Written Evidence Submitted by BIVDA
(C190082)
Introduction
BIVDA is the national industry association for the manufacturers and distributors of IVD products in the UK and we currently represent more than 95% of the industry and over a hundred organisations ranging from British start up companies to UK subsidiaries of multinational corporations. BIVDA members currently employ over 8,500 people in the UK, with a total industry turnover of approximately £820 million. We have welcomed the opportunity to play our part in scaling up our testing capacity and developing innovative new diagnostic tools for this novel virus. The innovation and dedication shown by the UK IVD industry is to be commended.
This short submission outlines what we believe needs to be done to ensure the United Kingdom learns lessons from the COVID-19 pandemic, remains ready to tackle any potential second spike, and prepare for any future pandemics that may occur in the years ahead.
The flexibility and agility of institutions, Government departments and public bodies, and processes to respond appropriately during the crisis AND The capacity to manufacture and distribute testing, diagnostics, therapeutics and vaccines.
Continuing to support COVID-19 testing capacity
In the immediate future, if we are to ensure the NHS does not struggle with demand as we approach the autumn and the traditional flu season, we must keep our hard-fought ability to rapidly re-scale up our COVID-19 testing capacity, alongside the restarting of ‘normal’ NHS operations. One of the biggest successes of the Government during this pandemic has been protecting the NHS from being overwhelmed, as other health systems, most notably Italy, appeared to be in the early stages of the crisis. Our members of all sizes stand ready to assist if needed and are continuing work to improve tests and develop better methodology, such as multiplexing for identification of COVID alongside the seasonal respiratory infections.
Reset and resumption of diagnostic testing in the NHS
Ensuring that the United Kingdom can respond to a pandemic – whether it be a second wave of COVID-19 later this year or another disease in the future – it is important that normal NHS operations are able to continue in some form, and patients are treated promptly. This will ensure hospitals are not overwhelmed, from an influx of pandemic patients, but others whose conditions have deteriorated due to months without routine testing and rapid diagnosis. Given the existing backlog of NHS cases, enhanced use of IVDs throughout all settings in the NHS – from primary care to hospital labs - will help identify illnesses earlier and help get people into treatment more quickly, improving outcomes. So yes, we need to see access to COVID-19 testing supplies reinforced , but we also need to see spare lab capacity and NHS staff capability being fully utilised to ensure as many tests for different illnesses are being done as possible if the NHS is going to get back to some sort of normality.
We note that the Nightingale Hospital in Exeter has been repurposed to provide a cancer testing facility – repurposing and restarting dormant assets could be one way to ensuring capacity is there, with the ability to turn these facilities back into pandemic- supportive settings if needed.
We understand that patients are still unwilling to go to hospital settings unless absolutely necessary. Enhanced use of IVDs in primary care settings and GP surgeries would help to get around this issue. There are historical issues which have to date hindered the use of IVDs by GPs (funding streams and lack of experience in particular) – policies to help break through this historical issue quickly would be very welcome.
Continued and resumed monitoring of patients with long term conditions
Long term conditions require continued monitoring of patient treatment after diagnosis and this has been disrupted by the pandemic. Patients must be able to access the routine assessment of their conditions to ensure that they do not get worse, pushing patients back into hospital beds in the autumn, when these beds may be needed to deal with any resurgence in COVID-19 cases. Again, encouraging greater use of community and primary care testing facilities will help keep hospitals free for critical patients and ensure patients can access services closer to home, at a time when unnecessary travel is still discouraged.
The contribution of research and development in understanding, modelling and predicting the nature and spread of the virus.
If we are to maintain our current testing capacity for COVID-19, while at the same time gearing up the NHS to restart its other diagnostic testing programmes, supporting medical research and innovation funding, will be critical in the months ahead.
IVD tests are central to the successful diagnosis, treatment and management of patients. 70% of clinical decisions by healthcare professionals are made using one form of IVD. Despite their benefits, IVDs continue to face a glass ceiling when it comes to the uptake and diffusion of new tests and technology across the health service. In fact, uptake of new IVDs within the NHS typically takes about 10 years – and this is at a time when we are hearing from our membership that demand for their cancer tests, for example, has fallen by 70% during the pandemic.
A significant amount of change needs to occur if we are to ensure that the full benefits of IVDs are experienced by patients, the NHS and the UK economy, and greater research & innovation support for our industry is vital if we are to maximise our potential.
1) Increasing investment in R&D
2) Developing a skilled and diverse R&D workforce
For the UK to tackle the challenges of the future, the Government should invest in an R&D workforce with a range of different skills, experiences and training, drawing on the contribution of individuals from diverse backgrounds. By 2025, there could be up to 4.2 million highly skilled jobs without suitable candidates – a skills gap that could cost the economy £90 billion each year. Therefore several steps should be taken to support the R&D workforce;
BIVDA has played an active role in the development of the Accelerated Access Review (AAR) and the Life Sciences Industrial Strategy, which we hope will provide a vital stepping-stone to faster adoption, so that patients of the future have access to the right IVDs, at the right time. Therefore, we urge the Government to proceed with implementing the recommendations of the AAR and pursuing the recommendations of the Industrial Strategy, as soon as practically possible.
Conclusion
The last few months have been extremely challenging, but there is a lot that the United Kingdom IVD sector can be proud of. From developing and rapidly scaling up the production of new COVID-19 PCR and antibody tests, and the ongoing work on T cell versions, to the logistical support we have provided to the NHS and Government, we have shown the necessity of a strong UK IVD industry.
With a potential second wave of the COVID-19 virus beginning in Europe, and the ongoing threat of other pandemic diseases in the future, the UK has a very small window to ensure that our systems are strong enough to cope – we believe lessons have been learned by the Government, NHS and associated bodies, but these lessons now need to be acted upon to ensure we remain agile, innovative, and to use the Government’s language, alert, to the potential challenges in the months ahead.