Legal instruments supporting the development of orphan medicinal products in the European Union.
Securing the freedoms of the Internal Market by the European Union entails an obligation to implement such mechanisms so that medicinal products placed on the market could be, on the one hand, widely available to the citizens of Member States and, on the other, so that medicinal products could be both safe and effective. The first aspect involves acting towards the improvement of public health and the prevention of human diseases and troubles, while the second--removing the sources of danger to human health. From this perspective, we need to highlight the problem of a deficit in the development, and thus a deficit in the availability of medicinal products authorized for marketing, which are intended for use in rare diseases. This paper aims to analyze the European Union pharmaceutical law in order to establish whether, and if yes--how the EU legal regulations support the development and availability of orphan medicinal products on the Internal Market.
Katarzyna
K
Miaskowska-Daszkiewicz
D055808:Drug Discovery; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence*