Global HealthPharmaceutical Regulations in Japan

Counter Measures 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 billion. 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. JPMA and its member companies will therefore make every effort to eradicate counterfeit medicines.

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.

Similarly, the Japanese Ministry of Health, Labor and Welfare has established the "Suspicious Drugs Reporting Network," a website for edifying the general public on counterfeit medicines (provided in Japanese only). The Ministry has also announced that the government and enterprises will collectively address countermeasures for counterfeit medicines. JPMA welcomes and supports these efforts.

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 can be an effective tool as a countermeasure against counterfeit medicines.

JPMA and its members recognize that substandard medicines, while differing from counterfeit medicines produced with criminal intent, 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.

Some JPMA member companies have established internal global functions to deal with issues related to securing the safety of medicines, including countermeasures against counterfeit medicines, and are contributing funding to activities to eradicate the criminal trade in counterfeit medicines. The JPMA itself is also currently conducting a survey of its membership regarding counterfeit medicines. Based on the insight garnered from this survey, JPMA and its member companies will identify concrete implementation measures with a view to cooperating with various national governments, the police, tax authorities and other stakeholders, and will continue its efforts geared towards the eradication of counterfeit medicines.

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 mislabelled with respect to identity and/or source.

Initiative by member companies

Participation in activities to eradicate counterfeit medicines through cooperating with Interpol
The global pharmaceutical enterprises provide financial assistance to activities by Interpol to eradicate counterfeit medicines, and are also engaged in other endeavors such as enlightenment activities and capacity building for identifying such medicines. From JPMA members, Astellas, Chugai, Daiichi Sankyo, Sumitomo Dainippon, Eisai, Otsuka, Shionogi, and Takeda participate in the activities.

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