[Ip-health] IP-Watch: World Health Assembly Debates New Draft Text Merging IP Resolutions

[Mike Palmedo]

http://www.ip-watch.org/weblog/index.php?p=3D316&res=3D1024_ff&print=3D0

World Health Assembly Debates New Draft Text Merging IP Resolutions

Tove Iren S. Gerhardsen and William New
IP-Watch
25/5/2006

A drafting group at the UN World Health Assembly today suggested a
possible merger of two key intellectual property resolutions, including
the establishment a global strategy and plan of action for research into
diseases disproportionately affecting poor countries with action to be
taken possibly within a year.

The Swiss chair of the drafting group proposed a text merging a
resolution proposed by Brazil and Kenya on a global framework for
essential medicine research and development (EB117 E13) and a resolution
contained in a report on the WHO Commission on Intellectual Property,
Innovations and Public Health=92s (CIPIH) report published in April (IPW,
Public Health, 24 May 2006).

The resolutions are under discussion in a technical committee at the
assembly, which is the annual meeting of the 192 member states of the
World Health Organization. At press time, the committee drafting group
had returned to discussions on the chair=92s text.

The original resolution based on the Brazil and Kenya proposal for a
framework on essential health research and development called for a
working group of interested member states to be set up to consider
alternative incentive mechanisms for =93needs-driven research, consistent
with appropriate public interest issues.=94

The chair=92s new proposed text titled, =93Public health, innovation and
intellectual property rights: a plan of action with special focus on
essential health research,=94 proposed the setting up of an
intergovernmental working group open to all interested member states,
which was suggested by both of the original resolutions.

The working group is to =93develop a global strategy and plan of action
which would provide a medium term framework for action to implement the
recommendations of the commission.=94

The CIPIH report makes some 50 recommendations on how research into and
access to medicines for neglected diseases may be improved, and it
appears the drafting group will look at all 50. This includes the
proposal that bilateral trade agreements should take into account
flexibilities from adherence to rules provided for in the World Trade
Organization Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS). The reference to flexibilities in bilaterals is still in
brackets in the chair=92s text, signifying a lack of full agreement.

The chair=92s text proposed that the global strategy and plan of action
should in particular address R&D =93relevant to diseases that
disproportionately affect developing countries,=94 and does not use the
term =93neglected diseases=94 that some proponents have used. It says clear
objectives and priorities should be set and funding needs should be
identified.

Under the draft, the working group is to report to the next World Health
Assembly (the 60th) on the progress of developing a plan of action
=93involving areas for immediate implementation including mechanisms
strengthening needs-driven research,=94 and submit a final plan to the
61st WHA.

A non-governmental organisation source said that Brazil had wanted to
draw up a list of neglected diseases to be covered by the resolution and
be updated regularly.

The 8-page chair=92s text included three pages of text stripped out of the
original resolutions, including specific references such as the Human
Genome Project and the support of thousands of scientists and others for
the resolutions. It also took out additional text on TRIPS flexibilities
and bilateral trade deals, the WTO Doha Declaration on Development.
Another item removed referred to intellectual property rights as =93one of
several tools to promote innovation, creativity, and the transfer of
technology.=94

CIPIH Chair Urges Global Framework

Ruth Dreifuss, a former Swiss president who chaired the CIPIH, told the
technical committee that there is a need for a global framework. She
said the report recognises that governments have =93major
responsibilities=94 in implementing the recommendations in the report, but
the WHO also has a coordinating role, she said.

=93Never have people hoped for so much from science,=94 Dreifuss said.

A key element in the debate is whether the proposed framework would lead
to a legally binding arrangement, something US delegation lead William
Steiger said his government could not support. In the Thursday committee
debate, Kenya said the framework would not have to be legally binding.
But in the closed drafting group meeting, another developing country
said it should not preclude such an instrument from ever being created,
sources said.

In the Thursday committee meeting, South Africa said on behalf of the
African nations that they are disappointed with the report as it does
not go far enough in its recommendations. It said that the price of
medicines often far exceeds that of the cost of R&D and production and
this is =93abuse of IP policy.=94

South Africa said a =93dedicated action plan that will produce results=94 i=
s
needed to produce medicines for diseases disproportionately affecting
developing countries but said it is unclear how the resolution aims to
achieve this goal.

Japan said the current IP system is working effectively and there is no
need for a new global framework. This was echoed by the International
Federation of Pharmaceutical Manufacturers and Associations, which said
the current R&D system is working, but that there is a need for more
public-private partnerships.

The United States said the report was =93generally evidence-based=94 but
that it exceeds its mandate particularly when it refers to human rights.
Also, it said there is no evidence that compulsory licenses will produce
tangible results, despite a recommendation that these be used by
countries as needed. The US delegate said more work is needed before a
treaty can be agreed to.

Norway countered with the suggestion that these issues are related to
human rights. It said the development of a global pan of action is =93well
worth examining=94 and more resources need to be put into R&D for
neglected diseases. The Norwegian delegate said he agreed that patents
are an important incentive for innovation, but said =93IPRs are definitely
not up to the challenges faced by poor countries.=94

A representative from Oxfam said the two resolutions =93provide an
opportunity for revision of the global public health agenda in ways that
recognise the extreme urgency of achieving access to medicines that are
relevant to global public health, and that support from long-term,
sustainable production of low-price public health goods through
reinforcing competition, and by introducing innovative ways to finance R&D.=
=94

There appear to be some differences as to whether the Brazil and Kenya
resolution would cover neglected diseases only or diseases beyond this
such as diabetes. James Love of the Consumer Project on Technology said
the resolution should lead to norms and mechanisms, in the short term,
for setting research priorities for neglected diseases as well as other
diseases. In the long term it should lead to a treaty. Moreover, it
should cover both public and private R&D. But others have sought to keep
it limited.

EU Under Scrutiny On R&D Resolutions

At a 23 May event, Brazil and Kenya presented the resolution that came
from their original proposal. At the event, Ellen =B4t Hoen of M=E9dicins
Sans Fronti=E8res said that the supporters of the resolution =93particularl=
y
count on European Union countries and governments=94 for support, adding
that =93the needs are enormous [and there is] no excuse for governments or
WHO not to take action.=94

Supporters of the resolutions this week have asserted that the European
Commission position closely reflects the position on the pharmaceutical
industry, and that it departs from an earlier position expressed by EU
commissioner responsible for Health and Consumer Protection, Markos
Kyprianou in a letter faxed to a Member of Parliament in March.
Commission officials declined to comment in detail on any of these issues.

Some also raised questions about the Commission=92s competence in health
matters, which are typically handled at the national level. On the IP
resolutions, the Commission is speaking on behalf of the 25 EU member
countries plus two accession countries, it said.

In the committee meeting, a European Commission official said that the
two resolutions duplicate each other in large measures. The Commission
is open to addressing this issue further, he said, but he emphasised
that mechanisms and flexibilities already exist under the TRIPS agreement.

Industry Concerned About Global Framework Reference

At the Brazil and Kenya event, one industry representative told
Intellectual Property Watch that the industry feared the reference to a
=93global framework=94 in the title, although this expression as well as
much in the resolution is still in brackets, indicating that no
agreement has been reached.

The source said many in the industry feared that the resolution did not
address the lack of research into neglected diseases only, but aimed at
=93breaking up the IP-based research and development (R&D) system.=94

He said the industry favours public-private partnerships instead and
said that over the past five years such agreements have led to a =93robust
pipeline of 60 diseases=94 on which research is being conducted. The
resolution, he argued, is =93more ideologically driven than needs driven.=
=94

The source said that =93everybody agrees=94 that more research has to be
carried out for these diseases but the partnerships and more public
funding into these would be a better idea than what was suggested in the
resolution.

A representative of the WHO Tropical Disease Research Centre said it is
=93very correct and proper=94 to focus on R&D but said research on how
medicines are used and implemented is also needed after product development=
.

A representative for the International Policy Network, which is
partially supported by the pharmaceutical industry, said that he found
it =93peculiar=94 that the resolution suggested to redesign the way in whic=
h
R&D is being conducted for =93minority diseases.=94 He also referred to a
recent London School of Economics study which concluded that
public-private partnerships are producing results.