Counterfeit/Fake and Substandard Medicines – A Global Bioethical Issue Requiring A Global Approach

Abstract

Counterfeit drugs are a global problem and a public health hazard. Nearly 10 percent of all medicines sold worldwide are fake, leading to an estimated 100,000 deaths each year, equating to an additional economic burden of close to $200 billion annually. Counterfeit medicines also thwart public health efforts to control infectious diseases like Covid-19 and Tuberculosis and lead to the worsening of other public health crises such as anti-microbial resistance (AMR). According to the CDC, more than 2.8 million antibiotic-resistant infections in the U.S each year, with more than 35,000 people dying, have been reported. Globalization and the internet's expansion have led to the rapid spreading of poor-quality medicines due to the high demand for cheap goods and lack of access - before adequate detection and intervention are possible. Moreover, selling counterfeit medicine is more profitable with lesser penalties, even in the U.S. As a clandestine market, there is no precise magnitude of how the counterfeit-medicine market flows. The WHO is alarmed by the lack of available data to demonstrate the extent and impact of fake/substandard medicines. Controlling counterfeit drugs' availability will not be easy; however, it has become necessary to protect public and global health. Through the lens of a case in Bangladesh that demonstrates how easy it is to sell and get away with selling fake medicines in developing countries - this paper discusses how counterfeit medicines negatively contribute significantly to human lives and sufferings in developing and developed countries. No single policy will be effective based on the different issues faced on multiple fronts due to fake/substandard medicines. However, a broad-based concerted effort across the various stakeholders to combat this counterfeit drug problem and secure the global supply chain is urgently needed.

Quality of medicines in Sri Lanka: a retrospective review of safety alerts

“…Medicine recalls have been reported all around the world including the West [2][3][4][5][6][7][8][9][10][11][12][13][14][18][19][20][21][22][23][24]. However, review articles have shown that this is a signi cant problem in developing countries, and most cases reported were from Asia and Africa compared to European and American continents [4,11].…”

Quality of medicines in Sri Lanka: A retrospective review of safety alerts

“…Medicine recalls have been reported all around the world including the West [2][3][4][5][6][7][8][9][10][11][12][13][14][18][19][20][21][22][23][24]. However, review articles have shown that this is a signi cant problem in developing countries, and most cases reported were from Asia and Africa compared to European and American continents [4,11].…”