The Falsified Medicines Directive comes into action tomorrow

8 February 2019

The Falsified Medicines Directive (FMD) is a new EU initiative which comes to force tomorrow, which aims to protect patients from counterfeit medicines.

A decade in the making, the new system means that all medicines will need have two new features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD). This allows each pack to be tracked as it progresses from the manufacturer through the supply chain, pharmacies, primary care and hospitals and finally to the patient.

The UK has played a leading role in developing the FMD. However, if a ‘no deal’ Brexit occurs, this would result in the UK dropping out of the new system, leaving NHS patients at greater risk of being exposed to fake medicines than those in the EU.

As part of Interpol’s globally co-ordinated Operation Pangea, last year UK authorities seized more than one million doses of counterfeit medicines and medical devices worth more than two million, in the space of just one week.

However, with the UK less than 50 days from its planned departure from the EU, the likelihood of a no-deal agreement is increasing, raising concern amongst industry leaders that patient safety will be adversely affected. This scenario would mean that the UK would have to revoke the FMD legislation, only seven weeks after its introduction.

“Billions of packs of medicines travel around the EU annually, destined for over 500 million patients. This new system means that patients across Europe will have the best protection from fake medicines in the world,” said Dr Rick Greville, director of supply chain at the UK industry's Association of the British Pharmaceutical Industry. “It would be an absolute travesty if NHS patients aren’t part of a system specifically designed to protect them.”

The FMD involves the use of new technology based on a cross-European database called the European Medicines Verification System (EMVS), which allows medicines dispensed anywhere in the EU to be authenticated.

“No patient should suffer as a result of Brexit,” said Niall Dickson, co-chair of the Brexit Health Alliance (BHA), an alliance of NHS, medical research, industry, patients and public health organisations. “A ‘no-deal’ without alternative arrangements to protect patients is simply not acceptable and could put lives at risk.”

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