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(This note is not part of the Regulations)
These Regulations principally amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the 2013 Regulations”). The 2013 Regulations govern the arrangements in England, under Part 7 of the National Health Service Act 2006, for the provision of pharmaceutical services and local pharmaceutical services.
The 2013 Regulations provide for pharmaceutical services provision by, amongst others, retail pharmacy businesses, and for pharmaceutical lists to be held by the National Health Service Commissioning Board (“the NHSCB”) of the retail pharmacy businesses entitled to provide pharmaceutical services, which are kept by reference to the areas of the Health and Wellbeing Board (“HWB”) of a local authority.
Retail pharmacy businesses that are included in a particular pharmaceutical list may wish to consolidate the services provided on two or more sites onto a single site. Such consolidations could require a change in the ownership of one of the businesses in question. Part 2 of these Regulations puts in place a process to facilitate such consolidations.
Applications to consolidate will be dealt with as “excepted applications” under the 2013 Regulations, which means in general terms they will not be assessed against the local plan known as the pharmaceutical needs assessment (“PNA”) produced by the HWB. Instead, they will follow a simpler procedure, the key to which is whether or not a gap in pharmaceutical service provision would be created by the consolidation. Some provision is also made in respect of continuity of services – for example, if the NHSCB intends to commission from the applicant “enhanced services” (additional pharmaceutical services, such as minor ailments schemes, that are commissioned locally) that have been provided at or from the closing premises, the applicant is required to provide undertakings to continue to provide those services (regulation 11). If the NHSCB is satisfied that the consolidation would create a gap in pharmaceutical services provision, it must refuse the application (regulation 7). The opinion of the HWB on this issue must be given when the application is notified locally and representations are sought (regulations 12 and 13). If the application is granted and pharmacy premises are removed from the relevant pharmaceutical list, if the HWB does not consider that a gap in service provision is created as a consequence, it must publish a supplementary statement published alongside its pharmaceutical needs assessment recording its view (regulation 3). Also, if the NHSCB does grant the application, it must then refuse any further applications known as “unforeseen benefits applications” by other chemists seeking inclusion in the pharmaceutical list, if the applicant is seeking to rely on the consolidation as a reason for saying there is now a gap in provision, at least until the next revision of the PNA (regulations 5 and 6).
Various supplementary amendments are made in relation to the new process, or to align the existing processes with the new process, including in relation to the undertakings to be given by applicants (regulation 11), enabling businesses to relocate onto an existing site in this particular context (regulation 8), notification by the NHSCB of decisions on consolidation applications (regulation 15), the notices to be sent by pharmacy businesses when premises close or open (regulations 9, 10 and 15 to 18), the NHSCB’s responsibilities to notify HWBs of changes to lists (regulation 4), and in relation to appeals (regulations 19 and 20).
Part 3 of these Regulations makes provision for the prescribing and dispensing, as part of NHS primary care services of prescriptions written by therapeutic radiographer independent prescribers and dietitians who are entitled to prescribe as supplementary prescribers – and for prescription charges to be levied in respect of such prescriptions (regulations 21 to 24).
Part 4 of these Regulations makes provision which allows prescription charges to be levied by providers of pharmaceutical or local pharmaceutical services who undertake emergency supplies of medicines at the request of a patient in accordance with specified types of arrangements with the NHSCB for the making of such supplies (regulation 26). However, providers of pharmaceutical services on pharmaceutical lists who have such arrangements are not obliged to publicise them as part of their clinical governance programme (regulation 25). Clinical governance programmes are not required terms of local pharmaceutical services contracts.
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