Abstract
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
Highlights
In general terms, and except special cases, all of us yearn for being healthy, but we should talk about the social dimension, understood health as the absence of disease, but as synonym of well-being
There is a large consumption/demand for medicines in developed countries led by the "marketing of fear", producing a "breeding ground" that on many occasions causes counterfeit medicines in certain areas
Both the insecurity and the uncertainty in the post-industrial societies7 are senses or feelings of citizenship rather than a true reality since in today's society it has been spread an exaggerated sense of insecurity, which does not seem to correspondence with such risks, but it is enhanced by the vast media coverage of hazardous or harmful events, because of the difficulties encountered by the average citizen to understand the rapid scientific and technological change and the need to adjust their daily lives to the change8
Summary
Except special cases, all of us yearn for being healthy, but we should talk about the social dimension, understood health as the absence of disease, but as synonym of well-being. The possible adverse drug reactions are not known with certainty and, in any case, these will appear years after the action is performed, for example, the case of some medicines marketed in which, after years of pharmacovigilance, some adverse, unforeseen and unexpected reactions were detected at the time the drug obtained marketing authorization (taking into account the scientific status at that time by the Medicines Agency of the country concerned)6 Overall, both the insecurity and the uncertainty in the post-industrial societies are senses or feelings of citizenship rather than a true reality since in today's society it has been spread an exaggerated sense of insecurity, which does not seem to correspondence with such risks, but it is enhanced by the vast media coverage of hazardous or harmful events, because of the difficulties encountered by the average citizen to understand the rapid scientific and technological change and the need to adjust their daily lives to the change. In that situation of insecurity and ignorance, the patient access to medicines and they are sometimes altered
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