The associations representing the European and British biomedical industry (AESGP, EFPIA, EuropaBio, EUCOPE, Medicines for Europe, ABPI, BGMA, BIA, PAGB) have insisted on the importance of ensuring cooperation between the United Kingdom and the European Union in terms of pharmaceutical regulation.
“Whilst we respect the phased approach of negotiations, we urge progress to be made in the negotiations as soon as possible,” they said in a statement made public on Tuesday. “We urge Brexit negotiators on both sides to agree on a transition period that adequately reflects the time needed by companies, as well as all relevant authorities at EU and national level to adapt to changes in view of the UK exiting the EU. The transition period should provide for continued EU-UK partnership on the regulation and supply of medicines, to avoid supply disruption while moving forward towards a future cooperation agreement between the EU and the UK.”
The aforementioned statement is an addition to the letter that the same associations sent last July to the negotiators of both parties, Michel Barnier and Hon David Davis, representatives of the EU and the United Kingdom respectively, in which they urged them to avoid the possible problems of access to medicines.
The associations now emphasize that the industry they represent is, “highly integrated across Europe, and regulated under EU law through a sophisticated system of legal and regulatory arrangements involving EU Institutions, Member States and national competent authorities.” They point out that, “for our sector Brexit represents a challenge in several areas, notably regulatory procedures, quality testing of medicines, supply chain, trade, and intellectual property. For example, medicines companies may need to submit applications for the transfer of marketing authorisation for many products, move batch release sites and duplicate quality testing for products or move personnel into either jurisdiction. This will take a significant amount of time and will result in capacity issues which cannot be resolved before March 2019.”
The representatives of the biomedical industry ask for clarity and certainty as soon as possible to enable the industry to, “make the necessary changes and to transition smoothly into the new framework. This is key to ensure that there is no disruption in the supply of medicines tor patients after March 2019.”
“Even in the context of the Brexit negotiations where all sectors are looking for clarity on the future, it’s important to recognise that medicines are different. Our goal is ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines through Brexit and beyond, and to ensure that there is no adverse impact on public health. This goal should be front of mind for both the EU and UK negotiating teams.”