EFPIA acknowledges the UK government’s decision to trigger Article 50 following the referendum in June last year.
EFPIA believes that negotiations around the UK’s exit must ensure minimal disruption to patients, healthcare systems and the research and development of new treatments.
EFPIA continues to underscore the importance of alignment between the UK and EU regulatory regimes in order to maintain capacity, processes and time-frames for the introduction of new medicines for patients and avoid divergence and duplication of regulatory standards and practices.
Supply chain operations are interconnected, which means that a diverse range of products, including active pharmaceutical ingredients and R&D materials move back and forth throughout the Europe as part of the manufacturing process. Any disruption could lead to delays in medicines reaching patients.
EFPIA seeks alignment and continuity of EU legislation relevant to life sciences and intellectual property (IP).
It is imperative that a well-functioning IP system is in place immediately upon Brexit to ensure that: all the rights already obtained are protected within UK law; the same rights can be obtained within the UK, corresponding to a level of protection at least equivalent to that of the EU; and any transitional measures be as simple and as least burdensome as possible.
EFPIA believes that the sustainability of research funding for life sciences should be guaranteed, by maintaining full involvement of the UK in current and future research collaborations (Horizon 2020, IMI etc.). This includes continued collaboration between UK and EU research hubs. The future of research collaborations will be based on the negotiations delivering reciprocal employment rights for UK and EU citizens, safe-guarding their employment within the life science sector, including those conducting research within academic institutions.
EFPIA would also call on the negotiators to make sure that the relocation of the EMA does not impact negatively on regulatory capacity, processes or timeframes for the approval of new, and the maintenance of existing medicines. The regulatory system is in place to support patient safety and access to medicines that save and enhance lives. We call on the EU Institutions to establish transparent criteria for potential locations at an early stage in the negotiations of the withdrawal agreement with the UK.
The pharmaceutical industry in Europe strives to innovate, deliver better health for patients and drive growth in the European and UK economy. Creating a post-Brexit environment that supports these objectives should be a high priority for both sides.