Countering the Burden of Illicit Trade in Pharmaceuticals in Africa

Illicit trade involves the sale of goods that violate national or international laws. These goods may be illegal due to their inherent characteristics, or because of issues related to their manufacture, distribution, marketing, labeling, identification, certification, or sale. Defining counterfeit medications is particularly complex. The World Health Organization (WHO) categorizes counterfeits into three groups: substandard, unregistered, and falsified[1]. Meanwhile, Interpol's Illicit Goods and Global Health (IGGH) program classifies illicit biopharmaceuticals into seven categories, which encompass the WHO's three categories and also include expired medications, trademark infringement (illegal use of a registered trademark), patent infringement (illegal use of a legally owned patent), and diverted products (legal products distributed through illegal channels)[2].

Understanding the Burden of Illicit Trade of Pharmaceuticals in Africa

The proliferation of illicit trade of pharmaceuticals in Africa can be attributed to the continent’s growing disease burden and limited access to affordable quality medications. Africa is home to 90% of population affected by Malaria, 60% of those affected by HIV/AIDs and 24% of those affected by tuberculosis. As of 2017, Africa’s pharmaceutical market value stood at about USD. 29, increasing by fivefold in the past decade[3]. ?Approximately 70-90% of medications in Africa are imported, making the continent particularly susceptible to counterfeit drugs. The globalization of supply chains creates opportunities for these counterfeit medications to infiltrate the African market. Imported medicines often pass through numerous intermediaries, each posing a potential entry point for counterfeits. The high cost of genuine medications drives demand for cheaper alternatives, which are often counterfeit. Additionally, many African countries lack the technological resources for thorough inspections, limiting the ability of health authorities to detect and intercept counterfeit medications.

The rising demand for pharmaceuticals with gaps in access drives the growth of illicit trade in biopharmaceuticals, exposing public health to these dangerous counterfeit products. Globally, illicit trade in biopharmaceuticals was valued at averagely 18% in 2019, constituting about 2.5% or more of total trade in biopharmaceuticals. Africa experiences the highest rate of falsified and substandard medications standing at 19%[4]. Between 2013 and 2017, a study conducted by the World Health Organization (WHO) revealed that 42% of counterfeit medications reported worldwide originated from Africa, with antibiotics and anti-malarials being the most commonly counterfeited drugs[5].

Between 2017 and 2021, over 605 tons of medical products were seized in West Africa, having been diverted from the legal supply chains, primarily from major exporting countries such as India and China. Despite being legally produced and registered, these diverted medications often include opioids. A study conducted in East Africa and Nigeria underscores the severity of this issue, highlighting the widespread abuse of codeine-based syrups in these regions[6]. This connection emphasizes the critical need for stronger regulatory measures and regional cooperation to prevent the diversion and abuse of legitimate medical products, ensuring public health and safety across the continent.

Consequences of Access to Counterfeit Pharmaceuticals

Despite significant efforts to reduce the disease burden in Africa, the circulation of illicit biopharmaceuticals in the continent is undermining these hard-won gains. The impact of counterfeit medications extends beyond public health, threatening environmental health, socioeconomic development and global health security.

Counterfeit medications expose public health to therapeutic failures and intoxications, potentially leading to disease progression and death. In a recent tragedy in Gambia, 66 children died from kidney failure after ingesting substandard cough syrup contaminated with diethylene glycol[7]. In sub-Saharan Africa, 116,000 deaths annually are attributed to substandard and falsified anti-malarials, and 169,000 children with pneumonia die from substandard and falsified antibiotics[8]. Furthermore, substandard and falsified medical products can render diseases untreatable, even in well-regulated markets, by promoting antimicrobial resistance. Counterfeit medications may only partially destroy pathogens, thereby contributing to the development of resistance.

Illicit biopharmaceuticals also indirectly have an economic toll on the countries affected. According to WHO, an estimate average of $30 billion is incurred annually on substandard and falsified medical products[9]. Moreover, there are higher costs associated with tackling the complex networks of criminal activities. Criminal involvement in the manufacture and supply of counterfeit medical products is alarming and potentially generates revenue to fund a broader spectrum of illicit activities. Studies in the United Kingdom position the trade of counterfeit medical products as being controlled by organized crime networks[10]. It also undermines public confidence in institutions like manufacturing companies, law enforcement and healthcare systems, exacerbating the threat to societal stability and safety.

Drug abuse has reached an all-time high due to the illicit trade of pharmaceuticals. The United Nations Office on Drugs and Crime World Drug Report of 2023 noted a 45% increase in the number of individuals suffering from drug abuse over the previous decade[11]. This increase is attributed to greater access to illegal drug markets, leading to higher death tolls.

While the pharmaceutical industry must meet environmental protection standards and reduce hazardous waste, counterfeit drug manufacturers exploit environmental shortcuts for financial gain. These illicit producers disregard the environmental impact of their chemical compounds, disposing of toxic dyes and chemicals without oversight and neglecting wastewater treatment.

How can we Address the Burden of Illicit Trade in Pharmaceuticals in Africa?

To address the burden of illicit trade in biopharmaceuticals in Africa, comprehensive strategies need to be implemented, as current efforts by several African states are insufficient. For instance, African states have implemented batch traceability systems in accordance with current Good Manufacturing Practices (cGMP). These systems mandate manufacturers to include batch numbers and expiry dates for their drugs. This initiative aims to enhance transparency and accountability within the pharmaceutical supply chain, ensuring that medications meet quality standards and are safe for public consumption. However, these measures alone are not enough to curb the growing problem of counterfeit medications.

We propose the following countermeasures and strategies to counter the growing burden of illicit trade in pharmaceuticals in the continent:

1.?Sensitization and Education of Stakeholders:

• Policy Makers: Increase awareness of the burden of illicit trade in pharmaceuticals and its severe public health implications.
• General Public: Educate the public to avoid purchasing medications from street vendors and unlicensed stores and to report any adverse effects from medication use.

2.?Strengthening Regulatory Procedures and Capacity:

• Capacity Building: Train healthcare professionals to identify any suspicious products and report the same to regulatory agencies enhancing vigilance.
• Adoption of European Union Falsified Medicine Directive, making it mandatory for all pharmaceutical companies supplying to Africa to use extensive serialization procedures and anti-counterfeiting measures on the packaging, including tamper-proof seals on all prescription drug packaging.
• Lome Initiative: A recent agreement among African countries that shares the MediCrime Treaty's goal of protecting public health by addressing the issue of counterfeit medical products. It is a multifaceted approach that aims at combatting the illicit trafficking of counterfeit medicines across the continent through regulatory strengthening, regional collaboration, technological innovation, resource allocation and criminalization of the import, manufacture, distribution and sale of fake medicines[12]. Although seven countries have committed to this initiative, a unified commitment from all African states is necessary to form a stronger front against this menace.

3.?Enhance tracking systems:

• Adoption of digital technologies in the tracking of pharmaceuticals to curb the vice of illicit products across the supply chain.

4.?Collaboration and information sharing:

• Strengthen cooperation at regional and continental levels to improve information sharing on counterfeit medications and coordinate efforts to combat the illicit trade. ?

[1] Trends in counterfeit drugs and pharmaceuticals before and during COVID-19 pandemic: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9277998/

[2] Assessment of COVID-19 pandemic impact on illicit medication in East Africa: https://www.interpol.int/content/download/15897/file/Report%20-%20FINAL%20Covid-19%20illicit%20medications%20East%20Africa.pdf

[3] Falsified and substandard medicines trafficking: A wakeup call for the African continent: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9461548/

[4] Problem of illicit trade in medical products: https://www.wto.org/english/res_e/booksp_e/tackling-illicit-trade_chap1_e.pdf

[5] WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products: https://iris.who.int/bitstream/handle/10665/326708/9789241513425-eng.pdf?ua=1

[6] The Burden of Drug Abuse in Nigeria: A Scoping Review of Epidemiological Studies and Drug Laws: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7904248/

[7] WHO alert over India-made cough syrups after deaths in The Gambia: https://www.bbc.com/news/world-africa-63150950

[8] 1 in 10 medical products in developing countries is substandard or falsified: https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified

[9] A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products: https://iris.who.int/bitstream/handle/10665/331690/9789241513432-eng.pdf;sequence=1

[10] Illicit pharmaceutical networks in Europe: Organizing the illicit medicine market in the United Kingdom and the Netherlands: https://www.researchgate.net/publication/315898631

[11] Fake medicines kill almost 500,000 sub-Saharan Africans a year: UNODC report:? https://www.ibanet.org/unodc-report-drug-use-increase

[12] Comment in The Lancet on the Lomé Initiative: https://www.iddo.org/news/comment-lancet-lome-initiative