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, for the provision of pharmaceutical and local pharmaceutical services, such as the dispensing of NHS prescriptions.

Most pharmaceutical services provision in England is by community pharmacies that are on lists, known as pharmaceutical lists, held by NHS England. Applications for entry onto those lists are determined by NHS England (who may now delegate this type of function to integrated care boards). Between 2005 and 2012, a number of community pharmacies were allowed onto pharmaceutical lists if they agreed to provide services for 100 hours per week, rather than the usual 40 core hours. Prior to these Regulations, those 100 hours pharmacies had not been allowed to reduce their 100 hours commitment. These Regulations allow them to reduce it to 72 hours per week (or to between 72 and 100 hours), if they make an application to NHS England to that effect. However, as part of the reduction, they are not allowed to reduce their hours between 5pm and 9pm, Monday to Saturday, or 11am to 4pm on a Sunday (with a limited exception for a rest break), or to reduce their overall number of hours on a Sunday. Any such evening or Sunday commitment that they had before these Regulations came into force becomes (with a limited exception for Sunday rest breaks) irreducible (regulation 12(1) and (2) and (4) to (7)).

The applications process that will allow for the reduction from 100 to 72 hours is a process which has applied to all opening hours changes for community pharmacies, apart from a specified group of changes that can proceed by way of notification only. Ordinarily, the applicant has been required to show that the new core opening hours are such as to ensure that pharmaceutical services provision in the area in which the pharmacy is located is on such days and at such times as are necessary to meet the needs of likely users of the pharmacy – and to provide information about any changes to those needs. This “needs” test is disapplied in cases where a pharmacy that is or ever was a 100 hours pharmacy is reducing its hours in the manner permitted – as is a separate test relating to the reasonableness of remuneration (regulations 11(3) and 12(3)).

In other cases, the “needs” test has itself been changed so that, going forward, the applicant who wants to change their core opening hours must either demonstrate that they are able to maintain as necessary the existing level of service provision for the people in that area, or, if maintaining the existing level of service provision is neither a necessary nor a realistically achievable outcome, they must instead show that they are able to maintain a sustainable level of adequate service provision (regulation 11(1) and (2)).

Routine applications for inclusion in a pharmaceutical list are assessed against a local plan known as a pharmaceutical needs assessment, but there are exceptions to this process that include some minor relocation applications and some minor relocation applications that are combined with changes of ownership. 100 hours conditions survive both relocation of a pharmacy business and changes of ownership, and the provisions that already provide for core opening hours directions to be restated if a pharmacy business relocates have been amended to accommodate the core opening hours directions that replace 100 hours conditions. At the same time, provision has been made to ensure that all core opening hours directions survive a change of ownership where the business does not move, and to ensure that where pharmacy businesses do relocate, the applications process requires undertakings to maintain existing hours where there are directed hours (regulations 3 and 4). The notice period that has to be given in cases of voluntary closures of premises that have core opening hours directions that replace 100 hours conditions becomes the same as it is for premises that are subject to 100 hours conditions, which is six months (regulation 5).

The specified group of changes to opening hours that can proceed by way of notification only is expanded to allow for rest breaks in core opening hours to be changed in this way, subject to caveats that include not allowing pharmacies that are subject to a 100 hours condition or directions that succeed such a condition to add or change a rest break in this way. For most cases that follow the notification procedure, the notice that has to be given to NHS England of the change is five weeks, but where the pharmacy wants to increase its supplementary hours, all that was required before these Regulations was that the pharmacy submitted a return to NHS England informing it of the change. These Regulations specify that such a return must be submitted before the change takes place (regulation 9(1) to (5)).

Breach of the opening hours requirements of the PLPS Regulations ordinarily puts a pharmacy in breach of their NHS terms of service, but this has not been the case if the breach was for a reason beyond the control of the pharmacy owner, they notified NHS England about the cessation of services as soon as was practicable and they used all reasonable endeavours to resume the provision of services as soon as was practicable. The notification requirement of this set of obligations is amended to advance notification, wherever possible, and a new obligation is added. Pharmacy owners will, going forward, also need to use all reasonable endeavours to implement a business continuity plan. Separately, they are required to have such a plan, and some of the components of business continuity plans are specified. However, the obligation on pharmacy owners, where practicable, to make arrangements with other providers of pharmaceutical or local pharmaceutical services in their area during a temporary suspension is removed (regulations 9(6) to (8) and 13).

In areas of England where people are experiencing or likely to experience significant difficulty in accessing pharmaceutical services, NHS England is given powers to establish local hours plans with community pharmacies that are willing to participate in them. These plans will set out revised opening hours for the participating pharmacies and will temporarily override their normal opening hours. There are arrangements for consultation in some circumstances, and notification in others, of local pharmaceutical committees – and for the revision and duration of the plans (regulation 10).

A small number of changes are made to the application procedure for entry onto a pharmaceutical list, which will apply not just to entry onto the lists of community pharmacies but also to entry onto the separate lists of dispensing appliance contractors. Firstly, once an application has been granted, the applicant has a limited time to send a “notice of commencement” specifying when it will open. Provided a notice has been sent before the end of that window period, the applicant is able to revise its notice of commencement. Going forward, the date specified as the date on which services are to be commenced, either in the notice initially or on revision, must be no more than 60 days after the end of that window period (regulation 8).

Separately, the information to be supplied by the applicant when their application is initially made is revised in three respects. Firstly, the information to be supplied about a key individual’s (usually a director’s or a superintendent’s) professional experience is limited to a work history covering the previous seven years, together with a supporting declaration about related matters. Secondly, in the case of applicants who are already on pharmaceutical lists, provision is made to clarify that the information that needs to be supplied by them about fitness matters is limited to information that NHS England does not already hold but is nevertheless material to the application, and a further amendment is made to make it clear that this includes up to date declarations. Thirdly, if information has been provided before by applicants who are already on pharmaceutical lists but more than seven years previously, this is to be treated as missing information and has to be submitted again (regulations 6 and 7).

An impact assessment in relation to these Regulations is available from the Department of Health and Social Care, 39 Victoria Street, London SW1H 0EU. A copy of it is also published alongside this instrument on www.legislation.gov.uk.