Falsified Medicines Directive must not disrupt the medicines supply chain post Brexit, says CCA

The introduction of new ‘patient safety features’ under the EU’s Falsified Medicines Directive (FMD), coming only weeks before Brexit, must not disrupt the integrity of the pharmacy supply chain to ensure patients still get their medicines on time, according to the Company Chemists’ Association’s response to a consultation on FMD.

The call is made today (21 September) in the CCA’s response to the MHRA consultation Implementing ‘safety features’ under the Falsified Medicines Directive.

Commenting on the consultation, Malcolm Harrison, Chief Executive of the CCA said: “Our priority for FMD is to ensure patient safety and integrity of the supply-chain are maintained as the UK leaves the EU, while not undermining the efficiency and cost-effectiveness of dispensing in community pharmacy. Our members are all working hard to ensure they will be compliant with FMD once it takes effect in February.

“The CCA is calling for a proportionate and risk-based approach to the implementation of the ‘safety features’ aspect of the Directive. We fully support the response of the UK FMD Working Group for Community Pharmacy to this consultation.

“Community pharmacy businesses, and wider pharmacy, do not know how long they will have access to the FMD system, because we do not know what agreement the UK Government and European Union will come to in this area. Pharmacy businesses are nevertheless having to enter into legal agreements with FMD system suppliers and make financial investments in IT, staff training and other elements of their operational platforms despite not knowing if they will be required on an ongoing basis.

“We agree with the FMD Working Group that the Government must be open and transparent with the pharmacy sector. This is to ensure that community pharmacy – which is already financially challenged – is not required to invest in FMD systems if they will not be needed in the future. If community pharmacies remain required to comply with these new aspects of the Directive, we believe the additional cost burden should be taken into account within any new NHS funding settlement.

“In the event of the UK medicines verification system being disconnected from the European hub after Brexit, we similarly agree with the FMD Working Group that the Government should fully compensate the sector, where all or part of the system which has been invested in becomes redundant.”

For further information, please contact Liz Skinner, the CCA’s Communications and Engagement Manager, tel 07384 514764, email [email protected]

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