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• The problem of counterfeit medicines is a huge one across the globe and Africa is not spared.

• A UNODC report showed that 267,000 people die annually in sub-Saharan Africa due to substandard or counterfeit anti-malarial medicines.

• In addition, 169,271 die as a result of counterfeit antibiotics typically used in the management of severe pneumonia in children.  

• According to the WHO’s Global Monitoring and Surveillance system, 42% of all cases of counterfeit or substandard medicines originate from the African continent.

• The numbers leave a lot to be desired.

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What qualifies as a Counterfeit?

Counterfeit medicines are those that have been deliberately or fraudulently manufactured and/or mislabeled with the intention of misrepresenting their identity, composition or source. They may contain the wrong active ingredient, wrong quantity of active ingredient or no active ingredient altogether.

What are the consequences?

Counterfeit medicines exert negative impact on both patients and pharmaceutical companies.

As it can be imagined, taking a tablet of corn starch, potato starch or chalk thinking it is your regular dose of Amoxil can have dire consequences. Patients end up struggling with treatment failure, increased lengths of hospital stay, adverse drug reactions, antibiotic resistance, increased treatment costs or even death.

It is estimated that the cost of treatment for patients who have consumed counterfeit or substandard antimalarial medicines in sub-Saharan Africa lies between $12 million to $44 million dollars annually.

With the flooding of counterfeits into the market, pharmaceutical companies have to cope with a tainted reputation on their brand and unimaginable losses in revenue. A report by Statista approximated that pharma companies in 2020 lost approximately $200 billion in expected revenue to the counterfeit market.

So what can be done?

Leverage on track and trace technology

A key strategy in the fight against counterfeit medicines is serialization of packaging and labels. This ensures that all packages receive a unique ID that allows tracking and tracing as they navigate the pharma supply chain processes. Examples of these identifiers include the QR code, Radio Frequency Identification, 2D matrix code and holographs that capture key data points:

• a unique product identification code
• manufacturing/import license number
• a serial shipping container code etc.

For this strategy to be successful, it is important to align relevant laws, regulations and policies to require all pharma manufacturers and market authorization holders to have their products serialized.

India, for example, approved a regulation requiring all imported and domestically manufactured Active Pharmaceutical Ingredients (APIs) to be labelled with QR codes. This is required at all levels of packaging.

African countries can adopt the same strategy.

Ramp up reporting and information sharing

I have always looked at reporting of poor-quality medicines as a more reactionary than pro-active method of addressing the issue of counterfeit medicines. However, I also acknowledge the crucial role this activity plays in limiting the spread of negative effects that counterfeit medicines can have in a region.

Constant and continuous sensitization on the importance of reporting of suspected poor-quality medicines should be the norm. Some countries have greatly focused on sensitization of health care workers which is a good thing. However, it should not end there.

Increased effort should be turned towards training the public on how to identify and report on suspected counterfeit medicines. Once these reports are made, the relevant agencies should provide feedback so as to encourage future engagement.

Increased collaboration among countries across the continent and global institutions such as Uppsala Monitoring Center and the WHO’s Global Surveillance and Monitoring (GSM) system is a key success factor. The GSM for Substandard and Falsified (SF) medical products in particular undertake crucial activities:

• Improve reporting of SF medical products
• Assess more accurately the scope, scale and harm caused by SF medical products
• Provide immediate co-ordination and technical support in emergencies
• Issue medical products rapid alerts
• Gather and analyze a detailed body of validated evidence for Member States to enable evidence-based policy making and investment
• Strengthen regional and national regulatory capacities to prevent, detect and respond to SF medical products

Effort has been put towards enhanced reporting of poor-quality drugs and African countries like Kenya have established an online reporting tool (https://pv.pharmacyboardkenya.org) to make the process more efficient.

However, more needs to be done to stamp out counterfeit.

Strengthen drug regulatory agencies

Drug regulatory agencies are the key departments concerned with compliance and investigative testing for medicines suspected to be counterfeit. These agencies are only able to execute their mandate through robust and well-resourced WHO pre-qualified quality control laboratories.

In reality though, most African countries lack this key resource.

As at August 2023 there exists only 9 WHO prequalified laboratories in the region, majority of which are widely under- resourced.

It is absolutely vital to increase the number and capacity of these quality control institutions especially those heavily reliant on Government funding. This can be in form of human resource, equipment and infrastructure to ensure that all health products that enter the market are of the required quality and safety specifications.

Bigger picture

It is expected that the African Medicines Agency (AMA) will play a crucial role in strengthening regulatory systems in the continent. With 33 AU country signatories as at October 2022, this agency has the goal of enhancing access to quality, safe and efficacious medicines across Africa.

This synergy of regulation is expected to develop the African pharma manufacturing sector and enhance the fight against substandard and counterfeit medicines.