Arzneimittelfälschungen: Problem, Risiken, Schutzmöglichkeiten
Praxis
Abstract
Counterfeit Medicines: Problems, Risks, Possible Safeguards
In 2007, counterfeit medicines achieved a global market share of 10 %, with the share in some developing countries already 30 %. Counterfeit medicines turn over approximately US$ 75 billion per year worldwide. According to the WHO definition, approximately 50 % of all counterfeit medicines contain no active agent, incorrect doses of active agent or impurifications, meaning that patients face potential damage to their health and sometimes even death. For companies the potential consequences are also grave: they can be liable for the damage to health and the lost lives caused by the medicines brought into circulation by counterfeiters. In the following we provide an overview of the global extent of the problem “counterfeit medicines“ and the liability risk for companies resulting from counterfeit products. On the basis of these facts we then proceed to formulate a catalog of requirements for effective safeguarding systems and report on first experience with the state-of-the-art safeguarding system IT'S TRUE®.
Zusammenfassung
Gefälschte Arzneimittel erreichten im Jahr 2007 einen Anteil von 10 % im gesamten Weltmarkt und in einigen Entwicklungsländern bereits 30 %. Weltweit entfallen rund 75 Milliarden US-Dollar Umsatz pro Jahr auf Arzneimittelfälschungen. Da nach der WHO-Definition rund 50 % aller Fälschungen keine oder falsch dosierte Wirkstoffe oder Verunreinigungen enthalten, müssen Patienten mit potenziell gesundheitsgefährdenden bis lebensbedrohlichen Folgen rechnen. Für
