With the Falsified Medicines Directive (FMD) coming into full force tomorrow (9 February 2019), two stories have highlighted the need for close attention to the Directive and the wider context.
In the UK, the Association of the British Pharmaceutical Industry (ABPI) has raised concerns, reported in PMLive, about Brexit and FMD. Specifically, in the event of a no-deal Brexit, the UK would be excluded from FMD (along with other European initiatives). Mike Thompson, Chief Executive of the ABPI said:
“‘No deal’ is not in the interest of the NHS or its patients. 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. Being part of a system that keeps them safe is the minimum that UK patients should expect.”
Dr Rick Greville, Director of Supply Chain at ABPI 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 Federal Association of the Pharmaceutical Industry e. V. (BPI) in Germany has reported on the imminent introduction of FMD with some excitement. They say:
“For the establishment of the anti-counterfeiting system, companies in the pharmaceutical industry have invested a lot of time, money and energy – always with the goal of providing patients with even safer medicines. This effort was preceded by the EU Counterfeiting Directive, which was adopted in 2011. Good news for the patients in Europe!”