The European Commission was trying to be reassuring when it presented, on Thursday 4 April, the impact of a no-deal Brexit on the health sector. There will be no shortage of medicines, promises Vice-President Jyrki Katainen, who nevertheless stresses that the procedures for authorising medicines and medical devices will have to be adapted.
"A no-deal exit of the United Kingdom from the European Union will necessarily lead to changes in the health sector. The United Kingdom will no longer be part of the cooperation system that ensures that medicines and medical devices are safe", explains the Vice-President, calling on all actors to prepare.
Concrete consequences
Medicines: the authorisation for placing medicinal products on the market must be adapted. In the event of a disorderly exit, certain essential functions (such as establishment in the EU, controls and batch release) will necessarily have to be performed in an EU-27 Member State.
Medical devices: the same applies to medical devices and in vitro medical devices, which will now have to be certified by an authority within the EU-27. In practice, this means that the four notified bodies responsible for ensuring the compliance of a device currently operating in the United Kingdom must either establish themselves in an EU Member State (this is what the body with the largest market share has done) or enter into an agreement with a notified body in the EU-27 that agrees to cooperate and therefore to ensure a second test (this is what a second notified body has done). The two remaining British notified bodies are a little further behind: one has transferred some of these certificates, while the other is still seeking authorisation from a national authority. To avoid facing supply disruptions, the Commission emphasises that Member States have the option of using the derogation provided for in Directive 93/42/EEC (Article 11(13)), which allows for the "temporary" placing on the market (until the end of 2019 at the latest) of medical devices not certified by an EU body.
Cross-border healthcare: a no-deal exit will also have an impact on British residents and tourists who have health problems while in the EU. For residents, there will be no change for those who work and are insured in the Member State where they work, while those who are retired will depend on unilateral measures taken by Member States. For British tourists in the EU, this will be the end of the European Social Security Card, which means that they will have to take out private insurance to be covered.
Credentialing of British doctors: doctors will be able to continue working without change if their credentials were recognised before Brexit. Otherwise, professionals will have to have their credentials recognised in the Member States in which they operate.
European Medicines Agency: Since 1 March, the European Medicines Agency (EMA) has moved from its seat from London to Amsterdam, first to temporary premises and then to a permanent location in November 2019. According to our latest information, at the end of January, nearly 130 staff members had already left for the Netherlands. By the end of March, there were expected to be 380 of them, with the remainder to work remotely, according to EMA forecasts, which expected a loss of 25% of its workforce (225 people). (Original version in French by Sophie Petitjean)