[Ip-health] IP-Watch: Chan Launches Inquest On Leaked WHO Documents; Meetings Proposed On R&D Expert Report

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ho-documents-meetings-proposed-on-rd-expert-report/

20 January 2010
Chan Launches Inquest On Leaked WHO Documents; Meetings Proposed On
R&D Expert Report
By Kaitlin Mara @ 11:26 am

The first public discussion of an expert report on how to finance the
often costly process of research and development to create new
medicines, vaccines and diagnostics needed by the poor to address
diseases that disproportionately effect them began this week at the
World Health Organization. There were immediate concerns about the
last-minute release of the report?s full text as well as concerns from
several governments that it came up short on critical areas, and it
was decided that an informal consultation process will take place over
the next few months.

Meanwhile, World Health Organization Director General Margaret Chan
said she has already begun an investigation to find out who leaked
drafts of the expert group?s work to an international industry group
in December (IPW, WHO, 9 December 2009). But she challenged those
concerned to come up with evidence indicating there was undue
influence by the pharmaceutical industry in the work of the WHO, and
said she attaches ?great importance to avoidance of conflict of
interest.?

Chan said she was ?extremely, extremely troubled by the leakage of
documents,? and vowed to ?find out exactly where the breach is? and if
it was internal to the WHO to take action, to the point of waiving the
diplomatic immunity of all staff ?to facilitate proper investigation.?

Meanwhile, progress on the rest of the implementation of the WHO
Global Strategy and Plan of Action on Public Health, Innovation and
Intellectual Property continues apace, according to a report of
programme coordinator Precious Matsoso, delivered yesterday. Progress
cited includes an agreement on cooperation between the WHO, the World
Trade Organization and the World Intellectual Property Organization at
the director general level to guide work on IP and public health as
well as a completed study on technology transfer and a framework for
monitoring and evaluating the implementation of the strategy.

One member of the expert working group said in an interview concerns
remain about the inclusion of key issues in the report.

Separately, the proposal being circulated this week by Canada for an
open-ended intergovernmental working group to address outstanding
issues in preparing for influenza pandemics is available
herecanada-non-paper-eb-2010. Pandemic influenza is the subject of
discussions at the WHO today.

All these discussions are happening in the context of the WHO
Executive Board meeting, taking place in Geneva from 18-23 January.
Recommendations made by the board are sent to the World Health
Assembly, the WHO?s decision-making body, which the director general
announced today will take place from 17-22 May.

Informal Discussions to be held on Expert Report

Comments on the report were somewhat hindered by the fact that its
full text was not out until the Friday evening before the Executive
Board commenced on Monday - and then only in English - so governments
were basing discussions off of an extended executive summary of the
work [pdf] made available in late December.

This concerned several states. For example, Thailand said using only
the executive summary for discussion was uncomfortably close to
signing a blank check and Brazil proposed that there be informal
meetings to discuss the full text prior to the May assembly. Uganda on
behalf of the African region supported Brazil ?considering that we are
unable to have an informed discussion at this moment.?

Chan promised that the translated reports would be available in all
six UN languages and transmitted to governments before the end of
February, and after a lengthy discussion member states decided to
undertake a web-based consultation on the final report, culminated in
a face-to-face consultation to be held 13 May, immediately prior to
the WHO Programme, Budget and Administration Committee.

Leaked Documents

Many - both governments and civil society - expressed concern over
selective transparency due to draft documents that were apparently
leaked to the International Federation of Pharmaceutical Manufacturers
and Associations.

?It?s no secret? Chan said, that in the past WHO staff have leaked
documents to forward their own agenda. But she refused to take the
criticism levelled at the WHO in response to the leak ?until there is
evidence to say that we are being influenced, or that the group of
experts is being influenced.? She then cautioned against putting too
much weight on what she called rumour and innuendo.

The working group chair, George Alleyne of the Pan American Health
Organization, said he ?rejected completely? the idea that
pharmaceutical companies had influenced the group. In fact, he told
Intellectual Property Watch, the group was so careful not to appear
impure in any way that they refused to privately meet with any
stakeholders during the process of their report writing.

A spokesperson for the IFPMA told Intellectual Property Watch the ?EWG
is doing critical and important work which depends on the contribution
of many different stakeholders. IFPMA believes participation and views
of all stakeholders should be welcomed as we all work together to
develop increased support and financing mechanisms for diseases of the
developing world.?

Chan promised that she would give governments a report of her
investigation when it is finished.

Questions on Gaps in Report and Secretariat Answers

Governments also questioned the WHO on substantive issues related to
the expert report, as several states wondered why certain issues had
not been included.

The ?report confirms our views that the poor bear double burdens on
diseases? as well as that ?commercial incentives provided by IP rights
have not provided solutions to health? issues faced by the developing
world, the delegate of India told the board Monday. But it would have
been ?most important and cost effective? to explore technology
transfer in more depth, she added, as it is one of the most promising
ways to increase medicines access. And it provides neither road map
nor guidance for greater access and wider dissemination of the
technologies already available, she added.

There were contradictions between earlier work done by the WHO on
intellectual property and health and report, said Brazil, including
the reintroduction of elements that had previously been rejected, such
as tax exemptions.

?The paucity of attention paid to IP? in the report is a ?serious
omission? for which the document does not provide justification, said
Bangladesh, adding that it should also have looked at de-linking the
cost of research and development from the price of products, concerns
later echoed by M=E9decins Sans Fronti=E8res (Doctors Without Borders).
?In our experience,? said the statement of India, ?the greatest
impediment to access to medicines has been their high cost and the
encumbrances posed by? IP rights.

The United States expressed concern about a proposal that the WHO host
and manage a patent pool initiated by UNITAID, saying it required
careful consideration of what role the WHO should be playing in global
health architecture and should not be rushed into.

A member of the expert group, senior Colombian Senator Cecilia L=F3pez
Monta=F1o, sent a 15 January open letter to the Executive Board arguing
that the report was incomplete and should not be accepted. She had
agreed to take up a position on the group to discuss the importance of
intellectual property rights, she told Intellectual Property Watch in
an interview yesterday.

But, she was ?very surprised that IP rights were not discussed,? and
when she tried to bring them up to the group they were resisted. ?I
couldn?t find the space to discuss the one subject for me that was
crucial, which was patents and intellectual property rights.?

If poor people in poor countries are to have cheaper medicines, she
said, ?you cannot ignore the debate? on IP. What the working group
came out with as a result was ?for me some sort of charity? mechanism,
she added. Her position is not hers alone, she said, but also held by
Colombian civil society groups whom she consulted during the process.
She also said she thought there might be other members of the expert
group who agreed with her.

L=F3pez Monta=F1o said yesterday she is satisfied that members of the
Executive Board raised the concern about IP in the discussion of the
working group report, and that the issue should come up in the
upcoming consultations on the issue.

Both Brazil and India proposed inviting the UN special rapporteur on
the right to health to the assembly to speak to delegates about a
March 2009 report on IP and access to medicines (IPW, Public Health,
16 June 2009). It is unclear what became of this suggestion.

Alleyne said that they were limited by a narrow mandate, and that
access to medicines outside of the research and development system -
while a matter ?dear to my personal heart? - was not a part of that
mandate.

?I am in perfect agreement with almost every one of the comments,?
about significant areas of public health and IP not touched on in the
report, he told Intellectual Property Watch. ?But many of them did not
pertain to the mandate? our remit was research and development? and
not the wider issue of availability of medicines, he explained.

Kaitlin Mara may be reached at kmara@ip-watch.ch

Comments

    1. James Love says:
       20 January 2010 at 1:00 pm

       It is quite incredible, or perhaps, not credible, for George
Alleyne to say that he did not consider access to medicines part of
his mandate. The WHO has passed countless resolutions on this topic,
including the one that created the EWG on R&D. At PAHO, Alleyne must
have appreciated that the WHO would give access a higher priority than
say, the private pharmaceutical industry. To suggest that the Chair of
this group did not see access as relevant to their work explains a
lot, when you look at the direction of the recommendations.

       If people have the time to look deeper at the report, it will
be apparent that it is mostly a search for positions acceptable to the
pharmaceutical industry, and that this was even the most important
aspect of the selection criteria for the funding proposals. As others
have pointed out during the review of the selection criteria, the EWG
should not have focused so much on what they thought was acceptable to
the pharmaceutical industry, but rather what would accomplish the
goals of the Global Strategy, and then present an effective case on
behalf of the useful proposals to policy makers.

       The claim that the report focused only on the most practical
recommendations (feasible) does not really hold up when looking at
what the EWG did recommend - unless one considers the tax on arms
shipments or Internet email, or an 80 percent subsidy for PDP outlays
to the private pharmaceutical industry to be particularly easy to
implement.