Combatting Counterfeiting in the Pharmaceutical Industry

What is a counterfeit medicine?

A counterfeit medicine is a medicinal product that falsely creates the impression of authenticity and misrepresents its identity and source. This includes medicines that bear logos, brand names, labels, packaging, color combinations, shapes, or design elements identical or deceptively similar to those of a third party's trademark. In simple terms, counterfeit medicines are “fake” or “knock-off” medicines. They may amount to infringement of IP rights such as trademarks, copyright and patents.

In public health discussions, the term “counterfeit medicines” is frequently misused as a catch-all descriptor for substandard, unregistered or falsified medicines. However, these terms are not synonymous and refer to distinct categories. Substandard medicines are medicines that are authorized but fail to meet established quality standards or specifications, often due to manufacturing errors, degradation, or expiration. Unregistered medicines are those that have not been evaluated or approved by the relevant regulatory authorities. Falsified medicines are those that deliberately misrepresent their identity, composition, or source, and may include adulterated or fraudulently manufactured medicines.

Impact of counterfeit medicines on public health, economies, and the environment

Counterfeit medicines pose a serious threat to public health, economies, and the environment. According to a 2020 report of the Organisation for Economic Co-operation and Development (OECD), adverse toxicity, treatment failure, and the development of antimicrobial resistance caused by counterfeit medicines contribute to an estimated 72,000 to 169,000 child deaths from pneumonia annually. Similarly, counterfeit anti-malarial medication may be responsible for an additional 116,000 deaths. The report also highlights that beyond health risks, counterfeit medicines result in significant economic losses.

Pharmaceutical companies suffer reputational damage from counterfeit medicines in instances where a trademark has been used in an unauthorized way, they may also suffer profit loss. This undercuts innovation and threatens future progress in medical innovation. Further, governments lose revenue and face increased healthcare costs due to adverse effects on patients. Therefore, while the consumption of counterfeit medicines may seem like an individual risk, the consequences extend far beyond, endangering public health.

Additionally, these illegal products are often manufactured in unregulated facilities, possibly leading to environmental harm through toxic waste disposal. The counterfeit medicines trade is also linked to organized crime, and their consumption can enable unlawful activity. Addressing this issue requires stronger regulations, international cooperation, and increased awareness to protect public health and ensure the integrity of the pharmaceutical supply chain.

Legal frameworks and industry initiatives to combat anti-counterfeiting

IP enforcement serves as a pillar of anti-counterfeiting efforts. Beyond securing IP registrations, a comprehensive IP enforcement strategy involves active market monitoring, timely and appropriate legal action against counterfeiters, and targeted training and awareness programs. Legal actions may include cease-and-desist notices, civil lawsuits, border enforcement actions (to check import of counterfeit medicines), and, where applicable, criminal prosecution. These actions help to not only curb ongoing counterfeiting but also to deter counterfeiters.

Technological measures also play a key role in combating counterfeiting by enabling authentication and ensuring traceability. Effective strategies include using standardized coding systems, overt and covert product markings such as holograms, color shifting inks and guilloches, and tamper-proof packaging to protect product integrity across the supply chain. These technologies, tailored to each manufacturer, make it more difficult for counterfeiters to replicate products and help customers and patients to verify authenticity at all stages, including at the point of dispensing.

Training and awareness initiatives by IP right holders are equally vital. These can be directed at end consumers, law enforcement agencies, and healthcare professionals (particularly those administering medicines) to help them better identify counterfeit products and respond appropriately.

Therefore, combatting counterfeit medicines requires a comprehensive, coordinated strategy at both international and national levels, involving efforts from international organizations, national governments, judicial bodies, law enforcement agencies, and pharmaceutical companies.

International law, including the TRIPS Agreement and the Medicrime Convention, mandates strong IP enforcement and border measures to combat counterfeit medicines. Global pharmaceutical associations support these frameworks and advocate for their wider adoption to protect both originator and generic drugs.

Several pharmaceutical companies, such as Pfizer and Roche, have proactively developed anti-counterfeiting programs to detect, disrupt, and deter counterfeit medicine distribution. Pfizer, for instance, has collaborated with wholesalers, pharmacies, customs officials, and law enforcement agencies, preventing over 302 million counterfeit doses from reaching patients worldwide since 2004.

WIPO partnerships and collaborative efforts

WIPO plays a key role by collaborating with various partners to address pharmaceutical anti-counterfeiting with national and international actors. WIPO’s Advisory Committee on Enforcement (ACE) facilitates policy dialogue on IP enforcement and respect for IP, focusing on technical assistance and coordination. WIPO’s Building Respect for IP Division aims to support informed and empirically well-founded policy discussions at the international level and to strengthen capacity in Member States for the effective enforcement of IP rights. This promotes social and economic development and consumer protection as well as a culture of respect for IP rights through education and awareness raising.

WIPO also cooperates at the international level with national, regional and international public and private stakeholders, including the International Criminal Police Organization (INTERPOL), the World Trade Organization (WTO), the World Customs Organization (WCO), the OECD and the United Nations Office on Drugs and Crime (UNODC) to further bolster global efforts against counterfeit goods.

Conclusion

Counterfeit medicines are a serious global challenge that threaten public health and harm economies. To effectively address this issue, actors at both national and international levels coordinate efforts to strengthen IP systems, raise consumer awareness, and enhance the anti-counterfeiting strategies of pharmaceutical companies. IP enforcement plays an important role in addressing this issue by promoting the removal of counterfeit medicines when they are detected and preventing their entry into the market.

By prioritizing strong IP enforcement and fostering international cooperation, we can significantly reduce the prevalence of counterfeit medicines and protect communities worldwide.