Written Evidence Submitted by The Association of the British Pharmaceutical Industry (ABPI)

(CRV0041)

Inquiry: The role of technology, research, and innovation in the COVID-19 recovery

About the ABPI

The ABPI exists to make the UK the best place in the world to research, develop and use new medicines. We represent companies of all sizes who invest in discovering the medicines of the future.

Our members supply cutting edge treatments that improve and save the lives of millions of people. We work in partnership with Government and the NHS so patients can get new treatments faster and the NHS can plan how much it spends on medicines.

Every day, we partner with organisations in the life sciences community and beyond to transform lives across the UK.

Summary

• The life sciences sector is well placed to provide a stable platform for economic recovery in the short medium and long term, as indicated by recent ONS figure.
• Targeted action by government can unlock significant economic growth for the pharmaceutical sector, support the UK’s economic recovery from COVID-19, and support the NHS to deliver improved outcomes for patients.
• This response outlines a number of policy interventions which government should seek to deliver through the CSR, Budget and comprehensive R&D plan (see table of recommendations).
• COVID-19 has had a major impact on the operation of non-COVID clinical trials in the UK.  Action is needed by government to restart non-COVID clinical research at pace and scale.
• COVID-19 also presents significant challenges for the research workforce and skills pipeline, which may impact on the sector’s ability to deliver sustained economic growth, and improved patient outcomes.
• COVID-19 has also highlighted areas of opportunity for medicines research and innovation in the future. Most notably in ensuring that regulatory processes are as efficient as possible in prioritising patient safety.  Reviewing this and understanding how to “lock in” positive changes will be critical for the future of the life sciences sector in the UK.

What role can technology, research, and innovation play in supporting the UK’s economic recovery from COVID-19 and how can it best be supported in this?

1.1  Over several decades, the pharmaceutical industry in the UK has consistently been the largest private sector investor in Research and Development (R&D), investing £4.5bn  in 2018 (1) – approximately £1 in every £5 of private sector R&D spend. The sector provides highly skilled, high-value jobs with more than twice the average level of UK labour productivity (2), and is also a key stabilising sector in times of economic turbulence, as demonstrated by the latest ONS statistics on output in the UK economy (3). This means the sector is well placed to provide a stable platform for economic recovery in the short, medium, and long term.

1.2  There are also significant opportunity areas for the pharmaceutical industry e.g. with the use of genomics increasing our understanding of the genetic profiles of patients, helping us to target research, and driving a new era of medicine discovery. Genomics-related activity in the UK is located in 50 sites with 2,700 employees, and a total turnover estimated at £2.3 billion. Between 2017 and 2019 the activity has increased employment by 1,100 and turnover by £0.6 billion. Building upon opportunities like this will be vital if the UK is to maintain its international competitiveness in life sciences and drive economic recovery through high quality job creation and increased turnover.

1.3  Action in the following areas are required, to ensure that the UK can provide a life sciences environment which is globally attractive – and which makes the most of economic growth opportunities.

Making the UK the destination of choice to locate clinical research

1.4  The development of new medicines and vaccines through clinical research, delivers major economic returns in addition to patient benefits. For each patient recruited onto a commercial trial supported by the NIHR Clinical Research Network (CRN), NHS providers in England received an estimated £9,200 from life sciences companies, and on average saved approximately £5,800 per patient where trial drugs replaced the standard treatment (4).

1.5  As outlined in the ABPI Clinical Trials Report 2019 (5), the UK can build an ecosystem fit for the future of clinical research and maximise economic benefit by:  

1. Increasing investment in  the National Institute for Health Research (NIHR), Health Research Authority (HRA) and other organisations which drive and facilitate clinical research. 
2. Optimising the processes for setting up and running clinical trials by a combination of continuous improvement of existing processes and implementation of new systems and ways-of working for use by commercial sponsors.
3. Building a workforce fit for the future by plugging skill-gaps and investing in training programmes to develop a workforce skilled in innovative clinical approaches.
4. Harnessing health data to support the efficient design, feasibility, recruitment and conduct of clinical trials
5. Embedding patient and public involvement in clinical research, working across the sector and with Government, to develop a system-wide approach to deliver this.
6. Ensuring continuing high standards for transparency which are consistent with other countries and practical to implement.
7. Ensuring science is central to the UK’s trade strategy, including the future UK – EU relationship

1.6  These recommendations must be accompanied by steps to Incentivise and embed clinical research in NHS culture and care delivery. Clinical research should be a fundamental part of healthcare delivery in the NHS. Embedding clinical research in clinical settings is proven to improve patient outcomes (6–8) and will be key to unlocking further breakthroughs in health research and innovation. To enable the NHS to become the best platform in the world for clinical research, commercial clinical research must be supported by making available increased time and resources to support clinical staff in setting up, delivering and successfully recruiting patients to clinical trials.

1.7  The recommendations outlined above, support a long-term vision which will dramatically improve the attractiveness of the UK’s clinical research environment, and the opportunities available for patients to take part in potentially lifesaving research. However, this cannot be disconnected from the challenging situation UK clinical research is currently in. COVID-19 has significantly impacted the operation of non-COVID clinical trials in the UK. The UK is currently lagging behind international competitors in restarting activity which was put on hold by the pandemic.

1.8  In order to reap the benefits of the long-term interventions outlined above and to preserve the UK’s global leadership on clinical trials, action is needed to restart non-COVID clinical research at pace and scale. Please see Paragraph 2.1 and annex A for further detail.

Harnessing the benefits of health data

1.9  The global response to COVID-19 has demonstrated the key role health data and digital technologies can play in supporting significant advances in our understanding of diseases, as well as the development of vaccines and therapeutics to combat them. Estimates by NHS England show harnessing data and delivering on NHS digital plans, including for research, could unlock productivity benefits of around £10bn a year (9).  

1.10          The UK can harness health data in research and maximise economic benefits by:

• Addressing the fragmentation of NHS data through the creation of a single strategy for the use of UK health data
• Harnessing health data to support the efficient design, feasibility, recruitment and conduct of clinical trials
• Enhancing the transparency, quality and accessibility of health data resources
• Broadening the data parameters used to help demonstrate value
• Establishing a national conversation with the public about the use of healthcare data – building upon existing examples such as the work of ‘Understanding Patient Data’, and ‘UseMyData’

Offering a globally competitive package of fiscal incentives for business R&D and advanced medicines manufacturing:

1.11          Increasingly, companies are co-locating R&D with advanced medicines manufacturing facilities. The introduction of capital grants would incentivise companies to locate advanced manufacturing in the UK and should be considered in the upcoming CSR. This would align the UK with competitors like Ireland, Singapore, and Germany, also support the anchoring of adjacent R&D activity and build upon the good work of UKRI’s Industrial Strategy Challenge Fund. Medicines manufacturing should be a key strength of the UK, leveraging our world-leading science base. However, despite this, the UK’s pharmaceutical trade balance runs a small deficit, whilst Ireland and Germany have trade surpluses of €26bn and €27.5bn respectively (10). 

1.12          Effective capital grant incentives would support significant job creation, and if targeted strategically – help to increase the UK’s supply resilience in the event of future pandemics. Furthermore, the EU is reportedly considering creating “financial incentives to entice drug manufacturers to relocate to the EU” (11), therefore it is essential that the UK leads the way with globally competitive incentives if we are to retain, and attract advanced medicines manufacturing facilities in the future.

1.13          Additionally the UK should also seek to modernise its R&D Tax Credit and R&D Expenditure Credit:

a)      by making capital costs eligible.  UK fiscal incentives for fixed capital formation (for R&D or otherwise) are the least competitive in the G7.  Adding capital into the R&D tax credit regime would also remove a clear disincentive to building new R&D sites in disadvantaged areas of the UK, helping grow nascent life science R&D clusters beyond traditional areas. ABPI analysis suggests this would raise R&D across all innovative industries by £1.2bn pa, raising GDP by £4bn within ten years.

b)      by amending the rules to support investment in health data (purchase of and access to datasets) and cloud computing, now core parts of R&D.  This would reflect the fast-changing nature of life sciences and support UK ambitions to lead in data-led technologies – attracting R&D hubs and supporting businesses to start up and scale up.  Building on 2019 analysis by Oxford Economics, including data could raise life sciences R&D by £60-70m pa[1].   

Improving innovation adoption in the NHS:

1.14          For innovative medicines to deliver maximum benefit to patients and society, the UK needs fit-for-purpose medicines assessment processes that help it remain a priority early launch market, with broader measures of value that better reflect the changing nature of treatments and their societal value. The NICE Methods Review is key to achieving this and must be supported by measures to improve NHS adoption of innovation. These should present no risk to the overall NHS budget, since growth in medicines spend is capped and the excess covered by the pharmaceutical industry through the Voluntary Pricing and Access Scheme (VPAS). Exploiting the full potential of the VPAS alongside an ambitious outcome from the NICE Methods Review is key to leveraging the NHS to seed and adopt innovation – a key ambition of the Government’s R&D roadmap.

Creating a regulatory environment which supports innovation in life sciences:

1.15          The Medicines and Medical Devices Bill (currently in the house of lords) will provide a mechanism and opportunity to implement forward thinking, innovative regulatory approaches which can keep pace with medical innovation, whilst supporting world leading standards of patient safety. Recent learning, in particular the work led by the MHRA to accelerate access to promising treatments in response to COVID-19, should be reviewed to see what processes could have a more permanent place in speeding up the approval of licences and variations for existing medicines, and should link into work underway to create more agile and sustained regulatory and Health Technology Assessment (HTA) systems and support patients getting fast access to new treatments.

1.16          Mutual Recognition Agreements should be leveraged to extend the UK’s global reputation and influence through international networks and partnerships. As the UK steps into a new global role, it has the potential to lead new work needed on regulatory frameworks and pathways for emerging innovation, such as cell and gene therapies as well as generic and biosimilar medicines.

1.17          The ABPI has been clear that a deal with the EU establishing close cooperation on healthcare and science is important for patients and innovation. Ensuring the UK has the best opportunity to collaborate and lead internationally with other regulators will enable the best results for patients.

1.18          Additionally, ABPI recommends the adoption of Regulatory Science Centres of Excellence (CoEs) to support the delivery of this, and support the UK to remain an attractive, globally influencing regulatory thought leader, and enable the MHRA to retain and promote its expertise.

Developing and attracting the skills needed to deliver this ambition:

1.19          The Science Industry Partnership 2030 Skills Strategy (SIP2030) (12) estimates 20,000 additional biopharma R&D jobs will be needed by 2030. To deliver this, a strategy focussing equally on attracting, retaining and developing talent and which considers individuals in specific groups in the short, medium, and long term, is required. Such a strategy must be underpinned by:  education policies which promote inclusivity and relevance of science in schools, facilitate development of homegrown talent from diverse backgrounds in STEM subjects and ensure the attractiveness of both UK universities and apprenticeships as routes to fulfilling careers; skills policies which allow for the flexibility to address evolving skills needs and which maximise the potential of the existing workforce to master integrated skills and cross-functional working; immigration policies which build on the Global Talent Visa to encompass industry alongside academia, equally attract and retain core systematic workers and maximise collaborative exchanges for scientists to benefit from working and studying abroad. The Office for Talent should play a key role in ensuring skills policy across different government departments is developed in an effective and coordinated way to support delivery of the above. ABPI recommend Government take the following actions.

• Delivering a new life sciences skills action plan, drawing upon the recommendations of SIP2030, refreshed in the light of COVID-19 to address priority skills needs and support companies considering investing or growing in the UK. SIP2030 can provide an overarching approach for the entire sector consisting of careers outreach for young people and their ‘career influencers’, a Life Sciences Equality, Diversity & Inclusion Toolkit, and a national social media campaign to raise awareness of careers in the sector. It can also offer new job opportunities for those transferring from other sectors and people looking for work with transferable skills post-COVID-19, through providing a range of workshops, learning strategies, guidance and materials, as well as measures to support the uptake of apprentices, particularly for SMEs.
• Convening a Life Sciences Skills Strategic Advisory Group which brings together industry, NHS, academia, learned societies and Government Departments to horizon-scan workforce needs for co-ordinated medium- and long-term planning.
• Supporting every NHS worker to take part in research delivery. Clinical research should not be separate from clinical care, it should be an integral part of how clinical care is routinely carried out in the NHS. Training programmes and support mechanisms should be introduced to provide NHS workers with the skills and confidence to deliver this.

How have research and innovation in UK universities, businesses and other settings been affected by the COVID-19 pandemic, and how might they be affected by any lasting changes post-COVID?

2.1  Following COVID-19, it will also be important to ensure the successful and full restart of paused non-COVID-19 research studies, in order to continue to maximise the economic and societal benefits of clinical research in the UK.

• Early in the COVID-19 pandemic, the DHSC issued a statement that the NIHR Clinical Research Network was pausing the site set-up of any new or ongoing studies at NHS and social care sites that were not nationally prioritised COVID-19 studies. This resulted in only a proportion of studies being able to continue, to varying degrees across non-commercial and commercial portfolios.
• This has had an immediate impact on clinical research activity in the UK for non-COVID-19 disease areas, with negative implications on NHS income and research funding and access opportunities for patients to participate in trials which provide access to experimental treatments and medicines (13–15). 
• It has become evident that restarting the UK’s vast portfolio of research is a complex process, with many operational challenges remaining, including patient recruitment, which is preventing a full restart of clinical research in non-COVID disease areas in the UK.
• Data from July 2020 shows that the number of patients entering clinical trials in the UK is down 55%, compared with average monthly enrolment for 2019. The same comparative data for Italy, showed that enrolment was up 1% (16).  Annex A presents further international comparison data. This is despite the significant efforts of MHRA to quickly assess and approve the set-up of trials throughout this period.
• The NHS and Government should work together with industry, academia medical research charities, as well as patients and the public to restart research into life-threatening disease areas and restore the UK’s clinical research environment.

2.2  For clinical trials that have been disrupted due to COVID-19, the lasting impact of delayed data read outs or potential gaps which cause concerns for the integrity of trial data are significant. This must be addressed through maintained open dialogue with regulators to ensure they are flexible in dealing with this disruption so that patients do not lose out.

2.3  COVID-19 also presents significant challenges for the research workforce and skills pipeline, which may impact on the sector’s ability to deliver sustained economic growth and deliver improved patient outcomes.

2.4  The ABPI is aligned with the National Centre for Universities and Business in asking BEIS and HMT to work with universities and industry to identify bold measures which will help those recently and currently completing postgraduate research degrees and PhDs into meaningful employment. This is considered critical to avoid losing a generation of researchers.

2.5  Apprenticeships underpin the Industrial Strategy and address some of the skill gaps in the industry and enhance industry-academia collaborations. The number of apprenticeships in the pharmaceutical industry have surged over the past 6 years, with the percentage of apprenticeships in research and development traditionally believed to suit science university students or postgraduates, due to the critical scientific thinking and laboratory skills required, have increased from 7% to 37%, perhaps reflecting the maturity of apprenticeship programmes and the growing confidence that companies have in bringing apprentices onboard.  However, apprentices and apprenticeship programmes are not exempt from the negative effect of the COVID pandemic and now, more than ever, it is important to consider possible outcomes for furloughed apprentices, alongside how to better sustain apprenticeships over the coming months to avoid a reversal of the above trend.

Does the current or post-COVID situation lead to any particular opportunities or challenges for economic growth driven by technology, research, and innovation?

Innovative regulation

3.1  The COVID-19 pandemic has highlighted that the UK can deliver research at pace and at scale, with agile and flexible approaches. The pharmaceutical industry has welcomed this approach, in particular the speedy approvals and support from UK regulators, MHRA and HRA.

3.2  These approaches coupled with the highest standards of patient safety in our regulatory and clinical research environment are important factors for global pharmaceutical companies when considering investment in clinical research. The Medicines and Medical Devices Bill offers the opportunity for Secondary Legislation that could lock-in positive changes which have supported accelerated R&D in response to COVID-19. This could help the UK anchor more clinical research activity in the UK, and with that further investment and economic benefit for the NHS and UK patients. Consultation with industry will be essential to identify which changes and flexibilities can have the maximum impact whilst maintaining the highest standards of patient safety. 

3.3  Innovative regulation was identified as a key area of opportunity in the Government’s R&D roadmap – the UK should seek to fulfil this ambition in life sciences, and build upon the UK’s reputation as a global thought leader in innovative regulation.  There is a short window to seize this opportunity, with other leading global regulators seeking to modernise regulations post COVID also.

International research collaboration

3.4  COVID-19 has demonstrated the benefit of international and national research collaborations, with joint private, public and charity sectors working together to research and develop new medicines and vaccines, with rapid uptake and translation of research findings into practice.

3.5  The Government should commit to prioritise Life Sciences in future trade negotiations to maintain the UK as a global hub for Life Sciences innovation and should develop trade deals that allow this innovation, as well as the UK’s exporting potential, the greatest possible global reach.

In the context of the Government’s ‘Research and Development Roadmap’, what shorter-term measures can best support UK research and innovation in recovering from the disruption of the COVID-19 pandemic and adapting to the post-COVID environment?

4. The recommendations outlined in response to question 1, all represent interventions which should be adopted in the short to medium term, therefore ABPI recommends that these are taken forward through the government’s R&D roadmap, with necessary coordination and collaboration across relevant government departments and bodies e.g. BEIS, DHSC, HMT, DIT, MHRA. 

For further information, please email jedwards@abpi.org.uk (Public Affairs Manager, ABPI) 

Bibliography

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Annex A:

Change in new patients entering study-sites by region, as assessed by analysing 5,089 studies and 194,506 study sites, globally. Analysis conducted by Medidata and published on 18th August 2020 (16).

(15 September 2020)