Explanatory note

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 Act”), for the provision of pharmaceutical and local pharmaceutical services.

The scheme for paying for pharmaceutical and local pharmaceutical services in Part 7 of the Act is predicated on the basis that the determining authorities for pharmaceutical remuneration will ordinarily include, in the payments for those services, an amount which is in respect of (but ordinarily slightly more than) the price paid by service providers when they purchased the prescription items that they supply or administer to NHS patients. However, there are powers in Part 7 to enable alternatives to these ordinary remuneration arrangements in some circumstances.

A new regulation 91A is included in the PLPS Regulations which provides that, where the Government has centrally purchased coronavirus vaccines or coronavirus antivirals and makes those products available to community pharmacies at no cost, the determining authorities for pharmaceutical remuneration are to set a zero or nominal NHS reimbursement price for those products, if certain conditions are met. However, this does not prevent the determining authorities from paying community pharmacies for the services (such as professional services) that they provide in conjunction with the supply or administration of those vaccines or antivirals (regulations 3 and 5).

These Regulations also make a small number of relatively minor amendments to the PLPS Regulations.

Applicants for inclusion in a pharmaceutical list (the basis on which most community pharmacies and all dispensing appliance contractors provide pharmaceutical services) are required to provide updates of the fitness to practise information about their superintendents up until they are actually included on such a list or the application can no longer be proceeded with (for example, because an application has been refused and the time for bringing an appeal has expired) – and consequential amendments are made to provide for the redetermination of applications where this becomes necessary on fitness grounds (regulations 6(2) and 7). The requirement for NHS England to keep lists of service providers that use the Electronic Prescription Service is removed (regulation 4). The consultation period in relation to applications to consolidate services onto a particular site is reduced (regulation 6(3)). The notice period where a community pharmacy on a pharmaceutical list wants to reduce its supplementary hours, which are ordinarily the hours it is open above 40 hours per week, is reduced – and the notification requirement is removed altogether where the pharmacy wants to increase its supplementary hours (regulation 8(2)). There is a new requirement for community pharmacies on pharmaceutical lists to undertake an annual workforce survey as part of its clinical governance obligations, but the existing requirement to undertake a patient satisfaction survey as part of those obligations is removed (regulation 8(3)).

A full impact assessment has not been undertaken in relation to this instrument as these Regulations are not expected to have a significant impact on the public and voluntary sectors, and only a limited impact on the private sector, below the threshold for undertaking a full impact assessment.