[Ip-health] IP-Watch: As Patients Wait, WHO Members Chip Away At Decision On Medical R&D Funding

Thiru Balasubramaniam thiru at keionline.org
Mon May 9 07:16:51 PDT 2016


As Patients Wait, WHO Members Chip Away At Decision On Medical R&D Funding

09/05/2016 BY WILLIAM NEW <http://www.ip-watch.org/author/william/>,


A number of World Health Organization member states attended a meeting last
week aimed finding ways to sustainably finance research and development for
medical products, especially those for poor populations lacking means to
pay high prices. According to the outcome document and a WHO official, they
heard many viewpoints from experts and made progress but much was left for
the World Health Assembly later this month.

The outcome report and draft decision from the meeting is available here
Sections marked yellow indicate a relative degree of agreement, according
to a source, but most of the document is in brackets indicating lack of
agreement. Member states effectively had one day for negotiations, and the
draft decision grew from two pages to eight pages as it filled with
proposed language.The Open-Ended Meeting of Member States to Assess
Progress and Continue Discussions on the Remaining Issues in Relation to
Monitoring, Coordination and Financing for Health Research and Development took
place from 2-4 May <http://www.who.int/phi/cewg/en/>.

Members left the draft decision largely without agreement, and recommended
to the upcoming World Health Assembly to set up a drafting group to
finalise discussions on a draft decision/resolution.

The remaining documents from the meeting, including a progress report and
presentations on a range of issues, are on the WHO website here

Numerous health advocates and others presented views to the member states
during the first two days. Some of those interventions will be captured in
a subsequent story.

The draft decision shows agreement on some preliminary paragraphs, but
becomes bracketed almost immediately with variations on how to mention the
new United Nations Sustainable Development Goals (SDGs). Later in the
document, agreement appears on a request to the WHO director general to
submit terms of reference and a costed workplan for the Global Observatory
on Health Research and Development to the 2017 World Health Assembly. A
couple of other measures on harmonisation and promotion of the Observatory
also are agreed.

India and Switzerland, at request of the chair, combined on some
alternative text to the draft decision, to be integrated into relevant
locations in the draft. Among other things, they urge member states provide
sustainable funding for the Global Observatory.

Lack of funding has emerged as perhaps the biggest question for the
initiative, according to sources. Nations have agreed for years that there
is a market failure punishing the world’s poorest, but cannot agree on how
to address it. The measures discussed in this meeting are considered
efforts in that direction.

The meeting was called for by the 2013 World Health Assembly, the annual
meeting of WHO member states, in Resolution WHA66.22. The WHO Consultative
Expert Working Group on R&D: Financing and Coordination (CEWG) has been
working on this issue for several years.

Last week’s open-ended meeting was chaired by B.P. Sharma of India, and
vice-chair was Tania Dussey-Cavassini of Switzerland. The first two days of
the meeting were open to WHO observers and official non-governmental
organisations. The final day was member states only. The whole event was
closed to the press.

The meeting was foreseen months ahead of time, but was inexplicably left to
the last minute before the 69th annual World Health Assembly taking place
on 23-28 May.

Funding Woes

The point of this effort is to come up with alternative ways to finance R&D
into neglected diseases and other medical issues that lack sufficient
private sector incentive to invest in R&D. And yet, perhaps ironically,
even the demonstration projects set up to provide experiments into
alternative funding themselves cannot find funding.

The CEWG had come up with some clear proposals for ways forward, such as an
R&D treaty, but developed countries have put up resistance. Governments
seem to be to looking for a way to sustainably finance
non-profit-generating health R&D in a way that does not overly threaten the
existing patent-based pricing model, and does not financially commit
developed country governments too much.

The 22 April progress report by the secretariat (Doc A/RDMCF/2) described
progress on several fronts, though lack of funding is cited throughout as a
slowing factor.

A Global Observatory on Health Research and Development was launched in
January, and it has started collecting data. An online portal was
demonstrated to last week’s meeting, and eventually the Observatory will
develop analyses of gaps in health R&D, contributing to priority-setting.

The Observatory is being developed by the UNICEF/UNDP/World Bank/WHO
Special Programme for Research and Training in Tropical Diseases. The WHO
secretariat and the Special Programme also are asked to look into the
possibility of hosting a pooled fund for voluntary contributions towards
R&D for diseases predominantly affecting poor populations.

The Programme developed a new tool, Portfolio-to-Impact (P2I) to model the
timeline and minimum funding required to develop new medicines, diagnostics
and vaccines for populations with limited resources. Using this tool, the
Programme set out seven implementation scenarios for a new financing
mechanism and estimated how many products, either new or re-purposed, might
be developed under such a mechanism, the report said.

The Programme also explored options for a scientific working group to be
responsible for managing the financing mechanism’s portfolio.

Another area of the report was on the CEWG’s recommendation to establish a
new global advisory body, the Advisory Committee on Health Research, a
formal expert group with a consultative mandate to support WHO.

Other areas of the report are on WHO’s R&D “blueprint” for action to
prevent epidemics, aimed – in cases such as the recent Ebola outbreak – at
“ensuring access to affordable, safe and effective health products for
which existing market mechanisms fail to provide incentives for health
research and development.”

Also significant work is being done on R&D for new antibiotics as part of
the WHO’s global action plan on antimicrobial resistance.

An update was also given on several “demonstration projects”, which are
shown to be at different levels of implementation.

In her presentation to the open-ended meeting (meeting presentations are
available here <http://www.who.int/phi/cewg-presentations/en/>),
Marie-Paule Kieny of the WHO highlighted innovation aspects in the
demonstration projects, such as: the intent to delink the price of the
final product from the cost of the R&D; utilisation of collaborative
approaches including open knowledge innovation, use of licensing that
secures access to research outputs and final products; testing of new
financing mechanisms including innovative, sustainable and pooled funding;
demonstration of coordination mechanisms; and mechanisms to strengthen
capacity for research, development and production in developing countries
including through technology transfer.

Kieny also mentioned a March 2016 report from WHO’s Tropical Disease
Research (TDR) section, entitled, Health Product R&D Fund: A Proposal for
Financing and Operation. This describes how a potential pooled fund could
operate under WHO with input from member states. The three areas of work
would be: modelling a financial mechanism, managing an R&D portfolio, and
developing a toolkit for portfolio management, she said.

The progress report states that the total financial requirement of
demonstration projects and establishment of the Observatory for four years
(2014-2017) is US$ 85 million. Member states have been asked to contribute
this but only a few have done so. The list is perhaps more notable for who
is not on it, than who is.

For the Observatory, France, Switzerland and the United States have given a
total of less than $1 million. And to a voluntary fund for demonstration
projects and Observatory, Brazil, India, Norway, South Africa and
Switzerland have given a total of $7.45 million. Switzerland and Norway
gave an additional $1.02 million as matching grants, and another $1.56
million was pledged, the report said.

So to date, funds received have been spent, and the gap sits at $74 million
by the end of 2017.

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