Paul Brooks, Executive Director, RAPS, comments on Brexit and the operational trade and regulatory environment affecting the UK's pharmaceutical and medical device sectors
It has been nearly 2 years since the UK voted to leave the EU.
And although we find ourselves only a year away from the official exit, significant ambiguity remains, and important negotiations still must take place.
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 world, post 29 March 2019 — undermines future regulatory planning and confidence.
It is currently unclear how the UK and the Medicines & Healthcare products Regulatory Agency (MHRA) will co-operate 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 owing to an enormous lack of clarity and uncertainty as negotiations continue.
The clock is ticking!
During the next 12 months, it is imperative that manufacturers realise the increasingly important role the regulatory profession plays in monitoring, collaborating and interpreting developments, preparing contingency plans and reacting by delivering successful regulatory strategies.
This requires manufacturers to strengthen and support their regulatory workforces to ensure a smooth transition when the time arrives.
Manufacturers with strong regulatory resources, intelligence and structure will be much better prepared to disseminate the outcomes in the new regulatory landscape as March 2019 approaches, and these well-prepared companies will, no doubt, position themselves as the most competitive in the market.
This will be especially true for small and medium-sized medical device companies.
Regulatory professionals are accustomed to leading and establishing predictability in activities where the outcomes are inherently unpredictable. Our role is to minimise the unexpected.
The outcomes and consequences of Brexit are still far from predictable, but our role as a profession is to press for practical, effective solutions that serve all stakeholders. The most important goal is that we maintain access for all Europeans to the most effective, affordable, safe and innovative healthcare products.
RAPS is closely monitoring this period of uncertainty and transition and is committed to informing regulatory professionals with the latest news and insights as they develop.