I spoke with several companies and logistics/regulatory experts to find out how Brexit might impact pharma supply chains. themedicinemaker.com/issues/0218/ho… 
Many companies, such as @LillyPad, have several products that cross UK/EU borders multiple times. Customs checks may force companies to “explore and validate new supply routes.”
Merck KGaA have said 12 percent of their products are “dropshipped” directly to customers from Germany “within 24 hours of an order being placed” and that any delays at UK ports would have a “significant impact” on the company’s ability to meet the needs of its clients.
J&J have also said “systems *must* [my emphasis] be put in place” to ensure that ingredients and products can continue to cross the border multiple times in the manufacturing and distribution process “without the need for Border Inspection Post Personnel checks and tariffs.”
Virgina Acha, Executive Director of Global Regulatory Policy at @MSDintheUK, told me “Biopharma discovery, development, manufacture and supply chain arrangements take many years to undertake and many years to change.”
There’s also the prospect of transferring MAs, orphan designations, batch release, Qualified Person Responsible for Pharmacovigilance, and Pharmacovigilance System Master Files, to the EEA...
Sascha Sonnenberg from Marken told me he’s concerned about a bottleneck on the EU side as companies rush to make sure they’re ready to carry out batch release, as it could "delay or endanger ongoing clinical trials."
David Jefferys from Eisai Europe said the cost of new premises and distribution, along with having to transfer MAs to the EEA, would cost in the region of £5 million for the company. And J&J have said the 50,000 additional tests every year would cost almost £1 million per year.
There are also some specific concerns around cell and gene therapies, some of which involve extracting patient cells shipping them for treatment, before sending them back to the patient – all within 48 hours...
...Often these are late-stage cancer treatments where the patient might not be in a position to donate additional cells.
Overall, pharma companies have had 25 years – since the single market was established – to build their supply chains upon a frictionless foundation. This is my attempt to lay out what is required for this to continue
And one final point is that even if pharma gets what it wants in terms of continued regulatory harmonization, it’s relying on frictionless trade for other sectors as well – they’ll be using the same ports and roads as exporters from other industries.
