[Ip-health] IP-Watch: WHO Experts To Analyse R&D Financing, Focus On Poor Country Diseases

Thiru Balasubramaniam 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  
stakeholder participation.

“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  
document says.

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.


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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