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Neglected Disease Tax Credit Genzyme proposes a bill for a Neglected Disease Research Tax Credit geared toward pharmaceutical companies. The bill proposes a 50% tax credit for non-clinical research expenditure related to neglected disease. To receive the credit companies must donate their Intellectual Property (IP) rights to a royalty free licensing pool, but would be free to use the IP for other commercial research initiatives within their organization. The proposal intends to reduce the financial burden of philanthropic research for pharmaceutical companies. |
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New Global Fund for R&D A Global Fund for R&D (comparable to the Global Fund to Fight AIDS, Tuberculosis and Malaria) could absorb contributions for global health research from governments, levies and voluntary contributions. The Fund could set research priorities and channel funding to critical areas. The Fund would likely include Type I, II and III diseases and stress capacity-building in developing countries. Having a unified international presence for global health R&D may garner more interest in R&D from the public and various governments. |
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New Innovation Fund The New Innovation Fund aims to benefit local R&D in the pharmaceutical sector and to improve market competitiveness. This fund would be a national level fund for R&D focusing on orphan and neglected diseases that would require all beneficiaries to license their technologies to generic manufacturers. The proponents pose two possibilities—the first offers innovators less project support and a two year monopoly period and the second offers a much higher level of financing but no period of market exclusivity. |
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Open Source Dividend for Prizes An open source dividend for the prizes, proposed by Bangladesh, Bolivia, Barbados and Suriname (BBBS) to the WHO Expert Working Group, rewards researchers and organizations for sharing knowledge and information relating to product development. In the BBBS proposal 10% of the total final product prize envelope for a TB diagnostic would be reserved for entities making useful information contributions to the end product, in this case a TB diagnostic. To qualify for the open source payment, entrants must make their work freely available. |
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Optimal Hedging to Smooth Public Health Expenditures The authors propose financial securities to redistribute the risk of developing countries investing in the development of new products for neglected diseases relative to investment in existing health technologies. Predicated on their own modeling work, the authors believe that increased funding for neglected disease R&D could decrease funding for already existing health technologies, and the proposed securities insure against the welfare loss in developing countries associated with those outcomes. |
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Orphan Drug Legislation Congress passed the Orphan Drug Act in 1983 to encourage R&D for rare diseases. Qualifying diseases either affect under 200,000 people in the country or have no promise of full cost recovery from treatment sales. The bill includes provisions for direct research grants, accelerated regulatory review, a 50% tax credit for human clinical testing, and 7 years of market exclusivity. Over a decade after the original bill was implemented, Congress approved an additional exemption that waives FDA user fees for companies submitting orphan drug applications. |
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Patent Buy-Outs Rather than waiting the full period of patent protection for pharmaceuticals to conclude, governments could potentially buy-out patents for useful global health technologies. The patents could then be available in the public domain, allowing researchers to pursue further innovation and improvements of the technology. Price setting could be handled through an auction mechanism. |
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Patent Fees ("Green IP") The Green IP Project proposes redirecting a part of patent related monetary flows to R&D while also offering “patent insurance.” The proposal suggests imposing an additional fee on patent applications, called an “insurance premium,” and using the funds collected to finance R&D for neglected disease. In return patent applicants would be protected against the risk of a compulsory license in addition to facing lesser registration fees and a fee waiver for extending their patents to new regions. |
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Pool for Open Innovation against Neglected Tropical Diseases The Pool for Open Innovation, which is administered by Bio Ventures for Global Health, began with GSK's efforts to create a “Patent Pool” of intellectual property for new medicines to treat neglected tropical diseases. Pharmaceutical and biotechnology companies, universities and non-governmental organizations are encouraged to donate small molecule compounds or process patents for neglected tropical diseases. Open access to this information may accelerate the development and production of new products and formulations for use in the developing world. |
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Priority Review Voucher (PRV) The FDA offers a priority review voucher that accelerates regulatory review for a product of the developer’s choice, to any entity registering a treatment or vaccine for a neglected disease. The voucher is transferrable and may be sold to a third party, giving the recipient flexibility on how to reap the voucher’s value. The voucher can reduce the review process by 4-12 months. To date the FDA has granted Novartis a priority review voucher for the registration of Coartem, an anti-malarial. |