Applications to provide NHS Pharmaceutical Services. A Consultation on the Control of Entry Arrangements and Dispensing GP Practices

Section 2: Consultation Issues

The stability of NHS services in remote, rural and island areas

2.1 The Wilson and Barber Review^[12] described how changes brought about by applications to open a community pharmacy under the current "control of entry" framework have caused significant concerns for some local communities, and have, on occasions, undermined the professional partnership between pharmacists and GPs.

2.2 In recent years the application, or approval, to open a pharmacy where there is an existing dispensing GP practice, has attracted high profile campaigning and lobbying to protect the dispensing GP practice concerned. It is strongly contended by dispensing GP practices and their patients that the income generated from dispensing medicines subsidises staff costs and other services offered by the practice, and the impact of opening a pharmacy would destabilise the viability of the practice and the healthcare hub they provide for their communities. The additional funding for providing a dispensing service within these practices is intended to remunerate for delivery of that service.

2.3 The consultation proposals in Part 1 aim to address this issue by offering a new approach to how NHS Boards consider pharmacy applications in remote, rural and island areas. It describes how existing primary legislation could be used to introduce amended regulations that would designate certain geographical areas as 'controlled remote, rural and island localities' for the purpose of considering new community pharmacy applications.

2.4 This approach involves additional legal tests which would include considering the impact that the opening of a new pharmacy might have on existing NHS services in the neighbourhood of the proposed pharmacy, including those NHS services provided by any dispensing GP practice and its branch surgeries where they exist.

2.5 The proposals in Part 1 also consider the importance of NHS Boards monitoring demographic changes and related changes in healthcare needs in these 'controlled remote, rural and island localities'. This is crucial in terms of ensuring that NHS pharmaceutical and primary medical services are able to respond to changing population and clinical care priorities; that the pharmaceutical care provided is safe, clinically effective, and deliver the best health outcome for patients from the medicines prescribed to them.

The wider pharmacy applications process

2.6 The issues discussed in Part 2 apply to all applications to open a community pharmacy whether in a remote, rural or island area, or in other parts of Scotland.

Public consultation and the community voice

2.7 It is also clear that there is a need to look again at the public consultation aspects of the pharmacy application process more generally. The Scottish Government is aware of concerns in some communities that the application process is not transparent or robust enough, with decisions taken behind closed doors. In addition they feel that their views and representations are not given sufficient weight in the decision-making process.

2.8 There is also a need to consider whether communities through a nominated representative should be given 'interested party' status and be invited to submit written and give oral representations at NHS Board Pharmacy Practice Committee (PPC) hearings alongside other interested parties.

2.9 The proposals in Part 2 of this consultation seek to introduce improvements in the consultation process undertaken by the applicant, and by the NHS Board upon the receipt of a pharmacy application. They also aim to give greater weight to community involvement and public engagement in the overall applications process including giving rights to members of the community or their representatives to make representations to the PPC. The proposals also aim to provide a greater balance of those permitted to make representations at PPC hearings so that no single party or person (the applicant or those affected by the application) is able to dominate the entire hearing.

2.10 The proposals in Part 2 also seek to place a greater responsibility on the applicant and the NHS Board to demonstrate the extent to which the views of the local community have been taken into account. This is particularly important when an NHS Board publishes its decision on the outcome of pharmacy applications.

2.11 Looking to future arrangements in relation to the planning of NHS pharmaceutical services, the proposals also consider a first stage in the application process whereby the prospective applicant should enter into a pre-application stage with the NHS Board. This is to help determine whether there is an identified unmet need in the provision of NHS pharmaceutical services. This new approach will introduce a shift in emphasis away from a largely applicant driven procedure to one where NHS Boards' Pharmaceutical Care Services Plans will have a greater role.

Securing NHS pharmaceutical services

2.12 We also want to ensure the rights of patients to receive reliable and sustainable NHS pharmaceutical services into the future. NHS Boards should be able to take into account how pharmaceutical services would be delivered in practice in the long term after an application has been received. This is central to NHS Boards ability to secure NHS services for the communities they serve.

Timeframes for reaching decisions

2.13 There has also been a growing case to look at timeframes for PPCs and the National Appeal Panel (NAP) to reach decisions. Applicants, NHS Boards and interested parties alike have expressed concerns about the perceived excessive time and resource involved in the application process. This includes, for example, from the time it takes from the application being submitted to the PPC hearing and decision, through to decisions of the NAP where appeals have been lodged and referred back to Boards for further action.

2.14 The length of the overall process can sometimes be a source of great anxiety for the community and the applicant, as well as costly in terms of the resource invested.

2.15 The proposals in Part 2 seek to address this by considering the introduction of a statutory timeframe within which PPCs and the NAP are obliged to reach decisions. It is recognised, however, that a balance needs to be struck to ensure that shorter timescales do not affect the quality of decisions that might lead to additional unnecessary appeals.

Expert advice and support to PPCs during deliberations

2.16 The constitution of the PPC largely consists of lay members and members who are generally not expert in the legal framework governing pharmacy applications and the associated legal tests. This is compounded by the infrequent need to convene a PPC in most NHS Board areas, and the turnover and availability of those willing and prepared to serve as members.

2.17 NHS Boards and their PPC Chairs have become concerned that this causes practical difficulties in how the PPC carries out its responsibilities when it withdraws from the open hearing to consider the evidence in detail and members casts their votes on the merits of the application.

2.18 In the past such expert advice and support has been provided by NHS Board officers, but there is a view that such advice and assistance to PPC members in the course of their private deliberations could amount to actual or perceived bias in the decision-making of the PPC. NHS Boards are trying alternative approaches to dealing with this issue, but are concerned that they have added to the overall timescales for PPCs in reaching a decision and can bring about additional costs and pressure on resources.

2.19 The proposal in Part 2 looks to bring about a more practical solution for NHS Boards in the form of a supporting independent legal assessor.