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<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style="">please place on PHA list serve....Thanks (from Martin Khor)<br>
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<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style="">TWN Info Service on Intellectual Property Issues <o:p></o:p></b></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style="">16 November 2007<o:p></o:p></b></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><st1:place
w:st="on"><b style="">Third World</b></st1:place><b style=""> Network<o:p></o:p></b></p>
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style=""><a moz-do-not-send="true" class="moz-txt-link-abbreviated"
href="http://www.twnside.org.sg">www.twnside.org.sg</a><o:p></o:p></b></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style=""><o:p> </o:p></b></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style=""> <o:p></o:p></b></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style="">WHO Working Group on IPR and innovation finishes</b></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style="">week of work, to meet again in April 2008<br>
</b></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style=""><br>
<o:p></o:p></b></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style="">Published in SUNS #6364 dated 13 November 2007</b> </p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><o:p> </o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><o:p></o:p> </p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">By
Riaz K. Tayob (Third World Network)<br>
</p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><br>
Geneva, 11 Nov 2007<br>
</p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><br>
Member governments of the World Health Organization ended Saturday a
week of intensive negotiations on a global strategy and plan of action
to improve access to health care in developing countries, in
particular, health research and development on diseases
disproportionately affecting developing countries.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">The
negotiations at the WHO Intergovernmental Working Group (IGWG) on
Public Health, Innovation and Intellectual Property Rights, chaired by
Peter Oldham of Canada, were suspended on 10 November evening to resume
again at a meeting tentatively set for 28 April to 3 May 2008. The
dates are to be confirmed by the bureau of the IGWG.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">At
the six-day talks, the negotiators are reported to have made some
progress in a few areas, but with considerable and difficult
negotiations ahead to agree and draw up "a global strategy and plan of
action" to provide a medium framework based on the recommendations of
the WHO Commission on Public Health, Innovation and Intellectual
Property Rights. The strategy and plan of action are to aim at among
others an enhanced and sustainable basis for essential health research
and development on diseases that disproportionately affect developing
countries. Clear objectives and priorities for research and development
in this area are to be set, and funding needs estimated.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">The
draft being negotiated includes texts on aim, focus and principles; and
on elements to prioritize and promote R&D, building innovative
capacity, transfer of technology, management of IP, improving delivery
and access, financing mechanisms, and monitoring and reporting systems.
The Plan of Action, based on the Global Strategy, includes specific
actions, stakeholders and indicators.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">The
negotiations were conducted in two drafting groups, the first Group A
chaired by Dr. Viroj Tangcharoensanthien of <st1:country-region
w:st="on">Thailand</st1:country-region>, and Group B, chaired by Mr.
N. Dayal of <st1:country-region w:st="on"><st1:place w:st="on">India</st1:place></st1:country-region>.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">On
Saturday, <st1:place w:st="on">Oldham</st1:place> proposed to the
Committee of the Whole, that the working group session be suspended to
resume before the meeting of the World Health Assembly next year. The
tentative dates for the working group are set at 28 April to 3 May. The
IGWG has been mandated to provide a draft Global Strategy and Plan of
Action to the 2008 WHA.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">The
secretariat, in consultation with the bureau, is to prepare a progress
report for the Executive Board (21-26 January 2008). The secretariat is
to prepare and issue (for the next meeting of the IGWG) a document on
the work so far - clearly indicating language that is agreed, bracketed
texts (parts discussed but where no agreement has been reached as yet),
and the parts of the texts yet to be discussed. Members will have time
till end January to comment on the parts not yet discussed, and the
secretariat will issue a paper with these comments. There will also be
an open-ended meeting of the sub-drafting group on elements one and two
of the Plan of Action (prioritizing R&D, and promoting R&D),
immediately after the January meeting of the Executive Board.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">While
member states are invited to make comments before end January on texts
not yet discussed, no comments are to be made on texts discussed, but
without reaching consensus. At the next meeting, the texts not yet
agreed are to be discussed, but no new texts can be introduced on them.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">A
Conference Paper issued on 10 November (to be finalised and revised by
the secretariat, taking account of the discussions on 11 November)
shows that Members have been unable to agree upon the aims of the
Global Strategy. Though members had not proposed any limitations, the
secretariat document of 31 July, limited the focus to 14 diseases. This
part is marked (but not agreed yet) for deletion, pending consensus.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">There
is consensus on the aim and strategy to promote R&D, focussing on
type II and type III diseases, and specific needs of developing
countries in respect of type I diseases - those that are incident in
rich and poor countries, and with large numbers of vulnerable
populations in each, Type II diseases are those in both rich and poor
countries, but with a majority of cases in poor countries - often
termed neglected diseases, like tuberculosis. Type III are those
diseases overwhelmingly or exclusively incident in developing
countries, and termed very neglected diseases. (See SUNS #6360 dated 7
November 2007.)<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">There
is lack of consensus on supporting the application and management of
intellectual property that maximises health-related innovation,
protects public health and promotes access to "health products" or
"medicines." Divergences exist on the use of the terms "health
products" or "medicines." There are also divergences on support to
explore and implement "innovative" or "alternative" incentive schemes
for R&D "to complement the existing ones." The <st1:country-region
w:st="on"><st1:place w:st="on">US</st1:place></st1:country-region> is
reportedly against suggestions that the current incentive system is
inappropriate.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Similarly,
there is consensus except from the US, regarding the development of
proposals for health-needs driven R&D to include a range of
incentive mechanisms and a method for tailoring the "optimal mix of
incentives" to a particular condition or product for addressing
diseases that disproportionately affect developing countries.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Under
Principles, there is consensus that, intellectual property rights are
an important incentive in the development of new health care products.
However, this incentive alone does not meet the need for the
development of new products where the potential market for the sale of
the products is small or uncertain.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Two
alternate principles are also pending further discussion. The Rio Text
Group (a group of 14 Latin American countries) has proposed that "right
to health takes precedence over commercial interests"; this is posed as
an alternative to the "objectives of public health and the interests of
trade should be appropriately balanced and coordinated."<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Under
element one, prioritising research and development needs, there is
consensus to map and identify gaps in research and development on
diseases that disproportionately affect developing countries.
Developing countries are also to set research priorities on traditional
medicine.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Under
element two, promoting research and development, there is no consensus
on whether developed countries "shall allocate a progressive percentage
of its budget" or an "appropriate proportion" of their health R&D
to the health needs of developing countries. There is also contention
on whether there should be facilitation of upstream research; the
identification of intellectual property provisions that might
negatively affect increased research on public health; the creation of
open databases and compound libraries; and consideration and assistance
of the use of research exemptions in legislations of developing
countries to address public health needs.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">There
is consensus that there should be support for national health research
programmes in developing countries through political action and "where
feasible and appropriate, long term funding." There is also
encouragement for further exploratory discussions on the utility of
possible instruments or mechanisms for essential health and biomedical
R&D including an essential health and biomedical R&D treaty.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Regarding
element three, building and improving innovative capacity, there is no
consensus to urge member states to mitigate the adverse impact of the
loss of health personnel through migration; strengthen clinical trials
and regulatory infrastructure in developing countries particularly in
sub-Saharan Africa; promote protection and documentation of traditional
knowledge and natural genetic resources in an international sui generis
framework; and, encourage and promote national and international
policies on traditional medicine to facilitate prior art for patent
regimes and disclosure and benefit sharing. There is consensus to
strengthen health surveillance and information systems, ethical reviews
in R&D, and regulatory capacity in developing countries.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Under
element four, transfer of technology, there is no consensus to devise a
list of essential technologies related to research and local
production; encourage/promote the dissemination of health-related
technology information contained in patents, patent applications and
information related to patent status, oppositions, revocations and
nullifications; make arrangement to support technology transfer from
the North to the South; and, consider additional or voluntary and
complementary or alternative mechanisms to promote innovation. There is
consensus to encourage North-South and South-South cooperation and to
continue to promote technology transfer to least developed countries
consistent with Article 66.2 of the WTO TRIPS agreement.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Under
element five, Management of Intellectual Property, there is agreement
that incentive schemes for R&D into type II and type III diseases
need to be explored, and where appropriate type I. However, there is no
consensus on many of the elements discussed thus far including support
for the application and management of intellectual property that
maximises health-related innovation to meet the R&D needs of
developing countries, and, the compilation and maintenance of global
databases on the status of health patents.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Discussions
are to continue in the reconvened session. The proposal to promote and
support national and regional institutional frameworks and
international cooperation to build and strengthen capacity to manage
and apply intellectual property in a manner orientated to public health
needs and priorities of developing countries, is pending consensus from
the <st1:country-region w:st="on"><st1:place w:st="on">US</st1:place></st1:country-region>.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">Regarding
element 7, promoting sustainable financing mechanisms, there is no
consensus on the establishment of a task force to examine current
financing, coordination and prioritisation of R&D; devising and
setting up sustainable sources of funding; or, the establishment of a
global R&D fund. Element 8, on monitoring and reporting systems
envisages the establishment of systems to monitor performance and
progress of the implementation of each element of the Global Strategy
and Plan of Action and to report periodically to the WHO governing
bodies. A progress report will be submitted every two years and a
comprehensive evaluation of the strategy will be undertaken after four
years.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">At
the closing session, WHO Director General, Margaret Chan, expressed
WHO's and her personal commitment to move forward in areas where "we
have mandates and the organisation is gearing to do more."<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><st1:country-region
w:st="on"><st1:place w:st="on">Kenya</st1:place></st1:country-region>,
for the 46 member states of the AFRO region, said that current systems
have failed to meet the needs of the poor and that type II and III
diseases are not given attention. It expressed the hope that no one
will put brackets around this.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">The
current proprietary regimes results in major problems in Africa and the
Working Group must provide leadership, <st1:country-region w:st="on"><st1:place
w:st="on">Kenya</st1:place></st1:country-region> said. Avoiding the
real problems will not bring a solution. To achieve results, "we must
have a clear funding mechanism; this is the cement that will hold the
structure together."<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><st1:country-region
w:st="on">Kenya</st1:country-region> assured the constructive role of <st1:place
w:st="on">Africa</st1:place> and urged others to negotiations with a
view to provide a solution through the spirit of flexibilities to save
lives and reduce suffering. It requested that AFRO members receive the
documentation for Working Group meetings well in advance. In addition, <st1:country-region
w:st="on"><st1:place w:st="on">Kenya</st1:place></st1:country-region>
looked to the Secretariat to provide for the participation of African
delegations so that it is not disorganised, particularly, as relates to
travel arrangements.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><st1:country-region
w:st="on">Honduras</st1:country-region>, on behalf of the Group of
Latin American and Caribbean Countries, reiterated what <st1:country-region
w:st="on"><st1:place w:st="on">Brazil</st1:place></st1:country-region>
had said regarding the follow-up process. <st1:country-region w:st="on"><st1:place
w:st="on">Honduras</st1:place></st1:country-region> emphasised that
the further discussions must take into account the (health) situation
of countries and their level of development.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><st1:country-region
w:st="on"><st1:place w:st="on">Libya</st1:place></st1:country-region>,
for the EMRO region, stressed that the main objective was to find
solutions and hoped there would be solid cooperation through transfer
of technology and exchange of experiences in order to produce medicines
that are available to all.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><st1:place
w:st="on">Oldham</st1:place>, in some personal comments, hoped that
there would be no reversal at the next meeting of the progress achieved
so far.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><st1:country-region
w:st="on"><st1:place w:st="on">Brazil</st1:place></st1:country-region>
said after the meeting that it takes a great amount of effort to change
a culture of monopoly and the concentration of power. Progress has been
painfully slow but WHO has shown itself to be more engaged. It said the
shortcomings of the intellectual property system go to the heart of
delivery and that the in-depth discussion would enrich the WHO.<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"> <o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;">The
<st1:country-region w:st="on">United States</st1:country-region>,
backed by the EU, expressed concern that some parts of the Conference
paper, that have been merged and marked as consensus, was not
acceptable to the <st1:country-region w:st="on"><st1:place w:st="on">US</st1:place></st1:country-region>,
and wanted a review to accurately reflect the discussions. +<o:p></o:p></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style=""><o:p> </o:p></b></p>
<p class="MsoNormal" style="margin: 0in 0in 0pt; text-align: justify;"><b
style=""><o:p> </o:p></b></p>
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