This note provide additional context for those who are just now following the issue of conflicts of interest and the WHO Consultative Expert Working Group (CEWG) on R&D Financing.
The CEWG follows a controversial, flawed and failed effort by an earlier group, the WHO Expert Working Group (EWG) on R&D Financing, to:
“examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases.”
The problems with the first EWG were many, including the superficial analysis given to new sustainable sources of funding, the failure to fairly examine proposals to de-link R&D costs from product prices, the lack of transparency of the process, the favored access by the pharmaceutical industry and the Gates Foundation, the penetration of and improper influence of the group by the IFPMA and its member organizations, and the conflicts of interest involving Mary Moran, who gave top rating to two spending proposals never formally submitted to the group, including one she authored and another for IAVI, a group for which Moran was a consultant.
Now the CEWG is being asked to “deepen” the analysis done by the EWG, and to revisit projects specificially rejected by the EWG. Among the most important elements of the CEWG work will be to re-examine the three spending mechanisms earlier endorsed by Moran the EWG. These included:
- Fund for Research and Development in Neglected Diseases (FRIND)
- Industry Research and Development Facilitation Fund (IRFF)
- Product Development Partnership Financing Facility. (PDPFF)
In addition to the FRIND, IRFF and PDPFF, the CEWG is expected to look at the new PDP Plus proposal, which is being developed jointly by the original proponents of the FRIND, IRFF and the PDPFF.
Briefly, the FRIND would create a highly centralized funding mechanisms that would allocate billions of dollars to private sector and non-profit research organizations, in some versions supervised by industry experts on R&D. The FRIND was developed by Paul Herrling, and often described as the IFPMA proposal. The author of the IRFF was Mary Moran, and it involved a fund to subsidize 80 percent of PDP’s payments to private industry (non-profit research organizations would not be eligible for the subsidies). The PDPFF was developed by IAVI, and involved government guarantees of bonds that would be paid back by the future sale of vaccines at a profit. Mary Moran was also a consultant to IAVI. Only the FRIND was formally submitted to the EWG for review.
Last Spring, Moran, Holly Wong of IAVI, and Paul Herrling of Novartis, began meeting to present a new PDP Plus proposal, that combined the FRIND, IRFF and PDPFF proposals. So, to be clear, the CEWG will spend a lot of time dealing with FRIND, and PDP Plus.
Switzerland has nominated Paul Herrling, the author of FRIND and the co-author of PDP Plus, to a seat on the CEWG. The WHO Secretariat has short-listed the Herrling nomination, and vigorously defended his nomination at the Monday WHO Executive Board meeting.
As noted in earlier blogs, Paul Herrling is a knowledgeable and well liked executive from Novartis who has spent considerable time focusing on issues relating to neglected diseases. KEI and other public health groups have a great deal of respect for Dr. Herrling, and value his many contributions. However, his appointment of the CEWG would put Dr. Herrling in the position of evaluating proposals that he either wrote or co-authored, or competing proposals.
In August 2010, Novartis published a five page paper titled: Funding neglected disease R&D, The next hurdle. The paper spells out the role of Dr. Herrling in shaping and advocating the leading funding proposals that the CEWG will certainly consider. Here are a few sections from the August 2010 Novartis paper:
Over the past three years, Dr. Herrling has been the driving force in design of a new financing mechanism – The Fund for R&D in Neglected Diseases, or FRIND – to support development of medicines and vaccines against neglected diseases. Funding would come primarily from a pool fed by donors ranging from industry and non-governmental organizations to private charities as well as governments, which increasingly are rechanneling existing funds already reserved for developing countries into research and development.
Novartis further notes:
Earlier this year, the FRIND proposal received a crucial endorsement from an Expert Working Group established by the World Health Organization to explore innovative models to finance neglected disease research and development. . . .
In addition to FRIND, the WHO’s Expert Working Group recommended further analysis of several proposed funding models. Product Development Partnerships were the focus of proposals from two other groups: the Product Development Partnership Financing Facility (PDPFF) and the Industry Research and Development Facilitation Fund (IRFF).
PDPFF is a proposal developed by the International AIDS Vaccine Initiative, the Aeras Global TB Foundation and the PATH Malaria Vaccine Initiative that proposes raising funds by selling bonds in private capital markets to support development of vaccines. Bond holders would be repaid from royalties on sales of the vaccines in high-and middle-income countries as well as donor-funded premiums on distribution of vaccines in developing countries. Borrowing by the fund would be backed with guarantees from governments and possibly donor foundations.
IRFF is a funding vehicle designed to continuously reimburse a large proportion of money distributed through Product Development Partnerships. Most funding would go to product development partnerships that advanced their portfolios most efficiently.
The report of the WHO’s Expert Working Group observed that Product Development Partnerships provide “optimal funding allocation at all stages of research and development” and high health impact in developing countries, as well as operational efficiency. “However, a mechanism is needed to assist donors to fund across product development partnerships, in a simpler manner than is currently possible,” the Working Group added, and raised the possibility of combining the three proposals to provide reliable, long-term funding to accelerate global health R&D. . .
In early April 2010, Dr. Herrling met with representatives of PDPFF and IRFF to explore possibilities of consolidating the best elements of each individual proposal within a single, joint mechanism to fund Product Development Partnerships. By mid-May, the talks had produced a preliminary agreement; core principles of the Product Development Partnership Plus (PDP-Plus) Fund were outlined for stakeholders during the WHO’s annual meeting in Geneva, Switzerland.
“There is no point in each of our three organizations pursuing this on its own,” Dr. Moran of the George Institute said. “This is a proposal that looks at existing Product Development Partnerships that are underfunded and have products about to fall off the cliff for want of the dollar. We need a mechanism that provides not only long-term funding but a lot more money than we had before – in a super risk-averse environment. So we need to reduce risk by pooling and address other needs of organizations and governments that don’t currently donate to neglected disease R&D.”
Many details – including diseases products and stages of R&D to be covered by the Fund – are yet to be finalized. While the PDP-Plus Fund would offer donors a single point of contact with Product Development Partnerships, portfolio management and resource allocation options remain under discussion.
The next step in evolution of the PDP-Plus Fund will be further consultations with stakeholders. “Clearly, we need to continue discussions with donors, representatives of Product Development Partnerships and other stakeholders in the global health and R&D worlds,” said Holly Wong, Vice President, Public Policy at the International AIDS Vaccine Initiative. “We have to figure out what our priorities and what trade-offs among our proposals might be possible. After getting these projects this far, it would be a tragedy for all of us if nothing more can be done to get these treatments to the patients who need them most.”
Here are some reports from the PDP Plus launch at the World Health Assembly in May 2010.
- James Love, PDP+ presented at WHA to skeptical audience, KEIonline.org , 17. May 2010.
- Holly Wong, Mary Moran and Paul Herrling, “The PDP+ Fund: Accelerating R&D in New Products for Diseases of Poverty, Center for Global Health Policy, May 17, 2010.
- Kimberly Mannon Reott, “The Emerging PDP+ Fund,” Results for Development, May 19, 2010
- Martin Enserink, Another Global Health Fund? Here’s Why, Science, 19 May 2010
- Declan Butler, “Neglected diseases fund touted: Initiative seeks billions of dollars to develop promising drugs and vaccines.,” 18 May 2010 | Nature 465, 277 (2010) | doi:10.1038/465277a.
This is a link to Malini Aisola’s 2010 analysis of the Novartis/IFPMA/FRIND, IAVI and Moran proposals:
A closer look at the WHO EWG endorsed proposals on funding product development partnerships