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Master Thesis

Dans quelle mesure les cadres nord-américain et européen ayant permis de stimuler la recherche et le développement pour les maladies rares sont-ils applicables aux maladies négligées ? Intérêt et limite de la perspective comparée entre maladies rares et maladies négligées

Abstract : In order to improve the health condition of patients in developing countries, some initiatives have emerged over the past thirty years to promote research and development (R&D) against neglected tropical diseases. However, the results still remain inadequate. The main reason being the lack of investment by traditional drug players. It is therefore essential to find sufficient incentives to promote R&D against neglected diseases. Considering the crucial roles of the Orphan Drug Act in the United States, and of the European regulations related to the development of drugs against rare diseases, it was relevant to question whether these North American and European frameworks were transposable to neglected diseases. This thesis shows us that the application of these legal and regulatory frameworks is limited: the paradigms are different and the model of rare diseases cannot be directly replicated to neglected diseases. The successes in the field of rare diseases can nevertheless be an inspiration for the management of neglected diseases, through some targeted adaptations which can be complemented by other measures, specific to developing countries. The proposed work streams include rethinking commercial exclusivity and intellectual property, allowing appropriate financial and tax incentives, establishing a dedicated regulatory framework which could facilitate and accelerate the marketing of these drugs in endemic countries, promoting technology / knowledge transfers as well as public-private partnerships.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03229577
Contributor : Jean-Hugues Morneau <>
Submitted on : Wednesday, May 19, 2021 - 9:27:05 AM
Last modification on : Friday, May 21, 2021 - 3:23:16 AM

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  • HAL Id : dumas-03229577, version 1

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Armelle Boillot. Dans quelle mesure les cadres nord-américain et européen ayant permis de stimuler la recherche et le développement pour les maladies rares sont-ils applicables aux maladies négligées ? Intérêt et limite de la perspective comparée entre maladies rares et maladies négligées. Sciences pharmaceutiques. 2021. ⟨dumas-03229577⟩

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