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, and the second was conducted in 2014.

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 Second Survey

1. Organizational structures for planning actions against counterfeit medicines

-Anti-counterfeit strategy is led by specialized Security Departments at global companies-

Countermeasures against counterfeit medicines involve coordination among various departments, such as the Quality Assurance Department, Production Department, Legal Department, and Intellectual Property Department. Many companies responded that the leading department is the Quality Assurance Department.

At the global level, the most common leading department is the Security Department. (A total of 7 companies among Foreign capital companies and Domestic capital companies.)

11 out of 12 Foreign capital companies (92%) indicated that there was a department responsible for this issue in Japan, while 19 out of 41 Domestic capital companies (46%) have a department that exclusively or mainly deals with counterfeit medicines. The number of companies that selected “Department that is devoted to, or has a principal/leadership role in efforts”was 10 out of 12 (83%) Foreign capital companies and 12 out of 41 (29%) Domestic capital companies. On the other hand, 18 out of 41 (44%) Domestic capital companies answered that there was no department responsible for this issue.

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

-Counterfeit medicines are reported in many therapeutic fields on a Global basis-

Domestically, the majority of counterfeit medicines were “drugs for improvement of sexual performance”. Globally, there are also many cases of counterfeiting “drugs for improving sexual performance”. However, the problem affects various therapeutic fields, and there have been reports of counterfeit “anticancer drugs”, “antidiabetic drugs”, and “antihypertensives”. It is expected that global business has a higher risk of being affected by counterfeit medicines.

3. Health problems due to counterfeit medicines

-Serious adverse reactions have been reported-

Concerning health problems resulting from the use of counterfeit medicines in Japan, 4 companies reported problems related to “drugs for improvement of sexual performance”and 1 company reported such problems for another product. 2 companies reported reactions that were considered to be critical, 1 company reported significant reactions that were not critical, and 2 companies reported reactions that were not significant.

4. Countermeasures against counterfeit medicines

-Strengthening of information collection activities and cooperation with public institutions and industry groups-

Domestically, many companies indicated that “We are altering our products in some way as a measure against counterfeits,”as well as selecting “Coordination with other pharmaceutical companies/industry groups,”and “Other information gathering activities aimed at understanding the state of counterfeit medicine.”On the other hand, 24 companies (45%) answered “No action has been taken at the product level.”

Globally, in addition to the answers from Domestic companies, the following responses were also provided:

“Cooperation in investigations by judicial authorities such as police or Interpol,”and “Countermeasures through coordination with industry professionals.*”However, 26 companies (49%) answered “No action has been taken at the product level.”

*)
The companies conducting surveillance and authentication of Internet-based pharmacies.

5. Increased awareness through events and changes to regulations

-Awareness of the issue has been increased through seminars organized by the JPMA-

Member companies of the JPMA have increased their awareness of the issue [13-15 out of 53 companies (about 25-28%)] of counterfeit medicines through participation in a media seminar organized by the JPMA, as well as various seminars for the member companies and changes of the regulations related to lifting the ban on sales of OTC drugs over the Internet and changes in government policy. On the other hand, some companies indicated that they were not aware of these events. Accordingly, it is believed that further activities are needed to increase industry awareness of the issues related to counterfeit medicines.

[Summary]

On a global basis, issues related to counterfeit medicines are not only limited to “drugs for improvement of sexual performance”, but also affect other therapeutic fields such as lifestyle-related diseases, and patients have developed health problems due to such medicines.

In order to prevent future expansion of counterfeit medicines in Japan, with reference to actions taken by proactive companies and countermeasures taken globally, it is necessary to prevent health problems related to counterfeit medicines through cooperation with stakeholders.

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