Guardians of Health: Battling the Fake Medicine Menace

What are counterfeit medicines?

Counterfeit pharmaceutical items can manifest in various ways. For instance, they might have the appropriate drug substance but in the wrong dosage, contain another active ingredient, or lack an active component altogether. Additionally, they could be legitimate medicines that have been redirected for unlawful resale, whether due to improper storage or having surpassed their expiration date. In many instances, patients are unaware that they have acquired a counterfeit product. Conversely, in some situations, falsified medicines are deliberately sought out for their use as doping or narcotic substances.

Counterfeit medicines: a rapidly rising threat

The market for illegal pharmaceutical products is expanding. Up until a few years ago, forgery was primarily associated with comfort medications – such as treatments for erectile dysfunction, which historically represented the most prevalent counterfeit items – yet now, every kind of drug and therapeutic area is impacted. From antimalarials to oncology therapies, and from chronic illness treatments to anxiolytics, no product is safe in the current marketplace. These counterfeit items are both produced and distributed globally.

This increase can be attributed to various factors, starting with the rise of e-commerce, which has led to the emergence of countless unregulated websites. Furthermore, a culture of self-medication and self-diagnosis has surfaced in regions where acquiring medical consultations has become overly challenging. While patients once hesitated to take medicines without a prescription, many are now enticed by the prospect of buying medications online without needing one.

Simultaneously, the counterfeit medicine market is becoming increasingly organized. Forgers show no reluctance in targeting high-value products, demonstrating agility comparable to that of pharmaceutical industry participants, along with a notable capacity to adjust to patient demands and social trends. This agility was especially visible at the onset of the Covid-19 pandemic when counterfeiters quickly managed to market essential supplies like masks, disinfectants, and oxygen kits. To address the growing availability of illicit products, stakeholders in the pharmaceutical sector – in collaboration with law enforcement bodies – have implemented essential strategies. An additional sign pointing to the need for action is the rising use of parcel delivery for transporting falsified medicines, exploiting the surge in daily parcels in transit.

What measures can be taken to shield patients from counterfeit medications?

In light of the expanding market for counterfeit drugs, law enforcement and health agencies, together with the pharmaceutical sector, are collaborating to dismantle illicit networks and guarantee patient safety. Pharmaceutical firms are also engaging in the creation of innovative solutions aimed at enhancing product traceability and safeguarding patients. One such initiative involves the aggregation of the pharmaceutical supply chain, a method that monitors a medicinal product at each stage of packaging. In essence, before a medicine’s box progresses to the subsequent level in the supply chain, tracking information is compiled into a database, starting from the individual unit (lowest level) to the pack, case, and pallet (highest level).

Collaboration, an essential component in the fight against counterfeiting

Collaboration among all parties is vital in combating the escalation of the illegal pharmaceuticals market.

Every participant has a distinct role that is critical for executing a comprehensive anti-counterfeiting strategy. For instance, pharmaceutical companies are tasked with global monitoring, enabling them to pinpoint criminal networks. They are therefore equipped to alert both their counterparts (private-private collaboration) and law enforcement (public-private collaboration), which can then unite efforts to expose and dismantle criminal syndicates and penalize traffickers (public-public partnership).

Technological advancements for safeguarding patients

Serialization – a compulsory measure in Europe – is a crucial element in the persistent endeavor to combat counterfeit pharmaceuticals. This process entails the application of a distinct identifier on every box of a prescription drug to ascertain the product’s identity. This identifying characteristic is placed by the pharmaceutical producer and scanned by the pharmacy prior to the medication being dispensed. A tamper-evident seal must also be present on all medicinal items to verify that the package has not been opened previously.

To preserve the integrity and quality of their medicines, several pharmaceutical companies, including Servier, have opted to extend beyond the serialization requirement by implementing a system of supply chain aggregation. This innovation mandates that the entire container (box or carton) in which the medicines are transported to pharmacies be specifically coded or labeled. This consequently offers an additional layer of security.

More broadly, recent advancements in digital technologies continually create new possibilities for enhancing product traceability. In France, for instance, a pilot project aimed at substituting medicine leaflets with digital versions accessible via QR Code scanning was initiated in 2024. By adding a digital aspect, these QR Codes complicate the falsification process. A comparable initiative will also be launched in Brazil.

For patients, the motto is vigilance

Notwithstanding the efforts of law enforcement, health authorities, and the pharmaceutical sector to ensure patient safety, continuous vigilance is essential when acquiring pharmaceutical products. Alongside consistently obtaining medicines from an authorized pharmacy or a certified online source, patients must closely observe the condition of the packaging, the manufacturing and expiration dates, and the quality of the package insert.

Hear from Jan Geissler, President of the Patvocates Think Tank, and patient representative on various committees.

^[1] OCDE – 2020
^[2] European Commission / EUIPO—2021
^[3] OMS – 2017
^[4] Interpol – https://www.interpol.int/fr/Actualites-et-evenements/Actualites/2023/Une-operation-d-INTERPOL-cible-les-medicaments-illicites-dans-le-monde
^[5] Gendinfo – https://www.gendarmerie.interieur.gouv.fr/gendinfo/actualites/2022/shield-un-bouclier-de-protection-contre-le-trafic-de-medicaments
^[6] https://www.gendarmerie.interieur.gouv.fr/gendinfo/actualites/2022/shield-un-bouclier-de-protection
^[7] Europol –