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- Title
The unintended effect of the Orphan Drug Act on the adoption of open innovation.
- Authors
Galati, Francesco; Bigliardi, Barbara
- Abstract
The Orphan Drug Act (ODA) was an historic attempt to stimulate the development of drugs for rare diseases, intended to help bring to the market drugs for diseases that the pharmaceutical industry might otherwise not have had the financial incentives to pursue. While the intended effects of this regulatory stimulus on innovation are widely analyzed, the unintended ones remain unexplored. Thus, the objective of this paper is to analyze and conceptualize the impact of a relevant regulatory stimulus, such as the ODA, on the adoption of the open innovation paradigm in the pharmaceutical industry. Results show that the ODA made the adoption of this paradigm by large pharmaceutical companies possible, even if it partially inhibited its implementation. Finally, this study develops a framework characterizing the orphan drug development process in terms of drivers, activities, and actors. Future avenues for research are also suggested.
- Subjects
UNITED States; ORPHAN drug laws; OPEN innovation; INDUSTRIES; PHARMACEUTICAL industry; DRUG development; TREATMENT of rare diseases
- Publication
Science & Public Policy (SPP), 2016, Vol 43, Issue 6, p840
- ISSN
0302-3427
- Publication type
Article
- DOI
10.1093/scipol/scw001