The Falsified Medicines Directive (FMD), the new system to protect patients from fake medicines is going live across the UK and Europe on 9 February. However, various stakeholders have raised concerns on the UK dropping out of the “safest medicines system in the world” in the event of ‘no deal’ Brexit.
The system – a world-first – will secure the supply chain of medicines. It ensures that from the moment a medicine comes off the production line to the point it reaches a patient, every person and organisation it has touched can verify and authenticate the pack: from pharmaceutical manufacturers to wholesalers to pharmacies to GP surgeries and hospitals.
But Brexit uncertainty means that organisations across the UK’s medicines supply chain don’t know whether the system will still be in place in 7-weeks’ time as a ‘no deal’ Brexit would mean a UK revocation of the FMD legislation.
“Billions of packs of medicines travel around the EU annually, destined for over 500 million patients. 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,” said Rick Greville, director of supply chain at the Association of the British Pharmaceutical Industry (ABPI).
Niall Dickson, chair of the Brexit Health Alliance (BHA) – an alliance of NHS, medical research, industry, patients and public health organisations – said: “It would be a tragedy were the UK not to be a part of this new system which ultimately protects patients from fake medicines. And it is another reason why the growing prospect of leaving the EU with no deal is a matter of such concern.
“No patient should suffer as a result of Brexit. A ‘no-deal’ without alternative arrangements to protect patients is simply not acceptable and could put lives at risk.”
The ambitious system uses new technology based on a cross-Europe database – the European Medicines Verification System (EMVS) – so that medicines dispensed anywhere in the EU can be authenticated.
Questions also remain around the UK’s continued access to other important European databases, including the clinical trials database and the system which flags medicines safety alerts.