[EN]The counterfeiting of medicines is a serious health concern worldwide, as it causes the loss of 200 000 to 1 000 000 people a year. Besides, it also affects societies by hampering their welfare states, as violation of property rights and tax revenues cause the loss of hundreds of direct and indirect jobs created by the pharmaceutical industry. Hence, given this scenario, local governments, as well as international organizations, such as the World Health Organization or the United Nations, have focused on carrying out strategies to counteract counterfeiting, both in developed and developing countries, as regardless of how monitored the legitimate supply chain within one country is, no country or pharmaceutical form is safe of being targeted by counterfeiting criminals. Thus, in this dissertation I sought to deliver an updated overview of the problem, focusing on the legislation being put into force in the three traditional pharmaceutical blocks, that is, the United States of America, Europe and Japan. Attention was also dragged to Argentina, Brazil and Italy, as their legislations came into force earlier than Europe?s Directive 2011/62/EU, which did so on February 9, 2019.

Trabajo de Fin de M?ster en Evaluaci?n y Desarrollo de Medicamentos. Curso 2018-2019