The World Health Organization (WHO) defines falsified or counterfeit medicines as those that deliberately or fraudulently misrepresent their identity, composition or source.
These are products that have been formulated and developed by entities other than the genuine manufacturers, attempting to mimic the original product without the requisite rights or authority.
In terms of composition, these medicines may contain no active pharmaceutical ingredient (API), the incorrect API or incorrect amount of API, often substituting this with inert substances like chalk, potato starch or corn starch.
The Challenge of Falsified Medicines
Falsified medicines are a pervasive global challenge, significantly impacting low- and middle-income countries, including those in Africa. It is estimated that 10% of medical products in these regions are either substandard or falsified.
Despite substantial investments in combating counterfeit medical products, this issue persists due to the lucrative nature of the counterfeit medicine market.
Falsified medicines are a $200 billion industry, accounting for the largest portion of the $1.7 trillion in fraudulent goods traded globally every year.
Ramifications of Counterfeit Medicines
Passing counterfeit medicines as authentic may have far-reaching implications affecting various stakeholders:
Patients: The highest concern lies with patients, who may suffer from fatal adverse drug reactions, treatment failures, prolonged hospital stays, antimicrobial resistance, increased healthcare costs, and even death. For instance, it is estimated that 450,000 people die annually from malaria due to falsified antimalarial medicines.
Authentic companies: Legitimate pharmaceutical companies face undue competition, losing revenue to counterfeit products and suffering brand damage. The fear of counterfeit medicines can deter patients from using genuine products, compelling companies to invest heavily in product authentication measures.
Healthcare providers and regulatory authorities: The prevalence of counterfeit medicines can erode trust in healthcare providers and regulatory authorities, questioning their ability to ensure the quality, safety and efficacy of medical products.
Countries: Nations dealing with the influx of counterfeit medicines may suffer reputational damage affecting their standing in the global community.
RELATED: Counterfeit medicines: 3 ways Africa can win the fight (africanpharmaceuticalreview.com)
Why Africa is Particularly Vulnerable
Corruption and porous borders
A significant portion of pharmaceutical products in Africa is imported.
And so are counterfeit medicines.
Although many African countries have stringent laws and policies for importing medical products, these measures often fail in practice. Corruption and weak border controls allow counterfeit medicines to enter the market unchecked.
High poverty rates
Africa has the highest poverty rate globally, with an estimated 35.5% of the population living on less than $1.90 a day. Limited financial resources make it difficult for many to access proper healthcare, leading them to purchase cheaper, unregulated medicines from informal sources. These unverified sources are often counterfeit.
Ineffective National Regulatory Authorities (NRAs)
Approximately, one-third of countries worldwide lack effective drug regulatory authorities, and many African nations fall into this category. Some countries don’t have dedicated national drug agencies, while others have regulatory bodies that lack autonomy, adequate financing, infrastructure, and human resources.
These shortcomings make it challenging to combat counterfeit medicines effectively.
Strategies to fight against counterfeit medicines
Outsourcing supply chain monitoring systems
Implementing advanced track-and-trace technology can significantly reduce the prevalence of counterfeit medicines.
However, the high initial cost deters many manufacturers.
Outsourcing this function to specialized companies can provide access to the latest technology without the need for substantial capital investment. These companies can develop new-generation taggants, unique identifiers, and encrypted data that can be authenticated by distributors or consumers through scanners and mobile applications.
Coordination between regulatory authorities
Strengthening national regulatory authorities is crucial, but collaboration among African countries is equally important.
By pooling resources, sharing information, and enhancing post-market surveillance, African nations can present a united front against counterfeit medicines. Cooperative efforts can make it more challenging for counterfeiters to navigate through multiple countries’ borders and regulatory systems.
Establishing more WHO-prequalified quality control laboratories can aid in the detection and prevention of counterfeit medicines.
Empower the consumers
Consumers must be educated about the dangers of counterfeit medicines.
Anti-counterfeiting strategies often focus on manufacturers, distributors, and regulatory authorities, overlooking the critical role of consumers.
Education programs should be designed to help consumers recognize, detect, and report counterfeit medicines. Leveraging platforms like social media and mobile technology (e.g., apps and USSD codes) can facilitate consumer engagement in monitoring and reporting counterfeit products.
Conclusion
Counterfeit medicines remain a huge challenge In Africa and the world at large.
The continent is extremely vulnerable to these medicines and the nature of the consequences are too devastating to turn a blind eye on.
Through initiatives such as regulatory harmonization, Africa is well placed to improve on its systemic issues that make it and an easy target for those engaging in the practice.
And through strategies like empowering consumers, increased coordination between African regulatory authorities and outsourcing supply chain monitoring systems, the continent can make significant strides in combating the scourge of falsified medicines, ensuring safer healthcare outcomes for all.
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About the Author
Bevin Likuyani is a Pharmacist with a MPharm (Pharmacoepidemiology & Pharmacovigilance) and MBA (Strategic Management) from School of Business, University of Nairobi). He is a Certified Supply Chain Pharmacist. (American Association of Supply Chain Management) and Editor at African Pharmaceutical Review. Email: bevin@africanpharmaceuticalreview.com LinkedIn
