[Ip-health] WHO Expert Group supports binding convention on health R&D for developing countries

Katy Athersuch katy.athersuch at googlemail.com
Wed May 2 08:52:02 PDT 2012


Results for Development Institute blog post:

http://healthresearchpolicy.org/blog/2012/may/2/who-expert-group-supports-binding-convention-health-rd-developing-countries
An Interview with Judit Rius Sanjuan,

Recently, the World Health Organization (WHO) Consultative Expert Working
Group on Research and Development: Financing and Coordination (CEWG)
released its final report Research and Development to Meet Health Needs in
Developing Countries: Strengthening Global Financing and
Coordination<http://www.who.int/phi/news/cewg_2011/en/index.html>
.

Soma Ghoshal <http://healthresearchpolicy.org/users/soma-ghoshal>interviewed
Judit Rius Sanjuan, US Manager of the Access Campaign of
Médecins Sans Frontières\Doctors Without Borders (MSF) to find out more
about the origins, significance, and likely impact of the CEWG’s work.

*1. Many of our readers may not be familiar with the history of this topic
within the WHO. Can you describe the origin and objectives of the CEWG?*

Many Member States, as well as civil society and experts, have long
recognized that the current system for health research and development
(R&D) do not adequately address the needs of developing countries, and as a
result, they have supported a series of initiatives to investigate and find
solutions to correct this imbalance, culminating in the creation of the WHO
Consultative Expert Working Group on Research and Development: Financing
and Coordination (CEWG) in 2010, which report was just released.

The CEWG was concretely tasked with examining “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 the needs of developing countries.”

The CEWG report begins with an important paragraph that sets the stage for
their work quite clearly:

“The issue we were asked to investigate was identified at least two decades
ago. Market mechanisms, and also publicly-funded research, collectively
result in far too little investment in research and development on diseases
that mainly affect developing countries. This means that poor people suffer
and die because there are no effective health technologies like medicines,
vaccines or diagnostics. Markets fail because intellectual property rights
are not an effective incentive in these circumstances, and public
investment is also dominated by the rich world and its own health needs.
This is the challenge for the world as a whole, which has guided our
discussions and deliberations. We have framed our recommendations to
indicate that finding solutions is the responsibility of all of us in this
interdependent world, in developed and developing countries alike.”

The experts considered a number of proposals for specific mechanisms to
address R&D gaps for the developing world submitted by Member States,
academics, industry and civil society, including a joint submission by MSF,
Health Action International Global, Initiative for Health & Equity in
Society, Knowledge Ecology International, and Third World Network entitled “
*Consideration of an Essential Health and Biomedical R&D Treaty*.”

The CEWG process was also informed by two previous and very important WHO
documents: the 2006 report of the Commission on Intellectual Property
Rights, Innovation and Public Health (CIPIH
Report<http://www.who.int/intellectualproperty/en/>),
which concluded that the current innovation system has failed patients in
developing countries, and the 2008 WHO Global Strategy and Plan of Action
on Public Health, Innovation and Intellectual
Property<http://www.who.int/phi/implementation/phi_globstat_action/en/index.html>,
that provided a roadmap on how to ensure innovation and access to medical
technologies highly negotiated by WHO Member States.

While the CEWG’s report contains a series of recommendations, arguably the
most striking recommendation is for WHO Member States to start negotiations
on a new, binding, global R&D convention. The CEWG report argues that a
binding convention “is needed 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.”

*2. In your opinion, what is the overall significance of the CEWG’s
recommendations?*

MSF considers the recommendation for a binding R&D treaty to be a landmark
development in global health. The CEWG’s recommendations have the potential
to boost R&D focused on the needs of patients living in developing
countries, but also to change the way R&D is conducted to ensure that
patients have affordable access to the fruits of innovations.

While efforts in recent years to address gaps in R&D have delivered some
urgently needed innovations for resource-poor environments, these ad hoc
efforts are not part of a sustainable system and are inadequate to meet the
health needs in developing countries.
The CEWG’s comprehensive proposal takes us beyond the current piecemeal
approach towards a more cohesive solution for priority-setting, funding and
coordination based on global health needs. A binding convention could be a
game changer in building a sustainable system to develop and deliver
urgently needed vaccines, diagnostics and drugs to patients in the
developing world.

The report contains an excellent analysis of the failures of the current
R&D system for the developing countries where we work. It also assesses a
variety of proposed R&D financing, coordination and incentive mechanisms
according to their potential public health impact, as well as their
technical and financial feasibility.

The report further concludes that removing the link between the cost of R&D
and the price of medicines should be a fundamental principle underpinning
approaches to R&D for developing countries to ensure that resulting medical
technologies will be affordable. In addition, the report specifies that an
absolutely necessary condition for implementing these approaches will be a
sustainable source of funding.

*3. What are some of the implications of the recommendations for current
R&D donors and other countries? *

The recommendations could be transformative for R&D donors in several ways.
The CEWG proposes the creation of new global norms for financing and
coordinating priority medical R&D. It also aims to promote a more
sustainable system for medical innovation to address the needs of patients
in developing countries, based on the fair and equitable sharing of costs,
access to benefits of R&D, and incentives to invest in needs-driven
innovation.

Regarding overall funding of R&D by governments, the CEWG report’s
principal conclusion is that all countries (developed and developing)
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 addition,
the CEWG report proposes that countries should consider these targets:
• 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•
Developed countries should aim to commit 0.15−0.2% of GDP to government
funded health research of all kinds

The global convention could be useful for donors who currently make
important contributions to global health R&D, especially in terms of
prioritizing and coordinating efforts in relation to global health needs,
but will also hopefully serve as a catalyst for countries that should be
committing more.

Independently from the WHO discussion, I hope the report and its
recommendations start a process of rethinking the way innovation is
financed and coordinated at the national and regional levels. The result
will hopefully be increased R&D financing and coordination for developing
countries, and better models for biomedical innovation that promote both
innovation and access.

*4. MSF and others often use a term called “de-linkage” when they talk
about the principles that they believe should govern the global innovation
system. Could you explain the basic concept of de-linkage and give a few
examples of how this principle could be successfully applied in practice?*

One of the main problems with the current innovation model is that it
relies on high prices, made possible with tools like patent-protected
monopolies, to recover R&D costs. This model has at least two major flaws:
a) high prices leave millions of patients without access to medicines that
they cannot afford; b) a lack of incentives to drive innovation for
patients (or governments that pay for their treatment) who cannot pay
high-prices or create a profitable market. The system encourages
profit-driven, rather than needs-driven, R&D, leaving many patient needs
unaddressed.

Therefore, MSF advocates for an innovation system that de-links, or
separates, the R&D cost from the sales price of products, therefore
ensuring both innovation and access, and re-directing R&D efforts towards a
more patients needs-driven approach.

Breaking the link between R&D costs and the sales price of products can be
accomplished through a variety of incentive mechanisms, and should be seen
as a standard for evaluating how well incentive mechanisms do against
public health objectives. For example, the concept of de-linkage could
serve as a way to assess incentive mechanisms currently being explored,
including Innovation Inducement Prizes, Advance Market Commitments, the US
FDA Priority Review Voucher, and the new USPTO Patents for Humanity pilot.

The WHO Member States have already recognized that separating the costs of
R&D from the sales price of products is an important issue that should be
further explored, and one of the main conclusions of the 2008 WHO Global
Strategy and Plan of Action was a mandate “to explore, and, where
appropriate, promote a range of incentive schemes for research and
developing including addressing, where appropriate, the de-linkage of the
costs of research and development and the price of health products, for
example through the award of prizes, with the objective of addressing
diseases which disproportionately affect developing countries.”

In its final report, the CEWG agrees that de-linkage is a powerful
principle. It mentions some examples where de-linkage has been or could be
applied, such as open innovation models where the R&D costs are covered by
public or philanthropic sources and research results are made available in
the public domain; licensing conditions imposed by funders or research
organizations that permit non-exclusive licensing or prescribe a low target
price for a product; or more comprehensive schemes that envision wholesale
replacement of the intellectual property system by government-funded
payments for R&D. MSF is especially interested in innovation inducement
prizes as one way to separate the cost of innovation from the final price
of products. During the negotiation of the WHO Global Strategy, the
governments of Barbados, Bolivia, Suriname, and Bangladesh presented
several proposals for prizes to reward innovation, including two proposals
that MSF has followed with particular interest, given the diseases that we
currently treat: a Chagas disease prize fund for the development of new
treatments, diagnostics and vaccines; and a prize fund for development of
low-cost rapid diagnostic test for tuberculosis.

In May 2012, the 65th World Health Assembly will deliberate over the
findings and recommendations of the CEWG. The key to translating the CEWG
recommendations into action will, of course, be political will and
leadership by the WHO and its Member States. MSF hopes that governments
will seize this opportunity and commit to starting the process of
establishing a binding convention on research and development relevant to
the health needs of developing countries.



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