1.1 There are no providers of pharmaceutical services adjacent or within close proximity of the best estimate address.

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1 14 April 2016 REF: SHA/18270 APPEAL AGAINST NHS COMMISSIONING BOARD ("NHS ENGLAND") DECISION TO GRANT AN APPLICATION BY S CHANDARANA FOR INCLUSION IN THE PHARMACEUTICAL LIST OFFERING UNFORESEEN BENEFITS UNDER REGULATION 18 WITHIN 200M FROM ME12 4RE, LEYSDOWN-ON-SEA, ISLE OF SHEPPEY 1 Trevelyan Square Boar Lane Leeds LS1 6AE Tel: Fax: fhsau@nhsla.com 1 The Application By application dated 10 May 2015, Mr S Chandarana ( the Applicant ) applied to NHS Commissioning Board ( NHS England ) for inclusion in the pharmaceutical list offering unforeseen benefits under Regulation 18 within 200m of Leysdown Road, Leysdown-On-Sea, Isle of Sheppey. In support of the application it was stated: This application should not be refused pursuant to Regulation 31 for the following reasons: 1.1 There are no providers of pharmaceutical services adjacent or within close proximity of the best estimate address. Information in support of the application: 1.2 There are currently no provider of pharmaceutical services in Leysdown-on- Sea despite there being a well established Doctors in the area. Patients currently living in Leysdown-on-Sea and the nearby villages of Eastchurch and Warden are currently deprived of any pharmaceutical care. The distances to the closest pharmacy is significant at 6 miles. The route to the closest pharmacies would involve using busy roads which would further impact on obtaining pharmaceutical care. The population of the area increases during a large proportion of the year due to the high number of caravan parks within the area. This inflates the population vastly. 1.3 Local residents include a significantly elderly population. The area is classed as a deprived area and as such not all families would have access to cars which would further delay essential treatment and services. 1.4 The application under Regulation 18 will secure unforeseen benefits that are not documented in the PNA, those unforeseen benefits being improved and better access to essential services, advanced service and public health services for the residents of and around Leysdown-on-Sea. The benefits are clear for the residents and holiday makers. This being relevant for the elderly population and young families and children. Please explain how you intend to secure the unforeseen benefits:

2 2 1.5 The Applicant s pharmacy would be ideally situated to offer an excellent service to all patients. The Applicant would be able to cater for the patients of Leysdown-on-Sea and nearby towns. This will help to meet the clear gap in provision as well as improve care of residents and holiday makers of surrounding villages. 2 The Decision NHS England considered and decided to grant the application. The decision letter dated 9 December 2015 states: 2.1 NHS England has considered the above application and is writing to confirm that it has been conditionally approved. 2.2 TSSB said that the application, when first received on 12 May 2015, defined the best estimate location of the proposed pharmacy as Within 200 metres of Leysdown Road, Leysdown-on- Sea It was considered that this definition was too imprecise as that road is some 4.5 km long. In a subsequent dated 18 May 2015, the Applicant had refined the best estimate location to be 200 metres from ME12 4RE. Consideration 2.3 NHS England considered whether or not to approve the application for a proposed new pharmacy and took into account the relevant Regulation(s) and a range of other factors including those set out in the Department of Health s publication Information for Primary Care Trusts, published in August Site visit 2.4 NHS England had previously discussed the need for a site visit and noted that the area was fairly isolated, rural and with no other nearby pharmaceutical services available to the local population. On that basis it did not consider that a specific site visit was necessary. It was felt sufficient to use internet resources including Google maps together with the fact that one of the NHS England [panel] members had local knowledge of the area in order to reach a decision. If NHS England had not felt it possible to do so in a safe manner, it would have deferred the decision pending a full site visit. Regulation NHS England first considered Regulation 31 of the regulations which states: (1) A routine or excepted application must be refused where paragraph (2) applies (2) This paragraph applies where (a) a person on the pharmaceutical list (which may or may not be the applicant) is providing or has undertaken to provide pharmaceutical services ("the existing services") from

3 (i) the premises to which the application relates, or (ii) adjacent premises; and (b) the NHSCB is satisfied that it is reasonable to treat the services that the applicant proposes to provide as part of the same service as the existing services (and so the premises to which the application relates and the existing listed chemist premises should be treated as the same site). 2.6 From the information before it, NHS England was of the view that it was not required to refuse the application under the provisions of Regulation 31 provided that any pharmacy subsequently opening as a result of this application was neither within, nor next door to, any premises occupied by an existing pharmacy contractor as there was no pharmaceutical contractors on the east side of the Isle of Sheppey. Regulation Regulation 41 states- [quotes Regulation 41] 2.8 NHS England noted that the Leysdown-on-Sea and the surrounding area was a controlled locality. It had been advised that, taking the postcode of ME12 4RE specified by the Applicant in their dated 18 May 2015 as the notional central point, the total registered population residing within a 1.6km radius of that point was 2,333. On that basis NHS England considered that the conditions of Regulation 41(3) had been met and agreed that the area should be regarded as a reserved location. Regulation NHS England noted that this was an application for unforeseen benefits and was to be considered under the provisions of Regulation 18 which states: [quotes Regulation 18] Will approving the application(s) secure improvements or better access to pharmaceutical services? (Reg 18(1)(a)) 2.10 The Applicant proposed to provide pharmaceutical services for 40 core hours a week, the pattern of which was as follows: Monday to Friday: 9.00 am 1.00 pm and 2.00 pm pm Saturdays: 9.00 am 2.00 pm Sundays: Closed 2.11 It was noted that including the supplementary hours, the pharmacy would be open for 59 hours per week, the pattern of which was as follows: Monday to Friday: 9.00 am 7.00 pm

4 Saturdays: 9.00 am 6.00 pm Sundays: Closed 2.12 The nearest pharmacy to the proposed site would appear to be Sheppey Hospital Pharmacy, Sheppey Hospital, Plover Road, Minster, Sheppey MEME12 3LT. The next nearest pharmacy on the Isle of Sheppey is Minster Pharmacy, Trafalgar Place, The Broadway Minster, Sheppey, ME12 2RW. These two pharmacies were respectively 9.3 km and 9.8 km away, from the proposed site and these journeys would take approximately 13 minutes by car. Both the distances and journey times are taken from Google maps. The pharmacy at Sheppey Hospital is open on Monday to Friday 8.00 am 8.00 pm and on Saturdays 9.00 am 6.00 pm. Minster Pharmacy is open Monday to Friday as 9.00 am 6.30pm and Saturdays 9am 5.30pm. There are other pharmacies on the Isle of Sheppey but these are located in Sheerness, even further away from the proposed site than the two pharmacies, the details of which are set out above Therefore, NHS England agreed that the application did provide significant improvements and better access to pharmaceutical services for both local residents and summer visitors of Leysdown-on-Sea. Were these improvements included in the PNA? (Reg 18(1)(b)) 2.14 NHS England then considered the 2015 PNA, published by Kent HWB, which contains an analysis of the situation as it was assessed at the time of publication March NHS England noted the following statement which it felt to be relevant: The key findings and recommendations of the PNA steering group are ) Overall there is good pharmaceutical service provision in the majority of Kent The best estimate location identified by the Applicant was in Leysdown-on- Sea, and NHS England noted that the PNA did not mention either the village or the Isle of Sheppey. The document does include reference to the dispensing doctor coverage across Kent. The findings and recommendations go on to say: Where the area is rural, there are enough dispensing practices to provide essential dispensing pharmaceutical services to the rural population Although no specific gaps in service had been identified in the PNA, it was agreed that the proposed application did secure better access to pharmaceutical services for both the local residential and visiting tourist populations within east Sheppey, Kent, as required by the Regulations. Would granting the application cause significant detriment to the proper planning of the provision of pharmaceutical services in the HWB s area? (Reg 18(2)(a)(i))

5 There was already good pharmaceutical coverage in the HWB area with no current plans for any changes. However, if the application was to be granted and the pharmacy opened NHS England felt that NHS England would be able to plan for the provision of services and that the existing arrangements for provision of pharmaceutical services in the area would not cause significant detriment to the planning of pharmaceutical services. Would granting the application cause significant detriment to the arrangements for the provision of pharmaceutical services in the area? (Reg 18(2)(a)(ii)) 2.18 NHS England had no information to demonstrate that pharmaceutical services would be significantly affected by the opening of a further pharmacy as there were no other pharmaceutical providers within 9 km of the proposed site It was noted that some of the comments from interested parties indicated that there was a misunderstanding of the difference between the dispensing services provided by doctors and pharmaceutical services provided by community pharmacists. However, as the area was a reserved locality the local practice would still be able to offer a dispensing service Reference had been made in some of those comments regarding the possible financial effects on the income that the local practice derived from dispensing medication to patients. NHS England was unable to take such matters as doctor s dispensing income into consideration when reaching its decision. There is judicial precedent saying that dispensing income should not support other income received by doctors. This was stated in the 1996 case of R v- North Yorkshire FHSA ex parte Dr. Wilson and Partners, Mr. Justice Carnwath said It is not part of the scheme of those regulations or indeed of the statute that pharmaceutical services should be relied upon to provide financial underpinning for medical services which are intended to be financed in other ways. Would significant benefits be conferred on persons in the HWB s area in relation to:- a. Reasonable choice? (Reg 18(2)(b)(i)) 2.21 NHS England was of the view that there was no choice of providers of pharmaceutical services in the Leysdown area; the local GP surgery offered a dispensing service, however, both of the nearest existing pharmacies were over 9 km away Therefore, NHS England considered that, to have a pharmacy in the proposed location, would result in a reasonable choice. On that basis it was of the opinion that a pharmacy at the proposed location would confer significant benefits to the persons in the HWB area. b. Reducing the difficulty of access to services of people with a protected characteristic? (Reg 18(2)(b)(ii)) 2.23 The Applicant had made general comments and provided some statistical data covering the Swale non-metropolitan area. However, the Applicant had not

6 6 presented any evidence to indicate that there were any persons with protected characteristics who are currently experiencing any difficulty accessing services. c. Providing an innovative approach to the delivery of pharmaceutical services? (Reg 18(2)(b)(iii)) 2.24 NHS England considered the range of services in the application, which the Applicant intended to provide should the application be granted. NHS England was of the view that the proposed services were basically the range of pharmaceutical services to be supplied by any pharmacist under the NHS contract e.g. essential, advanced and enhanced services. NHS England did not consider these to be innovative, either in type or method of delivery as envisaged by the Regulations. Decision 2.25 NHS England carefully considered the various factors against which applications made under Regulation 18 of the Regulations must be determined and decided that on balance the required criteria had been satisfied and accordingly granted the application The condition is that you are required to notify the address of the premises from which you will provide pharmaceutical services to NHS England within 6 months of the date of this letter or 6 months from the date of determination of any appeal to the Secretary of State. Please find enclosed the relevant form for the Applicant to use for this purpose. 3 The Appeal In a letter to the Family Health Services Appeal Unit of the NHS Litigation Authority ( the Appeal Unit ), dated 7 January 2016, Mr N Morley representing St Georges Medical Centre (the Appellant) appealed against NHS England's decision. The grounds of appeal are: 3.1 Mr Morley is instructed by St Georges Medical Centre Sheerness Kent whose interests are significantly affected by the determination to conditionally approve the above application. 3.2 The determination was made by NHS England South (South East Regional Team) and the Appellant were informed by the communication of 9 December The Appellant wishes to appeal the determination to approve the substantive application. On their behalf the Appellant s Representative would say: The Appellant is the sole dispensing practice on the Isle of Sheppey with a dispensing branch surgery within close proximity of the best estimate location which has been defined as within 200 metres of ME12 4RE. Their interests are therefore significantly affected by this application.

7 The Appellant notes that NHS England (as per the determination letter) did not consider a specific site visit was necessary. The Appellant respectfully adduce that in such an important matter, NHS England has misdirected themselves by not having a specific site visit especially, as only one of [panel members] have local knowledge of the area. The Appellant would therefore say that contrary to the assertion in the determination letter, the decision was not made in a safe manner The Appellant notes that NHS England considered Regulation 31 of the Regulations and are content with their decision The Appellant notes that NHS England have determined that Leysdown on Sea and the surrounding area are a controlled locality and the Appellant is content with that decision The Appellant notes that on the date of notification of the postcode ME12 4RE specified by the Applicant on 18 May 2015 as the notional central point, the total registered population residing within a 1.6km radius of that point was Therefore on that basis, NHS England considered that the conditions of Regulation 41 (3) had been met and agreed that the area should be regarded as a reserved location. The Appellant concurs and are content with that decision. Regulation The Appellant adduced substantial evidence in its letters of the 26 August 2015 in relation to the application and on the 2 November 2015 in relation to the responses from interested parties The Appellant attaches both letters. However, the Appellant would wish to reiterate the following points : The Appellant would robustly assert that the above Pharmaceutical Regulation 18 application should be refused as it does not meet the parameters of the NHS Pharmaceutical and Local Pharmaceutical Services Regulations 2013 in that there has been no major or minor changes to Leysdown on Sea since the publication of the last Pharmaceutical Needs Assessment (PNA) by the relevant Health and Wellbeing Board (HWB) Other than the assertion that there is no pharmaceutical provider in Leysdown on Sea, the Applicant has provided no evidence of issues regarding choice and access let alone any benefits to people with particular characteristics or innovative services. The Appellant would therefore say this application fails to meet any of the three tests of Regulation The Appellant would say in reference to the communication response of Kent Local Pharmaceutical Committee dated 14 July 2015 that significant weight should be put on the fact that Kent LPC has not supported this application.

8 8 Conclusion 3.4 There was no support of the above application and all interested parties adduced substantial relevant evidence confirming that in their opinion, that this application did not meet the parameters of Regulation The Appellant would say that on at least the balance of probabilities it is clear that the weight of evidence should allow the relevant Committee of the NHS LA to grant the Appellant s appeal and refuse this application. The Appellant respectfully invite the NHS Litigation Authority to refuse the Applicant a grant of consent to join the pharmaceutical list of NHS England at the above location. 3.6 The Appellant confirm its willingness to attend an NHS LA local oral hearing if such be constituted. The Appellant s Letter to NHS England dated 26 August The Appellant is the only dispensing medical practice on the Isle of Sheppey and therefore their interests are significantly affected by this application. 3.8 The Appellant would wish to comment as follows: The Appellant notes that the statement by NHS England that the locality of the Applicant s site is rural which the Appellant are in total agreement with. The Appellant would comment that there has been no substantial change since the last determination which would give cause to query the rurality of the area and indeed, there have been reductions in facilities and infrastructure in Leysdown on Sea The Appellant notes that according to your records the number of registered patients living within 1.6km of ME12 4RE on the date of receipt of the application was 2333 and therefore, the Appellant would say that Leysdown on Sea should be designated a reserved location Should Leysdown on Sea be determined not to be a reserved location (which the Appellant does not concede) the Appellant would say that there will be prejudice to medical services due to the non viability of the maintenance of a non dispensing branch surgery at Leysdown on Sea The Appellant, the St Georges Medical Practice, have three branch surgeries at Eastchurch, Leysdown and Warden Bay. All three branches are dispensing. The Appellants are the only dispensing practice on the Isle of Sheppey It is robustly asserted by the Appellant that it is only the dispensing income which allows it the luxury of maintaining three branch surgeries on the island. The Appellant s Representative is informed that none of the other prescribing only medical practices on the Isle of Sheppey have branch surgeries on the East side of the Island.

9 It is a matter of agreement between NHS England and the practice that the three branch surgeries whilst acknowledging the great clinical and pharmaceutical benefit to the islanders, are not fit for purpose and would emphatically fail a serious CQC Inspection if such were to occur. It has therefore been agreed by NHS England that they will be very supportive of the business case proposition supplied by the Appellants in that a new purpose built fully compliant Health Centre be built in the Leysdown / Warden Bay locality on Sea locality to replace the three existing branches on the Eastern side of the Island This new facility would be open every day for extended hours. Currently none of the three branch surgeries offers a full opening hours service especially in the afternoons when patients only have a choice of one branch surgery they can access The Appellant has received no complaints from their patients in respect of a lack of pharmaceutical services in Leysdown. It is understood that many of the pharmacies on the Island will deliver prescriptions on request patients in the locality - as do the Appellants NHS England will be aware of the large number of temporary residents that are serviced for both their medical and pharmaceutical needs at the three branch surgeries. Should this pharmacy application be granted, and the pharmacy open (which the Appellant does not concede) then substantial numbers of patients will be denied the opportunity to access medical and pharmaceutical dispensing services within a reasonable distance of their caravan park, bed and breakfast or other temporary residential accommodation In the event that NHS England decides, because of the significant impact of this application on local medical and pharmaceutical services to constitute an NHS England local oral hearing, the Appellant confirm their intention to attend to give oral evidence The Appellant would robustly assert that the above Pharmaceutical Regulation 18 application should be refused as it does not meet the parameters of the NHS Pharmaceutical and Local Pharmaceutical Services Regulations 2013 in that there has been no major or minor changes to Leysdown on Sea since the publication of the last Pharmaceutical Needs Assessment (PNA) by the relevant Health and Wellbeing Board (HWB) The Appellant would respectfully say that the Applicant s application shows a poverty of evidence and information in general and in particular, is believed to be a duplicate generic application of a similar style used by the Applicant in other applications to NHS Essex and other areas Other than the assertion that there is no pharmaceutical provider in Leysdown on Sea, the Applicant has provided no evidence of issues regarding choice and access let alone any benefits to people with

10 10 particular characteristics or innovative services. The Appellant would therefore say this application fails to meet any of the three tests of Regulation If this pharmaceutical application were to proceed to opening, then the Appellants assert without any hesitation or equivocation, that the new proposed health centre in Leysdown will not proceed and the future of the three branch surgeries cannot be guaranteed in view of their non compliance with CQC criteria. Conclusion The Appellant would say that Leysdown on Sea is a rural reserved location. The Appellant would robustly assert that the above Pharmaceutical Regulation 18 application should be refused as it does not meet any of the parameters of the current NHS Pharmaceutical and Local Pharmaceutical Services Regulations The Appellant respectfully invite NHS England after due consultation to refuse this application for unforeseen benefits as it is not compliant with the Regulations The Appellant respectfully invite NHS England after due consultation to confirm the rurality and reserved location status of Leysdown on Sea The Appellants are very content to engage with NHS England on any matter relating to this application or the relevance to the proposed new health centre in Leysdown on Sea or Warden Bay locality. The Appellant s Letter to NHS England dated 2 November The Appellant s Representative was surprised that it was not circulated with the responses to the consultation to the above application despite the fact that the Appellant s Representative had written to NHS England on the 26 August 2015 informing NHS England that the Appellant s Representative was instructed by St Georges Medical Centre Sheerness and that NHS England would have received a letter of authority from them The Appellant s Representative note this letter of 26 August is included in the responses sent to the Appellant The Appellant s Representative has now received belatedly a copy of the responses which was sent to the practice on second enquiry as your initial correspondence to the Appellant regarding the consultation responses was addressed to a Practice Manager whom The Appellant s Representative is informed left the practice 10 years ago The Appellant s Representative would like to make the following observations regarding the consultation responses.

11 11 Boots dated the 28 August The Appellant s Representative agree with all the comments made by Boots in general and in particular agree that the Applicant has not provided significant evidence even on the balance of probabilities to justify a grant of consent under the Pharmaceutical Regulations. Kent Local Medical Committee dated the 24 August The Appellant s Representative agree with the observations made by Kent Local Medical Committee in general and in particular, their reference to the current Pharmaceutical Needs Assessment. Paydens Limited 10th August The Appellant s Representative agree with the comments by this respondent in general except for the fact that the Appellant s Representative agree with NHS England s view of the Regulations in regard to the prejudice test and reserved locations rather than the view adduced by Paydens. Kent Local Pharmaceutical Committee dated the 14 July The Appellant s Representative would say that significant weight should be put on the fact that Kent LPC has not supported this application The Appellant s Representative note the comments by Warden Parish Council (21 August 2015), Lyesdown Parish Council (21 August 2015) and Swale Clinical Commissioning Group (12 August 2015) which are all opposed for various reasons, some peripheral to the Regulations, to the application. Conclusion None of the responses are supportive of the above application and all have adduced substantial relevant evidence which can be considered by NHS England under the Pharmaceutical Services Regulations The Appellant s Representative would say that on at least the balance of probabilities, it is clear that the weight of evidence should allow NHS England to refuse this application without the need of a local oral hearing. The Appellant s Representative respectfully invite NHS England to refuse this Applicant a grant of pharmaceutical commission The Appellant s Representative confirm its willingness to attend a local oral hearing if NHS England were to constitute the same. 4 Summary of Representations

12 12 This is a summary of representations received on the appeal. A summary of those representations made to the NHS England are only included insofar as they are relevant and add to those received on the appeal. 4.1 RUSHPORT ADVISORY LLP REPRESENTING MR S CHANDARANA (THE APPLICANT) The Applicant has already provided substantial information to NHS England in support of this case and rather than repeat this information which is relevant to the decision to be made the Applicant s Representative include a copy of previous communication for completeness Following consideration of the application NHS England approved the application with the decision subsequently appealed by just one party Mr Morley on behalf of St Georges Medical Centre. Initially the Applicant will deal with each of the grounds for appeal in turn [See above] In terms of the map which shows the location of pharmacy and GP services the Applicant believes that it is missing the main surgery location re: St Georges Medical Centre, 55 St Georges Ave, ME12 1QU No information has been provided in terms of how this application will significantly affect the interests of the GPs. This appeal ground should therefore be discounted [See above]] In relation to the site visit NHS England actually stated: [See 2.4 above] The Regulations don t stipulate that a site visit must be undertaken; the statement above makes it clear that local knowledge supported by online material and the acknowledged isolated area etc. is sufficient to allow NHS England to reach their considered decision. The Applicant agrees with NHS England s assessment of the merits of this case. Regulation In terms of Regulation 18 the Applicant respectfully refer the Appeals Unit to the attached correspondence with NHS England which clearly shows how this application satisfies Regulation 18. Matters to be considered: In relation to Regulation 31- there has been no evidence provided by any party to show that Regulation 31 is in play for this application.

13 In relation to: (a) granting the application would cause significant detriment to (i) proper planning in respect of the provision of pharmaceutical services in the Health and Wellbeing Board area, or (ii) the arrangements which the NHSCB has in place for the provision of pharmaceutical services in the Health and Wellbeing Board area; Nothing of substance has been submitted by any party and as such the Applicant s Representative s belief is that there is no evidence of significant detriment In relation to [18(b)(i):] NHS England considered reasonable choice and concluded: [See 2.21 and 2.22 above] The Applicant re-iterates that reasonable choice as per the Regulations is the consideration there being a reasonable choice with regard to obtaining pharmaceutical services in the area of the Health and Wellbeing Board emphasis added Whether there is a GP dispensing function is not a relevant matter in terms of reasonable choice as GP dispensing is not the provision of essential pharmaceutical services as there is no requirement for the GPs to fulfil any role other than a supply function unlike the pharmaceutical services contractual obligations that a pharmacy must adhere to In terms of reasonable choice the Appeal Unit will want to consider access to the nearest pharmaceutical service provider. NHS England describe pharmacies at over 9km away. Maps and photos provided by the Applicant clearly show that access on foot is not a reasonable consideration for well and able people and is clearly not possible for people with mobility restrictions NHS England state that a journey by car would take 13 minutes, the Applicant has provided data to evidence that the area of the application is deprived: % people claim incapacity benefits compared to 7% across Swale % people claim a working age benefit compared to 17% across Swale

14 % of households in Swale 006A have no access to a vehicle compared to 20.1% across Swale. (Census 2011) Public transport has been described as poor by interested parties. The Applicant attach a sample journey planner; the bus service runs every hour at best with no evening and very infrequent weekend cover. Additionally there are restrictions over certain months and the journey take c. 50 minutes each way. This is surely a journey that should be discounted as being unreasonable to expect people to take to access pharmaceutical services In terms of [18(b)(ii): NHS England state the Applicant had made general comments and provided some statistical data covering the Swale non- metropolitan area (emphasis added) This is incorrect; the Applicant has provided data in relation to the area of the application site. The data quoted is specific to Swale 006A, the map below shows that the coverage of this area is Leysdown On Sea only: [Area Map Available for Committee] The Applicant identifies people with a shared characteristic residing in Swale 006A, the area of the application site. The population of Swale 006A being 1,678 due to the fact that this area is less that the 1.6km measure used by NHS England to determine the number of people registered with a doctor (2,333). Age: Young 16 years and below: % (372 extrapolated to 2,333 population) Over the age of 60: % which is significantly greater than across Swale at 23.5% (859 extrapolated to 2,333 population.) Disability: People whose activity is limited a little or a lot % (810 extrapolated to 2,333 population) Compared to 18.6% across Swale People describing their health as bad/ very bad % (330 extrapolated to 2,333 population) Compared to 5.8% across Swale It is clear that people living within a distance of 1 mile of the application site are significantly older and living with mobility issues and in poor health compared to the wider Swale area.

15 There is a significant population in significantly poorer health and when factored in with distance and access issues on foot, by car and public transport it is clear that the benefits of providing pharmaceutical services is significant on people in the area People with no access to a vehicle is In terms of the Regulations the Applicant has identified significant numbers of people within 1.6km of the application site that are aged, in poor health and lack mobility due to health and disabilities or lack of transport. The Applicant therefore knows exactly where these people live and therefore can with certainty identify those very same people and describe their access issues to pharmaceutical services. With respect the Applicant asks the Appeal Unit to make an assumption on the balance of probability being mindful of the clear issues identified by the Applicant In regard to [18(b)(iii): The Applicant will provide a full and complete pharmaceutical service as per the application form covering 59 hours per week including a full service on Saturday Whereas pharmacy opening hours alone don t show innovative approaches in this instance where there is no pharmaceutical service and commissioners do not have the option to direct increased hours as again there is no provider of pharmaceutical services this application thereby does provide innovation in terms of the benefits to be conferred on people in the area This application satisfies the test re: Regulation 18 in that many benefits have been identified having a basis in need locally; the application being thoroughly evidenced; that were not foreseen when the PNA was published. Those benefits are significant in nature and ensure that reasonable choice is satisfied The Applicant believes that this application should be granted. The Applicant s Letter to NHS England dated 22 October Rushport Advisory LLP are instructed on behalf of the Applicant; please find enclosed comments made on behalf of the Applicant In direct response to representations: A number of interested parties quote the PNA- there is no identified need for a pharmacy at the application location and there wouldn t be as this is an application under Regulation 18 in that it identifies benefits that were unforeseen when the PNA was published. In essence the commissioners of the PNA have missed the opportunity to identify this rural location as requiring a full pharmaceutical service.

16 16 The PNA however does identify issues with areas within the geography such as the application site but fails to make the link and determine that there is a current gap in pharmaceutical provision The PNA states Pg.4: The key findings and recommendations of the PNA steering group are Overall there is good pharmaceutical service provision in the majority of Kent Where the area is rural, there are enough dispensing practices to provide basic dispensing pharmaceutical services to the rural population Point 2 describes dispensing practices providing a basic dispensing service, as NHS England is aware this does not contribute full essential pharmaceutical services provision which is acknowledged by the PNA as below The current provision of standard 40 hour pharmacies should be maintained especially in rural villages and areas such as Romney Marsh. (PNA Pg.4) This highlights that the Local Authority (LA) in publishing the PNA acknowledge the importance of pharmacy services in rural villages. If it is important to maintain such services it must be as important to ensure that anyone living in a rural location has reasonable choice in terms of accessing the full range of pharmaceutical services A map showing the 1 mile (1.6km) radius around community pharmacies and dispensing doctors, is available in the supplementary datasets (Appendix B). In areas listed as a controlled locality and therefore mainly rural, the pharmaceutical services are provided by dispensing practices. Some residents living in controlled localities fall within the 1 st and 2 nd quintile for the index of Multiple Deprivation (Appendix B, page 7). This is recognised as rural deprivation and access to pharmaceutical services for these patients needs to be reviewed regularly and maintained. PNA Pg. 9) Pharmaceutical services for people in rural locations and access needs to be reviewed regularly. The LA in publishing the PNA could have identified the application location as a current need, the Applicant is of the view that in light of the overarching rural strategy that this was a failed opportunity and hence this application identifies the unforeseen benefit Dispensing practices. Dispensing of medicines and appliances All dispensing practices carry out this service.

17 DRUMS Dispensing Review of Use of Medicines similar to MURs in pharmacies. This service is voluntary but most practices take part. (PNA Pg.12) The norm in England is for the separation of prescribing and dispensing functions except for rural populations, when community pharmacies are not viable. These patients can access dispensing services through authorised GP practices Surgeries must always give these patients the choice of obtaining the medicines through the GP dispensary or being allowed to take their prescription to a community pharmacy of choice Dispensing practices do not have to provide all the essential services. They mainly provide dispensing services and the advanced service of Dispensing review of the Use of Medicines (DRUMs). (PNA Pg.14) The PNA shows that the LA are aware that dispensing practices do not provide all essential services and are basically a dispensing function, they are in no way a replacement for the full range of pharmaceutical services contractually required of a retail pharmacy business in the everyday course of its duties and responsibilities. Reasonable Choice: As above the PNA identifies the importance of pharmaceutical services being available to rural people. The application site is c. 6 miles from the nearest pharmacy and therefore the population (number still to be determined) locally have no access to pharmaceutical services or pharmaceutical provider within a reasonable distance and as such reasonable choice cannot currently be satisfied The Regulations refer to reasonable choice in the area of the health and wellbeing board NOT to the total area and the Applicant is sure NHS England is aware of applications being granted on the basis of reasonable choice in rural locations where access to a pharmacy is difficult. The Applicant is sure NHS England recognise that those health and wellbeing boards had pharmacy operators across the geography and that reasonable choice as a determinant needs to be based on people s ability to reasonably access pharmacy and not just on whether a pharmacy exists across its geography. Access: Existing pharmaceutical services are located c. 6 miles from the application site [Map and photographs available for Committee] The Ariel view of the area shows pockets of dwellings with farm land between and rural roads. The Applicant is sure that when NHS

18 18 England conduct the site visit they shall appreciate the local issues experienced by people in the area [Photographs]- just some examples of typical routes / roads in the area frequently lacking lighting, adequate footpaths etc ONS Census 2011 identifies the characteristics of people in the area: People s general health, March 2011 Variable Measure Your Swale England neighbourhood Very good % Good % Fair % Bad % Very bad % [Data taken from the Indices of Deprivation 2015 Available for Committee] People claiming health related benefits, August 2010 Variable Measure Your Swale England neighbourhood Incapacity % Benefits Carers % Allowance Disabled % Benefits claimants as percentage of working age population, August 2010 Variable Measure Your Swale England neighbourhood Any key % working Age Benefit (16-64, Males 16-59, Females) Jobseekers % Allowance Incapacity Benefits %

19 The area of the application is deprived in nature considering recent statistics in terms of overall deprivation, income deprivation, health deprivation etc. Basically the people in the area are deprived and in poor health compared to the wider Swale area and England as a whole. Factoring in that this is clearly a rural area this must therefore be an example of rural deprivation that the PNA identifies as a risk and where pharmaceutical services are important. This is a benefit that was unforeseen by the LA when publishing the PNA and by granting this application a full pharmaceutical service can only confer significant benefits on people in the area i.e. the test for Reg 18 is satisfied. Car or Van Availability 2011 Variable Measure Swale 006A Swale (Non Metropolitan District) South East All households Count ,585 3,555,463 No Cars or Vans in household Count , ,430 % Car or Van in household 2 Cars or Vans in household 3 Cars or Vans in household 4 or more cars or vans in household All cars or vans in the Area Count ,545 1,483,911 % Count ,744 1,059,380 % Count 44 3, ,552 % Count 14 1,376 98,190 % Count ,421 4,803, Linking to access to pharmacy- distance and route are an issue on foot, public transport has been described as poor by interested parties and car ownership is lower than Swale and SE England average. The people in the area are deprived and not particularly mobile either due to their described poor health, significant proportion claiming health related benefits or due to ability to walk to pharmacy, lack of own car,

20 20 poor public transport. This is a benefit that was unforeseen by the LA when publishing the PNA The GPs no doubt believe their dispensing service is resulting in health improvements for the local population, this can t be the case as otherwise the combination of GP and dispensing services would be driving health indicators to improve. The GPs are providing a supply function only and this is no replacement for full pharmaceutical services Pharmacy contractors in excess of 6 miles away will no doubt say they offer a prescription delivery service, this is a delivery service and in no way can this replace the availability locally of a pharmacy healthcare professional offering a full pharmaceutical service. Protected characteristics: People in the area with a shared protected characteristic- Age % of people are aged 60 years plus compared to just 23.5% for the wider Swale area. This is a significantly greater number. Disability As above the health deprivation statistics being at the most deprived category across England People with a protected characteristic should be considered in their ability to access a reasonable choice of a full pharmaceutical service. Considering age, health, deprivation and lack of mobility of people in the area it should be assumed that the lack of pharmaceutical services is proving to be discriminatory against this protected patient group as per the Equality Act. This again is a benefit that was unforeseen by the LA when publishing the PNA and the application should be granted to allow access to pharmaceutical services locally In terms of comments specific to interested parties representations: Warden Parish Council: Cllr Sandle acknowledges health facilities are lacking in the area this will provide facilities on site that are currently unavailable, at the present time residents have to travel to Sheerness for some basic check-ups and services a trip of 22 miles Also people with a protected characteristic are identified many elderly and young parents young families and the elderly when they are unwell.

21 The area is described as a very bleak area highlighting obvious route and access issues. Our buses are expensive and not very frequent in fact non-existent after evening surgery It should be noted that the GP service operates from 9.30 to 12 Monday to Friday, with 2 evenings pm and no service on Saturday. The pharmacy applicant will provide pharmacy services 9-7pm Monday to Friday and a full day Saturday. A Regulation 18 application must allow for better/ improved access and the Applicant satisfies the Regulation allowing access to basic check-ups and services as described as missing by the Parish Council Finally acknowledging that the need for a pharmacy is apparent. Mr Morley: Mr Morley describes the possible development of a new GP surgery and the closure of 3 branch surgeries. The location is clearly not established to replace the three existing branches on the Eastern side of the island. It is therefore probable that many people will find themselves a greater distance from GP services once their branch closes; this is potentially a significant local change that makes reasonable access to pharmaceutical services more pressing It should be noted that there is no firm commitment / approval to deliver the stated new medical centre. Leysdown Parish Council: The letter is almost identical to that of Warden Parish Council and as such it does appear to support the need for a pharmacy locally supported by shared characteristics and demography / access rationale By granting this application NHS England will secure improved / better access to a full range of pharmaceutical services conferring on people in the area a significant benefit. This must be the case as again these health issues exist and would not if current provision was secured so that the benefits were not needed. The benefits this application will secure are significant and were not identified when the PNA was published. The PNA and other sources identify health issues specific to the application site; this application therefore has a basis in fact and is appropriately evidenced; but fails to reach the conclusion that a new pharmacy will allow better / improved access and therefore allow significant benefits. This application is therefore appropriate under Regulation 18 Unforeseen Benefits The Applicant trust NHS England recognise the significant benefits this application will allow [Copy of supporting information available for Committee]

22 NHS ENGLAND NHS England s representations on this appeal are set out in this letter. For ease of reference, these are set out using the same numbered paragraphs as the letter of appeal Point 1 [3.3.1 above] Noted Point 2 [3.3.2.above] - NHS England accepts that it would normally be appropriate to carry out a site visit before determining an application but, given the wide geographic spread of the area for which it is responsible (i.e. Kent, Surrey, both East and West Sussex and the City of Brighton and Hove), that has to be a judgement call taking into consideration the details available in each case. In this instance, it was felt sufficient to use internet resources together with the fact that one of NHS England panel members had local knowledge of the area in order to reach a decision. If NHS England had not felt it possible to do so in a safe manner, it would have deferred the decision pending a full site visit Points 3 to 5 [ to above] Noted. Regulation The application has been made under Regulation 18. That Regulation is quite clear when it says, in 18(1), that NHS England, when it receives a routine application, is required to determine whether (it) is satisfied that granting it, or granting it in respect of some only of the services specified in it, would secure improvements, or better access to pharmaceutical services, or pharmaceutical services of a specified type, in its area; but the improvements or better access that would be secured were or was not included in its pharmaceutical needs assessment (local emphasis applied). NHS England does not accept that there need to have been changes in the relevant area since the PNA was published last year as the letter of appeal suggests. If there had been, and they materially affected what the PNA had said, then a supplementary statement would have been issued amending the PNA. And then, of course, the offered improvements or better access as set out in the application would have not then been unforeseen. Crucial to the determination of applications made under Regulation 18 is that the proposed benefits must not have been included in the PNA As will be seen from Appendix A, the proposed location is towards the eastern end of the Isle of Sheppey. The nearest existing community pharmacies to that location are either the Sheppey Hospital Pharmacy, Sheppey Hospital, Plover Road, Minster, Sheppey ME12 3LT or Minster Pharmacy, Trafalgar Place, The Broadway Minster, Sheppey, ME12 2RW. These are respectively 9.3 km (5.7 miles) and 9.8 km (6 miles) away from the proposed site and these journeys would take approximately 13 minutes by car. Both the distances and journey times are taken from Google maps. Bus services are available

23 23 and run at varying times, sometimes with a gap of an hour between departures, and have a journey time of approximately 35 minutes each way meaning that a return trip could take up to 3 hours depending on service timings The PNA published last year contained a number of maps designed to give an overview of the areas covered by the various CCGs in Kent. The Isle of Sheppey, which contains the site proposed by this application, falls under the auspices of the Swale CCG. Attached as Appendix B is a map published as part of that document and which shows multiple deprivation quintiles within that CCG as of This shows that the three LSOAs that make up the eastern half of the Isle of Sheppey fell within the 5 th quartile (i.e. the 20% most deprived). The proposed site is indicated and is towards the very east of that area. That area contains no providers of pharmaceutical services, only three branch surgeries of the Appellant s medical practices providing dispensing services. Given the enhanced role of community pharmacists, NHS England would maintain that this is a clear demonstration of there being no reasonable choice with regard to obtaining pharmaceutical services (Regulation 18(2)(b)(ii) refers) The 2001 census data shows that 36.05% of the residents of the most eastern LSOA (Swale 006A) on the Isle of Sheppey (this containing the proposed site) said that their health was fair, bad or very bad. This is nearly twice the percentage of only 19.81% describing their health as such within the wider area of Swale (Non-Metropolitan District). Taking the same source, only 29.6% of the households in that LSOA had access to two or more vehicles compared to 37.5% over the wider area With regard to the specific requirements of Regulation 18(2)(b), NHS England is of the view that, notwithstanding that the improvements or better access were not included in the relevant pharmaceutical needs assessment, it is satisfied that, having regard in particular to the desirability of (i) there being a reasonable choice with regard to obtaining pharmaceutical services in the area of the relevant HWB is a standalone criterion as that section does not conclude with any qualifier (e.g. and ) such as that which links Regulations 18(2)(b)(ii) and (iii). These are simply matters to have regard to when considering the broader issues of improvements or better access On that basis, it does not accept that an application that satisfies the criteria set down in Regulation 18(2)(b)(i) also has to satisfy the criteria of the following two sub-paragraphs as the letter of appeal suggests In reaching that conclusion, NHS England had regard to the content of the FHSAU report reference SHA/17336, dated 20 February 2014, which said, in Section 9 Further Consideration :-

24 The Committee noted that the applicant had volunteered the fact that its application did not rely upon the improvement of access to services meeting the specific needs of persons sharing protected characteristics or the provision of innovative approaches taken with regard to the delivery of pharmaceutical services The Committee accepted that the applicant was not obliged to provide evidence that its application would satisfy the matters referred to in sub paragraphs (i) to (iii): They were simply matters to have regard to when considering the broader issues of improvements or better access NHS England can see no reason why significant weight should be attached to the comments received from Kent LPC. These seem, with respect, to concentrate more on the possible financial implications for the Appellant practice rather than the need, or otherwise, for a new pharmacy in this part of the Isle of Sheppey. Such implications are not ones which NHS England can take into account as was made clear in section 4 of the decision letter when reference was made to the 1996 case of R v- North Yorkshire FHSA ex parte Dr. Wilson and Partners, Mr. Justice Carnwath said It is not part of the scheme of those regulations or indeed of the statute that pharmaceutical services should be relied upon to provide financial underpinning for medical services which are intended to be financed in other ways In any case, as NHS England has determined that the area meets the criteria of a reserved location. In that situation, those issues are irrelevant as the Appellant practice will be able to continue providing dispensing services at the same level as they do now; should the decision of NHS England be confirmed. Conclusion NHS England wishes to maintain its view that the application satisfies the relevant requirements of Regulation 18 in that it would provide improvements and better access to pharmaceutical services that were not included in the PNA [Maps available for Committee] 4.3 KENT LPC Kent LPC note that the area of the application has been determined to be a reserved location Kent LPC further note that the Appellant states that other than the assertion that there is no pharmaceutical provider in Leysdown on Sea, the Applicant has provided no evidence of issues regarding choice and access let alone any benefits to people with particular characteristics or innovative services.

25 Leysdown is located a mile SSE of Warden and three miles ESE of Eastchurch and there are farms around the village; the economy is mainly driven by tourism in the summer months and the nearby caravan parks. To the southwest is an area of marshland and to the northeast is the North Sea. There is one major road into Leysdown, the B2231 with a regular bus service along it. The majority of the Isle of Sheppey residents reside in Sheerness, Queenborough and Minster From the above, the location of the application is relatively isolated and NHS England stated that there is no choice of providers of pharmaceutical services in the Leysdown area. the local GP surgery offers a dispensing service, however, both of the nearest existing pharmacies are over 9 km away. Therefore, logically, the inclusion of a new pharmacy in this area will provide access to full pharmaceutical services and so result in a reasonable choice In its response to the application Kent LPC stated that should NHS England go on to consider prejudice, Kent LPC would point out that it should not be decided according to whether dispensing doctors would be unable to continue to use income from dispensing to run branch surgery services but about whether dispensing doctors pharmaceutical services to the public will be prejudiced and unable to continue. 4.4 BOOTS UK LTD Boots disagree with NHS England s decision to grant this application as it feels the application fails on all parts to meet the criteria of Regulation 18, therefore Boots are in support of the appeal instigated by Mr Morley on behalf of the Appellant St Georges Medical Centre Leysdown on Sea is a small resort on the Isle of Sheppey, which is in the majority rural in nature. Boots has attached a NASA photo taken that clearly indicates this. In comparison to Sheerness in the north of the island, which is much larger and with a more dense population. Boots agree with the determination that the area around Leysdown on Sea is a controlled locality. Choice The Applicant fails to provide evidence of any lack of choice of pharmaceutical providers within the health and wellbeing board area or in particular within the Isle of Sheppey. It has already been highlighted the number of pharmaceutical providers on the island and those close by on the mainland. The closest pharmacy is between 5 and 6 miles away but distance alone is not necessarily the sole factor with regard to choice. Patients with protected characteristics The Applicant fails to provide evidence that patients with protected characteristics currently have difficulty accessing pharmaceutical

26 26 services within the vicinity of the address provided or indeed at all. Identifying that there are elderly people in the local resident population does not indicate that they are having difficulty The Applicant claims that patients living in the area are deprived but no evidence is provided by the Applicant to support this. They claim the area is deprived so not all families have access to cars, but again no evidence provided to support this statement. The 2011 census is inconclusive, car ownership is 74%, and seasonal holiday makers are likely to be closer to 100% The Applicant claims 'The benefits are clear and relevant of the elderly and young families and children'. Boots feel they are not. The Applicant has not even taken the time to review what locally commissioned services are required to meet the needs of the area or if there are gaps in provision, the average age according to the 2011 census is 45-49, neither elderly nor young families with children. Innovation The Applicant fails to provide any details of innovation or innovative services. The Applicant quotes finally, they will meet the clear gap in provision. There is no gap in provision as indicated in the 2015 PNA A response by the Applicant to the original representations was not circulated so Boots assume they did not make any argument either for or against the comments raised by all interested parties. This further indicates lack of knowledge and demographics of the area or any real desire to fulfil any potential needs of patients either living in the vicinity or visiting it. It is purely opportunistic In summary, this application is speculative, no evidence provided of a need in the area and as originally indicated by Mr Morley, purely a duplicated application that the Applicant is submitting to many of the NHS Area team nationally. In the decision letter circulated by NHS England, it is evident that in their opinion only the element of 'choice' was enough to grant this new application, and the Applicant failed to provide any evidence of the other two benefits. Boots fail to see how this therefore meets the required criteria of an unforeseen benefits application Boots therefore respectfully request therefore that the NHS Litigation Authority quash the original decision by NHS England and reject this application Please be aware that Boots may wish to attend any oral hearing should the NHS Litigation Authority feel it necessary. 4.5 PAYDENS LIMITED

27 Paydens Limited believe that this appeal should be granted and this proposed grant quashed. Paydens Limited reasons for this view are the following NHS England s decision letter states the application has been conditionally approved, a concept that does not appear to be available under these Regulations, and no conditions are specified in the decision letter The current PNA (published less than a year ago) clearly states that current pharmacy services provision is good and provides the pharmaceutical needs of the population as a whole. There have been no significant changes to the provision of NHS pharmaceutical services on the Isle of Sheppey since the current PNA was compiled, agreed and published The Applicant has provided little if any substantive evidence to substantiate his assertion that his proposed pharmacy would confer significant benefits upon patients. Nor has he provided any evidence at all of: patients with protected characteristics experiencing any difficulties in obtaining their pharmaceutical services and any innovative proposals regarding the delivery of pharmaceutical services by his proposed pharmacy Paydens Limited are surprised, and concerned, that in coming to their decision to grant this application NHS England appears to have totally ignored the representations of the Swale CCG, and others, as to the likely consequences of approving this standalone pharmacy application; see the CCG s letter to NHS England dated 12 th August Given that the current Kent PNA for the Swale area was compiled by the Swale CCG one would have expected NHS England to have provided a much stronger argument to justify their ignoring it The CCG s / PNA view was, and apparently still is, that the main deficiency in Sheppey is a 100hr pharmacy, not a standard 40 core hour pharmacy as offered here. A 100hr pharmacy, should it materialise in the future, would, given the population distribution, almost certainly need to be located in the western half of Sheppey to be viable, not as in this case a core 40 hours pharmacy in one of the two most easterly parishes of Sheppey, both of which have, per Kent County Council 2011 census based data, suffered population decreases in the last decade. Paydens Limited believe that rather than the current three limited (and unsuitable) branch surgeries with essential pharmaceutical services being provided by an uneconomic (and probably temporary) mix of dispensing doctors and a standalone core 40 hour pharmacy, the proposed single Health Centre, including a pharmacy, should be the way forward. Paydens Limited therefore share the CCG s and the medical practice s concerns that granting this

28 28 application would be highly likely to result in significant detriment to proper planning for both medical and pharmaceutical services in this increasingly thinly populated eastern end of the island Please note that in the event that the NHS LA Appeal Unit decides to hold an Oral Hearing Paydens Limited would wish to attend such a hearing in order to provide oral representations. SWALE CCG LETTER TO NHS ENGLAND DATED 12 AUGUST 2015 (AS PROVIDED BY PAYDENS LIMITED) This application was discussed at length at the Swale August Primary Care Strategy Group meeting and further due consideration was given by its Head of Commissioning and Head of Medicines Optimisation In summary, although Swale CCG welcome any additional services and investment in the health of residents of Swale CCG, Swale CCG feel that overall granting this application would have a disproportionate adverse effect on the health and wellbeing of its residents. As such, as a CCG Swale CCG are not able to support this application at this time In reaching this decision Swale CCG considered the benefits of additional services from a pharmacy such as MURs and NMS. But Swale CCG noted that the very recently published Swale PNA (the basis of the Market Entry test for pharmacy applications) stated that Swale had 26 pharmaceutical service providers per 100,000 population against a Kent average of 22 and national average of 23. Swale CCG noted 24 of which are pharmacies and 10 are in the Sheerness/Leysdown area. Swale CCG understand most if not all these pharmacies offer collection and deliver services and Electronic Prescription Services, which Swale CCG take to mean that all its residents have, at the very least, adequate access to pharmaceutical services. The CCG is not aware of residents having difficulties in accessing pharmaceutical services or has the Applicant provided any evidence of any such difficulties Hence, the CCG concluded [that] Swale CCG is well served for pharmacies and pharmacy services. The only gap in provision that the PNA identifies is that of an 100 hour pharmacy, by which Swale CCG take it to mean needing additional opening hours on the weekend especially Sunday, which this "40 core hour" application does not address The PNA, recognising that voluntary 100 hours applications to be unlikely, states Pharmacies and dispensing doctors are in the right locations in the locality for patients to access essential services It concludes, 'We therefore recommend that for the NHS Swale CGG area - the current provision of pharmaceutical services is good.and provides the pharmaceutical needs of the population on the whole.

29 29 5 Observations Swale CCG also considered the effect the loss of dispensing services would have on the dispensing practice. In summary, it is the view of the CCG that this application, if granted, would compromise the provision of General Medical Services in the area of Warden Bay, Leysdown and Eastchurch (together East Sheppey) for the following reasons: There has been an under- investment in primary care in the areas listed Currently there are 3 branch surgeries serving this population that are small, old and not fit for purpose. These are run by a main site surgery on the other side of the Isle of Sheppey These sites are only financially viable to the surgery because they have dispensing rights The practice have submitted plans for a new practice premises to serve the population into the future both in terms of a modern, fit for purpose premises but also in terms of attracting and being able to develop the appropriate workforce to work in the branch This will require significant investment, both by the partners of that practice and by NHS England. The partners have stated that it will be financially unviable for them to go ahead with any plans if dispensing rights are taken away from them The loss of the branch surgeries would mean a reduction in the accessibility of medical services for patients in the area, as patients would need to travel to the main site or nearby surgeries These sites are well served existing pharmacies. If current dispensing patients accessed these pharmacies when accessing medical services then the new pharmacy may become unviable leading to the loss of the pharmacy and GP dispensing services Therefore, it is Swale CCG s view that this application would have a destabilising effect on services in the area. So, on balance, the population of East Sheppey would be better served by an investment in a new general practice facility that has dispensing rights than by a new pharmacy that would put the provision of General Medical Services in the area at considerable risk. 5.1 RUSHPORT ADVISORY LLP REPRESENTING MR CHANDARANA (THE APPLICANT)

30 Please find final observations of behalf of the Applicant Mr S Chandarana The Applicant notes that there is no further detail from Mr Morley on behalf of the Appellant St Georges Medical Centre who submitted the appeal following the approval of the application by NHS England. Boots: Boots description of Leysdown on Sea as a small resort and their submission of a NASA map is really not relevant or substantiated. The Applicant has clearly provided accurate statistics from Census 2011 data which the Appeal Unit are in receipt of In terms of choice the test is whether there is reasonable choice and the factors submitted by the Applicant go much further than distance alone as suggested by Boots The Applicant has made the case for reasonable choice not being satisfied based on: Distance Accessibility on foot, by car, public transport People residing in Swale 006A Deprivation factors Health issues Mobility issues Transport/ accessibility issues NHS England being in agreement in terms of reasonable choice: b) As will be seen from Appendix A, the proposed location is towards the eastern end of the Isle of Sheppey. The nearest existing community pharmacies to that location are either the Sheppey Hospital Pharmacy. Sheppey Hospital, Plover Road, Minster, Sheppey ME12 3LT or Minster Pharmacy Trafalgar Place. The Broadway Minster, Sheppey, ME12 2RW. These are respectively 9.3 km (5.7 miles) and 9.8 km ((6 miles) away from the proposed site and these journey would take approximately 13 minutes by car. Both the distances and journey times are taken from Google maps. Bus services are available and run at varying times, sometimes with a gap of an hour between departures and have a journey time of approximately 35 minutes each way meaning that a return trip could take up to 3 hours depending on service timings.

31 The Applicant has been very clear in terms of people with a shared characteristic who experience difficulty accessing pharmaceutical services. The Appeal Unit is in receipt of the Applicant s definitions, number of people locally and comparisons to the wider area. In terms of the Regulations the Applicant has identified significant numbers of people within 1.6km of the application site that are aged, in poor health and lack mobility due to health and disabilities or lack of transport. In this case the Applicant knows these people have shared characteristics and as the data is in relation to Swale 006A the Applicant knows where these people live. As objectors have stated the area surrounding Leysdown On Sea is rural in nature this further reinforces that the people identified live immediately around the application site. This is sufficient detail for the Appeal Unit to be satisfied that this application will deliver better / improved access to pharmaceutical services where a need / unforeseen benefit has been identified. Boots though obviously don t believe this is sufficient and question the relevance of Census statistics therefore we submit a survey conducted with those very same people who reside around the application site and this clearly shows that access issues are currently detrimental to people accessing pharmaceutical services and that this application will provide significant benefits Boots challenge that the area is not deprived in nature; the Applicant respectfully refer the Appeal Unit to correspondence submitted by the Applicant to NHS England which clearly shows that in almost all deprivation factors the area of the application is clearly a more deprived location than the wider area. Additionally NHS England supports this fact: The PNA published last year contained a number of maps designed to give an overview of the areas covered by the various CCGs in Kent. The Isle of Sheppey, which contains the site proposed by this application, falls under the auspices of the Swale CCG. Attached as Appendix B is a map published as part of that document and which shows multiple deprivation quintiles within that CCG as of This shows that the three LSOAs that make up the eastern half of the Isle of Sheppey fell within the 5 th quartile (i.e. the 20% most deprived). The proposed site is indicated and is towards the very east of that area. That area contains no providers of pharmaceutical services, only three branch surgeries of the Appellant s medical practices providing dispensing services. Given the enhanced role of community pharmacists, NHS England would maintain that this is a clear demonstration of there being no reasonable choice with regard to obtaining pharmaceutical services (Regulation 18(2)(b)(ii) refers) The 2001 census data shows that 36.05% of the residents of the most eastern LSOA (Swale 006A) on the Isle of Sheppey (this containing the proposed site) said that their health was fair,

32 32 bad or very bad. This is nearly twice the percentage of only 19.81% describing their health as such within the wider area of Swale (Non-Metropolitan District). Taking the same source, only 29.6% of the households in that LSOA had access to two or more vehicles compared to 37.5% over the wider area The Applicant made a full reply to representations following NHS England s consultation of the application. The Applicant is sure NHS England can confirm. It is most likely that Boots has been remiss and have obviously not considered the detail of the application before jumping to their objections baseless. Paydens Limited: The PNA does not identify a need and therefore the Applicant has made the application under Regulation 18 Unforeseen Benefits As per the objections from Paydens the Applicant respectfully refer the Appeal Unit to the Applicant s submissions to NHS England and the Appeal Unit dated 22 October 2015 and 26 January 2016 respectfully, these documents clearly contain a full and factually based case which satisfies the Regulatory tests Paydens state that the PNA was compiled by Swale CCG; this isn t and can t be the case as the responsibility for health planning lies with the Local Authority Health and Wellbeing Board. What Paydens mean is the CCG was consulted as part of the process along with all other stakeholders as the PNA clearly states The Applicant does not understand the relevance of the points re: 100 hour and standard 40 hour pharmacies and their distribution across Sheppey. The only relevant point that should be considered is that the PNA does not identify a need and therefore this application secures unforeseen benefits as per Regulation In terms of Paydens point in relation to detriment to proper planning there is nothing submitted and has been nothing submitted during the application process to identify that any detriment would occur by allowing the Applicant s application. Terms such as We believe etc. do not substantiate any detriment. The Regulations require the Applicant to submit a full and reasoned case as to how it satisfies the Regulations and likewise it is for objecting parties to be as diligent in providing substance to any argument of detriment and there is nothing of substance In terms of the CCG letter the Applicant concurs with NHS England and their rationale: comments received from Kent LPC. These seem, with respect, to concentrate more on the possible financial

33 33 implications for the Appellant practice rather than the need, or otherwise, for a new pharmacy in this part of the Isle of Sheppey. Such implications are not ones which NHS England can take into account as was made clear in section 4 of the decision letter when reference was made to the 1996 case of R v- North Yorkshire FHSA ex parte Dr. Wilson and Partners, Mr. Justice Carnwath said It is not part of the scheme of those regulations or indeed of the statute that pharmaceutical services should be relied upon to provide financial underpinning for medical services which are intended to be financed in other ways In any case, as NHS England has determined that the area meets the criteria of a reserved location. In that situation, those issues are irrelevant as the Appellant practice will be able to continue providing dispensing services at the same level as they do now; should the decision of NHS England be confirmed The Applicant believes that this application should be granted and look forward to hearing further in due course. 5.2 MR N MORLEY REPRESENTING ST GEORGES MEDICAL CENTRE (THE APPELLANT) The Appellant notes that there have been no appeals or representations that the application is not in a reserved location in general and the Applicant has accepted by default that his application is in a reserved location. Conclusion 6 Late Observations In view of the fact that there have been no appeals or representations against the finding that the application is in a reserved location, the Appellant respectfully invite the NHS Litigation Authority to determine that the application is indeed in a reserved location The Appellant would say that on at least the balance of probabilities it is clear that the weight of evidence should allow the relevant committee of the NHS LA to grant the appeal and refuse this application. The Appellant respectfully invite the NHS Litigation Authority to refuse the Applicant a grant of consent to join the pharmaceutical list of NHS England at the above location The Appellant confirms its willingness to attend an NHS LA local oral hearing if such be constituted. 6.1 WARDEN PARISH COUNCIL

34 34 7 Consideration Warden Parish Council has looked again at the submission and are very concerned that this application only sets out the benefit for Leysdown residents, this area is made up of three distinct conurbations, Leysdown, Warden and Bayview At present Warden has a dispensing GP surgery and so have Leysdown, Bayview is situated at least a mile and a half from either. The existing GP practice is planning a very much needed Medical Centre in the heart of our communities which will provide in the short term a dispensing service to all three areas. And in the fullness of time a complete Pharmacy service if allowed The application before [the NHS LA] is solely concentrating on the Leysdown area which will be of minimal use to Warden and Bayview residents in the event that the existing service can no longer be provided at the GPs In Warden we have over 1000 on the electoral roll, plus at the last statistics some 650 children between the ages of 0-17 years If this pharmacy application is agreed it would / could make the building of the medical centre very financially doubtful and this would impact on far more of the population in this highly deprived area As a Parish Council Warden Parish Council would respectfully request that a member of [the NHS LA] panel visit this area before it makes its decision. 7.1 The Pharmacy Appeals Committee ( the Committee ) appointed by the Family Health Services Appeal Unit of the NHS Litigation Authority, had before it the papers considered by NHS England, together with a plan of the area showing existing pharmacies and doctors surgeries and the site of the proposed pharmacy. 7.2 It also had before it the responses to the NHS LA s own statutory consultations. 7.3 On the basis of this information, the Committee considered it was not necessary to hold an Oral Hearing. 7.4 The Committee had regard to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 ( the Regulations ). 7.5 The Committee first considered Regulation 31 of the regulations which states: (1) A routine or excepted application must be refused where paragraph (2) applies (2) This paragraph applies where -

35 35 (a) a person on the pharmaceutical list (which may or may not be the applicant) is providing or has undertaken to provide pharmaceutical services ("the existing services") from - (i) the premises to which the application relates, or (ii) adjacent premises; and (b) the NHSCB is satisfied that it is reasonable to treat the services that the applicant proposes to provide as part of the same service as the existing services (and so the premises to which the application relates and the existing listed chemist premises should be treated as the same site). 7.6 The Committee noted that in its application, the Applicant states that there are no providers of pharmaceutical services adjacent or within close proximity of the best estimate address. NHS England considered that it was not required to refuse the application under Regulation 31. The Committee noted that this view has not been disputed by parties. Based on the information before it, the Committee determined that it was not required to refuse the application under the provisions of Regulation The Committee noted that, if the application were granted, the successful Applicant would - in due course - have to notify NHS England of the precise location of its premises (in accordance with paragraph 31 of Schedule 2). Such a notification would be invalid (and the Applicant would not be able to commence provision of services) if the location then provided would (had it been known now) have led to the application being refused under Regulation There is no dispute that Leysdown on Sea and the surrounding area is in a controlled locality and the application was based on securing improvements or better access to pharmaceutical services in that controlled locality. 7.9 In those circumstances, the application (which is made under Regulation 18 of the Regulations) must be assessed against the provisions of Part 7 of the Regulations and, in particular, Regulation 41 which reads: (1) This paragraph applies to any routine application (a) for inclusion in a pharmaceutical list as an NHS pharmacist; or (b) from an NHS pharmacist included in such a list (i) to relocate to different pharmacy premises in the area of the relevant HWB, or (ii) to open, within the area of the relevant HWB, additional pharmacy premises from which to provide pharmaceutical services,

36 36 where the applicant is seeking the listing of pharmacy premises which are in a controlled locality and the NHSCB is required to notify the application under Part 3 of Schedule 2. (2) If paragraph (1) applies to an application (referred to in this regulation and regulation 42 as A1 ), subject to paragraph (5), the NHSCB must determine whether or not the relevant location, that is (a) the location of the premises for which the applicant is seeking the listing; or (b) if no particular premises are proposed for listing in A1, the location which is the best estimate that the NHSCB is able to make of where the proposed pharmacy premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2, is, on basis of the circumstances that pertained on the day on which A1 was received by the NHSCB, in a reserved location. (3) Subject to regulation 43(2), the area within a 1.6 kilometre radius of a relevant location is a reserved location if (a) the number of individuals residing in that area who are on a patient list (which may be an aggregate number of patients on more than one patient list) is less than 2,750; and (b) the NHSCB is not satisfied that if pharmaceutical services were provided at the relevant location, the use of those services would be similar to, or greater than, the use that might be expected if the number of individuals residing in that area who are on a patient list were 2,750 or more. (4) Before making a determination under paragraph (2) (referred to in this regulation and regulation 42 as D1 ), the NHSCB must (a) notify the persons notified under Part 3 of Schedule 2 about A1 that the NHSCB is required to make D1 (and it may make this notification at the same time as it notifies those persons about A1); and (b) invite them, within a specified period of not less than 30 days, to make representations to the NHSCB with regard to D1 (and the period specified must end no earlier than the date by which the person notified needs to make any representations that they have with regard to A1). (5) The NHSCB must not make a determination under paragraph (2) in respect of A1 in circumstances where an earlier application which was in respect of the relevant premises and to which paragraph (1), regulation 44 of the 2012 Regulations (prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved

37 37 location) or regulation 18ZA of the 2005 Regulations (refusal: premises which are in a controlled locality but not a reserved location) applied was refused (a) for the reasons relating to prejudice in (i) regulation 44(3), (ii) regulation 44(3) of the 2012 Regulations, or (iii) regulation 18ZA(2) of the 2005 Regulations; and (b) within the 5 year period starting on the date on which the proceedings relating to the refusal reached their final outcome and ending on the date on which A1 is made, unless the NHSCB is satisfied that since the date on which the 5 year period started, there has been a substantial and relevant change of circumstances affecting the controlled locality. (6) For the purposes of paragraph (5), the relevant premises are (a) the premises which are proposed for listing; or (b) if no particular premises are proposed for listing in A1, premises at the location which is the best estimate that the NHSCB is able to make of where the proposed listed pharmacy premises would be, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule The Committee considered the issue of reserved location status of Leysdown on Sea given that the answer to that question has an onward impact for the rest of the Committee's consideration The Committee noted that in its decision letter, NHS England state that the total registered population residing within 1.6km of the postcode ME12 4RE is 2,333. The Committee noted that this figure had not been challenged by parties Based on the information before it, the Committee concluded that at the date of the application, the number of patients was less than 2,750 and that the proposed location of the premises would be in a reserved location The Committee noted that no party had suggested that if pharmaceutical services were provided at the relevant location, the use of those services would be similar to, or greater than, the use that might be expected if the number of individuals residing in that area who are on a patient list were 2,750 or more. The Committee determined therefore on the information available to it that the use of pharmaceutical services would not be similar to, or greater than, the use that might be expected if the number of individuals residing in that area who are on a patient list were 2,750 or more.

38 Accordingly the Committee was not required to consider prejudice under Regulation The Committee noted that this was an application for unforeseen benefits and fell to be considered under the provisions of Regulation 18 which states: "(1) If (a) (b) the NHSCB receives a routine application and is required to determine whether it is satisfied that granting the application, or granting it in respect of some only of the services specified in it, would secure improvements, or better access, to pharmaceutical services, or pharmaceutical services of a specified type, in the area of the relevant HWB; and the improvements or better access that would be secured were or was not included in the relevant pharmaceutical needs assessment in accordance with paragraph 4 of Schedule 1, in determining whether it is satisfied as mentioned in section 129(2A) of the 2006 Act (regulations as to pharmaceutical services), the NHSCB must have regard to the matters set out in paragraph (2). (2) Those matters are (a) whether it is satisfied that granting the application would cause significant detriment to (i) (ii) proper planning in respect of the provision of pharmaceutical services in the area of the relevant HWB, or the arrangements the NHSCB has in place for the provision of pharmaceutical services in that area; (b) whether, notwithstanding that the improvements or better access were not included in the relevant pharmaceutical needs assessment, it is satisfied that, having regard in particular to the desirability of (i) (ii) there being a reasonable choice with regard to obtaining pharmaceutical services in the area of the relevant HWB (taking into account also the NHSCB s duties under sections 13I and 13P of the 2006 Act (duty as to patient choice and duty as respects variation in provision of health services)), people who share a protected characteristic having access to services that meet specific needs for pharmaceutical services that, in the area of the relevant HWB, are difficult for them to access (taking into

39 39 account also the NHSCB s duties under section 13G of the 2006 Act (duty as to reducing inequalities)), or (iii) there being innovative approaches taken with regard to the delivery of pharmaceutical services (taking into account also the NHSCB s duties under section 13K of the 2006 Act (duty to promote innovation)), granting the application would confer significant benefits on persons in the area of the relevant HWB which were not foreseen when the relevant pharmaceutical needs assessment was published; (c) (d) (e) (f) whether it is satisfied that it would be desirable to consider, at the same time as the applicant s application, applications from other persons offering to secure the improvements or better access that the applicant is offering to secure; whether it is satisfied that another application offering to secure the improvements or better access has been submitted to it, and it would be desirable to consider, at the same time as the applicant s application, that other application; whether it is satisfied that an appeal relating to another application offering to secure the improvements or better access is pending, and it would be desirable to await the outcome of that appeal before considering the applicant s application; whether the application needs to be deferred or refused by virtue of any provision of Part 5 to 7. (3) The NHSCB need only consider whether it is satisfied in accordance with paragraphs (2)(c) to (e) if it has reached at least a preliminary view (although this may change) that it is satisfied in accordance with paragraph (2)(b)." 7.16 Pursuant to paragraph 9(1)(a) of Schedule 3 to the Regulations, the Committee may: confirm NHS England s decision; quash NHS England s decision and redetermine the application; quash NHS England s decision and, if it considers that there should be a further notification to the parties to make representations, remit the matter to NHS England The Committee considered the Pharmaceutical Needs Assessment ("the PNA") prepared by Kent HWB, conscious that the document provides an analysis of the situation as it was assessed at the date of publication. The Committee bears in mind that, under regulation 6(2), the body responsible for the PNA must make a revised assessment as soon as reasonably practicable

40 40 (after identifying changes that have occurred that are relevant to the granting of applications) unless to do so appears to be a disproportionate response to those changes. Where it appears disproportionate, the responsible body may, but is not obliged to, issue a Supplementary Statement under regulation 6(3). Such a statement then forms part of the PNA. The Committee noted that the PNA was dated March The Committee noted that NHS England, when it had provided its paperwork had provided a link to a document entitled Kent PNA, NHS Swale CCG which was also dated March The Committee noted that parties had made reference to both documents which were noted above. The Swale CCG Kent PNA document states that it should: be read in conjunction with the main Kent PNA This CCG area was divided into two separate localities, Sittingbourne, and the Isle of Sheppey for the purposes of this assessment The majority of deprived areas in Swale are found on the Isle of Sheppey Additionally, evidence through consultation shows the need for 100hr contract provision on the Isle of Sheppey and in the town of Dover and The provision of pharmaceutical services outside of the standard 40 core hours needs to be maintained especially on the Isle of Sheppey The Committee also reviewed and verified the quotes which NHS England had quoted in its decision and the Applicant had made in its representations above from the Kent PNA published by the Kent HWB The Committee noted that the Applicant seeks to provide unforeseen benefits to the residents of and around Leysdown on Sea. The Committee noted that the improvements or better access that the Applicant was claiming would be secured by its application were not included in the relevant pharmaceutical needs assessment in accordance with paragraph 4 of Schedule In order to be satisfied in accordance with Regulation 18(1), regard is to be had to those matters set out at 18(2). The Committee's consideration of the issues is set out below. Regulation 18(2)(a)(i) 7.22 The Committee had regard to "(a) whether it is satisfied that granting the application would cause significant detriment to (i) proper planning in respect of the provision of pharmaceutical services in its area "

41 NHS England stated in its decision letter that it noted there was already good pharmaceutical coverage in the HWB area however it felt that if the application was granted, NHS England would be able to plan for the provision of pharmaceutical services and that existing arrangements for the provision of pharmaceutical services would not cause significant detriment to the planning of pharmaceutical services. Paydens Limited refer to and provided a copy of Swale CCG s representations on the application in support of its assertion that the granting of this application is likely to result in significant detriment to proper planning for both medical and pharmaceutical services at the eastern end of the island. No information was provided to support this assertion. The Committee was mindful that the planning of medical services did not fall to be considered under this limb of the Regulations. The Committee was of the view that the information provided did not demonstrate that the granting of this application would cause significant detriment to the planning of the provision of pharmaceutical services in its area On the basis of the information available, the Committee was not satisfied that, if the application were to be granted and the pharmacy to open, the ability of the NHS England thereafter to plan for the provision of services would be affected in a significant way The Committee was therefore not satisfied that significant detriment to the proper planning of pharmaceutical services would result from a grant of the application. Regulation 18(2)(a)(ii) 7.26 The Committee had regard to "(a) whether it is satisfied that granting the application would cause significant detriment to (ii) the arrangements the NHSCB has in place for the provision of pharmaceutical services in that area" 7.27 NHS England stated in its decision letter that it had no information to demonstrate that pharmaceutical services would be significantly affected by the opening of a further pharmacy as there were no pharmaceutical providers within 9km of the proposed site. NHS England further noted there was a difference between dispensing services provided by doctors and pharmaceutical services provided by a community pharmacist. NHS England had also noted that the area is a reserved locality and as such the local practice would still be able to provide dispensing services. NHS England further noted in its decision that financial effects on income for the practice could not be taken into account The Committee noted comments made by parties in response to the appeal. Paydens Limited refer to Swale CCG s representations to NHS England which states that it considered the adverse effect the loss of dispensing services would have on the dispensing practice. The Committee was of the view that the information provided did not demonstrate that a significant detriment to

42 42 the arrangements currently in place for the provision of pharmaceutical services would result from a grant of the application On the information available, the Committee was therefore not satisfied that significant detriment to the arrangements currently in place for the provision of pharmaceutical services would result from a grant of the application In the absence of any significant detriment as described in Regulation 18(2)(a), the Committee was not obliged to refuse the application and went on to consider Regulation 18(2)(b). Regulation 18(2)(b) 7.31 The Committee had regard to "(b) whether, notwithstanding that the improvements or better access were not included in the relevant pharmaceutical needs assessment, it is satisfied that, having regard in particular to the desirability of (i) (ii) (iii) there being a reasonable choice with regard to obtaining pharmaceutical services in the area of the relevant HWB (taking into account also the NHSCB s duties under sections 13I and 13P of the 2006 Act (duty as to patient choice and duty as respects variation in provision of health services)), people who share a protected characteristic having access to services that meet specific needs for pharmaceutical services that, in the area of the relevant HWB, are difficult for them to access (taking into account also the NHSCB s duties under section 13G of the 2006 Act (duty as to reducing inequalities)), or there being innovative approaches taken with regard to the delivery of pharmaceutical services (taking into account also the NHSCB s duties under section 13K of the 2006 Act (duty to promote innovation)), granting the application would confer significant benefits on persons in the area of the relevant HWB which were not foreseen when the relevant pharmaceutical needs assessment was published" Regulation 18(2)(b)(i) to (iii) 7.32 The Committee noted the Applicant states that the closest pharmacy is 6 miles away. NHS England has stated there are no pharmacies within 9km of the proposed site. Boots state the nearest pharmacy is 5 6 miles away. The Committee is of the view that there is no dispute with regard to the distance to the nearest pharmacy but it is also mindful that distance does not of itself indicate that there is a difficulty in obtaining a choice of pharmaceutical services and went on to consider other factors.

43 The Applicant states that with a distance of 9km to the nearest pharmacy, walking is not a reasonable consideration for well and able people and not possible for people with mobility restrictions. The Committee noted that the distance to the nearest pharmacies had not been disputed, described by parties as being between 5 and 6 miles away. The Committee was of the view that it would not be reasonable to expect people, either with or without mobility issues, to walk in order to access existing pharmaceutical services, however difficulties of access for those on foot did not of itself indicate that there was not a reasonable choice in obtaining pharmaceutical services. The Committee went on to consider ease of access to the nearest pharmacies by private and public transport The Applicant states that the area is deprived. This statement is corroborated by the Kent PNA document published by Swale CCG which states The majority of deprived areas in Swale are found on the Isle of Sheppey. The Applicant provided information in its representations which indicate car or van availability in 2011 in Swale compared poorly to the South East and that 23.2% of people in Swale 006A do not have access to a private vehicle. Boots, in its representations state that the 2011 census information is inconclusive with car ownership at 74% and seasonal holiday makers likely to be closer to 100%. The Committee was mindful that Boots had not provided information to support its assertion with regard to holiday makers. Paydens Ltd provided a copy of Swale CCG s representations on the application. Swale CCG state that there are 10 pharmacies in the Sheerness / Leysdown area and that most pharmacies offer collection and delivery service. The Committee is mindful however that such services are voluntary and can be removed at any time. The Committee considered therefore that there would be a large proportion of people who would need to access current pharmaceutical services by public transport. The Committee noted that the Applicant had provided a bus time table which indicate the service runs half hourly between 8.34am to 9.31am and again at 3.31pm to 5.31pm with an hourly service between 9.31am and 3.31pm. According to the timetable, the journey between Leysdown Bus Terminus and Tesco in Sheerness takes between 39 and 54 minutes apart from one bus at 2.31pm which takes 2 hours. The Applicant describes the bus service as poor and quotes from Warden Parish Council s representations to NHS England that buses are expensive and not very frequent in fact non existent after evening surgery. NHS England has stated that a return trip could take up to 3 hours depending on the service times. Kent LPC, in its representations, state the bus service is regular. The Committee considered the information provided and was of the view that it demonstrates that public transportation is not particularly regular, or is it frequent and does not provide an option into the evening The Committee further noted that the Applicant is proposing to open for 59 hours per week, 40 hours of which will be core hours. The core hours are offered from 9am to 1pm and 2pm to 5pm Monday to Friday and 9am to 12 noon on a Saturday. The Committee noted that it had not been provided with information regarding the opening hours of the existing pharmacies. The Committee was mindful that NHS England could direct the existing pharmacies with regard to their opening hours if there was a need, however,

44 44 given its findings above regarding access to the existing pharmacies from the information provided the granting of this application would lead to significant benefits to patients in terms of improved access during the core hours applied for The Committee was of the view that no information had been provided to demonstrate that for those who do have access to a car are not able to access the existing pharmaceutical services The Committee concluded that based upon the information provided, particularly access to existing provision for those without their own transport, there is not already reasonable choice with regard to obtaining pharmaceutical services in the area of the relevant HWB, such that granting the application would lead to significant benefits based on choice In considering Regulation 18(2)(b)(ii) the Committee was mindful of the need to consider any groups with protected characteristics for the purposes of the Equality Act 2010 and the Committee is therefore required to consider the elimination of discrimination and advancement of equality. The Committee noted that the Applicant, in its application refers to the elderly and those with young families and in its representations the Applicant refers to Age and Disability. Boots state that the average age in the 2011 census is year old, which it states is neither elderly or young families. The Applicant provided data regarding Deprivation Indices in 2015 which show that Health Deprivation is high and the numbers of people claiming health related benefits from August The Committee is mindful of its finding above regarding access to existing pharmaceutical services and was of the view that the elderly, disabled, people with mobility issues and those with young families would experience the same such difficulties in accessing existing pharmaceutical services and that they would therefore derive significant benefits from the grant of this application In considering Regulation 18(2)(b)(iii), the Committee noted that the Applicant states there is no pharmaceutical service and commissioners do not have the option to direct increased hours as again there is no provider of pharmaceutical services, this application thereby does provide innovation in terms of the benefits to be conferred on people in the area. The Committee considered whether there is something more over and above the usual delivery of pharmaceutical services that might be expected from all pharmacies. The Committee was of the view that Regulation 18(2)(b)(iii) is concerned with innovative approaches to the delivery of pharmaceutical services and that the opening of a pharmacy in the area is not of itself innovative. As such, the Committee considered that this was not an innovative approach to the delivery of pharmaceutical services. Regulation 18(2)(b) generally 7.40 The Committee noted the range of services the Applicant is proposing to provide. The Committee is mindful that given the difficulties regarding access to the nearest pharmacies, the granting of this application would lead to significant benefits on persons in the area of the relevant HWB.

45 The Committee noted comments made by parties with regard to the existing medical services, which provide dispensing services. However the Committee was mindful of its finding above that the test in accordance with Regulation 18 does not take into consideration the provision of medical services in the HWB. Further the Committee had found that the area is reserved and as such those currently providing dispensing services could continue to do so The Committee was of the view that in accordance with Regulation 18(2)(b) the granting of this application would confer significant benefits by way of access and choice on persons in the area of the HWB which were not foreseen when the PNA was published. Other considerations 7.43 Having determined that Regulation 18(2)(b) had been satisfied, the Committee needed to have regard to Regulation 18(2)(c) to (e) and found that no information had been provided of applications from other persons that it would be desirable to consider at the same time as the current application or of pending appeals that needed to be considered before determining the current application. Therefore there was no reason to delay this decision No deferral or refusal under Regulation 18(2)(f) was required in this case The Committee considered whether there were any further factors to be taken into account and concluded that there were not The Committee was satisfied that the information provided demonstrates that there is difficulty in accessing current pharmaceutical services such that a pharmacy at the proposed site would provide better access to pharmaceutical services The Committee noted that NHS England, in its decision had conditionally approved the application. The Committee reminded itself that a "conditional approval", under paragraph 33(1) of Schedule 2 to the Regulations does provide for the possibility of a grant being subject to a condition that services will not be provided until "some or all of the future circumstances, as a consequence of which the application was granted, have arisen", but these "future circumstances" are those which are required to have been set out in the PNA (i.e. it is not for NHS England to create conditions as part of the granting of an application). Therefore the Committee determined that the decision of NHS England must be quashed The Committee went on to consider whether there should be a further notification to the parties detailed at paragraph 19 of Schedule 2 of the Regulations to allow them to make representations if they so wished (in which case it would be appropriate to remit the matter to NHS England) or whether it was preferable for the Committee to redetermine the application The Committee noted that representations on Regulation 18 had been sought from parties by NHS England and representations had already been made by parties to NHS England in response. These had been circulated and seen by

46 46 all parties as part of the processing of the application by NHS England. The Committee further noted that when the appeal was circulated representations had been sought from parties on Regulation The Committee concluded that further notification under paragraph 19 of Schedule 2 would not be helpful in this case. 8 DECISION 8.1 The Committee quashes the decision of NHS England and redetermines the application. 8.2 The Committee concluded that the Isle of Sheppey is in a controlled locality and that the site of the application is in a reserved location. 8.3 The Committee therefore did not have the need to consider prejudice. 8.4 The Committee has considered whether the granting of the application would cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area covered by the HWB, or the arrangements in place for the provision of pharmaceutical services in that area and is not satisfied that it would; 8.5 The Committee determined that the application should be granted on the following basis: The Committee has also considered whether the granting of the application would confer significant benefits and has had regard to the fact that there is not already a reasonable choice with regard to obtaining pharmaceutical services, there is evidence of people sharing a protected characteristic having difficulty in accessing pharmaceutical services, and there is no evidence that innovative approaches would be taken with regard to the delivery of pharmaceutical services; Having taken these matters into account, the Committee is satisfied that granting the application would confer significant benefits as outlined above that would secure improvements or better access to pharmaceutical services. 8.6 The application is granted.

47 47 Alison McCafferty FHSAU Case Manager A copy of this decision is being sent to: Rushport Advisory LLP (Representing Mr S Chandarana, the Applicant) NHS England Mr N Morley (Representing St Georges Medical Centre, the Appellant) Kent LPC Boots UK Ltd Paydens Ltd Warden Parish Council