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The National Health Service (Pharmaceutical Services) (Scotland) (Miscellaneous Amendments) Regulations 2014

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Amendment to Schedule 3

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8.—(1) Schedule 3 (the Board) is amended as follows.

(2) In paragraph 1 (receipt and notification of applications)(1) for sub-paragraph (1) substitute—

(1) Upon receipt of an application to which regulation 5(10) applies, or receiving further information submitted under regulation 5(2E), the Board shall—

(a)assess whether the boundaries of the neighbourhood within which the applicant intends to provide pharmaceutical services, or any part of it, falls within a controlled locality; and

(b)within 10 working days of an assessment being made, give written notice of the application and any assessment that it is within a controlled locality to—

(i)the Area Pharmaceutical Committee;

(ii)the Area Medical Committee;

(iii)any person whose name is included in the pharmaceutical list or the provisional pharmaceutical list and whose interests may, in the opinion of the Board, be significantly affected if the application were granted;

(iv)any Board whose boundary is within two kilometres of the proposed premises; and

(v)any nominated community representative that covers the neighbourhood within which the applicant intends to provide pharmaceutical services, or any part of it,

and any person or body so notified may, within 30 days from the date on which the notification was sent to such person or body, make written representations about the application to the Board..

(3) After paragraph 1 insert—

Applications relating to areas of a prescribed description

1A.(1) For the purpose of section 27(4)(d) of the Act, a controlled locality is an area within a Health Board, which is remote or rural in character, and which is served by a dispensing doctor.

(2) The boundary of a controlled locality area is that of the dispensing doctor’s practice area under sub-paragraph (1) on the day before the day on which the application under regulation 5(2) is made.

(3) Upon identifying any areas which are a controlled locality in accordance with this paragraph, the Board must, as soon as reasonably practicable—

(a)give written notice to the dispensing doctor serving that controlled locality and to the person or body listed at paragraph 1 informing them of the identification of the controlled locality;

(b)delineate the boundaries of the controlled locality on a map; and

(c)record that controlled locality in its pharmaceutical care services plan.

Review of controlled locality

1B.(1) The Board shall, subject to sub-paragraph (2) and regulation 5(10B), no earlier than 3 years from the date of notification of a controlled locality in accordance with paragraph 1A, review that controlled locality designation.

(2) If the Board is satisfied that within that 3 year period there has been a substantial change in circumstances in relation to the controlled locality area then it may reconsider the controlled locality designation.

(3) Following a review, prior to a decision to keep or change the controlled locality designation, the Board must, as soon as practicable, give written notice to the dispensing doctor serving that controlled locality and to the persons or body mentioned in paragraph 1 informing them of—

(a)the proposal and the reasons for it; and

(b)their right, within 30 days from the date on which the notification was sent, to make written representations about that change to the Board containing a statement of reasons why that proposal should be reconsidered.

(4) Following consideration of any representations received in accordance with sub-paragraph (3) the Board must make their final decision and where applicable—

(a)delineate on a map the new boundaries of the controlled locality; or

(b)remove from the map, the delineated boundary of an area that has ceased to be a controlled locality..

(4) Omit paragraph 2 (public consultation).

(5) For paragraph 3 (determination of applications)(2) substitute—

Determination of applications

3.(1) In considering an application to which regulation 5(10)(a) applies, the Board shall have regard to—

(a)the pharmaceutical services already provided in the neighbourhood of the premises named in the application by persons whose names are included in a pharmaceutical list;

(b)pharmaceutical services to be provided in the neighbourhood at these premises by any person whose name is included in the provisional pharmaceutical list;

(c)any representations received by the Board under paragraph 1;

(d)any information available to the Board which, in its opinion, is relevant to consideration of the application;

(e)the consultation analysis report submitted in accordance with regulation 5A;

(f)the pharmaceutical care services plan; and

(g)the likely long term sustainability of the pharmaceutical services to be provided by the applicant.

(2) The Board may, if it considers that oral representations are unnecessary, determine the application without hearing oral representations.

(3) In any case in which the Board decides to hear oral representations, the Board must—

(a)give the applicant and any person from whom it received representations under paragraph 1 reasonable notice of the meeting at which such representations are to be heard;

(b)permit the applicant and any person making representations at the hearing to be assisted by another person;

(c)permit the applicant or any person making representations at the hearing either to—

(i)speak to their own representations; or

(ii)nominate the person assisting them to speak on their behalf; and

(d)confirm that any person assisting the applicant or any person making representations at the hearing is not appearing in the capacity of counsel, solicitor or paid advocate.

(4) The Board shall, subject to sub-paragraph (5), make a determination on the application within 6 weeks of the date that they received the consultation analysis report under regulation 5A.

(5) A 6 week determination period under sub-paragraph (4) may be extended in exceptional circumstances and in such an event the Board must inform the applicant and any person or body notified under paragraph 1 or 2A, of the extended time period and the reasons for it.

(6) The Board’s determination of an application must include—

(a)a summary of the consultation analysis report submitted in accordance with regulation 5A;

(b)an explanation of how the consultation analysis report was taken into account in arriving at the decision, with regard to the tests under regulation 5(10), as applicable; and

(c)the reasons for its decision.

(7) The functions of the Board under this paragraph shall be exercised on its behalf by the Pharmacy Practices Committee in accordance with Part I of Schedule 4..

(6) In paragraph 4 (notification of decisions), for “and the reasons for it” where those words occur substitute “and the information required under paragraph 3(6)”.

(7) After sub-paragraph (7) of paragraph 5 (appeals)(3) insert—

(7A) The National Appeal Panel shall, subject to sub-paragraph (7B), make a decision under sub-paragraph (5) or a determination under sub-paragraph (6) within 3 months of the date of receipt of a notice of appeal under sub-paragraph (4).

(7B) The 3 month period in sub-paragraph (7A) may be extended in exceptional circumstances and in such an event the National Appeal Panel must inform the interested parties of the extended time period and the reasons for it.

(7C) In this paragraph “interested parties” means the appellant, the applicant and any person mentioned in paragraph 1 who makes written representations to the Board about the application..

(8) In sub-paragraph (6) of paragraph 6 (form of appeal)(4) after “any person” insert “or body”.

(1)

Relevantly amended by S.S.I. 2011/32.

(2)

Relevantly amended by S.S.I. 2011/32.

(3)

Relevantly amended by S.S.I. 2011/32.

(4)

Inserted by S.S.I. 2011/32.

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