Brexit risk to European medicine supply 'revised down'

New information suggests pharma firms are on top of regulatory demands




Following its revised estimate of the number of centrally-authorised medicines (CAPs) linked to supply concerns post Brexit, there is evidence to suggest many pharmaceutical companies are boosting their efforts to avoid supply issues, according to the European Medicines Agency (EMA).

As reported by the European Pharmaceutical Review, new information from companies has seen the number of anticipated CAPs supply disruptions after 29 March 2019 decrease significantly from the initial projection – shrinking from 108 to 39.

A survey conducted by the EMA earlier this year uncovered serious concerns about the potential of supply shortages, including both human and veterinary products. Further study and communication with marketing authorisation holders over the summer found a greater level of reassurance when it comes to regulatory planning, allowing the EMA to revise down.

Many of those found to be in a better position than expected had taken the steps of transferring their marketing authorisation to one of the 27 EU member nations, reassigned their qualified representative for pharmacovigilance (QPPV), relocated their pharmacovigilance system master file (PSMF) or effectively adapted their logistics and manufacturing structure to better adapt to ensure their products can still be marketed in Europe and the UK.

“Over the past few months, EMA has made a concerted effort to reach out to the marketing authorisation holders of these 108 centrally-authorised medicines to minimise the risk of supply issues for patients,” said Noël Wathion, EMA Deputy Executive Director.

“This is a positive development for human and animal health, and, as regards the remaining 39 medicines, we want to take this opportunity to remind the marketing authorisation holders of these medicines to step up their planning now to protect patients and animals from non-supply.”

Through dialogue with its scientific committees, the EMA is continuing to investigate ways to minimise the impact of Brexit on public health, such as in providing patients with access to alternative medicines.

As previously reported by Pharma Logistics IQ, risks to the pharmaceutical supply chain do remain and stockpiling as a strategy may not be sufficient to prevent shortages.

"Stockpiling is also not without its challenges as the warehousing facilities used must meet certain regulatory standards," said Elisabethann Wright, Partner at Hogan Lovells.

"This creates potential cash flow issues given that companies often have to pay suppliers before they have received payment for the product from customers."