Abstract
The globalization of trade and internet access significantly increased the health risks associated with falsified medicines. International organizations, pharmaceutical companies and national governments developed a wide variety of measures to combat their pervasive penetration into the legal supply chains. However, the lack of harmonization, broad acceptance and legally bound enforcement obstructed their endeavours. The unsatisfying outcomes resulted in enhanced supranational cooperation focused on strengthening the pharmaceutical regulatory frameworks and the improvement of patient protection. 
 In 2011 the European Union joined the global fight with the adoption of Directive 2011/62/EU that became known as the Falsified Medicine Directive. It is legally binding for Member States and amends the fundamental for the pharmaceutical sector Directive 2001/83/EC. The objective of the present paper is to verify if it represents a comprehensive tool for effective prevention of the access of falsified medicines in the European legal pharmaceutical supply chains. The results revealed that although it is rather detailed, there are areas that could be further developed and improved when compared to analogical policies and initiatives.
Highlights
Falsified medicines pose serious threat to health systems, industry and society and the adoption of supranational coherent pharmaceutical policies focused on prevention, control and prosecution became an imperative step to eliminate their uncontrolled pervasion
The very title of Directive 2011/62/European Union (EU) specifies that its scope is limited to the falsified medicines
What happens to the other types and why they are not included? Corresponding national pharmaceutical laws include much broader definitions and regulations
Summary
Falsified medicines pose serious threat to health systems, industry and society and the adoption of supranational coherent pharmaceutical policies focused on prevention, control and prosecution became an imperative step to eliminate their uncontrolled pervasion. In 2011 the European Union (EU) joined the global fight with Directive 2011/62/EU or as it became known – the Falsified Medicine Directive (FMD). It is a result of long-term negotiations between the various participants in the complex pharmaceutical network – regional and national authorities, manufacturers, wholesalers, international industrial and patient organizations, etc. Harmonizing the interests of a diverse network of actors often requires compromises that might result in limitations of the regulations and create opportunities that criminal organizations would eagerly seize and exploit
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