(1)(a) to (f) of the 2001 Regulations where the dispensing contractor has information in the contractor’s possession at the time of supplying the item which confirms that the patient is entitled to the exemption claimed.

(11) Where the person presenting the prescription form does not show valid evidence of entitlement and the dispensing contractor, in respect of a claim for exemption made under regulation 7(1)(a) to (f) of the 2001 Regulations does not have evidence in the contractor’s possession to confirm that the patient is entitled to make that claim, the dispensing contractor shall mark the patient’s prescription form accordingly before supplying the prescribed item.

(12) The provisions of regulation 24 (fees and charges) apply in respect of the provision of any drugs, medicines or appliances by a contractor providing dispensing services as they apply in respect of prescriptions for drugs, medicines or appliances.

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

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

45

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

(a) shall 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 a 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 shall, 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 1968[^f00090] 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 shall 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) shall not apply in the case of—

(a) a medical practitioner employed in Scotland, by a Health Board, in England and Wales, by a NHS trust, a NHS foundation trust, or, in Northern Ireland, by a Health and Social Services 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 the Medical Act 1983[^f00092] acting in the course of the person’s employment in a resident medical capacity in an approved medical practice; or

Qualifications of performers

47

No health care professional other than one to whom paragraph 46 applies shall 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 shall ensure compliance with those conditions insofar as they are relevant to the contract.

Qualifications of performers

49

No health care professional shall 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 shall 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;

(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) shall apply with the modifications that—

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