The World Health Assembly, the annual gathering of health ministers in Geneva, Switzerland, served as a backdrop on Monday for the launch of a new idea to stimulate research and development on diseases that affect mostly poor countries. The so-called PDP+ Fund, proposed by the International Aids Vaccine Initiative (IAVI); the George Institute for International Health in Sydney, Australia; and pharma giant Novartis, would collect money from governments, Western consumers, and other sources and distribute it among so-called Product Development Partnerships (PDPs). Such partnerships—including IAVI, the Medicines for Malaria Venture, and the Aeras Global TB Vaccine Foundation—have proliferated in recent years; they combine the efforts of scientists, donors, and companies to develop products that would not otherwise make it to the market.
Why a new fund in the already crowded global health field? ScienceInsider talked to Mary Moran, director of the George Institute's Health Policy Division and an expert on R&D funding for neglected diseases. (In her definition, that includes the "big three"—AIDS, malaria, and TB—and a range of other diseases occurring mostly or only in the developing world.) Moran is the main author of G-FINDER, an annual survey funded by the Bill and Melinda Gates Foundation that tracks global expenditure on R&D for neglected diseases. She was also a member of the Expert Working Group (EWG) at the World Health Organization (WHO) that recently issued a series of recommendations on how to improve R&D funding for these diseases.
This interview has been edited for brevity and clarity.
Q: What's the idea behind the PDP+ Fund?
M.M.: PDPs now have over 140 products for neglected diseases in development. But there are a couple of problems. They don't get enough funding, and what they get is mostly grant funding for 1 or 2 years. They need more reliable sources of money, especially now that their products are getting into clinical trials, which are very expensive. Donors like to fund the early stages of product development, but when you get to the really big clinical trials, they like others to step in. They don't like the high risk of, say, a trial of an HIV vaccine or a rotavirus vaccine in 17,000 people. So right now, a PDP will plan a clinical trial and enroll several hundreds or thousands of people and they don't even know if they'll have the money to finish it. So the idea was that we need a way of providing a more long-term funding, and in a much higher volume. By pooling it, you share the cost and the risk.
The money could come from several sources. One is a new proposal for bond financing. You could also use consumer funds, such as airline or Internet taxes. And you could attract new donors, for instance, countries that don't have the capacity to review all the PDPs. We would like to get more countries involved.
Q: How would the fund distribute the money among PDPs?
M.M.: That needs to be worked out. There are different ways to approach it. You could, for instance, say, "These are the priority diseases, this is the amount of money the PDPs in this area would need," and attempt to raise that total amount. Or you could say, "This is the total amount we have, and now we have to decide which groups get it." We probably can't do everything we want to do, so we might need to start small and move up from there. Perhaps we'd start with the products that are most in need of funding now because they have the most advanced portfolio.
Q: Those are tough choices.
M.M.: Yes, but it will be better than the current situation. Because what's happening now is completely random. The PDPs that get funded are the ones that make the most persuasive case to the donors. In G-Finder, we found that 80% of the funding went to AIDS, TB, and malaria. It's not that those represent 80% of the need; it's just what donors are interested in, and those groups are most persuasive.
Q: So who would set the priorities?
M.M.: That's what's being discussed now; there are a number of proposals. Obviously, WHO would need to be involved, as well as donors, countries, scientists. ... You may need a board and a scientific panel. At the moment, we're talking to a lot of people and asking: "What's a structure that would be fair, transparent, scientifically credible, and inclusive?" We have only been talking about this for 6 weeks. When we presented this in Geneva on Monday, it was probably a bit early. People were expecting a completed idea, but we just wanted to say, "Folks, there are the issues that we want your input on."
Q: How did this plan come about?
M.M.: IAVI, Novartis, and the George Institute had each presented a plan to the Expert Working Group. But they were all just starter ideas, so we said, "Let's merge them into something better."
Q: Why spend all the money on PDPs?
M.M.: You can't do everything. The reason we selected PDPs is first of all, the EWG had recommended that they needed funding. They also have 140 products in development, none of which is funded beyond a couple of years. If you want a big bang for your buck, you focus on a group that covers a lot of the field, has a big portfolio that's moving forward successfully. That said, there are other approaches that work, but obviously we had to pick one.
Q: And your own research has shown that PDPs are successful?
M.M.: We've been looking at this field for 5 years. In 2004, we did an analysis of all neglected disease products developed from 1975 up until 2004, and we analyzed how quickly they had moved forward, how good the final products were, how affordable to poor countries, and how cost-effective. PDPs came very well out of that.
Q: You're studying this field as a scientist, but now you're becoming an actor as well. Isn't that a problem?
M.M.: I'm in it as a researcher. I don't have a PDP, we don't have products, we won't get any of the funding. I'm doing this purely from a research point of view, as an adviser, saying, "This approach works."
Q: But could you objectively study whether the PDP+ Fund is effective if you were one of the midwives?
M.M.: I think this is a good idea, and I don't think I should be sidelined from saying what I know. These groups really need some more central form of support. Besides, I may not be involved in this much longer; I might pull out.