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UK may lose access to verified medicines database

11/02/19

Parliamentary Correspondent

Patients will be at risk from fake medicines if the UK leaves the EU without a deal because access to a new EU-wide database could be lost, pharmaceutical leaders have warned.

Pill bottle

The new technology only went live on 9 February – allowing manufacturers, pharmacies, GP surgeries and hospitals to verify medicines from the production line to the point of treatment.

But this “safest medicines system in the world” will be shut off to the UK if it crashes out of the EU without an exit agreement on 29 March.

The new European Medicines Verification System (EMVS) involves serialising the packaging of prescription medicines with a unique identifier that is then uploaded.

Using specifically designed software, everyone along the supply chain will be able to scan the data matrix on the outer packaging to verify its authenticity as it travels through to the patient.

It has been built to support the Falsified Medicines Directive (FMD), which the Association of the British Pharmaceutical Industry (ABPI) said provided guarantees for the billions of packs of medicines that travel around the EU every year.

Travesty

“It would be an absolute travesty if NHS patients aren't part of a system specifically designed to protect them,” said Dr Rick Greville, director of supply chain at the ABPI.

“But that's exactly what could happen in a no-deal Brexit. It is just another reason why we urgently need a Brexit deal.”

Mike Thompson, the organisation’s chief executive added: “Not being part of the safest medicines system in the world, one that the UK has helped design and build, and which provides protection against fake medicines, makes no sense.”

Last year, UK authorities seized more than a million doses of fake medicines and medical devices worth in excess of £2 million in a single week.

The ABPI said there was also uncertainty around the UK's continued access to other European databases, including the clinical trials database and a system which flags medicines safety alerts.

Robust safety

The Medicines and Healthcare Products Regulatory Agency (MHRA) attempted to calm the concerns by insisting safety measures would continue to be “as robust as possible in the event of a no-deal scenario”.

“The UK has played an important role in helping to shape the Falsified Medicines Directive and, in the event of a no-deal, packs containing the FMD safety features will be accepted in the UK, provided they are in line with other UK packaging requirements,” a spokesperson said.

“We have one of the safest medicines systems in the world and we will continue to make sure the public has access to the best and most innovative medicines, as quickly and safely as possible.”

Image from GOV.UK, Open Government Licence v3.0

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