Medical Radioisotopes and No-Deal Brexit

by Dr Andrew Kuc

At 11pm on March 29th 2019 the United Kingdom will leave the European Union. Incredibly, with just six months to go, the manner of our leaving remains uncertain. If a deal on the Withdrawal Agreement is successfully reached and ratified by all parties then the UK will prolong its association with the EU in the form of a ‘standstill’ transition period. This would include continued enjoyment of the single market, the customs union, aviation agreements, and Euratom.



However, if no agreement is reached, or it is rejected by Parliament, the UK would face falling out of the European Union, thereby losing the benefits of membership immediately. The treaties would cease to apply.



In this article I address the implications of no-deal Brexit on medical radioisotopes - a narrow subject, but one that is of considerable importance and relevance to a great many UK patients.

Medical Radioisotopes

Medical radioisotopes are elements used to diagnose or treat a broad range of conditions. These include many cancers, endocrine and neurological diseases, palliative treatments and cardiovascular imaging. Approximately one million UK patients each year rely on radioisotope procedures. The UK is not self-sufficient in these materials, importing around 80% of the medical radioisotopes we use. Most of these come from the Netherlands, Belgium, and France.



Unlike many medicines, radioactive isotopes cannot be stockpiled. As soon as they are produced they begin to decay. The longer the delay, the smaller the dose of useful isotope that remains.

Delays

The most common radioisotope used in healthcare is Technetium-99m (99mTc). This extremely useful element has a half-life of just six hours, and so is transported to hospitals and radiopharmacies in the form of ‘technetium-99m generators’. These devices contain the decaying parent element, molybdenum-99 (99Mo) which has a half-life of sixty-six hours. As the UK has no research reactors capable of producing 99Mo, the element is imported via an efficient and reliable system.



Once a generator is produced at a reactor source, the product immediately starts to lose effectiveness in terms of useful doses, and so timely transport to UK hospitals is essential. Delays can disrupt the delicate, time-sensitive supply chain, and may result in increased costs, cancelled procedures, and a reduction in the numbers hospitals are able to treat. The process is so time-sensitive that even now and without border complications a delivery held up by delays en route can lead to appointment cancellations.



In 2008, a Channel Tunnel fire interrupted the supply of medical radioisotopes from the continent. Though the disturbance was brief, services were notably affected, resulting in the re-prioritising of patients. Similarly, industrial action at Calais in 2015 resulted in radioisotopes having to be flown in. The concern is that the effects of no-deal would be far greater than these incidents, and much harder to mitigate. The duration of disruption would be difficult to predict.



Speaking to the House of Commons Health Committee in December last year, Dr Jeanette Dickson, Vice-President of the Faculty of Clinical Oncology at the Royal College of Radiologists, raised a number of concerns related to radioisotopes and Brexit, which are also of particular relevance to no-deal.



Dr Dickson noted that if imported radioisotopes suffered delays then “the guarantee of supply will not be there and what comes out at the other end will not be, essentially, what we paid for.”



“If you delay that at customs or through border issues, you have paid for 100 but you get 50 doses. You therefore cannot treat patients adequately…and you are incurring a massive cost for the NHS”.



Dr Dickson also cast doubt on the government’s plan to transport radioisotopes into the country by air, pointing to the lack of specialist handlers and airport capacity.



“There are concerns about increasing the number coming in by air,” she told the Health Committee, “Most of the medical radioisotopes come through Coventry Airport, and there is a good bulk of expertise there on how to manage them efficiently and effectively. Does it have the capacity if we increase the amount coming in by air? We do not think so.”







The UK Government is already planning for significant delays at ports in the event that we leave the EU without a deal. It is also likely that UK haulage drivers would lose their rights to operate within the EU. Expectations of unprecedented impediments to imports (as well as exports) have given rise to official advice that pharmaceutical suppliers should stockpile six weeks’ worth of medicines.



In a letter to all NHS organisations at the end of August, Health Secretary Matt Hancock attempted to address the no-deal uncertainty regarding radioisotope supply. In an apparent admission that ports could prove unworkable, he wrote that in the event of no-deal the government would make “separate arrangements for the air freight of medicines with short shelf-lives, such as medical radioisotopes”.



This brief skeleton of a plan did not address Dr Dickson’s concerns, and in fact raises more questions than it seeks to answer.







Security of Supply

Currently, there are no explicit warnings from the government or the EU that purchasing medical radioisotopes from EU member states would come under any restrictions in the event of no-deal.



However, the subject is nuanced, and concerns have been raised by industry experts that there could be EU supply implications for no-deal and Brexit in general.



The UK’s membership of Euratom is set to continue through the transition period up until December 2020, as per the Withdrawal Agreement. But in the event of no agreement our membership would end abruptly on 29th March 2019. And though it is accepted that medical radioisotopes fall outside the stricter European safeguards which apply to special fissile materials, some fear that leaving Euratom might still affect supplies from the Continent.



An article published last year in The Lancet pointed out that the “generation, movement, and handling of these radioisotopes within Europe are governed by the Euratom treaty,” and that exiting Euratom “means that a new legal structure will be needed if supplies of radioactive medical isotopes for cancer treatments are to continue”. The authors highlight this as a “major threat”.



And although the Nuclear Safeguards Act 2018 (allowing domestic nuclear regulation) was passed earlier this year, ‘no-deal’ implies that there would be no agreement in place with the EU and Euratom members on this matter.



Tom Greatrex, CEO of the UK Nuclear Industry Association, has said, “While medical isotopes are not classed as special fissile material and so not subject to safeguarding provisions, it is not accurate to say that Euratom has no impact. They are subject to the [Euratom] treaty.”



One way in which Euratom has a role in medical radioisotopes is via the European Observatory of the Supply of Medical Radioisotopes, a body that was set up by the EU in response to previous 99Mo/99mTc shortages. This organisation is led by the Euratom Supply Agency (ESA) for the purposes of maintaining security of supply among Euratom members.



The European Association of Nuclear Medicine is also a member of the European Observatory alongside the ESA. Their President-elect, Professor Win Oyen, has warned that although no disruption is sought, “the danger is that, if there is no agreement, people retreat to formal legal positions because there is a vacuum in regulation.”



“The transport of isotopes across borders is regulated, so it is not something you can send in a package with DHL or FedEx and expect to be delivered the next day,” Professor Oyen said in reference to the inevitable formation of a UK-EU border.



Notably, after March the UK will no longer have the ability to propose or shape changes to the sector among Euratom members. In this sense, some control over our security of supply will have been ceded.



If restrictions from EU sources arose, it remains possible that we could increase imports from elsewhere in the world. However, this would prove more expensive. As Dr Dickson pointed out to the Health Committee, “You can import from South Africa, but you lose more activity and therefore reduce the number of patients you can treat.”



In addition, the BMA has raised concerns regarding the quality of product, should we need to increase imports from alternative international sources.



Import Costs:

It is widely expected that no-deal would result in a significant fall in the value of sterling. This would increase the cost to the NHS of importing medical and pharmaceutical supplies.



The ratings agency Moody’s has warned of a “sharp fall in the value of the British pound”.



Kamal Sharma of Bank of America Merrill Lynch commented earlier this year, "We think that a hard Brexit and no transition agreement could easily take GBP/USD down towards 1.10".



With the pound currently at around 1.30 to the US dollar, this would imply a sudden 18% rise in the costs of imported medical supplies (such imports have already suffered once from sterling’s devaluation post-referendum).



The imposition of tariffs (as is the government’s intention in no-deal) could see import costs rise even higher on some healthcare items.



Given that we import nearly all medical radioisotopes, delivery of these services could become significantly more expensive. So, either less patients would receive treatment or funds would have to be diverted from elsewhere.



It is also noteworthy that Health Secretary, Matt Hancock, has recently confirmed the cost of no-deal contingencies for medicines would be borne by the taxpayer.







Aviation:

The aviation industry continues to voice concerns over the ability to fly aircraft to and from the continent in a no-deal scenario, with fears that planes could be grounded in the immediate aftermath.



In short, an abrupt exit without agreement would see the UK leave the European Common Aviation Area (ECAA) and the European Aviation Safety Agency (EASA) overnight. EU-negotiated horizontal agreements would also cease (which allow UK planes to fly to 17 non-ECAA countries). Operating licences, safety certificate and registrations would be invalidated.



On September 12th, CEO of Ryanair Michael O’Leary said his company “remained concerned at the increasing risk of a hard (no-deal) Brexit” and added that the risk of flights being grounded for a period of days or weeks “is being underestimated.”



The government had been expected to release aviation notices for no-deal planning this week. However, they were not included with the latest tranche.





A No-Deal with a Deal?

As has been widely pointed out by sector experts, UK's no-deal plans rely to an uncomfortable extent on the adaptability and cooperation of the opposite party directly after talks had failed. Immediately we would be seeking the very things that we had failed to secure in two years of negotiations.



Some have suggested that a crisis could be averted or mitigated by hurried mutual agreements with the EU in crucial areas that might be vulnerable to both sides. Aviation and the ability to fly our planes back and forth between EU countries despite no-deal is a case in point.



There are legal concerns that this approach fails to appreciate the time-consuming legislative processes required to create such agreements with the European Union.



Moreover, since the beginning of September and the return of Parliament, a number of interventions have made such a series of mini-deals seem much less likely.



In giving evidence to the Exiting the EU Committee on September 3rd, Michel Barnier told ministers, “Now if there is a no deal there is no more discussion. There is no more negotiation. It is over, and each side will take its own unilateral contingency measures, and we will take them in such areas as aviation, but this does not mean mini-deals in the case of a no deal. We want a deal. We want an overall agreement; otherwise each will take their own contingency measures on their own side. That is why I want an agreement. I know full well, the worst scenario is indeed the no-deal scenario.”



It was perhaps noteworthy that M. Barnier chose to single out aviation.



Separately, the European Commissioner for Transport, Violeta Bulc, stated that without a deal this autumn there would be no other agreements made to protect the UK economy.



Despite these statements, Transport Secretary Chris Grayling this month attempted to circumvent the EU and seek bilateral aviation agreements with member states by writing to them individually. This manoeuvre was given short shrift by Brussels. Underlining the point, Barnier responded to Brexit Secretary Dominic Raab, “If there is no deal, there is no trust.”



Though perhaps unsurprising, this is a particularly worrying point given that UK no-deal preparations rely to a significant extent on active EU cooperation. The airlifting of medical radioisotopes is a case in point. A lack of aviation agreements would fatally undermine this fail-safe.





How Likely is No-Deal?

Roughly 80% of the Withdrawal Agreement has been agreed at negotiator level. Unfortunately, this has been the case for some time now. Further progress has been glacial, held up for the most part by the ‘backstop’ clause for the island of Ireland. This is the most difficult and politically sensitive area of the Withdrawal Agreement. And while the UK government has yet to propose their version of a legally operable backstop, the European Commission and the European Parliament separately insist that no backstop means no-deal.



Last month, frustration at the slow progress of talks led the International Trade Secretary, Dr Liam Fox, to announce that there was a 60% likelihood of no deal. Pessimism has also been found on the other side of talks, with EU officials and politicians such as Latvian Foreign Minister Edgars Rinkevics predicting a 50% chance of failure.



This month, the ratings agency Moody’s reported that “the prospect of the UK leaving the EU without any agreement has risen materially”.



And Sir Ivan Rogers, the former UK Permanent Representative to the EU, recently warned that the negotiators are “sleepwalking into a major crisis”.



With talks deadlocked, severe disagreements in the Conservative Party, open discussion of ousting the UK Prime Minister, MPs campaigning for no-deal by preference, threats in Westminster of voting against the Withdrawal Agreement, and only a handful of functional negotiating weeks before November (the October deadline has already been abandoned), it would seem unwise to dismiss the real possibility and jeopardy of no-deal.





Considerable Uncertainty:

Even at this late stage there is considerable uncertainty regarding the UK’s status six months from now. In recent weeks, rather than abating, this ambiguity has in fact increased.



The NHS as an organisation is adept at solving problems. Its skilled and dedicated staff do so routinely and effectively. But for every solution to the consequences of no-deal there will be a cost, whether it be resources, time, or money. And the problems which no-deal poses for the health sector are profound and far-reaching. The duration of any potential crisis is also unknown, making effective planning even more complex.



In a no-deal scenario the NHS could be plunged overnight into the unprecedented situation of simultaneously managing multiple challenges affecting its critical functions: the rights to remain for tens of thousands of staff (during an established staffing crisis), interruptions to pharmaceutical and medical supplies, the potential return of UK citizens currently in the EU and the meeting of their healthcare needs (including approximately 190,000 above retirement age), the loss of cooperative programs with the EU and associated funding (including ‘European Reference Networks’ for rare and complex diseases), a large rise in the cost of vital supplies from devaluation of the pound and the raising of tariffs, and additional challenges for Northern Ireland (whose services and staff are intertwined with those across the border in the Republic of Ireland).



For those that must consider the detail of healthcare functions, no-deal Brexit presents the makings of a monumental crisis. There can be little wonder that so many within the health sector, including the Royal College of Nursing and the British Medical Association, are calling on the government to do all they can to avoid it.



In summary, despite the government’s no-deal planning there are major questions over the UK’s ability to execute safeguard measures such as air freight deliveries of medical radioisotopes. Should aviation be unaffected by no-deal, the additional costs could nevertheless be large. And there is no guarantee that supplies would be smooth, predictable and uninterrupted. There is potential uncertainty over the sourcing of radioisotopes from the EU. Securing alternative sources internationally would have additional cost and reliability implications.



Medical radioisotopes represent just one fragile and time-sensitive supply chain, but even on this single issue the challenges are considerable. The smooth and uninterrupted transfer of radioisotopes is crucial to the continued delivery of vital, often life-saving, treatments and imaging. But with multiple links in the supply chain simultaneously threatened, the potential for serious disruption is immense. The costs incurred could be substantial, not least to the one million UK patients who each year depend on these services.



If no-deal delivers a sudden shock of such radical proportions, it seems inconceivable that the NHS and its patients would escape harm in the process. With just six months to go, the extent of this harm, like so much of our future under Brexit, remains a mystery.



However, there is nothing inevitable about no-deal. The warnings have been made, repeatedly and in good time. Now Her Majesty’s Government must respond.

Andrew Kuc is a medico-legal writer and medical doctor. He is on Twitter as @DrAndrewKuc



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