1.3 This application should not be refused pursuant to Regulation 31 for the following reasons: Not Applicable

15 January 2015 1 Trevelyan Square Boar Lane Leeds LS1 6AE REF: SHA/17757 APPEAL AGAINST BIRMINGHAM, SOLIHULL AND THE BLACK COUNTRY AREA TEAM, NHS C...
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15 January 2015

1 Trevelyan Square Boar Lane Leeds LS1 6AE

REF: SHA/17757 APPEAL AGAINST BIRMINGHAM, SOLIHULL AND THE BLACK COUNTRY AREA TEAM, NHS COMMISSIONING BOARD ("NHS ENGLAND") DECISION TO REFUSE AN APPLICATION BY RUSHPORT ADVISORY LLP FOR INCLUSION IN THE PHARMACEUTICAL LIST OFFERING UNFORESEEN BENEFITS UNDER REGULATION 18 AT TUDOR MEDICAL CENTRE, 1 TUDOR ROAD, HEATHTOWN, WOLVERHAMPTON, WV10 0LS

1

Tel: Fax: Email:

0113 86 65500 0207 821 0029 [email protected]

The Application By application dated 23 April 2014, Rushport Advisory LLP (“the Applicant”) applied to Birmingham, Solihull and The Black Country Area Team, Wolverhampton City Council HWB, NHS CB (“NHS England”) for inclusion in the pharmaceutical list offering unforeseen benefits under Regulation 18 at Tudor Medical Centre, 1 Tudor Road, Heathtown, Wolverhampton, WV10 0LS. In support of the application it was stated: Additional Information re Services Provision 1.1

The Applicant intends to provide all services commissioned by the Local Authority / NHSCB now and in the future and will ensure that all pharmacists employed are accredited to provide these services. The premises will also be accredited.

1.2

As these are new premises it is not possible to have them accredited in advance. A consultation room will be included in the new premises, but as there is not one there at present (as premises are currently not under the Applicant’s control), the Applicant has ticked stated 'N' above. The Applicant intends to introduce additional services in line with the LA's future provision requirements such as - diabetes screening, COPD services, CVO screening, Blood pressure testing, weight management and healthy lifestyle service, alcohol service, asthma service, blood cholesterol tests and flu vaccination.

1.3

This application should not be refused pursuant to Regulation 31 for the following reasons: Not Applicable.

Information in support of the application 1.4

A pharmacy at the application site will secure improvements and better access to pharmacy and pharmacy services that were not included in the PNA.

1.5

The area of the Health and Wellbeing Board that this pharmacy will serve is characterised by considerable deprivation which is affecting the health and wellbeing of the residents in the area. These deprivation statistics result in significant health issues as documented in the JSNA and therefore the need for pharmacy services is greater.

1.6

The area to be served by this application is the Heathtown ward. The ward is densely populated with a population of 13,965. Housing stock in the area is predominantly social rented property from the council 38% which is significantly greater than Wolverhampton as a whole 22.3%. 7.1% of residents describe their health as 'bad' or 'very bad' and 17.8% of residents describe living with long term health problems or

2 disability. 49.6% of households have no access to a car compared to 33.6% across Wolverhampton. (Census 2011)

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1.7

The area to be served by the pharmacy shows high levels of deprivation and a population that has low mobility. The deprivation results in health issues and health inequalities as described in the JSNA and PHE Health Profile 2013- Diabetes, Stroke and CHD, Infant mortality, smoking in pregnancy, alcohol and substance misuse, smoking, adult and child obesity, dementia and mental health.

1.8

Access to pharmaceutical services is poor for people in the area of the application; the new regulations shift the emphasis of pharmacy need to the application site and the improvements / better access that would be secured. Current pharmaceutical service is not addressing the heath inequalities prevalent in the area.

1.9

By approving this application NHS England will be securing significantly better access and by doing so will also significantly improve the availability of pharmaceutical services for the population of the area.

1.10

Given the above, this application under regulation 18 should be granted.

1.11

The granting of this application will significantly improve access resulting in significantly improved availability of pharmacy services. The location is easily accessible by all the local population and the location at GP premises will allow a joined up healthcare service to improve local health outcomes. The pharmacy will be operational for 63 hours weekly providing adequate cover for residents who access GP services or need pharmaceutical service access having not had the ability to see a GP. The Applicant will provide 63 hours as core hours thereby guaranteeing NHS England improved / better access in terms of service hours availability.

1.12

The Applicant will provide the full range of essential, advanced and enhanced pharmacy services from premises that are professionally fitted and fit for purpose. This will allow substantial improvement and better access both in terms of pharmacy opening hours, physical accessibility and the range of services that the population are able to access.

1.13

The pharmacy will deliver all essential, advanced and all currently commissioned and future commissioned enhanced services. These services included in the PNA are services that are required by the residents in the area to improve the current health inequalities.

1.14

Additionally a range of other services will be provided including blood pressure testing , diabetes screening, weight management, blood cholesterol tests, flu vaccination, COPD service, Asthma service, alcohol service, various PGDs and other services to support the LA achieve its health outcomes in an area of need as published in the JSNA.

The Decision NHS England considered and decided to refuse the application. The decision letter dated 17 September 2014 states:

3

2.1

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

2.2

NHS England determined that the application be refused on the grounds that it does not refer to benefits unforeseen in the PNA; and granting the application would not confer significant benefits or secure improvements or better access to pharmaceutical services.

The Appeal

3 In a letter to the Family Health Services Appeal Unit of the NHS Litigation Authority (“the Appeal Unit”), dated 6 October 2014, Rushport Advisory LLP, the Applicant appealed against NHS England's decision. The grounds of appeal are: 3.1

The Applicant writes to appeal the decision of NHS England (Birmingham, Solihull and Black Country Area Team) in rejecting the above application submitted by Rushport Advisory which was communicated by letter dated 17 September 2014.

3.2

NHS England has provided no rationale as to why they have refused the application other than a brief sentence ‘…it does not refer to benefits unforeseen in the PNA;…’ there is no decision report which leads the Applicant to believe that the decision making process is flawed and that the rationale provided in the application form and subsequent correspondence has not been considered.

3.3

At this stage the Applicant wishes to point out that it is difficult to submit to the appeal unit full rationale in terms of appeal grounds and / or evidence as again the basis of the decision reached by NHS England really doesn’t give the Applicant anything to constructively use. The Applicant therefore submits information which shows clear benefits / improvements that would be conferred in terms of access to pharmaceutical services but the Applicant reserves the right to submit further information once it has further details in relation to the nature of NHS England’s deliberations and their relevance to the legal tests to be satisfied.

3.4

The benefits that this application will confer have been identified from a number of sources such as: 3.4.1

Local Authority Joint Service Needs Assessment

3.4.2

Public Health England

3.4.3

Office for National Statistics

3.4.4

Pharmaceutical Needs Assessment

3.4.5

Local health care professionals

3.5

The significant benefits that this application will confer are evidenced from a wider source than the PNA, there are statistics and trends in the PNA but the benefits of this application are at present not being realised and the PNA does not identify benefits in relation to the people at the application site / area / geography and therefore this application is securing significant benefits not identified in the PNA, Regulation 18 Unforeseen Benefits are secured.

3.6

The area the application covers shows significant deprivation (income deprivation, employment deprivation, education deprivation, health deprivation.) Health deprivation results in greater numbers of people describing their health as bad or very bad compared to the wider Wolverhampton area and England as a whole. There is a real need to improve the health outcomes at the application site.

3.7

In terms of health, statistics provided are sourced from Public Health England and Census 2011. Health issues identified include: 3.7.1

Obesity- adults and children

3.7.2

Adult smoking

3.7.3

Smoking in pregnancy

3.7.4

Teenage pregnancy

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3.8

3.7.5

Drug misuse

3.7.6

Diabetes

3.7.7

Heart disease and strokes

Peoples lifestyles in the area of the application are causing these health issues, in addition to the sources provided above the Applicant is able to provide statistics relevant to the application site itself. 3.8.1

Smokers 1,764 patients (27%)

3.8.2

Drug misuse 38 patients

3.8.3

Sexual Health 18 patients

3.8.4

Obesity 600 patients

3.8.5

Alcohol abuse 81 patients

3.9

This highlights that the health issues identified in the wider application area of Heathtown and Wolverhampton are equally applicable at the site that this application will confer significant benefits. Health services are failing to improve the health outcomes for people in the area as evidenced by the layers of statistics and pharmaceutical service provision can only be concluded to be failing also.

3.10

The application clearly shows the services that this application will provide: 3.10.1 Essential pharmacy services 3.10.2 Advanced pharmacy services 3.10.3 Minor Ailments 3.10.4 EHC 3.10.5 Smoking Cessation 3.10.6 Supervised consumption 3.10.7 Needle exchange 3.10.8 Chlamydia 3.10.9 Diabetes screening 3.10.10 COPD screening 3.10.11 CVD screening 3.10.12 Blood pressure service 3.10.13 Weight management service 3.10.14 Alcohol service 3.10.15 Cholesterol service 3.10.16 Flu vaccination

5 3.11

Services provided by pharmacy will be delivered in collaboration with the GP service. Each service has a clear need as evidenced on a micro level specific to patients registered at the application site.

3.12

E.G- the GP service sees c.150 patients weekly where the outcome is a recommendation that would fall under the category of minor ailment. Collaborative approaches with the GP practice will free valuable GP time to make a real difference to major local health needs by allowing pharmacy to tackle minor ailment needs, this just doesn’t happen at the moment and this is a significant benefit to the NHS and local people.

3.13

Current service provision is failing to improve the health of people; a collaborative approach to these patients needs can only be seen as an improvement in terms of better access to pharmaceutical services that will confer a significant benefit. These services / improvements in services are NOT included in the PNA; in fact the PNA can best be described as being somewhat aware of local health needs but fails to provide a plan / solution. This application provides that plan / solution and therefore satisfies the test for an Unforeseen Benefits Regulation 18 application.

3.14

The Applicant believes that this application should be granted and the Applicant welcomes the opportunity to fully appeal the decision of NHS England.

Letter to NHS England in response to Representations on the Application 3.15

Objectors make reference to Wolverhampton PNA particularly the statement “The key findings from the analysis of current provision, location and opening times are that Wolverhampton City PCT has more than adequate pharmacy provision along with a wide range and spread across the city of pharmacies offering a full range of all essential, additional and enhanced services.”

3.16

There are a number of issues with this objection: 3.16.1 The PNA dates back to January 2011 and was produced by an NHS entity that no longer exists and probably by persons no longer involved in front line pharmaceutical service provision under the current NHS / LA structure. 3.16.2 This application is submitted under Regulation 18 i.e. offering to secure better access / improvements in pharmaceutical services of a nature that was unforeseen when the PNA was published. Therefore it really doesn’t matter what the PNA states as the nature of the significant benefits this application will confer in the population in the area was unforeseen in nature at the time the PNA was published. 3.16.3 The unforeseen benefits of this application are evidenced in publications produced post publication of the PNA and therefore the benefits cannot have been foreseen. 3.16.4 Local pharmacies are not offering a full range of all essential, additional and enhanced services which means the statement in the PNA is not correct. NHS England will realise this when deliberating services available from pharmacies in the area.

3.17

Objectors in terms of choice have simply quoted distances to pharmacy providers as measured via NHS choices (radius measurement). The Regulations are clear that NHS England must consider ‘reasonable choice’ which needs to include many more factors than distance alone. NHS England should consider distance by the most practical route, local demographics, mobility from a health and social demographic point of view, current health needs and service availability to satisfy need including essential, advanced, enhanced and other services.

6 3.18

In terms of the unforeseen benefits not being evidenced this is simply not correct, this application offers to improve on all essential service provision locally and advanced service provision while providing all enhanced services. The full range of enhanced services are not available from the existing pharmacies and this improvement alone is sufficient for NHS England to approve this application. This application offers to improve other services which is based on an identified need locally.

3.19

In terms of demographic need in the area the following clearly shows we are dealing with a deprived area with significant social and health needs despite any existing pharmaceutical service provision. The current pharmaceutical service provision is not positively impacting these social and health needs and therefore this application is proposing to provide a significant unforeseen benefit.

3.20

Area referenced re: Census 2011 [See supporting information supplied by the Applicant]

3.21

People’s general health, March 2011

Variable

Measure

Very good Good Fair Bad Very bad

% % % % %

Your neighbourhood 42.0 34.7 15.2 6.5 1.6

Wolverhampton

England

41.8 35.3 15.7 5.5 1.7

47.2 34.2 13.1 4.2 1.2

3.22

More residents describe bad health compared to Wolverhampton as a whole and England.

3.23

[See supporting information supplied by the Applicant] population have no formal qualifications

3.24

[See supporting information supplied by the Applicant] Significant deprivation exists across all indices which current pharmaceutical provision is failing to improve.

3.25

[See supporting information supplied by the Applicant] Life expectancy is significantly less than what is expected across England.

3.26

Children’s weight, 2010 - 2011

Variable Overweight children in reception year, aged 5 Obese children in reception year, aged 5 Overweight children in year 6, aged 11 Obese children in year 6, aged 11

Largest subsection of the

Measure %

Wolverhampton 14.0

England 13.2

%

12.6

9.4

%

14.9

14.4

%

23.8

19.0

3.27

Childhood obesity is significantly a greater issue than nationally.

3.28

Area referenced by Public Heath England (see Heath Profile 2013 attached)

3.29

Heathtown falls within the most deprived quintile in Wolverhampton and therefore the statistics referring to the Wolverhampton area are relevant to the area of this

7 application. It could be argued that the actual poor health statistics would be greater for Heathtown than those quoted as per across Wolverhampton. Key statistics: 3.30

All statistics are significantly worse than would be found across England and therefore are real issues that need improvement and again current pharmaceutical provision is failing to realise any improvements. 3.30.1 Adult smoking 22.2 compared to 20 England 3.30.2 Smoking in pregnancy 19.6 compared to 13.3 England 3.30.3 Smoking related deaths 230 compared to 201 England 3.30.4 Teenage pregnancy 49.7 compared to 34 England 3.30.5 Obese adults 27.5 compared to 24.2 England 3.30.6 Obese children 24.2 compared to 19.2 England 3.30.7 Drug misuse 13.3 compared to 8.6 England 3.30.8 People with diabetes 7.4 compared to 5.8 England 3.30.9 Early deaths heart disease and stroke 78.5 compared to 60.9 England

Area referenced by JSNA: 3.31

Published in 2013 this is the most up to date reference in terms of health need for the population including the area relevant to this application.

Wolverhampton Joint Health and Wellbeing Strategy 2013-2018 3.32

The top five priorities identified by the Health and Wellbeing Board were: 3.32.1 Wider Determinants of Health 3.32.2 Alcohol and Drugs 3.32.3 Dementia (early diagnosis) 3.32.4 Mental Health (Diagnosis and Early Intervention) 3.32.5 Urgent Care (Improving and Simplifying)

3.33

Page 10, Adults Delivery Board 3.33.1 Dementia (Early diagnosis and residential and nursing care admissions) 3.33.2 Long Term Conditions (Stroke Recovery and Diabetes) 3.33.3 Urgent Care (Reducing demand) 3.33.4 Mental Health (Diagnosis and early intervention, domestic abuse and premature mortality of people with mental health needs) 3.33.5 Supported Housing, Re-ablement and Prevention Wellbeing

8 3.34

Page 11, Public Health Delivery Board 3.34.1 Wider determinants of health (Fuel poverty and child development) 3.34.2 Health improvement (Childhood obesity and diabetes) 3.34.3 Prevention of mortality (Deaths from chronic liver disease and falls prevention) 3.34.4 Health protection

3.35

Page 11, highlights: 3.35.1 Dementia 3.35.2 Urgent care 3.35.3 Diabetes

3.36

As its priorities.

3.37

Page 13. What is the position and evidence in Wolverhampton? 3.37.1 Estimates show that there are 2,135 Opiate / Crack users and 5,264 dependant drinkers aged 16 years and over. There is no official estimate for the prevalence of drug use by young people at Local Authority level. However results of the Wolverhampton Health Related Behaviour Survey show that 25% of primary school pupils and 48% of secondary school pupils said that they have had an alcoholic drink, 5% of primary school pupils said they had been offered drugs, 12% of secondary school pupils reveals that they have been offered cannabis while 6% had taken an illegal drug; 3% of them in the month before the survey.

3.38

Page 25. Mortality 3.38.1 Alcohol abuse is one of the leading causes of premature mortality in the city. Primary care mortality data shows that between 2006 and 2010 it was the third highest contributer to years of life lost (YLL) after infant mortality and CHD. Alcohol related mortality rates have increased over the last few years.

3.39

Page 26. Rate of Drug Related Hospital Admissions 2009 – 2012. 3.39.1 [See supporting information supplied by the Applicant]

3.40

Page 30. Heathtown in the highest risk sub group 3.40.1 Rates of drug related hospital admissions during 2009 -12 where highest in wards in the north easr of the city and parts of the south west. Heath Town, Park and Bushbury South and Low Hill had the highest rates of admissions. 3.40.2 Services need to continue to engage people from the identified wards into treatment and reduce the risk of hospital admissions.

3.41

In this application Rushport will provide: 3.41.1 All essential pharmacy services 3.41.2 Advanced MUR and NMS

9 3.41.3 Enhanced pharmacy services: 3.41.3.1MAS 3.41.3.2EHC 3.41.3.3Smoking Cessation 3.41.3.4Supervised Consumption 3.41.3.5Needle exchange 3.41.3.6Chlamydia 3.41.4 Other Services: 3.41.4.1Diabetes screening 3.41.4.2COPD screening 3.41.4.3CVD screening 3.41.4.4Blood pressure service 3.41.4.5Weight management service 3.41.4.6Alcohol service 3.41.4.7Cholesterol service 3.41.4.8Flu vaccination 3.41.4.9Etc. 3.42

4

There is a clear identified need for a solution to tackle these issues prevalent across Heathtown and Wolverhampton and therefore the benefits that these services will deliver are evidenced in a number of publications excluding the PNA and therefore the benefits these services will confer on people in the area are unforeseen. On that basis NHS England can approve this application as satisfying the legal test associated with Regulation 18.

Summary of Representations This is a summary of representations received on the appeal. A summary of those representations made to the NHS England are only included insofar as they are relevant and add to those received on the appeal. 4.1

SYNC CHEM LTD T/A FALLING PARK PHARMACY 4.1.1

Falling Park Pharmacy would like to formally register its objection to the appeal to the above application.

4.1.2

The application is made as a routine application under regulation 18 of the NHS (Pharmaceutical Services) Regulations 2013 “unforeseen benefits”, the proposed premises are in close proximity to a number of listed chemist premises (Fallings Park Pharmacy, Lloyds Pharmacy (x3), Sainsburys Pharmacy and Boots Pharmacy) and therefore paragraph 6 of schedule 2 requires the Applicant to include in their application, details that explain why

10 the application should not be refused pursuant to regulation 31. This has not been completed so the application is non compliant and should be refused. 4.1.3

The Applicant has failed to explain in the application why they believe that approving the application would confer significant benefits on people in the area that were not foreseen when the PCT published its PNA (regulation 18(2)(b) and paragraph 7(1)(b) of Schedule 2), they have simply offered to provide services for which there is no basis in the PNA, they have alluded to the provision of better access but have firstly failed to evidence this in relation to existing access, which exceeds their proposed opening hours, and also which is not an identified need in the locality, either from the PNA, local patient groups or other evidenced source.

4.1.4

The Applicant has listed the health issues in the area of the proposed application and the services it wishes to provide. All of the services it has proposed are either being provided by current pharmacies or current pharmacies have indicated they would be willing to provide them if commissioned.

4.1.5

There may be incomplete data around provision of current services, this is the case with regards to the minor ailments scheme where it has been provided by contractor code FL396 and all data requested required by the commissioning team provided but payments have not been made, this may also show up as zero activity on reports but the zero activity indicates a lack of proper processing of claims as opposed to lack of provision of the service.

4.1.6

The Applicant has stated that services it would provide would be in collaboration with the GP service, current providers already work in collaboration with local GPs and there is no evidence to substantiate that this is either inadequate or the new provider would work any better with the local GPs.

4.1.7

The Applicant has failed to demonstrate any unforeseen benefit their application would provide. The application would fail to provide better access to pharmaceutical services in the area, it would be an alternative provider in an area that is already well served with a number and variety of providers. The application proposes a pharmacy that is open for less hours than many of the local providers and where no need has been evidenced for extended hours (either by current or new providers). The application lists the services it proposes to provide as: 4.1.7.1 All essential pharmacy services 4.1.7.1.1these are already provided by all the local providers so offer no unforeseen benefit by the Applicant. 4.1.7.2 Advance MUR and NMS 4.1.7.2.1these are already provided by all the local providers so offer no unforeseen benefit by the Applicant 4.1.7.3 Enhanced pharmacy services: MAS 4.1.7.3.1Was provided by a number of local providers and the scheme has now been superseded. Data for uptake of the new scheme is not yet available. A number of local providers have signed up to provide the new scheme.

11 EHC 4.1.7.3.2Provided by a range of the local pharmacies already so no unforeseen benefit of another provider. Smoking cessation 4.1.7.3.3Stage 1 and 2 provided by a range of local pharmacies so no unforeseen benefit of another provider. Supervised consumption 4.1.7.3.4Provided by a range of the local pharmacies already so no unforeseen benefit of another provider. Needle exchange 4.1.7.3.5Provided by a range of the local pharmacies already so no unforeseen benefit of another provider. Chlamydia 4.1.7.3.6Provided by a range of the local pharmacies already so no unforeseen benefit of another provider 4.1.7.4 Other services Diabetes Screening 4.1.7.4.1offered at a range of both local pharmacies (privately) and via local GPs (commissioned), this service has not been commissioned locally to be provided by pharmacies based on a needs assessment. The Applicant would be in the same position as existing contractors in terms of being able to provide the service privately (in an area of high economic deprivation). This would offer no unforeseen benefit. COPD screening 4.1.7.4.2Offered at a range of both local pharmacies (privately) and via local GPs (commissioned), this service has not been commissioned locally to be provided by pharmacies based on a needs assessment. The Applicant would be in the same position as existing contractors in terms of being able to provide the service privately (in an area of high economic deprivation). This would offer no unforeseen benefit. CVD Screening 4.1.7.4.3Offered at a range of both local pharmacies (privately) and via local GPs (commissioned), this service has not been commissioned locally to be provided by pharmacies based on a needs assessment. The Applicant would be in the same position as existing contractors in terms of being able to provide the service privately (in an area of high economic deprivation). This would offer no unforeseen benefit. Blood pressure service

12 4.1.7.4.4Offered at a range of both local pharmacies (privately) and via local GPs (commissioned), this service has not been commissioned locally to be provided by pharmacies based on a needs assessment. The Applicant would be in the same position as existing contractors in terms of being able to provide the service privately (in an area of high economic deprivation). This would offer no unforeseen benefit. Weight management service 4.1.7.4.5Offered at a range of both local pharmacies (privately) and via local GPs (commissioned), this service has not been commissioned locally to be provided by pharmacies based on a needs assessment. The Applicant would be in the same position as existing contractors in terms of being able to provide the service privately (in an area of high economic deprivation). This would offer no unforeseen benefit. Alcohol service 4.1.7.4.6Offered at a range of both local pharmacies (privately) and via local GPs (commissioned), this service has not been commissioned locally to be provided by pharmacies based on a needs assessment. The Applicant would be in the same position as existing contractors in terms of being able to provide the service privately (in an area of high economic deprivation). This would offer no unforeseen benefit. Cholesterol service 4.1.7.4.7Offered at a range of both local pharmacies (privately) and via local GPs (commissioned), this service has not been commissioned locally to be provided by pharmacies based on a needs assessment. The Applicant would be in the same position as existing contractors in terms of being able to provide the service privately (in an area of high economic deprivation). This would offer no unforeseen benefit. Flu vaccination 4.1.7.4.8Offered at a range of both local pharmacies (NHS + privately) and via local GPs (NHS + Private), this service has been commissioned locally to be provided by pharmacies based on a needs assessment. The Applicant would be in the same position as existing contractors in terms of being able to provide the service. Local contractors are already providing this service. This would offer no unforeseen benefit. This is also an example of how the local commissioners look at needs and plan provision to meet them as opposed to the applicants intention of providing services privately that have not been commissioned, to a patient population in an area of high economic deprivation where the majority would not be able to afford the services provided therefore exacerbating health inequalities, this is an unforeseen detriment if the application were to be granted. 4.1.8

With regards to regulation 18:

4.1.9

(a)(i) granting this application would hinder the local Health and Wellbeing Board in terms of proper planning because it would over populate the area

13 with pharmaceutical providers (using a measure of average Rx item numbers per pharmacy per head of population). The area is already well served with providers. 4.1.10 (a)(ii) the Local Health and Wellbeing Board already has adequate arrangement in place for the provision of pharmaceutical service in the area. Granting of the application would be economically detrimental to existing providers who would in turn be hindered in extending pharmaceutical services due to cost pressures and this would result in detrimental health outcomes for the local population. The economic pressure from the new Applicant would hinder the Local Health and Wellbeing Board in arranging pharmaceutical services in the area. 4.1.11 (b)(i) The Applicant offers no benefit or desirability with regards to reasonable choice as there is already a range and variety of provider for pharmaceutical services in the area. The area is not under served by pharmacy contractors using any recognised determinant of access e.g. walk times, public transport provision etc. 4.1.12 (b)(ii) The Applicant has not stated any benefits it would confer to any group of population who share a protected characteristic, therefore fail to confer unforeseen benefit or desirability with regards to this section of the regulations. 4.1.13 (b)(iii) The only innovation the Applicant proposes is to have a collaborative approach to working with the GP provider. They have not stated how this would be done or evidence to support the statement. The proposal is also not innovative and many of the existing providers already work collaboratively with both the GP around whose site this application is proposed and the wider population of GPs. The Applicant therefore fails to offer any innovative solution. 4.1.14 For the above reasons the application is both incomplete and unsatisfactory so should be rejected on grounds of technicality and merit. The Applicant has failed to show any unforeseen benefit they would provide and is speculative in nature and should be rejected. 4.2

BOOTS UK LTD 4.2.1

Boots has the following comments to make:

4.2.2

DoH guidance states 'Unforeseen benefits applications must be fully evidenced'. It is not sufficient to quote statistics and not support them with information on their relevance to the application.

4.2.3

ONS census figures consider their health Wolverhampton and 82.2% vs 79.5% in Wolverhampton, and Wolverhampton.

for 2011 show that people in Heath Town ward who to be very good or good is 78.8% vs that of 77.1% in those whose day-to-day activities are not limited is Wolverhampton. The average age is 31 vs 37 in the population aged 65 or older is 10.3% vs 16.2% in

Access 4.2.4

The Applicant has provided no evidence that patients living in Heathtown are having difficulty accessing existing pharmacies. The distance from the proposed location to the existing pharmacies is given below (source Google maps), and Boots submit that distance does not in itself indicate that there is a difficulty in obtaining a choice of pharmaceutical services.

14 4.2.4.1 Lloyds pharmacy at 181 Wednesfield Road is 550 metres to the west 4.2.4.2 Failings Park pharmacy is 1000 metres to the north 4.2.4.3 Boots Bentley Bridge Retail Park is 1200 metres to the east 4.2.4.4 Brooklands pharmacy is 1200 metres to the south 4.2.5

There is also no information provided to support a finding that pharmaceutical services are not currently provided at such times as they are needed. The granting of this application would not lead to a significant benefit in relation to opening hours.

4.2.6

Boots disagree with the Applicant that 'health services are failing' as there is no evidence to support this. Neither is there evidence to support the statement 'pharmaceutical provision can only be concluded to be failing also'.

4.2.7

Boots pharmacy at Bentley Bridge retail park offers supervised consumption, needle exchange, minor ailments (although this is currently on hold as the service is being reviewed by NHS England), flu vaccinations, MUR's and NMS. Smoking cessation will be available shortly (awaiting accreditation) along with EHC.

Choice 4.2.8

Within the area of the HWB and more specifically within a reasonable distance of the site of the application there is a wide choice of pharmacies and pharmaceutical services. There is no evidence that these existing pharmacies are not reasonably easy to access for the residents of Heathtown, either on foot, by car or by public transport.

Innovation 4.2.9

The Applicant is proposing to provide all essential, advanced and enhanced pharmaceutical services where commissioned now and in the future. Providing services that may be commissioned as part of a standard pharmacy contract cannot be considered to be innovative. Neither is the act of providing pharmaceutical services in a locality that does not currently contain a pharmacy considered to be an innovative approach as intended by the Regulations. Boots therefore submits that the granting of this application would not lead to significant benefits by virtue of innovation.

Conclusion 4.2.10 Based on the information provided in this appeal, Boots believe that there is insufficient evidence to show that access is such that the granting of this application would confer significant benefits in terms of access to services. 4.2.11 Boots believes that there is no information to suggest that there is not already a reasonable choice for patients with regard to obtaining pharmaceutical services. Boots submit therefore that granting this application would not lead to significant benefits by way of choice. 4.2.12 Boots also believes that the services the Applicant intends to provide are not outside of the scope of those normally provided, or able to be provided, by the existing pharmacies. They are not offering an innovative approach in the delivery of pharmaceutical services as intended within Regulation 18(2)(iii).

15 4.2.13 For these reasons Boots submit that this application does not offer improvements or better access to services as required under Regulation 18(2)(b), and should therefore be refused. 4.2.14 Please be aware that Boots may wish to make further representations at a later stage and attend any oral hearing that is deemed necessary. 4.3

BROOKLANDS PHARMACY 4.3.1

The comments Brookland Pharmacy would like to make in relation to the appeal made by Rushport LLP about the refusal to grant their application will, Brookland Pharmacy hope help the decision making process. Brookland Pharmacy stand by its original comments made to NHS England in their objection to the application, in the appeal letter the Applicant provides no evidence to back up the unforeseen benefits claim. The Applicant lists a range of enhanced services already provided or that would be provided by existing contractors if they were commissioned by NHS England or the local authority and a range of statistics about the Heath Town area. The PNA does not highlight any lack of provision to the area. There is a reasonable choice of provider with regard to pharmaceutical services. There is no evidence that people with protected characteristic have any difficulty accessing pharmaceutical services and there is no evidence that an innovative approach would be taken with regard to delivery of pharmaceutical services. These facts show that regulation 18 is not satisfied and the decision of NHS England should be upheld.

Brooklands Pharmacy, letter to NHS England dated 07 July 2014 4.3.2

Brooklands Pharmacy would like to oppose this application as it does not give unforeseen benefits as per regulation 18 of the NHS (pharmaceutical services) Regulations 2013. The Wolverhampton Pharmaceutical Needs assessment states:

4.3.3

"The key findings from the analysis of current provision, location and opening times are that Wolverhampton City PCT has more than adequate pharmacy provision along with a wide range and spread across the city of pharmacies offering a full range of all essential, additional and enhanced services" The reasons for this objection are:

4.3.4

There is already a reasonable choice of pharmacy given that there are 5 pharmacies within one mile of Tudor Road Medical Practice, covering all of the surgery opening hours and lots of out of hours cover.

4.3.5

The Applicant states that access to services is poor and by granting a new pharmacy contract this will significantly improve but no evidence is given to show why access is poor or how it will significantly improve and to my knowledge no complaints about access have been received by NHS England. The terrain between Tudor Road Medical Centre and the pharmacies is predominately flat, paved and well lit with numerous pedestrian crossing points, bus services are widely available and car parking at all pharmacies is not a problem.

4.3.6

A collection and delivery service is widely available for housebound patients. Detailed below are the comprehensive pharmaceutical services available (details from NHS Choices except where stated bus frequency from Network West Midlands website).

16 4.3.7

Lloyds pharmacy 181 Wednesfield Road open 58.5 hours per week 9am-7pm Monday to Friday (company website details) distance of 0.4 miles from Tudor Medical Centre a 9 minute walk or a short bus journey frequency every 4 minutes from 5am till 11.30pm 6 days a week.

4.3.8

Fallings Park Pharmacy 212 Bushbury Road open 40 hours Monday to Friday 9am-6pm distance of 0.6 miles from Tudor Road Medical Practice.

4.3.9

Boots Pharmacy Bentley Bridge retail Park open 78 hours 8am to 8pm Monday to Friday distance of 0.8 miles from Tudor Road Medical Practice also a bus journey with frequency of every 4 minutes.

4.3.10 Sainsbury Pharmacy Rookery Road open 100hrs 7am till 11pm Monday to Friday distance of 0.9 miles from Tudor Road Medical Practice also a bus journey with a frequency of every 6 minutes. 4.3.11 Brooklands Pharmacy open 54 hours 9am till 6.30 (Monday and Tuesday) 6pm (Wednesday and Friday) 5.30pm (Thursday) 0.8miles from Tudor Road Medical Practice and a bus journey with a frequency every 12 minutes. 4.3.12 Tudor Road Medical Practice reception is open from 8am until 6pm Monday to Friday except Thursday until 1pm and surgery times are from 9am until 6pm Monday to Friday except Thursday until 11.30 am. 4.3.13 The Applicant states that current pharmaceutical service is not addressing the health inequalities in the area but no evidence of this is given or how the pharmacy is going to improve the situation. 4.3.14 The Applicant states that by providing a full range of pharmaceutical services there will be a substantial improvement for the population but again no evidence of lack of pharmaceutical service has been provided and to my knowledge no complaints about pharmaceutical service availability have been received by NHS England. 4.3.15 There is no mention of an innovative approach in the application or patients with protected characteristics having difficulty accessing Pharmaceutical services. 4.3.16 In summary the application gives no evidence of any unforeseen benefits or an improvement in access required to grant it and is purely speculative and for that reason regulation 18 is not met and the application should be rejected. 4.4

LLOYDS PHARMACY 4.4.1

The Appellant provides no supporting evidence that patients of the Tudor Road Medical Centre have difficulty having their prescriptions dispensed or that the surrounding population has problems accessing pharmaceutical services.

4.4.2

The Applicant bases its application on the level of deprivation of the area however there are already pharmacies that meet the needs of this population.

4.4.3

Lloyds Pharmacy at 181 Wednesfield Road is already open to 19.00 weekdays and to 17.00 weekdays and Boots at Bentley Bridge Retail Park is open 7 days a week including to 20.00 weekdays and to 16.30 on Sundays.

4.4.4

There is no evidence provided within the application or the appeal that demonstrates it would secure improvements or better access to pharmaceutical services and therefore Lloyds Pharmacy ask that the

17 application be refused and appeal dismissed. required Lloyds Pharmacy would wish to attend. 5

In the event a hearing is

Additional Information Excerpt From NHS England Consideration of the Application 5.1

Rushport Advisory LLP are a Body Corporate who have applied to open a pharmacy within an existing GP practice, Tudor Road Medical Centre, which is located just after Heath Town but before you get to New Cross Hospital it sits on the corner of Wednesfield Road and Tudor Road. The practice has been there for a number of years and is well established.

5.2

The Applicant confirms within the application to provide: 5.2.1

63 core hours per week

5.2.2

all essential services

5.2.3

appliances listed in part 1X of the drug tariff

5.2.4

NMS

5.2.5

MUR

5.3

It is worth noting the opening hours are 8am to 7pm Monday to Friday and 9am to 5pm on a Saturday. These hours may exceed the opening hours of the GP practice but the Applicant has not clearly identified how patients would access services outside of GP practice hours. Committee should note the comments of the Applicant on page 4 of the application; it may read as if the Applicant expects the premises to become vacant, however [the NHS England Officer] is not aware of any plans for the surgery to relocate. Although on page 7 of the application form the Applicant makes reference to the GP premises still being there, it is not entirely clear.

5.4

The premises are not adjacent to another pharmacy. The nearest pharmacy is Lloyds Pharmacy 181 Wednesfield Road at 0.37 miles, opening hours listed as Monday - Friday, 9am to 5pm and Saturday 9am to 5.30pm. The next is Boots at Bentley Bridge at 0.56 miles opening hours listed as Monday to Saturday 8am to 8pm and Sun 10.30am to 4.30pm, (information taken from NHS Choices). Both of these existing sites are on busy commuter routes served by good public transport links and provide a range of services, listed on NHS Choices as follows:

5.5

Lloyds 181 Wednesfield Road, information located on NHS Choices 5.5.1

Consultation room

5.5.2

EHC

5.5.3

Collection service

5.5.4

Smoking cessation advice

5.5.5

Needle & syringe exchange

5.5.6

Incontinence supply

5.5.7

MUR

5.5.8

Minor Ailments

18 5.5.9 5.6

Stoma appliance customisation service

Boots, Bently Bridge, Information located on NHS Choices 5.6.1

Consultation room

5.6.2

EHC

5.6.3

Smoking cessation advice

5.6.4

Needle & syringe exchange

5.6.5

Incontinence supply

5.6.6

MUR

5.6.7

Minor Ailments

5.6.8

Pregnancy testing

5.6.9

Stoma appliance customisation service

The wider area

6

5.7

In total there are 12 pharmacies within a 2km radius of the Applicant’s chosen location.

5.8

The Applicant is applying for inclusion under regulation 18 Unforeseen benefits on the basis that they are offering to secure improvements or better access that were not included in the PCT's PNA, please refer to page 6 of the application form for more detail.

5.9

The Committee may wish to note that the following area's are due to undergo a large re-generation programme, information is available on the Wolverhampton City council website. 5.9.1

Heath Town

5.9.2

Heathfield

5.9.3

Springfield

Observations 6.1

RUSHPORT ADVISORY LLP (THE APPLICANT) 6.1.1

Please see below the Applicant’s final observations, all observations and documents supporting these observations are provided in rebuttal of statements made by objectors. No new matters are raised and all the Applicant’s observations are intended to provide the Appeal Unit with the rationale supporting its case/ rebuttal of objector statements.

Pharmacy Services Regulations Committee [NHS England] 6.1.1.1 “It is worth noting the opening hours are 8am to 7pm Monday to Friday and 9am to 5pm on a Saturday. These hours may exceed the opening hours of the GP practice but the Applicant has not clearly identified how patients would access services outside of GP practice hours. Committee should note the comments of the Applicant on

19 page 4 of the application; it may read as if the Applicant expects the premises to become vacant, however I am not aware of any plans for the surgery to relocate. Although on page 7 of the application for the Applicant makes reference to the GP premises still being there, it is not entirely clear.” 6.1.2

NHS England failed to clarify this with the Applicant during their deliberations. The pharmacy service is available outside the opening hours of the GP service and a separate pharmacy entrance is to be provided to allow patient access when the GP service is closed. The Applicant has never stated the GP service will close or relocate on the contrary the Applicant has described in submission to NHS England and the Appeal Unit that the pharmacy service is to compliment and collaborate with the GPs and their service to the population.

6.1.3

It should be noted that services described on page 2 of PSRC submission are taken from NHS Choices as is the distance. The list of services are not those that are commissioned and distances are measured by radius rather than the most practicable route. The Applicant is surprised NHS England has relied on such information. 6.1.3.1 “The Committee may wish to note that the following area’s are due to undergo a large re-generation programme, information is available on the Wolverhampton City Council website. 6.1.3.1.1Heath Town 6.1.3.1.2Heathfield 6.1.3.1.3Springfield”

6.1.4

This is correct; this is not referenced in the PNA. There is a need for pharmaceutical service improvements / better access now and in the future and therefore this application secures significant benefits that were unforeseen when the PNA was published. The Applicant attaches Wolverhampton LA ‘Neighbourhood Plan’ specific areas to note being: 6.1.4.1 “Local people work towards a neighbourhood plan for Heath Town, Springfield and New Park Village. 6.1.4.2 Why a Neighbourhood Plan for Heathfield Park? 6.1.4.3 Heathfield Park is one of the City of Wolverhampton’s fourteen Local Neighbourhood Partnership areas. It extends from the Eastern edge of Wolverhampton City Centre to the edge of the Bentley Brisge Retail Park, bounded by the A460 Cannock Road to the north and the Wyrley and Essington Canal to the South. 6.1.4.4 The name Heathfield Park was derived from the areas of Heath Town, Springfield and New Park Village contained within these borders. 6.1.4.5 As one of the most deprived areas in Wolverhampton City and also in the worst 5% of wards nationally in terms of deprivation, health, employment, educational attainment, housing and child poverty, we believe that Heathfield Park is a priority area for investment and remodelling.”

6.1.5

Map – available to Committee. (page 3 of Obs)

20 6.1.6

This mirrors almost identically with the area described as per the application.

6.1.7

Figure 3: Neighbourhood Plan Strategy Map. (Plan available to Committee (page 4 of Obs)

6.1.8

The area showing new residential, new employment and regeneration sites. The plan is currently in action.

6.1.9

“Policy 5: Provide Local Housing.

6.1.10 Over the lifetime of the Neighbourhood Plan 585 new homes will be built in the area. The majority of this housing will be provided on the housing site allocations listed below and shown on the site allocation plan. 6.1.11 Development for small scale residential infill within the Heathfield Park Neighbourhood Plan area will be supported if its well designed and meet relevant requirements set out in other policies in the Plan and the Core Strategy and UDP. The density of development should create a character that is appropriate to the site’s context and the development design must incorporate principles of creating good connections, transport and accessibility links”. Boots 6.1.12 Statistics referred to by Boots are not correct; the area that is relevant to the application is as per the Applicant’s previous submission and is identical to the neighbourhood plan as above. 6.1.13 Map – available to Committee (page 5 of Obs) 6.1.14 People’s general health, March 2011 Variable

Measure

Very good Good Fair Bad Very bad

% % % % %

Your neighbourhood 42.0 34.7 15.2 6.5 1.6

Wolverhampton

England

41.8 35.3 15.7 5.5 1.7

47.2 34.2 13.1 4.2 1.2

6.1.15 It is clear from all Census statistics, the PNA, the JSNA and the LA Neighbourhood Plan that Heathtown is significantly deprived. 6.1.16 Boots state: 6.1.16.1“We disagree with the Applicant that ‘health services are failing’ as there is no evidence to support this. Neither is there evidence to support the statement ‘pharmaceutical provision can only be concluded to be failing also’”. 6.1.17 The Applicant provide the evidence attached as exampled in CQC Intelligent Monitoring Report November 2014 from 3 local GP surgeries. The risks identified by CQC in relation to the population in the area of the application include: 6.1.17.1Coronary Heart Disease 6.1.17.2Dementia

21 6.1.17.3Diabetes 6.1.17.4Age and Influenza 6.1.17.5High blood pressure 6.1.17.6Elevated cholesterol 6.1.18 The risk associated with these health issues is greater than would be expected in this population therefore the Applicant’s statement that ‘health services are failing’ is true in key areas as measured by CQC. Additionally pharmacies are not delivering services that will help to improve these health issues and therefore the statement ‘Pharmaceutical provision can only be concluded as failing also’ is correct. 6.1.19 Boots themselves say in their correspondence that they don’t provide smoking cessation and EHC; it is worth re-stating the local issue by way of statistics that are readily available: 6.1.19.1Adult smoking 22.2 compared to 20 England 6.1.19.2Smoking in pregnancy 19.6 compared to 13.3 England 6.1.19.3Early deaths heart disease and stroke 78.5 compared to 60.9 England 6.1.19.4Teenage pregnancy 49.7 compared to 34 England (Public Health England) 6.1.20 Boots state: 6.1.20.1“There is also no information provided to support a finding that pharmaceutical services are not currently provided at such times as they are needed. The granting of this application would not lead to a significant benefit in relation to opening hours”. 6.1.21 Smoking and sexual health are the 2 main health and wellbeing issues afflicting the local population and Boots fails to deliver a service to this significant group of people. Boots own submission supports the Applicant’s application and supports the Applicant’s submission to the Appeal Unit: Rushport Submission to Appeal Unit 6.1.22 Current service provision is failing to improve the health of people; a collaborative approach to these patients needs can only be seen as an improvement in terms of better access to pharmaceutical services that will confer a significant benefit. These services / improvements in services are NOT included in the PNA; in fact the PNA can best be described as being somewhat aware of local health needs but fails to provide a plan / solution. This application provides that plan / solution and therefore satisfies the test for an Unforeseen Benefits Regulation 18 application. Brooklands Pharmacy 6.1.23 With respect Mr Laurence deduces that improved access relates only to physical access to a pharmacy. The Applicant does not agree that access is easy and should a person in the area require access to pharmaceutical services it is of no value being able to physically access a pharmacy premise if that person is then unable to avail themselves of the service required to

22 improve their health outcomes and contribute to the improvement in health locally. 6.1.24 Boots do not provide smoking cessation and EHC - there is a significant need for these services Boots does not provide the Minor Ailment Service (information provided by FOI 242275 NHS England). 6.1.25 Brooklands Pharmacy does not provide Smoking Cessation and Supervised Consumption (NHS Choices) Fallings Park Pharmacy 6.1.26 Using Fallings Park numbering: 6.1.27 This shows a lack of understanding of the Regulations; this application does not fail Regulation 31. 6.1.28 The Applicant refers to above (Boots) in terms of significant benefits in people’s health. 6.1.29 The services the Applicant proposes are not available consistently across pharmacies locally and Fallings Park does not provide: 6.1.29.1Smoking Cessation 6.1.29.2Supervised Consumption 6.1.29.3Chlamydia Service. (NHS Choices and telephone enquiry) 6.1.30 Fallings Park state ‘All the services it has proposed are either being provided by current pharmacies or current pharmacies have indicated they would be willing to provide them if commissioned.’ The Applicant says they surely cannot use this generic catch all phrase, they either do or do not provide the services. They do not and the Applicant is proposing to fill this gap the significant benefit being improvement in the health of people locally which is sorely needed. 6.1.31 Other objectors have described the MAS as being ‘on hold’ (Boots) and therefore there is no availability of this service which reinforces that better/ improved access to pharmaceutical services will result in significant benefits. 6.1.32 Please see attached letter from Dr Sumit Agrawal, Tudor Medical Centre i.e. the application site. [at 6.1.44 below] 6.1.33 This is contradictory: 6.1.33.1“The Applicant has failed to demonstrate any unforeseen benefit their application would provide. The application would fail to provide better access to pharmaceutical services in the area, it would be an alternative provider in an area that is already well served with a number and variety of providers. The application proposes a pharmacy that is open for less hours than many of the local providers and where no need has been evidenced for extended hours (either by current or new providers). The application lists the services it proposes to provide as:” 6.1.34 The Applicant will open as per the application: Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

Total

23 8am to 7pm

8am to 7pm

8am to 7pm

8am to 7pm

8am to 7pm

9am to 5pm

63

6.1.35 The Applicant offers additional better / improved access compared to existing pharmacy service providers with the exception of retail park and supermarket pharmacies which are not comparable and / or adequately accessible. 6.1.35.1Lloyds 58.5 hours 6.1.35.2Fallings Park 40 hours 6.1.35.3Brooklands 54 hours 6.1.36 Fallings Park go on to describe the extended hours as per the Applicant’s application, it is true no need has been evidenced; the Applicant assume this relates to the PNA; and as this application is offering to secure unforeseen benefits not identified in the PNA it does satisfy Regulation 18. 6.1.37 In terms of the list of services: 6.1.37.1MUR 6.1.37.2MAS- this isn’t being provided as things stand today 6.1.37.3EHC- gaps described above exist and there is documented evidence of prevalence / need for this service 6.1.37.4Smoking cessation- gaps described above, smoking is the largest issue to health locally 6.1.37.5Supervised consumption- gaps exist as described above 6.1.37.6Chlamydia service- gaps exist as described above 6.1.37.7Other services- for each of the other services that the Applicant will provide Fallings Park has quoted the same paragraph including ‘and via local GPs (commissioned)’ this is not relevant as the Regulations can only examine pharmaceutical services not GP or services commissioned via other health care providers. 6.1.37.8A number of the other services are not available locally at all as evidenced by telephone requests for such services namely 6.1.37.8.1COPD screening 6.1.37.8.2CVD screening 6.1.37.8.3Weight management 6.1.37.8.4Alcohol service 6.1.38 Fallings Park State: 6.1.38.1“With regards to Regulation 18: 6.1.38.2(a)(i) granting this application would hinder the local Health and Wellbeing Board in terms of proper planning because it would over populate the area with pharmaceutical providers (using a measure of

24 average Rx item numbers per pharmacy per head of population). The area is already well served with providers. 6.1.38.3(a)(ii) the Local Health and Wellbeing Board already has adequate arrangements in place for the provision of pharmaceutical service in the area. Granting of the application would be economically detrimental to existing providers who would in turn be hindered in extending pharmaceutical services due to cost pressures and this would result in detrimental health outcomes for the local population. The economic pressure from the new Applicant would hinder the Local Health and Wellbeing Board ain arranging pharmaceutical services in the area”. 6.1.39 In an attempt to prove ‘significant detriment’ Fallings Park has failed to recognise that they would need to provide documented evidence relating to significant detriment, the statements provided do not go far enough and therefore the only conclusion can be that this application will not cause significant detriment. 6.1.39.1“(b)(ii) the Applicant has not stated any benefits it would confer to any group of population who share a protected characteristic, therefore fail to confer unforeseen benefit or desirability with regards to this section of the regulations”. 6.1.40 The Applicant respectfully refers the Appeal Unit to the CQC Intelligent Monitoring Reports included. [Available to Committee] There are documented risks in the local population with the CQC data supporting other sources such as Census 2011, Public Health England, JSNA, PNA etc. The risks to health are real, these risks resulting in poor health compared to what is to be expected means that this pharmaceutical service proposal will deliver real and tangible improvements in these documented health issues. These are significant benefits and these benefits will be conferred on all the population in the area of the application. There is no differentiation between any particular group of population if using the definitions within the Equality Act, again ALL groups / individuals / population benefit. Lloyds 6.1.41 “The Applicant bases their application on the level of deprivation of the area however there are already pharmacies that meet the needs of this population”. 6.1.42 Deprivation is the key contributor in the significant health issues locally; if pharmacies were meeting the needs of this population there would not be such documented issues and therefore the Applicant must conclude that pharmacies are not meeting the needs of this population. Again this can be seen in terms of the data from numerous sources and that pharmacies are not delivering key services across the geography that would contribute to health improvements. 6.1.43 The Applicant believes this application satisfies Regulation 18 and trust the Appeal Unit will agree following deliberations. Supporting Information, Letter from Tudor Medical Centre 6.1.44 The Partners of the Practice feel most strongly that there is a need for an improved pharmacy service to our patients in the locality and this can be best realised by adopting a collaborative approach between the GPs and Pharmacy which Mr Devlin's application would facilitate to deliver. We would also highlight to you that our Patient Participation Group (PPG) totally

25 advocates the proposals and recognises that a proactive and integrated approach to working in Primary Care will maximise patient outcomes regarding their health and wellbeing. Supporting Information: [Available to Committee] 6.1.45 CQC Intelligent Monitoring Report, November 2014 – Poplars Medical Practice 6.1.46 CQC Intelligent Monitoring Report, November 2014 – Woden Road Surgery 6.1.47 CQC Intelligent Monitoring Report, November 2014 – Tudor Medical Centre 6.1.48 Heathfield Park, Neighbourhood Plan, 2014 - 2026 7

Consideration 7.1

The Pharmacy Appeals Committee (“the Committee”) appointed by the Family Health Services Appeal Unit of the NHS Litigation Authority, had before it the papers considered by NHS England, together with a plan of the area showing existing pharmacies and doctors’ surgeries and the site of the proposed pharmacy.

7.2

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

7.3

On the basis of this information, the Committee considered it was not necessary to hold an Oral Hearing.

7.4

The Committee had regard to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the Regulations”) as amended with effect from 1 April 2014.

7.5

The Committee first considered Regulation 31 of the regulations which states: (1) A routine or excepted application must be refused where paragraph (2) applies (2) This paragraph applies where (a) a person on the pharmaceutical list (which may or may not be the applicant) is providing or has undertaken to provide pharmaceutical services ("the existing services") from (i) the premises to which the application relates, or (ii) adjacent premises; and (b) the NHSCB is satisfied that it is reasonable to treat the services that the applicant proposes to provide as part of the same service as the existing services (and so the premises to which the application relates and the existing listed chemist premises should be treated as the same site).

7.6

The Committee noted that in its application, the Applicant had stated that Regulation 31 was not applicable in this case. The Committee noted that NHS England had not referred to Regulation 31 in its decision. The Committee noted comments by Falling Park Pharmacy that the proposed pharmacy is in close proximity to a number of existing pharmacies, including its own, 3 Lloyds Pharmacies, Sainsbury’s and Boots Pharmacy. The Committee is of the view that it had no information before it to indicate that the proposed premises are at premises or adjacent premises where there are existing services. Therefore, the Committee was of the view that it was not required to refuse the application under the provisions of Regulation 31.

26 7.7

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)

(b)

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;

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;

27

(3)

7.8

(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.

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)."

Pursuant to paragraph 9(1)(a) of Schedule 3 to the Regulations, the Committee may: 7.8.1

confirm NHS England’s decision;

7.8.2

quash NHS England’s decision and redetermine the application;

7.8.3

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.

7.9

The Committee considered the Pharmaceutical Needs Assessment ("the PNA") prepared by the Wolverhampton City PCT, 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 January 2011 and that a supplementary statement had been issued in April 2012.

7.10

The Committee noted that the PNA concentrates on considering provision across Wolverhampton generally rather than localities or wards within the City. The PNA does provide a map of the wards which includes Heath Town Ward. The PNA considers health inequalities, provision of essential, advanced and enhanced pharmaceutical services. The PNA concludes that “The key findings from the analysis of current provision, location and opening times are that Wolverhampton City PCT has more than adequate pharmacy provision along with a wide range and spread across the city of pharmacies offering a full range of all essential, additional and enhanced services”.

7.11

The Committee noted that the Applicant seeks to provide unforeseen benefits to the area of the Heathtown Ward.

7.12

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.

28 Regulation 18(2)(a)(i) 7.13

The Committee had regard to "(a)

whether it is satisfied that granting the application would cause significant detriment to— (i)

proper planning in respect of the provision of pharmaceutical services in its area …"

7.14

The Committee noted that NHS England has not referred to this aspect of the Regulations in its decision. Fallings Pharmacy, in its representations have stated that by over populating the area with pharmacy providers it would hinder the proper planning as the area is already well served with providers. The Committee decided to accept the Applicant’s view that no evidence has been provided to demonstrate that this would be the case.

7.15

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.

7.16

The Committee was therefore not satisfied that significant detriment to the proper planning of pharmaceutical services would result from a grant of the application.

Regulation 18(2)(a)(ii) 7.17

The Committee had regard to "(a)

whether it is satisfied that granting the application would cause significant detriment to— … (ii)

the arrangements the NHSCB has in place for the provision of pharmaceutical services in that area"

7.18

The Committee noted that NHS England has not referred to this criteria of the Regulations in its decision. Fallings Pharmacy, in its representations have stated that granting the application would be economically detrimental to existing providers which would lead to cost pressures and detrimental health outcomes for the local population. The Committee was of the view that no information had been provided in support of an assertion that accords with Regulation 18(2)(a)(ii).

7.19

The Committee was therefore not satisfied that significant detriment to the arrangements currently in place for the provision of pharmaceutical services would result from a grant of the application.

7.20

In the absence of any significant detriment as described in Regulation 18(2)(a), the Committee was not obliged to refuse the application and went on to consider Regulation 18(2)(b).

Regulation 18(2)(b) 7.21

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—

29 (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) 7.22

The Committee noted that NHS England, in additional information, has stated that there are 12 pharmacies within a 2 km radius of the proposed location. Parties objecting to the application have stated that walkways are flat, paved and lit with crossing points, that there is parking available at the existing pharmacies and that buses run regularly. Brooklands Pharmacy, in representations have also provided distances, times to walk and where available bus frequency to the 5 nearest existing pharmacies to the proposed premises. The Committee noted that whilst the Applicant had disputed the distances, he had not provided alternative measurements, nor any information to demonstrate that users of pharmaceutical services are currently experiencing difficulty accessing pharmaceutical services on foot or via public or private transport.

7.23

The Applicant states that access to pharmaceutical services is a problem in that some services it is proposing to provide are not available at certain pharmacies. The Applicant provides information to demonstrate that the health issues in the area indicate a need for these pharmaceutical services. Parties have stated that the services are provided and have referred to NHS Choices. The Committee had verified that NHS Choices shows the services as listed at 5.5 and 5.6 above to be offered apart from smoking cessation advice. The Committee is of the view that is for the Applicant to demonstrate which services are currently commissioned locally but are not being provided. The Committee is further of the view that if the services offered are not commissioned then there is no benefit to having a new pharmacy voluntarily providing services which could then be withdrawn. On the basis of the information available, the Committee concluded that there is already reasonable choice with regard to obtaining pharmaceutical services either from those pharmacies in the area or from those further afield, such that granting the application would not lead to significant benefits based on choice.

7.24

The Committee considered the “specific needs” that were “difficult to access” for those in the population “who share a protected characteristic” (as defined in the Equality Act 2010). The Applicant has in response to parties comments referred the Committee to the CQC Reports which it has provided with its observations. The Applicant states that these reports demonstrate the real risks to health and that its pharmaceutical proposal will benefit all groups within the Equality Act. The Committee was of the view, given its finding regarding choice and access as above, that the Applicant had not demonstrated that those persons sharing a protected characteristic have difficulty in accessing current pharmaceutical services, or that

30 services specific to their needs are not currently being provided by the existing pharmacies and that they would therefore derive significant benefits from the grant of this application 7.25

The Committee noted the Applicant is proposing to join up healthcare services in order to improve local health outcomes. Parties comment that the Applicant’s proposal to work with the GPs at the Medical Centre does not equate to an innovative approach to the delivery of pharmaceutical services and that existing pharmacies already work collaboratively with all the GPs in the wider area and the Committee agrees with this view. The Committee therefore concluded that the granting of this application would not lead to the significant benefits by virtue of innovation.

Regulation 18(2)(b) generally 7.26

The Committee considered the hours which the Applicant is proposing to provide, 8am to 7pm Monday to Friday and 9am to 5pm on Saturday, all of which are core hours totalling 63 hours a week. The Committee noted the Applicant states these hours offer additional better / improved access with the exception of the retail park and supermarket pharmacies. Parties have not disputed this view but claimed that there is a reasonable choice in consideration of opening hours and the location of existing pharmacies. The Committee was of the view that the Applicant had not demonstrated that pharmaceutical services are not currently provided at such times as needed and therefore the granting of this application would not lead to a significant benefit in relation to opening hours.

7.27

The Committee noted the information provided by the Applicant regarding the deprivation of the area and the reports which the Applicant uses to demonstrate the need to improve health outcomes in the area. The Committee noted that Boots had provided alternative information which the Applicant had disputed, however the Committee was of the view that the Applicant had not demonstrated that the granting of this application would lead to a significant benefit in relation to deprivation.

7.28

The Committee noted the Applicant has provided a Neighbourhood Plan 2014 to 2026 which shows the policy to provide local housing. The Committee noted that over the lifetime of the Neighbourhood Plan, 585 new homes will be built in the area. The Committee concluded that it had no information to demonstrate that existing pharmacies are unable to cope with demand either now or in the future.

7.29

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 7.30

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

7.31

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

7.32

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

7.33

The Committee was not satisfied that the information provided demonstrates that there is difficulty in accessing current pharmaceutical services such that a pharmacy at the proposed site would provide better access to pharmaceutical services.

7.34

In those circumstances, the Committee determined that the decision of NHS England must be quashed.

31

8

7.35

The Committee went on to consider whether there should be a further notification to the parties to allow them to make further representations (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.

7.36

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, that parties had been made aware of the amendments to the 2013 Regulations and had been given the opportunity to comment upon them.

7.37

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

DECISION 8.1

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

8.2

The Committee determined that the application should be refused on the following basis: 8.2.1

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

8.2.2

The Committee has also considered whether the granting of the application would confer significant benefits and has had regard to the fact that – 8.2.2.1 there is already a reasonable choice with regard to obtaining pharmaceutical services, 8.2.2.2 there is no evidence of people sharing a protected characteristic having difficulty in accessing pharmaceutical services, and 8.2.2.3 there is no evidence that innovative approaches would be taken with regard to the delivery of pharmaceutical services;

8.2.3

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

Alison McCafferty FHSAU Case Manager A copy of this decision is being sent to: Rushport Advisory LLP NHS England, Birmingham, Solihull and the Black County Area Team Synchem Chem Ltd t/a Falling Park Pharmacy Boots UK Ltd Brooklands Pharmacy Lloyds Pharmacy

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