Current Issues
Falsified Medicines Directive
The Falsified Medicines Directive (FMD) is a European Union regulation designed to protect Member States from the threat of falsified medicines. It requires individual medicines to be verified throughout the legitimate supply chain, protecting patients from potentially dangerous, illegal drugs, with individual packs of medicines being allocated unique 2D matrix codes that can be scanned to give details of authenticity.
It came into force in UK national law in August 2013, with the associated Delegated Regulation of the Directive coming into force in February 2016. The HDA was fully engaged at the national and EU level (through the European Healthcare Distribution Association, GIRP) throughout the process of the design and implementation of the Directive.
Brexit implications
Following the formal departure of the United Kingdom from the European Union on 31st January 2020, the UK entered into a Transition Period lasting until 31st December 2020. During the Transition Period, the UK remained part of the single market and consequently remained fully aligned to EU law, meaning the Falsified Medicines Directive (FMD) and associated Delegated Regulation (DR) continued to apply to all in the UK supply chain until 31st December 2020.
With the Transition Period having come to an end, the UK is now a third country in relation to the EU. UK legislation relating to the FMD and associated DR has therefore been revoked as of 1st January 2021 for GB countries (England, Scotland, Wales, Channel Islands and Isle of Man), with end users now disconnected from the UK Medicines Verification System.
With the ‘safety features’ elements of the EU FMD and DR ceasing to apply to GB end users, including wholesalers, they will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.
Northern Ireland
Under the terms of the Northern Ireland Protocol, FMD will still apply in Northern Ireland for at least four years, at which point Northern Ireland will decide through democratic consent whether or not these provisions remain in place.
The UK took part in discussions with the EU to agree a phased implementation of medicines regulations in Northern Ireland under the NI Protocol by 1st January 2022. The UK published a statement, agreed with the EU, on 5th November 2020 confirming a 12-month phased implementation of the Falsified Medicines Directive and regulatory importation requirements for medicines moving from GB to NI. Work is continuing with the EU to agree on operational specifics.
Future national falsified medicines system
The Medicines and Medical Devices Bill (currently progressing through Parliament) would enable the Government to make regulations aimed at preventing falsified medicines from entering the medicines supply chain. This could include establishing a national system based on the unique identification of individual packs that enables medicines to be authenticated and identified if tampered with. The Government will have to consult with industry stakeholders, including wholesalers, before introducing any new regulations. A timetable for consultation has not yet been set by the Government.
