Brexit: Uncertainty and ambiguity for pharma sector

It has been nearly two years since the UK voted to leave the European Union. While we find ourselves only a year away from the official exit, significant ambiguity remains, and important negotiations still must take place, notes Paul Brooks, executive director of the Regulatory Affairs Professionals Society (RAPS).

From the regulatory community’s perspective, we need to offer strategic regulatory direction, risk abatement and confidence on regulatory expectations. Current uncertainty about the operational trade and regulatory environment affecting the UK pharmaceutical and medical device sectors, and the ongoing relationship and reciprocity with the rest of the EU - and to a degree the rest of the word, post March 29, 2019 - undermines future regulatory planning and confidence.

It is currently unclear how the UK and the Medicines & Healthcare products Regulatory Agency (MHRA) will cooperate with the European Medicines Agency (EMA) and MHRA’s role will be under the new EU medical device regulations after Brexit. It is equally important to consider how UK expertise and values may continue to influence decisions taken within Europe and how they can support a healthy pan-European marketplace focused on achieving effective and safe innovation and serving/protecting key stakeholder expectations. This leaves the healthcare product industry at significant risk as we cannot begin to adequately prepare for future outcomes due to an enormous lack of clarity and uncertainty as negotiations continue. The clock is ticking, warns Mr Brooks.