1 Trevelyan Square Boar Lane

Leeds REF: SHA/18787 LS1 6AE

APPEAL AGAINST NORTH (LANCASHIRE AND Tel: 0113 86 65500 GREATER MANCHESTER) AREA TEAM, NHS Fax: 0207 821 0029 COMMISSIONING BOARD ("NHS ENGLAND") DECISION Email: [email protected] TO REFUSE AN APPLICATION BY GRIFFIN MARTLET LTD FOR INCLUSION IN THE PHARMACEUTICAL LIST OFFERING UNFORESEEN BENEFITS UNDER REGULATION 18 AT THE OVER WYRE MEDICAL CENTRE, WILKINSON WAY, PREESALL, LANCASHIRE, FY6 0FA

1 Outcome

1.1 The Pharmacy Appeals Committee (“Committee”), appointed by NHS Resolution, quashes the decision of NHS England 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 www.nhsla.com/Pages/PrivacyPolicy.aspx

REF: SHA/18787 1 Trevelyan Square Boar Lane Leeds APPEAL AGAINST NORTH (LANCASHIRE AND LS1 6AE GREATER MANCHESTER) AREA TEAM, NHS COMMISSIONING BOARD ("NHS ENGLAND") DECISION Tel: 0113 86 65500 TO REFUSE AN APPLICATION BY GRIFFIN MARTLET Fax: 0207 821 0029 LTD FOR INCLUSION IN THE PHARMACEUTICAL LIST Email: [email protected] OFFERING UNFORESEEN BENEFITS UNDER REGULATION 18 AT THE OVER WYRE MEDICAL CENTRE, WILKINSON WAY, PREESALL, LANCASHIRE, FY6 0FA

1 A summary of the application, decision, appeal and representations and observations are attached at Annex A.

2 Preliminary Consideration and Site Visit

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

2.2 It also had before it the responses to NHS Resolution’s own statutory consultations.

2.3 On the basis of the evidence before it the Committee decided to hold an oral hearing to determine the application. The hearing took place on 27th February, 2018 at The Preston Business Centre, Watling Street Road, Preston. The Committee comprised of Mr A Tomlinson (chair), Mrs G Curphey and Mr P Chapman. The Applicant was represented by Mr K Harrall and Mr M Phypers accompanied by Mr C Hill, Dr L Holmes and Cllr P Cartridge. Lloyds Pharmacy was represented by Mr C Daly accompanied by Mr M Cox and Ms L Brown and Community Pharmacy Lancashire was represented by Mr R Wood.

2.4 Before the hearing started the Committee undertook a site visit.

2.5 The Committee drove across the Shard Bridge through Hambleton to the Over Wyre Medical Centre at Preesall. The area to the east of the river Wyre was seen to be typically level for a coastal peninsula with little industry other than agriculture and a few signs of tourism in the form of caravan parks. The roads in the area were noted to be in good condition although narrow and winding in parts.

2.6 The Medical Centre was seen to be a recently extended modern building served by a large car park containing only a few cars at the time of the Committee’s visit. The Centre is situated away from the main road through Preesall and surrounded by housing although there are small signs advertising it for the benefit of passing motorists.

2.7 The Committee entered the Centre and noted the large and well-appointed dispensary to the right of the waiting area inside the main double entry doors. The practice manager confirmed that the proposed pharmacy would be located in the area occupied by the dispensary and he pointed out the shutters that could be lowered to seal off the surgery from the dispensary. The Committee noted that the dispensary did not have its own independent access from the car park.

2.8 The Committee walked from the Centre to a bus stop on the main road leading to Knott End using a footpath starting in the corner of the Centre car park and leading

through the adjoining houses. The path was in good condition and there were street lights at the side of the path. The walk to the bus stop took three minutes.

2.9 The Committee then walked into the centre of Knott End and observed the Lloyds pharmacy there. The walk took just less than 10 minutes. There was no obvious break between Preesall and Knott End. The housing in the area was noted to be mainly bungalows and the Committee observed a considerable number of elderly pedestrians despite the inclement weather.

2.10 The centre of Knott End was seen to comprise a significant variety of shops including a small supermarket and a post office and the Committee noticed a mobile bank at the side of the road in the central area. Car parking was available in designated small car parks, on the main and side roads and on the sea front close to the village centre.

2.11 The Committee walked back to the Centre then drove to the ferry terminus at the west end of the sea front. It was not clear if the ferry was operating. Access onto the ferry was gained off a sloping stone jetty without any protection from the weather.

2.12 The Committee then drove to Hambleton and observed the surgery and pharmacy there. They were seen to occupy a single building although with separate entrances, served by a small car park but next to a public house with a larger car park. Hambleton was seen to offer few retail or other facilities.

3 A summary of the above observations was provided to those in attendance. They were invited to comment upon them or indicate if any of the observations appeared to be inaccurate. The Applicant’s representative asked if the Committee had noted that the Lloyd’s pharmacy in Knott End had been closed as the pharmacist had not arrived but the Chair confirmed that it was open at the time of the Committee’s visit. Such other comments as were made appear in the next section.

4 Oral Hearing Submissions

4.1 Mr K Harrall (representing the Applicant)

4.1.1 The applicant company was owned by two of the GPs in the Over Wyre Medical Centre (“the Centre”). Chris Hall was also a director and practice pharmacist. He would be the superintendent pharmacist of the proposed pharmacy. All the GPs supported the application.

4.1.2 The practice was the only medical practice in Over Wyre and had been there since 1990. It had been a dispensing practice throughout that time. There was no dispensary at the branch in Hambleton although all services were available there apart from smear tests.

4.1.3 An extension had been completed at the Centre within the last 6 months and it was now future proof.

4.1.4 With regard to regulation 44 this had not been considered by NHS England. There would be no prejudice.

4.1.5 He described the history of the dispensing at the surgery and submitted that it was better if a pharmacist could dispense as other pharmaceutical services could be provided whereas doctors could only dispense. Dispensing doctors were only a safety net. The doctors intended to surrender their dispensing rights but only if and when the application was granted.

4.1.6 A limited dispensing service would be replaced with a comprehensive pharmaceutical service and there would be a big improvement although patients did not understand the details of the regulatory framework.

4.1.7 He referred to the description of the area in the written evidence. The sea and the river Wyre had a big influence. There were two ways to cross the river, the Shard bridge and the ferry but the ferry at best ran only hourly in winter and was a poor option. This made the Asda pharmacy in Fleetwood irrelevant.

4.1.8 It measured 5.3 miles from the Centre to the Shard bridge then another 2 miles to the pharmacy in Cleveleys. To the East, the nearest pharmacy was in Garstang. Even Hambleton was 4.5 miles. Most of the users of that pharmacy also used the branch surgery there. The facilities in Hambleton and Knott End served their own populations.

4.1.9 He listed the facilities in Knott End including the fire station.

4.1.10 He referred to the demographic statistics in the written evidence. He pointed out that 31% of the population were over 65 which was double the national average. He referred to page 152 which highlighted the poor health of the population. There was little employment in the area and the households with only one car were disadvantaged if the car was used by one person for getting to work. The area was not deprived but was not affluent.

4.1.11 There was a significant transient population, especially in summer, being the occupants of the caravans on the several parks.

4.1.12 He described the test set out in regulation 18 and submitted that the application would improve the provision of pharmaceutical services.

4.1.13 He referred to the NHS England decision. They had stated that access would not be improved as there was no weekend access but the Applicant’s core hours were a big improvement on the existing hours in the area, not to mention the supplementary hours. He referred to the opening hours for the Lloyds pharmacy and the difference between those hours and the Centre’s hours.

4.1.14 Out of normal hours the nearest pharmacy was Morrisons in Cleveleys.

4.1.15 He urged the Committee not to ignore supplemental hours. The pharmacy would open to match the surgery hours. The Applicant did not offer all the proposed hours as core hours to retain some flexibility. They did not intend to open on Saturday afternoon as there was no need. Access would be better in terms of opening hours.

4.1.16 With regard to detriment, NHS England had stated that the two nearby pharmacies would be at risk of closure but there had been no evidence of this. The onus was on the person alleging detriment. The pharmacy at Hambleton had produced no evidence to support this suggestion.

4.1.17 The Lloyds pharmacy at Knott End dispensed 11,000 items per month which was 1.5 times the national average. The Hambleton pharmacy (which was partly owned by the surgery doctors) dispensed 10,500 items per month. Both pharmacies would be able to withstand any pressures brought about by a pharmacy opening in the Centre.

4.1.18 He gave examples of low volume pharmacies that remained viable including a pharmacy in Morecambe that was for sale for £295,000 yet only dispensed 2,800 items per month.

4.1.19 The main purpose of the application was to replace the dispensary. That alone would have no effect on the pharmacies. Even if the number of patients attending the pharmacy doubled, the other pharmacies would still be viable.

4.1.20 He quoted the NHS England decision relating to patients with protected characteristics. It was wrong for them to suggest that the elderly did not have higher health needs. Their decision was also wrong when dealing with innovation.

4.1.21 With regard to choice all the pharmacies to the west of the river Wyre should be discounted as should pharmacies in Garstang and to the north of the area. The pharmacy in Hambleton was too far to walk. The bus service only ran twice an hour and cost £2.70 single. There was another service but this only ran every two hours.

4.1.22 Between the two local pharmacies they were dispensing 19,000 items per month, 3 times the national average. Lloyds was nearly at capacity for MURs and was starting to charge new patients for deliveries.

4.1.23 The Hambleton pharmacy had only recently started to offer MURs but only a few had been undertaken.

4.1.24 The Centre car park was never full. In contrast, parking in Knott End could be difficult, especially in summer. There was a designated area for parking for mobility scooters at the Centre. Scooters were not able to enter the Lloyds pharmacy. Choice was extremely limited with only the one pharmacy.

4.1.25 He referred to the statistics setting out the age profile of the population. The walk to the pharmacy from the Centre was not easy for someone who was not well and the weather was often a big factor.

4.1.26 With regard to innovation he invited the Committee to take a broad view of the benefits of the application.

4.1.27 There would be a triage system at the proposed pharmacy. The patient could be invited to purchase an over the counter medicine, make an appointment with a doctor or be referred to the pharmacist for advice. This would save GP time and would offer the patients great benefit.

4.1.28 He referred to previous applications but pointed out that this was the first application to proceed to an oral hearing and the first to be heard under the current regulations.

4.1.29 Following questions he agreed that the reliant population was the population living in the practice area as illustrated in the case papers. About 75% of the patients eligible for doctor dispensing used the service.

4.1.30 Patients did not find it difficult to access the Centre although the doctors carried out a few home visits.

4.1.31 No statistics were available showing how patients accessed the Centre.

4.1.32 About one third of the patient list were seen at the Hambleton surgery.

4.1.33 The practice served 2 residential homes and 4 nursing homes but the number of patients living there was not known.

4.1.34 The dispensary served temporary residents. The travellers referred to in the written evidence had moved on.

4.1.35 The exact number of patients who were not eligible for the Centre’s dispensing service but who had applied for permission to use it (serious difficulty applications) was not known but was “more than zero”.

4.1.36 The partners owned the Centre.

4.1.37 The branch surgery premises was owned by the Hambleton pharmacy and there was no intention to close it. There were ongoing discussions relating to the renewal of the lease.

4.1.38 The only two new services to be offered at the pharmacy were MURs and NMS. The doctors did not at present advise patients of their ability to get these services from pharmacies.

4.1.39 It was not the doctors’ primary aim to achieve an increase in profit from the proposed pharmacy. No financial model had been prepared.

4.1.40 The dispensary opened at 8.30 am for historical reasons to do with staff not 7.30 am which was the time of the first possible appointment.

4.1.41 The staffing structure of the proposed pharmacy had not yet been agreed.

4.1.42 He did not know the number of prescriptions which were dispensed out of normal hours.

4.1.43 The PPG had never raised dispensing as an issue.

4.1.44 NHS England had never supported the opening of a pharmacy in the Centre so as to create a “one stop shop”.

4.1.45 The Applicant was not saying that Lloyds were poor or could not cope. It was purely an issue of choice.

4.1.46 The doctors carried out their full allocation of DRUMS (10% of the dispensing list).

4.1.47 It was not known how many eligible dispensing patients would remain if a pharmacy opened.

4.1.48 In closing he submitted that the evidence of detriment had not been convincing. The figures were guesswork and were full of inconsistencies. Lloyds would not close.

4.1.49 It was impossible to predict the government’s level of support for pharmacies and he highlighted the high amount of depreciation factored into the accounts.

4.1.50 Lloyds could always sell the pharmacy. It would remain viable and provide a service.

4.1.51 The Applicant did not need to state if dispensing would cease.

4.1.52 The application was not just about MURs and NMS. The pharmacy was part of the future of the profession. All those using the dispensary (6,000 patients each month) would notice improved access. The pharmacy would match the Centre’s opening hours.

4.1.53 At present there was no choice other than Lloyds. He accepted that one pharmacy could offer a choice but the hours did not match the Centre, parking there was difficult and it had used its quota of MURs.

4.1.54 Choice was not reasonable.

4.1.55 DRUMS was not a pharmaceutical service so should be disregarded.

4.1.56 The Councillor was simply doing his job passing on concerns.

4.1.57 Those with protected characteristics would feel the access issues more acutely.

4.1.58 The application had been made in good faith even if there were a few inevitable inconsistencies.

4.2 Councillor Peter Cartridge

4.2.1 He was the councillor for the Preesall ward which was dominated by over 65s. His constituents had spoken to him about the limited pharmacy facilities.

4.2.2 The typical complaints were that they struggled to walk to the nearest pharmacy, they could not drive, they could not park in Knott End, especially in summer, they needed to use a taxi and they needed to rely on friends or relatives.

4.2.3 The ferry across the river was under threat.

4.2.4 The Lloyds pharmacy was not always open when the surgery was open so patients had to make a second outing. Adverse weather often made travel more difficult.

4.2.5 He had no financial interest in the pharmacy.

4.2.6 During questions there was a mention of entries on a Facebook page showing some members of the public were against the application but no written copies of any entries either for or against the application were available.

4.3 Dr Luke Holmes

4.3.1 He had been a GP at the Centre for 4.5 years and the Centre was classed as outstanding by CQC.

4.3.2 Patients faced difficulty accessing a pharmacy, especially following early or late appointments.

4.3.3 A pharmacy would bring great benefits including self-care for minor ailments.

4.4 Mr C Daly (representing Lloyds Pharmacy)

4.4.1 Granting the application would not secure better access. The application was inconsistent and lacked credibility.

4.4.2 The relevant area to be considered was the practice area. The Applicant was suggesting that access to the Centre and the effect of a grant of the application on the two local pharmacies should be ignored.

4.4.3 Preesall and Knott End were in effect one village. The services were all close to the pharmacy. Parking was free in the centre and was not difficult. It was reasonably easy to walk to the shops from the Centre.

4.4.4 The local population were able to access the shops easily so could access the pharmacy.

4.4.5 He referred to page 64 of the case papers. It was contradictory to say that people were retired but also went out to work and so a car was not available. A retired couple would have a car available at all times.

4.4.6 In the Preesall parish only 16.4% of the population had no car which was much lower than the national average. This was not surprising for a rural area.

4.4.7 He agreed that there were people with protected characteristics. But the applicant had failed to link this fact to regulation 18 by showing they had difficulty accessing services.

4.4.8 He objected to the Councillor’s evidence and pointed out that no evidence had been given of those who did not support the application. The PPG did not support it.

4.4.9 The Applicant had not shown how patients accessed the Centre if they did not have a car. If they lived too far from the Centre a pharmacy there would be no use to them.

4.4.10 The Lloyds pharmacy provided all advanced and enhanced services, was open 6 days a week which was commendable for a rural setting and carried out the full quota of MURs. No charge was made for deliveries.

4.4.11 The village had one surgery and one pharmacy and the pharmacy was in the best location, providing a good deal of health advice and selling many over the counter medicines.

4.4.12 There were no complaints about the current service and much of the Applicant’s evidence about complaints had been hearsay.

4.4.13 The Applicant had criticised the Hambleton pharmacy for not being open when the Centre opened but no patients from the Centre went there. That pharmacy did now provide MURs and NMS.

4.4.14 Pharmacies in Fleetwood and Cleveleys were not relevant.

4.4.15 He listed the opening hours for Lloyds which he submitted were good for a rural area (52 hours in total) and he pointed out that it did not close for lunch. The Applicant was offering 50 core hours. The doctors’ dispensary did not open early to match the doctors’ appointments and he suggested that the pharmacy would not do so either. It was rare that a patient needed a dispensing service before 9.00 am.

4.4.16 Opening hours on Saturday were important although not profitable and the Applicant would not commit to opening on a Saturday.

4.4.17 He pointed out that the dispensary did not offer a delivery on demand service or provide other services as they were entitled to do.

4.4.18 Morrisons in Cleveleys dispensed 27 items per month for local patients. It was not clear if these were all dispensed out of normal hours.

4.4.19 Dispensing patients only lacked MURs and NMS.

4.4.20 Patients with a serious difficulty wishing to apply for the dispensing service who were not otherwise eligible could apply for permission to use it.

4.4.21 The practice was commercially aware. They were seeking to dispense to all its patients but at best a pharmacy in the Centre would be convenient for a

few patients. It was not credible that the doctors would completely give up dispensing rights. They received more than a pharmacy for each item dispensed.

4.4.22 If a pharmacy opened the doctors would lose £80,000 in fees and would need to employ two pharmacists costing £90,000. The practice would lose rent reimbursement for the dispensary and would need to pay business rates.

4.4.23 It was inconceivable that they had not prepared a business plan. To offset the losses described they would need to target new dispensing patients at the pharmacy.

4.4.24 The test for showing prejudice or significant detriment was “on the balance of probabilities”. NHS England and the LPC had both suggested that there would be detriment.

4.4.25 He referred to the projected profit and loss figures for the pharmacy. The 2017 figures were actual figures, not estimates. The proposed pharmacy in the Centre would take the vast majority of business in the form of acute prescriptions from patients. The Applicant had suggested that 75% of those eligible used the dispensing service but he thought it was closer to 90%.

4.4.26 Funding cuts would also have an impact on the figures but this was not shown.

4.4.27 Lloyds received 98% of its business from the Centre and the Hambleton pharmacy received 93% of its business.

4.4.28 The proposed pharmacy would not secure improvements or better access, it would do the opposite.

4.4.29 Lloyds did not run any pharmacy at a loss.

4.4.30 The triage scheme described by the Applicant already existed and was known as the Pharmacy + scheme.

4.4.31 There had been no evidence of patients finding it difficult to access the pharmacy.

4.4.32 Following questions he confirmed that the profit and loss figures related to the year ending March 2018. It was not anticipated that all the lost business would occur in the first year following the opening of a new pharmacy. The figure stated for AIV in the accounts was Lloyds own forecast. This was challenged and he denied that it could drop by as little as 10p.

4.4.33 The margin for this pharmacy was actually 28%.

4.4.34 The pharmacy had 9 staff at present. Staffing levels that would apply if a pharmacy opened in the Centre had not been considered.

4.4.35 Depreciation totalled £20,000.

4.4.36 He agreed that patient loyalty was high and accepted that 87% of patients nominated Lloyds for the purpose of EPS.

4.4.37 There was a full time delivery driver. Lloyds were trialling charging for new deliveries elsewhere.

4.4.38 He relied on detriment rather than prejudice (regulation 44).

4.4.39 In closing he repeated that the application was inconsistent and lacked credibility.

4.4.40 The Centre was in the wrong position. Patients did not walk there. The pharmacy would be in the wrong position.

4.4.41 Access to the nearest pharmacy was not difficult.

4.4.42 The application should only be granted if the Committee was sure that it would secure improvements or better access. If the application was granted Lloyds would probably close.

5 Consideration

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

5.2 The Committee first considered Regulation 31 of the regulations which states:

(1) A routine or excepted application must be refused where paragraph (2) applies

(2) This paragraph applies where -

(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).

5.3 The Committee noted that the very detailed reasons from the Applicant in their original application form to NHS England as to why the application should not be refused under Regulation 31, however NHS England in their decision letter had not sought to consider Regulation 31. The Committee noted that there was no dispute from parties in representations that the criteria of Regulation 31 applied to this application. On the basis of the information before it, the Committee concluded that the premises to which this application relates, or the adjacent premises, are not already occupied by a person on a pharmaceutical list who is providing or has undertaken to provide pharmaceutical services and that it was not required to refuse the application under the provisions of Regulation 31.

5.4 Preesall is in a controlled locality and the application was based on securing improvements or better access to pharmaceutical services in that controlled locality.

5.5 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

(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) 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).]

5.6 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.

5.7 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 (b) the NHSCB is not satisfied that if pharmaceutical services were provided at the relevant location, the use of those services would be similar to, or greater than, the use that might be expected if the number of individuals residing in that area who are on a patient list were 2,750 or more.

(4) Before making a determination under paragraph (2) (referred to in this regulation and regulation 42 as “D1”), the NHSCB must— (a) notify the persons notified under Part 3 of Schedule 2 about A1 that the NHSCB is required to make D1 (and it may make this notification at the same time as it notifies those persons about A1); and (b) invite them, within a specified period of not less than 30 days, to make representations to the NHSCB with regard to D1 (and the period specified must end no earlier than the date by which the person notified needs to make any representations that they have with regard to A1).

(5) The NHSCB must not make a determination under paragraph (2) in respect of A1 in circumstances where an earlier application which was in respect of the relevant premises and to which paragraph (1), regulation 44 of the 2012 Regulations (prejudice test in respect of routine applications for new pharmacy premises in a part of a controlled locality that is not a reserved 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.

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

5.9 Depending on the Committee’s view on reserved location, it would then need to deal with prejudice as follows:

44(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. (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.

(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.

5.10 Regulation 41(2) is mandatory: it requires NHS England to make a determination regarding reserved location status in circumstances such as these. In the absence of any reference to reserved location in the NHS England decision dated 29 August 2017, the Committee has treated the decision as containing a determination that the location should continue to be treated as if it were not a reserved location.

5.11 The Committee noted the information provided by NHS England in the representations period which stated that there were “5,377 patients residing within 1.6 km of the proposed site who were registered at the Over Wyre Medical Centre” and that there are a further 194 patients who live within 1.6km of the proposed site who are registered with other medical practices. The Committee noted that the total number of residents registered with a GP practice and living within a 1.6km radius of the site is 5,571.

5.12 The Committee noted that neither the Applicant nor any other party had sought to challenge this in subsequent representations. The Chair had also announced to the

parties at the outset of the appeal that the Committee intended to treat the location as not being within a reserved location and that the prejudice provisions of regulation 44 would be considered.

5.13 Given this was not reserved the Committee went on to consider if granting the application would prejudice the proper provision of relevant NHS Services in the area of the relevant HWB or a neighbouring HWB of the relevant HWB.

5.14 The Committee was aware of guidance issued by the Department of Health regarding the provision of pharmaceutical services in controlled areas (Chapter 14) which states:

“The Regulations do not provide any definition of the concept of prejudice. In general, it means that nothing must be done which would compromise the ability of people in any controlled locality to access pharmaceutical services, LPS, dispensing services or primary medical services....

A mere reduction in the total level of service provided by a particular pharmacist or GP Practice is not of itself “prejudice”. Prejudice arises where the service that people can rightly expect to be provided by the NHS has in some respect to cease or otherwise be curtailed or withdrawn without proper substitution in the area. In practice, the existence of prejudice involves, to a greater or lesser extent, making a judgment about events that will occur in the future. Inevitably, therefore, it can often be extremely difficult to judge whether or not there will be prejudice.

The burden of proof is on the party alleging that prejudice will occur. Each case will, therefore, turn very much on its own particular facts. In considering questions of prejudice, it is important that decision-takers focus only on those services which have to be provided within the terms of service of NHS primary medical and pharmaceutical services provision. The fact that non-NHS services or NHS services provided above the standard level set by the terms of service may be curtailed should not be regarded as relevant”.

5.15 The Committee noted that parties, including the LPC, had suggested that there could be prejudice to pharmaceutical services and that this should have been considered by NHS England.

5.16 The Committee noted however that apart from these statements and assertions from parties there was no further information provided prior to the hearing to demonstrate that, if the application was granted, it would cause prejudice to the proper provision of relevant NHS services.

5.17 Mr Daly on behalf of Lloyds Pharmacy had submitted evidence in the form of financial accounts at the hearing with a view to showing that the Lloyds Pharmacy in Knott End could close if the application was granted. He had also submitted that such evidence was intended to show that granting the application would cause significant detriment for the purposes of regulation 18(2)(a) rather than prejudice as referred to in regulation 44.

5.18 The Committee considered that should the pharmacy in Knott End close on account of the opening of the Applicant’s pharmacy the proper provision of NHS services in the locality would not be prejudiced as the local patients would still be able to access pharmaceutical services from the Applicant’s pharmacy.

5.19 There was no further evidence that granting the application would prejudice the proper provision of NHS services.

5.20 The Committee concluded that the granting of this application would not cause prejudice to the proper provision of relevant NHS Services as referred to in regulation 44.

5.21 The Committee noted that this was an application for “unforeseen benefits” and fell to be considered under the provisions of Regulation 18 which states:

"(1) If—

(a) 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,

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)),

(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 (duty as to reducing inequalities)), or

(iii) there being innovative approaches taken with regard to the delivery of pharmaceutical services (taking into account also the NHSCB’s duties under section 13K of the 2006 Act (duty to promote innovation)),

granting the application would confer significant benefits on persons in the area of the relevant HWB which were not foreseen when the relevant pharmaceutical needs assessment was published;

(c) 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.

(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)."

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

5.22.1 confirm NHS England’s decision;

5.22.2 quash NHS England’s decision and redetermine the application;

5.22.3 quash NHS England’s decision and, if it considers that there should be a further notification to the parties to make representations, remit the matter to NHS England.

5.23 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

5.24 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.

5.25 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).

5.26 The Committee considered the Pharmaceutical Needs Assessment ("the PNA") prepared by the Lancashire Health and Wellbeing Board, conscious that the document provides an analysis of the situation as it was assessed at the date of publication. The Committee bears in mind that, under regulation 6(2), the body responsible for the PNA must make a revised assessment as soon as reasonably practicable (after identifying changes that have occurred that are relevant to the granting of applications) unless to do so appears to be a disproportionate response to those changes. Where it appears disproportionate, the responsible body may, but is not obliged to, issue a Supplementary Statement under regulation 6(3). Such a statement then forms part of the PNA. The Committee noted that the PNA was dated

2015 and that it was published prior to 1 April 2015 and that various supplementary statements had been issued in November 2016 and February, April, June and July 2017 that dealt with permanent changes of supplementary hours for pharmacies in the area of the PNA. A supplementary notice was also issued in June 2017 with regard to the closure of a pharmacy in Rossendale and a GP practice ceasing to dispense with effect from August 2017.

5.27 The Committee noted that for the purposes of the PNA Lancashire had been divided into smaller areas. The application site falls under the district of Wyre which is within the North Locality along with the districts of Fylde and Lancaster. The Committee noted that there is no specific references to Preesall within the PNA except for mention of the dispensing doctors practice and the existing pharmacies in the area, Lloyds and Hambleton Pharmacy. The Committee noted that the area of Wyre was looked at as a whole throughout the PNA.

5.28 The Committee noted that the PNA Executive Summary under “3.Findings” stated “There is currently no need for any further additional pharmacies as current pharmaceutical service provision is deemed adequate across Lancashire” and went on to state “There is good coverage in terms of opening hours across the county”. Under “4. Recommendations” the Committee noted that the PNA concluded “In conclusion, this PNA identifies that: the PNA should be the basis for all future pharmacy commissioning intentions, Pharmacies provide a wide range of services above core contracts and there was no identified need for additional pharmacies”.

5.29 The Committee noted that the Applicant seeks to provide unforeseen benefits to the patients of Over Wyre Medical Centre as well as those resident in Preesall and the surrounding area. The Committee noted that the improvements or better access that the Applicant was claiming would be secured by its application were not included in the relevant pharmaceutical needs assessment in accordance with paragraph 4 of Schedule 1.

5.30 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)

5.31 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”

5.32 The Committee noted that in its decision NHS England had stated that granting the application “would cause significant detriment to the proper planning and arrangements that the NHSCB had in relation to that particular area as the grant of the application would place two other providers of pharmaceutical services……. at significant risk of closure; these two providers offered a greater coverage of core hours on Saturday”.

5.33 No evidence had been provided by NHS England, save for the PNA as mentioned above, of any “planning” as mentioned in the regulation and no party at the hearing had submitted any such evidence.

5.34 The Committee decided to treat the evidence that had been presented relating to potential detriment as relevant to regulation 18(2)(a)(ii) and this is considered below.

5.35 On the basis of the information available, the Committee was not satisfied that, if the application were to be granted and the pharmacy to open, the ability of the NHS England thereafter to plan for the provision of services would be affected in a significant way.

5.36 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)

5.37 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"

5.38 The Committee again noted the comments made by NHS England in its decision letter as mentioned above. The Committee also noted the comments of Community Pharmacy Lancashire as quoted by NHS England that the proposed pharmacy could lead to the closure of the Knott End pharmacy depriving the patients in Knott End of pharmaceutical services and access to over the counter medicines.

5.39 The Committee noted that no evidence had been submitted relating to the possible closure of the Hambleton pharmacy.

5.40 The Committee considered carefully the financial statements submitted by Mr Daly on behalf of Lloyds illustrating the possible profit or loss for the Knott End pharmacy should the number of items dispensed at the pharmacy drop by 50, 60 or 70 per cent. These figures had been challenged by the Applicant: In particular it had been submitted that the assessment of AIV had not been realistic, staffing levels were too high and that the figure provided for by way of depreciation had been excessive.

5.41 The Applicant had also submitted evidence to show how the Knott End pharmacy would remain an attractive business to a potential buyer that could be sold even if the dispensing figures dropped from their current above average levels.

5.42 The Committee was aware that the pharmacy received 98% of its business from the Over Wyre medical centre and that should the proposed pharmacy open in the Centre it was likely to attract more patients than those dispensing patients currently served by the dispensary. However the Committee found it difficult to predict with any certainty the likely loss of business to the Knott End pharmacy.

5.43 The Committee concluded that any loss of business would not be immediate but would rather occur over a period of several months allowing the Knott End pharmacy the opportunity to make adjustments to its structure. The Committee also concluded that taking into account customer loyalty, the comments concerning viability made by the Applicant, the fact that the pharmacy would remain more accessible for many patients who did not need to visit the surgery before a visit to the pharmacy and the number of patients using the pharmacy’s delivery service, the pharmacy would remain viable and would be unlikely to close.

5.44 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.

5.45 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)

5.46 The Committee had regard to

"(b) whether, notwithstanding that the improvements or better access were not included in the relevant pharmaceutical needs assessment, it is satisfied that, having regard in particular to the desirability of—

(i) 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)),

(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 (duty as to reducing inequalities)), or

(iii) there being innovative approaches taken with regard to the delivery of pharmaceutical services (taking into account also the NHSCB’s duties under section 13K of the 2006 Act (duty to promote innovation)),

granting the application would confer significant benefits on persons in the area of the relevant HWB which were not foreseen when the relevant pharmaceutical needs assessment was published"

Regulation 18(2)(b)(i) to (iii)

5.47 The Committee began by assessing the reliant population to be served by the proposed pharmacy. It noted that the Over Wyre area was unusual in that it was a controlled area, served by a single medical practice with a branch surgery and two pharmacies and that owing to the geography of the area, few residents were registered with practices outside the area and the two pharmacies received an insignificant number of prescriptions from other medical practices (2% in the case of the Knott End pharmacy). The main surgery (but not the branch surgery) had a dispensary and dispensed to approximately 75% of the patients eligible for this service although this figure had been challenged.

5.48 The practice area as detailed in the written evidence comprised of 11,150 patients. At the hearing the Applicant had suggested that approximately one third of the patients were seen at the Hambleton surgery leaving approximately 7,500 patients served by the Centre. NHS England had stated that that the total number of residents registered with a GP practice and living within a 1.6km radius of the Centre is 5,571.

5.49 The Applicant had indicated that the doctors would give up all dispensing should the application be granted (this had been challenged) but could not state how many patients would remain eligible for dispensing. The Committee concluded that a high proportion of patients would remain eligible for dispensing as the patients to be made ineligible for dispensing by the opening of the proposed pharmacy included many already ineligible on account of the Lloyds pharmacy in Knott End.

5.50 The Committee accepted from the evidence that it was not necessary to consider the patients attending the Hambleton surgery. They had access to all the services available at the main surgery with one minor exception and had easy access to the adjacent pharmacy. The Committee concluded that Hambleton residents, including the patients of the surgery there, had little need to travel to Knott End or Preesall and

that they were more likely to cross over the river Wyre and shop in Cleveleys or further afield than visit other parts of the Over Wyre area.

5.51 Evidence had suggested that there were few visitors to the area other than tourists, mainly in the summer months, some of whom would stay for lengthy periods in the caravan parks. Dr Holmes had mentioned that the surgery treated a number of temporary residents and that they were eligible for the dispensing service.

5.52 The Committee had not been made aware of any likely changes to the local population and there had been no evidence of significant housebuilding in the area. The Committee also noted that there was no substantial source of employment in the area and that many residents from the area commuted to the west of the river Wyre or north to the Lancaster area.

5.53 The Committee had noted that Knott End offered several facilities and services that would satisfy the residents’ needs for everyday requirements. Better facilities were available in the nearby towns of Cleveleys, Fleetwood, Garstang and Blackpool but these were all accessible only by car or bus. The Committee did not consider that the residents of Knott End would routinely use the half hourly bus service to travel to the area west of the river Wyre in order to access services there.

5.54 The Committee accepted that the ferry service from Knott End to Fleetwood was not suitable or regular enough to be considered as a regular form of transport to Fleetwood for the residents of Over Wyre and therefore that the pharmacies in Fleetwood were not readily accessible to them.

5.55 The Committee concluded that the Lloyds pharmacy in Knott End was well positioned and reasonably accessible to all the residents of Knott End and Preesall being located in an area where many residents went to access other services on a regular basis. The Committee had also noted how it was difficult to determine the division between the two communities. The Committee considered that parking in the central area of Knott End close to the pharmacy was not difficult. It accepted that parking during the summer months might be more problematic but this would be mainly during the weekends.

5.56 The Committee also considered that most residents of Knott End and Preesall including those living close to the Over Wyre Medical Centre would be able to walk to the Lloyds pharmacy without any difficulty. The area had been seen to be level, served by good pavements without any obstacles or barriers. The Committee had noted that no evidence had been given as to how patients travelled to the Centre but suspected that most patients went by car save for those living in the immediate vicinity of the Centre.

5.57 The pharmacy, unlike the Centre, was also reasonably easy to find. The Committee accepted that patients of the Centre would be aware of the Centre’s location and that it was served by a good car park but the Committee considered that visitors to the area would not easily be able to find a pharmacy situated there and such pharmacy would attract no passing trade whatsoever and little business at times when the surgery was closed.

5.58 The Committee had been presented with no evidence of complaints relating to the service at the Lloyds pharmacy and had no evidence to suggest that it could not cope with the above average dispensing that took place there. The late opening of the pharmacy on the day of the hearing was in the Committee’s opinion excusable in the light of the unusual weather. The comments relating to access passed on by Councillor Cartridge had been noted and the Committee accepted that there would inevitably be a few patients inconvenienced by the lack of a pharmacy co-located with or adjacent to the surgery.

5.59 The Committee had considered the additional pharmaceutical services undertaken at the pharmacy and had not been made aware of any significant gaps in such services that the proposed pharmacy might fill.

5.60 Given the size of the reliant population, the geography of the area, the position of the Lloyds pharmacy and the mobility of the residents the Committee concluded that the single pharmacy provided the residents of Knott End and Preesall with an adequate choice of accessible pharmaceutical services.

5.61 Therefore considering choice in relation to physical access, and GP Service provision 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.

5.62 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.

5.63 The Committee accepted that there was a higher than average proportion of elderly residents in the Over Wyre area as it was a popular place to which to retire. The Committee accepted that such residents were likely to suffer from poor health as explained by the Applicant and that they shared the difficulties in accessing pharmaceutical services that were experienced by other residents. However the Committee had not been made aware of any particular difficulty experienced by such residents in accessing pharmaceutical services that met their specific needs.

5.64 The Committee had also not been made aware of any other group of patients sharing a protected characteristic for whom it was difficult to access pharmaceutical services that were specific to their needs.

5.65 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.

5.66 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.

5.67 The Applicant had stated that the “collaborative approach of including a pharmacy in the heart of the Medical Centre is an innovation which will result in an enhanced level of pharmaceutical service and convenience to patients”.

5.68 The Committee accepted that the pharmacy would be a “new development locally” as suggested by the Applicant but could not accept that this would be innovative as envisaged by the regulations which required something that could be regarded as an innovative development in a national or wider context.

5.69 The Committee was 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

5.70 The Committee noted that the Applicant had made submissions on the hours for which the Lloyds pharmacy in Knott End was open. It had been suggested that the pharmacy did not match the opening hours of the surgery and that the local population was therefore obliged to travel an unreasonable distance for a service outside of the pharmacy’s opening hours.

5.71 The Committee noted that the nearest pharmacy offering extended hours was the Morrison’s store in Cleveleys a short distance from the Shard bridge and evidence had suggested that this pharmacy dispensed 27 items per month although there was no evidence as to when such dispensing occurred.

5.72 Given the rural nature of the area and the mobility of the population the Committee concluded that there was a reasonably accessible provision of pharmaceutical services out of normal hours.

5.73 The Committee noted that the Lloyds pharmacy was open from 9.00 am to 6.00 pm Monday to Friday whereas the Centre offered appointments before 9.00 am and after 6.00 pm. The Committee also noted that the Centre did not open on Saturday although the pharmacy was open from 9.00 am to 4.00 pm.

5.74 The Committee concluded that very few patients would require a pharmaceutical service (mainly dispensing) at times when the Lloyds pharmacy was closed and that the opening hours of the dispensary as highlighted by Mr Daly reflected the demand for such services. A pharmacy offering hours that matched the surgery hours would be a convenience for a few patients but in the Committee’s opinion it had not been shown that the additional hours over and above those already available locally would be a significant benefit to the local residents.

5.75 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.

5.76 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.

Other considerations

5.77 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).

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

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

5.80 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.

5.81 In those circumstances given that the Committee has considered the issues of prejudice, regulation 31 and also evidence not presented to NHS England, the Committee determined that the decision of NHS England must be quashed.

5.82 The Committee went on to consider whether there should be a further notification to the parties detailed at paragraph 19 of Schedule 2 of the Regulations to allow them to

make representations if they so wished (in which case it would be appropriate to remit the matter to NHS England) or whether it was preferable for the Committee to redetermine the application.

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

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

6 DECISION

6.1 The Committee quashes the decision of NHS England and redetermines the application.

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

6.3 The Committee concluded that granting the application would not 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.

6.4 The Committee has considered whether the granting of the application would cause significant detriment to proper planning in respect of the provision of pharmaceutical services in the area covered by the HWB, or the arrangements in place for the provision of pharmaceutical services in that area and is not satisfied that it would;

6.5 The Committee determined that the application should be refused on the following basis:

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

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

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

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

6.5.2 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.

Committee Chair

Dated this twelfth day of March, 2018

A copy of this decision is being sent to:

Griffin Martlet Ltd Lloyds Pharmacy Boots UK Ltd Hambleton Pharmacy Community Pharmacy Lancashire (The LPC) NHS England – North (Lancashire and Greater Manchester) ANNEX A

REF: SHA/18787 1 Trevelyan Square Boar Lane APPEAL AGAINST NORTH (LANCASHIRE AND Leeds GREATER MANCHESTER) AREA TEAM, NHS LS1 6AE

COMMISSIONING BOARD ("NHS ENGLAND") DECISION Tel: 0113 86 65500 TO REFUSE AN APPLICATION BY GRIFFIN MARTLET Fax: 0207 821 0029 LTD FOR INCLUSION IN THE PHARMACEUTICAL LIST Email: [email protected] OFFERING UNFORESEEN BENEFITS UNDER REGULATION 18 AT THE OVER WYRE MEDICAL CENTRE, WILKINSON WAY, PREESALL, LANCASHIRE, FY6 0FA

1 The Application

By application dated 30 January 2016, Griffin Martlet Ltd (“the Applicant”) applied to NHS Commissioning Board (“NHS England”) for inclusion in the pharmaceutical list offering unforeseen benefits under Regulation 18 at The Over Wyre Medical Centre, Wilkinson Way, Preesall, Lancashire, FY6 0FA. In support of the application it was stated:

1.1 In response to why the application should not be refused pursuant to Regulation 31 the Applicant stated:

1.1.1 It is advised that the premises included in section 2 are not at the site of or adjacent to or in the immediate proximity of another pharmacy or dispensing appliance contractor premises. Notwithstanding this fact, given the application or regulation does not define what "close proximity" is, below it is set out why the application should not be refused pursuant to Regulation 31 in any event.

1.1.2 Regulation 31(1) provides that an application for inclusion in a Pharmaceutical list must be refused where sub-paragraph (2) applies.

1.1.3 Regulation 31(2) does not apply in this case because it clearly states in subsection (a) that this paragraph applies where "the existing services" are being provided from premises to which the application relates, or adjacent premises. In this case no existing services are being provided from either the premises to which the application relates or any adjacent premises. The wording of the statute does not prohibit existing services from being provided from premises in close proximity - but merely adjacent or the same premises.

1.1.4 Additionally, and/or alternatively, Regulation 31(2) does not apply because subsection (b) of this particular regulation does not apply in this case. Namely the services the applicant intends to provide will not be the same services as any existing services, and therefore the premises to which the

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application relates and existing dispensing doctors premises should not be treated as the same site. Specifically:

1.1.5 There would not be any justifiable basis for treating the Applicant's premises and any other existing service as the "same site". There is no commercial or interest of any other sort with any other pharmacies operating in the same locality.

1.1.6 Therefore this application in no sense is a request to divide any existing business, but rather to clearly establish a separate business providing unforeseen benefits which will be clearly outlined in section 6 of this application.

1.1.7 It is submitted that the purpose of Regulation 31 has to be borne in mind, for example, paragraph 116 of Department of Health Guidance titled Regulations under the Health and Social Care Act 2012: Market entry means of Pharmaceutical Needs Assessments (November 2013) at chapter 8 on Unforeseen Benefits, "The purpose of this regulation is to prevent a contractor from applying for multiple inclusions in a pharmaceutical list at the same address with no benefit to patients". There is absolutely no attempt by the applicant to do this in the present case, and there can be absolutely no concern in this regard in relation to this application.

1.2 The unforeseen benefit which is at the heart of the application is that there is a need for additional pharmacy provision in Preesall to ensure that the population living within the Over Wyre locality have:

1.2.1 Improved access to a full range of pharmaceutical services.

1.2.2 A choice of providers delivering essential, advanced and enhanced services.

1.2.3 The availability of essential, advanced and enhanced pharmacy services which are appropriate to the needs of the community and offer innovative services over and above those currently available.

Locality

1.3 Although for the purpose of this application the locality is that of Preesall, the actual area at the heart of this application focuses around the rural area known as "Over Wyre". Over Wyre is the collective name given to a group of villages in Lancashire which is situated on the Fylde coast peninsula to the north of the River Wyre.

1.4 The Over Wyre Medical Centre is a semi-rural practice which covers a wide geographical area of approximately 60 square miles.

1.5 The villages include Hambleton, Stalmine, Knott End-on-Sea, Preesall, Pilling, Cockerham, Nateby, Winmarleigh and Out Rawcliffe. It is an area that is geographically removed from the neighbouring areas of Fleetwood and Poulton due to the river Wyre which runs to the south and west. Access to Fleetwood is via a tide limited ferry service from Knott End and the only direct access to the town of Poulton is via the A588 over the Shard bridge.

1.6 The population of the area described above that this application will service is considerable.

1.7 The local population is 16,203 (Source; Office of National Statistics, ONS mid-2015 estimate) with the total reliant population in excess of 11,150 patients based on the current GP practice list size.

1.8 The sheer number of patients registered with the Medical Centre and the fact that the Medical Centre has been identified through a national infrastructure funding initiative as being in need of redevelopment to meet the present growing demand as well as future need demonstrates the need for investment in healthcare services in the locality. The absence of a pharmacy at the Over Wyre Medical Centre clearly shows that pharmaceutical services have been literally left behind while medical health services have moved forward significantly as a result of this recent central government investment.

The Over Wyre Medical Centre

1.9 The Over Wyre Medical Centre has seven GPs. The practice has eight practice nurses, two nurse practitioners and a community paramedic. Clinics provided at the practice include antenatal care, asthma, child health clinic, coil fitting, cardiovascular disease, counselling services, diabetes, family planning, minor illness, phlebotomist, smears, smoking cessation and vaccinations.

Population Challenges

1.10 It is significant that the Over Wyre Medical Centre has the highest age prevalence aged >65 in the Fylde and Wyre locality. (Source; Public Health England 2) The numbers of patients aged >65 at the Over Wyre Medical Centre is 34.2% which is significantly different than the England average (17.2%)

1.11 The population in Fylde and Wyre has a growing number of older people. There are already 10% more adults aged over 45 and 8% more adults aged over 65 than the national average.

1.12 By 2022 it is expected that the numbers of people aged over 70 will increase by nearly one third and by 2030 the number of people aged over 85 will have doubled. (Source; 2030 Vision for health and care in Fylde and Wyre. NHS Fylde and Wyre Clinical Commissioning Group April 2014 3)

1.13 The Over Wyre Medical Centre already has significantly more patients aged >85years than the national average i.e. 4.47% compared to England average 2.3% (Source; Public Health England 4)

1.14 As a consequence the elderly population increases the pressure on existing services because as people become older they are more likely to develop multiple long-term conditions such and not limited to diabetes, heart disease, breathing difficulties and dementia.

Health Challenges

1.15 Also of note is that patients from East Lancashire towns regularly move into the Over Wyre area to retire with their inner city medical problems. The patient population also includes a large group of travellers who live in the rural locality who have registered at the practice.

1.16 The Wyre area (Office of National Statistics Wyre 004 middle layer super output layer 5) also has a higher proportion of people (27%) living with a long term health problem or disability. England 17%, NW 20%, Wyre Metropolitan 23%.

New Housing

1.17 Wyre County Council have approved two new sites for the development of a total of 76 new dwellings which will further contribute to the increasing healthcare demand locally.

1.17.1 Hambleton 51 new dwellings (15/00500/FULMAJ)

1.17.2 Pilling 25 new dwellings (14/00631/FULMAJ)

(Source; Wyre Council Planning & Building Control 6)

Current Pharmaceutical Provision

1.18 NHS legislation provides that in certain rural areas, classified as controlled localities, general practitioners may apply to dispense NHS prescriptions. Permission is granted to GPs providing there is no "prejudice" to the existing medical or pharmaceutical services.

1.19 Prejudice is defined as: being unable to comply with the medical or pharmaceutical terms of service. The provisions to allow GPs to dispense were introduced to provide patients access to dispensing services in rural communities not having reasonable access to a community pharmacy.

1.20 At the time that the current Pharmaceutical Needs Assessment (PNA) was produced, the dispensary at the Over Wyre Medical Centre was operating and routinely dispensing over 8,000 prescription items each month.

1.21 The PNA at the time could not have foreseen that the ongoing provision of pharmaceutical services from this site is under review due to rising and unsustainable pressures in demand and that any disruption could lead to a reduction in access to pharmaceutical services to the patients regularly using and visiting the Over Wyre Medical Centre.

1.22 In order to meet this previously identified need the GPs at the Over Wyre Medical Centre were given provision to provide patients access to dispensing services. As such the dispensing doctors operate out of a small (11m2) box room that is no longer fit for purpose.

1.23 The demand for pharmaceutical services from the local population has increased dramatically since the initial provision for GP dispensing was granted. As such the demands and pressures of dispensing over 8,000 items per month from the existing small room are so great that the Applicant feels the present facilities are at saturation and that a tipping point has been reached which represents a risk to the current provision of pharmaceutical services from the dispensing doctors. The volume of prescription items dispensed via the dispensary are now regularly in excess of the national average (7,096) for community pharmacies. (Source: General Pharmaceutical Services England 2006/07 to 2015/16, Prescribing and medicines, NHS Digital Nov 2016 8)

1.24 It is therefore the Applicant's intention to relinquish the dispensing rights at the Over Wyre Medical Centre due to the unsustainability of continuing to provide this service for our patients in its current form should the pharmacy application be approved. This will secure the continued provision of pharmaceutical services in terms of the safe and effective dispensing of medicines as well as providing enhanced benefits to local residents in the form of an expanded range of pharmaceutical services that are only available from a pharmacy such as and not limited to MUR, NMS and pharmacy plus services.

Improvements to the Over Wyre Medical Centre

1.25 As a large semi-rural area with varied geography and multiple centres of population, there are particular unique challenges to meet the health needs of the people of Over Wyre. The strategic vision has been to develop, with their partners, particularly with the Neighbourhood Practice Group, integrated services accessible in as many localities as possible. In the neighbourhood group there are 7 practices covering 51,000 patients. There is a lack of space for all the practices so providing additional capacity will enhance access and care across the neighbourhood. Services are being

enhanced and the skill mix of staff is such that the needs of the local population can be met without the need for onward referral.

1.26 This approach is consistent with the objectives identified within the Local Health Plan that adheres to Fylde and Wyre CCG's 2030 Vision. This sets out the strategic direction, provides evidence of performance to date and the plans to address the national targets.

1.27 A unique opportunity has arisen in which the Over Wyre Medical Centre has successfully bid for NHS England capital investment to significantly upgrade the existing development to meet the present and future health care challenges.

1.28 The proposed building redevelopment will form the cornerstone of many partnerships to deliver a wide range of joined up, integrated services. Working in partnership with other agencies and the public, the Over Wyre Medical Centre aims to provide a cohesive framework amongst primary care and professional groups and between all other community care groups within the same areas to allow the development of services to the local population.

1.29 The Over Wyre Medical Centre would be responsible for delivering local, community based healthcare. This would be achieved by enhancing joint working relationships across the whole care pathway in terms of delivery of care models.

1.30 The Over Wyre Medical Centre has an important strategic location in relation to the neighbouring community and in its role in the network of neighbourhood practices providing facilities in the area. A project to upgrade the premises, develop and improve services at Over Wyre Medical Centre is considered an essential component of these objectives.

1.31 The redevelopment of the Over Wyre Medical Centre will provide a unique platform for the delivery of effective and efficient clinical services to meet all components of the Fylde & Wyre Health Care Strategy for 2030 and in line with the current evolving model of primary care.

1.32 NHS England awarded "vanguard status" to the Fylde coast health economy which includes Fylde and Wyre CCG. Vanguard sites are taking the lead transforming care for patients across England. As one of a select few 'vanguard' sites across the country to test new ways of organising and delivering healthcare for local people Fylde and Wyre CCG is changing the way episodic care is arranged, provided and accessed. Episodic care is for those people who have a minor short-term illness or health concern which does not require on-going treatment. The emphasis locally is to expand the use of pharmacies as the first choice for patients seeking episodic care.

1.33 In addition it will allow an expanded range of services and promote emerging models of care including preventative and self-care and facilitate meeting the target of implementing a self management framework in terms of expansion of range of products and services that will help local people adopt healthier lifestyles and maintain independence as well as facilitating the introduction of new innovative ways of working and in particular effective collaborative/partnership working. Finally, it will ensure delivery of the joint working which will enable integrated care to be developed.

1.34 Pharmaceutical services delivered through a pharmacy are clearly a fundamental part of the Fylde and Wyre Health Care strategy for 2030 in terms of promoting an emerging model of preventative and self-care. A pharmacy located within the heart of the Over Wyre Medical Centre is a key way of delivering better access to these services and significant improvements to the current level of pharmaceutical provision delivered from the Medical Centre.

1.35 Within the Over Wyre Medical Centre, progress is being made with the development of integrated primary care services. Nurses and Allied Health Professionals work in or

closely with all practices within the neighbourhood, and in doing this they are seeking to extend the range of services provided to meet such needs as smoking cessation, assessment of minor illnesses, management of patients with long-term conditions (e.g. diabetes, asthma, CHD Coronary Heart Disease), psychological support, minor surgery to avoid hospital waits and self-care.

1.36 The recent successful bid for NHS England capital investment represents a once in a generation opportunity to redevelop the Over Wyre Medical Centre to meet the healthcare needs of the local population both now and in the future. The addition of a pharmacy at the heart of these redevelopment plans is a vital step to achieving a fully integrated and improved level of patient care.

1.37 Further integration of GP and pharmacy systems is essential to enable the two professions to work more closely together in the care of patients - particularly those with complex, long term health problems whose medication regimes need careful management.

1.38 Greater integration and access to patient data will enable the pharmacy to carry out more effective medicine reviews and to integrate these into care pathways for minor ailments helping to reduce the 57 million GP consultations a year in this area. (Source; Joint paper submitted to the DH by the PSNC and the Proprietary Association of Great Britain, December 2007) This would clearly confer significant benefits for the reliant population.

1.39 Granting the application will confer significant benefits on the reliant population in terms of:

Access

1.40 As at October 2016, the Over Wyre Medical Centre has a patient list of 11,169. The total annual prescribing volume of the Medical Centre is approximately 375,000 prescription items i.e. 31,300 items per month. (Source; NHS Business Services Authority). The Over Wyre Medical Centre is a dispensing practice and serves patients in rural locations who live more than 1.6km from a pharmacy, the number of dispensing patients is currently 4,390. It should be noted that dispensing doctor dispensaries do not provide essential pharmaceutical services to the same extent as pharmacies and neither do they provide advanced and enhanced pharmaceutical services.

1.41 For the reliant population, including those who share a protected characteristic, access to pharmaceutical services is difficult by reason of the distance to existing pharmacies. The premises at the Over Wyre Medical Centre will provide the following facilities:

1.41.1 Convenient access via co-location within the Medical Centre premises.

1.41.2 DDA Complaint access to all pharmacy facilities

1.41.3 One private fully equipped consultation room.

1.41.4 Free car parking for 60 vehicles.

1.42 The application at the Over Wyre Medical Centre at Preesall proposes core opening hours of 50 hours:

1.42.1 Mon-Fri: 08.30am-6.30pm

1.43 Additionally, the Applicant would like to expand on the core hours by providing supplementary opening hours that exactly mirror the opening hours of the Medical Centre as well as provision on a Saturday morning.

1.43.1 Monday: 07.30am-8.00pm

1.43.2 Tuesday: 07.30am-6.30pm

1.43.3 Wednesday: 07.30am-6.30pm

1.43.4 Thursday: 07.30am-6.30pm

1.43.5 Friday: 07.30am-6.30pm

1.43.6 Saturday: 09:00am-13:00pm

1.44 There is currently no pharmacy located at the Over Wyre Medical Centre Preesall site. The nearest pharmacy is located in Knott End and is over 1.2km (Source: AA Route Planner 10) from the proposed site. This distance represents a barrier to accessing pharmaceutical services for the reliant population many of whom have a protected characteristic.

1.45 The public transport network in Over Wyre is poor. The only bus service linking Knott End, Preesall, Stalmine and Hambleton with the Over Wyre Medical Centre is the 2C operated by Blackpool Transport. This service operates less than twice per hour and the service is further compromised as there is no bus stop located at the Medical Centre. The nearest bus stop is located at a distance of 0.4km on the B5270 (Lancaster Road).

1.46 Granting the application would confer significant benefits on the reliant population since it will secure better access to a full range of pharmaceutical services from premises within the Medical Centre and give patients a reasonable choice of provider and overcome access difficulties for those travelling by means of foot or public transport.

1.47 The Government expects to see community pharmacies located in a substantial number of primary care centres (Pharmacy in the Future Implementing the NHS Plan; NHS September 2000) where "pharmacist can work alongside GPs, dentists, health visitors and social workers under one roof". The document also states that co-location of GPs and pharmacies for the benefits of their shared patients. (Emphasis added by applicant)

1.48 The design principles employed in the design of the upgraded Medical Centre are that the building is designed to provide:

1.48.1 Modern efficient and aesthetically pleasing accommodation in order for the practice to provide increased range and quality of primary care services

1.48.2 The new Medical Centre will provide an extended range of primary care services

1.49 A pharmacy located at the heart of the Medical Centre would confer substantial improvements for the reliant population through supporting healthy living and improving access to medicines and provision of a more integrated service to people who are taking medicines to help them with long term conditions and is in line with delivering the government's vision of pharmacies being repositioned, recognised and valued by all as healthy living and health-promoting centres, promoting health literacy and offering opportunistic and prescription-linked healthy lifestyle advice, and providing support for self-care and pressing public health concerns, such as smoking, alcohol, diet and nutrition. (Source; Pharmacy In England Building on strengths - delivering the future. April 2008)

1.50 A pharmacy based at the medical centre would improve access for patients as well as relieving the pressure on GPs as patient access to pharmaceutical services such as MUR, NMS and pharmacy plus services would be significantly enhanced.

1.51 The focus of the pharmacy application is to deliver to patients expanded access to pharmaceutical clinical services such as treating minor ailments and providing more support for people with long term conditions with routine check-ups and monitoring, available on a drop-in basis, offering vascular risk assessments together with improving access to services such as the New Medicine Service (NMS) for those who are starting to take regular medicines to treat their condition for the first time as well as the Medicines Use Review (MUR) to undertake structured adherence-centred reviews with patients on multiple medicines, particularly those receiving medicines for long-term conditions.

1.52 The pharmacy would also provide a home delivery service to any patient who requested it, thereby ensuring that the housebound received a consistent level of service. There is a great need for a pharmacy in Preesall to ensure the local population are provided with:

1.52.1 Access to the full range of Essential, Advanced and Enhanced Services.

1.52.2 Appropriate pharmacy services targeted at those with a protected characteristic.

1.53 For the reliant population, including those who share a protected characteristic, access to pharmaceutical services is limited to distance to existing pharmacies. The premises at the Over Wyre Medical Centre will provide convenient access, DDA compliant access to pharmacy facilities, a private fully equipped consultation room.

1.54 The numbers of items prescribed by the doctors at the Over Wyre Medical Centre is high and on average 31,000 items are issued each month. Within these there will be patients who do not use a collection and delivery service and who chose not to use the dispensing service at the Medical Centre. These patients and especially those who made an urgent appointment to deal with an acute condition are disadvantaged by the absence of a pharmacy within the Medical Centre.

Choice

1.55 The population of the Over Wyre locality is 16,203 (Source; Office of National Statistics, ONS mid-2015 estimate) The need for pharmaceutical services can be justified not only by the baseline population of a community, but also and more relevantly, by the specific health needs of the community. This in turn will influence the number of pharmacies necessary within a locality and the services provided.

1.56 Currently the reliant population only has the option to access pharmaceutical services from the Lloyds pharmacy based to the North at Knott End at a distance of 1.2km away from the Medical Centre and the proposed site of the pharmacy. A second pharmacy based at Hambleton is located to the south at a distance of 7.2km.(Source A Route Planner) This does not represent a real choice of pharmaceutical provider as the locations are a considerable distance apart.

1.57 It is an accepted fact that England has an aging population and as a proportion of the total population, this is growing rapidly. The proportion of elderly people does vary from community to community.

1.58 Nationally, the proportion of over 65's is 17.2% of the total population. In the case of the Over Wyre area this area has a significantly higher than average elderly population. (Source; Public Health England) The area of Wyre 004 (Middle Layer Super Output Area) has 31% aged 65 or over and the area of Wyre 009 (Middle Super Output Area) 21.9% aged 65 or over compared with 16.4% England. (Source;

Office of National Statistics 15) The high proportion of over 65's in turn influences the incidence of long term conditions.

1.59 The prevalence of Chronic Heart Disease, Chronic Obstructive Pulmonary Disease, Hypertension, Stroke and Cardiovascular Disease amongst Over Wyre Medical Centre patients is significantly higher than the national average and in all cases above the average for Fylde & Wyre. In 11 key health condition areas the Over Wyre Medical Centre population demonstrates prevalence rates that are consistently greater than the 93rd percentile.

1.60 Indeed, seven of these areas are either in the 99th and 98th percentile nationally which represents the top 1-2% nationally. These figures are a dramatic demonstration of the very high level of healthcare demand being faced locally.

1.61 The registered population prevalence data clearly demonstrates the unique and unprecedented health challenges and high demand for health services faced by the Over Wyre Medical Centre. The logical corollary to NHS England's recent investment in medical services at the medical centre is that the current level of local pharmaceutical service provision is also enhanced to complement this.

Prevalence Over Wyre MC NHS England Fyle & Wyre CCG % National % % Centile Atrial Fibrillation 3.2 97 1.7 2.6 Asthma 6.6 68 5.9 6.7 CHD 6.7 99 3.2 5.1 COPD 4.5 98 1.8 2.8 Dementia 1.9 98 0.8 1.2 Heart Failure 2.7 99 0.7 1.5 Hypertension 21.6 97 13.8 17.8 Stroke & TIA 3.7 99 1.7 2.6 Diabetes 7.6 93 5.3 5.9 Cancer 4.7 99 2.4 3.5 Peripheral arterial 1.6 98 0.6 1.1 disease Chronic kidney 6.7 96 3.2 5.8 disease (Source; Public health England with emphasis added by applicant)

1.62 Overall, the proportion with long standing health condition accounts for 62.5% compared with 59.5% for Fylde & Wyre and 53.2% nationally. (Source; Public Health England).

1.63 Those with caring responsibilities for another adult account for 24.9% of the population in the locality of Over Wyre compared to 20.5% in Fylde and Wyre and 17.8% nationally. (Source; Public Health England 18)

1.64 The PNA denies there are any gaps in service provision; however the demographics are spread across a wide area of diverse population, which obscures the actual needs of the local population and masks health inequalities between different parts of the PNA's area.

1.65 The applicant wishes to draw attention to both the very elderly demographics and the extremely high disease prevalence of the local population of the Over Wyre area and the existing high demand for pharmaceutical services locally.

1.66 Data supplied by NHS business Services Authority (NHSBSA) shows that the existing pharmacy provider in Knott End dispenses an average of 10,700 items per month (Source; NHSBSA Pharmacy and Appliance Contractor Dispensing Data) - which is significantly above the national average (7,096) for community pharmacies. (Source: General Pharmaceutical Services England 2006/07 to 2015/16, Prescribing and medicines, NHS Digital Nov 2016)

1.67 It might be reasonably expected that the demographics detailed above and the nature of long term conditions which prevail would lead to the existing pharmacies maximising the Medicines Use Review Service.

1.68 During the 12 months (Jan 15 - Jan 16), Lloyds Pharmacy Knott end claimed for 397 MURs having been completed (99% of the maximum permitted) and 386 NMS (Source; NHS Business Services Authority).

1.69 Such figures in relation to MUR and NMS activity would suggest that there is a clear need and high demand for such interventions and that current capacity in the locality is likely to be exceeded.

1.70 During the same time period the pharmacy based at Hambleton completed zero MURs and zero NMS interventions. This highlights a clear and demonstrable pharmaceutical service inequality for the reliant population and an absence of choice. (Source; NHS Business Services Authority)

1.71 Over Wyre Medical Centre is currently limited to the safe and effective dispensing of medicines.

1.72 Those patients who currently use the dispensing services offered at the Over Wyre Medical Centre are unlikely to be aware of the availability of such pharmaceutical services and that for them; a pharmacy within the Over Wyre Medical Centre to provide such services would be a significant benefit. Further to this, due to the lack of MUR and NMS pharmaceutical services offered by Hambleton pharmacy there is a lack of choice for patients in terms of accessing these services.

1.73 The volume of dispensing at the Over Wyre Medical Centre dispensary is approximately 8,000 prescription items per month.

1.74 The long term viability of this important service is at risk due to the huge demands for pharmaceutical services being placed by the large numbers of complex, comorbidity elderly residents in the area.

1.75 The Over Wyre dispensary has seen a 21% increase in prescription items since 2010 and it is anticipated that the impact of the demographic trend towards an older population will be continue to drive unsustainable growth in this area [sic].

1.76 The main benefit of the application is the provision of a choice and better access to pharmaceutical services to the population. One additional example of this is the provision of Medication Use Reviews (MURs), which are currently limited to 400 per pharmacy. Given that there are over 11,000 patients registered with the Medical Centre, it is likely that at present only 3.6% of these patients can access an MUR locally and even then, the pharmacy is some distance from the Medical Centre.

1.77 Allowing this application to be granted will increase the number of those patients who can access MURs or indeed any other service such as the New Medicine Service (NMS) and also provide an easily accessible location which is integrated with the Medical practice from which to deliver these services.

1.78 It is proposed that the establishment of a pharmacy at the present premises will not only secure the continued level of choice of pharmaceutical services currently

experienced by local residents but also provide improvements to the access and upgraded pharmaceutical services available directly from the Medical Centre.

Protected Characteristics

1.79 The Applicant believes there are two groups of people within this area who have protected characteristics and for whom current services provided do not adequately meet their needs.

1.80 The relevant protected characteristics are:

1.80.1 Age - The Over Wyre area this area has a significantly higher than average elderly population compared to the local Fylde & Wyre CCG (25.8%) and national figures (17.2%) (Source Public Health England) (see graph at Appendix A)

1.80.2 Disability -. The area of Wyre 004 (Middle Layer Super Output Area) 31% of residents have a long-term health problem or disability that resulted in day-to- day activities being limited a lot/a little and of the area of Wyre 009 (Middle Super Output Area) 18.7% compared with 17.6% for England. (Source; Office of National Statistics)

1.80.3 Residents with disabilities including mobility problems or chronic illness are disadvantaged by having to travel unreasonable distances to access pharmaceutical services. Given the high levels of limiting long-term illness in this area this is a significant problem which could be addressed through the opening of a pharmacy at the proposed site.

Innovation

1.81 The NHS is engaged in an urgent search for ways to provide better standards of care in the face of unprecedented pressure on budgets, and justifiably intense scrutiny of quality. Only by adapting to the needs of patients with long-term conditions and preventable illnesses can this be achieved. Pharmacists have a vital role in helping the NHS make the shift from acute to integrated care, and fulfilling the pressing need to do more for less.

1.82 The ongoing capital investment by NHS England into the Over Wyre Medical Centre is recognition of the important strategic location that the Medical Centre plays in the delivery of current and future healthcare services to the reliant population. The current and anticipated healthcare needs for Over Wyre calls for a radically different and innovative approach to local healthcare delivery.

1.83 As part of this strategy the establishment of a pharmacy will be fundamental to the aspiration of greater service integration and more effective collaborative working. The Applicant would like to establish an innovative approach that clearly positions the pharmacy at the heart of the redesigned Medical Centre that will facilitate the pharmacy healthcare team to work more closely with patients and healthcare colleagues in general practice, outreach teams, patients' homes, residential care, hospices, and hospitals.

1.84 The aim being to help patients to manage their own conditions, providing health checks, supporting best use of medicines and detecting early deterioration in patients' conditions.

1.85 The NHS Five Year Forward View 2014 document, (5YFV) proposes that new "Multispecialty Community Providers" could operate at scale across localities offering a broader range of services. The 5YFV also promotes the integrated "Primary and Acute Care Systems" and better care for people in care homes that will, at the very least, require pharmacists to work more closely with other providers.

1.86 The Applicant believes that the integration of pharmacy services with general practice leads to improved health outcomes for patients and a better level of service and that by facilitating this the Applicant can provide high quality care for patients that is both convenient and accessible.

1.87 This view is supported by the £31 million investment made by NHS England and Health Education England in the expansion of pharmacists roles in general practice and the establishment of a new pharmacy integration fund. (Source; General Practice Forward View April 2016)

1.88 The Royal College of GPs and Royal Pharmaceutical Society both identify the pressing need to increase capacity and provision of high quality care through GP surgeries. The two organisations believe that pharmacists with the appropriate skills and experience, based in GP practices will be able to contribute to the clinical work related to medicines, relieve service pressure and increase capacity to deliver improved patient care. (Source; RCGP and RPS Policy Statement on GP Practice based Pharmacists. February 2015)

1.89 Innovate by:

1.90 Services available from existing providers in addition to NHS dispensing appear to be a standard compilation i.e. one size fits all approach to service provision. There is little or no apparent evidence to indicate close co-operation with other health/clinical/or social care professionals to tackle the specific needs of any specified group and in the case or Over Wyre, the needs of the elderly as a higher proportion of the population.

1.91 Developing systems to increase the referrals to community pharmacy and increasing the referral of patients to community pharmacies by other primary and secondary care professionals and NHS 111 services would not only assist in managing constrained workload capacity in GP practices and hospitals, but it would also help to re-educate patients about the range of services available at their local community pharmacy.

1.92 Referring patients who are being discharged from hospital to their community pharmacy for provision of an MUR or NMS provides an example of such a referral which is clearly in the interests of the patient and the NHS, but which currently does not occur routinely.

1.93 Sharing patient information. The inability of most community pharmacy teams and GP practices to communicate effectively and share patient data electronically is proving to be a major block to developing new innovative services and effective collaborative relationships that would benefit patients.

1.94 A pharmacy based at the Over Wyre Medical Centre would be designed to be fully integrated into the existing patient clinical management systems to enhance and deliver significant improvements through greater inter-professional collaboration, data sharing and patient referral systems.

1.95 This would ensure that the pharmaceutical services delivered to the community compliment the practice's existing services and provide truly joined up health care provision and improve the patient journey through both the prescribing and dispensing process.

1.96 The Over Wyre Medical Centre is open from 07:30 until 20:00 Mondays and 07:30 until 18:30 Tuesday to Friday. It is closed on Saturdays and Sundays.

1.97 The nearest pharmacy, Lloyds Pharmacy Knott-End, is only open 09:00-18:00 Monday to Friday. This does not match the Over Wyre Medical Centre opening hours and therefore represents a gap in service provision for patients visiting the doctor for

a 90 minute period each morning, a two hour period on a Monday evening and a 30 minute period on all other evenings. Over a week this is a shortfall in provision of 11.5 hours while the Medical Centre is open.

1.98 The pharmacy located in the village of Hambleton is at a distance of over 7km and is open 09:00-18:00 but is closed for a period of 1hour 15 minutes each lunch time. Over a week there is a shortfall in provision of 22hrs 45 minutes while the Medical Centre is open. This means that the surgery opening hours are not currently adequately supported by pharmaceutical services and in addition, patients with GP appointments up to 20:00hrs on a Monday and 18:30hrs Tues-Thurs are not fully supported as there are no pharmaceutical services available in the locality from 18:00hrs.

1.99 The proposed pharmacy located at the Medical Centre will offer supplementary hours to the extended core hours in order to be open at all times which match the opening hours of the Over Wyre Medical Centre thereby securing unforeseen benefits for the local patient population. This will close the current gap in pharmacy provision for the Over Wyre population and represents an innovation in service delivery.

1.100 In 44% of Primary Care Trusts (PCTs), a significant number of patients stated that opening hours did not reflect their lifestyle needs. (Source; The Future of Community Pharmacy - A Kearney, Management Consultancy- October 2012) For patients this clearly represents an inadequate level of pharmaceutical provision and unfortunately appears to be a situation that is replicated locally.

1.101 For patients who wish to arrange appointments to see their GP early or late in the day and take advantage of the extended surgery opening times offered by the Over Wyre Medical Centre, if following their appointments they need to have a prescription dispensed - they either have to wait (maybe until the following day) or visit the next nearest pharmacy that is open. In the case of Preesall the next nearest pharmacy that is routinely open beyond 18:30hrs is a Morrisons supermarket pharmacy (Source; NHS Choices) 14.1km away in Thornton-Cleveleys (Source; AA Route Planner).

1.102 Ownership or access to one vehicle per household in the Over Wyre locality is lower than the national figure with 54% of Over Wyre households having either no access to vehicle or limited to access one vehicle (the proportion for England is 42.2%). (Source; Office of National Statistics for the Area: Wyre 004 Middle Layer Super Output Area, Wyre 009 Middle Layer Super Output Area)

1.103 In the case of households with access to one vehicle it is often the case that the vehicle is not available to all family members at all times. NHS England therefore cannot be satisfied that those in the area are able to travel by car in order to access medical and pharmaceutical services.

1.104 At the most difficult times of the day to access pharmaceutical services, patients living in the Over Wyre area would need to travel to Thornton-Cleveleys to access the nearest open pharmacy. Such a return journey (a total of 28km) plus waiting time at the pharmacy would take over an hour (Source AA Route Planner).

1.105 In the current climate of the need for care for the elderly and disadvantaged, journeys of this distance have to be considered unacceptable especially for anyone who is elderly and frail or is caring for a sick family member. Even for younger families where there is only one car per household being used by a working family member, access to existing pharmacy providers is difficult.

1.106 The Over Wyre Medical Centre provides NHS dispensing reflecting the rural nature of the area. It should be remembered that GP dispensaries and community pharmacies are very different in terms of the products and services available and the fact that GP

dispensaries can only dispense to those patients who do not live within 1.6km of a community pharmacy.

1.107 A patient, whether they are a dispensing patient or not will still need to access a community pharmacy for over the counter medicines and advanced and enhanced pharmacy services.

1.108 It is proposed to locate a pharmacy within the Medical Centre so that patients will be able to access their pharmaceutical services where they access their medical services.

1.109 A pharmacy located in the Medical Centre will provide the full range of essential, advanced, enhanced and public health pharmaceutical services from the premises, that will be professionally fitted and fit for purpose. This will allow substantial improvement and better access both in terms of pharmacy opening hours and the range of services that the population are able to access.

1.110 The availability of these essential services via other providers is not disputed as it is a mandatory part of their contract. However, access to these services for those patients attending the Medical Centre would represent a significant enhancement to the present service provision. It is relevant that the pharmacy in Hambleton has failed to carry out a single MUR or NMS to the reliant population in the last 18 months. (Source; NHS Business Services Authority)

1.111 In September 2016 the Fylde & Wyre Clinical Commissioning Group commissioned a pharmacy minor ailment and self-care scheme referred to locally as the pharmacy+ scheme.

1.112 The Pharmacy+ Clinic initiative has been developed because Fylde and Wyre patients have said that they want health services to keep them and their families well. They want it to be as easy as possible to make health choices and when they are unwell they want the best treatment or advice as quickly as possible. (Source; Fylde & Wyre Pharmacy + Clinic Support pack)

1.113 Pharmacy+ Clinic supports people to independently self-care. It gives people living in the NHS Fylde and Wyre CCG area the option of visiting a community pharmacy for advice on specified minor ailments and, if appropriate, supply of medication from a formulary at NHS expense.

1.114 Some of the advice provided will be on self-care - how to independently access good advice on minor ailments and keep patients healthy.

1.115 The service is aimed at those patients who do not currently self-care/purchase medicines but who use GP or out of hours (OOH) services when they have a minor ailment. In order to support a change in how people access healthcare general practice, OOHs and pharmacies will all be supplying the same advice and treatment. Patients will be triaged to a community pharmacy for relevant minor ailments and if a patient presents at a GP appointment with one of the included minor ailments they may be told to see their community pharmacy next time.

1.116 This newly commissioned pharmacy based service is a clear demonstration of the real and present need for wider access to pharmaceutical services locally. The CCG has listened to local residents and commissioned a pharmacy based service in accordance to their needs.

1.117 Co-locating a pharmacy within the Medical Centre clearly aligns to both the needs of the local population and the commissioning goals of the CCG and would significantly enhance access to such a service.

1.118 It is the aspiration of the applicant to establish a Healthy Living Pharmacy within the Medical Centre. Healthy Living Pharmacies (HLPs) aim to achieve consistent delivery of a broad range of high quality services through community pharmacies to meet local need, improving the health and wellbeing of the local population and helping to reduce health inequalities.

1.119 This clearly aligns with the local and national priorities in terms of "getting serious about prevention" (Source; NHS Five Year Forward View) in terms of incentivising and supporting healthier behaviour.

1.120 The political context for HLPs was set out in the 2008 pharmacy white paper, 'Pharmacy in England: Building on Strengths, Delivering the Future'. This described how, in time, community pharmacies would become healthy living centres, which would promote and support healthy living by offering healthy lifestyle advice and support on self-care and a range of pressing public health concerns. (Source; Pharmacy in England: Building on Strengths, Delivering the Future. Department of Health April 2008)

1.121 The Lancashire Pharmaceutical Needs Assessment 2015 identified that "the commissioning intentions for both Public Health England and NHS England would be to see as many HLPs as possible accredited throughout Lancashire, and to use these pharmacies as the platform from which to deliver high quality commissioned services within a setting where health and wellbeing information can be readily accessed. However, where a need exists and there are no HLPs, other community pharmacies will be used. All CCG areas have pharmacies working towards HLP accreditation." (Source; Lancashire Pharmaceutical Needs Assessment 2015)

1.122 At present there are no HLPs in the Preesall area. A pharmacy located within the Over Wyre Medical Centre with the ambition to achieve HLP status would clearly be innovative and deliver unforeseen benefits for the reliant population.

In answer to “Please explain how you intend to secure the unforeseen benefit(s)” the Applicant stated:

1.123 It is clear that the proposal to locate a pharmacy within the Over Wyre Medical Centre premises with opening hours that mirror the medical centre services being provided from the site will delivery significant benefits across the full spectrum of issues in terms of access to pharmaceutical services, choice and innovation.

1.124 A pharmacy at the Over Wyre Medical Centre will provide pharmaceutical services at times which will directly reflect the provision of medical services. this is not only an innovation but it also provides greater access and choice for the reliant population.

1.125 A pharmacy at the Over Wyre Medical Centre will cater for the very high health demand that the elderly community with a high prevalence of long term conditions generates, which on its own merits supports a pharmacy at the medical centre. It maximises the recent investment made by the public sector funding for the Over Wyre Medical Centre by providing a truly integrated one stop shop. It resolves the access difficulties experienced by patients at present and meets the specific needs of core groups of people in the area that have high health demands and the significant number of patients with protected characteristics. Finally it will enhance services in the area and provide patients with a clear choice in pharmacy provider.

1.126 The integration of services is in itself an innovation and has been states as being one of the CCG’s aims (Source 2030 Vision for Health and Care in Gyle and Wyre. NHS Fylde and Wyre Clinical Commissioning Group 2014). A pharmacy located at the Medical Centre would secure a unique level of inter-professional collaboration, integration and communication that would be of enormous benefits to patient care.

1.127 In addition, government policy describes an overall principle to give patients a choice of pharmacies and to provide better service through competition. (Source; Pharmacy in England: Building on Strengths, Delivery the Future. Department of Health April 2008). This aim, although not expressly mentioned in the PNA, is clearly something which can be achieved through the granting of this application and is therefore one way of delivery an unforeseen benefit.

2 The Decision

NHS England considered and decided to refuse the application. The decision letter dated 29 August 2017 states:

2.1 NHS England has considered the above application and are writing to confirm that it has been refused.

2.2 Please find reasoning for this decision from the PSRC meeting below:

2.3 The group felt in relation to the test outlined in Regulation 18(1)(a) that there would be no better access as the applicant was not proposing any extended hours i.e. core hours at the weekend which would therefore be secured by the patients accessing the service. The group also felt that in granting the application it would not secure improvements in the pharmaceutical services provided within the relevant HWB. In relation to Regulation 18(1)(b), the group considered that the improvements to pharmaceutical services proposed by the applicant were the emerging models of care which, whilst not mentioned within the PNA, are being introduced by pharmaceutical service providers within the HWB.

2.4 In relation to Regulation 18(2)(a)(i) and (ii), the group felt that in granting the application it would cause significant detriment to the proper planning and arrangements that the NHSCB had in relation to that particular area as the grant of the application would place two other providers of pharmaceutical services (Lloyds Pharmacy and Hambleton Pharmacy) at significant risk of closure; these two providers offered a greater coverage of core hours on Saturdays. Lloyds Pharmacy is only 0.8km away from the Medical Centre and so provides good access for patients in the area of the GP practice. The group paid particular attention to the comments of Community Pharmacy Lancashire in their representations that, “the granting of a Pharmacy Contract at the Over Wyre Medical Centre is likely to significantly affect and make a material difference to the financial ability of the Knott End Pharmacy to survive, thereby potentially depriving the residents of Knott End (a far larger village than the hamlet of Preesall), of their Pharmaceutical Services and access to over the counter medications.”

2.5 In consideration of Regulation 18(2)(b)(i), the group felt that there was sufficient choice in the relevant HWB area for pharmaceutical services as outlined above. In considering Regulation 18(2)(b)(ii), the group noted that the applicant had defined two patient groups with protected characteristics within their application; those that are over the age of 65 and those with a disability. The group however felt that the applicant had not sufficiently defined those patient groups as to why in particular they had a protected characteristic; because a patient is over the age of 65 does not necessarily mean that they will require a higher level of health service provision than other persons in the community. However, the group also considered that if groups of patients with a protected characteristic had been identified, the applicant had not detailed how they would secure improvements to the needs of those patients, nor had they detailed where the current service provision was lacking in relation to these patient groups.

2.6 In relation to Regulation 18(2)(b)(iii), the group acknowledged that whilst the applicant made reference within the application to service integration and new models of care, this was not seen as an example of innovation. The existing pharmaceutical service providers would be able to provide delivery of such service developments.

3 The Appeal

In a letter dated 25 September 2017 addressed to NHS Resolution, the Applicant appealed against NHS England's decision. The grounds of appeal are:

3.1 The Applicant wishes to appeal the decision in relation to the application (CAS- 70351D7QOD4).

3.2 The Applicant considers the reasoning for the decision from the PSRC meeting to be flawed.

3.3 The PSRC meeting highlights five areas which are presented as grounds for refusing the application.

3.3.1 There would be no better access as the Applicant was not proposing any extended hours at a weekend.

3.3.2 That it would cause significant detriment to the proper planning and arrangements that the NHSCB had in relation to that particular area as the grant of the application would place two other providers of pharmaceutical services at significant risk of closure.

3.3.3 The group felt that there was sufficient choice in the relevant HWB area for pharmaceutical services.

3.3.4 The Applicant had not sufficiently defined those patient groups as to why in particular they had a protected characteristic.

3.3.5 A lack of innovation.

3.4 In considering this appeal the [Authority] should therefore progress on the basis that significant benefits as outlined and improvements or better access to pharmaceutical services have been unreasonably and unfairly dismissed.

3.5 Notwithstanding the fact that the regulations pertaining to unforeseen benefits applications do not provide any definition of what constitutes "better access" it appears the group has a very one-sided and highly subjective view on how they define this term. It would appear that the threshold for demonstrating better access is a movable target which is completely at the discretion of the group.

3.6 Despite the Applicant providing a highly detailed and evidenced account of where the current level of pharmaceutical access is deficient and could be significantly improved by the granting of the application the group elected to completely disregard these improvements and instead elected to focus solely on the issue of core hours at the weekend. This is a straw man argument and is designed to deflect away from the legitimate benefits the application is seeking to achieve. Extending core hours during the working week to comprehensively cover GP surgery opening hours including late evenings where no such cover currently exists is self-evidently an unforeseen benefit that delivers better access to pharmaceutical services.

3.7 The group also elected to overlook the fact that the Medical Centre is a dispensing doctor practice and is therefore already a provider of pharmaceutical services. The dispensary at the Medical Centre provides a level of pharmaceutical service which is currently in excess of 8,000 prescription items per month. This level of service provision is significantly higher than the average workload of a community pharmacy in England. There is therefore already a clear, pre-existing and undeniable demand for pharmaceutical services in the local area that supports three pharmaceutical providers. This is not speculation or wishful thinking on behalf of the Applicant but hard, verifiable fact.

3.8 The assertion that the granting of the application would suddenly cause a significant detriment to the proper planning and arrangements is entirely without foundation. The group elected to selectively ignore the existence of three established providers of pharmaceutical services in the local area.

3.9 In making reference to the comments of Community Pharmacy Lancashire, there is not one piece of evidence put forward to support their claim. Locally NHS dispensing is partially reliant on GP Practice dispensing. The number of patients who need to access other pharmaceutical services is therefore understated by the number of dispensing patients. The demand for non-dispensing services from pharmacies is therefore likely to be much higher than pharmacy dispensing volumes might suggest.

3.10 The Applicant has clearly demonstrated that the Medical Centre is open for a total of 56.5 hours a week and during this time patients are unable to access pharmaceutical services from Lloyds pharmacy 20% of that time and 40% of that time at Hambleton pharmacy due to their respective opening hours. The situation described above shows that during the week access to pharmaceutical services is not only difficult and restricted at certain times, at other times it is actually impossible. The Applicant has proposed significant benefits and greater access by eliminating the large periods of time in the working week where there is no pharmaceutical provision or limited choice available to patients but these improvements have been unfairly summarily dismissed by the group without reference or explanation.

3.11 Currently patients who make an urgent appointment to deal with an acute condition are particularly disadvantaged by the absence of access to a pharmacy within or close to the Medical Centre for a 90 minute period each morning, a two hour period every Monday evening and a 30 minute period on all other evenings where there is no pharmaceutical provision to match the opening hours of the medical centre. How can it be reasoned that there is adequate patient choice if these pharmacies are not open when needed during the working week?

3.12 To add to this Hambleton pharmacy completed zero MUR and zero NMS interventions for the period January 2015- January 2016. How can there be sufficient choice if existing contractors are failing to provide a service?

3.13 The group asserts that the Applicant has not sufficiently defined those patient groups as to why in particular they had a protected characteristic. Regulation 18(2)(b)(ii) states there must be regard in particular to the desirability of 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)).

3.14 The high proportion of elderly patients in the local area in turn influences the prevalence of long term conditions. This is a nationally accepted fact and not a point of argument. By the time we reach our early eighties only one in seven of us will be free of any diagnosed long term health conditions and, once we reach the age of eighty five, eighty per cent of us will be living with at least two. Not only has the Applicant provided evidence about the existence of patients with protected characteristics the Applicant also went to great lengths to highlight the extremely high levels of disease prevalence in the local population to which those groups will inevitably belong. The disease prevalence figures provided all relate to long term conditions. The majority of patients with long term conditions will be aged over 65. To expect the Applicant to go beyond this description and provide a further breakdown and analysis of individual subsets of patients is unreasonable.

3.15 In relation to Regulation 18(2)(b)(iii) the collaborative approach of including a pharmacy in the heart of the Medical Centre is an innovation which will result in an enhanced level of pharmaceutical service and convenience to patients. The definition

of innovation is "the introduction of something new" and clearly this level of integration of medical and pharmaceutical would be a new development locally.

3.16 It is the view of the Applicant that the group has consistently and unfairly overlooked and disregarded a litany of factual information provided by the Applicant as a way of denying the granting of the application. The reasoning provided is consistently illogical and unbalanced and the Applicant would hope that the Appeal Unit employs a more robust approach when reaching a decision.

5 Summary of Representations

This is a summary of representations received on the appeal.

4.1 NHS ENGLAND

4.1.1 NHS England can confirm that Over Wyre Medical Centre (P81087) has 5,377 patients living within 1.6km/1 mile of the surgery.

4.1.2 There are 194 patients who live within 1.6km of the surgery who are registered with other medical practices.

4.2 BOOTS UK LTD

4.2.1 Unfortunately Boots have not been party to the decision report detailing why this application was refused, so they will address the points mentioned within the appeal letter in turn.

4.2.2 Boots do agree that this application should be refused

4.2.3 Within the appeal letter, comments are made with regards to extended core hours. Boots not that the Applicant is not offering Core hours on a Saturday and Sunday. The Applicant also states that cover does not exist currently to comprehensively cover GP hours and late evenings. Boots submit that Asda, 1.4 miles away (NHS Choices) offer extended hours by means of a 100 hour contract and are open from 7 am until 11pm Monday to Friday. Boots also fail to see how contractual hours can be considered an unforeseen benefit and should NHS England believe that there is a gap in service provision at certain times, they could approach existing providers.

4.2.4 Boots do not believe that the fact that the Medical Centre is a dispensing practice was overlooked when the decision to refuse the application was made. By the Applicant own admission, there is therefore already access to dispensing services at this location should patients of the Over Wyre Medical Centre require them.

4.2.5 Statements made with regards to patients requiring non-dispensing services and that they are likely to be much higher are not evidenced.

4.2.6 Boots are unaware of any complaints made to NHS England with regards to patients accessing pharmaceutical services in the area. The appellant states that the existing provision is not accessible at certain times but there is no evidence to say that patients are experiencing difficulty and Boots believe that this is purely speculative.

4.2.7 The Applicant makes reference to patients who require urgent appointments. As previously mentioned, Asda open early mornings and late into the evening and Boots ask the Applicant where patients would be expected to go should they require pharmaceutical services on a Saturday afternoon or a Sunday when they are not proposing to open? Pharmacies are no doubt required throughout the whole week and not just the "working week" as mentioned

within the appeal letter. The point is, that patients are accustomed to accessing pharmacy services currently when required to do so. This also is true of patients with protected characteristics. They are currently accessing services and Boots are not aware of any evidence suggesting otherwise.

4.2.8 The Applicant has failed to provide any evidence that granting the application would confer significant benefits not foreseen at the time the Pharmaceutical Needs Assessment was produced and Boots submit should be refused for this reason.

4.2.9 In conclusion, Boots submit that the above application does not meet the required criteria of the Regulations, and respectfully urge the Appeal Authority to dismiss this appeal accordingly.

4.2.10 Boots UK Limited would wish to attend any oral hearing that may be held in response to this appeal.

4.3 LLOYDS PHARMACY

4.3.1 The Committee will be aware that there have been numerous applications for inclusion in the pharmaceutical list at the Over Wyre Medical Centre. The most recent considered and refused by the NHSLA reference SHA/18484 in January 2010. The previous applications have all been refused due to adequate pharmaceutical services being available and accessible.

4.3.2 Lloyds note the current application by Griffin Martlet Ltd is a Company Registered at the Over Wyre Medical Practice and that GPs of the practice are also Directors of the company.

4.3.3 The appeal offers little supporting evidence the application will secure improvements or better access to pharmaceutical services. The applicant does not propose any core opening hours over the weekend and only offers core hours from 0830-1830 weekdays. The applicant states in their appeal “ extending core hours during the working week to comprehensively cover GP surgery opening hours including late evenings where no such provision currently exists is self-evidently an unforeseen benefit”. The Committee will note the applicant’s proposed core hours do not achieve this. This would not confer significant benefits to the population. Supplementary hours (as the Committee will be aware) can also be amended with 90 day notice and there is therefore no real commitment to these hours.

4.3.4 The Applicant has specifically chosen not to commit to the hours that form the main argument in support of the application. It is worth noting the Surgery’s own dispensary does not offer extended opening hours and is open 0830-1830 Monday to Friday – which indicates that even the doctors accept there is no requirement for extended hours.

4.3.5 As the Applicant states in their letter of appeal, the surgery is already providing pharmaceutical services to a large number of patients. The existence of these services is a relevant fact and demonstrates that those patients who live more than 1 mile from a pharmacy can use the dispensary at the surgery or any other pharmacy they choose; and those who live within 1 mile of a pharmacy can use that pharmacy or any other pharmacy that they choose.

4.3.6 In terms of whether the application will confer significant benefits in terms of reasonable choice, innovation or groups who share a protected characteristic, no evidence has been provided that support any of these. For example the Applicant does not provide evidence of a lack of reasonable choice as they state on page 2 of the appeal that there is a “demand for

pharmaceutical services in the local area that supports three pharmaceutical providers”. The Applicant does not provide evidence in either the application or appeal of specific groups that may share a protected characteristic of having difficulty accessing existing pharmaceutical services. The existence in a population of such groups is not in itself sufficient to satisfy this element of the Regulation 18. The existing pharmacy in Knott End is situated in the heart of the village centre where the local shops and services are situated and to which all groups will access. This includes post office, bakery, convenience stores, fruit and vegetable shops, library and so on. The Applicant provides no evidence of innovative services.

4.3.7 The proposed floor in the original application would appear to show the pharmacy having no external access.

4.3.8 Car parking in Knott End is free of charge. There is a small car park to the rear of the Lloyds pharmacy but also on street parking is available. The Applicant does not provide any evidence existing pharmacies cannot be readily accessed by car, by foot, or by public transport.

4.3.9 The Applicant refers to the area as ‘Over Wyre’. Alongside the Lloyds pharmacy in Knott End on Sea, this area includes the village of Hambleton which contains Hambleton Pharmacy. The Lancashire Pharmaceutical Needs Assessment identifies 6 pharmacies within the Wyre Locality. There is therefore already a choice of pharmaceutical services available. Within the wider Health and Wellbeing Board area there is a further choice of pharmacies in Fleetwood via the Fleetwood ferry that takes less than 10 minutes.

4.3.10 The Pharmaceutical Needs Assessment 2015-18 considered access to pharmaceutical services within the Wyre locality and made the following conclusion that the “majority of the road networks are within 20 minutes travelling distance from a pharmacy. This demonstrates that within the district there is good coverage of pharmacies. Note: While there are pockets of road networks more than 20 minutes away from a pharmacy or dispensing surgery by car, these are rural areas and mainly uninhabited”.

4.3.11 The Applicant refers (in their original application) of the intention of the surgery to relinquish their dispensing rights. This has not happened.

4.3.12 The Applicant refers to having a number of patients eligible for dispensing but of course not all these patients will need to access such services and they also have the choice of accessing existing pharmaceutical services.

4.3.13 The Medical Practice is situated within an area that has high levels of car ownership with significant numbers of households having more than 1 car. Appendix B(1) shows that the Preesall Ward has 26.9 per cent of households with 2 cars and 6.8 per cent of households that has 3 cars compared to 24.7 per cent and 5.5 per cent respectively at a national level.

4.3.14 The bus service route 2c runs every 30 minutes from Knott End through to Blackpool, passing through Hambleton and Poulton le Fylde. Lloyds enclose at Appendix B(2) copy of the route map and timetable. The absence of a bus stop outside the GP surgery enhances the desirability of the existing pharmacy in the village centre where there is a bus stop approximately 50 metres away at Barton Square in the centre of the village. Whilst the surgery may not have a convenient bus stop, the Lloyds Pharmacy does.

4.3.15 Putting another pharmacy into the medical centre therefore does nothing to help those who rely on public transport.

4.3.16 Lloyds would also ask the Committee to be mindful of Regulation 18 (2)(i) and (ii) in terms of whether there would be significant detriment to proper planning of pharmaceutical services and/or to current arrangements in place. Lloyds Pharmacy is the in the heart of Knott End in an accessible location as part of everyday life in the commercial area therefore the application could well have significant impact with regards to Regulation 18(2)(i) and (ii).

4.3.17 It is Lloyds opinion that Regulation 18 has not been met; therefore submit the application and appeal is refused. In the event an oral hearing is required Lloyds would wish to attend.

4.4 HAMBLETON PHARMACY

4.4.1 Early morning and late evening surgeries have been provided continuously by The Over Wyre Medical Centre, during weekdays only, since the Department of Health started encouraging them with enhanced payments, many years ago. Rarely, if ever, was urgent provision of prescription services an issue. Hambleton Pharmacy has never had, or heard of any complaints over the lack of prescription services at these times. The Applicant has not demonstrated any unforeseen need.

4.4.2 If the appeal was upheld and a third pharmacy was allowed to open in the geographically restricted Over Wyre area, the new pharmacy would reasonably be guaranteed to retain all the dispensing doctor prescriptions currently from dispensing patients who already have the freedom of choice of using either the GP dispensary or a local pharmacy. Inevitably, if only because of its advantageous position at the surgery with passing footfall, there would be reduction of current prescription numbers at the two local pharmacies situated in the two main community hubs of Knott End and Hambleton. The extent of this inevitable shift cannot be predicted and could easily jeopardise the viability of the two existing pharmacies in these increasingly uncertain and difficult political and economic times. The loss of either or both of these ideally sited pharmacies in the communities which they serve, would cause major unforeseen difficulties for susceptible patients, particularly in the light of restricted public transport in the area, and the distance of the Over Wyre surgery at Preesall from the bus route.

4.4.3 Both existing pharmacies now provide comprehensive enhanced clinical pharmaceutical services including MUR and NMS contrary to the Applicants claims (Hambleton Pharmacy's services listed below). There are no unforeseen needs.

4.4.4 The residents of Over Wyre have excellent existing pharmaceutical services and readily available choice of provider from three localities, maximised by the free delivery services by all three, and the increasing efficiency of the Electronic Prescription Service.

4.4.5 Sadly, there are inevitably worries as to possible conflicts of interests, and inadvertent prescription direction to the 'in house' pharmacy, by the GP partners and their staff. This unfortunate circumstance and resulting suspicions would be unavoidable if the appeal was upheld.

4.4.6 Hambleton Pharmacy services:-

4.4.6.1 EHC (Emergency hormonal contraception) Enhanced service 4.4.6.2 MUR 4.4.6.3 NMS 4.4.6.4 Advanced Flu Service 4.4.6.5 Lancashire Workforce Flu Service 4.4.6.6 NHS Health Checks including cholesterol testing

4.4.6.7 NRT Voucher scheme 4.4.6.8 Pharmacy Plus Clinic - Minor ailment scheme 4.4.6.9 Healthy Living Pharmacy - accreditation by December 4.4.6.10 TCES Community equipment prescription dispensing and supply (fitting grab rails, toilet seats & frames, bath seats, bed levers etc. etc.) 4.4.6.11 Appliance dispensing and customisation 4.4.6.12 Supervised methadone consumption 4.4.6.13 Transfer of Care ( Hospital referral for MUR on discharge) 4.4.6.14 Monitored dose dispensing trays 4.4.6.15 Nursing home dispensing

4.5 THE LPC (COMMUNITY PHARMACY LANCASHIRE)

4.5.1 The LPC include a copy of their original response to NHS England.

4.5.2 The LPC note that this is a routine application and should one be required they would be willing to attend an oral hearing if it were to be deemed necessary.

4.5.3 Community Pharmacy Lancashire have had the opportunity to consider the application and appeal and would like to make the following comments;

4.5.4 The current PNA (Pharmaceutical Needs Assessment) for Lancashire (2015) states:

There is currently no need for any further additional pharmacies as current pharmaceutical service provision is deemed adequate across Lancashire.

Further:

Across Lancashire, the number of pharmacies per 100,000 people is 25 compared to the England average of 22 and the North West average of 26. There is good coverage in terms of opening hours across the country.

4.5.5 Regulation 18 (a)

4.5.6 (i) As the exerts above from the most current PNA show there is no need for any additional pharmacies anywhere in Lancashire.

4.5.7 At a time when the system is under major financial constraints it would be detrimental to current pharmaceutical care provision.

4.5.8 (ii) If the NHS Commissioning Board felt that the opening hours of the local pharmacies were inadequate then they can be asked to open longer to remedy this perceived inadequacy. The LPC note that Griffin Martlet have not provided any evidence of this – no complaints from patients. Because of the unusual geographical aspect to this application and the fact that not everyone would want or be able to take the passenger ferry the nearest pharmacy offering late opening hours is Kepple Lane Pharmacy at Garstang 8.2 miles away (NHS Choices).

4.5.9 Regulation 18(b)

4.5.10 (i) Reasonable Choice relates to either using the Dispensing Doctors Practice, the Lloyds Pharmacy at Knott End (open on Saturdays) or Hambleton Pharmacy open half days on Saturday. We bring to the Appeals Committee’s attention that both pharmacies offer FREE Collection and Delivery Services and indeed Hambleton specifically offer a twice daily delivery service to all areas of Over Wyre including Knott End and Preesall

(as evidenced in their large A5 advert in the Over Wyre Medical Centre Information Booklet).

4.5.11 (ii) Protected Characteristic - see FREE Collection and Delivery Services above.

4.5.12 (iii) Innovation, the Applicant quotes, “the collaborative approach of including a pharmacy in the heart of the Medical Centre is an innovation which will result in an enhanced level of pharmaceutical service and convenience to patients. The definition of innovation is “the introduction of something new” and clearly this level of integration of medical and pharmaceutical would be a new development locally.”

4.5.13 The Applicant seems to forget they already have a Dispensary, is there not collaboration already going on – if so it cannot be new, and/or innovative.

4.5.14 With regard to Regulations 41 and 44 the LPC offer one additional comment, if the panel finds that on the day of the application being received by NHS England the location was not a Reserved Location then the nearest pharmacy is only 0.7 miles (1.2km) from the applicants address and the regulations use a distance of 1mile (1.6km) to define proximity to the nearest pharmacy.

4.5.15 In conclusion, the LPC still feel that the Applicant has failed to demonstrate that granting the application would confer significant benefits not foreseen at the time the PNA was published.

4.5.16 At a time when the system is under major financial constraints it would be detrimental to current pharmaceutical care provision.

4.5.17 The LPC respectfully request therefore that NHS Resolution reject this appeal.

In a letter to NHS England dated 5 April 2017 the LPC stated:

4.5.18 Thank you for informing Community Pharmacy Lancashire (CPL) the name adopted by Lancashire Local Pharmaceutical Committee, of the above application. We note that this is an application for unforeseen benefits, and should one be required we would be willing to attend an oral hearing if it were to be deemed necessary.

4.5.19 We would like to thank NHS England for acknowledging the exceptional geographical circumstances of this locality, that includes a coast line and tidal estuary. Their discretion in including Hambleton Pharmacy, Kiln Lane, Hambleton, Poulton-Le-Fylde, Lancashire, FY6 9AH as an interested party, and therefore having been formally notified of this application is recognised by the committee. Hambleton Pharmacy lies 4.5m / 7.2km (AA Route Master) by car from the applicant, is the second community pharmacy closest to the applicant on this side of the estuary, with the majority of their business coming from this practice, and is therefore highly likely to be significantly affected if the application were to be granted, making a material difference to the contractor.

4.5.20 We hope that by highlighting this geographical anomaly, that going forwards these types of exceptions are flagged, and in accordance with the Regulations, NHS England consult any pharmacy contractor whose interests might be significantly affected if an application were to be granted.

4.5.21 Having had the opportunity to consider the application CPL would like to make the following comments –

4.5.22 The current PNA (Pharmaceutical Needs Assessment) for Lancashire (2015) states:

There is currently no need for any further additional pharmacies as current pharmaceutical service provision is deemed adequate across Lancashire.

4.5.23 Further:

Across Lancashire, the number of pharmacies per 100,000 people is 25 compared to the England average of 22 and the North-West average of 26. There is good coverage in terms of opening hours across the country.

4.5.24 One of the main reasons for the pharmacy is to remedy the small size of a current Dispensary. CPL would question why the dispensary cannot be extended or relocated without the need for a Pharmacy Contract and, on site there is what appears to be a newly built modern dispensary

4.5.25 The application makes reference to future plans for housing in the area, the application for this Pharmacy Contract is intended to look at present needs, not future needs. In addition, neither of the two developments are in Preesall, indeed the larger of the two is in Hambleton where there is already a Pharmacy

4.5.26 The application provides data on NMS and MUR’s carried out by the local pharmacies, it should be noted firstly that this data is at best three months old. In addition, we would ask if the Doctors have liaised with Hambleton Pharmacy on this issue

4.5.27 Whilst the desire to create an HLP (Healthy Living Pharmacy) is admirable, CPL has doubts that with all the current requirements to set up a new Pharmacy and to dislocate themselves from the Dispensing Doctors setup (gradualisation), that this could be achieved in a timely manner

4.5.28 The application states that the practice would seek to relinquish its dispensing rights if the application were granted. This aspiration is not a reason to grant a new Pharmacy Contract, and if the Practice then decided it did not want to relinquish its contract (gradualisation) it could be reasonably argued that a new Pharmacy Contract has been awarded to a coterminous location. Despite the Applicant claims that close proximity is not definable

4.5.29 Both current Pharmacies (Lloyds in Knott End) and Hambleton offer a free Collection and Delivery Services, indeed Hambleton specifically offers a twice daily delivery to all areas of Over Wyre including Knott End and Preesall (evidenced by their large A5 advert in the Over Wyre Medical Centre Information Booklet)

4.5.30 The application provides a considerable amount of data on comorbidities and life expectancy but its relevance to the application is not clear

4.5.31 CPL would question whether a new contract should be awarded when the nearest pharmacy is only 0.7 miles (1.2km) by car, from the Applicants address (a gate with a footpath in the surgery car park also exists “cutting a corner off” for patients who wish to walk). The regulations use a distance of 1 mile (1.6km) to define proximity to the nearest Pharmacy

4.5.32 Finally, the granting of a Pharmacy Contract at the Over Wyre Medical Centre is likely to significantly affect and make a material difference to the financial ability of the Knott End Pharmacy to survive, thereby potentially depriving the residents of Knott End (a far larger village than the hamlet of

Preesall), of their Pharmaceutical Services and access to over the counter medications

4.5.33 In conclusion, we submit that the Applicant does not demonstrate that granting the application would confer significant benefits not foreseen at the time the PNA was published.

5 Observations

5.1 THE APPLICANT (GRIFFIN MARLET LTD)

5.1.1 The representations from the interested parties frequently quote the Lancashire Pharmaceutical Needs Assessment (PNA) - with the premise that there is no identified need for a pharmacy at the application location within the PNA. As this is an application under Regulation 18 it identifies benefits that were unforeseen when the PNA was published.

5.1.2 The Applicant would argue one would not expect the PNA to identify “unforeseen” benefits precisely because they are unforeseen at the time of writing the PNA and hence the submission under Regulation 18.

5.1.3 The Lancashire Local Pharmaceutical Committee (LLPC) references the Lancashire PNA as reasoning for not granting the application:

“Across Lancashire, the number of pharmacies per 100,000 people is 25 compared to the England average of 22 and the North West average of 26. There is good coverage in terms of opening hours across the county.”

5.1.4 This is an oversimplification as whenever an average is used to represent an uncertain quantity, it ends up distorting the results because it ignores the impact of the inevitable variations.

5.1.5 The demographics of Lancashire are spread across a wide area of diverse population which can obscure the actual needs of a local population. This lack of fine detail in the PNA assessment fails to take into account the extremely elderly demographics, extremely high disease prevalence, exceptional geographical circumstances, poor public transport and low car ownership/access in the Over Wyre locality.

5.1.6 The LLPC also suggests that:

“At a time when the system is under major financial constraints it would be detrimental to the current pharmaceutical care provision.”

5.1.7 Throughout the application process the Applicant has consistently had to provide detailed, verifiable evidence for any statement or reasoning pertaining to any statements made in support of the application. The representations made by the interested parties do not provide similar robust evidence in their representations. The LLPC statement is alarmist and emotive that is not verifiable or evidenced in any way. The LLPC provides no evidence to corroborate their claim and without such information cannot be taken as a statement of fact and should be disregarded.

5.1.8 Hambleton Pharmacy makes a similar claim with the statement:

“The extent of this inevitable shift cannot be predicted and could easily jeopardise the viability of the two existing pharmacies in these increasingly uncertain and difficult political and economic time.”

5.1.9 No evidence is provided to substantiate this claim. Indeed the inclusion of the phrase “…cannot be predicted” indicates that this is a statement based on supposition and speculation. In the absence of any real data to support this claim is entirely without foundation.

5.1.10 Neither the LLPC nor Hambleton Pharmacy acknowledge the long standing, established presence of a pharmaceutical service from the dispensing doctors at the Over Wyre Medical Centre. The size of this contribution to the local pharmaceutical provision is already very large and is in fact greater than an average community pharmacy operating in England (see reference 20 of original application) with absolutely no threat to the viability of other local pharmaceutical providers. To assert that the presence of a pharmacy at the Over Wyre Medical centre would suddenly and dramatically affect the viability of other providers has no basis in fact.

5.1.11 Several of the interested parties have made representations in relation to innovation. The LLPC in particular makes a statement addressing he applications proposals around innovation:

“The Applicant seems to forget they already have a Dispensary, is there not collaboration already going on- if so it cannot be new, and/or innovative.”

5.1.12 On the contrary it is precisely because the Applicant is proposing to gradualise from a dispensary to a pharmacy that will facilitate the innovation described. As a dispensing doctor the dispensary is restricted in the types of additional services that it can deliver for the benefit of patients. Gradualisation to a pharmacy would allow patients to benefit from MUR, NMR, Pharmacy Plus, Flu vaccination services and it is envisaged that these new services will be integrated into the current GP systems and processes to facilitate a more accessible, efficient and co-ordinated delivery of care to patients particularly for those patients with long term conditions. This level of integration and innovation is not currently in place as the Applicant is unable to currently provide these services to patients.

5.1.13 Boots, Hambleton and Lloyds Pharmacy have all made statements relating to the Applicant’s proposal around securing improvements and better access to pharmaceutical services. As clearly outlined in the main application Lloyds Pharmacy is closed for 20% of the working week and Hambleton Pharmacy is closed for 40% of the working week. During this time patients have no access to pharmaceutical services and correspondingly have no choice if these providers are closed. The Applicant has made an offer and commitment to the provision of core hours during the working the working week to comprehensively cover GP surgery opening hours including late evening where no such provision currently exists.

5.1.14 Lloyds appear to dispute the Applicants commitment to this by stating:

“The applicant has specifically chosen not to commit to the hours that form the main argument in support of the application. It is worth noting the Surgery’s own dispensary does not offer extended opening hours and is open 0830-1830 Monday to Friday- which indicates that even the doctors accept there is no requirement for extended hours.”

5.1.15 The Applicant is in a better position to judge the direction and impact of the continuous evolution around the policy of improving access to general practice as championed in the NHS General Practice Forward View. The requirements around extended access are not static but rather a continuing area of development within Clinical Commissioning Groups and NHS England. As such, in the current climate, it would be extremely myopic to set in stone a particular way of working based on the situation today. As the

requirements around extended access will inevitably change tomorrow and also the manner in which the Surgery delivers on these requirements will change as a consequence. The Applicant has made a fair and firm commitment based on the situation today but it requires the flexibility to be in a position to adjust the delivery should the nature of GP hours change in the future so that pharmaceutical access can mirror GP access.

5.1.16 Good access is not just about getting an appointment when patients need it. It is also about access to the right person, providing the right care, in the right place at the right time. This extends to the ability for patients to access pharmaceutical care which currently does not correspond to the current level of GP access.

5.1.17 Both Boots and Lloyds make reference to the pharmacies based in Fleetwood as a solution to the present lack of pharmaceutical provision during the working week. In highlighting a “solution” they tacitly acknowledge that there is a problem to be addressed. The 100 hours Asda pharmacy based in Fleetwood in particular is highlighted as the panacea to the obvious lack of access and choice faced by Over Wyre patients. The pharmacies based in Fleetwood are not viable options as they are only accessible on foot via a sporadic weather and tide limited ferry service. In order to use this service, patients would need to negotiate a wind exposed, wet concrete jetty. This is clearly not a realistic or practical solution appropriate for the majority of Over Wyre’s elderly population. Access to the Asda pharmacy by road is a round trip of 24 miles and a travel time of 1 hour.

5.1.18 The LLPC recognise that there is an unusual geographical aspect to this application:

“Because of the unusual geographical aspect to this application and the fact that not everyone would want or be able to take the passenger ferry the nearest pharmacy offering late opening hours is Kepple Lane Pharmacy at Garstang 8.2 miles away.”

5.1.19 Having recognised the problem with the present level of access and choice to pharmaceutical services the LLPC offer the solution as the Pharmacy based at Garstang. This Pharmacy is actually a round trip of 19.2miles and a round travel time of at least 40mins by car or at least 1 hour and 20minutes by public transport). The route uses long stretches of unlit, poorly maintained country roads which would present a significant barrier to the majority of Over Wyre residents who are predominantly elderly. The situation is further compounded when the poor vehicle access and very limited public transport network are also taken into account.

5.1.20 Boots make the following statement in relation to the current level of access to pharmaceutical services:

“The point is, that patients are accustomed to accessing pharmacy services currently when required to do so. This is also true of patients with protected characteristics. They are currently accessing services and we are not aware of evidence suggesting otherwise”

5.1.21 This statement implies that patients have adapted to the current level of access and choice to pharmaceutical care and that because of this there is no case to be answered in terms of improving the access and choice for patients. The Applicant has demonstrated that Over Wyre residents are unable to access Lloyds Pharmacy for 11.5hours (20%) of the normal working week Monday to Friday and Hambleton Pharmacy 22.75 hours (40%) of the normal working week Monday-Friday during the medical centre opening hours. These are stark statistics and it is self-evident from this that

there is a clear and present problem to be addressed in terms of access and choice for patients. Patients and communities may be accustomed to the current services but this does not equate or constitute evidence that there is a high quality provision of services and the submissions in the application and appeal have demonstrated that there is scope to improve access and choice to pharmaceutical services for local residents.

5.1.22 Hambleton Pharmacy makes the following statement in relation to the Over Wyre Medical Centre’s extended opening hours:

“Rarely, if ever, was an urgent prescription service an issue. We have never had, or heard of complaints over the lack of prescription services at these times.”

5.1.23 The Applicant has highlighted the current gap in pharmaceutical provision and choice at critical times of the week where patients would be unable to access pharmaceutical services. Patients issued with a prescription at the medical centre at certain times of the week will face difficulty finding somewhere to dispense these items. This is not a point of debate as the gap in service and choice is clearly identifiable as evidenced by the respective opening hours. The Applicant believes that Over Wyre patients deserve a more comprehensive and patient oriented service that fully caters for their needs.

5.1.24 The Lloyds statement in relation to the Lancashire PNA 2015-2018 regarding road networks:

…“that the majority of road networks are within 20 minutes travelling distance from a pharmacy”

5.1.25 This is an over simplification of the situation faced by Over Wyre residents. Ownership or access to one vehicle per household in the Over Wyre locality is lower than the national figure with 54% of Over Wyre households i.e. the majority of patients having no access to a vehicle or limited access to one vehicle (the proportion for England is 42%). In the case of households with access to one vehicle it is often the case that the vehicle is not available to all family members at all times. NHS England therefore cannot be satisfied that those in the area are able to travel by car in order to access medical and pharmaceutical services. (Reference 28 and 29 of original application)

5.1.26 There are large sections of the week where access and choice to a community pharmacy is severely restricted and at certain times impossible (Lloyds Pharmacy, Knott End is closed for 20%, and Hambleton Pharmacy is closed for 40% of the time the medical centre is open to patients). Given that the local public transport network is very limited and access to a vehicle for the purposes of travelling further afield to find a Pharmacy cannot be guaranteed due to the majority of Over Wyre residents having no access to a vehicle or reduced access to one vehicle.

5.1.27 Hambleton Pharmacy agrees as evidenced by the following statement in relation to the local public transport system:

“…particularly in the light of restricted public transport in the area, and the distance of the Over Wyre surgery at Preesall from the bus route.”

5.1.28 This statement highlights the restricted public transport and exacerbates the problems caused by the majority of Over Wyre patients having no access to a vehicle or limited access to one vehicle.

5.1.29 Lloyds makes reference to car parking:

“Car parking in Knott End is free of charge. There is a small car park to the rear of our existing pharmacy but also on street parking is available. The appellant does not provide any evidence existing pharmacies cannot readily be accessed by car, by foot, or by public transport.”

5.1.30 The opening hours at the Lloyds Pharmacy at Knott End do not match the Over Wyre Medical Centre opening hours. There is a gap in service provision for patients visiting the doctor for a 90 minute period each morning, a two hour period on a Monday evening and a 30 minute period on all other evenings. Over a week this is a shortfall in provision of 11.5 hours while the Medical Centre is open. During this time patient access and choice to pharmaceutical services whether by car, foot or public transport is not only limited, at certain times it is impossible.

5.1.31 In reference to the photograph provided by Lloyds the Applicant wishes to highlight how the image actually shows how very little parking is available, combined with a high number of roads, curbs and traffic obstacles. The ubiquitous single yellow line in the image indicates that there is a considerable form of parking or waiting restriction in place.

5.1.32 Unfortunately the same lack of choice and access to pharmaceutical services exists for patients with protected characteristics at certain periods of the day where there is no choice of provider. Therefore the availability of car parking is a moot point if the pharmacy is not open when required. Lloyds makes a statement relating to car ownership:

“The Medical Centre is situated within an area that has high levels of car ownership with significant numbers of households having more than 1 car.”

5.1.33 In actual fact ownership or access to one vehicle per household in the Over Wyre locality is lower than the national figure with 54% of Over Wyre households i.e. the majority, having no access to a vehicle or limited access to one vehicle (the proportion for England is 42%). In the case of households with access to one vehicle it is often the case that the vehicle is not available to all family members at all times. NHS England therefore cannot be satisfied that those in the area are able to travel by car in order to access medical and pharmaceutical services. The Applicant wishes to highlight that Lloyds have selectively referenced only the ONS data super output layer 004. Whereas the applicant has referenced both super output layer 004 and 009 which gives a much more representative view of car ownership in the Over Wyre locality. (Reference 28 and 29 of original application) .

5.1.34 In relation to the Lloyds statement on the local bus service:

“The absence of a bus stop outside the GP surgery enhances the desirability of the existing pharmacy in the village centre where there is a bus stop approximately 50 metres away at Barton Square in the centre of the village. Whilst the surgery may not have a convenient bus stop, the Lloyds Pharmacy does.”

5.1.35 The absence of a bus stop outside the GP surgery and the infrequent nature of the 2C service simply highlights the unnecessarily difficult and convoluted patient journey that many Over Wyre residents are faced with when attending the medical centre and obtaining a prescription. In these circumstances a patient would need to then make an additional journey to a Pharmacy to have a prescription dispensed. If the patient is reliant on public transport then this would be an arduous task given the poor state of the local public transport. Having the choice of accessing a Pharmacy within the medical centre would alleviate this situation and provide patients with improved access and choice.

5.1.36 Hambleton Pharmacy draws attention to the current provision of enhanced pharmaceutical services including MUR and NMS.

“Both existing pharmacies now provide comprehensive enhanced clinical pharmaceutical services including MUR and NMS contrary to the applicant’s claims”

5.1.37 The Applicant refers to reference 19 provided with the original application which clearly demonstrates that between January 2015 and July 2016 Hambleton Pharmacy completed zero MUR’s and zero NMS reviews. The Applicant utilised the most up to date information available at the time of submitting the application. The lack of provision of these services by Hambleton is fully evidenced and demonstrates how the application delivers improved access and choice of pharmaceutical services by widening access to this important group of services. The Applicant feels that the application should be judged on the merits of the information available at the time and should not be prejudiced by length of time required to conduct the application process and the subsequent defensive measures taken by local pharmacies after they became aware of the application.

5.1.38 Hambleton Pharmacy’s statement appears to question the integrity and probity of the GPs based at the Over Wyre Medical Centre.

“Sadly, there are inevitably worries as to possible conflicts of interests, and inadvertent prescription direction to the ‘on house’ pharmacy, the GP partners and their staff. This unfortunate circumstance and resulting suspicions would be unavoidable if the appeal was upheld.”

5.1.39 This is a highly inappropriate statement and is not supported by any evidence. The Applicant has passed all the necessary fitness to practice checks in connection with the application and believes that the comments made by Hambleton Pharmacy on this matter should be disregarded.

5.1.40 Lloyds makes reference to external access:

“The proposed floor in the original application would appear to show the pharmacy having no external access”

5.1.41 Access to the proposed pharmacy would be via the large external double sliding doors that are fully compliant with the Equality Act regulations.

5.1.42 In conclusion the Applicant presents these comments in response to the received representations. The representations received show that there is agreement in terms of the exceptional geographical characteristics of the Over Wyre locality and in terms of the inadequate local public transport network. At certain times of the day access to pharmaceutical services by private transport would require minimum round journey times of between 16- 19 miles. Access to private transport for the majority of the Over Wyre residents is worse than the national England average. Over Wyre residents, including those with protected characteristics, face significant difficulty accessing pharmaceutical services at critical times in the week when access and choice to Pharmacies is severely limited.

5.1.43 The Applicant has made proposals that would comprehensively provide improved access and choice to pharmaceutical services for local residents.

5.1.44 The Applicant hopes for a positive response which combined with our positive thinking results in a successful pharmacy application that meets the needs and aspirations of the wider Over Wyre community for this generation and beyond.

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