The Association of the British Pharmaceutical Industry (ABPI) warned Friday that in the event of a 'no deal' Brexit, the UK will drop out of an initiative set to launch across the EU on February 9 designed to protect patients from falsified or fake medicines. As part of the Falsified Medicines Directive (FMD), manufacturers will upload information about medicines to a central EU repository, dubbed the European Medicines Verification System, which is part of an end-to-end medicines verification system introduced by the regulation.
The technology behind the FMD means that medicines can be verified and authenticated from the moment they come off the production line to the point it reaches a patient. As part of the initiative, most prescription medicines and some over-the-counter drugs supplied in the EU will have a unique identifier and an anti-tampering device on their outer packaging.
Rick Greville, director of supply chain at the ABPI, said "this new system means that patients across Europe will have the best protection from fake medicines in the world." However, Greville noted "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."
According to the ABPI, the UK has contributed to the development of the FMD, while pharmaceutical companies, along with partners, have led the way in funding and setting up the system in the UK over the past two years. The ABPI warned "that organisations across the UK's medicines supply chain don't know whether the system will still be in place in seven-weeks' time as a 'no deal' Brexit would mean a UK revocation of the FMD legislation."
ABPI chief executive Mike Thompson remarked "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."
Under the scheme, the European Medicines Agency noted that depending on the source of the drug, wholesalers will also need to scan the medicine at different points in the supply chain to verify their authenticity. The regulator added that pharmacies and hospitals will then scan each medicine at the end of the supply chain to verify their authenticity and check them out from the repository before dispensing them to patients. The FMD applies to all members of the EU as of February 9, except for Greece and Italy, who have until 2025 to update their already existing tracking systems.