Imperial College London
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ProfessorMarisaMiraldo

Business School

Professor in Health Economics and Policy
 
 
 
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Contact

 

m.miraldo Website CV

 
 
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Location

 

418Business School BuildingSouth Kensington Campus

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Summary

 

Publications

Citation

BibTex format

@article{Aerts:2022:10.1007/s40290-022-00427-x,
author = {Aerts, C and Barrenho, E and Miraldo, M and Sicuri, E},
doi = {10.1007/s40290-022-00427-x},
journal = {Pharmaceutical Medicine},
title = {The impact of the priority review voucher on research and development for tropical diseases},
url = {http://dx.doi.org/10.1007/s40290-022-00427-x},
volume = {36},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundIn 2007, the priority review voucher (PRV) was implemented in the US to incentivize research and development (R&D) for tropical diseases. The PRV is issued by the US FDA and grants a quicker review to manufacturers upon successful development of a product for a disease eligible for the program.ObjectiveThe objective of this analysis was to assess whether the PRV has incentivized R&D (measured as clinical trial activity) for the intended tropical diseases.MethodWe used a difference-in-difference-in-differences (DDD) strategy by exploiting variation in its implementation across diseases and registries around the world. Clinical trials were retrieved from the World Health Organization International Clinical Trials Registry Platform for the years 2005–2019.ResultsWe found a positive, but not statistically significant, effect of the PRV on stimulating R&D activity. Delayed effects of the policy could not be found.ConclusionOur findings, which were robust across a series of robustness tests, suggest that the PRV program is not associated with a trigger in innovation for neglected diseases and therefore should not be considered as a stand-alone solution. It should be supplemented with other government measures to incentivize R&D activity. To increase the value of the program, we recommend that the PRV only be awarded to novel products and not to products that have already been licensed outside the US. Doing so would restrict the number of vouchers awarded and slow down their ongoing market depreciation. Finally, we propose that product sponsors be required to submit an access plan for PRV-awarded products.
AU  - Aerts,C
AU  - Barrenho,E
AU  - Miraldo,M
AU  - Sicuri,E
DO  - 10.1007/s40290-022-00427-x
PY  - 2022///
SN  - 1178-2595
TI  - The impact of the priority review voucher on research and development for tropical diseases
T2  - Pharmaceutical Medicine
UR  - http://dx.doi.org/10.1007/s40290-022-00427-x
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000798044900001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - https://link.springer.com/article/10.1007/s40290-022-00427-x
UR  - http://hdl.handle.net/10044/1/97923
VL  - 36
ER  -
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