What impact will the end of the transition period have on the supply of drugs and other medical products to the UK?
Starting from day one, 1 January 2021, the government expects new checks and bureaucracy at the short crossings between the UK and France to create immediate disruption for several months. A number of measures have been taken to try to reduce the impact of this on the availability of drugs and devices.
The government is again asking drug suppliers to build up a six week stockpile and is building up its own stockpile of devices and consumables. Ahead of previous possible “no deal” dates, stockpiling on this scale did seem to take place for drugs, but not for devices. The government is also making allowances delays in key customs processes and arranging new routes into the UK, including rapid air freight for urgent supplies.
This, however, will still mean a major logistical and legal shift overnight. In the context of already high and sensitively triggered generic drug shortages in recent years, it would take a lot of bravery to promise no shortfalls would occur, and ministers and NHS leaders have generally avoided saying so. This extra bureaucracy is also likely to cause a permanent increase of several percentage points in the cost of drugs. The NHS may face paying more, or companies may not see it as viable to bring products to the UK market.
Has the stockpile built up ahead of the original planned exit date been maintained?
Companies were not asked to maintain the drugs stockpile they built up around the exit dates in 2019, and the government guidance assumes they will need to build up a new one. This is not necessarily a serious concern. Trade data from last year suggest firms were able to build up a sizeable stockpile quickly just ahead of planned exit dates. The size and frictionless nature of the single market made it relatively easy to shift stocks into the UK as long as we were members, which we are until 31 December.
There is now a risk, however, that the exceptional demands and disruption caused by covid-19, and the need to rebuild the separate pandemic stockpile at the same time, may make this harder for some drugs. Again, medical devices and clinical consumables may be more of a concern, particularly given the higher need for items such as personal protective equipment (PPE) in caring safely for patients with covid-19.
It would probably not have been a defensible use of space and money to sit on a separate stockpile for more than a year when the date of the UK’s exit was so predictable. But, because the picture is much less clear than the general six week stockpile for all drugs, we do need more clarity about exactly what will be stockpiled, and progress with this.
How would a no deal Brexit affect the supply of drugs, and what would a good negotiated outcome look like at this stage?
A no deal Brexit will maximise the border disruption, in particular by limiting cooperation at the other side of the border so that truckers going in both directions are held up more in Calais. It is also likely to mean less cooperation on sharing data about medicines’ safety, and potentially a standoff in Northern Ireland, where the UK government has threatened to break the terms of a protocol agreed last year adding an additional source of uncertainty.
With a course already set for a fairly “hard” Brexit where the UK entirely leaves the single market, any deal possible at this stage will still cause significant disruption at the border and added costs. How much difference any agreement makes will depend on how ambitious it is for the drugs and devices sector. While the UK has quietly asked for some fairly ambitious measures, the EU appears to be resisting these for protectionist or tactical reasons. Surprisingly, given the pandemic, these sectors seem to have been a low priority for both sides.
The best case scenario would be that the EU and UK continue to mutually recognise tests of drugs, manufacturing assessments, and conformity with standards for devices. This would limit the added costs to drugs flowing either way and maintain the larger competitive market. We may, however, get a much “thinner,” less helpful deal.
How would a no deal Brexit affect drug safety and access to new drugs in the UK, and what would a good negotiated outcome look like?
In the short term, the UK plans to keep accepting EU regulatory processes to ensure drugs are safe and effective. Eventually, it will probably need to develop its own system to try to remain competitive.
As short term measures fade, it is probable that the UK as a separate market will not receive new drugs as fast as the EU, as is the case for other medium sized markets. According to one consultancy, in Canada, for example, a typical delay may be around 144 days. A deal may help in keeping the EU and UK relatively aligned so that at least for many stages of the manufacture and oversight of drugs—though not their actual approval—they can still be circulated relatively freely.
By default, leaving the single market will mean that the UK no longer submits or receives safety alerts and data from the EU systems for pharmacovigilance (EudraVigilance) or devices (EudaMed). The danger is that we are, as a result, less well informed about emerging or potential problems with drugs and devices on the market. The UK has asked to continue cooperation: the fate of this request during the past several months of negotiation has been even more obscure than queries around drug regulation.
Should doctors or patients be taking any action ahead of January to prepare for the end of the transition period?
These matters are fundamentally about the logistics and pharmaceuticals sectors, and there is limited scope for doctors or patients to change the picture other than by raising these matters as citizens. Stockpiling by individual patients, or doctors supporting this, would be dangerous because there is the potential for it to cause shortages which would not otherwise have happened. It may cause shortages in products which are not from the EU, and therefore have not been stockpiled by suppliers.
As many will already have done, doctors and pharmacists will want to be familiar with the new and initially contentious serious shortage protocol mechanism, already used for some products during covid-19. Exercises and planning will also need to anticipate how to cope if shortages affect the availability of PPE or other basic equipment—something that there has been recent experience of during the pandemic.
This Q&A was originally published in the BMJ on 6 November and is reproduced with permission.
Dayan M (2020) "How will Brexit affect the supply of drugs to UK patients? ”, Nuffield Trust comment.