Medicines and radioisotope supply in the event of a no-deal Brexit
The Department of Health and Social Care (DHSC) has announced the work it has been undertaking to mitigate disruption to medicines and healthcare products in the event of a no-deal Brexit.
This includes close coordination with suppliers and measures around product storage and stockpiling, as well as additional sea- and air freight routes and capacity to move medicines.
NHS England has also prepared online question and answer details, to help inform patients and healthcare providers about ordering prescriptions and potential shortages.
The RCR, along with colleagues from the British Nuclear Medicine Society (BNMS) and fellow clinical stakeholders, met with representatives from DHSC, the Department for Exiting the European Union and a number of other Government departments on 21 February to discuss logistical aspects of radioisotope supply, with a heavy focus on air transport and timings.
Key issues and outcomes from that meeting are detailed below:
Stockpiling, cost increases and mitigating transport delays
Government informed us that radioisotopes with long half-lives that are able to be stored for a number of weeks – such as iodine 125 and iridium 192 – are currently being stockpiled.
However, some questions remained over contingency planning for hospital use of short half-life products, including the need to import appropriate supplies and purchase larger sizes of technetium generators, which are the mainstay of UK nuclear medicine scans.
DHSC informed attendees that – as announced widely today (26 February) – in the event of no-deal, the UK's major radioisotope suppliers have committed to six-month air freight contracts as a contingency to allow them to increase the quantity of products flown in, rather than run the risk of road transport delays.
Clinicians raised questions over the logistical timing of these future flights into the UK and onward transport of the radioisotopes to hospitals. If theses radioactive substances do not reach the hospitals early in the morning ready for administration to patients, this will significantly and adversely impact on the amount of radioisotopes that hospitals need to order and budget for.
Another anticipated unwelcome consequence could be increased air transport costs being passed on to hospitals.
Officials confirmed an increased 'medicines bill' was a recognised potential outcome of having to create novel no-deal transport routes, but could not comment on whether funding might be available to help hospitals manage extra costs.
Attendees were told NHS England had not conducted specific prioritisation and product substitution planning to help providers who may be unable to access particular radioisotopes.
Representatives from the RCR and BNMS urged officials to address no-deal scheduling and prioritisation by hospital departments, particularly as scans and staff rotas are planned many weeks in advance and because supply issues could and would cascade down to impact on other services – for example, needing extra MRI machine capacity to scan patients who would normally have had a nuclear medicine scan.
Immediately following the meeting last week, an urgent working party of radionuclide and radiopharmacy experts, suppliers and officials was convened to discuss the specific detail of no-deal supply timings.
The RCR, BNMS and the UK Radiopharmacy Group are now preparing to provide hospital departments with some standard guidance on contingency pathways for nuclear scans and isotope treatment options in the event of a no-deal, which we will issue as soon as possible over coming days.
Regarding the paperwork accompanying radioisotopes, HM Revenue and Customs confirmed that commodity and prioritisation codes attached to these products will remain unaltered, regardless of the form of Brexit.
However, in the event of no-deal, suppliers will have to include new customs declarations accompanying inbound products. Government assured us it is working with both large and small radioisotope suppliers to mitigate any extra administrative impact of those declarations, in terms of customs IT, paperwork, and time spent waiting for these to be processed at borders.
However, officials also admitted that the EU could choose to impose additional customs requirements before radioisotope shipments leave EU countries for the UK, which we can only speculate upon, and over which we have no control.
Euratom Observatory membership
The Department for Business, Energy and Industrial Strategy confirmed that – as talks have yet to take place concerning a post-Brexit relationship between the UK and the EU/Euratom – the UK could be removed from the supply chain intelligence sharing that it currently benefits from as a member of the Euratom Observatory on the Supply of Medical Radioisotopes.
Product licences
The Medicines and Healthcare products Regulatory Agency confirmed that the EU marketing authorisations of existing radioisotope products are all being converted into UK licences, meaning all products will remain licensed for use post-Brexit.