This week marks six months until the European Medicines Agency relocates from London to Amsterdam, the Netherlands, as a result of the UK’s decision to withdraw – ‘Brexit’ – from the European Union (EU).
While it remains unclear whether the UK will align its regulations and regulatory processes for pharmaceuticals with those of the EU, “future-proofing a healthy industry that best serves patients and healthcare providers is at the top of the UK’s agenda,” said Regulatory Affairs Professionals Society (RAPS) executive director, Paul Brooks.
According to Brooks, there are too many variables to be able to accurately predict what the future holds for UK pharmaceutical companies post-Brexit.
“It is similarly difficult to forecast what the wider economic and logistical impacts will be on the pharmaceutical and medical device industries within the UK and the EU, as well as manufacturers outside the EU and UK wishing to place products onto the UK market.
“Clarity on the operational trade and regulatory post-Brexit environment is urgently needed,” he said.
According to Brooks, a mutual recognition agreement between the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and EU Member States could help reduce time and resources for drug manufacturers.
“Failing to reach a desirable outcome could be a significant problem for the UK pharmaceutical and medical device markets as it could potentially lead to a duplication of regulatory efforts if the processes and procedures for the UK and EU significantly diverge and/or don’t achieve mutual recognition,” said Brooks.
“The ramifications to the sector and all stakeholders will be very significant if manufacturers can’t efficiently access the European and UK markets through aligned systems with mutual recognition,” he added.
UK-based notified bodies (NBs) will be similarly affected by Brexit, we were told: “Most have implemented a plan B to move or duplicate their NB certification location to one of the 27 EU Member States to ensure continued recognition within the EU.”
In addition, “poorly prepared” companies could jeopardise their own businesses, said Brooks: “The entire European supply of medicines and medical devices could be in jeopardy as well,” he added.