Anti-Counterfeit Measures

In developing countries, it is reported that 10 to 30 percent of the medicines in circulation are counterfeit, posing a serious threat to the safety of patients. In Japan as well, the influx of counterfeit medicines through personal imports and other means and the resulting health hazards have been confirmed.

The threat of counterfeit pharmaceuticals (*1) is increasing globally, with the volume of counterfeit pharmaceuticals in circulation said to be as high as $75 billion (*2). In developing countries, it is reported that 10-30% of all medicines in circulation are counterfeit, posing a serious threat to patient safety. The intentional manufacture and sale of counterfeit medicines that falsely appear to be authentic, approved drugs poses the risk not only of ineffective treatment, but also of unexpected side effects that can lead to physical disability or death.
In Japan, the distribution of counterfeit medicines through personal imports from overseas via the Internet and other means has been confirmed as a health hazard. In the five fiscal years up to fiscal 2017, the customs authorities stopped the importation of more than 232,000 IP-infringing pharmaceutical products (*3), indicating that a large number of counterfeit pharmaceutical products are still being imported.
In addition, in 2017, the distribution of counterfeit hepatitis C drugs was discovered in Japan, bringing the issue of counterfeit drugs into the spotlight and increasing momentum for discussion of countermeasures.

In July 2012, the Pharmaceutical Manufacturers Association of Japan (PMAJ), together with other associations (IFPMA, PhRMA, EFPIA), issued a joint statement aimed at strengthening the crackdown on counterfeit drugs coming from illegal Internet pharmacies and other sources. In addition, we are making efforts to understand the actual situation of counterfeit medicines at member companies by conducting periodic surveys of member companies regarding counterfeit medicines.

In 2013, the MHLW (Ministry of Health, Labour and Welfare) launched a website, "Ayashii Yakubutsu Liaison Net," to educate the public and collect information on counterfeit medicines and other issues. (2) In April 2014, the Ministry announced the holding of the Council for the Promotion of Measures against Counterfeit Drugs and Designated Drugs to promote collaborative efforts among related parties to collect information on counterfeit drugs and designated drugs, publicize and educate the public, and promote measures to ensure proper operation of the system for personal importation. (iii) In 2014, the JCIA launched a commissioned project to monitor Internet sales sites in Japan and overseas, and in the three years through February 2017, it has removed 2,327 sites handling unapproved pharmaceuticals (*4). (*4) In 2017, the "Study Group on Measures to Prevent the Distribution of Counterfeit Ethical Drugs" was convened to discuss the desirable form of consistent measures from manufacturing to sales from the perspective of preventing the distribution of counterfeit drugs, and its final report (*5) was published.
With regard to customs, as one of the measures against counterfeit pharmaceuticals, there are numerous cases of crackdowns by customs authorities in various countries, including Japanese customs, against infringement of intellectual property rights, especially trademark rights.
The police have long been involved in the control of counterfeit pharmaceuticals and have a proven track record in seizures and arrests. In September 2017, a record number of 197 agencies from 123 countries, including Japan, participated in Operation Pangaea, a joint international crackdown on the advertising and sale of illegal drugs on the Internet, and seized a record number of 25 million drugs, amounting to US$51 million. The seizures amounted to the equivalent of US$51 million (*6).
The Pharmaceutical Manufacturers Association of Japan and its member companies will continue to contribute to the health of patients in Japan and developing countries by raising awareness of the problem of counterfeit medicines and preventing the distribution of counterfeit medicines through cooperation with the MHLW, customs, and police.
Although different from counterfeit medicines, we also consider substandard medicines to be an issue. Substandard drugs that are approved and legally manufactured but do not meet quality standards may pose a serious health risk. We believe that medicines that meet appropriate quality standards should be used worldwide. Where developing countries lack the technical capacity to meet the required standards, we will work to resolve these issues through public-private partnerships and other means.

Examples of member companies' efforts

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