The EU and United States are using legal directives to tackle the rising numbers of counterfeit medications. Do the new directives actually offer any protection against medication counterfeiting?
The pharmaceutical industry is acutely affected by counterfeiting, grey market trade and theft. The dangers are serious, because low-quality counterfeit medications pose a direct threat to patient health. In addition to the World Health Organization (WHO), other organisations such as the Pharmaceutical Security Institute (PSI) are also warning against the dangers of counterfeit medications. According to the PSI, the number of incidents with regard to counterfeiting, grey-market trade and theft in the pharmaceutical industry has risen by 50% since 2011.
The EU and United States are developing directives to protect against counterfeit medications
Given these developments, the EU (Falsified Medicines Directive; 2016/161/EU) and United States (Drug Supply Chain Security; DSCSA) have drawn up legal requirements which must be implemented by 2019 in the EU and by 2021 in the US. However, not all of the measures in the Directives are clearly indicated.
The directives of the EU and United States concern three main topics: serialisation, counterfeit protection and tamper protection. Some provisions leave room for interpretation, however – such as in the area of serialisation. According to EU directives, prescription drugs must bear a unique feature, such as a serial number, and provide specific product information via a DataMatrix code. The basic idea behind this measure is right: a genuine preparation must bear a marking unique to each individual item, which identifies it as original. It is only in this way that retailers, pharmacists and consumers are able to distinguish between genuine medications and counterfeit products.
However, the markings described above are not suitable for this on their own because they are printed marks. Counterfeiters can simply copy and reproduce them. That is exactly what happened in Turkey. In 2007, Turkey was among the first countries to begin a national serialisation project for the pharmaceutical industry. The marking concept is based on printed codes. Just shortly after introducing this marking standard, numerous copies appeared, as the Turkish newspaper Zaman Gündem reported in 2011. Any form of protection thus becomes irrelevant. In fact, the opposite effect is even seen: as a result of such copied markings, counterfeit preparations appear to be above board.
The markings only become counterfeit-proof once they are additionally safeguarded by physical security features, such as a security label unique to each individual item. These are not easy to reproduce and reliably identify genuine preparations.
The counterfeit protection directives from the EU and United States for the pharmaceutical industry are a step in the right direction and can serve as a base. But when it comes to effectively implementing the measures, pharmaceutical manufacturers are required to do this themselves.