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Pharmaceutical counterfeiting was deemed a global issue in 1985 by the World Health Organisation (WHO). It still is even to this day (this indicates that this crime has been succeeding for a significant number of years, when it should not have succeeded (KML Acri née Lybecker ‘Pharmaceutical Counterfeiting: Endangering Public Health, Society and the Economy (www.fraserinstitute.org, accessed 15-2-2020)).
A safe supply of medicine is essential for public health because when medication or medical product are being developed, it is meant to directly impact the health of its target (in this case the consumers or public who depend on such medication to improve their health) (A Krattiger and RT Mahoney ‘Intellectual property and public health’ (https://apps.who.int, accessed 6-6-2020)). Medicine or medical products, which are fake or substandard and do not meet the international or national standards can never be said to be as good as genuine and/or bona fide medication and medical products (the fake ones undersell the genuine ones), therefore, the health of the general public is inherently under threat (EA Blackstone, JP Fuhr and S Pociask ‘The Health and Economic Effects of Counterfeit Drugs’ (2014) 7(4) Am Health Drug Benefits 216).
Considering the context provided above, this article will provide a discussion on the causes of the subsistence of pharmaceutical counterfeiting within South Africa (SA).
Distinguishing counterfeit medicine or medical products from authentic ones is a difficult task for consumers to carry out, therefore, the crime of pharmaceutical counterfeiting, becomes difficult to detect (M Nelson, M Vizurraga and D Chang ‘Counterfeit Pharmaceuticals: A Worldwide Problem’ (2006) 96 TMR 1068). In an instance where a patient’s health improves due to the use of a medicinal product, such product will not be suspected of being a counterfeit and where the health of a patient deteriorates, such deterioration will typically be attributed to some other factor (such as a patient’s medical condition) instead of the medicine itself (Nelson and Chang (op cit) 1069). In a case where the medicinal product is suspected, it is often a legitimate manufacturer who gets persecuted and who ends up having to endure injury to their reputation and goodwill (M Nelson and D Chang (op cit) 1069).
Pharmaceutical counterfeiting is termed a perfect crime because the evidence (namely, the counterfeit medicine) is destroyed on ingestion and the packaging gets thrown away. Therefore, the counterfeit medicine is not always suspected at first when a patient’s condition does not improve because of the inability to visually identify the counterfeit product (DJ Gibson ‘Terrorism’s Next Target?’ www.healthplanusa.net, accessed 10-9-2020).
The fact that pharmaceutical counterfeiting is a crime that is not easy to detect makes it a noteworthy cause of the subsistence of same in any country dealing with the issue of counterfeiting of medicines and medical products.
Despite efforts by international regulatory agencies, the lack of enforcement of relevant legislation, the inefficient and inadequate regulation and the lack of commitment by the relevant stakeholders has played a major role in the subsistence of pharmaceutical counterfeiting (R Cartwright and A Baric ‘The rise of counterfeit pharmaceuticals in Africa’ https://enact-africa.s3.amazonaws.com, accessed 11-9-2021 ). Limited capacity, incapability, lack of proper definition of terms and corruption within regulatory bodies or authorities lead to the lack of regulation and furtherance of the crime of pharmaceutical counterfeiting (Cartwright and Baric (op cit) 11).
In many African countries, the enforcement of laws is rarely aimed at combating pharmaceutical counterfeiting, this is because the practice of pharmaceutical counterfeiting is not easy to detect, therefore, the responses aimed at combating it are not adequate (Cartwright and Baric (op cit) 12).
Pharmaceutical counterfeiters tend to find the African continent and its countries an easy target because of the lack of armour of responses needed against pharmaceutical counterfeiting, the lack of supply chain regulation, enforcement regimes, as well as the track-and-trace technology (Cartwright and Baric (op cit) 2). This context shows the danger attached to the lack of regulation and enforcement in as far as the crime of pharmaceutical counterfeiting is concerned.
In a country where pharmaceutical counterfeiting is not adequately or effectively regulated, counterfeiters will flourish in the trade because there are no punitive measures in place against their illegal practice, unless in countries, which have robust laws in place and which enforce such laws accordingly (K Child ‘Fake drugs flood SA’ (www.timeslive.co.za, accessed 6-8-2020)). In SA, particularly, the large number of ports of entry make it difficult for authorities to regulate the crime of pharmaceutical counterfeiting because of the country’s lack of manpower (Child (op cit)).
One other important issue attached to the regulation and enforcement of laws against pharmaceutical counterfeiting is the punishment of offenders for infringing intellectual property rights, in lieu of punishing such offenders for the death of the victims of counterfeit medicines and medical products. This motivates offenders because they will not be afraid of punishment since it is merely the intellectual property that has been infringed and they are not effectively punished for the murders they commit by counterfeiting medicines and medical products (C Koffi ‘Fake medicine is real business in Africa’ https://mg.co.za, accessed 13-9-2020)).
Owing to the large number of illegal pharmacy websites, SA is struggling to deal with the rise of online marketing of counterfeit drugs (this is by virtue of the failure of relevant authorities to carry out routine checks and effectively regulate illegal and unregistered medical networks within the borders of the country) (N Aminu and MS Gwarzo ‘The Imminent Threats of Counterfeit Drugs to Quality Health Care Delivery in Africa: Updates on Consequences and Way Forward’ (2017) 10 AJPCR 63).
An important cause of the subsistence of pharmaceutical counterfeiting which deserves mentioning is the confusion around the term ‘counterfeit’. Typically, counterfeit is defined to refer only to the trademark infringement of a pharmaceutical product (such as the definition contained in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, in lieu of making reference to the quality and/or manufacturing of such product, this is an issue because combating pharmaceutical counterfeiting becomes even more difficult since it may not be easy to answer the question of whether or not a pharmaceutical product has been counterfeited (L Menghaney ‘“Counterfeit” confusion diverts action from drug quality’ (https://msfaccess.org, acceded 10-9-2021). With SA having ratified the TRIPS Agreement, combating pharmaceutical counterfeiting is bound to be a mammoth task by virtue of the confusion around the term ‘counterfeit’.
In April 2018, an online survey in five countries within the African continent (SA, Egypt, Kenya, Nigeria and Cote d’Ivoire) was conducted to provide an understanding about patient perceptions relating to pharmaceutical counterfeiting (SANOFI ‘Fighting falsified medicine in Africa’ (www.sanofi.com, accessed 10-9- 2020). A total of 2 519 people participated in the online survey.
Among other things, the survey indicated that 97 % of the total number of participants believed they did not know enough to be able to protect themselves against counterfeit medicines, despite most people being aware of their existence and 44% having actually come across them (SANOFI (op cit)). These indications prove the fact that there are South Africans who are still not educated enough about the existence of counterfeit medicines in the market, this causes the subsistence of pharmaceutical counterfeiting because such counterfeit products are bound to be purchased without knowing they are counterfeit.
‘If you know the enemy and you know yourself, you need not fear the result of a hundred battles’ (A Parmar ‘10 Quotes From “The Art of War” That Will Transform Your Life’ https://medium.com, accessed 15-9-2020). This quote indicates the fact that knowing what you are up against serves as an important factor when preparing for combat, this equally applies to the general South African public, which is in combat with the scourge of pharmaceutical counterfeiting. Not being educated enough about the existence of counterfeit medicine in the market is the cause of the subsistence of pharmaceutical counterfeiting because such counterfeit medicine will be bought, and the counterfeiters will generate profit and be motivated to continue with their crime since it is proving to be successful and profitable (SANOFI (op cit)).
Using the Internet, counterfeiters are able to sell their illegal goods in large scales, directly to customers and in secured channels (IRACM ‘Fake Drugs on the Web’). The reasons for patients using the Internet so frequently are diverse and unlimited, some use the Internet because of the low prices when compared to prices in pharmacies, some use the Internet to preserve their anonymity when purchasing medicine which treat so-called shameful infections and/or diseases and also, some purchase medicine from the Internet because of their intention to abuse such medicine and feed their addiction (IRACM (op cit)). All these reasons are what counterfeiters exploit in carrying out their crime because they provide exactly what is demanded by patients and the crime is therefore able to subsist.
Since it is relatively difficult to identify anonymous Internet websites and track and trace counterfeit products, the Internet is deemed to be a provider of vast and optimum opportunities for counterfeiters to flourish in their speciality (Nelson and Chang (op cit) 1071). This premise is based on the fact that if a customer or patient’s health deteriorates by virtue of a counterfeit medicine bought online, such patient has little to no recourse since the physical location or operator of the website where the purchase was made may be unknown, the seller may be out of the patient’s reach and also, the Internet has no border controls (Nelson and Chang (op cit) 1071). This is a cause of the subsistence because this manner of sale is beneficial to counterfeiters since they can escape penalties and also, it is a cause of the subsistence, which affects any country that is combating the scourge of pharmaceutical counterfeiting, not a cause that only SA is faced with (Nelson and Chang (op cit) 1085).
Pharmaceutical counterfeiting is dubbed the ‘perfect crime’ because of the difficulty attached to detecting it. Customers tend to find out late (if not ever) that they have ingested a counterfeit medicine (Nelson and Chang (op cit) 1069 – 1070). This difficulty referred to serves as the cause of the subsistence of pharmaceutical counterfeiting because if counterfeiters realise that their crime is undetected, they will flourish and continue to commit their crime.
One other cause of the subsistence of pharmaceutical counterfeiting is the lack of regulation and law enforcement (this serves as a cause of the subsistence because counterfeiters are bound to flourish when they realise that the chances of them being punished for their crime are slim if not close to nought) (SANOFI (op cit)).
One other major cause of the subsistence of pharmaceutical counterfeiting is the lack of public awareness and education, this is deemed a cause because if the public is not aware of the existence of counterfeit medicine around them then they cannot know when they have purchased such counterfeit products, even if they are aware that counterfeit medicines exist, they still need to know how to spot such counterfeit products (SANOFI (op cit)).
Another major cause of the subsistence of pharmaceutical counterfeiting is the Internet. The Internet is deemed a cause of the subsistence of pharmaceutical counterfeiting because, inter alia, it is difficult to identify anonymous Internet websites and, patients who are victims of counterfeit medicine have little to no recourse against counterfeiters (IRACM (op cit)).
Mpho Adam Titong LLB (NWU) is an LLM candidate at the North-West University in Potchefstroom.
This article was first published in De Rebus in 2021 (Oct) DR 18.
