Only the parts of these regulations which affect the rights of CHCs are reproduced.

Citation and commencement

1. These regulations may be cited as the National Health Service (Pharmaceutical Services) Regulations 1992 and shall come into force on 1st April 1992.

Interpretation

2. -(1) In these Regulations, unless the context otherwise requires –

“the Act” means the National Health Service Act 1977;

“chemist” means –

(a) a registered pharmacist;

(b) a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968; or

(c) a supplier of appliances;

who is included in the list of an FHSA under section 42 of the Act;

“Community Health Council” means a body of that name established in accordance with section 20 of the Act;

“controlled locality” means an area which an FHSA or, on appeal, the Secretary of State has determined is rural in character in accordance with regulation 9 or, as the case may be, 10;

“FHSA” means a Family Health Services Authority;

“Family Health Services Authority” means a body of that name established by the Secretary of State under section 10(1) of the Act;

“Local Medical Committee” means a committee recognised under section 44 of the Act as being representative of persons providing general medical services in a locality;

“Local Pharmaceutical Committee” means a committee recognised under section 44 of the Act as being representative of persons providing pharmaceutical services in a locality;

“locality”, except in the expression “controlled locality”, means the locality for which an FHSA is established;

“pharmaceutical list” shall be construed in accordance with regulation 4;

“pharmacist” means a registered pharmacist, other than a supplier of appliances only, whose name is included in the list of an FHSA under section 42 of the Act or who is employed by a person (including a body corporate) whose name is so included;

“pharmacy” means any premises where drugs are provided by a pharmacist pursuant to arrangements made under section 41 of the Act;

(2) Except where expressly provided to the contrary, any document which is required or authorised to be given or sent to a person or body under these Regulations may be given or sent by delivering it to the person or, in the case of a body, to the secretary or general manager of that body, or by sending it in a pre-paid letter addressed to that person or, in the case of a body, to the secretary or general manger of that body at his usual or last known address.

Pharmaceutical lists

4. (1) An FHSA shall prepare lists, to be called pharmaceutical lists, of the persons, other than doctors and dentists-

(a) whose applications to be included in a pharmaceutical list have been granted by the FHSA, subject to and in accordance with the provisions of these regulations, and who accordingly undertake to provide pharmaceutical services from premises in the FHSA’s locality by way of the provision of drugs; and

(b) whose applications to be included in a pharmaceutical list have been granted by the FHSA, subject to and in accordance with the provisions of these regulations, and who accordingly undertake to provide pharmaceutical services from premises in the FHSA’s locality by way of the provision of appliances,

and each such list shall contain the addresses of premises in the FHSA’s locality from which those services are provided and particulars of the days and hours at which those premises are open for such provision and, in the case of a list referred to in sub-paragraph (a) of this paragraph, shall indicate whether or not the chemist has undertaken to provide supplemental services under regulation 16.

(2) A person, other than a doctor or dentist –

(a) who wishes to be included in a pharmaceutical list for the provision of pharmaceutical services from premises in an FHSA’s locality; or

(b) who is already included in a pharmaceutical list but wishes –

(i) to open, within an FHSA’s locality, additional premises from which to provide the same or different services,

(ii) to change the premises from which he provides pharmaceutical services to other premises within that locality from which he wishes to provide the same or different pharmaceutical services, or

(iii) to provide from his existing premises in that locality pharmaceutical services other than those already listed in relation to him,

shall apply to the FHSA in the form set out in Part I of Schedule 3, and in this regulation “applicant” and “application” shall be construed accordingly.

(3) In the case of any application under paragraph (2), where the applicant intends –

(a) to change within the neighbourhood the premises from which he provides pharmaceutical services, being the same services as he intends to provide from the new premises, and the FHSA is satisfied that the change is a minor relocation; or

(b) to provide pharmaceutical services at premises from which those services are, at the time of the application, provided by a person who is included in a pharmaceutical list prepared by the FHSA in accordance with paragraph 1(a) or (b), and the FHSA is satisfied that the same services will be provided from those premises,

and, in either case, the provision of pharmaceutical services will not be interrupted (except for such period as the FHSA may for good cause allow), the application shall be granted by the FHSA, subject, in a case falling within sub-paragraph (b) above, to paragraph (5).

(4) An application in any case other than those specified in paragraph (3) shall be granted by the FHSA only if it is satisfied that it is necessary or desirable to grant the application in order to secure, in the neighbourhood in which the premises from which the applicant intends to provide the services are located, the adequate provision, by persons included in the list, of the services, or some of the services, specified in the application.

(5) An application, other than one to which paragraph (3)(a) applies, which is made by a person who qualified to have his name registered under the Pharmacy Act 1954 by virtue of section 4A of that Act (qualification by European diploma) shall not be granted unless the applicant satisfies the FHSA that he has the knowledge of English which, in the interests of himself and persons making use of the services to which the application relates, is necessary for the provision of pharmaceutical services in the FHSA’s locality.

(6) An application to an FHSA may be granted either in respect of all, or in respect of some only, of the services specified in it.

(7) Subject to paragraph (8), any question whether an application should or should not be granted (whether in respect of some or all of the services specified in it) in accordance with the provisions of paragraphs (3) to (6), shall be determined by the FHSA in accordance with the procedure set out in regulations 5,6, 7 and 8.

(8) Where, by virtue of regulation 11, an application is one which falls to be determined in accordance with regulation 12, the FHSA shall not include the applicant in the relevant pharmaceutical list unless the application is finally granted under the provisions of regulation 12(16).

(9) Where an application is granted by the FHSA, the applicant shall be included in the relevant pharmaceutical list or lists only if, not less than 14 days before the expiry of six months after the date on which the grant was notified to him by the FHSA in accordance with regulation 7, or of such further period or periods, not in all exceeding 24 months from the date of the grant, as it, or, on appeal the Secretary of State, may for good cause allow, he notifies the FHSA, in the form set out in Part II of Schedule 3, that he will, within the next 14 days, commence the provision of the services in respect of which the application was made at the premises to which the application related.

(10) Where, at any time after making the application, but before the expiry of the six months referred to in paragraph (9), or of any further period allowed by the FHSA or, on appeal, by the Secretary of State in accordance with that paragraph, the applicant notifies the FHSA that he intends to change within the neighbourhood the premises from which he intends to provide pharmaceutical services, being the same services as those named in the application, and the FHSA is satisfied that the change is a minor relocation, it may amend the premises named in the original application.

(11) For the purposes of regulation 4(9), the date of the notification of any grant shall be –

(a) where no appeal is made under regulation 8(3) against the decision of the FHSA, the day after the expiry of the period of 30 days beginning with the date on which notice of that decision is given under regulation 7(1);

(b) where such an appeal is made, the date on which the Secretary of State gives notice of his decision under regulation 8(15).

Notification of applications

5 – (1) Where, on receiving an application under regulation 4(2), an FHSA is satisfied that the application is one to which regulation 4(4) applies, it shall, as soon as is practicable, give notice in writing, of the application to –

(a) the Local Pharmaceutical Committee;

(b) the Local Medical Committee;

(c) any person who is included in a pharmaceutical list and whose interests might, in the opinion of the FHSA, be significantly affected if the application were granted;

(d) any FHSA any part of whose locality is within two kilometres of the premises; and

(e) any Community health Council serving the locality of the FHSA or of any other FHSA notified under sub-paragraph (d),

and any person so notified may, within 30 days from the date on which the notification was sent, make representations in writing to the FHSA.

(2) An FHSA which is notified under paragraph (1)(d) shall, as soon as is practicable, give notice in writing, of the application, to –

(a) the Local Pharmaceutical Committee;

(b) the Local Medical Committee;

(c) any person who is included in a pharmaceutical list and whose interests might, in the opinion of the FHSA, be significantly affected if the application were granted;

and any person so notified may, within 30 days from the date on which the notification was sent, make representations in writing to the FHSA to which the application was sent.

(3) Any notice given under paragraph (1) or (2) shall include a notification of the right to make representations in accordance with that paragraph.

Determination of applications

6. – (1) In considering any application to which regulation 4(4) applies, an FHSA shall have regard in particular to –

(a) whether or not any of the pharmaceutical services specified in the application are already provided by persons included in a pharmaceutical list in the neighbourhood in which the premises named in the application are located;

(b) any information available to the FHSA which, in its opinion, is relevant to the consideration of the application; and

(c) any representations received by the FHSA under regulation 5(1) or (2).

(2) The FHSA may determine an application in such manner as it thinks fit and may, if it considers that oral representations are unnecessary, determine the application without hearing oral representations.

(3) In any case where the FHSA decides to hear oral representations, it shall give the applicant and any person from whom it has received representations under regulation 5(1) or (2) not less than 14 days notice of the time and place at which the oral representations are to be heard.

(4) The applicant and any person mentioned in paragraph (3) may be assisted at any such hearing in the presentation of his representations by some other person, but no person shall be entitled to be heard in the capacity of counsel or solicitor.

(5) The procedure by which representations are heard shall be such as the FHSA may determine.

(6) No person who provides or assists in providing general medical services or pharmaceutical services under Part II of the Act shall take part in any decision under this regulation.

(7) The FHSA 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 give notice in writing to the applicants and any persons to whom copies of the application were sent under regulation 5(1).

Notification of decisions

7. – (1) An FHSA shall, as soon as practicable, give notice in writing of its decision on an application under regulation 4(2), or of its decision whether or not to amend the premises named in the original application as mentioned in regulation 4(10), to –

(a) in the case of an application to which regulation 4(3) or (10) applies –

(i) the applicant

(ii) any person who is included in a pharmaceutical list and whose interests might, in the opinion of the FHSA, be significantly affected if the application were granted;

(iii) the Local Pharmaceutical Committee;

(iv) the Local Medical Committee;

(v) any FHSA any part of whose locality is within two kilometres of the premises; and

(vi) any Community health Council serving the locality of the FHSA or of any other FHSA notified under regulation 5(1)(d);and

(b) in the case of an application to which regulation 4(4) applies –

(i) the applicant, and

(ii) any person who has made representations to the FHSA in accordance with regulation 5(1) or (2),

and shall include with the notice a statement of the reasons for the decision and of any rights of appeal.

(2) Any FHSA which is notified under sub-paragraph (1)(a)(v) shall, as soon as practicable, give notice in writing of the decision and reasons to –

(a) the Local Pharmaceutical Committee;

(b) the Local Medical Committee;

(c) any person who is included in a pharmaceutical list and whose interests might, in the opinion of that Authority be significantly affected by the decision;

and shall notify them of any rights of appeal arising under regulation 8.

Appeals

8.(1) Where an FHSA has determined an application to which regulation 4(3) applied or made a decision whether or not to amend the premises named in the original application as mentioned in regulation 4(10), the applicant and any person who has been notified of the decision under regulation 7(1)(a)(ii) or regulation 7(2)(c) may appeal to the Secretary of State.

(2) Where an FHSA has determined an application to which regulation 4(4) applied, the persons who may appeal to the Secretary of State are –

(a) the applicant; and

(b) any person who –

(i) has been notified of the decision under regulation 7(1)(a)(ii) or regulation 7(2)(c), and

(ii) made representations to the FHSA in accordance with regulation 5(1) or (2)

(3) Where an FHSA refuses to allow an extension to the period within which an applicant is to notify the FHSA that he will commence the provision of services, as mentioned in regulation 4(9), the applicant may appeal to the Secretary of State.

(4) Any appeal under this regulation shall be made by sending to the Secretary of State a notice of appeal in writing within 30 days from the date on which the FHSA sent its decision to the appellant or, in the case of an appeal against a determination to which regulation 4(3) applied or a decision pursuant to regulation 4(10), such longer period as the Secretary of State may for reasonable cause allow.

(5) Where in determining an application, an FHSA has, pursuant to regulation 6(7), considered that an application together with one or more applications, any of the applicants and any of the persons mentioned in paragraph (1) or (2) may appeal against the determination of any of the applications, and where the Secretary of State receives appeals against two or more of the determinations, those appeals shall be considered together.

(6) Any notice of appeal made under this regulation shall contain a concise statement of the grounds of appeal.

(7) If the Secretary of State, after considering the notice of appeal, is of the opinion that it discloses not reasonable grounds for appeal or that the appeal is otherwise vexatious or frivolous, he may determine the appeal by dismissing it.

(8) Unless paragraph (7) applies, the Secretary of State shall send a copy of the notice of appeal to the FHSA whose determination is appealed against and –

(a) in the case of an appeal to which paragraph (1) or (3) relates, to the persons mentioned in regulation 7(1)(a); or

(b) in the case of an appeal to which paragraph (2) relates, to the persons mentioned in regulation 7(1)(b).

(9) Any person to whom a copy of the notice of appeal is sent pursuant to paragraph (8) may, within 30 days of the date on which the notice was sent to him, make representations in writing to the Secretary of State on the appeal.

(10) The Secretary of State may require an oral hearing before he determines the appeal.

(11) The Secretary of State shall, where he requires an oral hearing, appoint one or more persons to hear the appeal and to report to him on it.

(12) The procedure of any oral hearing shall be determined by the person or persons hearing the appeal.

(13) An oral hearing shall take place at such time and place as the Secretary of State may direct, and notice of the hearing shall be sent, not less than 14 days before the date fixed for the hearing, to the appellant and to any person to whom a copy of the notice of appeal was sent under paragraph (8).

(14) The appellant and any person to whom a notice of the hearing is sent under paragraph (13) may attend the hearing and be heard in person or by counsel, solicitor or other representative, and the FHSA may be represented at the hearing by any duly authorised officer or member, or by counsel or solicitor.

(15) On determining an appeal under this regulation the Secretary of State shall either-

(a) allow the appeal; or

(b) confirm the decision of the FHSA.

(16) The Secretary of State shall, as soon as practicable, send to the appellant and to any person to whom a copy of the notice of appeal was sent pursuant to paragraph (8) and who made representations under paragraph (9) notice in writing of his decision on the appeal and shall include in the notice a statement of his reasons for the decision and of his findings of fact.

A CHC does not have rights to make an appeal but is entitled to be notified of the appeal under para. (8), and to be notified of and attend the hearing, if there is one. The Secretary of State is open to judicial review in respect of a decision on appeal. It is not clear whether the court would permit a CHC to bring such an action.

Determination of applications in respect of controlled localities

12(1) Where an FHSA receives an application which it is required, by virtue of regulation 11, 14(3) or 21, to determine in accordance with the provisions of this regulation, it shall send a notice of the application and a copy of the application to –

(a) the Local Medical Committee;

(b) the Local Pharmaceutical Committee;

(c) any person who is included in the medical list or the pharmaceutical list of the FHSA who, in its opinion, might be affected by the grant of the application ;

(d) any other FHSA in whose medical list or pharmaceutical list is included the name of a person who, in its opinion, might be so affected; and

(e) any Community health Council serving the locality of the FHSA or of any other FHSA notified under sub-paragraph (d),

(2) (omitted)

 (3)Any person to whom an FHSA has sent a copy of the application may, within 30 days of the date on which that copy was sent to him make representations in writing to the FHSA to which the application was made.

(4) Any other person who considers that he might be affected by the decision on the application may, within such reasonable period as the FHSA to whom the application was made may allow, make representations in writing to it.

(5) The FHSA may determine an application in such manner as it thinks fit and may, if it considers that oral representations are unnecessary, determine the application without hearing any oral representations.

(6) In any case where the FHSA decides to hear oral representations, it shall give the applicant and any person from whom it has received representations under paragraph (3) or (4) not less than 14 days notice of the time and place at which the representations are to be heard.

 (7) The FHSA may invite any other person to give oral evidence as it thinks fit.

(8) to (13) omitted.

This procedure applies to controlled localities in rural areas and to the provision of pharmaceutical services by doctors in rural areas.

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