Info Service on Health Issues (May13/05)
22 May 2013
Third World Network
WHO: Concerns over draft text on R&D financing and coordination
Published in SUNS #7588 dated 22 May 2013
Geneva, 21 May (K. M. Gopakumar) -- A draft resolution on health research
and development (R&D) financing and coordination for the 66th
World Health Assembly (WHA) has raised critical concerns.
The draft resolution is a follow-up to the Report of the World Health
Organisation's Consultative Expert Working Group (CEWG) on the implementation
of the CEWG recommendations. Health ministers are scheduled to consider
this at the 66th WHA, which is taking place from 20-28 May in Geneva.
The CEWG Report made a set of important recommendations with regard
to coordination, monitoring and financing of R&D to meet the unmet
R&D health needs of developing countries.
One of the key recommendations of the Report is the establishment
of a legally binding instrument for the coordination and sustainable
financing of R&D to address those unmet health R&D needs.
The Report also recommended a set of principles and objectives of
the instrument, which includes open innovation and de-linking of the
cost of R&D from the price of products (See SUNS #7350 dated 16
The CEWG was established in 2010 to follow up on the Report of the
Expert Working Group on R&D Financing and Coordination, to implement
WHO's Global Strategy and Plan of Action on Public Health, Innovation
and Intellectual Property (See SUNS #6482 dated 27 May 2008).
In particular, it was appointed to implement Element 7.1(a) of the
Global Plan: " ... establish a results-oriented and time-limited
expert working group under the auspices of WHO and linking up with
other relevant groups to examine current financing and coordination
of research and development, as well as proposals for new and innovative
sources of financing to stimulate research and development related
to Type II and Type III diseases and the specific research and development
needs of developing countries in relation to Type I diseases; ..."
[Initially, the WHO Director-General established the Expert Working
Group on R&D Financing and Coordination under resolution WHA 62.16
to implement Element 7.1(a). The Group came under severe criticism
from the WHO Member States and civil society organisations for its
poor quality analyses and recommendations. (See SUNS #6847 dated 22
January 2010). As a way forward, the CEWG was established through
resolution WHA 63.28.]
The 65th WHA in 2012 adopted resolution WHA 65.22 to carry out the
follow-up on the CEWG Report. Among other things, it mandated an open-ended
meeting, which was held on 26-28 November 2012. The 66th WHA will
consider the outcome document of the open-ended meeting, which includes
a report and the draft resolution as an appendix.
Both the report and the draft resolution raise serious concerns on
the implementation of the CEWG recommendations to address the unmet
health R&D needs of developing countries. Moreover, the legitimacy
of the outcome document itself is in question.
Only 81 out of 194 WHO Member States attended the open-ended meeting,
which is less than half of the WHO membership. Further, according
to a developing country negotiator, at the time of the finalisation
of the report and the draft resolution, there were only around 20
Member States inside the negotiating room. The same delegate also
disclosed to this author that the delegate of Argentina, who was concerned
about the many provisions in the draft resolution, could not effectively
convey its views during the last three hours of the negotiation in
the absence of interpretation.
One of the most contentious paragraphs in the open-ended meeting report
is Paragraph 6, which states: "the open ended meeting of Member
States strongly recommends that the Executive Board considers this
report and its attached draft resolution with a view to recommending
the adoption of the resolution by the World Health Assembly without
(One delegate wondered how one-tenth of WHO Member States could make
such strong recommendations to the other 173-odd Member States to
surrender their constitutional right.)
[The constitution of WHO and the Rules of Procedure of the WHA allow
Member States to bring amendments to the draft resolutions at the
Expressing concern over this issue, a joint civil society letter signed
by MSF (Medecins Sans Frontieres), Oxfam, Knowledge Ecology International,
Health Action International, Peoples' Health Movement and the Third
World Network requested WHO Member States, during the 132nd Executive
Board meeting in January 2013, not to approve the document.
On the recommendation of the open-ended meeting against the reopening
of the resolution, the letter queried that, "A draft resolution
negotiated by a small number of Member States under less than ideal
conditions should not include such a far-reaching recommendation to
the Executive Board".
Many Member States challenged this recommendation during the January
Executive Board meeting, and the report and the draft resolution were
not approved. (All draft resolutions for the WHA sessions have to
be first approved by the Executive Board.)
One of the important shortcomings of the draft resolution is that
it follows a piecemeal approach to the CEWG Report. The CEWG made
recommendations on the following areas, viz. approaches to R&D,
funding mechanisms, pooling resources, strengthening of R&D capacity
and technology transfer and coordination. In order to implement these,
it recommended a binding global instrument for R&D and innovation
Thus, a binding instrument would be the overarching instrument to
contain these three pillars. However, the draft resolution only adopts
one of its recommendations, i. e. the establishment of a global health
observatory. The CEWG also recommended the creation of an advisory
mechanism for the coordination, but the draft resolution is silent
Operating Paragraph (OP) 4.3 of the draft resolution states: "to
establish a global health R&D observatory within WHO's Secretariat
in order to monitor and analyse relevant information on health R&D,
building on national and regional observatories (or equivalent functions)
and existing data collection mechanisms with a view to contributing
to the identification of gaps and opportunities for health R&D
and defining priorities in consultation with Member States, as well
as, in collaboration with other relevant stakeholders, as appropriate,
in order to support coordinated actions; ..."
Thus, the objective of the observatory is to monitor and analyse relevant
information on health R&D with a view to contributing to the identification
of gaps and opportunities for health R&D and defining priorities.
This is only one of the pillars of the CEWG recommendations. Monitoring,
identification of gaps and prioritisation are important; however,
they would not alone resolve the issue unless there is a mechanism
to ensure sustainable finance and a new R&D mechanism to ensure
both access and innovation based on an "open knowledge innovation"
model as recommended by the CEWG.
According to OP 4.3, the Secretariat would identify gaps and opportunities
on health R&D and define priorities in consultation with Member
States and also "in collaboration with other relevant stakeholders,
The term "other relevant stakeholders" normally implies
collaboration with the pharmaceutical industry, which has a totally
different perspective and approach to the unmet health R&D needs
of developing countries. Further, the collaboration with any relevant
stakeholders including the pharmaceutical industry should be free
from conflict of interest. The draft resolution is silent about the
issue of management of conflict of interest.
Another important concern is with regard to the process of finding
solutions to the implementation of the outstanding recommendations
of the CEWG. OP 4.7 of the draft resolution requests the WHO D-G "to
convene another open-ended meeting of Member States prior to the Sixty-ninth
World Health Assembly in May 2016, in order to assess progress and
continue discussions on the remaining issues in relation to monitoring,
coordination and financing for health R&D, taking into account
all relevant analyses and reports, including the analysis of the report
of the Consultative Expert Working Group on Research and Development:
Financing and Coordination".
Hence, the next concrete opportunity to discuss the outstanding recommendations
of the CEWG is the open-ended meeting mentioned in OP 4.7 and the
outcome of the open-ended meeting would be communicated to the 69th
WHA in 2016. Thus, the open-ended meeting can be held between the
68th WHA and 69th WHA, i. e. between 2015 and 2016. This means that
the process for finding solutions to outstanding recommendations has
been postponed by more than three years if the open-ended meeting
were to be held in 2016.
Moreover, there is an attempt to marginalise the importance of the
CEWG recommendations. OP 7 states that the open-ended meeting, while
discussing the remaining issues in relation to monitoring, coordination
and financing for health R&D, would take into account all relevant
analyses and reports, including the analyses of the CEWG Report. Thus,
there is an attempt to move away from the recommendations of the CEWG
The operational paragraphs of the draft resolution also lack clarity
in terms of its implementation. For instance, OP 2(7) states: "to
continue consultation, at national as well as at regional and global
levels, including through the governing bodies of WHO, on specific
aspects related to coordination, priority setting and financing of
health R&D; ..."
However, there is no clarity on how this would be implemented in practice.
It is not clear whether there will be a standing agenda item for the
discussion of specific aspects related to coordination, priority setting
and financing of health R&D or whether it will be up to each Member
State to propose this issue as an agenda item for each Governing Body
Further, the implementation of OP 2.7 would be in disarray in the
absence of a corresponding mandate to the WHO Secretariat to facilitate
the implementation of OP 2.7 in an effective manner. Similarly, OP
4(4) requests the WHO D-G "to facilitate through regional consultations
and broad engagement of relevant stakeholders the implementation of
a few health R&D demonstration projects to address identified
gaps that disproportionately affect developing countries, particularly
the poor, and for which immediate action can be taken".
This is a proposal pushed by the European Union (EU). However, this
operational paragraph lacks clarity with regard to the implementation
of demonstration projects.
The CEWG Report recommended certain guiding principles for R&D.
It recommends an open knowledge innovation approach to R&D . It
further defines this approach and states: "We characterise these
as ‘open knowledge innovation', and define this as research and innovation
that generate the knowledge which is free to use without legal or
Towards this end, it recommends three R&D models, viz. open approaches
to R&D and innovation, milestone prizes, equitable licenses and
patent pools. Apart from the cost effectiveness of R&D, the CEWG
finds these mechanisms can "also help to secure delinkage, inter
alia, by encouraging competitive pricing of end-products".
OP 4(4) is silent on whether the demonstration projects will be guided
by this new approach to R&D and innovation. The key question is
whether the implementation of demonstration of R&D projects would
be guided by the business-as-usual mainstream R&D paradigm or
the "open knowledge innovation" approach suggested by the
CEWG. Further, the use of the words "particularly poor"
poses the danger of narrowing down the scope of diseases that falls
within the mandate of the Global Strategy and Plan of Action on Public
Health, Innovation and Intellectual Property.
The aim of the Global Strategy and Action Plan clearly states: "The
global strategy on public health, innovation and intellectual property
aims to promote new thinking on innovation and access to medicines,
as well as, based on the recommendations of the CIPIH report, provide
a medium-term framework for securing an enhanced and sustainable basis
for needs driven essential health research and development relevant
to diseases which disproportionately affect developing countries,
proposing clear objectives and priorities for R&D, and estimating
funding needs in this area."
(CIPIH refers to the Commission on Intellectual Property Rights, Innovation
and Public Health of global experts convened by the UK that produced
a report in 2002.)
The engagement of "relevant stakeholders" is another problematic
construction. As mentioned above, it means the engagement with pharmaceutical
companies in practice, which has direct conflict of interest on this
Similarly, OP 1 endorses the further development of the strategic
work plan through broad engagement of public and private entities,
academia and civil society. However, there is no process laid down
to implement this endorsement except the engagement of relevant stakeholders
in the context of the global R&D observatory (OP 4.5) and demonstration
projects (OP 4.6).
Further, OP 4.5 and 4.6 generate worry on the duplication and repetition
of the work already carried out by the CEWG and other actors, which
are already in the public domain.
OP 4.5 requests the WHO D-G "to review existing mechanisms to
assess their suitability to perform the coordination function of health
R&D." OP 4.6 requests the WHO D-G "to explore and evaluate
existing mechanisms for contributions to health R&D and, if there
is no suitable mechanism, to develop a proposal for effective mechanisms,
including pooling resources and voluntary contributions, as well as
a plan to independently monitor their effectiveness; ..."
The Terms of Reference (ToR) of the CEWG set out in resolution WHA
63.28 clearly states: " ... (b) deepen the analysis of the proposals
in the Expert Working Group's report, and in particular: (i) examine
the practical details of the four innovative sources of financing
proposed by the Expert Working Group in its report; (ii) review the
five promising proposals identified by the Expert Working Group in
its report; and (iii) further explore the six proposals that did not
meet the criteria applied by the Expert Working Group; ..."
In addition, OP 2.2(d) of resolution WHA 63.28 mandates the CEWG,
while "carrying out the actions in subparagraphs 2(b) and 2(c),
examine the appropriateness of different research and development
financing approaches and the feasibility of implementation of these
approaches in each of the six WHO regions, with sub regional analysis,
In the absence of any direction to the Secretariat to build upon the
recommendation of the CEWG, further deliberations to move forward
on these two areas could be delayed.
NEGLECTED TROPICAL DISEASES
Further, the WHO Secretariat is currently engaged in a competing resolution
on Neglected Tropical Diseases (NTD) with a potential conflict of
approach recommended by the CEWG.
The draft resolution on NTD, however, is not yet publicly available.
The version presented during the 132nd Executive Board meeting in
January 2013 primarily urges Member States "to expand and implement
interventions against neglected tropical diseases in order to reach
the targets agreed by WHO and its partners in the London Declaration
on Neglected Tropical Diseases and set out in WHO's roadmap for accelerating
work to overcome the global impact of neglected tropical diseases".
The Bill & Melinda Gates Foundation, the World Bank and pharmaceutical
transnational corporations are the main promoters of the London Declaration.
Abbott, Astra Zeneca, Bayer, Becton Dickinson, Bristol Mayers Squibb,
Gilead, Glaxo SmithKline, Johnson and Johnson, Merck, Novartis, Pfizer
and Sanofi have endorsed the London Declaration.
On R&D, the London Declaration states: "Advance R&D through
partnerships and provision of funding to find next-generation treatments
and interventions for neglected diseases".
The declaration is silent on any new approaches to R&D, which
can address both innovation and access to medicines. It is disconcerting,
therefore, that the Secretariat-initiated resolution on NTD is silent
on the CEWG recommendations.
It is widely believed that the NTD initiative is to neutralise the
efforts to implement the recommendations of the CEWG. Critics cite
the absence of any direct or indirect reference to the CEWG recommendations
in the draft resolution circulated during the January meeting of the
Executive Board (EB).
During the Board's deliberations, Ecuador, on behalf of UNASUR (Union
of South American Nations), noted with concern that there were ambiguous
areas of the discussion and a lack of correlation between the preamble
and operative parts. Further, it stated that it is very important
to continue to search for coordination strategies and setting priorities
as well as funding for R&D at levels required to bring us beyond
the status quo at the present.
Further, Ecuador called upon the EB to consider the possibility of
strengthening OP 4.5 and OP 4.6 to streamline the coordination and
funding mechanism. Finally, it proposed to amend OP 4.7 to advance
the timeline of the open-ended meeting from 2016 to 2015.
China raised a procedural question on the last paragraph of the report,
which strongly recommends the adoption of the resolution by the WHA
without reopening it. Further, China said that even though the November
meeting was open ended, not all members took part in the discussion
and it also pointed out that the WHA is the paramount power of the
organisation. Therefore, China suggested that it is best for the WHA
to decide whether to discuss the resolution or not. In addition to
the remark on the last paragraph of the open-ended meeting report,
China suggested three amendments, terming it as friendly revisions,
to OP 2.3, OP
4.3 and OP 4.4.
Bolivia, Cuba and Argentina supported the position of Ecuador and
The United States responded that despite elements it did not agree
with in the resolution, it agreed because it was a way of moving forward.
Hence, to more and better R&D investment in diseases affecting
the poor. The US said that Ecuador should take the resolution as part
of that package and not reopen it. By reopening part of the resolution,
it would then reopen the entire package. Further, the US stated that
it has no problems with the wording introduced by China; however,
the US does not want to reopen any part of the resolution.
In response to a specific query referred by the Chair on the possibility
of amending the draft resolution at the EB, the legal counsel of the
WHO stated that "the WHA remains free to further discuss the
Director-General's report and the draft resolution", thus confirming
the possibility that the May session of the WHA can provide further
amendments to the draft resolution.
As a result, "The Board noted the report of the open-ended meeting
of Member States on the follow-up of the report of the Consultative
Expert Working Group on Research and Development: Financing and Coordination
and agreed that the comments made thereon by Member States would be
brought to the attention of the Health Assembly".
However, the Secretariat has not provided the comments made by Member
States during the EB meeting as a WHA document. The footnote simply
states: "See the summary record of the eleventh meeting of the
Executive Board at its 132nd session, section 2." This reference
is given without a URL to access the document on the WHO website.
Echoing similar concerns, the medical journal Lancet in an editorial
dated 26 January 2013 stated: "In April 2012, the Consultative
Expert Working Group on Research and Development (R&D) recommended
a framework for sustainable financing and coordination implemented
through a legally binding convention. However, this week WHO's Executive
Board has been asked to endorse a less ambitious plan by member states
for a more vaguely defined WHO Observatory on Global Health R&D,
which is weak on concrete action despite international consensus that
the current R&D model needs revision. The 2013 World Health Assembly
should be more ambitious and put back on the agenda the proposal for
new global rules to secure sustained financing mechanisms for essential
In a latest development, expressing concern on the draft resolution
and the report of the open-ended meeting, more than 50 civil society
organisations and concerned individuals jointly made this request:
WHO Member States to consider the CEWG recommendations holistically
including the central recommendation of the CEWG report which recommended
to Member States that "formal intergovernmental negotiations
should begin for a binding global instrument for R&D and innovation
The letter further urged "the World Health Organisation (WHO)
and its Member States to exercise leadership, ambition and innovative
thinking in developing new paradigms to take forward the work of the
Consultative Expert Working Group on Research and Development: Financing
and Coordination (CEWG) in reconciling the objectives of stimulating
medical innovation and ensuring access for all."
It further reminded the WHO and its Member States of the objective
of the Global Strategy and Plan of Action on Public Health, Innovation
and Intellectual Property and states that the Plan is to secure "an
enhanced and sustainable basis for needs driven, essential health
research and development relevant to diseases that disproportionately
affect developing countries".
The letter stressed that "The CEWG identified the concept of
de-linkage as the over-arching principle in which to secure this objective
by de-coupling the cost of R&D from the price of health technologies
including medicines, vaccines and diagnostic tools. The central recommendation
of the CEWG report that Member States were asked to consider was the
development of a legally binding global convention to address the
unmet R&D needs of developing countries".
The signatories of the letter are: AIDS Law Project Kenya; AIS-Bolivia;
AISLAC; AIS-Nicaragua; Alianza LAC-Global por el acceso a medicamentos;
All India Drug Action Network; American Medical Student Association;
Asia Pacific network for people living with HIV (APN+); Bolivian Committee
for Consumers Rights Protection - CODEDCO Bolivia; Center for Health,
Human Rights and Development (Uganda); Center for Technology and Society;
Fundacao Getulio Vargas; Delhi Network of Positive People (DNP+);
Diverse Women for Diversity; Farmamundi (Spain); Federacion Medica
Colombiana; Fundacion IFARMA (Colombia); GTPI/Rebrip - Grupo de Trabalho
sobre Propriedade Intelectual da Rede Brasileira pela Integracao;
dos Povos ; Health Action International; Health Gap; IDESAL Network
- Bolivia IFARMA; Initiative for Health & Equity in Society; JUSTICIA,
SALUD & DESARROLLO - Bolivia ; Kenya Treatment Access Movement;
Knowledge Ecology International; Medecins Sans Frontieres - Access
Campaign; Medicus Mundi International Network; Mision Salud Veeduria
Ciudadana (Colombia); Navdanya (India); Oxfam; Peoples' Health Movement;
PHM Benin; PHM Bolivia; Politicas Farmaceuticas - Chile; Public Citizen
(US); Public Health Association of Australia; Research Foundation
for Science, Technology and Ecology; Salud por Derecho; SECTION27;
Stop AIDS Campaign; The Berne Declaration; Third World Network; Treatment
Action Campaign; and Universities Allied for Essential Medicines.