Getting ready for Brexit

Hard Brexit or soft Brexit – however the UK will leave the European Union next year, the process is sure to cause some disruption. Now, pharma heavyweights Novartis and Sanofi said they have started stockpiling medicines in Britain to lessen the impact, Reuters reports. British drugmaker AstraZeneca had already announced similar measures mid-July.

“Alongside most other pharmaceutical companies, Novartis is preparing for the possibility of a no-deal Brexit. We are planning to hold increased inventories across our portfolio of medicines from both Novartis and Sandoz,” a statement by Novartis said. 

“Patient safety is our main priority and we have made arrangements for additional warehouse capacity in order to stockpile our products, where global supply allows, in the UK and increase UK-based resource to prepare for any changes to customs or regulatory processes,” commented Sanofi UK managing director Hugo Fry. 

Meanwhile, the European Medicines Agency announced it would have to suspend non-essential activities in order to safeguard core activities related to the evaluation and supervision of medicines. Due to the move of the agency to Amsterdam in March of 2019, EMA said they will have to cope with a loss of almost a third of its staff. “EMA has put in place supporting measures to facilitate the relocation of staff to Amsterdam and additional support is provided by the Dutch government. Other mitigating actions, such as a comprehensive staff recruitment programme, are already underway. However, in the short- to mid-term EMA will have to reprioritise its resources to fully maintain its core activities related to the evaluation and supervision of medicines to the level of quality and within the timelines expected,” said a statement. 

In mid-July, EMA had called upon pharma companies step up efforts to ensure medicine supply in the EU. A survey had shown that more than 100 marketing authorisation holders with manufacturing sites located in the UK only were not on track with their regulatory planning to ensure that their marketing authorisation remains valid once the UK leaves the EU. According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the EEA for a company to be able to market a medicine in the EU.