UK pharmacy group warns of fake meds risk due to Brexit

The Royal Pharmaceutical Society has called on the UK government to take “immediate action” to prevent falsified medicines entering the country after the end of this year.

In an open letter addressed to health secretary Matt Hancock, the RPS warns of an “influx” of counterfeits if the Falsified Medicines Directive (FMD) ceases to apply at the end of the Brexit transition period on January 1, 2021.

As it stands the FMD and other elements of the EU pharmaceutical framework will no longer be in force in England, Scotland and Wales if the transition period ends without a trade deal that extends its provisions, although it will still apply in Northern Ireland.

Time is running out to agree such a deal however, with the two negotiating teams reported to be struggling with almost irreconcilable differences.

The letter asks Hancock to ensure that “robust plans” are put in place urgently to maintain formal links with the EU to help authenticate the legitimacy of medicines that move between the EU and the UK.

“It is unacceptable that in the final months of the Brexit transition period, robust plans have not been put in place to prevent falsified or counterfeit medicines entering the UK,” commented RPS president Sandra Gidley.

“With 45 million packs of medicines moving between the UK and the EU every month, this is a critical issue for patient safety in the UK and every European country,” she added.

According to Gidley, establishing a technical agreement with the EU in this area is more critical than ever, ideally one that maintains continuity with the provisions of the FMD including the delegated regulation on safety features.

The FMD safety features requirements came into force on February 9, 2019. Along with serialised, unique 2D bar codes on medicine packs used to verify them at the point of dispensing, it also requires the use of tamper-evident seals.

Previously, the  Medicines and Healthcare products Regulatory Agency (MHRA) has said it anticipates the UK will not have access to the EU central data hub that powers the safety features system if the transition period ends without a deal.

It has also suggested that the UK may have to develop its own verification system that would operate in parallel to the EU’s platform.

The UK government is working on the Medicines and Medical Devices Bill (MMDB), which attempts to fill the regulatory void for medicines after the UK’s post-Brexit transition period ends. Amendments to the bill are due to be reviewed in committee in the House of Lords next week.