In an unprecedented move, eight leaders from associations representing the entire EU and UK pharmaceutical sector have written a joint letter to chief Brexit negotiators Michel Barnier and David Davis requesting that ongoing cooperation between the two territories for medicines be a negotiating priority.
Securing an agreement between the EU and UK “is the best way of ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines and to ensure that there is no adverse impact on public health,” the letter states.
The industry is highly integrated across Europe and regulated under EU law “through a sophisticated system of legal and regulatory arrangements between EU institutions, Member States and national competent authorities,” it notes, adding: “It is important that there is as much certainty as possible, as early as possible, to enable the pharmaceutical and life science industry to transition smoothly into the new framework, ensuring there is no disruption to patient access to medicines”.
The leaders call for the maintenance of previously granted European marketing authorisations both in the UK and the EU and continued cooperation between national authorities as facilitated by the European Medicines Agency and European Commission, and also stress that any changes to the EU-UK trading relationship “should not adversely affect the research, development, manufacture and supply of medicines across Europe, including for clinical trials.”
They also note that the UK’s MHRA currently makes “a significant contribution” to the work of the European regulatory network, and argue that there its withdrawal “would mean a loss of capacity and expertise for the network for the review of medicines as well as the capacity across Europe for the surveillance and safety supervision of products.”
The letter warns that, in the case of an “unorderly withdrawal”, there is a risk that all goods due to be moved between the UK and EU could be held either at border checks or in warehouses subject to extensive retesting requirements. “This would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines.”
An implementation period should also be agreed on by negotiators to allow pharmaceutical and biotech companies to transition to a new framework and “avoid any unintended consequences on the availability of the medicines.”
The move follows a letter published in the Financial Times last week by Jeremy Hunt, Secretary of State for Health, and Greg Clark, Secretary of State for Business, which said the UK “would like to find a way to continue to collaborate with the EU, in the interests of public health and safety” post Brexit.