With the current Brexit date less than a month away, the UK IVD industry is busy providing support to UK manufacturers and the pathology sector in an attempt to ensure no one gets caught out. Coinciding with this are the ongoing preparations for the EU IVDR, and a raft of UK-specific issues for the diagnostics industry.
“Everyone is trying to do business as usual while preparing for the unknown,” said British In Vitro Diagnostics Association (BIVDA) chief executive Doris-Ann Williams, in a reference to Brexit. The UK’s EU withdrawal timing and method remain equally uncertain, but in the absence of any other information, the UK will exit the bloc on 31 October, possibly without the trade deal that would keep cross border UK-EU business processes tariff-free and possibly as speedy and efficient as they are now.
Williams is now preparing BIVDA and the UK IVD industry for Brexit to happen at the third time of asking in 2019. “We’re at the point where we’re seeing March [the original planned withdrawal date] as a dress rehearsal for October,” she told Medtech Insight. “It feels like the government and the life sciences arena are ready.” But that’s clearly a philosophical view, for she added. “How can you budget for something you don’t know?”
Providing light among the gloom has been the mission at BIVDA in recent months. The association has held round tables for its members, taking input from the Office for Life Sciences (OLS) and the Department for Exiting the EU (DExEU). It will hold two further webinars on 8 October and 14 October as part of a business readiness support initiative funded by a grant from the Department for Business, Energy and Industrial Strategy (BEIS). BIVDA's next general meeting is on 3 October, and its regulatory seminar in October is fully booked.
The upcoming webinars will take companies through all aspects of leaving the EU, including the new UK regulation that would mirror the key elements of the EU IVDR and MDR. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (UK MDR 2019) would come into force in November 2019.
Given the UK prime minister’s consistent public position of not ruling out a no-deal – including in a “final offer” made to the EU today as part of ongoing UK-EU talks ̶ IVD device manufacturers have been looking at their options. The biggest issue arising from a no-deal exit would be the cost to IVD SMEs of stockpiling and warehousing of products at levels that will guarantee continuity of supply, Williams believes. In September, BIVDA and the consultancy Incisive Health issued a preparedness briefing for UK IVDs manufacturers readying for a no-deal exit. The 13-page briefing points out that:
- The EU Directive on in vitro diagnostics medical devices (IVDD, 98/79 EC) will continue to apply to the UK;
- EU CE-marked IVDs can continue to be placed on the UK market for a limited (as yet undefined) period, but UK notified body certifications will cease to be valid in the EU27. UK manufacturers will henceforth have to work with an EU27-based authorized representative (AR);
- A new UK Responsible Person (UKRP) must be appointed by manufacturers based outside the UK;
- UK notified bodies will be given legal status to serve the UK market, and existing certificates will remain valid, with the UK MHRA overseeing regulation in the UK market alone.
Brexit and the IVDR are separate issues, but are somehow interlinked, Williams observed. The biggest issue regarding the IVDR is that many IVD companies will suddenly need to engage a notified body for the first time. This will be an extra cost, and has given rise to the concern that capacity to audit files simply won’t be available.
“It is inevitable we’re going to lose product from the market” – BIVDA chief executive Doris-Ann Williams.
At present, only BSI is nearing the end of the process of being IVDR-accredited. Other Notified Bodies are further behind and too few in number, Williams observed. UK notified bodies accredited to do IVD work under the IVDD numbered just three anyway: SGS and UL, besides BSI, so capacity ̶ and cost – issues will inevitably have detrimental effects. “It is inevitable we’re going to lose product from the market,” she said.
Some IVD companies have pressed for a lightening of the regulatory load under the IVDR, as has been proposed on a limited scale within the MDR, for Class I medical devices. BIVDA has not heard anything similar in this direction for IVDs. But medical devices, with a closer deadline of 26 May 2020, are taking most of the attention at present.
No Let Up In UK Market Issues
Alongside regulatory issues and Brexit, BIVDA has a raft of other concerns. Williams said, “I’m very focused on UK issues at present,” one of which is the replacement for departed MHRA devices director John Wilkinson.
Other issues on Williams’ and BIVDA’s agendas include the input into the joint work being done with UK pharma association counterparts, the ABPI and BIA. Sam Roberts, the first chief executive of the Accelerated Access Collaborative (AAC), has rapidly shown much support for UK diagnostics innovation. She has helped secure an IVD industry seat on the board of the AAC. This has been filled by Werfen UK general manager Richard Hames.
Roberts has also included Williams in a working group on mandatory funding of products approved by NICE. “At least there is a recognition that there is no reason why devices and IVDs should not have the same funding direction as drugs.” There is even some talk of backdating funding. But this is not a simple theme with an obvious answer. Even in the medicines arena, the local Clinical Commissioning Groups (CCGs) do not always have the money to pay for a new NICE-approved drug, Williams observed.
Defining The IVDs Remit, Future Players And The LTP
With technology changing fast, BIVDA is continuing to assess how the word “pathology” meets the brief of BIVDA members, and also how the tech giants in the health care industry, the Apples and Googles, should play into the diagnostics sector. Those are works in progress for BIVDA, and Williams acknowledges that capacity to cover all bases for members can be a challenge with the resources available.
The NHS Long Term Plan has a lot of positives for diagnostics. Encouraged by this, BIVDA sent a position paper to health secretary Matt Hancock on how better use of diagnostics underpins the ambitions of the entire health care sector. The minister has yet to respond.
The LTP’s aim of ensuring seamless primary and secondary care is something the diagnostics industry can play into fully. “The right use of diagnostics will help identify patients who need to go into hospital, and will reduce the need for outpatient sessions.” The message has yet to be acted on fully by Hancock and counterparts, to the deep and ongoing frustration of the IVD industry.
Identifying unmet needs, getting the right level of evidence for products, and getting them adopted, are the overriding aims of the diagnostics industry. Much work is going on around dementia diagnosis. A Cancer Research UK (CRUK) workshop in October will focus on early diagnosis, and identifying the signs early with near-patient testing (NPT).
“The critical issue is that diagnostics provide information,” said Williams. “Ordinary” diagnostics may not be as “exciting” as novel diagnostic tools like genomics and digital health care, but they remain vital components of health care delivery and need better support, said Williams. The drive from BIVDA for a diagnostics strategy in place within NHS England should underpin that.
Credit to Ashley Yeo, Informa Intelligence
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