Center for Global Health R&D Policy Assessment

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Collaborative Drug Discovery The Collaborative Drug Discovery (CDD) is web based software tool that aims to accelerate the advancement of new drug candidates by facilitating the sharing of preclinical research data. The software allows private storage of scientific information, small group collaboration and a fully accessible shared drug discovery data set. As a private business, CDD is privately funded, collecting user fees associated from its private data services and collaboration tools. The service is provided with low-cost and free options to use the publicly accessible data options.
Cost Sharing for Clinical Trials Public support of clinical testing would enable the federal government and pharmaceutical companies to share the costs of clinical trials, thereby removing the direct link between the clinical trial sponsor and the drug tester. Clinical trials pose a significant cost to companies, and cost sharing could drive down the prices of final products. As a result, government funding of clinical trials could be offset by the reductions in government drug spending.
Discovery or Milestone Prizes Milestone Prizes are pull incentives that reward innovation for incremental achievements along the product development path. These prizes would likely be smaller in size than a final product prize and could be awarded for an R&D milestone that falls short of actually registering a product. The spectrum of potential milestone prizes is large—on one end Innocentive rewards developers with small sums whereas BVGH’s proposed incentive for a Chagas drug involves much larger reward payments.
Donor Funded, Capacity Building/Technology Transfer Projects for Vaccines These programs intend to build research capacity in developing countries while pursuing critical research for global health. For example, PATH has several programs that work with innovative developing country firms to accelerate vaccine development including the Pneumococcal Vaccine Project, the Rotavirus Vaccine Program and the Meningitis Vaccine Project. The International Vaccine Institute has similar projects on cholera and typhoid vaccines, and the Netherlands Vaccine Institute participates in technology transfer initiatives for Hib vaccine, seasonal flu and injectable polio vaccines.
EC Innovative Medicines Initiative (IMI) The Innovative Medicines Initiative (IMI) is a public-private partnership between the European Commission (EC) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) which includes Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Merck, Novartis and Pfizer. The IMI’s main objectives are to improve the efficiency of the drug development process with the long-term goal of producing safer and more efficient drugs and also to improve education and knowledge management in R&D.
EMEA Article 58 Article 58 of the European Medicines Agency (EMEA) allows the EMEA to express a scientific opinion on the safety of vaccines and health products for use outside of the European market. This opinion can help guide National Regulatory Agencies (NRA) in developing countries on regulatory decisions for new global health technologies. In the past some developing countries have depended on the regulatory decisions from the health technology’s country of origin. Article 58 offers an alternative regulatory pathway.
Equitable Licensing The proposal puts forward the concept of "Equitable Licensing" an idea for how intellectual property rights should be structured for R&D for NTDs. The proponents urge that the results of publicly funded R&D should be available for non-exclusive licensing. The proposal relies on 3 IP principles: Non-exclusive use of publicly funded research results should be the default principle. Exclusive rights should become the exception, not the rule. No premature IP transfer from publicly funded institutions to private industry
Fast-track Option (FTO) The Pharmaceutical R&D Policy Project of the London School of Economics proposes a Fast Track Option which would allow companies to purchase the right to expedited regulatory review of a drug candidate of its choice. The companies would compete through an auction system, effectively maximizing the fee collected. This proposal builds from the existing Priority Review and Fast Track programs of the FDA and counts incorporates learned from the existing administrative procedures for accelerated review within the Agency.
Fast-Track Review Fast Track is a program of the FDA that expedites the approval process for a new health technology that fulfills an unmet medical need. The biologic must either provide a new disease therapy or perform significantly better than the existing treatments. This program is not targeted at global health needs specifically, but includes an expansive range of diseases from HIV/AIDS to Diabetes.
Fund for R&D in Neglected Diseases (FRIND) Championed by Novartis, the Fund for Research in Neglected Disease (FRIND) would apply the portfolio management techniques used by private pharmaceutical firms for their mainstream drug pipelines for research in neglected disease. The proponents of FRIND argue that many individual research projects, some of which may duplicate efforts, currently compete for an inadequate pool of donor funding. FRIND proposes that all available funding be pooled and then allocated by a board that represents developing countries, major funders, OECD countries and other international health stakeholders.

Discover Policy Innovations

Our Policy Innovations page allows you to browse the dozens of proposed policies to accelerate product development for global health. You can use the search field to look for specific policies or you can simply browse through the entire list. The Innovations are divided into Push and Pull proposals. In other words, do the innovations help pay or manage R&D costs up front or do they present a reward for the development of the final product? The list is also divided into 8 types of Innovations which correspond to what specific area of R&D the Innovation intends to improve.

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Global Health R&D Policy Assessment Center is a project of Results for Development, with funding from the Bill & Melinda Gates Foundation.

The Bill & Melinda Gates Foundation Results for Development Institute

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Our Policy Innovations page allows you to browse through the dozens of policy innovations that have been proposed to accelerate global health R&D. You can use the search panel on the right side of the screen to view innovations by type or you can simply browse through the full list. If you click on the "+" button you can expand the list of innovation types.