Illicit Trade in Counterfeit Medicines: Challenges, Solutions, and a Case Study of Indonesia
DOI:
https://doi.org/10.15294/jils.v10i1.3692Keywords:
Counterfeit Medicines, Developing Countries, TRIPS Agreement, and Global CooperationAbstract
This paper examines the challenges posed by the trafficking of counterfeit medicines, particularly in developing countries affected by conflicts and challenging regimes. Counterfeit medicines imitate legitimate products, posing severe health risks to unsuspecting consumers. Criminal networks thrive in areas with weak regulations, governance, and enforcement capacity, taking advantage of chaos and limited oversight. Factors like corruption, porous borders, and high medicine costs further contribute to the spread of this illegal trade. The role of international organizations, such as the World Trade Organization (WTO), World Health Organization (WHO) and INTERPOL, in combating this crime is highlighted, emphasizing the need to strengthen enforcement efforts and enhance global cooperation. To address this significant global health threat, strict penalties, international collaboration, and prioritizing public health are crucial components of an effective approach. One avenue of change is that the developing countries be allowed to manufacture generic drugs but the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and patent protections limits access to affordable medicines, hindering the production of generic drugs in poor countries. By ensuring access to affordable medicines, the international community can protect vulnerable populations and combat the trafficking of counterfeit medicines.
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References
Abbott, Frederick M. "The Doha Declaration on the TRIPS Agreement and Public Health and the contradictory trend in bilateral and regional free trade agreements." Quaker United Nations Office (Geneva)(QUNO), Occasional Paper 14 (2004).
Abbott, Ryan Benjamin. "Access to Medicines and Intellectual Property in Jordan." Intellectual Property Watch, July 23 (2012). Available at SSRN: https://ssrn.com/abstract=2116096
Ahmadiani, Saeed, and Shekoufeh Nikfar. "Challenges of access to medicine and the responsibility of pharmaceutical companies: a legal perspective." DARU Journal of Pharmaceutical Sciences 24, no. 1 (2016): 13.
Amanda, R., and Minarosa M. “Criminal Action Responsibility Against Drug Counterfeiters According Indonesian Criminal Code and Law Number 36 of 2009 Concerning Health.” In Proceedings of the 3rd International Conference on Law, Social Science, Economics, and Education, ICLSSEE 2023, 6 May 2023, Salatiga, Central Java, Indonesia. Salatiga, Indonesia: EAI, 2023.
Anonymous. “Učestvovala i BiH: Velika akcija Europola, krivotvorili i krijumčarili lijekove [BiH also participated: Major Europol operation, counterfeit and smuggled medicines]”, N1 Info, December 19, 2022 https://n1info.ba/vijesti/ucestvovala-i-bih-velika-akcija-europola-krivotvorili-i-krijumcarili-lijekove/
Astrazeneca, “Responsible Research”, Sustainability Update, 2015. https://www.astrazeneca.com/content/dam/az/our-company/Sustainability/Responsible-Research.pdf
Attaran, Amir. "Stopping murder by medicine: introducing the model law on medicine crime." The American journal of tropical medicine and hygiene 92, no. Suppl 6 (2015): 127.
Bate, Roger. Phake: the deadly world of falsified and substandard medicines. Rowman & Littlefield, 2012; Ziniel, Francisca Anita Dommetieru. Socio-Economic Impact of Counterfeitmedicine/Fake Drugs on Ghana Under SDG 3. Diss. University of Ghana, 2021.
Bosnia and Herzegovina. Criminal Code of Bosnia and Herzegovina.
Bosnia and Herzegovina. Izvještaj o radu Multisektorske radne grupe za praćenje implementacije Konvencije Vijeća Evrope o krivotvorenju medicinskih proizvoda i sličnim krivičnim djelima koja predstavljaju prijetnju javnom zdravlju za 2022 [Report on the work of the Multisectoral Working Group for Monitoring the Implementation of the Council of Europe Convention against the Counterfeiting of Medicinal Products and Similar Criminal Offences Representing a Threat to Public Health for 2022]. https://mcp.gov.ba/publication/read/javne-konsultacije-o-dokumentu-izvjestaj-o-radu-multisektorske-radne-grupe-za-pracenje-implementaci?pageId=97
Buckley, Gillian J., and Lawrence O. Gostin. "The effects of falsified and substandard drugs." Countering the Problem of Falsified and Substandard Drugs. National Academies Press (US), 2013.
Caparini, Marina. "Transnational organized crime: A threat to global public goods." Stockholm International Peace Research Institute, SIPRI (2022). https://www.sipri.org/commentary/topical-backgrounder/2022/transnational-organized-crime-threat-global-public-goods.
Ćuzović, Sreten, Svetlana Sokolov Mladenović, and Đorđe Ćuzović. "Trade in counterfeit products in conditions of crisis caused by the COVID-19 pandemic." Counterfeiting and Fraud in Supply Chains. Emerald Publishing Limited, 2022, pp. 121-145.
Dégardin, Klara, Yves Roggo, and Pierre Margot. "Forensic intelligence for medicine anti-counterfeiting." Forensic Science International 248 (2015): 15-32.
Directorate-General for Trade and Economic Security Brussels. Commission publishes latest Counterfeit and Piracy Watch List. (European Commission, December 1, 2022). https://policy.trade.ec.europa.eu/news/commission-publishes-latest-counterfeit-and-piracy-watch-list-2022-12-01_en.
European Medicine Agency, “Ozempic”, retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic.
Europol, “Imports of counterfeit and pirated goods amounted to 119 billion euros in 2019”. Counterfeit and pirated goods get boost from pandemic, New Report confirms. (Europol, March 2022). https://www.europol.europa.eu/media-press/newsroom/news/counterfeit-and-pirated-goods-get-boost-pandemic-new-report-confirms.
Europol. Counterfeit and pirated goods get boost from pandemic, New Report confirms. Europol. https://www.europol.europa.eu/media-press/newsroom/news/counterfeit-and-pirated-goods-get-boost-pandemic-new-report-confirms>.
Fleck, Anna. “Counterfeit Drugs on the Rise Globally”, Statista, May 24, 2023. Retrieved from https://www.statista.com/chart/30067/worldwide-counterfeit-pharmaceuticals-incidents/
Glass, Beverley D. "Counterfeit drugs and medical devices in developing countries." Research and Reports in tropical Medicine (2014): 11-22.
Global Organized Crime Index, Indonesia. https://ocindex.net/country/indonesia
Guin, Ujjwal, Domenic Forte, and Mohammad Tehranipoor. "Anti-counterfeit techniques: From design to resign." 2013 14th International workshop on microprocessor test and verification. IEEE, 2013; Hall, Christo. "Technology for combating counterfeit medicine." Pathogens and Global Health 106, no. 2 (2012): 73-76.
Gurgula, Olga. "Strategic patenting by pharmaceutical companies–should competition law intervene?." IIC-International Review of Intellectual Property and Competition Law 51, no. 9 (2020): 1062-1085.
Hallam, Christopher, and David R. Bewley-Taylor. "Mapping the world drug problem: Science and politics in the United Nations drug control system." International Journal of Drug Policy 21, no. 1 (2010): 1-3.
Hapsari, Paundria Dwijo, Awallia Septiyana Putri, and Henzie Kerstan. "Legal Policy for Drug Users in Indonesia and the Netherlands." Journal of Creativity Student 7, no. 1 (2022): 35-66.
Hart, Robert. “Fake Wegovy: Pharma Giant Novo Nordisk Reportedly Steps Up Efforts Tackling Illegal Weight Loss Drugs Sold Online”, Forbes, December 18, 2023. Online at https://www.forbes.com/sites/roberthart/2023/12/18/fake-wegovy-pharma-giant-novo-nordisk-reportedly-steps-up-efforts-tackling-illegal-weight-loss-drugs-sold-online/?sh=bad10402966e
Helble, Matthias, and Benjamin Shepherd. Trade in health products: Reducing trade barriers for better health. No. 643. ADBI Working Paper, 2017.
International Council on Harmonization (ICH), https://www.ich.org/.
Jurua, Maria. "Access to drugs at risk: securing access to medicines for least developed countries." Africa Development 42, no. 1 (2017): 101-120.
Kazić-Çakar, Ena. “A Brief Discourse about Corruption in Bosnia and Herzegovina”. In Bosnia and Herzegovina and European Integration: Obstacles and Challenges, ed. by Dženita Šiljak and Kristian L. Nielsen (pp. 78–93). International University of Sarajevo.
Khwaileh, Khaled. “Jordan's international trading regime and integration with the Arab region through trade liberalization”. Thesis. Macquarie University, 2022. https://doi.org/10.25949/19443308.v1.
Khwaileh, Khaled. The US-Jordan free trade agreement: benign or malign for the economic development of Jordan?. Diss. Macquarie University.
Layachi, Ouarda Belkacem. "International and National Obligations to Protect from the Risks of Pharmaceutical Crime: The Crime of Counterfeit Pharmaceutical Products in the COVID-19 Crisis." Systematic Reviews in Pharmacy 11, no. 2 (2020).
Lee, Joo-Young, and Paul Hunt. "Human Rights Responsibilities of Pharmaceutical Companies in Relation to Access to Medicines." Journal of Law, Medicine & Ethics 40, no. 2 (2012): 220-233.
Lopert, Ruth, and Deborah Gleeson. "The high price of “free” trade: US trade agreements and access to medicines." Journal of Law, Medicine & Ethics 41, no. 1 (2013): 199-223.
Lopert, Ruth, and Deborah Gleeson. "The high price of “free” trade: US trade agreements and access to medicines." Journal of Law, Medicine & Ethics 41, no. 1 (2013): 199-223.
Mackey, Tim K., and Bryan A. Liang. "Improving global health governance to combat counterfeit medicines: a proposal for a UNODC-WHO-Interpol trilateral mechanism." BMC Medicine 11, no. 1 (2013): 233.
Mackey, Tim K., and Bryan A. Liang. "Improving global health governance to combat counterfeit medicines: a proposal for a UNODC-WHO-Interpol trilateral mechanism." BMC Medicine 11, no. 1 (2013): 233.
Malpani, Rohit. “All Costs, No Benefits: How TRIPS plus intellectual property rules in the US-Jordan FTA affect access to medicines”, Oxfam Briefing Paper, no. 102 (2007)
Marlyna, H., and A. Sardjono. "Research report on the knowledge, experience, and attitude of consumers towards counterfeit medicine in Jakarta: A legal analysis." in Harkrisnowo, H., Hikmahanto J., and Yu Un O. (ed.) Law and Justice in a Globalized World: Proceedings of the Asia-Pacific Research in Social Sciences and Humanities, Depok, Indonesia, November 7-9, 2016: Topics in Law and Justice. 1st ed. London: Routledge, 2017, pp. 15-22
Musgrove, Philip, Riadh Zeramdini, and Guy Carrin. "Basic patterns in national health expenditure." Bulletin of the World Health Organization 80 (2002): 134-146.
Niazi, Sarfaraz K., Waleed Mohammed Al-Shaqha, and Zafar Mirza. "Proposal of international council for harmonization (ICH) guideline for the approval of biosimilars." Journal of Market Access & Health Policy 11, no. 1 (2023): 2147286.
Nuryaasiinta, Cut Mayang Widya. "How Far is Consumer Protection in the Health Care Sector?." Unnes Law Journal 6, no. 1 (2020): 47-72.
Office of the United States Trade Representative, “Free Trade Agreements”, available online at https://ustr.gov/trade-agreements/free-trade-agreements.
Ofori-Parku, Sylvester Senyo. "Fighting the global counterfeit medicines challenge: A consumer-facing communication strategy in the US is an imperative." Journal of Global Health 12 (2022): 03018.
Ojha, Abhijeet, and Samir Bhargava. "International council for harmonisation (ICH) guidelines." Regulatory affairs in the pharmaceutical industry. Academic Press, 2022, pp. 47-74.
Pérez-y-Soto, Danny Grajales. “Counterfeiting and piracy in 2021 – the global impact”, World Trademark Review, May 11, 2021. https://www.worldtrademarkreview.com/global-guide/anti-counterfeiting-and-online-brand-enforcement/2021/article/counterfeiting-and-piracy-in-2021-the-global-impact.
Peter Behner, Marie-Lyn Hecht, and Fabian Wahl. Fighting Counterfeit Pharmaceuticals: New Defenses for an Underestimated—and Growing—Menace. (Strategy& PwC, 2017). https://www.strategyand.pwc.com/gx/en/insights/2017/fighting-counterfeit-pharmaceuticals/fighting-counterfeit-pharmaceuticals.pdf
PLoS Medicine Editors. "Drug companies should be held more accountable for their human rights responsibilities." PLoS medicine 7, no. 9 (2010): e1000344.
Prakoso, Bismo Teguh, Adrianus E. Meliala, and Arthur Josias Simon Runturambi. “The Politico-Criminal Configuration Relationship between Organized Crime and the State as a Form of State-Organized Crime in the Phenomenon of Production and Circulation of Counterfeit Drugs in Indonesia.” International Journal of Social Science and Human Research 4, no. 4 (2021): 678-684.
Republic of Croatia. Criminal Code of Republic of Croatia.
Sari, Chatrin Intan. "Consumer protection on illegal drugs cases in Indonesia." Indonesia Media Law Review 1, no. 1 (2022): 63-80.
Steketee, Tara. “Educating Consumers on the Danger of Counterfeit”, Bad Meds 8, no. 4 (2023). https://bpp.msu.edu/magazine/educating-consumers-bad-meds-december2023/.
Strobl, S. "Counterfeit drugs in industrialized and developing countries–A comparison." Faculty of Mathematics and Natural Sciences, University of Bonn, Germany (2011): 1-64.
Subhan, Junaid. "Scrutinized: the TRIPS agreement and public health." McGill Journal of Medicine: MJM 9, no. 2 (2006): 152.
Tenni, Brigitte, et al. "What is the impact of intellectual property rules on access to medicines? A systematic review." Globalization and health 18, no. 1 (2022): 40.
Toro, Nuria. "Who global strategy on integrated people-centred health services (IPCHS)/Estrategia mundial en servicios de salud integrada centrado en las personas (IPCHS)." International Journal of Integrated Care 15 (2015).
Trade, Illicit. Trade in counterfeit pharmaceutical products. OECD Publishing Paris, 2020.
UN General Assembly, International Covenant on Economic, Social and Cultural Right, 1966. https://digitallibrary.un.org/record/57676
United Nations Office on Drugs and Crime (UNODC). Transnational Organized Crime in East Asia and the Pacific: A Threat Assessment. (UNODC, 2013).
United Nations. “Fake medicines kill almost 500,000 sub-Saharan Africans a year: UNODC report”, UN News, 2023. Retrieved from https://news.un.org/en/story/2023/02/1133062
UNODC. Transnational Organized Crime in East Asia and the Pacific: A Threat Assessment, p. 129.
WHO. Guidelines for the development of measures to combat counterfeit drugs. Geneva: WHO, 1999.
WHO. Substandard and Falsified Medical Products. (WHO, 2018). Available online t https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products
WHO. WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products. (World Health Organization, Geneva, 2017). www.who.int/medicines/regulation/ssffc/publications/GSMSreport_EN.pdf?ua=1
Wingrove, Patrick. “Rise in reports of fake weight-loss drugs linked to shortage of real thing, WHO says”, Reuters, January 30, 2024. Online at https://www.reuters.com/business/healthcare-pharmaceuticals/rise-reports-fake-weight-loss-drugs-linked-shortage-real-thing-who-says-2024-01-29/
WIPO, “Committee on Development and Intellectual Property (CDIP)”, 2012. http://193.5.93.81/edocs/mdocs/mdocs/en/cdip_9/cdip_9_inf_5.pdf
Wojahn, Patrick L. "A conflict of rights: intellectual property under TRIPS, the right to health, and AIDS drugs." UCLA Journal of International Law and Foreign Affairs 6, no. 2 (2001): 463-497.
Wong, Hilary. "The case for compulsory licensing during COVID-19." Journal of global Health 10, no.1 (2020): 010358.
World Health Organization. Global Health Observatory (GHO) data: Neglected Tropical Diseases. (Geneva: WHO, 2019).
World Health Organization. WHO Guideline on Country Pharmaceutical Pricing Policies. (Geneva: WHO, 2015).
World Trade Organization. Declaration on the TRIPS agreement and public health. DOHA WTO MINISTERIAL 2001: TRIPS https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.
World Trade Organization. Obligations and Exceptions: Under TRIPS, what are member governments’ obligations on pharmaceutical patents?. Available online at https://www.wto.org/english/tratop_e/trips_e/factsheet_pharm02_e.htm.
World Trade Organization. Promoting access to medical technologies and innovation Intersections between public health, intellectual property and trade. WTO, 2013.
World Trade Organization. Uruguay round Agreement TRIPS: Part II — Standards concerning the availability, scope and use of Intellectual Property Rights. Available online at https://www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm.
Yenet, Aderaw, Getinet Nibret, and Bantayehu Addis Tegegne. "Challenges to the availability and affordability of essential medicines in African countries: a scoping review." ClinicoEconomics and Outcomes Research 15 (2023): 443-458.
Yuliani, Evelina, Widodo T. Novianto, and Hari Purwadi. "The Urgency of Law Enforcement of Illegal Medicine Distributions in Indonesia." Journal of Health Policy and Management 4, no. 2 (2019): 76-85.
Yuliani, Novianto, and Purwadi. See also Yunus, Nur Rohim, et al. "Drug Abuse as an Extra-Ordinary Crime: Some Legal and Political Debates." Jurnal Scientia Indonesia 8, no. 1 (2022): 71-88.
Zabyelina, Yuliya, and Stephen Noguera. "Organized Crime and the Pharmaceutical Industry." The Private Sector and Organized Crime. Routledge, 2022, pp. 224-241.
Ziavrou, Kalliroi S., Stephen Noguera, and Vassiliki A. Boumba. "Trends in counterfeit drugs and pharmaceuticals before and during COVID-19 pandemic." Forensic Science International 338 (2022): 111382.
Ziavrou, Kalliroi S., Stephen Noguera, and Vassiliki A. Boumba. "Trends in counterfeit drugs and pharmaceuticals before and during COVID-19 pandemic." Forensic Science International 338 (2022): 111382.
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