The National Health Service (Pharmaceutical Services) (Wales) Regulations 2020

PART 3 E+W Applications for inclusion in or amendment to pharmaceutical lists and dispensing doctor lists

Notice of certain applications E+W

8.—(1) This paragraph applies to applications for—

(a) inclusion in, or to make an amendment to, a—

(i) pharmaceutical list made under Part 5 of these Regulations, except for applications under regulation 22 (applications involving a change of ownership), and

(ii) dispensing doctor list made under Part 6 of these Regulations,

(b) an extension of the relevant time period under regulation 24, and

(c) a further determination as to whether premises are, or a relevant location is, in a reserved location under regulation 17(2).

(2) The Local Health Board to which the application was submitted must give notice in writing of the application in accordance with paragraph 9.

(3) Those notified of an application may within 30 days of the date on which the notification was sent to them, make representations on the application, in writing, to the Local Health Board to which the application was submitted, except for applications made pursuant to regulation 21 (applications involving temporary relocation).

Commencement Information

I1 Sch. 3 para. 8 in force at 1.10.2020, see reg. 1(2)(b)

Persons and bodies to be notified E+W

9.—(1) The persons and bodies that must be notified by a Local Health Board are—

(a) the Local Pharmaceutical Committee,

(b) the Local Medical Committee,

(c) any person—

(i) included in a pharmaceutical list maintained by it, or

(ii) who has been granted preliminary consent for inclusion in a pharmaceutical list, whose interests might, in the opinion of the Local Health Board, be significantly affected if the application is granted,

(d) any provider of local pharmaceutical services under a pilot scheme in the area for which the Local Health Board is established whose interests might, in the opinion of the Local Health Board, be significantly affected if the application is granted,

(e) [F1 the Citizen Voice Body],

(f) any patient group, consumer group or community group in the area of the Local Health Board that it considers has a significant interest in the provision of pharmaceutical services in the area,

(g) where the premises specified in the application are in a controlled locality, any person (except itself) who is a provider of primary medical services within the Local Health Board’s area or who is included in the dispensing doctor list maintained by the Local Health Board whose interests might, in the opinion of the Local Health Board, be significantly affected if the application is granted,

(h) any Local Health Board or equivalent body any part of whose area is within 2 kilometres of the premises or the location of the premises specified in the application, and

(i) in the case of an application made under regulation 20 (applications involving relocation between neighbouring Local Health Board areas), the Local Health Board from whose area the applicant wishes to relocate.

(2) A Local Health Board that provided the notification under sub-paragraph (1)(h) must—

(a) within 14 days of receiving the notification give notice in writing to the persons and bodies specified in sub-paragraph (1)(a) to (g) that are within or that serve the area for which the Local Health Board is established, and

(b) notify the Local Health Board that provided the notification under sub-paragraph (1) that it has provided the notification required by sub-paragraph (2)(a).

(3) An equivalent body notified under sub-paragraph (1)(h) may request the Local Health Board to give notification to such persons in the area for which the equivalent body is established whose interests might in the opinion of the equivalent body, be significantly affected if the application is granted and the Local Health Board must comply with any such request.

Textual Amendments

F1 Words in Sch. 3 para. 9(1)(e) substituted (1.4.2023) by The Health and Social Care (Quality and Engagement) (Wales) Act 2020 (Consequential, Supplementary and Incidental Amendments and Revocations) (Secondary Legislation) Regulations 2023 (S.I. 2023/299), regs. 1(2), 9(4)(b)

Commencement Information

I2 Sch. 3 para. 9 in force at 1.10.2020, see reg. 1(2)(b)

Content of notification E+W

10.  A notification of an application under paragraph 8 must—

(a) inform the person or body notified—

(i) of their right to make representations on the application under paragraph 8(3),

(ii) the circumstances in which the Local Health Board may require an oral hearing to be held under paragraph 11, and

(iii) if the Local Health Board intends to consider the application together with and in relation to any other application, of that intention,

(b) provide a copy of the application submitted by the applicant to enable the person or body notified to make informed representations with regard to whether or not the application should be granted, and

(c) where regulation 17(1) applies to an application under paragraph 8(1)(a) inform the person or body notified that the Local Health Board will be determining whether the premises or relevant location specified in the application that are in a controlled locality are also in a reserved location.

Commencement Information

I3 Sch. 3 para. 10 in force at 1.10.2020, see reg. 1(2)(b)

Oral hearings E+W

11.—(1) In the case of an application falling within paragraph 8, a Local Health Board may require an oral hearing to be held if it considers it is necessary to hear oral representations before determining such an application.

(2) If the Local Health Board does decide to hold an oral hearing, it must—

(a) give not less than 14 days’ notice of the time and place of the hearing to—

(i) the applicant, and

(ii) any person who has made representations on the application under paragraph 8(3),

(b) advise the applicant who has been given notice of the hearing, and

(c) advise those notified that they may make oral representations relating to the application at the hearing.

(3) Any person mentioned in sub-paragraph (2) wishing to make oral representations at the hearing may be assisted in the presentation of their representations by another person and may be represented by that other person at the hearing, including where the person notified under sub-paragraph (2) is unable to attend the hearing in person.

(4) A Local Health Board may determine the procedure to be followed at the oral hearing.

(5) A Local Health Board is not bound by any recommendations arising from an oral hearing.

Commencement Information

I4 Sch. 3 para. 11 in force at 1.10.2020, see reg. 1(2)(b)

Information to which a Local Health Board must have regard E+W

12.  In determining an application falling within paragraph 8, a Local Health Board must have regard, in particular, to—

(a) any representations received by the Local Health Board under paragraph 8(3),

(b) any recommendations arising from an oral hearing, if one is held under paragraph 11,

(c) the relevant pharmaceutical needs assessment and relevant locality, and

(d) any other information available to the Local Health Board which, in its opinion, is relevant to the consideration of the application.

Commencement Information

I5 Sch. 3 para. 12 in force at 1.10.2020, see reg. 1(2)(b)

Imposition of conditions E+W

13.—(1) This sub-paragraph applies where a Local Health Board decides to grant an application falling within—

(a) paragraph 8(1)(a)(i) where the premises specified in the application are in a controlled locality, or

(b) paragraph 8(1)(a)(ii).

(2) Where sub-paragraph (1) applies, a Local Health Board—

(a) must consider whether the provision of—

(i) primary medical services by a provider of such services (other than itself),

(ii) pharmaceutical services by an NHS pharmacist or NHS appliance contractor,

(iii) local pharmaceutical services provided under a pilot scheme, or

(iv) pharmaceutical services by a doctor,

is likely to be adversely affected as a consequence of its decision to grant the application, and

(b) may, where it is of the opinion that the provision of any of those services listed in sub-paragraph (2)(a) is likely to be adversely affected, impose conditions to postpone, for such period as it thinks fit, the making or termination of arrangements under regulation 26 (arrangements for the provision of pharmaceutical services by doctors) or equivalent provision by a doctor or GMS contractor of pharmaceutical services or dispensing services to patients on the relevant list.

Commencement Information

I6 Sch. 3 para. 13 in force at 1.10.2020, see reg. 1(2)(b)

Notification of decisions: applications for inclusion in or to make an amendment to a pharmaceutical list E+W

14.—(1) A Local Health Board must, as soon as is practicable after reaching a decision on an application falling within paragraph 8(1)(a)(i), give notice in writing of its decision (including the questions of the imposition of conditions under paragraph 13 and the determination of a reserved location under regulation 17(1)) to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) In the case of an application which is determined under regulation 22 (applications involving a change of ownership), a Local Health Board must as soon as practicable after reaching a decision give notice in writing in accordance with paragraph 9.

(3) A notification of a decision under this paragraph must include a statement of the reasons for the decision and of any rights of appeal.

Commencement Information

I7 Sch. 3 para. 14 in force at 1.10.2020, see reg. 1(2)(b)

Notification of decisions: applications for inclusion in or amendment to dispensing doctor lists E+W

15.—(1) A Local Health Board must, as soon as is practicable after reaching a decision on an application falling within paragraph 8(1)(a)(ii), give notice in writing of its decision (including the question of the imposition of conditions under paragraph 13) to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) A notification of a decision under this paragraph must include a statement of the reasons for the decision and of any rights of appeal.

Commencement Information

I8 Sch. 3 para. 15 in force at 1.10.2020, see reg. 1(2)(b)

Notification of decisions: applications under regulation 24 for extension of the relevant period E+W

16.—(1) A Local Health Board must, as soon as practicable after reaching a decision on an application falling within paragraph 8(1)(b), give notice in writing of its decision to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) Any notification of a decision under this paragraph must include a statement of the reasons for the decision.

Commencement Information

I9 Sch. 3 para. 16 in force at 1.10.2020, see reg. 1(2)(b)

Notification of decisions: applications under regulation 17(2) E+W

17.—(1) A Local Health Board must, as soon as practicable after reaching a decision on an application falling within paragraph 8(1)(c), give notice in writing of its decision to—

(a) the applicant, and

(b) any person who made representations on the application to the Local Health Board in accordance with paragraph 8(3).

(2) A notification of a decision under this paragraph must include a statement of the reasons for the decision and of any rights of appeal.

Commencement Information

I10 Sch. 3 para. 17 in force at 1.10.2020, see reg. 1(2)(b)

Action following determination in respect of reserved locations E+W

18.—(1) After determining an application under regulation 17(2) or making a determination in accordance with regulation 17(1), as soon as practicable after the relevant date, the Local Health Board must delineate precisely on a map the boundaries of any reserved location that it has determined, or remove the delineated boundary of a location that has ceased to be a reserved location, as the case may be.

(2) For the purposes of this paragraph, “the relevant date” is the later of—

(a) the date on which the period for bringing an appeal relating to the determination ends, or

(b) the date of the determination of any such appeal.

Commencement Information

I11 Sch. 3 para. 18 in force at 1.10.2020, see reg. 1(2)(b)