The Problem of Accessibility of Orphan Medicinal Products in the Light of the Right to Health Care
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Abstract
Currently in the European Union (EU) approximately 30 million people suffer from rare diseases. A European policy on rare disorders was put into action with the Regulation (EC) 141/2000 adopted on December 16, 1999, setting out a Community procedure for the designation of medicinal products and providing incentives for research, development and marketing of orphan medicinal products in the EU. The legislation on orphan medicinal products is a part of a broader Community policy to identify rare diseases as a priority area for action in the field of public health, which constitutes the area of common competence of EU and Member States.
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