Counterfeit and substandard medicines have existed for as long as medicines have existed.
‘Snake oil’ has become a popular vernacular when one suspects someone of peddling wares that are not going to provide the actual remedy they are claimed to bring. But in our increasingly networked, interconnected, and virtual world, counterfeit medicines have found an ideal breeding ground and have grown to truly epic proportions.
The OECD estimates the global trade in illicit pharmaceuticals to be worth at least $4.4 billion annually, which naturally attracts the involvement of organized crime groups around the world.
The pandemic supercharged the illicit trade in counterfeit medicines as consumers got increasingly comfortable with, and dependent on, sourcing many of their daily goods from online sellers. Purchasing medications online was just the next logical conclusion.
Unfortunately, criminal networks noticed these same trends and are taking advantage of them, with an ever-increasing number of illegal online pharmacies selling illicit, fake, falsified, or substandard medicines, without prescriptions, at discount prices to unsuspecting patients. The online offers range from fake COVID-19 tests and ineffective antibiotics to hazardous erectile dysfunction tablets.
In 2021, Operation Pangea XV, which was led by Interpol with involvement from 94 member countries, targeted illicit pharmaceuticals and medical products traded online, during a one-week coordinated law enforcement action.
During the operation, law enforcement seized more than 7,800 illicit and misbranded medicines and healthcare products, totaling more than 3 million individual units. In addition, the operation investigated and shut down, or removed, more than 4,000 web links containing adverts for illicit products.
These goods enter countries through international postal or express shipments and the 94 participating countries inspected nearly 3,000 packages at 280 postal hubs at airports, borders and mail distribution or cargo mail centers during the operation. And nearly half (48%) of inspected packages contained either illicit or falsified medicines.
In total, Operation Pangea XV netted seizures worth over $11 million in a single week. In addition, Interpol estimates that the operation disrupted the activities of at least 36 organized crime groups.
Counterfeit or unauthorized erectile dysfunction medicines comprised roughly 40% of all products seized. Meanwhile driven by the pandemic, law enforcement in Australia, Argentina, Malaysia, and the United States also seized more than 317,000 unauthorized COVID-19 test kits. And the United States seized millions of fake N-95 masks over the course of the year.
The operating base for criminal networks offering these illicit goods might be surprising to some: online pharmacies.
Driven by the rising costs of pharmaceuticals, lack of access to certain cures in certain countries and the worldwide quest to be forever healthy and young, criminal networks are utilizing the worldwide web to feed on these desires.
Criminal networks set up these fake pharmacies, make them look incredibly legitimate, and claim to be operating from ‘safe’ countries with superior and often socialized health systems, such as Canada or the UK.
According to a 2021 survey by the Global Alliance for Safe Online Pharmacies, 95% of online pharmacies are operating illegally. The majority of these pharmacies do not require prescriptions or doctor referrals. The counterfeit or substandard medications they send out either have limited or no active pharmaceutical ingredients, and in a ‘best case’ scenario only contain non-active or benign substances, such as saline or sugar. But they might also include harmful or toxic substances.
The illicit trade in falsified medicines is truly a global problem. Products are often produced in one country, then transshipped across several other countries to disguise their origins, until arriving under false declaration in the target country.
Meanwhile websites, servers and advertisements are hosted in many different countries, often out of the reach of law enforcement.
In addition, social media networks and messaging apps are increasingly utilized to advertise counterfeit and illicit medicines. As a matter of fact, Operation Pangea XV identified more than 1,200 ads for illicit products across all major platforms.
‘Two decades worth of experience has shown criminals will stop at nothing to make a profit, including selling counterfeit pharmaceuticals and medical devices despite dangers they cause,’ said Jim Mancuso, Director of the National Intellectual Property Rights Coordination Center in the United States, in Interpol’s press release.
Given the ongoing rise in counterfeit medicines, there is an increasing need for universal authentication technology, as well as global interconnected track and trace systems to assist law enforcement in identifying illicit goods and for consumers to be assured of a product’s efficacy and safety.
There are several key aspects as these technologies are developed and operationalized:
Interconnectivity/common standards: since medicines are regulated through national, not international, standards, and are restricted to certain geographies, this helps criminals disguise illicit goods. It is naturally harder for law enforcement and consumers to track the origin of a medicine when individual national systems are not connected.
It will be crucial going forward for track and trace systems to become interconnected and based on common standards, so medicines can be traced and authenticated by authorities quickly.
While technologically more challenging for technology providers, a unified standard will simplify technological implementation and ultimately increase adoption across countries. System and standards harmonization need to be a priority for countries as they continue to fight the rising tide of counterfeit medicines.
Affordability/cost effectiveness: law enforcement and border security agencies are restrained by their budgets and focus resources on their own ultimate mission: to protect the citizens of their country.
These two restraints result in government and law enforcement agencies having to pick and choose which technologies to implement and ultimately pay for.
In addition, any technology that is not focused on direct threats, but would be used to identify outbound or transshipped threats will naturally be deprioritized from an agency’s budget and mission.
Focusing on common standards and interconnectedness helps improve cost effectiveness, affordability and, ultimately, adoption. Similarly, if the technology is universal, customs authorities would be more likely to screen outbound and transshipped shipments as well as inbound shipments.
Secondarily, technology providers will be well advised to focus on affordability versus capability. The best technology, if out of range of the budgets of developing or undeveloped countries becomes, in effect, worthless.
Rather, simple tracking and tracing technologies, while not perfect, are to be preferred over having no system in place. While this may result in the implementation of common/open standard systems with simple barcodes or numerical identifiers, over proprietary systems with complex covert security markers, it will help combat the issue of counterfeit goods entering countries.
Consumer simplicity: similarly, the easier and more intuitive the technologies, and the more they are integrated into the day- to-day activities of consumers, the higher their adoption will be.
Instead of relying on complex covert or overt visual features – which are expensive, but which can also be counterfeited – integrating simplistic features which can be scanned, verified, or even automatically authenticated through a user’s mobile device will help drive adoption and protect vulnerable consumers.
Again, the drive for common identification/ authentication standards will help drive adoption and usage. If consumers need to ‘learn’ the unique authentication feature for each item they purchase, they will be less likely to use the feature, versus if the authentication is mostly identical (ie. cell phone scan). While potentially not being proprietary, and therefore less lucrative for providers initially, widespread adoption will make up for the initial revenue loss in the long run.
Counterfeit medicines are likely going to remain a threat on a global scale for years to come. The rapid deployment of standardized, affordable, and ultimately widely used technologies and systems will be important in our fight against fake medicines.
