Brexit could complicate marketing status of drugs, new licenses
- A decision by the U.K. to leave the E.U. would likely complicate the status of drugs approved under E.U. marketing authorizations, Reuters reports. Authorizations can only be held by companies located within the E.U., and a 'Brexit' would jeopardize the five-year initial licensing for new drugs—i.e. a drug winning approval one year before a U.K. departure might lose those remaining four years.
- One of the major advantages for life sciences companies in the E.U. is the ability to procure a single marketing authorization for the entire block of EU countries via European Medicines Agency (EMA) approval. Leaving would mean opting out of a harmonized regulatory system, and could force the EMA to move its headquarters from London.
- The European Federation of Pharmaceutical Industries and Associations (EFPIA) has repeatedly expressed concerns about the impact of Brexit on the EU-based life sciences industry.
Even though the U.K. will vote in a referendum on June 23, the actual Brexit would not be immediately imminent. But the potential downstream consequences for the life sciences industry across the E.U. would still be far-reaching. Challenges range from regulatory approvals and patient access to the status of current marketing approvals.
The EFPIA is categorically opposed to the UK opting out of the EU. In a February statement, the trade organization said it "believes that the UK’s continued membership of the EU is in the best interests of the pharmaceutical industry in the UK and across Europe."
If a Brexit occurred, U.K. drug companies would no longer gain access to the 500-million patient E.U. while E.U.-based companies would lose out on the U.K. market. U.K. drug companies could choose to transfer their licenses on drugs to businesses still located in the E.U. bloc.
Both AstraZeneca and and GlaxoSmithKline have drawn up contingency plans for an exit, Reuters writes.