Global HealthPharmaceutical Regulations in Japan

Countermeasures against Counterfeit Medicines

Reports that 10%-30% of medicines (by volume) distributed in developing countries are counterfeit is a powerful call to action to save patients from harm.

The threat of counterfeit medicines1 is increasing worldwide, and the value of these products is said to have reached US$75 billion2. In developing countries, it is reported that between 10% and 30% of distributed medicines are counterfeit, posing a serious threat to patient safety. Manufacturing and distributing counterfeit medicines while deliberately disguising them as genuine, authorized medicines results not only in patients being denied the desired treatment effect, but also risks causing physical disability or death due to unexpected effects. While counterfeit medicines have not been confirmed in Japanese domestic distribution routes, there have been confirmed cases of individual import of counterfeit medicines from overseas via the internet as well as associated damage to health, and the volume of transactions of counterfeit medicines is on the rise (according to Japan Customs, there is a rising trend in the number of seizures of imported IP infringing pharmaceuticals, with 88,543 cases of import seizure in 2015, more than double the previous year3).

In July in 2012, JPMA published a joint statement with the other major pharmaceutical industry associations, IFPMA, PhRMA and EFPIA, to support and encourage the efforts by national and international government organizations to reduce the illegal sale of medicines by illegitimate online drug sellers that endanger public health. In addition, the JPMA has made efforts to grasp the actual state of anti-counterfeiting efforts at member companies by regularly conducting a survey on counterfeit medicines among member companies.

Similarly, the Japanese Ministry of Health, Labor and Welfare has established the "Suspicious Drugs Reporting Network," a website for educating the general public on counterfeit medicines (provided in Japanese only). At a conference to promote countermeasures for counterfeit medicines and illicit drugs held in April 2014, the Ministry also announced that they would collaborate with stakeholders to promote policies for information gathering, reporting, raising awareness and optimizing regulations on individual importing of counterfeit medicines and illicit drugs.

Although the aim of anti-counterfeiting efforts is to protect patient health, in practice, cracking down on the infringement of intellectual property rights and trademark rights in particular via national customs agencies can be an effective tool as a countermeasure against counterfeit medicines. The JPMA will continue to protecting the health of patients in Japan as well as developing countries through alignment with national customs agencies.

JPMA and its members recognize that substandard medicines, while differing from counterfeit medicines, are also an important issue. Substandard medicines, which are the result of unfulfilled quality standards despite the medicines being approved and legally manufactured, could pose a serious health risk to patients, and JPMA strongly supports the highest standards for all patients across the world. We will therefore make efforts to solve the problem of substandard medicines using various methods, including where appropriate public-private cooperation, working to raise technical ability in developing countries to international standards.

  1. WHO discussed counterfeit medicines in IMPACT Meeting (Hammamet, Tunisia, 2008). In the meeting, the counterfeit medicine is defined a medicine, which is deliberately and fraudulently mislabeled with respect to identity and/or source.
  2. Growing threat from counterfeit medicines(Bulletin of the World Health Organization, Volume 88, Number 4, April 2010, 241-320)
  3. Data on import seizures of products suspected of IP infringemen(Japan Customs HP)
Initiative by member companies
Collaboration with INTERPOL Twenty-nine global pharmaceutical companies have given funding to INTERPOL for its efforts to combat counterfeit medicines (including raising awareness, exposing counterfeiters and distributors, capacity building for discovery of counterfeit medicines). JPMA member companies who participated in this initiative include Astellas, Chugai, Daiichi Sankyo, Dainippon Sumitomo, Eisai, Otsuka, Shionogi and Takeda.

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