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External Affairs – 6 Month Update

By June 1, 2022No Comments

The last six months have been very busy in terms of our External Affairs outreach and stakeholder activities. From the publishing of the Health and Care Bill into law, to the further roll-out of Community Diagnostics Centres, diagnostics has been a crucial topic of focus for parliamentary debate, policy setting and economic growth in the UK. Here are some highlights:


Doris-Ann has met with various stakeholders from the OLS, AHSNs, the Pathology Alliance, the Trade Advisory Group, AMR Diagnostics Programme Board and the Genome UK Implementation Group. Upcoming meetings in the diary include Mr Wes Streeting (Shadow Health Secretary), NHS Confederation’s Rosie Richards, and the MedTech Directorate (Sandra Barrow, David Wathey and Jack Attard to discuss the Diagnostics Strategy & other co-working).

Doris-Ann and Helen have also spoken on various roundtable events such as the NIHR Leeds remote diagnostics event, Westminster Health Forum webinars, a sustainability discussion from the Association for Clinical Biochemistry and Laboratory Medicine, and Bio Integrates discussion panel on pandemic preparedness.

Government and BIVDA activities

In February, a paper on the ‘Benefits of Brexit: How the UK is taking advantage of leaving the EU’ was published, timed with the two-year anniversary of the UK leaving the trading bloc. It highlighted the strong focus on Research and Development from thee Government, it plans to spend over “25 billion on these activities across the next three years. This brings Government R&D spending to its highest ever level. There is continued focus on the creation of UK domestic laws in the wake of Brexit, the MHRA has created a set of focus groups to deliver the new medical devices regime in the UK. BIVDA’s Regulatory Affairs Manager Ashleigh Batchen is leading work on this regarding future IVD regulation. Through BIVDA’s European Affairs function, we are advocating as much regulatory integration as possible and are liaising with the European Health Stakeholder Group on the UK’s formal association to the Horizon Europe research programme.

Also in February, BIVDA contributed to a White Paper published by the Infection Management Coalition (IMC), alongside other health organisation partners. It put forward a call for a transformational change in the way infection is detected, monitored, prevented, and managed across all facets of the NHS, healthcare systems and broader society, by adopting a whole system approach.

In March, news came of a new £200 million in funding announced by BEIS and DHSC to support critical health research into diagnostics and treatment through enhanced data access and digital clinical trial services. Following on from the Medicines and Diagnostics Manufacturing Transformation Fund, a new £60 million Life Sciences Innovative Manufacturing Fund (LSIMF) will help to broaden the commercial-scale manufacturing base of companies at the “leading-edge of innovation”, whose endeavours lead to improved diagnostic and medical device technologies.

The BIVDA team were delighted to be able to hold our AGM/Spring Meeting in-person in March. Among the list of speakers were George Freeman MP, Minister for Science, Innovation and Research, Jack Attard from the Medical Technologies Directorate at DHSC and Rosie Richards of the NHS Confederation European Office. Minister Freeman praised the UK diagnostics sector for its achievements in the pandemic response, and tackling urgent health challenges. “Not for the first time, BIVDA is at the heart of this [life sciences] landscape”, he told 40+ member attendees. Helen Tucker also was formally named the new BIVDA Chair at the event, taking over from Darren Stenlake.

In April it was announced that over 700,000 tests had been delivered by Community Diagnostic Centres (CDCs) since their initial set up in October 2021. 73 CDCs had already opened across the UK and, due to funds made available by the newly-launched Health and Social Care Levy, up to 160 are to open by 2025. While the Government believes that CDCs are a crucial tool to clear the backlog, they also claim it will provide an improved patient experience. This is due to their increased efficiency and convenience, as in the latter’s case they are often much closer to home for patients.

Doris-Ann and Helen were pleased to attend a ministerial roundtable for the Diagnostics Strategy in March. This was a fantastic opportunity to communicate the key asks within the Strategy to influential figures in the health space. Among the aims of the Strategy are clearing the backlog, sourcing additional equipment, boosting interoperability, developing a workforce plan and the expanded roll-out of Community Diagnostic Centres.

BIVDA reacted to the Health and Care Bill becoming law at the end of April, an important piece of legislation that boosts integration of local healthcare authorities and puts the new ICS structures on a statutory footing. Modern slavery is also being tackled in the Bill through tougher regulations across supply chains and automatic tendering has been prohibited to allow for more flexible decision making. Sadly, much-needed regular workforce projections were not accepted by the House of Commons during the latter legislative stages.

BIVDA is engaging closely with SNP MP Neale Hanvey who brought a discussion around UK diagnostics to the House of Commons

This month, the IVDR legislation took legal effect. This regulation applies to IVDs placed on the market in the European Union and Northern Ireland, bringing with it a heightened regulatory regime. The IVDR represents a revolutionary overhaul of the regulatory requirements: a strengthened notified body system which must assess about 70% of IVDs for the first time, a new risk classification system, updated clinical evidence requirements, a new post-market system, a new database enabling more transparency (EUDAMED), a unique device identification system facilitating supply chain traceability, and more. BIVDA is working to support companies with readiness to engage with the new requirements, and to call for sufficient IVD-focussed Notified Body capacity.

In May, some of the BIVDA team travelled to Barcelona for the MedTech Forum 2022 event, run by MedTech Europe. Catch-ups were held with EU colleagues from MedTech Europe, start-up companies and regulatory affairs experts in between fascinating discussion panel sessions addressing subjects such as IVDR, procurement, sustainability, circularity and digital health.

BIVDA’s co-management of the APPG for Life Sciences secretariat has been highly rewarding this year. Joint events with the APPG for Rare, Undiagnosed and Genetic Conditions and the APPG for Medical Research have been held, and in March a Westminster event was held to discuss using COVID-19 innovation as a springboard for future UK life science breakthroughs. MPs and Lords were in attendance, as well as our own member company Diagnostics for the Real World presenting on their SAMBA platform roll-out. The next event is set for July and will be oriented on the Life Sciences Vision’s progress one year on.

Ben Kemp