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

Regulation 2

SCHEDULE 1 REPEAT DISPENSING FORMS

PART 1 REPEATABLE PRESCRIPTION

PART 2 BATCH ISSUE

Regulation 16

SCHEDULE 2 ADDITIONAL SERVICES

Additional services generally

1.  The contractor shall provide, in relation to each additional service, such facilities and equipment as are necessary to enable it properly to perform that service.

Cervical screening

2.—(1) A contractor whose contract includes the provision of cervical screening services shall—

(a) provide all the services described in sub-paragraph (2); and

(b) make such records as are referred to in sub-paragraph (3).

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

(a) the provision of any necessary information and advice to assist women identified by the Primary Care Trust as recommended nationally for a cervical screening test in making an informed decision as to participation in the NHS Cervical Screening Programme;

(b) the performance of cervical screening tests on women who have agreed to participate in that Programme;

(c) arranging for women to be informed of the results of the test; and

(d) ensuring that test results are followed up appropriately.

(3) The records referred to in sub-paragraph (1)(b) are an accurate record of the carrying out of a cervical screening test, the result of the test and any clinical follow up requirements.

Contraceptive services

3.—(1) A contractor whose contract includes the provision of contraceptive services shall make available to all its patients who request such services the services described in sub-paragraph (2).

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

(a) the giving of advice about the full range of contraceptive methods;

(b) where appropriate, the medical examination of patients seeking such advice;

(c) the treatment of such patients for contraceptive purposes and the prescribing of contraceptive substances and appliances (excluding the fitting and implanting of intrauterine devices and implants);

(d) the giving of advice about emergency contraception and where appropriate, the supplying or prescribing of emergency hormonal contraception or, where the contractor has a conscientious objection to emergency contraception, prompt referral to another provider of primary medical services who does not have such conscientious objections;

(e) the provision of advice and referral in cases of unplanned or unwanted pregnancy, including advice about the availability of free pregnancy testing in the practice area and, where appropriate, where the contractor has a conscientious objection to the termination of pregnancy, prompt referral to another provider of primary medical services who does not have such conscientious objections;

(f) the giving of initial advice about sexual health promotion and sexually transmitted infections; and

(g) the referral as necessary for specialist sexual health services, including tests for sexually transmitted infections.

Vaccinations and immunisations

4.—(1) A contractor whose contract includes the provision of vaccinations and immunisations shall comply with the requirements in sub-paragraphs (2) and (3).

(2) The contractor shall—

(a) offer to provide to patients all vaccinations and immunisations (excluding childhood vaccinations and immunisations) of a type and in the circumstances for which a fee was provided for under the 2003–04 Statement of Fees and Allowances made under regulation 34 of the National Health Service (General Medical Services) Regulations 1992(1) other than influenza vaccination;

(b) provide appropriate information and advice to patients about such vaccinations and immunisations;

(c) record in the patient’s record kept in accordance with paragraph 73 of Schedule 6 any refusal of the offer referred to in paragraph (a);

(d) where the offer is accepted, administer the vaccinations and immunisations and include in the patient’s record kept in accordance with paragraph 73 of Schedule 6—

(i) the patient’s consent to the vaccination or immunisation or the name of the person who gave consent to the vaccination or immunisation and his relationship to the patient,

(ii) the batch numbers, expiry date and title of the vaccine,

(iii) the date of administration,

(iv) in a case where two vaccines are administered in close succession, the route of administration and the injection site of each vaccine,

(v) any contraindications to the vaccination or immunisation, and

(vi) any adverse reactions to the vaccination or immunisation.

(3) The contractor shall ensure that all staff involved in administering vaccines are trained in the recognition and initial treatment of anaphylaxis.

Childhood vaccinations and immunisations

5.—(1) A contractor whose contract includes the provision of childhood vaccinations and immunisations shall comply with the requirements in sub-paragraphs (2) and (3).

(2) The contractor shall—

(a) offer to provide to children all vaccinations and immunisations of a type and in the circumstances for which a fee was provided for under the 2003–04 Statement of Fees and Allowances made under regulation 34 of the National Health Service (General Medical Services) Regulations 1992;

(b) provide appropriate information and advice to patients and, where appropriate, their parents, about such vaccinations and immunisations;

(c) record in the patient’s record kept in accordance with paragraph 73 of Schedule 6 any refusal of the offer referred to in paragraph (a);

(d) where the offer is accepted, administer the vaccinations and immunisations and include in the patient’s record kept in accordance with paragraph 73 of Schedule 6—

(i) the name of the person who gave consent to the vaccination or immunisation and his relationship to the patient;

(ii) the batch numbers, expiry date and title of the vaccine;

(iii) the date of administration;

(iv) in a case where two vaccines are administered in close succession, the route of administration and the injection site of each vaccine;

(v) any contraindications to the vaccination or immunisation; and

(vi) any adverse reactions to the vaccination or immunisation.

(3) The contractor shall ensure that all staff involved in administering vaccines are trained in the recognition and initial treatment of anaphylaxis.

Child health surveillance

6.—(1) A contractor whose contract includes the provision of child health surveillance services shall, in respect of any child under the age of five for whom it has responsibility under the contract—

(a) provide all the services described in sub-paragraph (2), other than any examination so described which the parent refuses to allow the child to undergo, until the date upon which the child attains the age of five years; and

(b) maintain such records as are specified in sub-paragraph (3).

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

(a) the monitoring—

(i) by the consideration of any information concerning the child received by or on behalf of the contractor, and

(ii) on any occasion when the child is examined or observed by or on behalf of the contractor (whether pursuant to paragraph (b) or otherwise),

of the health, well-being and physical, mental and social development (all of which characteristics are referred to in this paragraph as “development”) of the child while under the age of 5 years with a view to detecting any deviations from normal development;

(b) the examination of the child at a frequency that has been agreed with the Primary Care Trust in accordance with the nationally agreed evidence based programme set out in the fourth edition of “Health for all Children”(2).

(3) The records mentioned in sub-paragraph (1)(b) are an accurate record of—

(a) the development of the child while under the age of 5 years, compiled as soon as is reasonably practicable following the first examination of that child and, where appropriate, amended following each subsequent examination; and

(b) the responses (if any) to offers made to the child’s parent for the child to undergo any examination referred to in sub-paragraph (2)(b).

Maternity medical services

7.—(1) A contractor whose contract includes the provision of maternity medical services shall—

(a) provide to female patients who have been diagnosed as pregnant all necessary maternity medical services throughout the antenatal period;

(b) provide to female patients and their babies all necessary maternity medical services throughout the postnatal period other than neonatal checks;

(c) provide all necessary maternity medical services to female patients whose pregnancy has terminated as a result of miscarriage or abortion or, where the contractor has a conscientious objection to the termination of pregnancy, prompt referral to another provider of primary medical services who does not have such conscientious objections.

(2) In this paragraph—

“antenatal period” means the period from the start of the pregnancy to the onset of labour;

“maternity medical services” means—

(a)

in relation to female patients (other than babies) all primary medical services relating to pregnancy, excluding intra partum care, and

(b)

in relation to babies, any primary medical services necessary in their first 14 days of life;

“postnatal period” means the period starting from the conclusion of delivery of the baby or the patient’s discharge from secondary care services, whichever is the later, and ending on the fourteenth day after the birth.

Minor surgery

8.—(1) A contractor whose contract includes the provision of minor surgery shall comply with the requirements in sub-paragraphs (2) and (3).

(2) The contractor shall make available to patients where appropriate—

(a) curettage;

(b) cautery; and

(c) cryocautery of warts, verrucae and other skin lesions.

(3) The contractor shall ensure that its record of any treatment provided under this paragraph includes the consent of the patient to that treatment.

Regulation 17

SCHEDULE 3 OPT OUTS OF ADDITIONAL AND OUT OF HOURS SERVICES

Opt outs of additional services: general

1.—(1) In this Schedule—

“opt out notice” means a notice given under sub-paragraph (5) to permanently opt out or temporarily opt out of the provision of the additional service;

“permanent opt out” in relation to the provision of an additional service that is funded through the global sum, means the termination of the obligation under the contract for the contractor to provide that service; and “permanently opt out” shall be construed accordingly;

“permanent opt out notice” means an opt out notice to permanently opt out;

“preliminary opt out notice” means a notice given under sub-paragraph (2) that a contractor wishes to temporarily opt out or permanently opt out of the provision of an additional service;

“temporary opt out” in relation to the provision of an additional service that is funded through the global sum, means the suspension of the obligation under the contract for the contractor to provide that service for a period of more than six months and less than twelve months and includes an extension of a temporary opt out and “temporarily opt out” and “temporarily opted out” shall be construed accordingly; and

“temporary opt out notice” means an opt out notice to temporarily opt out.

(2) A contractor who wishes to permanently or temporarily opt out shall give to the relevant Primary Care Trust in writing a preliminary opt out notice which shall state the reasons for wishing to opt out.

(3) As soon as is reasonably practicable and in any event within the period of 7 days beginning with the receipt of the preliminary opt out notice by the Primary Care Trust, the Primary Care Trust shall enter into discussions with the contractor concerning the support which the Primary Care Trust may give the contractor, or concerning other changes which the Primary Care Trust or the contractor may make, which would enable the contractor to continue to provide the additional service and the Primary Care Trust and the contractor shall use reasonable endeavours to achieve this aim.

(4) The discussions mentioned in sub-paragraph (3) shall be completed within the period of 10 days beginning with the date of the receipt of the preliminary opt out notice by the Primary Care Trust or as soon as reasonably practicable thereafter.

(5) Subject to sub-paragraph (9), if following the discussions mentioned in sub-paragraph (3), the contractor still wishes to opt out of the provision of the additional service, it shall send an opt out notice to the Primary Care Trust.

(6) An opt out notice shall specify—

(a) the additional service concerned;

(b) whether the contractor wishes to—

(i) permanently opt out, or

(ii) temporarily opt out;

(c) the reasons for wishing to opt out;

(d) the date from which the contractor would like the opt out to commence, which must—

(i) in the case of a temporary opt out be at least 14 days after the date of service of the opt out notice, and

(ii) in the case of a permanent opt out must be the day either three or six months after the date of service of the opt out notice, and

(e) in the case of a temporary opt out, the desired duration of the opt out.

(7) Where a contractor has given two previous temporary opt out notices within the period of three years ending with the date of the service of the latest opt out notice (whether or not the same additional service is concerned), the latest opt out notice shall be treated as a permanent opt out notice (even if the opt out notice says that it wishes to temporarily opt out).

(8) Paragraph 2 applies following the giving of a temporary opt out notice and paragraph 3 applies following the giving of a permanent opt out notice or a temporary opt out notice which pursuant to sub-paragraph (7) is treated as a permanent opt out notice.

(9) No temporary opt out notice may be served by a contractor prior to 1st April 2004.

Temporary opt outs and permanent opt outs following temporary opt outs

2.—(1) As soon as is reasonably practicable and in any event within the period of 7 days beginning with the date of receipt of a temporary opt out notice under paragraph 1(5), the Primary Care Trust shall—

(a) approve the opt out notice and specify in accordance with sub-paragraphs (3) and (4) the date on which the temporary opt out is to commence and the date that it is to come to an end (“the end date”); or

(b) reject the opt out notice in accordance with sub-paragraph (2),

and shall notify the contractor of its decision as soon as possible, including reasons for its decision.

(2) A Primary Care Trust may reject the opt out notice on the ground that the contractor—

(a) is providing additional services to patients other than its own registered patients or enhanced services; or

(b) has no reasonable need temporarily to opt out having regard to its ability to deliver the additional service.

(3) The date specified by the Primary Care Trust for the commencement of the temporary opt out shall wherever reasonably practicable be the date requested by the contractor in its opt out notice.

(4) Before determining the end date, the Primary Care Trust shall make reasonable efforts to reach agreement with the contractor.

(5) Where the Primary Care Trust approves an opt out notice, the contractor’s obligation to provide the additional service specified in the notice shall be suspended from the date specified by the Primary Care Trust in it’s decision under sub-paragraph (1), and shall remain suspended until the end date unless—

(a) the contractor and the Primary Care Trust agree in writing an earlier date, in which case the suspension shall come to an end on the earlier date agreed;

(b) the Primary Care Trust specifies a later date under sub-paragraph (6), in which case the suspension shall end on the later date specified;

(c) sub-paragraph (7) applies and the contractor refers the matter to the NHS dispute resolution procedure or the court, in which case the suspension shall end—

(i) where the outcome of the dispute is to uphold the decision of the Primary Care Trust, on the day after the date of the decision of the Secretary of State or the court,

(ii) where the outcome of the dispute is to overturn the decision of the Primary Care Trust, 28 days after the decision of the Secretary of State or the court, or

(iii) where the contractor ceases to pursue the NHS dispute resolution procedure or court proceedings, on the day after the date that the contractor withdraws its claim or the procedure is or proceedings are otherwise terminated by the Secretary of State or the court;

(d) sub-paragraph (9) applies and—

(i) the Primary Care Trust refuses the contractor’s request for a permanent opt out within the period of 28 days ending with the end date, in which case the suspension shall come to an end 28 days after the end date,

(ii) the Primary Care Trust refuses the contractor’s request for a permanent opt out after the end date, in which case the suspension shall come to an end 28 days after the date of service of the notice, or

(iii) the Primary Care Trust notifies the contractor after the end date that the relevant Strategic Health Authority has not approved its proposed decision to refuse the contractor’s request to permanently opt out under sub-paragraph (14), in which case the suspension shall come to an end 28 days after the date of service of the notice under this paragraph.

(6) Before the end date, a Primary Care Trust may, in exceptional circumstances and with the agreement of the contractor, notify the contractor in writing of a later date on which the temporary opt out is to come to an end, being a date no more than six months later than the end date.

(7) Where the Primary Care Trust considers that—

(a) the contractor will be unable to satisfactorily provide the additional service at the end of the temporary opt out; and

(b) it would not be appropriate to exercise its discretion under sub-paragraph (6) to specify a later date on which the temporary opt out is to come to an end or the contractor does not agree to a later date,

the Primary Care Trust may notify the contractor in writing at least 28 days before the end date that a permanent opt out shall follow a temporary opt out.

(8) Where a Primary Care Trust notifies the contractor under sub-paragraph (7) that a permanent opt out shall follow a temporary opt out, the permanent opt out shall take effect immediately after the end of the temporary opt out.

(9) A contractor who has temporarily opted out may, at least three months prior to the end date, notify the relevant Primary Care Trust in writing that it wishes to permanently opt out of the additional service in question.

(10) Where the contractor has notified the Primary Care Trust under sub-paragraph (9) that it wishes to permanently opt out, the temporary opt out shall be followed by a permanent opt out beginning on the day after the end date unless the Primary Care Trust refuses the contractor’s request to permanently opt out by giving a notice in writing to the contractor to this effect.

(11) A Primary Care Trust may only give a notice under sub-paragraph (10) with the approval of the relevant Strategic Health Authority.

(12) Where a Primary Care Trust seeks the approval of a Strategic Health Authority to a proposed decision to refuse a permanent opt out, it shall notify the contractor of having done so.

(13) If the relevant Strategic Health Authority has not reached a decision as to whether or not to approve the Primary Care Trust’s proposed decision to refuse a permanent opt out before the end date, the contractor’s obligation to provide the additional service shall remain suspended until the date specified in sub-paragraph (5)(d)(ii) or (iii) (whichever is applicable).

(14) Where after the end date the relevant Strategic Health Authority notifies the Primary Care Trust that it does not approve the Primary Care Trust’s proposed decision to refuse a permanent opt out, the Primary Care Trust shall notify the contractor in writing of this fact as soon as is reasonably practicable.

(15) A temporary opt out or permanent opt out commences, and a temporary opt out ends, at 08.00 on the relevant day unless—

(a) the day is a Saturday, Sunday, Good Friday, Christmas Day, or a bank holiday, in which case the opt out shall take effect on the next working day at 08.00; or

(b) the Primary Care Trust and the contractor agree a different day or time.

Permanent opt outs

3.—(1) In this paragraph—

“A day” is the day specified by the contractor in its permanent opt out notice to a Primary Care Trust for the commencement of the permanent opt out;

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

“C day” is the day nine months after the date of service of the permanent opt out notice.

(2) As soon as is reasonably practicable and in any event within the period of 28 days beginning with the date of receipt of a permanent opt out notice under paragraph 1(5) (or temporary opt out notice which is treated as a permanent opt out notice under paragraph 1(7)), the Primary Care Trust shall—

(a) approve the opt out notice; or

(b) reject the opt out notice in accordance with sub-paragraph (3),

and shall notify the contractor of its decision as soon as possible, including reasons for its decision where its decision is to reject the opt out notice.

(3) A Primary Care Trust may reject the opt out notice on the ground that the contractor is providing an additional service to patients other than its registered patients or enhanced services.

(4) A contractor may not withdraw an opt out notice once it has been approved by the Primary Care Trust in accordance with sub-paragraph (2)(a) without the Primary Care Trust’s agreement.

(5) If the Primary Care Trust approves the opt out notice under sub-paragraph (2)(a), it shall use its reasonable endeavours to make arrangements for the contractor’s registered patients to receive the additional service from an alternative provider from A day.

(6) The contractor’s duty to provide the additional service shall terminate on A day unless the Primary Care Trust serves a notice under sub-paragraph (7) (extending A day to B day or C day).

(7) If the Primary Care Trust is not successful in finding an alternative provider to take on the provision of the additional service from A day, then it shall notify the contractor in writing of this fact no later than one month before A day, and—

(a) in a case where A day is three months after service of the opt out notice, the contractor shall continue to provide the additional service until B day unless at least one month before B day it receives a notice in writing from the Primary Care Trust under sub-paragraph (8) that despite using its reasonable endeavours, it has failed to find an alternative provider to take on the provision of the additional service from B day;

(b) in a case where A day is six months after the service of the opt out notice, the contractor shall continue to provide the additional service until C day unless at least one month before C day it receives a notice from the Primary Care Trust under sub-paragraph (11) that it has made an application to the relevant Strategic Health Authority under sub-paragraph (10) seeking its approval of a decision to refuse a permanent opt out or to delay the commencement of a permanent opt out until after C day.

(8) Where in accordance with sub-paragraph (7)(a) the permanent opt out is to commence on B day and the Primary Care Trust, despite using its reasonable endeavours has failed to find an alternative provider to take on the provision of the additional service from that day, it shall notify the contractor in writing of this fact at least one month before B day, in which case the contractor shall continue to provide the additional service until C Day unless at least one month before C day it receives a notice from the Primary Care Trust under sub-paragraph (11) that it has applied to the relevant Strategic Health Authority under sub-paragraph (10) seeking the approval of the relevant Strategic Health Authority to a decision to refuse a permanent opt out or to postpone the commencement of a permanent opt out until after C day.

(9) As soon as is reasonably practicable and in any event within 7 days of the Primary Care Trust serving a notice under sub-paragraph (8), the Primary Care Trust shall enter into discussions with the contractor concerning the support that the Primary Care Trust may give to the contractor or other changes which the Primary Care Trust or the contractor may make in relation to the provision of the additional service until C day.

(10) The Primary Care Trust may, if it considers that there are exceptional circumstances, make an application to the relevant Strategic Health Authority for approval of a decision to—

(a) refuse a permanent opt out; or

(b) postpone the commencement of a permanent opt out until after C day.

(11) As soon as practicable after making an application under sub-paragraph (10) to the Strategic Health Authority, the Primary Care Trust shall notify the contractor in writing that it has made such an application.

(12) On receiving an application under sub-paragraph (10) for approval of a decision to refuse a permanent opt out, the Strategic Health Authority shall—

(a) approve the Primary Care Trust’s application;

(b) reject the Primary Care Trust’s application, but nonetheless recommend a different date for the commencement of the permanent opt out which shall be later than C day; or

(c) reject the Primary Care Trust’s application.

(13) On receiving an application under sub-paragraph (10) for approval of a decision to postpone the commencement of a permanent opt out until after C day, the Strategic Health Authority shall—

(a) approve the Primary Care Trust’s application;

(b) reject the Primary Care Trust’s application, but nonetheless recommend—

(i) that the permanent opt out commence on an earlier date to that proposed by the Primary Care Trust in its application, or

(ii) that the permanent opt out be refused; or

(c) reject the Primary Care Trust’s application.

(14) The relevant Strategic Health Authority shall notify the Primary Care Trust and the contractor in writing of its decision under sub-paragraph (12) or (13) as soon as is practicable, including reasons for its decision.

(15) Where the Strategic Health Authority—

(a) approves a decision to refuse an opt out under sub-paragraph (12)(a); or

(b) recommends that a permanent opt out be refused under sub-paragraph (13)(b)(ii),

the Primary Care Trust shall notify the contractor in writing that it may not opt out of the additional service.

(16) Where a Primary Care Trust notifies a contractor under sub-paragraph (15), the contractor may not serve a preliminary opt out notice in respect of that additional service for a period of 12 months beginning with the date of service of the Primary Care Trust’s notice under sub-paragraph (15) unless there has been a change in the circumstances of the contractor which affects its ability to deliver services under the contract.

(17) Where the Strategic Health Authority—

(a) recommends a different date for the commencement of the permanent opt out under sub-paragraph (12)(b);

(b) approves a Primary Care Trust’s application to postpone a permanent opt out under sub-paragraph (13)(a); or

(c) recommends an earlier date to that proposed by the Primary Care Trust in its application under sub-paragraph (13)(b)(i),

the Primary Care Trust shall in accordance with the decision of the Strategic Health Authority notify the contractor in writing of its decision and the notice shall specify the date from which the permanent opt out shall commence.

(18) Where the Strategic Health Authority rejects the Primary Care Trust’s application under sub-paragraph (12)(c) or (13)(c), the Primary Care Trust shall notify the contractor in writing that there shall be a permanent opt out and the permanent opt out shall commence on C day or 28 days after the date of service of the Primary Care Trust’s notice, whichever is the later.

(19) If the relevant Strategic Health Authority has not reached a decision on the Primary Care Trust’s application under sub-paragraph (10) before C day, the contractor’s obligation to provide the additional service shall continue until a notice is served on it by the Primary Care Trust under sub-paragraph (17) or (18).

(20) Nothing in sub-paragraphs (1) to (19) above shall prevent the contractor and the Primary Care Trust from agreeing a different date for the termination of the contractor’s duty under the contract to provide the additional service and accordingly, varying the contract in accordance with paragraph 104(1) of Schedule 6.

(21) The permanent opt out takes effect at 08.00 on the relevant day unless—

(a) the day is a Saturday, Sunday, Good Friday, Christmas Day, or a bank holiday, in which case the opt out shall take effect on the next working day at 08.00; or

(b) the Primary Care Trust and the contractor agree a different day or time.

Out of hours opt outs where the opt out notice is served after 30th September 2004

4.—(1) This paragraph applies where a contractor wishes to serve or serves an out of hours opt out notice after 30th September 2004.

(2) 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 relevant Primary Care Trust in writing to that effect (“an out of hours opt out notice”).

(3) An out of hours opt out notice shall specify the date from 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.

(4) As soon as is reasonably practicable and in any event within 28 days of receiving the out of hours opt out notice, the Primary Care Trust shall approve the notice and specify in accordance with sub-paragraph (6) the date on which the out of hours opt out is to commence (“OOH day”).

(5) The Primary Care Trust shall notify the contractor of its decision as soon as possible.

(6) The date specified in sub-paragraph (4) shall be the date specified in the out of hours opt out notice.

(7) A contractor may not withdraw an out of hours opt out notice once it has been approved by the Primary Care Trust under sub-paragraph (4) without the Primary Care Trust’s agreement.

(8) Following receipt of the out of hours opt out notice, the Primary Care Trust 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.

(9) Sub-paragraphs (6) to (21) 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(16) to a “preliminary opt out notice” was a reference to “an out of hours opt out notice”.

Out of hours opt outs where the 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 Primary Care Trust 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 Primary Care Trust 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 relevant Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust under sub-paragraph (5) without the Primary Care Trust’s agreement.

(9) Following receipt of the out of hours opt out notice, the Primary Care Trust must use its reasonable endeavours to make arrangements for the contractor’s registered patients to receive 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 Primary Care Trust—

(a) serves a 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 relevant Strategic Health Authority 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 Primary Care Trust is not successful in finding an alternative provider to take on the provision of the out 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 it receives a notice in writing from the Primary Care Trust under sub-paragraph (13) that despite using its reasonable endeavours, it 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 Primary Care Trust 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 it receives a notice from the Primary Care Trust under sub-paragraph (16) that it has made an application to the relevant Strategic Health Authority under sub-paragraph (14) seeking its 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 Primary Care Trust, 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 services until OOHC day (which shall be specified by the Primary Care Trust 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 it receives a notice from the Primary Care Trust under sub-paragraph (16) that it has applied to the relevant Strategic Health Authority under sub-paragraph (14) seeking the approval of the relevant Strategic Health Authority to a decision to refuse an opt out or to postpone the commencement of an opt out until after OOHC day.

(14) The Primary Care Trust may, if it considers there are exceptional circumstances, make an application to the relevant Strategic Health Authority 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 Strategic Health Authority, the Primary Care Trust shall notify the contractor in writing that it has made such an application.

(17) Sub-paragraphs (12) to (21) 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 Primary Care Trust and the contractor shall discuss how to inform the contractor’s patients of the proposed opt out.

(2) The contractor shall, if requested by the Primary Care Trust inform its 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 rooms; 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.

Regulation 21

SCHEDULE 4 LIST OF PRESCRIBED MEDICAL CERTIFICATES

Description of medical certificate	Enactment under or for the purpose of which certificate required
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.	Naval and Marine Pay and Pensions Act 1865(3) Air Force (Constitution) Act 1917(4) Pensions (Navy, Army, Air Force and Mercantile Marine) Act 1939(5) Personal Injuries (Emergency Provisions) Act 1939(6) Pensions (Mercantile Marine) Act 1942(7) Polish Resettlement Act 1947(8) Social Security Administration Act 1992(9) Social Security Contributions and Benefits Act 1992(10) Social Security Act 1998(11)
2.  To establish pregnancy for the purpose of obtaining welfare foods	Section 13 of the Social Security Act 1988 (schemes for distribution etc of welfare foods)(12)
3.  To secure registration of still-birth	Section 11 of the Births and Deaths Registration Act 1953 (special provision as to registration of still-birth) (13)
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	Section 142 of the Mental Health Act 1983 (pay, pensions etc of mentally disordered persons)(14)
5.  To establish unfitness for jury service	Juries Act 1974(15)
6.  To support late application for reinstatement in civil employment or notification of non-availability to take up employment owing to sickness	Reserve Forces (Safeguarding of Employment) Act 1985(16)
7.  To enable a person to be registered as an absent voter on grounds of physical incapacity	Representation of the People Act 1983(17)
8.  To support applications for certificates conferring exemption from charges in respect of drugs, medicines and appliances	National Health Service Act 1977(18)
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	Local Government Finance Act 1992(19)

Regulation 24

SCHEDULE 5 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 65 of the Act (accommodation and services for private patients), or

(ii) in a registered nursing home which is not providing services under that Act,

if, in either case, the person administering 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 Primary Care Trust, 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)(20);

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

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

(i) at his request at a police station in connection with possible criminal proceedings against him,

(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 Primary Care Trust 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 or 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 paragraphs (a), (b) or (c) of section 38(1) of the Act (arrangements for general ophthalmic services) applies (including by reason of regulations under section 38(6) of that Act);

(k) where it is a contractor which is authorised or required by a Primary Care Trust under regulation 20 of the Pharmaceutical Regulations or paragraphs 47 or 49 of Schedule 6 to provide drugs, medicines or appliances to a patient and provides for that patient, otherwise than by way of pharmaceutical services or dispensing services, any Scheduled drug;

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

Regulation 26

SCHEDULE 6 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) he is then offered an appointment to attend again within a time which is appropriate and reasonable having regard to all the circumstances and his 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 him 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 his last home address;

(b) such other place as the contractor has informed the patient and the Primary Care Trust is the place where it has agreed to visit and treat the patient; or

(c) some other place in the contractor’s practice area.

(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 Primary Care Trust,

the contractor shall, in addition 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 its 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, his 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 three years

5.  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 period of three years prior to the date of his 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.

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 his 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 him 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 its list of patients, it shall, as soon as reasonably practicable, provide a clinical report relating to the consultation, and any treatment provided, to the Primary Care Trust.

(2) The Primary Care Trust 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 Primary Care Trust 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 he 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 in the document entitled “Quality Standards in the Delivery of GP Out of Hours Services” published on 20th June 2002(21).

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

(c) out of hours services, either at all or in respect of some periods or some services,

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 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 Primary Care Trust 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.

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

(c) out of hours services, either at all or in respect of some periods or some services,

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

PART 2 PATIENTS

List of patients

14.  The Primary Care Trust 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 his 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 who has care of the child,

(ii) by a person duly authorised by a local authority to whose care the child has been committed under the Children Act 1989(22), 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 a relative or the primary carer of that person.

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

(6) On receipt of a notice under sub-paragraph (5), the Primary Care Trust 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 his normal place of residence and is not being provided with essential services (or their equivalent) under any other arrangement in the locality where he 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 he arrives in that place, he 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 him as a patient,

shall notify him 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 Primary Care Trust in writing of any person whom it accepted as a temporary resident.

Refusal of applications 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 Primary Care Trust 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 Primary Care Trust in writing of any request for removal from its list of patients received from a registered patient.

(2) Where the Primary Care Trust—

(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 Primary Care Trust receives 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 Primary Care Trust,

whichever is the sooner.

(4) The Primary Care Trust 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 Primary Care Trust 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 specified in sub-paragraph (4), a contractor may only request a removal under sub-paragraph (1), if, within the period of 12 months prior to the date of its request to the Primary Care Trust, it has warned the patient that he 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 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 one or more of the persons specified in sub-paragraph (5); or

(c) it is, in the opinion of the contractor, not otherwise reasonable or practical for a warning to be given.

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

(a) the contractor, where it is an individual medical practitioner;

(b) in the case of a contract with two or more individuals practising in partnership, a partner in that partnership;

(c) in the case of a contract with a company, a legal and beneficial owner of shares in that company;

(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

(c) in cases where sub-paragraph (2) applies, the grounds for a more specific reason not being appropriate,

and shall make this record available to the Primary Care Trust 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 Primary Care Trust receives notification of the registration of the person with another provider of essential services (or their equivalent); or

(b) the eighth day after the Primary Care Trust 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 seven days, the contractor shall notify the Primary Care Trust in writing of the fact and the removal shall take effect—

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

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

whichever is the sooner.

(10) The Primary Care Trust 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).

Removals 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 his safety; and

(b) it has reported the incident to the police,

shall notify the Primary Care Trust in accordance with sub-paragraph (3).

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

(a) the contractor where it is an individual medical practitioner;

(b) in the case of a contract with two or more individuals practising in partnership, a partner in that partnership;

(c) in the case of a contract with a company, a legal and beneficial owner of shares in that company;

(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 seven days (and for this purpose a faxed notification is not a written one).

(4) The Primary Care Trust 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 Primary Care Trust; or

(b) sends or delivers the notification to the Primary Care Trust.

(6) Where, pursuant to this paragraph, the contractor has notified the Primary Care Trust that it wishes to have a patient removed from its list of patients, 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 Primary Care Trust 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 his removal.

Removals from the list of patients registered elsewhere

22.—(1) The Primary Care Trust shall remove a patient from the contractor’s list of patients if—

(a) he has subsequently been registered with another provider of essential services (or their equivalent) in the area of the Primary Care Trust; or

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

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

(a) on the date on which the Primary Care Trust receives notification of the registration of the person with the new provider; or

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

(3) The Primary Care Trust shall notify the contractor in writing of persons 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 Primary Care Trust 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 Primary Care Trust 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 advice mentioned in paragraph (b), he has not acted in accordance with the advice and informed it accordingly, the Primary Care Trust will remove him 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 Primary Care Trust has not been notified of the action taken, it shall remove the patient from the contractor’s list of patients and inform him and the contractor accordingly.

24.  Where the address of a patient who is on the contractor’s list of patients is no longer known to the Primary Care Trust, the Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust 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;

(c) is serving a prison sentence of more than two years or sentences totalling in the aggregate more than that period;

(d) has been absent from the United Kingdom for a period of more than three months; or

(e) 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) to (c) from the date of the departure, enlistment or imprisonment or the date on which the Primary Care Trust first receives notification of the departure, enlistment or imprisonment whichever is the later; or

(b) in the cases referred to in sub-paragraph (1)(d) and (e) from the date on which the Primary Care Trust first receives notification of the absence or death.

(3) The Primary Care Trust 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 Primary Care Trust 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 patient’s stay in the place of temporary residence has exceeded three months; and

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

(2) The Primary Care Trust 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 him of—

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

(b) the name and address of the Primary Care Trust in whose area he 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 Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust 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,

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

(iii) on behalf of a person mentioned in sub-paragraph (i) or (ii), 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 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 he 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 him with the service in question; or

(c) it comes to the notice of the contractor that the patient—

(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 Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust shall enter into discussions with the contractor concerning the support which the Primary Care Trust may give the contractor, or other changes which the Primary Care Trust 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 Primary Care Trust’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 Primary Care Trust and the contractor reach agreement that the contractor’s list of patients should remain open, the Primary Care Trust shall send full details of the agreement in writing to the contractor.

(6) The Primary Care Trust 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 Primary Care Trust and the contractor reach agreement that the contractor’s list of patients should close; or

(b) the Primary Care Trust and the contractor fail to reach agreement and the contractor still wishes to close its list of patients,

the contractor shall send a closure notice to the Primary Care Trust.

(8) A closure notice shall be submitted in the form specified in Schedule 8, 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 12 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 from or reduction in provision of any additional or enhanced services which had previously been provided under the contract.

(9) The Primary Care Trust shall forthwith acknowledge receipt of the closure notice in writing to the contractor.

(10) Before the Primary Care Trust reaches a decision as to whether to approve or reject the closure notice under sub-paragraph (12), the Primary Care Trust and the contractor may enter into further discussions concerning the details of the closure notice referred to 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 12 months.

(11) A contractor may not withdraw a closure notice for a period of three months beginning with the date on which the Primary Care Trust has received the notice, unless the Primary Care Trust has agreed otherwise in writing.

(12) Within a period of 14 days beginning with the date of receipt of the closure notice, the Primary Care Trust 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 Primary Care Trust

30.—(1) If the Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust’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 the period of 12 months specified in paragraph 29(10) applies, 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 Primary Care Trust 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 12 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 Primary Care Trust shall notify the contractor in writing between seven and fourteen 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 Primary Care Trust

31.—(1) This regulation applies where the Primary Care Trust rejects the closure notice in accordance with paragraph 29(12)(b).

(2) The contractor and the Primary Care Trust 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 Primary Care Trust must ensure that the assessment panel is appointed 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 it should be permitted to do so.

(4) The Primary Care Trust shall provide the assessment panel with such information as the assessment panel may reasonably require to enable it to reach a determination and shall include in such information any written observations received from the contractor.

(5) The members of the assessment panel shall be—

(a) the Chief Executive of the Primary Care Trust of which the assessment panel is a committee or sub-committee;

(b) a person representative of patients in an area other than that of the Primary Care Trust which is a party to the contract; and

(c) a person representative of a Local Medical Committee which does not represent practitioners in the area of the Primary Care Trust which is a party to the contract.

(6) At least one member of the assessment panel shall visit the contractor before reaching a determination under sub-paragraph (7).

(7) Within the period of 28 days beginning with the date on which the Primary Care Trust rejected the closure notice, the assessment panel shall—

(a) approve the list closure; or

(b) reject the list closure,

and shall notify the Primary Care Trust and the contractor of its determination in writing as soon as possible.

(8) Where the assessment panel determines in accordance with sub-paragraph (7)(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).

(9) Where the assessment panel determines in accordance with sub-paragraph (7)(b) that the contractor’s list of patients may not close, that list shall remain open, and the Primary Care Trust and the contractor shall enter into discussions with a view to ensuring that the contractor receives support from the Primary Care Trust which will enable it to continue to provide services safely and effectively.

(10) Where the assessment panel determines in accordance with sub-paragraph (7)(b) that the contractor’s list of patients may not close, 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.

Assignment of patients to lists: open lists

32.—(1) A Primary Care Trust 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 Primary Care Trust;

(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

(c) wishes to be included in the list of patients of a contractor whose practice premises are within that area.

Assignment of patients to lists: closed lists

33.—(1) A Primary Care Trust 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 Primary Care Trust may, subject to paragraph 34, assign a new patient to a contractor whose practice premises are within the Primary Care Trust’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 Primary Care Trust’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 Secretary of State under paragraph 36(13) or (where applicable) by a court; and

(c) the Primary Care Trust 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 Primary Care Trust 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 Primary Care Trust, the patient’s name has been removed from the list of patients of any contractor in the area of the Primary Care Trust under paragraph 20 or its equivalent provision in relation to a section 28C provider in the area of the Primary Care Trust;

(d) whether the patient’s name has been removed from the list of patients of any contractor in the area of the Primary Care Trust under paragraph 21 or its equivalent provision in relation to a section 28C provider in the area of the Primary Care Trust and, if so, whether the contractor has appropriate facilities to deal with such a patient;

(e) such other matters as the Primary Care Trust 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 Primary Care Trust have closed their lists of patients.

(2) If the Primary Care Trust 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 which must include details of those contractors to which the Primary Care Trust wishes to assign patients.

(3) The Primary Care Trust must ensure that the assessment panel is appointed to consider and determine its proposal made under sub-paragraph (2), and the composition of the assessment panel shall be as described in paragraph 31(5).

(4) The Primary Care Trust shall notify in writing—

(a) the relevant Strategic Health Authority;

(b) contractors or section 28C providers whose practice premises are within the Primary Care Trust’s area which—

(i) have closed their list of patients, and

(ii) may, in the opinion of the Primary Care Trust, be affected by the determination of the assessment panel; and

(c) the Local Medical Committee (if any) for the area of the Primary Care Trust,

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 Primary Care Trust 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 Primary Care Trust may assign patients to contractors which have closed their lists of patients; and if it determines that the Primary Care Trust may make such assignments, it shall also determine those contractors to which patients may be assigned.

(8) The assessment panel may determine that the Primary Care Trust may assign patients to contractors other than those contractors specified by the Primary Care Trust in its proposal under sub-paragraph (2), as long as the contractors were notified under sub-paragraph (4)(b).

(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—

(a) the relevant Strategic Health Authority; and

(b) those contractors which were notified under sub-paragraph (4)(b).

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 Primary Care Trust 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 Secretary of State to review the determination of the assessment panel.

(2) Where a matter is referred to the Secretary of State in accordance with sub-paragraph (1), it shall be reviewed in accordance with the procedure specified in the following sub-paragraphs.

(3) 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 Secretary of State shall review the matter in relation to those contractors together.

(4) Within the period of 7 days beginning with the date of the determination by the assessment panel in accordance with paragraph 35(7), the contractor (or contractors) shall send to the Secretary of State a written request for dispute resolution which shall include or be accompanied by—

(a) the names and addresses of the parties to the dispute;

(b) a copy of the contract (or contracts); and

(c) a brief statement describing the nature and circumstances of the dispute.

(5) Within the period of 7 days beginning with the date on which the matter was referred to him, the Secretary of State shall—

(a) give to the parties notice in writing that he is dealing with the matter; and

(b) include with the notice a written request to the parties to make in writing within a specified period any representations which they may wish to make about the dispute.

(6) The Secretary of State shall give, with the notice given under sub-paragraph (5), to the party other than the one which referred the matter to dispute resolution a copy of any document by which the dispute was referred to dispute resolution.

(7) The Secretary of State shall, upon receiving any representations from a party, give a copy of them to the other party, and shall in each case request (in writing) a party to which a copy of the representations is given to make within a specified period any written observations which it wishes to make on those representations.

(8) For the purpose of assisting it in its consideration of the matter, the Secretary of State may—

(a) invite representatives of the parties to appear before him to make oral representations either together or, with the agreement of the parties, separately, and may in advance provide the parties with a list of matters or questions to which he wishes them to give special consideration; or

(b) consult other persons whose expertise he considers will assist him in his consideration of the dispute.

(9) Where the Secretary of State consults another person under sub-paragraph (8)(b), he shall notify the parties accordingly in writing and, where he considers that the interests of any party might be substantially affected by the result of the consultation, he shall give to the parties such opportunity as he considers reasonable in the circumstances to make observations on those results.

(10) In considering the dispute, the Secretary of State shall consider—

(a) any written representations made in response to a request under sub-paragraph (5)(b), but only if they are made within the specified period;

(b) any written observations made in response to a request under sub-paragraph (7), but only if they are made within the specified period;

(c) any oral representations made in response to an invitation under sub-paragraph (8)(a);

(d) the results of any consultation under sub-paragraph (8)(b); and

(e) any observations made in accordance with an opportunity given under sub-paragraph (9).

(11) Subject to the other provisions of this paragraph and to any agreement by the parties, the Secretary of State shall have wide discretion in determining the procedure of the dispute resolution to ensure the just, expeditious, economical and final determination of the dispute.

(12) In this paragraph, “specified period” means such period as the Secretary of State shall specify in the request, being not less than one, nor more than two, weeks beginning with the date on which the notice referred to is given, but the Secretary of State may, if the period for determination of the dispute has been extended in accordance with sub-paragraph (16), extend any such period (even after it has expired) and, where he does so, a reference in this paragraph to the specified period is to the period as so extended.

(13) Subject to sub-paragraph (16), within the period of 21 days beginning with the date on which the matter was referred to him, the Secretary of State shall determine whether the Primary Care Trust may assign patients to contractors which have closed their lists of patients; and if he determines that the Primary Care Trust may make such assignments, he shall also determine those contractors to which patients may be assigned.

(14) The Secretary of State 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).

(15) In the case of a matter referred jointly by contractors in accordance with sub-paragraph (3), the Secretary of State may determine that patients may be assigned to one, some or all of the contractors which referred the matter.

(16) The period of 21 days referred to in sub-paragraph (13) 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 Secretary of State;

(b) the Primary Care Trust; and

(c) the contractor (or contractors) which referred the matter to dispute resolution.

(17) The Secretary of State shall record his determination, and the reasons for it, in writing and shall give notice of the determination (including the record of the reasons) to the parties.

Assignments to closed lists: assignments of patients by a Primary Care Trust

37.—(1) Before the Primary Care Trust 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 Primary Care Trust can offer the contractor, and the Primary Care Trust 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 or repeatable prescription for drugs, medicines or appliances issued by a prescriber complies as appropriate with the requirements in paragraphs 39 and 41 to 44.

39.—(1) Subject to paragraphs 42 and 43, 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 or a repeatable prescription and such a prescription form or repeatable prescription shall not be used in any other circumstances.

(2) A prescriber may order drugs, medicines or appliances on a repeatable prescription only where the drugs, medicines or appliances are to be provided more than once.

(3) In issuing any such prescription form or repeatable prescription the prescriber shall himself sign the prescription form or repeatable prescription in ink with his initials, or forenames, and surname in his 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 or repeatable prescription, and—

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

(b) a separate prescription form or repeatable prescription shall be used for each patient, except where a bulk prescription is issued for a school or institution under paragraph 44.

(4) Where a prescriber orders the drug buprenorphine or a drug specified in Schedule 2 to the Misuse of Drugs Regulations 2001 (controlled drugs to which regulations 14, 15, 16, 18, 19, 20, 21, 23, 26 and 27 of those Regulations apply)(23) for supply by instalments for treating addiction to any drug specified in that Schedule, he shall—

(a) use only the prescription form provided specially for the purposes of supply by instalments;

(a) specify the number of instalments to be dispensed and the interval between each instalment; and

(c) order only such quantity of the drug as will provide treatment for a period not exceeding 14 days.

(5) The prescription form provided specially for the purpose of supply by instalments shall not be used for any purpose other than ordering drugs in accordance with sub-paragraph (4).

(6) In a case of urgency a prescriber may request a chemist to dispense a drug or medicine before a prescription form or repeatable prescription 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(24), other than a drug which is for the time being specified in Schedules 4 or 5 to the Misuse of Drugs Regulations 2001(25); and

(c) he undertakes to furnish the chemist, within 72 hours, with a prescription form or repeatable prescription completed in accordance with sub-paragraph (3).

(7) In a case of urgency a prescriber may request a chemist to dispense an appliance before a prescription form or repeatable prescription 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) he undertakes to furnish the chemist, within 72 hours, with a prescription form or repeatable prescription completed in accordance with sub-paragraph (3).

Repeatable prescribing services

40.—(1) The contractor may only provide repeatable prescribing services to any person on its list of patients if it—

(a) satisfies the conditions in sub-paragraph (2); and

(b) has notified the Primary Care Trust of its intention to provide repeatable prescribing services in accordance with sub-paragraphs (3) and (4).

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

(a) the contractor holds a contract with a Primary Care Trust specified in Schedule 9;

(b) the contractor has access to computer systems and software which enable it to issue repeatable prescriptions and batch issues; and

(c) the practice premises at which the repeatable prescribing services are to be provided are located in an area of the Primary Care Trust in which there is also located the premises of at least one chemist who has undertaken to provide, or has entered into an arrangement to provide, repeat dispensing services.

(3) The notification referred to in sub-paragraph (1)(b) is a notification, in writing, by the contractor to the Primary Care Trust that it—

(a) wishes to provide repeatable prescribing services; and

(b) intends to begin to provide those services from a specified date; and

(c) satisfies the conditions in paragraph (2).

(4) The date specified by the contractor pursuant to sub-paragraph (3)(b) must be at least ten days after the date on which the notification specified in sub-paragraph (1) is given.

(5) Nothing in this paragraph requires a contractor or prescriber to provide repeatable prescribing services to any person.

(6) A prescriber may only provide repeatable prescribing services to a person on a particular occasion if—

(a) that person has agreed to receive such services on that occasion; and

(b) the prescriber considers that it is clinically appropriate to provide such services to that person on that occasion.

(7) The contractor may not provide repeatable prescribing services to any patient of its to whom—

(a) it is authorised or required by the Primary Care Trust to provide dispensing services under paragraph 47 or 49; or

(b) any of the persons specified in sub-paragraph (8) is authorised or required by the Primary Care Trust under regulation 20 of the Pharmaceutical Regulations to provide pharmaceutical services.

(8) The persons referred to in sub-paragraph (7) are—

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

(b) in the case of a contract with two or more individuals practising in partnership, any medical practitioner who is a partner;

(c) in the case of a contract with a company, any medical practitioner who is a legal and beneficial shareholder in that company; or

(d) any medical practitioner employed by the contractor.

Repeatable prescriptions

41.—(1) A prescriber who issues a repeatable prescription must at the same time issue the appropriate number of batch issues.

(2) A prescriber who has provided repeatable prescribing services to a person must, as soon as is practicable, notify that person, and make reasonable efforts to contact the chemist providing repeat dispensing services to that person, if—

(a) he makes any change to the type, quantity, strength or dosage of drugs, medicines or appliances ordered on that person’s repeatable prescription; or

(b) he considers that it is no longer appropriate or safe for that person to receive the drugs, medicines or appliances ordered on his repeatable prescription, or no longer appropriate or safe for him to continue to receive repeatable prescribing services.

(3) If a prescriber provides repeatable prescribing services to a person in respect of whom he has previously issued a repeatable prescription which has not yet expired (for example, because that person wishes to obtain the drugs, medicines or appliances from a different chemist), the prescriber must make reasonable efforts to notify the chemist which has in its possession the repeatable prescription which is no longer required.

(4) If a prescriber has issued a repeatable prescription in respect of a person, and (before the expiry of that repeatable prescription) it comes to his notice that that person has been removed from the list of patients of the contractor on whose behalf the prescription was issued, that prescriber must—

(a) notify that person; and

(b) make reasonable efforts to notify the chemist who has been providing repeat dispensing services to that person,

that the repeatable prescription should no longer be used to obtain or provide repeat dispensing services.

Restrictions on prescribing by medical practitioners

42.—(1) In the course of treating a patient to whom he is providing treatment under the contract, a medical practitioner shall not order on a prescription form or repeatable prescription a drug, medicine or other substance specified in any directions given by the Secretary of State under section 28U of the Act (GMS contracts: prescription of drugs etc)(26) 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, medicine 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 he is providing treatment under the contract, a medical practitioner shall not order on a prescription form or repeatable prescription a drug, medicine or other substance specified in any directions given by the Secretary of State under section 28U 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

(c) the practitioner endorses the form with the reference “SLS”,

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 he is providing treatment under the contract, a medical practitioner shall not order on a prescription form or repeatable prescription 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.

(4) In the course of treating a patient to whom he is providing treatment under the contract, a medical practitioner shall not order on a repeatable prescription 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 to the Misuse of Drugs Regulations 2001, but may, subject to regulation 24(2)(b), prescribe such a drug for that patient in the course of that treatment under a private arrangement.

Restrictions on prescribing by supplementary prescribers

43.—(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

(c) give directions for the administration of a prescription only medicine for parenteral administration,

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

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

(a) the person satisfies the applicable conditions set out in article 3B(3) of the POM Order (prescribing and administration by supplementary prescribers)(27), 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 Secretary of State under section 28U 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 Secretary of State under section 28U 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, he endorses the face of the form with the reference “SLS”.

(3) Where the functions of 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 he 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 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) he 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 Secretary of State under section 28U 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 Secretary of State under section 28U 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, he 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(28), 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 is a prescription for an appliance, the appliance is listed in Part IX 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 IX 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, he endorses the face of the form with the reference “SLS”.

(5) In sub-paragraph (4)(a), “clinical management plan” means a written 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

(c) any supplementary prescriber who is to prescribe, give directions for administration or administer under the plan.

(6) In relation to any time from the coming into force of any regulations made by the Secretary of under section 2(2) of the European Communities Act 1972 (general implementation of treaties)(29) to implement Directive 2001/83/EC on the Community code relating to medicinal products for human use(30), 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.

Bulk prescribing

44.—(1) Where—

(a) a contractor is responsible under the contract for the treatment of 10 or more persons in a school or other institution in which at least 20 persons normally reside; and

(b) a prescriber orders, for any two or more of those persons for whose treatment the contractor is responsible, drugs, medicines or appliances to which this paragraph applies,

the prescriber may use a single prescription form for the purpose.

(2) Where a prescriber uses a single prescription form for the purpose mentioned in sub-paragraph (1)(b), he shall (instead of entering on the form the names of the persons for whom the drugs, medicines or appliances are ordered) enter on the form—

(a) the name of the school or institution in which those persons reside; and

(b) the number of persons residing there for whose treatment the contractor is responsible.

(3) This paragraph applies to any drug, medicine or appliance which can be supplied as part of pharmaceutical services or local pharmaceutical services and which—

(a) in the case of a drug or medicine, is not a product of a description or class which is for the time being specified in an order made under section 58(1) of the Medicines Act 1968 (medicinal products on prescription only)(31); or

(b) in the case of an appliance, does not contain such a product.

Interpretation of paragraphs 38, 39 and 41 to 44

45.  For the purposes of paragraphs 38, 39 and 41 to 44 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

46.—(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 Primary Care Trust shall seek the views of the Local Medical Committee (if any) for its area.

Provision of dispensing services

47.—(1) Without prejudice to any separate right one or more medical practitioners may have under regulation 20 of the Pharmaceutical Regulations (arrangements for provision of pharmaceutical services by doctors)(32), a contractor may provide dispensing services to its registered patients under the contract only if it is authorised or required to do so by the Primary Care Trust in accordance with the following provisions of this paragraph or paragraph 49.

(2) A Primary Care Trust may authorise or require a contractor to provide dispensing services to a registered patient only if that patient—

(a) satisfies one of the conditions in sub-paragraph (3); and

(b) has requested the contractor in writing to provide him with dispensing services.

(3) The conditions referred to in sub-paragraph (2)(a) are that the patient—

(a) satisfies the Primary Care Trust that he would have serious difficulty in obtaining any necessary drugs, medicines or appliances from a pharmacy by reason of distance or inadequacy of means of communication; or

(b) is resident in a controlled locality at a distance of more than 1.6 kilometres from any pharmacy, and both the conditions in sub-paragraph (4) are satisfied in his case.

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

(a) the contractor has been granted consent to dispense under paragraph 48 in respect of—

(i) the area in which the patient resides, and

(ii) the contract under which the patient receives primary medical services; and

(b) any conditions imposed in connection with that grant under regulation 12(15) or 13(13)(b) of the Pharmaceutical Regulations as they apply pursuant to paragraph 48(5) or (6) are such as to permit dispensing services to be provided under this paragraph by that contractor to the patient.

(5) If a contractor which has been requested to provide dispensing services by a patient who satisfies one of the conditions in sub-paragraph (3)—

(a) applies to the Primary Care Trust for the right to provide dispensing services to that patient, and sends with its application the patient’s request to the contractor, the Primary Care Trust shall grant its application; or

(b) does not so apply, within the period of 30 days beginning with the date on which the patient made that request, a Primary Care Trust may, subject to sub-paragraph (7), require the contractor to provide dispensing services to that patient, and shall give the contractor notice in writing to that effect.

(6) An application granted by a Primary Care Trust under sub-paragraph (5)(a) shall, with effect from the date of the patient’s request to the contractor, enable that contractor to provide dispensing services to that patient, so long as the contract remains in effect.

(7) A Primary Care Trust shall not, under sub-paragraph (5)(b), require a contractor to provide dispensing services to a patient if the contractor satisfies the Primary Care Trust that—

(a) it does not normally provide dispensing services under the contract; or

(b) in the case of a patient to whom sub-paragraph (3)(b) applies, the patient would not have serious difficulty by reason of distance or inadequacy of means of communication in obtaining drugs, medicines or appliances from a pharmacy.

(8) A Primary Care Trust shall give the contractor reasonable notice—

(a) that it requires it to provide dispensing services to a registered patient in accordance with the contract; or

(b) that, subject to sub-paragraph (9), where a patient no longer satisfies the requirements of sub-paragraph (3), the contractor shall discontinue the provision of dispensing services to that patient.

(9) A notice under sub-paragraph (8)(b)—

(a) shall be subject to any postponement or termination of arrangements to provide dispensing services under this paragraph in accordance with conditions imposed under regulation 12(15) or 13(13) of the Pharmaceutical Regulations as they apply pursuant to paragraph 48(5) or (6); and

(b) shall not be given—

(i) pending the outcome of the resolution of any dispute concerning the decision by a Primary Care Trust to postpone the making or termination of arrangements to provide dispensing services under this paragraph in accordance with conditions referred to in paragraph (a); or

(ii) during the period for bringing an appeal, or pending the determination of any appeal, referred to in regulation 9(10) of the Pharmaceutical Regulations (determination of whether an area is a controlled locality).

(10) A contractor which has been granted the right under this paragraph to provide dispensing services to some or all of its registered patients may provide any necessary dispensing services to a person whom that contractor has accepted as a temporary resident.

(11) In this paragraph, “controlled locality” and “pharmacy” have the same meanings as in the Pharmaceutical Regulations.

Consent to dispense

48.—(1) A contractor which wishes to be granted the right under paragraph 47 to secure the provision of dispensing services to some or all of its registered patients may apply to the Primary Care Trust in writing for consent to dispense, specifying—

(a) the area; and

(b) the contract,

in relation to which it wishes the consent to dispense to be granted.

(2) An application under sub-paragraph (1) shall be determined by the Primary Care Trust in accordance with regulations 12 and 13 of the Pharmaceutical Regulations (as modified in accordance with sub-paragraphs (5) and (6)), as though it were an application under regulation 21 of those Regulations.

(3) Consent to dispense, in relation to the specified contract, shall have effect from its final grant but shall cease to have effect if—

(a) no dispensing services have been provided under that contract within 12 months from the final grant of the consent to dispense; or

(b) more than 12 months has elapsed since the last provision of dispensing services under that contract pursuant to the grant of consent.

(4) In sub-paragraph (3), “final grant” shall be construed in accordance with regulation 12(16) of the Pharmaceutical Regulations.

(5) Regulation 12 of the Pharmaceutical Regulations shall apply as if modified as follows—

(a) all references to provisions being “subject to regulation 6A” were omitted;

(b) for all references to regulation 21, there were substituted references to this paragraph;

(c) in paragraph (14), the reference to “regulation 4(4)” were omitted; and

(d) in paragraph (15)—

(i) for “regulation 20” there were substituted a reference to paragraph 47, and

(ii) for the reference to “provision by a doctor of pharmaceutical services” there were substituted a reference to provision by a contractor of dispensing services.

(6) Regulation 13 of the Pharmaceutical Regulations shall apply as if modified as follows—

(a) in paragraph (2), for “regulation 20” there were substituted a reference to paragraph 47; and

(b) in paragraph (13)(b)—

(i) for “regulation 20” there were substituted a reference to paragraph 47, and

(ii) for the reference to “provision by a doctor of pharmaceutical services” there were substituted a reference to provision by a contractor of dispensing services.

Contractors who previously provided dispensing services under pilot schemes or section 28C arrangements

49.—(1) This paragraph applies where, immediately before the commencement of the contract—

(a) one of the persons specified in sub-paragraph (2), was a pilot doctor in the area of the Primary Care Trust; or

(b) the contractor was providing primary medical services in the area of the Primary Care Trust in accordance with section 28C arrangements,

and the requirements in sub-paragraph (3) are met.

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

(a) the contractor;

(b) in the case of a contract with two or more individuals practising in partnership, one or more of those individuals; or

(c) in the case of a contract with a company, one or more of the legal and beneficial shareholders in that company.

(3) The requirements referred to in sub-paragraph (1) are that—

(a) the pilot doctor, or, as the case may be, the contractor was, immediately before the commencement of the contract, providing dispensing services to some or all of his or its patients under the pilot scheme or in accordance with the section 28C arrangements; and

(b) the contractor has notified the Primary Care Trust before entering into the contract that it intends to provide dispensing services under it.

(4) In a case to which this paragraph applies, the contractor shall be regarded—

(a) as being authorised or required under paragraph 47 to provide dispensing services under the contract to any patient—

(i) to whom, immediately before commencement of the contract, it or, as the case may be, the pilot doctor, provided dispensing services under the pilot scheme or section 28C arrangement, and

(ii) who wishes the contractor to continue to provide him with such services; and

(b) subject to sub-paragraph (5), as having been granted consent to dispense in relation to the contract under paragraph 48 in relation to the area for which it or, as the case may be, the pilot doctor, had such consent under the pilot scheme or section 28C arrangement.

(5) Paragraph 48(3) shall apply in relation to a contract to which this paragraph applies as if the references to the final grant of the consent to dispense were references to the date of commencement of the contract.

(6) In this paragraph “pilot doctor” means a medical practitioner who performs personal medical services in connection with a pilot scheme.

Terms relating to the provision of dispensing services

50.—(1) A contractor which has been granted the right to provide dispensing services under paragraph 47 or 49 shall ensure that dispensing services are provided in accordance with the following sub-paragraphs.

(2) Subject to sub-paragraphs (3) and (4), a contractor providing dispensing services shall—

(a) record an order for the provision of any drugs, medicines or appliances which are needed for the treatment of the patient on a prescription form completed in accordance with paragraph 39(3);

(b) provide those drugs, medicines or appliances in a suitable container;

(c) provide for the patient a drug or medicine specified in any directions given by the Secretary of State under section 28U of the Act (GMS contracts: prescription of drugs etc)(33) as being a drug or medicine which can only be ordered for specified patients and specified purposes only if—

(i) that patient is a person of the specified description, and

(ii) the drug or medicine is supplied for that patient only for the specified purpose; and

(d) provide for the patient a restricted availability appliance only if the patient is a person, or it is for a purpose, specified in the Drug Tariff.

(3) Sub-paragraph (2) does not apply to drugs, medicines or appliances ordered on a prescription form by an independent nurse prescriber.

(4) Where a patient presents an order on a prescription form for drugs, medicines or appliances signed by an independent nurse prescriber, or an order for a restricted availability appliance signed by and endorsed on its face with the reference “SLS” by an independent nurse prescriber, to a contractor who may provide dispensing services, the contractor may provide to the patient such of the drugs, medicines or appliances so ordered as it supplies in the normal course of its practice.

(5) Drugs, medicines or appliances provided under sub-paragraph (4) shall be provided in a suitable container.

(6) A contractor providing dispensing services shall not provide for a patient a drug or medicine specified in any directions given by the Secretary of State under section 28U of the Act as being drugs or medicines which may not be ordered for patients in the provision of medical services under the contract, except that, where it has ordered a drug or medicine which has an appropriate non-proprietary name either by the name or by its formula, it may provide a drug or medicine which has the same specification notwithstanding that it is a drug or medicine specified in such directions (but, in the case of a drug or medicine which combines more than one drug, only if the combination has an appropriate non-proprietary name).

(7) Subject to sub-paragraph (9), 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.

(8) A contractor providing dispensing services shall comply with paragraph 11B of Schedule 2 to the Pharmaceutical Regulations(34), as if modified as follows—

(a) for “paragraph 11(a)”, substitute “sub-paragraph (3)(a)”;

(b) for “paragraph 11A(2)”, substitute “sub-paragraph (5)”;

(c) for “a doctor who is authorised or required by the Health Authority or Primary Care Trust under regulation 20 to provide drugs and appliances to a patient”, substitute “a contractor providing dispensing services to a patient”; and

(d) for “doctor”, substitute “medical practitioner”.

(9) 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.

(10) A contractor who is entitled to provide dispensing services may, with the consent of the patient, order a drug, medicine or appliance for a patient on a prescription form or a repeatable prescription, rather than providing it itself.

Dispensing contractor list

51.—(1) Where the contractor is authorised or required by the Primary Care Trust under paragraph 47 or 49 to provide dispensing services to its patients and is actually doing so, the Primary Care Trust shall include—

(a) the contractor’s name; and

(b) the address of the practice premises from which it is authorised or required to dispense,

on a list of such contractors (to be called the dispensing contractors list) which it shall prepare, maintain and publish.

(2) The Primary Care Trust shall remove the name of the contractor from the list referred to in sub-paragraph (1) where—

(a) the contractor’s consent to dispense ceases to have effect pursuant to paragraph 48(3); or

(b) the contractor ceases to provide dispensing services to its patients for any other reason.

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

52.—(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 he 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(35) or any regulations or orders made thereunder.

PART 4 PERSONS WHO PERFORM SERVICES

Qualifications of performers

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

(a) included in a medical performers list for a Primary Care Trust in England;

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

(c) not subject to interim suspension under section 41A of the Medical Act 1983 (interim orders)(36).

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

(a) a medical practitioner employed by an NHS trust, an NHS foundation trust, (in Scotland) a Health Board, or (in Northern Ireland) 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(37) acting in the course of his employment in a resident medical capacity in an approved medical practice; or

(c) a GP Registrar during the first two months of his training period.

54.  No health care professional other than one to whom paragraph 53 applies shall perform clinical services under the contract unless he is appropriately registered with his relevant professional body and his registration is not currently suspended.

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

56.  No health care professional shall perform any clinical services unless he has such clinical experience and training as are necessary to enable him properly to perform such services.

Conditions for employment and engagement

57.—(1) Subject to sub-paragraphs (2) and (3), a contractor shall not employ or engage a medical practitioner (other than one falling within paragraph 53(2)) unless—

(a) that practitioner has provided it with the name and address of the Primary Care Trust on whose medical performers list he appears; and

(b) the contractor has checked that the practitioner meets the requirements in paragraph 53.

(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 53 in accordance with sub-paragraph (1)(b) before employing or engaging him he 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—

(a) the name and address provided under sub-paragraph (1) may be the name and address of the Primary Care Trust on whose list he has applied for inclusion; and

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

58.—(1) A contractor shall not employ or engage—

(a) a health care professional other than one to whom paragraph 53 applies unless the contractor has checked that he meets the requirements in paragraph 54; or

(b) a health care professional to perform clinical services unless he has taken reasonable steps to satisfy himself that he meets the requirements in paragraph 56.

(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 54 in accordance with sub-paragraph (1) before employing or engaging him, he 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 shall 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 him and any relevant clinical experience gained by him.

59.—(1) The contractor shall 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 health care professional 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 him, he may be employed or engaged on a temporary basis for a single period of up to 14 days whilst his 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.

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

(2) The duty imposed by sub-paragraph (1) is in addition to the duties imposed by paragraphs 57 to 59.

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

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

(b) his education and training; and

(c) his previous employment or work experience.

Training

61.  The contractor shall 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 his skills and knowledge in relation to the services which he is performing or assisting in performing.

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

Terms and conditions

63.  The contractor shall 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 new GMS contract 2003(38).

Arrangements for GP Registrars

64.—(1) The contractor shall only employ a GP Registrar for the purpose of being trained by a GP Trainer with the agreement of the Secretary of State and subject to the conditions in sub-paragraph (2).

(2) The conditions referred to in sub-paragraph (1) are that the contractor shall 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 a GP Registrar shall—

(a) offer him terms of employment in accordance with the rates and subject to the conditions contained in any directions given by the Secretary of State to Strategic Health Authorities under section 17 of the Act (Secretary of State’s directions: exercise of functions) concerning the grants, fees, travelling and other allowances payable to GP Registrars(39); and

(b) take into account any guidance issued by the Secretary of State in relation to the GP Registrar Scheme(40).

Independent nurse prescribers and supplementary prescribers

65.—(1) Where—

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

(b) a party to the contract is an independent nurse prescriber or a supplementary prescriber whose functions will include prescribing; or

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

it shall notify the Primary Care Trust in writing within the period of seven days beginning with the date on which the contractor employed or engaged the person, the party became a party to the contract (unless immediately before becoming such a party, he fell under paragraph (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 nurse prescriber or a supplementary prescriber whose functions included prescribing in its practice;

(b) the party to the contract who is an independent nurse prescriber or a supplementary prescriber whose functions include prescribing, ceases to be a party to the contract;

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

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

it shall notify the Primary Care Trust in writing by the end of the second working day after the day when the event occurred.

(3) The contractor shall provide the following information when it notifies the Primary Care Trust in accordance with sub-paragraph (1)—

(a) the person’s full name;

(b) his professional qualifications;

(c) his identifying number which appears in the relevant register;

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

(e) the date on which—

(i) he was employed or engaged, if applicable,

(ii) he became a party to the contract, if applicable, or

(iii) one of his functions became to prescribe in its practice.

(4) The contractor shall provide the following information when it notifies the Primary Care Trust in accordance with sub-paragraph (2)—

(a) the person’s full name;

(b) his professional qualifications;

(c) his identifying number which appears in the relevant register;

(d) the date—

(i) he ceased to be employed or engaged in its practice,

(ii) he ceased to be a party to the contract,

(iii) his functions changed so as no longer to include prescribing, or

(iv) on which he was removed or suspended from the relevant register.

Signing of documents

66.—(1) In addition to any other requirements relating to such documents whether in these regulations or otherwise, the contractor shall ensure that the documents specified in 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 21, unless regulations relating to particular certificates provide otherwise;

(b) prescription forms and repeatable prescriptions; and

(c) any other clinical documents.

Level of skill

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

Appraisal and assessment

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

(a) participates in the appraisal system provided by the Primary Care Trust unless he participates in an appraisal system provided by another health service body or is an armed forces GP; and

(b) co-operates with an assessment by the NCAA when requested to do so by the Primary Care Trust.

(2) The Primary Care Trust shall provide an appraisal system for the purposes of sub-paragraph (1)(a) after consultation with the Local Medical Committee (if any) for the area of the Primary Care Trust and such other persons as appear to it 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.

Sub-contracting of clinical matters

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

(a) in all cases, including those which fall within paragraph 70, it has taken reasonable steps to satisfy itself that—

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

(ii) that person is qualified and competent to provide the service; and

(b) except in cases which fall within paragraph 70, it has notified the Primary Care Trust in writing 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) shall not apply to a contract for services with a health care professional for the provision by that professional personally of clinical services.

(3) The notification referred to in sub-paragraph (1)(b) shall include—

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

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

(c) the services to be covered; and

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

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

(5) The contractor shall not proceed with the sub-contract or, if it has already taken effect, shall take appropriate steps to terminate it, where, within 28 days of receipt of the notice referred to in sub-paragraph (1)(b), the Primary Care Trust 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 Trust at risk of material financial loss; or

(b) the sub-contractor would be unable to meet the contractor’s obligations under the contract.

(6) Where the Primary Care Trust objects to a proposed sub-contract in accordance with sub-paragraph (5), it shall include with the notice of objection a statement in writing of the reasons for its objection.

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

(8) Where a Primary Care Trust does not object to a proposed sub-contract under paragraph (5), the parties to the contract shall 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 104(1) shall 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.

Sub-contracting of out of hours services

70.—(1) A contractor shall not, otherwise than in accordance with the written approval of the Primary Care Trust, sub-contract all or part of its duty to provide out of hours services to any person other than those listed in sub-paragraph (2) other than on a short-term occasional basis.

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

(a) a person who holds a general medical services contract with a Primary Care Trust which includes out of hours services;

(b) a section 28C provider who is required to provide the equivalent of essential services to his patients during all or part of the out of hours period;

(c) a health care professional, not falling within paragraph (a) or (b), who is to provide the out of hours services personally under a contract for services; or

(d) a group of medical practitioners, whether in partnership or not, who provide out of hours services for each other under informal rota arrangements.

(3) An application for approval under sub-paragraph (1) shall be made by the contractor in writing to the Primary Care Trust and shall state—

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

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

(c) the duration of the proposed sub-contract;

(d) the services to be covered by the arrangement; and

(e) how it is proposed that the sub-contractor will meet the contractor’s obligations under the contract in respect of the services covered by the arrangement.

(4) Within 7 days of receipt of an application under sub-paragraph (3), a Primary Care Trust may request such further information relating to the proposed arrangements as seem to it to be reasonable.

(5) Within 28 days of receipt of an application which meets the requirements specified in sub-paragraph (3) or the further information requested under sub-paragraph (4) (whichever is the later), the Primary Care Trust shall—

(a) approve the application;

(b) approve the application with conditions; or

(c) refuse the application.

(6) The Primary Care Trust shall not refuse the application if it is satisfied that the proposed arrangement will, in respect of the services to be covered, enable the contractor to meet satisfactorily its obligations under the contract and will not—

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

(b) put the Trust at risk of material financial loss.

(7) The Primary Care Trust shall inform the contractor by notice in writing of its decision on the application and, where it refuses an application, it shall include in the notice a statement of the reasons for its refusal.

(8) Where a Primary Care Trust approves an application under this paragraph the parties to the contract shall be deemed to have agreed a variation of the contract which has the effect of adding to the list of practice premises, for the purposes of the provision of services in accordance with that application, any premises whose address was notified to it under sub-paragraph (3)(b) and paragraph 104(1) shall not apply.

(9) Sub-paragraphs (1) to (8) shall also apply in relation to any renewal or material variation of a sub-contract in relation to out of hours services.

(10) A contract with a sub-contractor must prohibit the sub-contractor from sub-contracting the out of hours services it has agreed with the contractor to provide.

Withdrawal and variation of approval under paragraph 70

71.—(1) Without prejudice to any other remedies which it may have under the contract, where a Primary Care Trust has approved an application made under paragraph 70(3) it shall, subject to paragraph 72, be entitled to serve notice on the contractor withdrawing or varying that approval, from a date specified in the notice, if it is no longer satisfied that the proposed arrangement will enable the contractor to meet satisfactorily its obligations under the contract.

(2) The date specified in the notice shall be such as appears reasonable in all the circumstances to the Primary Care Trust.

(3) The notice referred to in sub-paragraph (1) shall take effect on whichever is the later of—

(a) the date specified in the notice; or

(b) (if applicable) the date of the final determination of the NHS dispute resolution procedure (or any court proceedings) relating to the notice in favour of the Primary Care Trust.

72.—(1) Without prejudice to any other remedies which it may have under the contract, where a Primary Care Trust has approved an application made under paragraph 70(3) it shall be entitled to serve notice on the contractor withdrawing or varying that approval with immediate effect if—

(a) it is no longer satisfied that the proposed arrangement will enable the contractor to meet satisfactorily its obligations under the contract; and

(b) it is satisfied that immediate withdrawal or variation is necessary to protect the safety of the contractor’s patients.

(2) An immediate withdrawal of approval under sub-paragraph (1) shall take effect on the date on which the notice referred to in that sub-paragraph is received by the contractor.

PART 5 RECORDS, INFORMATION, NOTIFICATIONS AND RIGHTS OF ENTRY

Patient records

73.—(1) In this paragraph, “computerised records” means records created by way of entries on a computer.

(2) The contractor shall keep adequate records of its attendance on and treatment of its patients and shall do so—

(a) on forms supplied to it for the purpose by the Primary Care Trust; or

(b) with the written consent of the Primary Care Trust, by way of computerised records,

or in a combination of those two ways.

(3) The contractor shall include in the records referred to in sub-paragraph (2) clinical reports sent in accordance with paragraph 7 of this Schedule or from any other health care professional who has provided clinical services to a person on its list of patients.

(4) The consent of the Primary Care Trust required by sub-paragraph (2)(b) shall not be withheld or withdrawn provided the Primary Care Trust is satisfied, and continues to be satisfied, that—

(a) the computer system upon which the contractor proposes to keep the records has been accredited by the Secretary of State or another person on his behalf in accordance with “General Medical Practice Computer Systems—Requirements for Accreditation—RFA99” version 1.0, 1.1 or 1.2 (DTS/Nurse Prescribing)(41);

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

(c) the contractor is aware of, and has signed an undertaking that it will have regard to the guidelines contained in “Good Practice Guidelines for General Practice Electronic Patient Records” published on 26th September 2003(42).

(5) Where a patient’s records are computerised records, the contractor shall, as soon as possible following a request from the Primary Care Trust, allow the Trust to access the information recorded on the computer system on which those records are held by means of the audit function referred to in sub-paragraph (4)(b) to the extent necessary for the Trust to confirm that the audit function is enabled and functioning correctly.

(6) The contractor shall send the complete records relating to a patient to the Primary Care Trust—

(a) where a person on its list dies, before the end of the period of 14 days beginning with the date on which it was informed by the Primary Care Trust of the death, or (in any other case) before the end of the period of one month beginning with the date on which it learned of the death; or

(b) in any other case where the person is no longer registered with the contractor, as soon as possible at the request of the Primary Care Trust.

(7) To the extent that a patient’s records are computerised records, the contractor complies with sub-paragraph (6) if it sends to the Primary Care Trust a copy of those records—

(a) in written form; or

(b) with the written consent of the Primary Care Trust in any other form.

(8) The consent of the Primary Care Trust to the transmission of information other than in written form for the purposes of sub-paragraph (7)(b) shall not be withheld or withdrawn provided it is satisfied, and continues to be satisfied, with the following matters—

(a) the contractor’s proposals as to how the record will be transmitted;

(b) the contractor’s proposals as to the format of the transmitted record;

(c) how the contractor will ensure that the record received by the Primary Care Trust is identical to that transmitted; and

(d) how a written copy of the record can be produced by the Primary Care Trust.

(9) A contractor whose patient records are computerised records shall not disable, or attempt to disable, either the security measures or the audit and system management functions referred to in sub-paragraph (4)(b).

Access to records for the purpose of the Quality Information Preparation Scheme

74.—(1) The contractor must provide access to its patient records on request to any appropriately qualified person with whom the Primary Care Trust has made arrangements for the provision of the Quality Information Preparation Scheme referred to in section 7 of the GMS Statement of Financial Entitlements.

(2) The contractor shall not be obliged to grant access to a person referred to in sub-paragraph (1) unless he produces, on request, written evidence that he is authorised by the Primary Care Trust to act on its behalf.

Confidentiality of personal data

75.  The contractor shall nominate a person with responsibility for practices and procedures relating to the confidentiality of personal data held by it.

Practice leaflet

76.  The contractor shall—

(a) compile a document (in this paragraph called a practice leaflet) which shall include the information specified in Schedule 10;

(b) review its practice leaflet at least once in every period of 12 months and make any amendments necessary to maintain its accuracy; and

(c) make available a copy of the leaflet, and any subsequent updates, to its patients and prospective patients.

Provision of information

77.—(1) Subject to sub-paragraph (2), the contractor shall, at the request of the Primary Care Trust, produce to the Primary Care Trust or to a person authorised in writing by the Primary Care Trust or allow it, or a person authorised in writing by it, to access—

(a) any information which is reasonably required by the Primary Care Trust for the purposes of or in connection with the contract; and

(b) any other information which is reasonably required in connection with the Primary Care Trust’s functions.

(2) The contractor shall not be required to comply with any request made in accordance with sub-paragraph (1) unless it has been made by the Primary Care Trust in accordance with directions relating to the provision of information by contractors given to it by the Secretary of State under section 17 of the Act (Secretary of State’s directions: exercise of functions)(43).

Requests for information from Patients' Forums

78.—(1) Subject to sub-paragraph (2), where the contractor receives a written request from the Patients' Forum established for the Primary Care Trust to produce any information which appears to the Forum to be necessary for the effective carrying out of its functions it shall comply with that request promptly and in any event no later than the twentieth working day following the date the request was made.

(2) The contractor shall not be required to produce information under sub-paragraph (1) which—

(a) is confidential and relates to a living individual, unless at least one of the conditions specified in sub-paragraph (3) applies; or

(b) is prohibited from disclosure by or under any enactment or any ruling of a court of competent jurisdiction or is protected by the common law, unless sub-paragraph (4) applies.

(3) The conditions referred to in sub-paragraph (2)(a) are—

(a) the information can be disclosed in a form from which the identity of the individual cannot be ascertained; or

(b) the individual consents to the information being disclosed.

(4) This paragraph applies where—

(a) the prohibition of the disclosure of information arises because the information is capable of identifying an individual; and

(b) the information can be disclosed in a form from which the identity of the individual cannot be ascertained.

(5) In a case where the information falls within—

(a) sub-paragraph (2)(a) and the condition in sub-paragraph (3)(a) applies; or

(b) sub-paragraph (2)(b) and sub-paragraph (4) applies,

a Patients' Forum may require the contractor to disclose the information in a form from which the identity of the individual concerned cannot be ascertained.

Inquiries about prescriptions and referrals

79.—(1) The contractor shall, subject to sub-paragraphs (2) and (3), sufficiently answer any inquiries whether oral or in writing from the Primary Care Trust concerning—

(a) any prescription form or repeatable prescription issued by a prescriber;

(b) the considerations by reference to which prescribers issue such forms;

(c) the referral by or on behalf of the contractor of any patient to any other services provided under the Act; or

(d) the considerations by which the contractor makes such referrals or provides for them to be made on its behalf.

(2) An inquiry referred to in sub-paragraph (1) may only be made for the purpose either of obtaining information to assist the Primary Care Trust to discharge its functions or of assisting the contractor in the discharge of its obligations under the contract.

(3) The contractor shall not be obliged to answer any inquiry referred to in sub-paragraph (1) unless it is made—

(a) in the case of sub-paragraph (1)(a) or (b), by an appropriately qualified health care professional; or

(b) in the case of sub-paragraph (1)(c) or (d), by an appropriately qualified medical practitioner,

appointed in either case by the Primary Care Trust to assist it in the exercise of its functions under this paragraph and that person produces, on request, written evidence that he is authorised by the Primary Care Trust to make such an inquiry on its behalf.

Reports to a medical officer

80.—(1) The contractor shall, if it is satisfied that the patient consents—

(a) supply in writing to a medical officer within such reasonable period as that officer, or an officer of the Department for Work and Pensions on his behalf and at his direction, may specify, such clinical information as the medical officer considers relevant about a patient to whom the contractor or a person acting on the contractor’s behalf has issued or has refused to issue a medical certificate; and

(b) answer any inquiries by a medical officer, or by an officer of the Department for Work and Pensions on his behalf and at his direction, about a prescription form or medical certificate issued by the contractor or on its behalf or about any statement which the contractor or a person acting on the contractor’s behalf has made in a report.

(2) For the purpose of satisfying himself that the patient has consented as required by paragraph (1), the contractor may (unless it has reason to believe the patient does not consent) rely on an assurance in writing from the medical officer, or any officer of the Department for Work and Pensions, that he holds the patient’s written consent.

Annual return and review

81.—(1) The contractor shall submit an annual return relating to the contract to the Primary Care Trust which shall require the same categories of information from all persons who hold contracts with that Trust.

(2) Following receipt of the return referred to in sub-paragraph (1), the Primary Care Trust shall arrange with the contractor an annual review of its performance in relation to the contract.

(3) Either the contractor or the Primary Care Trust may, if it wishes to do so, invite the Local Medical Committee for the area of the Primary Care Trust to participate in the annual review.

(4) The Primary Care Trust shall prepare a draft record of the review referred to in sub-paragraph (2) for comment by the contractor and, having regard to such comments, shall produce a final written record of the review.

(5) A copy of the final record referred to in sub-paragraph (4) shall be sent to the contractor.

Notifications to the Primary Care Trust

82.  In addition to any requirements of notification elsewhere in the regulations, the contractor shall notify the Primary Care Trust in writing, as soon as reasonably practicable, of—

(a) any serious incident that, in the reasonable opinion of the contractor, affects or is likely to affect the contractor’s performance of its obligations under the contract;

(b) any circumstances which give rise to the Primary Care Trust’s right to terminate the contract under paragraph 111, 112 or 113(1);

(c) any appointments system which it proposes to operate and the proposed discontinuance of any such system;

(d) any change of which it is aware in the address of a registered patient; and

(e) the death of any patient of which it is aware.

83.  The contractor shall, unless it is impracticable for it to do so, notify the Primary Care Trust in writing within 28 days of any occurrence requiring a change in the information about it published by the Primary Care Trust in accordance with regulations made under section 16CC(3) of the Act (primary medical services)(44).

84.  The contractor shall notify the Primary Care Trust in writing of any person other than a registered patient or a person whom it has accepted as a temporary resident to whom it has provided the essential services described in regulation 15(6) or (8) within the period of 28 days beginning on the day that the services were provided.

Notice provisions specific to a contract with a company limited by shares

85.—(1) A contractor which is a company limited by shares shall give notice in writing to the Primary Care Trust forthwith when—

(a) any share in the contractor is transmitted or transferred (whether legally or beneficially) to another person on a date after the contract has been entered into;

(b) it passes a resolution or a court of competent jurisdiction makes an order that the contractor be wound up;

(c) circumstances arise which might entitle a creditor or a court to appoint a receiver, administrator or administrative receiver for the contractor;

(d) circumstances arise which would enable the court to make a winding up order in respect of the contractor; or

(e) the contractor is unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 (definition of inability to pay debts) (45).

(2) A notice under sub-paragraph (1)(a) shall confirm that the new shareholder, or, as the case may be, the personal representative of a deceased shareholder—

(a) is a medical practitioner, or that he satisfies the conditions specified in section 28S(2)(b)(i) to (iv) of the Act (persons eligible to enter into GMS contracts); and

(b) meets the further conditions imposed on shareholders by virtue of regulations 4 and 5.

Notice provisions specific to a contract with two or more individuals practising in partnership

86.—(1) A contractor which is a partnership shall give notice in writing to the Primary Care Trust forthwith when—

(a) a partner leaves or informs his partners that he intends to leave the partnership, and the date upon which he left or will leave the partnership;

(b) a new partner joins the partnership.

(2) A notice under sub-paragraph (1)(b) shall—

(a) state the date that the new partner joined the partnership;

(b) confirm that the new partner is a medical practitioner, or that he satisfies the conditions specified in section 28S(2)(b)(i) to (iv) of the Act(46);

(c) confirm that the new partner meets the conditions imposed by regulations 4 and 5; and

(d) state whether the new partner is a general or a limited partner.

Notification of deaths

87.—(1) The contractor shall report in writing to the Primary Care Trust the death on its practice premises of any patient no later than the end of the first working day after the date on which the death occurred.

(2) The report shall include—

(a) the patient’s full name;

(b) the patient’s National Health Service number where known;

(c) the date and place of death;

(d) a brief description of the circumstances, as known, surrounding the death;

(e) the name of any medical practitioner or other person treating the patient whilst on the practice premises; and

(f) the name, where known, of any other person who was present at the time of the death.

(3) The contractor shall send a copy of the report referred to in sub-paragraph (1) to any other Primary Care Trust in whose area the deceased was resident at the time of his death.

Notifications to patients following variation of the contract

88.  Where the contract is varied in accordance with Part 8 of this Schedule and, as a result of that variation—

(a) there is to be a change in the range of services provided to the contractor’s registered patients; or

(b) patients who are on the contractor’s list of patients are to be removed from that list,

the Primary Care Trust shall notify those patients in writing of the variation and its effect and inform them of the steps they can take to obtain elsewhere the services in question or, as the case may be, register elsewhere for the provision of essential services (or their equivalent).

Entry and inspection by the Primary Care Trust

89.—(1) Subject to the conditions in sub-paragraph (2), the contractor shall allow persons authorised in writing by the Primary Care Trust to enter and inspect the practice premises at any reasonable time.

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

(a) reasonable notice of the intended entry has been given;

(b) written evidence of the authority of the person seeking entry is produced to the contractor on request; and

(c) entry is not made to any premises or part of the premises used as residential accommodation without the consent of the resident.

(3) Either the contractor or the Primary Care Trust may, if it wishes to do so, invite the Local Medical Committee for the area of the Primary Care Trust to be present at an inspection of the practice premises which takes place under this paragraph.

Entry and inspection by members of Patients' Forums

90.  The contractor shall allow members of a Patients' Forum authorised by or under regulation 3 of the Patients' Forums (Functions) Regulations 2003(47) to enter and inspect the practice premises for the purpose of any of the Forum’s functions in accordance with the requirements of that regulation.

Entry and inspection by the Commission for Healthcare Audit and Inspection

91.  The contractor shall allow persons authorised by the Commission for Healthcare Audit and Inspection to enter and inspect the premises in accordance with section 66 of the Health and Social Care (Community Health and Standards) Act 2003 (right of entry)(48).

PART 6 COMPLAINTS

Complaints procedure

92.—(1) The contractor shall establish and operate a complaints procedure to deal with any complaints in relation to any matter reasonably connected with the provision of services under the contract which shall—

(a) until the coming into force of regulations in relation to complaints about general medical services made under section 113 of the Health and Social Care (Community Health and Standards) Act 2003 (complaints about health care) comply with the requirements in paragraphs 93 to 96 and 98; and

(b) on the coming into force of such regulations, comply with those regulations.

(2) The contractor shall take reasonable steps to ensure that patients are aware of—

(a) the complaints procedure;

(b) the role of the Primary Care Trust and other bodies in relation to complaints about services under the contract; and

(c) their right to assistance with any complaint from independent advocacy services provided under section 19A of the Act (independent advocacy services)(49).

(3) The contractor shall take reasonable steps to ensure that the complaints procedure is accessible to all patients.

Making of complaints

93.  A complaint may be made by or, with his consent, on behalf of a patient, or former patient, who is receiving or has received services under the contract, or—

(a) where the patient is a child—

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

(ii) by a person duly authorised by a local authority to whose care the child has been committed under the provisions of the Children Act 1989(50); or

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

(b) where the patient is incapable of making a complaint, by a relative or other adult who has an interest in his welfare.

94.  Where a patient has died a complaint may be made by a relative or other adult person who had an interest in his welfare or, where the patient falls within paragraph 93(a)(ii) or (iii), by the authority or voluntary organisation.

Period for making complaints

95.—(1) Subject to sub-paragraph (2), the period for making a complaint is—

(a) six months from the date on which the matter which is the subject of the complaint occurred; or

(b) six months from the date on which the matter which is the subject of the complaint comes to the complainant’s notice provided that the complaint is made no later than 12 months after the date on which the matter which is the subject of the complaint occurred.

(2) Where a complaint is not made during the period specified in sub-paragraph (1), it shall be referred to the person nominated under paragraph 96(2)(a) and if he is of the opinion that—

(a) having regard to all the circumstances of the case, it would have been unreasonable for the complainant to make the complaint within that period; and

(b) notwithstanding the time that has elapsed since the date on which the matter which is the subject matter of the complaint occurred, it is still possible to investigate the complaint properly,

the complaint shall be treated as if it had been received during the period specified in sub-paragraph (1).

Further requirements for complaints procedures

96.—(1) A complaints procedure shall also comply with the requirements set out in sub-paragraphs (2) to (6).

(2) The contractor must nominate—

(a) a person (who need not be connected with the contractor and who, in the case of an individual, may be specified by his job title) to be responsible for the operation of the complaints procedure and the investigation of complaints; and

(b) a partner, or other senior person associated with the contractor, to be responsible for the effective management of the complaints procedure and for ensuring that action is taken in the light of the outcome of any investigation.

(3) All complaints must be—

(a) either made or recorded in writing;

(b) acknowledged in writing within the period of three working days beginning with the day on which the complaint was made or, where that is not possible, as soon as reasonably practicable; and

(c) properly investigated.

(4) Within the period of 10 working days beginning with the day on which the complaint was received by the person specified under sub-paragraph (2)(a) or, where that is not possible, as soon as reasonably practicable, the complainant must be given a written summary of the investigation and its conclusions.

(5) Where the investigation of the complaint requires consideration of the patient’s medical records, the person specified under sub-paragraph (2)(a) must inform the patient or person acting on his behalf if the investigation will involve disclosure of information contained in those records to a person other than the contractor or an employee of the contractor.

(6) The contractor must keep a record of all complaints and copies of all correspondence relating to complaints, but such records must be kept separate from patients' medical records.

Co-operation with investigations

97.—(1) The contractor shall co-operate with—

(a) any investigation of a complaint in relation to any matter reasonably connected with the provision of services under the contract undertaken by—

(i) the Primary Care Trust, and

(ii) the Commission for Healthcare Audit and Inspection; and

(b) any investigation of a complaint by an NHS body or local authority which relates to a patient or former patient of the contractor.

(2) In sub-paragraph (1)—

“NHS body” means a Primary Care Trust, (in England and Wales and Scotland) an NHS trust, an NHS foundation trust, a Strategic Health Authority, a Local Health Board, a Health Board, a Health and Social Services Board or a Health and Social Services Trust;

“local authority” means—

(a)

any of the bodies listed in section 1 of the Local Authority Social Services Act 1970 (local authorities)(51),

(b)

the Council of the Isles of Scilly, or

(c)

a council constituted under section 2 of the Local Government etc, (Scotland) Act 1994 (constitution of councils)(52).

(3) The co-operation required by sub-paragraph (1) includes—

(a) answering questions reasonably put to the contractor by the Primary Care Trust;

(b) providing any information relating to the complaint reasonably required by the Primary Care Trust; and

(c) attending any meeting to consider the complaint (if held at a reasonably accessible place and at a reasonable hour, and due notice has been given) if the contractor’s presence at the meeting is reasonably required by the Primary Care Trust.

Provision of information about complaints

98.  The contractor shall inform the Primary Care Trust, at such intervals as required, of the number of complaints it has received under the procedure established in accordance with this Part.

PART 7 DISPUTE RESOLUTION

Local resolution of contract disputes

99.—(1) Subject to sub-paragraph (3), in the case of any dispute arising out of or in connection with the contract, the contractor and the Primary Care Trust must make every reasonable effort to communicate and cooperate with each other with a view to resolving the dispute, before referring the dispute for determination in accordance with the NHS dispute resolution procedure (or, where applicable, before commencing court proceedings).

(2) Either the contractor or the Primary Care Trust may, if it wishes to do so, invite the Local Medical Committee for the area of the Primary Care Trust to participate in discussions which take place pursuant to sub-paragraph (1).

(3) In the case of a dispute which falls to be dealt with under the procedure specified in paragraph 36, sub-paragraph (1) does not apply where it is not practicable for the parties to attempt local resolution before the expiry of the period specified in paragraph 36(4).

Dispute resolution: non-NHS contracts

100.—(1) In the case of a contract which is not an NHS contract, any dispute arising out of or in connection with the contract, except matters dealt with under the complaints procedure pursuant to Part 6 of this Schedule, may be referred for consideration and determination to the Secretary of State, if —

(a) the Primary Care Trust so wishes and the contractor has agreed in writing; or

(b) the contractor so wishes (even if the Primary Care Trust does not agree).

(2) In the case of a dispute referred to the Secretary of State under sub-paragraph (1)—

(a) the procedure to be followed is the NHS dispute resolution procedure; and

(b) the parties agree to be bound by any determination made by the adjudicator.

NHS dispute resolution procedure

101.—(1) Subject to sub-paragraph (2), the procedure specified in the following sub-paragraphs and paragraph 102 applies in the case of any dispute arising out of or in connection with the contract which is referred to the Secretary of State—

(a) in accordance with section 4(3) of the 1990 Act (where the contract is an NHS contract); or

(b) in accordance with paragraph 100(1) (where the contract is not an NHS contract).

(2) The procedure specified in this paragraph and paragraph 102 does not apply where a contractor refers a matter for determination in accordance with paragraph 36(1) of this Schedule, and in such a case the procedure specified in that paragraph shall apply instead.

(3) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) shall send to the Secretary of State a written request for dispute resolution which shall include or be accompanied by—

(a) the names and addresses of the parties to the dispute;

(b) a copy of the contract; and

(c) a brief statement describing the nature and circumstances of the dispute.

(4) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send the request under sub-paragraph (3) within a period of three years beginning with the date on which the matter giving rise to the dispute happened or should reasonably have come to the attention of the party wishing to refer the dispute.

(5) Where the dispute relates to a contract which is not an NHS contract, the Secretary of State may determine the matter himself or, if he considers it appropriate, appoint a person or persons to consider and determine it(53).

(6) Before reaching a decision as to who should determine the dispute, either under sub-paragraph (5) or under section 4(5) of the 1990 Act, the Secretary of State shall, within the period of 7 days beginning with the date on which a matter was referred to him, send a written request to the parties to make in writing, within a specified period, any representations which they may wish to make about the matter.

(7) The Secretary of State shall give, with the notice given under sub-paragraph (6), to the party other than the one which referred the matter to dispute resolution a copy of any document by which the matter was referred to dispute resolution.

(8) The Secretary of State shall give a copy of any representations received from a party to the other party and shall in each case request (in writing) a party to whom a copy of the representations is given to make within a specified period any written observations which it wishes to make on those representations.

(9) Following receipt of any representations from the parties or, if earlier, at the end of the period for making such representations specified in the request sent under sub-paragraph (6) or (8), the Secretary of State shall, if he decides to appoint a person or persons to hear the dispute—

(a) inform the parties in writing of the name of the person or persons whom he has appointed; and

(b) pass to the person or persons so appointed any documents received from the parties under or pursuant to paragraph (3), (6) or (8).

(10) For the purpose of assisting him in his consideration of the matter, the adjudicator may—

(a) invite representatives of the parties to appear before him to make oral representations either together or, with the agreement of the parties, separately, and may in advance provide the parties with a list of matters or questions to which he wishes them to give special consideration; or

(b) consult other persons whose expertise he considers will assist him in his consideration of the matter.

(11) Where the adjudicator consults another person under sub-paragraph (10)(b), he shall notify the parties accordingly in writing and, where he considers that the interests of any party might be substantially affected by the result of the consultation, he shall give to the parties such opportunity as he considers reasonable in the circumstances to make observations on those results.

(12) In considering the matter, the adjudicator shall consider—

(a) any written representations made in response to a request under sub-paragraph (6), but only if they are made within the specified period;

(b) any written observations made in response to a request under sub-paragraph (8), but only if they are made within the specified period;

(c) any oral representations made in response to an invitation under sub-paragraph (10)(a);

(d) the results of any consultation under sub-paragraph (10)(b); and

(e) any observations made in accordance with an opportunity given under sub-paragraph (11).

(13) In this paragraph, “specified period” means such period as the Secretary of State shall specify in the request, being not less than 2, nor more than 4, weeks beginning with the date on which the notice referred to is given, but the Secretary of State may, if he considers that there is good reason for doing so, extend any such period (even after it has expired) and, where he does so, a reference in this paragraph to the specified period is to the period as so extended.

(14) Subject to the other provisions of this paragraph and paragraph 102 and to any agreement by the parties, the adjudicator shall have wide discretion in determining the procedure of the dispute resolution to ensure the just, expeditious, economical and final determination of the dispute.

Determination of dispute

102.—(1) The adjudicator shall record his determination and the reasons for it, in writing and shall give notice of the determination (including the record of the reasons) to the parties.

(2) In the case of a contract referred for determination in accordance with paragraph 100(1), subsection (8) of section 4 of the 1990 Act shall apply as that subsection applies in the case of a contract referred for determination in accordance with subsection (3) of section 4 of that Act.

(3) In the case of a contract referred for determination in accordance with paragraph 100(1), subsection (5) of section 28W of the Act(54) shall apply as that subsection applies in the case of a contract referred for determination in accordance with subsection (3) of section 4 of the 1990 Act.

Interpretation of Part 7

103.—(1) In this Part, “any dispute arising out of or in connection with the contract” includes any dispute arising out of or in connection with the termination of the contract.

(2) Any term of the contract that makes provision in respect of the requirements in this Part shall survive even where the contract has terminated.

PART 8 VARIATION AND TERMINATION OF CONTRACTS

Variation of a contract: general

104.—(1) Subject to Schedule 3, paragraphs 69(8), 70(8), 105, 106 and 117 and paragraph 3 of Schedule 7, no amendment or variation shall have effect unless it is in writing and signed by or on behalf of the Primary Care Trust and the contractor.

(2) In addition to the specific provision made in paragraphs 105(6), 106(6) and 117, the Primary Care Trust may vary the contract without the contractor’s consent where it—

(a) is reasonably satisfied that it is necessary to vary the contract so as to comply with the Act, any regulations made pursuant to that Act, or any direction given by the Secretary of State pursuant to that Act; and

(b) notifies the contractor in writing of the wording of the proposed variation and the date upon which that variation is to take effect,

and, where it is reasonably practicable to do so, the date that the proposed variation is to take effect shall be not less than 14 days after the date on which the notice under paragraph (b) is served on the contractor.

Variation provisions specific to a contract with an individual medical practitioner

105.—(1) If a contractor which is an individual medical practitioner proposes to practise in partnership with one or more persons during the existence of the contract, the contractor shall notify the Primary Care Trust in writing of—

(a) the name of the person or persons with whom it proposes to practise in partnership; and

(b) the date on which the contractor wishes to change its status as a contractor from that of an individual medical practitioner to that of a partnership, which shall be not less than 28 days after the date upon which it has served the notice on the Primary Care Trust pursuant to this sub-paragraph.

(2) A notice under sub-paragraph (1) shall in respect of the person or each of the persons with whom the contractor is proposing to practise in partnership, and also in respect of itself as regards the matters specified in paragraph (c)—

(a) confirm that he is either—

(i) a medical practitioner, or

(ii) a person who satisfies the conditions specified in section 28S(2)(b)(i) to (iv) of the Act(55);

(b) confirm that he is a person who satisfies the conditions imposed by regulations 4 and 5; and

(c) state whether or not it is to be a limited partnership, and if so, who is to be a limited and who a general partner,

and the notice shall be signed by the individual medical practitioner and by the person, or each of the persons (as the case may be), with whom he is proposing to practise in partnership.

(3) The contractor shall ensure that any person who will practise in partnership with it is bound by the contract, whether by virtue of a partnership deed or otherwise.

(4) If the Primary Care Trust is satisfied as to the accuracy of the matters specified in sub-paragraph (2) that are included in the notice, the Primary Care Trust shall give notice in writing to the contractor confirming that the contract shall continue with the partnership entered into by the contractor and its partners, from a date that the Primary Care Trust specifies in that notice.

(5) Where it is reasonably practicable, the date specified by the Primary Care Trust pursuant to sub-paragraph (4) shall be the date requested in the notice served by the contractor pursuant to sub-paragraph (1), or, where that date is not reasonably practicable, the date specified shall be a date after the requested date that is as close to the requested date as is reasonably practicable.

(6) Where a contractor has given notice to the Primary Care Trust pursuant to sub-paragraph (1), the Primary Care Trust—

(a) may vary the contract but only to the extent that it is satisfied is necessary to reflect the change in status of the contractor from an individual medical practitioner to a partnership; and

(b) if it does propose to so vary the contract, it shall include in the notice served on the contractor pursuant to sub-paragraph (4) the wording of the proposed variation and the date upon which that variation is to take effect.

Variation provisions specific to a contract with two or more individuals practising in partnership

106.—(1) Subject to sub-paragraph (4), where a contractor consists of two or more individuals practising in partnership in the event that the partnership is terminated or dissolved, the contract shall only continue with one of the former partners if that partner is—

(a) nominated in accordance with sub-paragraph (3); and

(b) a medical practitioner who meets the condition in regulation 4(2)(a),

and provided that the requirements in sub-paragraphs (2) and (3) are met.

(2) A contractor shall notify the Primary Care Trust in writing at least 28 days in advance of the date on which the contractor proposes to change its status from that of a partnership to that of an individual medical practitioner pursuant to sub-paragraph (1).

(3) A notice under sub-paragraph (2) shall—

(a) specify the date on which the contractor proposes to change its status from that of a partnership to that of an individual medical practitioner;

(b) specify the name of the medical practitioner with whom the contract will continue, which must be one of the partners; and

(c) be signed by all of the persons who are practising in partnership.

(4) If a partnership is terminated or dissolved because, in a partnership consisting of two individuals practising in partnership, one of the partners has died, sub-paragraphs (1), (2) and (3) shall not apply and—

(a) the contract shall continue with the individual who has not died only if that individual is a medical practitioner who meets the condition in regulation 4(2)(a); and

(b) that individual shall in any event notify the Primary Care Trust in writing as soon as is reasonably practicable of the death of his partner.

(5) When the Primary Care Trust receives a notice pursuant to sub-paragraph (2) or (4)(b), it shall acknowledge in writing receipt of the notice, and in relation to a notice served pursuant to sub-paragraph (2), the Trust shall do so before the date specified pursuant to sub-paragraph (3)(a).

(6) Where a contractor gives notice to the Primary Care Trust pursuant to sub-paragraph (2) or (4)(b), the Primary Care Trust may vary the contract but only to the extent that it is satisfied is necessary to reflect the change in status of the contractor from a partnership to an individual medical practitioner.

(7) If the Primary Care Trust varies the contract pursuant to sub-paragraph (6), it shall notify the contractor in writing of the wording of the proposed variation and the date upon which that variation is to take effect.

Termination by agreement

107.  The Primary Care Trust and the contractor may agree in writing to terminate the contract, and if the parties so agree, they shall agree the date upon which that termination should take effect and any further terms upon which the contract should be terminated.

Termination by the contractor

108.—(1) A contractor may terminate the contract by serving notice in writing on the Primary Care Trust at any time.

(2) Where a contractor serves notice pursuant to sub-paragraph (1), the contract shall, subject to sub-paragraph (3), terminate six months after the date on which the notice is served (“the termination date”), save that if the termination date is not the last calendar day of a month, the contract shall instead terminate on the last calendar day of the month in which the termination date falls.

(3) Where the contractor is an individual medical practitioner, sub-paragraph (2) shall apply to the contractor, save that the reference to “six months” shall instead be to “three months”.

(4) This paragraph and paragraph 109 are without prejudice to any other rights to terminate the contract that the contractor may have.

Late payment notices

109.—(1) The contractor may give notice in writing (a “late payment notice”) to the Primary Care Trust if the Trust has failed to make any payments due to the contractor in accordance with a term of the contract that has the effect specified in regulation 22, and the contractor shall specify in the late payment notice the payments that the Trust has failed to make in accordance with that regulation.

(2) Subject to sub-paragraph (3), the contractor may, at least 28 days after having served a late payment notice, terminate the contract by a further written notice if the Primary Care Trust has still failed to make the payments due to the contractor, and that were specified in the late payment notice served on the Primary Care Trust pursuant to sub-paragraph (1).

(3) If, following receipt of a late payment notice, the Primary Care Trust refers the matter to the NHS dispute resolution procedure within 28 days of the date upon which it is served with the late payment notice, and it notifies the contractor in writing that it has done so within that period of time, the contractor may not terminate the contract pursuant to sub-paragraph (2) until—

(a) there has been a determination of the dispute pursuant to paragraph 102 and that determination permits the contractor to terminate the contract; or

(b) the Primary Care Trust ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

Termination by the Primary Care Trust: general

110.  The Primary Care Trust may only terminate the contract in accordance with the provisions in this Part.

Termination by the Primary Care Trust for breach of conditions in regulation 4

111.—(1) The Primary Care Trust shall serve notice in writing on the contractor terminating the contract forthwith if the contractor is an individual medical practitioner and the medical practitioner no longer satisfies the condition specified in regulation 4(1).

(2) Where the contractor is—

(a) two or more persons practising in partnership, and the condition specified in regulation 4(2)(a) is no longer satisfied; or

(b) a company limited by shares, and the condition specified in regulation 4(3)(a) is no longer satisfied,

sub-paragraph (3) shall apply.

(3) Where sub-paragraph (2)(a) or (b) applies, the Primary Care Trust shall—

(a) serve notice in writing on the contractor terminating the contract forthwith; or

(b) serve notice in writing on the contractor confirming that the Primary Care Trust will allow the contract to continue, for a period specified by the Primary Care Trust of up to six months (the “interim period”), during which time the Primary Care Trust shall, with the consent of the contractor, employ or supply one or more general medical practitioners to the contractor for the interim period to assist the contractor in the provision of clinical services under the contract.

(4) Before deciding which of the options in sub-paragraph (3) to pursue, the Primary Care Trust shall, whenever it is reasonably practicable to do so, consult the Local Medical Committee (if any) for its area.

(5) If the contractor does not, pursuant to sub-paragraph (3)(b), consent to the Primary Care Trust employing or supplying a general medical practitioner during the interim period, the Primary Care Trust shall serve notice in writing on the contractor terminating the contract forthwith.

(6) If, at the end of the interim period, the contractor still falls within sub-paragraph (2)(a) or (b), the Primary Care Trust shall serve notice in writing on the contractor terminating the contract forthwith.

Termination by the Primary Care Trust for the provision of untrue etc. information

112.  The Primary Care Trust may serve notice in writing on the contractor terminating the contract forthwith, or from such date as may be specified in the notice if, after the contract has been entered into, it comes to the attention of the Primary Care Trust that written information provided to the Primary Care Trust by the contractor before the contract was entered into in relation to the conditions set out in regulation 4 and 5 (and compliance with those conditions) was, when given, untrue or inaccurate in a material respect.

Other grounds for termination by the Primary Care Trust

113.—(1) The Primary Care Trust may serve notice in writing on the contractor terminating the contract forthwith, or from such date as may be specified in the notice if—

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

(b) in the case of a contract with two or more individuals practising in partnership, any individual or the partnership; and

(c) in the case of a contract with a company limited by shares—

(i) the company,

(ii) any person legally and beneficially owning a share in the company, or

(iii) any director or secretary of the company,

falls within sub-paragraph (2) during the existence of the contract.

(2) A person falls within this sub-paragraph if—

(a) it does not satisfy the conditions prescribed in section 28S(2)(b) or (3)(b) of the Act;

(b) he or it is the subject of a national disqualification;

(c) subject to sub-paragraph (3), he or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation or a suspension on the grounds of ill-health) from practising by any licensing body anywhere in the world;

(d) subject to sub-paragraph (4), he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body unless before the Primary Care Trust has served a notice terminating the contract pursuant to this paragraph, he is employed by the health service body that dismissed him or by another health service body;

(e) he or it is removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act respectively(56)) unless his name has subsequently been included in such a list;

(f) he has been convicted in the United Kingdom of murder;

(g) he has been convicted in the United Kingdom of a criminal offence other than murder and has been sentenced to a term of imprisonment of over six months;

(h) subject to sub-paragraph (5), he has been convicted elsewhere of an offence which would if committed in England and Wales—

(i) constitute murder, or

(ii) constitute a criminal offence other than murder and been sentenced to a term of imprisonment of over six months;

(i) he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933(57) (offences against children and young persons with respect to which special provisions of this Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995(58) (offences against children under the age of 17 years to which special provisions apply);

(j) he or it has—

(i) been adjudged bankrupt or had sequestration of his estate awarded unless (in either case) he has been discharged or the bankruptcy order has been annulled,

(ii) been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986(59), unless that order has ceased to have effect or has been annulled,

(iii) made a composition or arrangement with, or granted a trust deed for, his or its creditors unless he or it has been discharged in respect of it, or

(iv) been wound up under Part IV of the Insolvency Act 1986;

(k) there is—

(i) an administrator, administrative receiver or receiver appointed in respect of it, or

(ii) an administration order made in respect of it under Schedule B1 to the Insolvency Act 1986(60);

(l) that person is a partnership and—

(i) a dissolution of the partnership is ordered by any competent court, tribunal or arbitrator, or

(ii) an event happens that makes it unlawful for the business of the partnership to continue, or for members of the partnership to carry on in partnership;

(m) he has been—

(i) removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated, or

(ii) removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990(61) (powers of the Court of Session to deal with management of charities), from being concerned in the management or control of any body;

(n) he is subject to a disqualification order under the Company Directors Disqualification Act 1986(62), the Companies (Northern Ireland) Order 1986(63) or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order); or

(o) he has refused to comply with a request by the Primary Care Trust for him to be medically examined on the grounds that it is concerned that he is incapable of adequately providing services under the contract and, in a case where the contract is with two or more individuals practising in partnership or with a company, the Primary Care Trust is not satisfied that the contractor is taking adequate steps to deal with the matter.

(3) A Primary Care Trust shall not terminate the contract pursuant to sub-paragraph (2)(c) where the Primary Care Trust is satisfied that the disqualification or suspension imposed by a licensing body outside the United Kingdom does not make the person unsuitable to be—

(a) a contractor;

(b) a partner, in the case of a contract with two or more individuals practising in partnership; or

(c) in the case of a contract with a company limited by shares—

(i) a person legally and beneficially holding a share in the company, or

(ii) a director or secretary of the company,

as the case may be.

(4) A Primary Care Trust shall not terminate the contract pursuant to sub-paragraph (2)(d)—

(a) until a period of at least three months has elapsed since the date of the dismissal of the person concerned; or

(b) if, during the period of time specified in paragraph (a), the person concerned brings proceedings in any competent tribunal or court in respect of his dismissal, until proceedings before that tribunal or court are concluded,

and the Primary Care Trust may only terminate the contract at the end of the period specified in paragraph (b) if there is no finding of unfair dismissal at the end of those proceedings.

(5) A Primary Care Trust shall not terminate the contract pursuant to sub-paragraph (2)(h) where the Primary Care Trust is satisfied that the conviction does not make the person unsuitable to be—

(a) a contractor;

(b) a partner, in the case of a contract with two or more individuals practising in partnership; or

(c) in the case of a contract with a company limited by shares—

(i) a person legally and beneficially holding a share in the company, or

(ii) a director or secretary of the company,

as the case may be.

114.  The Primary Care Trust may serve notice in writing on the contractor terminating the contract forthwith or with effect from such date as may be specified in the notice if—

(a) the contractor has breached the contract and as a result of that breach, the safety of the contractor’s patients is at serious risk if the contract is not terminated; or

(b) the contractor’s financial situation is such that the Primary Care Trust considers that the Primary Care Trust is at risk of material financial loss.

Termination by the Primary Care Trust: remedial notices and breach notices

115.—(1) Where a contractor has breached the contract other than as specified in paragraphs 111 to 114 and the breach is capable of remedy, the Primary Care Trust shall, before taking any action it is otherwise entitled to take by virtue of the contract, serve a notice on the contractor requiring it to remedy the breach (“remedial notice”).

(2) A remedial notice shall specify—

(a) details of the breach;

(b) the steps the contractor must take to the satisfaction of the Primary Care Trust in order to remedy the breach; and

(c) the period during which the steps must be taken (“the notice period”).

(3) The notice period shall, unless the Primary Care Trust is satisfied that a shorter period is necessary to—

(a) protect the safety of the contractor’s patients; or

(b) protect itself from material financial loss,

be no less than 28 days from the date that notice is given.

(4) Where a Primary Care Trust is satisfied that the contractor has not taken the required steps to remedy the breach by the end of the notice period, the Primary Care Trust may terminate the contract with effect from such date as the Primary Care Trust may specify in a further notice to the contractor.

(5) Where a contractor has breached the contract other than as specified in paragraphs 111 to 114 and the breach is not capable of remedy, the Primary Care Trust may serve notice on the contractor requiring the contractor not to repeat the breach (“breach notice”).

(6) If, following a breach notice or a remedial notice, the contractor—

(a) repeats the breach that was the subject of the breach notice or the remedial notice; or

(b) otherwise breaches the contract resulting in either a remedial notice or a further breach notice,

the Primary Care Trust may serve notice on the contractor terminating the contract with effect from such date as may be specified in that notice.

(7) The Primary Care Trust shall not exercise its right to terminate the contract under sub-paragraph (6) unless it is satisfied that the cumulative effect of the breaches is such that the Primary Care Trust considers that to allow the contract to continue would be prejudicial to the efficiency of the services to be provided under the contract.

(8) If the contractor is in breach of any obligation and a breach notice or a remedial notice in respect of that default has been given to the contractor, the Primary Care Trust may withhold or deduct monies which would otherwise be payable under the contract in respect of that obligation which is the subject of the default.

Termination by the Primary Care Trust: additional provisions specific to contracts with two or more individuals practising in partnership and companies limited by shares

116.—(1) Where the contractor is a company limited by shares, if the Primary Care Trust becomes aware that the contractor is carrying on any business which the Primary Care Trust considers to be detrimental to the contractor’s performance of its obligations under the contract—

(a) the Primary Care Trust shall be entitled to give notice to the contractor requiring that it ceases carrying on that business before the end of a period of not less than 28 days beginning on the day on which the notice is given (“the notice period”); and

(b) if the contractor has not satisfied the Primary Care Trust that it has ceased carrying on that business by the end of the notice period, the Primary Care Trust may, by a further written notice, terminate the contract forthwith or from such date as may be specified in the notice.

(2) Where the contractor is two or more persons practising in partnership, the Primary Care Trust shall be entitled to terminate the contract by notice in writing on such date as may be specified in that notice where one or more partners have left the practice during the existence of the contract if in its reasonable opinion, the Primary Care Trust considers that the change in membership of the partnership is likely to have a serious adverse impact on the ability of the contractor or the Primary Care Trust to perform its obligations under the contract.

(3) A notice given to the contractor pursuant to sub-paragraph (2) shall specify—

(a) the date upon which the contract is to be terminated; and

(b) the Primary Care Trust’s reasons for considering that the change in the membership of the partnership is likely to have a serious adverse impact on the ability of the contractor or the Primary Care Trust to perform its obligations under the contract.

Contract sanctions

117.—(1) In this paragraph and paragraph 118, “contract sanction” means—

(a) termination of specified reciprocal obligations under the contract;

(b) suspension of specified reciprocal obligations under the contract for a period of up to six months; or

(c) withholding or deducting monies otherwise payable under the contract.

(2) Where the Primary Care Trust is entitled to terminate the contract pursuant to paragraph 112, 113, 114 or 115(4) or (6) or paragraph 116, it may instead impose any of the contract sanctions if the Primary Care Trust is reasonably satisfied that the contract sanction to be imposed is appropriate and proportionate to the circumstances giving rise to the Primary Care Trust’s entitlement to terminate the contract.

(3) The Primary Care Trust shall not, under sub-paragraph (2), be entitled to impose any contract sanction that has the effect of terminating or suspending any obligation to provide, or any obligation that relates to, essential services.

(4) If the Primary Care Trust decides to impose a contract sanction, it must notify the contractor of the contract sanction that it proposes to impose, the date upon which that sanction will be imposed and provide in that notice an explanation of the effect of the imposition of that sanction.

(5) Subject to paragraph 118, the Primary Care Trust shall not impose the contract sanction until at least 28 days after it has served notice on the contractor pursuant to sub-paragraph (4) unless the Primary Care Trust is satisfied that it is necessary to do so in order to—

(a) protect the safety of the contractor’s patients; or

(b) protect itself from material financial loss.

(6) Where the Primary Care Trust imposes a contract sanction, the Primary Care Trust shall be entitled to charge the contractor the reasonable costs of additional administration that the Primary Care Trust has incurred in order to impose, or as a result of imposing, the contract sanction.

Contract sanctions and the NHS dispute resolution procedure

118.—(1) If there is a dispute between the Primary Care Trust and the contractor in relation to a contract sanction that the Primary Care Trust is proposing to impose, the Primary Care Trust shall not, subject to sub-paragraph (4), impose the proposed contract sanction except in the circumstances specified in sub-paragraph (2)(a) or (b).

(2) If the contractor refers the dispute relating to the contract sanction to the NHS dispute resolution procedure within 28 days beginning on the date on which the Primary Care Trust served notice on the contractor in accordance with paragraph 117(4) (or such longer period as may be agreed in writing with the Primary Care Trust), and notifies the Primary Care Trust in writing that it has done so, the Primary Care Trust shall not impose the contract sanction unless—

(a) there has been a determination of the dispute pursuant to paragraph 102 and that determination permits the Primary Care Trust to impose the contract sanction; or

(b) the contractor ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

(3) If the contractor does not invoke the NHS dispute resolution procedure within the time specified in sub-paragraph (2), the Primary Care Trust shall be entitled to impose the contract sanction forthwith.

(4) If the Primary Care Trust is satisfied that it is necessary to impose the contract sanction before the NHS dispute resolution procedure is concluded in order to—

(a) protect the safety of the contractor’s patients; or

(b) protect itself from material financial loss,

the Primary Care Trust shall be entitled to impose the contract sanction forthwith, pending the outcome of that procedure.

Termination and the NHS dispute resolution procedure

119.—(1) Where the Primary Care Trust is entitled to serve written notice on the contractor terminating the contract pursuant to paragraph 112, 113, 114, or 115(4) or (6), the Primary Care Trust shall, in the notice served on the contractor pursuant to those provisions, specify a date on which the contract terminates that is not less than 28 days after the date on which the Primary Care Trust has served that notice on the contractor unless sub-paragraph (2) applies.

(2) This sub-paragraph applies if the Primary Care Trust is satisfied that a period less than 28 days is necessary in order to—

(a) protect the safety of the contractor’s patients; or

(b) protect itself from material financial loss.

(3) In a case falling with sub-paragraph (1), where the exceptions in sub-paragraph (2) do not apply, where the contractor invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1), and it notifies the Primary Care Trust in writing that it has done so, the contract shall not terminate at the end of the notice period but instead shall only terminate in the circumstances specified in sub-paragraph (4).

(4) The contract shall only terminate if and when—

(a) there has been a determination of the dispute pursuant to paragraph 102 and that determination permits the Primary Care Trust to terminate the contract; or

(b) the contractor ceases to pursue the NHS dispute resolution procedure,

whichever is the sooner.

(5) If the Primary Care Trust is satisfied that it is necessary to terminate the contract before the NHS dispute resolution procedure is concluded in order to—

(a) protect the safety of the contractor’s patients; or

(b) protect itself from material financial loss,

sub-paragraphs (3) and (4) shall not apply and the Primary Care Trust shall be entitled to confirm, by written notice to be served on the contractor, that the contract will nevertheless terminate at the end of the period of the notice it served pursuant to paragraph 112, 113(1), 114, 115(4) or (6) or 116.

Consultation with the Local Medical Committee

120.—(1) Whenever the Primary Care Trust is considering—

(a) terminating the contract pursuant to paragraph 112, 113, 114, 115(4) or (6) or 116; or

(b) imposing a contract sanction,

it shall, whenever it is reasonably practicable to do so, consult the Local Medical Committee (if any) for its area before it terminates the contract or imposes a contract sanction.

(2) Whether or not the Local Medical Committee has been consulted pursuant to sub-paragraph (1), whenever the Primary Care Trust imposes a contract sanction on a contractor or terminates a contract pursuant to this Part, it shall, as soon as reasonably practicable, notify the Local Medical Committee in writing of the contract sanction imposed or of the termination of the contract (as the case may be).

PART 9 MISCELLANEOUS

Clinical governance

121.—(1) The contractor shall have an effective system of clinical governance.

(2) The contractor shall nominate a person who will have responsibility for ensuring the effective operation of the system of clinical governance.

(3) The person nominated under sub-paragraph (2) shall be a person who performs or manages services under the contract.

(4) In this paragraph “system of clinical governance” means a framework through which the contractor endeavours continuously to improve the quality of its services and safeguard high standards of care by creating an environment in which clinical excellence can flourish.

Insurance

122.—(1) The contractor shall at all times hold adequate insurance against liability arising from negligent performance of clinical services under the contract.

(2) The contractor shall not sub-contract its obligations to provide clinical services under the contract unless it has satisfied itself that the sub-contractor holds adequate insurance against liability arising from negligent performance of such services.

(3) In this paragraph—

(a) “insurance” means a contract of insurance or other arrangement made for the purpose of indemnifying the contractor; and

(b) a contractor shall be regarded as holding insurance if it is held by an employee of its in connection with clinical services which that employee provides under the contract or, as the case may be, sub-contract.

123.  The contractor shall at all times hold adequate public liability insurance in relation to liabilities to third parties arising under or in connection with the contract which are not covered by the insurance referred to in paragraph 122(1).

Gifts

124.—(1) The contractor shall keep a register of gifts which—

(a) are given to any of the persons specified in sub-paragraph (2) by or on behalf of—

(i) a patient,

(ii) a relative of a patient, or

(iii) any person who provides or wishes to provide services to the contractor or its patients in connection with the contract; and

(b) have, in its reasonable opinion, an individual value of more than £100.00.

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

(a) the contractor;

(b) where the contract is with two or more individuals practising in partnership, any partner;

(c) where the contract is with a company—

(i) any person legally and beneficially holding a share in the company, or

(ii) a director or secretary of the company;

(d) any person employed by the contractor for the purposes of the contract;

(e) any general medical practitioner engaged by the contractor for the purposes of the contract;

(f) any spouse of a contractor (where the contractor is an individual medical practitioner) or of a person specified in paragraphs (b) to (e); or

(g) any person (whether or not of the opposite sex) whose relationship with a contractor (where the contractor is an individual medical practitioner) or with a person specified in paragraphs (b) to (e) has the characteristics of the relationship between husband and wife.

(3) Sub-paragraph (1) does not only apply where—

(a) there are reasonable grounds for believing that the gift is unconnected with services provided or to be provided by the contractor;

(b) the contractor is not aware of the gift; or

(c) the contractor is not aware that the donor wishes to provide services to the contractor.

(4) The contractor shall take reasonable steps to ensure that it is informed of gifts which fall within sub-paragraph (1) and which are given to the persons specified in sub-paragraph (2)(b) to (g).

(5) The register referred to in sub-paragraph (1) shall include the following information—

(a) the name of the donor;

(b) in a case where the donor is a patient, the patient’s National Health Service number or, if the number is not known, his address;

(c) in any other case, the address of the donor;

(d) the nature of the gift;

(e) the estimated value of the gift; and

(f) the name of the person or persons who received the gift.

(6) The contractor shall make the register available to the Primary Care Trust on request.

Compliance with legislation and guidance

125.  The contractor shall—

(a) comply with all relevant legislation; and

(b) have regard to all relevant guidance issued by the Primary Care Trust, the relevant Strategic Health Authority or the Secretary of State.

Third party rights

126.  The contract shall not create any right enforceable by any person not a party to it.

Regulation 32

SCHEDULE 7 OUT OF HOURS SERVICES

Temporary arrangements for transfer of obligations and liabilities in relation to certain out of hours services

1.—(1) In this Schedule—

“accredited service provider” has the meaning given to it by regulation 2 of the Out of Hours Regulations;

“Out of Hours Regulations” means the National Health Service (Out of Hours Medical Services) and National Health Service (General Medical Services) Amendment Regulations 2002(64);

“out of hours arrangement” means an arrangement under sub-paragraph (2); and

“transferee doctor” means a person referred to in sub-paragraph (5)(b) who has undertaken to carry out the obligations of a contractor during all or part of the out of hours period in accordance with an out of hours arrangement referred to in sub-paragraph (2).

(2) Subject to the provisions of this Schedule, where a contractor is required to provide out of hours services pursuant to regulation 30 or 31, it may, with the approval of the Primary Care Trust, make an arrangement with one of the persons specified in sub-paragraph (5) as if regulations 1 to 11 of the Out of Hours Regulations, subject to the modifications specified in sub-paragraph (6), were still in force.

(3) Any arrangement made pursuant to sub-paragraph (2) shall cease to have effect on 1st January 2005.

(4) An arrangement made in accordance with sub-paragraph (2) shall, for so long as it continues, or is not suspended under paragraph 7(1), relieve the contractor of—

(a) its obligations to provide out of hours services pursuant to regulation 30 or 31; and

(b) all liabilities under the contract in respect of those services.

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

(a) an accredited service provider; or

(b) a person who holds a general medical services contract with the Primary Care Trust which includes the provision of out of hours services.

(6) The modifications referred to in sub-paragraph (2) are—

(a) as if out of hours period had the meaning given in regulation 2 of these Regulations;

(b) as if the requirements relating to an assessing authority in regulation 4(5) to (8) did not apply in cases where, in the opinion of the accrediting authority, it was appropriate and safe to dispense with them;

(c) as if the reference to a medical practitioner in regulation 11(2)(c) was a reference to a contractor;

(d) as if the reference to section 44 in regulation 11(2)(d) was to section 45A of the Act(65); and

(e) as if the reference to a medical list or supplementary list in paragraph 7 of the Schedule was to a medical performers list and the words “or he is named in an agreement under section 2 of the 1997 Act as a performer of personal medical services” were omitted.

(7) A contractor may make more than one out of hours arrangement and may do so (for example) with different transferee doctors or accredited service providers and in respect of different patients, different times and different parts of its practice area.

(8) A contractor may retain responsibility for, or make separate out of hours arrangements in respect of, the provision to any patients of maternity medical services during the out of hours period which the contractor is required to provide pursuant to regulation 30 or 31 and any separate out of hours arrangements it makes may encompass all or any part of the maternity medical services it provides.

(9) Nothing in this paragraph prevents a contractor from retaining or resuming its obligations in relation to named patients.

Application for approval of an out of hours arrangement

2.—(1) An application to the Primary Care Trust for approval of an out of hours arrangement shall be made in writing and shall state—

(a) the name and address of the accredited service provider or the proposed transferee doctor;

(b) the periods during which the contractor’s obligations under the contract are to be transferred;

(c) how the accredited service provider or proposed transferee doctor intends to meet the contractor’s obligations during the periods specified under paragraph (b);

(d) the arrangements for the transfer of the contractor’s obligations under the contract to and from the accredited service provider or transferee doctor at the beginning and end of the periods specified under paragraph (b);

(e) whether the proposed arrangement includes the contractor’s obligations in respect of maternity medical services; and

(f) how long the proposed arrangements are intended to last and the circumstances in which the contractor’s obligations under the contract during the periods specified under paragraph (b) would revert to it.

(2) The Primary Care Trust shall determine the application before the end of the period of 28 days beginning with the day on which the Primary Care Trust received it.

(3) The Primary Care Trust shall grant approval to a proposed out of hours arrangement if it is satisfied—

(a) having regard to the overall provision of primary medical services provided in the out of hours period in its area, that the arrangement is reasonable and will contribute to the efficient provision of such services in the area;

(b) having regard, in particular, to the interests of the contractor’s patients, that the arrangement is reasonable;

(c) having regard, in particular, to all reasonably foreseeable circumstances, that the arrangement is practicable and will work satisfactorily;

(d) that any arrangement with a person referred to in paragraph 1(5)(b) will be of an equivalent standard to an arrangement with a person referred to in paragraph 1(5)(a);

(e) that in the case of an arrangement with a person referred to in paragraph 1(5)(a), the practice premises are within the geographical area in respect of which approval is given under regulation 5 of the Out of Hours Regulations;

(f) that it will be clear to the contractor’s patients how to seek primary medical services during the out of hours period;

(g) where maternity medical services are to be provided under the out of hours arrangement, that they will be performed by a medical practitioner who has such medical experience and training as are necessary to enable him properly to perform such services; and

(h) that if the arrangement comes to an end, the contractor has in place proper arrangements for the immediate resumption of its responsibilities,

and shall not refuse to grant approval without first consulting the Local Medical Committee (if any) for its area.

(4) The Primary Care Trust shall give notice to the contractor of its determination and, where it refuses an application, it shall send the contractor a statement in writing of the reasons for its determination.

(5) A contractor which wishes to refer the matter in accordance with the NHS dispute resolution procedure must do so before the end of the period of 30 days beginning with the day on which the Primary Care Trust’s notification under sub-paragraph (4) was sent.

Effect of approval of an arrangement with a transferee doctor

3.  Where the Primary Care Trust has approved an out of hours arrangement with a transferee doctor the Primary Care Trust and the transferee doctor shall be deemed to have agreed a variation of their contract which has the effect of including in it, from the date on which the out of hours arrangement commences and for so long as that arrangement is not suspended or terminated, the services covered by that arrangement and paragraph 104(1) of Schedule 6 shall not apply.

Review of approval

4.—(1) Where it appears to the Primary Care Trust that it may no longer be satisfied of any of the matters referred to in paragraphs (a) to (h) of paragraph 2(3), it may give notice to the contractor that it proposes to review its approval of the out of hours arrangement.

(2) On any review under sub-paragraph (1), the Primary Care Trust shall allow the contractor a period of 30 days, beginning with the day on which it sent the notice, within which to make representations in writing to the Primary Care Trust.

(3) After considering any representations made in accordance with sub-paragraph (2), the Primary Care Trust may determine to—

(a) continue its approval;

(b) withdraw its approval following a period of notice; or

(c) if it appears to it that it is necessary in the interests of the contractor’s patients, withdraw its approval immediately.

(4) Except in the case of an immediate withdrawal of approval, the Primary Care Trust shall not withdraw its approval without first consulting the Local Medical Committee (if any) for its area.

(5) Where the Primary Care Trust determines to withdraw its approval immediately, it shall notify the Local Medical Committee (if any) for its area.

(6) The Primary Care Trust shall give notice to the contractor of its determination under sub-paragraph (3).

(7) Where the Primary Care Trust withdraws its approval, whether immediately or on notice, it shall include with the notice a statement in writing of the reasons for its determination.

(8) A contractor which wishes to refer the matter in accordance with the NHS dispute resolution procedure must do so before the end of the period of 30 days beginning with the day on which the Primary Care Trust’s notification under sub-paragraph (6) was sent.

(9) Where the Primary Care Trust determines to withdraw its approval following a period of notice, the withdrawal shall take effect at the end of the period of two months beginning with—

(a) the date on which the notice referred to in sub-paragraph (6) was sent; or

(b) where there has been a dispute which has been referred under the NHS dispute resolution procedure and the dispute is determined in favour of withdrawal, the date on which the contractor receives notice of the determination.

(10) Where the Primary Care Trust determines to withdraw its approval immediately, the withdrawal shall take effect on the day on which the notice referred to in sub-paragraph (6) is received by the contractor.

Suspension of approval

5.—(1) Where the Primary Care Trust suspends its approval of an accredited service provider under regulation 9 of the Out of Hours Regulations or receives notice of suspension of such approval under regulation 11 of those Regulations, it shall forthwith suspend its approval of any out of hours arrangement made by the contractor with that accredited service provider.

(2) A suspension of approval under sub-paragraph (1) shall take effect on the day on which the contractor receives notice of suspension of approval of the accredited service provider under regulation 11 of the Out of Hours Regulations.

Immediate withdrawal of approval other than following review

6.—(1) The Primary Care Trust shall withdraw its approval of an out of hours arrangement immediately—

(a) in the case of an arrangement with a person referred to in paragraph 1(5)(a), if it withdraws its approval of the accredited service provider under regulation 8 of the Out of Hours Regulations or receives notice of withdrawal of such approval under regulation 11 of those Regulations;

(b) in the case of an arrangement with a person referred to in paragraph 1(5)(b), if the person with whom it is made ceases to hold a general medical services contract with the Primary Care Trust which includes the provision of out of hours services; or

(c) where, without any review having taken place under paragraph 4, it appears to the Primary Care Trust that it is necessary in the interests of the contractor’s patients to withdraw its approval immediately.

(2) The Primary Care Trust shall give notice to the contractor of a withdrawal of approval under sub-paragraph (1)(b) or (c) and shall include with the notice a statement in writing of the reasons for its determination.

(3) An immediate withdrawal of approval under sub-paragraph (1) shall take effect—

(a) in the case of a withdrawal under sub-paragraph (1)(a), on the day on which the contractor receives notice of withdrawal of approval of the accredited service provider under Regulation 11 of the Out of Hours regulations; or

(b) in the case of a withdrawal under sub-paragraph (1)(b) or (c), on the day on which the notice referred to in sub-paragraph (2) is received by the contractor.

(4) The Primary Care Trust shall notify the Local Medical Committee (if any) for its area of a withdrawal of approval under sub-paragraph (1)(c).

(5) A contractor which wishes to refer a withdrawal of approval under sub-paragraph (1)(c) in accordance with the NHS dispute resolution procedure must do so before the end of the period of 30 days beginning with the day on which the Primary Care Trust’s notification under sub-paragraph (2) was sent.

Suspension or termination of an out of hours arrangement

7.—(1) The contractor shall suspend an arrangement made with an accredited service provider under paragraph 1(2) on receipt of the notice of suspension of approval of that provider under regulation 11 of the Out of Hours Regulations.

(2) The contractor shall terminate an out of hours arrangement made under paragraph 1(2) with effect from the date of the taking effect of the withdrawal of the Primary Care Trust’s approval of that arrangement under paragraph 4 or 6.

Schedule 6, paragraph 29(8)

SCHEDULE 8 CLOSURE NOTICE

Schedule 6, paragraph 40(2)

SCHEDULE 9 PRIMARY CARE TRUSTS SPECIFIED

FOR THE PURPOSES OF REPEATABLE PRESCRIBING

• Amber Valley Primary Care Trust

• Bath and North East Somerset Primary Care Trust

• Bebington and West Wirral Primary Care Trust

• Bedfordshire Heartlands Primary Care Trust

• Birkenhead and Wallasey Primary Care Trust

• Blackburn with Darwen Primary Care Trust

• Blackwater Valley and Hart Primary Care Trust

• Bradford South and West Primary Care Trust

• Bristol North Primary Care Trust

• Bristol South and West Primary Care Trust

• Bromley Primary Care Trust

• Burnley Pendle and Rossendale Primary Care Trust

• Burntwood, Lichfield and Tamworth Primary Care Trust

• Camden Primary Care Trust

• Castle Point and Rochford Primary Care Trust

• Central Cornwall Primary Care Trust

• Charnwood and North West Leicestershire Primary Care Trust

• Chelmsford Primary Care Trust

• Cheltenham and Tewkesbury Primary Care Trust

• Cheshire West Primary Care Trust

• Cotswold and Vale Primary Care Trust

• Coventry Primary Care Trust

• Durham and Chester-le-Street Primary Care Trust

• Durham Dales Primary Care Trust

• East Devon Primary Care Trust

• East Elmbridge and Mid Surrey Primary Care Trust

• East Hampshire Primary Care Trust

• East Leeds Primary Care Trust

• East Yorkshire Primary Care Trust

• Eastern Birmingham Primary Care Trust

• Erewash Primary Care Trust

• Exeter Primary Care Trust

• Gateshead Primary Care Trust

• Great Yarmouth Primary Care Trust

• Harrow Primary Care Trust

• Hartlepool Primary Care Trust

• Herefordshire Primary Care Trust

• Hounslow Primary Care Trust

• Hyndburn and Ribble Valley Primary Care Trust

• Ipswich Primary Care Trust

• Leicester Primary Care Trust

• Medway Primary Care Trust

• Mendip Primary Care Trust

• Mid Devon Primary Care Trust

• Newbury and Community Primary Care Trust

• Newcastle Primary Care Trust

• New Forest Primary Care Trust

• Newham Primary Care Trust

• North Birmingham Primary Care Trust

• North Hertfordshire and Stevenage Primary Care Trust

• North Liverpool Primary Care Trust

• North Peterborough Primary Care Trust

• North Sheffield Primary Care Trust

• Northamptonshire Heartlands Primary Care Trust

• Northumberland Primary Care Trust

• Norwich Primary Care Trust

• Portsmouth City Primary Care Trust

• Preston Primary Care Trust

• Redditch and Bromsgrove Primary Care Trust

• Sheffield West Primary Care Trust

• Somerset Coast Primary Care Trust

• South East Hertfordshire Primary Care Trust

• South East Oxfordshire Primary Care Trust

• South East Sheffield Primary Care Trust

• South Gloucestershire Primary Care Trust

• South Peterborough Primary Care Trust

• South Warwickshire Primary Care Trust

• South West Dorset Primary Care Trust

• South West Oxfordshire Primary Care Trust

• South Worcestershire Primary Care Trust

• Southern Norfolk Primary Care Trust

• Southwark Primary Care Trust

• Stockport Primary Care Trust

• Suffolk Coastal Primary Care Trust

• Sunderland Teaching Primary Care Trust

• Sutton and Merton Primary Care Trust

• Taunton Deane Primary Care Trust

• Torbay Primary Care Trust

• Vale of Aylesbury Primary Care Trust

• Wakefield West Primary Care Trust

• Walsall Teaching Primary Care Trust

• West Hull Primary Care Trust

• West Lincolnshire Primary Care Trust

• West of Cornwall Primary Care Trust

• Western Sussex Primary Care Trust

• Witham, Braintree and Halstead Primary Care Trust

• Wolverhampton Primary Care Trust

• Wycombe Primary Care Trust

• Wyre Forest Primary Care Trust

Schedule 6, paragraph 76

SCHEDULE 10 INFORMATION TO BE INCLUDED IN PRACTICE LEAFLETS

A practice leaflet shall include—

1.  The name of the contractor.

2.  In the case of a contract with a partnership—

(a) whether or not it is a limited partnership; and

(b) the names of all the partners and, in the case of a limited partnership, their status as a general or limited partner.

3.  In the case of a contract with a company—

(a) the names of the directors, the company secretary and the shareholders of that company; and

(b) the address of the company’s registered office.

4.  The full name of each person performing services under the contract.

5.  In the case of each health care professional performing services under the contract his professional qualifications.

6.  Whether the contractor undertakes the teaching or training of health care professionals or persons intending to become health care professionals.

7.  The contractor’s practice area, by reference to a sketch diagram, plan or postcode.

8.  The address of each of the practice premises.

9.  The contractor’s telephone and fax numbers and the address of its website (if any).

10.  Whether the practice premises have suitable access for disabled patients and, if not, the alternative arrangements for providing services to such patients.

11.  How to register as a patient.

12.  The right of patients to express a preference of practitioner in accordance with paragraph 18 of Schedule 6 and the means of expressing such a preference.

13.  The services available under the contract.

14.  The opening hours of the practice premises and the method of obtaining access to services throughout the core hours.

15.  The criteria for home visits and the method of obtaining such a visit.

16.  The consultations available to patients under paragraphs 5 and 6 of Schedule 6.

17.  The arrangements for services in the out of hours period (whether or not provided by the contractor) and how the patient may contact such services.

18.  If the services in paragraph 17 are not provided by the contractor, the fact that the Primary Care Trust referred to in paragraph 28 is responsible for commissioning the services.

19.  The name and address of any local walk-in centre.

20.  The telephone number of NHS Direct and details of NHS Direct online.

21.  The method by which patients are to obtain repeat prescriptions.

22.  If the contractor offers repeatable prescribing services, the arrangements for providing such services.

23.  If the contractor is a dispensing contractor, the arrangements for dispensing prescriptions.

24.  How patients may make a complaint or comment on the provision of service.

25.  The rights and responsibilities of the patient, including keeping appointments.

26.  The action that may be taken where a patient is violent or abusive to the contractor, its staff, persons present on the practice premises or in the place where treatment is provided under the contract or other persons specified in paragraph 21(2) of Schedule 6.

27.  Details of who has access to patient information (including information from which the identity of the individual can be ascertained) and the patient’s rights in relation to disclosure of such information.

28.  The name, address and telephone number of the Primary Care Trust which is a party to the contract and from whom details of primary medical services in the area may be obtained.

(1)

S.I. 1992/635; regulation 34 was amended by S.I. 1993/540, 1997/2468, 2000/601, 2001/3742 and 2002/2469.

(2)

David Hall and David Elliman, January 2003, Oxford University Press, ISBN 0-19-85188-X.

(3)

1865 c. 73.

(4)

1917 c. 51.

(5)

1939 c. 83.

(6)

1939 c. 82.

(7)

1942 c. 26.

(8)

1947 c. 19.

(9)

1992 c. 5.

(10)

1992 c. 4.

(11)

1998 c. 14.

(12)

1988 c. 7. Section 13 was amended by the Social Security Act 1990 (c. 27), Schedule 6, paragraph 8(11)(a), and the Social Security (Consequential Provisions) Act 1992 (c. 6), Schedule 2, paragraph 94 and prospectively substituted by the Health and Social Care (Community Health and Standards) Act 2003 (c. 45), section 185.

(13)

1953 c. 20. Section 11 was amended by the Population (Statistics) Act 1960 (c. 32) section 2 and by S.I. 1992/2395, article 2(3).

(14)

1983 c. 20. Section 142 was amended by S.I. 1999/1820.

(15)

1974 c. 23.

(16)

1985 c. 17.

(17)

1983 c. 2.

(18)

1977 c. 49.

(19)

1992 c. 14.

(20)

1988 c. 52. Section 158 was amended by S.I. 1995/889, article 3.

(21)

The document “Quality Standards in the Delivery of GP Out of Hours Services” published on 20th June 2002 is published by the Department of Health on its website at www.doh.gov.uk/pricare/qualitystandards.htm or a copy may be obtained by writing to Primary Care, Room 7E28, Department of Health, Quarry House, Quarry Hill, Leeds, LS2 7UE or by e-mailing [e-mail].

(22)

1989 c. 41.

(23)

S.I. 2001/3998; Schedule 2 was amended by S.I. 2003/1432.

(24)

1971 c. 38.

(25)

Schedule 4 was amended by S.I. 2003/1432.

(26)

Section 28U was inserted into the Act by section 175(1) of the 2003 Act.

(27)

Article 3B was inserted into the POM Order by S.I. 2003/696.

(28)

1968 c. 67.

(29)

1972 c. 68.

(30)

OJ L 311, 28.11.2001, p.67.

(31)

Section 58(1) was amended by the Medicinal Products: Prescription by Nurses etc. Act 1992 (c. 28), section 1 and the 2001 Act, section 63(2).

(32)

Regulation 20 was amended by S.I. 1998/681, 1999/696, 2001/2888, 2002/2469 and 2002/2861.

(33)

Section 28U was inserted into the Act by section 175(1) of the 2003 Act.

(34)

Paragraph 11B was inserted by S.I. 1999/696 and amended by S.I. 1999/2563, 2001/2888, 2002/551 and 2469, 2003/699 and 1084.

(35)

1968 c. 67.

(36)

1983 c. 54. Section 41A was inserted by S.I. 2000/1803.

(37)

Section 15A was inserted by regulations 2 and 3 of S.I. 2000/3041; section 21 was amended by S.I. 2002/6135, article 6(4).

(38)

This document is published jointly by the General Practitioners Committee of the British Medical Association and the NHS Confederation. It is available on the Department of Health’s website at www.doh.gov.uk/gmscontract/supportingdocs.htm or a copy may be obtained by writing to the NHS Confederation, 1, Warwick Row, London SW1E 5ER.

(39)

Section 17 of the Act was substituted by the Health Act 1999 (c. 8), section 12(1) and amended by the Health and Social Care Act 2001 (c. 15), Schedule 5, paragraph 5(3) and the National Health Service Reform and Health Care Professions Act 2002 (c. 17), Schedule 1, paragraph 7. The current directions are the directions to Strategic Health Authorities concerning GP Registrars dated 3rd November 2003. A copy of these directions can be obtained by writing to the Department of Health P.O. Box 777, London SE1 6XH.

(40)

The current guidance is the GP Registrar Scheme Vocational Guide for General Medical Practice—the UK Guide 2000 published by the Department of Health and available on their website at www.doh.gov.uk/medicaltrainingintheuk or by writing to the Department of Health, P.O. Box 777, London SE1 6XH.

(41)

RFA99 is published by the NHS Information Authority. Version 1.0 was published in October 1999, version 1.1 in February 2001 and version 1.2 (DTS/Nurse Prescribing) in August 2003. Copies are available on the NHS Information Authority’s website at www.nhsia.nhs.uk/sat/specification/pages. Copies may also be obtained by writing to the NHS Information Authority, Systems Accreditation and Testing team, Aqueous 2, Aston Cross, Rocky Lane, Birmingham B6 5RQ.

(42)

This document is available on the Department of Health website at www.doh.gov.uk/pricare/computing or a copy can be obtained by writing to the Department of Health, PCIT Branch, Room 1N06, Quarry House, Quarry Hill, Leeds LS2 7UE.

(43)

Section 17 of the Act was substituted by the Health Act 1999 (c. 8), section 12(1) and amended by the Health and Social Care Act 2001 (c. 15), Schedule 5, paragraph 5(3) and the National Health Service Reform and Health Care Professions Act 2002 (c. 17), Schedule 1, paragraph 7.

(44)

Section 16CC was inserted into the Act by section 174 of the 2003 Act.

(45)

1986 c. 45.

(46)

Section 28S was inserted into the Act by section 175(1) of the 2003 Act.

(47)

S.I. 2003/2124.

(48)

2003 c. 43.

(49)

Section 19A was inserted by the Health and Social Care Act 2001 (c. 15), section 12.

(50)

1989 c. 41.

(51)

1970 c. 42; section 1 was amended by the Local Government Act 1972 (c. 70), section 195 and by the Local Government (Wales) Act 1994 (c. 19), Schedule 10, paragraph 7.

(52)

1994 c. 39.

(53)

Where the dispute relates to a contract which is an NHS contract, section 4(5) of the 1990 Act applies.

(54)

Section 28W was inserted into the Act by section 175(1) of the 2003 Act.

(55)

Section 28S was inserted into the Act by section 175(1) of the 2003 Act.

(56)

Section 49F was inserted into the Act by section 25 of the Health and Social Care Act 2001 (c. 15) and amended by the National Health Service Reform and Health Care Professions Act 2002 (c. 17), Schedule 2, paragraph 21 and the 2003 Act, Schedule 14, Part 2.

(57)

1933 c. 12, as amended by the Criminal Justice Act 1988 (c. 33), section 170, Schedule 15, paragraph 8 and Schedule 16, paragraph 16; the Sexual Offences Act 1956 (c. 69), sections 48 and 51 and Schedules 3 and 4, as modified by the Criminal Justice Act 1988, section 170(1), Schedule 15, paragraph 9.

(58)

1995 c. 46.

(59)

1986 c. 45. Schedule 4A was inserted by section 257 of and Schedule 2 to the Enterprise Act 2002 (c. 40).

(60)

Schedule B1 was inserted by section 248 of and Schedule 16 to the Enterprise Act 2002.

(61)

1990 c. 40.

(62)

1986 c. 46 as amended by the Insolvency Act 2000 (2000 c. 39).

(63)

S.I. 1986/1032 (N.I.6).

(64)

S.I. 2002/2548 as amended by S.I. 2003/26.

(65)

Section 45A was inserted into the Act by paragraph 23 of Schedule 11 to the 2003 Act.