Health and Care Bill

Joint written evidence submitted by The Academy of Medical Sciences, Alzheimer’s Research UK, The Association of Medical Research Charities, The Association of the British Pharmaceutical Industry, British Heart Foundation, British Pharmacological Society, Cancer Research UK, Medical Schools Council, Northern Health Science Alliance, Royal College of Obstetricians & Gynaecologists, Royal College of Physicians, University of Liverpool, and Versus Arthritis (HCB41)

Cross sector evidence submission to Health and Care Bill Public Bill Committee

About this submission: This submission is supported by the following organisations:

· The Academy of Medical Sciences

· Alzheimer’s Research UK

· The Association of Medical Research Charities

· The Association of the British Pharmaceutical Industry

· British Heart Foundation

· British Pharmacological Society

· Cancer Research UK

· Medical Schools Council

· Northern Health Science Alliance

· Royal College of Obstetricians & Gynaecologists

· Royal College of Physicians

· University of Liverpool

· Versus Arthritis

Collectively our organisations represent patients, NHS clinicians, and the breadth of the UK’s life sciences community including industry, academia, and medical research charities.

Summary:

· To deliver on Government’s ambition to make the UK the destination of choice for clinical research, the Health and Care Bill should introduce a strengthened mandate for research delivery. This should mandate that Integrated Care Systems ensure that NHS organisations for which they are responsible conduct and resource clinical research.

· Existing legislation (the Health and Social Care Act 2012) includes only a duty for CCGs to ‘promote’ research. The NHS’s ability to prioritise the resourcing and delivery of research has been a major impediment to improving the UK’s clinical research environment over the last decade. This has contributed to a significant variability of opportunities for patients to engage in research, with disparities in participation reported for geographic location, socioeconomic background, ethnic origin, and across different disease areas.

· There is a major opportunity to embed a research-active culture within the NHS, building upon the response to COVID-19 which has seen more NHS sites, staff and patients engage in research than ever before.

· Combined with effective resourcing and support for NHS staff to engage in research opportunities – a strengthened research mandate will help to deliver a number of well evidenced benefits including: improved patient outcomes, improved staff satisfaction, and delivering economic benefits for the NHS and broader economy.

An opportunity to embed research within the NHS

The Government has set an ambition for the UK to become the destination of choice for clinical research; an ambition shared by the UK’s research and life sciences community.

The Future of UK clinical research delivery vision outlines that the "NHS will be encouraged to put delivery of research at the heart of everything they do, making it an essential and rewarding part of effective patient care".

The Health and Care Bill provides a once-in-a-decade opportunity to embed research at the heart of the NHS, by putting this ambition on a statutory footing.

Recommendation:

The new Health and Care Bill should mandate that Integrated Care Systems ensure that NHS organisations for which they are responsible conduct and resource clinical research.

A strengthened legislative mandate, which moves beyond the current duty to promote research (as below), will support patients, clinicians and NHS organisations across the country having equal access to the well-documented benefits brought by research participation

Current wording in the bill:

Clause 19, Page 17:

14Z40 Duty in respect of research

Each integrated care board must, in the exercise of its functions, promote-

(a) research on matters relevant to the health service, and

(b) the use in the health service of evidence obtained from research.

Benefits a strengthened mandate would help to deliver include:

· Delivering improved patient outcomes

· Increasing staff satisfaction

· Delivering economic benefits for the NHS and the broader economy

· Supporting levelling-up and our ability to address health inequalities

· Enhancing the UK’s status as a science superpower

Why is legislation needed, and why now?

The Health and Care Bill provides a once-in-a-decade opportunity to embed research at the heart of the NHS. The last major NHS legislation was passed 9 years ago, and to set the tone for the decade ahead, it is critical that the opportunity presented by Health and Care Bill is not missed.

Alongside the legislation and forthcoming NHS reforms, the response to COVID-19 has seen more patients, NHS staff and sites engaging in research than ever before. Legislation presents a unique opportunity to not only retain, but build upon the research-active NHS culture we have seen in response to COVID-19.

The combination of the Vision for Clinical Research, the learnings from COVID-19 and the Health and Care Bill provides us with a time-limited opportunity to lay the foundations which will truly transform clinical research in the UK for the benefit of patients, NHS staff, and the UK economy. These benefits are well recognised:

Patient benefits

The benefits for patients treated in research-active NHS organisations are well documented, with evidence showing that patients treated in these settings have improved outcomes, lower mortality rates and increased confidence in the care being delivered, with NHS organisations seeing improved Care Quality Commission ratings.

NHS staff benefits

A strong body of evidence shows that engaging in research improves job satisfaction amongst health workers, boosts staff morale and can reduce burnout.

57% of doctors surveyed by the Royal College of Physicians (RCP) said they would like to be more involved in research. 67% of those surveyed said having dedicated time for research would make them more likely to apply for a role. Care Quality Commission analysis also shows that staff working in NHS sites with higher clinical research activity levels are more likely to recommend their own organisation.

Economic benefits

Clinical research represents a sound economic investment and investment in UK intellectual capital. The NIHR Clinical Research Network supported clinical research activity generated £2.7 billion GVA in 2018/2019, with the estimated income for the NHS from life sciences companies totalling £355 million.

For every patient recruited onto a commercial clinical trial between 2016 and 2018, the NHS in England received £9,189 from life sciences companies, and, where a trial drug replaced the standard of care treatment, saved £5,813.

Why does existing legislation fall short ?

Health and Social Care Act 2012

Despite the well-recognised benefits that a research-active NHS delivers, current NHS legislation (the Health and Social Care Act 2012) does not mandate clinical research activity, stating only that there is a duty for CCGs (Clinical Commissioning Groups) to "promote" research. This same duty is proposed in current text of the Health and Care Bill. The NHS’s ability to prioritise the resourcing and delivery of research has been a major impediment to improving the UK’s clinical research environment over the last decade. A clear legislative mandate is therefore needed.

Because it is not mandatory, clinical research has in some cases been regarded as an optional extra, rather than a key part of routine patient care. During the pandemic response, non-COVID clinical research has faced enormous disruption, with studies paused or cancelled altogether, and key research staff redeployed to support the frontline effort or prioritise COVID-19 studies. As we build back a more resilient health and care system, we should ensure that the ongoing provision of clinical research across all disease areas remains a priority and that there are the staff and resources in place to deliver this ambition alongside other critical health and care duties.

Levelling-up and addressing health inequalities.

There is significant variability of opportunities for patients to engage in research, with disparities in participation reported for geographic location, socioeconomic background, ethnic origin, and across different disease areas. Traditionally, metropolitan hubs (often with teaching hospitals and an active engagement in clinical research delivery) can offer patients in their locality greater opportunity to enrol in clinical studies.

With clear evidence on the benefits to patient outcomes and the economy, unequal distribution of research opportunities across the country is holding back both the levelling-up agenda, and our ability to address health inequalities.

A legislative requirement, with improved accountability for ICS leadership teams, and a more inclusive research workforce, will play a key role in ensuring all patients have the opportunity to take part in clinical research, regardless of where they live, their gender or their ethnicity.

This would support the ambition set out in the Government’s Clinical Research Vision to "to make access and participation in research as easy as possible for everyone across the UK, including rural, diverse and under-served populations".

Why we must act now . An o pportunity for change

COVID-19 has raised public awareness about the benefits of clinical research to unprecedented levels and has also increased the number of NHS staff engaging in research, with major studies such as RECOVERY providing research opportunities for new staff and previously inactive sites. The Health and Care Bill provides a significant but time limited window of opportunity to embed these developments, enhance the UK’s clinical research environment and deliver the Government’s vision.

Introducing a research requirement into the new NHS Integrated Care System structures will play a vital role in embedding a ‘research-active’ culture across the NHS.

It will also help to ensure that ICS leadership teams are accountable for providing patients and staff within NHS organisations for which they are responsible, with opportunities to engage with and participate in clinical research. ICSs are being established as the strategic system leaders for the NHS and its partner organisations to deliver integrated care and take a whole system approach. Research must be a core element of ICS regional plans if we are to maximise the strengths of the NHS and our world leading science capability for the benefit of patients.

While legislation is a critical element in delivering the Government’s ambition for UK Clinical Research, it is important to stress that it must be accompanied by the necessary infrastructure (e.g. staffing levels and research capability, digital resources and tools, access to services), efficient trial approvals processes, the ability to reliably recruit patients, guidance, and dedicated staff time for research.

It is important to recognise the current pressure NHS Staff and organisations are under following the COVID response, with a sizeable backlog of care and workforce fatigue. The evidence outlined in this brief shows that clinical research, rather than being a burdensome addition, can play a major role in our health system recovery which supports not only patient outcomes, but staff satisfaction also. However, to harness these benefits, it is imperative staff are supported to make the most of research opportunities. Addressing workforce shortages and promoting clinical academic careers will be a vital component of this. The research community is committed and able to work with NHSE/ICSs to co-create the necessary partnerships and ways of working to ensure all parts of the NHS can deliver clinical research.

Further resources outlining the steps needed to support clinical research in the UK are included on the following page.

Additional resources:

· ABPI: Clinical Trials Report

· Academy of Medical Sciences: Transforming health through innovation: Integrating the NHS and academia

· CRUK: Creating Time for Research

· NIHR: Embedding a research culture

· Royal College of Physicians: Research for all: developing, delivering and driving better research

September 2021