The Global Health Innovative Technology (GHIT) Fund: financing medical innovations for neglected populations
Authors: BT Slingsby, Kiyoshi Kurokawa
Journal: The Lancet Global Health (2013)

The newly launched Global Health Innovative Technology (GHIT) Fund, which is multisectoral, interdisciplinary, and not for profit, aims to expedite the generation of novel medical technologies and drugs to diagnose, prevent, and treat high-prevalence infectious diseases worldwide. The GHIT Fund represents the first public–private partnership to involve a national government, a UN agency, a consortium of pharmaceutical companies, and an international philanthropic foundation (founding partners are the Japanese Ministry of Foreign Affairs; the Japanese Ministry of Health, Labour and Welfare; the UN Development Programme; Astellas Pharma; Daiichi Sankyo Company; Eisai Company; Shionogi & Company; Takeda; and the Bill & Melinda Gates Foundation). The initial targets are key poverty-exacerbating diseases prevalent in developing nations—namely, HIV/AIDS, malaria, tuberculosis, and 17 disorders designated as neglected tropical diseases by WHO (panel). These disorders still thrive in poor, marginalised communities, causing severe pain, disability, and death for more than 1 billion people. Investments to control them can substantially reduce poverty,1Hotez PJ Fenwick A Savioli L Molyneux DH Rescuing the bottom billion through control of neglected tropical diseases.Lancet. 2009; 373: 1570-1575Summary Full Text Full Text PDF PubMed Scopus (637) Google Scholar but overall funding for neglected tropical diseases has remained static since 2009.2Moran M Guzman J Henderson K et al.Global Funding of Innovation for Neglected Diseases (G-Finder). Neglected disease research and development: a five year review. Policy Cures.http://www.policycures.org/downloads/GF2012_Report.pdfDate: 2012Google ScholarPanelInitial target diseases •HIV/AIDS•Malaria•Tuberculosis•Buruli ulcer•Chagas disease (American trypanosomiasis)•Dengue•Dracunculiasis (guinea worm)•Echinococcosis•Foodborne trematodiasis•Human African trypanosomiasis (sleeping sickness)•Leishmaniasis•Leprosy•Lymphatic filariasis (elephantiasis)•Onchocerciasis (river blindness)•Rabies•Schistosomiasis (bilharziasis)•Soil-transmitted helminthiases (ascariasis [roundworm], trichuriasis [hookworm], and ancylostomiasis [whipworm])•Trachoma•Taeniasis and cysticercosis•Endemic treponematoses (yaws, endemic syphilis, pinta) •HIV/AIDS•Malaria•Tuberculosis•Buruli ulcer•Chagas disease (American trypanosomiasis)•Dengue•Dracunculiasis (guinea worm)•Echinococcosis•Foodborne trematodiasis•Human African trypanosomiasis (sleeping sickness)•Leishmaniasis•Leprosy•Lymphatic filariasis (elephantiasis)•Onchocerciasis (river blindness)•Rabies•Schistosomiasis (bilharziasis)•Soil-transmitted helminthiases (ascariasis [roundworm], trichuriasis [hookworm], and ancylostomiasis [whipworm])•Trachoma•Taeniasis and cysticercosis•Endemic treponematoses (yaws, endemic syphilis, pinta) The Tokyo-based Fund is a result of recent changes in Japan's research and development system, placement of global health as a central component of foreign policy, and the country's proactive pharmaceutical sector, together with a shift in focus of international efforts since the mid-1990s to combat neglected tropical diseases. With a broad-based participatory approach, Japan aims to maintain its role at the forefront of global public health initiatives, and to prioritise the health aid sector.3Japanese Organization for International Cooperation in Family Planning (JOICFP)Health and Development Service (HANDS)A study on Japan's global health aid policy: toward the formulation of a new policy. Final report.www.mofa.go.jp/policy/oda/sector/health/pdfs/study.pdfDate: March, 2010Google Scholar, 4Sugiyama H Yamaguchi A Murakami H Japan's global health policy: developing a comprehensive approach in a period of economic stress. A report of the Global Health Policy Center and the HGPI Global Health Policy Center. Center for Strategic and International Studies, Washington, DC2013http://csis.org/files/publication/130506_Sugiyama_JapanGlobalHealth_web.pdfGoogle Scholar The GHIT Fund will draw on Japan's advanced technology and innovation sectors to accelerate the creation of new biomedical systems, methods, and products that are appropriate, effective, affordable, and easy-to-use. Where possible, capacity building and technology-transfer components will be integrated into these efforts. The Fund's main goal will be the generation of novel drugs, vaccines (both preventive and therapeutic), and diagnostic technologies. The Fund will enable international partnerships in research and development, involving existing or new Japanese and non-Japanese entities. Its work might include anything from discovery through to licensing. The first requests for proposals issued by the Fund included: preclinical drug development (eg, in-vitro and in-vivo studies, chemistry, and formulation); clinical development (eg, phase 1 to phase 3 clinical trials, and manufacturing); and licensing (eg, WHO prequalification). In addition to its grant-making mechanism, the Fund will invest in a new drug-discovery screening platform to assist the screening of compound libraries housed within Japanese companies and academic institutions. Japanese entities will provide compounds to partners, with the Fund reimbursing screening costs and leveraging screening programmes of existing product-development partners (eg, the Drugs for Neglected Diseases initiative, the Global Alliance for TB Drug Development, and the Medicines for Malaria Venture). In 2012, research-based pharmaceutical companies were engaged in 132 projects to develop new medicines and vaccines for global health, whereas almost all the important, innovative vaccines introduced in the past century originated in public-sector research institutions.5Stevens AJ Jensen JJ Wyller K Kilgore PC Chatterjee S Rohrbaugh ML The role of public-sector research in the discovery of drugs and vaccines.N Engl J Med. 2011; 364: 535-541Crossref PubMed Scopus (174) Google Scholar In view of this fact, the Fund's founding-partner pharmaceutical companies, along with national research institutions and universities, will allow improved access to some of the world's richest and most diverse chemical collections. With an initial committed capital of more than US$100 million, the Fund will follow an evidence-based operational system, allocating grants to encourage international research collaborations to share and exploit expertise, knowledge, technologies, and resources. An independent selection committee of experts will review and select grant proposals for approval by the board of directors. A transparent operational policy will ensure data quality, security, and open access, with a view to perfecting translation into optimum end products. Confidentiality will be respected, in addition to all intellectual and proprietary rights. The Fund will encourage the equitable sharing of information and knowledge, and assignation of rights or licences to third parties. End-products emerging from GHIT-supported endeavours will be regarded as public health goods, and their accessibility to individuals who need them most will be paramount, meaning that they will be priced on a no gain, no loss basis. Products mainly funded by the GHIT Fund will be subject to royalty-free licences in countries included on the World Bank's list of low-income countries, whereas countries on the Bank's lower-middle-income and upper-middle-income listings will benefit from licences designed to improve access for poor patients and populations. WHO recognised the serious lack of biomedical innovation and access to medical devices, particularly for developing countries, more than two decades ago. The need for concerted action to create a framework for research and development that coordinates and finances medical innovations for neglected populations was re-emphasised by the Commission on Intellectual Property Rights, Innovation and Public Health in 2006,6WHOPublic health, innovation and intellectual property rights: report of the Commission on Intellectual Property Rights, Innovation and Public Health.http://apps.who.int/medicinedocs/documents/s14146e/s14146e.pdfGoogle Scholar since when little has happened. The GHIT Fund is Japan's attempt to rectify that wholly unacceptable inaction. We declare that we have no conflicts of interest. We thank GHIT Fund staff and Andy Crump for their invaluable assistance in the preparation of this Comment.