Estimated to generate up to $431 billion annually, the illicit medicines trade is a global threat, yet its true scale remains unknown, as most incidents go undetected or unreported.
Criminal networks are exploiting the internet to industrialise the trade, bypassing the checkpoints that once caught fake products before they reached patients.
Tackling pharmaceutical crime requires consumer awareness, supply chain integrity, and anti-corruption measures.
In May, authorities from 15 European countries jointly cracked down on a criminal group allegedly selling €240 million-worth of fake supplements and medicines claimed to cure serious illnesses. The case adds to a growing body of evidence that the illicit medicines trade is a global threat that is only increasing. At an estimated $431 billion annually, it is also one of the most egregious forms of pharmaceutical crime.
Operating since 2019, the criminal group allegedly established companies through which it marketed and sold supplements not authorised for sale. The group used hundreds of websites and social media pages, and managed to sell over 400 differently named products over the course of its operations.
Once victims filled in a form on any of the websites, they would receive calls from call centre operators pretending to be medical specialists. Their pitch was that the supplements treated serious illness, from diabetes and psoriasis to cancer. All products, despite purporting to address different diseases, allegedly contained identical ingredients and were of no therapeutic effect. In particularly troubling cases, victims have discontinued medically prescribed treatments in favour of the fraudulent products, putting their health at serious risk. When complaints accumulated against a specific product, the perpetrators simply relaunched it under a new name.
The group’s adaptability, along with its use of apparently legitimate companies with registered offices and bank accounts in several countries, made detection particularly difficult, according to the authorities. Eurojust says that the group operated in a hierarchical manner, with members’ duties ranging from commercial administration and websites management to recruitment and training of new members.
The action day on 12 May resulted in searches of 113 locations across Bulgaria, Greece, Hungary, Poland, Romania, and the Republic of Moldova; the freezing of €1.8 million in assets in Poland; the blocking of 196 websites in Romania; and the identification of a central warehouse in Bulgaria.
This case is not an isolated event, but part of a broader and intensifying pattern of pharmaceutical crime that enforcement agencies across Europe and beyond have been tracking with increasing concern.
The Online Dimension of Illicit Medicine
Also in May, Interpol announced the results of Operation Pangea XVIII, an annual coordinated crackdown on the online sale of illicit pharmaceuticals, which spanned 90 countries and territories and resulted in the seizure of 6.42 million doses of unapproved and counterfeit pharmaceuticals worth $15.5 million.
Authorities dismantled 66 criminal groups, arrested almost 270 individuals, and disrupted roughly 5,700 criminal-linked websites, social media pages, channels, and automated bots used to market and sell illicit medicines.
Interpol Secretary General Valdecy Urquiza highlighted the risks associated with fake medicine sold online: “Fake medicines are not just a fraud – they put lives at risk. Through online marketplaces and informal supply chains, criminals can exploit gaps in oversight, targeting people looking for fast or affordable treatment. The consequences can be severe, or even fatal.”
The online realm is now central to how the illicit medicines trade operates. The World Health Organization (WHO) estimates that 50 percent of medicines sold online are fake, while the American National Association of Boards of Pharmacy (NABP) says that nearly 95 percent of websites offering prescription-only drugs online operate illegally.
Europol noted in its 2025 threat assessment that social media platforms and online marketplaces, operating on both the surface and dark web, remain essential to the trade in counterfeit pharmaceuticals, providing degrees of anonymity that hinder detection, as well as the capacity to target large populations at scale.
Aline Plançon, health security expert, criminologist, and former head of Interpol’s global pharmaceutical crime programme, underscores just how fast criminal networks have adapted to the digital environment: “More than 15 years ago, the fake medicines market in Europe was largely a ‘trunk-of-a-car’ business, dominated by lifestyle products such as erectile dysfunction medicines”, she said.
Today the picture is substantially different from that earlier era: “In recent years, criminal networks have increasingly shifted from importing fake medicines into Europe to manufacturing them within Europe itself. Profit remains the sole objective, with criminal proceeds reinvested to expand and professionalise their operations.” The speed advantage, Plançon argues, has shifted decisively to criminals: “The challenge is one of speed: criminal networks can produce and sell fake medicines online in a fraction of the time it takes law enforcement to conduct an international investigation.”
The medical products are also evolving rapidly. Operation Pangea XVIII recorded a sharp increase in the seizure of antiparasitic medicines, driven by their online promotion as alternative cancer treatments, despite repeated warnings from health authorities that such claims have no scientific basis. The operation also flagged illicit versions of GLP-1 medicines, often manufactured in Asia and sold online for as little as $10; in some cases, these were found to contain sibutramine, a substance banned in many countries over links to heart attacks and strokes.
The darknet adds a further layer of complexity. In a US case concluded in May 2026, four Massachusetts men were sentenced to a combined total of over 57 years in prison for manufacturing counterfeit Oxycodone, Adderall, and Xanax pills laced with fentanyl and synthetic opioids and distributing them primarily through darknet marketplaces and the US Postal Service, with over a dozen fatal overdoses linked to their conspiracy. This is not the first time such schemes have resulted in death.
In another US case, 18 defendants were charged in 2024 with selling counterfeit pharmaceuticals that led to the death of at least nine victims from narcotics poisoning. The defendants sold them fentanyl pills disguised as legitimate prescription medications via fake online pharmacies.
The US Food and Drug Administration (FDA) acknowledges that “there has been an increase in overdose deaths that are related to fentanyl-laced counterfeit drugs”.
“Counterfeit (fake or falsified) medicines may be harmful to your health because while being passed off as authentic, may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients”, the agency warns.
From a detection standpoint, the shift to online meant losing the controls and checkpoints available in a physical supply chain. Professor Paul Newton of the University of Oxford, one of the world’s leading authorities on falsified medicine detection, explains the core problem: “In physical supply chains, inspectors have the ability, along with outlet pharmacists, to detect substandard and falsified medicines and vaccines in outlets before they reach patients. When patients buy directly from distributors online this ability is lost, except if intercepted in mail rooms, but whose staff are unlikely to be highly trained in detecting poor quality medical products. Hence, a key check is lost.”
On the question of accountability when someone is harmed by a falsified medicine purchased online, Professor Newton argues that “accountability varies across countries”. Still, he suggests “that both distributors and those producing these products should be held accountable. Both should have systems in place to ensure that what they sell is what they are labelled as being.”
The Multiple Faces of Pharma Crime
Pharma crime is a complex umbrella term encompassing activity related to fake, falsified or counterfeit medicine, as well as corporate misconduct, such as illegally promoting medications for unapproved uses.
The WHO draws a key distinction between two categories of questionable medicines: substandard medical products, which are those that fail to meet quality standards due to poor manufacturing or inadequate quality control; and falsified medical products, which are those that deliberately misrepresent their identity, composition, or source to deceive consumers for financial gain. In practice, the line between the two is essential for how enforcement agencies respond.
The scale of the problem is difficult to grasp. WHO estimates that at least one in ten medicines in low- and middle-income countries are falsified or substandard, while financial estimates of the total illicit medicines market put global annual sales at between $200 billion and $431 billion.
To put things into perspective, Plançon told Financial Crime Digest: “In 2024, approximately 3.6 trillion doses of medicines were legally produced worldwide. Applying the WHO’s 10.5 percent estimate for substandard and falsified medical products as a simple illustration would equate to roughly 378 billion compromised doses. The figure is hypothetical, but it highlights the potential scale of the threat.” She cautions, however, that “the true scale of the problem remains unknown”, because “what we see is only the portion that is detected and reported”.
In some parts of Africa and Asia, the proportion of medicines in circulation that are counterfeit may reach 70 percent. Notably, Operation Pangea XVIII revealed that, in Africa, unlike other regions, seizures there were dominated by essential medicines such as painkillers, antibiotics, and antimalarials, which are sold through informal markets in areas with limited access to affordable healthcare.
In addition to posing risks to consumer health and their financials, the illicit medicine trade is negatively impacting the wider economy. According to the Pacific Research Institute, the US biopharmaceutical industry is estimated to lose between $37.6 billion and $162.1 billion in revenues annually to counterfeit and illicit competition. These losses, in turn, reduce total US economic output by between $82 billion and $353 billion and cost between 57,500 and 247,800 jobs, the Institute says.
The actors behind pharma crime also span a wide spectrum. On one end are dedicated organised crime networks, hierarchical, multi-jurisdictional structures similar to the one dismantled in the Eurojust- and Europol-coordinated operation. Europol says that such organisations are involved not only in importing and distributing fake medicines but also in establishing clandestine manufacturing laboratories on EU soil.
Since its first edition in 2020, Europol coordinated Operation Shield has seized 43 clandestine laboratories and led to investigations into 264 alleged organised crime groups.
Plançon describes the diversity of these networks: “Some organised crime groups are involved at every stage of the supply chain, from manufacturing to distribution and sale. Some organised crime groups operate across several illicit activities, including narcotics and fake medicines, following the same logic: high profits and relatively limited risks.”
On the other end of the spectrum are opportunistic actors operating within the legitimate sector. “You may find printers, brokers, transporters or wholesalers engaging in non-compliant behaviour because of profit and opportunity. What emerges is an ecosystem where legal and illegal actors intersect at multiple points along the supply chain”, Plançon stated.
The Corporate Side of Pharma Crime
Another dimension of pharmaceutical crime relates to the conduct of pharma companies themselves. This includes promoting medication for unapproved uses, concealing or misrepresenting information about a product’s adverse side effects, and manipulating prices to defraud government healthcare programmes.
Such misconduct is heavily documented in the US, where authorities distinguish between counterfeit medicine – cases such as the fentanyl-laced medicines – and what the FDA terms medication health fraud: the marketing of products that make false or unproven claims about their ability to treat health conditions. In some cases, the products may conceal dangerous hidden ingredients, including banned substances and harmful chemicals.
The FDA says that it has identified over 1,000 fraudulent products sold through channels ranging from online platforms to physical stores and petrol stations.
Two of the most common schemes documented in the US include off-label marketing, which stands for pharma companies promoting a medicine for uses not approved by the FDA; and illegal kickbacks, which are payments or other financial incentives made to physicians or hospitals to induce prescribing of certain medication.
The Federal and State False Claims Acts have been the primary tool for prosecuting pharmaceutical fraud against government healthcare programmes, with over $19 billion having been recovered since 2007 from pharmaceutical companies for pricing, billing, and marketing schemes in violation of federal and state false laws. These recoveries are the visible tip of a much larger iceberg, with billions more in fraudulent activity believed to go undetected.
Several cases have resulted in massive penalties. In 2012, global health care giant GlaxoSmithKline LLC agreed to plead guilty and to pay $3 billion to resolve criminal and civil proceedings revolving around several violations, including the company’s unlawful promotion of certain prescription drugs. The previous record had been held by Pfizer Inc, which paid $2.3 billion to resolve similar allegations.
Money Laundering and the Corruption Nexus
The UN Office on Drugs and Crime (UNODC) recognises that pharmaceutical crime, especially falsified medical products, often entails a plethora of related criminal activity, such as money laundering, corruption, document fraud and obstruction of justice.
“Falsified medical product-related crime is a lucrative enterprise for high-level offenders”, the UNODC says.
Criminals will often launder the funds generated from selling the fake medical products to conceal their illegal origin. For instance, the €240 million attributed to the network dismantled in May did not sit in cash in a warehouse. It moved through networks of apparently legitimate companies across multiple European jurisdictions, exploiting the appearance of lawful corporate activity to layer and integrate the proceeds of a mass consumer fraud.
In a separate, multi-million dollar case in the US, several defendants were found to have established a tanning business whose primary purpose was to launder the proceeds from the manufacturing and selling of falsely labelled steroid products.
Corruption plays the role of the enabler of pharma crime. A 2013 paper argues that the “falsification of medicines has its roots in crime and corruption”. WHO supports this finding, having specifically identified corruption within regulatory bodies, law enforcement, and pharmaceutical supply chains as a driver of the falsified medicines problem.
Corruption enables the falsified medicine phenomenon, on the one hand, by allowing the manufacturing or marketing of such products by legitimate and authorised actors in regulated supply chains; and, on the other hand, by facilitating fake medicines’ manufacturing or sale by illegitimate and unauthorised actors. A 2022 paper focusing on Colombia suggests that tackling the fake medicines scourge requires anti-corruption and accountability efforts directed at “all actors, public and private”.
Plançon, who has worked at the intersection of health and law enforcement for many years, puts it plainly: “When falsified medicines penetrate supply chains, corruption is often part of the equation. Addressing it is fundamental to any effective response.”
Meanwhile, Professor Newton points to the detection gap as the most urgent systemic shortcoming. “Due to the paucity of data, there is much uncertainty about how many falsified and substandard medicines escape detection and reach patients – what evidence we have suggests that it is substantial”, he says.
“The main reason that surveillance systems do not detect more incidents is that many countries, especially those more financially constrained, do not have effective systems in place for post-market surveillance. National medicine regulatory authorities are the keystones for such work, requiring experienced investigators and accessible and affordable reference laboratories. As these are expensive, the budget required for effective surveillance is significant.”
He does, however, identify a reason for cautious optimism: “A great hope is that recently developed handheld screening devices for detecting substandard and falsified medicines and vaccines in supply chains will empower investigators and allow more efficient and cost-effective surveillance.”
For Plançon, addressing the issue of falsified medicine will require action on multiple fronts simultaneously: strengthening consumer awareness to reduce demand, reducing vulnerabilities across the fragmented pharmaceutical supply chain, and tackling the corruption that enables criminal infiltration.
Source: Financial Crime Digest — Aperio Intelligence
