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The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulation 2009

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Insertion of new regulations in the principal Regulations

18.  After regulation 21C of the principal Regulations insert the following regulations—

Premises approval: additional and new premises after outline consent has taken effect

21D.(1) A doctor who—

(a)has been granted outline consent which has taken effect; or

(b)provides pharmaceutical services in reliance on regulation 20(3)(b),

and who wishes to be granted premises approval in relation to premises in addition to those in respect of which premises approval has been given (“additional premises”) may apply to all the appropriate Local Health Boards and—

(i)the application will be determined by the relevant Local Health Board, and

(ii)regulations 12 and 21 apply to such an application as they apply to an application for outline consent under regulation 21.

(2) For the purposes of this regulation—

(a)the “appropriate Local Health Boards” are those who hold dispensing doctor lists on which the doctor making the application is included; and

(b)the “relevant Local Health Board” is the Local Health Board in whose area the additional premises are situated.

(3) A doctor wishing to be granted premises approval in relation to premises (“new premises”) where he or she wishes to dispense instead of listed premises may apply to all the appropriate Local Health Boards and the application will be determined by the relevant Local Health Board in accordance with paragraph (4).

(4) The relevant Local Health Board must—

(a)grant the application made in accordance with paragraph (3) where—

(i)the new premises are less than 500 metres by the most practicable route on foot from the listed premises which they are to replace, or

(ii)the Local Health Board is otherwise satisfied that granting the application would not result in a significant change in the arrangements for the provision of pharmaceutical or dispensing services to any part of a controlled locality, provided that no further applications will be granted under this sub-paragraph for a period of twelve months beginning with the date on which the doctor commenced providing services from the new premises unless the Local Health Board for good cause allows; or

(b)in any other case determine the application in accordance with paragraph (1) as if the references to additional premises were to new premises.

(5) The relevant Local Health Board must notify its determination under paragraph (4)(a) to the persons to whom the notice is required to be given under regulation 12(2) and (3) and to the appropriate Local Health Boards.

(6) A determination by the relevant Local Health Board may be appealed to the Welsh Ministers under regulation 13 by the applicant and any of the persons notified under paragraph (5) apart from any Local Pharmaceutical Committee or any Local Medical Committee.

(7) Subject to paragraph (8), when granted in relation to new or additional premises, the premises approval will take effect from the date of notification of the grant and for this purpose the date of the notification of a grant of any application is to be—

(a)where no appeal is made under paragraph (6) against the decision of the relevant Local Health Board, the date after the expiry of 30 days beginning with the date on which notice of that decision is given under paragraph (5); or

(b)where such an appeal is made, the date on which the Welsh Ministers give notice of their decision under regulation 13.

(8) Where—

(a)the premises approval is granted in relation to additional premises; and

(b)in relation to the premises for which the approval is granted there were, at the date of the grant, outstanding applications,

the premises approval will take effect on the date which is the day after the end of a period of one year, or such longer period (not exceeding three months) as the relevant Local Health Board may for good cause allow before the expiration of that year, from the final resolution of any outstanding application.

(9) The relevant Local Health Board may grant temporary premises approval to a doctor who has outline consent and premises approval in relation to additional or new premises where it considers it desirable to do so to secure the adequate provision of pharmaceutical services in the area served by the additional or new premises, and renew any such temporary approval granted, to secure such adequate provision, and where it does so it must—

(a)notify those persons to whom notice of the application under regulation 21 was required to be given under regulation 12(2) and (3) and applicants in relation to outstanding applications;

(b)state the period during which the temporary premises approval is to apply; and

(c)include those premises in the dispensing doctor list in relation to that doctor.

(10) Temporary premises approval may be granted for a period not exceeding twelve months, and may be renewed for a further period not exceeding three months.

Premises approval: practice amalgamations

21E.(1) For the purposes of these Regulations, “a practice amalgamation” occurs where either—

(a)two or more providers of primary medical services merge; or

(b)a GMS contractor, an APMS contractor or a doctor who provides primary medical services for an LHBMS practice is employed or engaged by another GMS contractor or APMS contractor or by a Local Health Board to provide services within another LHBMS practice,

as a result of which two or more patient lists are combined.

(2) If, following a practice amalgamation, all the practice premises of the new practice are premises in respect of which premises approval was in effect immediately prior to the practice amalgamation, then outline consent and premises approval will continue to have effect.

(3) Where there is, or will be, a practice amalgamation and none or not all of the practice premises of the new amalgamating practice had been premises in respect of which premises approval was in effect immediately prior to the practice amalgamation, a doctor who is party to the practice amalgamation and who has been granted outline consent and premises approval which is in effect either immediately before the practice amalgamation or the date of the application under this paragraph, may make an application for premises approval, and such an application will be determined as provided in regulation 21D as if it were an application from a doctor with premises approval to have the right to dispense from—

(a)additional premises where the premise approval is required for additional premises as defined in regulation 21D(1); or

(b)new premises where the premises approval is required for new premises as defined in regulation 21D(3),

and the Local Health Board may grant temporary premises approval under regulation 21D(9).

(4) An application mentioned in paragraph (3) may be made before or after the practice amalgamation takes place, and where the practice amalgamation takes effect before the application has been finally determined—

(a)any premises approval in effect at the date of the practice amalgamation will have effect from the date of the amalgamation as if it were a temporary premises approval under regulation 21D(9) for a period stated by the Local Health Board not exceeding one year; and

(b)the new practice will have temporary premises approval from the date of the practice amalgamation to dispense from any premises mentioned in the application for a period stated by the Local Health Board not exceeding one year.

(5) When the practice amalgamation takes effect the doctors must notify all Local Health Boards in whose area the amalgamated practice is situated that the practice amalgamation has taken place.

(6) Subject to paragraph (7), where an application made under paragraph (3) was granted before the practice amalgamation takes place, premises approval will take effect from the date of the practice amalgamation.

(7) Where an application was made under paragraph (3) before the practice amalgamation takes place and the practice amalgamation has not taken place before the end of a period of one year beginning with the date that premises approval was granted under that paragraph, that grant will lapse.

(8) Where an application under paragraph (3) for premises approval is refused either for all or any of the premises specified in the application, whether before or after the practice amalgamation takes place, the doctors who had premises approval prior to making the application, and any other doctor in the new practice after that date will have residual premises approval.

(9) For the purposes of this regulation “residual premises approval” means premises approval to dispense—

(a)from premises in respect of which the doctor or another doctor in his or her practice had premises approval at the time of the application in relation to the practice amalgamation; and

(b)to—

(i)a patient for whom the doctor making the application is authorised to provide pharmaceutical services on the date the application was refused, but excluding any such patient who ceases to be a patient mentioned in regulation 20(1)(b) or (c); or

(ii)a patient who is not mentioned in paragraph (i) but who is mentioned in regulation 20(1)(a) or (d) and for whom the doctor making the application is authorised to provide pharmaceutical services on the date the application was refused.

(10) For the purposes of paragraph (9), regulation 20(1)(b) or (c) is to be read as if the words “and one of the conditions specified in paragraph (3) is satisfied in his or her case” were omitted.

Premises Approval: transitional provisions

21F.(1) This regulation applies to a doctor who, before the coming into force of these Regulations—

(a)has been finally granted outline consent; or

(b)for whom arrangements were in effect,

to provide drugs and appliances to patients and that consent is, or those arrangements or requirements are, in effect on the date these Regulations come into force.

(2) For the purposes of this regulation “relevant premises” means—

(a)premises from which, at the date of notification under paragraph (5), the doctor is providing primary medical services; or

(b)premises in addition to or in place of the premises specified in paragraph (a) where, immediately before the coming into force of these Regulations, the doctor intended to dispense.

(3) The Local Health Board must determine whether or not to grant premises approval to relevant premises in accordance with paragraphs (4) to (6).

(4) Before the end of the period of 30 days beginning with the date these Regulations come into force, the Local Health Board must notify each doctor on its dispensing doctors list that—

(a)the Local Health Board is required to make a determination under paragraph (3) as to whether or not to grant premises approval in respect of the relevant premises; and

(b)the doctor may make written representations to the Local Health Board in relation to such a determination within the period of 30 days beginning with the date of the Local Health Board’s notification or such longer period as the Local Health Board may for good cause allow.

(5) The Local Health Board must—

(a)also notify the Local Medical Committee and the Local Pharmaceutical Committee, to which it is required to send a copy of the application under regulations 12(2) and (3), and inform them that they may make written representations within the period of 30 days beginning with the date of the Local Health Board’s notification;

(b)consider any representations received from the Committees mentioned in sub-paragraph (a) and the doctor;

(c)determine whether the doctor has premises approval for premises which are, or are part of, relevant premises; and

(d)notify its decision to—

(i)the doctor,

(ii)the Committees mentioned in sub-paragraph (a),

(iii)any person providing pharmaceutical services or dispensing services in the Local Health Board’s area whose interests might, in the opinion of the Local Health Board, be affected, and

(iv)all Community Health Councils in that area.

(6) The Local Health Board will grant premises approval under paragraph (3) where—

(a)it is satisfied that the relevant premises were, prior to the coming into force of these Regulations, being routinely used to provide dispensing services; or

(b)outline consent had been granted in respect of relevant premises after 16 July 2008.

(7) The Local Health Board must not refuse to grant premises approval under paragraph (3) by reason of the relevant premises being within 1.6 kilometres of any pharmacy.

(8) The Local Health Board’s decision under paragraph (5)(c) may be appealed to the Welsh Ministers by a person notified of the determination under paragraph (5)(d) except the Committees mentioned in paragraph (5)(a), and regulations 13(6) to (16) apply to such appeals except that, for this purpose, regulation 13 is to be read as if—

(a)in paragraph (8) of that regulation the reference to “those persons mentioned, where relevant in paragraph (1)(b), (2)(b) or (4)(a)” were a reference to those persons notified under paragraph (5)(d);

(b)in paragraph (13) of that regulation the list of persons to whom notice of the hearing should be sent were a reference to the persons notified under paragraph (5)(d); and

(c)in paragraph (15) of that regulation sub-paragraphs (b), (c) and (d) were omitted.

(9) Until—

(a)the date of the determination of the Local Health Board under paragraph (3); or

(b)the date that any appeal under paragraph (8) is decided,

whichever is the later, a doctor will be deemed to have been granted premises approval for the relevant premises, but he or she may not make any application under regulation 21C or 21D by virtue of this paragraph.

Dispensing doctor lists

21G.(1) The Local Health Board must prepare, maintain and publish a list, to be called the dispensing doctor list, of the names of those doctors authorised or required by the Local Health Board under regulation 20 to provide pharmaceutical services to their patients and who are actually doing so.

(2) The dispensing doctor list must indicate the name and address of the relevant GMS contractor or APMS contractor from whose premises any doctor whose name is included in that list performs primary medical services.

(3) Where the doctor whose name is included in the dispensing doctor list provides primary medical services with an LHBMS practice, the list must give the name and address of the Local Health Board.

(4) The dispensing doctor list must, in addition to the information required under paragraphs (2) and (3)—

(a)include the premises in relation to which the doctor has premises approval;

(b)state in relation to each premises included—

(i)if premises approval is deemed, temporary or residual, that this is the case,

(ii)the date on which premises approval took effect or where it has not taken effect the date that it was finally granted,

(c)state the area in relation to which there is outline consent and premises approval; and

(d)include and identify separately, any premises in relation to which the doctor has outstanding applications for premises approval.

Removal of entries from dispensing doctor lists

21H.  A Local Health Board must remove the name of a doctor from its dispensing doctor list where the Local Health Board determines that—

(a)the doctor has died;

(b)the doctor is no longer performing primary medical services within the area of the Local Health Board;

(c)more than 12 months have elapsed since the doctor last provided drugs or appliances under an arrangement made with the Local Health Board pursuant to regulation 20; or

(d)the doctor has been removed from the medical performers list..

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