[Ip-health] IP-Watch: WHO Group Lays Foundation For Global Neglected Diseases R&D Plan

Mon Dec 11 07:51:15 2006

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The strategy and plan of action was supposed to be based on the CIPIH
report, but according to an analysis =93non-paper=94 issued by the
Netherlands, there were a number of issues omitted from the initial
paper prepared by WHO.

Renganathan said that WHO had had to reduce the 60 recommendations of
the CIPIH to a =93manageable number,=94 and a tangible number of action
points. Moreover, the selection had been based on what it is realistic
to expect can be achieved in a 10-year time frame. WHO had prepared the
paper, however, in cooperation with all the WHO six regional offices.

Many of the omitted recommendations were brought back in during the
week and are now reflected in the final paper, but Brazil still took
issue with the process toward the end. Brazil told the meeting that the
discussion paper, as of 7 December, was inadequate as it still did not
reflect affordability and price of medicines, patent pooling and access
to health as an overriding human right.

Having compared the initial WHO paper with the approximately 60
recommendations in the CIPIH report, a number of the CIPIH=92s proposals
on using flexibilities in the patent system were left out of the paper,
the Netherlands said.

Almost all of the CIPIH recommendations sought by Brazil in a
submission paper during the 1-15 November online consultation process
on the group were left out, according to the Dutch paper. =93Everything
Brazil found important is not in there,=94 Sabina Voogd, senior policy
advisor at the Dutch Ministry of Foreign Affairs, told Intellectual
Property Watch.

Voogd said that issues highlighted in Brazil=92s submission, such as
technology transfer to developing countries according to Article 7 of
the WTO Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS), =93early working=94 exception and general encouragement of
generic market entry upon patent expiry, data exclusivity regulations
related to clinical trials data that delays the entry of generic
medicines and ensuring strict application of the patentability
criteria, were not included in the original draft.

Many of these measures were worked in during the discussions, including
language on avoiding =93TRIPS-plus=94 requirements in bilateral trade
agreements (beyond the TRIPS requirements), references to Article 66.2
of the TRIPS agreement on technology transfer, and the =93early working=94
system for generics (IPW, Public Health, 7 December 2006).

Voogd said it is the =93mystery of the whole thing=94 why the WHO
secretariat had not just listed all the CIPIH recommendations, or
indicated with number references which recommendations had been
included in the document. She suggested that the member states could
now lean on the Dutch non-paper to bring issues back into the
discussion paper. She said members should =93not throw away all that
valuable work done by the CIPIH.=94

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A number of sources have questioned why, in particular, the
intergovernmental organisation, the South Centre, was not given special
accreditation (it does not have WHO =93effective relations=94 status),
especially as it was indicated at the meeting that it had been
difficult to get developing country experts on short notice, sources
said. Internal WHO email correspondence from before the meeting
suggests that legally an exception might have been possible.

Paragraph 4 of resolution WHA59.24 states that the director general to
=93invite experts and a limited number of concerned public and private
entities to attend the sessions.=94

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11/12/2006

WHO Group Lays Foundation For Global Neglected Diseases R&D Plan

By Tove Iren S. Gerhardsen

During a 4-8 December meeting of some 100 World Health Organization
(WHO) member states and other stakeholders, the foundation was laid for
discussions of a global plan for providing medicines for diseases
predominantly affecting poor countries. The process will continue in
the coming year, and a second intergovernmental meeting is scheduled
for October 2007.

In the meantime, a report will be submitted to the WHO Executive Board
meeting in January 2007, and regional meetings may be held in the
run-up to the next meeting. A final report is due to be submitted to
the World Health Assembly in May 2008, the WHO said.

This was the first meeting of the Intergovernmental Working Group on
Public Health, Innovation and Intellectual Property (IGWG).

Participants=92 reactions after the meeting were mixed with some
expressing disappointment that more was not done. Expectation going
into the uncommon format varied widely. Perspectives on the working
group do not appear to clearly divide along North-South lines.

The meeting made =93some progress=94 although =93perhaps not as much [as we=
]
would have liked,=94 the chair, Peter Oldham of Canada, said at the end,
adding that the whole process had been =93very compressed.=94

Developing countries were praised by many participants, however, for
bringing many of the issues of concern to them back into the papers
under discussion in the meeting. This was despite what sources said was
pressure from the United States beforehand [see related story to come],
and an unbalanced representation vis-=E0-vis developed countries. Some 95
least-developed or developing countries of WHO=92s 193 member states were
not present, according to the meeting participant list.

Two developed country officials said that this was the first meeting
involving a range of controversial issues, and having an outline of a
process was therefore not bad. While somewhat disappointed about the
outcome, one of them said there had been =93a lot of goodwill.=94 One
noted, however, that there is =93a lot to do over the next 12 months,=94
and another developed country delegate said that the meeting had =93not
agreed to anything at all.=94

This was =93not an entirely satisfactory first step,=94 one participant
said from a developing country perspective, but added that one has a
government-led momentum building up. Yet a third stated that this was a
=93total disaster, just like they wanted,=94 as there was not a clearer way
ahead.

=93We are in a mess, but we will have a good result,=94 another developed
country official said. Developed countries appeared to vary somewhat on
how much the group should focus on the three areas of its mandate:
public health, intellectual property rights, and innovation.

Elil Renganathan of the WHO working group secretariat told Intellectual
Property Watch that the meeting had provided a framework for the whole
exercise, adding that this was the first time innovation and access to
medicines had been discussed at the same time.

Tussle Over IP in Global Plan

The group was created and tasked by the World Health Assembly in May to
come up with a global strategy and plan of action for providing
medicines for diseases predominantly affecting poor countries, based on
the recommendations of the WHO Commission on Public Health, Innovation
and Intellectual Property Rights (CIPIH). The mandate of the group was
=93to provide a medium-term framework based on the recommendations of the
commission,=94 according to resolution WHA59.24.

A paper from the meeting=92s discussions, entitled: =93Elements of a global
strategy and plan of action, Progress to date in the Intergovernmental
Working Group,=94 [A/PHI/IGWG/1/5] will form the basis of further work.
Separate papers on strategy and plan of action were combined on the
final day.

WHO will post online members=92 statements made late in week and not
reflected in the latest draft if they are submitted in written form by
February, it said. WHO will prepare a new document reflecting all
comments made by member states at the meeting by June 2007, relating
both to the global strategy and the plan of action.

A number of countries welcomed the meeting=92s paper, but the United
States said it was =93a step backwards of what we had yesterday [7
December].=94 But all in all a developed country official said the United
States viewed the meeting as a good outcome that had moved the process
forward, although it emphasised that nothing had been agreed to.

The paper contains elements for a global plan of action, including
prioritising research and development needs, promoting research and
development, building and improving innovative capacity, transfer of
technology, management of intellectual property, improving delivery and
access, ensuring sustainable financing mechanisms, and establishing
monitoring and reporting systems. It also contains a global strategy,
including =93making intellectual property work for health.=94

Based on this, the =93bureau,=94 consisting of the chair and the five
regional vice-chairs, will send a short report to the WHO Executive
Board meeting in January 2007.

The discussions may also continue at regional meetings in the meantime,
as countries such as Brazil and Canada said the momentum should be
sustained.

The working group meeting will not, however, be able to report on any
agreed, identified early action points of the plan that can be
implemented immediately, despite a mandate to do so in the original
assembly resolution. Some countries had specific suggestions, such as
Brazil, Switzerland (which held a separate meeting with various member
states of diverse backgrounds) and Thailand, but there was not enough
time to prepare a written document on early actions, WHO said.

There was quite a degree of difference between countries in terms of
preparedness, with some having officials from health, foreign affairs
as well as development agencies present, while others came to the
meeting without having done their =93homework,=94 and were apparently quite
unprepared for the exercise.

One nongovernmental source said that =93both sides,=94 referring to the WHO
secretariat and delegations (citing the European Union, which spoke
with different voices), seemed unprepared. This was partly
understandable given time constraints, she said, but was also
unacceptable considering that the meeting cost $600,000, as stated by
WHO.

Opening WHO Documents Omit Key CIPIH Provisions

During the week, developing countries managed to get many of the issues
dear to them, particularly those related to new ways of thinking about
intellectual property rights and medicines, into the discussion paper
that was prepared by WHO in advance.