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Conflicts of Interest, and the WHO evaluation of the FRIND and the PDP Plus funding proposals by the CEWG
18 มกราคม 2554
Date: 18 January 2011
Source: Knowledge Ecology International
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 identify
sustainable sources of funding, and new incentive mechanisms, including those
that
"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
giving to new sustainable sources of funding, the failure to fairly examine
proposal 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
mechaqnisms 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 [1]. 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.?
Regrettably, this would not be the first time such a conflict would take place,
in the context of the WHO`s efforts to address the topic of sustainable
financing for R&D. Earlier, Mary Moran, a member of the previous WHO Expert
Working Group (EWG), played the key role in evaluating the proposals, and the
EWG ended up giving her own proposal its highest ranking. Moran also gave high
marks to a proposal by IAVI, a group that she had a consulting relationship
with. Now, as noted by Novartis, Moran, IAVI and Novartis are trying to merge
the three competing proposals into a single, PDP+ proposal, that will be considered
by the CEWG.
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 [2], 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 [3], Center for Global Health
Policy, May 17, 2010.
Kimberly Mannon Reott, "The Emerging PDP+ Fund, [4]" Results for
Development, May 19, 2010
Martin Enserink, Another Global Health Fund? Here`s Why [5], Science, 19 May
2010 Declan Butler, "Neglected diseases fund touted: Initiative seeks billions
of dollars to develop promising drugs and vaccines. [6]," 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 [7]
