As the UK moves towards the intended ‘exit day’ of March 29th, 2019, some of the details of the foreseen – and unforeseen – consequences of Brexit are becoming clearer. One of these is the UK Government’s stated aim to withdraw from Euratom, and the likely effects or otherwise of Brexit upon medical isotope supply. Here, Dr Hywel Owen explains in detail some of the issues around supply of technetium-99m, which is widely used for medical imaging procedures in the UK.

• Technetium-99m is the most widely used medical isotope, both in the world and in the UK
• Withdrawal from Euratom requires new equivalent procedures for handling medical isotopes
• Euratom oversight of isotope supply will be removed, and UK has to put in place alternative arrangements to ensure security of supply
• The UK does not currently manufacture technetium-99m, or its precursor, but may do so in the future; until then, it is vulnerable to cross-border transport disruption

Some of my colleagues (Prof. Juan Matthews, Prof. Francis Livens and Prof. Tim Abram) have previously written to explain the consequences of the UK leaving Euratom as part of Brexit. Much of the scientific community (and many voters too) were surprised by the decision to leave Euratom, and whilst the negative effects on the UK’s nuclear industry and research have been well reported the any benefits are still unclear.

Euratom oversees many of the processes in the movement of radioactive materials, and replacement arrangements on nuclear fuel and other fissile material movement will have to be made. However, manufacture and movement of medical isotopes is somewhat different to other radioactive materials.

Nuclear medicine: The importance of isotopes for diagnosis

Medical imaging with radioactive isotopes – nuclear medicine – is where material administered to a patient emits small quantities of radiation that can be detected and used in diagnosis. Fluorine-18 is one such medical isotope, and it is made in the UK in a number of commercial and hospital-based cyclotrons. However, the bulk (over 80%) of nuclear medicine in the UK utilises technetium-99m. In common with all medical isotopes technetium-99m has a short shelf-life (in the case of technetium only 6 hours) and so new stocks must be manufactured weekly. One particular technetium imaging procedure (“perfusion imaging”) is often used to diagnose heart problems, and it is also commonly used for so-called ‘bone scans’ to examine the progression of some cancers.

Technetium-99m supply involves many time-critical steps to maintain its effectiveness, and the potential for disruption was shown in 2009 when several of the reactors used in the supply chain failed at once; there were significant shortages that highlighted the risk of having a limited number of large suppliers. In response, a number of groups assisted in improving management of supply (NEA, AIPES and Euratom, in particular the European Supply Agency); the British Nuclear Medicine Society produced a report at the end of 2014 that made the following points:

• The need for technetium will continue, and that need will grow slowly
• Fluorine-18 can’t really replace technetium-99m to any great degree since our hospital scanners run at capacity for both
• The UK should support the diversification of reactor supply across Europe and elsewhere
• Cyclotrons are a viable alternative to reactors for producing technetium-99m, but the UK still needs its present reactor supply route.

The impact of Brexit on essential medical supplies

Before the Brexit decision the supply of technetium from other European countries (and from further afield) was considered more-or-less sufficient; European reactors have a natural advantage as they are closer, so less activity is lost during shipping. The UK has no research reactor of its own – it would be very costly and take many years to build one – so much of our present technetium supply is effectively subsidised by the reactor centres elsewhere. We therefore rely on timely shipments across borders and even with our present frictionless transport, patient appointments need to be timed to match deliveries.

Importing technetium doesn’t fall under the safeguards restrictions that apply to other (fissile) nuclear materials. So in principle there is no problem in shipping technetium after Brexit, as long as suitable arrangements are put in place before March 29th to replace the current regulations. And assuming an overall Brexit deal is concluded. However, it seems unlikely that the administrative burden for shipments from Europe will be reduced, which could well increase their costs and hence the price to end users (which includes the costs to the NHS).

The risk to technetium supply disruption has been voiced by a number of professional groups in the UK, including the BMA and the British Nuclear Medicine Society, which have been widely reported in the general and in the specialist press. The risk due in particular to a no-deal Brexit has been recognised by the NHS, who are actively planning on how to maintain medicine supplies in case of shipping difficulties.

Whilst it is possible to stockpile some medicines, it is obviously not possible to stockpile a radioactive material with a half-life of only a few hours. It’s also not a great idea to have generators on vans stuck in long queues at the border.

Technetium supplies for British hospitals: Current plans and next steps

The risk of supply disruption has been recognised within Government , and it is encouraging that planning is being done to ensure security of isotope supply. These include contingency measures to prioritise time-critical products – such as technetium – in the event of border problems after March 29th; it remains to be seen what will happen in practice, and whilst the recently-published Brexit White Paper makes reassurances it lacks sufficient detail. Overall, it is worth reiterating that there don’t appear to be any real benefits to leaving Euratom; the measures under discussion can only mitigate (to varying extents) a situation that will be strictly worse for us than our present arrangements.

On a positive note, the Government contingency planning letter mentioned above points out the opportunity of using cyclotrons as an alternative means to obtain domestic technetium supply, as we argued in our BNMS report and I reported on a few years ago. It is very encouraging to see that Alliance Medical intends to produce technetium directly using a new cyclotron they are installing. In principle, two such cyclotrons might provide for the bulk of the 700,000 technetium procedures the NHS administers each year. However, it is not expected that these cyclotrons will be ready – and the produced material licensed for patient use – in time for ‘exit day’. And as with the reactors they replace, it is unwise to put all your eggs in one production basket.

So in the meantime we need to make sure we have a secure supply of technetium coming from Europe for a few more years at least.