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The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

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PART 9U.K.Conditional inclusion in pharmaceutical lists: certain specific conditions that do not relate to fitness or performance

Distance selling premises: specific conditionsU.K.

64.—[F1(1) Paragraph (2) applies where—

(a)an application in respect of distance selling premises is granted under these Regulations; or

(b)an application was granted under the 2005 Regulations or 2012 Regulations in respect of premises which were, for the purposes of the Regulations under which the application was granted, distance selling premises.]

(2) The inclusion in the pharmaceutical list of the person (X) listed in relation to—

(a)those distance selling premises; or

(b)if there has been a relocation of the retail pharmacy business or appliance contractor business at those distance selling premises to other premises, those other premises,

is subject to the conditions set out in paragraph (3).

(3) Those conditions are—

(a)X must not offer to provide pharmaceutical services, other than directed services, to persons who are present at (which includes in the vicinity of) the listed chemist premises;

(b)the means by which X provides pharmaceutical services, other than directed services, must be such that any person receiving those services does so otherwise than at the listed chemist premises;

(c)the listed chemist premises must not be on the same site or in the same building as the premises of a provider of primary medical services with a patient list;

(d)in the case of pharmacy premises, the pharmacy procedures for the premises must be such as to secure—

(i)the uninterrupted provision of essential services, during the opening hours of the premises, to persons anywhere in England who request those services, and

(ii)the safe and effective provision of essential services without face to face contact between any person receiving the services, whether on their own or on someone else's behalf, and X or X's staff; and

(e)nothing in X's practice leaflet, in X's publicity material in respect of the listed chemist premises, in material published on behalf of X publicising services provided at or from the listed chemist premises or in any communication (written or oral) from X or X's staff to any person seeking the provision of essential services from X must represent, either expressly or impliedly, that—

(i)the essential services provided at or from the premises are only available to persons in particular areas of England, or

(ii)X is likely to refuse, for reasons other than those provided for in X's terms of service, to provide drugs or appliances ordered on prescription forms or repeatable prescription forms which are presented by particular categories of patients (for example, because the availability of essential services from X is limited to other categories of patients).

(4) [F2NHS England] may not vary or remove the conditions set out in paragraph (3).

Textual Amendments

Modifications etc. (not altering text)

Core opening hours conditionsU.K.

65.—(1) If an application to which regulation 13(1)(b) of the 2005 Regulations (exemption from the necessary or expedient test) applied was granted, the inclusion in the pharmaceutical list of the person listed in relation to—

(a)the premises that were listed as a consequence of that application; or

(b)if there has been a relocation of the retail pharmacy business or appliance contractor business at those premises to other premises, those other premises,

is subject to the condition set out in paragraph (2) (“the 100 hours condition”).

(2) The condition is that the premises must be kept open for at least 100 hours per week for the provision of pharmaceutical services.

F3(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F4(3A) NHS England may remove a 100 hours condition in respect of premises of an NHS pharmacist and replace it with a direction under paragraph (4) or (5) or paragraph 25 or 26 of Schedule 4, but that direction, and any subsequent direction which replaces that direction (whether it is in respect of those premises or any premises to which that NHS pharmacist, or any NHS pharmacist that is in succession to that NHS pharmacist, relocates), must specify a total number of core opening hours of not less than 72.]

(4) Where, in the course of making a routine application or an excepted application to which regulation 24 or 26(2) applies—

(a)for inclusion in a pharmaceutical list as mentioned in regulation 10(2)(a), or from a person already included in such a list to relocate to different pharmacy premises or to open, within the area of the relevant HWB, additional pharmacy premises—

(i)an NHS pharmacist undertook to provide pharmaceutical services at the proposed pharmacy premises for a specified number of core opening hours each week which is more than 40 F5...,

(ii)the NHS pharmacist and [F2NHS England] agreed [F6, or the NHS pharmacist undertook,] that pharmaceutical services are to be provided at the proposed pharmacy premises during [F7any additional] opening hours specified [F8, or any core hours specified that replace (at any distance in succession) a 100 hours condition,] at set times and on set days, and

(iii)the application was granted having regard to [F9any such undertaking or] agreement,

when it includes the premises in a pharmaceutical list, [F2NHS England] must direct that the person listed in relation to the premises is to provide pharmaceutical services at those premises for the specified number of core opening hours so undertaken, and F10... at the set times and on the set days so agreed [F11or undertaken]; or

(b)for inclusion in a pharmaceutical list as mentioned in regulation 10(2)(b), or from a person already included in such a list to relocate to different appliance contractor premises or to open, within the area of the relevant HWB, additional appliance contractor premises—

(i)an NHS appliance contractor undertook to provide pharmaceutical services at proposed appliance contractor premises for a specified number of core opening hours each week which is more than 30 (other than as a consequence of a 100 hours condition),

(ii)the NHS appliance contractor and [F2NHS England] agreed that pharmaceutical services are to be provided at the appliance contractor premises during the additional opening hours specified (that is, the hours which are the difference between the total number of hours specified and 30) at set times and on set days, and

(iii)the application was granted having regard to that undertaking and that agreement,

when it includes the premises in a pharmaceutical list, [F2NHS England] must direct that the person listed in relation to the premises is to provide pharmaceutical services at those premises for the specified number of core opening hours so undertaken, and during the additional opening hours at the set times and on the set days so agreed.

(5) Where [F2NHS England] has—

(a)invited an NHS chemist to increase the total number of core opening hours during which the NHS chemist is to provide pharmaceutical services at listed chemist premises; and

(b)thereafter agreed with the NHS chemist—

(i)an increased number of core opening hours, and

(ii)if the NHS chemist—

(aa)is an NHS pharmacist, that pharmaceutical services are to be provided at the pharmacy premises during any additional opening hours [F12, or any core hours specified that replace (at any distance in succession) a 100 hours condition,] at set times and on set days, and

(bb)is an NHS appliance contractor, that pharmaceutical services are to be provided at the appliance contractor premises during any additional opening hours (that is, the hours which are the difference between the total number of hours specified and 30) at set times and on set days,

[F2NHS England] must direct that the person listed in relation to the premises is to provide pharmaceutical services at those premises for the specified number of core opening hours so undertaken, and F13... at the set times and on the set days so agreed [F14or undertaken].

(6) Except as provided for under paragraph (5) and subject to paragraph (7), [F2NHS England] may only vary a direction given under paragraph (4) or (5), or regulation 65(4) or (5) of the 2012 Regulations (core opening hours conditions), in accordance with paragraph 25 or 26 of Schedule 4 or paragraph 15 or 16 of Schedule 5.

(7) A direction given under paragraph (4) or (5), or regulation 65(4) or (5) of the 2012 Regulations, must not be varied within 3 years of the direction being given.

Textual Amendments

[F15Continuity in respect of opening hours directionsU.K.

65A.—(1) In this regulation, “opening hours directions” means directions that have been given under regulation 65(4) or (5), or issued in accordance with paragraph 25 or 26 of Schedule 4 or paragraph 15 or 16 of Schedule 5, or given under or issued in accordance with earlier provisions which that regulation and those paragraphs have (at any distance in succession) replaced.

(2) Opening hours directions given or issued in respect of premises included in a pharmaceutical list apply to any NHS chemist listed in relation to those premises, not just to the NHS chemist to whom they were given or issued.

(3) Where, by virtue of regulation 24 or 26(2), an excepted application may be granted in circumstances where the applicant is undertaking to provide the same pharmaceutical services as those that are already being provided, but at premises that are not already included in a pharmaceutical list, that application must be refused where opening hours directions apply in respect of the premises from which the applicant is relocating the relevant business, unless—

(a)the applicant, as part of their undertaking, undertakes to provide pharmaceutical services for any total number of core opening hours, and on any set days and at any set times, specified in those opening hours directions, taking into account any variation in respect of a rest break in accordance with paragraph 23(7)(bd) of Schedule 4; and

(b)NHS England is, accordingly, required to give directions under regulation 65(4) in the same terms as those given in those opening hours directions, but in respect of the premises to which the applicant is relocating the relevant business and taking into account any variation in respect of a rest break in accordance with paragraph 23(7)(bd) of Schedule 4.

(4) In circumstances where, in respect of any premises, there are opening hours directions that have replaced (at any distance in succession) a 100 hours condition, whether that condition applied in respect of those premises or other premises, any routine application to relocate from those premises must be refused unless—

(a)the applicant undertakes to provide pharmaceutical services, at the premises to which the applicant is relocating the relevant business, for any total number of core opening hours, and on any set days and at any set times, specified in those opening hours directions; and

(b)NHS England is, accordingly, required to give directions under regulation 65(4) in the same terms as those given in those opening hours directions but in respect of the premises to which the applicant is relocating the relevant business.]

Textual Amendments

Conditions relating to providing directed servicesU.K.

66.—(1) Where, immediately before these Regulations came into force, the inclusion in the pharmaceutical list of an NHS chemist (C1) was subject to a condition imposed in relation to listed chemist premises by virtue of regulation 13(3)(b) of the 2005 Regulations (exemption from the necessary or expedient test), including such a condition as varied in accordance with regulation 14 of the 2005 Regulations M1 (variation of directed services in respect of exempted premises) or regulation 66(2) and (3) of the 2012 Regulations (conditions relating to providing directed services), it is a condition of the inclusion in the pharmaceutical list of the person listed in relation to those premises—

(a)if, before these Regulations came into force, C1 had not been requested by a Primary Care Trust to provide the directed services specified as regards C1 for the purposes of that condition, that they must provide those directed services at those premises, where requested to do so by [F2NHS England] unless thereafter [F2NHS England] ceases to commission those services; or

(b)if, before these Regulations came into force, C1 was providing, or had been requested by a Primary Care Trust to provide, the directed services specified as regards C1 for purposes of that condition, that they must provide those directed services at those premises unless [F2NHS England] does not continue to commission those services.

(2) The person listed in relation to the premises may apply to [F2NHS England] to vary the directed services specified for the purposes of the condition imposed by virtue of paragraph (1), or to remove the condition, but only if at least 3 years have elapsed—

(a)since the condition was imposed by virtue of the 2005 Regulations; and

(b)during that period neither a Primary Care Trust nor [F2NHS England] has requested that the services be provided at the premises in respect of which the condition was imposed,

but otherwise [F2NHS England] may not vary or remove the condition imposed by virtue of paragraph (1).

(3) If, pursuant to an application under paragraph (2), [F2NHS England] does vary the directed services specified for the purposes of the condition imposed by virtue of paragraph (1) in respect of any premises, it is a condition of the inclusion in the pharmaceutical list of the person listed in relation to those premises that they must—

(a)provide the directed services specified as regards C1 as a consequence of the application—

(i)if [F2NHS England] commissions the services within 3 years of the date on which the condition is imposed by virtue of these Regulations, and

(ii)unless thereafter [F2NHS England] ceases to commission the services; and

(b)not withhold agreement to a service specification for those services unreasonably.

(4) Where, in the course of making a routine or excepted application under these Regulations or the 2012 Regulations, an NHS chemist undertook—

(a)to provide the directed services mentioned in the application, if a Primary Care Trust or [F2NHS England] commissioned the services within 3 years of the date of either the grant of the application or, if later, the listing in relation to the applicant of the premises to which the application relates;

(b)if the directed services were commissioned, to provide the services in accordance with an agreed service specification; and

(c)not to withhold agreement to a service specification unreasonably,

the inclusion in the pharmaceutical list of the person (C2) listed in relation to the premises that were listed as a consequence of that application is subject to the condition set out in paragraph (5).

(5) The condition is that, at those premises, C2 must—

(a)provide the directed services mentioned in the application (whether or not C2 was the applicant); and

(b)not withhold agreement to a service specification for those services unreasonably,

if the Primary Care Trust or [F2NHS England] commissions the services from C2 within 3 years of the date of either the grant of the application or, if later, the listing in relation to the applicant of the premises to which the application relates, unless thereafter [F2NHS England] ceases to commission the services (if it has commissioned them) or does not continue to commission services (that is, if only the Primary Care Trust, and not [F2NHS England], has commissioned them).

(6) Where a Primary Care Trust or [F2NHS England] specifies that a requirement to provide directed services arising out of a condition imposed by virtue of this regulation is to take effect by a specified date, the requirement takes effect—

(a)on that date; or

(b)on the date on which provision of the directed service is commenced,

whichever is the sooner.

(7) [F2NHS England] may not vary or remove the condition imposed by virtue of paragraphs (3) to (5).

Textual Amendments

Marginal Citations

M1Prior to its revocation, regulation 14 was amended by S.I. 2006/3373.

Conditions relating to voluntary closure of premisesU.K.

67.—(1) Except in the circumstances described in paragraph (3) [F16or (5)], where an NHS chemist (C) wishes, other than as a consequence of a change of ownership application [F17or a consolidation application]—

(a)to withdraw from a pharmaceutical list, or

(b)for particular listed chemist premises no longer to be listed in relation to C,

C must comply with paragraph (2).

(2) C must notify [F2NHS England] of C's wish—

(a)unless sub-paragraph (b) applies, at least 3 months in advance of the date on which pharmaceutical services are no longer to be provided;

(b)at least—

[F18(i)6 months in advance of that date, in the case of premises in respect of which a 100 hours condition applies or has ever applied, or in respect of which a direction that replaced (at any distance in succession) a 100 hours condition applies, or]

(ii)30 days in advance of that date, if—

(aa)a condition is imposed under regulation 35,

(bb)C appeals that condition to the First-tier Tribunal,

(cc)on appeal, the First-tier Tribunal confirms the imposition of that condition or imposes another condition, and

(dd)within 30 days of being informed of the decision of the First-tier Tribunal, C notifies [F2NHS England] that C wishes to withdraw from the pharmaceutical list within a shorter period of not less than 30 days,

unless either it is impracticable for C to do so, in which case C must notify [F2NHS England] as soon as it is practicable for C to do so, or [F2NHS England] agrees to a shorter notification period.

(3) If C has consented to—

(a)particular listed chemist premises no longer being listed in relation to C by [F2NHS England]; or

(b)being removed from the pharmaceutical list for the area of a HWB,

in the context of a relocation application, [F19which is not part of a consolidation application,] paragraph (4) applies.

(4) In the circumstances described in paragraph (3), C must, where the relocation application is granted, when C gives notice to [F2NHS England] of C's intention to commence the provision of pharmaceutical services at the new premises (in accordance with paragraph 34 of Schedule 2), give notice to [F2NHS England] of when, before C commences the provision of pharmaceutical services at the new premises, C is to cease to provide pharmaceutical services at the existing premises.

[F20(5) If C has consented to—

(a)particular listed chemist premises no longer being listed by [F2NHS England]; or

(b)being removed from a pharmaceutical list for the area of a HWB,

in the context of a consolidation application, paragraph (6) applies.

(6) In the circumstances described in paragraph (5), in the context of an application—

(a)to which regulation 26A(3) applies, if it is granted—

(i)C who is the person listed in relation to S2 for the purposes of regulation 26A(3)(b) must give notice of C’s intention to cease the provision of pharmaceutical services at the same time as C who is P1 for the purposes of regulation 26A(3) issues a notice in accordance with paragraph 34A of Schedule 2; but

(ii)C who is P1 for the purposes of regulation 26A(3) need not issue a notice under this regulation;

(b)to which regulation 26A(4) applies, if it is granted—

(i)C who is the person listed in relation to S1 for the purposes of regulation 26A(4) must give notice of C’s intention to cease the provision of pharmaceutical services at the same time as C who is P2 for the purposes of regulation 26A(4) issues a notice in accordance with paragraph 34A of Schedule 2; but

(ii)C who is P2 for the purposes of regulation 26A(4) need not issue a notice under this regulation.]

Textual Amendments

[F21Condition relating to entering administrationU.K.

67A.—(1) An NHS chemist must, if the NHS chemist enters administration, notify [F2NHS England] of that fact.

(2) For these purposes, “enters administration” has the meaning given in paragraph 1(2)(b) of Schedule B1 to the Insolvency Act 1986 (administration).]

Textual Amendments

Conditions relating to local resolution of disputes over terms of serviceU.K.

68.—(1) It is a condition of the inclusion of each NHS chemist (C) in a pharmaceutical list by [F2NHS England] that C makes every reasonable effort to communicate and co-operate with [F2NHS England] with a view to resolving any dispute between C and [F2NHS England] relating to C's compliance with the terms of service under which C provides pharmaceutical services for [F2NHS England].

(2) [F2NHS England] may not vary or remove the condition imposed by virtue of paragraph (1).

Textual Amendments

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