[Ip-health] IP-Watch: WHO Experts To Analyse R&D Financing, Focus On Poor Country Diseases
thiru at keionline.org
Thu Mar 31 09:49:24 PDT 2011
Intellectual Property Watch
31 March 2011
WHO Experts To Analyse R&D Financing, Focus On Poor Country Diseases
By Catherine Saez @ 6:11 pm
The World Health Organization expert working group tasked with
studying proposals on financing and coordinating research and
development for diseases that disproportionately affect developing
countries will meet next week. The working group’s path is not easy as
it follows a predecessor group that sustained allegations of conflict
of interest and lack of transparency.
The WHO is showing a resolve to demonstrate that a new era of
transparency will now be the norm in the discussions with an unusual
move to open part of the consultations to stakeholders, who may bring
new proposals for discussion. Nevertheless, stakeholders may have a
difficult finding existing proposals under discussion in the group on
the WHO website, as they are not clearly posted and apparently some
may have changed since last year.
The Consultative Expert Working Group on Research and Development:
financing and coordination (CEWG) is meeting from 5-7 April (IPW, IP
Live, 29 March 2011). It takes forward the work of the Expert Working
Group (EWG). The group will give a progress report at the May 2011
World Health Assembly and a final report to the May 2012 assembly.
The CEWG is part of a larger WHO initiative, the Global Strategy and
Plan of Action on Public Health, Innovation and Intellectual Property
(GSPOA). The Global Strategy is a medium term strategic plan
(2008-2015), formulated in 2009, which aims to “foster innovation and
improve access for people in developing countries.”
The Global Strategy has eight elements. CEWG is part of the 7th
element “promoting sustainable financing mechanisms.” Asked about
progress in the implementation of this plan of action by WHO Executive
Board members in January, Marie-Paule Kieny, WHO assistant director
general for innovation, information, evidence and research, gave a
presentation highlighting that progress was being made.
According to Zafar Mirza, coordinator of the WHO Department of Public
Health, Innovation and Intellectual Property, the first meeting of the
CEWG shows the commitment of the WHO leadership to be as transparent
as possible. That’s because the meeting has been opened up to full
“We thought opening this meeting would be an opportunity also to
respond to member states’ desire for more transparency on the CEWG,”
he told Intellectual Property Watch.
The tentative agenda shows an open session on conflict of interest and
transparency during the first day of the CEWG. In January, during the
WHO Executive Board meeting, the panel of 21 experts to sit in the
CEWG was presented by the WHO secretariat. This list led to
controversy as it included a representative from the pharmaceutical
industry who is author of one of the proposals that the CEWG has to
take into consideration. Some countries and civil society complained
about a possible conflict of interest (IPW, WHO, 22 January 2011). The
list of experts was ultimately approved by the Board.
The CEWG mandate will be presented in an open session on 5 April. Then
on 6 April, there will be an open forum to enable the CEWG “to
understand better the perspective of different stakeholders on the
issues before it and any additional submissions and proposals,”
according to the WHO website.
On 7 April, CEWG members will work in closed session before a summary
is made by the chair in an open session at the end of the day.
“For stakeholders, this meeting is an early opportunity to give
suggestions, new developments, and new ideas,” Mirza said. WHA
Resolution 63.28 asks to bring transparency and provide regular
updates to member states. “This is a new way of working, more
transparent, more open, more interactive, and hopefully more
productive,” he said.
Three sets of proposals will be examined by the working group, Mirza
said. This includes a set of proposals short-listed by the EWG, a set
that was not short listed by the EWG, and a set composed of any new
proposals that might be put forward. The first two categories include
“improvement” on previous proposals, he said. Some countries had
criticised the EWG for not including some of their proposals in the
process, like Bolivia [pdf] (IPW, WHO, 18 May 2010).
The working group was also criticised for not paying enough attention
to proposals to de-link costs of research and development from the
price of health products, and for not sufficiently taking into account
intellectual property rights in the criteria used to evaluate
proposals. All countries’ comments are here.
According to the CEWG’s term of reference, the working group will
“deepen the analysis of the EWG, in particular by examining the
practical details of four innovative financing sources proposed by the
EWG, reviewing five promising proposals identified by the EWG, and
exploring further six proposals that did not meet the EWG criteria.”
The WHA resolution setting up the CEWG “is silent about whether the
CEWG should deal with five proposals” in section 5.4 of the EWG report
[pdf], about approaches to funding allocation, and two proposals in
section 5.5 of the report on proposals to improve efficiency. “The
CEWG will need to decide how to deal with these proposals,” the
The four innovative financing sources (section 5.3 of the EWG report)
are: a new indirect tax, voluntary contributions from businesses and
consumers, the taxation of repatriated pharmaceutical industry
profits, and new donor funds for health research and development. The
five “promising” proposals (section 5.6 of the EWG report) are: open
source, patent pools, the Health Impact Fund, a priority review
voucher, and orphan drug legislation. The six further proposals (annex
2 of the EWG report) are: transferable intellectual property rights,
green intellectual property, the removal of data exclusivity, a
biomedical research and development treaty, large end-stage prizes,
and neglected disease tax breaks for companies.
Asked if an analysis of those different proposals had been made by the
WHO secretariat, Mirza said this is not the secretariat’s mandate, but
the mandate of CEWG. In this first meeting, “the working group members
will decide how they want to look at these proposals, and what will be
their method of work. They might, if they wish, ask for technical
assistance from the secretariat to analyse the proposals,” he said.
The EWG was in charge of examining “current financing and coordination
of research and development, as well as proposals for new 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,” according to the CEWG background paper.
Type I diseases are incident in both rich and poor countries, with
large numbers of vulnerable populations in each, Type II diseases are
incident on both rich and poor countries, but with a substantial
proportion of the cases in poor countries, and Type III diseases are
those that are overwhelmingly or exclusively occurring in developing
countries, according to the WHO.
Knowledge Ecology International (KEI)
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