Pharmas urged to review anti-counterfeiting plans ahead of no-deal Brexit

Pharmaceutical manufacturers are being urged to review their anti-counterfeiting plans ahead of the possible failure by the UK Government to agree on a Brexit deal with the EU.

Global trade body the International Hologram Manufacturers Association (IHMA) has warned that the UK could see a flood of counterfeit medicines after the Falsified Medicines Directive (FMD) ceases to apply at the end of the Brexit transition period on 1 January 2021.

In place since early 2019, the FMD uses mandatory safety features and an EU-wide database to help stem the distribution tide of fake or counterfeit medicines which could endanger lives.

The FMD will cease to apply if there’s no deal, leaving the UK with no access to the EU database except in Northern Ireland, where the FMD will continue to apply.

Interpol, Europol and national medicines agencies seize many falsified medicines and close hundreds of illegal websites selling them every year. Indeed, a report published by Europol’s Intellectual Property Office in 2019 estimates that counterfeit medicines cost the EU pharmaceutical sector more than ten billion Euros annually in lost revenue.

Fuelling the problem

The IHMA has stated that the COVID-19 crisis is also fuelling the counterfeit problem. Criminals are taking advantage of the pandemic to market and distribute fake pharmaceuticals, spurred on by increased demand and a shortage of basic drugs and medicines.

Illicit goods, or those with a vague provenance, can threaten people’s lives as well as damage corporate reputations and investment in companies and their products.

The IHMA has echoed calls by the National Pharmacy Association that, in the interests of patient safety, there should be ‘…the continuation of an anti-counterfeit system. However, not [one] necessarily governed by the rules of the FMD’.

The Royal Pharmaceutical Society has also voiced its concern over the issue, pressing Government to put “robust plans” in place in a bid to ensure that counterfeit medicines don’t enter the supply chain.

Infiltrating supply chains

Dr Paul Dunn, chair of the IHMA, said: “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. Furthermore, items such as falsified medicines and drugs bought online pose a terrible threat and can endanger lives.”

Dunn continued: “Whether or not the Government introduces new measures, the latest track-and-trace holographic systems remain a fast and effective front line security device in the battle to protect against any post-Brexit threats and keep medicines, and people, as safe as possible.”

He added: “Holograms can be effective in the front line fight against counterfeiters and fraudsters, protecting brands and profits alike. Those involved in the supply chain are reassured by holograms’ presence on products, recognising the security and financial benefits that are provided.”

The use of well-designed and properly deployed authentication solutions, as advocated by ISO 1293, enables examiners to verify the authenticity of a legitimate product, differentiating it from fake products coming from counterfeiting ‘hot spots’ in Asia and eastern Europe. Even those that carry a ‘fake’ authentication feature can be distinguished from the genuine item if that item carries a carefully thought-out authentication solution.

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