No-deal Brexit ‘raises risk of falsified medicines entering UK’

If the UK leaves the EU with no deal on October 31 there will be “harmful consequences” for the detection of unsafe or counterfeit medicines, says a new report.

The document – from the House of Commons Exiting the EU Committee – reiterates the point that the UK will be treated as a third country if it crashes out of the EU, and there will be no provisions in place on the exchange of data.

That will exclude the UK from the verification systems implemented under the Falsified Medicines Directive, as well as data-sharing systems important for clinical trials and the detection of adverse drug reactions.

That means, says the committee, that the UK must “set out urgently options for a replacement safety framework to eliminate the risk of unsafe and counterfeit medicines entering the UK supply chain.”

The FMD has required that February 9, 2019, every pack of medicine put on the EU market has a unique barcode to be scanned before the medicine can be dispensed, to prevent patients receiving falsified, expired, recalled or otherwise unsafe drugs.

In testimony to the committee, the chief executive of the biopharma trade group the BioIndustry Association (BIA), Steve Bates, said that in a no-deal situation “packs of medicines would be expected to have their unique code decommissioned on export from the EU.”

Without access to the central hub that underpins the European medicines verification system, the UK has stated it will revoke the FMD safety features legislation as part of its contingency planning.

“Regulatory obligations relating to FMD safety features would therefore cease to apply in the UK,” said Bates, and that would result in a “real threat of counterfeit medicines entering the UK supply chain.”

The report also points out that there will be major challenges in pharma manufacturing as ingredients and components often have to cross borders multiple times during the production process.

The final conclusion of the report makes it clear how serious the consequences of a no-deal exit would be, despite the protestations of the new government under Prime Minister Boris Johnson, whose latest play has been to accuse opposition MPs of colluding with the EU to try to prevent Brexit altogether.

“Some have argued that a no deal exit would bring the EU “back to the table” and that the UK would secure a better deal as a result. This is, at best, a gamble,” it says.

“At worst, it could lead to severe disruption of the economy, pose a fundamental risk to the competitiveness of key sectors of the UK economy, and put many jobs and livelihoods at risk.”

Labour Party leader Jeremy Corbyn has urged the leaders of the other opposition parties as well as rebels from the ruling Conservative party to install him as caretaker PM in order to stop a no-deal Brexit.

Corbyn wants to call a vote of no confidence in the government, delay Brexit in order to allow a general election to take place and – apparently reluctantly – campaign for a second referendum.