How Will Britain’s Potential Withdrawal from the Euratom Treaty Affect the Supply of Radiopharmaceuticals?

The UK’s ability to ensure a reliable and consistent supply of pharmaceuticals is highly vulnerable to supply chain disruption. Lack of in-country manufacturing capability makes us reliant on overseas imports, which in turn are vulnerable to market pressures and international trade arrangements.

RUSI has explored this challenge for the Home Office in relation to our ability to rapidly manufacture medical counter measures, required to respond to a bioterrorism attack or an unexpected outbreak of serious infectious disease, and more generally as part of a UK country report on supply chain resilience.

The themes and challenges raised in these reports are equally applicable to the current debate over the consequences to the medical sector of the UK’s withdrawal from the Euratom Treaty, which, among others, supports the supply and use of medical isotopes within the EU.

The overarching treaty ensures compliance with good manufacturing practice and enables effective negotiation between suppliers, distributors and patient-oriented services. Its framework governs international nuclear cooperation agreements between EU members and countries, including Canada, Japan and the US.

The British government’s position is that Brexit automatically requires withdrawal from Euratom on the basis that the two treaties are legally joined. The Euratom Treaty will cease, therefore, to apply to the UK on 30 March 2019.

The government has stated that new agreements to replace it will be in place before then and that withdrawal will not have a significant impact. True, medical isotopes can be imported and exported independently of Euratom, as they are not fissile materials. Non-EU countries have obtained associate membership, in which the guarantees and safeguards associated with membership are preserved.

Nonetheless, the British Nuclear Medicine Society (BNMS) and other key stakeholders question the degree to which it is realistic to expect that withdrawal will not have a negative impact on the UK nuclear medicine industry.

Medical isotopes are chemicals that undergo radioactive decay. The excess radiation they emit enables diagnosis, as it can be picked up by medical scanners to produce images, and as therapy, as it damages harmful cells such as cancers.

The UK does not produce any of the longer-lived medical radioisotopes most often used, however, in particular Technetium-99m (99mTc), which is used for more than 80% of diagnostic nuclear medicine scans. The majority of imports are received from EU countries, especially the Netherlands and France.

99mTc is made from Molybdenum-99 (99Mo), which in turn is made from enriched uranium. A second challenge comes from the aging condition of many reactors, which were built in the 1950s and 60s and are reaching the end of their lifespans. In 2009, two major reactors in the Netherlands and Canada were closed temporarily simultaneously.

The two were responsible for two-thirds of the world’s 99Mo supply, and this led to a major review of the way in which medical isotopes are made and distributed. However, investment in new facilities has not been a high priority and there are conflicting views, including from the OECD and the Association of Imaging Producers & Equipment Suppliers (AIPES), about whether 99mTc shortages will be a problem in future.

Building a new reactor in the UK would take ten years and cost £240–£400million. In the short-term, it might be better for Britain to invest in existing projects in Belgium and the Netherlands, in exchange for guarantee of isotopes, but this raises separate jurisdictional issues for Brexit negotiations.

Alternative medical procedures that do not use 99mTc are possible, but switching would need considerable investment. Other options can be more expensive and may expose the patient to a higher dose of radiation. A shortage of 99Mo could also affect therapeutic isotopes due to their production in research reactors and here, too, the UK is entirely dependent on imports.

Other ways of producing 99mTc have been investigated since the 2009 shortage, such as in cyclotrons/particle accelerators, directly from the naturally occurring 100Mo. This would bypass the need for uranium and produce less waste. Such methods are not yet in use, however, and current UK cyclotrons are not powerful enough. The private company Alliance Medical is building two new ones that will be, but how vulnerable this could make the NHS to one private UK supplier is also an issue.

All efforts need to be focused on minimising the impact on the management of patients both in the UK and other countries who depend on the supply of these essential drugs.

The BNMS has carried out extensive work on the future supply of medical radioisotopes in the UK and believes that leaving Euratom will have an impact on their supply and cost. Greater clarity is needed on future arrangements in order to secure the future supply to UK hospitals.

In addition, confusion over the regulatory aspects of safe provision and transport of radioactive medicinal products between UK and Europe should be dispelled as soon as possible.

Current arrangements for patients who travel between Northern Ireland and the Republic of Ireland to receive radioisotopes for diagnosis or therapy also need to be considered.

Frank discussions between all relevant stakeholders, including government, industry, professional medical societies and medical royal colleges, is needed to ensure the implications of a withdrawal from Euratom are fully understood and the possible alternatives fully scoped and costed within realistic timeframes.

To facilitate this, RUSI and the BNMS intend to host a forum for debate in September. For more information, and to register your interest in taking part, please contact Jennifer Cole, Senior Research Fellow, Resilience and Emergency Management.

Jennifer Cole, RUSI Senior Research Fellow, Resilience and Emergency Management.

Sobhan Vinjamuri is President, the British Nuclear Medicine Society.