What happened to those Brexit medicines shortages?

As we neared the UK’s departure date from the single market on January 1st this year, the risk of medical supply shortages loomed large. The Nuffield Trust warned that alongside export bans, with which the EU did indeed threaten the UK, the general disruption caused by new customs and regulatory barriers would be a serious difficulty during Covid-19.

The government clearly took this very seriously. Preparing over several years for both a possible “no deal” exit and the actual departure from the single market with a deal in place, it introduced comprehensive stockpiling; spent millions on new routes into the UK specifically for medicines; and prepared for the worst with a network to manage shortages and a new law on “Serious Shortage Protocols” allowing pharmacists to prescribe different products when they became unavailable.

As we review the UK’s first nine months outside the single market for the Health and International Relations Monitor project funded by the Health Foundation, what can we say has actually happened?

A one-off prescription

Trade data shows that the introduction of customs controls and transport requirements on January 1st had exactly the effect that was feared on supplies from the EU. Medicine imports from the trading bloc – which have historically made up two-thirds of NHS supply – crashed to their lowest level in years. Even now they have recovered only quite weakly compared to earlier years: they have been below their 2016 level for the whole of 2021.

Imports of EU medical devices, too, reached their lowest level in several years in January 2021, although they recovered more strongly.

However, the strategies to avoid this causing immediate shortages seem to have been remarkably effective in the first few months of the year. Shortages happen all the time and measuring them is intrinsically difficult: there is a grey area of products simply not being available at the price the NHS expects. But none of the obvious metrics show a jump in products not being available.

The graph below, obtained through a Freedom of Information request from the DHSC, shows the number of anticipated medicines supply issues officially reported by manufacturers and importers who held medicine licences in six-month periods. While higher than in 2020, supply issues in 2021 are being reported at a lower level than in late 2019, and there is no sign of a dramatic shift.

The British Generic Manufacturers Association publishes trackers of supply notifications and more severe “disruption alerts” issued by DHSC. These show a similar picture. Price concessions for generic medicines, often a sign of a stretched market, have if anything been lower in 2021 than in 2020.

One possibly concerning indicator is that the number of Serious Shortage Protocols issued in case of a severe lack of supply did peak this spring, at five. However, with the number being so small and mostly accounted for by just one drug – Fluoxetine or Prozac – drawing wider conclusions is difficult.

The NHS leaders we have interviewed for our tracker project unanimously agreed that there had not been a widespread jump in shortages of the type that was feared.

This represents an impressive achievement by two of the UK’s least often applauded institutions: large pharmaceutical corporations and government bureaucrats. By ordering and complying with an industry-wide stockpile, changing routes into the UK market before new barriers officially came in, and checking their supply chains for vulnerabilities, they protected British patients to a remarkable extent. The logistics industry and the often smaller firms which work in the medical devices and consumables industry also deserve credit.

Running out of road?

However, as of late summer this year, a number of high-profile shortages began to emerge in medicines and clinical consumables. Many appear to be at least partially related to the longer-term effects of Brexit – though not directly to the immediate logistical problems expected back in January. The most notable is a shortage of blood tubes, used to take and keep samples and stop them coagulating, which has been so severe that NHS England has issued guidance suspending their use in training and spacing their use further apart where safe. Flu vaccines and pipettes have also seen shortfalls.

This partly reflects global issues. For example, the Food and Drug Administration in the USA has also been issuing recommendations to deal with the blood tube shortage. However, the more drastic actions taken in the UK suggest a more severe situation. The most obvious factor is the ongoing shortage of heavy goods vehicle drivers, driven by the post-Brexit migration system as well as the new red tape required to move people and products into and out of Great Britain now that it has left the single market.

The firm responsible for most blood tubes, Becton Dickinson, has also consistently pointed in its statements to “UK border challenges”. This suggests they see a direct effect from the additional checks and requirements being imposed as a result of leaving the EU.

Are these shortages, or the success in containing them we saw at the start of the year, more likely to be the pattern in future?

Standing alone

As a health policy researcher I have little insight into the market for HGV drivers, but this should in time be possible to address – through training or pay eventually if the attempt to open up visas falls flat. The level of checks at the UK border, however, is scheduled to intensify. The UK has temporarily suspended several, including notification of meat imports and entry summary declarations, for incoming goods to try to reduce disruption. But these are intended to be reintroduced in time. The dynamic of the UK getting the worst of global shortages because barriers separate it from the two largest markets with the deepest supplies, the EU and USA, may intensify.

This is a particularly live consideration for medicines and medical devices. Another of the measures taken to stave off shortages was for the UK to accept EU regulatory approvals for these products at every level: from the CE marks on medical devices, to the approvals of new types of medicine. This is very welcome among the industry officials we have spoken to.

But these allowances too are scheduled to end. Northern Ireland has its own set of deadlines on medicines regulation as it transitions to a status partially inside the single market, with an ongoing battle between the UK and EU over proposed solutions.

The rest of the UK has a strategic choice to make between sovereignty and access to medicines. Effectively rubber-stamping a neighbouring jurisdiction’s approvals is an unusual position for any developed country, let alone one that has just revolutionised its international relations in the interests of sovereignty. Yet the government’s advisory Regulatory Horizons Council recently published an important paper on medical devices that called for the UK to further extend the period of accepting European CE marks for some products, in order to “avoid risking a shortage in the supply of medical devices to UK patients”.

Another difficult question will be how much the NHS is willing to pay. Modelling ahead of Brexit suggested that leaving the single market would increase the cost of medicines in the UK through the regulatory barriers it creates. The health service is currently shielded from this by its price control systems, most notably the Voluntary Pricing and Access Scheme that caps spending on branded medicine until the end of 2023. At this stage, the total amount the pharmaceutical industry demands to provide the same medicines available in the EU may reflect increases to their costs as a result of new regulatory requirements.

That the government internally accepts these challenges are far from over can be seen in the DHSC’s recent advertisement for a “Medicine Supply Resilience Lead”. The job summary notes that the need for this reflects “multiple threats to the continuity of supply of medicines to the UK, including... EU exit”.

The additional barriers to bringing products into Great Britain are expensive and inconvenient rather than insurmountable. The NHS, government and industry largely succeeded in overcoming the first round with minimal implications for patients. But continued success will not come for free: it will depend on how much sovereignty the UK wants to exert, and how much more it is willing to pay.