NATIONAL HEALTH SERVICE, ENGLAND AND WALES Citation, commencement and interpretation 1 1 These Regulations may be cited as the National Health Service (General Medical and Pharmaceutical Services) Amendment (No. 2) Regulations 1990 and shall come into force on 17th September 1990. 2 In these Regulations, “the principal Regulations ” means the National Health Service (General Medical and Pharmaceutical Services) Regulations 1974 . Amendment of regulation 2 of the principal Regulations 2 In regulation 2(1) of the principal Regulations (interpretation), a the following definitions shall be inserted in the appropriate places in alphabetical order:— “Family Health Services Authority” means a body of that name established by the Secretary of State under section 10(1) of the National Health Service Act 1977 ; “pharmacist” means a chemist, other than a person who is either an authorised seller of poisons or a supplier of medical or pharmaceutical appliances only, whose name is included in the list of the Family Health Service Authority under section 42 of the National Health Service Act 1977 and “pharmacy” shall be construed accordingly; ; b in the definition of “finally granted”, for the words “regulation 30E(9)” there shall be substituted the words “regulation 30E(8)”. Amendment of regulation 3B of the principal Regulations 3 In regulation 3B(1) of the principal Regulations (minor surgery list) for the words “minor surgery services” there shall be substituted the words “all of the procedures listed in Schedule 1B to these Regulations”. Amendment of regulation 4 of the principal Regulations 4 In regulation 4 of the principal Regulations (medical list), in paragraph (4)(e) for the word “map” there shall be substituted the words “sketch, diagram or plan”. Amendment of regulation 16 of the principal Regulations 5 In regulation 16 of the principal Regulations (assignment of persons to doctors)— a in paragraph (1)— i for the words from “his application” to “shall assign” there shall be substituted the words “the Family Health Services Authority shall assign”, ii in sub-paragraph (c) for the words “the Allocation Joint Committee” there shall be substituted the words “the Family Health Services Authority”; b paragraph (2) shall be omitted; c in paragraphs (3) and (4) for the words “the Allocation Joint Committee shall have power to” there shall in each case be substituted the words “The Family Health Services Authority may”; d for paragraph (5) there shall be substituted the following paragraphs: 5 A doctor in respect of whom a Family Health Services Authority has made a determination (“the initial determination”) under paragraph (1), (3) or (4) may, within 7 days of receiving notice of it, make representations in writing to that Authority against that determination. 6 Where a doctor makes representations under paragraph (5) the Family Health Services Authority shall give that doctor the opportunity to address it in the course of an oral hearing in support of those representations. 7 A doctor who has made representations against a determination under paragraph (1) shall remain responsible for the treatment of the person concerned until the expiry of 7 days after the next meeting of the Family Health Services Authority— a where there is an oral hearing under paragraph (6), following that hearing; b in any other case, following the making of representations under paragraph (5). 8 Where representations are made under paragraph (5) the Family Health Services Authority shall, subject to paragraph (9), review its initial determina-tion and shall either confirm or revise it. 9 No person who participated in the making of an initial determination under this regulation shall participate in a review of that determination under paragraph (8). 10 The Family Health Services Authority shall, within 7 days of making a determination under paragraph (8), notify the doctor thereof, and, where an initial determination made under paragraph (1) has been revised, shall notify also the patient and the other doctor to whom the patient is assigned under the revised determination. . Amendment of regulation 17 of the principal Regulations 6 In regulation 17 (limitation of number of persons on doctors' lists)— a in paragraph (1) the words “a report by the Allocation Joint Committee on” and the words “and of the Allocation Joint Committee’s recommendations” shall be omitted; b in paragraph (3)(c) for the words “Allocation Joint Committee” there shall be substituted the words “Family Health Services Authority”; c for paragraph (6) there shall be substituted the following paragraph:— 6 In carrying out its functions under this regulation, the Family Health Services Authority shall consult as necessary with any other such Authority of an adjoining locality whose medical list includes a doctor concerned. . Amendment of regulation 26 of the principal Regulations 7 In regulation 26 of the principal Regulations (pharmaceutical lists) for paragraph (6), there shall be substituted the following paragraph:— 6 Where by virtue of regulation 26A an application is one which falls to be determined in accordance with Part VIIIB of these Regulations, the Family Health Services Authority shall not make a decision under paragraph (3), (4) or (4A) above unless the application is finally granted under the provisions of regulation 30E or 30G. . Substitution of regulation 26A in the principal Regulations 8 For regulation 26A of the principal Regulations (referral of application to Rural Dispensing Committee) there shall be substituted the following new regulation:— Application in respect of controlled locality 26A 1 Subject to paragraph (4), where the premises specified in an application under regulation 26(2)(a) are in a controlled locality that application shall be determined under Part VIIIB of these Regulations unless— a the applicant intends to change within that controlled locality the premises at which he provides pharmaceutical services; and b the granting of the application would not, in the view of the Family Health Services Authority, result in a significant change in the arrangements for the provision of pharmaceutical services in any part of the controlled locality. 2 Subject to paragraph (4), where— a the premises specified in an application under regulation 26(2)(a) (not being in a controlled locality) are within one mile of any part of any controlled locality in which reside patients for whom a doctor provides pharmaceutical services; and b the granting of the application would, in the view of the Family Health Services Authority, result in a significant change in the arrangements for the provision of pharmaceutical services in any part of the controlled locality; the Family Health Services Authority shall grant the application but shall consider the conditions (if any) which are to be imposed in relation to that grant under Part VIIIB of these Regulations, and, pending the final determination of such conditions, pursuant to regulation 30(9), shall not in consequence of the grant give notice to any doctor to discontinue the provision of pharmaceutical services to any patient. 3 Where the premises specified in an application under regulation 26(2)(a) are within one mile of the locality of another Family Health Services Authority, the Family Health Services Authority shall make enquiries as to controlled localities in that locality in order to determine— a whether the application is of the description specified in paragraph (2); and b which controlled localities are to be considered for the purposes of paragraph (1)(b) or (2)(b); and where it is satisfied that there is a relevant controlled locality in that locality, it shall consult that Family Health Services Authority before a decision is taken under paragraph (1)(b) or (2)(b). 4 An application shall not be determined under Part VIIIB of these Regulations— a where regulation 26C applies; or b where the applicant intends to provide pharmaceutical services in the place of, and at the same location as, another person who provides pharmaceuti-cal services. . Amendment of regulation 26B of the principal Regulations 9 In regulation 26B of the principal Regulations (preliminary consent to be included in the pharmaceutical list), for paragraphs (3) and (4), there shall be substituted the following paragraphs:— 3 An application for preliminary consent shall be determined by the Family Health Services Authority under the provisions of Part VIIIB in the circumstances specified in regulation 26A in relation to applications under regulation 26(2) of these Regulations. 4 The Family Health Services Authority shall grant any application for preliminary consent, other than an application which is required by paragraph (3) to be determined under the provisions of Part VIIIB, only if the Family Health Services Authority is satisfied that, had the application for preliminary consent been an application for inclusion in the pharmaceutical list other than in the case specified in regulation 26(3), it would have granted it under the provisions of regulation 26(4). . Amendment of regulation 26C of the principal Regulations 10 In regulation 26C of the principal Regulations (effect of preliminary consent)— a in paragraph (2)(b), for the words “by the Rural Dispensing Committee or the Secretary of State on appeal”, there shall be substituted the words “under the provisions of Part VIIIB of these Regulations”; b in paragraph (3), the words “by the Rural Dispensing Committee or the Secretary of State” shall be omitted. Amendment of regulation 30 of the principal Regulations 11 In regulation 30 of the principal Regulations (arrangements for provision of pharmaceutical services by doctors)— a in paragraph (2)(b), for the words “the premises of any chemist”, there shall be substituted the words “any pharmacy”; b in paragraph (3)(b), for the words from “imposed” to “regulation 30E(11)” there shall be substituted the words “imposed under regulation 30E(9)”; c in sub-paragraph (b) of paragraph (6), for the word “chemist”, there shall be substituted the word “pharmacy”; d for paragraph (9)(b), there shall be substituted the following sub-paragraph:— b not be given while final determination under Part VIIIB of conditions capable of having that effect is pending or where regulation 30D(7) so requires. Amendment of regulation 30A of the principal Regulations 12 In regulation 30A of the principal Regulations (outline consent), for paragraph (2), there shall be substituted the following paragraph:— 2 An application under paragraph (1) shall be determined in accordance with Part VIIIB of these Regulations. . Amendment of regulation 30D of the principal Regulations 13 In regulation 30D of the principal Regulations (determination of controlled locality)— a for paragraph (1), there shall be substituted the following paragraph:— 1 Subject to the provisions of these Regulations, where, before 17th September 1990— a a Family Practitioner Committee under this regulation as then in force; or b the Rural Dispensing Committee under the provisions of regulation 30F as then in force; formed an opinion that any area is rural in character, that area shall be a controlled locality. ; b in paragraph (7), for the words “refer an application to the Rural Dispensing Committee” there shall be substituted the words “determine an application under Part VIIIB”. c after paragraph (7) there shall be inserted the following paragraph:— 7A The Family Health Services Authority shall, before making a determination under the preceding paragraphs, give notice in writing to the Local Medical Committee, the Local Pharmaceutical Committee and any doctor or pharmacist who in the opinion of the Family Health Services Authority may be affected by the determination and shall inform them that they may make such representations as they wish to make in writing within one month from the date on which the notice was sent. ; d in paragraph (8), for the words from “notice” to “affected by the determination” there shall be substituted the words “to the persons and bodies mentioned in paragraph (7A) notice in writing of its determination and of the reasons for it”; e for paragraph (9) there shall be substituted the following paragraphs:— 9 Subject to paragraph (10), where the question whether or not an area is rural in character has been determined— a by a Family Health Services Authority under this regulation; or b on appeal, under regulation 30F; that question shall not again be considered in relation to that area or any part of it during the period of five years immediately following the date of the determination. 10 A question to which paragraph (9) applies may be considered by a Family Health Services Authority during the period referred to in that paragraph only where the Family Health Services Authority is satisfied, whether on an application under paragraph (3) or otherwise, that there has been a substantial change of circumstances in relation to the area in question or any part of it since the question was last determined. . Substitution of regulation 30E in the principal Regulations 14 For regulation 30E of the principal Regulations (determination by Rural Dispensing Committee of application to provide pharmaceutical services), there shall be substituted the following new regulation— Determination by Family Health Services Authorities of applications to provide pharmaceutical services in controlled localities 30E 1 Where the Family Health Services Authority receives an application which it is required, by virtue of regulation 26A, 26B(3) or 30A, to determine in accordance with the provisions of this Part, it shall send a notice of the application and a copy of the application to— a the Local Medical Committee and the Local Pharmaceutical Commitee; b any person whose name is included in the medical list or the pharmaceutical list of the Family Health Services Authority who, in its opinion, might be affected by the grant of the application; c any other Family Health Services Authority in whose medical list or pharmaceutical list is included the name of a person who, in the opinion of the Family Health Services Authority, might be so affected; and shall, where the applicant so requests, send to him a copy of the application. 2 Where a Family Health Services Authority is sent a copy of an application under paragraph (1)(c), it shall send a copy to— a its Local Medical Committee and Local Pharmaceutical Committee; b any person whose name is included in its medical list or pharmaceutical list who might in its opinion be affected by the grant of the application. 3 The provisions of Schedule 4B to these Regulations shall apply to the proceedings under this regulation. 4 Subject to the other provisions of this regulation and of Schedule 4B to these Regulations, the procedure for the determination of applications under this regulation shall be such as the Family Health Services Authority may determine. 5 The Family Health Services Authority may, where it thinks fit, consider two or more applications together in relation to each other and where it proposes to do so, it shall so inform the applicants and the persons to whom copies of the applications were sent under this regulation. 6 The Family Health Services Authority— a shall refuse any application to the extent that it is of the opinion that to grant it would prejudice the proper provision of general medical services or pharmaceutical services in any locality; b shall refuse any application under regulation 30A in relation to any part of the area specified in the application— i which is not in a controlled locality; or ii which is within one mile of any pharmacy; c may refuse an application in a case to which paragraph (5) applies (notwithstanding that it would, if determining that application in isolation, grant it) where the number of applications is such or the applications are made in such circumstances as so to prejudice services if they all (or more than one of them) were granted; and any refusal of such an application may relate to all or any part of the area specified in the application within the controlled locality. 7 Subject to paragraph (6), the Family Health Services Authority shall grant every application subject to any conditions which it may impose under paragraph (9). 8 An application determined in accordance with the provisions of this regulation shall not be treated as finally granted for the purposes of these Regulations until the end of the period for bringing an appeal under regulation 30G or until the determination of any such appeal as is brought and “final grant” shall be construed accordingly. 9 The Family Health Services Authority in relation to any application to which this regulation applies may impose such conditions upon the implementation of the grant as to reduce so far as is practicable any adverse consequences thereof to any doctor or chemist over such period as it may think fit. 10 Subject to paragraph (11), a Family Health Services Authority shall not consider under this regulation— a any application under regulation 30A where, during the relevant period an application made under that regulation in respect of the same area has been finally refused; b any application to which regulation 26A or 26B applies, where the location of the premises at which the pharmacist intends to provide pharmaceutical services is a controlled locality and— i is in an area in respect of which an application under regulation 30A was finally granted during the relevant period, or ii is within one mile of the location of premises in respect of which an application to which regulation 26A or 26B applies was finally refused during the relevant period. 11 Notwithstanding paragraph (10), a Family Health Services Authority may at any time consider an application if it is satisfied that, since the date of the refusal or, as the case may be, grant referred to in paragraph (10)(a) or (b), or where there has been more than one such refusal or grant during the relevant period, the last such refusal or grant, there has been a substantial change of circumstances affecting the controlled locality. 12 In this regulation “relevant period” means the period of 5 years immediately preceding the making of the application. . Amendment of regulation 30G of the principal Regulations 15 In regulation 30G of the principal Regulations (appeals to the Secretary of State from decision of Rural Dispensing Committee on applications to provide pharmaceutical services)— a for the words “Rural Dispensing Committee” in each instance where they occur, there shall be substituted the words “Family Health Services Authority”; b in paragraph (3), for the words “14 days”, there shall be substituted the words “one month”; c in paragraph (10), for the words “under paragraphs (5)”, there shall be substituted the words “under paragraphs (4)”. Amendment of Schedule 1 to the principal Regulations 16 1 In Part I of Schedule 1 to the principal Regulations (doctors' terms of service)— a in paragraph 4(4), the words “request its Allocation Joint Committee to” shall be omitted; b in paragraph 5 for the words “Allocation Joint Committee” in both instances where they occur there shall be substituted the words “Family Health Services Authority”; c in paragraph 9C there shall be added the following sub-paragraph:— 3 Nothing in paragraph 9A(b) or in this paragraph shall prevent any doctor personally performing, in the course of providing general medical services (otherwise than by way of minor surgery services) to a patient, a procedure described in Schedule 1B to those Regulations. ; d in paragraph 13A(1)(b)(ii) after the word “where” there shall be inserted the word “he”; e in paragraph 13C— i in sub-paragraph (1)(b)(i) after the word “doctor” there shall be added the words “in the course of his provision of general medical services”, ii in sub-paragraph (5)(b)(i) the words “height, weight and” shall be omitted, iii in sub-paragraph (5)(b), after sub-head (ii) there shall be inserted the following sub-head:— iii the measurement necessary to detect any changes in his body mass; , iv after sub-paragraph (5) there shall be added the following sub-paragraph:— 6 In this paragraph “body mass” means the figure produced by dividing the number of kilograms in the patient’s weight by the square of the number of metres in his height. ; f in paragraph 25— i sub-paragraph (7)(c) shall be omitted, ii after sub-paragraph (14) there shall be added the following paragraphs:— 15 A doctor may apply to a Family Health Services Authority for a variation of the times and places at which, in accordance with a determination under this paragraph (“the earlier determination”), he is required to be normally available, and sub-paragraphs (2) to (13) shall apply to the making and determination (“the subsequent determination”) of an application under this sub-paragraph as if it were the first application by that doctor for the purposes of this paragraph. 16 Where an application made under sub-paragraph (15) is approved or is approved subject to conditions, for the purposes of sub-paragraphs (1) and (14) the earlier determination mentioned in sub-paragraph (15) shall cease to have effect and the subsequent determination mentioned in that sub-paragraph shall have effect instead— a where the subsequent determination is made by a Family Health Services Authority and no appeal is made, from the day falling 8 weeks after the date on which the doctor receives notification of that Authority’s determination; b where the subsequent determination is made on appeal, from the day falling 8 weeks after the date on which the doctor receives notification of the Secretary of State’s determination. 17 Where it appears to a Family Health Services Authority that a doctor’s hours of availability are allocated for the purposes of sub-paragraph (2)(b) in a manner which may no longer be convenient to his patients, it may, subject to sub-paragraph (24), review the terms of— a any approval granted under sub-paragraph (9)(a) or (b); or b any direction given under sub-paragraph (19)(a); by the Authority or the Secretary of State as to such allocation. 18 On any review under sub-paragraph (17) the Family Health Services Authority shall— a give notice to the doctor of its proposed re-allocation of his hours of availability; and b allow him 28 days within which to make representations to that Authority about its proposals. 19 After considering any representations made in accordance with sub-paragraph (18)(b), the Family Health Services Authority shall either— a direct the doctor to revise the allocation of his hours of availability in the manner specified in the direction; or b confirm that the existing allocation of the doctor’s hours of availability continues to be convenient to his patients. 20 A Family Health Services Authority shall notify the doctor in writing of its determination under sub-paragraph (19), and where it gives a direction under head (a) of that sub-paragraph, it shall include with the notice a statement in writing of the reasons for its determination and of the doctor’s right of appeal under sub-paragraph (21). 21 A doctor may, within 28 days of receiving notification under sub-paragraph (20), appeal in writing to the Secretary of State against a direction under sub-paragraph (19)(a). 22 Sub-paragraphs (12) and (13) shall apply to any appeal made under sub-paragraph (21). 23 A doctor in respect of whom a direction is given under sub-paragraph (19) shall revise the allocation of his hours of availability so as to give effect to the direction— a where the direction is given by a Family Health Services Authority and no appeal is made, not later than 8 weeks after the date on which he receives notification under sub-paragraph (20); b where the direction is given or confirmed on appeal, not later than 8 weeks after the date on which he receives notification of the Secretary of State’s decision; and the allocation of hours as so revised shall be regarded as having been approved for the purposes of sub-paragraphs (1) and (14). 24 No Family Health Services Authority shall undertake a review under sub-paragraph (17) on more than one occasion in any period of 2 years. ; g in paragraph 25B(1) after the words “as the case may be” there shall be added the words “, and as if paragraph 25(2)(a)(iii) did not apply in the case of that doctor”; h in paragraphs 25C(1) and 25D(1) after “paragraph 25(2)(a)(ii)” there shall be added “or (iii)”. 2 In Part II of Schedule 1 to the principal Regulations (information and undertakings to be included in an application for inclusion in the medical list)— a in item 11 for the words “proposed practice area (including street map)” there shall be substituted the words “the geographical boundary of his proposed practice area by reference to a sketch, diagram or plan of a scale approved by the Family Health Services Authority”; b in item 12 before the word “proposed” there shall be inserted the words “address of”. 3 In Part III of Schedule 1 of the principal Regulations (information and undertakings to be included in an application to fill a vacancy) for item 7 there shall be substituted the following item:— 7 Address of the practice premises to that practice, and details of the geographical boundary of its practice area by reference to a sketch, diagram or plan of a scale approved by the Family Health Services Authority. . Amendment of Schedule 1B to the principal Regulations 17 In Schedule 1B to the principal Regulations (minor surgery procedures) the entries “ganglions” and “ligation of varicose veins” shall be omitted. Amendment of Schedule 1D to the principal Regulations 18 In Schedule 1D to the principal Regulations (information to be included in practice leaflets) in paragraph 17 for the word “map” there shall be substituted the words “sketch, diagram or plan”. Substitution of Schedule 4B to the principal Regulations 19 For Schedule 4B to the principal Regulations (Rural Dispensing Committee procedure on application to provide pharmaceutical services), there shall be substituted the following new Schedule:— SCHEDULE 4B Regulation 30E(4)PROCEDURE FOR DETERMINATION OF APPLICATION UNDER REGULATION 30E 1 1 Any person to whom the Family Health Services Authority has sent a copy of the application may, within one month of the date on which that copy was sent to him or within such longer period as the Family Health Services Authority may for reasonable cause allow, submit written evidence to the Family Health Services Authority. 2 Any other person who considers that he might be affected by the decision on the application may, within such reasonable period as the Family Health Services Authority may allow, submit written evidence to it. 2 1 Unless the Family Health Services Authority considers that the application may properly be determined without hearing oral evidence, any person who has submitted written evidence under paragraph 1 above may give oral evidence to it. 2 The Family Health Services Authority may invite any other person to give oral evidence as it thinks fit. 3 The procedure at any oral hearing under this Schedule shall be such as the Family Health Services Authority may determine. 4 No person who provides or assists in providing general medical or pharmaceutical services under Part II of the National Health Service Act 1977 shall take part in any decision under this Schedule. 5 The Family Health Services Authority shall, as soon as practicable after determining the application— a give notice in writing of its decision to— i the applicant, ii the Local Medical Committee, iii the Local Pharmaceutical Committee, iv any other Family Health Services Authority to which notice was sent pursuant to regulation 30E(1), v the Local Medical Committee and the Local Pharmaceutical Committee notified pursuant to regulation 30E(2), and vi any other person who has given evidence under the provisions of sub-paragraph (1) or (2) of paragraph 2 above; and b notify the rights of appeal provided for by regulation 30G(1) to— i the applicant, and ii any person who gave evidence under the provisions of sub-paragraph (1) or (2) of paragraph 2 above. . Amendment of Schedule 4C to the principal Regulations 20 In Schedule 4C to the principal Regulations (provision further to regulation 26)— a In Part I (procedure on, and determination of, applications to which regulation 26(3) or (4) applies)— i for the words “within 28 days”, in each instance where they occur, there shall be substituted the words “within one month”; ii after paragraph 2(5), there shall be inserted the following new sub-paragraph:— 6 No person who provides or assists in providing general medical or pharmaceutical services under Part II of the National Health Service Act 1977 shall take part in any decision under this Part of this Schedule. ; b Part II (pharmacy practices sub-committee) and Part III (procedure at meetings of the pharmacy practices sub-committee) shall be omitted. Revocations in the principal Regulations 21 Regulations 15 (Allocation Joint Committee), 30B (establishment of dispensing sub-committee) and 30C (functions of the dispensing sub-committee) of, and Schedule 4A (dispensing sub-committee) to, the principal Regulations are hereby revoked. Transitional arrangements 22 Where, prior to 17th September 1990— a any application or question has been referred to the Rural Dispensing Committee for determination under regulation 26A, 26B or 30A of the principal Regulations, and b that application or question has not been determined by that Committee before that date, the principal Regulations shall, in relation to the determination by that Committee of that application or question, have effect as if these Regulations had not come into force. Signed by authority of the Secretary of State for Health. Stephen Dorrell Parliamentary Under-Secretary of State, Department of Health 23rd August 1990