British In Vitro Diagnostics Association (BIVDA) – Written evidence (LSI0030)
Introduction
The British In Vitro Diagnostics Association (BIVDA) would like to thank the House of Lords Science and Technology Committee for the opportunity to participate in the inquiry on life sciences and the industrial strategy.
Background
BIVDA is the national industry association for manufactures and suppliers of in vitro diagnostics (IVDs). We currently represent approximately 150 members, ranging from British start-up companies to UK subsidiaries of multinational corporations. BIVDA member companies employ more than 8,000 people in the UK, with total industry sales to the NHS of approximately £900 million.
Response
Science and innovation
What can be done to ensure the UK has the necessary skills and manpower to build a world class life sciences sector, both within the research base and the NHS?
The movement of highly-skilled workers from the EU and further afield into the UK, especially into the life sciences and healthcare sectors, has been and will continue to remain an important factor in maintaining the UK’s productivity and ability to promote a thriving life science sector.
For example, in the IVD sector, approximately 35% of our members state that more than 5% of their UK workforce are foreign nationals. For specialist areas, such as within IVD manufacturing and R&D, there is often a need to spread the recruitment net further than simply the UK. Also, allowing commercial staff to move within different EU health systems – particularly for UK subsidiaries where people may move to other countries to gain broader experience – or to retain staff that may need to be re-located to another site in another country, free movement is important.
Therefore, negotiating reciprocal rights for UK scientists within Europe will be important to retain the intellectual exchange that currently occurs across the EU.
Industrial Strategy
Does the strategy contain the right recommendations? What should it contain/what is missing?
BIVDA is delighted that the Life Sciences Industrial Strategy includes a number of strong recommendations to enable the IVD sector to play its part in delivering benefits for patients, the NHS and UK economy.
Diagnosis-led healthcare is the key to better outcomes and we hope the Government will implement the recommendations contained in the Strategy as soon as possible.
Health Advanced Research Programme
To ensure the continuing success of the life sciences sector, it is vital that plans are made for the long-term future of the industry. We welcome the proposed Health Advanced Research Programme (HARP), which will bring multiple partners together to deliver solutions to future healthcare challenges.
Steps should be taken as soon as possible to establish the programme for the benefit of patients, the NHS and the life sciences industry.
Genomics
We are delighted that genomics has been identified as a potential focus for one of the HARP projects. Advances in stratified medicines have helped to transform the way understand and treat health conditions in the UK. However, patient access to personalised treatments is reliant on the availability of molecular diagnostic tests, which has typically been varied due to a fragmented commissioning structure.
BIVDA welcomes the support shown to the Chief Medical Officer’s report ‘Generation Genome’, and backs the call for a National Genomics Board.
Early Diagnosis
Early diagnosis is critical for improving patient outcomes and increasing the efficiency of the NHS. Therefore, we were pleased to see an ambition included under HARP to establish a platform to allow early phase diagnostics to be tested and evaluated.
Digital Pathology
Along with other life science sectors, the use of digital technologies will be critical to enable the best function of many IVDs, for example the implementation of digital pathology systems. Therefore, the reference to digital pathology is a welcome inclusion in today's report.
Pathology services are at the heart of the NHS, but they are under-resourced and are facing a rising number of patient samples due to an ageing population. We believe a wider digitisation of pathology would increase efficiencies and allow the best use of the trained pathology specialists we currently have.
R&D
BIVDA welcomed the Government’s 2016 commitment to increase science spending. However, we agree that in order to maintain momentum, the UK should aim to be in the top quartile of OECD countries for R&D spending.
NHS Collaboration
The IVD industry already works in partnership with the NHS but welcomes the report’s acknowledgement that there needs to be greater collaboration in order to achieve the best outcomes for patients.
We strongly agree that the NHS should partner with diagnostics companies to help reshape clinical pathways and improve efficiency. Through working in collaboration, we can deliver on the goal that the UK should be in the top quartile for the speed of adoption and overall uptake of innovative products by the end of 2023.
Skills
The IVD industry, like many other industries in the life sciences sector, is underpinned by highly skilled workers from both the EU and further afield.
BIVDA supports the call for a migration system to be established that allows rapid recruitment and retention of highly skilled workers from the EU and beyond.
How do the devolved administrations and city regions fit into the strategy? Scotland has its own life sciences strategy, how will the two interact?
The Life Sciences Industrial Strategy recommends the “UK’s existing clusters should work together and with government to promote a ‘single front door’ to the UK for research collaboration, partnership and investment”.
BIVDA strongly supports the ‘single front door’ approach, as it will make it easier, particularly for SMEs, to know who to approach in the complicated landscape.
Responsibility and accountability
Who should take responsibility for the implementation of the Life Sciences Industrial Strategy and to whom should they be accountable? What should the UK Government’s role be? What should the role of the academic, charitable and business sectors be?
BIVDA believes that responsibility for implementation of the strategy should be shared between the Office for Life Sciences, Department of Health and the Department for Business, Energy and Industrial Strategy.
Coordination of the strategy should be led by these Departments and include active involvement from academics, charities and industry.
What is the role of companies within the sector, particularly the large pharmaceutical companies, in the implementation of the strategy? How are they accountable for its success?
Industry should be supportive of the Life Sciences Strategy and collaborate with other partners to ensure its success.
Does the Government have the right structures in place to support the life science sector? Is the Office of Life Sciences effective? Should the Government appoint a dedicated Life Sciences Minister? If so, should that Minister have UK-wide or England-only responsibilities?
BIVDA is grateful for the support and dedication the Office for Life Sciences, the Department of Health and the Department for Business, Energy and Industrial Strategy have shown to the sector.
We would encourage the appointment of another Life Sciences Minister, as it sends a strong message that the Government truly values the life sciences industry.
Brexit
What impact will Brexit have on the Life Sciences sector? Will the strategy help the sector to mitigate the risks and take advantage of the opportunities of Brexit?
While IVD businesses are already feeling some effects of Brexit (e.g. exchange rates), at this early stage, it is unclear what longer term impacts Brexit will have on the life sciences sector. As with other industry sectors, BIVDA’s members have questions regarding the future of trade, free movement and regulation, which still need to be answered. The IVD industry would welcome clarity on these issues as soon as is practically feasible.
We think that the Life Sciences Industrial Strategy will provide an opportunity to ensure that the life sciences remains the ‘jewel in the crown’, despite Brexit. By focusing on areas such as genomics, the Strategy provides the UK with an opportunity to establish itself as a world leader.
How should the regulatory framework be changed or improved after Brexit to support the sector?
Since the EU Referendum, BIVDA has been calling for the UK Government to align with the EU IVD Regulation. We therefore welcome the assertion in the Life Sciences Industrial strategy that it would be reasonable for the UK to seek to continue to operate within the CE-mark framework.
In order to be able to trade with EU countries, IVD companies will have to continue to abide by the Regulation anyway, therefore it is not in the best interests of industry, patients or the NHS to design and implement a new regulatory framework at this time.
To what extent should the UK remain involved with and contribute to agencies such as the EMA post Brexit?
Post Brexit, BIVDA consider that the UK should engage with agencies such as the EMA as much as is practically possible for the benefit of patients and the NHS.
14 September 2017