Info Service on Intellectual Property Issues (Apr12/01)
16 April 2012
Third World Network
Binding agreement on South's technology needs recommended
Published in SUNS #7350 dated 16 April 2012
New Delhi, 13 Apr (K. M. Gopakumar) -- A World Health Organisation experts'
group has recommended a new binding agreement for financing and coordination
mechanisms to meet the health technology needs of developing countries.
The Consultative Expert Working Group on Research and Development: Financing
and Coordination (CEWG) stated in its report that the focus of the proposed
agreement is the development of health technologies for Type II and
Type III diseases as well as the specific needs of developing countries
related to Type I diseases.
The CEWG was appointed by the 63rd session of the World Health Assembly
(WHA) in 2010 in response to concerns that insufficient resources were
being devoted globally to research and development (R&D) to address
diseases that principally affected developing countries.
This followed agreement in 2008 on the global strategy and plan of action
on public health, innovation and intellectual property (GSPA-PHI) which
aimed "... inter alia, at securing an enhanced and sustainable
basis for needs-driven, essential health research and development relevant
to diseases that disproportionately affect developing countries."
This was a follow up to the report of the Expert Working Group on Research
and Development: Coordination and Financing (EWG) that was appointed
by the WHO Director-General based on a decision of the WHA in 2008.
The CEWG was tasked with the following terms of reference: (a) take
forward the work of the EWG; (b) deepen the analysis of the proposals
in the EWG report, and in particular: (i) examine the practical details
of the four innovative sources of financing proposed by the EWG in its
report, (ii) review the five promising proposals identified by the EWG
in its report, and (iii) further explore the six proposals that did
not meet the criteria applied by the EWG; (c) consider additional submissions
and proposals from WHO Member States, any regional and subregional consultations,
and from other stakeholders; (d) in carrying out the actions in subparagraphs
(b) and (c) above, 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 subregional
analysis, as appropriate; (e) observe scientific integrity and be free
from conflict of interest in its work.
[A decision of the 2008 WHA requested the WHO 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 I diseases, and open to consideration
of proposals from Member States, and to submit a progress report to
the 62nd WHA and the final report to the 63rd WHA through the Executive
Board. However, Member States were not satisfied with the report of
EWG and thus constituted the CEWG.
[Type I diseases are incident in both rich and poor countries, with
large numbers of vulnerable populations in each. Type II diseases are
incident in both rich and poor countries, but with a substantial proportion
of the cases in poor countries. Type III diseases are those that are
overwhelmingly or exclusively incident in developing countries.]
The CEWG recommends that negotiations on the binding agreement should
take place under Article 19 of the WHO Constitution, whereby the Health
Assembly shall have the authority to adopt conventions or agreements
with respect to any matter within the competence of the organization.
A two-thirds vote of the Health Assembly shall be required for the adoption
of such conventions or agreements, which shall come into force for each
Member when accepted by it in accordance with its constitutional process.
The CEWG lists elements of the binding agreement in order to provide
a framework for the negotiation process, viz. objectives, financing
The elements of Objectives are as follows: Implementing states' obligations
and commitments arising under applicable international human rights
instruments with provisions relevant to health; Promoting R&D for
developing new health technologies addressing the global challenges
constituted by the health needs of developing countries by means which
secure access and affordability through de-linking R&D costs and
the prices of the products; Securing sustainable funding to address
identified R&D priorities in developing countries; Improving the
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; Improving priority-setting based on the public
health needs of developing countries and decision-making relying on
governance structures which are transparent and give developing countries
a strong voice; Core elements under the convention should focus on development
of health technologies for Type II and Type III diseases as well as
the specific needs of developing countries related to Type I diseases.
The elements on Finance are as follows:
* All countries should aim to achieve specified levels of public funding
on health R&D relevant to the needs of developing countries;
* Countries could fulfil their financial commitment through contributions
to a financing mechanism established under the convention, in combination
with domestic spending on R&D undertaken to attain the convention's
objectives, or through development assistance where applicable;
* A financing mechanism should be established on the basis of contributions
by governments. The convention may determine a level of contribution,
taking account of countries' own investments in relevant R&D, either
domestically or in other countries. We (CEWG) have suggested a contribution
of 20-50% of their total funding obligation to a pooled funding mechanism;
* Such financing may be generated from existing taxpayer resources,
from new national revenue-raising measures, or by channelling a portion
of the resources raised from any new international mechanism to this
purpose. Voluntary additional public, private and philanthropic contributions
to a pooled funding mechanism can also be envisaged;
* The convention and its financing mechanisms for the more defined objectives
of R&D need to be supportive to the broader context of overall allocation
of public financing to health research and the sustainability of financing
in other areas of health research;
* The convention should define which research entities in the public
and private sectors, in public-private partnerships, and in developed
or developing countries, should be eligible for funding;
* Funding should be directed so as to promote cost-effective R&D
in ways that will also promote subsequent access to technologies in
developing countries, in particular using the tools identified in our
(CEWG) report which best meet these criteria, such as open knowledge
* Funding should also be directed in ways that promote capacity building
and technology transfer to the public and private sectors in developing
On the issue of Coordination, the CEWG concludes that a coordination
mechanism will be needed which would help to promote, in particular,
the objective of "improving Cooperation, participation and coordination
of health and biomedical research and development" in Element 2.3
of the Global Strategy and Plan of Action on Public Health, Innovation
and Intellectual Property adopted in 2009.
Further, the coordination mechanism would need to improve the measurement
of the volume, type and distribution of relevant R&D and the evaluation
of R&D outcomes, particularly so that progress against commitments
and compliance could be measured. This will depend in part on data and
reports provided by parties to the convention.
Regarding the compliance mechanism, the CEWG states that this needs
to be devised, including through cooperation between the Parties to
As a follow-up to its report, the CEWG makes three recommendations to
the Member States to be considered at the upcoming WHA in Geneva.
First, the CEWG proposes two ideas to carry out the preparatory work
of the convention: (i) the establishment of a working group or technical
committee to undertake the preparatory work on the elements of a draft
agreement. This group is to solicit inputs from other Member States,
relevant intergovernmental organizations, funders, researchers, private
sector, civil society and academics; (ii) the establishment of an open-ended
inter-governmental working group with appropriate technical support
as in the case of the WHO Framework Convention on Tobacco Control.
Further, the CEWG proposes the establishment of an inter-governmental
negotiating body open to all Member States under Rule 40 of WHA's rules
and procedures to draft and negotiate the proposed R&D Agreement
following on from the report of the working group.
The CEWG also recommends the allocation of sufficient resources to support
the working group or technical committee.
Regarding the approaches to R&D, the CEWG recommends "open
knowledge innovation and define this research and innovation that generate
knowledge which is free to use without legal or contractual restrictions".
In this regard, it recommends specifically open approaches to R&D,
which includes pre-competitive research and development platforms, open
source and open access schemes and milestone prizes.
Regarding the financing of health R&D, the CEWG examined four recommendations
of the earlier EWG viz. new indirect tax, voluntary contributions from
business and consumers, taxation of repatriated pharmaceutical industry
profits and new donor funds. The CEWG concluded that, "some form
of taxation is the most fruitful avenue to explore in the search of
new and sustainable sources of funding".
Considering the various development needs in mind, the CEWG does not
think "one specific new source would or should be devoted to the
particular field of health R&D relevance to the developing countries".
Instead, it argues that a specific portion of the new source of funding
should be devoted to fund both the improvement of health and currently
underfunded R&D areas.
The CEWG did not specify any specific form of tax to fund R&D. It
states that "countries should first consider at national level
what tax options might be appropriate to them as a means of raising
revenue to devote to health and R&D". However, the CEWG highlights
two possible taxes viz. Financial Transactions Tax and the Tobacco Solidarity
Contribution, as a potential new source of funding that could be channelled
through international mechanisms to supplement national resources.
The CEWG proposes a new approach to set targets in countries' R&D
spending to its GDP. It recommends 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 in relation to the
types of R&D defined in our mandate"
i. e. Type II and Type III diseases and the specific research and development
needs of developing countries in relation to Type I diseases.
Further, the CEWG makes two more specific recommendations in this regard.
First, developing countries with a potential research capacity should
aim to commit 0.05-0.1% of GDP to government-funded health research
of all kinds. Secondly, developed countries should aim to commit 0.15-0.2%
of GDP to government funded health research of all kinds.
On strengthening of the global coordination in health R&D, the CEWG
examined current mechanisms and suggests a way forward for better coordination.
Towards this end, it proposes a global Health R&D Observatory and
advisory mechanisms. The observatory would collect and analyse data
regarding the financial flows to R&D, R&D pipeline and learning
lessons. The advisory mechanism established by the WHO Member States,
should contain the following elements viz. a network of research institutions
and funders, and an advisory committee.
The CEWG reviewed 22 proposals mentioned in the EWG report as well as
another 22 proposals received as a result of the CEWG call for submissions
using a set of criteria. These are: public health impact, efficiency/cost
effectiveness, technical feasibility, financial feasibility, intellectual
property management issues, de-linking of R&D costs and price of
the product, access, governance and accountability and capacity-building.
The CEWG concludes that six proposals meet the criteria. These proposals
fall into the following category viz. global framework on R&D, open
approaches to R&D and innovation, pooled funds, direct grants to
companies, milestone prizes and end prizes, and patent pools.
Some experts view that the novelty of the CEWG report is that unlike
the earlier EWG report, the CEWG report clearly lays down a roadmap
for a legally binding instrument to address the R&D needs of developing
countries in Type II and Type III diseases and the specific research
and development needs of developing countries in relation to Type I
According to observers, the upcoming WHA is expected to lay down the
mechanism and a process to take forward the recommendations of the CEWG.
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