Debater a Europa (Feb 2015)

Performances and Standards against the Global and Current Proliferation of Counterfeit Medicines

  • Carlos del Castillo Rodríguez

DOI
https://doi.org/10.14195/1647-6336_14_11
Journal volume & issue
no. 14

Abstract

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Counterfeit medicines are an emerging problem in today's society as well as its possible impact on health, legal and today's economy. This issue has caused a significant change in the aim's view of the origin and development of counterfeit medicines and its relationship with the Spanish legal system in accordance with EU and international law. Efficacy, quality and safety of medicines depend on several elements present in traceability or in their life, such as research and development of an active ingredient or appropriate pharmaceutical agent, manufacturing, quality control, distribution, testing requirements, reliable information for health professionals, diagnosis, prescription, medicine dispensation, treatment compliance and pharmacovigilance. At each level, conflicts of interests among the groups involved arise, and in many occasions, the patient pays the consequences of these divergences. This is the case of counterfeit medicine, since it is a product deliberately and fraudulently mislabeled with respect to its identity or its source. Counterfeiting can be made in both branded and generic medicines, with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging. Counterfeiting practice is a major cause of morbidity and mortality in both developing and developed countries. In the present work we analyse this problem and how effective solutions have been developed to try solving such proliferation both at European and international level. http://dx.doi.org/10.14195/1647-6336_14_11

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