Global HealthPharmaceutical Regulations in Japan

Survey among Member Companies

Survey on Counterfeit Medicines among Member Companies

JPMA regularly conducts a survey on counterfeit medicines among member companies to grasp the actual state of anti-counterfeiting efforts at member companies. The first survey was conducted in 2012, the second was conducted in 2014 and the third was conducted in 2018.

Analysis of the results revealed the differences in the impact of damage from counterfeit medicines lead to differences in awareness of issues and initiatives at each company, and found many implications for countermeasures and policy for counterfeit medicine. 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 stakeholders, and will continue its efforts geared towards the eradication of counterfeit medicines.

Executive Summary of the Third Survey

1. Organizational structure for planning actions against counterfeit medicines

-More companies are tackling with the problems of counterfeit medicines-

The percentage of “domestic capital” companies that reported to currently tackle with the problems of counterfeit medicines in Japan increased from approximately 35% in the 1st survey (2013) and approximately 46% in the 2nd survey (2015) to approximately 62% in this survey. As division for activities on counterfeit medicines, “Production/Quality related division” including Quality Assurance Division, Reliability Assurance Division, and Production Division, were common as well as Business Division, Pharmaceutical Affairs Division, and Legal Division among the member companies.

Many companies responded that the leading division for activities on counterfeit medicines was “Production/Quality related divisions” for the domestic and global sectors, or “Security related division” including global and product security.

Many “foreign capital” companies had “Security related division.” Since counterfeit medicines in multiple fields are frequently found in the global sector in many countries/regions, it is assumed that “Security related division” is established to collaborate between health organizations/law enforcement, and to take cross-sectional actions for criminal trials and other purposes.

2. Status of counterfeit medicines confirmed (over the past 2 years)

-Counterfeit medicines in Japan are not only drugs for improvement of sexual performance-

This questionnaire survey found counterfeit medicines of oral contraceptives for the first time in Japan. Counterfeit medicines of drugs for improvement of sexual performance were found in the 1st (2013) and the 2nd surveys (2015), while those of antifungal drugs were also found in the 2nd surveys (2015). These results reveal that counterfeit medicines are continuously present.

As counterfeit medicines of multiple anti-cancer drugs, antipsychotics, antibiotics, antihypertensives, and antidiabetic drugs were found in the global sector, suggesting that fields in top sales ranking are likely to be the target of counterfeit medicines. For companies who deal with or plan to launch major products, preventive measures (product countermeasures: e.g., prevention of counterfeiting, evaluation/ introduction of identification methods, and supply chain security) is a challenge.

Most of the confirmed cases of counterfeit medicines were drugs for improvement of sexual performance regardless of domestic or global sector. In Japan, private imports are frequently observed via agents for private imports because of its characteristics (including non-insurance coverage and hesitation to visit a specialist), slipping counterfeit medicines into such cases via unauthorized route, and boarder crackdowns (import suspension measure) of such counterfeit medicines at customs office in Japan are plausible factors.

3. Health damage due to counterfeit medicines

-Serious adverse reactions have been reported-

In Japan, 3 of 4 companies reporting counterfeit medicines in “drugs for improvement of sexual performance” confirmed “there were reactions that were considered insignificant.” For the global sector, “there were reactions that were considered significant” was found in counterfeit medicines of “antidiabetic drugs”. “There were no critical reactions, but reactions were not insignificant” was found in counterfeit medicines of “antidiabetic drugs” and “drugs for improvement of sexual performance,” while “there were reactions that were considered insignificant” was found in counterfeit medicines of “antacids”. These results suggest that counterfeit medicines continue to be a serious threat to patient health.

4. Countermeasures against counterfeit medicines

-“Improvement of internal system” and “coordination with public institutions/industry groups” are strengthening-

The companies who confirmed counterfeit medicines take actions and measures, including import injunction requests to customs office, purchase/analysis of samples of counterfeit drugs (identification of true/false), detection in cooperation with health organizations and police, and collaboration with sales companies.

The responses to the questions for all member companies found that many companies strengthened <improvements of internal system> (“clarification of responsible and relevant divisions”, “clarification of incident reporting/information sharing process about falsified medicine” and “establishment/awareness of internal procedure manual (including group companies)” in Japan. These results suggest the impact of the issue of counterfeit medicines for type C hepatitis occurred in 2017. Many companies reported “product countermeasures” are taken in both domestic and global sectors, but about 18% of the companies reported “getting stronger” and “getting slightly stronger” that was significantly lower than in the global sector (30%). Similar to the 2nd survey (2015), many companies received information on counterfeit medicines from organizations, including the Federation of Pharmaceutical Manufacturers’ Associations of Japan (EPMAJ), JPMA, International Pharmaceutical Manufacturers & Associations (IFPMA), Pharmaceutical Security Institute (PSI), suggesting the importance of the role of industry organizations. Some companies take active measures, including information sharing and collaboration with MHLW, police, and customs office, press seminars, purchase investigation, and collaboration with universities.

Although few companies confirmed counterfeit medicines in Japan, it is important for a majority of the member companies to keep information collection regarding counterfeit medicines in collaboration with pharmaceutical companies/industry groups, in addition to continuous preventative measures for own products and <improvements of internal system> with reference to their own and global efforts.

5. Awareness about events and change to regulations

- About 80% of the companies changed their awareness of the issue by the domestic distribution of counterfeit medicines -

About 80% of the companies reported “issue awareness increased” of “counterfeit medicines for type C hepatitis” occurred in 2017. Their awareness of the issue was influenced by the relevant “Discussion board for prevention of falsified medicine distribution in Japan organized by the Ministry of Health, Labour and Welfare (MHLW),” and “the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical devices, ministerial order to partially revise the enforcement regulations (Establishment of new regulations for pharmacies, wholesalers, store sellers, and household distributors in order to prevent from falsified medicine distribution)”. The detection of counterfeit medicines in the domestic distribution channel gave a great impact on patients and medical product industry, and this issue was widely covered by media such as TV and national newspapers. The results of this questionnaire survey confirmed a significant impact on the member companies.

[Summary]

Counterfeit medicines are prevalent in multiple therapeutic fields, and patients have developed health problems due to such medicines. Hopefully, this will be a good opportunity for the member companies to learn from actions of proactive companies and global measures and to review measures to prevent health damage and counterplan for the event of health damage. Future tendencies deserve continued attention, and joint efforts of the member companies and relevant parties are necessary to share information and actions to prevent the expansion and eradicate counterfeit medicines.

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