The Falsified Medicines Directive (FMD) will require every pharmacy in the UK to scan barcodes and check tamper-proof devices from February 9, 2019 – less than two months before the UK is due to leave the EU, on March 29.
The Company Chemists’ Association (CCA) – which represents the UK’s largest multiples – said it was “inevitably difficult to respond” to a Medicines and Healthcare products Regulatory Agency (MHRA) consultation on implementing the directive, “in the context of significant uncertainty arising from the UK exiting from the EU”.
CCA chief executive Malcolm Harrison said last Friday (September 21): “Pharmacy businesses…do not know how long they will have access to the FMD system, because we do not know what agreement the UK government and the European Union will come to.”
“In this situation of uncertainty, pharmacy businesses are nevertheless having to enter into legal agreements and make financial investments in IT, staff training and other operationalisation platforms with FMD system suppliers, despite not knowing if they will be required on an ongoing basis,” he added.
The CCA also stressed the government should compensate the sector if the process of verifying medicines in the UK becomes disconnected from the EU's system and the FMD becomes redundant.
It called for “clarity and certainty” on the longevity of the FMD after Brexit “as soon as possible”.
Civil sanctions for non-compliance
In July, the government proposed “the sole use of criminal sanctions for failure to comply” with the FMD, in the form of “an unlimited fine...or imprisonment for a term not exceeding two years, or both”.
However, the CCA argued that apart from serious cases – such as wilful non-compliance or fraud – civil sanctions should be applied.
“We would not expect a punitive legal approach to any instances of non-compliance in the early stages of implementation, but rather we call for an opportunity for local, company-level and system-wide learning,” the CCA said.
Brexit must not disrupt supply chain
The CCA also said the FMD must not disrupt the pharmacy supply chain, to “ensure patients still get their medicines on time”.
“Our priority for FMD is to ensure patient safety and integrity of the supply chain are maintained as the UK leaves the EU,” Mr Harrison added.