Following months of talks and a major last-minute hitch, UK Prime Minister Theresa May and European Commission President Jean Claude-Junker have announced that “sufficient progress” has been made in the first phase of Brexit negotiations and work can now begin on the all-important future trade deal.
The Prime Minister outlined the outcomes of the first phase of negotiations, stating that they represent a “fair and reciprocal deal” between the UK and EU. This deal guarantees the rights of UK and EU citizens to continue to reside in each respective jurisdiction and establishes an agreement on the UK’s financial obligations to the EU. Significantly, the agreement recognises the need to uphold the Belfast agreement in full, therefore retaining the common travel area with Ireland. In addition, citizens’ rights will be upheld in UK courts while paying due regard to relevant European Court of Justice (ECJ) case law, and for eight years after the UK’s exit, UK courts will be able to voluntarily ask for interpretation by the ECJ where existing law is unclear.
Given the recent impasse in Brexit negotiations, this breakthrough in Brexit negotiations has been welcomed by the pharmaceutical industry, particularly in light of the joint statement underlining the importance of securing cooperation between the UK and EU on medicines regulation that was issued on 28 November by associations representing the European and British life science industry. The Prime Minister has stated that arrangements around areas including pharmaceuticals are matters for negotiation in the second phase of negotiations, and the sector is now clearly keen to push for progress in terms of regulatory arrangements for medicines and medical devices.
In a statement welcoming the agreement, Steve Bates, Chief Executive of the UK BioIndustry Association said: “It is now crucial that the UK and EU agree a transition period to ensure that the supply of medicines to patients in the UK and across Europe is not affected. Public health and health security should be the first priority for the second phase of talks and we stand ready as a unified life science sector to provide expert input on such a process.
“On the detail, greater certainty in key areas proposed is welcome… My initial reading of the ‘goods on the market’ proposals is that it should enable medicinal products that have been tested and released prior to the Brexit date (which may well now be later than March 2019) to be freely available in the EU, even if that testing and release is carried out in the UK and the goods are shipped to other EU countries after the UK withdraws. This is important detail for global companies deciding how, and crucially when, to progress existing Brexit contingency plans.”
Also ‘warmly welcoming’ the breakthrough, The Association of the British Pharmaceutical Industry said: “As we now focus on phase two of the negotiations, it is now crucial that the regulation and supply of medicines for UK and EU patients is prioritised. A cooperation agreement between the UK and the EU on medicines is the best way to ensure that there is no disruption to 500m patients receiving the medicines that they need. This breakthrough, alongside a single-step fixed-term transition period that allows companies to make any necessary changes to the supply chain, will be critical. Protecting public health in the UK and Europe must be a priority.”