No-deal Brexit could put UK patients at risk of fake medicines

The Association of the British Pharmaceutical Industry (ABPI), a trade group representing drugmakers in the UK, has warned that patients in the country could be at risk of counterfeit medicines in the event of a no-deal Brexit.

The warning comes as a new technology designed to identify counterfeit medicines is set to go live across Europe on 9 February 2019.

The new European Medicines Verification System (EMVS) is to be used by all parties in the drug supply chain, including manufacturers, wholesalers, pharmacies and hospitals.

It is linked with a cross-Europe database in order to facilitate authentication of medicines dispensed anywhere in the European Union (EU).

Developed and co-ordinated by the European Medicines Verification Organisation (EMVO), the new system is being implemented through the Falsified Medicines Directive (FMD).

However, the UK leaving the EU without a deal would mean dropping out of the new system as well. This would expose the patients to the dangers of fake medicines, the ABPI noted.

ABPI supply chain director Rick Greville said: "Billions of packs of medicines travel around the EU annually, destined for over 500 million patients. This new system means that patients across Europe will have the best protection from fake medicines in the world.

"It would be an absolute travesty if NHS patients aren’t part of a system specifically designed to protect them. But that’s exactly what could happen in a ‘no deal’ Brexit. It is just another reason why we urgently need a Brexit deal."

Meanwhile, the US is also boosting its efforts to improve security across the drug supply chain.

The US Food and Drug Administration (FDA) has announced a pilot project of new technologies and methods to track and verify prescription drugs in the country.

As part of the pilot, participants representing the drug supply chain will be able to use an electronic, interoperable track-and-trace system that is scheduled to go into effect in 2023.

This new system is intended to minimise diversion of drugs and prevent falsified medicines from reaching patients.

According to the World Health Organization (WHO), counterfeit medicines are a growing threat across all countries and regions. An estimate shows that one in ten medical products in low- and middle-income countries is substandard or falsified.

Additional reporting by Allie Nawrat: 

The EU’s Falsified Medicines Directive was adopted by the EU Parliament and the European Council in 2011. The final part of the plan, the EMCV, will come into effect on 9 February 2019.

The core aspects of the EMCV’s new safety features are a unique identifier placed on the product to be scanned at various points in the supply chain and tamper evident features on the pack.

If at any point during the supply chain a warning is linked with a certain pack, the medicine or medical device will not be supplied to a patient. This will trigger an investigation into whether the product is counterfeit or not.

In its updated January guidance on preparations for no-deal Brexit, the MHRA said: "In the event of no deal, it is expected UK stakeholders would no longer be able to comply with the requirement to verify and authenticate. Therefore, the legal obligations related to this would be removed for all actors in the UK supply chain.

"Packs containing the Falsified Medicines Directive (FMD) safety features would still be accepted in the UK, provided that they are in line with other UK packaging requirements.

"In the interests of public safety, we will evaluate the options for a future UK falsified medicines regulatory framework, taking into account the investment already made by stakeholders."

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