The United Nations Office on Drugs and Crime (UNODC) is a United Nations office that was established in 1997 as the Office for Drug Control and Crime Prevention by combining the United Nations International Drug Control Program (UNDCP) and the Crime Prevention and Criminal Justice Division in the United Nations Office at Vienna and was renamed the United Nations Office on Drugs and Crime in 2002. The agency’s focus is the trafficking in and abuse of illicit drugs, crime prevention and criminal justice, international terrorism, and political corruption. It is a member of the United Nations Development Group.
Date of publication/Date de publication: January 2023
Site of publication/ Site de publication: Office on Drugs and Crime
Extracts from pages/ Les extraits proviennent des pages : 9-10, 12-14, 16-19, 22-23
For the purpose of this report, “Sahel countries” refers to Burkina Faso, Chad, Mali, Mauritania and Niger.
Trafficking in Medical Products in the Sahel
The Sahel has been a trade and migration route for centuries.
“A convenient transit area for products transported by sea from coastal countries, the region has become the epicentre of a growing market for trafficked medical products.”
Factors such as limited access to quality, safe, effective and affordable medical products, corruption among law enforcement and customs officers and a lack of border controls have contributed to the creation of an environment conducive to trafficking in and beyond the Sahel countries, Burkina Faso, Chad, Mali, Mauritania and the Niger. This situation has been exacerbated by the ongoing war in Mali, subsequent conflicts and the spread of insurgent and terrorist groups that threaten the peace and stability of the region. Infectious diseases are among the leading causes of death in the Sahel countries, with the estimated incidence of malaria in the region being among the highest in the world.
Yet the Sahel countries continue to face challenges in making healthcare available and accessible to their populations.For instance, World Health Organization (WHO) data from a regional survey show that, in 2018, the Sahel countries had a health workforce density well below the Sustainable Development Goal minimum density threshold of 4.45 doctors, nurses and midwives per 1,000 population.
Affordability is another hindrance to accessing quality, safe and effective medical products, not least because universal health coverage (UHC) in the region remains low.The UHC index measures the average coverage of essential services, including reproductive, maternal, newborn and child health, infectious diseases, non-communicable diseases and service capacity and access. The index reflects a performance score where 100 indicates the Sustainable Development Goal aim of achieving universal health coverage for all by 2030 has been met. In 2019, the global average on this index was 67 per cent, but it was just 43 per cent in Burkina Faso, 42 per cent in Mali, 40 per cent in Mauritania, 37 per cent in Niger and 28 per cent in Chad. After Somalia (17 per cent), Chad has the next lowest universal health coverage index in the world.
The high prevalence of infectious diseases, including malaria, in the Sahel countries and their neighbours, coupled with challenges in terms of the availability and affordability of and access to healthcare, creates an environment in which the demand for medical products and services is not fully met through formal channels.
“This disparity between the supply of and demand for medical care is at least partly filled by medicines supplied from the illegal market to treat self-diagnosed diseases or symptoms”.
Street markets and unauthorized sellers, in particular in rural areas and areas affected by conflict, are sometimes the only sources of medicines and pharmaceutical products. Reliable studies on trafficking in medical products in the Sahel countries are few and far between, but the quantity of medical products seized by law enforcement agencies, coupled with regular medical product alerts from WHO, on antimalarials in particular, suggest that falsified pharmaceutical products are circulating in the region. In countries with efficient regulatory systems, the quality, safety and efficacy of medical products are monitored at different points in the supply chain.
Broad Definition of Trafficking in medical products
In the Sahel countries, as in the rest of West Africa, however, medical products may be sold without having been approved, cleared or licensed, may have passed their expiry date, or may not contain the purported active ingredients. The disparity between the supply of and demand for regulated pharmaceutical products leaves room for trafficking, provides an incentive for the involvement of organized criminal groups and fuels the ongoing threat to public safety and public health both in the Sahel countries and in the world in general.
Trafficking in medical products can be defined as the production, distribution, sale and dispensing of medical products outside the legal supply chain, that is “the supply chain paths and participants that are recognized and authorized by the government(s) of jurisdiction”. Although trafficking in medical products in the Sahel countries is widely acknowledged, its complexities are poorly understood.
It stems primarily from the poor traceability of medical products, which in turn relates to poor infrastructure and poor tracking across borders. Trafficking in medical products is a multifaceted activity that includes but is not limited to substandard, falsified or unregistered/unlicensed medical products as defined by WHO. It also refers to other forms of disruptions to the legal supply chain, such as the diversion of medical products.
While the UNODC mandate specifically covers falsified medical products, the present report also discusses other forms of trafficking in medical products because the available evidence and data on falsified medicines cannot be disentangled from other issues related to their trafficking.
Nature of the market
“Between January 2017 and December 2021, at least 605 tons of different medical products were seized in West Africa during international operations.”
Large seizures of medical products are also reported by law enforcement agencies in the Sahel countries, although not on a consistent basis and the nature of the products seized is not always known or confirmed, preventing the production of reliable aggregated estimates. In Mali, the Rapid Intervention Brigade within the General Directorate of Customs seized nearly 20 tons of illicitly supplied medical products in the country between 2015 and 2018. More recently, the Sikasso branch of the Central Narcotics Office (OCS) reported various seizures, including 4 cartons of amoxicillin (antibiotic), 54 cartons of paracetamol (analgesic) and 40 cartons of liquid cevamec (antiparasitic) in June 2020, and more than 3 tons of medical products in July 2020, reportedly from an organized group that was trafficking unauthorized medicines between Mali and Burkina Faso.
Seizures included medicines illegally diverted from the legal supply chain (prohibited or restricted medicines, non-declared medicines and medicines purchased by unlicensed wholesalers) and substandard (expired medicines). While there are no reliable estimates of the overall quantities of medical products that are trafficked in different ways and forms in the Sahel countries, studies related to different geographical coverage and different product types point to a percentage of substandard and falsified medicines in the medical market of between 19 and 50 per cent. A 2016 study in the Central African Economic and Monetary Community, which includes Chad, found that trafficked medical products accounted for between 20 and 55 per cent of the products in the medical market.
A global systematic review of 265 studies published in 2018 estimated that the highest percentage of substandard and falsified medicines in the medical market was observed in Africa Although the basis of this and other estimates are sometimes unclear, the figures are alarming, especially given the lack of capacity for monitoring, reporting and investigating infringements in the Sahel countries, indicating that the scale of the illicit market may be significantly bigger.
Focus on falsified medical products
Estimating the percentage of falsified medical products in the market is a challenge considering the weak regulatory framework in the Sahel countries as well as the absence of an established operational system and equipment for the analysis of medical products seized. The WHO Global Surveillance and Monitoring System, which captures data on incidents of substandard and falsified medical products received from various sources,contains useful information on trafficking in falsified medical products in the Sahel countries.This includes just under 150 product records created between 2013 and 2021, of which over 75 per cent have been either confirmed as, or suspected of being, falsified on the basis that their identity, composition or source have been deliberately misrepresented; the remainder includes either substandard or unregistered products.
Some 40 per cent of the substandard and falsified medical products reported in the Sahel countries was discovered in the regulated supply chain. Just as regulated medical products can be diverted, illicitly manufactured medical products can find their way into authorized pharmaceutical outlets, which shows how much the regulated (legal) and unregulated (illicit) supply chains are interconnected. In Niger, for example, when the country experienced an outbreak of meningitis C in 2015, as the vaccine in stock was not sufficient to meet demand, the Government and pharmacies had to turn to wholesalers in neighbouring countries to bridge the gap. The use of vaccine labels and cartons bearing plausible product information that misrepresented the nature of the product suggested that the manufacturing of falsified products during the 2017 meningitis C outbreak had become an organized criminal activity on an indus- trial scale.Similar products were reported during another outbreak in 2019.
Provenance and transit of medical products
Sub-Saharan countries, including those in the Sahel, rely heavily on imports of medical products because their pharmaceutical industries are still in the early stages of development. Of total pharmaceutical expenditure in sub-Saharan Africa in 2019, imports represented as much as 70 to 90 per cent (roughly $14 billion).As products are diverted from legal supply chains, the medical products seized often originate in the main exporting countries of medical products to the Sahel countries, in particular Belgium and France.
A study conducted in Cotonou, Benin, between 2005 and 2007 investigated the origin of the medical products sold on the informal market at the city’s Dantokpá market, one of the largest markets in West Africa. Between 2017 and 2021, the Sahel countries imported roughly $103–$194 millions worth of pharmaceutical products from China and India. A study conducted by UNODC in 2021 documented that while most tramadol trafficked from Asia was manufactured for non-medical use (as evidenced by seizures of the drug with dosages higher than those approved for medical use), some tramadol was also diverted from the legal supply chain.
Other medical products trafficked in the Sahel were manufactured in neighbouring countries, including in North Africa and the Gulf of Guinea. In the ECOWAS States, Ghana, Nigeria and, to a lesser extent, Côte d’Ivoire and Senegal have relatively sizeable pharmaceutical industries, enabling them to manufacture products for their domestic markets as well as export them to neighbouring countries.Based on interviews with vendors and observations conducted in Niger, some medical products found on the country’s informal market that are unauthorized for sale through formal pharmaceutical channels, originate in Ghana and Nigeria.
Medical products often proceed to their destination through mainstream international trade channels. Roughly 80 per cent of all global trade by volume and over 70 percent of global trade by value are transported by sea.Based on interviews with law enforcement agencies, including the police, health inspection services and customs officials, and the analysis of datasets related to seizures, the following seaports in the Gulf of Guinea can be identified as major entry points for medical products destined for the Sahel countries : Conakry (Guinea), Tema (Ghana), Lomé (Togo), Cotonou (Benin) and Apapa (Nigeria). Trafficking by air, using postal shipments or carried out by commercial air passengers, is employed for smuggling smaller quantities of medical products.
Main actors involved in trafficking medical products
Investigations have revealed the involvement of a wide range of opportunistic actors in trafficking in medical products in the Sahel countries, from employees of pharmaceutical companies, public officials, law enforcement officers and health agency workers to street ven- dors, all motivated by potential financial gain. Some operate individually, such as pharmacists selling illicitly acquired medicines on the informal market, while others operate at different levels of the supply chain together with others, thus constituting organized criminal groups as defined by article 2 of the United Nations Convention against Transnational Organized Crime.
Recent prosecutions in the Sahel countries demonstrate the involvement of wholesalers and distributors in trafficking in medical products.They usually import medical products (falsified or not) illegally with the help of the Asian networks mentioned above, sell them directly without prescription, keep some for the informal market, or dilute shipments of legitimate medical products by replacing part of their stock with falsified or substandard medical products, retaining the remainder for resale. In Niger, following inspections in 2019, some wholesalers were shut down after evidence showed that a portion of the stock involved was intended for the informal market. As in the rest of West Africa, most large-scale trafficking in medical products in the Sahel countries hinges on corruption.
Armed groups and trafficking in medical products
Terrorist groups and non-state armed groups are commonly associated with trafficking in medical products in the Sahel. However, most reported cases in the region show that the involvement of such groups is limited and mainly revolves around consuming medical products or levying “taxes” on them in the areas under their control. Examples of terrorist group members using pharmaceuticals for non-medical purposes have been reported in the media.
In March 2016, for example, following attacks by Al-Qaida in the Lands of the Islamic Maghreb (AQIM) in Grand-Bassam, Côte d’Ivoire, investigations revealed the group’s attempts to buy rivotril (clonaze- pam), a synthetic opioid-like drug. In northern Mali and the northern Niger, many groups have an influence on segments of the smuggling route that fall within their territory. Such groups include jihadist groups designated as terrorists, various armed groups that form part of the coalition that signed the 2015 Agreement on Peace and Reconciliation in Mali, those that broke away from the signatory groups, as well as local militias and gangs.
Impact and policy implications
Trafficking in medical products is an obstacle to development in the Sahel countries. This phenomenon is part of the larger cyclical problem of healthcare delivery in the region, which is a combination of converging factors: a lack of public sector healthcare delivery centres as well as of skilled staff and resources; the poor quality of the healthcare system; corruption, mismanagement and quality of education. Healthcare delivery is also hampered by the absence of adequate social security or meaningful commitment to the welfare of those most affected among the population, as well as by increasing competition between drug peddlers and private clinics.
Medical products that circulate without regulatory oversight or market control measures may contain harmful substances, or not contain the active ingredients for which they have been prescribed. They may have expired or may have deteriorated due to poor storage conditions, or they may be sold without prescription for purposes other than their medical use. For all these reasons, they may be ineffective and cause harm, including by contributing to antimicrobial resistance.
Moreover, falsified medical products are often produced in poor and unhygienic conditions by unqualified personnel, they may contain unknown impurities and are sometimes contaminated with bacteria. By their very nature, falsified medical products are difficult to detect, as they are often designed to appear identical to the genuine product and may not cause an obvious adverse reaction.
“However, they often fail to adequately treat the disease or condition for which they were intended and can lead to serious health consequences, including death.”
In sub-Saharan Africa, WHO estimates that between 72,000 and 267,000 deaths per year are linked to falsified and substandard antimalarial medicines. In addition, up to 169,271 are linked to falsified and substandard antibiotics used to treat severe pneumonia in children.In relation to the falsified meningitis vaccines found in Niger in 2015, WHO noted that 8,580 cases of meningitis C were reported in 2015 and that nearly 600 people died. The organization clarified that there is no way of knowing how many of those cases might have been averted if every vaccine administered had been a quality-assured product. Ineffective treatments related to trafficking in medical products also erode public confidence in health services and the Government as service providers.
Furthermore, trafficking in medical products has a direct economic impact. According to WHO, the cost of caring for people who have used falsified or substandard medical products for malaria treatment in sub-Saharan Africa ranges from $12 million to $44.7 million per year. The economic impact is also indirect since trafficking in medical products affects the competition between stakeholders selling medicines in the regulated formal sector, while the saturation of the market with unauthorized products creates an obstacle to the development of the pharmaceutical industry in the region. In addition, the proceeds from trafficking in medical products are reinvested in the formal economy through laundering schemes that threaten the integrity of the economic and financial systems of the countries concerned. Finally, people involved in trafficking undermine the rule of law through the corruption of health and law enforcement officials and through their use of violence to pro- tect their interests.
The threat to public health caused by trafficking in medical products requires a stronger and more coordinated response at the national and international levels in order to improve access to medical products through legal supply chains (to address demand), while effectively detecting and combat- ting disruptions in those supply chains (to address supply). Demand and supply need to be addressed simultaneously because focusing solely on curbing the supply of medical products is unlikely to yield results and could be counterproductive as people in the Sahel are sometimes left with no alternative but to purchase medicines through informal markets.
The African Medicines Regulatory Harmonization initiative is an attempt by the African Union to improve existing levels of regulatory capacity, encourage local production and build a regional harmonized approach. Recently, all the Sahel countries but Mauritania ratified the Treaty for the establishment of the African Medicines Agency (AMA). All the Sahel countries have legal provisions in place relating to trafficking in medical products but some laws are outdated. They need to be revised if they are to remain applicable to the increasingly complex nature of pharmaceutical markets and pharmaceutical crimes. For example, law enforcement officials have raised concerns that sentences, which can be limited to a fine, are not sufficient to deter criminals.
Since medical products entering the Sahel countries can easily be transported and sold across the region, cross-border cooperation should be strengthened to systematically gather data and information, to enhance timely information-sharing and collaborative action on the quality of suspected falsified and substandard medicines among regulators and partners, and to facilitate enforcement and judicial responses. Considering the estimates of falsified medical products finding their way into authorized outlets in the Sahel, law enforcement and judicial efforts that safeguard the legal supply chain should be a priority.