[Ip-health] EWG process

Mary Moran mmoran at policycures.org
Sun Jan 23 17:35:56 PST 2011

Could I please ask KEI to stop printing misleading assertions about me and my work?  It is beginning to smack of a hate campaign, which is surely something the international health community would not and should not either indulge in or endorse.

KEI knows that all members of the EWG were specifically requested to submit their own proposals for review.  Many members did so:  the full list is available on the WHO website.
KEI knows that the EWG was specifically asked to review not only the few proposals submitted to the group but also the many other proposals not submitted (over 94 in total).  Inclusion of the IRFF for review was completely unexceptional, as all known proposals were reviewed including several in which other EWG members were involved.
 *   KEI knows that other EWG members had proposals recommended in which they were involved, including the UNITAID patent pool proposal (the head of UNITAID was on the EWG) and SBIR grants, such as those of the NIH (a senior NIH representative was on the EWG).  It is unclear why I am being singled out.
KEI's careful wording of my "consultancy for IAVI" also suggests they know that I was not a consultant for IAVI at any time close to the EWG.  I did one short project for IAVI several years before (examining ways for Europe to stimulate HIV biotech work ), but had done much more work for MSF (who also submitted proposals); had worked with KEI staff at the inception of the R&D Treaty proposal; and have, as an expert, conducted research or been an adviser to many public and philanthropic international health groups involved in many of the proposals submitted.  I presume this is why I was selected, as with the other members.

I have rarely come across an organisation so apparently willing to use deception to undermine those it does not agree with.  This posting again appears to be a deliberate misrepresentation of the facts in order to suggest that I am corrupt or biased.  I am not.

Mary Moran

Conflicts of Interest, and the WHO evaluation of the FRIND and the PDP
Plus funding proposals by the CEWG

By thiru
Created 18 Jan 2011 - 1:19pm
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

• 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]

[1] http://www.novartis.com/downloads/newsroom/news/2010-08-05_Herrling.pdf
[2] http://keionline.org/node/843
[3] http://sciencespeaksblog.org/2010/05/17/the-pdp-fund-accelerating-rd-in-new-products-for-diseases-of-poverty/
[4] http://healthresearchpolicy.org/blog/2010/may/19/emerging-pdp-fund
[5] http://news.sciencemag.org/scienceinsider/2010/05/another-global-health-fund-heres.html
[6] http://www.nature.com/news/2010/100519/full/465277a.html
[7] http://keionline.org/node/751
[8] http://keionline.org/sites/default/files/2010-08-05_Herrling.pdf

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