By Gavin Yamey, Alexander Gunn
Sustainable Development Goal (SDG) 3—ensuring healthy lives and promoting wellbeing for all—is accompanied by a very ambitious set of targets. These include ending avertable child deaths and ending the epidemics of AIDS, tuberculosis (TB), malaria, and neglected tropical diseases by 2030. Are these achievable or can they be dismissed as just a “fairytale”?
ARE THE TARGETS ACHIEVABLE?
Researchers have tried to answer this question using two complementary approaches. The first is to look at recent trends in death rates and then extrapolate these trends forward to 2030. The second is to model what would happen if today’s health interventions—such as medicines, vaccines, insecticidal bed nets, and diagnostics—were scaled up to very high coverage levels everywhere. In both cases, the results have been disturbing.
In an example of the first approach, McArthur, Rasmussen, and Yamey examined trends in child and maternal mortality over the most recent 10 years for which data were available and then extrapolated the 10-year trend to 2030. They found that 42 countries are not on track to reach both the child and maternal mortality targets in SDG3, and a further 37 countries will miss at least one of these. The Commission on Investing in Health (CIH), chaired by Larry Summers, used the second approach and found that the world would fall short of many SDG3 targets even if today’s health tools were scaled up to around 90-95 percent coverage worldwide.
WE NEED TOMORROW’S TOOLS
The implication of these studies is clear. For many of the SDG3 targets, today’s tools are not enough—we will need tomorrow’s tools as well. While investing in the development and delivery of new health technologies is not the only way to accelerate progress, it may be the most effective. From 1970 to 2000, around 80 percent of the decline in child death rates was linked to the spread of new health tools. Countries that aggressively adopt and disseminate new health technologies gain an additional 2 percent per year decline in their child mortality rate over countries that do not.
Further, investing in health R&D has wider benefits for economic development. A new method of economic evaluation called extended cost-effectiveness analysis shows that many technologies that address poverty-related and neglected diseases (PRNDs) not only improve health but also provide protection against impoverishment and are pro-poor.
WHAT’S IN THE R&D PIPELINE?
So what kind of progress is being made in developing the “game-changing” health technologies that will bend the mortality curve and help countries reach the SDG3 targets? To address this question, we recently conducted a multi-center study, as discussed in the New York Times. We were part of a large research team—15 researchers in total—based at Duke University, Policy Cures Research, the Special Programme for Research and Training in Tropical Diseases, SEEK Development, and the Foundation for Innovative New Diagnostics.
There were three key steps in our study. First, we did a painstaking review of the current R&D pipeline, looking for product candidates that are under development for a set of 35 PRNDs. This review was tough sledding. There are many obstacles to finding out what is in the pipeline; for example, there is no single, centralized database of candidates and pharmaceutical companies often hide what they are developing out of proprietary interests. Second, we used a new financial modeling tool called the Portfolio to Impact (P2I) tool to estimate the costs to move these candidates through the pipeline over the next decade and the likely product launches. This second step showed that the current pipeline is unlikely to yield several important products by 2030—therefore in the final step, we estimated the costs to develop a set of priority “missing” products (e.g., a highly effective HIV vaccine).
Our study has both good news and bad news. Depending on how you view it, the pipeline is both half-full and half-empty. We are likely to see plenty of launches of new products to tackle PRNDs—but some of the most critically needed products are unlikely to see the light of the day by 2030.
We found 685 product candidates for PRNDs, of which 538 candidates met inclusion criteria for input into the P2I modeling tool. Based on standard attrition rates for candidates as they move along the development pipeline, our model suggests that there will be around 128 product launches (Figure 1).
Figure 1. Breakdown of the 128 anticipated product launches, by disease target and product type
Abbreviations: PRNDs: poverty-related and neglected diseases; HAT: human African trypanosomiasis (sleeping sickness); NCEs: new chemical entities
In the CIH report, Summers and colleagues proposed a list of “important” or “game changing” diagnostics, drugs, and vaccines that could bend the mortality curve. Based on what is currently in the pipeline, our study suggests that 18 of these needed products are unlikely to be launched by 2030, including highly effective HIV, TB, or malaria vaccines, and breakthrough medicines for TB.
THE R&D FUNDING GAP
In our modeling, the total estimated costs to move current candidates through the pipeline and to develop these 18 missing products would be around $4.5-5.8 billion per year over the next five years. Given that we are currently spending about $3 billion per year on product development for PRNDs, the annual financing gap is at least $1.5-2.8 billion. This is an underestimate of total resource needs, as the P2I model does not include all R&D costs—for example, it excludes the costs of early preclinical development (drug discovery and basic research) and of regulatory review and marketing authorization.
This brings us to another alarming trend. Every year, Policy Cures Research publishes an estimate of total spending on product development for PRNDs. Its annual surveys have shown that since 2009, there has been a steady decrease in annual funding, with the exception of a short-term injection of funding for Ebola R&D in the wake of the 2014-2016 West African outbreak.
RHETORIC AND REALITY DO NOT MATCH
So let us review. The rhetoric in SDG3 is utopian, calling for the “end” of multiple diseases and conditions within the next 12 years. However, in reality, much of the world is off track to achieve many of these SDG3 targets. One of the most effective ways to get countries back on track is through the development and deployment of new tools to control PRNDs. Yet along with a continued decline in funding to develop these new tools, our analysis also shows that the current pipeline is unlikely to produce many of the most critically needed technologies.
There’s a profound mismatch happening here. Our global health targets have become more ambitious, yet the global health community is going backward in supporting the innovations need to achieve them. Or as Mary Moran has put it: “In a somewhat Kafkaesque disconnect, these statements by the global health community of their support for—and belief in—the need for R&D of new global health tools are not reflected by their actions in the real world.”
The mismatch not only threatens the achievement of SDG3. It also represents one of the greatest missed opportunities to invest in the health, wellbeing, and economic livelihood of the world’s poor.