Latham lawyers explain the impact of a no-deal Brexit scenario and how it will impact life sciences companies operating in the UK
There are now fewer than three months to go until the United Kingdom’s exit from the European Union on March 29, 2019. On Jan. 15, 2019, the UK government rejected the provisional deal proposed by the prime minister and accepted by the EU which would have offered terms for Brexit and future interactions between the UK and the EU following the withdrawal date. Unless the EU and the UK agree to an alternative deal, the withdrawal date is delayed or Article 50 is revoked, all EU primary and secondary law will cease to apply to the UK with effect from the withdrawal date, and the UK will become a “third country” for the purposes of EU legislation. Under this no-deal Brexitscenario, all provisions of EU law relating to EU member states will no longer apply to the UK, with potentially chaotic results for the life sciences industry.
In particular, the impact on marketing authorizations could be highly disruptive. The marketing authorization holder, or MAH, of a marketing authorization approved via the European Medicines Agency’s centralized approval procedure (each a CMA) must be established in the European Economic Area. Following the withdrawal date, the UK will no longer be part of the EEA, so any CMA held by a UK MAH will need to be transferred to an entity within the EEA prior to the withdrawal date. If not, it will be unlawful for the relevant CMA-approved product to be placed on the market in the EU. The EMA follows a 30-day timeline from submission of a CMA transfer application to finalization of the EMA’s transfer opinion. However, after the transfer opinion is issued, the European Commission must deliver its decision on the transfer before it becomes effective, a process which generally takes between two and three months, following which product labeling must be updated and implemented. To the extent that a CMA transfer application is not already underway, it will be too late to transfer such CMA to an EU MAH before the withdrawal date and avoid disruption to supply, even where bridging stock will be used to build supply in markets as a contingency measure.