Introduction of European priority review vouchers to encourage development of new medicines for neglected diseases

@article{Ridley2010IntroductionOE,
  title={Introduction of European priority review vouchers to encourage development of new medicines for neglected diseases},
  author={David B. Ridley and Alfonso Calles S{\'a}nchez},
  journal={The Lancet},
  year={2010},
  volume={376},
  pages={922-927}
}
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26 Citations
Highly Influential Citations
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Background Citations
8
Methods Citations
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26 Citations

Advancing Pharmaceutical R&D on Neglected Diseases: Valuing Push and Pull Economic Incentive Mechanisms
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The context for the problem of insufficient affordable medicines to address health issues in developing countries is set out and “push” mechanisms that subsidize research inputs, and ‘pull’ mechanisms that reward research output are described.
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This paper presents policy makers and other relevant stakeholders with a short list of feasible and realistic solutions for Europe to stimulate R&D by attempting to determine the size of the various incentives needed to make the net present value (NPV) for antibiotic development more competitive relative to other therapeutic classes.
Can a regulatory instrument promote research and development into neglected diseases? A Policy Delphi Survey
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This research project gathered stakeholders’ opinions on the desirability and the feasibility of implementing a regulatory instrument to promote R&D into drugs for neglected diseases and explored the acceptance and the viability of the method of the Policy Delphi.
Incentives for New Drugs to Tackle Anti-Microbial Resistance
TLDR
Both Transferable Intellectual Property Rights and the Market Entry Reward should be further explored for use in the EU as a regional "pull" incentive.
The Commercial Market For Priority Review Vouchers.
TLDR
Congress should be cautious about expanding the priority review voucher program, because increasing the number of vouchers sharply decreases the expected price and lower voucher prices could undermine the incentive to develop new medicines for neglected diseases.
Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases.
TLDR
Compared to drugs for rare adult diseases, drugs forRare pediatric diseases progressed more quickly through all phases of clinical testing and were more likely to be first-in-class.
Incentives for R&D for New Antimicrobial Drugs
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It is concluded that higher prices linked to targeted use with diagnostic tests and/or an AMC-based “prize” for registering (but not necessarily using) desired new drugs would be effective, and could be linked to push measures.
New Vaccines for the World's Poorest People.
TLDR
Global efforts to accelerate the development of NTD vaccines are emphasized and some of the hurdles to ensuring their availability to the world's poorest people are emphasized.
Evaluating and improving orphan drug regulations in Europe: a Delphi policy study.
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References

SHOWING 1-10 OF 30 REFERENCES
In Defence of Priority Review Vouchers
TLDR
It is argued that with a few amendments in place, the priority review voucher scheme constitutes an attractive way of stimulating R&D of drugs for neglected diseases.
Priority Review Vouchers to Encourage Innovation for Neglected Diseases
TLDR
This Seminar Briefing recounts a presentation by one of the originators of the PRV and includes his thoughts on - the potential impact of this incentive on the development of new drugs for neglected disease and how it interacts with other incentives.
FDA review vouchers.
TLDR
The current priority-review voucher program can provide new incentives for drug development at relatively low government cost, speed the review of another product that the market values, and even speed approval of the generic version of that product.
Developing drugs for developing countries.
TLDR
This work proposes that developers of treatments for neglected diseases receive a "priority review voucher" that could save an average of one year of U.S. Food and Drug Administration review and be sold by the developer to the manufacturer of a blockbuster drug.
Drug development for neglected diseases: a deficient market and a public-health policy failure
Drug development for neglected diseases - the trouble with FDA review vouchers.
A new federal program will give the sponsor of a drug for a tropical disease a “voucher” entitling the company to expedited FDA review of a new drug application for any other product it makes. Dr.…
Advance price or purchase commitments to create markets for treatments for diseases of poverty: lessons from three policies.
TLDR
This paper looks at design issues for APPCs for drugs and vaccines for diseases of poverty drawing on experience and lessons from three case studies: the introduction of the meningitis C vaccine in the United Kingdom; the Orphan Drug Act (ODA), and the newly legislated US Project BioShield for bioterrorist interventions.
Advance market commitments for vaccines against neglected diseases: estimating costs and effectiveness.
TLDR
A commitment comparable in value to sales earned by the average of a sample of recently launched commercial products (adjusted for lower marketing costs) would be a highly cost-effective way to address HIV/AIDS, malaria, and tuberculosis.
Prescribing cultures and pharmaceutical policy in the Asia-Pacific
TLDR
Prescribing Cultures examines how pharmaceuticals and their regulation play an important and often contentious role in the health systems of the Asia-Pacific, and addresses pharmaceutical policy in China, Korea, Japan, Thailand, Taiwan, Australia, and India.
Fast Track Options (FTO) as a fundraising mechanism to support R&D into Neglected Diseases
TLDR
Most current policy proposals are aimed at mobilising substantial public finances to commercialise the neglected disease market, thereby allowing it to compete in company R&D priorities with traditional Western markets.
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