In the midst of the vaccination race, the London government claimed to be able to approve the Covid-19 vaccine developed by Pfizer and BioNTech faster than the European Union because of Brexit. However, the United Kingdom, which is covered by European law until 31 December 2020, has until now used the urgency procedure permitted by the European treaties.
The end of the post-Brexit transition period marks the beginning of the new relationship, now governed by the Trade and Cooperation Agreement. The UK is now free to opt out of the centralised market authorisation system of the European Medicines Agency (EMA).
However, the agreement on the EU/UK relationship contains an annex devoted specifically to medical products. According to this annex, “the Parties shall endeavour to cooperate in strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines”. The text provides for mutual consultation in the event of major changes to the rules in force. For the rest, the Annex supports mutual recognition of inspections and good manufacturing practices.
In the fight against health threats, the UK is allowed to participate, as appropriate, in certain EU structures, such as the Health Security Committee (HSC) or the Early Warning and Response System (EWRS). This participation - which will remain “limited in time and content”, says the European Commission - will be decided on a case-by-case basis by the EU27.
The text also provides for the European Centre for Disease Prevention and Control (ECDC) and the UK Health Protection Agency to cooperate on issues of mutual interest. The two agencies could also conclude a memorandum of understanding to this effect.
Finally, concerning cross-border healthcare, the text provides for a status quo for temporary travel (a tourist, a student, a business traveller). To put it plainly: the country of insurance will continue to reimburse the country of residence. For longer journeys, the agreement specifies that the immigration rules of the host country may require additional criteria, such as the current health surcharge required by the UK to grant an entry visa of more than six months.
See the Trade and Cooperation Agreement between the EU and the United Kingdom: https://bit.ly/3s3wH1R (Original version in French by Sophie Petitjean)