While counterfeit products can be found in every country and every sector of the global economy, the situation in the global pharmaceutical supply chain is particularly concerning. “The online sale of drugs and black market trade pose a significant barrier to fighting counterfeiting, meaning that national borders do not limit the circulation of fake and harmful products,” explains Ian Lemon, Essentra’s global product director, Health and Personal Care. “As a result, as many as 62% of medicines bought online are illicit, according to the European Alliance for Access to Safe Medicines.”
Lemon says that criminals find sophisticated ways to infiltrate legitimate supply chains. “The high demand for specific drugs works as an incentive for them to take advantage of consumers who cannot afford the cost of authentic products. Price differences fixed by national governments or multinational companies encourage parallel trade. According to Interpol, patients across the world put their health, even lives, at risk by unknowingly consuming fake drugs, or genuine products that have been doctored, badly stored, or that have expired. In addition, counterfeit products can also affect a brand’s reputation.”
To identify potential solutions, it helps to first understand the market factors contributing to this global issue. Lemon tellsPMP News about four key factors that appear to be driving counterfeit growth:
1) Supply Chain Complexity
The supply chain for pharmaceuticals is global and increasingly complex. There are multiple opportunities for significant cost savings, but also increased opportunity for illegal activity. The focus should therefore be on monitoring and maintaining the integrity of the supply chain by paying more attention to details and having proper protocols in place.
2) Development of E-Commerce
Many legitimate platforms exist, but the Internet has given counterfeiters direct and easy access to consumers. As a result, rogue Internet pharmacy sites are proliferating, and it is becoming harder to track criminals and their products down.
3) Counterfeit Sophistication
The high potential profit and relatively low risk of punishment associated with counterfeiting encourage criminals to invest their resources into making their products look as similar as possible to authentic goods. Accordingly, solutions entail working with brand owners to develop cutting-edge covert security technologies such as infra-red (IR) and ultra-violet (UV) inks, microtext, and microscopic tagging. Such solutions are both invisible and difficult to detect and replicate without specialist equipment.
4) Lack of Coordinated Enforcement Capacity
Sufficient enforcement capacity across the industry to tackle counterfeiting is lacking. Putting the topic on governments’ agendas and setting it as a top priority for businesses will be essential to help enforcement agencies develop a coordinated initiative that will make the fight less challenging and time-consuming. It is today impossible for governments to monitor all exports and imports of goods; only a joint effort between industry and governments will enable a realistic solution.
Pharmaceutical companies can utilize a variety of solutions proposed to fight counterfeiting. Serialization, as promoted in the EU Falsified Medicines Directive, is one approach, and Lemon recently urged the adoption of common legislation globally for pharmaceutical products.
However, serialization is “not a panacea, as coding alone is not authentication,” he tells PMP News. “Training and enforcement methods still must be addressed. Coding initiatives have focused exclusively on digital methods and overlooked physical protection opportunities. Tamper verification allows consumers to check for themselves if a product has been tampered with. Indeed, by empowering the patient, the industry could help raise awareness on the issue.”
Lemon advises a “layered approach to security and authentication—using overt, covert, and forensic features— to combine both physical and digital attributes and deliver enhanced protection.”
He explains that “overt technologies enable instant authentication through visual inspection, and most commonly feature holographic devices and color-shift inks. Covert solutions, on the other hand, such as microtext and microscopic tagging, are difficult to detect without specialist equipment, and rely upon technologies such as infra-red and ultra-violet inks. Finally, forensic features, which include molecular markers and biological tracers, offer a further layer of authentication and can only be identified using laboratory equipment.”
Building such a “multi-layered approach would help stakeholders throughout the supply chain—as well as consumers—identify and address counterfeit medicines,” he says. “This would shut down opportunities for counterfeiters to produce or insert fake goods into the supply chain—ultimately making it possible to mitigate and, ideally, solve counterfeiting challenges.”