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More cost- and risk-sharing
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Market creation; • procurement guarantees via: high-volume bulk orders, extended contracts, product "bundling" subsidies for poorest countries; • revolving funds for national and/or regional purchasing; • ODA for health infrastructure and education, drug logistics;
Multi-tiered pricing; • careful articulation of rationales to re-start legislative dialogue
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Patent extension; • exploration of extension of patents for expired compounds with potential utility in new antimicrobials; • explicit inclusion of antibiotics under Patent Term Restoration Act;
Stabilization of funding; • examination of R&D implications of ODA decreases, annual volatility;
Financial support to universities and biotechnology companies for taking promising leads to proof-of-principle;
Venture fund for early-stage development of product leads
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Orphan drug legislation; • exploration of applications of OD law in developing products for emerging infections, especially niche products, with primary market outside U.S.A.;
Accelerated regulatory approval; • accelerated enrollment in trials; • aggregation of efficacy data from multiple sources; • continuing the progress in predictability and efficiency in regulatory oversight processes;
Building CRO capability in developing countries to reduce costs and enhance infrastructure for clinical trials;
Financial subsidy for phase II/III trials, with payback on success
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NOTE: ODA = Official Development Assistance; R&D = Research and Development; OD = Orphan Drug; and CRO = Contract Research Organization.
We want to acknowledge the importance to this table of the list, presented at the workshop by the representative from the World Bank, of suggestions from a survey of pharmaceutical company executives on how to promote health product development for low-income countries. The tabular material presented here is a broader synthesis that draws on the whole range of workshop presentations, including discussions of public-sector needs and priorities; industry perspectives on needs; lessons learned from the Children's Vaccine Initiative and other models; and legal and regulatory issues involved in development of drugs and vaccines for emerging infections. That there is so much concordance about which areas merit attention, as well as the kind of attention they require, is impressive.
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