EFPIA Expresses Concern at Postponement of Resolution on EMA Relocation
As talks begin in earnest on the United Kingdom’s departure from the EU, EFPIA expresses its concern that the Heads of State yesterday decided to postpone a resolution on the relocation of the European Medicines Agency until November this year.
We acknowledge the extensive range of issues that must be addressed during the Brexit negotiations over the next one-and-a-half years. Nevertheless, the research based pharmaceutical industry underscores that medicines constitute a special case in term of securing swift agreement on both sides, given the fact that they affect directly the health and wellbeing of citizens in both Europe and the UK.
For over two decades, EU Member States have benefitted from and relied upon the critical work undertaken by the EMA. The agency continues to be a world-class regulator, whose scientific recommendations, new medicines approvals, pharmacovigilance and safety monitoring activities are vital elements of the ongoing effort to provide EU citizens with effective, safe and high-quality medicines.
It is imperative for the safeguarding of public health that we ensure future alignment between the UK and EU regulatory regimes in order to maintain capacity, processes and timeframes for the introduction of new medicines for patients. It will be critical to avoid divergence and duplication of regulatory standards and practices, so that patient safety is not put at risk.
Any future location of the EMA must have world-class connectivity. This is a critical requirement, which will ensure that the agency is capable of managing and accommodating the 36,000 expert visits that it must facilitate currently on an annual basis, in addition to a great number of regulatory exchanges with the global pharmaceutical industry.
Equally important will be: excellent transport links (international, regional and local transport); a building that will allow the EMA to host the vast number of essential expert meetings it organises annually; and a location that offers a large number of hotel rooms needed to accommodate the necessary scientific and regulatory experts who engage with the agency.
The same attention must be given to retaining a highly competent staff component. Sufficient and adequate housing, access to international/ European schools for staff with children, employment opportunities for spouses/ partners are also likely to be prerequisite factors for any future location selection process. A failure to take into account the minimum prerequisites or the failure to achieve a rapid resolution on the future location of the EMA would threaten the quality of its work and the future of the European Medicines Regulatory Network .
We believe therefore that priority must be given to ending the uncertainty over the location of the EMA and to ensuring that transitional arrangements are in place for issues that may impact patient safety and patient health. It is a serious concern that the Heads of State deliberations on the Agency’s future has not resulted in an early decision on the EMA’s relocation: in the event of obstruction or eventual failure, Europe possesses no backup option.