224.This section amends sections 83 and 84 of the 2006 Act. Section 83 of that Act sets out the principal regulation-making powers governing the provision of NHS pharmaceutical services in Wales, whilst section 84 provides for rights of appeal resulting from decisions made under section 83.
225.Section 83(2)(c) of the 2006 Act sets out the legislative criteria which a LHB must apply when considering applications to be included on a LHB’s pharmaceutical list and applications for changes to the list. These criteria are often referred to as the “control of entry test”.
226.Subsections (2) and (3) modify the ”control of entry test” that LHBs are required to apply when considering applications to join their pharmaceutical list. Subsection (2) removes the requirement for LHBs to consider whether it is “necessary or expedient” to grant the application in order to secure “adequate” provision of pharmaceutical services within the neighbourhood.
227.In its place, subsection (3) inserts the new subsection (2B) into the 2006 Act which provides that a LHB may grant an application where it is satisfied, having regard to its most recently published pharmaceutical needs assessment, and any matters that are specified in regulations, that to grant the application would meet the need(s) identified within its assessment. This means that the “control of entry test” will be clearly based on meeting assessed local pharmaceutical needs.
228.Section 112(3) also inserts a new subsection (2A) into section 83 of the 2006 Act, which permits the Welsh Ministers to specify, in regulations, persons, or the description of persons, who are not to be included within a pharmaceutical list.
229.Section 112(3) also inserts a new subsection (2C) into the 2006 Act which makes additional provision in cases where a LHB is satisfied that an application meets the criteria for grant of the application required under subsection (2B). First, new subsection (2C) provides that the regulations may set out the procedure which the LHB must follow when determining an application for inclusion in a pharmaceutical list. For example, the regulations may provide that a LHB must seek representations from local patient representative bodies and other key interested parties. Second, new subsection (2C) provides that the regulations may stipulate certain matters which a LHB must or must not take into consideration when deciding whether or not to grant an application under subsection (2B).
230.Subsections (4), (5) and (6) modify the existing provisions which enable regulations to specify the circumstances in which two or more applications are considered together by a LHB.
231.Subsection (4) inserts a new subsection (3A) into the 2006 Act to provide that the regulations may prescribe the circumstances in which two or more applications may be considered together by a LHB. Subsection (5) amends section 83(4) of the 2006 Act to create a general power to make provision for the case where two or more applications, taken individually, meet the test under the new subsection (2B), but, taken together, do not.
232.Section 112(7) inserts a new subsection (6)(za) into section 83 of the 2006 Act, which permits the regulations to prescribe the circumstances in which LHBs may invite applications for inclusion in their pharmaceutical list. This will enable a LHB, if it is not receiving applications to provide the pharmaceutical services which are required to meet needs identified in its pharmaceutical needs assessment, to actively seek applications that will fulfil those needs.
233.Section 112(7)(b) inserts a new subsection (6)(fa) into section 83 of the 2006 Act, which permits the regulations to prescribe the timescale within which a LHB must determine applications for inclusion in or amendment to an inclusion in the pharmaceutical list.
234.Section 112(7)(d) makes amendments to section 83(6)(g) of the 2006 Act so that regulations under section 83 may provide grounds for removal of a person from the pharmaceutical list that are not connected with a person’s fitness to practise. This power enables LHBs to remove pharmacists from the pharmaceutical list for serious and/or persistent breaches to their terms and conditions of service. Before removing a person from the pharmaceutical list an LHB must first issue the person with a notice describing the alleged breach (a so called “breach notice”) and any action required by the person to rectify it. A person may only be removed from the pharmaceutical list where they fail to comply with the requirements stipulated in a breach notice. Appeals against removal from the pharmaceutical list will be to the Welsh Ministers.
235.Section 112(9) inserts subsection (10A) which requires LHBs to provide reasons for their decisions as to any matters covered within section 83.
236.The remaining subsections amend section 84 of the 2006 Act, which deals with appeals against decisions made by LHBs under the regulations provided for in section 83.
237.Section 112(10) amends section 84 of the 2006 Act so as to ensure that appeals against a LHB’s determination of an application for inclusion in a pharmaceutical list are heard by the First Tier Tribunal only if they are on fitness to practise grounds. This removes the requirement relating to redetermination so that the First Tier Tribunal is not limited in the way it determines the appeal, for example, it could remit the matter back to the LHB. Appeals on other grounds are to be made to the Welsh Ministers – including appeals against a removal from the list for breaches of terms and conditions of service.
238.Section 112(11) provides that if regulations made under section 83 of the 2006 Act include provision for removal of a person or an entry in respect of premises from a pharmaceutical list, the regulations must require LHBs to give a pharmacist notice of their intention to remove him/her from the list, together with their reasons for this. The regulations must also set out the rights that a pharmacist will have to make representations prior to a LHB taking such a decision.
239.Section 112(12) removes text relating to section 83(6)(d) of the 2006 Act from the table in Schedule 6 (repeals and revocations) of the Health Act 2009.