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Falsified Medicines Directive is an opportunity for pharmacies regardless of Brexit outcome

Falsified Medicines Directive is an opportunity for pharmacies regardless of Brexit outcome


A no-deal Brexit outcome could revoke the Falsified Medicines Directive (FMD) which is due to come into effect in February 2019, under proposals put forward by the Medicines and Healthcare products Regulatory Agency (MHRA).


The mandatory EU FMD, initially established in 2011, was launched to introduce new harmonised measures to ensure that medicines are safe and that trade in medicines is properly controlled.


The FMD is designed to protect patients by minimising the chances of counterfeit medicines entering established supply chains across the European Union. It will enable manufacturers, wholesalers and distributors to verify the authenticity of a medicinal product, identify individual packs and check whether the outer packaging of medicines has been tampered with.


From 9 February 2019, UK pharmacies are expected to comply by scanning medicines before they are dispensed, using a unique identifier in the form of a barcode. This will be registered on a database called the European Medicines Verification System.


The cost of non-compliance?

The new legislation will require an overhaul of working processes and investment in compliant software systems and associated technologies which has been met with concern by cash-strapped community pharmacies.


Furthermore, a lack of clarity over how much the FMD will cost to implement and the availability of Government funding, combined with continued uncertainty over Brexit, have led many pharmacies to put their plans on hold and risk non-compliance.


The MHRA's proposal for a no-deal Brexit has prompted the Association of the British Pharmaceutical Industry and the UK Bioindustry Association to suggest such an outcome would increase the risk of counterfeit medicines entering both the UK and EU supply chain.


Benefits beyond patient safety and compliance


Amidst the confusion over Brexit and reticence from some to comply with the FMD, the value and opportunities presented by investing in new technology are in danger of being blurred. The benefits of FMD solutions go beyond simply complying and improving patient safety.


They extend to improving service efficiency and reducing costs by eliminating administrative, paper-based processes which will have a positive impact at every stage of the supply chain.


From being able to automatically validate expiry dates and easily identify and locate every product when a safety recall is issued, digitising the prescribing and distribution of medicines has significant potential to transform patient care.


What would having access to real-time product and patient data through traceability technology mean for your pharmacy and the communities you serve?


Tailored and flexible asset finance solutions, from specialist providers to pharmacies, include funding for digital technologies and equipment, including IT software and associated hardware and maintenance services.


As a result, pharmacists do not have to dip into vital cash reserves and attempt to purchase new items in one lump sum. In doing so, they can spread the cost (usually over 1 to 5 years) to protect essential working capital while maintaining their existing banking lines.


Regardless of the eventual outcome of Brexit, surely improving the lives of countless people is the right deal for everyone?


Author - John Clarke

John Clarke is Head of Business Development at Wesleyan Bank. John has amassed 18 years' experience in the finance industry and has deep domain expertise in the professions, specifically within the pharmacy, dental and legal sectors. He has recently played a key role in several multi-million pound pharmacy acquisition transactions.

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