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Fighting the Fakes: Securing Patient Safety

Updated: Dec 16, 2019

Words by Saskia Pronk

With the potential to be more lucrative than the illegal drug trade, the business of falsified medicines is booming. In fact, the market has seen a 90% global increase over the past 5 years, according to the WHO. Intentionally deceiving patients and putting lives at risk, falsified medicines are designed to mimic real medicines, but contain no active agent, the wrong agent, or the wrong amount of the correct active agent. To address this increasing threat, Europe is gearing up for one of the largest regulatory introductions in years. The Falsified Medicines Directive (FMD) will be rolled out from February 2019 to help eliminate fake medicines, but with Brexit looming, what is the future for the legislation in ensuring the UK’s reputation as a safe link in the supply chain?

The supply and distribution of falsified medicines poses an extremely serious global public health safety issue. “Counterfeit medicines are not produced to regulated quality standards and are substandard, ineffective, and harmful to the health and wellbeing of individual patients as well as to a wider section of the community”, explains Peter Feldschreiber, Former Senior Medical Assessor, Medicines and Healthcare Products Regulatory Agency (MHRA) and Special Litigation Coordinator to the Commission on Human Medicines.

Often, counterfeiters target unlicensed internet sales of lifestyle drugs (e.g., Viagra), but in a concerning trend, life-saving medicines are now the fastest growing category of falsification. A pivotal study, from the University of California, found that 52.8% of all counterfeit medicines detected in the legitimate supply chain are life-saving-related treatments; the most common being antibiotics.

Life-saving medicines are now the fastest growing category of falsification

Not only does falsification prove dangerous to health, the economic impacts are substantial. To scale the problem, “The EU’s pharmaceutical industry loses €10.2 bn a year, that’s equivalent to 4.4% of overall sales”, says Feldschreiber, and in the UK market, “Losses are estimated to be 3.3% of sales, costing over 3,000 jobs annually.”

To combat these far-reaching implications, the FMD aims to secure the supply chain. Feldschreiber explains that under the European Directive, two new safety features are required: “All prescription drugs packaging are required to carry a 2D [data matrix] barcode on their packaging and [secondly] an anti-tamper device.” A unique identifier code contained in the barcode will be uploaded by manufacturers to the European Medicines Verification System via the European Medicines Verification Organisation and supply chain stakeholders (e.g., pharmacies), can check the legitimate status of each pack at any point along the supply chain, thus ensuring patient safety.

The FMD is scheduled to go live on 9 February 2019, just 4 weeks before the UK’s departure from the EU, but with a trade deal yet to be reached, the vision of Britain’s FMD adoption is somewhat confused. All EU members, European Economic Area countries, and those with EU Free Trade Agreements are embracing the legislation, and while still an EU member with a potential trade deal on the cards, the UK must commit to the same FMD preparations.

The EU’s pharmaceutical industry loses €10.2 bn a year, that’s equivalent to 4.4% of overall sales

It was previously thought that despite Brexit’s outcome, the UK would most likely adopt the FMD. However, the MHRA recently stated that in a no-deal scenario, the FMD would be revoked: “We expect the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify, and decommission the unique identifier on packs of medicines in the UK.”

Despite the uncertainty, what remains crystal-clear is the threat that falsification presents. Therefore, clear and effective regulatory frameworks, whether this be the FMD or a separate UK national system, will prove critical to fighting the fakes, enabling public safety, while maintaining Britain as a safe link in the medicines supply chain.

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