Counterfeit drugs are more prevalent around the world than many might realize.
In fact, this problem is becoming increasingly prevalent across Europe, putting consumers at risk and straining the healthcare system.
The Growing Threat of Counterfeit OTC Medications: What You Need to Know About Traceability
The Ground Reality of Counterfeit Medications in Europe
For the EU as a whole, the estimated total counterfeiting effect amounts to 4.4% of sales or €10.2 billion. (Source)
This is a direct estimate of sales lost by legitimate manufacturers and wholesalers of medicines in the EU each year due to counterfeiting.
Apart from that,
1. Weight Loss Drugs: Fake Ozempic and Wegovy Surge in Europe
MEDICAL ALERT: The World Health Organization is warning the public and professionals to be vigilant after fake batches of Ozempic were found in Brazil, the UK and the US. More on the dangers: https://t.co/aEj6qpP8nK pic.twitter.com/1ocbuRYsTm
— Fox News (@FoxNews) June 22, 2024
In 2023, Europe experienced a significant surge in counterfeit and potentially harmful versions of the weight loss drugs Ozempic and Wegovy, driven by heightened demand and supply shortages.
As these drugs, which contain the active ingredient semaglutide, became scarce due to restrictions and high demand, individuals turned to online sources and social media to obtain them.
This led to a dramatic increase in illegal imports and the proliferation of counterfeit products, including those sold with fake prescriptions or through rogue sellers. (Source)
2. Fake Medicines Worth EUR 64 Million off EU Markets
Between April and October 2023, Europol coordinated Operation SHIELD IV, a global initiative targeting the trafficking of counterfeit and illicit medicines and doping substances.
Authorities seized over EUR 64 million worth of illegal pharmaceuticals, raw materials, and active ingredients, dismantled four underground labs, and shut down 92 websites. (Source)
Top Challenges Faced by Authorities and Big Pharma Giants
Combatting counterfeit medications presents several challenges.
1. Pharmaceutical Supply Chain (PSC)
The PSC is vulnerable to the entry of counterfeit drugs, which can infiltrate at various stages, often during distribution and repackaging.
Many companies rely on raw materials from countries like China and India, where the demand-driven market can lead to compromised product quality.
Suppliers may prioritize speed over thorough quality checks, creating opportunities for counterfeiters.
Additionally, wholesalers inadvertently facilitate the spread of counterfeit drugs through arbitrage – buying drugs cheaply in one market and selling them at a higher price elsewhere – potentially introducing fake products into the legitimate supply chain.
2. Limited Resources
Regulatory agencies often face budget and manpower shortages, making it hard to conduct thorough inspections and investigations.
Counterfeiters, meanwhile, are well-funded and constantly adapting, which puts authorities at a disadvantage.
3. Technological Gaps
While counterfeiters rapidly adopt new technologies, regulatory agencies can be slower to update their tools and methods.
The use of outdated systems for tracking and verification may leave gaps that counterfeiters can exploit.
Additionally, integrating new technologies into existing regulatory frameworks can be both costly and time-consuming.
4. Rise of Online Sales
The growth of online pharmacies has made it easier for counterfeiters to reach consumers directly.
In fact, approx. 50% of the medications offered and purchased online are counterfeit according to the WHO. (Source)
Current Regulations in Europe and Their Effectiveness
Europe has implemented several regulations to tackle the issue of counterfeit medications.
1. Falsified Medicines Directive (FMD)
FMD mandates that prescription and OTC medications have unique serial numbers and tamper-evident packaging to aid in their verification.
Despite these regulations, the effectiveness is mixed.
While the FMD has improved the tracking of prescription medications, OTC drugs face less stringent controls.
2. European Medicines Verification System (EMVS)
The EMVS supports the FMD by allowing pharmacies and wholesalers to verify the authenticity of medicines through a central database.
(Source)
The EMVS has been effective in preventing counterfeit prescription drugs from reaching patients. Its real-time verification process adds a layer of security.
However, like the FMD, its effectiveness is limited when it comes to OTC medications, many of which are not serialized and therefore not part of this verification system.
The Role of Traceability in Combating Counterfeits OTC Medications
Traceability refers to the ability to track the journey of a product from its origin to the end consumer.
In the context of OTC medications, it involves assigning a unique identifier to each package and using technology to track its movement through the supply chain.
Here is how it can help overcome the threat of counterfeit OTC medications.
Technologies Enabling Traceability for OTC Medications
1. Blockchain
A decentralized ledger system that records every transaction in the supply chain, making it nearly impossible to alter or counterfeit information.
Blockchain technology is increasingly used in the pharmaceutical industry to ensure the authenticity of products, providing a secure, transparent record of each transaction.
(Source)
2. RFID
Tags that use radio waves to communicate information about a product.
These tags can be used to track products throughout the supply chain, offering real-time data on the location and status of medications, ensuring they remain within the legitimate supply chain.
3. QR Codes & Barcodes
Simple yet effective ways to encode product information.
When scanned, they provide details about the product’s origin, manufacturing date, and distribution history, enabling easy verification by consumers and professionals alike.
4. Internet of Things (IoT)
Connected devices that monitor and report on the conditions (such as temperature and humidity) in which medications are stored and transported.
This ensures they remain in optimal conditions, reducing the risk of counterfeit or degraded products entering the supply chain.
5. Data Analytics
The vast amount of data generated throughout the supply chain – from production to delivery – can be aggregated and analyzed to identify patterns, anomalies, and potential risks.
Data analytics can detect unusual patterns in the supply chain that might indicate counterfeit activity, such as unexpected changes in shipping routes or volumes.
6. Artificial Intelligence
AI algorithms can analyze vast amounts of supply chain data to identify patterns that might indicate counterfeit activity.
For example, AI can detect discrepancies in product movement or flag inconsistencies in product packaging or labeling.
7. Cloud Computing
Cloud platforms provide scalable, secure storage for the vast amounts of data generated by traceability systems.
This data can be accessed in real-time by authorized stakeholders across the globe, facilitating quicker decision-making and more efficient supply chain management.
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