Sha/23372 Appeal Against Nhs Commissioning Board

Home , Biddenham, Dunstable, Linslade, Shortstown, Wixams

1 September 2020 Arena Point Merrion Way Leeds LS2 8PA REF: SHA/23372

Tel: 0203 928 2000 APPEAL AGAINST NHS COMMISSIONING BOARD - Fax: 0207 821 0029 NHS ENGLAND & NHS IMPROVEMENT EAST OF Email: [email protected] ENGLAND ("NHSE&I") DECISION TO REFUSE AN APPLICATION BY KALKI HEALTH LTD, FOR INCLUSION IN THE PHARMACEUTICAL LIST OFFERING UNFORESEEN BENEFITS UNDER REGULATION 18 AT BEDFORD ROAD, BETWEEN WATSON ROAD AND FALCON FIELD, WIXAMS

1 Outcome

1.1 The Pharmacy Appeals Committee (“Committee”), appointed by NHS Resolution, quashes the decision of NHSE&I and redetermines the application.

1.2 The Committee determined that the application should be refused.

NHS Resolution is the operating name of NHS Litigation Authority – we were established in 1995 as a Special Health Authority and are a not-for-profit part of the NHS. Our purpose is to provide expertise to the NHS on resolving concerns fairly, share learning for improvement and preserve resources for patient care. To find out how we use personal information, please read our privacy statement at https://resolution.nhs.uk/privacy-cookies/primary-care- appeals/

Arena Point 1 September 2020 Merrion Way Leeds REF: SHA/23372 LS2 8PA

1 The Application

By application dated 19 July 2019, Kalki Health Ltd (“the Applicant”) applied to NHS Commissioning Board – NHS England & NHS Improvement East of England (“NHSE&I”) for inclusion in the pharmaceutical list offering unforeseen benefits under Regulation 18 at Bedford Road, between Watson Road and Falcon Field, Wixams (map provided). In support of the application it was stated:

1.1 In response to Part 5 of the application form (reference to Regulation 31) the Applicant stated: “There is no pharmacy in the same or adjacent premises to the proposed site.”

Background

1.2 The location of the proposed new pharmacy is the major development near Bedford called Wixams. The Applicant intends to provide all commissioned services and will ensure that all pharmacists employed are accredited to provide these services. The premises will also be accredited.

1.3 Wixams new settlement is 3 miles (5km) south of Bedford and covers an area of approximately 384 hectares. Based upon the site of the former Elstow Storage Depot, it will eventually establish a community of around 10,000 people with potential to expand to around 15,000. It will represent the single largest development in the county and straddles the border between Bedford Borough and central Bedfordshire.

1.4 Wixams will include a town centre and several “villages” with 4,500 homes, 25% of which will be affordable homes, employment land, schools, shops and recreational spaces such as sports pitches, allotments and community buildings. The street design will prioritise safety and facilitate ease of movement using public transport, cycles and walking.

PNA

1.5 Although the PNA mentions the Wixam southern extension, the PNA states “The additional pharmaceutical needs will have to be assessed with actual increase in population.” The PNA therefore has not made a statement as to a need to be provided to meet a current need for pharmaceutical services or a statement of services which would secure improvements or better access in the area and therefore the application falls to be considered under Regulation 18. When considering whether this application secures improvements or better access to pharmaceutical services, the Applicant is aware that NHSE&I has to have regard to the matter set out in Regulation 18(2)(b) and the Applicant deals with these criteria below.

1.6 Choice - “There being a reasonable choice with regard to obtaining pharmaceutical services in the area of the relevant HWB.”

1.7 The nearest pharmacy is 0.9 miles away, Wilstead Pharmacy, and is only open on Mondays to Fridays from 9am to 6pm and is closed on Saturday and Sunday. The Applicant’s pharmacy will be open on Saturday and Sunday. Boots Pharmacy is 1.6 miles away at Interchange Retail Park and Berkley Pharmacy is 1.9 miles away. The walking distance to the nearest pharmacy is approximately 17 minutes across the A6. The lack of any sort of healthcare provision in this developing settlement is surprising as there is already a self-contained community at the Wixams development. The current population is approximately 2,617 people. There is a primary school, secondary school, a Budgens supermarket and a fish and chip shop. There is also a community centre, a garden centre and there will shortly be a train station. The residents’ everyday requirements therefore can be satisfied within the Wixams development. There is therefore a current high need for a pharmacy to offer the population accessible pharmaceutical services and importantly, where there is no surgery, healthcare advice.

1.8 The Wixams Master plan shows that the developers plan to build a health facility with space for 4 GP’s in the town centre. There is significant pressure from the community for a new medical centre and once this is built there will be a need for support of the health centre with pharmaceutical services, in particular dispensing acute prescriptions issued by the surgery.

1.9 In summary, it is clear there is no reasonable choice for the residents for Wixams in relation to the provision of pharmaceutical services.

1.10 Services – “People who share a protected characteristic having access to services that meet specific needs for pharmaceutical services that, in the area of the HWB, are difficult for them to access, …..”

1.11 The Applicant will be providing services for the new residents of the development, particularly those who have difficulty accessing other pharmacies in other areas such as the elderly, infirm, disabled or parents of young children. There is a particularly high need for services in the following areas:-

Pharmaceutical services for children

1.11.1 There are already three schools in the Wixams area;

1.11.2 Lakeview School (Primary) - 444 pupils on their roll;

1.11.3 Wixams Academy (Secondary) - pupil numbers for the year 2017/2018 are 112 . The school opened in September 2017 and they admit a new year 7 group each September. Accordingly, the number of pupils is likely to increase by 112 every year until the first intake reach the second year of sixth form;

1.11.4 Wixams Tree Primary School - as at 8 March 2019, they had 48 pupils. The school capacity is 420.

Pharmaceutical services to the elderly

1.11.5 There will be a high demand for pharmaceutical services for the elderly;

1.11.6 There is a newly opened retirement village in Wixams which contains 230 homes;

1.11.7 A planning application was submitted in November 2018 to build an 80 bedroom care home in Wixams.

1.12 In addition, the developers have covenanted to provide 25% affordable housing in the new development and the connection between low income and ill health, and therefore need for pharmaceutical services, is well known.

1.13 As can be seen from Part 4 of the application, the Pharmacy will provide all essential services, advanced and enhanced services commissioned by the HWB.

1.14 The Pharmacy would also offer a number of free services which would include home delivery, blister pack medication, blood pressure screening, diabetes type II screening, BMI checks, as well as the more usual services that make up the package of essential services. Many of these free services would assist patients with protected characteristics and they are not currently accessible for these people. The commissioned services the Pharmacy would hope to provide would be:

1.14.1 Advanced services:

1.14.1.1 Medicines use review;

1.14.1.2 New medicine service;

1.14.1.3 NUMSAS;

1.14.1.4 Seasonal flu vaccination.

1.14.2 Enhanced services:

1.14.2.1 Minor ailments scheme;

1.14.2.2 Emergency hormonal contraception;

1.14.2.3 Palliative care;

1.14.2.4 Smoking cessation;

1.14.2.5 Supervised methadone;

1.14.2.6 Chlamydia screening;

1.14.2.7 Chlamydia treatment.

1.15 Flu vaccines could be provided at home which would make the service more accessible for patients who are unable to leave their homes and are vulnerable. Vaccination will also be offered as a walk in service.

1.16 The Pharmacy would also aim to become a health living pharmacy: it is noted that the PNA recommends that more pharmacy contractors work towards achieving health living pharmacy status. As well as proactively offering a medicines use review service, the Pharmacy would offer advisory support for carers to enable them to administer medicines. As the pharmacy is open on weekends, it will be able to offer NUMSAS as an advanced service. The pharmacy will deal with referrals from NHS111 and consequently reduce hospital visits for emergency medication.

1.17 The pharmacy would offer free delivery.

1.18 Bedfordshire-wide health concerns include targeting groups at risk of high levels of smoking. The Pharmacy would provide a stop smoking service. Alcohol dependence is also an area of concern for Bedford Council. The pharmacy would support, provide alcohol intervention and signpost patients where necessary.

1.19 The Pharmacy would be close to the wards in Bedford identified as teenage pregnancy hotspots and would want to provide EHC and support other sexual health services as they emerge.

1.20 The Pharmacy would be willing to provide a needle exchange service – presently only two pharmacies in the Bedford area do so.

1.21 The Pharmacy would also provide private services, including flu vaccinations, health checks and other services after opening once needs are identified.

1.22 The Applicant confirms that if any surgery is opened in the development, it will match the surgery hours including early morning surgeries and evening surgeries.

1.23 Innovation – “There being innovative approaches taken with regard to the delivery of pharmaceutical services.”

1.24 The Pharmacy proposes innovative services such as ear wax removal and syringing, mindfulness, nutrition and healthy living workshops and a travel clinic but these will not be offered as NHS services.

1.25 In summary, this is an application from a company with a proven track record of providing good quality services. The application would secure improvements and better access to pharmaceutical services and would provide significant benefits to the community.

1.26 The Applicant intends to provide the following services:

1.26.1 Essential services;

1.26.2 Appliances as listed in Part IV of the Drug Tariff;

1.26.3 Advanced and Enhanced services as indicated at point 1.14.

1.27 The Applicant’s proposed core opening hours are:

1.27.1 Mon to Fri 09.00 to 17.00

1.27.2 Sat -

1.27.3 Sun -

1.28 The Applicant’s proposed total opening hours are:

1.28.1 Mon to Fri 08.30 to 18.30

1.28.2 Sat 09.00 to 14.00

1.28.3 Sun 10.00 to 16.00

2 The Decision

NHSE&I considered and decided to refuse the application. The decision letter dated 18 May 2020 from Primary Care Support England states:

Covering letter

2.1 NHSE&I has considered the application and is writing to confirm that it has been refused. Please see the enclosed report for the full reasoning.

Decision report

Kalki Health Ltd:

Application for inclusion in a pharmaceutical list: routine application offering to secure unforeseen benefits Wixams

And

Burnam Healthcare Ltd

Application for inclusion in a pharmaceutical list: routine application offering to secure unforeseen benefits Wixams

2.2 The Pharmaceutical Services Regulations Committee (hereafter referred to as “the Committee”) considers all pharmaceutical services applications on behalf of NHSE&I in accordance with the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 as amended (hereafter referred to as “the Regulations”).

Background

2.3 Wixams is a new development located just south west of Bedford town centre. It is expected to have 4,500 homes, and is likely to provide housing capacity for people who work in Bedford, Milton Keynes and London. Plans for a railway station in Wixams have been postponed, however there are 3 railway stations within Bedford Borough – Bedford, Bedford St Johns and Kempston Hardwick – all of which are a 10-15 minute drive from the centre of Wixams. There are bus routes into Bedford and surrounding villages.

2.4 Wixams has a convenience store, a community centre, a fish and chip shop and a garden centre with a coffee shop/restaurant, and a veterinary practice. There are 3 schools: Lakeview School (a Nursery and Primary School), Wixams Tree Primary School, and Wixams Acadamy (Secondary School).

2.5 There are at least 30 pharmacies within a 5 mile radius of the centre of the best estimate area as per the NHS website, 13 of these being within 3 miles. The Committee had sight of a report detailing the nearest pharmacy and surgery opening hours which was disseminated to all members and attendees prior to the meeting.

Consideration

2.6 The Committee agreed to consider both applications at the same time.

2.7 The Committee first considered these unforeseen benefits applications under Regulation 31 of the Regulations.

Regulation 31(1) a routine or excepted application must be refused where paragraph (2) applies

Regulation 31(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

(i) the premises from 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 service (and so the premises to which the application relates and the existing listed chemist premises should be treated as the same site).

2.8 The Committee agreed that this condition is not met as there are no existing services from the best estimate of the proposed pharmacy premises or at adjacent premises. There are no existing pharmacies operating from the proposed area and therefore, under this provision, Regulation 31 would not cause the applications to be refused.

2.9 The Committee then went on to consider Regulation 40 of the Regulations.

Regulation 40.—(1) This paragraph applies to all routine applications—

(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, where the applicant is seeking the listing of pharmacy premises which are in a controlled locality.

2.10 The Committee noted that neither of the Applicants has disputed that the area of the best estimate of the proposed premises, where they are seeking listing of pharmacy premises, is within a controlled locality.

2.11 The Committee agreed that Regulation 40(2) is not applicable as there has been no refusal of an application that would impose the 5 year rule.

Regulation 40 (3) For the purposes of paragraphs (1) and (2), if no particular premises are proposed for listing in A1, the applicant is to be treated as seeking the listing of pharmacy 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 2.

2.12 The Committee noted that for the purposes of this regulation NHSE&I determined the best estimate postcode as MK42 6BZ, being the centre of Wixams.

2.13 The Committee next considered whether the location of the proposed pharmacies is in a reserved location as defined in Regulation 41 (3)

Regulation 41(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.

2.14 The Committee noted that on the dates the applications were received, the number of NHS registered patients living within a 1.6 kilometre radius of the centre of Wixams was 3,953.

2.15 The Committee agreed that the reserved location status does not apply.

2.16 The Committee went on to consider Regulation 44 of the Regulations.

2.17 Prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved location

Regulation 44.—(1) This paragraph applies to all routine applications—

(a) for inclusion in a pharmaceutical list as an NHS pharmacist;

(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.

(2) As regards any application to which paragraph (1) applies, the NHSCB must have regard to whether or not the applicant is seeking the listing of pharmacy premises which are in a part of a controlled locality that is not a reserved location.

2.18 The Committee noted that the Applicants are seeking the listing of a pharmacy premises which are in a controlled locality that is not a reserved location.

(3) If the applicant is seeking the listing of pharmacy premises which are in a part of a controlled locality that is not in a reserved location, the NHSCB must refuse the application if granting it would, in the opinion of the NHSCB, prejudice the proper provision of relevant NHS services in the area of—

(a) the relevant HWB; or

(b) a neighbouring HWB of the relevant HWB.

(4) For the purposes of paragraphs (2) and (3), if no particular premises are proposed for listing in the application, the applicant is to be treated as seeking the listing of pharmacy premises which are in a controlled locality if the best estimate that the NHSCB is able to make of where the proposed pharmacy premises would be is at a location which is in a controlled locality, having regard to the best estimate given by the applicant under paragraph 1(7)(a)(ii) of Schedule 2.

2.19 The Committee noted that there are currently no GP practices in Wixams. Most patients living in Wixams are registered at GP practices within Bedford and Ampthill with some registered in Wootton and Shortstown. All these GP practices have pharmacies within close proximity. There is also a pharmacy in the nearby village of Wilstead, within a mile from the location of the best estimate.

2.20 The Committee noted that the representation (submitted for both applications) from Meiklejohn Pharmacy Ltd, mentions that;

2.20.1 “increasing NHS Contracts could have disastrous consequences on small but vital pharmacies”.

2.21 This could be considered as evidence to suggest that existing pharmacies could be prejudiced should the application be granted, however there is no indication as to what these consequences will be. The representation goes on to reference the reduction of the global sum and that the PSNC estimates that hundreds of pharmacies will close. It also stated that the granting of these applications at this stage will result in a significant harm to the existing provision of pharmaceutical services in the relevant area potentially affecting the viability of existing pharmacies. No evidence was provided that pharmacies will close if the application is granted, nor is there any evidence provided that the viability of existing pharmacies will be affected.

2.22 Kalki Health Ltd does not believe that granting the application would prejudice the proper provision of general medical services in the HWBs area, but does not provide any evidence that the application will not prejudice the proper provision of pharmaceutical services in the HWBs area.

2.23 Burnham Healthcare Ltd does not provide any evidence that the application will or will not prejudice the proper provision of pharmaceutical services in the HWBs area.

2.24 The Committee had no evidence before it to suggest if the granting of the application would prejudice the proper provision of relevant NHS services in the HWB or a neighbouring HWB for the relevant HWB. The Committee could therefore not refuse under this regulatory test.

2.25 The Committee went on to consider Regulation 18 of the Regulations.

Regulation18.—

(1) If—

(a) 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

(b) 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,

(c) in determining whether it is satisfied as mentioned in section 129(2A) of the 2006 Act(1) (regulations as to pharmaceutical services), the NHSCB must have regard to the matters set out in paragraph (2).

2.26 The Committee noted that Wixams is listed in both Bedford Borough PNA (2018) and Central Bedfordshire PNA (2018).

2.27 The Bedford Borough PNA (2018) states:

2.27.1 “Key growth locations are currently Land West of Kempston, Biddenham Loop/Gt Denham, Wixams, New Cardington, Wootton, Stewartby and Land North of Bromham Road, Biddenham. Over the last five years completions across the Borough have averaged 938 per year with 2016/17 recording the highest completions on record at 1248 net additional dwellings. Most recent completions have been in and around the urban area, though large sites are also being built out close to the A421 at Wootton and Stewartby. The Local Plan 2035 strategy may see a change to this pattern of growth with more

development allocated in larger villages north of the town than has been the case in recent years.

2.27.2 This PNA takes into consideration the proposed residential development in the Growth Areas in Bedford Borough and the current capacity for pharmaceutical provision. Should the population increase significantly before the PNA is revised in 3 years’ time, the pharmaceutical needs for the growth areas will be reviewed.”

2.28 It also states that 609 dwellings so far have been developed in Wixams and their provision is included in this pharmaceutical needs assessment. Wixams is located on the border with Central Bedfordshire and some residents access pharmaceutical needs in that area.

2.29 The Central Bedfordshire PNA (2018), on page 30, states that the number of homes planned for Wixams southern extension area over the period of time is not large and some of these have already been developed and as such included in the current needs assessment. Additional pharmaceutical needs will have to be assessed with actual increase in population. It also states that residents at Wixams have access to pharmacies in Wilstead, Marston and Ampthill.

2.30 Both PNAs show an analysis of the situation as it was assessed at the date of publication (April 1st 2018) and there have been no revised assessments issued, in the form of a Supplementary Statement under Regulation 6(3), in regard to this area.

2.31 In both PNAs, the conclusion states:

2.31.1 “Overall, the level of pharmaceutical service (as described in the regulations) currently provided across Bedford Borough/Central Bedfordshire meets the health needs of the population and provision of pharmaceutical services is good in our areas of deprivation.”

2.32 The Committee noted the Applicants seek to provide unforeseen benefits to the resident and reliant population in the area surrounding the application and in order to be satisfied in accordance with Regulation 18(1), the criteria set out in Regulation 18(2) should be considered.

(2) Those matters are—

(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 the area of the relevant HWB, or

(ii) the arrangements the NHSCB has in place for the provision of pharmaceutical services in that area;

2.33 The Committee agreed that if the applications were granted and a pharmacy was to open, the ability of NHSE&I to plan for the provision of services would not be significantly affected and therefore it could be concluded that the proposed pharmacy would not cause significant detriment to the proper planning of pharmaceutical services. Further, that granting the application would not cause significant detriment to the arrangements currently in place for the provision of pharmaceutical services.

2.33.1 (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—

2.33.1.1(i) 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(2) (duty as to patient choice and duty as respects variation in provision of health services)),

2.34 The Committee noted there are 30 pharmacies within a 5 mile radius of the proposed location covering opening hours between 08:00 – 22:30, seven days a week.

2.35 The Committee noted both Applicants stated that the nearest pharmacy is not open on a Saturday or Sunday.

2.36 Kalki Health Ltd has proposed core opening hours of 40 hours in order to secure unforeseen benefits, but is not proposing any core hours on a Saturday or Sunday, but will provide supplementary hours at the weekend.

2.37 Both Applicants also proposed that supplementary hours will be provided but the Committee should note that supplementary hours may be withdrawn at any time after giving the required notice period.

2.38 Kalki Health Ltd states that the Wixams residents’ everyday needs can be satisfied within the Wixams development and therefore there is a current high need for a pharmacy to offer the population accessible pharmaceutical services where there is no surgery, healthcare advice.

2.39 The Committee noted that there is no evidence to show that residents of Wixams are currently experiencing any difficulties accessing existing pharmaceutical services in the course of their routine lives, or would receive significant benefits from the granting of one or both applications.

(ii) 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(3) (duty as to reducing inequalities)), and

2.40 The Committee noted that both Applications do not provide any evidence that patients in these patient groups living within the area have difficulties in accessing services that meet any specific needs. Therefore the Committee considered, from the evidence supplied, that any specific patient group, that shares a protected characteristic, would not receive significant benefits from the granting of these applications.

(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(4) (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;

2.41 The Committee had regard to the desirability of innovative approaches to the delivery of pharmaceutical services and considered whether there is something more over and above the usual delivery of pharmaceutical services that might be expected from all pharmacies, some ‘added value’ on offer at the location. The Committee noted the innovative services proposed by Kalki Health Ltd will not be offered as NHS services.

2.42 The Committee agreed that there is no information to suggest that either Applicant is proposing any innovative approaches to the delivery of pharmaceutical services, or any services that cannot be accessed already.

2.43 The Committee reminded themselves that they should be satisfied that granting an application would give significant benefits on the population of Wixams.

Paragraph 31, (Schedule2)

2.44 Conditional grant of applications where the address of the premises is unknown 31.—

(1) As regards any routine application, sub-paragraph (2) applies where—

(a) the applicant (A) is seeking the listing of premises not already listed in relation to A (whether or not A is already included in the pharmaceutical list); and

(b) prior to the determination of the application, A was only able to provide a best estimate of where the proposed listed chemist premises would be (not the address of those premises).

(2) Where this sub-paragraph applies, it is a condition of the grant of that application that A notifies to the NHSCB the address of the premises to be listed within 6 months of—

(a) the date on which A was sent the notice of decision under paragraph 28 (having regard also to paragraph 10(2) of Schedule 3);

(b) if the grant of the application is appealed to the Secretary of State by a person with third party appeal rights, the date on which the appeal is determined by the Secretary of State; or (c) in a case of an application which is subject to a condition imposed by virtue of paragraph 33(2), the date on which that condition becomes spent, whichever is the latest.

(3) A notification under sub-paragraph (2) is only valid if the NHSCB is satisfied that the premises are at a location that is within the range of possible locations covered by the estimate referred to in sub-paragraph (1)(b).

(4) If the NHSCB receives a purported notification under sub-paragraph (2), it must, within 14 days of receiving that purported notification—

(a)notify A of whether or not it is satisfied that it is a valid notification;

(b)if it is satisfied that it is a valid notification, notify the address to the persons notified of the decision to grant the application; and

(c)if the NHSCB is not satisfied that it is a valid notification, it must include with that notification—

(i)the reasons for its decision, and

(ii)an explanation of how A’s rights of appeal under paragraph 36(1)(b) may be exercised.

(5) The NHSCB may not vary or remove a condition imposed by virtue of this paragraph.

(6) If A breaches a condition imposed by virtue of this paragraph, the grant of the application lapses.

2.45 The Committee noted that NHSE&I would need to have regard to this requirement as the proposed location for both applications is for a best estimate and, if approved, the

body corporates would be required to notify the address of the premises within 6 months of the date of any determination.

Decision

2.46 After careful consideration, the Committee refused the Applications from Kalki Health Ltd and Burnam Healthcare Ltd on the following basis:

2.46.1 Bedford Borough’s PNA published in April 2018 did not identify a need for additional pharmaceutical services in the area;

2.46.2 There is already a reasonable choice with regard to obtaining pharmaceutical services;

2.46.3 There is no evidence of people sharing a protected characteristic having difficulty in accessing pharmaceutical services; and

2.46.4 There is no evidence that innovative approaches will be taken with regard to the delivery of innovative pharmaceutical services;

2.46.5 Patients can access an array of Distance Selling pharmacies.

2.47 Appeal rights: The Committee agreed that appeal rights be granted to the Applicants.

3 The Appeal

In a letter dated 3 June 2020 addressed to NHS Resolution, Charles Russell Speechlys LLP appealed on behalf of the Applicant (Kalki Health Ltd) against NHSE&I's decision. The grounds of appeal are:

3.1 The Applicant’s ground of appeal is that NHSE&I, whilst appearing to accept the significant local developments taking place, failed properly to assess whether granting this application would “secure” improvements or better access having regard to these developments and the growing health needs of this new community. Given the level of certainty which exists in relation the Wixams development and the fact that, if granted, the Applicant would have until late 2021 to commence the provision of pharmaceutical services, NHSE&I should have determined this application having regard to the wider context of ongoing developments.

3.2 NHSE&I’s reason to refuse the application appears to be based on the number of pharmacies within a 5-mile radius of the Wixams development. However, this approach was too narrow and simplistic in the context of the size and scale of the development taking place. NHSE&I appears to have failed to give any consideration to the benefits of having a pharmacy located within the development itself in order to secure the pharmaceutical needs of the new and rapidly expanding population.

Background to Wixams development

3.3 In 1999 Bedford Borough Council approved outline planning permission for a new Wixams settlement on a brownfield site on the boundary of Bedford Borough and Central Bedfordshire Councils, comprising 4,500 dwellings, a care home and assisted living complex with associated retail, leisure, road, rail, education and health infrastructure. The s106 requirement for land to be developed into a primary care facility located in the Wixams town centre formed part of that permission.

3.4 The Wixams development is formed of four “villages”, each with a local centre, and then a “town centre” area. This is shown on the map (provided).

3.5 Building work on Village 1 (now known as Lakeview Village) began as early as 2007 with the first units being occupied in 2009. Construction work was initially relatively slow, not least because of the financial crisis and subsequent recession. However, Lakeview Village, providing 950 homes with 25 per cent affordable housing, a new primary school, village shops, community hall and recreational facilities for residents is largely complete. Work has now started on Villages 2 and 4.

3.6 When completed Wixams will include:

3.6.1 4,500 homes;

3.6.2 Over a million square feet of office space;

3.6.3 Warehousing and industrial units;

3.6.4 Four Primary Schools and a Secondary School;

3.6.5 A primary healthcare centre;

3.6.6 A town centre, likely to include a large supermarket;

3.6.7 A retirement village;

3.6.8 A range of shops;

3.6.9 Over 300 acres (1.2 km2) of parkland and public open space, featuring a series of lakes, water bodies and wetland areas. These are a legacy of the former open cast mineral extraction on the site, which lies within the Forest of Marston Vale, a brickmaking and gravel extraction area with many exhausted pits;

3.6.10 A large waste incinerator (capacity 0.5 million tons of waste per annum).

3.7 On completion Wixams will be one of the largest new communities built in the UK in recent times.

Housing development

3.8 As of October 2019, 1,200 homes had been completed and occupied, so over a quarter of the Wixams development. The projected build-out rate is a further 400-500 homes per year, with the last dwellings expected to be completed by 2027/2028, by which time it is projected that 12,000 people will live in the Wixams new town.

3.9 It is estimated that as at June 2020, 1,500 homes have been completed and occupied, with over 4,000 people now living in Wixams. This will increase by a projected 1,000 to 1,300 more inhabitants each year and for the next 7 years.

3.10 In common with most large-scale developments, there is a requirement that 25% of homes will be affordable homes.

Schooling

3.11 In order to facilitate the number of homes proposed and to ensure that the development is sustainable, Wixams will also accommodate 4 primary schools and 1 secondary school.

3.12 Two out of the 4 primary schools have already been constructed and opened: Lakeview School opened to pupils in September 2009 and is now over capacity, with 450 pupils aged from 3 to 11 (its capacity is 420). Wixams Tree Primary opened in September 2017. It currently has 162 pupils on the roll and, again, when full, will have a 420-pupil

capacity. The Wixams Academy, a secondary school, also opened its doors in September 2017 for pupils aged 11 to 19. It currently has 236 pupils on its roll, with a capacity of 824.

3.13 The schools are all located around Lakeside Village, as shown on the map provided (the proposed location for the Applicant’s pharmacy is in the vicinity of the Seasons Garden Centre, which is also shown on the map).

Employment

3.14 Wixams will contain a range of employment opportunities, including industrial units, office space and warehousing. Information taken from the http://www.wixams.org/g- park website gives the following detail regarding planned and existing warehousing and industrial units.

3.15 There are already a number of warehouses either built, being built or planned for Wixams:

3.15.1 Wilstead Industrial Park contains over a dozen warehouses/units; Three new 24/7 units are currently being completed in Wilstead Ind. Park totalling 15,739 m2 (169,400 ft2) with parking for 161 cars and 113 HGVs (source: Wilstead Industrial Park Brochure). These units have no currently planned occupiers. RED;

3.15.2 The B&M warehouse is now operational, it totals 91,000 m2 (979,515 ft2) (source: www.bbc.co.uk/news/uk-england-beds-bucks-herts-43825804). PURPLE;

3.15.3 A new Aldi distribution centre is to be built close to the B&M warehouse, its buildings will total 78,857 m2 (848,809 ft2) and it will have parking for 611 cars and 229 HGV loading docks (source: Planning Application 17 02657 MAR). YELLOW;

3.15.4 5 new units are to be built north of Fisherwood Road totalling 7,358 m2 (79,203 ft2) and will have parking for 109 vehicles (source: Planning Application 19 02398 MAF) ORANGE;

3.15.5 This gives a total of around 250,000 m2 (2.7M ft2) of warehouse/unit space.

3.16 These developments are shown on the photo - map provided (note, also, that the map shows the “Seasons” Garden Centre, which is the Applicant’s proposed location).

3.17 A further planning application has been submitted for 50,000m2 of warehousing in three units which are shown in blue on the map (provided).

Primary Care Centre

3.18 As part of the s106 agreement for the Wixams development, the developers are committed to providing land to the CCG for construction of a new Primary Care Centre in Wixams.

3.19 The CCG is committed to providing this facility, which is anticipated will have a 17,000 patient list size capacity. It is currently in detailed discussions with the developer regarding an appropriate site, with the NHS regarding funding and with local GP surgeries regarding the operation of the Primary Care Centre (two local GP practices have expressed an interest in operating the new surgery).

3.20 The scale of the Wixams development and the distance to existing health care services is putting increased strain on the existing network, with pressure growing for healthcare facilities within Wixams to meet current and anticipated future demand. 14

Retirement village and care home

3.21 Wixams retirement village has now been constructed and is open. It provides 230 one and two bedroom apartments for those aged over 55, available for sale, shared ownership or rental. The village provides the option for residents to receive care support tailored to their needs, and has a range of onsite facilities for the use of residents and non-residents (such as a village hall, library and IT suite, bar and bistro, fitness gym, hairdressing and beauty salon and shop) and organises regular clubs and activities for residents.

3.22 Construction of a new 82-bed care home in Wixams commenced in Q3 of 2019 and is expected to be completed by Q2 of 2021.

3.23 The location of both of these sites is shown on the map (provided).

Shops

3.24 As with any development of this size, there will be a significant number of shops constructed to meet the daily shopping needs of new residents.

3.25 Each of the four “villages” will have its own local centre. The Lakeside Village local centre is already complete and occupied, and houses a Budgens Store and Café together with the Lakeside Village Hall. On Bedford Road (where the Applicant’s pharmacy would be located) is the Seasons Garden Centre and Scotts Veterinary Clinic.

3.26 The town centre will contain a larger range of shops and services, including up to 10 shops, an Assembly Hall (which will include a library), a large (8,000m2) supermarket and a gym/fitness centre.

Regulation 18 considerations

3.27 In light of the size and nature of Wixams, the existing pharmacy network does not meet the pharmaceutical needs of this rapidly expanding population in terms of location and service delivery. Taking access and service delivery for the nearest pharmacies, the following difficulties arise:

Distance

3.28 The nearest pharmacy to the proposed location, Wilstead Pharmacy, is 1.1 miles away.

3.29 The distance to Boots Pharmacy is 2.8 miles, Berkeley Pharmacy is 3 miles away, Shortstown Pharmacy and Meiklejohn Pharmacy are both 3.9 miles away.

3.30 Given the size and nature of the new and rapidly expanding population in Wixams, it is unreasonable to expect all residents to have to make journeys of this distance in order to access pharmaceutical services.

Road network

3.31 The journey from Wixams to existing pharmacies is difficult for pedestrians to walk. To access Wilstead Pharmacy patients have two possible routes. The slightly shorter route requires pedestrians to walk along Bedford Road and then to take a pedestrian footpath through open land for approximately 200 metres. That pedestrian footpath includes an underpass underneath the A6 trunk road. The nature of the route is shown on the google street view image (provided).

3.32 In addition to the significant distance, this route is therefore unsuitable for more vulnerable walkers, particularly during inclement weather and outside of daylight hours.

3.33 The alternative route via the road network crosses the A6 at the roundabout junction with Southern Cross. However, this is not an appropriate route for pedestrians as there are no pavements or crossing points at the roundabout as shown in the image provided. There are also no pavements the entire length of Bedford Road from the A6 roundabout into Wilstead village, with that route running through open countryside.

3.34 The route to other pharmacies which are located to the north of Wixams are equally unsuitable for pedestrians. The most direct route is via the A6, but this is a dual carriageway trunk road with no pavements.

3.35 The alternative is to use Wilstead Lane which requires pedestrians to cross the A6 roundabout (which has no pavements or pedestrian crossing facilities) and to walk along Wilstead Lane which, itself, has no pavements or street lighting and runs through open countryside (image provided).

Access by car

3.36 Whilst existing pharmacies are, of course, accessible by car, it is self-evident that not every resident of Wixams will have access to a car when they require access to pharmaceutical services.

3.37 Even for those that do have a car, there are some difficulties. Any route taken requires either joining or crossing the A6 at a roundabout either to the north or south of Wixams, with its associated congestion.

3.38 Wilstead village centre can also be congested, with limited dedicated car parking and on-street parking not always available in the immediate vicinity of the pharmacy.

Bus network

3.39 The bus service between Wixams, Wilstead to the south and Bedford to the north is limited.

3.40 Wixams is served by two bus routes, but each runs only once an hour as shown in the timetables (provided).

3.41 In addition to the above factors which apply to access to all pharmacies within the existing pharmacy network, there are specific access issues which apply to the nearest pharmacies.

3.42 Wilstead Pharmacy is located within the village of Wilstead, which is entirely separate and distinct from Wixams and is located on the other side of the A6. Wilstead Pharmacy is not in a convenient location for those living in Wixams because it is not in a location which would be passed by residents as part of their daily lives, so they would have to make a special journey to access Wilstead. That issue becomes compounded as more and more services become available within Wixams itself.

3.43 Wilstead Pharmacy itself is extremely busy, dispensing approximately 11,000 items per month and undertaking a large number of MURs and NMS. This is significantly above the national average (of approximately 7,000 items per pharmacy per month) and suggests an increased pressure on local health services.

3.44 Other pharmacies are located in Bedford, to the north of the A421, which is similarly separate and distinct from the Wixams development.

Regulation 18(2)

3.45 Having regard to the information above, granting the application would secure improvements and better access to pharmaceutical services which are not contained within the relevant PNA. 16

3.46 The relevant PNA is the 2018-2021 Bedford Borough HWB Pharmaceutical Needs Assessment. Whilst the PNA referred to the Wixams development (amongst others), it does not appear to have made a proper assessment of the size and scale of the development or its impact on access. It is now also over 2 years old, and relies on data that appears to have been gathered in 2017.

Regulation 18(2)(a)

3.47 The Applicant does not believe that granting its application would cause significant detriment either to proper planning in respect of the provision of pharmaceutical services or to the arrangements in place for the provision of pharmaceutical services in the HWB’s area.

Regulation 18(2)(b)(i)

3.48 The provision of pharmaceutical services must keep pace with population growth both in terms of the location of pharmacies and overall capacity in order to maintain a reasonable choice of service provision.

3.49 In its Executive Summary, the Bedford Borough PNA notes that there are 23 pharmacies per 100,000 population, which is broadly in line with the national average. This is one pharmacy for every 4,300 residents approximately.

3.50 Assuming a need to maintain at least the stated ratio of 23 pharmacies per 100,000 in order to meet overall demand for pharmaceutical services in the Borough (the PNA does not state that there is an oversupply of pharmacy provision), a development the size of Wixams (which is the size of a town) would have to contain 2 or possibly 3 pharmacies. Since there are already approximately 4,000 people now living in Wixams, a new pharmacy would maintain the current ratio of one pharmacy for every 4,300 residents. Not to grant a new pharmacy application for Wixams will result in supply failing to keep pace with population growth, leading to a diminution in choice.

3.51 There is also a geographical reduction in patient choice which arises as a result of the large-scale development taking place in Wixams. Pharmacies must be located in areas where there is a need for pharmaceutical services in order to secure a reasonable choice: a pharmacy which is difficult to access cannot secure a choice.

3.52 This is particularly relevant in Wixams, where there is a rapidly expanding population with the construction of related services such as schools, shops and local amenities such as parks and playgrounds.

3.53 The current population in Wixams and the population which will move into the new community in the short to medium term has a need for pharmaceutical service provision, both in terms of essential services but also in relation to commissioned services. Locally commissioned services in Bedford include a stop smoking service, sexual health services, supervised administration, needle exchange and an out of hours service (pharmacy rota for Christmas and Easter holidays).

3.54 This range of services, together with national services such as flu vaccination and the community pharmacy consultant service are of particular benefit in communities where there is no other healthcare provision, making community pharmacy an essential first point of contact, reducing pressure in GP practices and the need for patients to travel outside the local area in order to access healthcare advice and provision.

3.55 Granting this application will secure a reasonable choice for residents of Wixams and would confer significant benefits on the population.

Regulation 18(2)(b)(ii)

3.56 As stated above, Wixams has a significant and growing resident population which has specific health needs. For example, parents with small children have a need for services such as support for self-care when their child is unwell; where patients require dispensing services otherwise than immediately after a visit to their GP (for example for repeat prescriptions or ETP) there is and will be need for dispensing services; young women will require access to EHC; elderly residents and those with specified health conditions will require a flu vaccination; those signposted by NHS111 will require access to the CPCS, etc.

3.57 It is currently difficult for patients to access the pharmaceutical services that they need as a result of a protected characteristic for the reasons given above.

3.58 Granting this application would secure the provision of pharmaceutical services in Wixams and at a location which is in the heart of the new community (within walking distance of the Lakeside Village amenities and on Bedford Road, so highly visible). The proposed pharmacy location will have ample free car parking and will be easily accessible.

3.59 Granting the application will therefore confer significant benefits in terms of access to pharmaceutical services because it will overcome the difficulties that currently exist in terms of access.

Conclusion

3.60 In conclusion, for the reasons given above and those given in the application, the Applicant invites NHS Resolution to conclude that granting this application would secure improvements and better access to pharmaceutical services and to grant the application.

4 Summary of Representations

This is a summary of representations received on the appeal.

NHSE&I

4.1 NHSE&I has nothing further to add in respect of the application.

4.2 The matter was considered by the Pharmaceutical Services Regulations Committee (PSRC) at its meeting on the 26 March 2020. NHSE&I stands by the decision made by the PSRC on 26 March 2020 to refuse the application. The decision made was based on the information in the application and the representations of interested parties received at the time.

Bedfordshire Local Pharmaceutical Committee (LPC)

4.3 Please refer to the previous comments in the LPC’s letter dated 4 October 2019, attached for convenience. These comments remain relevant.

4.4 The LPC agrees with the decision by NHSE&I to reject the application offering unforeseen benefits by Khalki Health Limited, received on 18 May 2020.

4.5 The LPC have the following additional comments to make.

4.6 It is the LPC’s understanding that although building work at Wixams is taking place the development is, as yet not complete and the additional dwellings that have been completed are a small fraction of the projected proposed development. Furthermore, the LPC have been advised by Bedford Borough Planning Policy Department that it may be some years before the development’s proposed town centre will be complete.

4.7 The development has been underway since 2007 and still appears to be someway off being complete.

4.8 This is reflected in the PNA for the area.

4.9 Refer to Page 30

4.9.1 Areas of Housing Developments - The Wixam southern extension;

4.9.2 Proposed development (up to 2031) – 500 new homes;

4.9.3 Current Pharmaceutical provision - Residents at Wixams have access to pharmacies in Wilstead, Marston and Ampthill.

Note – the LPC would suggest that existing pharmaceutical provision in and around the Bedford Town area should also be factored in here.

4.9.4 Comments - The number of homes planned for this area over the period of time is not large and some of these have already been developed and as such included in the current needs assessment. Additional pharmaceutical needs will have to be assessed with actual increase in population.

4.10 With reference to Regulation 18(2)(b) there is no evidence to support the view that patients do not currently have access to a reasonable choice of pharmaceutical services. The existing pharmacies provide adequate services and access to pharmaceutical care throughout the week.

4.11 There are adequate pharmaceutical services for those who share a protected characteristic.

4.12 Wixams Retirement Village and the Wixams area are both easily accessible; located directly off the A6 with good connections to Bedford town centre. The road network for the area has recently been updated and improved to support this.

4.13 Taking into consideration the above, the LPC suggest that the timing of the application is premature.

Bedfordshire LPC’s letter to Primary Care Support England dated 4 October 2019

4.14 NHSE&I has advised that the proposed location is within a controlled locality. They have reported that there are 3,953 patients registered within 1.6km of the proposed location (MK42 6AE). NHSE&I must first determine whether the proposed pharmacy is within a reserved locality.

4.15 Bedfordshire LPC has following observations.

The relevant Area

4.16 Wixams is planned to ultimately consist of four "villages" with an eventual total of 4,500 homes.

4.17 Village 1 (Lakeview) and Village 2 will be largely residential, Village 3 will house the proposed commercial and shopping centre and Village 4 will include a new rail link and railway station.

4.18 There are between 950 and 1,000 dwellings completed in Village 1 and 66 competed in Village 2, where the application has been made. Over the next 10 to 15 years it is expected that between 120 and 150 additional dwellings will be completed per year, subject to the economic climate at the time.

4.19 There is currently a small community centre in the village with a hall and a few retail units, including a Budgens supermarket. Lakeview Lower School has an enrolment of 450 pupils.

Access to Services

4.20 There are no GP surgeries Wixams. There is a branch surgery of the Ampthill Medical Centre, located in the adjacent village of Wilstead, which provides a clinic on the first and second Tuesday of every month in the Methodist Church Hall.

4.21 The distance from the proposed application site in Wixams to Wilstead Pharmacy is approximately one mile by car.

4.22 There is a shorter route for pedestrians, starting from the community centre and along the Bedford Road towards Wilstead. The route proceeds towards Wilstead via a pedestrian underpass under the A6 and emerging on the Wilstead side a short distance from the Church hall - total distance 0.85 miles and taking 20 minutes on foot.

4.23 The underpass itself is short and brightly lit. The route is also well lit and the pavements have stepped kerbs along most of the way. There is a noticeable incline for a short distance to the entrance to the underpass.

4.24 There are regular bus services linking Wixams to Wilstead and Bedford.

4.25 Car ownership in Wixams is higher than the percentage in Bedford with over 50% of residents owning two or more cars (Ward Profiles 2011).

Existing Pharmacy Provision

4.26 The Applicant has stated that they propose to provide pharmaceutical services at the pharmacy to include a Minor Ailments service and Health checks. At present these are not locally commissioned community pharmacy services.

4.27 The Applicant is proposing to provide seasonal flu vaccination, which the LPC assume to mean the NHS Flu vaccination service. They also propose separately to provide Flu vaccinations which the LPC assume will be provided privately to patients.

4.28 The nearest pharmacy to the development is in the village of Wilstead which can be accessed via the underpass (see above) or by car approx. 1.4 miles.

4.29 There is adequate provision of pharmaceutical services from community pharmacies in the vicinity of the proposed location.

4.30 The Applicant says that there is a current ‘high need for a pharmacy to offer the population accessible pharmaceutical services’ but they fail to say how that they will address this, without recognising the wide range of pharmaceutical services presently be provided by existing community pharmacies within the area.

4.31 The Applicant states that they aim to become a Healthy Living Pharmacy. All community pharmacies will be required to become Healthy Living Pharmacies.

4.32 They also state that they will deal with referrals from NHS 111; all community pharmacies from October 2019 will be able to accept NHS 111 referrals via the new Community Pharmacy Consultation Service (CPCS).

4.33 The Applicant has not suggested that they will be providing any original or innovative services for the population at Wixams that are not already being providing by the existing pharmacies.

4.34 Nor have they suggested that they will be providing services to those members of the community with a protected characteristic, which is not already being provided.

4.35 Bedfordshire LPC suggests that the application is considered as being premature and that the existing pharmaceutical service provision is adequate in relation to the current population size. Bedford Borough’s PNA published in April 2018 did not identify a need for additional pharmaceutical services in the area.

4.36 Bedfordshire LPC suggests that granting the application at this stage will result in a significant detriment to the existing provision of pharmaceutical services in the relevant area, potentially affecting the viability of existing pharmacies.

Meiklejohn Pharmacy Ltd

4.37 Please refer to the previous comments and as they remain relevant.

4.38 Meiklejohn Pharmacy Ltd agree with the decision by NHSE&I to reject the application offering unforeseen benefits by Khalki Health Limited, received on 18 May 2020.

4.39 The following additional comments are to be take into consideration:

4.39.1 As advised by Bedford Borough Planning Policy Department to date only 1,150 homes have been built and occupations are very slow especially over the Covid-19 period. It has taken 10 years to build 950 homes and at the current, building rate is very slow and is likely to remain so due to Covid-19 and with the likely pending financial crisis, this can only reduce the build rates in the forthcoming years. This is reflected in the PNA for the area.

4.39.2 There is no evidence to support the view that patients do not currently have access to a reasonable choice of pharmaceutical services. The existing pharmacies provide adequate services and access to pharmaceutical care throughout the week, with reference to Regulation 18(2)(b).There are adequate pharmaceutical services for those who share a protected characteristic.

4.39.3 Both Wixams Retirement Village and the Wixams are easily accessible; there is Park and Ride on the A6 as well and so connections into Bedford are good.

4.39.4 The timing of this application is premature, taking into account the above.

Undated letter Meiklejohn Pharmacy Ltd to NHSE&I

4.40 Comments on the application from Kalki Health offering unforeseen benefits at Wixams in Bedfordshire.

4.41 The proposed location is within a controlled locality as advised by NHSE&I, they further report that there are 3,953 patients registered within 1.6km of the proposed location. Currently there are no GP Surgery in the Wixams Development.

4.42 There are good road and bus links between Wixams and Bedford, hence access and travel time to other pharmacies is relatively short, Wilstead Pharmacy is within one mile driving distance and within 20 minutes walking distance of the proposed location, access to this pharmacy is via a well-lit underpass under the A6 road.

4.43 There are above average percentage of car owners here with many families having multiple car’s.

4.44 Central Bedfordshire pharmaceutical needs assessment 2018-2021 states: ‘’This PNA takes into consideration the areas of proposed residential development and the current capacity for pharmaceutical provision. The Wixams southern extension 500 new homes

(sic). Residents at Wixams have access to pharmacies in Wilstead, Marston and Ampthill.” It concludes, ‘’The number of homes planned for this area over the period of time is not large and some of these have already been developed and as such included in the current need’s assessment. Additional pharmaceutical needs will have to be assessed with actual increase in population’’.

4.45 This application for a pharmacy is within a few miles of:

4.45.1 McLaren Pharmacy;

4.45.2 Wilstead Pharmacy;

4.45.3 Wootton pharmacy;

4.45.4 Boots Pharmacy;

4.45.5 Berkeley pharmacy;

4.45.6 Shortstown Pharmacy;

4.45.7 Meiklejohn Pharmacy;

4.45.8 2 Lloyds Pharmacy.

4.46 As NHSE&I are aware many of these pharmacies are open on the weekends and provide free delivery service. NHS funding for community pharmacy has seen a cut in funding since 2016 and a renewed emphasis placed on clinical services. Clustering of pharmacies undermines the existing network and moves pharmacies away from the deprived communities where they are most needed. Berkeley pharmacy is within a very deprived ward and as a pharmacy is able to provide all the aforementioned services that this application suggests as can most of the other pharmacies who are moving to a more clinical focused patient centrist care model and will enhance their service offerings to the 2,500 residents of the Wixam’s development. Meiklejohn Pharmacy Ltd are experienced in providing care home-based services to elderly patients in care homes and this is extended to areas such as Wixam, Wootton, Wilstead, Cotton End.

4.47 NHSE&I is empowered by the tax payers to invest in health providers which can provide additional and advantageous services to the general public however in this case the same health provider is within a practical proximity to accommodate pharmaceutical needs for patients. The country cannot afford an unlimited number of pharmacies. There could be a pharmacy on every street corner, which would be great for access and choice, but it would be unaffordable and unsustainable. The pharmacy network is about so much more than just dispensing prescriptions. It is about public health, care of long-term conditions and helping people to stay independent in their own homes. Using a blunt instrument like increasing NHS contracts could have disastrous consequences on small but vital pharmacies. These are the backbone of an essential infrastructure that should be protected.

4.48 This application does not suggest that it will provide any services that are new, innovative and different to those already provided by the existing pharmacies. The needs of the local community members with protected characteristics are already well served by all the pharmacies mentioned.

4.49 The annual global sum is remaining at its reduced level of £2.592 billion for the next five years, and medicines use reviews (MURs) phased out in favour of new clinical services. The DH used the term “clustering” to justify the 12% cut to pharmacy funding in England in 2016, claiming that “40% of pharmacies are in a cluster where there are three or more pharmacies within 10 minutes’ walk”. Since then, PSNC estimates there have been 233 confirmed pharmacy closures – with hundreds more expected.

4.50 Elstow New Settlement Planning and Development Brief 1999 outlines that the end outcome would be like to see 10,000 residents living in 4 to 5 villages however 20 years on there are only 2,500 people living in the new development area with only village 1 completed. Master development company Gallagher Estates responsible for the current development in Wixam have most recently been acquired by L&Q in 2017. Referring to Brexit, ‘The housing’ reported that the 95,000-home housing association (L&Q) said that the whole housing sector “is operating in one of the most challenging environments in recent history”. In August 2019 they confirmed , its financial statements confirmed a 42% drop in surplus for 2018/19 to £202m, down from £350m, as turnover fell and costs rose. David Montague, chief executive at L&Q, said: “We have already slowed our development programme and will now pause taking on new projects for the moment’’. Brexit has complicated and increased costs implicit in development of housing projects and it may interfere with the desired housing for 10,000 people in Wixam. The original plan for the Wixams development included the provision of a railway station. However, there has been considerable delays and an absence of any progress on building a station through the planning process. Progress in this area has been limited which impairs influx of residents into the Wixam development. Wilstead and South Bedford pharmacies and Houghton Conquest are in close proximities offering free deliveries and all services proposed by new application. Berkeley pharmacy ideally located alongside Boots and Wilstead to provide all the patient requirements for Wixam patients and are able to provide off site flu vaccinations to care homes in Wixam. Prescriptions can be fulfilled without issue in these areas.

4.51 The Applicant states that they aim to become a Healthy Living Pharmacy. All community pharmacies will be required to become Healthy Living Pharmacies.

4.52 They also state that they will deal with referrals from NHS 111; all community pharmacies from October 2019 will be able to accept NHS 111 referrals via the new Community Pharmacy Consultation Service (CPCS).

4.53 Meiklejohn pharmacy Ltd considers this application as being premature and that the existing pharmaceutical service provision is adequate. The granting of this application at this stage will result in a significant harm to the existing provision of pharmaceutical services in the relevant area potentially affecting the viability of existing pharmacies.

Wilstead Pharmacy

4.54 Wilstead Pharmacy has attached its initial appeal letter for the Committee’s attention.

4.55 Further to the letter, Wilstead Pharmacy will attempt to respond to the points made by Charles Russell.

4.56 With reference to ‘As of October 2019, 1,200 homes had been completed and occupied, so over a quarter of the Wixams development’, this would imply that since the inception of Wixams in 2007 that 25% of the development has been completed, in turn, using this as a metrics guideline, this would mean that 100% of the development would be expected to be completed by 2059. This is based on the current actual performance. Furthermore, with the current Covid-19 delays, this will have a further consequential delay on the completion of the development, not to mention the deep recession we are likely to face and a potential subsequent housing market crash which may hinder the progress of the development further.

4.57 In the original application made by Kalki Health Ltd, they stated the population of Wixams being 2,617. Since the inception of Wixams in 2007, this equates to 218 residents per year. Based on these calculations, the current population would be approx. 2,835. Over which time Wilstead pharmacy has been providing an adequate service to the residents of Wixams, including a free delivery service to all its residents. Even during the Covid-19 Pandemic, where other pharmacies were struggling, Wilstead Pharmacy was able to maintain all pharmacy services, including NMS and MURs.

4.58 Charles Russell discussed the presence of Lakeview School, Wixams Tree Primary and Wixams Academy, however these schools serve a wider area and not just Wixams, where other pharmacies are located. In Wilstead Pharmacy’s experience parents access a pharmacy on behalf of a child at a time and place that is suitable for them. Children who are sick enough to require acute prescriptions are unlikely to be in school.

Primary Care Centre

4.59 As stated in the appeal letter ‘The scale of the Wixams development and the distance to existing health care services is putting increased strain on the existing network, with pressure growing for healthcare facilities within Wixams to meet current and anticipated future demand’- this largely makes reference to GP’s, and the potential need for a GP Surgery on the development, this shouldn’t be confused for the need of a Pharmacy, where current demand is being more than adequately met by both community and online pharmacies.

Retirement Village and Care Home

4.60 Wilstead Pharmacy more than adequately provides the Retirement Village with its pharmaceutical needs, please see a letter of good standing (provided) from the registered Care Manager of the Retirement Village. Wilstead Pharmacy, are Care Home specialists supplying over 20 care homes throughout Bedfordshire, and are more than happy to supply the new Care Home in Wixams if they wish.

Regulation 18 considerations

4.61 Wilstead Pharmacy is 0.9 miles away from Wixams, there is a pedestrian foot path and an underpass directly leading from Wixams into Wilstead, with disability, bike and pedestrian access. The route is easily accessible and straight forward. There is also a bus route running every hour, taking 5 mins and stopping directly outside the pharmacy (photograph provided).

4.62 Please refer to the photo provided displaying the position of the bus stop in relation to Wilstead Pharmacy.

4.63 The pharmacy offers a free delivery service to all residents of Wixams and surrounding areas, the deliveries take place during the working day and in the evenings by Wilstead Pharmacy’s dedicated delivery driver, which circumvents any issues around using the pedestrian path during inclement weather or outside daylight hours. Other local pharmacies also offer similar delivery services, so the residents of Wixams are well serviced.

4.64 Wilstead Pharmacy and other local pharmacies offer telephone consultations/ advice for those patients wishing not to leave their house hold and thus in the majority of cases eliminates the need for patients even having to visit the pharmacy, which works extremely well during local/national outbreaks including the Covid-19 pandemic. The pharmaceutical needs of Wixams are being adequately met by local pharmacies and local online pharmacies including Smarta Healthcare and Pharmacy 2U, which also provide a free delivery service.

Access by car

4.65 The journey by car from Wixams to Wilstead is very straight forward: Please see map (provided) for route.

4.66 As can be seen, the journey takes on average 2 minutes, with very little if any congestion. The journey is very convenient for residents living in Wixams, due to its close proximity and given that the pharmacy is located only 2 minutes away, it wouldn’t be classed as making a ‘special journey’. As can be seen from the image, Wilstead Pharmacy is actually located on the outskirts of Wilstead in close proximity to Wixams,

this way residents can easily access the pharmacy should they wish without having to travel through Wilstead Village.

4.67 A typical part of the Wixams development is shown in the photograph provided, where it can be seen within the development there are a lot of cars parked in driveways, or on the street which can be used by residents to access pharmaceutical services.

4.68 Nearby pharmacies, including: Wilstead pharmacy, Shortstown pharmacy and Boots interchange all have ample free car parking space for patients. Wilstead pharmacy additionally has free off street parking, both of which are in the immediate vicinity of the pharmacy, please refer to photos (provided) (a) demonstrating free car parking directly outside of Wilstead Pharmacy (b) demonstrating free off street parking in the immediate vicinity of Wilstead Pharmacy.

Pharmacy Items

4.69 Wilstead Pharmacy’s average monthly dispensing items is approximately 10,000 items, which comprises of 4,500 items from care homes and the remaining items from community pharmacy services.

4.70 Granting the application of another pharmacy in the local area of Wixams, would have a significant detrimental impact on the financial viability of Wilstead pharmacy. Given the ongoing financial pharmacy cuts, the loss of services and the ever increasing costs related to running a business, the pharmacy would to be in real danger of closure, along with the closure of 142 pharmacies across England as documented by the analysis of Department of Health and Social Care and NHS digital data.

4.71 The pharmacy receives it prescriptions from fifteen different GP surgeries across Bedfordshire, this would not suggest an increase pressure on local health services as patients within Wixams can register with any surgery throughout Bedfordshire, which avoids placing undue stress on specific GP surgeries.

4.72 The pharmacy is more than adequately staffed with sufficient space for dispensing across two floors. The pharmacy has the capacity (both staffing and space) to dispense significantly higher volumes and is actively seeking further items and services to deliver. The Pharmacy is well managed and delivers pharmacy services with no issues.

4.73 Charles Russell suggested that Wilstead Pharmacy is carrying out a large number of MURs and NMS. The MUR service is being decommissioned by the year 2021 which in turn will create an opportunity for the pharmacy to seek/ deliver further services to the local community.

Regulation 18(2)

4.74 Since the inception of the Wixams development in 2007, and over the course of 13 years, out of the four proposed villages and one town centre, only one village ‘village 1’ has been completed. Given that the other proposed villages are larger, the time likely to be taken to complete each village will be a minimum of 13 years assuming the work being carried out remains at the same rate of progress. Given the current halt in work due to the Covid-19 pandemic, this will have a further impact in the delay of the project. With the current climate, and deep financial recession likely to follow, the demand for housing will likely be lower and may further hinder the development due to a lack of public interest.

4.75 From the data that was gathered in 2017 on which the PNA was formed, there has been no significant increase in residents or housing development to warrant a change in the PNA or warrant the granting of a new pharmacy application.

18(2)a

4.76 With the current population and state of the Wixams development, access to pharmaceutical services are more than adequate, being serviced by multiple local community and online pharmacies.

4.77 Granting this application currently will have a detrimental financial/service impact for all local pharmacies as the development is still in its infancy, and in Wilstead Pharmacy’s opinion the appeal/application is immature.

18(2)b

4.78 As stated in the PNA: ‘There has been an increase in the number of community pharmacies in Bedford Borough to provide pharmaceutical services under the NHS pharmacy contract i.e. from 29 in 2011 to 33 as of 31st July 2017 (27 community pharmacies, 3 community pharmacies with 100 hour opening contract and 1 distant selling pharmacy which cannot offer services on the premises but delivers service remotely)’, in addition ‘there are 7 dispensing doctors in Bedford Borough who provide dispensing services to 17,274 patients on their dispensing list. This increases access to pharmaceutical service providers in the area’.

4.79 In the same PNA: ‘Bedford borough has 23 pharmaceutical providers per 100,000 population which is within the range of provision across the country and is higher than the England average’, so the need for an additional pharmacy as mentioned in the appeal by Charles Russell is not required as per the PNA. Granting a pharmacy application for Wixams, would in fact further increase the already high number of pharmacies within Bedfordshire beyond the national average as per the PNA.

4.80 Wilstead pharmacy along with other local pharmacies are well positioned to provide more than adequate access to residents of Wixams in order to meet the provision of patient choice.

4.81 As already mentioned, the population of Wixams is slowly growing, and the current climate is likely to hinder that progress.

4.82 Wilstead Pharmacy alongside other local community pharmacies provide all available locally commissioned services including, stop smoking service and sexual health service as well as national services such as flu vaccinations and community pharmacy consultation services. Services such as supervised methadone and needle exchange are not identified as a need in the JSNA for the area. Wilstead pharmacy is currently in the process of setting up private healthcare services including travel vaccinations and health checks.

4.83 The Applicant does not suggest that they will provide any services that are new, innovative or different to those already provided by existing pharmacies.

4.84 As it stands, there is currently more than adequate choice for residents of Wixams and granting this application would serve no local benefit.

Regulation 18(2)(b)(ii)

4.85 Wilstead Pharmacy and surrounding pharmacies are more than capable of providing the specific health needs for the growing population of Wixams.

4.86 Wilstead pharmacy in conjunction with other local pharmacies offer all the services mentioned by Charles Russel. It is easy for the residents of Wixams to access these pharmacy services through the existing local pharmacy network and there have been no reported issues with access. Wilstead Pharmacy have attached a letter of good standing (provided) from the Parish council, to acknowledge the adequate provision of pharmaceutical services to Wixams and Wilstead by Wilstead Pharmacy.

4.87 Furthermore, Wilstead pharmacy offers a free delivery service running from 9am to 8pm. The pharmacy offers a wide range of OTC products and health care advice from head lice treatment to remedies for coughs and colds as well as EHC/chlamydia testing and treatments.

4.88 Wilstead Pharmacy has built close relations with the retirement village, providing medication for many of the residents already, with a twice a day delivery service. The pharmacy offers dossettes to the elderly and to those that require assistance.

Conclusion

4.89 In conclusion, for the reasons given above, Wilstead Pharmacy considers the proposed appeal and original application to be premature as there is more than adequate pharmaceutical provision locally to provide the current and future needs of the residents of Wixams, especially given that the nearest pharmacy (Wilstead Pharmacy) is only 0.9 miles from Wixams. The Applicant’s appeal should therefore be refused.

Wilstead Pharmacy’s letter to NHSE&I dated 2 October 2019

Re: Application offering unforeseen benefits at best estimate: Bedford Road between Watson Road and Falcon Field by Kalki Health Ltd.

And

Re: Application offering unforeseen benefits at The parade of shops containing Budgens and two other units located on Brooklands Avenue, Wixams Estate, Bedfordshire Best Estimate postcode MK42 6AE by Burnam Healthcare Ltd

4.90 As both applications are for essentially the same location and rely on essentially the same submissions, this reply covers both applications.

4.91 According to the Applicants, Wixams is a new village which has been under construction for some 10 years now. In that time approximately 950 dwellings have been completed, which suggests a population in the region of 2,375 persons once all of these houses are occupied. Wixams has a small range of facilities and those moving to this area will be well aware of the facilities that are available to them. Wilstead Pharmacy assume that people have made the choice to live in this area with this knowledge.

4.92 A second village is to be started in Wixams and if the progress to date is a reliable indicator then it will be 15 or more years before this second village is complete.

4.93 Whilst the Applicant’s mention construction of a “town centre” and other services, most or all of these are no more than plans and the reality is that, in terms of provision for day to day shopping and recreation, services are very limited and the population will look outside of Wixams for most of its needs.

4.94 The Central Bedfordshire PNA 2018 specifically mentions the Wixams development and correctly states that it is “not large” and that residents will have access to the pharmacy in Wilstead and other pharmacies in Marston and Ampthill.

4.95 Burnham Healthcare Ltd say that the construction of the new houses has created a demand for pharmaceutical services within the Wixams development itself. No evidence is presented to support this and Wilstead Pharmacy is perfectly able to meet the normal demand generated by this development.

4.96 Wilstead Pharmacy agree with Burnham Healthcare Ltd that residents should have reasonable access to existing pharmacies and it is clear that they do have more than reasonable access. No evidence of any difficulty travelling to a pharmacy has been presented to support any other conclusion. 27

4.97 The Applicant’s offer some opening hours on Saturday and Sunday. There is no evidence of an unmet demand for services on these days. Boots at the Interchange (1.6miles from Wixams) is open 9am-7pm on Saturday and 11am-5pm on Sunday.

4.98 Kalki Health Limited makes similar claims to Burnham Healthcare Ltd with comments such as “There is therefore a current high need for a pharmacy…”, but without any evidence of such a need being provided.

4.99 Kalki Health Ltd also lists schools in Wixams but these schools serve a wider area where other pharmacies are located. Kalki Health claims that this shows a high need for “pharmaceutical services for children” but does not explain what they mean by this. In Wilstead Pharmacy’s experience parents access a pharmacy on behalf of a child at a time and place that is suitable for them. Children who are sick enough to require acute prescriptions are unlikely to be in school.

4.100 Kalki Health also claims that those who purchase the “affordable” homes in Wixams will be earning low incomes and suffering from ill health. Kalki health has simply mixed up affordable housing with health/income deprivation and there is no evidence to support their submission.

4.101 Similarly Kalki Health claims that if the pharmacy was granted it would be “close to the wards in Bedford identified as teenage pregnancy hotspots…”. Wilstead Pharmacy are willing to accept that they would be close to these wards, which are Manshead and Northfields, but these wards are located in Dunstable, which is 17 miles from Wixams. It is not clear why the Applicant thinks that wards located 17 miles from the application site are considered “close”, but they ignore the existence of the many pharmacies located much closer than 17 miles to Wixams or claim that they are not easy to access.

4.102 The information that does exist about Wixams from the 2011 census shows that it is a healthy area with a lower than average deprivation. No up to date census data is available and it is therefore sensible to consider the style and layout of the new houses. A typical part of the development is shown below (photograph provided) and does not look like you would expect a deprived area to look.

4.103 Within the development here are a lot of cars parked in driveways, or on the street which can be used by residents to access services such as the pharmacy in Wilstead which is less than 1 mile away. Residents can also use the bus service which serves the new houses and which stops almost outside Wilstead Pharmacy. Walking distance is less than 1 mile and there is an underpass at the A6 for pedestrians. Wilstead Pharmacy also deliver to all patients who request this service and this is free of charge.

4.104 The majority of property sales in Wixams during the last year were detached properties, selling for an average price of £412,298. Semi-detached properties sold for an average of £293,237, with terraced properties fetching £284,268.

4.105 Wixams, with an overall average price of £328,517, was similar in terms of sold prices to nearby Wilstead (£340,251), but was more expensive than Bedford (£279,971) and Kempston (£285,042).

4.106 Both applications should therefore be refused.

4.107 The following letters from the Registered Care Manager of Wixams Retirement Village, and from the Chair of Wilshamstead Parish Council, were provided with Wilstead Pharmacy’s representations.

To Whom It May Concern:

4.108 Wilstead Pharmacy, have been providing Wixams Retirement Village with a pharmaceutical service in the delivery of medication for residents since the facility opened in 2019. Wixams Retirement Village have an excellent working relationship

with Wilstead Pharmacy, the team go above and beyond in terms of both service and patient care.

4.109 Wixams Retirement Village are not looking to move its care related medication scripts, to any other pharmacy.

Registered Care Manager Wixams Retirement Village Bedford Road Wixams Bedford MK42 6EA

15/07/2020

To whom it may concern:

4.110 The Parish Council have just learnt that the refusal for pharmacies in Wixams has been appealed by the Applicants and that the deadline for any response to this appeal is tomorrow the 16 July.

4.111 The Parish Council would just re-iterate that it is happy with the pharmaceutical provision provided by Wilstead Pharmacy and that it adequately provides the pharmaceutical needs of Wilstead and Wixams.

Regards

Chairman Wilshamstead Parish Council

5 Unsolicited comments

Cllr. Graeme S. Coombes, Wilshamstead Ward, Leader of the Conservative Group, Bedford Borough Council

5.1 Cllr Coombes understands that NHS Resolution are currently considering an appeal by Kalki Health Limited with regard to an application for a pharmacy licence at Wixams, Bedfordshire.

5.2 Cllr Coombes has been made aware of some of the claims by the Applicant's representative, Charles Russell Speechlys, in support of the application, which in Cllr Coombes opinion are either false or exaggerated.

Housing

5.3 The suggested rate of housing development is vastly overestimated:

5.3.1 Currently in Cllr Coombes ward, which includes the Bedford Borough half of Wixams, there are approximately 1100 properties occupied, not 1500 as is claimed.

5.3.2 Village 2 is expected to see 1,200 houses built over a period of 7-8 years, not 400-500 per year as is claimed.

5.3.3 There are c.2,400 adults on the electoral roll for Wixams. If we assume 20% of the population are under 18, this gives a total of 300 residents, not the 4,000 being claimed.

5.3.4 A build rate of 200 houses per year, with an average 1.8 adults per dwelling is likely to see an increase in population of 450 per year (1.8 x 200 plus 20% for under 18's) not the 1,000-1,300 being claimed.

Transport

5.3.5 Wilstead Pharmacy is just a 12-15 minute walk from Wixams. It is not 'difficult for pedestrians to walk' as is being claimed.

5.3.6 There is also a direct bus route with to and from bus stops about 50 yards from the Wilstead Pharmacy.

5.3.7 Bedford Road, where the Wixams Pharmacy is being suggested, is already a busy route with speeding traffic issues and a large amount of vehicles using Seasons Garden Centre on a daily basis. A new pharmacy there would add to traffic problems.

Primary Care Centre

5.3.8 This is something which has been long delayed and which residents and the Borough Council are still pushing BCCG to drive forward. To base part of the Applicant's claim on this, shows little understanding of the battle there has been to make this happen and their presumption that it will happen any time soon is overly optimistic.

Other

5.3.9 The 'large waste incinerator' is located in Stewartby, not Wixams - Cllr Coombes is also not sure how this is relevant to a pharmacy licence application.

5.3.10 A proportion of the new Wixams development is actually towards Stewartby and as there are currently no link roads in place, would actually find is easier to get to Wilstead Pharmacy or Wootton, Boots at Interchange Retail park, rather than going the long way around to get to the Lakeview section of Wixams along the A6.

5.4 In general, the Applicant's representative is trying to make out that the speed of development at Wixams is much faster than it is. There seems to be little local knowledge in their statement. Additionally, they are unfairly dismissive of the Wilstead Pharmacy, which continues to serve Wixams perfectly well and might be lost if it becomes unsustainable as a result of lost customers to a new Wixams pharmacy.

5.5 In short, there is no current requirement for a pharmacy at Wixams. Cllr Coombes believes the representative for Kalki Health has wildly overestimated the current and proposed seed of development. Cllr Coombes notices they are remote from Wixams, being based in Surrey, whereas Cllr Coombes has lived here since 2009 and represented Wixams on Bedford Borough Council since 2011, so is in a much better position to know what is happening locally and what Wixams needs.

5.6 There is already a perfectly good pharmacy in Wilstead within a short walk, drive or bus journey of Wixams. There is much infrastructure at Wixams which we are missing, but another pharmacy is neither wanted nor needed.

6 Observations

Charles Russell Speechlys LLP (on behalf of the Applicant)

Bedford Borough Council

6.1 It is not clear on what basis Councillor Coombes has submitted representations to NHS Resolution. NHS Resolution states that the email is from “Bedford Borough Council”, noting that these are unsolicited comments, but the email does not purport to be written on behalf of the Council and appears to be from the Councillor himself. It is of note that Councillor Coombes is the local Councillor for the area in which Wilstead Pharmacy is located.

6.2 The figures contained within the letter of appeal were taken from information contained within a briefing note which was produced by the Bedfordshire Clinical Commissioning Group in October 2019, a copy of which is provided. Whilst Councillor Coombes comments about the number of houses constructed, this is not independently evidenced.

6.3 In relation to those on the electoral register, firstly, whilst 21% of the UK population is aged under 18, given that Wixams contains family homes and has significant provision for schooling, it is anticipated that the proportion of those aged under 18 living on the estate is likely to be higher than the UK average. Additionally, people do not always join the electoral register as soon as they move into a new home. The estimate provided by Councillor Coombes by reference to the electoral register is therefore likely to be a significant underestimate.

6.4 In any event, a population of 3,000 which is rising, on the Councillor’s own figures, by 450 a year is significant. It is not at all clear why the Councillor believes that this number of residents and their needs should be discounted.

6.5 In terms of the walk to Wixams (sic) the walking time does, of course, depend on your starting point. It also ignores the other barriers to access in addition to distance which are described in detail in the Applicant’s letter of appeal and to which the Councillor does not refer.

6.6 The Councillor refers to a bus service, but does not give any information about its frequency (hourly). The bus service is infrequent and does not overcome the access barriers that exist, particularly when not talking about a rural area, but a town location with a significant population.

6.7 The Councillor refers to the Applicant’s existing site, but merely emphasises that it is a highly-visible and frequently accessed site. There is no evidence of traffic congestion or speeding at the proposed site.

6.8 It may well be that there has been a significant amount of discussion regarding the new GP surgery, but it is clear that this is supported by the local CCG who are under significant pressure from local residents and the Council to secure primary care medical services for the local population. In the meantime, of course, residents would gain significant benefit from the provision of pharmaceutical services where currently there is no healthcare provision within the estate.

6.9 A plan of the development is included within the letter of appeal. None of the villages are located to the east (Wilstead) side of the A6 so it is not clear to what the Councillor is referring.

6.10 Councillor Coombes states that there is no need for a pharmacy in Wixams, but it is not clear whether he has consulted with any of his constituents about this. It would be surprising if his constituents would object to a new pharmacy within their estate in the way that Councillor Coombes has in his email, and the basis upon which he makes these comments is unclear.

6.11 The Applicant makes no comment on the address of its registered office which is, of course, irrelevant to the determination of this appeal.

Meiklejohn Pharmacy

6.12 The Applicant has already attached evidence to this letter of the build rate described in the letter of appeal. It is not clear where the figures from Meiklejohn Pharmacy have come from. However, it often takes some time for planning, preparatory and grounds works to be concluded before the construction of housing can take place. It is not unusual for building work to initially appear to be slow, but then to pick up pace as the ground works are completed.

6.13 Evidence of the access difficulties that exist are contained within the Applicant’s letter of appeal. Meiklejohn Pharmacy do not appear to dispute these.

6.14 In relation to Meiklejohn Pharmacy’s representations to NHSE&I, the Applicant has already addressed these both in its response to NHSE&I (which, the Applicant assumes, NHS Resolution has) and in the letter of appeal.

Wilstead Pharmacy

6.15 The Applicant has evidenced the housing development numbers provided in the letter of appeal.

6.16 The timings set out by Wilstead Pharmacy are clearly inaccurate, since they ignore the time taken to finalise planning, prepare groundworks, access roads, etc. As stated above, developments usually appear to start off slowly while preparatory works take place and then speed up as housing is started.

6.17 The Applicant’s application is not made on the basis of any inadequacy in the services offered by Wilstead to those in Wilstead, but on the basis of a need for a pharmacy in this large and growing new community where access to existing pharmacies is difficult for the reasons set out in detail in the letter of appeal.

6.18 Wilstead Pharmacy refer to people coming into Wilstead to access schools. Whilst no further information is provided by Wilstead Pharmacy to support this statement, it merely serves to increase the potential reliant population for a pharmacy in Wixams to include those coming into the area to access services. Wilstead Pharmacy refer to parents accessing pharmaceutical services at a time and location which is convenient to them, but presumably Wilstead Pharmacy would agree that this time and location may well be as they are dropping off or picking up their children at or from school?

6.19 No confusion exists between the stated need for primary medical services and the significant benefits of the provision of pharmaceutical services within Wixams, both to provide dispensing services (for patients who are registered with the new GP surgery and patients registered with other surgeries) and patients who require access to pharmaceutical services other than after a visit to their GP.

6.20 The Applicant has already described the access difficulties which are present in its letter of appeal. An hourly bus service does not overcome these difficulties.

6.21 The provision of a delivery service does not overcome the barriers to accessing pharmaceutical services, since many services cannot be provided by a delivery driver (e.g. flu vaccination, MUR, NMS, healthy lifestyle advice, support for self-care, CPCS, etc.).

6.22 Wilstead Pharmacy refer to access by car but, of course, many households will not have access to a car when they require access to pharmaceutical services and a photograph of a street on the estate with cars parked outside is not evidence that patients have access to a car when they need access to a pharmacy (the Applicant does not know when the photograph was taken, for example, and the situation during the daytime on a normal working day may be very different from a Sunday morning). It is also unreasonable to expect every one of thousands of residents to have to get in a car (assuming they have one) and drive a mile or more to an entirely separate and distinct village on the other side of the A6 in order to access pharmaceutical services.

6.23 The average number of items dispensed by a pharmacy in England is approximately 7,500 per month. Wilstead Pharmacy dispenses 33% more items than the average pharmacy. There is no realistic prospect that granting the Applicant’s application would materially affect the viability of Wilstead Pharmacy. Indeed, by making this submission, Wilstead Pharmacy appears to be accepting that the proposed pharmacy would be well-used, which is a reason for granting this application, not a reason for refusing it.

6.24 It is accepted that the relevant PNA does not identify a need for a pharmacy in Wixams, which is why the Applicant’s application is submitted pursuant to regulation 18.

6.25 The letter from the Retirement Village is noted but, of course, residents in the Retirement Village have the freedom to choose from where they access pharmaceutical services and may well benefit from pharmaceutical services provision much closer to the Village.

6.26 In short, the Applicant does not seek to disparage the service offered by Wilstead Pharmacy, but the fact remains that Wilstead Pharmacy is located in Wilstead and is neither easily nor conveniently accessible for the large and growing population on the Wixams estate.

Bedfordshire LPC

6.27 The LPC appears to support a new pharmacy in Wixams but believes that this application is “premature”. The difficulty with this position is that it leaves patients who are currently living on the estate or are moving in now with no pharmaceutical service provision until the LPC deems that the time is right. This is unfair to existing residents and fails to “secure” the provision of pharmaceutical services for Wixams both now and in the future.

NHSE&I

6.28 It is, of course, to be expected that NHSE&I would support its previous decision, although a significant amount of additional information is provided in the Applicant’s letter of appeal than was provided at the NHSE&I stage.

6.29 In conclusion, the Applicant believes that this application satisfies the requirements of regulation 18 and invites NHS Resolution to uphold the appeal and grant it.

7 Consideration

7.1 The Pharmacy Appeals Committee (“the Committee”), appointed by NHS Resolution, had before it the papers considered by NHSE&I, together with a plan of the area showing existing pharmacies and doctors’ surgeries and the location of the proposed pharmacy.

7.2 It also had before it the responses to NHS Resolution’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 noted NHSE&I’s decision letter refers to two applications (the other by Burnam Healthcare Ltd) for inclusion in the pharmaceutical list at Wixams. Both applications were refused. The Committee having noted that Burnam Healthcare Ltd had not appealed against NHSE&I’s decision, proceeded on the basis of there being only one application for it to consider.

7.5 The Committee had regard to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the Regulations”).

7.6 There is no dispute that Wixams is in a controlled locality and the application was based on securing improvements or better access to pharmaceutical services in that controlled locality.

7.7 The Committee considered that the correct course was to first consider if the application must be refused pursuant to Regulation 31. The Committee will then consider if the application must be refused pursuant to Regulation 40. If the Committee is not so required to refuse the application, it will consider the issue of reserved location pursuant to Regulation 41. The Committee will then consider the application under Regulation 18. If the Committee has determined that the Applicant is seeking the listing of pharmacy premises which are in a part of a controlled locality that is not in a reserved location, it will consider the issue of prejudice under Regulation 44 last. The reason for this staged approach and in particular for dealing with prejudice last is that if the application does not meet the requirements of Regulation 18 the Committee is required to refuse it and prejudice cannot arise. The potential for prejudice only arises if the Committee has concluded that the application meets the requirements of Regulation 18 and may be granted.

Regulation 31

7.8 The Committee first considered Regulation 31 of the Regulations which states:

(1) A routine or excepted application, other than a consolidation 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 -

(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).

7.9 The Committee noted Part 5 of the application form (reference to Regulation 31) where the Applicant had stated: ““There is no pharmacy in the same or adjacent premises to the proposed site.” Further, NHSE&I’s decision letter includes: “There are no existing pharmacies operating from the proposed area and therefore, under this provision, Regulation 31 would not cause the applications to be refused.” Mindful of the above, and that it had no information to cause it to conclude otherwise, the Committee was not required to refuse the application under the provisions of Regulation 31.

7.10 The Committee noted that, if the application were granted, the successful applicant would - in due course - have to notify NHSE&I 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 31.

Regulation 40

7.11 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 40 which reads:

(1) This paragraph applies to all routine applications—

(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

(2) If the NHSCB receives an application (A1) to which paragraph (1) applies, it must refuse A1 (without needing to make any notification of that application under Part 3 of Schedule 2), where the applicant is seeking the listing of premises at a location which is—

(a) in an area in relation to which outline consent has been granted under these Regulations, the 2012 Regulations or under the 2005 Regulations within the 5 year period—

(i) starting on the date on which the proceedings relating to the grant of outline consent reached their final outcome, and

(ii) ending on the date on which A1 is made; or

(b) within 1.6 kilometres of the location of proposed pharmacy premises (other than proposed distance selling premises), in respect of which—

(i) a routine application under these Regulations or the 2012 Regulations, or

(ii) an application to which regulation 22(1) or (3) of the 2005 Regulations (relevant procedures for applications) applied,

was refused 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.

(3) For the purposes of paragraphs (1) and (2), if no particular premises are proposed for listing in A1, the applicant is to be treated as seeking the listing of pharmacy 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 2.

(4) Paragraph (2)(b) does not apply where the NHSCB is satisfied that there are reasonable grounds for believing the person making the refused application was motivated (wholly or partly) by a desire for that application to be refused.

(5) The refusal of an application pursuant to paragraph (2)(b), or regulation 40(2)(b) of the 2012 Regulations (applications for new pharmacy premises in controlled localities:

refusals because of preliminary matters), is to be ignored for the purposes of the calculation of a 5 year period pursuant to paragraph (2)(b).

7.12 The Committee noted that there was no information to suggest that the instant application was in respect of a location where outline consent had been granted or there had been a refusal for a previous application within the last 5 years.

Regulation 41

7.13 Based on its conclusion above, the Committee went on to consider the application in light of the remainder 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,

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

(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 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 2.

7.14 The Committee considered the issue of reserved location for premises described in the application.

7.15 The Committee noted NHSE&I’s decision letter includes that on the date the application was received, the number of NHS registered patients living within a 1.6 kilometre radius of the centre of Wixams was 3,953. NHSE&I had concluded that the reserved location status does not apply. The Committee noted that the Applicant nor any other party, had challenged NHSE&I’s position that the Applicant’s best estimate site is not within a reserved location. The Committee was satisfied from the information provided to it, that the relevant location is not in a reserved location.

7.16 The Committee was aware that, given its view on reserved location, it may then need to deal with prejudice. However, the Committee considered that prejudice could only arise if the application meets the requirements of Regulation 18 and may therefore be granted. It therefore next considered whether the application met the requirements of Regulation 18.

Regulation 18 37

7.17 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—

(b) 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) proper planning in respect of the provision of pharmaceutical services in the area of the relevant HWB, or

(ii) 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) 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)),

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) 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;

(d) 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;

(e) 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;

(f) whether the application needs to be deferred or refused by virtue of any provision of Part 5 to 7.

(g) whether it is satisfied that the application presupposes that a gap in pharmaceutical services provision has been or is to be created—

(i) by the removal of chemist premises from a pharmaceutical list as a consequence of the grant of a consolidation application, and

(ii) since the last revision of the relevant HWB's pharmaceutical needs assessment other than by way of a supplementary statement.

(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)."

7.18 The Committee considered that Regulation 18(1)(a) was satisfied in that it was required to determine whether it was 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.

7.19 The Committee went on to consider whether Regulation 18(1)(b) was satisfied, i.e. whether the improvements or better access that would be secured if the application was granted were or was included in the PNA in accordance with paragraph 4 of Schedule 1 of the Regulations.

7.20 Paragraph 4 of Schedule 1 requires the PNA to include: “a statement of the pharmaceutical services that the HWB had identified (if it has) as services that are not provided in the area of the HWB but which the HWB is satisfied (a) would if they were provided….secure improvements or better access, to pharmaceutical services… (b) would if in specified future circumstances they were provided…secure future improvements or better access to pharmaceutical services…” (emphasis added).

7.21 The Committee considered the Central Bedfordshire Pharmaceutical Needs Assessment ("the PNA") prepared by The Central Bedfordshire Borough Health and Wellbeing Board, as well as the Bedfordshire Borough PNA conscious that both documents are referred to in NHSE&I’s decision letter. The PNA’s provide 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 (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 both PNA’s were dated 2018-2021 and that no supplementary statements had been issued in respect of either PNA.

7.22 The Committee noted that page 10 of the Central Bedfordshire PNA under the heading ‘Executive Summary’ and sub-heading ‘Conclusion’ states:

7.22.1 “Overall, the level of pharmaceutical service (as described in the regulations) currently provided across Central Bedfordshire meets the health needs of the population and provision of pharmaceutical services is good in our areas of deprivation.

7.22.2 Community pharmacies are valued community assets and are easy to access. Their potential role should be considered as part of strategies to improve health and reduce health inequalities.

7.22.3 It is recognised that Central Bedfordshire is an area of housing growth, with the total population of Central Bedfordshire is forecast to increase by 15% between 2017 and 2030. The PNA will be reviewed during 2020 and republished in April 2021 unless there are significant changes to local need or provision in the interim.”

7.23 The Committee noted reference to Wixams on page 29 under the heading ‘New Housing Development’:

7.23.1 “Most of the development will be on five strategic sites namely: Houghton Regis, area north of Luton, Leighton Linslade, Wixams and Chaul End.”

And

7.24 On page 30, Table 4 – ‘Current Pharmaceutical provision for areas of planned development’ which states:

“Areas of Housing Development

7.24.1 The Wixam southern extension

Proposed development (up to 2031)

7.24.2 500 new homes

Current Pharmaceutical Provision

7.24.3 Residents at Wixams have access to pharmacies in Wilstead, Marston and Ampthill

Comments

7.24.4 The number of homes planned for this area over the period of time is not large and some of these have already been developed and as such included in the current needs assessment. Additional pharmaceutical needs will have to be assessed with actual increase in population.”

7.25 The Committee noted the Bedfordshire Borough Draft PNA ‘Executive Summary’ includes under the sub-heading ‘Conclusion’ on page 10:

7.25.1 “Overall, the level of pharmaceutical service (as described in the regulations) currently provided across Bedford Borough meets the health needs of the

population and provision of pharmaceutical services is good in our areas of deprivation.

7.25.2 Community pharmacies are valued community assets and are easy to access. Their potential role should considered as part of strategies to improve health and reduce health inequalities.

7.25.3 The PNA will be reviewed during 2020 and republished in April 2021 unless there are significant changes to local need or provision in the interim.”

7.26 The Committee further noted under the heading ‘Transport’ on pages 29/30 the following reference to Wixams:

7.26.1 “The Borough is well connected by rail with four stations within the Borough area – Bedford Midland, Bedford St Johns, Kempston Hardwick and Stewartby. The opening of a new station at Wixams, on the Thameslink line to London and the South coast has been delayed.”

And

7.27 Under the heading “New Housing Development’:

7.27.1 “The Council’s Housing Monitoring Report 2016/17 shows that at 31 March 2017 the available housing supply is around 9,500 dwellings. About 8,600 of these have planning permission and about 900 are identified in adopted plans or are waiting for legal agreements to be finalised. Key growth locations are currently Land West of Kempston, Biddenham Loop/Gt Denham, Wixams, New Cardington, Wootton, Stewartby and Land North of Bromham Road, Biddenham…..”

7.28 The Committee noted on page 32 under the heading: ‘Table 1: ‘Pharmaceutical provision in Bedford Borough Growth Area’ includes:

“Growth Area

7.28.1 Wixams

Number of dwellings built in the monitoring period of April 2012 to March 2013

7.28.2 113

Current Pharmaceutical provision

7.28.3 Residents at Wixams have access to pharmacies in Wilstead, Marston and Ampthill

Comments

7.28.4 609 dwellings so far have been developed in Wixams and their provision is included in this pharmaceutical needs assessment. Wixams is located on the border with Central Bedfordshire and some residents access pharmaceutical needs in that area.”

7.29 The Committee noted that the Applicant seeks to provide unforeseen benefits to the patients of Wixams. 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 assessments in accordance with paragraph 4 of Schedule 1.

7.30 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)

7.31 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 the area of the relevant HWB"

7.32 The Committee noted NHSE&I’s decision letter includes: “The Committee agreed that if the applications were granted and a pharmacy was to open, the ability of NHSE&I to plan for the provision of services would not be significantly affected and therefore it could be concluded that the proposed pharmacy would not cause significant detriment to the proper planning of pharmaceutical services.”

7.33 The Committee noted that the above had not been disputed on appeal.

7.34 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 NHSE&I thereafter to plan for the provision of services would be affected in a significant way.

7.35 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)

7.36 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"

7.37 The Committee noted that the LPC had argued in its representations on the application: “Bedfordshire LPC suggests that granting the application at this stage will result in a significant detriment to the existing provision of pharmaceutical services in the relevant area, potentially affecting the viability of existing pharmacies.” NHSE&I’s decision letter indicates its view that “…..granting the application would not cause significant detriment to the arrangements currently in place for the provision of pharmaceutical services.”

7.38 The Committee noted Wilstead Pharmacy’s representations to NHS Resolution on the appeal, include:

7.38.1 “Granting the application of another pharmacy in the local area of Wixams, would have a significant detrimental impact on the financial viability of Wilstead pharmacy.”

And

7.38.2 “Granting this application currently will have a detrimental financial / service impact for all local pharmacies as the development is still in its infancy, and in our opinion the appeal/application is immature.”

7.39 The Committee noted that neither the LPC nor Wilstead Pharmacy had provided any information to show that there would be significant detriment as referred to in Regulation 18(2)(a)(ii). 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.

7.40 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)

7.41 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—

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)

7.42 The Committee noted Wixams is located 3 miles (5km) south of Bedford and covers an area of approximately 384 hectares. According to the Applicant, it will eventually establish a community of around 10,000 people with potential to expand to around 15,000. According to NHSE&I’s comment, Wixams is expected to have 4,500 homes, and likely to provide housing capacity for people who work in Bedford, Milton Keynes and London. The Committee considered this is a development of not insignificant size particularly in the event that it is fully realised.

7.43 The Committee noted Wixams development is intended to comprise of four “villages”, each with a local centre, and then a “town centre” area. The town centre will contain a larger range of shops and services, including up to 10 shops, an Assembly Hall (which will include a library), a large (8,000m2) supermarket and a gym/fitness centre. There is no dispute that building work on Village 1 (now known as Lakeview Village) providing 950 homes with 25 per cent affordable housing, a new primary school, a Budgens Store, Café and recreational facilities for residents is largely complete. On Bedford Road (where the Applicant’s pharmacy would be located) there is the Seasons Garden Centre and Scotts Veterinary Clinic. NHSE&I commented that Wixams has a convenience store, a community centre, a fish and chip shop and a garden centre with a coffee shop/restaurant, and a veterinary practice. There are three schools: Lakeview

School (a Nursery and Primary School), Wixams Tree Primary School, and Wixams Academy (Secondary School).

7.44 The Committee noted work has now started on Villages 2 and 4. Village 2 will be largely residential, Village 3 will house the proposed commercial and shopping centre and Village 4 will include a new rail link and railway station. A map provided on appeal by the Applicant, also shows areas entitled ‘Northern Expansion’ ‘Retirement village’ ‘Future Development’. According to the Applicant, Wixams street design will prioritise safety and facilitate ease of movement using public transport, cycles and walking.

7.45 The Committee noted that in addition to the number of dwellings referred to above (which is still far short of the overall intended number) the Wixams development will include a care home and assisted living complex and health infrastructure, over 300 acres (1.2 km2 parkland and public open space, featuring a series of lakes, water bodies and wetland areas).

7.46 The Committee has already recognised the not insignificant scale of the development and noted the above mentioned services and facilities which already exist, or are intended. The Committee appreciated that the services and facilities may be used by those persons that live, work in or are visitors to the Wixams area, during the course of their everyday lives. The information provided to the Committee did not however, suggest that persons will have no need to access services at other locations convenient to themselves. The Committee was mindful of NHSE&I’s comment that Wixams is likely to provide housing capacity for people who work in Bedford, Milton Keynes and London. This indicated to the Committee a population that is at least in part, highly mobile with access to services in other larger locations.

7.47 The Committee noted the Applicant’s claim that the application should not be regarded as premature. A level of certainty exists in relation the Wixams development and if granted, the Applicant would have until late 2021 to commence the provision of pharmaceutical services. The Committee noted there is much disagreement between the parties concerning the size of, and timescale for completion of the development. The Committee could not know whether the Wixams development will be affected by external factors. It is though a possibility. The Committee was of the view that any new development which is designed to materialise over a period of time, cannot be regarded as definite until it is finally completed.

7.48 The Committee has already noted the presence of residents, workers and visitors in the area. Reference by the Applicant to provision for 25% affordable housing may or may not indicate some residents with a low income. The Committee appreciated that low income and ill health are factors often associated with an increased demand for pharmaceutical services. The Applicant had not however, provided information to show there is any increased demand due to health or social deprivation, that is not currently being met.

7.49 The Committee noted that there are currently no GP practices in Wixams. Most patients living in Wixams are registered at GP practices within Bedford, Ampthill (also a branch surgery in Wilstead village), Wootton and Shortstown. The Committee noted the Applicant’s comment that as part of the s106 agreement for the Wixams development, the developers are committed to providing land to the CCG for construction of a new Primary Care Centre. The Committee noted realisation of a Primary Care Centre in Wixams may be some way off. Whilst the Committee appreciated the convenience of a pharmacy located within the same Wixams development as any future GP surgery, that did not mean that only the proposed new pharmacy can secure significant benefits for persons in the area.

7.50 The Committee noted NHSE&I’s comment that there are at least 30 pharmacies within a 5 mile radius of the centre of the best estimate area as per the NHS website, 13 of these being within 3 miles. According to the Applicant, the nearest pharmacy (Wilstead Pharmacy) is 0.9 miles away (also said by the Applicant to be 1.1 miles). Other existing

pharmacies are Boots Pharmacy (2.8 miles), Berkeley Pharmacy (3 miles), Shortstown Pharmacy and Meiklejohn Pharmacy (both 3.9 miles away).

7.51 The Committee noted the Applicant’s comment that assuming there is a need to maintain at least the stated ratio of 23 pharmacies per 100,000 in order to meet overall demand for pharmaceutical services in the Borough (Bedford Borough), a development the size of Wixams would have to contain 2 or possibly 3 pharmacies. The Committee attached no weight to this broad statistical approach. Nor was it relevant to the test under the Regulations.

7.52 The Committee noted the Applicant’s comment that Wilstead Pharmacy is extremely busy. The Committee further noted Wilstead Pharmacy’s response that it is more than adequately staffed with sufficient space for dispensing across two floors. The pharmacy has the capacity (both staffing and space) to dispense significantly higher volumes and is actively seeking further items and services to deliver. The Committee having regard to the above comments, and noting that no other party including NHSE&I had suggested otherwise, was satisfied that it had no information to show that Wilstead pharmacy or other existing pharmacies in the area, are unable to cope with any increased demand for services as a result of the increasing number of persons in Wixams.

7.53 The Committee considered access to existing pharmacies for those at the Applicant’s best estimate location. On distance alone, the Committee thought it unlikely persons would attempt to access the pharmacies on foot (beyond the pharmacy in Wilstead). Some persons with limited mobility may even find the distance to Wilstead Pharmacy inhibitive, although others may regard it as reasonable.

7.54 The Committee noted there are two possible walking routes to Wilstead Pharmacy. The slightly shorter route was said by the Applicant to require pedestrians to walk along Bedford Road and then take a pedestrian footpath through open land for approximately 200 metres. That pedestrian footpath includes an underpass underneath the A6 trunk road. In the Applicant’s view, these features rendered this route unsuitable for more vulnerable walkers, particularly during inclement weather and outside of daylight hours. The LPC described the underpass as being short and brightly lit. Further that pavements en-route have stepped kerbs along most of the way. The LPC did note what it described as a noticeable incline for a short distance to the entrance of the underpass. The Committee had no information to show that for persons prepared to walk to Wilstead Pharmacy, the incline will be a barrier.

7.55 Further regarding access to Wilstead Pharmacy via the underpass, the Committee noted the Applicant’s photograph showing a wide path and cycle lane in a good state of repair and with street lighting. Whilst it appears to run through some undeveloped ground, the isolation of this route did not appear to be extensive. There was no image of the subway under the A6 and the nature of the route on the ‘Wilstead side’ of the A6. The Committee concluded that the Applicant’s information did not show that persons are having difficulty using the route to access Wilstead Pharmacy.

7.56 The Committee noted that the alternative routes for accessing Wilstead Pharmacy as referred to by the Applicant, were not really alternatives as they include a lack of proper crossing points over the A6, a lack of pavements with some parts of the routes also running through open countryside. The Applicant provided two photographs to illustrate this.

7.57 For those persons unable or unwilling to access Wilstead Pharmacy on foot, the Committee next considered access using public transport. The Committee noted Wilstead Pharmacy’s reference to there being a bus route running every hour, taking 5 minutes and stopping directly outside the pharmacy (photograph provided). Cllr Coombes also commented that there is a direct bus route with to and from bus stops about 50 yards from the Wilstead Pharmacy. The Committee noted the Applicant’s comment that Wixams is served by two bus routes, numbers 44 and 81 for which copy

timetables were provided. The Committee noted that the 44 runs between Bedford bus station and Luton, Monday to Friday. Services are frequent. The 44 route has stops at Wixams Dove Lane and then Wilstead The Woolpack, the journey taking approximately 5 minutes. The Committee noted services commence at 04.25 until 19.30 at approximately 45 minutes to an hour frequency. The service becomes hourly from 14.00 onwards. On Saturdays, the service remains frequent although between 9.20 and 15.20 there are seemingly no Route 44 services. The timetable for bus service 81 shows that it commences in Luton and travels to Bedford bus station with stops at Wilstead The Woolpack and Wixams opp. Dove Lane. Monday to Friday with two buses in the morning approximately one hour and 30 minutes apart. Service are more frequent during the afternoon. There is a service on Saturdays with one more service in the mornings, and fewer in the early to mid-afternoon where after services pick up again. The Committee mindful of the information and comments provided to it, concluded bus services are a reasonable alternative means of reaching Wilstead Pharmacy and possibly those located in Bedford when considering access in a rural area.

7.58 The Committee considered access to existing pharmacies in the area for patients with access to their own vehicle. The LPC claimed that car ownership in Wixams is higher than the percentage in Bedford with over 50% of residents owning two or more cars (Ward Profiles 2011). This is undisputed. Meikeljohn Pharmacy stated that there are above average percentage of car owners here with many families having multiple cars.

7.59 The Committee noted the Applicant’s comment that even for those that do have a car, there are some difficulties in accessing Wilstead Pharmacy. The Applicant described how any route taken requires either joining or crossing the A6 at a roundabout either to the north or south of Wixams, with its associated congestion. The Committee further noted the Applicant’s claim that Wilstead village centre can be congested, with limited dedicated car parking and on-street parking not always available in the immediate vicinity of the pharmacy. The Committee concluded that the need to negotiate busy roads and junctions is an everyday feature for many road users. In terms of congestion, no evidence was provided to support the Applicant’s claim. The Committee was doubtful that the features highlighted by the Applicant, given that Wilstead Pharmacy and other existing pharmacies are relatively close by car, would dissuade persons with access to their own vehicle from making the necessary journey. The Applicant’s reference to dedicated car parking and on street parking in Wilstead indicated that car parking is likely to be available at some point during the day. The Committee, having also noted reference to other existing pharmacies in the area, was satisfied that those with access to their own vehicle do have reasonable access to existing pharmaceutical services.

7.60 The Committee was of the view that there is already reasonable choice with regard to obtaining pharmaceutical services in the area of the relevant HWB, such that it was not satisfied that, having regard to the desirability of there being a reasonable choice with regard to obtaining services, granting the application would confer significant benefits on persons.

7.61 In considering Regulation 18(2)(b)(ii) the Committee reminded itself that it was required to address itself to people who share a protected characteristic having access to services that meet specific needs for pharmaceutical services that are difficult for them to access. The Committee was also aware of its duties under the Equality Act 2010 which include considering the elimination of discrimination and advancement of equality between patients who share protected characteristics and those without such characteristics.

7.62 The Committee noted the Applicant’s comment that the persons for whom it wishes to provide pharmaceutical services, include the elderly, infirm, disabled or parents of young children. The Committee noted Wilstead Pharmacy’s comment that it more than adequately provides the Retirement Village with its pharmaceutical needs. Wixams Retirement Village manager has stated that it has an excellent working relationship

with Wilstead Pharmacy, and is not looking to move its care related medication scripts, to any other pharmacy. The Committee considered that it had not been provided with any information to show that anyone with a protected characteristic is having difficulty accessing services in the area to meet specific needs for pharmaceutical services. The Committee was therefore not satisfied that, having regard to the desirability of people who share a protected characteristic having access to services that meet specific needs for pharmaceutical services that are difficult for them to access, granting the application would confer significant benefits on persons.

7.63 In considering Regulation 18(2)(b)(iii) the Committee had regard to the desirability of innovative approaches to the delivery of pharmaceutical services. In doing so, the Committee would consider whether there was something more over and above the usual delivery of pharmaceutical services that might be expected from all pharmacies, some ‘added value’ on offer at the location.

7.64 The Committee noted the Applicant’s comment that the proposed pharmacy proposes to provide the following services which it regards as innovative:

7.64.1 ear wax removal and syringing,

7.64.2 mindfulness,

7.64.3 nutrition and healthy living workshops

7.64.4 travel clinic

7.65 The Committee mindful of the above definition, did not regard the above services as being innovative. The Committee was therefore not satisfied that, having regard to the desirability of there being innovative approaches taken with regard to the deliverability of pharmaceutical services, granting the application would confer significant benefits on persons.

Regulation 18(2)(b) generally

7.66 The Committee had no information to show that where they are not already doing so, existing pharmacies are unable or unwilling to provide the services proposed by the Applicant.

7.67 The Committee noted the Applicant’s proposed opening hours and took into account the possibility of there being a GP surgery in Wixams. The Applicant intends to open on Saturdays and Sundays whereas Wilstead Pharmacy is closed on both days. The Committee noted these hours would not be core hours. The Committee noted NHSE&I’s comment that there are 30 pharmacies within a 5 mile radius of the proposed location covering opening hours between 08:00 – 22:30, seven days a week. The Committee was also mindful that where it considers there is a need to do so, NHSE&I already has the power to bring about changes to the opening hours of existing pharmacies.

7.68 The Committee was of the view that there was no information provided to support a finding that pharmaceutical services are not currently provided at such times as needed and therefore it was not satisfied that, having regard to the desirability of there being a reasonable choice with regard to obtaining services, granting the application would confer significant benefits (in relation to opening hours) on persons.

7.69 The Committee was of the view that in accordance with Regulation 18(2)(b) the granting of this application would not confer significant benefits on persons in the area of the HWB which were not foreseen when the PNA was published.

Regulation 44 – Prejudice

7.70 The Committee has already indicated that if the application does not meet the requirements of Regulation 18 then the Committee is required to refuse it and prejudice cannot arise. The potential for prejudice only arises if the Committee has concluded that the application meets the requirements of Regulation 18 and may be granted. As indicated above, the Committee has determined that the application does not meet the requirements of Regulation 18 and therefore the Committee considered that consideration of prejudice was not required.

Other considerations

7.71 Having determined that Regulation 18(2)(b) had not been satisfied, the Committee did not need to have regard to Regulation 18(2)(c) to (e).

7.72 No deferral or refusal under Regulation 18(2)(f) was required in this case.

7.73 The Committee had regard to Regulation 18(2)(g) and found that it did not apply in this instance.

7.74 The Committee considered whether there were any further factors to be taken into account and concluded that there were not.

7.75 The Committee was not 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.

7.76 Pursuant to paragraph 9(1)(a) of Schedule 3 to the Regulations, the Committee may:

7.76.1 confirm NHSE&I’s decision;

7.76.2 quash NHSE&I’s decision and redetermine the application; quash NHSE&I’s decision and, if it considers that there should be a further notification to the parties to make representations, remit the matter to NHSE&I.

7.77 Given its different reasoning for refusing the application, the Committee determined that the decision of NHSE&I must be quashed.

7.78 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 NHSE&I) or whether it was preferable for the Committee to redetermine the application.

7.79 The Committee noted that representations on Regulation 18 had been sought from parties by NHSE&I and representations had already been made by parties to NHSE&I in response. These had been circulated and seen by all parties as part of the processing of the application by NHSE&I. The Committee further noted that when the appeal was circulated representations had been sought from parties on Regulation 18.

7.80 The Committee concluded that further notification under paragraph 19 of Schedule 2 would not be helpful in this case.

8 DECISION

8.1 The Pharmacy Appeals Committee (“Committee”), appointed by NHS Resolution, quashes the decision of NHSE&I, for the reasons given above, and redetermines the application.

8.2 The Committee determined that the application should be refused.

8.3 The Committee concluded that it was not required to refuse the application under the provisions of Regulation 31.

8.4 The Committee concluded that Wixams is in a controlled locality and that the site of the application is not in a reserved location.

8.5 Having determined that the application should be refused, it was unnecessary for the Committee to make a decision upon whether granting the application would prejudice the proper provision of relevant NHS services in the area of (a) the relevant HWB; or (b) a neighbouring HWB of the relevant HWB.

8.6 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;

8.7 The Committee refused the application on the following basis:

8.7.1 In considering whether the granting of the application would confer significant benefits, the Committee determined that –

8.7.1.1 there is already a reasonable choice with regard to obtaining pharmaceutical services;

8.7.1.2 there is no evidence of people sharing a protected characteristic having difficulty in accessing pharmaceutical services; and

8.7.1.3 there is no evidence that innovative approaches would be taken with regard to the delivery of pharmaceutical services;

8.7.2 Having taken these matters into account, the Committee is not satisfied that granting the application would confer significant benefits as outlined above that would secure improvements or better access to pharmaceutical services.

Case Manager Primary Care Appeals

A copy of this decision is being sent to:

Charles Russell Speechlys on behalf of the Applicant NHSE&I Wilstead Pharmacy Bedfordshire Local Pharmaceutical Committee Meiklejohn Pharmacy Ltd