[Ip-health] EB136: WHO outlines contours of a Pooled Fund for Global Health Research and Development

Thiru Balasubramaniam thiru at keionline.org
Tue Dec 30 03:06:37 PST 2014


http://keionline.org/node/2157

Submitted by thiru on 22. December 2014 - 7:43

In May 2014, the World Health Organization's member countries passed decision
67(15) <http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_DIV3-en.pdf>
instructing
WHO Director-General Margaret Chan to explore, with TDR, the possibility of
hosting a pooled funding mechanism for R&D. In preparation for the
Executive Board (EB136) in January 2015, the WHO Director-General has
prepared document, EB/136/30, Follow-up of the report of the Consultative
Expert Working Group on Research and Development: Financing and Coordination
<http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_30-en.pdf>, describing
the contours of how such a fund operate, under the management of TDR and
its relationship with the proposed Global Health Research and Development
Observatory and the "future coordination mechanism".

With respect to the scope and the principles of the R&D fund, the
Director-General's report stresses that the

focus of the fund would be the development of effective and affordable
health technologies related to type III and type II diseases and the
specific research and development needs of developing countries in relation
to type I diseases, taking into account the principles formulated by the
Consultative Expert Working Group on Research and Development: Financing
and Coordination, namely delinkage of the delivery price from research and
development costs, the use of open knowledge innovation, and licensing for
access.

While noting that the CEWG demonstration projects are "independent of the
possible creation of a pooled funds, the Director-General's report notes
that,

together with the budget line established by the Special Programme for
Research and Training in Tropical Diseases to accommodate their funding, as
well as the Global Observatory, could provide the nucleus for the
development of the fund. WHO and the Special Programme for Research and
Training in Tropical Diseases will work in collaboration to maximize the
opportunities to use the demonstration projects to inform the development
of the final research and development fund.

In terms of governance, the report notes that the pooled fund will be
managed by TDR, and the global observatory and the coordination mechanism
would be managed by the Secretariat. According to the Director-General's
report, the observatory and the coordination mechanism would identify the
priority research gaps to be financed by the pool fund. The report, while
noting that health technologies financed by the pooled fund could be
provided to those in need through "at cost, preferential, non-exclusive
licensing agreements" or licenses to the WHO or TDR, is short on details of
these provisions.

3. In resolution WHA66.22, the Health Assembly recognized the interlinkage
of monitoring, coordination and financing of health research and
development. That interlinkage will inform the scope of the fund, which
would finance research and development projects to address priority
research gaps as identified by the Global Observatory and the future
coordination mechanism. A functional research and development observatory
and a coordination mechanism are essential to ensuring that the fund meets
the Health Assembly’s expectations. The fund will be managed by the Special
Programme, and the Global Observatory and the coordination mechanism will
be managed by the Secretariat. The focus of the fund would be the
development of effective and affordable health technologies related to type
III and type II diseases and the specific research and development needs of
developing countries in relation to type I diseases, taking into account
the principles formulated by the Consultative Expert Working Group on
Research and Development: Financing and Coordination, namely delinkage of
the delivery price from research and development costs, the use of open
knowledge innovation, and licensing for access. The contractual
arrangements for the funding of projects will ensure that any future health
technologies financed through the fund will be accessible to those in need.
Arrangements could include clauses on at-cost or preferential pricing,
non-exclusive licensing agreements or licences to WHO or the Special
Programme.

4. The priorities of the fund would be informed by the analysis of the
research landscape provided by the Global Observatory. General priority
areas would be recommended by the coordination mechanism. WHO is currently
examining options for such a mechanism.

In terms of management of the Fund, the Director-General's report notes
that TDR would establish a new scientific review group which would "prepare
and manage calls focusing on priority needs in line with the WHO’s global
strategy and plan of action on public health, innovation and intellectual
property" (EB/136/30). The scientific review group would work in concert
with the priorities identified by the global observatory and the
recommendations of the coordination mechanism. TDR's Joint Coordination
Board (JCB) would approve the final set of projects submitted by the
scientific review group.

With regards to membership of the scientific review group,

The membership of the scientific review group would reflect the scientific
disciplines required, experience of product development, gender balance and
representation of disease-endemic countries, taking into account the
expanded scope of diseases from the Special Programme’s current mandate.
Management of conflicts of interest for members of the scientific review
group would follow WHO’s current policy for expert committees.

The Director-General's report makes clear that the establishment of the
pooled fund and the Global Observatory is contingent on the availability of
new funding sources. The report that fundraising for the pooled fund and
the global observatory falls under the purview of the WHO not TDR.

The report provides the following models of financing for consideration:

(i) Some organizations rely on ad hoc voluntary contributions, including
the Special Programme for Research and Training in Tropical Diseases and
the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research,
Development and Research Training in Human Reproduction, as well as most
product development partnerships. The disadvantage of such a mechanism is
that funding is difficult to predict.

(ii) Other organizations use a replenishment model, in which each donor
independently fixes its contribution in the form of a pledge. Pledges are
public, legally non-binding statements on planned contributions.
Contributions are voluntary as donors themselves fix the amount of pledges,
but such a mechanism provides for some planning security as pledges span a
certain time period. Examples of this model are the Global Fund to Fight
AIDS, Tuberculosis and Malaria, the International Drug Purchase Facility
(UNITAID) and the GAVI Alliance, with the latter using additional
innovative financing mechanisms.Countries may want to consider implementing
innovative funding mechanisms at national or regional levels to raise
financial resources and to ensure a sustainable flow of funding. The pooled
fund should also be able to accept voluntary, preferably unspecified
funding by non-State actors such as philanthropic foundations following
WHO’s rules on acceptance of donations. The Special Programme for Research
and Training in Tropical Diseases will ensure appropriate management of
conflicts of interest in subsequent decisions on allocation from the fund,
in other words that such contributions have no impact on the process of
selection of projects

In terms of the financial management of the fund, the report provides two
options for EB136 to consider.

FINANCIAL MANAGEMENT OF THE FUND

11. There are two main options for the financial management of the fund
account (receiving donations and making payments). If the fund is held
directly by the Special Programme for Research and Training in Tropical
Diseases, the current arrangement is for WHO to implement an administrative
charge that covers costs associated with the administration of the Special
Programme’s designated funds. Alternatively, the fund could be held as a
trust fund account by a third party, for example, the World Bank, which is
a cosponsor of the Special Programme. The third party trustee would
disburse funding on the Joint Coordinating Board’s instruction, in line
with the Health Assembly’s recommendation regarding the division of the
research and development fund. It would invest the funds according to the
trustee’s investment strategy and report on financial management to the
Joint Coordinating Board. These options are being investigated in order to
identify the most
efficient mechanism.

As the global health community considers establishing a pooled fund for
R&D, predicated upon the principle that R&D costs must be de-linked from
product prices, there is a window of opportunity to pave the way for
creating global norms on R&D funding. Of course this is contingent on
countries stepping up to the plate.



More information about the Ip-health mailing list