Counterfeit pharmaceuticals: innovative strategies for combatting global health threats

Gökçe İzgi
Moroğlu Arseven, Istanbul
gizgi@morogluarseven.com

Merve Altınay
Moroğlu Arseven, Istanbul
maltinay@morogluarseven.com

According to the World Health Organization (WHO), counterfeit pharmaceuticals are ‘medicines that are deliberately and fraudulently mislabeled with respect to their identity and/or source’. This definition is in line with the regulations in Türkiye.

This definition includes pharmaceuticals that may contain the wrong ingredients, insufficient quantities of active ingredients and even those that contain no active ingredients at all. The term ‘counterfeit’ encompasses a broad range of fraudulent practices, from fake pharmaceuticals that are sold as legitimate medications to substandard products that fail to meet the required quality standards.

Counterfeit pharmaceuticals represent a significant and growing global health threat, endangering millions of lives worldwide. These products, which often mimic legitimate medicines, are produced and sold illegally, lacking adherence to the required quality control and safety standards. The consequences of counterfeit drugs are dire, ranging from treatment failure to the emergence of drug-resistant diseases and, even, death. In addition to this, as is the case with all counterfeit product markets, the actors involved the counterfeit pharmaceuticals market are also major players in the black market, and the illicit profits generated from the trade in counterfeit pharmaceuticals contribute to other illegal activities.

Understanding the global impact of counterfeit pharmaceuticals

The scale of the counterfeit pharmaceuticals market is astounding. According to estimates by the WHO, the annual value of the global counterfeit pharmaceuticals market ranges between $75bn and $200bn. This is a conservative estimate, and the actual size could be much higher, as a significant proportion of counterfeit drugs remains unreported or undetected.

According to the WHO, up to ten per cent of medicines in low- and middle-income countries are estimated to be counterfeit, while in high-income countries, the percentage is somewhat lower, but is still significant.

In the specific context of counterfeit medicines, Türkiye acts as a critical transit point for counterfeit drugs, originating primarily from China and India, the leading producers of such products, to reach the European market. According to the WHO, Türkiye is ranked among the top five sources of counterfeit medicines globally, alongside China, Mexico, the United Kingdom and India. This market, often controlled by organised crime groups, employs various smuggling routes, involving land and sea transport, to deliver these products to target markets. Historically, these counterfeit medicines were sold through networks with weaker oversight, such as the deep/dark web. However, in recent years, social media has increasingly become a marketplace for these products, enabling counterfeit medicines to be offered and sold directly to consumers.

The economic impact of counterfeit pharmaceuticals is immense, as it leads to lost revenues for legitimate drug manufacturers, healthcare costs associated with adverse events and undermines public trust in health systems. This situation is made worse by the fact that problems in the pharmaceutical supply system and shortages in the availability of medicines unfortunately drive patients to seek medication from unreliable sources.

Despite efforts to curb the trade, counterfeit drugs continue to proliferate due to factors such as weak regulatory enforcement, the growing demand for inexpensive medications and the lack of adequate technological solutions for detecting fake drugs throughout the supply chain.

Innovative strategies for combatting counterfeit pharmaceuticals

The fight against counterfeit pharmaceuticals requires a multifaceted approach, combining technological advancements, stricter regulations and international cooperation.

Below are some of the innovative strategies being used around the world to combat the trade in counterfeit pharmaceuticals.

Track-and-trace systems

One of the most effective ways to combat counterfeit pharmaceuticals is using track-and-trace systems. These systems allow the authorities to monitor the movement of pharmaceutical products throughout the supply chain, ensuring that they are genuine and have not been tampered with. The system works by assigning a unique identifier, such as a barcode or a 2D matrix code, to each package of medicine, ie, serialisation. This code can be scanned at various points in the supply chain, allowing different stakeholders, from manufacturers to distributors and pharmacists, to verify the authenticity of the product.

For the purpose of serialisation, blockchain technology can also be used to improve the traceability and security of pharmaceutical products. Blockchain, as a decentralised and tamper-proof digital ledger, is increasingly being explored for its potential to combat counterfeit pharmaceuticals. It can provide an immutable record of a drug’s journey from the manufacturer to the consumer, making it nearly impossible for counterfeiters to alter the product’s history.

In Türkiye, the Ministry of Health has implemented a national Pharmaceutical Tracking and Verification System, known as the ITS. This system allows every pharmaceutical distributed in the Turkish market to be tracked from the manufacturer to the point of sale. Since its implementation, the ITS has played a significant role in reducing the incidence of counterfeit drugs in the country, increasing both consumer confidence and safety.

According to the Guidelines on Counterfeit, Illicit or Medicines Outside the Legal Supply Chain, published by the Turkish Medicines and Medical Devices Agency (Türkiye İlaç ve Tıbbi Cihaz Kurumu  or TMMDA), which is the authorised body responsible for determining the procedures and principles regarding the licensing, production, storage, sale, import, export, marketing, distribution, provision, recall and use of medicines, all suspected counterfeit or smuggled medicines are required to be reported to the TMMDA, following specific procedures. This obligation applies to marketing authorisation holders, pharmaceutical warehouses, pharmacies, hospitals, drug manufacturing facilities, physicians, healthcare personnel, provincial health directorates, the Ministry of Health and its departments, and even to patients. Judicial and administrative actions are carried out concerning suspicious products and the involved parties are reported to the TMMDA through various channels. Through these practices, communication and collaboration between all the actors at all stages of the pharmaceutical trade is fostered.

Smart packaging and authentication technologies

Smart packaging technologies are another innovative strategy being employed to combat counterfeit pharmaceuticals. These include technologies such as radio-frequency identification (RFID), near-field communication (NFC) and holographic labels, all of which enable the authentication of a product at the point of sale. RFID, in particular, enables the creation of a digital passport for each product, which can be read at every stage of the supply chain, from the manufacturer to the distributor to the end consumer.

For example, some companies are incorporating quick response (QR) codes and NFC-enabled labels into their packaging, which can be scanned by consumers using a smartphone By simply scanning the code, consumers can access detailed information about the product, including its manufacturing details, expiration date and batch number.

In combination with smart packaging systems, portable devices for authenticity verification can be effective. These handheld devices can quickly analyse the chemical composition of a drug, assess packaging integrity and provide instant feedback on whether a product is authentic.

International collaboration and information sharing

Combatting counterfeit pharmaceuticals is a global challenge that requires international cooperation, especially considering the effectiveness of strong enforcement at borders and customs. Many counterfeit drugs originate in countries with weak regulatory frameworks or inadequate enforcement, making it necessary for nations to collaborate in order to prevent the flow of these drugs across borders.

Given the transnational nature of the counterfeit drug trade, international cooperation is essential in regard to combatting the problem. Organisations such as the WHO and the International Criminal Police Organisation (INTERPOL) are critical in regard to the coordination of global efforts to combat counterfeit medicines.

Moreover, regional and worldwide collaborations to enhance intelligence sharing and enforcement, such as activities involving the World Customs Organisation and the MEDICRIME Convention, will help to provide more effective preventative results.

Public awareness campaigns

Public awareness campaigns and efforts to educate the public about the harms of counterfeit and illegal medicinal products are the most sustainable solutions available to governments in the fight against counterfeiting. Many consumers are unaware of the risks posed by counterfeit pharmaceuticals and they may unknowingly purchase counterfeit products due to their low cost or a lack of information. Governments, non-governmental organisations (NGOs) and industry associations must work together to educate the public on how to identify counterfeit drugs and the dangers they pose.

Stronger penalties and legal frameworks

Among the various solutions in the fight against counterfeiting, and perhaps the most traditional, remains legal regulations.

The route to combatting counterfeit products should be multifaceted, including administrative steps that can be taken at customs, criminal actions brought based on smuggling regulations, as well as articles regarding public health and civil and criminal actions available to the holders of intellectual property (IP) rights.

For example, in Türkiye, in addition to the regulatory rules governing the supply chain, the provisions in the Turkish Criminal Code, the Anti-Smuggling Law and the Industrial Property Law can also be applied in order to address the trade in counterfeit medicines.

According to the Turkish Criminal Code, crimes against public health include the trade of adulterated or altered food or medicines, as well as the production or sale of medicines in a manner that endangers human life and health. In regard to both offences, the protected value is public health, and the condition for the crime to materialise is that the products in question pose a health risk. Therefore, not every product defined as a counterfeit medicine in this context can serve as grounds for criminal liability under these provisions, unless the product is harmful to human health.

At this point, the crime of trademark infringement under the Industrial Property Law gains importance. According to the relevant provisions, acts such as manufacturing goods or providing services by imitating or creating confusion with another’s trademark, offering them for sale, selling, importing, exporting, purchasing, possessing, transporting or storing such goods for commercial purposes are defined as criminal offences. As a result, in any case involving a counterfeit product, criminal provisions concerning trademark infringement may be applicable.

Effective, decisive and consistent enforcement in countries through the use of different legal channels will reduce the prevalence of counterfeit medicines. Stronger penalties and more robust enforcement mechanisms discourage counterfeiters and disrupt their illegal operations.

Tackling the online market

Like in some other countries, the online pharmaceutical market in Turkey is highly regulated, and the sale of prescription drugs over the internet is strictly prohibited under Turkish Law. That said, vitamins and supplements can be sold through licensed e-commerce platforms and pharmacy websites.

When the issue is considered in terms of countries where pharmaceuticals are sold online, the rise of online pharmacies has made it easier for counterfeit pharmaceuticals to reach consumers worldwide. To address this, the authorities are taking different steps to regulate and monitor the online sale of pharmaceuticals, as follows:

• the regulation of online pharmacies: some countries have implemented laws and regulations requiring that online pharmacies adhere to the same standards as physical pharmacies. Some governments have set up official registries or certification programmes for legitimate online pharmacies;
• a crackdown on illicit online pharmacies: law enforcement agencies use online monitoring tools to detect and shutdown websites selling counterfeit drugs. INTERPOL and national authorities regularly conduct operations to remove counterfeit drug websites and takedown online sellers operating without the necessary licences. The impact of the effective enforcement of IP rights can also support the removal of counterfeit products from online pharmacies; and
• raising public awareness of the risks posed by rogue online pharmacies: authorities and industry groups are educating consumers on how to recognise and avoid rogue online pharmacies. This includes advising patients to only purchase medications from trusted websites and not to buy drugs from unauthorised online platforms.

Artificial Intelligence (AI) and machine learning

AI and machine learning technologies are being used to detect counterfeit drugs more efficiently. AI can be applied in several ways to identify suspicious patterns, such as pattern recognition for identifying irregularities in product packaging, labelling or the chemical composition of drugs and predictive analytics.

Conclusion

Innovative strategies and technologies are playing a vital role in the fight against counterfeit pharmaceuticals. By leveraging advancements in serialisation, blockchain, AI, portable detection devices and online verification systems, stakeholders are creating a more secure and transparent pharmaceutical supply chain. Collaborative efforts between governments, international organisations, private companies and consumers are also key to fighting counterfeit drugs on a global scale. These innovations not only help protect patients' health, but also ensure the integrity of the global pharmaceutical industry. Only through continued innovation and global collaboration can we hope to eradicate counterfeit pharmaceuticals and protect public health for future generations.