There is an alarming increase in the number of detected falsified medicines in the world. These medicines are fake medicines, which are deliberately presented as real, authorized medicines, for which the quality, safety and efficacy of the medicinal product have been proven during the process of obtaining a marketing authorization.
A falsified medicine is any medicine that falsely presents:
- its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients,
- its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder, or
- its history, including the records and documents relating to the distribution channels used.
This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.
Most often, such products appear as:
- copies of original medicines
- medicines with the wrong active ingredients
- medicines without active ingredients
- medicines with real active ingredients but fake packaging
- medicines with a high percentage of impurities
- falsified active ingredients/ingredients in otherwise original medicines
- medicine with a lower or higher dose of the active ingredient than the declared content
Falsified medicines are often manufactured under conditions that do not correspond to good manufacturing practice and reach patients not only through illegal channels but also through the legal supply chain. All of this threatens public health and causes people to distrust the legal supply system of medicines.
In response to the growing threat of falsified medicines, Directive 2011/62/EU (Falsified Medicines Directive – FMD) was adopted in 2011. The provisions of the directive have been transposed into the Slovenian legal order by the Medicinal Product Act. Directive 2011/62/EU sets out the requirements that must be met by manufacturers as well as wholesalers, parallel traders, and brokers of medicinal products.
These requirements include:
- obligations to apply safety features and check the authenticity of each unit of the medicine,
- stricter rules for the import of active pharmaceutical ingredients and strengthened control and inspections of pharmaceutical ingredients,
- Strengthened requirements for wholesale distributors,
- additional security requirements when selling medicines online.
The globalization of the market for active pharmaceutical ingredients and medicines requires effective international cooperation to ensure the protection of people’s health and their right to access to quality, safe and effective medicines. To combat organized crime in this area, the Council of Europe Convention on counterfeiting of medical products, including medicines, medical devices and other health support products, and similar criminal offenses endangering public health (Medicrime Convention) was adopted.
