Anticipating a no-deal Brexit, drug company AstraZeneca plans to enhance its stockpiles of drugs in Europe by almost 20%.
There could be a possible hard Brexit in April 2019 and the European regulator has informed companies to get ready for such an eventuality.
That means in order to ensure that there is a smooth supply of medicines, drug companies would need to duplicate drugs testing, replicate licences and undertake other necessary measures.
Already £40m has bene spent in preparing for “no-deal”, the FTSE 100 drugs giant said.
Ever since the 2016 referendum., preparations for a no-deal Brexit was being made by the company, said Juliette White, vice-president of global external manufacturing at AstraZeneca.
“Ultimately – and as a safety net – we will increase the amount of finished medicines available to pharmacies and hospitals in those countries,” said White, referring to both the UK and the European Union.
“We always have an additional amount of medicines available. We are increasing that by about 20%.”
While there is monthly export of about 45 million packs of medicine from the UK to Europe, about 37 million packs move to the UK from the EU. The relevant medicines regulators need to license, test and certify those medicines.
Currently a test done in the UK is considered to be valid in the EU and vice versa. That would not be the same in case of a no-deal Brexit. And companies have already been told by the European regulator to make plans for a no-deal Brexit.
To be legally valid, drugs would need to be authorised and tested within the EU.
About 7,000 people is employed in the UK by AstraZeneca.at the current moment, the company is striving to create duplicate labs in its European manufacturing facilities in line with its UK labs, shifting of technology and methods to European countries, transferring of critical personnel, and shifting or duplicating regulatory approvals which is also known as marketing authorisations in various jurisdictions.
This second largest UK drug manufacturer has created a team comprising of over 30 members to work on Brexit preparations.
There had to be early planning for hard Brexit by companies operating in the highly regulated industries such as pharmaceuticals and banking. However, for the pharma industry the time remaining is very limited.
The European Medicines Agency said last week that it had “serious concerns” in relation to the work the still requires to get completed by the 108 drugs which are only manufactured within the UK.
The industry could encounter problems, AstraZeneca had already warned regulators, White said.
“In the event of a hard Brexit and a particular product that we couldn’t complete all of those complex activities in time for, then we’d ask for a specific time extension from those regulatory authorities,” she said.
(Adapted from BBC.com)