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

4. PART TWO: WIDER PHARMACY APPLICATION PROCESSES

Background

4.1 The proposals covered in Part Two of the consultation relate to all applications to open a community pharmacy, whether in remote, rural or island areas, or in other parts of Scotland.

Public consultation and the community voice

4.2 At present the NHS Board must notify the Area Pharmaceutical Committee (APC), the Area Medical Committee (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".

4.3 Concern has been expressed that the application process is not transparent or robust enough, and does not give sufficient weight to views of the community in the evidence-gathering and decision-making process.

4.4 Proposal 4 is intended to address this concern.

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.

4.5 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

4.6 80 respondents provided views on Proposal 4. Table 4.1 provides their responses to the closed aspect of the question. A majority (61%) of those who provided a view agreed with Proposal 4, with a significant minority (39%) disagreeing.

Table 4.1 Level of agreement with Proposal 4

Category	Agree			Disagree		Total
	No. of respondents	%		No. of respondents	%	No. of respondents
Individuals	22		65	12	35	34
NHS Board committees	7		58	5	42	12
NHS Boards	6		60	4	40	10
Representative or professional bodies	4		57	3	43	7
Pharmacy contractors	-		-	7	100	7
GP practices	3		100	-	-	3
MSP/MP	1		100	-	-	1
Community Councils	2		100	-	-	2
NHS support organisations	2		100	-	-	2
Other	2		100	-	-	2
Total	49		61	31	39	80

Views in support of the proposal

4.7 A few broad reasons were provided, largely by individuals, in favour of the proposal. It was seen as enabling the voice of communities to be heard, promoting democracy, transparency and autonomy, and appeared to be reasonable, fair and logical. One respondent (MSP/MP) remarked that the proposal offered a way to counteract a current weakness in that at present the community has no means to make further representation after the public consultation closes.

View opposing the proposal

4.8 A common view amongst those opposing the proposal was that there is no need to include a community representative among those who should be notified as an "interested party". They argued that under existing regulations there are already many ways for communities to provide their views. For example, one individual respondent remarked:

"It is unnecessary because the existing regulations were developed with Public Consultation in mind and contain a raft of processes that ensure that any application for a new pharmacy will have been given ample opportunity to gather in a broad and balanced representation of the views of the local community in the form of letters, surveys, public meetings, communities groups viewpoints etc. These representations are drawn together and presented to the decision-making body to enable them to take a broad and balanced view of the wishes of the community" (Individual).

4.9 Another recurring view from respondents across a wide range of respondent categories was that a representative of the community is likely to lack the knowledge and expertise necessary for those involved in representations relating to applications. In particular, the intricacies associated with the "legal test" were considered to be potentially challenging. It was considered that any lack of understanding could contribute to a lack of balance in representation which could undermine the hearing process. One respondent commented:

"Pharmaceutical applications processes are complex and if the community representative is unaware of the procedures then there may be significant disruption at hearings" (Pharm).

4.10 Several respondents recommended that community representatives who are notified as "interested parties" will require comprehensive briefing on all aspects of the application.

4.11 Four respondents from three different categories raised concerns over how the involvement of a community representative would impact on other members of the panel, particularly other lay people. It was predicted that community representatives, rather than providing a "balanced" view, would be largely in favour of the applicant, which may put undue pressure on other panel members.

4.12 Six respondents across four categories considered that the proposal did not make clear precisely how representations from community representatives would be taken into account, for example, what weight would be attached to them in relation to other representations?

4.13 Two respondents argued that the "lay man" should not be able to influence healthcare decisions (Pharm) or commercial decisions (Ind).

4.14 Two respondents (Pharm, HB) cautioned that the community representative could potentially be subject to lobbying from other "interested parties".

4.15 Two individual respondents urged that hearings are made accessible to community representatives, keeping inconvenience to them to a minimum.

Views on representing the local community

4.16 Many respondents questioned how community views could firstly be harnessed, then subsequently represented in a balanced fashion. There was general agreement from across a wide range of categories that community representatives should be impartial, and present views of the wider community, based on evidence rather than emotion.

4.17 The main problem envisaged by respondents across a wide range of categories was putting this ideal into practice where communities are diverse, with different factions and representative bodies holding their own, possibly conflicting views. Some respondents commented that there may be diverging views even within different groups.

4.18 Five respondents, including three NHS Boards, recommended that a system be established for systematic identification of an appropriate person to represent the community. Two NHS Board committees argued that NHS Boards should not be permitted to nominate a person, in order to avoid any perception of bias in their choice.

4.19 Seven respondents considered that community councils were obvious choices as representatives of communities. In contrast, one NHS Board cautioned that neighbourhoods may have more than one community council and therefore they would not make good representatives. Seven further respondents argued for local elected members of local authorities to be selected as community representatives. The view of three respondents (two NHS Boards and one NHS support organisation) was for representatives to be drawn from Public Partnership Forums.

4.20 One individual respondent questioned the meaning of a "balanced" viewpoint, and how this would be judged.

4.21 A common view (ten respondents across a range of categories) was that although the proposal implies that a community representative will have themselves undertaken consultation across the local community in order to represent its views, it does not specify how this should be done. Some called for an appropriate mechanism to be articulated or guidance provided, and supported with funding.

Views on the proposal for a right of appeal for the community representative

4.22 Whilst two respondents (GP, HB) welcomed this proposal, six others disagreed. The most common view was that in virtually all cases the right of appeal is restricted to errors in the legal process, which opponents perceived to be outwith the scope of community consideration. One respondent (Rep/Prof) remarked that should a decision be appealed by a community representative, the legality of their appealing a decision in which they played a part as an interested party originally, could be questioned.

Handling of NHS Board PPC hearings

4.23 In the interests 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.

4.24 Proposal 5 is intended to address this concern.

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.

4.25 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

4.26 81 respondents provided views on Proposal 5. Table 4.2 overleaf provides their responses to the closed aspect of the question. Almost three-quarters (72%) of those who provided a view agreed with Proposal 5, with just over one-quarter (26%) disagreeing. Two respondents agreed with aspects of the proposal and disagreed with others.

4.27 Broad reasons for supporting the proposal were provided by 19 respondents, largely individuals. It was perceived to promote fairness and good practice, ensuring that the voices of powerful national companies and/or vocal individuals are able to be balanced by others.

Table 4.2 Level of agreement with Proposal 5

Category	Agree		Disagree		Partially agree		Total
	No. of respondents	%	No. of respondents	%	No. of respondents	%	No. of respondents
Individuals	28	82	5	15	1	3	34
NHS Board committees	9	69	4	31	-	-	13
NHS Boards	7	70	3	30	-	-	10
Representative or professional bodies	3	38	4	50	1	12	8
Pharmacy contractors	2	29	5	71	-	-	7
GP practices	3	100	-	-	-	-	3
MSP/MP	1	100	-	-	-	-	1
Community Councils	2	100	-	-	-	-	2
NHS support organisations	1	100	-	-	-	-	1
Other	2	100	-	-	-	-	2
Total	58	72	21	26	2	2	81

Views on limiting the time allowed to give oral representations

4.28 This aspect of the proposal received the most attention from respondents. Whilst four respondents, all from different categories, gave the proposal broad support, for the sake of expediency, others were more cautious.

4.29 A dominant theme across many different categories was concern that restricting time for contributions could result in unfairness if a party is unable to present their full case, which in turn could lead to appeals. Typical comments included:

"Past decisions have been appealed on the basis of a party not receiving a full and fair hearing, for example where they have been limited in time" (HB).

"In many cases the interested parties provide a wealth of information to the PPC in order to ensure they have all the relevant facts to make a fair a correct decision. Limiting time could create a situation where vital information is not presented. The presentations at each hearing will vary widely, this is in part due to the fact that the evidence for each application will also, to a great extent, be varied. Therefore if a time limitation were to be imposed, this could in turn impinge on a true representation of the evidence. I understand that there may be cases where one interested party takes more time than others at a hearing. However this is often the nature of deliberations with two opposing viewpoints and it can be the case that the dominant viewpoint inherently has more evidence to present/discuss.

This process has a significant impact on the livelihoods of those involved and as such should be taken seriously and given as much time as is required. I believe it is the responsibility of each interested party to present as much information as possible to ensure their view is fairly considered. Any time limit imposed could result in a misrepresentation and ultimately an unjust decision" (Individual).

4.30 Others considered the imposition of time limits to be "artificial" and not a mechanism used in other fields.

4.31 26 respondents from a wide range of categories argued that an effective Chair could negate the need for the imposition of time limits. Comments included:

"We believe, rather than needing to be prescriptive with process, a strong Chair should be able to run the hearing as they see fit and avoid inappropriate amounts of time being taken by any party" (Rep/Prof).

"Any experienced and competent PPC chair should be able to ensure that all sides have a fair and proportionate time to present their arguments and that time is not wasted on unnecessary discussions" (Pharm).

4.32 Several respondents recommended that structured, national training be provided for Chairs.

4.33 Three respondents (HB, HBC, Pharm) advocated applicants being allocated relatively more time than others to speak at hearings, in order to establish the merits of the application and also have time to rebut arguments against this. One individual respondent recommended that each party be given equal time.

4.34 One individual suggested that only one interested party be nominated to speak against the applicant, with the others permitted to provide written evidence only.

4.35 Four respondents (two NHS Boards and two pharmacy contractors) considered that time could be saved at hearings by better pre-planning and time management. For example, written statements could be requested several weeks before the hearing and circulated to all relevant parties for briefing prior to meeting.

Views on issuing guidance

4.36 The proposal to issue guidance to PPCs was generally welcomed although a few respondents urged that this should avoid being overly prescriptive. Six respondents from five different respondent categories recommended that guidance is drawn up in conjunction with interested parties: British Medical Association; Dispensing Doctors' Association; Community Pharmacy Scotland and patients' associations.

4.37 Eight respondents commented that guidelines already exist.

Views on standardising processes

4.38 15 respondents from a range of categories provided explicit support for the proposal that all PPC meetings in future follow a standard process in the management of PPC hearings.

4.39 Advantages of a standard process were identified as enabling all to know what to expect, achieving consistency, and reducing the risk of judicial reviews. One individual respondent stated that they could not comment as they were unaware of what formats were currently in operation.

4.40 One NHS Board suggested that the Scottish Government consider developing standardised information packs to support all those attending PPCs.

Other comments

4.41 Three respondents (two individuals and one representative or professional body) called for GP practices to be able to represent themselves at PPCs.

4.42 Two individuals criticised PPC hearings for being held behind closed doors.

Assisting those making representations at oral hearings

4.43 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.

4.44 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.

4.45 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

4.46 79 respondents provided views on Proposal 6. Table 4.3 provides their responses to the closed aspect of the question. Around two-thirds (68%) of those who provided a view agreed with Proposal 6, with around one-third (32%) disagreeing. Pharmacy contractors were those most likely to disagree with the proposal, with five of the seven who provided a view opposing it.

Table 4.3: Level of agreement with Proposal 6

Category	Agree			Disagree		Total
	No. of respondents	%		No. of respondents	%	No. of respondents
Individuals	27		82	6	18	33
NHS Board committees	9		69	4	31	13
NHS Boards	7		70	3	30	10
Representative or professional bodies	3		43	4	57	7
Pharmacy contractors	2		29	5	71	7
GP practices	3		100	-	-	3
MSP/MP	1		100	-	-	1
Community Councils	1		50	1	50	2
NHS support organisations	-		-	1	100	1
Other	1		50	1	50	2
Total	54		68	25	32	79

Views in support of the proposal

4.47 Four main reasons to support the proposal emerged. Most frequently mentioned (by 12 respondents from a range of categories) was that the current system creates a barrier to effective communication, and the proposal would enable views to be presented more knowledgably and directly, rather than through a third person. Linked to this was the argument (put forward by eight respondents from five different categories) that the proposal would lead to more constructive, better quality debate which was in the interests of democracy. A further eight respondents from five categories considered that proceedings would be smoother and would speed up if the proposal was implemented. Finally, five respondents from three categories provided their view that the current system is flawed and at times farcical and embarrassing, and needs to be replaced.

4.48 A view from one respondent (MSP/MP) was that the proposal would enable wider participation in the hearing process. A pharmacy contractor commented that this would bring Scottish legislation in line with that operating elsewhere in Britain.

4.49 Despite supporting the proposal, many respondents qualified their view:

• The assistant who speaks should be limited to answering questions, rather than assisting in the presentation of the case.
• There needs to be a framework which defines the new process clearly, and outlines clearly the respective roles of principal and assisting representative.
• Only one nominated representative should be permitted to speak.
• The speaker should conform to normal standards of meeting etiquette.

Views against the proposal

4.50 The most frequent argument put forward against the proposal was that it would result in the proceedings slowing down. Seven respondents from a range of categories shared this view, with one remarking:

"This will elongate what can already be a lengthy and drawn out process. Two points of view for each interested party will dilute oral representations" (Ind).

4.51 One respondent argued that allowing more than one person to speak would complicate matters (Pharm).

4.52 Another dominant view (six respondents from a range of categories) was that the proposal would risk "professionalising" the process by involving legal representatives. One commented:

".....professionalisation of PPC proceedings may be at odds with a commitment to hearing the community voice. There is the potential for a local community council to be speaking on behalf of their community against a professional legal or pharmaceutically trained advisor to an applicant. This approach takes the PPC proceedings further down the quasi legal road rather than placing it within NHS Board planning arrangements as it should be" (NHS Board).

4.53 Two respondents (CC, HBC) argued that the proposal could create bias by adding extra weight to particular arguments over others. Another (Support) agreed that disadvantage could be introduced if one party did not have this assistance and another did.

4.54 One view (HBC) was that it is important that an applicant presents their own case, from their own perspective, and not through someone else.

4.55 Three respondents (two individuals and one representative or professional body) considered that the current system works and there is no need to change it.

Views on legal representation

4.56 Whilst two individual respondents emphasised their view that it is essential for local communities to have legal representation at PPC hearings, in order to stand up to experienced professional parties, 12 respondents (six being NHS Boards) presented the opposite case. Their view was that no party should have the advantage which legal representation will offer.

Public consultation and pre-application stage

4.57 The Scottish Government wishes to look again at the public consultation aspects of the pharmacy application process. It 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 provided during the consultation process are not given sufficient weight in the decision-making process.

Proposal 7

The Scottish Government proposes that going forward those applying to open a pharmacy, for the purposes 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.

4.58 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

4.59 82 respondents provided views on Proposal 7. Table 4.4 provides their responses to the closed aspect of the question. A majority (61%) of respondents who provided a view supported the proposal, with a significant minority (39%) against. Individual respondents were amongst those most likely to favour the proposal. Most NHS Board committees, NHS Boards, representative or professional bodies and pharmacy contractors opposed it.

Table 4.4: Level of agreement with Proposal 7

Category	Agree			Disagree		Total
	No. of respondents	%		No. of respondents	%	No. of respondents
Individuals	27		79	7	21	34
NHS Board committees	4		33	8	67	12
NHS Boards	4		40	6	60	10
Representative or professional bodies	3		38	5	62	8
Pharmacy contractors	1		14	6	86	7
GP practices	3		100	-	-	3
MSP/MP	2		100	-	-	2
Community Councils	2		100	-	-	2
NHS support organisations	2		100	-	-	2
Other	2		100	-	-	2
Total	50		61	32	39	82

4.60 A few of those in favour of the proposal commented broadly that the proposal would help to reduce unnecessary and frivolous applications in their area; would provide a more cohesive approach than at present; and would be more transparent in process.

Pre-application stage

4.61 Many respondents criticised the proposal to introduce a pre-application stage. NHS Boards and NHS Board committees in particular expressed much concern that involving NHS Board staff in this stage could be perceived as introducing bias into proceedings, with applications proceeding past this stage viewed as having been endorsed by NHS Boards.

4.62 A recurring view amongst respondents from different categories was that considering applications should be the prerogative of PPCs only, with access to full information from all interested parties. Involvement of NHS Boards at a pre-application stage was seen as potentially undermining the independence of the PPC.

4.63 Three individuals expressed concern that NHS Boards may not have a detailed understanding of local, neighbourhood need. Two respondents (HB, Ind) recommended that the role of NHS Boards at pre-application stage be very clearly defined in order to prevent overreach.

4.64 Nine respondents from a range of categories argued that dispensing GPs should also be involved in the pre-application stage. Two respondents (Support, Ind) called for the involvement of the community in the pre-application deliberations. One NHS Board committee considered that the APC should be party to the process. Three NHS Board committees commented that in the interests of fairness, all interested parties should have the same opportunity as applicants, but clearly this would be unworkable.

4.65 Three respondents perceived the proposal to introduce a pre-application stage as simply adding another layer of bureaucracy and possibly confusion.

4.66 Eight respondents from a range of categories suggested that there is no need for the applicant to enter into pre-application discussions, if they are given access to the PCSP.

4.67 Six respondents sought clarification over whether NHS Boards could act as gatekeepers at the pre-application stage, and block an application from going further. This was not supported, with one pharmacy contractor suggesting this could be viewed as anti-competitive.

4.68 A few respondents envisaged this stage to be informal and potentially very useful. One NHS Board in particular commented that they already entered into such pre-application discussions and provided un-biased support for applicants.

Views on the role of the PCSP

4.69 Many respondents commented on the proposed use of the PCSP by NHS Boards when determining the urgency of the demand for NHS pharmaceutical services identified by the applicant and whether there are service gaps.

4.70 Overall, many of those who commented, from a range of categories, foresaw potential benefits of using the PCSP as a tool for assessment of applications, but not in its current form. A recurring view was that plans would need to be more robust, open to scrutiny and fit for purpose, before being deployed by those considering applications. One individual respondent remarked:

"The pharmaceutical care plans that have been developed by the Boards to date have been woefully inadequate and could in no way help to determine if an application should go ahead. Furthermore, this represents a way for Boards to slow down applications and reject them out of hand without taking a robust and transparent approach to them" (Individual).

4.71 One NHS Board committee queried how PCSPs could be used in this way, perceiving the focus of the plan to be geographically wide and strategic, contrasting with the local neighbourhood focus of applications.

4.72 Four NHS Boards welcomed the use of PCSPs at the pre-application stage, perceiving these to be part of a shift in culture from reacting to applications to proactively planning services. A recurring comment, however, was that introducing a greater role for PCSPs, is not compatible with the current control of entry process.

Views on the proposals for consulting with communities

4.73 A dominant view to emerge across several respondent categories was that rather than both NHS Boards and applicants undertaking separate consultations with communities, only one should be conducted, by NHS Boards, with the outcome shared with the applicant and paid for by the applicant. This was seen as streamlining the consultation process, promoting greater community response, and ensuring transparency and quality of process. A few respondents suggested that should the application be successful, the consultation costs would be refunded to the applicant.

4.74 One key concern over the proposals regarding consultations undertaken by applicants is that they will need to define "neighbourhood" prior to the PPC's designation of this area. Three respondents emphasised their view that NHS Board consultations should be confined to those residing within the "neighbourhood".

4.75 Three NHS Boards argued that the proposal brought no added benefit as consultations are already conducted and that normal processes of consultation should continue.

Views on the proposal for advertising the application

4.76 The proposal that both applicants and NHS Boards advertise in a newspaper and all circulating local news free-sheets and newsletters in the neighbourhood received a cautious welcome with many respondents identifying a number of practical challenges to overcome.

4.77 In general, those who provided a view recommended that flexibility is permitted for advertising in media tailored to local contexts. For example, on some Scottish islands, local radio is widely listened to, and local newspapers an important way of providing information. Two NHS Board committees commented that in the absence of central registers of all free- sheets and newsletters in an area, it would be difficult to ascertain if adverts had been placed in all of them. Three respondents (Rep/Prof, HBC, Pharm) agreed that if regulations on advertising are too prescriptive this risked appeals on the grounds that comprehensive advertising had not been achieved.

4.78 Six respondents recommended that social media such as Facebook and Twitter, and other ways of advertising be considered.

4.79 Several respondents expressed concern over the potential costs of widescale advertising for both NHS Boards and the applicant. Three respondents (HB, HBC, Pharm) warned that such costs may discourage small, independent pharmacies from applying. One pharmacy contractor suggested that all advertising is undertaken by NHS Boards, with the applicant funding this. Another remarked that running two separate sets of adverts risked communities responding to one and not the other.

Specifying the extent to which community views have been taken into account

4.80 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.

4.81 The Pharmaceutical Services Regulations direct PPCs to have regard to any consultation responses when considering whether the application meets the tests of necessity or desirability. They are also required to publish decisions about applications on their websites alongside the reasons for the decisions.

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 outcomes of a pharmacy application.

4.82 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

4.83 78 respondents provided views on Proposal 8. Table 4.5 overleaf provides their responses to the closed aspect of the question. A majority (85%) of those providing a view stated that they agreed with the proposal. Amongst the different respondent categories, pharmacy contractors were more divided than others in opinion, with four agreeing and three disagreeing with the proposal.

4.84 It emerged from responses that some individual respondents agreed to the proposal as they perceived it to mean that more account would be taken of community views than at present, rather than NHS Boards specifying to what extent the views had been taken into account.

Table 4.5: Level of agreement with Proposal 8

Category	Agree		Disagree		Neither agree nor disagree		Total
	No. of respondents	%	No. of respondents	%	No. of respondents	%	No. of respondents
Individuals	28	90	3	10	-	-	31
NHS Board committees	11	85	2	15	-	-	13
NHS Boards	7	70	2	20	1	10	10
Representative or professional bodies	5	83	1	17	-	-	6
Pharmacy contractors	4	57	3	43	-	-	7
GP practices	3	100	-	-	-	-	3
MSP/MP	2	100	-	-	-	-	2
Community Councils	2	100	-	-	-	-	2
NHS support organisations	2	100	-	-	-	-	2
Other	2	100	-	-	-	-	2
Total	66	85	11	14	1	1	78

4.85 Ten respondents (largely NHS Boards and individuals) remarked that the extent to which community views have or have not been taken into account is already published, for example, in the minutes of PPC meetings. Five respondents from four different categories recommended national guidelines providing clear criteria for assessing public response and the weight to be applied to it, in order to ensure consistency of reporting across Scotland. One respondent (Rep/Prof) advocated training for the Chair and PPC committee in how to incorporate public consultation results into their decision-making.

4.86 Three reasons to support the proposal were put forward repeatedly:

• promotes transparency and openness (21 mentions)
• is more accountable to communities, particularly where the decision goes against the view expressed by the community (5 mentions)
• promotes public understanding and confidence in the decision-making process (5 mentions). One respondent commented:

"At present it is felt that the PPC minutes give a true, honest and fair reflection of the proceedings. If by providing more information to the public is helpful to them understanding the decision made by the PPC we would fully support this. This should be applicable to evidence presented by both the applicant and interested parties" (HBC).

4.87 Ten respondents from a range of categories highlighted what they perceived to be the importance of establishing a right of appeal for communities, if information on the extent to which their views have been taken into account is published.

4.88 A recurring view amongst 11 respondents (six of them NHS Boards or NHS Board committees) was that the proposal should not result in additional weight given to community views over those of any other party, or affect the primacy of the legal test in assessing applications. Comments included:

"It is vital however that the measure by which the application is judged is the legal test of adequacy, and whether it is necessary or desirable to grant the application to gain an adequate service. Members of the general public should be made aware that although the PPC must recognise the views of the public the legal test is the critical factor in assessing pharmacy applications" (Rep/Prof).

"It is important that the views of the community are considered in PPC discussions. However, views of the community are not part of the adequacy or prejudice test to a greater or lesser extent than any other interested party. So while supportive of published decisions include narrative explaining the outcome of a pharmacy application, and in particular to respond to the views put forward of all interested parties not just the community, ..........(we) do not support a requirement where the community view is held above all other views, either in decision making or in recording deliberations" (HB).

4.89 Three individual respondents and one pharmacy contractor considered that the proposal added no value. Assessing the extent to which views are taken into account was seen as difficult to quantify and a "grey area".

Securing NHS pharmaceutical services

4.90 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.

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.

4.91 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

4.92 78 respondents provided views on Proposal 9. Table 4.6 provides their responses to the closed aspect of the question. Around three-quarters (72%) of those responding agreed with the proposal. However, most NHS Board committees, representative or professional bodies and pharmacy contractors disagreed with the proposal.

Table 4.6: Level of agreement with Proposal 9

Category	Agree			Disagree		Total
	No. of respondents	%		No. of respondents	%	No. of respondents
Individuals	28		88	4	12	32
NHS Board committees	6		46	7	54	13
NHS Boards	8		80	2	20	10
Representative or professional bodies	3		43	4	57	7
Pharmacy contractors	2		29	5	71	7
GP practices	3		100	-	-	3
MSP/MP	1		100	-	-	1
Community Councils	2		100	-	-	2
NHS support organisations	1		100	-	-	1
Other	2		100	-	-	2
Total	56		72	22	28	78

Views in favour of the proposal

4.93 Amongst the supporters of the proposal were many respondents from a range of categories (although largely individuals) who considered that such consideration would help to protect the rights of patients to receive sustainable NHS pharmaceutical services. One NHS Board committee suggested that knowing that their financial viability will be examined will put off potential speculative applicants.

4.94 Many respondents recommended that in addition to examining the financial viability of the pharmacy business proposed, NHS Boards should also take into consideration their likely impact on the viability of local businesses.

Concerns about the proposal

4.95 Many concerns were raised over the legitimacy, usefulness and efficacy of the proposal. These are listed below in order of number of times the concern was raised by respondents:

• NHS Boards do not have the expertise to assess financial viability of applicants. This is an extremely complex area (22 mentions). One pharmacy contractor commented:

"We question what capacity there is at Health Boards to be able to undertake an assessment of financial viability. Many NHS employees will be unaware of the complexities of financing and running a commercial business and therefore we do not believe that the Health Board will be properly resourced to undertake this activity" (Pharm).

• NHS Boards will not have the full financial information needed on which to base decisions on viability. For example, they would not have information on non-NHS contract business, nor the applicant's business plan (although two respondents (HB, Ind) recommended that applicants are required to submit this) (12 mentions).
• No other primary care contractor's business is subject to such scrutiny and if the proposal is implemented, the financial viability of existing providers should also be assessed (8 mentions).
• There are no criteria on which to base a financial viability assessment. What would this involve? How would "long term" be assessed? Would this be based on the wider business chain viability or the individual contractor finances? It was noted that large chains may choose to open speculatively even if the individual pharmacy is unlikely to be profitable initially (8 mentions).
• The proposal is redundant as viability is already encompassed by the requirement that services are "secured" (8 mentions). A few respondents, however, considered that it may be useful to make clear in regulations precisely what this entailed.
• A company's financial information is commercially sensitive and they may not wish to hand it over (5 mentions).
• Any financial risk is assessed by the business prior to application and is a business matter, not one for the NHS Board (4 mentions).
• Rather than focusing on potential viability, a more effective way of protecting services is to enforce the contractual obligations, such as agreed opening hours, post contract, (4 mentions).
• If the proposal is implemented, and a contract awarded to a pharmacy which then fails, this will undermine NHS Board decisions (3 mentions).
• It is not possible to see into the future as many factors can affect viability over short time periods (3 mentions).
• Introducing a financial viability assessment will provide new grounds for appeals (2 mentions).

Timeframes for reaching decisions

4.96 Applicants, NHS Boards and interested parties alike have expressed concerns about the sometimes excessive time and resource involved in the application process. 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 through to fruition.

Proposal 10

The Scottish Government proposes that going forward the regulatory framework would require NHS Board PPCs to make a decision within six weeks of the end of the public consultation process and the NAP to make a decision within three 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.

4.97 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

4.98 81 respondents provided views on Proposal 10. Table 4.7 overleaf provides their responses to the closed aspect of the question. A majority (89%) of respondents agreed with the proposal. The only significant opposition came from individuals, five of whom disagreed, and one of whom provided only partial agreement.

4.99 The concept of introducing timeframes was generally welcomed as being sensible, helping to reduce uncertainty, providing an incentive to NHS Boards to deal with applications promptly, and contributing to fairness. One individual respondent remarked:

"Timely decisions are as important as transparent ones."

4.100 Six respondents recommended that a further time limit is imposed for reconsidering applications which have been returned to PPCs from the NAP.

4.101 NHS Boards expressed more caution than others over the timeframe for the PPC decision, some describing the proposed six week period as "challenging". One individual recommended that the PPC decision timeframe be extended to eight weeks. One NHS Board suggested that on islands, where there are logistical problems to contend with to bring PPC members together, the timeframe should be longer than on mainland areas. A few NHS Boards felt that further trained PPC members would be required in order to enable them to adhere to this timescale. One respondent (Rep/Prof) recommended reviewing timescales once the system has been embedded. Two respondents (Pharm, Ind) emphasised that the introduction of timescales should not compromise the quality of hearings.

Table 4.7: Level of agreement with Proposal 10

Category	Agree		Disagree		Partially agree		Total
	No. of respondents	%	No. of respondents	%	No. of respondents	%	No. of respondents
Individuals	29	83	5	14	1	3	35
NHS Board committees	12	92	1	8	-	-	13
NHS Boards	9	90	1	10	-	-	10
Representative or professional bodies	8	100	-	-	-	-	8
Pharmacy contractors	6	86	1	14	-	-	7
GP practices	3	100	-	-	-	-	3
MSP/MP	1	100	-	-	-	-	1
Community Councils	1	100	-	-	-	-	1
NHS support organisations	1	100	-	-	-	-	1
Other	2	100	-	-	-	-	2
Total	72	89	8	10	1	1	81

4.102 Three respondents (two individuals and one GP) perceived the proposed timeframe to be too long. Five respondents from three different categories argued that the timeframe for the NAP decision is too long. They envisaged this being restricted to between one month and six weeks, in order to be compatible with the timeframe for the PPC decision.

4.103 A dominant theme was that flexibility should be built in for unforeseen circumstances which could impact on timings. However, one individual respondent recommended that no exceptions are made; another advocated timings being decided on a case-by-case basis.

4.104 Requests were made by respondents from many different categories, for clear definitions of "good cause" for delay; and "complex cases". Several emphasised that cases may not be "complex" but may still demand longer timeframes for example: those taking place over summer/holiday periods when PPC members may not be readily available; extremely adverse weather may result in hearings being cancelled; PPCs may receive multiple applications at one time and require more time in order not to compromise due consideration.

4.105 One pharmacy contractor sought clarity on the length of permitted extensions. Three respondents recommended that any extensions to timeframes be notified to all interested parties promptly.

Expert advice and support to PPCs during deliberations

4.106 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.

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.

4.107 The consultation asked respondents whether or not they agreed with this proposal and to give their reasons.

4.108 77 respondents provided views on Proposal 11. Table 4.8 overleaf provides their responses to the closed aspect of the question. A majority (79%) of respondents agreed with giving NHS Board PPCs access to an independent legal assessor as set out in the proposal. NHS Boards and NHS Board committees were more divided in view than other categories of respondent.

4.109 It was generally agreed amongst those supporting the proposal that involving an independent legal assessor in a supporting and advisory capacity would lead to better decision-making in an area of increasingly complex law. A few respondents remarked that this would improve consistency between different NHS Boards.

4.110 12 respondents from a range of categories envisaged that such expert help in PPCs would result in a reduction in appeals. Others considered that processes would be speeded up due to fewer adjournments and the removal of the need to contact NHS Central Legal Office (CLO). One indirect benefit was identified as aiding the training of PPC members (HB).

4.111 19 respondents (largely NHS Boards and NHS Board committees) expressed concern over how much the proposal would cost to operate and who would fund it.

Table 4.8: Level of agreement with Proposal 11

Category	Agree			Disagree		Total
	No. of respondents	%		No. of respondents	%	No. of respondents
Individuals	27		82	6	18	33
NHS Board committees	7		64	4	36	11
NHS Boards	6		60	4	40	10
Representative or professional bodies	7		88	1	12	8
Pharmacy contractors	7		100	-	-	7
GP practices	3		100	-	-	3
MSP/MP	1		100	-	-	1
Community Councils	-		-	1	100	1
NHS support organisations	1		100	-	-	1
Other	2		100	-	-	2
Total	61		79	16	21	77

4.112 Another recurring concern was over the ready availability of such assessors. Six respondents (four of them NHS Boards) considered that a sufficient pool of assessors would be required to accommodate demands of different NHS Boards without causing delays in setting hearings. The challenges which the proposal may create for islands was raised (HB).

4.113 One NHS Board committee raised the possibility of CLO advice conflicting with that provided by the independent legal assessor.

4.114 Calls were made for the role and responsibilities of the assessor to be clearly defined, perhaps in national guidance (HBC, HB). Three respondents (CC, Oth, Ind) suggested that the person take on the role of Chair of the PPC.

4.115 It was considered that the proposal be further enhanced by the provision of central administrative support for taking minutes, given the importance of the decisions being documented (HBC, Ind).

4.116 One respondent (Pharm) requested that a quality assurance review date be set to assess whether the proposal is providing value for money.

Suggestions for alternative arrangements

4.117 Six respondents considered there to be a role for NHS Board members to attend PPC hearings (either with the independent legal assessor or instead of). One remarked:

"Board officials have successfully undertaken this function for many years and provided that they are not present during the private deliberations of the PPC then we would propose that this continues. These officials have built up knowledge and experience over a number of years and the independent legal assessor would not necessarily have a better understanding of the Regulations" (HBC).

4.118 Five respondents (including three representative or professional bodies) argued for regular, national training to improve the expertise of PPC members.

4.119 Other suggestions for alternatives to the proposal were:

• Simply have a legally qualified person as Chair (Ind).
• Deploy NHS Board officials from other NHS Boards to remove any perception of bias (HB).
• Continue to refer to CLO when advice is required (HBC).
• Make the legislation less complex so that there is no need for additional legal advice (several respondents alluded to this in their responses).
• Move from this reactive model to a proactive approach based on the PCSP, which would remove the need for the entire Control of Entry process (HB).

OVERVIEW

4.120 Overall, respondents supported establishing a meaningful role for local communities in decision-making regarding applications for new community pharmacies. However, many acknowledged the difficulties in identifying appropriate community representatives, given the diversity of local communities and different needs within them. Respondents provided ideas for streamlining consultation processes, reducing duplication of effort and promoting higher quality of input and higher response rates.

4.121 Mixed views emerged on another proposal aimed at facilitating more efficient application processes. Whilst a slight majority of the respondents who provided a view favoured the introduction of a pre-application stage in which those applying to open a pharmacy could enter into discussions with the NHS Board over the need for NHS pharmaceutical services in the area, others expressed concern that this could be viewed as introducing bias into proceedings, with applications proceeding past this stage perhaps seen as having NHS Board endorsement.

4.122 Although there was much support for NHS Boards being able to take account of the financial viability of proposed pharmacies prior to securing their services, a significant proportion of respondents questioned whether NHS Boards actually had the expertise or the available information to undertake this.

4.123 There was also much support for the introduction of timeframes into the regulatory framework for NHS Board PPC and NAP decisions. This was seen as a way of reducing uncertainty, although it was acknowledged that in some cases a degree of flexibility over timings would be necessary.