Written evidence submitted by Roche Products Ltd

(C190085)

Roche is the world’s largest biotech company, with a diverse pipeline and a wide ranging portfolio of medicines in major diseases and areas such as oncology, immunology, infectious diseases and neuroscience. We work across pharmaceuticals, diagnostics and diabetes care. This submission is made on behalf of Roche Products, the pharmaceutical part of our business.

Roche is actively working in continued partnership with public health bodies, the Department of Health and Social Care and the NHS in all parts of the UK to tackle COVID-19. Roche welcomes the opportunity to provide input to the Science & Technology Select Committee’s inquiry into UK Science, Research and Technology Capability and Influence on Global Disease Outbreaks. As expected, there has been a great deal of focus on the immediate response to the COVID-19 pandemic. Nonetheless, it is positive to also see parliamentary scrutiny on the UK’s medium to long term preparedness for future potential pandemic outbreaks. This submission aims to address both the UK short term response as well as future preparedness.

Executive summary

The COVID-19 pandemic has demonstrated the importance of strengthening the UK’s research base to ensure the UK is able to respond to future disease outbreaks. The UK’s science and technology research base has made significant progress in effective data use, private-public partnerships, international collaboration and regulatory flexibility throughout the COVID-19 pandemic. This has enabled quick mobilisation of clinical trials, data sharing and continued supply of treatments, diagnostics and equipment. More needs to be done if we are realise the scale of the UK’s ambitions.

As the transition period comes to an end and the UK formally leaves the European Union, now is the time for the UK to become a scientific superpower in research and innovation by leveraging the lessons learned during this pandemic.

This innovative and pragmatic approach could see the UK’s science and technology research base revitalised, bringing new investment and growth to the UK at a time when it is most needed. Roche strongly believes that the outward-looking and collaborative approach in working with global partners, across private and public partnerships, must be maintained to ensure the UK is prepared for future outbreaks.

Recommendations

●        It is crucial that the strong partnership between industry, researchers and regulatory bodies is built on through the creation of a new forum to ensure collaboration is maintained throughout the duration of the COVID-19 pandemic and beyond.

●        There is a pressing need, now more than ever, for industry to work more closely with health systems and regulators in developing new treatments to address the big health challenges, such as future outbreaks.

●        Roche strongly recommends that the flexibility and agility of regulatory bodies demonstrated during the pandemic is maintained. Urgent action is needed to build on this and increase the speed of clinical trial set up in the UK, and ensure we are better prepared for future outbreaks.

●        It is critical that the pragmatic approach to using data in response to COVID-19 is retained and accelerated to ensure the UK’s preparedness for future outbreaks.

1. The capacity and capability of the UK research base in providing a response to the outbreak, in terms of: the development and testing of therapeutics

1.1  Following the 2002 SARS outbreak UK Research and Innovation invested £25 million in coronavirus-related research activities[1] strengthening the UK’s innovative science base. The UK was considered a leader in pandemic preparedness by the World Health Organisation on publication of the 2011 UK Influenza Pandemic Preparedness Strategy[2], which should have left the UK well-placed to respond to the COVID-19 pandemic. However, the UK response has been ranked less favourably than other OECD countries[3], with commentary suggesting that public sector spending cuts made over the last decade left the NHS and other institutions unprepared for the current pandemic.

1.2  The Conservative Party manifesto committed to reach the target of 2.4 per cent of GDP invested into research and development by doubling domestic public research and development, in addition to incentivising private sector investment. To realise this ambition, the speed and efficiency in setting up clinical trials in the UK needs to be improved to encourage investment from global life sciences, and position the UK as a global leader. The UK must maintain its current outward-looking and collaborative approach to share best practice and lessons learnt in preparation for future outbreaks. It has been encouraging to see progress already, with the Department for Health and Social Care (via the National Institute for Health Research) working with UKRI to try and deliver rapid responses to a call for research proposals.

1.3  The NHS can be a fantastic partner in research, as has been demonstrated throughout this pandemic. However, we believe there is more that could be done to improve the NHS’s potential in this area and improve the capacity of the UK’s research base. There needs to be greater recognition that research is a core deliverable for any health service, not an add on service. This needs to be a very clear message from central government and NHS England/Improvement to NHS organisations to ensure NHS services are organised to reflect this priority. If the UK is to become a scientific superpower, it is vital that any future NHS funding settlement provides the right resources to allow the NHS greater capacity for engagement in research.

1.4  Researchers, sponsors and regulators are coordinating efforts to explore the efficacy of existing medicines for patients with COVID-19, we are working closely with these stakeholders and the National Institute for Health Research (NIHR) to understand the potential of our existing and future portfolio. These efforts have the potential to significantly impact patient outcomes and enable access much more quickly than with a new medicine[4]. Roche is currently involved in a number of clinical trials in the UK exploring the potential of our medicines in treating COVID-19, including our collaboration with the University of Oxford for the RECOVERY study.

1.5  In parallel to our participation in these trials, we have also been in dialogue with the Medicines and Healthcare Regulatory Agency (MHRA), the offices of the Chief Medical Officers and the NHS (across England, Scotland, Northern Ireland and Wales) to better understand their response strategy. This collaboration and open dialogue with key partners has been a positive step forward in preparing for future outbreaks, and we strongly recommend closer public-private collaboration like this continues throughout the duration of this pandemic and beyond. Government has a key role in enabling these new partnerships, through facilitating earlier conversations and supporting new networks of collaboration. The creation of a new long-strategic forum for continued engagement discussions, in addition to the existing Life Sciences Council, will help create the conditions necessary to accelerate and embed innovation.

2. The flexibility and agility of institutions and processes to respond on the above during a crisis including: the availability and responsiveness of funding; and the optimal functioning of regulatory and ethical processes;

2.1  The response to the pandemic has seen much greater flexibility and agility in research, with other projects being paused to prioritise the pandemic[5]. Roche welcomes the efforts of institutions like the National Institute for Health Research (NIHR) in their flexibility to respond to the changing demands of this pandemic, in particular, the ACCORD platform. The development and delivery of this national clinical trial initiative to accelerate COVID-19 research and development has enabled prioritisation of COVID-19 clinical trials[6], which has been instrumental in ensuring the UK’s research base is operationalised to tackle the pandemic.

2.2  There has been a pressing need to initiate new clinical trials to study potential treatments for COVID-19 patients. Roche welcomes the efforts of regulatory bodies in their agile and flexible approach. This pandemic has demonstrated the ability of the MHRA to respond to new challenges. As a result of this response, we have seen rapid approval of clinical trials such as the aforementioned RECOVERY trial. This dramatic shift in the clinical trials environment has enabled quick set up of trials and patient recruitment to help identify appropriate treatments to tackle COVID-19. Roche strongly recommends that this is built on and that the MHRA prioritises efficiency and speed to ensure the UK is prepared for future outbreaks.

2.3  Roche welcomes the efforts of the healthcare system in adapting quickly to meet the challenges of the pandemic. It has been encouraging to see NICE collaborate with NHSE to quickly produce COVID-19 guidelines, including temporary treatment regimens during the pandemic.

2.4  The response to the pandemic has demonstrated the agility of the UK life sciences sector; prioritisation of COVID-19 activities can be seen across the board, whether this is supporting rapid research and development of vaccines, or treatments and diagnostics, or investigations to better understand the virus. Many companies have opted to collaborate and share knowledge of existing compounds to expedite fast tracking of potential clinical trials. These partnerships have not been without complications, such as working across different sites and organisations, but the sector has adapted to this new way of working and to using digital technology to collaborate.

2.5  Innovation within industry has extended in meaningful ways beyond digital developments, to new methods of data sharing - another effort to fast track available vaccines and treatments. Although Roche does not develop vaccines, we do have expertise areas like infectious diseases and immunology. There is a pressing need, now more than ever, for industry to work more closely with health systems and regulators in developing new treatments to address the major health challenges, such as future outbreaks.

3. Use of healthcare data during the crisis and beyond

3.1   Data is an important enabler of research including in tackling pandemics. Throughout this pandemic there has been increased use of digital and data-driven technologies for a number of different purposes including research, clinical care and the immediate pandemic response - such as the creation of the NHS test and trace application. This has been crucial to track the spread of the virus and identify potential hotspots. Using data and technology effectively will be essential as the Government begins to remove restrictions and reopen the economy.

3.2  The pragmatic approach to using data in research, such as the set up of clinical trials, enabling ethics approvals to be fast tracked while undergoing robust governance, has ensured the quick initiation of clinical trials to test potential COVID-19 treatments. This approach has meant research in this area is considerably further ahead than it would have been in normal times. There has also been significant progress in using data to support effective clinical care; for example, greater collaboration across the four nations to gather and share important data on the availability of medicines. During this time the public, industry, researchers, the NHS and other stakeholders have become more open in sharing their data, and collaborating with key partners. This has led to progress in understanding this pandemic. It is critical that this pragmatic approach to using and sharing data across all aspects of healthcare is retained and accelerated to ensure the UK is prepared for future outbreaks.

3.3   The NHS has a huge opportunity to build on its current data and research capability to enable the UK to be better prepared for future outbreaks. However, more needs to be done to mobilise access to real-time national data on patient outcomes and service performance if we are to successfully stratify patients based on the urgency of their needs. The Health Data Research Hubs[7], centres of excellence working to maximise the insights and innovations developed from the health data, provide an excellent foundation to build on.

3.4  The pandemic has been a catalyst for the uptake of digital technologies, enabling new technology to be developed and used to help tackle the pandemic, for example COVID-19 symptom tracker apps[8] which have the potential to support research efforts for COVID-19 and for future disease outbreaks. There is huge potential in this area and more needs to be done to accelerate uptake of digital technologies. This includes digitalising NHS systems and standardising electronic health records, as well as introducing e-consent and engaging with patients at home through video calls and wearables to track patient status for trial follow up for example. The creation of a national digital health infrastructure would enable data captured in the healthcare system to be used to help tackle future outbreaks early on. This should be a spending priority for the increased government investment in R&D

3.5   Roche recommends a single strategy for the use of UK health data, building on changes made during the pandemic. This needs to be accompanied by a national conversation with citizens about the use of healthcare data to ensure the public do not lose faith in how healthcare data is shared and stored.

(July 2020)