Countdown to Brexit: Impact on radiology

2018 09 18 19 32 3502 Brexit Bull And Bear 400

There are less than six months to go until the U.K. officially "leaves" the European Union (EU). But are we any clearer on what this will mean for medical imaging? Having taken a deep breath and dug into some of the technical guidance papers issued recently by the U.K. government, I can confirm that unfortunately there's not a great deal of positive news to report.

Perhaps most shocking has been the lack of progress or detail on two of the biggest issues facing the imaging community: resources and radioisotope supply. The latest releases from the U.K. government do little to address or appease radiologists and nuclear medicine specialists on either topic.

Skill shortages

The ongoing shortfall of radiologists in the U.K. continues to stretch radiological services in the National Health Service (NHS), as exemplified by the recent Royal College of Radiologists (RCR) annual workforce census. While this was already a serious issue before Brexit, the latest data from 2017 suggest more than 10% of radiology vacancies are unfilled.

Stephen Holloway from Signify Research.Stephen Holloway from Signify Research.

Almost all scenarios and commentators appear to suggest Brexit will only exacerbate the problem. Around 31% of employed radiologists in the U.K. gained their primary degree from a European medical school outside of the U.K., yet there has been little clarity on the rights of European citizens living and working in the U.K., putting a significant proportion of the radiology workforce in an uncertain situation as to their future in the U.K.

Anecdotally, many non-U.K. EU radiologists have expressed concern over their future and could be looking to leave the U.K. system. Some have already left. There has been little progress of late to make them think again, creating serious concern as to whether the NHS will be able to retain a significant proportion of its workforce.

The root of the problem lies in the limited number of training places for new radiologists, which has been the case for some time. Some additional funding for new training places has been found, but it is too small and too late to have any long-term effect. The U.K.'s piecemeal approach to radiology IT adoption has not helped either, especially in terms of the ability for hospitals to cluster together to share radiologist reading resource. Add to this a raging debate over the value and safety of outsourcing radiological services abroad and there looks to be no clear way to solve the crisis.

The recommendation on 18 September from the U.K. Migration Advisory Committee (MAC) to focus on a "no-preference" policy for immigration of skilled workers, does at least offer some hope. In theory, it could open a wider global radiologist pool for the NHS to hire, without needing to provide preferential entry to skilled EU workers. However, the recommendation is a long way from future U.K. government policy and a highly contentious issue. It will be some time before it could have a realistic impact on U.K. radiologist numbers, if at all. Overall then, the staffing picture remains gloomy.

Radioisotope supply's still shaky

Radioisotope supply has been another significant concern with Brexit, especially with a planned move for the U.K. to leave the EU Euratom regulatory body in favor of its own Office of Nuclear Regulation.

Today, the U.K. has no domestic supply of key isotopes used in nuclear medicine, which are used to support half a million nuclear medicine scans. Instead, the U.K. has been using a "just in time" approach for supply of common radioisotopes from France, the Netherlands, and Belgium, especially those with a short half-life, such as technetium-99m (Tc-99m) and molybdenum-99 (Mo-99).

Recent updates from the U.K. government have done little to appease ongoing clinical concern. The latest technical guidance issued on availability of medicines and medical supplies merely suggested that suppliers of products with short shelf-lives should look to transfer their freight operations to air freight, to limit the impact of any immediate post-Brexit issues at road and sea ports.

While it is unclear if this directly impacts radioisotope supply, it is hardly reassuring given the short time left for further detail. It would be no surprise then to see a delay or suspension of some nuclear medical services in the NHS post-Brexit, unless new guidance is forthcoming. Short-term suspensions are not abnormal for nuclear medicine, as scans are often delayed due to issues in radioisotope supply; however more prolonged delays due to regulatory compliance issues post-Brexit would have serious consequences for nuclear medicine studies in the NHS and would have a significant impact on patient care.

Mirror, mirror on the wall

What is clearer from the recent guidance on medical device, pharmaceutical, and clinical trial regulation, is that not much will change on 29 March 2019 in this regard. Intended to provide reassurance in the likelihood of "no deal" being reached between the U.K. and the EU, U.K. government papers released in August and September 2018 lay out the likely implications. Thus, we can say with more confidence that the U.K. will essentially adopt the European Medicines Agency (EMA) list of already approved medicines and CE-Marked devices in the case of a no-deal scenario.

In terms of how long this will continue is not known, but we can assume that in most cases this will extend through the widely anticipated transitory period after Brexit of two years. This is also hinted at within the U.K. guidance in aiming to comply with all "key elements" of new EU regulation for medical devices and in-vitro devices to be brought into effect in 2020 and 2022 effectively. This should then provide further time for the U.K. EMA equivalent, the Medicines and Healthcare products Regulatory Agency (MHRA), to establish itself as the main regulatory body in the U.K.

For new devices and pharmaceuticals wanting to enter the U.K. market, a new process of regulation will be required. This will need to be direct to the MHRA, in effect from the date of the U.K. withdrawal from the EU. However, the technical papers note the new system will create "minimal impact" in comparison to the CE approval process; thus, we can expect a very similar process to the CE approvals mark in the near term at least. Consequently, the worst-case scenario will be temporary delays in new device and pharmaceutical approvals in 2019 (something also expected from the EMA due to their delayed move to new headquarters in the Netherlands) and a potential backlog of approvals.

What is less clear is how the regulatory environment would be changed if a deal is agreed upon, as the details have not been disclosed. However, the U.K. will benefit little from a sweeping move away from European regulation, especially in the short term given the economic risks and potential disruption well documented. Over time, it could be that the U.K. government and MHRA will start to diverge from the EMA, and thus exert more control over U.K. medical device and pharmaceutical regulation. However, this is dependent on many broad economic, political, and business influences -- something that would be remiss to predict at this stage. Therefore, given that the new powers for the MHRA and administrative burden of Brexit will take some time to work through, we should expect the U.K. to mirror the European system for some time to come in terms of regulation of medical devices and pharmaceuticals.

Stiff upper lip required

In my early 2017 column, I outlined my perspective on market impact over the Brexit period, suggesting that procurement would tail off in the lead up to Brexit, a result of NHS uncertainty over funding and rising prices on account of U.K. currency fluctuations.

In general, this has been the case across the U.K. in the last 18 months -- imaging modality markets have seen a significant dip in revenues, especially for MRI and CT, as seen in comments in June 2018 from the Association of Healthcare Technology Providers for Imaging, Radiotherapy and Care (AXREM). Software and services for imaging has also stagnated, with many deals delayed or extensions of pre-existing contracts. Over this period, the NHS has received more guidance on future budgets and what funding will be available in coming budget years, but this has done little to promote new procurement or market confidence. A rebound anytime soon seems out of the question.

New funding initiatives around technology and IT for the NHS have also tended to focus on broader, vague themes of data interoperability and digital technology adoption. This does not help over-stretched radiology departments in the coming years. The efficiency mantra of "do more with less" seems to be here to stay. Worse still, many questions remain over the future of NHS procurement post-Brexit in 2019, especially as relates to whether the U.K. will change EU competition law for procurement after leaving. Combine this with uncertainty over how the MHRA will handle new device regulation and delays for new approvals to the U.K. market should be expected, further slowing market demand.

Ongoing uncertainty further consolidates pessimistic outlook

So, with the clock ticking, little appears to have been decided. Recent guidance offers some comfort that the worst-case scenarios can be avoided, and U.K. health and radiology services will see limited short-term impact. However, with underlying radiology resource shortages and no clear plan of how to fill a growing vacancy list, the confusion and uncertainty that Brexit will bring looks set to further compound this fundamental issue.

Furthermore, a difficult and complex extraction from EU regulatory bodies will continue to doggedly impact the now struggling U.K. market, no doubt causing some vendors to reassess the viability of local subsidiaries and local operations.

Amidst a raft of uncertainty though, one thing appears nailed on -- regardless of deal or no-deal, the legacy of Brexit will have far-reaching, long-term consequences for U.K. radiology. On balance today, those consequences appear to fall far more heavily on the negative than the positive.

Steve Holloway is principal analyst at Signify Research, a U.K.-based independent supplier of market intelligence and consultancy to the global healthcare technology industry.

The comments and observations expressed herein do not necessarily reflect the opinions of, nor should they be construed as an endorsement or admonishment of any particular vendor, analyst, industry consultant, or consulting group.

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