Organisations representing the life science industry in the EU and the UK have called for medicines to be a priority in phase 2 of the Article 50 negotiations.
Setting out their priorities in advance of the European Council taking place on 14-15 December in Brussels, the sector has sent a clear message that the regulation, trade and supply of medicines must be a priority for the second phase of negotiations.
Whilst being encouraged by the breakthrough in phase 1 of the negotiations so that the second phase can now begin, the sector states that focusing on the framework for transitional arrangements and future relations with the UK must be a priority for negotiators.
The organisations are of the opinion that the agreement of transitional arrangements after March 2019 will be critical in ensuring there is minimal disruption to patients receiving medicines after the UK leaves the EU.
Such a period will be essential in allowing companies to make the necessary changes to marketing authorisations and to their supply chains and ensure patients experience no disruption to their access to medicines.
As such, negotiators should include access to medicines and the implications of Brexit for patients across the EU in the second phase of negotiations and be agreed in both the future agreement and in transitional arrangements.
The publication of this joint policy paper shows that the integrated nature of the supply chains for medicines across Europe, alongside a shared regulatory framework, means that patients in both the UK and EU need an early agreement on the future of medicines in phase 2 of the negotiations.
Among several key priorities, the joint paper sets out the following:
- patient access to medicines must be a primary consideration for phase two of the Article 50 negotiations
- close cooperation in the regulation of medicines, including mutual recognition of regulatory activities and quality testing, is essential in ensuring that patients in the EU and the UK can continue to access medicines
- trade between the UK and EU will ensure that medicines are able to continue to move between both regions, ensuring that both UK and EU patients can continue to access medicines
- provided the UK remains in the single market or in a new legal arrangement with the EU based on consistency of regulatory frameworks, the EU and the UK IP systems should remain aligned in order to avoid uncertainties for industry.