Five Reasons Why Experts Say GS1 is not a Solution against Counterfeit Medicines in the African Context, Despite its Global Relevance
A number of countries in Africa are adapting GS1 as a solution to the challenge of the high prevalence of counterfeited medicines. Experts have commented that this solution is not the best suited for the African context and we are listening. At Medicines for Africa, we follow where the evidence leads. We have therefore put together a clear breakdown of some o the reasons why GS1 is not the best-fit solution for the African context, despite its global relevance.
GS1 standards were created for highly structured supply chains in Western economies, where regulatory oversight, infrastructure, and enforcement mechanisms are strong. Africa’s reality is different: a large proportion of medicines flow through *informal and parallel markets**, which GS1 traceability systems cannot adequately cover.
2. Identification ≠ Authentication
GS1 helps identify and trace products (via barcodes and serialization), but it does not prevent criminals from duplicating codes or counterfeiting packaging. In Africa, where falsified medicines are widely distributed, *authenticity verification at point of sale** is more urgent than product identification alone.
3. Infrastructure gaps
Implementing GS1 requires *digital infrastructure, reliable internet, scanners, databases, and trained personnel**. Many African markets, especially in rural areas, lack these resources. Without such infrastructure, GS1 becomes impractical and risks excluding parts of the population.
4. High cost and sustainability challenges
Setting up and maintaining GS1 systems involves *significant financial and technical investment. For many low- and middle-income African countries, this raises concerns about long-term sustainability.
5. Does not address root causes
Africa’s biggest challenge is not just tracking products but *tackling the infiltration of falsified and substandard medicines** in informal supply chains. GS1 does not solve systemic issues like weak border control, affordability gaps, or unregulated distribution channels.
GS1 can play a supporting role in formal supply chains, but it is not sufficient as a stand-alone solution for Africa. What’s needed is a combination of authentication technologies, stronger enforcement, regional regulatory harmonisation, and community-level engagement to effectively fight falsified medicines.
Author: Lenias Hwenda is the Founder and CEO of medicines for africa (mfa)
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Head of Quality & Regulatory, Responsible Person & Responsible Person for Import
2wIs the solution an African Medicines verification system, similar to the European one, whereby products on any African market are verified before being placed on that market
Thank you all for a very informative debate. Your points ware well noted. GS1 is a framework, not a standalone solution. The example from India is a powerful reminder that standards without enforcement, adaptation, or complementary tools like unit-level authentication can fall short, or even mislead. In Africa, where informal markets dominate and regulatory capacity varies widely, it’s critical that we don’t mistake structure for substance. GS1 can support traceability, but only as part of a layered approach that includes strong local enforcement, practical technology solutions, and systems designed with African realities in mind.
Engineering Simplicity into Complexity | Pharma Tech Leader | Serialization, ePI, Automation & Beyond
2wmedicines for africa (mfa) I think there’s some confusion here about what GS1 standards are actually for - the standards primarily facilitate the exchange of information across supply chains. They really have nothing to do with authentication or tackling counterfeiting. As Pascal Aulagnet correctly pointed out, GS1 is not a solution, rather a set of standards. Verifying a serial number is not the same thing as verifying that the packaging is authentic (inferring then that the product is authentic - which is not always a corrected inference). This is why the experts who question whether the priority should be traceability (oversight, recalls, visibility) versus authenticity (anti-counterfeiting) are asking the right questions. They’re two very different challenges - and we won’t solve either by pretending they’re the same. The issue is, while we thankfully have GS1 standards for Traceability, there is no standard yet for Anticounterfeiting that would allow this to be easily implemented across all suppliers - thus making authenticity verification at the point of sale a challenge.
Director Market and Regulatory Engagement - Pfizer Serialization Center of Excellence | Patient Safety & Traceability champion
2wGS1 is not a solution. GS1 offers a set of Standards that are really helpful and useful while implementation solutions to address the challenges of high prevalence of counterfeited medicines. The GS1 Standards will allow interoperability, easy implementation and a common language between all the stakeholders and IT systems. So yes this is not THE solution, but it plays a central and support role