One in ten medications circulating in developed countries is fake or does not meet the required quality standards, according to data from the World Health Organization (WHO)This alarming figure not only represents a serious risk to public health, but also an economic loss for the pharmaceutical industry and a brake on global scientific and medical development.
Counterfeit medicines represent a serious health risk, as they may contain Wrong ingredients, incorrect dosages, expired date, or contain dangerous substancesTheir use endangers patients' lives, especially in the treatment of serious illnesses such as cancer, HIV/AIDS, tuberculosis, or malaria. In these cases, the use of counterfeit products is not only ineffective but can worsen the patient's condition, promote the development of resistance to treatment, and impair the effectiveness of public health policies.
A health problem with global impact
The consequences of using counterfeit medicines are especially dangerous when they include low-quality antibiotics or those in insufficient dosesInstead of eliminating the infection, these products allow some bacteria to survive and grow stronger, encouraging the emergence of resistant strains.
Digital commerce and counterfeit medicines
Despite efforts by authorities and industry to curb this threat, counterfeit medicines continue to increase. In the last five years, the supply of these illicit products has increased by 35%, driven primarily by the rise of e-commerce. Digital platforms allow counterfeiters to reach a much wider audience, benefiting from the anonymity offered by the internet and making them considerably more difficult to track and prosecute.
The situation has become so serious that security forces have intensified their operations against illegal drug trafficking. The most recent, Operation Shield V, coordinated by Europol Between April and November 2024, 30 countries participated. This operation resulted in the arrest of 418 people and the seizure of counterfeit medicines valued at more than €11,1 million. These figures demonstrate the magnitude of the problem and its direct connection to organized crime networks.
The institutional response to drug counterfeiting
In order to combat this threat, European countries have implemented traceability and verification systems in the legal drug supply chain. In Spain, the Spanish Medicines Verification System (SEVeM), a key tool to guarantee the authenticity of each package dispensed in pharmacies.
The SEVeM assigns each medication a unique identifier, similar to a QR code, which is verified at the time of dispensing. This system can detect whether a product has been tampered with or does not belong to the authorized supply chain. Currently, more than 22.000 pharmacies, 216 private hospitals, 340 distributors, and 543 laboratories are connected to this network.
Furthermore, by virtue of the Delegated Regulation (EU) 2016/161As of September 30, 2024, the dispensing of medications that generate alerts in the system and cannot be ruled out as suspected counterfeit is prohibited. This regulation reinforces patient safety and requires all agents in the pharmaceutical chain to act with the utmost diligence.
The work of the AEMPS and public-private collaboration
La Spanish Agency for Medicines and Health Products (AEMPS) has established specific procedures for reporting suspected counterfeit medicines, accessible to laboratories, distributors, and pharmacies. These notifications are continuously updated and constitute a valuable resource for identifying patterns and preventing new threats.
The fight against piracy requires effective coordination between public institutions, pharmaceutical sector operators, and citizens. Information, training, and social awareness are essential to reducing demand for these products and encouraging safe purchases through official channels.
Beyond health: impact on the economy and innovation
The damage caused by counterfeit medicines is not limited to public health. The economic losses for laboratories are significant, since these illegal products compete directly with the originals, damaging brands' reputations and reducing the return on investment in innovation.
Furthermore, discourage scientific researchDeveloping a new drug requires years of work and enormous financial resources. The entry of counterfeit products into the market undermines this effort, making investment in science and technology less attractive. Without sustained investment in R&D, medical progress stagnates, and millions of people could be left without access to effective and safe treatments.
The impact also reaches public health systems., who must face the consequences of using ineffective medications: repeated treatments, adverse effects, unnecessary hospitalizations, and product detection or withdrawal campaigns.
Good practices to prevent counterfeit medicines
To protect yourself from the risks associated with counterfeit medicines, it is advisable to follow these guidelines:
- Buy exclusively from authorized pharmacies, whether physical or online.
- Check that the packaging has not been tampered with and retains the security seal.
- Consult the drug's registration number in the AEMPS CIMA database.
- Report any suspected counterfeit product to the competent authorities or the manufacturing laboratory.
Drug piracy is a global public health problem. It harms patients, damages the economy, jeopardizes innovation, and strengthens organized criminal networks. Strengthening surveillance, promoting citizen education and encouraging the purchase of medicines through official channels are essential steps. to combat this threat.
From Elzaburu, we continue to support the protection of industrial property rights and collaborate with authorities and companies to guarantee the security consumer and market integrity.
Alberto Gallo. Associate of the Area of Antipiracy by Elzaburu
