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FALSIFIED MEDICINES – A PROBLEM OF REGULATING THE PHARMACEUTICAL LEGISLATION BY STANDARDIZING THE EUROPEAN LAW
Abstract
At the level of the European Union there are legislative initiatives designed to create a business environment favourable to research and innovation which promotes the competitiveness of the pharmaceutical sector. When examining the compatibility with EU law of the conditions for the retail supply of medicinal products, the Court of Justice of the European Union stated that the health and life of humans rank first among the values and interests protected by the TFEU and that Member States are responsible for deciding the level of public health protection they wish to provide and the means to be implemented to achieve this level. In this context, this article examines the evolution of the legislative process regulating the internal market for medicines to ensure a high level of protection of public health against falsified medicines. Because counterfeit medicines represent a global problem, the article aims to analyse the legislative initiatives which have been taken at EU level, taking account of the new risk profiles aimed to ensure, on the one hand, the functioning of the internal market for medicines and, on the other hand, the right of consumers to have access to safe, effective, high quality and innovative medicines. The fight against the entrance of falsified medicines in the legal supply chain without hampering the functioning of the internal market of medicines is a goal that cannot be sufficiently achieved by the Member States, but can be better achieved by the European Union, which is strongly committed to achieving a high level of protection, competitiveness and innovation in the public health field.
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