Anti-Counterfeit Initiatives

Amidst the recent globalization of distribution and the growth of electronic trading, the risk of contamination by counterfeit drugs (“medical products that deliberately/fraudulently misrepresent their identity, composition or source” ^*1) and the risk of illegitimate transactions have been increasing, and criminal activity involving pharmaceutical drugs has also become a global problem ^*2. In addition, counterfeit drugs are reportedly responsible for the death of more than 1 million people annually ^*3, and the importance of initiatives to prevent access to dangerous products has attained global recognition in recent years.

It can no longer be claimed that stable production of high-quality pharmaceutical drugs alone is enough to ensure product quality; rather, pharmaceutical companies are now expected to adopt further initiatives that contribute to both patient healthcare and human health.

Despite previous assumptions that official drug distribution channels in Japan posed a rock-solid barrier capable of preventing counterfeit drugs from entering the country, counterfeit drugs were discovered in Japan in 2017. Since then, the regulatory authorities and pharmaceutical industry have been cooperating to promote new countermeasures.

Since entering into a strategic alliance with Roche, Chugai has not only been importing products into Japan, but has also been exporting its in-house developed products overseas, so it has been working on supply-chain security measures on a global scale as well as in Japan.

• *1: Seventieth World Health Assembly: “Member State mechanism on substandard/spurious/falsely-labelled/falsified/ counterfeit medical products.”
• *2: World Health Organization (3 December 2024). “Substandard and falsified medical products.”
• *3: Natalie Southwick (2013). Counterfeit Drugs Kill 1 Mn People Annually: Interpol, InSight Crime

Based on the common anti-counterfeit policy within the Chugai Group in Japan and overseas, Chugai has been working on the following measures to protect patients from the globally-expanding threat of counterfeit drugs and to ensure confidence in its drugs.

Introduction of Anti-Counterfeit Technology

Chugai will introduce product and packaging anti-counterfeit technologies and improve security to prevent counterfeiting of its products.

Security Measures

Chugai has established its own GDP (Good Distribution Practice) to ensure the integrity of official distribution channels, and has been implementing supply-chain security measures together with distributors.

GMP: Good Manufacturing Practice

Prevention of Fraudulent Distribution

Given that most counterfeit drugs are distributed via online pharmacies and websites, Chugai is investigating the marketing of Chugai products on the internet to gain a clear picture of how its products are fraudulently distributed with the aim of applying the findings to preventive measures.

Participation in External Preventive Activities

As a member of the Pharmaceutical Security Institute (PSI, an industry group dedicated to protecting public health), Chugai cooperates on activities to eradicate counterfeit drugs and also participates in and supports the drug anti-counterfeiting activities of Japanese and foreign law enforcement agencies, regulatory authorities, and industry groups.

Awareness-Raising Activities

Chugai will make use of various opportunities, including workshops and industry meetings in Japan and overseas, to promote anti-counterfeit drug measures not only in the pharmaceutical industry but also in other industries, by raising awareness of and disseminate information about the danger of counterfeit drugs and the need for preventive measures.

Handling on Discovery

In cooperation with the entire Chugai Group, Chugai has established an anti-counterfeit structure to enable rapid response upon receipt of any information or samples related to the counterfeiting of Chugai products, with the aim of preventing and minimizing health injuries to patients.

Based on its anti-counterfeit drugs policy, Chugai has established a cross-departmental team to work on countermeasures and to collaborate with the Roche Group and relevant external entities.

Organization Chart of Chugai’s Anti-Counterfeit Initiatives