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<DIV><B>From:</B> <A title=twnet@po.jaring.my
href="mailto:twnet@po.jaring.my">Third World Network</A> </DIV>
<DIV style="FONT: 10pt arial">
<DIV> </DIV></DIV>
<DIV>
<P class=MsoPlainText style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal"><SPAN
style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman'"><A
href="http://www.twnside.org.sg">www.twnside.org.sg</A><o:p></o:p></SPAN></B></P>
<P class=MsoPlainText style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal"><SPAN
style="FONT-SIZE: 12pt; FONT-FAMILY: 'Times New Roman'"><o:p> </o:p></SPAN></B></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal">Impasse on TRIPS talks and the Health
permanent solution<o:p></o:p></B></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal"><o:p> </o:p></B></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal">The World Trade Organisation was supposed
to conclude a ‘permanent solution’ to the problem facing countries that have no
or inadequate drug manufacturing capacity so that they can have access to
affordable medicines.<o:p></o:p></B></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal"><o:p> </o:p></B></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal">The impasse that has taken place in the
recent negotiations brings into focus the importance of the issue to the
developing countries in the light of the global avian flu threat and the
shortage of the anti viral drug to treat bird flu.<o:p></o:p></B></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal"><o:p> </o:p></B></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal">We include the background note by Sangeetha
Shashikant and the report on the talks by Martin Khor.<o:p></o:p></B></P></DIV>
<DIV style="TEXT-ALIGN: justify"><FONT face=Arial size=2></FONT> </DIV>
<DIV>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify">Please find
below the latest news on negotiations taking place in the World Trade
Organization in Geneva on TRIPS (Trade Related Aspects of Intellectual Property
Rights) and Public Health, in relation to supply of medicines to countries with
insufficient or no manufacturing capacity.</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"><B
style="mso-bidi-font-weight: normal">Background Note: <o:p></o:p></B></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal">[For those not familiar with Paragraph 6
Negotiations (also known as the 30 August Decision)]<o:p></o:p></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">In November
2001, Trade Ministers in <st1:City w:st="on"><st1:place
w:st="on">Doha</st1:place></st1:City> agreed on a special declaration
recognizing the right of countries to take measures to protect public health and
promote access to medicines. This Declaration came to be known as the Doha
Declaration on the TRIPS Agreement and Public Health (available at <A
href="http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.doc"
target=_blank><SPAN
style="COLOR: #003399; TEXT-DECORATION: none; text-underline: none">http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.doc</SPAN></A>
.</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 Doha
Declaration as it is commonly known, confirmed among others the right of
developing countries to use compulsory licenses (for purposes of import,
manufacture and export of generic medicines without the consent of the patent
holder but subject to certain conditions), parallel importation etc. </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">It was
expressly recognized by Paragraph 6 of the Doha Declaration that a solution has
to be found about supplying essential medicines to countries with insufficient
or no manufacturing capacity.</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">This concern
arose largely from the fact that once countries that are major producers and
exporters of generic products such as <st1:country-region w:st="on"><st1:place
w:st="on">India</st1:place></st1:country-region> put in place laws that grant
patents on pharmaceutical products, these countries will face legal obstacles to
produce and export cheap generic copies of patented medicines. This will be
detrimental to the supply of medicines to countries with insufficient or no
manufacturing capacity. </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">India</st1:place></st1:country-region> has
beginning of this year allowed patents for pharmaceuticals products.</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">Essentially
if there a patent on a pharmaceutical product, production for export can only
take place under a compulsory license. However the TRIPS Agreement establishes
that a compulsory license must be “predominantly for the supply of the domestic
market”. For more information on the procedures relating to compulsory license
please refer to the TWN Manual at <A
href="http://www.twnside.org.sg/title2/manual.htm" target=_blank><SPAN
style="COLOR: #003399; TEXT-DECORATION: none; text-underline: none">http://www.twnside.org.sg/title2/manual.htm</SPAN></A>
</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"><I
style="mso-bidi-font-style: normal">Example</I>:</P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify">If a
pharmaceutical product is patented in <st1:country-region w:st="on"><st1:place
w:st="on">India</st1:place></st1:country-region>, it cannot simply manufacture
and export. The Indian government will have to issue a compulsory license
to manufacture and the manufacturing must be “predominantly” to supply the
Indian domestic market. Only the balance (the non-predominant portion) can be
exported. </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">In
recognition of this problem paragraph 6 of the Doha Declaration directed that a
solution be found. After months of debates, a temporary agreement to address the
problem was finally reached on 30 August 2003 (the Decision). The Decision
outlines various procedures that importing and exporting countries have to
follow. Many have criticized this Decision as cumbersome and difficult to use. A
Statement was also read by the Chair that presided over the meeting that came up
with the Decision (Chairman’s Statement). The Chairman’s statement further
requires more cumbersome procedures to be followed. Both the August Decision and
the Chairman’s statement came about following intense pressure from the
multinational pharmaceutical companies in the developed countries particularly
the <st1:country-region w:st="on"><st1:place
w:st="on">US</st1:place></st1:country-region>.</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"
align=left>The 30 August Decision can be found at - <A
href="http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm"
target=_blank><SPAN
style="COLOR: #003399; TEXT-DECORATION: none; text-underline: none">http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm</SPAN></A>
</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
Chairman’s Statement can be found at - <A
href="http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm"
target=_blank><SPAN
style="COLOR: #003399; TEXT-DECORATION: none; text-underline: none">http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm</SPAN></A>
</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 Africa
Group submitted early this year a proposal to make the temporary agreement,
permanent by amending the TRIPS Agreement as well as proposed the removal of the
many procedures found in the August Decision. The Africa Group does not want to
make any reference to the Chairman’s statement. <st1:country-region
w:st="on">Brazil</st1:country-region> and <st1:country-region
w:st="on"><st1:place w:st="on">India</st1:place></st1:country-region> have found
the Africa Group proposal to be a good basis for discussion on how to amend the
TRIPS Agreement. <st1:country-region w:st="on">Brazil</st1:country-region> and
<st1:country-region w:st="on"><st1:place
w:st="on">India</st1:place></st1:country-region> are not happy with the way the
consultations on this matter have taken place.</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 US and
European Community (EC) are not in agreement with the Africa Group proposal.
They do not want to change any aspect of the August Decision and the Chairman’s
statement. Of particular concern is to the developed countries is the legal
status of the Chairman’s statement. </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">For now
(pending a permanent resolution of this matter), countries that wish to import a
product that is patented in the manufacturing country (e.g. in
<st1:country-region w:st="on"><st1:place
w:st="on">India</st1:place></st1:country-region>), there may be a need to use
the 30 August Decision. To learn about when the 30 August Decision is triggered
and the procedures that are required to be complied to produce, export and
import generic medicines, please refer to the WHO publication to be found at
</P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><A
href="http://www.who.int/medicines/areas/policy/WTO_DOHA_DecisionPara6final.pdf"
target=_blank><SPAN
style="COLOR: #003399; TEXT-DECORATION: none; text-underline: none">http://www.who.int/medicines/areas/policy/WTO_DOHA_DecisionPara6final.pdf</SPAN></A>
</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"><I
style="mso-bidi-font-style: normal">Further Resources:<o:p></o:p></I></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify">For More
information on the history and current Paragraph 6 Negotiations please click -
<A href="http://www.cptech.org/ip/wto/p6/" target=_blank><SPAN
style="COLOR: #003399; TEXT-DECORATION: none; text-underline: none">http://www.cptech.org/ip/wto/p6/</SPAN></A>
</P>
<P class=MsoNormal
style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><o:p> </o:p></P></DIV>
<DIV class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"
align=left>Text of the TRIPS Agreement - <A
href="http://www.wto.org/english/docs_e/legal_e/27-trips.doc"
target=_blank><SPAN
style="COLOR: #003399; TEXT-DECORATION: none; text-underline: none">http://www.wto.org/english/docs_e/legal_e/27-trips.doc</SPAN></A>
</DIV>
<DIV>
<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">Please do
not hesitate to contact us should you wish to have further information.</P>
<P class=MsoNormal
style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><o:p> </o:p></P>
<DIV class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: center"
align=center>
<HR align=center width="100%" SIZE=2>
</DIV>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><B
style="mso-bidi-font-weight: normal">Impasse on talks on TRIPS and Health
“permanent solution”<o:p></o:p></B></P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><FONT
face=Arial size=2></FONT><FONT face=Arial size=2></FONT><FONT face=Arial
size=2></FONT><FONT face=Arial size=2></FONT><FONT face=Arial
size=2></FONT><BR>An impasse became evident on negotiations on the major
remaining issue relating to the TRIPS Agreement and Public Health when some key
WTO members appeared far apart on a solution, and disagreed even on how the
process of consultations is going on, during a meeting of the TRIPS Council on
25 October.</P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><FONT
face=Arial size=2></FONT> </P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify">Some
developing countries, particularly <st1:country-region
w:st="on">Brazil</st1:country-region> and <st1:country-region
w:st="on"><st1:place w:st="on">India</st1:place></st1:country-region>,
complained that they had been left out of consultations taking place between a
few countries. They also reiterated their support for the proposal by the
African Group as a good basis for negotiations towards a solution.</P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><FONT
face=Arial size=2></FONT> </P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify">African
countries indicated that they were prepared to engage with others, and quoted a
declaration by the African Health Ministers for the need to find a permanent
solution that removes all constraints and procedural requirements to the export
and import of generic medicines.</P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><FONT
face=Arial size=2></FONT> </P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify">The
<st1:country-region w:st="on"><st1:place
w:st="on">US</st1:place></st1:country-region> was adamant that a solution must
include the statement of the Chair of the General Council before the adoption of
a decision on 30 August 2003. However, <st1:country-region
w:st="on">India</st1:country-region>, <st1:country-region w:st="on"><st1:place
w:st="on">Brazil</st1:place></st1:country-region> and other developing countries
did not want a solution in which the Chairman’s statement is upgraded to a
higher legal status than what it now has.</P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><FONT
face=Arial size=2></FONT> </P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify">The issue at
hand is the TRIPS Council’s search for a “permanent solution” to ensuring access
to medicines for countries that have no or inadequate drug manufacturing
capacity.</P>
<P class=MsoNormal style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"><FONT
face=Arial size=2></FONT> </P>
<P class=MsoNormal
style="MARGIN: 0in 0in 0pt; TEXT-ALIGN: justify"> </P></DIV></BODY></HTML>