Orphan Drugs: Incentive Measures, Acquisition Procedures and Problematic Hypotheses Maria Carmen Agnello

Maria Carmen Agnello

Department of Biological, Chemical, and Pharmaceutical Sciences and Technologies, University of Palermo, Italy

Dr. Maria Carmen Agnello, Department of Biological, Chemical, and Pharmaceutical Sciences and Technologies, University of Palermo, Italy.

Keywords: Orphan Drugs; Regulation; Safety; Sustainability; Budget Law

Abstract

The article analyses the set of measures put in place at different levels of regulation and programming to ensure a fair distribution of orphan drugs compared to the increasing diversification of rare diseases. These measures are preventive in supporting research and production in abandoned pharmaceutical sectors, as they are not profitable. At the same time, safety measures had to be taken not only to monitor but also to assess the costs and benefits. A specific focus is dedicated to the different distribution of the pay back provided by the last Finance Act of 2019 in order to encourage research and production in this sector.

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).