Info Service on Intellectual Property Issues (May12/01)
30 May 2012
Third World Network
friends and colleagues,
Below is a news report on discussions that took place during the World
Health Assembly on the report of the Consultative Expert Working Group
(CEWG) report that called for WHO to being negotiations on a binding
agreement on R&D.
Third World Network
States to discuss Expert recommendations on health R&D
Published in SUNS #7378 dated 30 May 2012
29 May (Sangeeta Shashikant*) - The World Health Assembly (WHA) could
only agree to a cautious approach to the recently-released recommendations
of the Consultative Expert Working Group on Research and Development:
Financing and Coordination (CEWG) mainly due to opposition by the
Several developing countries pushed for the setting up of an intergovernmental
working group to begin discussions on implementation of the CEWG recommendations,
particularly that called for a binding agreement on R&D relevant
to the health needs of developing countries, but this move was vehemently
opposed by developed countries, in particular the US, EU and Switzerland.
Thus, the WHA, which met from 21-26 May, agreed to a less ambitious
outcome, i.e. to hold an open-ended Member States' meeting to analyse
the CEWG report and the feasibility of its recommendations.
The meeting is also mandated to develop proposals or options relating
to research coordination, financing and monitoring of R&D expenditures
to be presented to the 2013 Executive Board in January and the Health
Assembly later in May, taking into account the results of national
consultations and regional committee discussions.
This compromise was reached after lengthy negotiations in a drafting
group convened midway through the Assembly (on Wednesday, 23 May)
to find a solution to four draft resolutions that had been submitted
on the matter. Dr Viroj Tangcharoensathien of Thailand chaired the
Two of the draft resolutions (presented by Kenya and the Union of
South American Nations - UNASUR) proposed formal processes to discuss
the implementation of the CEWG recommendations, in particular, developing
a legally binding instrument on R&D.
The other two resolutions put forward by developed countries (i.e.
Switzerland, and a group of developed countries - Australia, Canada,
Japan, Monaco and the US) proposed informal consultations, without
committing to the CEWG recommendations.
According to sources participating in the drafting group, the developed
countries made attempts to marginalise and block implementation of
the CEWG recommendations.
The US explicitly refused to accept the CEWG recommendations, particularly
the recommendation that called for a binding agreement on R&D.
The US also favoured language that "Notes the report of the Consultative
Expert Working Group", and opposed language that "Welcomes
the report of the Consultative Expert Working Group". Thus, the
final agreed language reads: "Welcomes the analysis of the CEWG
According to sources, the US also apparently pronounced during the
drafting group meetings that it did not favour the concept of "public
The EU took a similar but more nuanced position in that it favoured
more clarity on the outcome before discussing the legal nature of
the outcome of the discussion. The EU, with the support of other developed
countries, also attempted to push for a narrowing of the scope of
diseases but this was firmly rejected by other developing countries.
The developed countries (the US, the EU and Switzerland) also favoured
informal consultations to the holding of formal intergovernmental
discussions to take forward the CEWG recommendations. However on this,
according to sources, Switzerland showed least flexibility and only
relented when it lost the support of the EU and the US.
The final resolution adopted by the WHA, in its preambular paragraph,
"Welcomes the analysis of the CEWG report".
In the operative paragraphs, the Resolution:
"Urges Member States:
"(1) to hold national level consultations among all relevant
stakeholders in order to discuss the CEWG report and other relevant
analyses resulting in concrete proposals and actions;
"(2) to actively participate in the meetings at regional and
global level referred to in this resolution;
"(3) to implement, where feasible, in their respective countries,
proposals and actions identified by national consultations;
"(4) to establish and/or strengthen mechanisms for improving
coordination of research and development (R&D) in collaboration
with WHO and other relevant partners, as appropriate;"
"Calls upon member States, the private sector, academic institutions
and non-governmental organizations to increase investments in health
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 1 diseases;"
"Requests regional committees to discuss at their 2012 meetings
the report of the CEWG in the context of the implementation of the
Global strategy and plan of action on public health, innovation and
intellectual property in order to contribute to concrete proposals
"Requests the Director-General to hold an open-ended Member States'
meeting in order to analyse thoroughly the report and the feasibility
of the recommendations proposed by the CEWG, taking into account,
as appropriate, related studies. The meeting will also take into account
the results from national consultations and regional committee discussions
and develop proposals or options relating to (1) research coordination,
(2) financing and (3) monitoring of R&D expenditures, to be presented
under a substantive item dedicated to the follow up of the CEWG report
at the Sixty-sixth World Health Assembly, through the Executive Board
at its 132nd session."
CEWG: TIME FOR A BINDING R&D AGREEMENT
The creation of the CEWG follows a succession of initiatives in WHO
going back to 2003. The CEWG was established in 2010, to address shortcomings
in the report of the Expert Working Group (EWG) on R&D (A63/6
Add. 1) which was widely criticized by many Member States and public
health NGOs. (See SUNS #6931 dated 27 May 2010 available at http://www.twnside.org.sg/title2/intellectual_property/info.service/2010/ipr.info.100509.htm)
The EWG was set up following resolution WHA 61.21, which adopted the
Global Strategy and Plan of Action on Public Health, Innovation and
IP and requested the Director-General to "establish urgently
a results-oriented and time-limited expert working group 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 research and development needs of developing countries
in relation to Type 1 diseases".
These initiatives arose from concerns that insufficient resources
are being devoted globally to R&D to address diseases that principally
affect developing countries. In particular, the concern centred on
the failure of intellectual property rights to stimulate innovation
in healthcare products needed by developing countries, and in relation
to the constraints created by such rights for access to needed products,
especially by the poor.
Nine years on, the R&D challenges remain and the matter unresolved,
leading the CEWG to conclude in its recently-released report that
"it is time to consider new ways forward to achieve the objectives
that WHO Member States have been grappling with for so long",
adding that "There is a need for a coherent global framework
that combines the different elements and recommendations into a concerted
More specifically, after a close examination of over 100 R&D proposals,
the CEWG concludes that "a binding instrument on R&D is necessary
to secure appropriate funding and coordination to promote R&D
needed to address the diseases that disproportionately affect developing
countries and which constitute a common global responsibility".
The CEWG report also outlines elements that should be part of the
binding instrument on R&D.
For instance, it proposes that the binding instrument have as its
objectives, among others: securing sustainable funding to address
identified R&D priorities in developing countries; improving coordination
of public and private R&D; enhancing the innovative capacity in
developing countries and technology transfer to these countries; generating
R&D outcomes as public goods, freely available for further research
and production; and improving priority setting based on the public
health needs of developing countries; and decision-making relying
on governance structures that are transparent and giving developing
countries a strong voice.
Specifically, on financing, it calls for a financing mechanism to
be established based on government contributions. It concludes that
all countries should commit to spend at least 0.01% of GDP on government
funded R&D devoted to meeting the health needs of developing countries
with a contribution of 20-50% of the total funding obligation to a
pooled funding mechanism. (For a summary of the CEWG report, see SUNS
#7350 dated 16 April 2012 available at http://www.twnside.org.sg/title2/intellectual_property/info.service/2012/ipr.info.120401.htm).
Four draft resolutions were put before the WHA for consideration proposing
different approaches to the CEWG recommendations.
Kenya and UNASUR proposed draft resolutions with language endorsing
the development of a binding agreement on R&D, although the approach
to the process differed.
Kenya, in its draft resolution (A65/A/Conf. Paper No. 1), proposed
the establishment of an Intergovernmental Negotiating Body to develop
the WHO Convention on Research and Development Financing and Coordination,
taking into account the CEWG recommendations, in particular, the strengthening
and securing of sustainable funding to address identified R&D
priorities of developing countries; promoting R&D in diseases
that disproportionately affect developing countries; de-linking R&D
costs and prices of products; enhancing innovative capacity of developing
countries and technology transfer; generating R&D outcomes as
public goods; and strengthening R&D coordination mechanisms.
According to sources, mid-way through the discussions of the drafting
group, Kenya withdrew its draft resolution and supported the draft
presented by UNASUR.
UNASUR, in its draft resolution (A65/A/Conf. Paper No. 4), proposed
the convening of an open-ended, Member State-driven process to make
a detailed, in-depth study of the mechanisms proposed by the CEWG
with a view to their implementation and "to achieve consensus
on the principles, objectives and governance instruments that could
form part of a binding agreement, and the necessary means of bringing
On the other hand, the developed countries favoured informal consultations
between the Director-General of WHO (DG) and Member States, with no
commitment to take the CEWG recommendations forward.
Switzerland (A/65/A/Conf. Paper No. 2) proposed informal consultations
between the DG and Member States on the feasibility of the recommendations
in the CEWG report, and the presentation of a compilation of views
expressed to the next WHA.
The joint draft resolution of the US, Australia, Canada, Japan and
Monaco (A65/A/Conf. Paper No. 5) also proposed the holding of informal
consultations between the DG and Member States, on improving coordination
and financing for research and development to better address the health-care
needs of developing countries, including, but not limited to, the
possible methods recommended by the CEWG in the context of the GSPOA
(Global Strategy and Plan of Action on Public Health, Innovation and
Divergent views were also expressed over the CEWG report during the
plenary discussion in Committee A of the Assembly, prior to the convening
of the drafting group.
Paraguay, speaking on behalf of UNASUR, noted that the CEWG report
contains many valid suggestions and it is a clear call on Member States
for action within a global framework.
Brazil highlighted the fact that enormous inequalities persist, and
that technology is an opportunity, but if not adequately shared, it
can become a threat. "We have a moral obligation", Brazil
added. It said that Member States should initiate a debate on how
to implement the recommendation by the CEWG with an open heart. "We
should not fear controversy", Brazil added.
Congo, speaking on behalf of the African Regional Office (AFRO), said
that most African countries favoured a legally binding instrument
and called for accelerating the process in order to relieve the suffering
of the African people. Congo stressed the need to find new ways of
China said that intellectual property rights are not enough, and that
developing countries lack effective health technologies. It supported
WHO playing a leading role in health R&D and welcomed the CEWG
report, adding that the recommendations deserve careful study and
Denmark, on behalf of the European Union, thanked the CEWG for its
report, and acknowledged that current measures are insufficient. However,
it stressed that "more clarity is needed on what we want to achieve
before discussing the legal nature of the outcome of the discussion",
adding: "The EU is confident that exploring practical and flexible
solutions is likely to help set the components of a comprehensive
approach. If its different parameters are clearly defined and agreed
upon, this could lead to framing a global package".
It further stressed that there was a need to first agree on the exact
scope of the initiative, including how to deal with the categories
of diseases, and by which to possibly start; the need to have sufficient
data on Member States' current R&D efforts and public spending
on health research; and the need for the discussion to be put in perspective
with the WHO reform process. It added that there was a need for feasibility
studies and a clear assessment of where the item fits in the WHO priority-setting,
its work and the next General Program of Work.
The EU also supported the draft resolution proposed by the US, Canada,
Australia, Japan and Monaco.
The US expressed several concerns with regard to the CEWG recommendation.
i.e. that it does not support a binding instrument on financing, adding
that many other countries were also not prepared to commit 0.01% of
their GDP under the binding instrument.
The US also said that it did not support putting in place a new financing
mechanism that could be characterised as a globally-collected tax
and proposal to establish a single pooled financing mechanism. It
also did not favour establishing intergovernmental working groups.
It further called for the Member States' discussion to include consideration
of proposals passed over by the CEWG such as advance marketing and
procurement agreements, orphan drug legislation, regulatory harmonization
and priority review vouchers.
[The CEWG report did analyse and consider these proposals but found
these proposals either unsuitable for stimulating R&D needed by
developing countries or that they do not contribute to improved financing
or coordination of R&D.]
Japan said that options in the CEWG report must be analysed in terms
of feasibility and financial implications.
Switzerland, a proponent of one of the draft resolution texts, proposed
consultations within and between countries, saying that there is no
clear vision yet for an instrument, be it binding or non-binding.
(* This article has benefited from valuable contributions from Heba
Wanis, Project Coordinator of People's Health Movement - PHM - Project
on Democratising Global Health Governance, Alice Fabbri, PHM-Italy
and Meike Schleiff, PHM-USA.)