Falsified medicinal products
What are falsified medicinal product?
According to the definition given by Article 1 of the Directive 2011/62/EU, a falsified medicinal product is “any medicinal product with a false representation of: (a) 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; (b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or (c) its history, including the records and documents relating to the distribution channels used”.
Falsified medical products must be distinguished from other illegal medicinal products and the products infringing intellectual property rights. Furthermore, according to the Directive, “medicinal products with unintentional quality defects resulting from manufacturing or distribution errors should not be confused with falsified medicinal products”.
Why are falsified medicinal products dangerous?
Falsified medicinal products are dangerous because they usually lack the correct ingredients or contain sub-standard or falsified ingredients. Those products could also contain ingredients, including active substances, in the wrong dosage.
The number of those products detected in the European Union is increasing and they may have entered also in the legal supply chain. This represents an extreme threat to health and may cause a lack of trust of the patient.
What is the extent of the problem?
It is impossible to provide a precise quantification of the market, even if there is consensus that it is highly profitable. According to the WHO, the business value of falsified medicines is estimated at around 75 billion dollars per year, and the trade in falsified medicinal products corresponds to about 10 percent of the global trade in medicines.
Even if the falsification of medicinal products is a pervasive and global phenomenon, its extent varies according to the area of the world considered. In developing countries, falsified medicines are a dramatic problem for healthcare: it has been estimated that in certain African, Asian, and Latin American countries at least 30 per cent of the medicines consumed are falsified. The situation is even more serious for certain types of medicines, such as antimalarials in Southeast Asia, where the falsified percentage is estimated at around 40 percent, causing major impediments to malaria control.
By contrast, in developed countries estimates are far more optimistic: less than 1 per cent of medicines are likely to be falsified. Illegal/rogue online pharmacies are basically the only way in which falsified medicinal products can enter these markets, since the legal production and supply chains are essentially safe because of effective control policies set by national authorities.