Primary Care Respiratory Society Strategic Review

Contents Introduction

Purpose of the review 2 Current strategic framework 2

Situational AnalysisPart 1 - External review 4

Section 1 Societal trends 41.1 Political 41.2 Economic 41.3 Socio Cultural 41.4 Technology 5

Section 2: NHS Environment 62.1 Introduction 62.2 The drive for transformation & sustainability – new models of care 72.3 Primary care organisations & their place in the system 92.4 Primary care workforce & education 132.5 Impact of Brexit 172.6 Patient activation 172.7 Respiratory disease status in the NHS 192.8 Private provision of healthcare 222.9 Sources 24

Appendix 1 Visualisation of evolving NHS structures 27

Section 3: Disease understanding 28A. Overview

3.1 Airway Disease update 283.2 The problem of non-compliance 293.3 Greener Respiratory Healthcare 29

B. Some other potentially significant thinking/considerations 31C. New medicines & Value-Based Healthcare 31

Section 4: Funding review 324.1 Overview 324.2 Pharmaceutical industry funding 33

For internal review and Competitor / Stakeholder analysis, please see separate document: situational analysis part 2_3.

1

Introduction 1. Purpose of the review The last strategic review was conducted in February 2015 and we are now three years into the implementation of the direction and plan agreed at that time. The PCRS executive and trustees have therefore agreed that it is timely to conduct a further strategic review.

The purpose of the new strategic review is to;

Reach a shared view on how the changing world is/will impact healthcare, in particular for people with respiratory disease, in the next 2-5 years

Identify the opportunities for PCRS to embed itself in the future and the threats it may face in doing that

Evaluate the different strategic options that PCRS could pursue that will enable it to have the biggest impact and make the greatest difference to people with respiratory conditions and healthcare, in a way that;

o brings value to members, o is aligned with health service changes o is financially sustainable

2. Current strategic framework The objects of PCRS as a registered Charity currently relate to 'common respiratory conditions found in primary care' and to promoting interest in educating and facilitating research for the benefit of the public,(See www.pcrs-uk.org/sites/pcrs-uk.org/files/files/memorandum_of_assoc_290909.pdf). Formal membership is open to any doctor, nurse or other health professional involved or interested in the management of respiratory disease in primary or community care setting.

The current strategic framework as agreed and articulated in the 2018 business plan is summarised overleaf.

2

Situational analysis

Part 1: External review

3

The PCRS Cause

A collective ambition owned by members for the benefit of every person with or at risk of lung disease:

• To be the respiratory leader within the lung health community that thinks comprehensively about the whole person and involves them in decision making

• For lung disease to have parity with CV disease and diabetes

• To challenge complacency, where respiratory diagnosis and management is not taken seriously

• That demands professionals are trained to do the job they do

• For the basics, informed by evidence and value, to be done the right way as standard

• To raise the bar and be ‘cutting edge' through a passion for excellence and improvement

• That prioritises respect, inclusivity, joy and camaraderie - bringing people together / providing the catalyst for change

Supporting high value patient centred (‘optimal’) care available to all people with lung disease now and in the future

Achieved By;

• Campaigning to influence policy and set standards in respiratory medicine, relevant to populations nationally and locally.

• Educating health professionals working in primary and community settings to deliver and influence out of hospital respiratory care through open access to succinct best practice, evidence based clinical guidance and resources.

• Promoting and disseminating real life respiratory research relevant to population health needs that supports policy and education activities.

• Describing how to deliver value based healthcare that provides a better patient experience, is clinically effective and safe and supports service development and redesign

Supported by:

• A committed and engaged multi-disciplinary membership of respiratory interested generalist and respiratory specialist health professionals working in primary or community settings, providing our unique respiratory expertise

• Strategic partnerships allowing us to reach out to wider audiences ◦ The wider generalist primary care professional audience

◦ Those responsible for commissioning and providing respiratory services

◦ A global audience of academic researchers

The aim of the external review is to help bring the PCRS Executive and trustees to a shared understanding of the external environment in which PCRS operates such that the most significant opportunities and threats facing PCRS can be identified. The review considers topline trends in society and some thinking on the respiratory disease background as well as a more detailed review of the NHS environment. A summary of the funding environment is included for completion. Some background information has been provided where it was felt necessary / appropriate for a common understanding but overall a high level of knowledge is assumed and the review focuses only on those areas of change that the authors see as most relevant to PCRS.

The review is focussed primarily on the NHS in England; whilst the specific incentives / delivery mechanisms are specific to England. Our understanding is that the same demographic / workforce pressures exist in Scotland and presumably also Wales / N Ireland.

Section 1 Societal trendsThis section provides a very topline ‘analysis of the political, economic, socio-cultural and technological factors’ (PEST analysis) that could impact respiratory care and PCRS.

It’s been drawn together by Anne Smith and is only intended as a very topline set of points to stimulate thinking and that that the executive/trustees may wish to consider in the course of the strategic review.

1.1 Political Impact of Brexit – good or bad for the person with respiratory conditions? (See further points in

sections below) Privatisation as the ‘right wing’ solutions to healthcare and what it will mean for models of

healthcare delivery and traditional primary care/general practice. Risk of NHS being left for the complex/difficult /’sink’ patients with the rest being ‘cherry picked’? (See also section 2)

Expectation that people take more responsibility for their own health (e.g. life style choices, self- management of diseases) (See also 1.4 technology)

1.2 Economic Impact of Brexit will almost inevitably be a downturn in the economy threatening funding for the

NHS and increasing health inequities Impact on Brexit/future trade agreements on pharmaceutical industry (see funding section Funding model for the NHS (and social care) that is recognised as unsustainable(given demand -see

below) but little beyond hypotheses as to how it is solved Emergence of London as a ‘super city’ with a growing economic gap to the rest of the UK - impact

on funding/models of healthcare?

1.3 Socio Cultural Workforce - see also NHS section, 2.4

Impact of Brexit/immigration policy on future NHS & social care workforce (see NHS section, 2.5) Trend to ‘multiple careers over the course of one’s working life, ‘portfolio careers ‘, as well as part

time & flexible working potentially reinforces disruption/disintegration of traditional general practice but opens up opportunities with respect to available time members (clinicians & others) to play an active role in PCRS.

Demographics

4

Trend in aging population and number of older people (in particular 75+ years group) living with complex multiple morbidities and impact on health and social care demand

Number of ‘retired ‘people outnumbering number of those in work – economic impact; impact on health & social care demand/funding?

Impact of Brexit/immigration policies on ethnic diversity /healthcare need of UK population?

Digital revolution

Digital technology has and will continue to transform: o Scope to build virtual communities/networks of practice o Methods of communication and ability to reach and engage with large numbers of

individualso Ability to understand and learn about users/potential users of services through collection

and analysis of data (see internal review section 6.2).

Environment

Increased recognition and concern across Society about the sustainability and addressing the carbon footprint

o General issues related to waste in healthcare; escalated by concerns re infection o Issues specific to respiratory include use of propellants in inhalers

Antibiotic resistant - to what extent will this impact our ability to treat infection in the next five years?

o Is infection/appropriate use of antibiotics something that we should pay greater attention to from a respiratory point of view (albeit recognising that the use of antibiotics in humans is relatively tiny compared to use in animals and crops).

1.4 Technology

Artificial intelligence (AI)

How quickly will AI be applied to respiratory medicine: given the unique ability of AI to analyse data /see patterns?

o How readily for example could it be applied to spirometry interpretation? o Opportunities for supported self-management; are there means (e.g. peak flow monitoring)

whereby patient can collect data/monitor own condition and be given advice/direction (as per type 1 diabetes/artificial pancreas technology)?

For more information on how AI is transforming healthcare see: https://www.pwc.com/gx/en/industries/healthcare/publications/ai-robotics-new-health/transforming-healthcare.html

And for a quick digest of what clinicians need to be doing, hot off the press see: https://www.rcplondon.ac.uk/news/ai-nhs-how-should-physicians-respond

Automation (+/- AI)

What processes in respiratory care could be automated and hence have potential to be performed by robots – could certain elements of for example diagnostics be undertaken by trained robots (e.g. performing spirometry, co testing or FeNO testing?)

Digital

Impact on patient care

5

o Asthma e.g. development/use of Apps? o In COPD as a chronic deteriorating condition (e.g. Apps for both patient and carers)? o Quicker diagnostic results available from new devices

Telehealth – e.g. automated alerts/feedback helping to keep people out of hospital? Chat bots – role in supporting consultations; evidence from mental health that patients can be

more open talking to a chat bot than a health professional Genetics/disease understanding: Understanding of the human genome and microbiome (see

section 3, part A) has developed exponentially and potentially changes how diseases are thought of and treated?

o In the case of respiratory diseases, how long will disease labels such as asthma/COPD remain relevant – or will the concepts of treatable traits become the established approach (see section 3, part B)

o To what extent will identification of genetic phenotypes opening up opportunity for targeted therapies/personalised care?

Our expectation is that any impact for respiratory within the next 5 years+ will be limited to a very small number of patients (see section 3 part C) and will not impact the vast majority of routine on-going care.

Section 2. NHS ENVIRONMENT The section on the NHS environment has been updated by Bronwen Thompson, based on published documents (see list of sources, section 2.9), and a one hour interview with Professor Mike Morgan (National clinical director for respiratory). A visualisation of the evolving NHS structures can be found in the appendix to section 2 (p X). The King’s fund also provide good information on how the NHS in England works including an excellent animation see https://www.kingsfund.org.uk/audio-video/how-does-nhs-in-england-work

2.1 Introduction Having been set up in 1948 for the needs of the UK population at the time, the NHS has been struggling with how to stay true to its founding principles while meeting the healthcare needs of the people 70 years later. Changing disease patterns, longer life expectancy, multimorbidity, new technology and an increasingly demanding public are all important factors in determining the kinds of change that need to take place. Importantly, all these factors place enormous pressure on the cost of providing healthcare, and it is now recognised that efforts to make savings through efficiency measures alone will not be enough to plug the funding gap.

Changing the way the NHS works to make it fit to meet current healthcare challenges is no mean feat, and has to happen in the midst of a funding crisis and staffing and capacity issues across the system. While the rhetoric is that more care needs to take place closer to the patient and outside hospitals, creating that shift within current systems, skills and structures is proving difficult, and the Five Year Forward View (FYFV) was a 5 year strategy (2014) that put forward proposals for a managed transition to new models of care. These were expected to have a significant impact on primary care and general practice, where is it was acknowledged that important changes need to take place. General practice continues to feature as a key area of focus, but more as an element within a range of models of integrated care, than that the solution to the NHS challenges themselves lie in primary care.

A key judgment underpinning the review is on the pace and certainty of change. The issues to be addressed and the overall direction have not changed in the last 20+ years. Whilst much uncertainty exists, the drivers

6

for change in terms of increased/changing demand and financial crisis have reached a new level. The strength of the current NHS leadership (Simon Stevens) is also seen by many as a significant force that is unlikely to be deterred by, for example, a change of government.

2.2 The drive for transformation and sustainability – new models of care The Five Year Forward View (FYFV) heralded new ways of working in recognition of the fact that the healthcare challenges faced by the NHS required it to undergo significant reconfiguration if it is to be sustainable in future. Multi-specialty Community Providers (MCPs) and Primary and Acute Care systems PACs) are being trialled and tracked. Vanguards were set up to pilot new collaborative approaches to healthcare and think tanks were commissioned to support them and evaluate their impact.

Meanwhile, the whole debate about the ideal population size on which to plan and deliver services came to the fore as current structures - CCGs, Trusts and primary care - were gathered under the auspices of 44 Sustainability and Transformation Partnership (STP) footprints across England. The intention was to see different sectors collaborate, not compete, in planning and providing the services their population need. The NHS needs to break down barriers between services and to work differently by providing more care in people’s homes and the community. Breaking down barriers means co-ordinating the work of general practices, community services and hospitals to meet the needs of people requiring care. This is particularly important for the growing numbers of people with several long term medical conditions who receive care and support from a variety of health and social care staff.

The next steps then created confusion and anxiety. Concepts borrowed from the USA were introduced with insufficient explanation about how they related to existing structures in the NHS – and also stimulated concern about a wider role for the private sector. While STPs were only just getting underway, the terms Accountable care organisations (ACOs) and Accountable care systems (ACSs) appeared. A report from the Health and Care Committee in June 2018 summarised the situation nicely:

‘We support the move away from a competitive landscape of autonomous providers towards more integrated, collaborative and placed-based care. However, understanding of these changes has been hampered by poor communication and a confusing acronym spaghetti of changing titles and terminology, poorly understood even by those working within the system.’

Hot on the heels of this ‘acronym spaghetti’ came the announcement that the favoured terminology was to be Integrated Care Systems (ICSs) or Integrated Care Partnerships (ICPs). In essence, there is a consistent theme – that different parts of the health and social care system and local government and independent and third sectors should work together to develop preventative and care approaches by working across their traditional boundaries. This may be achieved in a loose, collaborative way, by more formally sharing budgets to deliver their services, or by forming organisations with a single budget. Different parts of the country are exploring different models and it is likely that several models will emerge as viable ways of achieving improved healthcare. Whatever the model, it seems that the principle of integrated delivery of healthcare and the language of ‘Integrated Care Partnerships/Systems’ signal the direction of travel. In the update to the FYFV in 2017, the government talked of ‘using the next several years to make the biggest national move to integrated care of any major western country’.

The first 10 ICS areas* were selected on the basis of the quality of their STPs and an assessment of their ability to work at scale to demonstrate progress in taking forward the ambitions of the FYFV. Updated NHS planning guidance published in February 2018 states that other areas would become integrated care systems where they can demonstrate strong leadership, a track record of delivery, strong financial management, a coherent and defined population, and compelling plans to integrate care. A further four ICS* areas were selected in May 2018.

7

*1st wave: South Yorkshire and Bassetlaw; Frimley Health and Care; Dorset; Befordshire, Luton and Milton Keynes; Nottinghamshire; Lancashire and South Cumbria; Berkshire West; Buckinghamshire; Greater Manchester (devolution deal); Surrey Heartlands (devolution deal)

*2nd wave; Gloucestershire; West Yorkshire and Harrogate; Suffolk and North East Essex; North Cumbria;

The concept of the ACO is not yet dead, and a proposed ACO contract has been designed to enable a contract with a single organisation for the majority of health and care services and for population health. It is acknowledged that this could take several years to come to fruition. The Kings Fund view is that the principal rationale for making the ACO contract available appears to be to enable GPs to lead the development of integrated care, building on the work of MCPs. One version of the contract would allow core funding for general practices to be included in the budgets controlled by ACOs, though GPs may be reluctant to put their own income at risk in this way. The contract could also be used to commission services from ICPs developed through the PACS programme if commissioners and providers decide that a single contract would be preferable to using different contracts to integrate care.

This illustrates the variety of ways in which different parts of the country are free to explore different models of integrated care, based on the vanguard projects which were heralded by the FYFV, but evolving at a local level into trial initiatives which may all look very different from each other. The concept of a ‘National’ Health Service is becoming increasingly diversified, as different areas create different expressions of integrated working.

What is becoming clear is that whether by design or default, the well-established NHS ‘market’ with a purchaser and provider split, is being eroded in favour of a more collaborative approach to plan services for a population. We may see longer term, outcome based contracts, and population based budgets, and the role of commissioner may focus more on developing integrated services and on holding providers to account. What is less clear is whether the focus on more integrated approaches will actually cost the NHS less – though certainly there should be more flexibility at local level to move money around the system. This is being echoed at the centre, where NHS England and NHS Improvement are working increasingly closely and looking at how to get rid of the barriers to integrated care, which Lansley’s reforms introduced in 2012-13.

New models of care: key points

The principles of the FYFV are still relevant now – four years on, and are being played out in a wide variety of pilots

Integration of planning and care is seen as the way forward to address the challenges the NHS is facing

Different models of integrated care are being piloted and it is likely that several models will emerge, not just one

The purchaser/provider split is being eroded in favour of an integrated and collaborative approach to planning and providing services

8

2.3 Primary care organisations and their place in the systemIn 2015, it seemed that the principle of a list based primary care service was still central, although new models of care were being promoted which would integrate primary care within those models. There is still considerable interest in how general practice can evolve to become more proactive, responsive and holistic in the face of rising pressures on the acute sector and particularly unplanned admissions, and how it can work more seamlessly with social care, mental health services and the acute sector. General practice is seen as the place where preventative approaches, demand management and risk profiling could help to relieve the burden on the acute sector. However, this hope comes at a time when the pressure on primary care has risen to an unprecedented level. Chronic funding shortfalls, acute workforce shortages and massive patient demand have left primary care on its knees. General practice is unlikely to be the knight in shining armour that is going to rescue the health service from its woes.

In 2016, NHS England published the General Practice Forward View, to set out the part general practice would play in the way forward set out in FYFV. This identified the specific challenges general practice was facing and committed support in areas such as funding, IT, infrastructure, workload and workforce. In April 2018, they published an update on progress.

An extra £2.4 billion for general practice is due to be delivered each year by 2020/21 (up from £9.6 billion in 2015/16 to £13 billion per annum by 2020/21) This represents a 14% real terms increase for general practice, against 8% for the rest of the NHS. There is faster than expected progress on extending practice hours into weekends and evenings (one of the target areas for investment), so that more than half of the country now has extended hours access.

2.3.1 General practice working collaboratively

The FYFV proposed that most GP surgeries will increasingly work together in primary care networks or hubs. This is because a combined patient population of at least 30,000-50,000 allows practices to share community nursing, mental health, and clinical pharmacy teams, expand diagnostic facilities, and pool responsibility for urgent care and extended access. There are various routes to achieving this that are now in hand covering a majority of practices across England, including clusters, federations, ‘super-surgeries’, primary care homes, ‘Multispecialty community providers’ (MCPs) and Integrated Care Systems/Partnerships (ICS/P).

It is clear that general practices are working more collaboratively with a range of organisations, and this may be one of the most significant changes for primary care over the last 3 years. A survey conducted by Nuffield Health with RCGP in 2017 found that 81% of general practice-based respondents reported that they were part of a formal or informal collaboration, up from 73% in 2015. However, the landscape is complex. Practices often belong to multiple collaborations that operate at different levels in the system, having been set up to fulfil different purposes.

The main priorities of all collaborations over the last year were: increasing access for patients, improving sustainability, and shifting services into the community. Both providers and commissioners reported that time and work pressures were the biggest challenge to collaborations achieving their aims.

When asked about developments in their local area, over half of GP staff and one-third of CCG staff surveyed felt practices and collaborations had not been at all influential in shaping the local sustainability and transformation partnership (STP). Only one-fifth of GPs thought STPs would deliver meaningful change in primary care. CCGs were more optimistic, with 61% reporting that meaningful change was probable. It seems then that many practices have been only on the margins of the significant changes in integrated working and reconfiguration taking place over the last four years.

9

It is interesting that when questioned about future models of care, around half of practice partners (53%) said they would be 'unwilling' or 'very unwilling' to give up their current GMS/PMS/APMS contract to join a new models contract (e.g. MCP or PACS contract). The most common reason they gave was that they did not want to lose control of decision-making and leadership in their practice. Yet The Kings Fund is specific about the pivotal role of clinicians – ‘ We need clinicians to be at the heart of integrated care developments, building on the work of the new care models and recognising that the principal benefits of integrated care result from clinical integration rather than organisational integration.’ Think tanks have repeatedly highlighted the need for innovation in general practice, and the importance of clustering smaller practices into larger groups to achieve economies of scale. For the vision of integrated care to deliver the change the NHS needs, general practice needs to be fully engaged.

Another initiative hosted by the Royal College of General Practitioners (RCGP) and the Nuffield Trust is the ‘GP at Scale’ scheme, which has nearly 1,000 members. It enables regional and national networking and evidence sharing, including developing guidance and resources to help providers working at scale – in networks, federations, multi-site practices, etc. – to create safe and resilient organisations. It is also developing a new evidence base and guidance regarding quality improvement and management of services provided in primary care networks.

The National Association of Primary Care (NAPC) developed a concept which concentrated on providing care for populations of 30,000 to 50,000 patients - the Primary Care Home (PCH) model. Established in 2016, the development of a primary care home is a journey which begins with practices and other first contact care providers coming together, forming relationships and developing a sense of belonging among patients and staff. The model was piloted in 15 rapid test sites, each of which qualified for £40,000 of start-up funding from NHS England. By June 2018, they reported 200 sites covering 9 million patients – 16% of population. In 2017 Nuffield Trust published an independent evaluation of progress. Their key findings were that such collaboration; had forged new relationships, stimulated new services, and focused on some high risk groups; needed significant investment in time, money and support to enable change (more than the £40k); other concurrent changes, e.g. STPs, could help or hinder the PCH Model; good quality data – and the ability to use it – are essential for future evaluations of these models.

General Practice collaborative working: key points

The days of practices working in isolation are numbered, but the traditional model of funding general practice via the GMS contract may prove a stumbling block to more integrated working

Collaboration will take many forms – there is no one size fits all.

2.3.2 Fragmentation of general practice? – Long term, continuity of care vs episodic, rapid access

The last three years have seen the growth of new services to enable patients to have rapid access to a GP via apps, and remote consultations by phone or video link – 24/7. The Uber and Tinder generation use their phones for rapid access to everything, so why not healthcare advice? At a time when some practices are struggling to provide patients with appointments within 3 weeks, others are handing back the keys and contract to CCGs, and others are surviving by appointing staff from other professional groups to replace GPs, it is not surprising that some people will vote with their feet. This is, after all, compatible with patient choice.

10

The most high profile NHS service of this type is ‘GP at hand’ which operates as a partnership between a Fulham GP practice and Babylon which has developed the IT based interface. There have been mixed reactions from within the NHS, with accusations of cherry picking (most patients are under 40), and of lack of clarity that patients would be delisted from their existing GP practice. CCGs have asked who is going to pick up out of hours and home visits for these patients. The Babylon ‘chatbot’ symptom checker has raised concerns amongst safety regulators, after multiple complaints. GP at hand recruited 25,000 patients within 6 months. Their rapid growth has prompted concerns among GPs, regulators and commissioners that the service could destabilise the primary care system by undermining the financial viability of GP practices that are losing patients’ and CCGs struggling with the sudden shift in costs. NHS England blocked GP at Hand’s plan to expand into Manchester and Birmingham in November 2017 amid concerns about the disruption of the existing primary care model. Online/digital services employ GPs of course, which means they are potentially contributing to the erosion of already challenged GP numbers in general practice.

On the other hand, removal of these patients from traditional GP lists could be argued to free up more time so that complex patients with multiple co-morbidities can be seen in their practices more quickly by staff who have known them for many years and have the benefit of in depth knowledge of the patient and their social context. The jury is divided.

There are also private GP services, where patients pay for a consultation with a ‘remote’ GP. In 2017 CQC reported that there were up to 40 online providers of primary care registered with the CQC, and it spoke about the “significant concerns” it had around digital primary care services, with some having failed a CQC inspection for unsafe practices.

However, the majority of patients remain in the mainstream primary care system, registered with a local practice. Patient organisations tell us that patients want coordinated, joined up care. This may particularly be the case for people with long term conditions or complex care needs. Long term relationships and continuity of care in a practice where they know the staff and the staff know them, provides the foundation of care but they may also be drawing on other sources - third sector, peer support, online resources – to help them. This personalised network may be opaque to health and care services and professionals within it. This has important implications for how policymakers and local services think about integration. The NHS version of integrated care, which focuses on structures and organisations, may fall short of delivering what it is that patients want when they describe coordinated, joined up care. The NHS still has a way to go in being genuinely patient centred.

11

Fragmentation of general practice? – Long term, continuity of care vs episodic, rapid access: key points:

The majority of patients are still relying on a traditional model of primary care, but may be more demanding of a range of providers to deliver the coordinated support that they want

Private providers are being brought in under NHS contracts to offer services to give patients more choice and improve efficiency, but there are also services which patients themselves are paying for.

Digital solutions to achieve rapid access to medical help have taken off in the last 3 years NHS still needs to be more patient centred about the support desired by people with complex

needs

2.3.3 Generalism vs specialism

‘Patients want specialism. The system needs generalism’, says Professor Mike Morgan, National clinical director for respiratory. The debate about the relative merits of these approaches is a long running one. In hospitals, general physicians have all but disappeared – apart from geriatricians and paediatricians. And there are more hospital specialists employed than 5 years ago. But as technology moves on, and our understanding of disease increases, it could be argued that even greater specialism is needed. The National COPD audit repeatedly calls for greater specialist involvement in acute episodes of COPD because outcomes are improved when patients see someone who has specialist training, whether a nurse or doctor. If asthma is being redefined as a cluster of treatable traits, and GOLD guidelines identify different types of COPD and therefore different pathways, then having access to more precise diagnostic techniques, and a more specialist approach to treatment may be called for.

And what is the place of specialism, when people live long enough to collect a handful of comorbidities along the way – and need to be treated by people who understand the unique health burden that they are living with as individuals? Should GPs become recognised as the ‘specialist generalists’ who can coordinate access to specialists and super-specialists as required but continue to be the first point of contact on a day to day basis? Perhaps general practice needs to position itself as the service which investigates symptoms systematically – ie breathlessness and cough in the case of lung disease, and proceeds to diagnosis, or refers. Mike points out that there is no shortage of jobs for respiratory hospital specialists, though there are some skill shortages in areas such as adult cystic fibrosis.

This is an important debate in respiratory disease, where we know that skills to diagnose and manage respiratory disease in the community are not uniformly high, access to timely GP appointments in the interests of continuity can be very difficult to achieve due to capacity pressures in primary care, and specialist services are a finite resource and should be used appropriately in order not to be overwhelmed.

The growth in numbers of integrated respiratory consultants may prove to be one of the more important legacies of the regional respiratory programme led by Department of Health between 2010 and 2013. Certainly the last few years has seen greater involvement of these roles in PCRS and has been a real bonus in bringing a different perspective into our committees and work. This brings specialism into the community and broadens the scope of influence of specialists - to educate, to follow up patients, to raise the overall standards of care of respiratory disease.

12

Generalism v’s specialism Key points

The NHS needs both generalists and specialists, but deciding how they work together and where they are placed in a system where integrated care is the buzz word, is not yet clear, and may look different in different places.

2.4 Primary care workforce and education

While the number of GPs has been falling over the last few years, the overall number of staff working in general practice has increased, as more roles are being introduced into the primary care team. As at end of March 2018, provisional data indicates that 92,759 full time equivalent (FTE) non-GP health professionals were working in general practice, an increase of 4,484 from September 2015, against a target of 5,000 by September 2020.

In 2017, NHS and Public Health England jointly published a draft strategy for the workforce to 2027 – the first for 25 years. This sets out the challenges and some of the solutions that a range of organisations are working towards.

2.4.1 Practice nurses

A series of initiatives in the last few years have addressed the important role of practice nurses. £15 million was earmarked to develop practice nursing in 2017. A focus on the changes required to improve recruitment and retention, and encourage the return of nurses to general practice came in 2017 with the publication of a Ten point action plan for general practice from NHSE/Health Education England (HEE).(‘General practice: developing confidence capability and capacity‘). This followed the pledge in the GP Forward View of a major expansion of the primary care workforce including nurses in general practice and HEE’s March 2017 publication ‘General Practice Nursing Workforce Development Plan – Recognise, Rethink and Reform’. This included a series of recommendations for organisations that can influence the general practice nursing workforce. Key report recommendations include: raising the profile of general practice nursing, to increase the uptake of the role as a first-destination career; improving training capacity for the general practice nurse workforce by providing access to accredited training; increasing the number of pre-registration nurse clinical placements in general practice; offer of a specific general practice ‘return to practice’ programme; developing PN educator and leadership roles and develop mentorship programmes.

The reason for this flurry of activity on practice nurses is that numbers are projected to fall at a time when the NHS needs numbers to increase. HEE data in 2017 showed that under 3% of PNs are under 30, 9% are

13

under 35 and 31% are age 55 and over. A survey of 3,426 registered nurses working in general practice by the Queens Nursing Institute (2016) and corroborated by Ipsos MORI research (2017) revealed that a third expressed an intention to retire by 2020. If this figure is extrapolated to the 23,100 headcount of GPNs nationally (NHS Digital, Sept 2016) it would imply that over 8,000 may leave the workforce in the next three years.

2.4.2 GPs

Jeremy Hunt’s pledge of 5000 more GPs by 2020 is now acknowledged to be an unreachable goal. Provisional data indicates a decrease of 1,018 FTE GPs since September 2015 against a target of an additional 5,000 FTE by September 2020. There are now fewer GPs than there were two years ago, with many GPs retiring or leaving the profession early. In September 2017, NHS Digital reported that the headcount number of GPs had fallen below 2012 levels. This is causing considerable concern, and strategies to address this issue include retaining more of the existing GPs; training and recruiting more; and providing better support for GPs to return to practice.

The RCGP has warned of burnout – ‘20% of GPs are now working intensively for more than 60 hours a week’ – and acknowledges that to retain existing GPs and encourage others return to practice, workload and stress levels in general practice must be tackled. And while they want to see the additional £2.4 bn a year delivered to primary care, it is still hard to see how the GP gap is going to be plugged. Health Education England (HEE) has been working on a range of incentives to get trainee doctors to choose general practice as their workplace of choice.

Surveys of GP morale tell us what we already know – that the pressure is unprecedented. Although overall job satisfaction has increased slightly between 2015 and 2017, the levels of satisfaction in 2015 were the lowest since 2001. In terms of the overall series, satisfaction with aspects of the job, such as remuneration, hours of work and amount of responsibility given, are lower than in the surveys undertaken before the introduction of the new GP contract in 2004.

Respondents reported most stress with ‘increasing workloads’, ‘having insufficient time to do the job justice’, ‘paperwork’ and ‘changes to meet requirements from external bodies’. They reported least stress with ‘finding a locum’, ‘interruptions by emergency calls during surgery’ and ‘adverse publicity by the media’.

More than nine out of 10 GPs reported experiencing considerable or high pressure from ‘increasing workloads’. Particularly high average levels of pressure are reported in ‘having insufficient time to do the job justice’, ‘increasing workloads’, ‘paperwork’ and ‘increased demand from patients’.

HEE’s Primary Care Workforce Commission identified that a flexible multidisciplinary team, led by a GP and supported by technology delivers the best primary care. HEE has established Community Education Provider Networks (CEPNs) to deliver MDT training and support local recruitment, retention and return to practice programmes. All practices should now have access to a local CEPN.

Looking ahead to projections of future numbers of GPs is a bleak exercise. A survey by the University of Manchester, found that the number of GPs who say they are likely to quit direct patient care within five years rose to 39% in 2017 from 35% in 2015. Most worryingly, 13% of GPs aged under 50 years indicated that there was a considerable or high likelihood of leaving direct patient care within five years. Amongst those aged 50 years or over, the corresponding figure was 62%, and the vast majority of these indicated that the likelihood of this happening was high. In Helen Lampard’s words, "It's incredibly worrying to hear that so many GPs are thinking about leaving the profession within the next five years, but it certainly isn't

14

surprising, given the intense pressures family doctors are facing – something about which the College has long been raising concerns.’

Given the central role that primary care is expected to play in integrated care, the dearth of GPs looks like being a rate limiting factor. The development of the GP role into GP extensivists does not appear to have progressed much beyond a few pilot initiatives. GPs have their hands full with mainstream routine general practice and redirecting their efforts towards in-reach and proactive patient management may appear effective in theory but it is hard to see them becoming widespread while general practice is under such pressure.

Other professional groups

Practice based pharmacists

Over 720 (FTE) GP practice based clinical pharmacists were actively working in general practice (as at March 2018), an increase of over 550 since September 2015. It is anticipated that 1,200 FTE clinical pharmacists across over 3,000 practices and benefitting 34 million patients, will be in place by summer 2018 - with more planned as we move towards the target of 2,000 clinical pharmacists in post by 2020/21.

GP practice-based clinical pharmacists work as part of the general practice team to improve value and help patients get the best outcomes from their medicines. This includes providing extra help to manage long-term conditions, advice for those on multiple medicines and better access to health checks. It improves patient safety and frees up more time for GPs, with one practice alone saving 80 hours of GP time per fortnight. The NHS is on track to spend the £112m in full, with a second wave not far behind.

We know of several of these within PCRS.

2.4.3 Physician associates

This group of healthcare practitioners has become better well established in the last few years, and is now supported by a Faculty within RCP.

Physician associates (PAs) can be found working in GP surgeries, accident and emergency departments, and inpatient medical and surgical wards throughout the UK. While a relatively new member of the clinical team, they are seen as complementary to GPs rather than a substitute. They can fulfil an enabling role in general practice, taking on certain areas of workload, helping to free GPs to focus on the more complex patient cases as well as other staff, such as nurses so they can focus on their areas of competency. This means that GPs can continue to lead multi-disciplinary teams to adapt to the evolving healthcare needs of patients in response to the growing and ageing population. This does not overcome the need to address the shortage of GPs or reduce the need for other practice staff. Instead PAs can help to broaden the capacity of the GP role and skill mix within the practice team to deliver patient care.

Physician associates work within a defined scope of practice and limits of competence. They:

take medical histories from patients carry out physical examinations see patients with undifferentiated diagnoses see patients with long-term chronic conditions formulate differential diagnoses and management plans perform diagnostic and therapeutic procedures develop and deliver appropriate treatment and management plans request and interpret diagnostic studies provide health promotion and disease prevention advice for patients

15

It is not clear how many are currently working in primary care, nor are we aware of any members who are Physician Associates. However it is clear that they could be involved in the care of respiratory disease and make a contribution to the work currently being undertaken by GPs and PNs.

2.4.4 Physiotherapists

There is no doubt that a multidisciplinary approach to the management of respiratory conditions is becoming more widespread. Respiratory physiotherapists are one of the professional groups which is being increasingly recognised for the value it can bring to respiratory management, and their role has been developing from one traditionally limited to tasks such as sputum clearance to areas including pulmonary rehabilitation and supervision of non-invasive ventilation.

Physiotherapy services can be used at all ages and at all stages of disease, from early diagnosis, through chronic illness, to acute episodes and care at the terminal stage. As such, physiotherapists have a clear and specific role in most clinical care pathways. The physiotherapist’s role in patient care includes assessment, advice, education and hands-on intervention. Exercise equipment has long been used in pulmonary rehabilitation programmes; however, physiotherapists may also use supplementary oxygen, noninvasive mechanical ventilation, complex training modalities or neuromuscular electrical stimulation to enhance the effectiveness of exercise training in respiratory patients.

The role of physiotherapists is widening as health services place a greater emphasis on chronic disease management and the maintenance of patient independence and function: where appropriate, patients are increasingly managed in the primary care setting, with the advent of domiciliary and hospital-at-home services. We are seeing respiratory physiotherapists as one of the groups championing more integrated ways of working for people with multiple morbidities as their generic training makes them suitable to lead services which bridge disciplines such as cardiology and respiratory. So we see joint cardio-pulmonary

16

rehabilitation services led by physios, for example. Like their colleagues in other professions, physiotherapists should have greater involvement in tackling unhealthy behaviour (smoking, inactivity) in all aspects of healthcare.

Within PCRS we have seen respiratory physios having greater prominence, taking on committee roles and attending the Respiratory leaders’ programme.

Primary Care Workforce and education; key points

Primary care/general practice will see a wider range of healthcare professionals working together to deliver care. The traditional roles of GP and practice nurse as the primary people delivering care in general practice will give way to a more flexible multidisciplinary approach.

This is an area in flux and will need monitoring as creative ways are developed to overcome the shortage of GPs and practice nurses.

Since the move from PCTs to CCGs in 2013 many GPs have spent time working at CCG level alongside their clinical role, which has been part of a more general move towards more flexible working patterns and ‘portfolio careers’ and away from the traditional pattern of junior full-time GP partner, moving towards senior partner across a 40 year career.

2.5 Impact of Brexit

The most significant impact of Brexit for healthcare may be that it is taking up so much government time that getting the legislative changes for healthcare onto the agenda is not happening any time soon. This may ultimately be a huge benefit to getting organisations to work together collaboratively within existing organisational structures, rather than bringing in the legal framework to reorganise and e.g. to allow STPs to become statutory bodies and hold budget. We know that the last thing the NHS needs is more structural reconfiguration. The legislative impasse creates the opportunity for the behavioural change that needs to happen within existing structures.

2.6 Patient activation

Helping patients and carers to be more active in managing their own health issues may actually relieve some of the burden on the NHS, but will require a significant shift in mind-set in how most healthcare

17

professionals perceive their role and will also require them to learn different skills from those on which their initial training concentrated.

The NHS FYFV set out a central ambition for the NHS to become better at helping people to manage their own health. To meet this commitment, NHS England is making supported self-care a key part of personalising care. NHS Digital is supporting the use and design of technology to allow self-care and self-management for patients in primary care. This involves scaling up support for people living with LTCs to manage and make decisions about their own health and wellbeing. Patient activation is a core enabler for this programme.

The concept of a Patient Activation Measure (PAM) is increasingly talked about. This assessment helps support next steps on what would be needed to increase their levels of knowledge, skills and confidence in order to improve their health and wellbeing outcomes. It can be used to tailor interventions to individual needs, significantly increasing the likelihood that people will adopt behaviours that contribute to better health. It can also help commissioners to make available the kinds of interventions needed, especially for those with low levels of activation who have most to gain.

National Voices reports that although the rhetoric is that patient activation is important, there is no consistent way to measure patient centred care in practice, or whether the NHS is indeed taking seriously its claims that greater engagement of and support for patients in managing their own health are key to the future of health in the UK. While there have been advances towards people being involved in decisions and being in control of their lives and their care, especially for specific groups, in mainstream healthcare and some residential settings, the findings are worse. Despite it being central to person-centred care, evidence about the extent and quality of personalised care planning is very patchy, but suggests that in most mainstream NHS settings — and in some residential care — it is largely absent. Neither the NHS nor adult social care can demonstrate, from people’s reports of their experience, that they are coordinating care around the person. Family involvement appears to remain marginal to the practice and measurement of person-centred care. Some carers have received additional help, but the majority are not getting support for their own needs. National Voices concludes that it is time for a strategic review and overhaul of person-centred care measures across health and care, based on common outcomes, for the era of integrated and accountable care systems.

As we have seen with Babylon/GP at home, digital solutions to accessing care are having some traction with some parts of society. NHS digital is working with general practice to offer patients better self-care through online services, rather than having to visit to their GP. Whether accessing online information or using apps targeted at specific patient groups, this will be a growing sector of the healthcare ‘market’, particularly if access to primary care continues to be inconvenient for many patients. A report by Asthma UK found that patients were open to their health data being available to healthcare organisations if it enabled better targeting of care to their needs. Over 90% of people with asthma would welcome the use of data collected through apps to tell healthcare professionals when their asthma needs to be reviewed.

In respiratory, an online support tool MyCOPD has met with variable response amongst healthcare professionals. If CCGs perceive it as a replacement intervention for pulmonary rehabilitation – based on cost, there is an understandably negative reaction from respiratory interested clinicians. On the other hand, if it helps towards patient activation, and if remote monitoring of patients is possible, then the response is more positive. In broad terms, a service like this needs an evidence base to support its widespread adoption, and to date it seems that this has been lacking.

18

What is not clear is what demands these evolutions in technology will place on healthcare professionals, and how they will incorporate these independently accessed sources of support and information into a holistic provision of care. There will be an increasing need for ‘technological literacy’ alongside compassionate caring on the part of healthcare professionals.

Health professionals for a new century Lancet 2010

Patient activation; key points

Digital and online technology and resources coupled with increasingly pressurised primary care services are likely to create a climate where there is increasing reliance on non- traditional services.

These may be part of NHS services or may be paid for by the patient. Whether hard pressed clinical staff will have time to invest in supporting patients in self-

management remains to be seen.

2.7 Respiratory disease status in the NHS We should recognise that respiratory disease has better outcomes and interventions that it did 20 years ago. A great deal has been achieved: fall in asthma mortality, better access to treatments for COPD – pulmonary rehab and oxygen, case finding in COPD and lung health screening programmes (Manchester).

Lack of priority for respiratory disease at national level has been a source of frustration for the respiratory community for some time. While the DH national programme for respiratory disease looked strong for 3-4 years from 2009, the effective disappearance of the Outcomes framework for COPD and asthma shortly after it appeared in 2012 has led to a sense of resignation and disappointment that a lot of good work has come to nothing. Cancer, CHD and mental health have had the limelight for many years, and it is heartening to see that this prolonged focus has delivered improvements in mortality and treatment.

In 2017, the report on achievement of reductions in mortality under 75 indicated that under 75 mortality had not improved in the previous 12 months. The updated table for 2018 showed that only 2 disease areas had deteriorating mortality over a 5 year period. Respiratory and serious mental illness in adults.

19

This has not gone un-noticed at NHS England. Mike Morgan feels more optimistic about respiratory disease being recognised as a major area for improvement than at any point in the last 5 years. These national level data on mortality have received further scrutiny and it seems that deprivation is coming through as a significant contributor to a failure to improve mortality.

If respiratory disease does indeed get onto the national agenda, it is likely that inequalities will be a major focus. The importance of deprivation was borne out by the first National COPD audit in primary care, which

20

indicated that the 10% most deprived patients were 27% less likely to have received a flu vaccination, and 7% less likely to have an MRC score recorded in the previous 12 months, than the 50% least deprived.

It is recognised that respiratory infection contributed significantly to winter pressures in 2017/18, and RightCare has developed a pack for the North of England to take pre-emptive action on respiratory health this year to avoid a repeat situation.

So while NHSE’s stated intentions are to maintain a focus on transformation and sustainability, and to pursue models of integrated care in order to deliver the FYFV, we may well see respiratory disease becoming more prominent in the coming months and years. Though the National Screening Committee has reviewed the suitability of COPD for a national screening programme, it is unlikely to be successful as the determinants of COPD are not clinically treatable (compared e.g. with breast, cervical or bowel cancer).

At a local level, respiratory disease is on the agendas of some CCGs, particularly where respiratory disease is responsible for high levels of admissions. However, asthma, though a very prevalent condition, features rarely as a priority at a local level albeit NRAD has stirred the water a bit in recent years. Some STPs are focusing on aspects of respiratory disease and this is likely to be continued into integrated care systems/partnerships. However, there are still significant blind spots and disconnects within the system which need addressing if respiratory disease is actually going to see improved outcomes: lack of focus on treating tobacco dependency and ensuring all patients have access to trained staff to support them; the spirometry circus – where a National Scrutiny Board lacks the legitimacy and authority to oversee a non-mandatory National register, and the BMA has put the cat amongst the pigeons by highlighting that spirometry is optional within the GMS contract, and it is unclear which part of the system is responsible for the cost of training and certification; lack of joining up primary and secondary care for timely follow up after exacerbations of respiratory conditions; inadequate focus on supported self-management.

The NICE guideline for COPD is undergoing an update (due November 2018), having become very out of date, which has meant many UK healthcare professionals turning to the International GOLD strategy as the most up to date source of guidance. Guidance on asthma care is now available from a range of sources (BTS/SIGN, NICE, GINA) and where they differ on key points, PCRS has an important role in developing pragmatic guidance for primary care.

The last three years have seen a raft of new pharmacological treatments becoming available – both new compounds and combination inhalers. RightBreathe has become a valued comprehensive reference source of information on inhalers, as it is keeping up with the new inhaled treatments coming on the market, which NICE is not.

The British Lung Foundation has set up the Lung Health Taskforce to prevent more people from developing lung disease, and to transform the care of people living with lung disease. By bringing together the most influential voices in UK lung health they hope to create a new vision for better services for everyone affected by lung disease. PCRS has a seat at the table, and we are supporting their call for evidence about the main areas in which improvements are needed in lung disease. If respiratory disease gets onto the national agenda as a priority area, the taskforce will be in a good position to orchestrate support from the 30 organisations that make up the taskforce.

Respiratory Disease Status in the NHS: key points

Respiratory disease may be on the brink of having a higher profile than recently due to failing to improve mortality in under 75s, and the contribution of respiratory disease to rising acute admissions particularly in winter.

A focus on deprivation may become central to any initiatives to improve outcomes in respiratory disease if it is confirmed that the gap between the most and least deprived is widening.

21

The Lung Health Taskforce could play an important role in uniting the respiratory community to address poor outcomes.

2.8 Private provision of healthcare The Lansley reforms of 2012/13 heightened suspicions that there was a hidden agenda to introduce private providers by stealth into the NHS, as a gradual move towards overall privatisation, due to unsustainability of NHS funding. This has been around for as long as the purchaser/provider split has been in place in England. The fact is that the NHS has been contracting with private organisations for many years. GPs and pharmacists have been private contractors since the NHS began.

There has certainly been an expansion in the role of the private sector since the early 2000s: for example, the use of private sector investment to fund new hospitals (e.g. PFI) and independent treatment centres to reduce waiting times for elective care. More recently, there has been an increase in non-NHS providers of NHS-funded care, with the most significant increase being in community health services. Community health service contracts have gone to a range of providers including charities, social enterprises and community interest companies as well as private companies. We have also seen high profile failures of the private sector – most notably, Circle pulling out of running Hinchingbrooke hospital due to not being able to balance the books within the budget available.

In 2008, Somerset‘s community respiratory services were awarded to Avanaula and Clinovia ltd after a competitive tendering process. This was a high profile move to the private sector for respiratory, and IMPRESS (a collaboration between BTS and PCRS to explore and promote integrated care) published a document outlining the process and issues it raised. The focus of the bid from Avanaula and Clinovia was on admission avoidance rather than rapid discharge, and Somerset PCT deemed it to be the best offer on the table, and gave them the contract.

Fears were heightened again when the language of Accountable care organisations/systems (ACOs/ACSs) started to be used more widely in the last 12-18 months in the context of new models of care and as a development of the pilots introduced by the Five Year Forward View (FYFV). This language is firmly rooted in the US healthcare system, and it has now been recognised that lifting such language and concepts from another healthcare system with inadequate explanation was unhelpful, and simply raised hackles. (The term ‘Integrated care systems’ is now preferred).

However, the NHS did get as far as developing a standard contract for an ACO in 2017. The contract aimed to provide advice and guidance to areas planning to procure integrated care models and the government is consulting on changes to regulations to enable its implementation. The contract is not currently in use (but is being considered by Dudley and City of Manchester) and is likely to be used cautiously when it does become available because of its complexities. It has been pointed out that there is little room to extract profits given the available budgets and so these contracts are unlikely to appeal to the private sector in the way that some fear. NHS Partners Network, a representative of independent sector providers, has indicated that in the current environment it does not expect private providers to take on an ACO contract for a whole system.

However, the appearance of the ACO contract has given rise to two separate legal challenges. One of these questions the legality of ACOs under the Health and Social Care Act 2012 while the other claims that ACOs will lead to increased privatisation. Campaigners have criticised the government and NHS England for lack of transparency in developing their plans and are concerned that NHSE intends to replace multiple smaller NHS contracts with a single long-term lead ACO contractor for each area of England. (Keep our NHS public campaign).

The Kings Fund believes that there is considerable misunderstanding about what is actually happening in the NHS and many of the concerns that exist are misplaced. NHS England needs to do much more to explain

22

what the ACO contract would add to existing ways of integrating care and indeed whether it is needed at all at this stage in the development of integrated care. On balance it would appear that there is less threat of private providers taking over large chunks of NHS work, since the collaborative working models were brought in by the FYFV to break down boundaries between healthcare organisations, that at the time of the Health and Social care Act 2013.

Private provision and general practice

It has been suggested that ACOs may be a threat to GP independence because they would have to relinquish their GMS contracts. The BMA has expressed concerns that it would entail ‘radically altering the current model of general practice and would be incompatible with independent contractor status.’ In fact the NHSE guidance on the draft ACO contract envisages multiple models of GP participation, including a ‘partial integration’ model, where services covered by GMS and PMS contracts are excluded and a ‘virtual integration’ model, where existing commissioning contracts are kept, but bound together.

Technology presents opportunities for innovative, new services to supplement or replace the traditional model of general practice as mentioned earlier. Examples of services provided by private providers under contract to the NHS include:

MyCOPD is a service which CCGs may commission at £20 per patient to provide an online support package for patients. This intervention has not been reviewed by NICE and as there are no RCTs or health economic assessments it is unlikely to be NICE approved for some time. There have been concerns that as one element includes aspects of pulmonary rehabilitation that this could be seen as a replacement for a full pulmonary rehabilitation service.

GP at hand is a controversial on line appointment service provided by Babylon commissioned by the NHS in London which offers an on line appointment within minutes and a face to face appointment within 5 bases across London.

Asthma UK is piloting a 12 week programme (sponsored by Dept health) which identifies and challenges patients’ – those defined as having severe asthma through use of oral steroids or admissions in the last year - beliefs about their asthma and their medicines, improving self-management and adherence. Using emails, texts, and apps, alongside web-based resources, this programme uses digital media to support patients. Patients will leave the programme with new confidence and skills to continue managing their asthma well even after the programme has ended. Similarly,

Online consultations and prescribing is an area where there has been considerable growth in services which bypass the GP surgery where the patient is registered. While ‘patient choice’ may be the driver for the NHS to allow the proliferation of such services – with accompanying economies for the patient on the cost of medicines – CQC inspections have identified some very poor practice with prescription services not operating safely, and thereby putting patients at risk. Their concern has been so great that they issued guidelines in 2017 for people wanting to use online GP and prescribing services. ‘Inspectors found services that were putting patients at risk of harm by selling medicines without doing enough to check they were appropriate.’ The specific issue in respiratory is that there is no opportunity to ensure that the patient receives the inhaler they are familiar with if it is prescribed generically – they could get a different one at the point of online dispensing. And there is no opportunity to check inhaler technique at the point of online prescribing or dispensing.

Private organisations are also providing primary care services. For example, Virgin Care reports having 21 primary care service contracts ranging from urgent care centres, GP out of hours, to GP practices. They are also offering a range of GP services directly to patients: one-off GP consultations for £55; diagnostics; health checks etc.

23

Though it operates out of hospitals, it is worth mentioning that sleep apnoea equipment increasingly provides the opportunity for the data from individual patients to be downloaded each morning for review by the sleep service so that they can make contact with patients who are not getting full benefit from their CPAP equipment. They can even make adjustments to the settings remotely. This is transforming the ability of the sleep service to shorten the time taken to get a patient settled onto CPAP and to respond quickly to the needs of individual patients. The ability to monitor patients remotely could well have value for people with other respiratory conditions through the use of modems to download data from patients’ homes.

Private provision in community services

The Health Foundation highlights that this is an increasingly common area for the NHS contracting with private providers. In 2010/11, data from primary care trust accounts showed that non-NHS providers accounted for 20% of all community care spending. In 2012/13 the figure was 31%. The most recent research from 2017 showed that 47% was provided by non-NHS providers.

A company like BOC has diversified from simply providing oxygen, to providing clinical services such as a community respiratory service, and oxygen assessment and review, or a pulmonary rehabilitation service. Their website lists 13 different contracts for clinical services. A more generic company such as Virgin Care also provides community services – e.g. for children or dermatology as well as comprehensive community services.

Privatisation of healthcare - key points:

Much misunderstanding of the threat – there will continue to be services provided by private organisations, but there is still no talk of changing the funding mechanism so that the NHS is ‘privatised’. Indeed the threat of ‘privatisation’ is less since new models of care were introduced by FYFV

However, there are increasing numbers of services being delivered under contract by non-NHS organisations

Patients may also be receiving advice via apps/online sites to supplement GP services, which they may be funding themselves

Any attempts to have large companies taking over as an ACO in an area are likely to meet with legal challenge.

2.9 Sources: Five year forward view NHS England October 2014 http://www.england.nhs.uk/wp-content/uploads/2014/10/5yfv-web.pdf

Next steps on the NHS 5 year forward view NHS England 2017 https://www.england.nhs.uk/wp-content/uploads/2017/03/NEXT-STEPS-ON-THE-NHS-FIVE-YEAR-FORWARD-VIEW.pdf

GP forward view April 2016 https://www.england.nhs.uk/wp-content/uploads/2016/04/gpfv.pdf

GP forward view update April 2018 https://www.england.nhs.uk/wp-content/uploads/2018/05/general-practice-forward-view-progress-update-april-2018.pdf

GP Forward View two years on: NHS England's assessment. Reported in Pulse - 6 June 2018 http://www.pulsetoday.co.uk/news/hot-topics/general-practice-forward-view/gp-forward-view-two-years-on-nhs-englands-assessment/20036817.article

Integrated care: organisations, partnerships and systems. Report from Health and social care committee 2018 https://publications.parliament.uk/pa/cm201719/cmselect/cmhealth/650/65002.htm

24

https://www.rcplondon.ac.uk/news/rcp-welcomes-health-and-social-care-committees-integrated-care-report

Making Sense of Integrated Care systems Kings fund February 2018 https://www.kingsfund.org.uk/publications/making-sense-integrated-care-systems

Accountable Care Organisations House of commons library briefing paper March 2018

Divided we fall: getting the best out of general practice Nuffield Trust February 2018 https://www.nuffieldtrust.org.uk/research/divided-we-fall-getting-the-best-out-of-general-practice

Primary care home evaluation report Nuffield Trust 2018 https://www.nuffieldtrust.org.uk/research/primary-care-home-evaluating-a-new-model-of-primary-care Primary care home NAPC 2018 http://napc.co.uk/wp-content/uploads/2018/06/PCH-brochure-2018.pdf

Facing the facts, shaping the future: Consultation on health and care workforce strategy for England to 2027 Health Education England 2017 https://www.hee.nhs.uk/sites/default/files/documents/Facing%20the%20Facts%2C%20Shaping%20the%20Future%20%E2%80%93%20a%20draft%20health%20and%20care%20workforce%20strategy%20for%20England%20to%202027.pdf

The general practice nursing workforce development plan- Recognise, Reform, Rethink March 2017 https://www.hee.nhs.uk/sites/default/files/documents/The%20general%20practice%20nursing%20workforce%20development%20plan.pdf

General practice: developing confidence capability and capacity NHS England https://www.england.nhs.uk/wp-content/uploads/2018/01/general-practice-nursing-ten-point-plan-v17.pdf

The recruitment, retention and return of nurses to general practice nursing in England Ipsos Mori 2017 https://www.england.nhs.uk/wp-content/uploads/2017/07/recruitment-retention-return-of-nurses-to-general-practice.pdf

http://www.rcgp.org.uk/about-us/news/2018/may/gps-leaving-profession-at-incredibly-worrying-rates-says-college.aspx

Ninth national GP worklife survey 2017 http://blogs.lshtm.ac.uk/prucomm/files/2018/05/Ninth-National-GP-Worklife-Survey.pdf

https://www.kingsfund.org.uk/press/press-releases/kings-fund-response-nhs-staff-survey

Jeremy Hunt on 5000 new GPs https://www.hsj.co.uk/daily-insight/daily-insight-hunt-loses-confidence-in-ridiculed-gp-pledge-/7022617.article

Collaboration in General practice Nuffield Trust/RCGP 2017 https://www.nuffieldtrust.org.uk/files/2017-10/collaboration-in-general-practice-2017-final.pdf

Faculty of physician associates http://www.fparcp.co.uk/

Person Centred care National Voices 2017 https://www.nationalvoices.org.uk/sites/default/files/public/publications/person-centred_care_in_2017_-_national_voices.pdf

25

Data sharing and technology: exploring the attitudes of patients with asthma Asthma UK 2017 https://www.asthma.org.uk/globalassets/get-involved/external-affairs-campaigns/publications/smart-asthma/auk_smartasthma_feb2017.pdf

NHS digital supporting general practice https://digital.nhs.uk/about-nhs-digital/our-work/transforming-health-and-care-through-technology/transforming-general-practice-domain-c

European lung white book https://www.erswhitebook.org/chapters/allied-respiratory-professionals/

Keep our NHS public https://keepournhspublic.com/campaigns/accountable-care/

Choosing online healthcare services https://www.cqc.org.uk/help-advice/help-choosing-care-services/choosing-online-healthcare-service

Online healthcare services https://www.cqc.org.uk/news/stories/online-healthcare-services

NHS England should work with local leaders and clinicians to explain accountable care https://www.kingsfund.org.uk/blog/2017/12/nhs-england-should-work-local-leaders-and-clinicians-explain-accountable-care

Complex picture of NHS community care revealed by new analysis https://www.health.org.uk/news/complex-picture-nhs-community-care-revealed-new-analysis

26

Appendix 1: Visualisation of evolving NHS structures

27

Section 3: Disease UnderstandingThis section looks at how thinking and understanding of respiratory disease is changing. An overview is provided by Martyn Partridge followed by links to some other potentially significant considerations plus some additional information on new pharmaceutical products.

A. Overview The purpose of this section written by Martyn Partridge is to examine what might have changed in understanding of lung diseases or emphasis since the last strategy day. It provides a personal view regarding two areas which might need greater focus.

3.1 Airway Disease update (Again a personal view and I have little interest or expertise in the plethora of largely me-too medications* that have come to market, and which attract far too much attention and expenditure).

*see end for information on new medicines

3.1.1Asthma: The conflict caused by the emergence of a new national guideline has been amply discussed but it does highlight our lack of progress in developing an easy diagnostic tool for use in all age groups. Advances may come from unexpected angles such as our increasing understanding of the importance of the lung microbiome (1). Until relatively recently the lung was thought to be sterile, that is to say free of bacteria. It is now realised that in the same way that our gut contains masses of bacteria so does the lung and which ones you contain, the bacterial signature or microbiome, may influence development of disease, progression of disease, risk of complications, frequency of exacerbation etc. Pending new diagnostic tools the emphasis upon well conducted spirometry and its correct interpretation remains vital but new processes of accreditation for those undertaking spirometry may impact upon availability and needs to be monitored. We now have a better insight into the diversity of severity of asthma, {most is mild} (2), but confidential inquiries into asthma deaths continue to show deficiencies in care which are applicable not just to those who die. This is reiterated by the BTS Asthma Audit and this will now be an ongoing process in the newly launched (March 2018) National Asthma and COPD Audit Programme (NACAP). Respiratory Physician interest in the disease is often focused on the Difficult Asthma end of the spectrum but wider implementation of the BTS asthma discharge checklists, which is an auditable target in the new programme, is an opportunity for a more specialist response to this condition both in primary and secondary care. (Point being that a requirement of the checklist to check inhaler technique, issue a self-management plan, and follow up the patients is going to discourage the involvement of gastroenterologists, AMU physicians etc. and necessitate more involvement of respiratory interested health professionals).

A major challenge in this disease remains that of compliance (syn, concordance/adherence) – See later section below.

3.1.2Chronic Obstructive Pulmonary Disease (COPD): Challenges remain those of correct diagnosis, correct treatment and assessment of comorbidity, and the uptake of pulmonary rehabilitation remains poor emphasising the important role of motivation in this condition - motivation of both health professional and patient. The National Asthma and COPD Audit programme referred to above and the use of COPD discharge checklists should provide the same opportunities in COPD management as it does for asthma. Specific new recent understandings have arisen from the use of risk stratification tools such as DECAF (3) and PEARL (4) and these provide clarity to the safe selection of patients for hospital at home schemes, and emphasise the importance of fraility and the need for comprehensive geriatric assessments for many of these patients. Again, as in asthma, understanding of the lung microbiome is likely to lead to advances in predicting and

28

treating exacerbations as well as explain how the microbiome and pollution may together explain the heterogeneity of this condition.

A major challenge in this disease, as in asthma, remains that of compliance (syn, concordance/adherence) – See later section below.

3.1.3 Obstructive Sleep Apnoea syndrome (OSAS): To a group of health professionals working in primary care who are facing increasing challenges the suggestion that they should embrace a further respiratory condition may appear unrealistic. Nevertheless there is now increasing evidence that the diagnosis of OSAS can and should be simplified (5) and burgeoning evidence that the condition can be fully diagnosed and well managed in primary care (6, 7). OSAS cannot be ignored. It is a massive and increasing problem and a major public health threat and one which will suddenly bounce up the agenda if some calamitous accident occurs because someone falls asleep driving a juggernaut. But it is a major cardiovascular risk as well and quite capable of being screened for and treated in the community.

Whether GPs wish to ask another question but one which raises the generalism versus specialism question. Many of us feel that the problem to guard against is the one of unnecessary super specialism, with the aim being more specialist care being delivered nearer to the patient by specialists (whether nursing or medical, originally primary or originally secondary care trained) who are well trained in whole person medicine. One step in this direction would be the concept of the co morbid specialist - someone who runs a COPD service but is absolutely competent also in identifying and treating depression, lung cancer, muscle deconditioning and osteoporosis and who can accurately diagnose, apportion contribution of, and treat heart failure without onward referral.

So what are the other two 2018-2021 key challenges in respiratory medicine?

3.2 The problem of non-compliance:Patients not benefiting from what is available happens for a variety of reasons including not being prescribed a medication or intervention or not taking it whether due to forgetfulness, lack of knowledge, or conscious decision not to take it due to real or imagined side effects or lack of beliefs. It inherently reflects a failure of partnership medicine, a failure to implement shared decision making, poor use of motivational techniques and sub optimal communication. It is not a new problem but non-compliance with ineffective interventions may not adversely affect outcomes whereas not complying with effective treatments leads to waste (of which more in the next section) and morbidity and mortality. What is new in respiratory medicine is recent objective evidence that this is a massive problem (8, 9 & 10) and one which needs to be much higher up our agenda and being addressed by ‘new’ approaches to consultation. New approaches to consultation involve a real commitment to shared decision making, to motivational interviewing whether within the traditional face to face consultation or in newer methods whether by telephone, E mail or Skype or whatever, and by health professionals actively recommending to patients reliable sources of information rather than allowing them to be misled by random internet searches.

3.3 Greener Respiratory Healthcare:Respiratory interested health professionals have played a major role in the development of tobacco control strategies, in the phase out of CFCs, and in pollution control despite these being activities that adversely affect more than just the lung. More recently several health institutions have addressed the issue of healthcare’s contribution to pollution and published general and speciality specific documents (11, 12) and (https://www.brit-thoracic.org.uk/document-library/audit-and-quality-improvement/environment-and-lung-health/the-environment-and-lung-health/). Many understandably focus upon greener buildings and savings in heating and lighting and waste disposal but this is a marvellous opportunity to look at what we do in practice each day and to focus on inefficiencies that lead to waste that could be easily addressed (13). Such a respiratory green taskforce could look at unnecessary use of plastics (e.g. nebulisers), obsession with

29

single use disposables (more probably die as a result of pollution than prion disease yet disposable laryngoscopes abound), unnecessarily large pack sizes (ever discarded 8 out of 10 gauze swabs in a packet?), unnecessary travel / visits (underuse of the telephone, poor co location of facilities), unnecessary investigations, and patient non-compliance because of misunderstanding due to poor communication or health literacy issues, forgetfulness which could be addressed by electronic reminders, or failure to discuss side effects.

I cannot plead too strongly but green respiratory healthcare would be a great new strategy because it isn’t just about the environment and pollution, nor just about energy saving, it is about waste, waste and more waste which is a dominant problem in the NHS. Waste from non-compliance as well as waste from over prescribing, unnecessary investigations, over ordering of sterile supplies, transport to surgery when follow up could equally have been done over the phone, referral to hospital when systems that let you ring a duty doc in each speciality for advice may save the referral etc., etc., etc.

I wonder therefore whether PCRS might wish to address in greater detail, the two connected subjects of compliance/adherence and Green respiratory healthcare? The latter is often misleadingly referred to as sustainability but what I like about the subject is the incentive it gives us to be more efficient about everything we do...to quote ourselves “Every respiratory physician working in a hospital without a Green Hospital Task Force should lead an initiative to establish one and this must extend beyond buildings and infrastructure into a detailed study of all daily processes in the delivery of efficient healthcare, with the clear aim of achieving a minimal environmental footprint across all strata of clinical activity. We believe that such a broad aim is almost perfectly aligned with the delivery of high-quality, efficient, appropriate, and timely medical care. The time has come for us to recognise collectively, that in the course of doing good work, there is no longer any excuse for incurring excessive waste or burden to the environment.”(13) Whilst this was written to stimulate chest physicians I believe it is equally relevant to primary care and provides a great focus on more effective care?

References:

1) Moffat MF and Cookson WOCM The lung microbiome in health and disease. Clin Med December 1, 2017 vol. 17 no. 6 525-529

2) Bloom CI, Nissen F, Douglas IJ, et al Exacerbation risk and characterisation of the UK’s asthma population from infants to old age Thorax 2018;73:313-320.

3) Echevarria C, Gray J, Hartley T, et al Home treatment of COPD exacerbation selected by DECAF score: a non-inferiority, randomised controlled trial and economic evaluation Thorax Published Online First: 21 April 2018. doi: 10.1136/thoraxjnl-2017-211197

4) Echevarria C, Steer J, Heslop-Marshall K, et al The PEARL score predicts 90-day readmission or death after hospitalisation for acute exacerbation of COPD Thorax 2017;72:686-693.

5) Corral J, Sánchez-Quiroga MÁ, Carmona-Bernal C, Sánchez-Armengol Á, de la Torre AS, Durán-Cantolla J, et al.; Spanish Sleep Network. Conventional polysomnography is not necessary for the management of most patients with suspected obstructive sleep apnea: noninferiority, randomized controlled trial. Am J Respir Crit Care Med 2017;196:1181–1190.

6) Hui DS, Ng SS, To KW, Ko FW, Ngai J, Chan KK, et al. A randomized controlled trial of an ambulatory approach versus the hospital-based approach in managing suspected obstructive sleep apnea syndrome. Sci Rep 2017;8:45901.

7) Stradling J Obstructive sleep apnoea: is it moving into primary care? Br J Gen Pract 2016; 66 (643): e149-e151.

8) Tøttenborg, Sandra Søgaard et al .Socioeconomic inequalities in adherence to inhaled maintenance medications and clinical prognosis of COPD .Respiratory Medicine , Volume 119 , 160 – 167

9) Sulaiman I et al .Objective Assessment of Adherence to Inhalers by Patients with Chronic Obstructive Pulmonary Disease Am J respir Crit Care Med 2017 Am J Respir Crit Care Med Vol 195, Iss 10, pp 1333–1343, May 15, 2017

30

10) Lee J, Tay TR, Radhakrishna N, et al. Nonadherence in the era of severe asthma biologics and thermoplasty. Eur Respir J 2018; 51: 1701836 [https://doi.org/10.1183/13993003.01836-2017].

11) Bretti S, Porcile G, Romizi R, Palazzo S, Oliani C, Crispino S, Labianca R. “Green Oncology”: the Italian medical oncolo-gists’ challenge to reduce the ecological impact of their clinical activity. Medicina. 2013;2:3-9.

12) Connor A, Mortimer F, Tomson C. Clinical transformation: the key to green nephrology. Nephron Clinical Practice. 2010;116 (3):c200-6.

13) Hui, C.K., Xu, B., Chung, K.F. and Partridge, M.R. (2018) Green respiratory health care: Time for us all to act. Respirology, 23: 452–454. doi: 10.1111/resp.13281.

B. Some other potentially significant thinking/considerations A question underlying much of how PCRS communicates and presents its work is the issue of whether the labels asthma and COPD are a help or hindrance. We have already moved for the purposes of diagnosis to a focus on symptoms (breathlessness primarily, but also cough) and are only using the terms asthma/COPD for treatment/management once the patients has been appropriately diagnosed/is on the right pathway. Such discussion was brought further to the fore by the publication of a Lancet review in 2017.

A recent editorial in Thorax by Michael Marmot also provides an important perspective (particular when taken in light of the input from Mike Morgan – see NHS section 2.7, with respect to health inequalities /deprivation.

C. New Medicines and Value-Based HealthcareThis section is written by Anne Smith following consultation with Iain small, Vince Mak and Anna Murphy

There is already a wide plethora of inhalers available to treat respiratory disease, which causes significant confusion amongst generalist primary care health professionals. The main developments currently are

1. An explosion in the number of dual combination branded generics available - offering a wide range of different inhaler devices, containing different combinations of the off- patent long-acting beta agonists (LABA), long acting muscarinic antagonists (LAMA) and inhaled corticosteroids (ICS) - from the larger generic manufacturers, new to the respiratory market (such as Sandoz, Ciphla, Mylan) as well as longstanding respiratory players Teva and Chiesi.

2. New triple combination (ICS/LAMA/LABA) products in an array of devices for COPD (only appropriate in relatively small circa 20% patients).

3. Expensive biologics injectable -primarily for specialist use in severe asthma, interstitial lung disease (ILD).

There is a strong view amongst those consulted that PCRS needs to continue to focus on appropriate prescribing/value-based care. ‘’As a Society, we have to put forward the message of getting the best value out of the limited resources we have as they will need to go round more and more people in the next decades. We cannot afford expensive therapies in non-adherent patients. We should have a responsibility to promote Value based practice’’.

This link is to a presentation given by Vince Mak at the recent IPCRG conference, ‘ ’value in a resource constrained world was the main theme.

For more information on what is on the horizon for asthma and COPD follow these links:

Asthma horizon scanning

COPD horizon scanning

31

Section 4. Funding reviewThis section is based on the review provided in 2015 prepared by Anne Smith. Red text indicates areas that have been updated

4.1 Overview This section is intended as an overview of the various sources from which Charities and other not for profit organisations typically secure income from. A more specific discussion is included of the relation to the pharmaceutical industry and medical education funding in section 2.2, as this is currently the predominant source of income for PCRS.

VOLUNTARY INCOME Public fundraising

activities Grant making bodies

Voluntary income is money 'given' altruistically (donations) by the public or grant making body to support a specific cause with no requirement on the charity to provide s service or benefit to the funder in return. The ability to secure voluntary income is driven by the perceived importance/attractiveness of the 'cause' of the organisation (measured for example in terms of 'public benefit'. This is an important source of income for patient charities who are working directly with the ultimate 'beneficiary'. It is in general not a realistic option for professional societies such as PCRS, who from the perspective of a funder/member of the public would be seen as essentially raising money to fund professional education which would not be perceived as a 'worthwhile/compelling cause'. The exception to this is the giving of grants/donations/'core funding' by commercial companies to charities where the company has a direct business interest in the work of that organisation; such funding however is driven by business interest not genuine altruism. Donations (including legacies) specifically from members or the 'alumni'/ those who have benefitted from its service are however feasible for professional societies/educational and learned bodies - and are for example a key source of income for some schools/universities/hospitals.

STATUTORY SERVICE PROVISION (contracts)

Many charities secure significant income from delivering public services (relevant to their objects) under contract to the government nationally/ locally. In securing such contracts, charities are competing with 'in-house' public service delivery and private/commercial providers.

PRIMARY PURPOSE TRADING - sale of services to individual 'users' e.g. Membership

packages Publishing Events Other training

/education

This is where charities are selling services, directly relevant to their cause/ objects to their users.The sale of membership, events fees and publishing are the main sources of income for most well established and successful professional societies (e.g. BTS).Similarly the sale of training/education is the main source of income for training organisations such as Education for Health. In some cases the purchase of such services may be funded by a third party rather than the individual/direct service user, in situations where it is in the interests of the third party for that service to be provided to the end user. For example a CCG or pharmaceutical company purchasing professional memberships (e.g. PCRS membership) or training courses for health professionals (e.g. EfH one day training courses).

32

OTHER TRADING Commercial partnerships/sponsorship

This is where the charity and a commercial company (or other organisation) has overlapping interests/goals such as between PCRS and the pharmaceutical industry.'Sponsorship' is where a commercial company (or other organisations) provides funding towards a specific activity that the Charity wishes to undertake, that is of relevance to the company's business (e.g. PCRS respiratory leaders programme); in return the company typically secures certain benefits in terms of advertising, the rights to use the materials generated etc. Commercial partnerships are where the two organisations work jointly together to deliver a specific activity (examples from PCRS include Paper to Patient programme with GSK 'respiratory journal watch with DNUK, spirometry training programme with ICST.

Advertising /marketing services

This is where advertising/marketing opportunities (e.g. Journal/website advertising, exhibition space, mailing services) are sold by the Charity to an interested third party (e.g. commercial company) to generate income. It is relevant where the Charity is working with an audience (e.g. health professionals) that is relevant to commercial/other organisations (e.g. pharmaceutical company)

Merchandise/other This is the sale of items to raise money (e.g. mugs, Xmas cards, lapel badges) etc. and at the same time raise the profile/advertise the Charity. There is no direct relevance to the Charity's objects.

4.2 Pharmaceutical industry funding 4.2.1 The last 10 -15 years

The pharmaceutical industry has traditionally been keen to form close working relationships with healthcare charities and professional societies working in the disease areas relevant to their business - as means of influencing the management of those conditions and thus the use of their products. Indeed the pharmaceutical industry has been responsible for setting up, and / or providing significant core funding to, many such organisations.

The pharmaceutical industry has also traditionally funded a very high proportion of medical education, particularly in large chronic disease areas and general practice, either directly through their own educational programmes, or through sponsorship of programmes produced through specialist third party providers (commercial companies and charities / other not for profits) or through commercial partnerships with such third party providers. Pharmaceutical industry funding for medical education has dominated other forms of funding, including NHS / statutory, practice / employer and, individual / self-funding.

As result of its close relationship with healthcare charities / professional societies and dominance of medical education, there is no doubt that the pharmaceutical industry has exerted very significant influence on the development of care in many disease areas not least respiratory disease; whilst this has made a very positive contribution to patient care in many areas, it has also had a significant impact on the medicines bill and the use of expensive brands. Moreover the potential profiteering (whether real or simply perceived), at the expense of the NHS / public money, of large pharmaceutical companies (and individuals) from their relationship with healthcare charities / professional societies and health professionals is of public concern.

33

The relationship of the pharmaceutical industry with healthcare charities / professional societies and health professionals has and continues therefore to be under intense scrutiny.

As a result, there has been a steady tightening up over the last 10-15 years in the regulations controlling the relationship pharmaceutical companies can have with charities / professional societies. In particular there has been a far greater emphasis on transparency and ensuring companies are not using the provision of funding to health professionals / their societies as an inducement to prescribe brands (or in the case of patient charities as an inducement to promote their brands to the public / patients). Issues of transparency have made it much harder for pharmaceutical companies to provide core funding charities / professional societies as it is harder to see exactly where / how such money is used. All funding provided by pharmaceutical companies to healthcare professionals where that individuals or organisations such as PCRS, must now be publicly disclosed via Disclosure UK

At the same time as governance regulations have been tightening, the pressure on profit levels / budgets within pharmaceutical companies has increased due to pressure on the medicines bill and prescribing costs within the NHS. These pressures are seen both locally via influences on prescribing (e.g. formularies, prescribing advisors etc. - prescribing in most geographical and disease areas is now controlled by formulary) and nationally via the pharmaceutical price regulation scheme (PPRS); the PPRS is negotiated between the ABPI (on behalf of member pharmaceutical companies) and the government, and controls the profit levels of pharmaceutical company and the prices they can charge for branded medicines. The PPRS negotiation for 2019-2023 is about to get underway; the outcome is unknown but it is anticipated to be a tough negotiation and companies are likely to be nervous in in the meantime.

Pressure on pharmaceutical company profit levels / budgets has been further intensified in some areas (including very notably respiratory in more recent years) as a result of patent expiries and / or a plethora of new product launches and in particular branded generics leading to dramatically increased competition. As a result some of the major companies have reduced investment in the respiratory market and all have become increasingly concerned to be able to demonstrate the business return on any money invested. There has been a strong shift to focus on brand promotion rather than market development /education.

These two factors (i.e. governance regulations and budget pressures) combined have led to a significant change in the funding relationship between the pharmaceutical industry and healthcare charities / professional societies industry, with a shift in the last 10-15 years away from core funding towards a model based on project sponsorship, commercial partnerships and sale of advertising / marketing. Companies have been keen in particular to move away from 'cheque book funding' of projects to a more collaborative relationship, involving sharing of synergistic skills / knowledge / expertise / resources to jointly deliver an agreed project. The partnership route enables pharmaceutical companies to provide greater 'added value' to healthcare whilst at the same time enabling them to exert greater influence.

Overall the total funding from the pharmaceutical industry available, certainly in the respiratory market, has however continued to be relatively buoyant as a result new companies preparing to enter the market and keen to build relationships and their knowledge of / profile in respiratory medicine. The majority of new companies entering the market are principally generic manufacturers with a very different culture to the traditional pharmaceutical companies and a different attitude to investing in longer term market development.

The commercial considerations (i.e. the business benefits / return) and the governance considerations (which strive to distance the company from receiving any benefit from the funding) pose an inherent conflict for pharmaceutical companies providing funding to healthcare charities / professional societies. Traditionally the decision by a pharmaceutical company to provide funding to a healthcare charity / professional society has been driven by the commercial side of the business and although governance considerations have played an increasingly key role in the last 10 years in 'how' money is given, the

34

decision as to how much has been made on commercial grounds. Each pharmaceutical company however interprets the external (e.g. ABPI) regulations differently and has its own internal policies as to where / how lines are drawn in terms of what they can / cannot fund. As a result the distinction between 'voluntary donations / grants' / sponsorship / commercial partnerships and trading has very often been blurred - in the last 2-3 years it has or is becoming much clearer for most companies albeit it can take considerable time marketing groups to work out with their legal groups which route to go down.

The policy no payment health professionals introduced by GSK in 2015, while significantly affecting funding available from GSK to societies such as PCRS, has not as yet become more widespread amongst other companies, with no immediate signal that it is likely to. Whilst there were some signs of health professionals starting to fund more of their own education, that does not appear currently to be a widespread trend.

4.2.2 The future

It is currently a very uncertain time for the UK pharmaceutical industry; the implications of Brexit are still not clear and the outcome of the PPRS negotiation for 2019-2023 is unknown. The key implications and concerns of the industry with respect to Brexit are:

regulation of pharmaceutical products and future relationship vis-à-vis the European medicines agency (EMA)

free trade and movement medicines and pharmaceutical supplies between the EU and the UK access to talent and an immigration system that allows the industry to attract/transfer students,

scientists and other professionals around the world access to EU funding for research (e.g. horizon 2020 and similar)

Subject to the outcome of Brexit and PPRS negotiations there is a risk that companies will reduce investment in the UK and some may even pull out. The UK has traditionally been a leading market for most companies, post Brexit it this is much less likely to be the case which is likely to reduce investment levels.

35