Orphan Drugs, Compounded Medication and Pharmaceutical Commons

Autor: Marc Dooms, Kim Hendrickx
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Frontiers in Pharmacology, Vol 12 (2021)
Frontiers in Pharmacology
ISSN: 1663-9812
DOI: 10.3389/fphar.2021.738458/full
Popis: Regulatory agencies installed orphan drug regulations to stimulate research and development of new innovative treatments for life-threatening diseases with a low prevalence (rare diseases). We established a list of well-known food-related ingredients with clinical evidence for rare diseases in the open medical literature that obtained marketing authorization as an expensive "orphan drug", protected by intellectual property (IP) rights. We show that these ingredients are part of an established practice of medicinal compounding-a form of point of care manufacturing. We argue that these ingredients should be considered as "pharmaceutical commons", and that regulatory incentives for private companies and market protection mechanisms such as IP rights are not justified in this case. ispartof: FRONTIERS IN PHARMACOLOGY vol:12 ispartof: location:Switzerland status: published
Databáze: OpenAIRE