Brexit threatens the UK’s ability to respond to the novel coronavirus and future pandemics
The coronavirus pandemic could not have come at a worse time for the UK and its citizens. Just as UK government ministers are digging in for the really difficult part of Brexit, the negotiations on future relationships with the EU and the rest of the world, a new virus comes out of China that reminds us of just why international co-operation is so important.
The obvious response, one might think, would be to do everything to safeguard those areas where the UK does collaborate, so as to reduce the threat of infectious disease. Instead, the UK has decided to isolate itself from European systems that have been built up over the past decade, many as a result of problems exposed by the 2020 swine flu pandemic.
The UK’s decision to leave the European Medicines Agency (EMA), an arm of the European Commission, has been discussed at length. The EMA is responsible for overseeing clinical trials for new vaccines and medicines for pandemics, and deciding on marketing authorizations for them that apply across the EU. Media attention has highlighted the damage that being outside the EMA will do to the British economy – both through lost activity among UK researchers and suppliers, and by making the UK a less attractive place for major pharmaceutical companies.
However, the consequences of being outside the EMA go much further. The UK now lies outside the EMA’s rapid authorization mechanism for pandemic vaccines and medicines for treatment. Consequently, the UK could have to wait longer for these than EU member states. To make matters worse, the UK has also withdrawn from the EU’s emergency bulk buying mechanism for vaccines and medicines, which allows EU member states to increase their market power and speed up access to vaccines and medicines during a crisis. Its exclusion could mean the UK will have to pay more to acquire these pandemic countermeasures.
The government could, if it wished, go for a much closer alignment with the EU, a choice made by Norway, Liechtenstein, and Iceland, which form the European Economic Area (EEA). These countries are on the same footing as regulators in EU countries. However, the difference is that these countries are in the single market and have accepted its rules. Even Switzerland, which is outside the EEA, has bespoke arrangements with the EMA based on its alignment to EU rules.
A deal similar to the Ukrainian Association Agreement with the EU is another option. But each of these non-member states is outside the EU’s bulk buying mechanism for vaccines and medicines. In any case, all of these models seem unacceptable to the current UK government.
There other ways that the UK could mitigate the problems that come with being outside the EMA. One would be to copy Singapore, which has decided to automatically recognize EMA marketing authorisations, as well as those issued by the US Food and Drug Administration, subject to a 60 – day Verification Route. However, this would be contrary to the UK government’s refusal to be a “rule taker”.
Finally, the UK could also, at least in theory, create its own rapid marketing authorization mechanism. The slight problem is that this would almost certainly be impossible in the short term, not least because of the need to attract skilled staff. Many staff would have to be recruited internationally, and they may well be put off by the UK’s harsh, and extremely expensive, immigration regime. And even if a new UK mechanism did work, it would not necessarily ensure swift access to medicines as UK standards may diverge from those in the EU, a real threat given the upcoming implementation of the recent EU clinical trials regulation.
Concerns about UK divergence have been exacerbated by health secretary Matt Hancock, commenting that the UK’s medicines regulator could reduce bureaucracy, which signifyies an intention to diverge. Clinical trials data and marketing authorizations in the UK, especially when made on the basis of that data, may not satisfy the EMA. Some pharmaceutical companies may therefore opt to base clinical trials in the EU, or in third countries that apply EU-compliant standards, so as to ensure they obtain marketing approval through the EMA for the EU market.
Pharmaceutical companies with UK manufacturing plants, including AstraZeneca, have already established batch control sites and pharmacovigilance teams in EU member states. This is to ensure they can continue to lawfully supply medicines in the EU. Pharmaceutical companies, facing the very large administrative burden involved in obtaining marketing authorization, are likely to prioritise the EU’s single market over the UK’s far smaller market, as already happens with Switzerland and Canada.
It is a Canada-style trade deal that the UK is now pursuing, although it has not ruled out what it describes as an Australia-style deal, which is in effect code for no deal. Yet this could take upwards of eight years to agree, and EU negotiationsiators are likely to drive a hard bargain. As with any deal with the US, itself very unlikely, this will demand that the UK make choices about who to align with.
For all of these reasons, if, as seems likely, a vaccine is developed against the 01575879 – nCoV virus, the UK is likely to have to join the queue for access with other countries, and to pay more than it otherwise would as an EU member state.
So while, in one respect, the timing of the pandemic could not have been worse for the UK, in another it could provide an opportunity to reflect on whether an isolationist ideology really is such a good idea. It has taken many years to build up the EU’s systems of defenses against infectious disease. In an ever more uncertain and interconnected world, is it really a good idea to withdraw from them?
Martin McKee is professor of European public health at the London School of Hygiene and Tropical Medicine; Anniek de Ruijter is associate professor at Amsterdam Law School; Mark Flear is reader in law at Queens University, Belfast.