A biotech company CEO approached me at a conference recently with a potential solution for a rapid point-of-care diagnostic for tuberculosis. This is a disease with nearly 9 million new cases and over a million deaths annually, a disease that desperately needs a rapid diagnostic since patients with active TB, if left undiagnosed, can infect an average of 10-15 additional people each year.
The CEO said his company could develop a product that could predict active disease and wanted to know how he could get funding to enable his company to move meaningfully into product development. This is a common problem for companies interested in creating new tools for infectious diseases of low- and middle-income countries: They possess valuable experience and capacity and a promising starting point, but current market incentives — namely pricing — fail to justify investment in the R&D. They simply can’t expect a financial return for such products.
Yet we need the private sector. Put simply, life-science companies like biotech and pharma form the only entity that can effectively develop, produce and manufacture these products.
It’s not a question of demand. Around the world, 43 percent is at risk of contracting HIV and AIDS, tuberculosis, malaria or a neglected tropical disease, and one in seven people worldwide is already infected. These diseases kill millions of people each year, primarily in the low- and middle-income countries with weak health system infrastructure, but most of these people are too poor to pay for the tools that could save them. As a result, drug and vaccine development stalls out at the level of the tinkering scientists and well-meaning executives.
This presents a critical problem for the global health and development community: Even the best health infrastructure, the most innovative delivery models, and well-trained caregivers can only accomplish so much without the right drugs, vaccines and diagnostics to treat and prevent endemic diseases. When those health tools are outdated, carry worrisome side effects, have no pediatric formulations, or are experiencing increasing resistance — as is the case for most of these diseases, in the unique instances where such tools exist at all — the key question around global health R&D isn’t why, but rather how.
For Japan, a product development leader and long-time global health supporter, the “how” lies in innovative all-sectors-in financing and public-private partnerships — where the private sector truly has a seat at the table alongside government and civil society. The success of this approach serves as a crucial model for other countries with innovative life science sectors and policymakers committed to global health, global economic prosperity and human security.
In response to the lack of investment in products for infectious disease, Japan has created a pioneering model for global health R&D financing and governance. The first fund of its kind globally, the GHIT Fund is an international nonprofit funded jointly by the Japanese government, Japanese pharmaceutical companies, Bill & Melinda Gates Foundation, Wellcome Trust and United Nations Development Program. GHIT promotes the development of drugs, vaccines and diagnostics as part of the fight against infectious disease primarily prevalent in low- and middle-income countries.
The pharmaceutical companies that contribute to GHIT’s funding also work through international partnerships to discover and develop new products. To transcend any potential conflicts of interests, these same companies are precluded from investment decision-making: No company participates in the board of directors, selection committee, advisory panel and the management team. By separating its funding from organizational operations and decision-making, GHIT avoids conflicts of interest and can partner with both the government and private corporations as appropriate to advance product development.
GHIT is international in its governance and management. The board of directors is comprised of members from around the world. In addition to delegating the direction of investment opportunities to a separate selection committee, the board is responsible for establishing the organization’s bylaws and assessing its performance. The selection committee consists of professionals from both Japan and elsewhere who are specialists in product development for infectious diseases.
Partnership and funding are the tools, but they don't mean much without concrete measures of success. For us, success means effective, accessible products. It also means rigorously measuring progress along the way so that we can shift our investment if key milestones aren’t met.
In just two-and-a-half years since it was formed, GHIT has invested in the development of more than 40 new products, with allocations totaling more than $50 million. As of 2015, GHIT is advancing six clinical trials in Burkina Faso, Bolivia, Ivory Coast, Peru, Tanzania, Thailand and Uganda, and two more clinical trials will begin in 2016. The first product is scheduled to complete development in 2018.
GHIT not only invests in clinical development of products but also proactively leverages the capacities and capabilities of universities, research institutions and companies in Japan for the discovery and translational research of new products. Regardless of the stage of development, Japan, through the GHIT Fund, is transforming the portfolio for infectious disease products.
Governments, pharmaceutical companies, NGOs, and universities around the world have stepped up to contribute and engage substantively in global health R&D. But it’s not enough. More governments and life science companies need to invest — and, more specifically, partner. Now is the time for national governments and their domestic biotech and pharmaceutical companies to come together and determine what experience, capacity, and technology they can collectively bring to the global health table, without holding back. And then, of course, they need to deliver it.