Legal aspects in detecting counterfeit medicines

Abstract

Background: With the rapid development of the pharmaceutical industry cases of counterfeit medicines are more and more frequent. This is a real crime that influences Public Health, counterfeit medicines being harmful and even fatal. Material and methods: For this study we carried out an objective analysis of the world legislative framework, with predilection for the European and national one. As landmarks served: setting the research objectives, data collection, data analysis, formulation of results and conclusions. Results: The number of counterfeiting incidents during 2011 – 2015 constituted: 2011 – 1986 crimes, 2012 – 2018 crimes, 2013 – 2193 crimes, 2014 – 2177 crimes, 2015 – 3002 crimes. So far numerous directives have been approved, laws have been adopted and measures have been taken to stop the counterfeiting of medicines (Directive 2011/62/EU of 8 September 2011, the Convention MEDICRIME, Resolution 65.19 of the World Health Assembly, Rapid Alert System, global and regional operations of Interpol). Conclusions: Counterfeiting of pharmaceuticals is a global problem that involves: institutions, law enforcement, customs, doctors, pharmacists, patients and citizens. The competent national authorities in collaboration with the associations of doctors, pharmacists and patients must lead risk awareness campaigns regarding purchasing of pharmaceutical products from illegal sources. Patients should be informed of the risks they assume by purchasing drugs from different websites. The population should know that websites that sell drugs must have links directing to the competent national authority or the website of European Medicines Agency or Medicines and Medical Devices Agency from the Republic of Moldova.