In case you missed it early last month (I almost did), a new organization for funding R and D for global health was launched, clearly a need, but based on available information, I question its impact. According to its website (complete with requisite picture of smiling kids), the Global Health Innovative Technology Fund (GHIT) will fund projects that are collaborations between a Japanese organization (could be not-for or for-profit including the multi-national pharma companies [MNCs] that have a facility in Japan) and another non-Japanese organization and aimed at developing a treatment, diagnostic, or vaccine for an infectious disease (named are the Big Three of TB, malaria, and HIV/AIDS and the official neglected diseases). The initial funding comes from the government of Japan, five Japanese pharmaceutical companies (Astellas, Daiichi Sankyo, Eisai, Shionogi, and Takeda), and the Bill & Melinda Gates Foundation, and, although the total amount committed is not given at the website, according to a recent Financial Times article, it is $100 million. As described on the application page, the projects may be at any stage of development (preclinical, clinical or submission for WHO pre-qualification [which I think is relevant to vaccines only]) and awards will be based on scientific and technical merit, potential impact on a global health need, and organizational and managerial capability. No maximum or minimum is stated for a project’s budget, but funding seems to be only for one or two years, clearly not long enough to result in a product that will have any measurable impact on health. According to the Financial Times article, the funding for each project may be $50K to “several million dollars.”
Some of the bumps I noted are that the award criteria (collaborations with managerial capability) are slanted against small, possibly more inventive, organizations and the short timeline for submitting an application (about six weeks after the announcement) seems to favor those groups that knew about GHIT in advance. Also, I have my typical criticism that GHIT seems to have an overly large administration (a governing council, board of directors, selection committee, advisory panel, and management team, about 30 people in all) that is generally lacking in product development experience (a handful are from the pharma industry, most representing the sponsors) and in developing world living and working experience. The organization also does not seem to have an interest in or concern for the commercialization or ultimate use of products that may result from the projects, although it has a “Data and Product Access Policy” with the intent “to optimize the translation of findings in the global advancement of new healthcare technologies” (GHIT RFP). But the subsequent details of the Policy, describing how products will be licensed (at no cost) and priced (at no profit) in low, low-middle, upper-middle income countries, as defined by the World Bank, seem unrealistic, unworkable, and unenforceable.
Although I could not figure out GHIT’s origin (my search yielded almost exclusively references to the original press release by the Medicines for Malaria Venture [MMV PR]), the key person seems to be the its executive director and CEO, BT Slingsby, MD, PhD, MPH, who, according to his GHIT bio, “was involved in the founding of for-profit and non-profit entities in the US and Japan and since 2010 was responsible for global access strategies for Eisai Co. & Ltd.” (Slingsby bio). Apparently, BT and I are on the same page regarding the need for the MNCs to figure out how to develop and deliver affordable but profitable products to the rest of the world. In an interview in January 2012, he said “New business models [for the industry] have to be integrated, they have to be innovative, they have to look at volume instead of profit margin, they have to address the unique needs of the healthcare system as a whole, and they have to look at how patients in each country access healthcare and medicines.” He also said that joint projects between pharma companies and the product development programs (the grant-funded, non-profit PDPs) were important: “To partner with PDPs and contribute to the research and development of new medicines and vaccines for the developing world is a vital investment for any global pharmaceutical company” and “Many global pharma companies including our company, Eisai, recognize that commitments to advance the development of new healthcare technologies vis-a-vis PDPs are not only a responsibility but a returnable long-term investment” (National Bureau of Asian Research interview). My read is that BT came up with the idea of a PDP-funding program at Eisai and was able to sell to the other Japanese pharmas and the Gates.
If the GHIT scheme sounds familiar, it may be. As I noted in a 2009 post (“A Friend for FRIND”), Dr. Paul L. Herrling, Head of Corporate Research at Novartis and Chairman of the Board of the Novartis Institute for Tropical Diseases, proposed a plan to fund and manage the development of treatments for neglected diseases in 2008. His plan, the Fund for R&D in Neglected Diseases (FRIND), was published in Global Forum Update on Research for Health (Global Health Update) and was intended to provide funding and management of the preclinical development and clinical testing of treatments in the pipeline of academic institutions, product development partnerships (PDPs), and companies. He promoted FRIND widely and at WHO where it was shot down due to the general animosity of some representatives of governments of low- and mid-income countries toward pharma companies. I still think the FRIND scheme is sound because the funders also have responsibility for managing the product development and therefore are efficiency- and results-driven unlike the GHIT where the only obligation of a developer to the funders is an annual report. GHIT is likely attractive to the Japanese pharmas since they are relatively smaller and less involved in global health/access to medicine programs than other MNCs (see Access to Medicines Index).
It will be interesting to see when the grants are awarded if this new money will accelerate real product development or be diluted away in multiple small grants for the already under-funded and –managed pipelines of the PDPs.