The government has confirmed that a promised consultation into introducing a UK-specific falsified medicines system is yet to begin.
In a parliamentary answer, published on 11 January 2024, health minister Andrew Stephenson said that the government was “considering the right approach for the future” on a UK version of the Falsified Medicines Directive (FMD), which ceased to apply in the UK, with the exception of Northern Ireland, at the end of the Brexit transition period on 31 December 2020.
The FMD came into effect on 9 February 2019, making use of mandatory safety features and an EU-wide database to prevent falsified medicines reaching patients. A unique identifying code was added to packs of medicines by manufacturers, which was scanned in pharmacies when a pack was dispensed to a patient.
When the UK left the European Union on 31 January 2020, there was no deal agreed regarding the continue use of the FMD in the UK.
In October 2020, the Royal Pharmaceutical Society (RPS) raised concerns that there could be an “influx of counterfeit medicines” into the UK as a result of the FMD ceasing to apply.
The government then committed to establishing a UK version of the scheme in a Department of Health and Social Care factsheet, published in January 2021, which stated that a consultation into a falsified medicines scheme for the UK was expected “within 12 months of the royal assent” of the Medicines and Medical Devices Act 2021, which was granted on 11 February 2021.
However, the government missed this deadline and is yet to begin a consultation into a scheme.
In his response to a written question from Liberal Democrat MP Daisy Cooper about the progress of a UK falsified medicines scheme, Stephenson said: “The Department of Health and Social Care is considering the right approach for the future, and regulations would be needed to set out the detail of any scheme, which would require consultation.
“The Medicines and Healthcare products Regulatory Agency has robust measures in place for the management of falsified medicines detected by the UK supply chain,” he added.
The DHSC declined to comment.