The National Health Service (Charges, Primary Medical Services and Pharmaceutical and Local Pharmaceutical Services) (Coronavirus) (Further Amendments) Regulations 2021

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the PLPS Regulations”). The PLPS Regulations govern the arrangements in England, under Part 7 of the National Health Service Act 2006 (“the 2006 Act”), for the provision of pharmaceutical and local pharmaceutical services. These Regulations also amend the National Health Service (Charges for Drugs and Appliances) Regulations 2015 (“the Charges Regulations”), which include the charges payable for the supply of drugs and appliances as part of the NHS in England. They also amend the National Health Service (General Medical Services Contracts) Regulations 2015 (“the GMS Regulations”) and the National Health Service (Personal Medical Services Agreements) Regulations 2015 (“the PMS Regulations”), which make provision in respect of the services provided in England under a general medical services contract and a personal medical services agreement made pursuant to Part 4 of the 2006 Act.

Each local authority Health and Wellbeing Board (HWB) has to publish a plan, known as a pharmaceutical needs assessment (PNA) for its area. The primary purpose of PNAs is to support pharmaceutical services commissioning decisions of the National Health Service Commissioning Board (now known as NHS England). Ordinarily, formal revisions of PNAs are published on a three year cycle, but preparation of revised PNAs had already been delayed because of the coronavirus pandemic. These Regulations amend the PLPS Regulations to further extend the deadline for HWBs to publish their revised PNAs from 1st April 2022 to 1st October 2022 (regulation 3(2)(b), (3) and (5)). However, HWBs established on or after 1st January 2022 are given 12 months from the date of their establishment to prepare their first PNA (regulation 3(2)(a), (4) and (5)). A consequential amendment is made to a provision relating to revising PNAs (regulation 3(6)). HWBs can, pending a formal revision of their PNA, issue supplementary statements on matters relevant to NHS England’s commissioning decisions – if this is essential to prevent significant detriment to pharmaceutical services provision in their area. These Regulations allow new HWBs to issue supplementary statements updating the PNAs they inherit from the HWBs they replace, pending the publication of the new HWB’s own first PNA (regulation 3(7)). Any supplementary statements that the old or new HWBs have issued then become part of the PNA that NHS England uses to support commissioning decisions that relate to the area of the new HWB – and a spent provision about Primary Care Trust PNAs is omitted (regulation 4).

Where a retail pharmacy business or a dispensing appliance contractor wishes to apply for new premises in the area of a HWB based on gaps or improvements identified in the HWB’s PNA, they may make what is known as a “routine application” to NHS England. Such applications allow the applicant, for example, to offer to open on days or at times when the PNA indicates there could be better access to what are known as “essential services”, which are the core pharmaceutical services that include dispensing services. Amendments made by these Regulations to the PLPS Regulations require NHS England to turn down routine applications that, in essence, offer better access to essential services via extended or different opening hours, if NHS England are satisfied that granting the application would lead to an undesirable increase in the availability of essential services in the area of the HWB (regulation 5).

Retail pharmacy businesses and dispensing appliance contractors, as well as providing the pharmaceutical services that they are required to provide (as set out, in particular, in respectively Schedules 4 and 5 to the PLPS Regulations), may also provide what are known as “additional pharmaceutical services” – provision for which is made in directions under section 127 of the 2006 Act. The additional pharmaceutical services that NHS England are authorised, as opposed to required, to commission are known as “enhanced services”. Historically, the expectation has been that these services will be commissioned on the basis of locally agreed terms and conditions, and consultation on the terms of remuneration has been required with the Local Pharmaceutical Committee of the area in which the service is to be provided. However, if these “enhanced services” are to be based on standard conditions set nationally, consultation will need instead to be with a body that represents the interests of retail pharmacy businesses or, as the case may be, dispensing appliance contractors nationally (regulation 6).

There are a number of different ways in which pandemic treatments may be ordered for and supplied to NHS patients in England. Two of the routes to supply – pandemic treatment protocols (PTPs) and pandemic treatment patient group directions (PTPGDs) – do not require a treatment decision by an authorised prescriber, who might in ordinary circumstances be a general practitioner (GP). If the supply is to be made by a retail pharmacy business (and so at or from a community pharmacy), it is possible that arrangements may be made for that supply either as part of essential services or as part of additional pharmaceutical services. These Regulations amend the PLPS Regulations to provide that where arrangements are in place for the supply of pandemic treatments under PTPs or PTPGDs as part of additional pharmaceutical services, they are to be supplied on the basis of those arrangements and not by community pharmacies as part of essential services or by dispensing doctors (GPs in rural areas that supply prescription items to those of their registered patients to whom they are entitled to provide dispensing services) (regulation 7 and 9(2)).

An alternative route to supply of pandemic treatments is via a listed prescription items voucher (LPIV). These may be in an electronic form and can be used for the free supply of prescription items, the supply of which is for or in anticipation of pandemic disease, or for certain other emergency situations. If these prescription items are prescription only medicines, the LPIV will be a prescription of an authorised prescriber – but in all cases, although they will be issued under NHS arrangements, they will not be one of the ordinary forms of NHS prescriptions. If a community pharmacy receives an LPIV, amendments to the PLPS Regulations made by these Regulations require the community pharmacy to dispense the prescription item as part of essential services, as it would an ordinary NHS prescription – unless arrangements are in place for the LPIV to be dispensed as part of additional pharmaceutical services, in which case it is only to be dispensed as part of additional pharmaceutical services. Arrangements are also made so that dispensaries of dispensing doctors are also able to supply prescription items against LPIVs unless they are instead to be supplied as part of additional pharmaceutical services (regulations 2, 7, 9 and 10).

Amendments are also made to the GMS and PMS Regulations, and a consequential amendment made to the Charges Regulations (regulation 12), that are related to these LPIV changes. Arrangements were already in place under the GMS Regulations and PMS Regulations for authorised prescribers at GP practices to order medicines on vouchers, before now described as “listed medicines vouchers” – the relevant list being the medicines mentioned in regulation 13(1) of the Charges Regulations, which relates to the free supply of pandemic treatments and treatments needed in certain other emergency situations. These Regulations amend the GMS Regulations and the PMS Regulations to update those references to take account of the fact that the arrangements for free supply could now be for prescription items that are not medicines (and so listed medicines vouchers have become LPIVs). These Regulations also amend the GMS Regulations and the PMS Regulations to take account of the fact that the vouchers could be electronic vouchers (regulations 15 to 24).

Those community pharmacies whose terms of service are principally set out in Schedule 4 to the PLPS Regulations are, as part of those terms of service, required to have in place arrangements for clinical governance and the promotion of healthy living, which includes a number of programmes. These Regulations update those arrangements so that in future the programmes will include, if NHS England requests that they do, a pandemic response programme with specified elements (regulation 8).

These Regulations also amend the Charges Regulations to include new provisions in respect of medical and maternity exemption certificates. There is a new statutory information gateway to support the claiming and provision of such certificates, and the management of those processes (regulation 14). The provisions relating to the making of claims for exemption certificates are amended so that applications can be made either by a person claiming exemption or a health care professional acting on their behalf – and removing a reference to a named form. Arrangements relating to live and still births are substantially aligned, and mothers who applied for their certificate before their child was born (including those whose child was still born) may apply for extensions to their certificates if the date of birth is later than the expected date of confinement (regulation 13).