The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2015

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 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 (apart from the terms of service of piloted services).

The National Health Service Commissioning Board (“NHSCB”) holds lists, known as pharmaceutical lists, of approved providers of pharmaceutical services. These lists are kept by reference to local authority areas. An amendment is made to regulation 25 of the 2013 Regulations to make it clear that an applicant for new distance selling premises who is already included in a particular pharmaceutical list but who is seeking replacement premises in the same local authority area is subject to the requirements in respect of distance selling premises applications in regulation 25 (regulation 2).

Under regulation 99 of the 2013 Regulations, the NHSCB may designate premises or a neighbourhood for the purpose of giving priority in that place to the development of schemes for the provision of local pharmaceutical services (a form of contractual arrangement for the provision of pharmaceutical services that is separate from the pharmaceutical list system). The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417) erroneously amended regulation 32 of the 2013 Regulations so that the NHSCB was required to refuse pharmaceutical list applications that related to a neighbourhood or premises covered by such a designation, rather than simply giving the NHSCB the power to defer such an application. Regulation 3 corrects that error.

A local pharmaceutical services contractor may choose to be a “health service body” and so for their contract to be an NHS contract – and if they do, they may also choose to cease to be such a body and so for their contract to cease to be an NHS contract. Where a local pharmaceutical services contractor does choose to cease to be a health service body, the amendments made by these Regulations have the effect of providing that all disputes relating to the period when their contract was an NHS contract are to be dealt with via the NHS dispute resolution procedure (regulation 4, 5(a) and 9). An exception is made in a transitional provision which provides, in effect, that if a dispute was already the subject of legal proceedings before these Regulations came into force, that dispute is to be determined in accordance with the relevant legislation as it applied at that time (regulation 10). Before these Regulations came into force, disputes under a local pharmaceutical services contract that was not an NHS contract, but which related to a time when the contact was an NHS contract, could only be dealt with via the NHS dispute resolution procedure (if they had not been referred to that procedure when the contract was an NHS contract) with the contractor’s consent.

Regulations 5(b) and 7 correct drafting errors.

Applicants for inclusion in a pharmaceutical list may be granted subject to a condition that relates to the applicant’s fitness to provide pharmaceutical services. If that condition is appealed by the applicant, and the appeal is lost, the application may lapse if a required notification is not given by the applicant. In respect of cases where the applicant makes a subsequent pharmaceutical list application, the application procedures are amended so that the applicant must make reference in the new application to the earlier lapsed application (regulation 6(a)). The pharmaceutical list applications procedures are also amended so that in all cases where the applicant is seeking the listing of premises that are the same as, or in close proximity to, premises that are already listed, the applicant must explain why they believe the application should not be refused under regulation 31 of the 2013 Regulations, which prevents the granting of applications where the proposed and existing premises should be treated as the same site (regulation 6(b)).

The terms of service of providers of pharmaceutical services on pharmaceutical lists that dispense both drugs and some appliances are amended so that they are required to give appropriate advice about the benefits of repeat dispensing to specified categories of patients. In addition, their audit programme requirements are amended so that rather than in all cases having to undertake two clinical audits, they are required to undertake a clinical audit of their choice, and either a clinical or policy based audit as specified by the NHSCB (regulation 8).