Brexit Update: Calls for Customs Clarity

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released a survey that highlights the heavily integrated nature of pharma supply chains in the EU and UK. According to the authors, 45 million patient packs are supplied from the UK to other EU/European Economic Area (EEA) countries each month, with over 37 million going the other way. Over 2600 final products have some stage of manufacture based in the UK (1).

“Companies manufacturing these products will be amongst the most aware of the impact that World Trade Organization (WTO) rules will have on their businesses, particularly in the case of medicines, which are very time-sensitive,” says Elizabeth Kuiper, Executive Director of Public Affairs at the EFPIA. “Each company is preparing for Brexit and taking contingency planning extremely seriously.” When the UK leaves the EU, it will become a “third country.” And unless the UK remains a member of the EEA, over 12,000 licensed presentations of centrally authorized medicines will require a separate Market Authorization in the UK before they can be prescribed to patients. According to the survey, 17 percent of centralized marketing authorizations are held in the UK.

In the event that the UK and the EU fail to reach an agreement, the UK will revert back to “WTO rules.” The US, Canada, Australia, Japan and Switzerland all have Mutual Recognition Agreements (MRAs) – plus other bilateral agreements – with the EU to facilitate trade with the block. According to EFPIA’s survey, 45 percent of EFPIA members expect trade delays if the UK and Europe fall back to WTO rules. “A ‘no deal’ scenario would result in multiple barriers to frictionless trade, and is likely to disrupt the complex supply chains for medicines,” says Kuiper. “We would be concerned that any customs delays may impact on medicines reaching patients. It is essential that the EU and UK put patients first in the Article 50 negotiations, and secure cooperation on medicines regulation and supply.” A “no deal” scenario could also impact ongoing clinical trials. The survey found that 70 percent of investigative medicinal products being used in ongoing EU clinical trials have been released from the UK, with 50 percent of those trials scheduled to continue beyond March 2019 – the end of the Article 50 process.

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