Abstract
The world is full of businesses handling imitated and counterfeit products. A business engaged in poor quality pharmaceuticals is part of them and is almost common in characteristics to them; it is not a unique phenomenon occurring in the field of medicine. One end of the problem of poor quality pharmaceuticals is the result of the act of malicious criminals and the other end, the result of an act that is based on good intentions but which is undeveloped technologically. Between these two ends, there exists more than one condition that cannot be determined to be included in either category. Systematic data with which we can investigate this complicated and tangled problem have been scarce and reliable analyses so far have been insufficient. Work to link fragmentary information and data together so as to identify the actual status of the problem is necessary. Counterfeit medicines derived from poor quality pharmaceuticals have some things in common with imitated products available as ordinary goods. Both are inauthentic. Both are usually inferior in quality to and less expensive than genuine products.
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Notes
- 1.
This report covers the infringement of intellectual property rights, trademark rights, copyrights, patent rights, and design rights in the TRIPS Agreement of the World Trade Organization (WTO), and focuses on infringement cases in the automotive and electrical appliances industries.
- 2.
Twenty-eight companies, government agencies, and international organization participate in the PSI.
Government: European Commission, INTERPOL, Medicines and Healthcare Products Regulatory Agency (MHRA), U.S. Dept of Justice—CCIPS, U.S. Food and Drug Administration (FDA), U.S. Immigration & Customs Enforcement, WHO-IMPACT.
Non-Government: Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb, GlaxoSmith Kline, Eli Lilly and Company, International Federation of Pharmaceutical Manufacturers Associations (IFPMA), Novartis, Partnership for Safe Medicines, Partnership for Safe Medicines India, Pfizer, Roche, RxPatrol, Sanofi.
- 3.
The 12 countries are Cambodia, Colombia, Ecuador, Ghana, Guyana, Kenya, Laos, Mozambique, Peru, the Philippines, Thailand, and Vietnam.
- 4.
Interview conducted by the author 19 November 2014 in Tokyo.
- 5.
Interview conducted by the author with a person working for the Japanese Ministry of Health, Labour and Welfare (MHLW) who was sent to the WHO, 18 November 2014 in Tokyo.
- 6.
As far as the authors know, no empirical research has demonstrated the amount of loss pharmaceutical companies suffer because of counterfeit medicines.
- 7.
Pneumonia in this model refers to acute lower respiratory infection in children aged 0–5 years.
- 8.
The Member State Mechanism was established within the WHO after the IMPACT reached the deadlock, with the aim of encouraging all Member States to address the problem of poor quality pharmaceuticals.
References
Almuzaini, Tariq, Imti Choonara, and Helen Sammons. 2013. Substandard and counterfeit medicines: a systematic review of literature. BMJ 3 (8). https://bmjopen.bmj.com/content/3/8/e002923. Accessed 6 June 2019.
Best, Joel. 2004. More Dammed Lies and Statistics. Trans. University of California Press.
Bogdanich, Walt, 2008. Heparin Find May Point to Chinese Counterfeiting. The New York Times. http://www.nytimes.com/2008/03/20/health/20heparin.html. Accessed 8 Dec 2016.
Caudron, J.-M., et al. 2008. Substandard medicines in resource-poor settings: a problem that can be no longer be ignored. Tropical Medicine & International Health 13 (8): 1062–1072.
Caulfield, T. 2004. The Commercialisation of Medical and Scientific Reporting. PLoS Med 1 (3): e38. https://doi.org/10.1371/journal.pmed.0010038. Accessed 2 Sept 2018.
EMA. Falsified medicines. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000186.jsp&mid=WC0b01ac058002d4e8. Accessed 9 Sept 2016.
FDA. Counterfeit medicines. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm. Accessed 9 Sept 2016.
Franco, A. 2007. A counterfeit contaminated drugs linked to Wan Guiping, shown with police officers after his arrest, killed at least 18 people in China. The New York Times. http://www.nytimes.com/2007/05/06/world/americas/06poison.html. Accessed 2 October 2016.
Frontier economics. The economic impact of counterfeiting and piracy. https://www.inta.org/communications/documents/2017_frontier_report.pdf#search=%27THE+ECONOMIC+IMPACT+OF+COUNTERFEITING+AND+PIRACY++Executive+Summary+2015%27. Accessed 9 Sept 2018.
IFPMA, PhRMA, EFPIA, et al. 2012. Intahnetto Hanbai to Anzen na Iyakuhin Akusesu ni kansuru IFPMA/PhRMA/EFPIA/JPM no Kyodo Seimei ni tsuite [Joint Announcement by IFPMA/PhRMA/EFPIA/JPMA on Internet Sales and Safe Access to Pharmaceutical Products]. Accessed 8 2016.
IMPACT Secretariat. 2011. IMPACT International Medical Products Anti-counterfeiting Taskforce The Handbook 2006–2010. http://apps.who.int/medicinedocs/documents/s20967en/s20967en.pdf. Accessed 10 Oct 2013.
Interpol. Pharmaceutical crime. http://www.interpol.int/News-andmedia/Publications2/Fact-sheets2. Accessed 9 Sept 2016.
JETRO Singapore Center. 2009. Indoneshia, Tai, Shingapohru ni okeru Mohoh-hin Ryutsu Jittaichohsa Tokkyocho Itakujigyo [Surveillance on imitated products in the markets of Indonesia, Thailand and Singapore] Commissioned project by Japan Patent Office.
Johnston, A., and D.W. Holt. 2014. Substandard drugs: a potential crisis for public health. British Journal of Clinical Pharmacology 78 (2): 218–243. https://doi.org/10.1111/bcp.12298. https://www.ncbi.nlm.nih.gov/pubmed/24286459. Accessed 2 Sept 2018.
JPMA. 2012. Gizo Iyakuhin ni taisuru Torikumi [Countermeasures Against Counterfeit Pharmaceuticals]. http://www.jpma.or.jp/globalhealth/fake/. (In Japanese) Accessed 8 Sept 2016.
JPMA. http://www.jpma.or.jp/eventedia/release/pdf/120724_01_j.pdf. (In Japanese) Accessed 8 Sept 2016.
Kimura, Kazuko. 2009. Kauntafitto Yaku (Gizoiyakuhin) Hirogaru Osen, Ou Taisaku [Expanding pollution with counterfeit drugs, followed by delayed countermeasures]. Media Forum 9 June 2009. http://www.jpma.or.jp/event_media/forum/repo_20.html. (In Japanese) Accessed 3 Oct 2018.
Kimura, Kazuko. 2013. Chikyu Kibo no Mozoyaku (Kauntafitto Yaku) Man-en ni taisuru Kisei to Kenko Eikyo ni kansuru Chohsa Kenkyu [Survey Research on Regulatory Control Against Global Prevalence of Counterfeit drugs and Impact on Health]. http://mhlw-grants.niph.go.jp/niph/search/NIDD00.do?resrchNum=201203005A. (In Japanese) Accessed 13 Sept 2016.
McGinnis, M. 2013. Media Reports on Medicine Quality: Focusing on USAID-assisted Countries. United States Pharmacopeia. http://www.usp.org/sites/default/files/usp_pdf/EN/PQM/pqm-mediareports.pdf#search=‘1%29+Media+Reports+on+Medicine+Quality%3A+Focusing+on+USAIDassisted+Countries. Accessed 3 March 2016.
MHLW Japan. 2014. Gizo Iyakuhin oyobi Shitei Yakubutsu ni taisuru KohseiRohdohSyoh no Torikumi [MHLW’s Countermeasures Against Counterfeit Medicines and Designated Drugs]. https://www.mhlw.go.jp/file/05-Shingikai-11121000-Iyakushokuhinkyoku-Soumuka/0000043360_1.pdf#search=%27%E5%8E%9A%E7%94%9F%E5%8A%B4%E5%83%8D%E7%9C%81%E5%8C%BB%E8%96%AC%E5%93%81%E9%A3%9F%E5%93%81%E5%B1%80+%E7%9B%A3%E6%9F%BB%E6%8C%87%E5%B0%8E%E3%83%BB%E9%BA%BB%E8%96%AC%E5%AF%BE%E7%AD%96%E8%AA%B2%2C+%E5%81%BD%E9%80%A0%E5%8C%BB%E8%96%AC%E5%93%81%E5%8F%8A%E3%81%B3%E6%8C%87%E5%AE%9A%E8%96%AC%E7%89%A9%E3%81%AB%E5%AF%BE%E3%81%99%E3%82%8B%E5%8E%9A%E7%94%9F%E5%8A%B4%E5%83%8D%E7%9C%81%E3%81%AE%E5%8F%96%E3%82%8A%E7%B5%84%E3%81%BF%27.
Moore, Thomas, David Lee, Niranjan Konduri, et al. 2012. Assuring the Quality of Essential Medicines Procured with Donor Funds. World Bank. Washington DC. https://openknowledge.worldbank.org/handle/10986/13577. Accessed 2 Sept 2018.
Nakao, Sasuke. 1992. Bunrui no Hasso [Concept of Classification]. Tokyo: Asahisensyo. (In Japanese).
OECD. 2007. The Economic Impact of Counterfeiting and Piracy Executive Summary. https://www.oecd.org/sti/38707619.pdf. Accessed 3 June 2018.
OECD. 2008, The Economic Impact of Counterfeiting and Piracy. http://apps.who.int/medicinedocs/documents/s19845en/s19845en.pdf#search=%27THE+ECONOMIC+IMPACT+OF+COUNTERFEITING+AND+PIRACY+2008%27. Accessed 9 Sept 2018.
Pharmaceutical Security Institute. 2014. Counterfeit situation. http://www.psi-inc.org/geographicDistributions.cfm. Accessed 3 April 2014.
Pharmaceutical Security Institute. 2016. Counterfeit Situation/Incident Trends. http://www.psi-inc.org/incidentTrends.cfm. Accessed 5 April 2016.
Suzuki, Atsushi. 2011. Yudoku Manzu Wain Jiken [The Affairs of Toxic-Manns Wines]. In Sengo Iryosi [Post War History of Medical Affairs] 368–370. Tokyo: Jiho. (In Japanese).
UNICRI. 2012. Counterfeit medicines and organised crime. http://www.unicri.it/topics/counterfeiting/medicines/report/Ctf_medicines_and_oc_advance_unedited2013.pdf. Accessed 9 Sept 2016.
UNODC. Counterfeit Goods—A bargain or a costly mistake? https://www.unodc.org/documents/toc/factsheets/TOC12_fs_counterfeit_EN_HIRES.pdf. Accessed 9 Sept 2016.
USP. Medicines Quality Database. http://www.usp.org/global-public-health/medicines-quality-database. Accessed 2 Sept 2018.
WHO. 1999. Counterfeit and Substandard Drugs in Myanmar and Viet Nam. http://apps.who.int/medicinedocs/en/d/Js2276e/6.html. Accessed 6 March 2016.
WHO. 2011. Chan M, Director-General of the World Health Organization, Meeting on substandard/spurious/falsely-labeled/falsified/counterfeit medical products. http://www.who.int/dg/speeches/2012/medical_products_20121119/en/. Accessed 14 Sept 2016.
WHO. 2017a. WHO Global Surveillance and Monitoring System for substandard and falsified medical products Reports and Executive summary. http://www.who.int/medicines/regulation/ssffc/publications/gsms-report-sf/en/. Accessed 3 June 2018.
WHO. 2017b. A study on the public health and socioeconomic impact of substandard and falsified medical products. http://www.who.int/medicines/regulation/ssffc/publications/se-study-sf/en/. Accessed 3 June 2018.
WHO. 2018. Low quality healthcare is increasing the burden of illness and health cost globally. http://www.who.int/news-room/detail/05-07-2018-low-quality-healthcare-is-increasing-the-burden-of-illness-and-health-costs-globally. Accessed 11 Aug 2018.
WIPO. 2006. Factsheet (Revised November 2006). http://www.wipo.int/edocs/mdocs/enforcement/en/third_global_congress/third_global_congress_ref_z3.pdf. Accessed 3 June 2018.
Yuk, W.Y., and T. Lane. 2009. Characteristics of Medical Research News Reported on Front Pages of Newspapers. PloS One. https://doi.org/10.1371/journal.pone.0006103. Accessed 2 Sept 2018.
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Kimura, S., Nakamura, Y. (2020). Global Circulation of Imitated Products, Poor Quality Pharmaceuticals, Fake Products, and Health Problems. In: Poor Quality Pharmaceuticals in Global Public Health. Trust, vol 5. Springer, Singapore. https://doi.org/10.1007/978-981-15-2089-1_2
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