The Falsified Medicines Directive is an EU-wide legislation which aims to provide a secure supply chain from manufacturers through wholesale and pre-wholesale to dispensers and to patients.

The Directive says that every medicinal product should now have a special identifier and a tamper-proof seal so that each pack can be verified at the point of dispensing. The unique identifier, embedded in a 2D barcode, will allow the medicine to be tracked through the supply chain from manufacturer to patient. Each pack’s unique identification data will be stored in an EU-wide central hub called the European Medicines Verification System (EMVS).

Each EU member state must have a single national body to manage and implement the terms of the Directive,  in Ireland it’s called the Irish Medicines Verification Organisation (IMVO) which is a group made up of key stakeholders in the Irish prescription medicines supply chain.

With this new barcode system due to take effect from February 2019, pharmaceutical manufacturers, wholesalers, pharmacists and hospitals are working to ensure that all necessary systems are in place by the deadline.

Falsified or “fake” medicines are a growing problem globally. Historically, the use of counterfeit drugs has not been widespread in industrialized countries such as the US or Western Europe, although with many consumers now being drawn to the internet to buy cheap medicine, examples of fake medicine have seen a proliferation worldwide.

The Health Products Regulatory Authority (HPRA), in partnership with Revenue’s Customs Service, An Garda Síochána and regulatory and law enforcement agencies worldwide, revealed in June 2016 that they had detained, in Ireland, 60,000 falsified/counterfeit and other illegal medicines worth €350,000.1

Teva, through our membership of Medicines for Ireland, has been involved in the development of IMVO and is committed to making sure that this system of verification is successfully in place by the 2019 deadline.

We believe its implementation will make sure patients are protected against counterfeit medicines because the products will be tracked and verified better. However, putting this Directive into action will place an extra cost and time burden on the pharmaceutical industry, which could impact medicine prices in the longer term.

Falsified medicines may contain ingredients which are of poor quality or in the wrong dose. As they have not undergone the standard quality, safety and efficacy checks that apply to all legitimate medicines, they could be harmful to patients who take them. As falsifications become more sophisticated, the risk that falsified medicines reach patients in the EU and therefore Ireland increases every year.

 

References

1. http://www.hpra.ie/homepage/about-us/news-and-events/item?t=/global-operaton-targeting-flasified-medicines&id=7a760626-9782-6eee-9b55-ff00008c97d0 accessed 05.11.2018