Medicines: Counterfeit | South Africa

Counterfeit Medicines in South Africa: A Public Health Crisis

Unsatisfactory and fake drugs can be incredibly hazardous. They are deceitfully made to deceive consumers about the product's quality, authenticity, and effectiveness. These drugs do not meet regulatory and quality standards.

Such drugs are typically produced by organized criminal groups, often involved in cross-border trade. These products can be bought online, in informal shops, or street markets. Occasionally, they even find their way into legitimate supply chains, appearing in registered pharmacies and hospitals.

Counterfeit medicines come in many forms, including pills for erectile dysfunction, weight loss, antidepressants, anabolic steroids, antibiotics, and pain relievers. These medications are accessible and cheap, making them appealing to consumers, but they can cause immense harm. Some may contain incorrect ingredients, while others might have no active ingredients or lower concentrations than advertised. They may also include toxic substances like rat poison, boric acid, chalk, or antifreeze.

Researchers suggest that as much as 42% of medicines supplied in African countries are counterfeit. The World Health Organization estimates over 1 million deaths annually are due to substandard and fake medications. Around 53% of anti-malarial drugs in Southeast Asia and sub-Saharan Africa may be tied to the use of ineffective or counterfeit medicines.

Efforts to Combat the Problem

International organizations like the World Health Organization, the United Nations Office on Drugs and Crime, and Interpol have collaborated on strategies to tackle the issue. But how is South Africa addressing the problem of counterfeit and substandard drugs? Unfortunately, the response is lacking, primarily due to the absence of a specific anti-counterfeit policy for medications.

Gaps and Concerns in South Africa

South Africa's drug regulatory framework is known to be stringent, aligned with international standards, and stronger than many other countries in sub-Saharan Africa. However, this system lacks robust enforcement strategies. For example, there is no specific legislation to address drug-related crime and counterfeiting. This type of policy would address intellectual property issues and provide clear guidelines on policing areas, responsibilities, and action plans.

The current legislation, such as the Medicines and Related Substances Act 101 of 1965 and the Counterfeit Goods Act 37 of 1997, prescribes penalties for counterfeiting. However, fines of R5,000 to R10,000 or jail sentences of 3 to 10 years are insufficient deterrents.

Political Will and Regional Cooperation

Another issue is the lack of political will and resources to enforce existing laws. For example, South Africa lacks a drug testing laboratory, operated by the national medicines regulator, to check the composition of suspected counterfeit drugs. A well-resourced lab could randomly test therapeutic products in the market.

Weak penalties, short jail sentences, and an overburdened criminal justice system lead to poor prosecution rates. Interviewees in our study highlighted the lack of regional cooperation in the Southern African Development Community. African criminal justice systems struggle with transparency and resources, hindering effective collaboration to combat transnational crimes like drug counterfeiting.

Although various government and law enforcement agencies are involved, they don’t work together effectively, creating gaps in the supply chain. This allows counterfeit and substandard drugs to proliferate.

Addressing Online Sales

We also identified numerous websites selling prescription drugs without proper oversight. Many were registered as South African domains but operated from countries like Denmark and Switzerland. None provided reliable contact details for licensed pharmacists, highlighting the need to update the Medicines and Related Substances Act to address the sale of drugs online.

Moving Forward

The implications of not having a dedicated drug crime and anti-counterfeit legal framework are wide-ranging. It hampers the government’s ability to prevent the proliferation of substandard and counterfeit drugs and effectively enforce the law once fake products are seized. Implementing a national anti-counterfeit policy would establish a legal mandate with clear objectives and responsibilities, enabling relevant authorities to collaborate effectively.

Public engagement through awareness campaigns and education is another crucial strategy, as seen in Ghana, Nigeria, and the UK. In these countries, social media platforms have empowered consumers to identify counterfeit products online, and mobile authentication systems have improved product traceability.

Additionally, collaboration between private companies and governments can help. For example, the partnership between the Center for Safe Internet Pharmacies, internet service providers like Google, Yahoo, and Microsoft, and the US government has been effective in shutting down illegal websites and supporting public awareness campaigns.