Citation, commencement and interpretation

1.-(1) These regulations may be cited as the General Medical Services Contracts (Amendment) Regulations (Northern Ireland) 2013 and shall come into operation on 1st April 2013.

(2) In these Regulations "the principal Regulations" means the Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004(4).

Amendment of regulation 2 of the principal Regulations

2.-(1) Regulation 2 (Interpretation) shall be amended as provided in the following paragraphs.

(2) In the definition of "additional services", in sub-paragraphs (c) and (d), for "vaccinations" substitute "vaccines";

(3) In the definition of "assessment panel", for "paragraphs 31 and 35", substitute "paragraph 35";

(4) For the definition of "Board", substitute "the Board" means the Regional Board;

(5) In the definition of "CCT", omit ", including any such certificate awarded in pursuance of the competent authority functions of the Postgraduate Medical Education and Training Board specified in article 20(3)(a) of that Order";

(6) In the definition of "childhood vaccinations and immunisations", for "vaccination", substitute "vaccines";

(7) In the definition of "Local Medical Committee", for "a Board", substitute "the Board";

(8) In the definition of "medical card", for "Agency", substitute "RBSO";

(9) For the definition of "the 2003 Order", substitute "the 2010 Order";

(10) "the 2010 Order" means the Postgraduate Medical Education and Training Order of Council 2010(5).

(11) In the definition of "prescription form", for "Agency", substitute "RBSO".

Amendment of regulation 4 of the principal Regulations

3.-(1) Regulation 4 (Conditions relating solely to medical practitioners) shall be amended as provided in the following paragraphs.

(2) For paragraph 4 substitute-

"(4) In paragraphs (1), (2)(a) and (3)(a), "general medical practitioner" does not include a medical practitioner whose name is included in the General Practitioner Register by virtue of-

(a)article 4(3) of the 2010 Order (general practitioners eligible for entry in the General Practitioner Register) because of an exemption under regulation 5(1)(d) of the one or more of the sets of Regulations specified in paragraph (5);

(b)article 6(2) of the 2010 Order (persons with acquired rights) by virtue of being a restricted services principal (within the meaning of one or more of the sets of Regulations specified in paragraph (6) included in a list specified in that article; or

(c)article 6(6) of the 2010 Order.".

(3) In paragraph (5), for "paragraph (4)(a)(iii) and (b)(i)(bb)", substitute "paragraph (4)(a)".

(4) For paragraph (6), substitute-

"(6) The Regulations referred to in paragraph (4)(b) are the General Medical Services Regulations Northern Ireland 1997, National Health Service (General Medical Services) Regulations 1992 and the National Health Service (General Medical Services) (Scotland) Regulations 1995.".

Amendment of regulation 5 of the principal Regulations

4.-(1) Regulation 5 (General conditions relating to all contracts) shall be amended as provided in the following paragraphs.

(2) in paragraph (2)(i)(ii), after "Insolvency Act 1986" insert "or Schedule 2A to the Insolvency (Northern Ireland) Order 1989(6);

(3) in paragraph (2)(k)(ii), after "(powers of the Court of Session to deal with management of charities)", insert "or under section 34 of the Charities and Trustee Investment (Scotland) Act 2005(7) (powers of Court of Session)".

Amendment of regulation 14 of the principal Regulations

5.  Regulation 14 (Duration), in paragraph (3), delete "of the Board".

Amendment of regulation 18 of the principal Regulations

6.-(1) Regulation 18 (Services generally) shall be amended as provided in the following paragraphs.

(2) After paragraph (1), insert-

"(1A) A contract-

(a)may also specify an area, other than the area referred to in paragraph 1(d), which is to be known as the outer boundary area as respects which a patient-

(i)who moves into that outer boundary area to reside; and

(ii)who wishes to remain on the contractor's list of patients,

may remain on that list if the contractor so agrees, notwithstanding that the patient no longer resides in the area referred to in paragraph (1)(d); and

(b)which specifies an outer boundary must specify that where a patient remains on the contractor's list of patients as a consequence of sub-paragraph (a) the outer boundary area is to be treated as part of the practice area for the purposes of the application of any other terms and conditions of the contract in respect of that patient.".

(3) Omit Paragraph (4)

Amendment of regulation 21 of the principal Regulations

7.  In regulation 21 (Certificates), for paragraph 2, substitute-

"(2) The exception in paragraph (1)(a) does not apply where the certificate is issued in accordance with regulation 2(1) of the Social Security (Medical Evidence) Regulations (Northern Ireland) 1976(8) (Evidence of incapacity for work, limited capability for work and confinement) or regulation 2(1) of the Statutory Sick Pay (Medical Evidence) Regulations (Northern Ireland) 1985(9) (Medical information).".

Amendment of Schedule 1 to the principal Regulations

8.-(1) Schedule 1 (Additional services) shall be amended as provided in the following paragraphs.

(2) For paragraph 4, substitute-

"Vaccines and Immunisations

4.-(1) This paragraph applies to a contractor whose contract includes the provision of vaccines and immunisations but does not apply in the case of the provision of-

(a)childhood immunisations; and

(b)the combined Haemophilius influenza type B and Meningitis C booster vaccine.

(2) A contractor must comply with the requirements in sub-paragraphs (3) and (4).

(3) The contractor must-

(a)offer to provide patients, all vaccines and immunisations (other than those mentioned in sub-paragraph (1)(a) and (b)) of the type and in the circumstances which are set out in the GMS Statement of Financial Entitlements;

(b)taking into account the individual circumstances of the patient, consider whether immunisation ought to be administered by the contractor or other health professional or a prescription form ought to be provided for the purpose of the patient self-administering immunisation;

(c)provide appropriate information and advice to patients about such vaccines and immunisation;

(d)record in the patient's record, any refusal of the offer referred to in paragraph (3)(a);

(e)where the offer is accepted and immunisation is to be administered by the contractor or other health professional, include in the patient's record-

(i)the patient's consent to immunisation or the name of the person who gave consent to immunisation and that person's relationship to the patient;

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

(iii)the date of administration;

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

(v)any contraindications to the vaccine; and

(vi)any adverse reaction to the vaccine; and

(f)where the offer is accepted and the immunisation is not to be administered by the contractor or other health professional, issue a prescription form for the purpose of self-administration by the patient.

(4) The contractor must ensure that all staff involved in the administration of immunisations are trained in the recognition and initial treatment of anaphylaxis.

(5) In this paragraph "patient's record" means the record which is kept in accordance with paragraph 68 of Schedule 5.".

(3) In paragraph 5-

(a)in the heading for that paragraph and in sub-paragraph (1), for "childhood vaccinations and immunisations", substitute "childhood vaccines and immunisations";

(b)for sub-paragraph (2)(a), substitute "offer to provide to children, all vaccines and immunisations of the type and in the circumstances which are set out in the GMS Statement of Financial Entitlements";

(c)in sub-paragraph (2)(b), for "vaccinations" substitute "vaccines"; and

(d)in sub-paragraph (2)(d)-

(i)omit "vaccinations and";

(ii)in sub-paragraph (i), omit "vaccination or"; and

(iii)in sub-paragraphs (v) and (vi), in each place "vaccination or immunisation" occurs, substitute "vaccine".

Amendment of Schedule 5 to the principal Regulations

9.-(1) Schedule 5 (Other contractual terms) shall be amended as provided in the following paragraphs.

(2) After paragraph 1A (Telephone services), insert

"Cost of relevant calls

1B.-(1) The contractor must not enter into, renew or extend a contract or other arrangement for telephone services unless it is satisfied that, having regard to the arrangement as a whole, persons will not pay more to make relevant calls to the practice than they would to make equivalent calls to a geographical number.

(2) Where a contractor is party to an existing contract or other arrangement for telephone services under which persons making relevant calls to the practice call a number which is not a geographical number, the contractor must comply with sub-paragraph (3).

(3) The contractor must-

(a)before 1st April 2014, review the arrangement and consider whether, having regard to the arrangement as a whole, persons pay more to make relevant calls than they would to make equivalent calls to a geographical number; and

(b)if the contractor so considers, take all reasonable steps, including in particular considering the matters specified in sub-paragraph (4), to ensure that, having regard to the arrangement as a whole, persons will not pay more to make relevant calls than they would to make equivalent calls to a geographical number.

(4) The matters referred to in sub-paragraph (3)(b) are-

(a)varying the terms of the contract or arrangement;

(b)renegotiating the terms of the contract or arrangement;

(c)terminating the contract or arrangement.

(5) If, despite taking all reasonable steps referred to in sub-paragraph (3)(b), it has not been possible to ensure that, having regard to the arrangement as a whole, persons will not pay more to relevant calls to the practice than they would to make equivalent calls to a geographical number, the contractor must consider introducing a system under which if a caller asks to be called back, the contractor will do so at the contractor's expense.

(6) In this paragraph-

(a)"existing contract or other arrangement" means a contract or arrangement that was entered into prior to 1st April 2013 and which remains in force on 1st April 2013;

(b)"geographical number" means a number which has a geographical area code as its prefix; and

(i)made by patients to the practice for any reason related to services provided under the contract, and

(ii)made by persons, other than patients, to the practice in relation to services provided as part of the health service.".

(3) In paragraph 11 (Standards for out of hours services)-

(a)omit "From 1st January 2005,".

(4) Paragraph 11A shall be amended as follows-

(a)In the definition of "necessary drugs, medicines and appliances"-

(i)after "which" where it appears for the second time on the second line, insert "in";

(ii)after "obtain" on the fourth line, insert "them".

(b)In the definition of "out of hours performer", after "health" on the second line, insert "care".

(c)In the definition of "supply form", for "Agency", substitute "RBSO".

(5) In paragraph 17 (Refusal of applications for inclusion in the list of patients or for acceptance as a temporary resident), for paragraph 17(2), substitute-

"(2) The reasonable grounds referred to in paragraph (1) may, in the case of an application made under paragraph 15, include the grounds that the applicant-

(a)does not live in the contractor's practice area; or

(b)lives in the outer boundary area (the area referred to in paragraph 18(1A)).".

(6) In paragraph 20 (Removal from the list at the request of the contractor), in sub-paragraph (1), second line for "applicant's" substitute "patient's" and in the fourth line for "applicant" substitute "patient".

(7) Omit paragraph 29 (Closure of lists of patients) and insert after paragraph 28 (Termination of responsibility for patients not registered with the contractor)-

"Application for closure of lists of patients

29A.-(1) A contractor which wishes to close its list of patients must send a written application ("the Application") to close its list to the Board and the Application must include the following details-

(a)the options which the contractor has considered, rejected or implemented in an attempt to relieve the difficulties which the contractor has encountered in respect of its open list and, if any of the options were implemented, the level of success in reducing or extinguishing such difficulties;

(b)any discussions between the contractor and its patients and a summary of those discussions including whether in the opinion of those patients the list of patients should or should not be closed;

(c)any discussions between the contractor and other contractors in the practice area and a summary of the opinion of the other contractors as to whether the list of patients should or should not be closed;

(d)the period of time during which the contractor wishes its list of patients to be closed and that period must not be less than 3 months and not more than 12 months;

(e)any reasonable support from the Board which the contractor considers would enable its list of patients to remain open or would enable the period of proposed closure to be minimised;

(f)any plans the contractor may have to alleviate the difficulties mentioned in that Application during the period the list of patients may be closed in order for that list to reopen at the end of the proposed closure period without the existence of those difficulties; and

(g)any other information which the contractor considers ought to be drawn to the attention of the Board.

(2) The Board must acknowledge receipt of the Application within a period of 7 days starting on and including the date the Application was received by the Board.

(3) The Board must consider the Application and may request such other information from the contractor which it requires to enable it to consider the Application.

(4) The Board must enter into discussions with the contractor concerning-

(a)the support which the Board may give to the contractor; or

(b)changes which the Board or contractor may make,

to enable the contractor to keep its list of patients open.

(5) The Board and the contractor must, throughout the discussions referred to in sub-paragraph (4), use its reasonable endeavours to achieve the aim of keeping the contractor's list of patients open.

(6) The Board or the contractor may, at any stage during the discussions, invite the Local Medical Committee for the area to attend any meetings arranged between the Board and contractor to discuss the Application.

(7) The Board may consult such persons as it appears to the Board may be affected by the closure of the contractor's list of patients, and if it does so, the Board must provide to the contractor a summary of the views expressed by those consulted in respect of the Application.

(8) The Board must enable the contractor to consider and comment on all the information before the Board makes a decision in respect of the Application.

(9) A contractor may withdraw its Application at any time before the Board makes a decision in respect of that Application.

(10) Within a period of 21 days starting on and including the date of receipt of the Application (or within such longer period as the parties may agree), the Board must make a decision-

(a)to approve the Application and determine the date the closure is to take effect snd the date the list of patients is to reopen; or

(b)to reject the Application.

(11) The Board must notify the contractor of its decision to approve the Application in accordance with paragraph 29B, or in the case where the Application is rejected, in accordance with paragraph 29C.

(12) A contractor must not submit more than one application to close its list of patients in any period of 12 months starting on and including the date on which the Board makes its decision on the Application unless-

(a)paragraph 29C applies; or

(b)there has been a change in the circumstances of the contractor which affects its ability to deliver services under the contract.

Approval of an application to close a list of patients

29B.-(1) Where the Board approves an application to close a list of patients, it must-

(a)notify the contractor of its decision in writing as soon as possible and the notification ("the closure notice") must include the details referred to in sub-paragraph (2); and

(b)at the same time as it notifies the contractor, send a copy of the closure notice to the Local Medical Committee for the area and to any person it consulted in accordance with paragraph 29A(7).

(2) The closure notice must include-

(a)the period of time for which the contractor's list of patients will be closed which must be-

(i)the period specified in the application to close the list of patients; or

(ii)in the case where the Board and contractor have agreed in writing a different period, that different period, and in either case, the period must be not less than 3 months and not more than 12 months;

(b)the date from which the closure of the list of patients is to take effect; and

(c)the date from which the list of patients is to re-open.

(3) Subject to paragraph 29E, a contractor must close its list of patients with effect from the date the closure of the list of patients is to take effect and the list of patients must remain closed for the duration of the closure period as specified in the closure notice.

Rejection of an application to close a list of patients

29C.-(1) Where a Board rejects an application to close a list of patients it must-

(a)notify the contractor of its decision in writing as soon as possible and the notification must include the reasons for the rejection of the application; and

(b)at the same time as it notifies the contractor, send a copy of the notification to the Local Medical Committee for the area and to any person it consulted in accordance with paragraph 29A(7).

(2) Subject to sub-paragraph (3), if a Board makes a decision to reject a contractor's application to close its list of patients, the contractor must not make a further application until-

(a)the end of the period of 3 months, starting on and including the date of the decision of the Board; or

(b)the end of the period of 3 months, starting on and including the date of the final determination in respect of a dispute arising from the decision to reject the application made pursuant to the dispute resolution procedure (or any court proceedings),

whichever is the later.

(3) A contractor may make a further application to close its list of patients where there has been a change in the circumstances of the contractor which affects its ability to deliver services under the contract.

Application for an extension to a closure period

29D.-(1) A contractor may apply to extend a closure period by sending a written application to extend the closure period no later than 8 weeks before the date that period is due to expire.

(2) The application to extend the closure period must include-

(a)details of the options the contractor has considered, rejected or implemented in an attempt to relieve the difficulties which have been encountered during the closure period or which may be encountered when the closure period expires;

(b)the period of time during which the contractor wishes its list of patients to remain closed, which extended period of desired closure must not be more than 12 months;

(c)details of any reasonable support from the Board which the contractor considers would enable its list of patients to re-open or would enable the proposed extension of the closure period to be minimised;

(d)details of any plans the contractor may have to alleviate the difficulties mentioned in the application to extend the closure period in order for the list of patients to re-open at the end of the proposed extension of the closure period without the existence of those difficulties; and

(e)any other information which the contractor considers ought to be drawn to the attention of the Board.

(3) The Board must acknowledge receipt of the application for an extension to the closure period within a period of 7 days starting on and including the date the application was received by the Board.

(4) The Board must consider the application for an extension to the closure period and may request such other information from the contractor which it requires to enable it to consider that application.

(5) The Board may enter into discussions with the contractor concerning-

(a)the support which the Board may give to the contractor; or

(b)changes which the Board or contractor may make,

to enable the contractor to re-open its list of patients.

(6) Within a period of 14 days starting on and including the date of receipt of the application to extend the closure period (or within such longer period as the parties may agree), the Board must make a decision.

(7) The Board must notify the contractor of its decision to approve or reject the application to extend the closure period as soon as possible after making its decision.

(8) Where the Board approves the application to extend the closure period, it must-

(a)notify the contractor of its decision in writing and the notification ("the extended closure notice") shall include the details referred to in sub-paragraph (9); and

(b)at the same time as it notifies the contractor, send a copy of the extended closure notice to the Local Medical Committee for the area and to any person it consulted in accordance with paragraph 29A(7).

(9) The extended closure notice must include-

(a)the period of time for which the contractor's list of patients will remain closed which must be-

(i)the period specified in the application to extend the closure period; or

(ii)in the case where the Board and contractor have agreed in writing a different period to the period specified in application to extend the closure period, the period which is agreed,

and in either case, the period ("the extended closure period"), must be not less than 3 months and not more than 12 months;

(b)the date from which the extended closure period is to take effect; and

(c)the date on which the list of patients is to re-open.

(10) Where the Board rejects an application to extend the closure period it must-

(a)notify the contractor of its decision in writing and the notification must include the reasons for the rejection of the application; and

(b)at the same time as it notifies the contractor, send a copy of the notification to the Local Medical Committee.

(11) Where an application for an extension of the closure period is made in accordance with sub-paragraphs (1) and (2), the list of patients will remain closed pending-

(a)the determination by the Board of the application for an extension of the closure period; or

(b)the contractor ceasing to pursue any dispute arising from the application for an extension of the closure period pursuant to the dispute resolution procedure (or any court proceedings),

whichever is the later.

Re-opening of list of patients

29E.  The contractor may re-open its list of patients before the expiry of the closure period if the Board and contractor agree that the contractor should re-open its list of patients"."

(8) Omit paragraph 30 (Approval of closure notice by the Board) and paragraph 31 (Rejection of closure notice by the Board).

(9) For paragraph 35 substitute-

"Assignments to closed lists: determinations of the assessment panel

35.-(1) This paragraph applies where most or all of the providers of essential services whose practice premises are within a Local Medical Committee area have closed their lists of patients.

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

(3) The Board 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 sub-paragraph (3A).

(3A) The members of the assessment panel must be-

(a)The Chief Executive of the Board;

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

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

(10) In paragraph 38 (Prescribing)-

(a)after "prescription form", insert "or repeatable prescription";

(b)for "39, 40 and 41", substitute "39 to 44".

(11) In paragraph 48(2)(d) (Qualification of performers), for "the Postgraduate Medical Education and Training Board" substitute "the General Medical Council".

(12) In paragraph 68 (Patient records) in sub-paragraph (4)(a), for the words from "General Medical" to the end substitute "General Practice Systems of Choice Level 0 and the Northern Ireland Minimum Systems Specification Version 2."

(13) After paragraph 71 (Practice leaflet), insert-

"Provision of information on website

71A.  In the case where a contractor has a website, the contractor must publish on that website details of the practice area, including the area known as the outer boundary area (within the meaning given in regulation 18(1A)), by reference to a sketch diagram, plan or postcode."

(14) For paragraph 74 (Reports to a medical officer), substitute-

"Provision of information to a medical officer etc.

74.-(1) The contractor must, if satisfied that the patient consents-

(a)supply in writing to any person specified in sub-paragraph (3), within such reasonable period as that person may specify, such clinical information as any of the persons mentioned in sub-paragraph (3)(a) to (d) considers relevant about a patient to whom the contractor or a person acting on behalf of the contractor has issued or has refused to issue a medical certificate; and

(b)answer any inquiries by any person mentioned in sub-paragraph (3) about-

(i)a prescription form or medical certificate issued or created by, or on behalf of, the contractor, or

(ii)any statement which the contractor or a person acting on behalf of the contractor has made in a report.

(2) For the purposes of being satisfied that a patient consents, a contractor may rely on an assurance in writing from any person mentioned in sub-paragraph (3) that the consent of the patient has been obtained, unless the contractor has reason to believe that the patient does not consent.

(3) For the purposes of sub-paragraphs (1) and (2), the persons are-

(a)a medical officer;

(b)a nursing officer;

(c)an occupational therapist;

(d)a physiotherapist; or

(e)an officer of the Department for Social Development who is acting on behalf of, and at the direction of, any person specified in paragraphs (a) to (d).

(4) In this paragraph-

(a)"medical officer" means a medical practitioner who is-

(i)employed or engaged by the Department for Social Development, or

(ii)provided by an organisation under a contract entered into with the Department for Social Development;

(b)"nursing officer" means a health care professional who is registered on the Nursing and Midwifery Register and-

(i)employed or engaged by the Department for Social Development, or

(ii)provided by an organisation under a contract entered into with the Department for Social Development;

(c)"occupational therapist" means a health care professional who is registered in the part of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001(10) relating to occupational therapists and-

(i)employed or engaged by the Department for Social Development, or

(ii)provided by an organisation under a contract entered into with the Department of Social Development; and

(d)"physiotherapist" means a health care professional who is registered in the part of the register maintained by the Health Professions Council under article 5 of the Health Professions Order 2001 relating to physiotherapists and-

(i)employed by the Department for Social Development, or

(ii)provided by an organisation under a contract entered into with the Department for Social Development"."

(15) In paragraph 105 (Other grounds for termination by the Board)-

(a)in sub-paragraph (2)(j)(ii), after "Insolvency Act 1986" insert "or Schedule 2A to the Insolvency (Northern Ireland) Order 1989";

(b)in sub-paragraph (2)(m)(ii), after "(powers of the Court of Session to deal with the management of charities)", insert "or under section 34 of the Charities and Trustee Investment (Scotland) Act 2005 (powers of Court of Session)".

(16) In paragraph 107 (Termination by the Board: remedial notices and breach notices), in sub-paragraphs (1) and (5), for "specified in paragraphs 103 to 106" substitute "specified in paragraphs 103 to 106A".

(17) In paragraph 112(1) (Consultation with the Local Medical Committee), for sub-paragraphs (a) and (b) substitute-

"(a)terminating the contract pursuant to paragraph 104, 105, 106, 107(4) or (6) or 108;

(b)which of the alternative sanctions in writing available under the provisions of paragraph 106A it will serve; or

(c)imposing a contract sanction,";

(18) In paragraph 113(1) (Clinical governance), after "effective system of clinical governance" insert "which shall include appropriate standard operating procedures in relation to the management and use of controlled drugs";

(19) After paragraph 113, insert the following-

"113A.  The contractor shall co-operate with the Board in the discharge of any obligations of the Board or its accountable officer under the Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009(11).".

Omission of Schedule 7 to the principal Regulations

10.  Omit Schedule 7 (Closure Notice).

Amendment of Schedule 8 to the principal Regulations

11.  Schedule 8 (Information to be included in practice leaflets) shall be amended as follows-

(a)For paragraph 7, substitute "The Contractor's practice area, including the area known as the outer boundary area, (within the meaning of regulation 18(1A)), by reference to a sketch diagram, plan or postcode".

EXPLANATORY NOTE

(This note is not part of the Regulations)

These regulations make amendments to The Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004.

Regulation 2 updates the definition of "CCT", and makes minor amendments to several of the definitions in Regulation 2 of the GMS Regulations;

Regulation 3 amends Regulation 4 (Conditions relating solely to medical practitioners) as a consequence of the General and Specialist Medical Practice (Education, Training and Qualifications) Order 2010 (S.I. 2010/234 and the Postgraduate Medical Education and Training Order of Council 2010 (S.I. 2010/473);

Regulations 4 and 9(15) update references to the provisions relating to removal of a person being concerned in the management or control of a charity or body as a consequence of the Charities and Trustee Investment (Scotland) Act 2005;

Regulation 6 inserts a new paragraph in regulation 18 that enables all contracts to specify an outer boundary area in addition to the practice area. Regulation 9(5) makes a consequential amendment to ensure that it is regarded as reasonable if a contractor refuses an application for inclusion in its list of patients where person lives in the outer boundary area. Regulation 9(13) and regulation 11 make amendments respectively to Schedule 5 and Schedule 8 in respect of information relating to the outer boundary area which is contained on the practice website and in the practice leaflet;

Regulation 7 amends regulation 21 (Certificates) of the regulations as a consequence of the introduction in the Social Security (Medical Evidence) and Statutory Sick Pay (Medical Evidence (Amendment) Regulations 2010 (S.R. 2010/55) of new rules relating to medical evidence;

Regulation 8 amends paragraphs 4 and 5 of Schedule 1 to the regulations to update references to the term "vaccine" and to update the cross-references to the GMS Statement of Financial Entitlement which sets out which vaccines and immunisations a contractor must offer;

Regulation 9(2) amends Schedule 5 by inserting new provisions in respect of the use of certain telephone numbers which charge patients more than the equivalent cost of calling a geographical number;

Regulation 9(3) amends Schedule 5 by updating the reference to requirements which a contractor must comply with in providing out of hours services;

Regulation 9(4) makes minor amendments to paragraph 11A in Schedule 5;

Regulation 9(5) makes minor amendments to paragraphs 17 in Schedule 5, as a consequence of the introduction of Regulation 6 (outer boundary area);

Regulation 9(6) makes a minor amendment to paragraph 20 in Schedule 5;

Regulation 9(7) inserts new paragraphs 29A to 29E into Schedule 5 of the regulations to provide for a new procedure relating to applications for the closure of a contractor's list of patients. Regulations 6(3), 9(8), 9(9) and 9(13) make consequential provisions in respect of the new procedures;

Regulation 9(12) updates the reference in respect of electronic patient records;

Regulation 9(14) makes changes to the arrangements under which contractors must disclose information (with the consent of the patient) in connection with claims for benefits; and

Regulation 9(18) and 9(19) make amendments to the provisions relating to the contractor's clinical governance system to provide that such systems must include standard operating procedures in relation to the management and use of controlled drugs and also makes amendments which require contractors to co-operate in the discharge of any obligations of the Board or its accountable officer in relation to the management and use of controlled drugs.