Medicines – very closely monitored
According to WHO, a medicine can be defined as “any substance or composition presented as having curative or preventive properties for human diseases. Any substance or composition that can be administered to humans to establish a medical diagnosis or restore, correct or modify human physiological functions is also considered as a medicine.” But a medicine is not just any type of product. It is probably the most strictly regulated product of all time, from creation to development and right up to the marketing phase (pharmacovigilance).
Falsified, counterfeit or fake medicines?
This is a question of use, but all these terms are used to describe similar cases.
Falsification is “the action of voluntarily adulterating a substance or any other element with a view to deceit”. So the term “falsification” is used rather than “counterfeit” to emphasise the risks of damage to public health.
The term “counterfeit” has a more legal connotation focusing on the notion of infringing intellectual property rights.
In Europe the term ‘counterfeit’ is more common, although falsification is increasingly used. In the US however, the word ‘fake’ is more often used. This is a medicine that is not what it claims to be and is intended to trick the consumer.
Fake identity, fake source or fake history
The EU directive published on 8 June 2011 proposed the most complete definition of a falsified medicinal product:
“Any medicinal product with a false presentation of at least one of the following:
- 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;
- 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.”