Counterfeiting of drugs are on the rise in Europe and worldwide, putting the health of millions of patients at risk. These drugs are dangerous as they are not produced under safe manufacturing conditions that are supervised by regulatory authorities.European statistics show a strong increase of drug counterfeit seizures at European customs.
The global counterfeit drug market is estimated at EUR 160 billion. To help combat the scourge of counterfeit drugs, the European directive 2011/62/EU (with reference to the medicinal products for human use and prevention of entry into the legal supply chain of falsified medicinal products, patient safety) specifies a combination of three actions: a) Verify the authenticity of the medicinal products; b) Identify individual packs or batches, and c) Check whether the outer packaging has been tampered with. As there is no easy solution to the counterfeit drugs problem, the pharmaceutical manufacturers, wholesalers, dispensers, government regulators and patients must recognise the important role they are to play to ensure a safe and secure drug supply chain. Blockchain is one of the most promising and potentially efficient tracking, verification and authentication technologies. The end-to-end blockchain-based authentication solution to be implemented in PharmaLedger integrates all stakeholders of the supply chain.