Illegal Medicines: The Silent Risk Threatening Patient Safety

Medications are not just another product; they are a critical intervention that can mean the difference between life and death. Each one is the result of years of scientific research, clinical development, and evaluation under strict health regulations, with the purpose of preventing or controlling diseases, increasing survival rates, improving well-being, and, in many cases, saving lives. Behind every treatment lies a life-changing diagnosis, a family holding onto hope, and a patient who trusts.

That is why, when we talk about an illegitimate vaccine, medicine, or medical product — one whose identity, composition, or origin has been deliberately falsified — or a substandard product that fails to meet proper manufacturing standards, we are not simply facing a regulatory or market issue. We are confronting a direct threat that not only endangers patient safety but also undermines trust in the healthcare system and the credibility of the pharmaceutical industry.

Most alarming is that this phenomenon is no longer an isolated occurrence, but has evolved into a parallel, silent, persistent, and increasingly sophisticated system that operates outside the law and continuously adapts to evade regulatory controls. The World Health Organization estimates that 1 in 10 medicines in low- and middle-income countries are of substandard quality or counterfeit

In Mexico, authorities have documented a sustained increase in recent years in cases involving falsified, stolen, or suspicious medical products, evolving from isolated incidents into dozens of annual alerts, particularly linked to the illicit trade of antibiotics and treatments for chronic diseases.

This problem does not arise in a vacuum. Globally, it is fueled by several structural factors: the complexity of supply chains involving multiple intermediaries; gaps in access to treatments in remote regions; the proliferation of unregulated websites, social media platforms, apps, and sales points; as well as the limited verification culture on the part of the end consumer.

This vulnerability is exploited by illegal structures that take advantage of human need, urgency, and suffering, offering solutions that may not contain the active ingredient, have incorrect or expired doses, or include impurities or harmful substances. In every case, the outcome is the same: therapeutic failure, preventable medical complications, and loss of life. Patients are the ones who suffer the consequences, while the black market generates profits exceeding MX$11.5 billion (US$664 million), impacting the national economy.

As an industry, our position has been firm and non-negotiable: an illegitimate or substandard medicine is not a cheaper alternative; it is a direct threat to public health and the national economy. Therefore, a reactive response is insufficient; we must evolve from an approach based on “alerts” to one of “preventive intelligence” that anticipates, detects, and neutralizes risk.

This requires shared responsibility among the pharmaceutical industry, health authorities, healthcare professionals, distributors, and society at large in order to strengthen end-to-end traceability — the tracking of a medicine from its manufacture to its dispensing to the patient — enhance interoperability — the ability of systems to exchange information seamlessly and in a compatible way — and consolidate a regulatory, intellectual property, and legal framework that imposes broader sanctions and closes gaps that enable informality, both in physical and digital channels.

Strengthening Ecosystem Integrity

In this regard, we recognize and value the initiatives promoted by the government of Mexico to strengthen the integrity of the pharmaceutical ecosystem and patient safety:

1. Sanitary Registration Viewer. A tool developed by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) that strengthens trust in the market by enabling the public and digital verification of key data such as regulatory status, manufacturer, and registration validity. Beyond its informational function, it helps reduce information asymmetries between authorities, industry, healthcare institutions, and patients.

2. IMPI–COFEPRIS Linkage System. A platform from the Mexican Institute of Industrial Property (IMPI) that connects patent information with sanitary registration processes, streamlining the entry of both innovative and generic medicines. At the same time, it reduces regulatory uncertainty that could be exploited by counterfeit or unauthorized products, thereby strengthening legality and system traceability.

3. “Operation Cleanup.” Operations aimed at seizing illicit goods in warehouses and markets of large distributors and importers, while avoiding harm to small businesses.

On the other hand, our pharmaceutical and medical device industry has also been adopting increasingly stringent strategies to help prevent the commercialization of illegitimate products or those lacking guarantees of origin, quality, and efficacy.

With 80 years of history in Mexico, the company I represent has implemented advanced packaging with holograms, security inks, and technologies that are difficult to replicate for greater control of the supply chain; tracking and tracing systems to monitor the medication from its manufacture to the point of sale; frequent training — both internal and external — to learn how to identify a genuine medication from a counterfeit one; we immediately report to the authorities and collaborate with them when we detect violations or irregularities in our products; and, through our sector chambers, we support awareness campaigns for the public about the risks of buying medications through unauthorized channels.

Although this is a complex issue and much remains to be done to eradicate it, joint efforts between the government and our sector have contributed to Mexico’s recent removal from the USTR “Special 301 Report.” Its exclusion from the priority watch list represents recognition of progress in intellectual property protection, anti-piracy enforcement, patent protection, and the strengthening of the sanitary regulatory framework.

This comes at a strategic moment ahead of the USMCA review, strengthening Mexico’s position with its trading partners, reflecting meaningful institutional progress in the protection of innovation and public health, and fostering a more favorable environment for continued investment. Our shared goal remains the same: to strengthen transparency, legality, and trust in Mexico’s pharmaceutical ecosystem, key pillars to protect patients and ensure safe access to essential and innovative treatments.

Similarly, society also plays a key role in avoiding the pitfalls of falsification. It is essential to learn how to distinguish authentic medicines from suspicious ones, purchase them only through authorized channels, be wary of unusually low prices, and always consult a healthcare professional in case of any doubt.

Medicine integrity is not a technical issue nor one exclusive to the health sector; it is a collective cause that protects what is most essential to us: life. Therefore, the message is clear: There is no room to let our guard down. Reporting, verifying, educating, and demanding legality are not complementary actions; they are essential parts of patient protection. Because ultimately, the real question is not how advanced our healthcare system is, but how capable we are of defending, with concrete actions, the trust that sustains it.