Orphan Drugs: Why the US legislation approves more than the EU?

Cyril Benoît () and Philippe Gorry
Additional contact information
Cyril Benoît: CED - Centre Émile Durkheim - IEP Bordeaux - Sciences Po Bordeaux - Institut d'études politiques de Bordeaux - UB - Université de Bordeaux - CNRS - Centre National de la Recherche Scientifique

Post-Print from HAL

Abstract: Since the early 2000's, the European Union (EU) is implementing a policy agenda in favour of rare diseases (RD). A key milestone legislation was the adoption of the Orphan regulation in 1999, in order to encourage the development of "orphan drugs" (OD, i.e. drugs to treat RD and which qualifies as viable from a scientifically aspect but that would not be economically viable in the absence of policy intervention). Mainly operating through the European Medicines Agency (EMA) regulatory framework, this project is aiming at fostering RD drug research and development while ensuring fair access for the patients. In this respect, several incentives are provided to the manufacturer who successfully applied for an orphan drug status, such as a ten-year marketing exclusivity and tax reductions. However, the number of orphan drug designations (as well as orphan drug market approvals) application approvals in Europe is still significantly lower than in it is the US. The goal of this paper is to explain this discrepancy, by providing empirical, quantitative materials on the basis of an analysis of all of the decisions delivered by the EMA for this category of products. More precisely, the validity of three explanations will be further explored and discussed: 1 – Effects of bureaucratic politics at the EMA (avoiding "salami-slicing" behaviours); 2 – Smaller engagement from academics and biotechnology companies (and rent-seekers Big Pharmas); 3 – The consequences of the structure of tax-credits (US vs. EU).

Date: 2017-02-16
References: Add references at CitEc
Citations:

Published in International Health Policy Conference, London School of Economics, Feb 2017, Londres, United Kingdom

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-02195836

Access Statistics for this paper

More papers in Post-Print from HAL
Bibliographic data for series maintained by CCSD ().