With a further round of Brexit negotiations now underway, we are all learning far more about the institutions and processes of EU decision-making than we knew before the June 2016 referendum. Only the other week, the structure for European cooperation on nuclear issues—Euratom—became headline news when it was claimed that withdrawal from this organisation could disrupt access to isotopes uses to treat and detect cancer.
But if you were worried that Brexit might be bad for your health, it is not just the UK’s withdrawal from Euratom that should concern you.
A tangle of regulations
Awareness has been growing that the really difficult part of Brexit is how to manage the UK’s departure from all the institutions, agencies and networks of administrators that make the EU’s rulebook work.Although it has been clear for some time that the UK intends to replicate existing EU rules and regulations in domestic law—the aim of the ‘Repeal Bill’—it was never going to be enough to simply reproduce these EU rules in UK law. Rules needs structures and systems to operate properly, especially when those rules are intended to work across borders. This is where problems might emerge.
Take one example…
For certain types of medicines, for instance—including those used to treat cancer, diabetes, HIV and neurodegenerative disorders—there is a single European procedure which allows these drugs to be placed on the European market. The European Medicines Agency (EMA), currently based in London but set to be relocated to another EU state after Brexit, carries out the technical assessment of these new drugs.If a new medicine passes scrutiny, the European Commission grants a market authorisation to the pharmaceutical company that is valid throughout the EU. And because Norway, Iceland and Liechtenstein are part of the European Economic Area (EEA), market authorisations are also valid in these European states. So, what might happen when the UK leaves the EU?
Companies could leave
An EU market authorisation can only be held by a company based in an EU/EEA state. For companies like AstraZeneca and GlaxoSmithKline which between them employ around 24,000 people in their UK operations, that means transferring existing authorisations to an entity based inside the EU/EEA and outside the UK. New applications would need to be made through a European company or subsidiary.In other words, these companies will face the same sorts of issues as UK-based financial services companies: namely, the need to transact business through an EU-based entity post-Brexit. That raises the issue of where best to locate and deploy resources, including human resources.
The impact on patients
But does that have an impact on UK patients? Companies will want to ensure that any new medicines reach the European market quickly, and will devote time and resources to these Europe-wide authorisations, potentially at the expense of seeking a purely national authorisation from a post-Brexit UK medicines regulator.UK regulators may find themselves simply having to recognise and implement decisions made by EU regulatory bodies to avoid delaying access to new cancer medicines for UK patients.
How problems are solved
But it’s not just about getting new treatments onto the market. The manufacture of medicines and medical devices like pacemakers are subject to EU rules controlled by an array of ‘competent authorities’ and ‘notified bodies’.These national structures ensure that manufacturers comply with European standards, with higher risk products subject to third party testing to make sure that manufacturing processes really do result in a product that is safe to be used by medical professionals.
Should there be a problem, mechanisms exist for information to flow between European regulators to alert national authorities to investigate and if necessary withdraw a product from the market.
This regulatory system works through a continual flow of information between industry and national regulators, and cooperation between national regulators across European borders.
So what happens after Brexit?
After Brexit, a UK company will still be able to do business in Europe but it will need to develop relationships with regulators in other Member States and will be subject to EU rules.But it may be more uncertain for an EU-based company, not because the rules are different, but because it may be less clear how EU and UK regulatory authorities will cooperate and what mechanisms will exist to manage problems and resolves disputes. Forget the jurisdiction of the European Court of Justice: the daily grind of ensuring that the EU rulebook works is a task for a network of national and EU regulators and administrators that has evolved and matured over decades.
Demolishing our own house
So, as the Parliamentary process gets underway to convert EU law into UK law, including important rules governing the safety of medicines, what remains to be addressed are the risks that will emerge when the UK detaches itself from European regulatory structures which implement the rules and handle any problems in their cross-border application.Brexit increasingly looks like a decision to demolish a house only then to spend millions of pounds rebuilding it to look the same as it did before—but without access to any of the essential utilities which make it function.
Kenneth Armstrong’s new book Brexit Time: Leaving the EU – Why, How and When? is published by Cambridge University Press and is out now.
