A warning has been issued to pharmaceutical manufacturers to carry out reviews of their anti-counterfeiting plans in case the UK heads out of the EU without a deal in place for Brexit, when the Falsified Medicines Directive no longer applies.

It’s possible that, as a result, the UK could be hit with an influx of counterfeit medication, the European Pharmaceutical Review reports. In a no-deal Brexit scenario, the UK will no longer have access to the Directive database, which implements mandatory safety features and helps prevent the distribution and sale of fake drugs.

Chair of the International Hologram Manufacturers’ Association (IHMA) Dr Paul Dunn was quoted by the news source as saying: “Failure to secure a Brexit deal could leave the door wide open to crafty criminals, who are infiltrating global supply channels, deploying scams and counterfeiting measures to trick consumers and damage manufacturers.”

A recent report published last year by Europol’s Intellectual Property Office found that counterfeit medication cost the pharmaceutical sector in the EU over €10 billion each year in lost revenue, a problem that the IHMA has said is now being exacerbated by the global pandemic.

The organisation went on to explain that criminals are taking advantage of the crisis to market and distribute fake drugs, driven by a rise in demand and a shortage of some drugs and medicines.

The IHMA now wants to see the use of well-designed authentication systems that will allow examiners to make sure that products are authentic and legitimate. Such solutions would mean that even products bearing a falsified authentication feature could then be identified as counterfeit.

Similarly, the Royal Pharmaceutical Society recently wrote to health secretary Matt Hancock, emphasising the need for strong plans to be implemented urgently in order to maintain formal links with the EU and authenticate the legitimacy of medication moving between the UK and the EU.

President of the RPS Sandra Gidley noted that it is “unacceptable” that with the Brexit transition period coming to an end in just a few months, there have been no plans put in place to prevent counterfeit drugs from entering the country.

She described the issue as critical for patient safety, given that 45 million packs of medicines move between the two locations every month, saying: “We have made it clear that the ideal way forward is for continuity of the provisions of the Falsified Medicines Directive, enabling ongoing connectivity between the UK and Europe.”

Ms Gidley went on to note that this move would provide patients with the assurances they need about the safety of their medication, as well as making sure the UK continues to benefit from the investments made by the NHS and the pharmaceutical sector.

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