Associations that represent both the European and British life sciences industries have urged the UK and European member states to secure cooperation post-Brexit so that access to medicine for patients can be safeguarded.
Brexit relations
The AESGP, EFPIA, EuropaBio, EUCOPE, Medicines for Europe, ABPI, BGMA, BIA and PAGB have joined forces to underline the importance of future cooperation and urge for progress to be made on the negotiations as soon as possible.
In a statement released by the EFPIA, it was announced:
“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.
“Our industry 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.
“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.
“Clarity and certainty are needed as early as possible to enable our 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.”