1:23 PM
Apr 11, 2019
 |  BC Extra  |  Politics & Policy

Regulatory reprieve with Brexit delay

An EU-granted extension for Brexit means short-term clarity for biopharma companies expecting EMA or European Commission decisions before the new Oct. 31 deadline.

The U.K. had been scheduled to leave the union Friday.

At least seven companies are awaiting a CHMP opinion or EC action this quarter: Evolus Inc. (NASDAQ:EOLS); Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX); Sanofi (Euronext:SAN; NASDAQ:SNY), Novartis AG (NYSE:NVS; SIX:NOVN); RegenxBio Inc. (NASDAQ:RGNX); Portola Pharmaceuticals Inc. (NASDAQ:PTLA); Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NASDAQ:SNY) (see “Big Caps Under Pressure”).

The extension also presents industry and government agencies an opportunity to better prepare in case no political agreement is struck by the new deadline.

On Monday, U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) added another document to bring its package of guidances on a possible no-deal scenario to 40, this time assuring it would be prepared to issue certificates permitting the export of grandfathered pharmaceutical products (see “As Brexit Votes Loom, New Drug Regulatory Pathway Takes Shape”).

Both European Federation of Pharmaceutical Industries and Associations (EFPIA) and Association of the British Pharmaceutical Industry (ABPI) said that companies are doing all they can to protect the supply of drugs whatever the outcome. They plan to review whether current plans for a no-deal Brexit are still appropriate.

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