Pharma unaware of key no-deal Brexit impact; report

US and EU drug companies seem to be unaware of a development in the event of a no-deal Brexit that could seriously disrupt the supply chain, says GlobalData.

Citing comments by NSF International’s Lynne Byers at a recent industry event, the market research firm says that “if drug makers change their drug’s batch release site or have to reapply for a marketing authorisation, they will need to repackage their drug, making this Brexit’s biggest and currently least understood impact on pharma companies.”

Currently, new drugs are approved in the EU by a mutual recognition procedure (MRP) whereby a single EU country assesses the product and awards a marketing authorisation, which then holds for all EU countries.

In the event of a no-deal Brexit, the UK has said that it will automatically grant UK marketing authorisation to drugs that already have a centralised EU approval after Brexit occurs on March 29, 2019. However, GlobalData notes that this UK license “will require a new marketing authorisation number that must be placed on the outside of the drug packaging.”

The same rule applies to products that are currently being sold in the EU after being originally approved in the UK, it points out. They will also require a new marketing authorisation number to continue to be sold in the EU.

Companies are already starting to move authorisations to legal entities in pertinent jurisdiction to sidestep the issue and, according to GlobalData, the UK has given companies until the end of 2020 to make these adjustments. However, the official EU deadline for acquiring a new marketing authorisation holder (MAH) within the EU is on the date the UK leaves the EU, i.e. March 29, 2019.

It is expected that many countries will give a grace period of six months for companies to change their drug packaging so that the new marketing authorization number is displayed, says GlobalData’s Fiona Barry, who adds: “this change remains a huge task for pharma companies with large product portfolios which typically have thousands of units in stock.”

“Few pharma companies have in-house artwork and design teams preferring instead to outsource their requirements to specialist design agencies,” continues Barry. “These agencies are typically small to medium sized enterprises (SMEs) and it is unclear whether they or the other suppliers in the packaging supply chain, like contract packaging organisations (CPOs) and contract manufacturing organisations (CMOs) will have the capacity or resources to produce all of the required updated packaging on time across an entire global market.”