Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Rare diseases and market access to orphan drugs - analysis of the related legislation in the region of LATAM from a comparative perspective with Europe and USA

Isabel Valentin Verdeguer (Abschlußjahr: 2022)

Summary
Language: English
Emerging countries, like those belonging to the region of LATAM, are suffering from an unfavorable position regarding access to orphan drugs and, therefore, in the conditions for improving the life quality of rare diseases’ population.
This bibliographical review analyzes economic, political and healthcare factors together with the implication of the different regulatory bodies and other national and international authorities, as well as pharmaceutical companies and patients themselves, in order to compare the conditions in Latin-American countries with those in more developed regions like the European Union or USA, in the framework of rare diseases and orphan drugs.
The conclusion will reflect on the challenges that the region of LATAM is facing, how the progress in rare disease’s knowledge is contributing to the development of orphan drugs' market, the importance of the international collaboration and the impact of COVID-19 pandemic in the mentioned topics.
Pages: 66
Annexes: 1 Pages: 2