Counterfeit Medicines: Getting On The Right Track

Counterfeit medicines remain a threat globally. The EU and the US already have track and trace systems in place, and other regions are following suit.

The growing number of governments using track and trace systems in the pharmaceutical industry is partly down to an increase in mandates originating from APAC nation governments. Many serialization solution vendors are now working to expand their geographical presence to other regions. We spoke to Advanco CEO Alf Goebel to find out why the APAC region is seeing considerable attention – and how else technology can change pharma’s future.

How big is the threat of counterfeit medicines in the online age?

The threat posed by counterfeit medicines has been present for many years. However, the internet, where drugs can be sold directly to consumers without the need for any physical premises, adds to this threat.

I want to be very clear. We are not criticizing regulated, legal online pharmacies. They provide a valuable service for many people and are now established as part of the fabric of the healthcare system in many geographies. However, the modus operandi does provide criminals with the means to distribute their goods in a manner that means they are much less likely to be traced.

It is worth reminding ourselves of the scale of the problem. Figures from the Pharmaceutical Security Institute show that 6,615 pharmaceutical crime incidents were reported in 2022, up 10 percent on the year before.

The greatest number was recorded in North America (3,029) followed by the Asia Pacific (1,738), Latin America (934), the Near East (825), Eurasia (650), Europe (278) and Africa (185). The order of this list is largely due to how well countries in these regions are effectively identifying pharmaceutical crime through law enforcement activity and inspections by drug regulatory agencies.

According to the World Health Organization, roughly 10 percent of medical products circulating in low- and middle-income countries are substandard or falsified. In sub-Saharan African nations, this share of counterfeit medicines is believed to be even higher – rising up to 19–50 percent. However, the actual number of incidents of fake drugs being manufactured and distributed may be far higher, considering the many cases where counterfeits have not been detected or reported.  

Counterfeit medicines are not just a regulatory challenge; they pose significant risks to public health. These fake drugs are often produced in unregulated environments, leading to the inclusion of dangerous substances that can cause serious harm. The absence of proper oversight means that these counterfeit medicines may contain incorrect dosages, harmful chemicals, or even toxic materials. This not only renders the medication ineffective but also introduces severe health risks, including allergic reactions, poisoning, and the exacerbation of existing conditions.

I think it is necessary to see the issue of counterfeit medicines as a global one that affects everyone. To fight the overall problem, every country needs to work hard to deploy resources.

What is driving expansion in the APAC region?

Combating counterfeit medicines requires coordinated efforts across the global pharmaceutical industry and governmental bodies. Many countries are now implementing stringent track-and-trace systems to monitor the distribution of medicines from manufacturers to consumers. These systems help ensure that every stage of the supply chain is monitored and verified, reducing the likelihood of counterfeit products entering the market. In the Asia-Pacific (APAC) region, for instance, nations like India, China, and South Korea have taken the lead in mandating serialization and traceability measures. These efforts are complemented by cross-border collaborations that enhance information sharing and enforcement actions against counterfeiters.

In the middle of such major developments, a dedicated APAC-focused resource will enable us to serve the region much more closely.

What are the key challenges in implementing track and trace systems?

Some pharma serialization solutions are perhaps too complex – and also inflexible. Regulations change and you need to be able to accommodate those changes. As an example (and something that I argue against), many providers will install specific software that can only be used with their hardware. When this happens, the pharma company risks losing the ability to either expand or adapt its manufacturing capabilities because of vendor lock in. Furthermore, it results in ever-increasing costs because of the by-design inflexibility of the all-in-one vendor systems, as well as the ongoing upgrade costs.

The serialization sector needs to be far more transparent. If there were to be another pandemic, the pharma sector would face challenges that would demand the ability to identify and deploy the most appropriate action. In such a scenario, the ability for serialization and traceability solutions across the board to work together in unison would be a massive advantage. It would enable packaging serialization solutions to coordinate in warehouses and shop floors right across the globe. Such capability could potentially save millions of lives in an emergency.

The COVID-19 pandemic saw the rapid design and roll-out of an entirely new pharmaceutical cold chain capable of preparing, shipping, and storing vaccines in temperatures as low as minus 80 degrees. This was done through collaboration – and we need to ensure that collaboration of this kind continues, so that we can be prepared for the next pandemic.

How else can new technologies help shape the future of the industry?

Health itself is becoming increasingly digital. Think of all the opportunities in healthcare, from telehealth solutions to wearable devices. There are a whole raft of personal medicine applications to manage the patient treatment lifecycle at an individual level.

For pharmaceutical manufacturers, technology can help increase the efficiency of systems, products, and services. The cloud, for example, has rewritten the way computing works, allowing firms to power their system and retain full records without a single server on site. Computing and automation is also being used to reduce the risk of human error. In the future, I expect robotics to become much more affordable and available to organizations of every size. From picking products at a warehouse to getting them ready to ship, autonomous robots can quickly and safely support manufacturers. Likewise, we will see distribution centers that will use autonomous cranes and trucks to streamline operations as they accept shipping containers.

The fight against counterfeit medicines has broader implications beyond just protecting consumers. For pharmaceutical companies, it is also about safeguarding their brand reputation and ensuring the integrity of their products. Counterfeiting not only affects public health but also undermines trust in legitimate products and can lead to significant financial losses. Moreover, as health systems become increasingly digitized, the importance of robust anti-counterfeiting measures grows. Technologies like AI and machine learning, which enable real-time product authentication and supply chain visibility, are becoming crucial in this battle. These advancements not only help in identifying and eliminating counterfeits but also contribute to the overall efficiency and security of the pharmaceutical supply chain.

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