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

CONSULTATION PROPOSALS PART 2

WIDER PHARMACY APPLICATION PROCESSES

1. The proposals 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. These will be routine considerations for all applications.

Public consultation and the community voice

2. Under Paragraph 1 of Schedule 3 to the National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009, the NHS Board must notify the Area Pharmaceutical Committee ('the APC'), the Area Medical Committee ('the AMC'), any person named on the pharmaceutical or provisional pharmaceutical lists whose interests the Board considers the granting of that application may significantly affect and any Board within a 2km boundary of the proposed premises. These are known as 'interested parties'.

3. The Scottish Government acknowledges that there is 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 Practices Committee (PPC) hearings alongside other interested parties.

4. The NHS Board could invite a nominated representative from, for example, the local Community Council or the local Residents Association or another appropriate local community representative body recognised by the NHS Board. The representative would be required to present a balanced viewpoint from the local community.

5. This approach is intended to address concerns that the application process is not transparent or robust enough, and to give sufficient weight to views of the community in the evidence gathering and decision-making process.

6. Once each interested party, including the community representative, has presented their evidence in turn they would then leave the hearing leaving the PPC to consider all the evidence presented.

Proposal 4:

The Scottish Government proposes that the regulatory framework going forward will look to include a community representative among those who should be notified, as an 'interested party or persons', of any application to open a community pharmacy in the locality. The community would therefore be considered in statute as a body or party whose interests may be significantly affected by the pharmacy application.

This would be a nominated representative from, for example, the local Community Council or the local Residents Association or another appropriate local community representative body recognised by the NHS Board.

As an 'interested party' the community representative would be entitled to make written representations about the application to the Board to which the application is made within 30 days of receipt of the Board's notification of the application.

In addition, where the NHS Board PPC decides to hear oral representations, the community representative will be entitled to take part, together with the applicant and the other interested parties, and would be given reasonable notice of the meeting where those oral representations are to be heard. Once each interested party, including the community representative, has presented their evidence in turn they would then leave the hearing leaving the PPC to consider all the evidence presented.

As an 'interested party' the community representative will also have a right of appeal against the decision of the NHS Board PPC to represent the views of the local community.

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7. In the interest of fairness during meetings where the NHS Board PPC decides to take oral representations, in order to achieve a greater balance of those permitted to make representations, the Scottish Government is considering the case that no one single party or person (the applicant or those affected by the application) is able to dominate the entire hearing.

Proposal 5:

The Scottish Government is of the view that in the future PPC hearings should be handled in such a way so that no one person or organisation is able to dominate the entire hearing. This might include options such as limiting the time allocated to give oral representations or the issuing of guidance to PPCs. The Scottish Government thinks that all PPC meetings in future should follow a standard process in the management of PPC Hearings.

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8. The 2009 Regulations set out that the applicant and 'interested parties' making oral representations can be assisted in making representations at the meetings by another person. However, a person who assists cannot appear in a capacity of counsel, solicitor or paid advocate nor can they speak on behalf of the person they are assisting.

9. Going forward the Scottish Government is considering the case for changing this rule so that those assisting can speak on behalf of those they are assisting. This case is strongest for those assisting oral representations on behalf of the community.

Proposal 6:

The Scottish Government proposes that going forward those assisting in oral representations by the applicant, the community and other interested parties in attendance are able to speak on behalf of those they are assisting.

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10. It is also clear that there is a need to look again at the public consultation aspects of the pharmacy application process. 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, and that their views given during the consultation process are not given sufficient weight in the decision-making process.

11. Under the current process, the community is entitled to participate in two consultations, namely, the consultation the applicant requires to complete and the public consultation of the NHS Board. In addition, the PPC is directed to have regard to any consultation responses when considering whether the application meets the test of necessity or desirability.

12. At present a person who wishes to be included in the pharmaceutical list for the provision of pharmaceutical services must make an application to the NHS Board in which the area of the application relates.

13. Within twenty working days prior to making the above application, the applicant must complete a consultation with the communities affected. The aim is to assess whether the neighbourhood to which the application relates has adequate provision of some or all of the pharmaceutical services the applicant intends to provide. Notice of the consultation must be given by being published in a newspaper circulating in the neighbourhood of the application.

14. On receipt of the application the NHS Board must take reasonable steps to consult with the public who may receive pharmaceutical services as a result of the application. This should normally take place over a 60 day period.

15. Going forward the Scottish Government considers the case for placing two requirements on the applicant. The first is that the applicant should enter into a pre-application stage with the NHS Board to determine whether there is in fact an identified unmet need in the provision of pharmaceutical services. This represents a shift away from a largely applicant driven procedure to one where NHS Boards Pharmaceutical Care Services Plans will have a greater role.

16. It would also assist NHS Boards in determining the urgency of the demand for NHS pharmaceutical services identified by the applicant. Therefore, NHS Boards' Pharmaceutical Care Services Plans would need to reflect an assessment of service gaps and where need is most urgent.

17. The Scottish Government considers this to be an important first step towards the aims set out Prescription for Excellence where NHS Board Pharmaceutical Care Services Plans will be the main statutory vehicle through which NHS Scotland plans, provides and delivers pharmaceutical care and medicines to its communities.

18. Secondly, the applicant will also be required to provide evidence that they have taken positive steps to consult with the community in compiling their assessment of need. This means that notice of the consultation must be given by being published in a newspaper circulating in the neighbourhood of the application. The notice must also be advertised in all circulating local news free-sheets and newsletters in the neighbourhood in order to reach the vast majority of residents the applicant intends to provide services to. A similar requirement will be placed on NHS Boards for their consultation exercise.

19. The purpose of this is to actively consult and engage with residents in the neighbourhood in which the applicant intends to provide pharmaceutical services in order to obtain their views.

Proposal 7:

The Scottish Government proposes that going forward those applying to open a pharmacy, for the purpose of providing NHS pharmaceutical services, should first enter into a pre-application stage with the NHS Board to determine whether there is an identified unmet need in the provision of NHS pharmaceutical services.

This would assist NHS Boards in determining the urgency of the demand for NHS pharmaceutical services identified by the applicant. NHS Boards Pharmaceutical Care Services Plans would need to reflect an assessment of service gaps and where need is most urgent.

Where an application proceeds, the applicant must be able to provide evidence to the NHS Board and the affected communities that every effort has been made to publicise the intention to open a community pharmacy and to consult and obtain responses from residents in the associated neighbourhood. Also, the notice must be advertised in a newspaper and all circulating local news free-sheets and newsletters in the neighbourhood in order to reach the vast majority of residents.

NHS Boards will also be required to do the same level of advertising in relation to its consultation activities.

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20. With regard to the public consultation undertaken by the NHS Board, communities have expressed concerns that it is not always clear how, or if, their views have been taken into account and what part they have played in the NHS Board PPC decision.

21. The current 2009 Regulations direct PPCs to have regard to any consultation responses when considering whether the application meets the test of necessity or desirability. They are also required to publish decisions about applications on their websites alongside the reasons for the decision.

Proposal 8:

The Scottish Government proposes that going forward NHS Boards specify to what extent the views of the community have or have not been taken into account in their published decisions on the outcome of a pharmacy application.

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Securing NHS pharmaceutical services

22. The Scottish Government is committed to protecting the rights of patients to receive reliable and sustainable NHS pharmaceutical services. The financial viability of the proposed pharmacy is a key factor in securing those services for the local community concerned.

23. NHS Boards should therefore be able to actively take into account how NHS 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 in the communities they serve.

Proposal 9:

The Scottish Government considers that NHS Boards should be able to take into account how NHS pharmaceutical services would be delivered in practice in the long term after an application has been received. This includes taking into account the financial viability of the pharmacy business proposed. This is an important factor in securing these services in the long term.

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Timeframes for reaching decisions

24. 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 sometimes excessive time and resource involved in the application process.

25. 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 to see the application process through to fruition.

26. The Scottish Government aims to address this by considering the introduction of a statutory timeframe within which PPCs and the NAP are obliged to reach decisions. The Scottish Government considers that there may be a case to require NHS Board PPCs to make a decision within 6 weeks of the end of the public consultation process and the NAP to make a decision within 3 months upon receipt of an appeal (or appeals) being lodged by 'interested parties'.

27. However, a balance would need to be struck to ensure that statutory timescales would not affect the quality of decisions that might lead to additional unnecessary appeals. In more complex cases the timeframe would be made extendable where there is a good cause for delay. This would apply to both PPC and NAP decisions.

Proposal 10:

The Scottish Government proposes that going forward the regulatory framework would require NHS Board PPCs to make a decision within 6 weeks of the end of the public consultation process and the NAP to make a decision within 3 months upon receipt of an appeal (or appeals) being lodged.

In more complex cases the timeframe would be made extendable where there is a good cause for delay.

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Expert advice and support to PPCs during deliberations

28. 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 associated legal tests

29. 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.

30. 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 PPC hearing to consider the evidence in detail and members casts their votes on the merits of the application.

31. In the past 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.

32. The Scottish Government is of the view that NHS Board PPCs should have access to an independent legal assessor to provide technical support and guidance to the PPC regarding due process and adherence to the necessary considerations required to assess the legal tests set out in primary and secondary legislation.

Proposal 11:

The Scottish Government proposes that going forward the regulatory framework would make provisions for the appropriate role of an independent legal assessor acting in a supporting and advisory capacity, including providing advice and guidance on technical and legal aspects of the application process during PPC deliberations.

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