An European Medicines Agency (EMA) survey on industry preparedness for Brexit, conducted earlier this year, found nearly half of companies were not adequately prepared.
Earlier this week, the EMA announced the overall number of medicines that could be subject to disruption has now dropped from 108 to 39.
The reason for potential disruption is due to the number of medicines that have a step of their manufacturing process within the UK; companies that have a UK-based process method need to ensure that they transfer marketing authorisation to a country within the EU, as well as having a qualified person for pharmacovigilance located within the EU and needing to relocate their pharmacovigilance system master file – amongst other requirements.
Though the number is vastly reduced, there are still 39 medicines deemed ‘at risk’: “For each of the 39 remaining products (25 human medicines and 14 veterinary medicines), EMA is analysing how to minimise supply disruptions and any resulting impact on public and animal health.”
In addition, the agency noted that it would continue to work directly with the marketing authorisation holders to attempt to minimise any potential disruption.
Many of the larger pharmaceutical companies concerned have moved to ensure a stockpile of medicine is built prior to the Brexit deadline of March 29, 2019.
Even before the UK government advised companies to build a greater surplus of medicines, there had been a number of announcements from companies such as AstraZeneca and Sanofi stating that they were preparing for potential disruption of supply.
Once the announcement had been made, further companies came forward to announce that they too would be stockpiling products.
Even the EMA itself has had to make adjustments leading up to the deadline announcing plans to reduce its activity in order to manage the number of staff that would be lost as a result of Brexit.