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.
- The first Survey on Counterfeit Medicines (survey period: September 14 to October 12, 2012, valid responses: 67/70 companies)
- The second Survey on Counterfeit Medicines (survey period: November 13 to December 10, 2014, valid responses: 53/72 companies)
- The Third Survey on Counterfeit Medicines (survey period: January 26 to February 23, 2018, valid responses: 49/72 companies)
Analysis of the results revealed the differences in the impact of damage from counterfeit medicines lead to differences in awareness of issues and Analysis 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 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
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%. 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 divisions for activities on counterfeit medicines, "Production/Quality related divisions" including Quality Assurance Division, Reliability Assurance Division, and Quality Assurance Division. As divisions for activities on counterfeit medicines, "Production/Quality related divisions" 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 members. Many companies responded that the leading division is the Pharmaceutical Affairs Division, the Pharmaceutical Affairs Division, and the Legal Division among the member companies.
Many companies responded that the leading division for activities on counterfeit medicines was "Production/Quality related divisions 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 divisions" including global and product security.
Many "foreign capital" companies had "Security related divisions. Since counterfeit medicines in multiple fields are frequently found in the global sector in many countries/regions, it is assumed that "Security related divisions" is established to collaborate between 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.
Status of counterfeit medicines confirmed (over the past 2 years) 3.
Awareness about events and change to regulations -More companies are tackling with the problems of counterfeit medicines- -More companies are tackling with the problems of counterfeit medicines- -Serious adverse reactions have had
This questionnaire survey found counterfeit medicines of oral contraceptives for the first time in Japan. This questionnaire survey found 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 For companies who deal with or plan to launch major products, preventive measures (product, product, and product) are continuously present. For companies who deal with or plan to launch major products, preventive measures (product countermeasures: e.g., prevention of counterfeiting, evaluation/ introduction of For companies who deal 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 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. In Japan, 3 of 4 companies reporting 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.
Health damage due to counterfeit medicines 4.
-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. For the global sector, "there were no critical reactions, but reactions were not insignificant" was found in counterfeit medicines of "antidiabetic drugs" and "drugs for improvement of improvement. "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 "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.
Countermeasures against counterfeit medicines 5.
"Improvement of internal system" and "coordination with public institutions/industry groups "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/ 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
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 These results suggest 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 were significantly 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 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 ( Some companies take active measures, including information sharing and collaboration with industry organizations. Some companies take active measures, including information sharing and collaboration with MHLW, police, and customs office, press seminars, purchase investigation, and 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 However few companies confirmed counterfeit medicines in Japan, it is important for a majority of the member companies/industry groups in collaboration with pharmaceutical companies/industry groups, in addition to continuous preventive measures for own In addition to continuous preventive measures for own products and <improvements of internal system> with reference to their own and global About 80% of the companies reported "no".
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 Their awareness of the issue was influenced by the relevant "Discussion board for prevention of 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 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) enforcement regulations (Establishment of new regulations for pharmacies, wholesalers, store sellers, and household distributors in order to The detection of counterfeit medicines The detection of counterfeit medicines in the domestic distribution channel gave a great impact on patients and the medical product industry, and this issue The results of this questionnaire survey confirmed a significant impact on the member The results of this questionnaire survey confirmed a significant impact on the member companies.
Summary
The results of this questionnaire survey confirmed a significant impact on the member companies. 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 Future tendencies deserve continued attention, and joint efforts of the member companies and relevant parties are necessary to share information 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.