UK manufacturers should review counterfeit plans ahead of no-deal Brexit, trade body warns

The UK could see a surge of counterfeit medicines come into the country if a no-deal Brexit occurs, global trade body International Hologram Manufacturers Association  (IHMA) has warned.

The IHMA has stressed how the Falsified Medicines Directive (FMD) ceases to apply at the end of the Brexit transition period on 1 January next year, potentially leaving the UK open to an influx of counterfeit medicines.

As such, IHMA is urging manufacturers to review anti-counterfeiting plans ahead of the transition period.

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

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 directive will continue to apply.

Counterfeit medicines are thought to cost the EU pharmaceutical sector more than €10 billion every year and can also threaten patients’ lives.

Covid-19 is also fuelling the counterfeit problem according to the IHMA, with criminals taking advantage of the pandemic to market and distribute fake pharmaceuticals, spurred on by increased demand and a shortage of basic drugs and medicines.

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 FMD’.

The Royal Pharmaceutical Society has also voiced its concern over the issue, pressing government to put ‘robust plans’ in place to ensure counterfeit medicines don’t enter the supply chain.

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.

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

“Holograms can be effective in the frontline fight against counterfeiters and fraudsters, protecting brands and profits. Those involved in the supply chain are reassured by their presence on products, recognising the security and financial benefits provided.”

The IHMA has said that authentication solutions, such as those advocated by the ISO12931 standard, 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.