MEDICRIME Unit, Directorate General: Human Rights and Rule of Law. (2025) An assessment of publicly reported incidents of illicit diversion and falsification of medicines. Strasbourg: European Commission. CRIMFAMED (2025) 11.
Preview | Title | Contact |
---|---|---|
|
PDF (An assessment of publicly reported incidents of illicit diversion and falsification of medicines)
1MB |
External website: https://rm.coe.int/crimfamed-2025-11-diverted-and-...
This paper has been produced in support of the Project entitled “Countering Falsified Medical Products Global programme” (hereinafter, CRIMFAMED) which aims at promoting the MEDICRIME Convention. The challenge faced by authorities in preventing, detecting, and responding to reports of the illicit diversion of authorised medicines and the identification of falsified versions of legitimate medicines are significant. These challenges include protecting the patient and wider public health whilst ensuring the security of the regulated supply chain both in terms of preventing falsified medicines entering the supply chain but also in preventing medicines being intentionally removed from the intended supply chain and diverted into an unintended supply chain in another country or to the illicit market.
Through open-source online research, i.e. publicly available information, the intention of this paper is to identify those medicines which have been more commonly subject of illicit diversion or falsification reports. From the information gathered during the preparation of this paper it is suggested that:
- reported incidents indicate that controlled medicines appear more generally at risk to both illicit diversion and falsification;
- falsified controlled medicines often contain undisclosed high-risk ingredients;
- falsified controlled medicines have been reported to have contributed to fatal outcomes in many differing contexts;
- illicit diversion maybe a threat indicator of future risk of the production of falsified versions of the diverted product;
- whilst limited to publicly available information, reported incidents are suggestive of high-income countries being most at risk of the illicit diversion and falsification of controlled medicines;
- regulated supply chain losses and thefts may play a significant role in illicit diversion.
To allow States to develop evidence-based policies three key areas may require further consideration and development to resolve:
• limited availability of data/ comprehensive data set;
• limited research of the topic and sub-topics;
• a paucity of detailed analysis to inform focus and direction.
This report is presented in three sub-sections. The first offers a visual presentation (report table 1) which lists products identified as subject of reported incidents of illicit diversion and/or falsification divided into the three categories which this paper will focus upon:
• Medicines
• Medicines that are subject to further controls
• Psychoactive and other substances
The second section provides an additional narrative on the nature of the reports of illicit diversion and falsification of the products concerned and the source from which the information has been identified. Each of the identified sources provides more detailed information on the individual incident, criminal methodology and volumes of the named product involved. To conclude the report the information gathered during this research is drawn to together to provide some higher-level findings.
B Substances > New (novel) psychoactive substances > Synthetic opioids > Fentanyl, Fentanils
B Substances > New (novel) psychoactive substances > Synthetic opioids > Benzimidazole, Nitazenes, Brorphine
B Substances > New (novel) psychoactive substances > Other novel substances > Xylazine, detomidine, medetomidine
E Concepts in biomedical areas > Medical substance > Over the counter drug (medicine / medication)
E Concepts in biomedical areas > Medical substance > Prescription drug (medicine / medication)
E Concepts in biomedical areas > Pharmacology and toxicology > Purity / adulterant
J Health care, prevention, harm reduction and treatment > Risk and needs assessment > Risk assessment > Early warning monitoring system
MM-MO Crime and law > Organised crime
MM-MO Crime and law > Crime > Substance related crime > Crime associated with substance production and distribution
MM-MO Crime and law > Substance related offence > Drug offence > Illegal production of drugs
MM-MO Crime and law > Substance related offence > Drug offence > Illegal transportation of drugs (smuggling / trafficking)
MM-MO Crime and law > Substance related offence > Drug offence > Illegal distribution of drugs (drug market / dealing)
MM-MO Crime and law > Substance related offence > Drug offence > Illegal drug possession (seizures)
MM-MO Crime and law > Crime deterrence
VA Geographic area > Europe
VA Geographic area > Europe > Ireland
Repository Staff Only: item control page