Combating Sale of Counterfeit and Falsified Medicines Online: A Losing Battle

摘要

The lucrative and popularity of selling medicine online The rapid growth of technology has transformed many brick-and-mortar businesses into online businesses, and medicines are now being sold over the internet. Influenced by the notions that online purchases are economical and do not require a prescription, the general public are keen to purchase medicine online through websites, social media and mobile apps. Online medicine purchase is presumed to be convenient and confidential, free from embarrassment of sharing personal and sensitive health information to a healthcare professional. Public in United States, Europe, Australia is generally aware that internet sales form part of the official medicines distribution channels, often a valid prescription is required for controlled medicine. However, unlicensed, substandard and falsified medicines with various dubious medical claims are advertised and sold illegally in many rogue online pharmacies (Jack, 2016 ). These include medications for weight loss, hair growth, and treatment of erectile dysfunction. Such medicines are termed as substandard, spurious, falsely labeled, falsified and counterfeit medical products by the World Health Organisation (WHO). Similarly, the European Commission defines such products as falsified medicines or fake medicines that pass themselves off as real, authorized medicines (European Commission, 2016 ). These medicines may contain substandard active ingredients, which are low quality and/or an incorrect amount, either too high or too low, and have not been properly evaluated by authorities in terms of quality, safety, and efficacy. It must be noted that falsified medicines are often confused with counterfeit medicines. According to European Commission, counterfeit medicines refers to medicines that do not comply with European Union law on intellectual and industrial property rights, for example, unregistered medicines sourced from parallel import (European Medicines Agency ~(1) ). In this article, the illegal sales of both counterfeit and falsified medicines (CFMs) are discussed.In 2012, the WHO estimated the CFMs industry to be worth USD 431 billion a year, but further estimates has not been reported in the recent years due to the fast growing, widespread practice of this industry, making it impractical to estimate on a global scale (Garrett, 2012 ). Authorities are finding it difficult to curb CFMs due to the lack of governance over the internet. Furthermore, fragmented cybercrime legislation leads to large substantive and procedural lacunae in law, rendering law enforcement efforts useless. Plaguing the lacunae: case studies of India, China and African Countries The crackdown on CFMs sale by authorities can only be effective with the present of relevant legislation to empower the judiciary to impose substantial sentences. Countries such as China, India and African countries previously had either no specific or weak law governing the control of CFMs. To address this problem, new legislations have been drafted and combined with the existing legislation. Strengthening of drug legislation is vital as CFMs are found alongside genuine medicines in legitimate distribution channels, making it impossible for consumers to determine the authenticity of the medicines (Office of the United States Trade Representative, 2016 ). In 2013, the China Food and Drug Administration led an inter-agency operation named “Two Strikes, Two Setups” targeting illegal manufacture and sale of medicines, which successfully closed down 194 Chinese websites and reported 609 overseas websites to their relevant countries for further enforcement actions (Alliance for Safe Online Pharmacies, 2015 ). China, believed to be the biggest producers of CFMs, is showing encouraging signs in this issue with the amendment of Article 141 of the Criminal Law in 2011. The amended penalties for manufacturing and selling CFMs are punishable to a minimum imprisonment of 10 years, in addition to a fine or forfeiture of property (Congressional-Executive Commission on China, 2011 ). For India, harsh sentences imposed in 2008 through the Drug and Cosmetic Act 1940 amendments, result in a minimum 10 years and/or a minimum fine of Indian Rupees (INR) 1 million (USD 15,000) or three times the value of the medicines confiscated. However, the anti-counterfeiting and anti-falsifying provision does not extend to the regulating of online pharmacies, due to the lack of clarity in the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 (Nagaraj et al., 2014 ). In December 2015, the office of the Drugs Controller General (India) issued a directive banning the sale of medicines over the internet and taking action against online pharmacies such as Zigy.com, Netmeds.com and mCHEMIST.com (Reddy, 2015 ). However, in the absence of clear legislations and policies on online pharmacies, the directive is under scrutiny due to the differences in the interpretation of law, impeding the auth