Questionnaire survey of member companies

Questionnaire Survey of Member Companies on Counterfeit Pharmaceuticals

The Pharmaceutical Manufacturers Association of Japan (PMAJ) periodically conducts a questionnaire survey on counterfeit pharmaceuticals among its member companies to ascertain the actual status of measures taken by member companies against counterfeit pharmaceuticals. 2012 was the first survey, 2014 the second survey, and 2018 the third survey.

The results of the analysis revealed differences in the efforts and heightened awareness of the problem among member companies, depending on the state of damage caused by counterfeit pharmaceuticals, and also provided rich insights into countermeasures and future directions for counterfeit pharmaceuticals. Based on the results of the questionnaire analysis, the Pharmaceutical Manufacturers Association of Japan (PMAJ) and its member companies will work together with stakeholders to find concrete measures for the future in order to eliminate counterfeit pharmaceuticals.

Third Questionnaire Survey Executive Summary

1. Organizational structure to tackle counterfeit pharmaceuticals

The number of companies working against counterfeit pharmaceuticals is increasing.

The number of "domestic" companies in Japan that responded that they have a department working to combat counterfeit pharmaceuticals has increased to approximately 62% from approximately 35% in the first survey (2013) and 46% in the second survey (2015). As for the departments involved in the fight against counterfeit pharmaceuticals, many companies indicated that they are "production and quality-related departments," such as the quality assurance department, reliability assurance promotion department, and production department, as well as the sales department, pharmaceutical affairs department, and legal department.
Many companies, both in Japan and globally, chose "production and quality-related divisions" or "security-related divisions" such as global security and product security as the divisions in charge of countermeasures against counterfeit medicines.
Foreign-affiliated" companies were more likely to have a "security-related division. Since counterfeit medicines have been identified in many countries and regions globally, it is assumed that these companies have established "security-related divisions" that can take a cross-sectional approach to countering counterfeit medicines, such as cooperation with health authorities and investigative agencies, and measures against criminal trials.

2. Facts about confirmed counterfeit medicines (for the past two years)

Counterfeit drugs in Japan are not limited to sexual function enhancers

In Japan, counterfeit oral contraceptives were identified for the first time in this survey. Counterfeit medicines for sexual function enhancers were also identified in the first (2013) and second (2015) surveys, and counterfeit medicines for fungal infection treatments were identified in the second (2015) survey, confirming the continued existence of counterfeit medicines.
Global counterfeit medicines for cancer drugs, antipsychotics, antibiotics, antihypertensive drugs, and diabetes treatments have been identified, suggesting that the top-selling areas are likely to be targeted by counterfeit medicines. Companies that handle large products, as well as those that are preparing to launch large products, will be challenged to implement preventive measures (e.g., product countermeasures, including the consideration and introduction of anti-counterfeiting and identification features, supply chain security, etc.).
The majority of confirmed cases of counterfeit medicines, both domestic and global, were for sexual function enhancers. In Japan, counterfeit medicines are often imported from overseas via personal import agents due to their characteristics (e.g., not covered by insurance, difficulty in seeing a specialist, etc.), counterfeit medicines are often mixed in through unauthorized channels, and these counterfeit medicines are detected by Japanese customs through border control measures (import injunctions). This is thought to be due to the fact that counterfeit medicines are being detected by Japanese customs through frontline measures (import injunctions).

Health hazards caused by counterfeit medicines

There have been reports of serious side effects

In Japan, three of the four companies that responded that they had confirmed the presence of counterfeit "sexual function enhancers" were found to have "what are considered to be minor side effects. Globally, "what are considered to be serious side effects" were confirmed in counterfeit "diabetes drugs". In addition, "non-serious but not minor adverse reactions" were identified in counterfeit "diabetes drugs" and "sexual function enhancers," and "minor adverse reactions" were identified in counterfeit "antacids. Counterfeit medicines continue to be considered a major threat to patient health.

Efforts against counterfeit medicines

Internal systems and cooperation with public institutions and industry associations are being strengthened.

Companies that have actually confirmed the existence of counterfeit pharmaceuticals are taking initiatives and countermeasures such as filing import injunctions with customs, conducting trial purchases and analysis (to determine authenticity), cooperating with health authorities and investigative authorities to detect them, and working with sales companies.
A question targeting all member companies confirmed that many companies in Japan are strengthening their "internal system development" ("clarification of responsible and related departments," "clarification of reporting and information sharing routes in case of counterfeit drug cases," and "establishment and dissemination of internal (including group company) procedure manuals"). This is presumably due to the impact of the hepatitis C drug counterfeit drug distribution case in Japan that occurred in 2017. While a large number of companies both in Japan and globally reported that they have "product countermeasures" in place, only about 18% of companies in Japan answered that they are "reinforcing" or "somewhat reinforcing" these measures, which is much lower than the 30% of companies globally. As in the second survey (2015), many companies receive information on counterfeit pharmaceuticals from industry associations (such as the Japan Pharmaceutical Manufacturers Association, the Pharmaceutical Manufacturers Association of Japan, IFPMA, and pharmaceutical security institute (PSI)), indicating the importance of the role played by industry associations. In addition, some companies took proactive measures such as information sharing and cooperation with the Ministry of Health, Labor and Welfare, police, customs, etc., holding press seminars, conducting buy-up surveys, and collaborating with universities.
Although only a few companies in Japan have confirmed the presence of counterfeit pharmaceuticals, it is important for the majority of member companies to continue to take some preventive measures and establish internal systems for their own products, and to keep up with information gathering on counterfeit pharmaceuticals through cooperation with pharmaceutical companies and industry associations, based on these companies and global efforts. It is considered important to take a proactive stance.

5. Awareness of events, system reforms, etc.

80% of companies have changed their awareness of the problem due to the distribution of counterfeit medicines in Japan

About 80% of companies responded that "awareness of the problem has increased" with regard to the "domestic distribution of counterfeit hepatitis C drugs" that occurred in 2017. Related to this, the "Study Group on Measures to Prevent the Distribution of Counterfeit Ethical Drugs by the Ministry of Health, Labour and Welfare," "Enforcement of the Ministerial Ordinance Partially Amending the Enforcement Regulations of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices, etc. (for the prevention of distribution of counterfeit pharmaceutical products, pharmacy operators, wholesale distributors (rules for compliance by pharmacy operators, wholesale distributors, retailers, and distributors of pharmaceuticals to prevent the distribution of counterfeit pharmaceuticals) also changed the awareness of the issue. The discovery of counterfeit drugs through distribution channels in Japan has had a major impact on patients and those involved in the pharmaceutical industry, and has been widely covered on TV and in national newspapers, etc. This survey again confirmed that member companies have also been strongly impacted by the discovery.

Summary

The survey confirmed that counterfeit pharmaceuticals have been found in multiple therapeutic areas, and that the damage has even reached the point of being hazardous to patients' health. The members are encouraged to review how to prevent damage and what to do in the event of damage by referring to the efforts of companies that have taken the lead in countermeasures against counterfeit pharmaceuticals and their global countermeasures. In addition, it is necessary to keep a close watch on future trends, and member companies and related parties should work together to prevent and eradicate the spread of counterfeit pharmaceuticals by sharing information and taking joint measures.

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