RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/M/33
2 November 2001
(01-5392)
Council for Trade-Related Aspects
of Intellectual Property Rights
MINUTES OF MEETING
Held in the Centre William Rappard
on 19 and 20 September 2001
Acting Chairperson:  Ambassador Alejandro Jara (Chile)
Subjects discussed: Para. Nos .
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT 2-5
(i) Notifications under Article 63.2 2-4
(ii) Notifications under Article 69 5
B. REVIEW OF NATIONAL IMPLEMENTING LEGISLATION 6-39
(i) Outstanding initial questions from the review of the legislation
of Kuwait initiated in November 2000 6-8
(ii) Outstanding initial questions from the reviews of the
legislation of Bolivia, Cameroon, Congo, Grenada, Guyana
and Suriname initiated in April 2001 9-14
(iii) Outstanding initial questions from reviews initiated in June 2001 15-20
(iv) Follow-up to the reviews already undertaken 21-39
C. IMPLEMENTATION OF ARTICLE 70.8 AND 70.9 40
D. IMPLEMENTATION OF ARTICLE 66.2 41-54
E. INFORMATION ON TECHNOLOGY CAPACITY -BUILDING 55
F. TECHNICAL COOPERATION 56-68
(i) Annual Updates on Technical Cooperation Activities 56-64
(ii) Joint Initiative 65-68IP/C/M/33
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Subjects discussed: Para. Nos .
G. IMPLEMENTATION OF ARTICLE 23.4 69-73
H. IMPLEMENTATION OF ARTICLE 24.1 74-103
I. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE
SECTION ON GEOGRAPHICAL INDICATIONS UNDER ARTICLE 24.2 104-109
J. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(b) 110-131
K. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT
UNDER ARTICLE 71.1 132
L. NON-VIOLATION AND SITUATION COMPLAINTS 133-137
M. ELECTRONIC COMMERCE 138-147
N. INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES 148-248
O. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO 249-253
(i) Accessions 249-250
(ii) Dispute settlement 251-253
P. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS 254-256
Q. ANNUAL REPORT TO THE GENERAL COUNCIL 257-258
_______________
1. Since the Chairperson of the Council, Ambassador Boniface Chidyausiku of Zimbabwe, was
not in a position to attend the present meeting due to other obligations, and in view of consultations
held by the Chairperson of the General Council, the meeting was chaired on his behalf by
Ambassador Alejandro Jara of Chile.
A. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT
(i) Notifications under Article 63.2
- Notifications from Members whose transitional periods under Article 65.2 or 65.3
expired on 1 January 2000 or who acceded to the WTO after that date
2. The Chairperson informed the Council that the Secretariat had updated its note reflecting the
status of the notifications received from these Members so far (JOB(01)/133).  The note showed from
which of the Members in question notifications had been received by 14 September 2001.  Since then,
additional notifications of laws and regulations had been received from Costa Rica
(IP/N/1/CRI/1/Add.1) and Nigeria (IP/N/1/NGA/C/1, I/1 and T/1).  Although there were moreIP/C/M/33
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notifications than at the time of the Council's previous meeting, he said that there were still Members
whose legislation was scheduled to be reviewed in 2001 who had not yet submitted any notification
concerning their implementing legislation.  No tifications from a number of other Members were
incomplete.  Once again, he urged these Members to submit the outstanding material without delay.
He recalled that pursuant to Article 63.2 of the Agreement the notifications of the laws and
regulations in question were due as of 1 January 2000.  He urged the delegations in question, if someof the material to be notified was not yet ready, to submit whatever could be notified at once and
complement the notification later when other parts of the material were ready.  He reminded
delegations that, under the Agreement Between WIPO and the WTO and decisions taken by WIPO's
Governing Bodies, the International Bureau of WIPO was in a position to assist delegations with the
translation of their main dedicated intellectual property laws and regulations, as required.
3. The representative of Canada said that her delegation would make an additional notification
of legislation shortly.
- Notifications from other Members
4. The Chairperson informed the Council that, since the last meeting, amendments to legislation
notified earlier had been received from the Czech Republic;  Hong Kong, China;  and Slovenia.
These notifications would be available in the IP/N/1/- series of documents as soon as possible.
(ii) Notifications under Article 69
5. The Chairperson informed the Council that, si nce the previous meeting, notifications of
contact points under Article 69 of the Agreement had been received from Belize, Costa Rica, Croatia,
Lithuania, Mali and St. Lucia.  These notifications would be circulated in the IP/N/3/- series of
documents as soon as possible.  There were now 109 Members who had notified contact points under
Article 69.
B. REVIEW OF NATIONAL IMPLEMENTING LEGISLATION
(i) Outstanding initial questions from the review  of the legislation of Kuwait initiated in
November 2000
6. The Chairperson recalled that, at its previous meeting, the Council had noted that Kuwait had
not responded to some initial questions posed in the review of its legislation, which had been initiated
in November 2000.  The Secretariat had recently received copies of further responses from Kuwait,
which would be available in document IP/C/W/232/Add.4, but there was still a small number of initial
questions outstanding.
7. The representative of Kuwait said that there were eight initial questions outstanding due to
technical reasons.  He apologised for the delay in submitting the responses and said that they would
be submitted by the next meeting.  He asked any delegation that wished to submit follow-up questions
to do so without delay.
8. The Council took note of this statement, urged  Kuwait to submit the outstanding replies
without delay and agreed to revert to this sub-item at its next meeting.
(ii) Outstanding initial questions from the reviews of the legislation of Bolivia, 
Cameroon, Congo, Grenada, Guyana and Suriname initiated in April 2001
9. The Chairperson recalled that, at the previous meeting of the Council, eight Members whose
reviews had been initiated in April 2001 had had initial questions outstanding.  He informed theIP/C/M/33
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Council that, since that time, some of the outst anding answers had been received from Cameroon1 and
Grenada2, but that replies to initial questions remained outstanding from all six Members.  The
Secretariat had not received copies of responses from Guyana to any of the questions posed to it.
10. The representative of Bolivia said that the only questions outstanding for his delegation
concerned requests for statistics by the United States.  He said that his delegation could not provide
the requested statistics, as such statistics were not collected in his country.
11. The Chairperson suggested that the delegation of Bolivia submit this statement in writing to
the United States, with a copy to the Secretariat, as its response to the outstanding questions.
12. The representative of Congo said that his delegation had answered all initial questions except
those posed by the European Communities and their member States, as circulated in document
IP/C/W/244, which it had not yet received in French.
13. The Chairperson said that a French translation of the questions was now available and asked
the Secretariat to provide a copy to the delegation of Congo.
14. The Council took note of the statements made, urged  the six Members in question to supply
their replies without delay and agreed to revert to this sub-item at its next meeting.
(iii) Outstanding initial questions from reviews initiated in June 2001
15. The Chairperson recalled that, at its previous meeting, the Council had initiated the reviews of
22 Members.  Since that meeting, outstanding responses to initial questions had been received from
Albania3, Bahrain4, Croatia5, Dominica6, the Dominican Republic7, Jamaica8 and Oman9.  Responses
to initial questions remained outstanding from the following Members:  Botswana, Côte d'Ivoire,
Egypt, Fiji10, Georgia, Jamaica, Kenya, Mauritius, Morocco, the Philippines, St. Kitts and Nevis and
the United Arab Emirates.
16. The representative of Egypt said that his delegation would submit the responses to
outstanding initial questions before the Council's next meeting.
17. The representative of Jamaica said that her mission had received the responses to outstanding
questions from the capital and would submit them shortly.
18. The representative of Kenya said that his delegation had answered all but one initial question.
It would provide the response to that question before the Council's next meeting.
                                                     
1 Document IP/C/W/302.
2 Document IP/C/W/301.
3 Document IP/C/W/267/Add.2.
4 Document IP/C/W/309 and Add.1.
5 Document IP/C/W/262/Add.3.
6 Document IP/C/W/275/Rev.1.
7 Document IP/C/W/285/Add.1.
8 Document IP/C/W/266/Add.1.
9 Document IP/C/W/282/Add.2.
10 The delegation of Fiji submitted many responses to initial questions shortly after the meeting and
these have been circulated in document IP/C/W/311.IP/C/M/33
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19. The representative of Morocco said that his delegation had answered all but seven initial
questions.  He would submit responses to all but one of the outstanding questions shortly.11
20. The Council took note of the statements made, urged  those Members who had not supplied
responses to initial questions to do so without delay and agreed to revert to this sub-item at its next
meeting.
(iv) Follow-up to the reviews already undertaken
21. The Chairperson informed the Council that ther e remained outstanding a number of follow-up
questions posed during the review meetings in November 2000 and April and June 2001.  With
respect to the reviews initiated in November 2000, since the previous meeting the Secretariat had
received a copy of the outstanding responses from Paraguay.12  Kuwait still had some follow-up
questions outstanding.
22. The representative of Kuwait said that he expected to be able to submit the responses to the
outstanding follow-up questions within three weeks.
23. The Chairperson informed the Council that, with respect to the reviews initiated in
April 2001, the Secretariat had received responses to all outstanding questions from Saint Lucia.  He
suggested that the review of the legislation of Saint Lucia be deleted from the agenda, it being
understood that any Member could revert to any matter stemming from this review at any time.
24. It was so agreed.
25. The Chairperson informed the Council that Congo, Namibia, Papua New Guinea and
Suriname, whose reviews of legislation had also been initiated in April 2001 had not yet provided
responses to all follow-up questions.  Papua New Guinea had not yet made its introductory statement
either.
26. The representative of Congo said that he expected to be able to submit responses to
outstanding follow-up questions before the Council's next meeting.
27. The Chairperson informed the Council that, with respect to the reviews initiated in June 2001,
responses to follow-up questions had been received from Argentina13, Botswana14, Costa Rica15,
Croatia16, the Dominican Republic17 and Honduras.18  However, responses to some or all follow-up
questions were still outstanding from Albania, Bo tswana, Côte d'Ivoire, Egypt, Georgia, Jamaica,
Kenya, Morocco, Nicaragua, Oman, the Philippines and the United Arab Emirates.
28. The representative of Bahrain said that his delegation had responded to all initial questions
and would be happy to respond to any follow-up questions that delegations might wish to pose.
29. The representative of Jamaica said that her mission had received the responses to outstanding
follow-up questions from the capital and would submit them shortly.
                                                     
11 These responses have been circulated in document IP/C/W/265/Add.5.
12 Document IP/C/W/231/Add.2.
13 Document IP/C/W/271/Add.4 and 5.
14 Document IP/C/W/295.
15 Document IP/C/W/269/Add.3.
16 Document IP/C/W/262/Add.4.
17 Document IP/C/W/285/Add.1.
18 Document IP/C/W/277/Add.2 and 3.IP/C/M/33
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30. The representative of Kenya said that his delegation had received three follow-up questions to
which it would respond before the next meeting.
31. The representative of Nicaragua said that his delegation had already sent its responses to
follow-up questions to the delegation of Switzerland and would submit a copy to the Secretariat.19
32. The representative of the United States thanked delegations for their responses to the
numerous questions that his delegation had posed.  He hoped that the reviews of legislation had
facilitated the process of implementation of the Agreement.
33. The representative of the European Communities said that his delegation attached the greatest
importance to the reviews of national legislation.  It found the procedure useful and instructive.
34. The representative of Canada thanked Bahrain, the Dominican Republic and Kuwait for the
responses that they had provided to additional questions posed by Canada in the review of legislation.
35. The Council urged those Members who had not supplied responses to follow-up questions to
do so without delay.
36. The Chairperson informed the Council that, at its next meeting, in November 2001, it was
scheduled to initiate the reviews of  the legislation of 21 Members.  These were Antigua and Barbuda,
Barbados, Brazil, Brunei Darussalam, Cuba, Gabon, Ghana, India, Lithuania, Malaysia, Nigeria,
Pakistan, Qatar, Senegal20, Sri Lanka, St. Vincent and the Grenadines, Swaziland, Thailand, Tunisia,
Uruguay and Zimbabwe.  He recalled that, at its meeting in April 2001, the Council had agreed that itwould begin with the legislation of Saint Vincent and the Grenadines and continue in alphabetical
order.  The Council had also agreed that questions should be posed to Members concerned by
14 September 2001 and responses to questions posed within that deadline should be submitted by
26 October 2001.  However, to date, the Secretariat had not yet received copies of any questions for
these reviews, apart from the questions posed on the legislation of Antigua and Barbuda, Brazil,Ghana and Qatar, whose reviews had originally been scheduled to be initiated at an earlier meeting,
but which had been postponed until the Council's meeting in November 2001.
37. The Council urged delegations who wished to pose questions in the November review to
submit their questions in writing to the Members concerned, with a copy to the Secretariat, without
delay.
38. The Chairperson informed the Council that Brazil had submitted responses to questions posed
by the European Communities and their member States, Japan, Switzerland and the United States,
which had been circulated in documents IP/C/W/303 and Add.1.
39. The Council took note of the statements made and agreed  to revert to this sub-item at its next
meeting.
C. IMPLEMENTATION OF ARTICLE 70.8 AND 70.9
40. The Chairperson informed the Council that Costa Rica's additional notification of laws under
Article 63.2, to which he had referred under agenda item A, also contained information relating to
Article 70.8 and 70.9 of the Agreement.21
                                                     
19 Subsequently received and circul ated in document IP/C/W/288/Add.3.
20 Subject to confirmation, in view of Senegal's new LDC status.
21 This will be circulated in document IP/N/1/CRI/1/Add.1.IP/C/M/33
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D. IMPLEMENTATION OF ARTICLE 66.2
41. The Chairperson recalled that the implementation of Article 66.2 had been under discussion
in the Council since December 1998 and that the Council had received information from 20 developed
country Members on how that provision was being implemented in their territories (documents
IP/C/W/132 and addenda).  Since June 2000, the Council had also had before it a Secretariat note
(IP/C/W/169) prepared on a request from the Council, setting out the types of incentive measures thathad been notified, with cross references to where further details could be found;  as well as a proposal
from the delegation of Zambia relating to special and differential treatment in respect of technology
transfer (IP/C/W/199).  In relation to Article 66.2, the Special Session of the General Council had
agreed, at its meeting of 18 October 2000, to invite the TRIPS Council, with a view to facilitating full
implementation of Article 66.2:  to give consideration to drawing up an illustrative list of incentives of
the sort envisaged by Article 66.2;  to put on a regular and systematic basis its procedure for the
notification and monitoring of measures in acco rdance with the provisions of Article 66.2 and, in
doing so, to give consideration to avoiding unnecess ary burdens in notification procedures;  that the
TRIPS Council invite other intergovernmental organi zations to provide information on their activities
aimed at technology capacity-building.  At its pr evious meeting, the Council had had an initial
discussion on issues addressed in a communication it had received from Zambia (document
IP/C/W/298) relevant to this agenda item and agenda items E and K.
42. The representative of the United States provided information on how the United States had
implemented its obligations under Article 66.2.  He highlighted a program that might be of particular
interest to the African Group, named the US African Development Fund ("ADF").  The ADF had
been established by the US Congress in 1984 as a US public corporation to work directly with
community-based groups in sub-Saharan African countries to help diagnose and solve communityproblems.  The programme was unique because all ADF-funded activities were conceived and
implemented locally in the countries involved and grants were awarded directly to grassroots African
groups, entrepreneurs and researchers to fund those activities.  To illustrate, he referred to several
recent projects.  Twenty-two women Members of the Home Girls Cooperative, located 250 miles
from the capital of Zimbabwe, had been given a grant of US$87,467 over a period of five years totransform their jewellery making into a profitable jewellery and accessory-making enterprise that
earned a steady income.  The group had doubled its share of the domestic jewellery market to
28 per cent and had initiated sales in South Africa and Japan.  The funds were used to purchase raw
materials for beads, to construct and electrify their production facility, and to obtain management
training.  The Nyamaropa-Nyakomba Paprika Growers Association, formed in 1997, had received agrant of US$201,616 over five years to help small-scale paprika farmers enter local, regional and
international markets through increasing productivity, enhancing quality and obtaining marketing and
technical assistance.  The project had increased the average incomes of paprika producers from
Z$8,000 to Z$24,340 per acre by year three.  The Uganda Gender Micro Credit and Afforestation
Project, an umbrella non-governmental organization with over 27,000 members in 1,202 groups, had
been given a grant of US$209,332 over five years.  The organization used the grant to provide
drastically needed alternatives to subsistence farming for its members by providing training and 6,000small loans to establish small tree nurseries for fruit trees and fuel-wood trees, operated by 25 groups
in five target districts.  Group members were trained in credit administration, business management
and afforestation.  The Opportunities Industrialization Centers of Tanzania had been given a grant of
US$37,243 for over six months to provide local non- governmental organizations with training in
financial and organizational sustainability so that staff in these organizations could understand financeand enterprise development as the country moved progressively toward a market economy.  The
Diourbei Fish Preservation and Marketing Project, a union of 57 women's cooperatives in Senegal,
had been given a grant of US$208,083 over five years to construct a fish processing and cold storage
facility in order to provide reliable employment and increasing revenue for the group.  The new
working capital expanded the credit fund, and training was provided cooperative members inmarketing, management and food preservation.  By the fifth year, the union expected to sell 7.5 tonsIP/C/M/33
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of fish weekly, benefitting 3,000 members, their families and local fishermen.  The Djiratawa
Irrigated Area Cooperatives in Niger had received  a grant of US$236,096 over five years through
repair of its water system and construction of wells that strengthened the capacity of 872 households
to produce tomatoes, cotton and wheat for sale to local processors.  Women members used the grain
mill to produce traditional pasta.  A portion of the proceeds from these activities went to support a
revolving fund for further income-gathering activities.  In the southern region of Namibia, theVaaigras Ostrich Pilot Project had received a grant of US$55,532 over fourteen months to establish
the first group of farmers in Namibia to engage in commercial ostrich production.  The project
provided working capital for feedstock, technica l assistance and office equipment for agricultural
management.  The results were a new, more environmentally friendly industry for subsistence
communal farmers.  These were just a few examples of the activities for which the ADF provided
grants but they represented important changes in the lives of the people who benefitted from them.
The ADF was unique in that it carried out its mission by providing grants to community groups,cooperatives, micro-entrepreneurs, small farmers and African non-governmental organizations to fund
projects that had a direct impact on local African society.  The agency had found that micro-credit
projects in Africa could yield high development returns particularly among the populations that had
historically not had access to commercial credit.  Through several of its projects in New Guinea in
which it had formed partnerships with USAID and the World Bank, the ADF had also found that itsgrassroots-focused development approach could be of use in helping large institutions infuse
significant resources in specific regions so that longer-term sustainable impacts could be achieved.
The ADF had established country liaison officers in Benin, Botswana, Cameroon, Cape Verde,
Ghana, Guinea, Lesotho, Mali, Namibia, Niger, Senegal, Tanzania, Uganda and Zimbabwe.  More
detailed information on the ADF was available at the ADF homepage at http://www.adf.gov and athttp://linux.adf.gov, including a list of these liaison officers and information for contacting them.
43. The representative of the European Communities said that his delegation was still examining
Zambia's proposal and would respond at a later time.
44. The representative of Switzerland said that he would make available a list of measures taken
by Switzerland during the past year.
45. The representative of Canada referred to the information submitted by her delegation in
document IP/C/W/132/Add.7.  Her delegation had also provided further technical assistance which
she would notify in due course.
46. The representative of Zambia proposed that the Council request UNCTAD to provide further
information at the next meeting on the UNCTAD Ex pert Meeting on International Arrangements for
Transfer of Technology:  Best Practices for Access to and Measures to Encourage Transfer of
Technology with a view to Ca pacity-Building in Developing Countries, Especially in
Least-Developed Countries, held in Geneva from 27 to 29 June 2001.  That meeting had noted that
"the concerns of the international community with respect to enhancing the transfer of technology to
developing countries, in particular to the least-developed countries, as well as their technological
capabilities, are reflected in several dozen internat ional instruments.  These instruments express the
willingness of development partners to cooperate  multilaterally.  There has been some success in
implementation, but more needs to be done".  A number of best practices examined by the experts
included the following:  "International instrume nts with built-in implementation mechanisms,
including financial provisions and monitoring arrangements, have a promising implementation record
and should be emulated.  These instruments are relatively few and mainly for purposes of the public
good, such as environmental protection.  Nevertheless, they can serve as a model in other areas suchas infrastructure, health, nutrition and telecommunication".  The model in question included precisely
some environmentally-related transfer of technology, such as the Montreal Protocol or the CBD,IP/C/M/33
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containing a mechanism for financing transfer of technology to developing countries.22  Responding
to the intervention by the United States, he said that not all the examples given concerned the
implementation of Article 66.2, since some of the countries referred to were not least-developed
country Members.  He reminded developed country Members of his request at the previous meeting
for specific types of information on the implementation of Article 66.2 (as circulated in document
IP/C/W/298) and asked them to respond in writing before the next meeting.
47. The representatives of Brazil, Canada  and India  supported Zambia's proposal that the Council
request UNCTAD to provide further information on the outcome of its Expert Meeting at the
Council's next meeting.
48. The representative of India suggested that, in future, developed country Members follow the
format for information suggested by Zambia in do cument IP/C/W/298.  The emphasis in Article 66.2
was on transfer of technology and it might be useful to know in each case the field of technology, the
mode of transfer, the specific incentives and also whether the transferred technology was patented ornot.
49. The representative of Zambia asked developed country Members to distinguish between
technical assistance and technology transfer.  The fo rmer was not a substitute for the latter.  He also
emphasized that the format of information submitted was important.  He recalled that Members
followed a specific format when notifying impl ementing legislation under Article 63.2 and, in the
same way, information on the implementation of Article 66.2 should also follow a specific format.  It
would be helpful if developed country Members foll owed the format that his delegation had suggested
in document IP/C/W/298.
50. The representative of Brazil stressed that Article 66.2 contained a mandatory obligation for
developed country Members.  He also distinguished between technical cooperation and transfer of
technology.
51. The representative of the European Communities said that he certainly acknowledged that
Article 66.2 contained a mandatory obligation for developed country Members.  He clarified that he
had not promised to submit information in the format suggested by Zambia.  His delegation was still
considering what to submit and in which format.
52. The representative of Canada said that it was not always easy to submit information in a
particular format but that her delegation would try to do so.
53. The Chairperson suggested that the Council urge those developed country Members who had
not yet done so to provide the information request ed by Zambia;  invite UNCTAD to submit written
information on the outcome of the UNCTAD Expert Meeting on International Arrangements forTransfer of Technology in June 2001 for distribution to WTO Members, and to make a statement at
the next meeting of the Council updating it on the work on-going in UNCTAD relevant to the
implementation of Article 66.2 of the TRIPS Agreement, in particular as a result of its Expert
Meeting;  take note of the format for information suggested by Zambia in document IP/C/W/298;  and
revert to the matter at its next meeting.
54. The Council so agreed, while taking note of the statements made.
                                                     
22 See "International arrangements for transfer of technology", Outcome of the Expert Meeting,
UNCTAD document TD/B/COM.2/EM.9/L.1 dated 4 July 2001.IP/C/M/33
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E. INFORMATION ON TECHNOLOGY CAPACITY -BUILDING
55. The Chairperson recalled that the Council had agreed, at its meeting in November 2000, to
invite the Secretariats of  UNCTAD, WIPO, UNIDO, the World Bank and the CBD to provide to it
written information on their activities on techno logy capacity-building.  Such information had been
received from WIPO, UNIDO, the CBD Secretariat and UNCTAD and distributed in documents
IP/C/W/243 and addenda.  At the previous meeting, the Council had received a communication fromthe delegation of Zambia relevant to this info rmation (document IP/C/W/298) and discussed this
matter.
F.
TECHNICAL COOPERATION
(i) Annual Updates on Technical Cooperation Activities
56. The Chairperson recalled that the Council had agreed, at its last meeting, to focus on technical
cooperation at the present meeting.  In preparation for this annual review, developed country
Members were once more requested to update information on their technical and financial cooperationactivities relevant to the implementation of the TR IPS Agreement in time for this meeting.  Other
Members who also made available technical cooperation were encouraged to share information on
these activities if they so wished.  In addition, intergovernmental organizations observers to the
Council as well as the WTO Secretariat were also invited to provide information.  As of
20 September 2001, updated information had been received from Australia, Japan, Switzerland andthe United States, as well as from WIPO, the FAO, the IMF, WHO, UPOV, UNCTAD and the WTO
Secretariat.  The information from developed country Members had been circulated in documents
IP/C/W/306 and addenda, from intergovernmenta l organizations in documents IP/C/W/305 and
addenda, and from the WTO Secretariat in document IP/C/W/304.  Given that some of this
information had been received only shortly before the meeting and that most of it was only availablein the original language, he suggested that Members be given an opportunity to comment on it at the
next meeting as well.
57. The representative of the European Communities said that his delegation was preparing its
communication of updated information and would submit it as soon as possible.
58. The representative of New Zealand said that her delegation would submit its updated
information shortly.  New Zealand remained willing to consider requests for technical cooperation.
59. The representative of Morocco said that his delegation had recently notified its technical
cooperation activities to the Secretariat.  He highlighted certain elements.  Morocco's technical
cooperation activities in intellectual property benefitted Arab and African countries and mainly
related to industrial property and new plant varieties.  Morocco provided a certain number of trainingstages , for example on examination of the homogeneity and stability of plant varieties.  As a
developing country, Morocco provided south-south technical cooperation, demonstrating its belief
that it was necessary to optimize and use the TRIPS Agreement for technology transfer among all
Members.
60. The representative of the United States recognized that many developing country Members
continued to work to bring their intellectual proper ty regimes into full compliance with the TRIPS
Agreement.  He reaffirmed his delegation's commitment to providing assistance in drafting strongintellectual property laws and building the structures needed to enforce those laws.  The United States
often did this in partnership with the WIPO and WTO Secretariats and its own private sector.  The
United States' notification (document IP/C/W/306) showed that it had participated in over
170 programmes for officials from more than 110 countries.  This was substantial evidence of
broad-ranging and substantive technical cooperation.  The United States would continue to provideIP/C/M/33
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this assistance as it had already done for many years.  He invited Members to provide feedback and
make observations about these programs and their utility.  He foreshadowed an amendment to his
delegation's notification which would list efforts by the United States' private sector to provide
technical assistance to Members.
61. The representative of Australia said that her delegation had provided its annual update
(IP/C/W/306/Add.2), which showed that Australia fu lfilled its commitments under Article 67 at the
multilateral, regional and bilateral levels.  The efforts were focused on developing countries in the
Asia-Pacific region.
62. The representative of Japan said that his delegation had provided its annual update
(IP/C/W/306/Add.1), which was self-e xplanatory.  Japan had been carrying out a variety of technical
cooperation activities and continued to be committed to technical cooperation.
63. The representative of Djibouti thanked the developed country Members that provided funds
for technical cooperation but stressed that, for other Members to fulfil their obligations under the
TRIPS Agreement, they needed financial resources to understand the proper functioning of the system
that the Agreement put in place.
64. The Council urged those developed country Members who had not yet provided information
to do so without delay and agreed to revert to this matter at its next meeting, while taking note of the
statements made.
(ii) Joint Initiative
65. The Chairperson recalled that the WIPO and WTO Secretariats had launched, on
14 June 2001, a Joint Initiative on Technical Cooperation for Least-Developed Countries.
66. The representative of the Secretariat recalled the information provided on the Joint Initiative
at the previous meeting and updated the Council as to the information contained in Annex 2 to
document IP/C/W/304.  The first phase of the ini tiative involved two regional workshops – one for
LDCs in sub-Saharan Africa and Haiti, the other for LDCs in the Asia-Pacific region.  These
workshops, together with bilateral contacts, would also help to draw up a list of priority forms of
assistance that should be provided under the Joint Initiative in the second phase which would focus onspecific country action plans.  The two Secretariats were in close contact on the implementation of the
first phase.  They were exploring venues and dates and in contact with some LDCs who had offered to
host a workshop.  It was hoped that the first workshop could be held in May 2002 and the second in
the second half of 2002.  Eight LDCs had expressed interest or made specific requests under the Joint
Initiative.  He welcomed this and recalled that technical cooperation, including this Joint Initiative,was essentially demand-driven.  It was therefore important that interested countries put forward their
requests and identify their needs and priorities, in order to help the two Secretariats provide
tailor-made programmes.  The Secretariats were in contact with each other in deciding how to respond
to the requests that had already been received fr om specific countries.  He added that the Joint
Initiative did not substitute for, but complemented the ongoing technical cooperation work of the two
organizations, both for developing and for least-developed countries.
67. The representative of WIPO said that, in launching the second Joint Initiative for the benefit
of LDCs, invitations had been sent to all 49 LDCs on the United Nations' list.  It should be noted that
WIPO's legal and technical assistance programmes had always included LDCs.  Referring to WIPO's
updated information on technical cooperation on TRIPS implementation (IP/C/W/305), up until the
end of 2000, 34 LDCs had received assistance in draf ting or amending their legislation, and all LDCs
on the United Nations' list, except Somalia, had benefitted from WIPO's legal and technical assistanceprogrammes.  LDCs that wished to make additional or specific requests for assistance under the JointIP/C/M/33
Page 12
Initiative, or that were interested in hosting one of the workshops in 2002, should contact the
Secretariat of either WIPO or the WTO.
68. The Council took note of these statements.
G. IMPLEMENTATION OF ARTICLE 23.4
69. The Chairperson recalled that, at its previous meeting, the Council had received a
comparative table from the delegation of the European Communities (IP/C/W/259) juxtaposing the
proposals that were before the Council concerning the notification and registration system for
geographical indications to be negotiated under Article 23.4 and had had another extensive discussion
of this matter on the basis of these proposals, i. e. the proposal from the EC itself (IP/C/W/107/Rev.1),
the joint proposal from Canada, Chile, Japan and the United States (IP/C/W/133/Rev.1), and the
proposal from Hungary (IP/C/W/234 and 255).
70. The representative of the European Communities, referring to the discussion at the previous
Council meeting following his delegation's submission of the comparative table contained in
document IP/C/W/259, reiterated that he was not im pressed by the arguments of those Members who
did not favour the proposal from the European Communities and their member States and supported
by a large number of Members, and expressed once again his regret not to see any willingness to
begin negotiations on the register.  He took it that  Members were waiting for a signal from Ministers
at Doha in this respect and that more substantial progress could be made in the future.  The EuropeanCommunities and their member States remained strongly committed to the proposals they had made
and hoped that Members would be able to start real negotiations in this area soon and book some
important successes in the future.  In response to co mments that had been made, he wished to make it
clear that the EC proposal intended to facilitate the protection of geographical indications of certain
products, but also aimed at facilitating trade in these products.  Some Members had expressed theconcern that there was an imbalance between Members in respect of geographical indications, since
some Members had large numbers of geographical indications and others did not.  However, clearly,
also for the EC it would be logical at a first stage to notify the geographical indications with a
significant trade impact.  References had also been made to distinctions between a multilateral register
and bilateral agreements.  In this regard, he would like to reiterate that the concept of a multilateralregister was fundamentally different from whatever parties might agree bilaterally and cautioned
Members not to mix up these two approaches.  Furt hermore, he indicated that when referring to
"facilitation" his delegation meant to eliminate all impediments to trade.  In its proposal, his
delegation had indicated that, whenever a geographical indication would be notified, it should be
accompanied by evidence that this geographical indication was valid.  Therefore, he did notunderstand why some Members thought that it would be necessary to establish a database.
71. The representative of Chile, referring to the EC's assertion that some delegations were not
willing to begin negotiations on the register and th erefore prevented the Council from fulfilling the
mandate in Article 23.4 of the Agreement, said that the main reason for the lack of real progress on
this agenda item was the different reading delegations had of this mandate.  There was a group of
delegations which wanted to go far beyond what other delegations, such as his own, understood they
had been assuming during the TRIPS negotiations in the Uruguay Round;  for example, the bindingnature of registration and the introduction of an opposition procedure had never been proposed in the
course of these negotiations.
72. The Chairperson said that, as the representative of the European Communities had said,
Members would wait for the signals from Ministers at the Fourth Ministerial Conference.  He
suggested that the Council take note of the statements made and revert to the matter at its nextmeeting.IP/C/M/33
Page 13
73. The Council so agreed.
H. IMPLEMENTATION OF ARTICLE 24.1
74. The Chairperson recalled that, at its previous meeting, the Council had considered a paper
(document IP/C/W/289) which had been jointly submitted by the delegations of Argentina, Australia,
Canada, Chile, Guatemala, New Zealand, Paraguay and the United States and which outlined those
delegations' views with regard to the joint proposal that the Council had had before it since itsmeeting in April this year and which was sponsored by the delegations of Bulgaria, Cuba, the Czech
Republic, Egypt, Iceland, India, Jamaica, Kenya, Liechtenstein, Mauritius, Nigeria, Pakistan,
Slovenia, Sri Lanka, Switzerland, Turkey and Ve nezuela (document IP/C/W/247/Rev.1).  A new
paper on the matter had recently been received from the delegations of Bulgaria, Cuba, the Czech
Republic, Georgia, Hungary, Iceland, India, Keny a, the Kyrgyz Republic, Liechtenstein, Moldova,
Nigeria, Pakistan, Slovenia, Sri Lanka, Switzerland and Turkey (document IP/C/W/308).
75. The representative of Switzerland, introducing the new paper the Council had received from
17 delegations, said that this was intended to respond to three concerns expressed by the opponents of
extension in document IP/C/W/289.  Switzerland and its co-sponsors were convinced that those
concerns were not sustained.  There seemed to be a persistent misunderstanding on the part of some
delegations as to what was the goal of extension.  Firstly, on the question of costs, he disagreed that
extension of the additional protection of Article 23.1 would create the obligation for Members tocreate a new, costly and burdensome regime such as, for example, a register for geographical
indications.  Members already had to provide protection to geographical indications under Articles 22
and 23.  In implementing these provisions, they had the freedom under Article 1.1 to determine the
appropriate method of implementation within their own legal system and practice.  Extension tried to
ensure that geographical indications were only used for products actually originating in the placeindicated, as was currently the case for wines and spirits.  The use of an indication such as "Carolina
rice" for rice grown in India, should be just as il legitimate as the use of "Napa valley wine" produced
in Switzerland.  Extension was actually facilitating protection and not complicating it.  Whether the
use of an indication was legitimate would be decided upon objective criteria, namely whether the
product actually originated in the place indicated.  This would facilitate the work of judicial andadministrative authorities as well as enforcement by those entitled to use the geographical indications.
This would produce not only more effective protection but also cost savings to Members.  The cost
argument against extension was therefore invalid.  S econdly, it had been alleged that extension would
lead to renaming of products and thereby confus e consumers.  However, geographical indications
indicated the true origin of a product and prevented consumers from being misled, thereby benefittingconsumers.  Under the exceptions provisions of Article 24, indications used in good faith and in a
customary manner over time and for specific products would not have to be abandoned.  Thirdly, it
had been alleged that extension and more effective protection of geographical indications could
restrict trade.  On the contrary, it held trade opportunities and would be an additional incentive for
producers to improve the quality and reputation of their local products and to compete on the
worldwide market.  As for the use of geographical indications for products neither having this origin
nor qualifying for any of the exceptions in Article 24, it was the legitimate goal of intellectualproperty protection to prevent such free-riding us e.  Any other line of reasoning would lead to
dangerous waters when applied to other fields of intellectual property protection.  Switzerland and the
other sponsors of document IP/C/W/308 were convinced that the concerns of the opponents of
extension were not justified.  Extension would establish a level playing field for the protection of
geographical indications and offered the opportunity for all Members to benefit from their products ina way which was currently only true for wines and spirits.  Every Member had a national heritage and
traditional products which either by their origin or inherited know-how were of a unique blend and
character, whether Members were already making use of this added value or were only beginning to
do so on the world market.  Extension held much to gain for all Members, developed, developing and
least-developed.IP/C/M/33
Page 14
76. The representative of India, also responding to the arguments raised by the opponents of
extension, drew the attention to the last sentence of paragraph 8 of document IP/C/W/308, where it
was pointed out that Article 23, unlike Article 22, prohibited the use of accompanying expressions
such as "style", "type", "kind", "imitation" or the like.  The fundamental problem for India was that
products of world-class reputation, such as Basma ti rice and Darjeeling tea, faced competition from
products sold under the same name in combination with the word "style" and thus free rode on theindication of origin.  He asked opponents of extens ion to explain how India could avoid losing trade
through these practices, which Members were permitted to allow under the TRIPS Agreement for
products other than wines and spirits.  Regarding costs, it should be borne in mind that Article 23 did
not oblige Member governments to enforce the protection available for geographical indications
themselves, but to ensure that the legal means to do so were available for the beneficiaries of such
protection.  Extending Article 23 to other products did not require a separate administrative or legal
structure.  Without too much effort, Members should be able to extend their enforcement mechanismsunder Article 23 to other products.  were enforcing Article 23 already, they should be able to extend it
to other products without too much effort.  The basic problem was the imbalance in the Agreement
and there had been no convincing argument as to why wines and spirits alone should benefit from
additional protection.  Since the entry into force of the Agreement, some Members had realized that
they had products worthy of additional protection u nder the Agreement.  Negotiations were needed to
achieve this, for which a mandate already existed.  There had been little progress in the Council and,
as had been mentioned under the previous agenda item in respect of the multilateral register,
hopefully there would be signals from the Ministerial Conference.  He called upon the opponents of
extension to seriously consider the arguments advan ced in document IP/C/W/308 so that work could
move forward.
77. The representative of Jamaica said that her delegation should be added as a sponsor of
document IP/C/W/308.23  Geographical indications were a form of intellectual property like patents,
trademarks and copyright and the prevention of their misuse was legitimate.  They helped consumers
identify the true origin of a product.  The pape r introduced by Switzerland dispelled concerns that
extension would be costly or burdensome.  On the contrary, the benefits of more effective protection
of geographical indications in world trade would outweigh any costs.
78. The representative of Turkey expressed his delegation's support for the statements made by
India, Jamaica and Switzerland.  Turkey was pleased with the progress of the rich debate on the issue
of extension, which was being discussed in other WTO fora as well.  Although he did not agree with
the views expressed in document IP/C/W/289, it ha d provided the opportunity to clarify issues.
Referring to the preliminary views he had expressed at the last meeting, and to the detailed arguments
in document IP/C/W/308, he wished to highlight some of the points made.  It was difficult for his
delegation to understand which potential costs would be incurred in case of extension.  Extension did
not have to be burdensome or imply unreasonable costs.  The list of supporters of extension included
a wide geographical distribution of Members, both  developed and developing  countries.  Although he
should say, as a result of his delegation's first-hand experience, that the process of implementing the
additional protection for wines and spirits had not been smooth, once the mechanisms had beenestablished, it was a negligible effort to extend them to other products, as Turkey and other
developing countries supporting extension had experienced.  In some cases, there might be certain
additional costs, but the concept of intellectual property consisted, by definition, of a process of
dynamic self-development.  Therefore, existing lega l instruments regulating this area in general and
the TRIPS Agreement in particular necessitated revisions from time to time.  The provisions of theTRIPS Agreement calling for reviews were evidence of this fact.  These reviews and revisions were to
bring advantages and benefits to all Members.  Any costs entailed were to be offset by the advantages,
especially in the case of extension of geographical indication protection.  As for the potential
                                                     
23 Document IP/C/W/308/Rev.1 circulated after the meeting reflects two additional sponsors of the
paper contained in document IP/C/W/308, namely Bangladesh and Jamaica.IP/C/M/33
Page 15
implications of extension for consumers, any such implications would be positive ones, such
consumers would be enabled to make a better choice if they had more accurate information on the
products they wished to buy.  If a product really possessed certain qualities for the benefit of
consumers, its producers should not worry about competition and did not need to resort to abuse of
the reputation of another product originating in a certain region.  The validity of this principle having
been accepted for certain products, it was not reasonable to exclude other products categorically fromits application and sustain the resulting imbalance.  As regards the potential effects on trade, these
were, in his delegation's view, solely positive.  Thanks to technological development, a wide range of
products were within consumers' reach and more was known abut the products made and consumed
all around the world.  As a result, many producers currently supplying their goods and services to
markets of limited scale now had the chance to increase their market reach, but could only do so if
they would be in a position to avail themselves of the benefits of systems protecting the characteristics
of their products against unfair competition.  This was especially important for producers indeveloping countries.  If there were producers and industries which might somehow be affected
negatively by extension, the prospects of increased trade as a result of extension would certainly be
positive and far outweigh such negative effects.  Moreover, it had to be borne in mind that the
producers who would suffer from these negative effects would be those who were free riding on
geographical indications.  If existing legal instruments should be interpreted so as to protect these freeriders, why should this be different for industries violating copyright or trademarks?  For the above
reasons, his delegation was not persuaded that the arguments raised in document IP/C/W/289
outweighed the potential benefits of extension for producers and consumers.
79. The representative of Venezuela expressed support for document IP/C/W/308 and the
statements made by India and Switzerland.  Wishing to emphasize the arguments advanced by these
delegations in response to allegations made concerning the possible trade effects of extension, she
referred to a seminar on geographical indications held recently in Venezuela which had shown the
positive effects of the registration of Venezuela's two geographical indications, i.e. Chuao coffee and
"Cocui de Pecaya", both in terms of trade and of the organization of agricultural and traditional
communities.  Protection of these geographical indications had had a multiplier effect on the relevantcommunities and had resulted in other communities also requesting this form of protection.  Thanks to
these geographical indications these communities' traditional knowledge could be protected and the
preservation of their traditions promoted.  She believed that this experience showed the importance of
the matter for Venezuela and other developing countries.
80. The representative of the European Communities welcomed the paper introduced by
Switzerland (document IP/C/W/308) and said that he was encouraged by the statements by India and
Switzerland.  His delegation fully subscribed to their arguments and counter-arguments.
81. The representative of the Czech Republic said that her delegation was grateful for the rich
debate on the issue of extension in the Council, in which so many delegations participated.
Document IP/C/W/308, of which her delegation was one of the sponsors, demonstrated that the
benefits of extension outweighed any negative effects, especially for honest producers using them and
who relying on the protection of geographical i ndications and their enforcement.  Sharing her
delegation's observations with regard to document IP/C/W/289, she first referred to paragraph 9 of the
paper and said that her delegation remained to be persuaded that the imbalance in levels of protection
resulting from Article 23 could also be removed in another way than by extending its scope to all
products.  She understood from document IP/C/W/289 that its sponsors were of the view that the
protection offered by Article 22 would also be sufficient for geographical indications of wines andspirits and that these products did not have distinctive characteristics that would predestine them to
require better protection and enforcement.  Accordingly, both advocates and opponents of extension
apparently agreed that there was an imbalance in the Agreement's Section on geographical indications
and only disagreed on an appropriate solution.  In her delegation's view, right holders of the same
category of intellectual property could not be divided according to the nature of goods that theyIP/C/M/33
Page 16
produced and had to rely on the same level of protection and enforcement of their rights.  From the
perspective of producers, who were using geographical indications with the aim of improving the
marketing of their products, the higher level of protection and enforcement of geographical
indications was always more advantageous and permitted them to better use all trade opportunities.
The promotion of legitimate producers' interests should be taken into account in the debate aiming at
resolving the TRIPS Agreement's imbalance in this area.  Extension would not harm consumers'interests either, as consumers would be able to bett er identify the origin of a good.  They would soon
get used to the new market conditions under which only goods with the qualities and conditions
attributable to their geographical indication would be available and no imitations, kinds, styles or
other false use of geographical indications.  Any possible consumer confusion caused by the
elimination of products falsely using geographical indications, or by renaming and relabelling them,
would be limited in time and overcome by consumer certainty resulting from the clear and easy
designation of goods.  The balance of interest s between consumers and producers would also be
ensured by the possibility offered by Article 23.3, under which it was acceptable - in the case of
geographical indications for wines - to use and protect homonymous geographical indications under
certain conditions.  Extension would not force any producer to rename his product if the geographical
indication did not falsely represented to the public that his product originated in another territory.  Her
delegation believed only extension of the scope of Article 23 to products other than wines and spiritswould solve the imbalance in Section 3 of Part II of the Agreement and lead to positive and optimally
balanced results.  As suggested in document IP/C/W/289, the imbalance could also be removed by
aligning the protection of geographical indications under the Agreement to the level offered by
Article 22.  However, thus, the standards of protection agreed in the Uruguay Round would be
lowered, which might set a precedent for other categories of intellectual property under theAgreement.  Her delegation believed that Members' aim should be to ensure the same protection for
all right holders within the same category of intellectual property, without discrimination as to the
kind of product to which the protection related.  To compare with other categories of intellectual
property, the Agreement did not differentiate in of fering providing patent protection in respect of
inventions in the area of, for example, engineering and pharmaceutical products, nor in providingcopyright protection in respect of, for example, novels and songs.  Similarly, the Agreement should
not distinguish between geographical indications for wines and spirits as opposed to those for other
products.  Such a non-discriminatory approach would be in harmony with the need to promote
adequate and effective protection of intellectual property rights, which should be maintained for all
categories of intellectual property that were the su bject of in Sections 1 to 7 of Part II of the
Agreement.  Finally, she wished to stress that extension would benefit all producers and consumers
and would help to prevent piracy and free-riding on the reputation of others.
82. The representative of Sri Lanka requested clarification from the sponsors of
document IP/C/W/289 as to the reference in paragraph 5 of the paper to "TRIPS-plus laws".  She did
not believe that extension involved TRIPS-plus la ws, which was a term referring to situations when
countries were pressured not to use certain measures with respect to compulsory licensing.  She also
wished to point out that, while paragraph 5 of the paper also referred to "possible closing-off of futuremarket opportunities", the use of geographical indications could protect traditional knowledge and
actually create new market opportunities for developing countries.  She was disappointed about the
slow pace of the debate on this issue and hoped that there would be developments before the
Ministerial Conference.
83. The representative of Australia referred to paragraph 114 of the minutes of the previous
meeting (document IP/C/M/32) and added the follow ing preliminary comments in response to the new
paper that had been introduced by Switzerland (document IP/C/W/308) as a further demonstration of
her delegation's willingness to engage seriously and constructively in the extension debate and to
further assist Members in making a measured and balanced assessment of the potential benefits and
costs of amending the treaty provisions.  It was a gross oversimplification of the costs involved inimplementing new obligations to increase the higher level of protection of Article 23 to all products.IP/C/M/33
Page 17
It was easy for countries which already had elaborate geographical indication protection systems in
place to claim that new obligations would only re quire minor legal changes, but there was a whole
range of other costs that needed to be considered, including the differential impact that these might
have on Members.  Implementing and administering new laws involved considerable costs, both in
terms of money and other resources, for most governments and might impact proportionately more on
developing countries.  Members had different systems in place to protect geographical indications andthis was a fundamental aspect of TRIPS flexibility under Article 1.1.  Accordingly, a change in
obligations would have a much greater impact on some Members than others and it was a gross
generalization to dismiss the changes as minor for all Members.  The proposed new obligations would
apply to all goods and all Members, even those who chose not to protect any of their own domestic
geographical indications.  Every Member would be obliged to protect the geographical indications of
all other Members at the enhanced level of protection in order to avoid MFN violations.  This could
involve a considerable burden as some Members had hundreds, if not thousands, of geographicalindications.  The costs would not just be minor legi slative changes.  The Council needed to consider
the entire costs that extension would entail, including administration of modified laws, trade
implications for producers, including possible closure of market access opportunities, increased
potential for consumer confusion, costs to industry of relabelling and marketing and the other costs
outlined in document IP/C/W/289.  Regarding the claim that extension would reduce potentialconsumer confusion by enhancing clarity and security about the origin of the product, Article 22
already operated to ensure that the consumer was not misled as to the origin of the product.  This
reflected the fundamental function of a geographical indication as a means of informing the consumer
about the geographic origin of a product.  Accordingly, the existing protection conferred on all goods
under TRIPS by Article 22 already guaranteed that consumers were not misled as to the origin of aproduct.  The additional protection conferred under Article 23 did not provide the consumer with any
additional information concerning the origin of the product.  Regarding the argument that Article 22
was inadequate because the use of qualifiers such as "style" and "kind" undermined the genuine
geographical indication over the long term and made them generic, she said that the use of these
qualifiers provided a clear distinction between the use of the geographical indication on a productentitled to it, and a similar product that did not have a particular quality, reputation or other
characteristic that was essentially attributable to that geographic origin.  The demandeurs  had not
presented any evidence of cases where a geographical indication, which was protected in its country
of origin, had become generic in this way.  This led to the conclusion that this risk was not very real.
If there were genuine concern, then Members should examine more closely the meaning andimplementation by Members of Article 24.6 to see how this provision was functioning.  Australia had
long advocated the need for a thorough examination of each of the provisions on geographical
indications in the TRIPS Agreement in the context of the Article 24.2 review.  The argument that
extension would reduce the costs for plaintiffs and judicial authorities since they would not have to
prove the misleading element of Article 22, and that this would compensate for the additional costs of
extension, conceded that there would be costs and that these costs should be accompanied by
compensatory benefits.  The fundamental question that needed to be asked was what exactly were thefull costs that would result from extension and whether these were outweighed by any likely benefits.
The suggestion that removing the need to prove the misleading element would be compensation for
the increased costs was misconceived as the producers that would gain the purported benefit of
increased protection were not the same party that would suffer the increased costs.  It was the
government that needed to implement the more bu rdensome steps to protect geographical indications.
Costs would also be redistributed to industries that would be subject to claims that they could no
longer use certain words and would need to defend th eir rights and re-label their products.  Consumers
would also be confused about products.  This exam ple pointed to the critical importance of Members
considering the full picture and taking to heart the range of interests that would be affected by a
change to existing levels of protection.  Paragraph 6 of document IP/C/W/308 recognized that anational registration system was not the only means or a prerequisite to implementation of Article 23
obligations.  It was useful that the sponsors of the paper had pointed this out, but it begged the
question as to what other forms of protection would in fact be sufficient to fulfill obligations underIP/C/M/33
Page 18
Article 23 and underlined the lack of examination of this issue in the Council.  Paragraph 15 of
document IP/C/W/308 acknowledged that Article 24 exceptions would not have to be abandoned.
She welcomed this clarification, but this begged the question as to what effect those exceptions would
have on the eligibility for protection of many geographical indications that countries were seeking to
protect, including those mentioned by India.  In conclusion, document IP/C/W/308 underlined the
need for a much more thorough examination of the issues associated with calls for extension.
84. The representative of Barbados welcomed the paper introduced by Switzerland, which she
considered well-argued and a positive contribution.  She hoped that there would be progress on this
issue.
85. The representative of Kenya said that the additional cost of extension should not be a major
issue.  Developing countries were facing considerable costs in implementing the TRIPS Agreement.
Small additional costs resulting from extension would be offset by the benefits that accrue from it.
Especially for Members from the developing world geographical indications in the areas ofagriculture, handicraft and foodstuffs were a mainstay in their economy and trade.  The Doha
Ministerial should agree on a clear mandate on this issue.
86. The representative of Argentina thanked Switzerland for the explanations provided
concerning the paper it had introduced.  However, paragraph 8 of the paper confused obligations
under Articles 22 and 23, as the additional criteria were under Article 22 and not 23.  Paragraph 11looked only at the producers' perspective, but did not take into account that there would be a transfer
of costs from producers to Member governments.  Moreover, the paper also seemed to say that
geographical indication protection was just a matter of authorities checking the true origin of goods,
like under rules of origin, when, in fact, there was also the question of whether a term was a
geographical indication at all.  This also added confusion to the debate.
87. The representative of Bolivia said that many of the elements in the paper introduced by
Switzerland reflected his delegation's position.
88. The representative of Hungary said that his delegation was sponsoring document IP/C/W/308,
because it believed that the paper successfully rebutted the arguments presented in
document IP/C/W/289.  He wished to highlight, in particular, the arguments as to why extensionshould and would not result in disproportionate costs.  He urged delegations to read the two
documents together.  At the previous meeting, he had strongly disagreed with the assertion in
paragraph 8 of the attachment to document IP/C/W/289 that free and fair imitation of a product often
enhanced the intrinsic value and premium of the genuine geographical indication, and asked Australia
whether it would be willing to support the same line of argument in respect of other forms ofintellectual property.  Australia had responded at that meeting by referring to the fair use exceptions
that had since long been recognized in intellec tual property law and by pointing at Articles 13, 17
and 30 of the TRIPS Agreement, which provided for limitations or exceptions to each of the major
categories of intellectual property in recognition of the need to strike an appropriate balance of rights
and obligations.  However, none of these limited exceptions gave a blank cheque for the wholesale
commercial use of the protected intellectual property in question.  According to Article 13, Members
had to confine limitations or exceptions to exclusive rights to certain special cases which did notconflict with a normal exploitation of the work and did not unreasonably prejudice the legitimate
interests of the right holder.  Article 17 said that Members might provide limited exceptions to the
rights conferred by a trademark, provided that such exceptions took account of the legitimate interests
of the owner of the trademark.  Article 30 similarly stated that limited exceptions conferred by a
patent could be made, provided that such except ions did not unreasonably conflict with a normal
exploitation of the patent and did not unreasonably prejudice the legitimate interests of the patent
owner.  Section 3 of Part II of the TRIPS Agreement on geographical indications contained two
limited general exceptions, i.e. in Article 24.5 and 24.6 regarding prior good faith use of a trademarkIP/C/M/33
Page 19
and generic terms, neither of which allowed wholesale and unconditional commercial use of
geographical indications of other Members.  Document IP/C/W/289, in particular paragraphs 8, 21
and 22 of its attachment, the last two of which spoke of the importance of the possibility to use
"commercially significant terms", especially in the new and emerging dairy and processed food
industries seemed to support the wholesale commercial use of terms containing geographical
indications and did not make clear the conditions u nder which such use would be in line with the
obligations under the TRIPS Agreement.  He noted that, contrary to what IP/C/W/289, seemed to
imply, the use of geographical indications for products other than wines and spirits accompanied by
expressions such as "style", "kind", "imitation", etc. was not expressly and unconditionally permitted
by the TRIPS Agreement, and recalled that the obligation in Article 22.2(a) was to provide legal
means against the use of any means in the designation or presentation of a good that misled the public
as to the genuine geographic origin of the good.  At the last meeting, he had asked the sponsors of
document IP/C/W/289 what they meant by "commercially significant terms" and their relationshipwith geographical indications.  He looked forward to such a clarification at the present or a future
meeting.
89. The representative of Mexico said that her delegation's position on the issue of the extension
of Article 23 to other products than wines and spirits was well-known and had not changed.  Her
delegation had listened carefully to the arguments that Switzerland and other delegations hadadvanced during the meeting, but remained unconvinced as to the need for extending the scope of
Article 23.  It also had serious concerns as to the costs and legal, administrative and trade implications
that such an extension would give rise to.  Therefore, Mexico continued to support the general
approach and most of the arguments contained in document IP/C/W/289.
90. The representative of Egypt said that, although Egypt was not among the sponsors of
document IP/C/W/308, it wished to indicate its full support for that document and all the arguments
contained in it.
91. The representative of the United States said that her delegation had serious reservations about
the arguments expressed in document IP/C/W/308, which it had just received and to which it would
come back at a later time.
92. The representative of New Zealand wished to convey some preliminary comments on
document IP/C/W/308, which her delegation was still examining in detail.  She expressed
appreciation for the attempt made by the sponsors to allay the concerns that her delegations and others
had put forward earlier on.  However, unfortunately, on preliminary reading most of those concerns
remained.  In the section on potential costs of extending protection, paragraph 10 of documentIP/C/W/308 referred to the undesirability of using public opinion as a decisive criterion in granting
protection.  In this regard, her delegation believed that it was important to point out that the emphasis
in the paper on public opinion was too simplistic and in fact incorrect.  It was not public opinion that
was the determining factor in the protection provided by Article 22.  Rather this was the accepted
legal concept of whether the public was misled.  Th e emphasis in the section of the paper regarding
the supposed increased legal certainty that extension would create and the more simplistic test or
examination that would have to be carried out by authorities was in a way emphasizing the heavyexclusivity or automaticity of intellectual property rights that extension would provide.  Comparing
the rights that were being suggested to be provided under a system of extended protection for
geographical indications, with other forms of intellectual property rights, the beneficiaries of these
latter intellectual property rights did not have an exclusive, automatic monopoly right in an absolute
sense.  Her delegation saw this as upsetting the balance striven for in the TRIPS Agreement betweenstrong and effective protection for intellectual property rights and broader economic and social
objectives.  In the same section, the paper helpfully acknowledged that a national register type
approach to protecting geographical indications wa s not the only means of protection available nor a
pre-requisite.  The paper otherwise tended to ignore the different regulatory enforcement systems andIP/C/M/33
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approaches amongst Members and their different views of the desirability of ex officio enforcement.
The paper also ignored the fundamentally different le vels of resources across Members to provide this
enforcement.  New Zealand remained concerned that some Members might well find extension of
Article 23 to be an administratively costly and burdensome exercise for minimal benefit.  In the
section on potential implications of extension for consumers, a particularly important point had been
made by the sponsors of the document, namely that the exceptions provided for under Article 24 ofthe TRIPS Agreement meant that a number of indications would not have to be abandoned.
Document IP/C/W/289, of which her delegation was a co-sponsor, made the same point.  To the mind
of her delegation, these exceptions meant that many indications that Members might be expecting
could receive additional protection in fact would not.  In this case, this would even further load the
imbalance of costs for these countries with re spect to the administration and policing of the
geographical indications of their trading partners.  Finally, she noted that document IP/C/W/308
continued to underestimate the potential disruption to trade for many exporters who were currentlyusing terms in good faith, that might become questionable if Article 23 were to be extended to all
products.
93. The representative of Colombia said that the question as to whether or not to extend the
protection of geographical indications, which so far had been addressed in terms of economic and
administrative costs, should also be debated in the light of other developments that were taking placein the WTO.  As Members of the WTO, delegations should clarify the relationship between rules of
origin and geographical indications.  In this respect, she agreed with the delegation of Argentina,
which had made the same point in commenting on paragraph 11 of document IP/C/W308.  Rules of
origin referred to the concept of substantial tr ansformation in accordance with the Agreement on
Rules of Origin.  Geographical indications referred to quality, reputation or other characteristics of aproduct that derived basically from its geographical origin as under Article 22 of the TRIPS
Agreement.  What was not clear was the harmonious application of these disciplines.  Members had
been unsuccessful in their attempt to clarify this in the Committee on Rules of Origin.  The delegation
of the United States had, in its paper circulated as document G/RO/W/65, alluded to the uncertainty
that would be created if the harmonized rules of origin were applied for purposes of Article 22.3 ofthe TRIPS Agreement.  She therefore appealed to the Council that, in addition to the points raised in
its debate, this particular feature be analysed with sufficient care.  Her delegation believed that it was
Members' responsibility to look for alternatives that might lead to a harmonious implementation of all
their multilateral commitments.  Members should no t, for the sake of the trade interests of some
Members, hastily adopt decisions whose application would have to be clarified by panels.
94. The representative of Guatemala, providing preliminary comments to document IP/C/W/308,
said that her delegation believed that confusion had been created as to what was going to be protected
if Article 23 were to be extended to all products.  Some delegations wanted to protect traditional
knowledge through geographical indications, but had not explained how existing protection under
Article 22 was insufficient and that it was absolutely necessary to extend the protection under
Article 23.  Further discussions were required so as to clarify the matter and to allow Members to
understand new commitments they might be taking on.
95. The representative of Australia said that Hungary, in regard to the issues it had raised, again
appeared to have missed the point made in document IP/C/W/289.  In its statement, the delegation of
Hungary completely ignored the existence of the protection offered by Article 22 to geographical
indications for all products.  If Hungary was suggesting that Article 22, which Australia had never
suggested should be undermined, permitted the whol esale, unconditional commercial use of another's
geographical indications, then it would appear that the negotiators of the TRIPS Agreement did not
know much about intellectual property rights, which she did not believe to be the case.IP/C/M/33
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96. The representative of Canada said that she had sent document IP/C/W/308 to her authorities
in the capital for comments at a later time and that, despite arguments put forward at the present
meeting, her delegation continued to believe that the meaning of Article 24.1 and the mandate it
provided the TRIPS Council were very clear.  All the same, Members continued to have different
views.  However, as had been pointed out by others, Members were facing a different set of
circumstances should any extension of the protection of Article 23 occur.  There were costs thatwould emerge for Members, true costs, but they did not seem to be taken under consideration.  In
particular for Members who did not have a solid base to start from, the costs would be quite high.
97. The representative of Japan reiterated that Japan wished to examine this issue carefully,
weighing both negative and positive impacts the proposed extension might have on administrative and
judicial systems, the interests of consumers and producers, normal business practices as well as on the
international and national trade of Members.  Additional protection under Article 23, i.e. without
testing whether the public was misled, was an exceptionally preferential treatment of a certainproduct.  Therefore, Japan would like to carefully examine whether or not a good justification
consisted for each extension to another product.  In this respect, both document IP/C/W/308 and
document IP/C/W/289 were most informative and us eful for examining the possible impacts of the
proposed extension of additional protection.  His delegation would analyse these papers in depth.  His
delegation was interested in participating in the discussion of this issue in the process towards Dohaand after Doha.
98. The representative of Chile said that for some time now Members had been discussing in the
Council the possibility of extending or not additional protection for geographical indications for wines
and spirits to all types of goods.  As he had said on other occasions, in the view of his delegation, a
request of this type clearly broke not only the balance achieved after lengthy negotiations but, moreimportantly, the whole architecture of the protection for geographical indications agreed in the
Uruguay Round, where the consensus had been to establish common protection for all goods and an
additional protection for those relating to wines and spirits.  So far, no reason had been put forward to
justify breaking down this scheme.  Moreover, there were the greater burdens on Members and costs
involved, including for consumers.  Chile did not agree at all with the statement made indocument IP/C/W/308 that additional protection would be to the benefit of all Members and would
benefit trade and consumers.  Such protection would only benefit some to the detriment of others.
Geographical indications as opposed to other categories of intellectual property, such as patents,
trademarks and industrial designs, had been developed with greater impact only in some countries,
which had made them an extraordinarily effective instrument of commercialization.  Until allcountries achieved that or similar levels of development in the use of geographical indications, it
would be impossible to obtain from the system a ll the benefits claimed or even those outlined in
Article 23.  Extension of additional protection meant for some countries, such as Chile, giving up
rights that they had acquired through negotiations.  Under the present rules, a company in Chile could
use on products other than wines and spirits an expression that indicated that such a good was similar
to or like another good identified by a geographica l indication without misleading the public, if the
true origin of the good was indicated explicitly.  Chile would like to continue to have the prerogativeof exercising this right and not have to renounce it as some delegations claimed it should.  At the next
meeting, his delegation would respond to the other arguments set out in document IP/C/W/308.
99. The representative of Djibouti expressed his delegation's support for document IP/C/W/308.
The document answered to those who had been calling for clarifications and was to the benefit of all.
100. The representative of Malaysia, speaking on behalf of the ASEAN Members of the WTO,
referring to the questions she had posed at the last meeting as to what was the status quo regarding the
additional protection for geographical indications and why it had to be changed, noted that
Article 23.1 provided for unqualified protection of private rights whereas Article 22 was intended to
protect the public from being misled.  Article 22 provided a balance between private and public rights.IP/C/M/33
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She wondered how this balance between private and public interests could be ensured in case of an
extension of Article 23 to other products.  The ASEAN Members had also been considering a
practical problem to the Article 24.1 issue, i.e. that, in case a country were to seek international
geographical indication protection for a product from a certain region in its territory, it would have to
ensure that other regions in the country did not use this appellation.  Her concern was that this could
cause domestic problems in the country.  At present, there was not a consensus for amending theTRIPS Agreement so as to extend the product coverage of Article 23.  When considering possible
negotiations aimed at any such amendment, some Members had to anticipate, in the light of possible
domestic problems, that they would be hard presse d to explain to their own constituents why there
should be an amendment to the TRIPS Agreement for this particular issue and, in addition, possibly
also why other amendments, which might be equally important to them, were not being contemplated.
Therefore, she cautioned against a hasty consideration of the issue.
101. The representative of Bulgaria, responding to some of the objections that had been expressed
to document IP/C/W/308, said that no doubt extension of the coverage of Article 23 could be achieved
in various ways, some of which would be more complicated or costly than others.  However, there
was no need for it to be costly.  Moreover, the number of foreign geographical indications which
would benefit from extended protection under Article 23 did not affect any costs involved in
extending protection to them, because the costs of making available legislative means to defendgeographical indications did not differ depending on the number of geographical indications to be
defended.  He expressed his satisfaction with the way the debate was conducted in the Council and
looked forward to continuing it.  Although many arguments were being repeated, and had to be
repeated in order to make the points made clear, there were also some arguments which deserved
additional discussion.
102. The Chairperson said that no doubt Members would welcome some indications from the
Fourth Session of the Ministerial Conference on this matter.  He suggested that the Council take note
of the statements made and revert to the matter at its next meeting.
103. The Council so agreed.
I. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHICAL
INDICATIONS UNDER ARTICLE 24.2
104. The Chairperson recalled that, at the Council's meeting in April 2001, Australia had posed a
number of questions in the context of the review of the experience and practice with the application of
the provisions in the TRIPS Agreement on geographical indications that the Council had started with
the aid of the main section headings in the Secretariat's summary paper (IP/C/W/253) of the responsesto the Article 24.2 questionnaire, including some questions specifically addressed to the European
Communities and to Turkey under the heading "Definitions and Criteria for Recognition" and some
questions specifically addressed to the European Communities and to Switzerland under the heading
"Procedures for Recognition".
105. The representative of Turkey thanked Austra lia for its interest in Turkey's domestic
procedures for the recognition of foreign geographical indications.  As a result of the importance his
delegation attached to the protection of geographical indications, this protection was accordinglyprovided in domestic regulations.  The protection conferred by Turkey's law was at the disposal of
natural and legal persons who were resident in Turkey or possessed an industrial and commercial
establishment in Turkey, or those persons who were entitled to rights under the Conventions of Paris
or Berne or the Agreement Establishing the WTO.  Natural and legal persons other than those already
referred to, who were nationals of States which accorded legal and de facto protection to the nationalsof Turkey were also to enjoy protection in Turkey in accordance with the reciprocity principle.  This
protection was granted to all products.  The Turkish legislation in question had been notified to theIP/C/M/33
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Council and circulated in documents IP/N/1/T UR/G/1 and IP/N/1/TUR/G/2.  He referred, in
particular, to Articles 2, 4, 5 and 20 of Decree Law No. 555 on the Protection of Geographical Signs
and Article 14 of the Implementing Regulati ons under Decree-Law No. 555 pertaining to the
Protection of Geographical Signs.  He also wished to recall that these provisions were submitted and
distributed on the occasion of the review of Turkey 's TRIPS implementing legislation by the Council
last year.  His delegation would provide any further clarification Members might desire.
106. The representative of Switzerland said that Australia had sought complementary information
from his delegation because Switzerland was referred to in footnote 238 of the Secretariat's summary
paper (document IP/C/W/253)24, which was attached to the following ground for opposition to the
registration of a geographical indication listed in paragraph 73 of that paper:  "the proposed
registration of a name would jeopardise the existence of an entirely or partly identical name or
trademark or the existence of products which were legally on the market".  In responding to this
question, he first wished to indicate that this ground for opposition, as reflected in documentIP/C/W/253, only partly concerned what was provided for in Swiss legislation, which laid down that
the registration of a geographical indication could be opposed where "the proposed registration of a
name would jeopardise the existence of an entirely or partly identical name or trademark".  In the
context of the Swiss Ordinance concerning the Protection of Appellations of Origin and Geographical
Indications with respect to Agricultural Products and Processed Agricultural Products, referred to infootnote 238 of document IP/C/W/253, an application for registration could be the subject of an
opposition, as stipulated in Articles 10 and 11 of the Ordinance.  Various grounds of opposition could
be invoked, in particular:  that the name did not satisfy the conditions laid down in the Ordinance;
that the name was a generic one;  that the group was not representative;  or that the proposed
registration would jeopardize renowned and reputable, entirely or partly homonymous names ortrademarks which had been in use for a long time.  The last of these grounds aimed to take into
account, in the context of a procedure for the registration of an appellation of origin or a geographical
indication, both the interests of the owners of trademarks existing prior to the date of the application
for such registration and containing the "geogra phical indication" that was the subject of the
application for registration of an appellation of origin or a geographical indication, and the interests ofpersons who were using, for the commercialization of their products, a name without necessarily
having registered it as a trademark.  All intellectual  property rights deserving to be treated on an equal
footing, this ground for opposition had been retained in Swiss legislation in a way which took duly
account of the various constellations of rights that might exist in the context of a procedure for the
registration of an appellation of origin or a ge ographical indication.  The Federal Agriculture Office
had the competence to rule on oppositions.  For this purpose, it would consult an expert commission
(the Commission for Protected Appellations of Orig in and Protected Geographical Indications).  Its
decisions on oppositions could be challenged before the Appeals Commission of the Federal
Department of Economy and, in the last instance, before the Federal Tribunal (i.e. the supreme court).
Given that, to date, this ground had never been invoked in the context of an opposition procedure
related to the registration of an appellation of origin or a geographical indication, his delegation was
not in a position to provide further details to Australia on the way in which this ground for oppositionwould be taken into account in practice.
107. The representative of the European Communities said that he had no additional information to
provide.
108. The representative of Australia thanked Turkey and Switzerland for their responses.  She
would appreciate receiving these responses in writing,  in particular in light of their complexity and
technicality, which clearly underlined the complex nature of the area and the need for the Council to
                                                     
24 When posing the question, Australia had referred to the preliminary version of the summary paper
(document JOB(00/5619).IP/C/M/33
Page 24
undertake a thorough examination of it in order to enhance Members' collective understanding of the
matter.
109. The Council took note of the statements made and agreed  to revert to the matter at its next
meeting.
J. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(b)
110. The Chairperson said that the Secretariat had received two new sets of responses to the
questionnaire contained in document IP/C/W/273, namely from Hong Kong, China and from
Thailand, which had been circulated as documents IP/C/W/125/Add.21 and 22, respectively.
Furthermore, the Czech Republic had submitted a set of new responses, which supplemented the
information contained in the responses to the illustrative list of questions it had provided earlier.
These new responses were being circulated as document IP/C/W/125/Add.8/Suppl.1.
111. He recalled that, at the last meeting, the Council had received two new contributions, namely
from Norway and Switzerland (documents IP/C /W/293 and 284, respectively) and continued its
discussion both on a number of substantive issues and on a number of procedural questions relating to
how the Council should handle its further work on this matter, in particular about the extent to which
all the issues that had been raised under Article 27.3(b) should be pursued in that context or whether
some might more suitably form part of the items to  be taken up in the context of the review of the
implementation of the TRIPS Agreement under Article 71.1.  A new paper on the matter had beenreceived recently from the delegation of Australia, which would be circulated as
document IP/C/W/310.
112. The representative of Australia, introducing document IP/C/W/310, said that the mandated
review of Article 27.3(b) had included extensive discussions of important and broader related issues.
Her delegation believed that it could be counterproductive to try to deal with these issues relating tointellectual property, genetic resources and trad itional knowledge within the narrow scope of this
review.  For example, the intellectual property re lated issues arising in the implementation of the
obligations of the CBD fell outside the scope of this review.  One of these issues concerned the
establishment of effective national régimes for regulating access to genetic resources.  Australia had
recently produced a draft legislative model in this area and provided an overview of this model indocument IP/C/W/310.  Consistent with her delegati on's view that existing legal and administrative
mechanisms could provide effective protection for traditional knowledge, the paper also detailed
Australia's experience in this area.  Going through the major headings of the paper, she said that the
first section addressed the scope of the Article 27.3(b) review.  As she had said before, her delegation
believed that the coverage of this item was relatively narrow, dealing with the review of theeffectiveness of the operation of an optional exclusion to patentability.  That said, she acknowledged
the importance of broader issues related to this provision.  Those issues included access to and control
of genetic resources and protection of traditional knowledge.  Her delegation agreed that these had
become matters of international concern.  While there was also a role to be played by the international
community in the debate on these matters, Australia believed that a lot more could be done at the level
of national legislation.  In this regard, she strongly supported the encouraging progress being made by
WIPO's Intergovernmental Committee on Intellectual Property and Genetic Resources, TraditionalKnowledge and Folklore.  Her delegation hoped that the work being done in this committee would
make a substantial contribution to a debate that had, at times, been characterized by misinformation
and partial truths.  She also reiterated that her delegation believed that, to the extent that the issues
that she had just mentioned, might be relevant to TRIPS, they would be more appropriately
approached under the Article 71.1 review, as they warranted the holistic perspective that aconsideration under that agenda item could provide.IP/C/M/33
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113. Turning to the issue of TRIPS and genetic resources, she said that calls had been made for
amendments to be made to Article 27.3(b), as outlined in paragraph 6 of her delegation's paper.
Australia had two reservations concerning these proposed amendments at this stage.  The first was
that her delegation believed that more analysis needed to be undertaken into the most effective way of
ensuring that access to material that was subsequently the subject of a patent application was sourced
in compliance with the provisions of the CBD.  It was not clear that an amendment to the TRIPS
Agreement was required to achieve this goal.  Australia believed that more effort should be made to
examine the potential for compatible implementation of both the TRIPS Agreement and the CBD at
the level of national legislation and policy-making before taking the major step of amending one of
these instruments.  Her delegation's second reservation related to the proposal that such an
amendment should  be contained in Article 27 of the TRIPS Agreement.  It might be more suitably
located in Article 29.  Within the context of an orderly and properly sequenced survey of the situation
that currently existed, Australia would support the examination of options for disclosing informationabout the source of biological material into patent  application processes.  Following this process,
consideration could be given to whether this necessitated an amendment to the TRIPS Agreement.
However, again, Australia's fundamental position was that much more analysis was required to
exhaustively examine the links between TRIPS and these broader issues before any consideration was
given to the issue of possible amendments.
114. As regards the next section of the paper, concerning the implementation of obligations of the
CBD, her delegation also believed that much could be done at the level of national and local
initiatives to contribute to efforts to address the related problems of the protection of biodiversity and
indigenous knowledge.  This point had been made by a range of Members in the discussions to date
on this item.  It was an important initial step in examining whether international action was necessary.She believed that it was clear from the contributions by Members on these issues to date that there
was great potential for national level initiatives in this area and it was worth noting in this regard that
many of these initiatives fell outside the realm of intellectual property.  One of the key areas was the
action that could be taken by Members to improve régimes at the national level to control and regulate
access to genetic resources.  Australia, as one of the world's seventeen mega-biodiverse nations had amajor interest in conserving its biological resources.  Her delegation was therefore very sensitive to
the urgency of ensuring that Australia's biological resources were effectively and sustainably
managed, not only in Australia's national interest but for the preservation of global biodiversity.  To
this end, Australia was currently developing proposals for improving the management and
stewardship of its biological resources.  In September 2000, the Australian Minister for theEnvironment had released the findings of an enquiry into the regulation of access to biological
resources on areas controlled by the Australian Federal Government.  Document IP/C/W/310 referred
to the web-site address where the report on this enquiry could be accessed.  Subsequently, the details
of a draft legislative scheme based on the enquiries' findings were released for public comment.  As
drafted, these regulations would provide for management of access to genetic and biochemical
material found in native plants and animals in Federal Government areas, such as Commonwealth
National Parks.  They would require bio-prospectors to obtain a permit to ensure that the collection ofbiological material in such areas was ecologically sustainable.  The proposed scheme also provided
that a benefit-sharing agreement must be entered into by the access provider and the bio-prospector.
The purpose of the benefit-sharing agreement was to  ensure an equitable sharing of the benefits
arising from the bio-prospecting.  There was also a particular focus on ensuring that any commercial
benefits arising from the use of indigenous knowledge about plants and animals was shared with therelevant indigenous communities.  The Australian Environment Minister had said that the proposed
regulations would minimize red tape and provide certainty for industry while safeguarding Australia's
unique biodiversity.  The draft regulations could also be accessed on a web-site, the address of which
could be found in paragraph 17 of document IP/C/W/310.  She noted that a guide to the scheme was
attached as an annex to the document.IP/C/M/33
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115. Referring to the next heading, concerning primary producers and the national intellectual
property regime, she highlighted the fact that the Australian House of Representative's Standing
Committee on Primary Industries and Regional Services had recently tabled a report entitled " Inquiry
into Primary Producer Access to Gene Technology - Work in Progress:  Proceed with Caution ".
From this report, it was clear that much could be done at the national level to ensure that intellectual
property served an individual country's social and economic development goals.  Also in this respectthe paper provided a web-site address for further information.
116. She then turned to the issue of traditional k nowledge saying that Australia strongly supported
further work both in the WIPO process to which she had already referred and elsewhere to examine
ways of improving protection, including the examination of the potential use of databases to assist
with searches of prior art.  Furthermore, there ex isted potential for these databases to be linked with
others established for the documentation of biological diversity.  However, such international
initiatives must always be mindful of their workability in national regimes, and not underestimate therôle of mechanisms at the national level to contribute to the eventual solution.  The Australian
Government was conscious of the need to examine effective protection of indigenous intellectual and
cultural property within Australia.  However, premature international initiatives must not work to
restrict or hinder national processes of developing policy and legislative responses that met the needs
of indigenous communities.  The intellectual property concerns of Australia's Indigenous people hadbeen explored and articulated in another report, which was entitled " Our Culture, Our Future:  Report
on Australian Indigenous Cultural and Intellectual Property " and contained a comprehensive range of
proposals for advancing indigenous concerns relating to the legal protection of indigenous intellectual
and cultural property.  The paper mentioned the web-site where the report could be accessed.
117. As regards the use of the existing legal framew ork for the protection of traditional knowledge,
the subject addressed under the next heading in her delegation's paper, Australia believed that its
approach to finding solutions to protecting indigenous intellectual and cultural property was best
described as pursuing two paths, i.e. an assess ment of the existing legal framework and the
application of practical measures that had been taken to accommodate indigenous concerns.  The
existing system had been criticised by some comm entators as being inadequate and inappropriate for
the protection of indigenous intellectual and cultural property, thus prompting proposals for wholesale
reform and sui generis  forms of protection.  Australia believed, however, that dismissing the
applicability of the current system ignored not only the potential benefits to be gained, and identifying
legitimate "gaps" in protection, but could also create extra regulatory burdens and procedures and
systems that would invariably stifle innovation and creation.  The rights in the existing system werewidely used by indigenous artists, and those rights were consistently enforced in the courts.  Australia
was pleased that it had been able to contribute its experience in the area of protection of traditional
knowledge using the existing intellectual property system through being one of the three countries
chosen by WIPO for a series of case studies, undertaken over 2000-2001.  Eight specific case studies
had been done in Australia involving a range of issues as reflected on page 6 of
document IP/C/W/310.  The findings of the study of these cases could be consulted on a web-site, the
address of which was mentioned in the paper.  Form ulating a distinct new form  of statutory protection
for indigenous intellectual and cultural property would be a dramatic step.  There was considerable
research and analysis of this option being conducted and the Australian Government would watch
with interest the continued discussion on this issue.
118. Turning to other practical measures for the protection of traditional knowledge, Australia
believed that the application of practical measures could serve to accommodate indigenous concernsin the day to day management and administration of indigenous intellectual and cultural property and
its views in this regard could be found under this last section of the paper.
119. The representative of Brazil said that his delegation would study the Australian paper and
revert to it at the next meeting.  As regards the paper from Norway, he expressed support for many ofIP/C/M/33
Page 27
the points made in it.  He agreed that the objectives of the TRIPS Agreement and the objectives of the
CBD, although indeed different, contained many common elements.  It was particularly important to
realize, for example, that Article 7 of the TRIPS Ag reement referred to transfer of technology as the
main thrust of the objective of the Agreement, while Article 1 of the CBD contained precisely the
objective of transfer of technology as one of the elements to provide sustainable exploitation of
biological resources.  Another common element could be identified in the balance of rights andobligations in Article 7 of the TRIPS Agreement, on the one hand, and benefit-sharing, which was not
too distant an element in Article 1 of the CBD as well as the Convention as a whole, on the other
hand.  Another important element was contained in the social and economic welfare referred to in
Article 7 of the TRIPS Agreement, which was certainly compatible with the overall objective of
sustainable exploitation of biological resources in the CBD.  Referring to section 6 of the Norwegian
paper, he welcomed the positive view expressed there in connection with suggestions that had been
made to incorporate disclosure requirements for genetic material contained in inventions.
120. Continuing, he informed the Council of a semi nar that had been organized by the Government
of Brazil and the European Communities on intellectual property rights and biodiversity, which had
taken place from 9 to 11 September 2001 in the Amazon region, in the city of Manaus.  The Brazilian
Government had been represented by the Minister of Foreign Relations, Mr. Celso Lafer, and the
European Communities by Mr. Paul Vandoren.  There had been many international participants andhis delegation believed that the discussion had been very productive, in that possible solutions had
been considered to the several issues at stake.  Of course, there might still be differences in the
positions of Brazil and the European Communities on various elements as well as issues related to, for
example, how the review of the provisions of Arti cle 27.3(b) should be handled.  There was, however,
a good level of common ground and his delegation had taken good note of the willingness of theEuropean Communities to engage in the discussion to wards meaningful results.  He also wished to
note that from a national perspective the seminar had been a most important event for consolidating
and increasing awareness in Brazil among the various constituencies in this respect.
121. Addressing the issue of results in the Arti cle 27.3(b) review, he said that the coming
Ministerial Conference would be a significant opportunity for Members to present positive solutionsfrom this review.  He recalled that, in November 2000, Brazil had proposed the inclusion of some
elements of the CBD in Article 27.3(b).  This woul d be an important outcome of the review of that
provision.  There was a coincidence of scope between Article 27.3(b), i.e. plants, animals and micro-
organisms, and the CBD, i.e. biological resources.  Members had to ensure that Article 27.3(b) would
not run against the objectives of the CBD.  Brazil therefore maintained its proposal on this issue andexpected that the Ministerial Conference would address and incorporate it in the context of the review
of Article 27.3(b).  Another important outcome of the Doha Ministerial, already expressed publicly by
the Brazilian Minister of Foreign Relations at the Manaus seminar, would be a political statement to
be included in the Ministerial Declaration based on the language of Article 16(5) of the CBD, which
laid down that national and international legislation on intellectual property should be supportive of
and not run counter to the objectives of the CBD.  Along the same lines, Brazil would very much
favour the Ministerial Conference expressing that the TRIPS Agreement should be supportive of andnot run counter to the objectives of the CBD.  Th e meaning of this language was known to Members
that were signatories of the CBD, even though they might not be contracting parties.  Taking it up in
the Ministerial Declaration would send a most positive signal and, moreover, establish some
guidelines for the TRIPS Council's discussion in  the context of the Article 27.3(b) review.
122. The Chairperson referred to agenda item P concerning the issue of the pending requests for
observer status from intergovernmental organizations, which the Council regrettably had been unable
to solve to date, including the request of the CBD Secretariat.
123. The representative of the European Communities said that his delegation considered the paper
tabled by Australia a most positive contribution to the rich debate the Council had had over the lastIP/C/M/33
Page 28
couple of years on a number of issues that had been put on the table by a significant number of
Members.  After an in-depth analysis of its cont ents, his delegation would come back to the paper at
the next meeting.  As regards the seminar in Manaus, on which Brazil had informed the Council and
which the European Communities had co-organized, he agreed with Brazil that it had been a major
success and added that there had been more than 250 participants from some 40 developing and
developed countries.  With regard to the process, he said that one of the impressions he had takenaway from the seminar was that the Intergovernmental Committee of WIPO dealing with genetic
resources, traditional knowledge and folklore surely  had a most important task ahead of it and his
delegation was certainly interested in learning about the conclusions or recommendations of the work
of that committee.  Clearly, this work would take some time, but he was sure that at the appropriate
time the results of that committee would also be fed into the work of the TRIPS Council.
124. The representative of India shared the regret expressed by the Chairperson as regards the
pending requests for observer status and stressed the fact that the Council had been unable to find a
consensus to grant observer status to the CBD Secretariat, despite a clear invitation by the General
Council to consider this.  By way of preliminary co mment to the Australian paper, he said that what
appealed to him as something worthy of consideration was the guide on access to genetic resources
and benefit-sharing that was annexed to the document.  As another initial comment, he took issue with
the Australian delegation's suggestion as to the scope of the Article 27.3(b) review, i.e. that most ofthe issues raised under it should now be transfer red to the Article 71.1 review.  He would come back
to the paper at the next meeting.  Referring to  document IP/C/W/293, he said that Norway had
probably stood out among the developed countries as the most constructive delegation in the
Article 27.3(b) review, as it had also done in the Council's discussions on intellectual property and
access to medicines.  He welcomed this Norwegian spirit.  He asked the other developed countries tofollow suit emphasizing two points, namely, first, that the sui generis  option of Article 27.3(b) really
deserved to be interpreted flexibly and, second, that  a disclosure requirement concerning the origin of
genetic resources be included in the TRIPS Agreement.  These most sensible suggestions of the
Norwegian delegation were worthy of considerati on and could not be said to fundamentally change
the balance in the TRIPS Agreement, let alone destro y it.  The only point on which he took issue with
the Norwegian delegation was its first conclusion, i.e. that there was no legal conflict between the
CBD and the TRIPS Agreement.  In his delegation's view, it was difficult to make this a truism for all
circumstances.  Had not Brazil pointed out that there were times when intellectual property protection
as implemented by Members ran counter to the objectives of the CBD?  He had never meant to say
that, as a rule, both instruments were fundamentally incompatible or came into conflict, but that therewas a provision in the CBD laying down that intell ectual property protection should not run counter to
the objectives of the CBD, which by implication was understood to mean that there were at least some
circumstances in which the instruments would pose  a problem if not implemented harmoniously.  It
was only to that extent that he took issue with the Norwegian conclusion.  Having said all of that, he
believed that, if there were steps taken, such as the one which Norway itself had suggested concerning
the disclosure requirement and prior informed cons ent and, indeed, the benefit-sharing that Australia
and others were talking about in their submissions, it was perfectly possible for a country toimplement both instruments harmoniously.  This  required action on the part of implementing
Members, but it was not correct to exclude action by the TRIPS Council and the CBD.  The CBD
Secretariat had established an expert group, which was looking at the interrelationship between the
TRIPS Agreement and the CBD, while the TRIPS Council had so far taken an ostrich policy saying
that it would not even allow the CBD Secretariat to be present at its meetings and refuse to examinethe two instruments in the light of the issues that delegations had raised.  He expressed support for
Brazil that Ministers in Doha needed to direct the TRIPS Council on this issue.  There was a checklist
of issues which, although not accepted by all Member s, reflected the universe of issues that had been
raised and could be used to bring the Article 27.3(b) review to fruition, without prejudice to the
Article 71.1 review.IP/C/M/33
Page 29
125. The representative of Bolivia, speaking on behalf of the Andean Community Members, said
that the Members in question wished to reaffirm the need to ensure compatibility of the TRIPS
Agreement with the principles and objectives of the CBD, such as the fair and equitable sharing of
benefits and prior informed consent.  Consequently, it was essential to reiterate the sovereign right of
Members to adopt standards which regulated these principles, such as the identification of and legal
access to genetic resources and traditional knowledge used in inventions;  and the revocation ofpatents granted without respecting prior informed consent or without a correct access contract.
However, providing for such protection at the national or regional level alone was not sufficient for it
to be effective vis-à-vis  third parties.  Hence, it was necessary to extend this protection to the
international level and in this connection the TRIPS Council should evaluate the best way of
protecting these legitimate rights.  He requested the Chairperson to convey these concerns to the
Chairperson of the General Council, so that they might be incorporated in the Declaration of the
Fourth Ministerial Conference.
126. The representative of the Czech Republic said that her delegation, which had not contributed
to the discussion concerning Article 27.3(b) so far,  would like to take the opportunity now to express
its views on the issues involved.  She said that the supplementary answers of her delegation to the
illustrative list of questions, which the Chairperson had mentioned, mirrored recent changes in the law
of her country and that the new legislation as notified under Article 63.2 would be available in theIP/N/1/- series of documents shortly.  The flexibility of Article 27.3(b) had allowed the Czech
Republic to protect plant varieties by an effective sui generis  system, i.e. the UPOV system, the
efficiency of which was ensured by the breeder's exemption and the farmer's privilege.  The Czech
legislation was based on the 1991 Act of the UPOV Convention.  Her delegation believed that this last
UPOV revision ensured more sophisticated protection for plant varieties.  As to the relationshipbetween the TRIPS Agreement and the CBD, her delegation found the discussion in the Council
important and useful.  It believed that the problem could not be definitively solved in the framework
of the TRIPS Agreement alone.  In her delegation's view, there was no legal conflict between the
TRIPS Agreement and the CBD.  According to the opinion of its experts, the CBD recognized the
patentability of products ensuing from genetic resources.  The TRIPS Agreement set minimumstandards of intellectual property protection, while genetic resources in nature could not be the subject
of patents, as a general rule.  The effective cooperation between the WTO and the CBD Secretariat
was necessary for achieving the objectives of both instruments.  Moreover, technical assistance
provided to developing countries to implement the two instruments placed an important rôle in this
field.  The Czech Republic supported the opinion of the European Communities and other Membersthat the TRIPS Agreement and the CBD could be implemented in a mutually supportive way.
127. The representative of Venezuela said, while emphasizing the interest of her country in the
subject, that her delegation would study the Australian paper carefully and hoped to be able to present
its comments at the next meeting.  She endorsed the statement made by Bolivia on behalf of her
delegation and the other member States of the An dean Community.  Her delegation had participated
in the Manaus seminar on which Brazil and the European Communities had informed the Council and
considered the results of that seminar most positive.  A few days before this Manaus meeting, therehad been a workshop in Caracas on traditional know ledge, held in cooperation with WIPO.  All the
competent public bodies involved in this area and indigenous and traditional communities participated
in this workshop.  The results of the workshop were highly positive and there were important
conclusions that had emerged.  By way of exampl e, she wished to highlight a mandate allowing
indigenous communities and the Government to work closely in seeking solutions.  Referring to theNorwegian paper contained in document IP/C/W/293, she expressed support, in particular, for the
fifth conclusion, namely that the introduction should be considered of a provision on the disclosure of
the origin of genetic resources in the TRIPS Ag reement, so as to ensure a more effective
implementation of the CBD.IP/C/M/33
Page 30
128. The representative of Peru said that her delegation had not had a chance yet to study the
Australian paper and would come back to it at the next meeting.  She endorsed the statement made by
Bolivia on behalf of her delegation and the other member States of the Andean Community.  Her
delegation considered it essential to ensure comp atibility and complementarity between the TRIPS
Agreement and the CBD.  However, this required amendments.  She reiterated her delegation's
support for granting observer status to the CBD Secretariat and urged other delegations who wereopposing this to reconsider their positions.  Her delegation did not agree with the opinion expressed in
the Swiss paper that had been circulated in docum ent IP/C/W/284 that the discussion of the review of
Article 27.3(b) should be limited to just addressing exclusions from patentability for plants and
animals.  In this connection, she drew attention to the fact that Section III of the Swiss paper itself
recognized that issues such as access to genetic resources and fair and equitable sharing of benefits
were "related issues".  Although she was aware that these issues were being discussed in other fora,
such as the CBD, WIPO and the FAO, there were some aspects which had to be addressed by theTRIPS Council, since they were related directly to intellectual property, in particular in the areas of
patents and geographical indications.  Switzerland's suggestion that the elements contained in the
paper from the United States that had been circulated in document IP/C/W/209 could usefully guide
national legislators to draw up sui generis  systems for the protection of plant varieties other than those
based on the UPOV system, in her delegation's view, limited the freedom of Members to establishsui generis  systems in line with their needs.  Article 27.3(b) only spoke of a sui generis  system
without providing specific details as to how plant va rieties should be protected through such a system.
As regards paragraph 31 of the Swiss paper, which called for a mutually supportive implementation of
the CBD, the FAO International Undertaking and the second sentence of Article 27.3(b), her
delegation wondered how Members could defend their rights if there were no multilateral provisionsto ensure that there was compliance with the prin ciples of prior informed consent and fair and
equitable sharing of benefits.  She thanked and congratulated Norway for its interesting submission
(document IP/C/W/293) and said that her delegation agreed with many of the points made in this
paper, which recognized the need to ensure co mpatibility between the TRIPS Agreement and the
CBD and gave a few useful options.
129. The representative of Korea expressed her delegation's appreciation for the paper presented
by Australia, which took a very careful approach.  Korea had continuously proposed that it was vital
to collect as much as possible examples of legal, administrative and other measures or regulations
related to access to genetic resources and benefit-sh aring in force in Members.  In this regard, her
delegation was impressed by Australia's valuable experience in this area.  Korea would like to makecontributions in the same direction and call for ot her Members to do likewise.  She reiterated her
delegation's view that the relationship between the CBD and the TRIPS Agreement should be
mutually supportive.  In this regard, Korea supported the idea advanced by Australia and Norway that
the effective national implementation of the obligations under the two instruments was a key to
addressing the concerns of many Members in this area.  Her delegation also agreed on the importance
of cooperation between the WTO Secretariat and the CBD Secretariat, which would further enhance
consistency in the implementation of both instruments.
130. The Chairperson said that the Council had again had a rich debate on the issues under
discussion and that the importance of Members' submissions for the furtherance of the debate on these
complex issues had again been proved.  Perhaps, this was an area in which guidance from the
Ministerial Conference was required.  He suggested that the Council take note of the statements made
and revert to the matter at its next meeting.
131. The Council so agreed.IP/C/M/33
Page 31
K. REVIEW OF THE IMPLEMENTATION OF THE AGREEMENT UNDER ARTICLE 71.1
132. The Chairperson recalled that, at the last meeting, a new paper on the matter had been
received from the delegation of Zambia.
L. NON-VIOLATION AND SITUATION COMPLAINTS
133. The Chairperson recalled that, at the last meeting, Members had had a further discussion of
this matter, with the aid of a note circulated by the Chairperson suggesting some headings for
organizing the further discussion on this matter (JOB(01)/70).
134. The representative of Bolivia, speaking on behalf of the Andean Community Members of the
WTO, said that with respect to the issue of non-viol ation and situation complaints the countries of the
Andean Community considered that it was important  to continue the debate in the TRIPS Council as
long as the scope and modalities of their application in the TRIPS area had not been clarified.  It
should be recalled that the concept of non-violation and situation complaints had been developed in
the context of GATT for the purpose of preserving tariff concessions, while the TRIPS Agreementwas an instrument which established minimum standa rds of protection of intellectual property rights.
Therefore, the countries on behalf of which he spoke considered that the concept was not germane to
intellectual property and that, until such time as the TRIPS Council had developed the required
clarifications, non-violation and situation complaints should not be admitted in the TRIPS area.
Otherwise, a great deal of uncertainty would be introduced in the application of the TRIPSAgreement.  He requested the Chairperson to inform the Chairperson of the General Council about
these concerns.
135. The representatives of Brazil and India
 expressed support for the statement made by Bolivia.
136. The Chairperson said that he would be making a report to the Chairperson of the General
Council on anything coming out of this meeting which might be relevant to the work that he was
engaged in as regards the preparatory process for Doha.
137. The Council took note of the statements made and agreed  to revert to the matter at its next
meeting.
M. ELECTRONIC COMMERCE
138. The Chairperson recalled that, at the last meeting, the Council had received new papers from
Cuba and Switzerland and continued its discussion of the matter following the invitation by the
General Council, at its meeting of 8-9 May, to inter alia  the Council for TRIPS, to continue its work
on e-commerce and report back to the General Council.
139. The representative of the European Communities noted that, in its submission (IP/C/W/286),
Switzerland had reiterated that the Internet was just a new form of communication which created
certain new problems due to its technical nature, but did not require a general re-evaluation of the
interests at stake.  He supported the Swiss proposal to request a further Secretariat study on
intellectual property and electronic commerce, and recalled that his delegation had already indicated,
in a communication submitted in November 200025, that a further study was required to identify
possible shortcomings of the TRIPS Agreement resulting from new technological developments and
the emergence of electronic commerce.  This study should take into account the analysis and work
undertaken so far by WIPO.  Following the identification of possible shortcomings of the TRIPS
                                                     
25 Document IP/C/W/224.IP/C/M/33
Page 32
Agreement, the Council should determine whethe r or not such shortcomings would need to be
addressed in the framework of the TRIPS Agreement.
140. The representative of Australia supported a further study as proposed in the Swiss
submission, provided that it would be understood that  such a study would be without prejudice to any
alternative views which TRIPS Council Members mi ght arrive at independently, and that views
expressed in the study were not intended to take precedence over the views independently expressedby TRIPS Council Members.  The study by the Secretariat should be a factual contribution to the
Council's discussions.
141. The representative of United States supported the views expressed by Australia in its
submission of November 200026 that it was not necessary to create a whole new parallel set of
intellectual property norms and principles in the context of the WTO because of the increased
utilisation of electronic commerce technologies.  The TRIPS Agreement was applicable in those
areas.  Expressing his support for the preparation of a Secretariat study as proposed by Switzerland,he noted that such a study might be of particular benefit to Members if it were to focus on practical
issues of what countries were doing when implementing the TRIPS Agreement in the on-line
environment.
142. The representative of Korea noted that the Swiss paper was based of the premise that what
was valid off-line was valid on-line.  The paper also  argued that the TRIPS provisions were equally
applicable to on-line trade because of their technological neutrality.  She said that the term
"technological neutrality" should be used with cautio n in the TRIPS context.  She recalled that the
term had been first used in the context of the negotiations on basic telecommunications in 1997.
Subsequently, the term had mainly been used in the service negotiations.  In GATS, "technological
neutrality" meant that specific commitments made under the GATS Agreement applied to alltechnological means of supplying a service unless otherwise specified.  She recalled that the TRIPS
Council's report to the General Council (IP/C/18) noted that the notion of technological neutrality had
been challenged and that the matter might require additional analysis.  The point had been made that
the TRIPS Agreement had been negotiated before in tellectual property in the on-line environment had
become an issue facing the international community  as a result of the emergence of global networks.
In her delegation's view, a further study was necessary to incorporate technological neutrality into the
TRIPS Agreement.  A way to prepare a study would be that the WTO Secretariat would update its
excellent previous paper contained in document IP/C/W/128.
143. The Chairperson noted that there seemed to be a desire for a Secretariat contribution to the
discussion in the form of a study but that, at the same time, there appeared to be some sensitivities as
to what such a study might actually entail.  He suggested that the Secretariat consult with interested
delegations, on the basis of the discussion at the present meeting and previous contributions, in order
to get a clearer picture as to what kind of study it might be asked to prepare.
144. The representative Brazil said that, in the absence of a clear understanding on the possible
contents of a study, he preferred the Council to simply revert to the matter at the next meeting.
145. The representative of Switzerland expressed support for the suggestion by the Chairperson
that the Secretariat consult on the contents of a possible study before the next meeting and that the
results of these consultations be made available at that meeting.
146. The Chairperson suggested that the Council, while taking note of the statements made, revert
to the matter at its next meeting, including the issue of a possible study by the Secretariat, which
should, in the meantime, consult with interested delegations on the contents of such a possible study.
                                                     
26 Document IP/C/W/233.IP/C/M/33
Page 33
147. The Council so agreed.
N. INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES27
148. The Chairperson recalled that, in concluding the informal meeting of the Council on
25 July 2001, its Chairperson, Ambassador Chidyausiku of Zimbabwe, had indicated that he would
hold consultations prior to the present meeting of the Council to see whether Members could come up
with a framework for capturing the progress in their work on this subject.  He had also said that hewould consult with the Chairperson of the General Council on the issues that had been raised in the
discussion at the informal meeting on 25 July about the relationship between the TRIPS Council's
work and work in the General Council's preparatory process for Doha on the issue of intellectual
property and access to medicines.  The two Chairpersons had been in touch with each other and had
agreed that, at least until the present Council meeting, it would make sense for the work in the
Council to cover the totality of the elements that might be sent to Doha on intellectual property and
access to medicines, both the preambular or more  political aspects and the more technical ones
relating to the clarification of the relevant provisions of the TRIPS Agreement.  Consequently,
Ambassador Chidyausiku had held a series of consultations with some of the delegations that had
been most active in the debate on intellectual property and access to medicines in small groups.
149. Continuing, he said that a number of delegations had indicated that they were preparing
proposals for language for the Doha Ministerial Conference and would introduce these some timeduring the present meeting of the Council.  He recalled that the Chairperson of the General Council
had indicated his intention to submit to Members a draft text of elements for a Ministerial Declaration
towards the end of the month.  There was therefore little time in which to make progress in capturing
in writing what Members had achieved and what they might be able to further achieve.  As regards the
fruits of the work in the Council for TRIPS on clarifying the provisions which provided flexibility toMembers under the Agreement, he recalled that the Council had agreed, at its informal meeting of
25 July 2001, to focus the discussions on:  the objectives and principles of the TRIPS Agreement as
enshrined in Articles 7 and 8;  the provisions relating to compulsory licensing;  and the provisions
relating to parallel imports.
150. The representative of India said that these and other issues were all addressed in a proposal
from a group of developing countries, including India, for a Ministerial declaration on the TRIPS
Agreement and public health, which the delegation of Zimbabwe would present later during the
meeting and which his delegation was ready to take up in the TRIPS Council or in the General
Council.  In terms of expectations from the exerci se in the TRIPS Council, it would be unacceptable
for his delegation if this exercise would result in  a reduction of the flexibility existing under the
TRIPS Agreement as perceived by a large number of countries.  The same applied to any preambular
or "comfort" language simply re-stating the TRIPS wo rding.  Furthermore, the scope of the text to be
developed should concern TRIPS and public health and should not be limited to addressing issues
concerning the tragic HIV/AIDS crisis alone.  What his delegation expected from the Council for
TRIPS was text that would set out the maximum possible limits under the TRIPS Agreement.  He
emphasized that the sponsors of the submission to be presented by Zimbabwe were not operating in a
vacuum and referred to a recent statement made by  a large number of NGOs on the matter.  Members
had a responsibility vis-à-vis  these NGOs, in particular those Members who argued that the TRIPS
Agreement contained the right balance and offered enough flexibility.
151. As regards Articles 7 and 8, his delegation was of the view that these provisions were of
overarching importance.  For a variety of reasons, the TRIPS Council and other WTO bodies should
take these provisions as a benchmark for the interpretation and clarification of the TRIPS Agreement.
                                                     
27 The Council agreed to a request from UNAIDS to be admitted as observer to the present meeting of
the Council as far as the discussion under this agenda item N was concerned (see under agenda item P below).IP/C/M/33
Page 34
It was for that reason that they appeared in Part I of the TRIPS Agreement, which concerned general
provisions and basic principles.  What was at stake was the balance contained in the Agreement
between, on the one hand, protecting the rights of patent owners and, on the other hand, allowing
Members to pursue developmental, technological and social objectives, which incorporated each
Member's freedom to formulate policies, in particular public health policies.  He believed that the
TRIPS Agreement should go further and recalled that, according to public opinion, the TRIPSAgreement should not only protect the legitimate rights of patent right holders, but also enable
Members to promote the objectives which were already enshrined in the Agreement as illustrated by
its Article 7.  The aim of the present discussion among Members should be to see if the TRIPS
Council could clarify and interpret the Agreement while at the same time confirming that Members
could also use the Agreement to promote these objectives.  As regards the principles contained in
Article 8, he believed that Ministers, when signing the TRIPS Agreement, had not signed away the
right of WTO Members to protect public health and nutrition and highlighted the emphasis inArticle 8 on sectors of vital importance to the socio-economic and technological development of
developing countries.  Some delegations had made reference to factors other than patents which could
influence access to medicines, such as weak infrastructures.  In his view, these factors were covered
by the objectives of "socio-economic and technological development" and consequently by Article 8
of the TRIPS Agreement.  It was important for Ministers to affirm the importance of Articles 7 and 8.Panels and the Appellate Body would in any even t do likewise on the basis on the Vienna Convention
on the Law of Treaties, according to which the provisions of an Agreement had to be interpreted  in
the light of its context, objectives and principles.
152. On compulsory licensing, he said that, if there would be a consensus among Members that the
TRIPS Agreement did not limit the grounds for the grant of compulsory licences, this should be speltout clearly and categorically.  He also emphasized the need for Members to address the issue of
compulsory licensing for exports to countries not having the manufacturing capacity to make products
under a compulsory licence, stressing that India was not such a country.
153. As regards parallel imports, his delegation believed that this could be an important tool to
ensure access to medicines.  Therefore, it was important for Members to have full freedom andflexibility to exercise the right available under the TRIPS Agreement to promote public health and
nutrition.  Ensuring adequate access to medicines would serve the important purpose of protecting
public health.  In the light of Article 6 of the TRIPS Agreement, Ministers could confirm
unconditionally the right of each WTO Member to determine its own exhaustion regime.
154. The representative of the European Communities said that his delegation fully concurred with
the concluding remarks of the Chair at the informal meeting of the Council on 25 July 2001 when he
had said that the focus of discussion at the present meeting should be on the objectives and principles
as enshrined in Articles 7 and 8, on the provisions on compulsory licensing, and on parallel imports.
Since these issues were likely to be included, one wa y or another, in the Doha Ministerial Declaration,
the results of the discussions at the present meeting should be carried over to the preparatory process
for the Ministerial Conference.  The mandate of the TRIPS Council for the work at the present
meeting as well as for the content of the Ministerial Declaration had been agreed at its meeting inApril 2001, when the Council had set the parameters for the exercise as follows
28:  "Bearing in mind
that two sub-items had been identified as topics on which Members would exchange their views,
i.e. the interpretation and application of the relevant provisions of the TRIPS Agreement with a view
to clarifying the flexibility to which Members were entitled under the Agreement and the relationship
between the TRIPS Agreement and affordable access to medicines, …".  In referring to "access tomedicines", this mandate was narrower than "publi c health and nutrition", to which the representative
of India had referred and in fact all the time spent on this issue to date had related to access to
medicines and not to nutrition.  Referring to a comment made by the representative of India that the
                                                     
28 Document IP/C/M/30, paragraph 251.IP/C/M/33
Page 35
Ministerial Declaration should not lead to a reduction of flexibility, he said that the result aimed at
should be clarification of the flexibility existing under the Agreement.  He drew attention to his
delegation's communication (document IP/C/W/280) and statement at the previous meeting of the
Council in which it had set out its views on the issues under discussion and offered solutions to these
issues, including interpretative language.  His de legation would elaborate further on its views and on
elements which the Chairperson of the General Council might suggest should be taken into account inthe preparatory process for the Ministerial Conference.
155. He said that Articles 7 and 8 were of prime importance for the implementation of the TRIPS
Agreement.  They provided essential guidance for interpreting all the provisions of the Agreement,
especially those which provided scope for flexible interpretation or which allowed Members to
fine-tune the balance between the rights of the right holders and those of the public at large.  Article 7
made clear that implementation was not just a matter of protecting private rights but should be done in
a manner which achieved the objectives set out in that provision, such as the promotion oftechnological innovation, the transfer and dissemination of technology to the mutual advantage of
producers and users of technological knowledge, and "in a manner conducive to social and economic
welfare and to a balance of rights and obligations".  The fact that the Agreement contained two
separate articles dealing with the Agreement's objectives and principles underlined the importance
that Members should attach to their guidance when  implementing the Agreement.  Article 8 could not
be considered as an autonomous right to grant exceptions to patent rights.  The relevant exceptions
provisions were set out in Articles 27.2, 30 and 31.
156. As regards compulsory licensing and parallel importation, he wished to limit himself for the
moment to recalling that his delegation had already addressed these issues in its communication
(document IP/C/W/280), in particular the question of compulsory licences granted for the benefit ofcountries with little or no local pharmaceutical production capacity.
157. The representative of Brazil recalled that, on 20 June 2001, the TRIPS Council had for the
first time had the opportunity to discuss TRIPS and public health.  A broad range of issues had been
raised by delegations showing the high degree of preparation and interest of delegations.  The formal
and informal discussions since then seemed to evolve towards a general consensus on the need toaddress the issue at the coming Ministerial Conference.  The idea of drafting a specific declaration on
the issue of TRIPS and public health appeared to be accepted.  Brazil had supported this idea from the
outset, in light of the political relevance of the issue.  The WTO should send a clear message to civil
society that its Members were committed to ensure that the TRIPS Agreement would not interfere
with Members' prerogative to protect public health  policies.  Clearly, for Brazil, the exercise of
clarification of the TRIPS Agreement could not be limited to preambular language.  In order to
establish clear and unambiguous clarifications, operative language was required to prevent that any
ambiguities in the provisions of the TRIPS Agreement could be used in a way that would run against
public health policies.
158. As regards the scope of the exercise, Brazil believed that discussions should not be limited to
a specific disease, such as HIV/AIDS, or a category of diseases, such as communicable diseases.  As
dramatic as the HIV/AIDS epidemic was, Brazil had never engaged in the process with a view toexclude from the scope of discussions the great number of other diseases that affected its population.
Any attempt to limit the scope to some specific diseases would leave Brazil in a position of having to
explain to its constituencies affected by other diseases the reasons why national public health policies
would or could be limited by the TRIPS Agreement.  Brazil would not accept to be in such a position.
In its view, the scope of the exercise was therefore public health bearing in mind the basis thatArticle 8 of the TRIPS Agreement provided for it.
159. Turning to the language of the principles and objectives of the Agreement, he recalled the
elements presented by a group of developing countries in document IP/C/W/296 and the emphasis putIP/C/M/33
Page 36
by the sponsors of this submission on the importance of Articles 7 and 8 for interpreting each
provision of the TRIPS Agreement.  The Vienna Convention on the Law of Treaties, in particular its
Article 31, provided support for this view, laying dow n that a treaty must be interpreted in good faith
in accordance with the ordinary meaning to be give n to the terms of the treaty in their context and in
light of its object and purpose.  Article 7 was the key provision that defined the objectives of the
TRIPS Agreement and clearly established that the protection and enforcement of intellectual propertyrights did not exist in a vacuum.  They were supposed to benefit society as a whole and not merely
protect private rights.  Some of the elements in Article 7 were particularly relevant in order to ensure
that the provisions of the TRIPS Agreement did not conflict with health policies, such as the
promotion of technological innovation, the transfer and dissemination of technology, the mutual
advantage of producers and users of technological knowledge, social and economic welfare, and a
balance of rights and obligations.  The objective of the promotion of technological innovation and the
transfer and dissemination of technology placed the protection and enforcement of intellectualproperty rights in the context of the interests of society.  Such an objective was essential for the
promotion of health policies, as it encouraged the development of domestic production of
pharmaceutical products, which was a goal supported by the World Health Assembly resolution
in 2001.  Whenever economically feasible, local production of pharmaceuticals ensured that
medications would be more readily available on the market at more affordable prices.  Localmanufacturing also encouraged sustainable access to medicines, for example by insulating the price of
patented medicines against currency devaluat ion, which was a problem common to developing
countries in times of global economic difficulties.  It also supported the development of local
expertise, which was vital in addressing local needs.  These objectives could be attained by the normal
exercise of patent rights;  however, where the patent holder failed to meet the objectives of the TRIPSAgreement and of public health policies, Members were allowed to take measures to ensure transfer
and dissemination of technology to provide better access to pharmaceuticals.  Article 8 of the TRIPS
Agreement affirmed that Members were allowed to adopt measures to protect public health, among
other overarching public policy objectives such as public health and nutrition or economic and
technological development.  Any interpretation of the provisions of the Agreement should take into
account the principles set forth in Article 8.  The reading of those provisions should confirm that
nothing in the TRIPS Agreement should prevent Members from adopting measures to protect public
health as well as from pursuing the overarching principles of Article 8.
160. The representative of the United States said that Members should bear in mind throughout the
discussion of the particular provisions related to access to medicines that the TRIPS obligations
relating to access to medicines only applied where patents or other intellectual property rights existed.
If innovators had chosen not to obtain rights for an invention in a particular market or if the patent on
a particular medicine had expired, anyone was allowed to make, use, offer for sale or sell the product
in question in that market, or import it into the market or use the process in question for making it.  He
had chosen to emphasize this point, because some documents and reports as well as statements made
in the TRIPS Council or other fora gave the impression that the TRIPS Agreement was part of the
problem, where in fact it was part of the solution to the issue of access to medicines.  A recent studyconducted by Harvard University demonstrated that very few patents existed in sub-Saharan Africa
for medicines for HIV/AIDS, including anti-retrovirals.  While this study had not yet been published,
its results had already been made available widely on the Internet.  In addition, a number of
developing countries with generic pharmaceutical industries were availing themselves of the transition
period provided for in Article 65.4 with regard to pharmaceuticals and their generic industries wereproducing many of the medicines used for HIV/AIDS, malaria and tuberculosis treatment.  For these
reasons, he reiterated his delegation's interest in an explanation of the reasons why Members believed
that patent protection was responsible for the lack of access to medicines or for the price of medicines
in developing and least-developed country Members' markets.  These preliminary remarks should not
be taken to mean that his delegation no longer supported the efforts in the Council aimed at clarifyingthe flexibilities existing under the Agreement.  The United States was fully committed to ensuring that
Members had the ability to use that flexibility in order to address situations such as those concerningIP/C/M/33
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HIV/AIDS and other pandemics.  He agreed with India that the process should not result in any
limitation of the existing flexibility.  However, ne ither should the process result in any limitation of
existing obligations.
161. As regards Article 7, he said that, in his delegation's view, this provision set out the objectives
that full implementation of the TRIPS Agreement was intended to achieve.  Those objectives had
certainly been achieved in the United States and in other Members that had already incorporated thestandards of protection for the various forms of intellectual property in their laws and practices.  It
might not be the case in those Members that had not yet implemented these standards.  For example,
absent the incentive provided by a modern patent system, investment, domestic or foreign, in the
development of new technologies in a Member was unlikely to occur, because potential investors
would recognize that there would be no "mutual advant age", i.e. no rights to balance with obligations,
and other parties would be free to use technology developed by a producer to compete in the same
market without the need to recover research and development costs.  Likewise, those that haddeveloped technology elsewhere were not likely to transfer that technology to a country where the
technology could not be protected.  Absent implem entation of the minimum standards of protection
and enforcement established by the TRIPS Agreement for the various forms of intellectual property,
domestic and foreign investment would be concentrated on existing technologies, meaning that
business enterprises in the territory of a Member would always be followers and never leaders,because the incentive for leadership was lacking.  Implementation of the standards of the TRIPS
Agreement created a legal environment that promoted investment, domestic and foreign, in the
development of new technologies and encouraged the transfer of technology in a manner conducive to
social and economic development.  The rights of innovators and creators were balanced by
obligations, such as the obligation, in the case of pate nts, to disclose their inventions clearly, so that
others skilled in the relevant art could  practice the invention and build upon it.  Such disclosure often
brought about additional innovation in the form of improvements or new uses of existing technology
and sometimes the creation of new technologies.  Rather than impeding access to medicines,
therefore, patent regimes actually met the objectives of Article 7 by contributing to the promotion of
technological innovation and to the transfer and di ssemination of technology.   In his delegation's
view, the objectives of the TRIPS Agreement as outlined in its Article 7 should indeed be used to
interpret the provisions of the TRIPS Agreement, bearing in mind though that the provision stated
what "protection and enforcement of intellectual property rights" should do.  Obviously, where the
standards for such rights and enforcement were not met through full implementation, the objectives
would not be met either.
162. Turning to Article 8, he said that conspicuously missing from the discussions so far had been
an analysis of the full text of this provision, which, in clear and unambiguous wording, permitted a
Member to adopt measures necessary to protect public health and nutrition, to promote the public
interest in sectors of vital importance to the Member in certain areas, to prevent the abuse of
intellectual property rights, and to prevent practices that restrained trade or the transfer of technology
unreasonably, so long as those measures were consistent with the provisions of the TRIPS Agreement.
The final clause of the text indicated that Article 8 did not provide an exception to the obligations ofthe Agreement.  Article 8  provided guidance as to  the flexibility of the Agreement and had the same
function as other permissive provisions of the Agreement.  For example, Article 1.1 did not specify
the method for implementing the provisions of the Agreement, but rather allowed Members to
determine for themselves the appropriate method for implementation within their own legal system
and practice.  Article 8, like the other permissive provisions of the TRIPS Agreement, was intended tomake clear that particular actions were allowed under the Agreement, so long as they were consistent
with the Agreement, and established the conditions under which the actions were allowed.  The
conditions established boundaries to the flexibilities explicated in the permissive provisions, and were
an integral part of each provision.  Because of the purpose Article 8 served, it should not be seen as a
tool for interpreting the TRIPS Agreement, but rath er as another of the flexibilities built into the
Agreement that ensured that the objectives listed in Article 7 were achieved.IP/C/M/33
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163. On compulsory licensing, he referred back to his delegation's extensive statement during the
Council's special discussion in June 2001 regarding the provisions contained in Article 31  (document
IP/C/M/31, pages 37 to 40).
164. With regard to parallel imports, there was, in his delegation's view, no question that Article 6
denied Members the ability to avail themselves of dispute settlement in relation to exhaustion of
intellectual property rights, except if the issue involved national treatment or most-favoured-nation
treatment.  However, Article 6 did not authorize  parallel imports;  it did not alter the substantive
obligations of the TRIPS Agreement, particularly thos e contained in Part II of the Agreement.  In his
delegation's view, advocates of parallel importation overlooked the fact that permitting such imports
ultimately created a barrier to access to medicines, since it discouraged patent owners from pricing
their products differently in different markets based upon the level of economic development because
of the likelihood that, for example products placed on the market for a low price in a poor country
would be bought up by middle men and sent to wealth ier markets where they could be sold at higher
prices, for the benefit only of the middle men.  Lack of protection against parallel imports could also
have significant health and safety implications.  Law enforcement and regulatory agencies in his
country, especially the US Food and Drug Administration, had commented on the significant
difficulties of keeping counterfeit and unapproved drugs out of the United States, even with the strong
protection provided to intellectual property rights in the United States.
165. In conclusion, he noted that, at the Council's meeting in June 2001, it had been universally
recognized by delegations that it was necessary to  provide incentives for investment in research and
development of new and more effective pharmaceuticals.  Effective patent systems, therefore, were
crucial to finding better treatments and, ultimately, cures for HIV/AIDS and the many other diseases
and health conditions that afflicted the world's population.  The TRIPS Agreement appropriatelyrequired Members to provide such effective patent systems.  The Agreement also provided sufficient
flexibility through the possibility of certain limitations on patent rights so that, among other things,
Members could provide access to affordable medicines for the treatment and cure of diseases.
166. The representative of Indonesia said that her country fully associated itself with the
submission to be presented later at the meeting by Zimbabwe on behalf of a group of developing
countries.  Her delegation believed that in the run up to the Doha Ministerial Meeting, the issue of
TRIPS  and public health had become of increasing importance not just because of the sensitivity the
issue had brought among Members of the WTO, but also because of the significant impact the issue
had on the ability of developing countries to protect and promote public health domestically.  In the
view of Indonesia, the right to life and to attain a reasonable standard of physical and mental health,including the prevention and treatment of diseases, whether they were life-threatening or not, was a
fundamental human right of all people.  The protect ion of this fundamental human right was not just
the responsibility of national governments but, to a certain extent, should be the universal
responsibility of all people of the world.  Nobody must stand back in helplessness while people
suffered and died from diseases if there were possible cures but people were deprived from having
access to these cures.  Indonesia recognized the importance of the TRIPS Agreement in providing a
balance between promoting research and development and safeguarding public interest.  However, itcould not be ignored that, under the TRIPS Agreement, public interest in relation to public health had
not been fully safeguarded.  Although Article 8 allowed Members to adopt measures to protect public
health, elements were there that could make private interests override the public needs and interest to
public health.  Indonesia fully respected the importance of intellectual property protection in
providing private rewards and, to some extent, a stim ulus towards research and development.  It also
recognized that patents enabled pharmaceutical manufacturers to charge prices considerably higher
than their cost of production.  However, in developing countries like Indonesia, where out of
220 million people only 15 per cent were covered by health insurance and government expenditure on
medicines was less than one dollar per capita, the impact of charging excessive economic rent on
drugs and medicines greatly undermined the accessibility to medicines and public health.IP/C/M/33
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Furthermore, developing countries had also had limited options to make available needed medicines
at affordable prices due to the wide price variations between countries resulting from the practice of
differential pricing by pharmaceutical manufacturers, which was also coupled with the inability of
developing countries to conduct research and development on medicines.  Although her delegation
believed that provisions such as the "Bolar" provision might provide some relief in allowing
developing countries with production capabilities to conduct early testing and approval to producegeneric drugs, such provisions did not, however, ensure that the needed medicines could be made
available on a timely basis without the "operationalization" of other provisions of the TRIPS
Agreement.  Against this background, the role of compulsory licences was of crucial importance for
governments to secure public health protection.  For this reason, her delegation believed that, for the
purposes of public health, the interpretation of Article 31 by Members should not be restricted and
held up by procedural requirements or process obstacles hindering developing countries in issuing
compulsory licences.  The use of parallel imports was also an important life line for developing andleast-developed countries in providing adequate medicines at affordable prices.  Although many
developing countries like Indonesia had striven hard to create the needed infrastructure for
pharmaceutical industries, parallel imports were essential not just to ensure greater access to
medicines but also to reduce anti-competitive practices.  She believed that the TRIPS Agreement,
under its Article 6, provided for this flexibility and thus called for an explicit acknowledgement of thisright by all WTO Members.  Indonesia was of the view that, without full and faithful implementation,
the flexibility of the TRIPS Agreement would greatly  impede developing countries' ability to provide
adequate public health to their people.  Whilst it was committed to the full and faithful
implementation of the TRIPS Agreement, her dele gation also believed that the TRIPS Agreement
should not prevent Members from taking measures to protect public health.  For this reason, Indonesiaconsidered it highly important for the WTO to address the concerns of developing countries on this
issue with a view to finding an appropriate solution and wished to express support for a declaration on
the issue at the Doha Ministerial Conference.
167. The representative of Peru agreed with previous speakers that there should be a separate
Ministerial Declaration on the relationship between the TRIPS Agreement and public health and,
referring to the draft for such a declaration to be presented later at the meeting by Zimbabwe on
behalf of a group of developing countries, highlighted some of the main elements which her
delegation believed should appear in this Ministerial Declaration..  The Doha Ministerial Conference
provided an opportunity to show civil society that the WTO could contribute to the well-being of all
Members, especially to populations with fewer resources in developing countries and least-developedcountries.  In the context of public health, the TRIPS Agreement and patent rights should be exercised
in a manner that not only granted benefits and incentives to right holders, but also took into account
the needs of users of medicines and promoted social and economic well-being while preserving a
balance between rights and obligations.  Therefore, all provisions of the TRIPS Agreement should be
read in the light of the objectives and principles in Articles 7 and 8.  Article 7 was a fundamental
provision for the interpretation of the Agreement, because it required that the protection and
enforcement of intellectual property rights not exist in a vacuum.  The objectives of the promotion oftechnological innovation and the transfer of tech nology were also contemplated by the Agreement.
This should not be forgotten.  Regarding public health, the protection of intellectual property rights, in
particular patents, should stimulate the production of new medicines and the international transfer of
technology.  Article 8 expressly recognized that Members could adopt measures to protect public
health, among other general public policy objectives, such as nutrition and socio-economic andtechnological development.  Article 31 stipulated that Members could issue compulsory licences for
various reasons, including the protection of the health of their populations.  Her delegation wished to
reaffirm its understanding that none of the provisions of the Agreement limited the grounds on which
governments could issue compulsory licences.  Parallel importation was another important instrument
and should be considered a legitimate measure which Members could adopt for the protection ofpublic health and nutrition.  Article 6 granted Members the freedom to incorporate in their domestic
legislation the principle of international exhaustion of rights, which was the legal basis for parallelIP/C/M/33
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imports.  As regards Article 39.3, since the market entry of competitive medicines was at stake, the
provision should not be interpreted in a slanted way.  In cases in which marketing approval
procedures required the submission of test data, the only obligations under Article 39.3 were the
protection of such data against unfair commercial  use and against disclosure.  The provision did not
establish any obligation to prohibit applications by, or permission for, third parties to produce generic
or other versions of medicines that had already received approval.  Lastly, there was also reason toclarify that no Member should exercise bilateral pressure or threats to begin dispute settlement
proceedings against Members adopting measures which they considered necessary to promote public
health and nutrition.
168. The representative of Canada said that access to medicines was one of the most challenging
issues the Council for TRIPS had the responsibility to address, as lives were at stake.  The provision
of drug therapies for health epidemics such as HIV/AIDS, malaria and tuberculosis was a complex
question which encompassed broader issues than intellectual property rights.  It involved theestablishment of adequate systems to deliver and monitor drug usage as well as direct and alternative
mechanisms to finance drug purchases.  Developing and least-developed countries needed assistance
to develop their health systems and infrastructure capacity for the delivery and monitoring of complex
drug regimes.  The special discussion of the Council on 20 June had shown that Members shared their
perspectives on the various issues and the range of provisions that could be related to intellectualproperty and access to medicines.  She recalled that, at the informal meeting of the Council on
25 July, Canada had called for a holistic approach to addressing the issue of access to medicines.
Canada had recognized that, while important work was being done in other fora, e.g. the WHO, it was
important that the Council for TRIPS continued its work on these issues in cooperation with those
other bodies.  At that meeting in July, Canada had also offered preliminary comments on a number ofTRIPS provisions identified in the checklist prepared by the WTO Secretariat (JOB(01)/113) and
noted the flexibility Canada believed these provisions offered to Members in addressing health
epidemics.  Canada looked forward to continued work on this most important issue and recognized
the full urgency of the need to address access to medicines concerns.  It was only by working together
that Members could hope to achieve a feasible and equitable strategy for those who expended theirresources to generate new life saving medicines, and for those who desperately needed access to
medicines to address health epidemics such as HIV/AIDS, malaria and tuberculosis.
169. Turning to Articles 7 and 8, she said that Article 7 referred to "social and economic welfare"
as an objective, while Article 8 referred to protecting "public health" as a principle.  Both provisions
were important for recognizing and understanding the delicate balance and flexibility provided for inthe TRIPS Agreement.  Article 8 required that measures adopted that were necessary to protect public
health must be consistent with the provisions of the TRIPS Agreement.  This struck the appropriate
balance between the need to have a rule-based international trading system and the flexibilities
provided for with respect to parallel importation and compulsory licensing.  Canada had successfully
called on Articles 7 and 8 in its defence of its pharmaceutical patent system in a WTO dispute in
which this system had been challenged by the European Communities and their member States, in
particular the "early working" provision as a limited exception to the exclusive rights conferred by apatent.  Canada had introduced its arguments in this case with an analysis of the object and purpose of
the TRIPS Agreement.  It had argued that one of the key goals of Article 7 was a balance between the
intellectual property rights created by the Agreement and other important socio-economic policies of
WTO Member governments.  Since public health, as articulated in Article 8, was one of the
socio-economic policies in question, Canada had argued that this called for a liberal interpretation ofArticle 30, so that governments would have the necessary flexibility to adjust patent rights to maintain
the desired balance with other important national policies.  In its submission, Canada had also called
on the Vienna Convention on the Law of Treaties to assist in interpreting the TRIPS Agreement.  The
WTO panel had confirmed that the TRIPS Agreement allowed Members to balance social and health
priorities with the interests of innovators and creators.  In doing so, the panel had held that "both thegoals and limitations stated in Articles 7 and 8.1 must obviously be borne in mind …".IP/C/M/33
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170. Regarding parallel importation, she said that, for several Members, parallel importation might
well be the best way to improve access to medicines, due to the limited local capacity to produce raw
materials and undertake drug manufacturing, and/or because the size of local markets did not justify
local marketing.  Article 6 on exhaustion ensured that Members could not be subject to dispute
settlement, whether they chose to permit or prohibit parallel imports, provided that the obligations for
national treatment (Article 3) and most-favoured-nation treatment (Article 4) were observed.Otherwise, the TRIPS Agreement left it up to each Member to determine its position on parallel
imports.  It must be noted that Article 6 applied to all forms of intellectual property rights:  copyright,
trademarks, patents, etc.  However, given the potential breadth of its application and in order to
facilitate a more fruitful discussion on access to medicines, Canada would restrict its comments to the
access issue.  With respect to patents, Article 28.1(a) contained an express right to control importation
of patented products, but a footnote made it plain that this right was subject to Article 6.  Two other
TRIPS provisions might also be relevant to the issue of parallel importation, namely Article 44 oninjunctions and Article 51 on suspension of release by customs authorities.  The Paris
Convention (1967) as incorporated into the TRIPS Agreement by means of a reference in Article 2.1
did not expressly confer on the right holder a power to control importation, let alone parallel imports.
Article 5A(1) of the Paris Convention (1967) expr essly provided that, with regard to patents,
importation by the right holder would not constitute a ground for forfeiture.  Article 9(1) of the ParisConvention (1967) dealt with seizure and importatio n of goods which unlawfully bore a trademark or
a trade name.  Although the TRIPS Agreement generally left it up to Members to determine their
stance on parallel importation, there might be a number of other issues that might be relevant to the
discussion, such as repackaging and relabelling requirements.  Many of these issues revolved around
the notion that the products had been legitimately placed on the market of the exporting nation withthe consent/authorization of the right holder.  Further study was also needed to consider situations
where a compulsory licence had been granted or price restrictions were in effect in the exporting
country.  A pharmaceutical sold in a different country might require repackaging and a change of
language and product warnings, which could raise a host of copyright and trademark implications.  If
the pack size was inconvenient or different from the norm in the country of importation, the importerwould likely need to repack the contents to suit the local market.  Repackaging became even more of
an issue if the original condition of the product was adversely affected.  A tiered or discounted pricing
system, as had been proposed by the European Communities, would offer lower drug prices to
developing countries, while maintaining prices in the developed country markets.  Implementation of
such a system would require safeguards against the "leakage" of low-priced medicines back into
developed country markets.  Canada had already si gnalled that further elaboration of this proposal
would be helpful.
171. Turning to compulsory licensing, she said that her delegation recognized that drug therapies
for health epidemics, such as HIV/AIDS, unlike th e majority of drugs on the WHO List of Essential
Drugs, were currently under patent protection and, thus, the flexibility of the compulsory licensing
provisions of the TRIPS Agreement might prove useful.  Canada had consistently maintained that
flexibility was one of the pillars upon which the TRIPS Agreement was built.  It believed that theexisting TRIPS provisions on compulsory licensing, if used effectively by Members, could be part of
the solution to the issue of access to medicines.  Article 1 of the TRIPS Agreement provided that
Members were "… free to determine the appropriate method of implementing the provisions of the
Agreement within their own legal system and practice".  Accordingly, the TRIPS Agreement
permitted the use of administrative practices in Article 31 decisions, including determining thegrounds for issuing compulsory licences, setting of compensation and the appeal processes.
Article 31(i) required that the administrative and/or  judicial process provided an "independent review"
by a distinct higher authority.  Members had consid erable latitude in accomplishing this.  The TRIPS
Agreement required that a system be created th at would carry out the purposes of compulsory
licensing and include a process that was fair and straightforward.  Other flexibilities available toMembers concerning compulsory licensing related to the otherwise mandated availability  of
injunctions.  Article 31 did not restrict the grounds for granting compulsory licences on patents;IP/C/M/33
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however, it contained a set of conditions and requirements, including the need to grant such licences
on a case-by-case basis;  the requirement - in some cases - of a prior request to the patent owner;  the
non-exclusive and non-assignable character of the licences;  the stipulation of compensation;  and
conditions for termination of the authorization.  Certain of these conditions or requirements were
much less strict in instances of "a national emergency or other circumstances of extreme urgency".  In
interpreting the grounds upon which a compulsory licence might be granted, and in particular whatconstituted "a national emergency or other circumstances of extreme urgency", recognized rules on
the interpretation of international agreements and treaties had to be followed.  Articles 7 and 8, as the
objectives and principles provisions of the Agreement, would also play a significant role in
interpreting any particular provision, such as Article 31.  Canada fully supported what appeared to be
a growing consensus among Members, that HIV/AIDS qualified as "a national emergency or other
circumstances of extreme urgency" justifying the us e of compulsory licences by certain Members.  It
was imperative that this determination be granted on a case-by-case  basis, in accordance with
Article 31(a).  HIV/AIDS concerned all Members, but it clearly had varying degrees of impact on
Members.  Even among developing country Members, the specific access to medicines needs might
be different.  For instance, countries with more developed medical infrastructures were likely to have
a better capacity to effectively use combination anti-retroviral drugs.  For other developing countries,
it might be more important to obtain greater access to anti-microbial and other prophylactic drugs.Article 31(c) required that the scope and duration of the compulsory licence be limited to the purpose
for which it was authorized.  This restriction was appropriate if a compulsory licence was granted to
address access to medicines concerns related to a health epidemic.  Also closely related was
Article 31(g), which provided that the authorization for a compulsory licence could be terminated.
Concerns that this condition would discourage applications for compulsory licences was unfounded,since the provision went on to clarify that termination would only occur "if and when the
circumstances which led to it cease to exist and are unlikely to recur".  Article 31(h) required that the
right holder be paid adequate remuneration in the circumstances of each case, taking into account the
economic value of the authorization.  Articles 7 and 8 would be applicable in applying Article 31(h).
Canada would not be supportive of any proposal that did not provide adequate remuneration to theright holder.  To do so would be to stifle the innovation of new medicines and nullify the effect of a
patent system.  Nevertheless, Members had considerable discretion in determining remuneration.  The
task for a Member was to provide a fair process for reaching a reasonable result.   For example, one
way to proceed might be to create a set of compensation guidelines that would provide a framework
for decision making, and also provide some predictability and transparency for the system.  Membershad indicated their interest in gaining a better understanding of Article 31(f), specifically as to the
issue of its application to situations where the domestic manufacturing capacity did not exist for a
Member who met the conditions for granting a compulsory licence and wished to do so.  If the
concern was that the size of the local market did not justify local manufacturing, her delegation would
suggest that other TRIPS flexibilities, such as parallel importation, might provide more appropriate
solutions.  Article 31(f) provided that "any such use shall be authorized predominantly for the supply
of the domestic market of the Member authorizing such use".  This provision would therefore appearto provide a limitation on the amount or proportion that could be exported.  The word
"predominantly" would, however, suggest that ex ports might be possible, although they should not
constitute the main activity of the licensee with re gard to the licenced product.  To justify exports
which fell outside the scope of the latitude pr ovided for by the word "predominantly", a more
comprehensive analysis of the TRIPS Agreement would need to be undertaken.  Finally, she pointedout that Canada believed in the importance of finding other solutions to the challenge of health
epidemics such as HIV/AIDS.  To that end, soluti ons might not even need recourse to compulsory
licences.  One suggestion, as had been mentioned by other delegations, was to encourage
pharmaceutical companies to grant unconditional voluntary licences.  Other non-TRIPS options that
might help to improve access and affordability included price controls, reduced duties and taxes,improved distribution efficiency, reduced distribution and dispensing costs, international procurement
initiatives, and further efforts to encourage pharmaceutical companies to make donations or lower
their prices to improve access to medicines.IP/C/M/33
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172. The representative of Norway agreed that the elements outlined by the Chairperson should be
the focus of the meeting.  As to the first of thes e items, as his delegation had already advanced during
the previous discussions on 20 June and 25 July 2001, Articles 7 and 8 intended to strike a balance
between intellectual property rights and other interests, including those relating to public health.  The
provisions in question would have to weigh heavily in the discussion on "intellectual property and
access to medicines".  The objectives mentioned in Article 7 provided for a balance of interestsbetween those who benefitted from the protection of intellectual property, on the one hand, and the
interests of those who wanted to make use of protected technology seeking the transfer and
dissemination of technology, on the other hand, to the mutual advantage of both producers and users
of technological knowledge.  The overriding goal was to achieve both technological progress and
social and economic welfare.  The principles under Article 8 specifically referred to Members' rights
to take measures to protect public health, to prevent the abuse of intellectual property rights by right
holders and the resort to practices which adversely affected the international transfer of technology.Both Articles 7 and 8 pointed to the flexibility which was inherent in the TRIPS Agreement.
Furthermore, it was clear to the Norwegian delegation that all other provisions of the TRIPS
Agreement would have to be read and interpreted in light of its Articles 7 and 8.  He disagreed
therefore with what the United States had said in this respect.  The objectives and principles
mentioned in Articles 7 and 8 were particularly important for the interpretation of Article 31, sincethis provision incorporated many of these objectives and principles in a very specific way.  This was
particularly the case as regards access to medicines and access to public health.
173. He recalled that his delegation had already given its opinion on several interpretative aspects
of Article 31.  In its view, this provision must be interpreted in a way that took into account both the
interests of the right holder and the interests of those deeming it necessary that a compulsory licencebe issued.  He emphasized that a Member was free to determine the grounds upon which to issue a
compulsory licence and that the Council for TRIPS ha d to find a solution to the important issue that a
Member in issuing a compulsory licence should ha ve the option of doing so even if production would
take place outside its own territory.  It would be  unfortunate if WTO Members were to leave the Doha
Ministerial Conference without a solution to this question.  Norway could not accept that Memberswith small domestic markets or low technological skills, pursuing legitimate national public health
goals, be placed in a disadvantaged position as to the possible use of Article 31.
174. Regarding parallel imports, he recalled his delegation's comments in the context of
preferential pricing, which was one of several methods available that could increase the availability
and affordability of patented medicines in developing countries, in particular the poorest ones.Article 6 of the Agreement concerned the question of exhaustion of intellectual property rights and the
extent to which a Member was free to decide under its own legislation whether or not rights under a
patent in respect of a product put on the market with the consent of the right holder had been
exhausted.  Article 6, as Articles 7 and 8, formed part of Part I of the TRIPS Agreement, i.e. of the
general provisions and basic principles.  The wording of Article 6 determined that, subject to the
provisions on national treatment and most-favour ed-nation treatment, nothing in the Agreement
"[shall] be used to address the issue of exhaustion of intellectual property rights".  In his delegation'sview, this meant that the TRIPS Agreement allowed a Member to choose whether to apply national or
international exhaustion as regards all types of intellectual property rights.  Moreover, Members of a
customs union could opt for regional exhaustion, which meant that a patented product could circulate
freely within the customs union once it had been put on the market with the consent of the right
holder.  For instance, in respect of patents, Norway had practised a system of national exhaustion untilthe EEA (European Economic Area) Agreement with the EC came into force, but a system of regional
exhaustion since that time.  He concurred with Canada that nothing in Article 6 prevented a Member
from having a system of exhaustion in respect of patents different from that in respect of, for example,
trademarks.  The wording of Article 6 specifically applied for the purposes of dispute settlement.  A
panel would not therefore be allowed to state that a particular system concerning the exhaustion ofrights chosen by a Member would be in contrave ntion of the TRIPS Agreement.  Article 6 must,IP/C/M/33
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however, be understood in a general sense, which meant that, irrespective of which system was
chosen, there would be no contravention per se of the TRIPS Agreement.  Some had claimed that
Article 28 led to a different result than Article 6.  Article 28 enumerated the exclusive rights which a
patent - whether for a product or a process - conferred upon its right holder.  The right of importation
was one of the rights mentioned in Article 28, which on the face of it might seem to be in
contradiction with Article 6.  This apparent contradiction, however, was resolved by a footnote, whichmade it clear that the exclusive right "in respect of the use, sale, importation, or other distribution of
goods, [is] subject to the provisions of Article 6".  The footnote was attached to Article 28.1(a), which
concerned a patent whose subject-matter was a product, i.e. a category in which medicines fell.  The
footnote itself, however, made it clear that it also  applied to process patents.  Consequently, Norway
remained of the opinion that it was up to each Member to decide which exhaustion regime it wished
to employ.
175. The representative of Zimbabwe said that he had requested the Secretariat to make available
for delegations the text of a proposal for a Ministerial declaration on the TRIPS Agreement and public
health, to which some delegations had already referred and which was sponsored by the African
Group, Bangladesh, Barbados, Bolivia, Brazil, Cuba , Dominican Republic, Ecuador, Haiti, Honduras,
India, Indonesia, Jamaica, Pakistan, Paraguay, Phil ippines, Peru, Sri Lanka, Thailand and Venezuela.
He recalled that consultations had been undertaken by the Chairperson of the Council for TRIPS inorder to move the process forward.  Due to the shor t time left and for the sake of progress, Zimbabwe
and other developing countries had worked on a text to be included in an appropriate declaration at
Doha.  The group of Members on behalf of whom he was now introducing this text clearly preferred a
separate declaration on the issue of TRIPS and public health.  The text submitted was without
prejudice to individual Members' positions and their right to submit additional proposals asdiscussions would move on the issue.  The submission went beyond the three sets of "technical"
issues on which the Chairperson had suggested that the discussion focus at the present meting;  it also
called for "utmost restraint" in dispute settlement and an extension of the transition periods, which
were important issues in the context of a holistic approach to move the process forward.  The paper
was submitted both in the context of the TRIPS Council and of the Doha process in the GeneralCouncil.
29  The delegations on behalf of which he spoke commended the draft declaration for
consideration and adoption by the Council for TRIPS, so that it could be forwarded to the General
Council.  It went without saying that there were high expectations, not only within the WTO but also
outside the Organization, to ensure that this be a deliverable at Doha and that the Organization rose to
the challenge and contributed in a comprehensive way to making the world a better place andstopping the high mortality rate.
176. The first part of the paper contained preambular language highlighting the context in which
the proposal was made.  First and foremost, it stressed that the protection and promotion of public
health and nutrition was a fundamental obligation and prerogative of the State and that Members
retained their sovereign power in this regard.  It also emphasized the inability of large segments of the
population to have access to medicines at affordable prices.  It  took cognizance of the concerns
expressed by non-governmental organizations, pub lic health advocates and the world wide public
regarding potential implications of the TRIPS Agreement on the availability and affordability of
needed medicines and other healthcare products.  It also underlined the concerns about the lack of
adequate research and development into medicines for the prevention and treatment of diseases
predominantly  affecting people in developing and least-developed countries.  At the same time, it
emphasised that the protection of intellectual property rights, in particular patent protection, shouldencourage the development of new medicines and the international transfer of and access to
technology to promote the development and main tenance of sustainable domestic manufacturing
capacities for medicines and other healthcare products.  It recognized that in implementing domestic
health policies, especially with regard to the availability and affordability of medicines and other
                                                     
29 Subsequently formally submitted and distributed under the symbols IP/C/W/312 and WT/GC/W/450.IP/C/M/33
Page 45
healthcare products, both the research-based and the generic pharmaceutical industries had important
and complementary roles to perform, particularly in developing and least-developed countries.  It also
recalled the Preamble of the TRIPS Agreement, which, among others, prescribed that measures and
procedures to enforce intellectual property rights should not themselves become barriers to legitimate
trade and recognized the special needs of the least-developed country Members in respect of
maximum flexibility in the domestic implementation of laws and regulations in order to enable themto create a sound and viable technological base.  It reaffirmed the General Council decision at its
meeting of 7 and 8 February 2000, contained in document WT/GC/M/53, that the mandated review of
the TRIPS Agreement, among others, should address the impact of the Agreement on the trade and
development prospects of developing countries.  It recognized that challenges within the WTO
dispute settlement system might in themselves inhibit or curtail the ability of Members to formulate
and implement measures to protect and promote public health.  It  highlighted that drawing attention
to and reaffirming the context of the TRIPS Agreement and certain provisions thereof as an initialconcrete step would further encourage Members, particularly developing and least-developed country
Members, towards considering every possible policy option for the protection and promotion of
public health.  It emphasised the fundamental importance of the objectives and principles of the
TRIPS Agreement.
177. The second part of the paper contained operational language proposed to be adopted by
Ministers in Doha.  This part proposed that, first, nothing in the TRIPS Agreement should prevent
Members from taking measures to protect public health;  second, that each Member retained the right
to establish its own policy and rules regarding the exhaustion of intellectual property rights;  third,
that each Member had the right to allow other use of the subject-matter of a patent without the
authorization of the right holder, including use by the government or third parties authorized by the
government, and to determine the grounds upon which such use was allowed;  fourth, that in the case
of a national emergency or other circumstances of extreme urgency, or in cases of public
non-commercial use, Members could grant compulsory licences without prior efforts on the part of
the user to obtain authorization from the right holde r;  fifth, that a compulsory licence issued by a
Member might be given effect by another Member, and that such other Member might authorize asupplier within its territory to make and export the product covered by the licence predominantly for
the supply of the domestic market of the Member granting the licence, production and export under
these conditions not constituting infringements of th e rights of the patent holder;  sixth, that Members
were not obliged to apply the conditions set fort h in Article 31(b) and (f) of the TRIPS Agreement
where use of the subject-matter of a patent was permitted to remedy a practice determined afterjudicial or administrative process to be anti-competitive;  seventh, that nothing in the TRIPS
Agreement should prevent Members from establishing or maintaining marketing approval procedures
for generic medicines and other healthcare products, or applying summary or abbreviated marketing
approval procedures based on marketing approvals granted earlier for equivalent products;  eighth,
that nothing in the TRIPS Agreement should preven t Members from disclosing or using information
held by its authorities or the patent holder where it was so required for reasons of public interest,
including where such disclosure or use was necessary to implement effectively any compulsorylicences or other measures adopted by public authorities in the public interest;  ninth, that under
Article 30 of the TRIPS Agreement, Members might, among others, authorize the production and
export of medicines by persons other than holders  of patents on those medicines to address public
health needs in importing Members;  tenth, that each Member should refrain, within or beyond the
framework of the WTO, from imposing or threatening to impose sanctions and refrain fromemploying the grant of incentives or other benefits in a manner which could curtail the ability of
developing and least-developed country Members to  avail themselves of every possible policy option
to protect and promote public health;  eleventh, that  Members exercised utmost restraint in initiating
and pursuing dispute settlement proceedings relating to measures adopted or implemented,
particularly by developing and least-developed country Members, to protect and promote publichealth;  twelfth, that in its examination of the scope and modalities for the possible application of
subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994 to the settlement of disputes under theIP/C/M/33
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TRIPS Agreement, and without prejudice to recommendations that the Council for TRIPS might
adopt and submit to the Ministerial Conference on other relevant aspects, these subparagraphs in no
event should be rendered applicable to measures adopted and implemented by Members, particularly
developing and least-developed country Members, to protect and promote public health;  thirteenth,
that in view of the special needs and requirements of developing and least-developed country
Members, their economic, financial and administrative constraints, and their need for flexibility tocreate a viable technological base, the transition periods provided for their benefit under Articles 65.4
and 66.1 of the TRIPS Agreement should be extended for another period of five years from the
expiration of the transition periods provided thereunder, particularly in respect of the obligation to
render available patent protection on products or processes relating to public health, without prejudice
to further extensions;  and fourteenth, that the TRIPS Council should monitor and evaluate on an
ongoing basis, in collaboration with relevant international organizations, the effects of the TRIPS
Agreement on health, with particular emphasis on access to medicines and research and developmenton medicines for the prevention and treatment of diseases predominantly affecting people in
developing and least-developed countries.
178. The representative of Switzerland said that his delegation acknowledged that access to
medicines for treatment of HIV/AIDS and other pandemics, such as malaria and tuberculosis,
especially by the poorest populations of the globe, was one of the major challenges for the globalcommunity and for its sustainable development.  Like others, Switzerland considered that a strong
national health system played a key role in the delivery of efficient treatment.  It was also aware that
the crucial problem was that many developing countries and least-developed countries did not have
the financial resources or public health infrastructu re to provide more than the most basic healthcare.
Switzerland therefore recognized that an effective response to this challenge required a mix ofcomplementary social, economic and health policies and practices as well as education and prevention
programmes.  It was the common responsibility of all international organizations, all WTO
governments, non-governmental organizations and private actors, through their areas of responsibility,
to contribute to the promotion of the most favourable conditions for improving access to medicines
for treatment of HIV/AIDS and other pandemics.  The determinant factors for improving access tomedicines included an efficient infrastructure to distribute, deliver and monitor drug usage and
provide the necessary information and education;  increased research and development, particularly
targeted at the major communicable diseases of relevance to developing and least-developed
countries;  mechanisms to finance drug purchases and affordable pharmaceuticals;  and the
implementation of effective and sustainable healthcare systems.  His delegation agreed that the TRIPSAgreement might play a role with regard to access to medicines.  However, it believed that the
Agreement afforded enough flexibility for Members to pursue their health policy objectives and that it
did therefore not stand in the way of affordable access to existing drugs.  It was indeed convinced that
strong, effective and balanced protection for intellectual property was a necessary incentive for
research and development into life-saving drugs.  Intellectual property protection was therefore a
crucial element in public health objectives, national or international.  Switzerland was therefore
concerned about any possible weakening of intellectual property protection in this field.  Such adevelopment might have a most negative impact on the development of badly needed new medicines,
thus depriving the world of the means to eradicate diseases incurable today.  His delegation was
nevertheless ready to continue the discussion on "intellectual property and access to medicines" in the
Council for TRIPS and to participate actively in id entifying elements of flexibility that the TRIPS
Agreement provided to Members to combat the public health crisis some countries were facing due toHIV/AIDS and other pandemics, such as malaria and tuberculosis.  It also agreed that the question of
health and TRIPS might be appropriately addressed at the coming Ministerial Conference.  Access to
healthcare and medicines, especially for the poorest populations in least-developed countries, was
indeed a challenge and a prerequisite to sustainable development in these countries.  However,
Switzerland considered it important that the Counc il for TRIPS avoid raising wrong hopes as to what
it could contribute with its discussion here or with a Ministerial declaration on the flexibility in the
TRIPS Agreement for the treatment of HIV/AIDS and other pandemics.  It was convinced thatIP/C/M/33
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intellectual property protection was not the reason for insufficient access to medicines.  He recalled
that patent protection for over 95 per cent of t hose drugs on the WHO List of Essential Drugs had
expired and that these drugs were therefore available on the market today off patent product together
with generic copies of the original products.  Of the remaining five per cent, only a minor part was
actually patented in developing and least-developed countries.  Moreover, many drugs used in the
anti-HIV/AIDS cocktails were not patented in sub-Saharan countries which were among thoseaffected most by the HIV/AIDS crisis.  Also, ma ny older medicines or vaccines were no longer on
patent.  Compared to the highly sophisticated and research intensive anti-retroviral drugs against
AIDS, many medicines or vaccines, e.g. those for malaria, whether on or off patent, were available on
the market at a relatively low price.  Nevertheless, only a small percentage of the population in need
of these drugs had actually any, not to speak of sustainable, access to them, and this was mainly due
to donation programmes under which medicines were distributed for free.  For an effective and
result-oriented discussion, it was necessary to know and understand the problems arising from theTRIPS Agreement in the view of the demandeurs of this discussion.  In order to know what the
Council for TRIPS should clarify in this ongoing discussion, the Council first needed to know what
problems arose in practice from the individual TRI PS provisions in relation to access to medicines
and why the flexibility inherent in the TRIPS Agreement, in the view of the demandeurs , seemed
sufficient.
179. As regards the scope of the discussions, he recalled that, at the Council's meeting in
April 2001, Members had set the mandate for the discussions and agreed, next to looking at the
relationship between the TRIPS Agreement and affordable access to medicines, to exchange views on
the interpretation and application of the relevant provisions of the TRIPS Agreement with a view to
clarifying Members' views on the flexibility to which Members were entitled under the Agreement.In order to do effective work, the Council would ne ed to limit itself to those issues covered by the
mandate.  In other words,  the Council would have to focus on the relationship between the TRIPS
Agreement and affordable access to medicines.  If it broadened and extended the discussion to all
sorts of related problems, the discussion would not be result-oriented, as all agreed it needed to be,
and would eventually fail to reach any concrete result.  In the special discussion of the Council in Juneand its informal meeting in July, Members had iden tified the key provisions of the TRIPS Agreement
relevant to this issue, namely Articles 6, 7, 8, and 31.  It seemed to him that, from the discussions so
far, points of convergence regarding the flexibility in these provisions were emerging.  Of course, the
work could not result in reducing or broadening the flexibility in the TRIPS Agreement.
Interpretation could only clarify what flexibility existed under the Agreement and was to be done inaccordance with the rules for treaty interpretation as established by the Vienna Convention on the
Law of Treaties.
180. Continuing, he said that, while the TRIPS Agreement in its substantive provisions enumerated
the right of importation as part of the exclusive rights conferred by a patent to the right holder,
Article 6 provided that dispute settlement was not available to challenge a Member's practice
concerning the exhaustion of rights on patented products, subject to the observance of the principles
of national treatment and most-favoured-nation treatment.  Article 6 therefore provided flexibility forMembers in their choice and implementation of an exhaustion regime and, as a result, of parallel
trade.  When talking of parallel importation, it was important, however, that Members agreed also on
the definition of this legal term and the limits of the scope of Article 6.  For Switzerland, it was clear
that parallel trade referred to original products put on the market with the consent of the owner of the
patented product, but then exported or imported through channels other than those authorized by theowner of the patented product or his licensee.  In  other words, intellectual property rights were
exhausted in a market only when the goods to which these intellectual property rights applied had
been sold in that market by the right holder or with his consent.  Therefore, the import of generic
copies or medicines produced under a compulsory licence into a country where the original product
was patented did not fall under the notion of parallel imports, since they were not original productsnor put on the market with the authorization of the right holder.IP/C/M/33
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181. Turning to Articles 7 and 8, he said that his delegation held the view that these provisions, as
explained by a recent author, "set the framework for the TRIPS Agreement in terms that are consistent
also with developing countries interests".  However, they were not the basis for specific exceptions.
In Switzerland's understanding, Article 7, although not well-suited to be in itself a basis for exceptions
to the substantive TRIPS obligations, could  nevertheless be of assistance when interpreting the
substantive TRIPS provisions and obligations.  Under Article 7, the objective of the TRIPSAgreement was to contribute to the promotion of technological innovation and to the transfer and
dissemination of technology.  Clearly, for technology to be transferred, there had to be incentives for
such innovative technology to be created in the firs t place and a safe legal framework for the transfer
of such technology to actually happen.  To that end, adequate and effective intellectual property
protection was a prerequisite.  Article 8, which established overall principles, could and should be
taken into consideration when Members adopted measures necessary in the field of protecting public
health.  Any such measure had to be consistent, however, with the provisions of the TRIPSAgreement.
182. Regarding Article 31, Switzerland believed that in the discussions to date on this key
provision several points of convergence seemed to be emerging.  First, the provision of Article 31 in
the TRIPS Agreement, i.e. the possibility to grant compulsory licences as an exception to the
exclusive rights normally conferred by a patent, was evidence of the flexibility in the TRIPSAgreement.  Second, Article 31 did not specify the grounds on which Members could grant a
compulsory licence, but left sufficient flexibilit y to Members in this regard, provided that the
safeguards contained in Article 31 were complied with.  Third, Article 31(b), i.e. so-called "fast track"
compulsory licensing permissible in cases of a national emergency or other circumstances of extreme
urgency, was further evidence of the flexibility under the Agreement allowing exceptions to theconditions to be followed normally when authorizing a compulsory licence in case of a health
emergency in Members faced with, for example, an AIDS pandemic.  Whether such an emergency
situation existed would have to be decided on a case -by-case basis.  It was not possible to state in
general terms which cases constituted such a national emergency or other circumstances of extreme
urgency.  Here again, the TRIPS Agreement provided scope for flexibility to Members, since it wasleft to Members themselves to decide when such a situation of national emergency was present.
There seemed to be a consensus emerging among Members that, for example, the AIDS crisis in some
Members had risen to such a degree that it could be called a situation of national emergency or
extreme urgency allowing for the grant of a compulsory licence, if a medicine was not available in a
sufficient manner.  Fourth, Members seemed to agree that voluntary licences were preferable tocompulsory licences.  Fifth, compulsory licensing might be a tool to remedy an anti-competitive
practice of an intellectual property right holder, if such a practice was determined to be
anti-competitive as a result of a national judicial or administrative process.  Sixth, export of products
made under a compulsory licence should be possible as long as local supply remained predominant.
Seventh, compulsory licences should not be used as a tool for industrial policy.  In particular, a
compulsory licence was not to be granted in order to force local production.  A compulsory licence
could only be granted as a response to either a non-use or an abuse of a patent right.  The absence of"local working" could not be construed as a non-use or an abuse allowing for the grant of a
compulsory licence.  Article 27.1, in combination with Article 28, explicitly considered a decision by
a patent owner not to produce locally but rather to import a product under patent protection as one of
the rights conferred by the patent.  Moreover, any other interpretation that would force patent holders
to "work" their product in every Member, even where the necessary conditions and requirements forpossibly highly complex manufacturing processes did not exist, was neither rational nor feasible
economically.  It would not allow for consistent quality, nor for economies of scale necessary to offer
medicines at low cost.  Nevertheless, considerable flexibility was available under the Agreement as
regards the application of compulsory licensing, as there was under the transitional periods for
developing and least-developed country Members, in respect of parallel imports.  Together withvoluntary licensing, all these tools could be of assistance in addressing a public health crisis, if
adequately used in appropriate circumstances.IP/C/M/33
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183. The representative of the Czech Republic said that her delegation had examined the issue of
intellectual property and access to medicines from the perspective of the concrete steps and the
concrete actions that were needed.  It had concentrated its efforts on the elements which had been
indicated as the main questions to be discussed at the present meeting.  Nevertheless, in the course of
the analysis, it had met many problems related to the issue which were not - or not only - of an
intellectual property nature.  For this reason, her delegation was convinced that the discussion onaccess to medicines had to be broadened to other relevant WTO bodies, which should examine some
specific aspects that were within their responsibility.  In its view, it would be useful if the Council for
TRIPS would invite other WTO bodies to include this issue in their work.  The preliminary
conclusion reached by the Czech Republic concerned prices and competition.  First, it was without
doubt that ensuring access to medicines was a question of prices.  However, not only pricing policies
by intellectual property rights holders that could arise from the protection of intellectual property
rights should be considered, but all components of prices under which any pharmaceutical productwas available for consumers in a given market.  Im portant components of final consumer prices were
customs duties and other measures and tools of protectionism, which raised prices for consumers and
made products less affordable.  The role of customs tariffs on medicines should be discussed in the
Council for Trade in Goods in connection with  the balance between market access and market
protection.  Second, in the framework of her delegation's analysis of the question of access tomedicines, it had also considered the question of  health services.  Could commitments within the
GATS Agreement contribute to better access to medicines and to better access to healthcare in
general?  This question, and maybe some others, were to be addressed in the Council for Trade in
Services.  Third, there were also some competition aspects to the issue of access to medicines, namely
in respect of parallel imports.  Discussions on these aspects could not be limited to the relevant TRIPSprovisions, i.e. Articles 6, 28 and 40, but should also take place in the Working Group on the
Interaction between Trade and Competition Policy.
184. Regarding compulsory licensing, the Czech Republic was of the view that this issue should be
conceived as a mutual relationship of various aspects and be looked at from several perspectives, i.e.
legal, economic, technological, etc.  However, before taking into consideration these aspects andbefore analysing them, the scope of the issue with respect to access to medicines should be clarified.
Members recognized that use of the subject matter of a patent without authorization of the right holder
could be a useful tool to prevent the abuse of intellectual property rights by right holders, provided
that certain conditions were respected.  In her delegation's opinion, it should be underlined that a
measure allowing such use could be taken only if there was a patent on a particular drug in thecountry concerned.  Consequently, in considering the issue of access to medicines, Members should
first examine whether concrete life-saving pharmaceuticals were actually covered by patent
protection.  According to numerous studies, a large percentage of life-saving pharmaceuticals and
essential drugs were off-patent.  In these cases, patents could not limit consumers' access to medicines
and the cause of limited access had to be found elsewhere, for example in the capacity of generic
producers to make and offer drugs at affordable prices or to differentiate prices of medicines.  The
scope of analysis should be limited to pharmaceuticals that were under patent protection elsewhere inthe world, because only for these products compulsory  licences could be useful.  It was without doubt
that compulsory licensing  could serve, under specified conditions, the production in a country where
the drug was under patent protection and which had a generic industry.  The situation was more
complicated in cases where the patented product was not available on the market concerned or the
country in question had no technical and labour conditions to produce drugs.  It would be very usefulto base the discussion on information relating to which part of life-saving pharmaceuticals was
protected by patents and to develop a direction for the debate.
185. As regards parallel imports and the related question of exhaustion of rights, she recalled that
the debate on their pros and cons was taking place world wide and drew Members' attention to an
analysis issued in the context of the OECD Joint Group on Trade and Competition in May 2001.
Although this study related to the economic effects of exhaustion policies in general, its results couldIP/C/M/33
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be extended also to the issue of access to medicines.  The summary of this study acknowledged that
permitting parallel imports could result in considerable benefits, especially in countries which were
net importers of goods having substantial intellectual property components and whose consumers
were paying higher prices due to restrictions on parallel imports.  On the other hand, restrictions on
parallel imports could help to prevent piracy and free riding and, with regard to pharmaceuticals, they
could protect consumers from counterfeit goods that can cause irreversible health damage.  It shouldalways be taken into account that the costly research and development in the field of pharmaceuticals
depended on the profits that the patent protection system could ensure.  A question to be answered to
was to what extent parallel imports undermined the level of the profits that could be devoted to further
development of medicines.  Another question concerned the relationship between restrictions on
parallel imports and pricing policies by right holders.  Restrictions on the re-exportation of drugs
could ensure a lower level of prices of drugs.  Her delegation was therefore of the opinion that the
perspective of the domestic empirical effects of parallel imports on both sides - consumers fromdeveloping countries and right holders - could also contribute to the debate.  In the light of all the
questions discussed, she wished to share with Members the Czech Republic's experience in the field
of patent protection for pharmaceuticals.  The Czech Republic had implemented a system extending
patent protection to this area ten years ago, i.e. a period long enough to be able to illustrate the
resulting impact on healthcare.  According to an analysis made by her country's experts, patentprotection for pharmaceuticals had not worsened access by patients to drugs.  Strengthening the
intellectual property system in general had created a transparent and stable environment for all
investors and the Czech Republic was looking forward to welcoming also the research-oriented
pharmaceutical industry in the coming years.
186. The representative of Thailand said that the proposal introduced by Zimbabwe, of which his
delegation was one of the sponsors, was an attempt to achieve a meaningful result on this issue at the
Doha Ministerial Conference.  The elements put fo rward in the proposed draft declaration were the
ones which his delegation believed could be agreed upon at Doha and, while not requiring any
amendment to the Agreement, would improve Members' understanding of and confidence in the
TRIPS Agreement and its rôle to help finding a mu ch-needed solution to the health crisis in some
Member countries.  A decision on this issue was a challenge to the WTO's ability to address social
issues.  Referring to the intervention by Switzerland, he said that he did not think that the sponsors of
the proposal introduced by Zimbabwe had come to the conclusion that the current flexibilities under
the TRIPS Agreement were insufficient, but were simply seeking clarification as to what these
flexibilities were and guidance as to how they could be operationalized.  For his delegation, this wasjust the beginning of an on-going process of work on elements in the context of the TRIPS Agreement
to ensure the availability and affordability of medicines for those who needed them.  Over the next
days, Members should concentrate on those elements on which they could deliver at Doha.  Other
elements, which would require more time for reflection and discussion, should be left aside and be
reverted to under a work programme on TRIPS and public health after the Doha Ministerial
Conference.  In  concluding the informal mee ting on 25 July, the Chairperson had identified three
elements on which the discussions should be focussed at the present meeting.  His delegation believedthat these elements were the minimum on which Members could deliver at Doha, i.e. parallel imports,
compulsory licensing, and interpretation of the Agreement in the light of its objectives and principles.
That should, however, not be all.  His delegation would also like to see agreement on a general
statement to the effect that "nothing in the TRIPS Agreement shall prevent Members from taking
measures to protect public health".  Such language would leave no one in any doubt that the DohaDeclaration supported the current flexibility in the Agreement and under no circumstances reduced it.
The choice of certain specific issues in the Declaration should not imply anything about other issues
that were not covered yet.  After Doha, no Member should be in any doubt or fear of exercising its
existing rights under the Agreement as it would see fit.IP/C/M/33
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187. Turning to parallel imports, he said that Memb ers should reaffirm that the TRIPS Agreement
did not address the issue of exhaustion of intellectu al property rights and that each Member, therefore,
retained therefore the right to establish its own policy and rules regarding parallel imports.
188. As regards compulsory licensing, he said that Members should reaffirm that the TRIPS
Agreement did not limit the grounds on which a Member could grant compulsory licences;  that
HIV/AIDS constituted a national emergency within the meaning of Article 31(b);  that Memberscould grant compulsory licences to persons of any nationality;  that Members could grant compulsory
licences for importation as well as for production;  and that pharmaceuticals could be produced under
a compulsory licence for export to countries with little or no manufacturing capacity.
189. Regarding interpretation of the Agreement, he said that Members should reaffirm that all
provisions of the Agreement should be interpreted in the light of the objectives and principles set forth
in Articles 7 and 8 and that these provisions, together with the Preamble of the TRIPS Agreement,
constituted an important part of the context of every provision of the Agreement.
190. Regarding dispute settlement, he said that Ministers should agree to exercise due restraint in
invoking WTO dispute settlement proceedings and unilateral threats of action outside the WTO
system with respect to measures taken to protect public health.
191. As regards a future work programme on TRIPS and public health, the Ministerial Declaration
should direct the TRIPS Council to examine the impact of the TRIPS Agreement and itsimplementation on the availability and affordability of medicines and to report to the Fifth Ministerial
Conference submitting, where appropriate, recomm endations on legal interpretations or amendments
of the Agreement.
192. The representative of Egypt said that Articles 7 and 8 provided some flexibilities aimed at
balancing rights and obligations under the TRIPS Agreement, to the mutual advantage of producers
and users of technological knowledge, in a manner conducive to social and economic welfare.  They
allowed governments to adopt measures necessary to protect public health and nutrition, and to
prevent the abuse of intellectual property rights by resorting to anti-competitive practices, as long as
these measures were not prohibited by the Agreement.
193. Parallel imports, he said, were allowed under Article 6 on the exhaustion of intellectual
property rights.  The footnote to Article 28 confirmed this flexibility.
194. Referring to Article 31, he said that compulsory licensing was another area where a degree of
flexibility was available, for application whenever necessary.  However, coupling compulsory
licences with numerous conditions made them difficult to be used effectively.  Restrictive
interpretation of the provisions on compulsory licensing, as well as those on parallel imports for thatmatter, would not offset rising prices associated with the extension of monopolies and restrictions on
the production of generics.  Attention should be given, inter alia , to Article 31(f), which permitted the
use of locally produced medicines to alleviate adverse health situations in another country.  Moreover,
as also alluded to by Switzerland, Article 31 did not limit the grounds on which a Member might
consider the grant of a compulsory licence.
195. The representative of Guatemala said that his delegation concurred with other delegations on
the importance attached to the relationship between  the TRIPS Agreement and public health policies
and a reaffirmation of the flexibility that the Agreement provided in this area.  Reduction of this
flexibility was unacceptable.  Guatemala was interested in discussing how the provisions on
compulsory licensing and the flexibility granted by Article 6 regarding parallel importation could be
of use to countries with little technological production capacity.  Referring to the proposal introduced
by Zimbabwe, he said that his delegation would provide its comments as soon as possible.IP/C/M/33
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196. The representative of the United States introduced a text which he made available to
delegations and which contained preambular language for a Ministerial declaration on access to
medicines for HIV/AIDS and other pandemics.30  The text in question was sponsored by Australia,
Canada, Japan, Switzerland and the United States and recognized that access to medicines for
treatment of HIV/AIDS and other pandemics, such as malaria and tuberculosis, especially by the
poorest populations of the globe, was one of the major challenges for the global community and for itssustainable development.  The sponsors of the proposal believed that an effective response to this
challenge required a mix of complementary social, economic and health policies and practices,
including education and prevention programs.  He hoped to be in a position by the end of the week to
submit language on specific clarifications of relevant provisions of the TRIPS Agreement, based on
the Members' discussions in the TRIPS Council.  The five countries on behalf of which he spoke
recognized that strong, effective and balanced protection for intellectual property was a necessary
incentive for research and development of life-saving drugs and, therefore, that intellectual propertycontributed to public health objectives globally.  They believed that, by providing for such protection,
the TRIPS Agreement contributed to the availability of medicines and wished to reaffirm their
commitment to the Agreement and its implementation.  Their proposal reaffirmed the appropriateness
of Members using the flexibility afforded by the Agr eement.  They believed that use of the flexibility
was especially important to ensure that medicines for treatment of HIV/AIDS and other pandemicswould be available to the citizens who needed th em, particularly those who were unable to afford
basic medical care.  In preparing the proposed language, the sponsors of the paper had taken into
consideration the discussions that had been held in the Council for TRIPS up to this very moment,
during which Members had clarified their views on the flexibility contained in the Agreement.  The
proposal for operational language still to be submitted would reflect the consideration given to allMembers' views expressed by that time.
197. Continuing, he said that, while some Members had objected to references to subjects that
were not directly related to the TRIPS Agreement, the five countries on behalf of which he spoke
believed that reference must be made to Members' willingness to work with other Members with
severe HIV/AIDS crises and other pandemics as well as with the private sector, including thepharmaceutical industry, to facilitate the broadest possible provision of drugs in an affordable,
medically effective, and WTO-consistent manner.  As part of this collaboration, Members should be
encouraged, regardless of the exhaustion régime they might have chosen, to take measures to prevent
medicines that were provided for the poorest populations of the globe, either under discounted pricing
schemes or aid schemes, from being diverted from those for whom they were destined to markets forwhich they were not intended.  The sponsors of the paper also wished to affirm the importance of
technical assistance for developing and least-developed country Members regarding the
implementation of their TRIPS obligations, taking account of their health concerns and to express
their readiness to work with all delegations on the development of specific clarifications of the
relevant provisions of the TRIPS Agreement, in order to give all Members greater confidence
regarding the flexibility contained in the Agreement.
198. The representative of Malaysia said that the several TRIPS meetings that had been held to
date had focused on the promotion of public health interests and their relationship with the TRIPS
Agreement.  Most if not all Members had acknowledged that there was a need to ensure that the
TRIPS Agreement was part of the solution to the issue of public health and access to affordable
medicines and was not an impediment to the achievement of public health objectives.  The TRIPS
Agreement did allow Members to strike a balance between private rights and public interests in thepromotion of public health objectives.  Articles 7 and 8, the provisions on exhaustion of rights and
those on compulsory licensing duly provided some of the safeguards for governments to undertake
measures to promote public health.  However, curr ent experience suggested that there was a need for
assurance and, as also suggested by the United States, a need for confidence as well as improved
                                                     
30 Subsequently formally submitted and distributed as document IP/C/W/313.IP/C/M/33
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understanding of the application of these flexibilities allowed under the TRIPS Agreement.  Based on
the discussion at the informal meeting on 25 July 2001, Malaysia agreed that the Doha Declaration
should include elements pertaining to Articles 6, 7, 8 and 31 as well as any other mutually agreed
elements that might be usefully elaborated for the same purpose and improve public perception
regarding the relationship between TRIPS and public health.
199. As to the substance of these elements, she suggested to further elaborate on the flexibilities in
the TRIPS Agreement regarding the right of Members to adopt measures to protect public health;  the
right to allow other use of a patent without authorization of its owner and the grounds upon which
such use could be allowed;  how the right to issue a compulsory licence could be exercised in a way
which gave full effect to this right;  and the right to determine their own régime of exhaustion of
rights.  She said that it would also be useful if  Members could agree that they would not undermine
the achievement of these rights, nor curtail Members in availing themselves fully of these rights.  She
expressed Malaysia's support for the proposal introduced by Zimbabwe for a separate Ministerialdeclaration.  It would be useful to give focus to th e issue raised and to highlight to the outside world
that the WTO was giving its fullest consideration to the issue of the promotion of public health.
Malaysia also agreed with Thailand on the need for a future work programme on unresolved issues
and hoped that progress could be made at Doha.
200. The representative of Brazil said that the paper introduced by Zimbabwe, of which his
delegation was one of the sponsors, was intended to facilitate the preparation of a special Ministerial
declaration on the relationship between the TRIPS Agreement and public health.  It was also intended
to focus debate on specific issues which should not be controversial.  It was not necessarily an
exhaustive list of issues, although it was intended to include the most relevant issues.  It was without
prejudice to the rights of Members, either individually or collectively, to bring further draftingproposals.  Wishing to highlight some features of the proposal, he said that the preambular language
should set the context for the discussion.  Brazil would expect the preamble, inter alia , to reaffirm the
prerogative and sovereignty of States in protecting public health and to refer to the dramatic crisis of
the pandemics of HIV/AIDS, malaria and tuberculosis.  It was also important for the declaration to
rebut the concerns of civil society as to the possible negative effects of the TRIPS Agreement on thisissue by providing clear and unambiguous answers.  Brazil was open to discuss other preambular
language.  He would comment later on the proposal that had just been introduced by the United
States.
201. Referring to the operative language in the proposal that had been introduced by Zimbabwe, he
said that Brazil attributed the highest priority to the language stating that "nothing in the Agreement
shall prevent Members from taking measures to protect public health".  Such language was crucial to
clarify TRIPS provisions vis-à-vis  public health policies.  Brazil would be surprised if such language
were controversial.  Obviously, every government was sovereign and had the prerogative to take
measures to protect public health.  He invited any Member who believed that the TRIPS Agreement
prevented Members from taking such measures, to identify the relevant provisions.  If it could be
shown that some elements in the Agreement restricted Members' freedom to protect public health, a
broader question would arise as to the actual scope of the Agreement.  The TRIPS Agreement coveredthe protection of intellectual property rights with a view to the transfer of technology, as set forth in
Article 7.  It certainly did not address public health policies.  If Members were not in a position to
confirm that nothing in the TRIPS Agreement prevented Members from taking measures to protect
public health, this would be a tacit admission that the Agreement was more far-reaching than
originally envisaged and Brazil would have to rethink the whole contents of the Agreement.  Hebelieved that this would be an unfortunate scenario.
202. He said that there did not seem to be opposition to the view that the Agreement did not limit
the grounds upon which compulsory licences could be granted.  Switzerland had recognized this at the
present meeting and the United States had circulated similar language.  It was important that theIP/C/M/33
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Declaration make this clarification.  The proposal that had been introduced by Zimbabwe also
addressed the issue of compulsory licences granted to a foreign supplier.  This issue had been raised
for the first time in the Council in the European  Communities' paper (IP/C/W/280) and he hoped that
Members would be able to agree on language that would solve this issue.  Article 31(f) provided that
compulsory licences should be authorized "predominantly for the supply of the domestic market of
the Member authorizing such use".  Developing countries were seeking a permissive interpretationwhich would allow the export of medicines to countries which lacked local manufacturing capacity.
In doing so, they were limiting the language to medicines, so that the scope of such an interpretation
would be narrow.  Taking into account its Article 30, such supply of medicines should be permitted
wherever it did not interfere with the "normal exploi tation" of a patent in the country of production.
203. Turning to parallel importation, he said that a text recognizing that each Member was free to
establish its own policy and rules regarding exhaustion of rights should not encounter any objections,
as it merely confirmed the situation existing under the Agreement.  In this connection, he referred toan article entitled "The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial
Conference" by Professor Frederick Abbott.  This article explained the domestic situation on
exhaustion of rights in some Members and indicated that the prevailing doctrine in the United States
was that of international exhaustion or the "first sale" of patented products.  Parallel imports of
medicines were not regulated by patent law, but by public health regulations or standards.  Hewondered whether the United States could confirm the correctness of this information.  If so, there
should be no major concerns regarding the language that Brazil and its co-sponsors had proposed.
Referring to Switzerland, the article indicated that the Tribunal Fédéral  had recently acknowledged
that, while the prevailing regime in Switzerland was one of national exhaustion, the TRIPS
Agreement allowed Members to put in place any régime for the exhaustion of rights that they
considered convenient.  He also referred to Japan, where the Supreme Court had ruled in favour of the
international exhaustion of rights.  This information being most important, he would appreciate a
reaction form these Members as well.
204. Continuing, he said that the proposal introduced by Zimbabwe was submitted both to the
TRIPS Council and the General Council, as certain of its elements were to be discussed moreappropriately in the General Council as well as to ensure a coordinated discussion.  Referring to
previous interventions, he expressed his delegation's disagreement with the United States that neither
patents nor the TRIPS Agreement prevented access to medicines in any way.  Brazil was not in a
position to agree with language that would state that the TRIPS Agreement provided access to
pharmaceuticals, because any conclusive evidence to that effect was lacking.  He said that the UnitedStates had referred to a study on patents in Africa and wondered whether the United States could
share the contents of that study with delegations.  Was the United States perhaps referring to a paper
prepared by Professor Amir Attaran?  He had learned about this paper due to a recent discussion of its
contents but, as far as he knew, Professor Attaran had cautioned readers to whom it had been given
for comments that the paper, which had not yet been publicly disclosed, might still contain
inaccuracies.  The author was still verifying the data and conclusions contained in the paper and
acknowledged that these data had not yet been confirmed.  It might be interesting to check with theauthor whether the conclusions of the paper supported the conclusion drawn by the United States.
Brazil did not take it for granted that the TRIPS Agreement ensured access to medicines.  Neither was
it stating otherwise, although there were elements that might lead to that conclusion.  The Ministerial
declaration should not contain language accommodating only one perspective.  Many Members had
expressed doubts that the TRIPS Agreement unambiguously ensured access to medicines.
205. The representative of Canada believed that the text that her delegation had tabled jointly with
Australia, Japan, Switzerland and the United States addressed the issues that all delegations had
agreed the Council for TRIPS had to address, when discussions had been initiated on this important
issue.  The TRIPS Council had agreed to engage in a discussion with a view to clarifying the TRIPS
provisions that were relevant to questions of access to medicines that were needed in developing andIP/C/M/33
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least-developed countries to combat HIV/AIDS and other health pandemics.  Canada acknowledged
that there was a devastating public health and economic dilemma facing developing and
least-developed countries.  As already stated, it believed that a solution to the broader problem would
require that a holistic approach be undertaken by  non-governmental organizations, governments and
the private sector, including the pharmaceutical industry.  For Canada, it was however essential that
the Council remain focussed on the issue as defined in its mandate;  it was clearly important to everyWTO Member that it continue to work with respect to clarifying the relevant provisions in preparation
for Doha.
206. Continuing, she said that the paper that had been introduced by Zimbabwe clearly expanded
the discussion far beyond the scope of the Council's mandate concerning access to medicines issue.
She recalled that, in the TRIPS Council's discussions in June and July 2001, a number of provisions
had been considered and that, at the end of the informal meeting on 25 July, the Chairperson had
summarized the discussion by suggesting that Articles 7 and 8, the provisions on compulsorylicensing and the issue of parallel imports were most relevant to the issue of access to medicines
needed to combat health pandemics such as tuberc ulosis, malaria and HIV/AIDS.   Both sides in this
debate had clearly stated that patent protection played a key role and was in fact critical to the
provision of better and more effective drugs so that countries in need could fight the pandemics facing
them.  There was general agreement that health epidemics such as HIV/AIDS were clearly nationalemergencies.  There was flexibility in the TRIPS Agreement with respect to compulsory licensing in
cases of national emergencies and the Agreement cl early did not prevent the use of parallel imports.
For these reasons and others already elaborated in the Council for TRIPS, Canada continued to
believe that there was sufficient flexibility in th e TRIPS Agreement for Members to deal with health
crises caused by HIV/AIDS and other pandemics.
207. The representative of Australia said that the proposed preambular language that had been
introduced by the United States reflected considerable work by the co-sponsors of this text, which
included her delegation, to find the middle ground while recognizing the need for strong, effective and
balanced intellectual property protection.  The propos ed text represented a good starting-point and she
encouraged other Members to approach the issue in an equally constructive manner.  In the debate,the TRIPS Agreement had to be regarded as part of  the solution to the issue of access to affordable
medicines and not as part of the problem.  The Agreement struck a balance between public health
policy needs and providing sufficient incentives for investment into research and development of
drugs.  The overall problem was a complex one cutting across global development and health policy
and solutions could therefore not just be found in reviewing trade rules.  The TRIPS Agreementcontained provisions allowing Members to take measures to enable the importation or production of
medicines under compulsory licences to address circumstances such as national health emergencies.
The gravity of the HIV/AIDS pandemic had highlighted the need to address developing countries'
concerns over access to medicines at Doha.  The current uncertainties could be resolved in common
sense language without reopening or limiting the TRIPS Agreement.
208. Continuing, she welcomed proposals that had been made aimed at improving access to
affordable medicines in developing countries, including those regarding global tiered or differentialpricing systems, but expressed the view that the substantive discussions on such arrangements were to
be addressed more appropriately in other fora, such as the WHO, UNAIDS, UNDP and the Global
AIDS and Health Fund.  In general, concerns about the leakage of drugs to unintended markets could
be addressed by drawing on existing precedents which were managed directly through bilateral
arrangements.  Therefore, there was no need to consider this issue in the examination of Article 6 ofthe TRIPS Agreement.  The TRIPS Agreement did not constrain parallel importation apart from the
national treatment and MFN disciplines and this flexibility at the multilateral level should be retained.
209. She said that, at the meeting of the Council in April 2001, it had already been endorsed that
governments who faced national health emergencies, such as the HIV/AIDS pandemic, could use theIP/C/M/33
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compulsory licensing provisions of the TRIPS Agreement.  The TRIPS Agreement clearly enabled
them to put in place measures to produce medicine s without the authorization of the patent holder in
certain circumstances.  There were a number of points in this area on which Members had
demonstrated a commonality of view.
210. As regards the proposal that had been introduced by Zimbabwe, she said that calls for a
moratorium or due restraint for initiating dispute settlement action were understandable.  However,Australia expected that the results of the Ministerial Conference would address the underlying
concerns and provide surety to ward off any possibility of frivolous disputes.  A moratorium was a
blunt instrument that sent the wrong signal to countries seeking to increase their research and
development capacity through investment.  Bearing in mind these parameters, her delegation would
look constructively at the text proposed by the developing countries.  Regarding calls for an extension
of transitional periods for developing countries and LDCs, while Australia was sensitive to the
reasons behind these proposals, and appreciated the significant efforts that had been made bycountries in implementation, her delegation wished to point out that Article 66.1 already provided the
possibility for LDCs to seek extensions.  It was difficult to see how the proposal could be applied
broadly to developing countries, given that many of them had already implemented the TRIPS
Agreement.  The key issue was to provide technical assistance in accordance with Article 67 to enable
developing countries and LDCs to take advantage of the development benefits that could be derivedfrom the TRIPS Agreement.
211. The representative of New Zealand said that her delegation recognized the importance of
Ministers at Doha addressing the issue of access to medicines for the treatment of HIV/AIDS and
other pandemics.  She appreciated the fact that te xts had been put forward for addressing this issue.
Language on the issue should highlight the relevance of the WTO to the work of other internationalorganizations, national governments, and private actors, who were all significant players in
combatting these serious health crises, but it should also underline that it could deal with but one
element of the complex range of issues associated with those pandemics.  New Zealand shared with
other delegations the conviction that the TRIPS Agr eement was, and must remain, part of the solution.
It provided a framework that balanced the rights of property owners against the broader social andeconomic objectives of governments.  The Agreement enabled Members to adopt measures necessary
to protect public health.  At the same time, it also provided the necessary incentive structure to
encourage active research and development into new medicines.  The key to this balance lay in the
flexibility provided under the Agreement in a number of areas.  As a result of the current debate, all
Members should feel fully comfortable with thei r rights to exercise the full range of existing
flexibilities to the fullest extent possible.  For this reason, New Zealand supported the incorporation of
specific clarifications into language for Doha.  It was open as to the form that a declaration on this
issue might take.
212. On Article 6, she said that the issue of leakage or diversion was a potential difficulty which
needed to be kept in mind.  It was a complex problem and Members should be careful not to foreclose
any existing options already available.  The TRI PS Agreement left Members the freedom to choose
the exhaustion regime that best suited their intellectual property policy objectives.  Members werefree to allow parallel imports into their territory.  Her delegation viewed this flexibility as very
important to ensure that developing and least-developed country Members were able to explore a full
range of approaches to address particular difficulties regarding the access to medicines.
213. New Zealand was open to ideas for addressing the issues associated with Article 31(f).  As a
small country, it was perhaps more attuned than some others to the particular difficulties that arose forMembers with small domestic markets, the more so if those Members were developing or
least-developed countries.  In this respect, she had noted with interest the comments by the Canadian
delegation regarding the role that parallel importation and a generous approach to the concept of
"predominantly" might play.IP/C/M/33
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214. The representative of India said that his delegation was looking forward to Members'
reactions to the operative part of the draft Ministerial declaration that Zimbabwe had introduced on
behalf of a group of developing countries, including  India.  He agreed with Malaysia and Thailand
that this was the beginning of a process and that a future work programme needed to be discussed at
some point and prepared for adoption at Doha.  India and its co-sponsors had proposed that the
Ministerial declaration state that nothing in the Agreement prevented Members from taking measuresto protect public health.  He invited Members who disagreed to explain in specific terms what they
believed prevented other Members from taking such measures.  He reiterated that, to his delegation,
any reduction in flexibility was unacceptable.
215. Regarding Articles 7 and 8, he referred to what one delegation had advanced, i.e. that the way
to realize the objectives and principles referred to  in these provisions was simply to implement the
Agreement.  This missed the point.  India and its co-sponsors were seeking to ensure that Members
could implement the Agreement in such a way as to achieve these objectives and principles.  It wasfor the Council to set out the flexibility provided for in the Agreement in such a way that Members
could exercise it.  If the Council would not be able to do so, any dispute settlement panel would
interpret the Agreement's provisions in the light of Articles 7 and 8 anyway, as Canada had pointed
out.  However, the Council should be able to agree on such a basic issue.
216. Regarding parallel imports, he recalled that one delegation had said that the Agreement did
not authorize parallel imports and another delegation that it could agree to what India had proposed
only on the condition that parallel imports were defined as those marketed with the consent of the
patent holder.  India did not agree with either of these positions.  The first delegation was in effect
saying that the Agreement did not allow parallel imports, but that it could not take dispute settlement
action to prevent them.  The second was not accepting India's position that, in some circumstances,parallel imports were goods marketed without the consent of the patent holder.  These were examples
of the lack of flexibility offered in implementation.
217. He appreciated that Switzerland had accepted that the scope of the issue was TRIPS and
"health", but did not understand why it believed that voluntary licences were preferable to compulsory
licences.  Nor did he understand Switzerland's view th at compulsory licensing should not be used as a
tool to promote industrial development.  If com pulsory licensing was not such a tool, how was a
developing country expected to achieve the objectives and principles of Articles 7 and 8?  Was there
any other instrument available under the TRIPS Agreement to achieve these objectives and
principles?  Was Switzerland suggesting that granting full rights to patent holders was supposed to
take care of them?  Statements to the effect that compulsory licences were not to be preferred or thatthey could not be used for certain purposes sought to reduce the flexibility in the Agreement.  This
showed how the present discussions could lead to a reduction in flexibility and called into question
the value of the whole exercise.  India and its co-sponsors had proposed clear language, because they
did not want to fudge the issues and be worse off at the end of the exercise than at the beginning.
218. Commenting on the preambular language that had been introduced by the United States, he
referred to the fourth recital and said that it was a most conspicuous omission not to refer to patents
when listing the factors to be addressed for improv ing access to medicines.  He queried the motivation
behind this omission.  The fifth recital stated that "intellectual property contributes to public health
objectives globally".  India believed that this was true under some circumstances, but it was not clear
that it was always true in practice.  This was the whole point of the current debate.  The sixth recital
reaffirmed that "the TRIPS Agreement contributed to the availability of medicines".  He supported
what Brazil had said on this recital while emphasizing that many developing countries did not believethat this was always true.  India would only be able to agree to something like the sixth recital if
Members could agree to language stating that nothing in the Agreement prevented Members taking
measures to protect public health.  While noting that the paper introduced by the United States
foreshadowed "clarification language", he invited de legations to indicate with which sections of theIP/C/M/33
Page 58
operative part of the draft Ministerial declaration proposed by India and its co-sponsors they could
agree and with which they had problems, so as to facilitate finding common ground on which to build
a text that would be acceptable to all.  It was regrettable that the two texts that had been made
available seemed to be working at cross-purposes, with each addressing different issues.
219. The representative of the European Communities said that it appeared that most developing
countries and least-developed countries favoured a separate declaration on this issue.  His delegation
was still open on this point.  A separate declaration would indicate that Ministers attached much
importance to this issue, perhaps more than if it were part of the main Declaration.  A text on this
issue should be agreed at Doha and should not be referred to a work programme after the Ministerial
Conference.
220. Commenting on the proposal that had been introduced by Zimbabwe, he first referred to the
title, which referred to TRIPS and "public health", an d the first recital, which referred to TRIPS and
"public health and nutrition", and reiterated his delegation's view that the mandate of the Council waslimited to TRIPS and access to medicines.  Referring to the last recital, which emphasized the
fundamental importance of the objectives and prin ciples of the Agreement, he wondered why the
operative part did not address their role in concrete terms.  As regards the first paragraph of the
operative part, he wondered whether the negative statement that "nothing in the TRIPS Agreement
shall prevent Members from taking measures to protect public health" might not be phrased in apositive way, for example "implementation of the TRIPS Agreement should contribute to enabling
Members to have access to affordable medicines".  His delegation believed that it was normal and
proper for Members to take measures necessary to protect public health.  Paragraphs 2, 3 and 4 of the
operative part were unacceptable to his delegation and he invited the sponsors of the text to as precise
as possible so as to prevent misinterpretation.  As regards paragraph 5 concerning compulsory
licensing, he referred to his delegation's paper circulated as document IP/C/W/280.  He was not sure
that paragraph 5 dealt with the issue adequately.  In regard to paragraphs 7 and 8 relating to
Article 39.3 of the Agreement, he referred to document IP/C/W/280 as well.  Paragraphs 7 and 8
seemed fairly open-ended.  Moreover, data protection was not among the issues on which the Council
was focussing the discussion at the present meeting and might well overload the debate.  He thereforesuggested that the discussion remain focused on the key provisions as summarized by the Chairperson
in concluding the informal meeting in July.  He would appreciate clarification of the objective of
paragraph 9 and how this paragraph related to paragraph 6, in particular in view of the reference to
Article 30 in paragraph 9.  Paragraph 10, he said, appeared to go beyond the scope of the WTO
framework.  As regards paragraph 11, he wondered why Ministers at Doha should also agree on amoratorium or restraint in dispute settlement, if they would agree on clarifications of the most
important issues at stake.  Referring to paragraph 12, he said that the issue of non-violation disputes
was more appropriately addressed in the main Declaration.  Turning to paragraph 13, he was not
convinced that it was necessary to decide, in 2001, to extend the transitional period for
least-developed countries under Article 66.1, which would not expire until the end of 2005.  Nor had
he heard any reason why there was an urgent need to extend the transitional period under Article 65.4.
As to paragraph 14, he would not favour the Council duplicating work conducted in other fora.Neither was he convinced of the need to evaluate the effects of the TRIPS Agreement on health on an
"ongoing basis".  Issues could be raised in the Council as and when they arose anyway.  He believed
that the Council should focus on operative, rather than preambular, language at this stage.
221. The representative of Korea recalled that his delegation had underlined the importance of
achieving a balance between the short-term objective of improving access to medicines and the
long-term objective of protecting patent rights for promoting research and development into new
medicines.  In this regard, it was encouraging to see an emerging convergence of views among
Members on the relationship between the TRIPS Agreement and access to medicines.  All recognized
that the Agreement was not part of the problem, but could be part of the solution, in particular if
Members took advantage of the flexibility provided  in the relevant provisions.  The remaining taskIP/C/M/33
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was to further clarify the nature and level of this flexibility.  In this regard, Korea shared the
understanding that Articles 7 and 8 provided flexibility for individual Members implementing the
necessary policies for improving public health.
222. Article 31 was a provision of exceptional nature, confining the restriction of the patent rights
to inevitable and unavoidable circumstances.  The application and implementation of compulsory
licensing should only be conducted for explicit and emergency-responding purposes.  This wouldcontribute to maintaining the balance between the rights of inventors and those of consumers, both
guaranteed under the TRIPS Agreement.  In view of the serious public health situation in some
developing countries, there was a need for the Council for TRIPS to seek easy access to medicines by
those countries through a flexible interpretation and application of compulsory licensing.  In this
context, Article 31(f) was understood as not implying complete prohibition of export or import.  As
regards the suggested grant of compulsory licences to a manufacturer in a third country for the supply
of those least-developed countries that had no manufacturing capacity, there was need for furtherefforts to forge an international consensus, in view of the different perception among Members,
including as to the method for the control of exports and imports and of possible violations of patent
rights within the countries of production.
223. Turning to Article 6, he said that the apparent lack of a definition of "parallel imports"
appeared to result in different views among Members on such a definition.  In Korea's view, it wasnecessary to reach a common understanding on a definition of "parallel imports".  Such a definition
should enhance the balance in the TRIPS Agreement and improve access to medicines.
224. The representative of Hong Kong, China said that his delegation was acutely conscious that
millions of people in developing countries were facing a serious health crisis caused by AIDS or some
other life-threatening but preventable and treatable di seases.  This problem was not simply confined to
Africa but was a global problem.  It was clear that solving the problem would require a global effort.
The debate so far had focussed on the effect of the patent régime on the affordability of medicines to
treat AIDS and other infectious diseases.  Some Members had asserted that, because of the patent
obligations reflected in the TRIPS Agreement, the high cost of certain drugs had resulted in their
inability to treat those suffering from these debilitating diseases to the extent necessary to prevent anational catastrophe.  Hong Kong, China still harboured doubts whether this focus on patents was
correct and whether by focusing on such issues Members would not risk distracting themselves from
other vital healthcare infrastructure issues.  For Hong Kong, China, a question of reconciliation lay at
the very heart of the issue.  No one would doubt that millions of seriously ill people were unable to
afford the medicines they needed to survive.  At the same time, speakers as well as representatives of
coalitions of international voluntary agencies ha d affirmed their support for obligations imposed by
treaty law for protecting intellectual property rights that had been laboriously negotiated over many
years in order to provide incentives for investment into pharmaceutical research and for disclosing
details of inventions so that others might study them, thus helping technological progress and
dissemination.  Hong Kong, China believed that the TRIPS Agreement already provided sufficient
flexibility for Members to pursue policy options to address public health and nutrition concerns.  In
the field of patents, it allowed governments to make exceptions to patent holders' rights, for examplein cases of national emergencies, anti-competitive practices, or if the right holder did not supply the
patented invention, provided certain conditions were fulfilled.  For Hong Kong, China, there was no
need to add to or subtract from the totality of rights and obligations under the TRIPS Agreement.
Specifically, Article 8 of the TRIPS Agreement allowed Members to adopt measures necessary to
protect public health and nutrition, provided that such measures were consistent with the provisions ofthe Agreement.
225. Article 31 contained detailed provisions relating to the use of a patent without the
authorization of its owner.  One of these provisio ns allowed compulsory licensing by a government in
a national emergency situation.  A widely accepted example of such an emergency that Hong Kong,IP/C/M/33
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China fully endorsed was when a country faced an HIV/AIDS epidemic within its territory.  The
compulsory licensing provisions in the TRIPS Agreement allowed a country facing a national
emergency to license a generic drug manufacturer to produce and supply the relevant patented drug,
without having first to negotiate with the patent owner for a voluntary licence.  As many developing
countries did not have the industrial capacity to produce the drug themselves, a key issue was whether
a manufacturer in a third country might produce and supply the drug based on a compulsory licenceissued by the country suffering from the emergency.  A related issue was the extent to which a
manufacturer who had been granted a compulsory licence could sell the drug to other markets.
Hong Kong, China believed that it would be approp riate, in the face of the seriousness of the
HIV/AIDS crisis, to be flexible in interpreting Article 31 so as to permit such a practice.
226. Regarding parallel importation, Hong Kong, China held the view that Article 6 of the TRIPS
Agreement allowed individual Members to establish their own rules, provided that they did not
discriminate among patent holders on the basis of their nationality, and to be free from any challengeby other Members in the WTO.
227. Hong Kong, China recognized the flexibility provided in the TRIPS Agreement to enable
Members to pursue public health objectives, and the need for Members to have the necessary certainty
and security in using this flexibility.  It considered that further discussion and dialogue in the WTO
were needed to bring more certainty to the interp retation of the flexibility in the TRIPS Agreement,
and to find solutions to the various problems.  Put bluntly, the TRIPS machine worked.  Yet, no
patient should have to die because of a lack of certainty about the interpretation of the instruction
manual.  Hong Kong, China supported the idea that any consensus arising from such discussion
should be reflected in a declaration by Ministers at Doha.
228. The representative of Hungary welcomed the continuation of the Council's work on the
important issue of the relationship between intellec tual property and access to medicines.  He recalled
that it had been decided, at the informal meeting in July, that the present meeting would mainly focus
on the key provisions of Articles 6, 7, 8 and 31.  He hoped that there would be a declaration at Doha
containing an agreed interpretation of the flexibility inherent in these provisions.  Hungary was open
as to whether or not it should appear in a separate declaration.  There was merit in having a separatedeclaration provided that it could be filled with substance.  A declaration containing only political
language would send the wrong message.  There was an encouraging convergence of views on some
important points, which gave hope that the Council's work might lead to both substantive and specific
outcomes by the Ministerial Conference.  He welcomed both papers tabled at the present meeting,
which at least partially clarified positions on various issues.
229. Continuing, he said that Article 7 made it clear that the protection of intellectual property
rights was meant to serve society as a whole by striking an adequate balance among the interests of
private right holders - inventors, authors and manufacturers - and users of their inventions.  Article 8
permitted Members to "adopt measures necessary to protect public health […] provided that such
measures are consistent with the provisions of the Agreement".  He recalled that the panel report on
Canada - Patent Protection for Pharmaceutical Products (WT/DS114/R)  had confirmed that the
TRIPS Agreement allowed Members to balance social and health priorities with the interests ofprivate right holders.  Article 31 of the Vienna Convention on the Law of Treaties established that a
treaty should be interpreted in the light of its object and purpose.  Therefore, there should be no
dispute that all provisions of the TRIPS Agreement s hould be read in the light of the objectives and
principles as set forth in its Articles 7 and 8.
230. Regarding compulsory licensing, Article 31 of the TRIPS Agreement did not specify the
grounds on the basis of which compulsory licences could legitimately be granted.  The provision
simply set out extensive procedural safeguards, some of which might be vague, including the
reference to "national emergency and other circumstances of extreme urgency".  Although suchIP/C/M/33
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situations could only be judged on a case-by-case basis, the terrible problems caused by HIV/AIDS in
the seriously affected countries would definitely fall within this category.  The absence of any explicit
reference to public health in Article 31 could not be interpreted as preventing Members from invoking
public health considerations when granting compulsory licences.  Article 31(f) warranted special
attention since it was not clear under this provisi on whether a Member without sufficient domestic
manufacturing capacity was allowed to grant a compulsory licence to a manufacturer in anothercountry where the product was protected by a patent.  This was a real issue which had best be solved
through a permissive interpretation.  He expressed the hope that such interpretative language could be
achieved before the Doha Ministerial Conference.  In its consideration of this issue, the Council
should be guided by the objective of ensuring access to reliable and most cost-effective supplies of the
medicines in question.
231. Hungary had noted with interest Canada's point that parallel importation could contribute to a
solution in these cases.  The TRIPS Agreement le ft it to individual Members to determine their
positions on parallel importation, allowing them to choose an appropriate regime concerning the
exhaustion of intellectual property rights, i.e. whether they would employ a national, regional or
international exhaustion regime.  Article 6 made it clear that Members' exhaustion regimes could not
be the subject of WTO dispute settlement proceedings, provided that the obligations on
non-discrimination in Articles 3 and 4 were met.  Although Article 28.1(a) provided for an exclusiveright to prevent importation, the footnote to that provision laid down that the provision was subject to
Article 6.
232. The representative of Kenya said that the period between the TRIPS Council meeting and the
Doha Ministerial Conference provided Members an opportunity to reach a common understanding on
certain provisions of the TRIPS Agreement that related to public health.  At Doha, Ministers wouldhave to take a position on access to affordable life-saving medicines and public health.  At stake were
the lives of millions of people, mainly in the third world.  It was for this reason that Kenya appealed
to Members to accept the draft declaration that had been introduced by Zimbabwe on behalf of a
group of developing countries, including Kenya.  Whether the TRIPS Council would be able to take
action on the issue of TRIPS and access to affordable life-saving medicines would be widely seen as amajor test as to whether the WTO managed the multilateral trading system for people's welfare or
simply for profit.  The outside world was waiting impatiently and Members had to act now to
guarantee millions of poor people access to affordable life-saving medicines and 
 treatment for their
survival.
233. Wishing to highlight certain elements of the draft declaration that had been introduced by
Zimbabwe, he first said that the protection and promotion of public health was one of the major
national policy objectives that the government of Kenya, or any other government, sought to address
in pursuit of the welfare of its people outside of  its international commitments.  Thus, when Kenya
had joined the WTO and ratified its Agreements, including the TRIPS Agreement, Kenya had not
given up its sovereign powers to undertake regulatory action with respect to the protection and
promotion of the health and safety of its people.  In spite of economic hardships, the government of
Kenya was committed towards ensuring that the people of Kenya could obtain access to affordablemedicines and medical treatment.  Second, in the absence of a clear and categorical statement by
WTO Members recognizing the right of governments to undertake regulatory action to promote the
health of their people, the rights indicated in the TRIPS Agreement in favour of the right holders of
patented pharmaceutical products might potentially impact adversely on the ability of any government
to promote national public health objectives through various regulatory actions intended to makemedicines, including patented ones, more availabl e and affordable.  Non-governmental organizations,
public health advocates, the WHO and the public in g
eneral had expressed concerns in this regard.
Kenya recognized and shared these concer ns.  Third, the right and responsibility of governments to protect
and promote the health of their people had to be co nsidered as independent and superior, not subordinate,
to the protection of the rights of patent right holders under the TRIPS Agreement.  Fourth, the overridingIP/C/M/33
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public welfare interest involved in, inter alia , protecting and promoting the right of the people to access
affordable and life-saving medicines could be said to be likewise clearly recognized by the provisions of
TRIPS Agreement itself.  In this respect, Article  7 required that the protection and enforcement of
intellectual property rights had to be done "in a manner conducive to social and economic welfare and to a
balance of rights and obligations".  This clearly indicated that the primordial objective of the protection of
intellectual property rights was the people's welfare - including their right to acce ss affordable medicines -
and that, hence, the protection of intellectual property rights might, whenever deemed needed by a WTOMember, be tempered to take into consideration the public welfare.  Article 8.1 recognized as a
fundamental principle of the TRIPS Agreement the right of Members to "adopt measures necessary to
protect health and nutrition".  Members, therefore, were free to undertake regulatory action to ensure theavailability and affordabilitv of medicines for their people and should be presumed to be doing so
consistently with their obligations under the TRIPS Agreement, so that the burden of proving any
inconsistency of such action with the TRIPS Agreement would rest with the Member alleging such
inconsistency.  Article 8.2, when coupled with Article 7, implicitly recognized the right of Members to
undertake appropriate measures that limit the ability of patent right holders to exercise and benefit from
their intellectual property rights when such exercise, in the discretion of the Member, amounted to an
abuse of such rights to the detriment of the Member's national interests and the welfare of its people.  Such
measures included compulsory licensing and parallel importation.  Article 30 reiterated the sense ofArticle 8.2 in recognizing the right of Members to impose limits on and exceptions to exclusive rights
enjoyed by patent right holders.  Where a Member deemed the imposition of such limits to be needed in
order to protect and promote its people's health, such imposition would clearly be reasonable within the
meaning of Article 30.  Such limits could include:  (a) the establishment of a regime of international
exhaustion regime as part of the Member's national legislation;  (b) the grant of authorization by a Memberimporting patented medicines for the production and export of medicines by persons other than the patent
right holders of such medicines in order to address the public health needs of such Member.  
Fifth, in the
past, threatened recourse to the WTO dispute settlement system by some Members against other
Members wishing to pursue their national public health interests through measures authorized under
the TRIPS Agreement had created a "chilling effect" on the use of such TRIPS-authorized measures.
This had resulted in effectively imposing limits on the ability of Members, especially developing and
least-developed country Members, to freely adopt and implement public health measures in the faceof grave and urgent public health crises in their countries.  Hence, Kenya supported the call in the
draft declaration for Members to refrain from using the WTO dispute settlement system with respect
to disputes concerning measures adopted by other Members, especially developing and
least-developed country Members, to protect and promote public health.  Finally, the initiative for a
separate Ministerial declaration would highlight and underline the intent and political will of allMembers of the WTO to jointly and collaboratively promote public health, on national and
international levels, through measures as they might deem necessary to achieve this objective, and
ensure that the interpretation and implementati on of the TRIPS Agreement would not hinder the
achievement of such objective.
234. The representative of Japan said that his delegation shared the positive assessments on the
outcome of the discussions at the earlier meetings of the Council on the issue.  He understood that
there was some common ground among Members acknowledging the importance of coping withpandemics of HIV/AIDS and other major communi cable diseases.  There was also some common
ground for clarifications as to the flexibility available in the application of some, if not all, TRIPS
provisions.  Given the importance and urgency of the problem, it was desirable that WTO Members
could achieve a concrete positive result as soon as possible.  In this respect, his delegation wished to
offer some preliminary comments on the text that had been introduced by Zimbabwe.  Regarding thescope of the text, he said that, in his delegation's view, Members should, at this stage, focus their
efforts on the issue of access to medicines for HIV/AIDS and other pandemics, such as malaria and
tuberculosis.  Given the urgency of the problem, Members should concentrate on coping with these
pandemics.  While it did not want to deny the importance of securing the public health or nutrition of
people, his delegation did not believe that the Council's discussion of public health and nutritionIP/C/M/33
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issues other than the drug access issue was ripe for Doha.  Expanding the scope of the work in
preparation for Doha by including these other issues risked delaying a favourable outcome and
jeopardized the much-needed solution to cope with the pandemics he had referred to soon.  The same
would apply to the efforts to clarify the flexibility of the provisions of the Agreement.  Consequently,
the Council should concentrate on the provisions of Articles 6, 7, 8 and 31.
235. With regard to the question of a separate declaration, his delegation was of the view that the
form of the declaration should be discussed at a later stage and that discussions should focus first on
the substantive points.  With regard to the elements to be incorporated in the text of the Ministerial
declaration, he said that his delegation had not yet had the time to analyse the proposal that had been
introduced by Zimbabwe.  However, Japan's position on elements for a Ministerial declaration were
reflected in the text that had been introduced by the United States on behalf of, inter alia , Japan.  He
expressed support for the statement made by Switzerland.  He emphasized that the message to be sent
by the Ministerial declaration was that the TRIPS Ag reement was not part of the problem, but part of
the solution.  The text should recognize the important role of intellectual property protection in giving
the necessary incentives for research and developmen t into life-saving drugs.  Without appropriate
protection for intellectual property, new life-saving drugs would not be developed.  In this regard, the
TRIPS Agreement contributed to the availability of medicines and to public health objectives.
236. He recalled that his delegation had submitted, at the Council meeting in June 2001, a
non-paper presenting Japan's views on the flexibility contained in Article 31 on compulsory licensing
and in Article 6 on exhaustion.31
237. As regards Article 7, Japan held the view that this provision was a guiding principle for
interpreting and applying other provisions of the TRIPS Agreement.  However, it could not be
interpreted so as to allow Members to take measures which were inconsistent with other provisions ofthe Agreement.  It should also be noted that the extent of the effect of Article 7 should be examined
on a case-by-case basis.  Turning to Article 8, he said that Japan was of the view that this provision
provided one of the balancing mechanisms of the TRIPS Agreement.  However, it should be noted
that provisos were contained in both Article 8.1 and Article 8.2, which clearly spelled out that
measure adopted had to be "consistent with the provisions of this Agreement".  Therefore, Article 8could not be interpreted so as to entitle Members to take measures inconsistent with other provisions
of the TRIPS Agreement.  It should also be noted that the effect of Article 8 should be examined on a
case-by-case basis.
238. The representative of Norway said that his delegation had read both the paper introduced by
Zimbabwe and the one introduced by the United States as contributions forming a basis for a separate
declaration to be adopted by the Doha Ministerial Conference.  He expressed support for such a
procedure.  On substance, his delegation saw merit in many of the paragraphs of the preamble
proposed in the paper that had been introduced by Zimbabwe, which pointed to a number of important
general principles and obligations common to all Members and addressed the particular problems a
large number of developing countries were facing in their efforts to provide satisfactory solutions
relating to public health, including access to patented medicines.  As to the operational paragraphs of
this paper, some were formulated as expressions of general policy views, many of which Norwayshared.  Others were more closely related to the interpretation of specific provisions of the TRIPS
Agreement.  Based on a first reading, his delegation believed that the content of a number of
paragraphs were close to positions held by Norway.  Referring to India's request for concrete feedback
on the draft text, he said that his delegation would have to take a closer look at the form and wording
of the paragraphs and would, in doing so, also look at:  the appropriateness of some of the paragraphswithin the context of the TRIPS Council's mandate;  the sheer length of the draft;  and how it might be
made more palatable to other Members.  He also expressed his delegation's appreciation for the
                                                     
31 JOB(01)/97/Add.3.IP/C/M/33
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preambular language that had been introduced by the United States and looked forward to receiving
its operational paragraphs soon.  Norway saw the two papers as the basis for further deliberations
towards Doha.  Although time was running short and there were a number of unresolved issues in
many areas, he hoped that the issues related to TRIPS and access to medicines could be solved before
the Doha Ministerial Conference.
239. The representative of Switzerland, referring to India's comment concerning Switzerland's
view that voluntary licensing was preferable to compulsory licensing, called Members' attention to the
titles of Article 31 - "Other Use Without the Authorization of the Right Holder" - and of Article 30 -
"Exceptions to Rights Conferred", which both pointed at exceptions to the normal situation.
Moreover, under Article 31(b), a compulsory licence should normally be issued only if, prior to its
grant, the proposed user had made efforts to obtain authorization from the right holder on reasonable
terms and conditions and such efforts had not been successful within a reasonable period of time.  In
other words, first negotiations for a contractual licence had to be undertaken before a compulsorylicence could be granted.  For these reasons, voluntary licences were preferable to compulsory ones.
Compulsory licences could be issued only if prior negotiations with the patent owner had failed or if
there was "a national emergency and other circumstances of extreme urgency".  As regards parallel
imports, he referred to his earlier intervention.  In Switzerland's view, when products covered by a
patent had been put on the market without the consent of the patent holder, the latter could oppose theparallel importation of these products.  This was also the line of thinking reflected in a recent decision
by the European Court of Justice.  He also reiterated his delegation's view that compulsory licensing
should not be used as a tool for industrial policy.  A compulsory licence could only be granted in
certain situations, e.g. for reasons of non-use or abuse of the patent rights.  The absence of local
working could not be construed as non-use or abuse of the patent rights.  Article 27.1 in combinationwith Article 28 explicitly considered it one of the rights conferred by a patent on its owner to decide
whether he wished to produce locally rather than to  import a product still under patent protection.  His
delegation had not had time yet to analyse the proposal that had been introduced by Zimbabwe.  He
reiterated his delegation's view that, in order to be able to clarify the flexibility in the provisions of the
TRIPS Agreement in relation to the issue of access to medicines, the Council first needed factualinformation about the problems that Members were facing in this regard.
240. The representative of Zimbabwe said that Members appeared to be narrowing the differences
between them and to be moving towards a convergenc e of views on most of the issues.  It was now a
question of fine-tuning.  Regarding the question of the mandate, he recalled that, at its meeting in
April 2001, the Council had mandated the Chairperson to undertake consultations with Members onthe issues to be addressed and, ever since that time, developing countries had said that, to the extent
possible, the language of the TRIPS Agreement itself should be used to identify the issues that had
been raised.  The Agreement referred to "public health and nutrition".  Along the way, developing
countries had shown flexibility and agreed that the focus in the current discussions might perhaps be
limited to "TRIPS and public health".  Nutrition could be addressed at another time.  The work so far
on clarifying flexibilities as well as on the question of affordable access all fell under the broad
heading of "TRIPS and public health".  The headin g suggested by Switzerland seemed to downplay
the defects that Zimbabwe had raised on behalf of the African Group when it had first requested the
Council to address this matter.  He recalled that that request had been made against the background of
legal challenges both under municipal law and in a WTO dispute settlement case.  The African Group
was of the view that it needed guarantees and confirmation that the flexibilities under discussion were
available for Members without challenge.  Although the legal challenges had since been dropped, thecomplainants, both in national courts and at the WTO, had reserved their rights to come back to these
issues.  The current discussion reflected that experience and was not taking place in a vacuum and the
Council needed to send an unambiguous message to the world that its discussion was to overcome
misconceptions about the rôle of the TRIPS Agreement.  If Members were able to say that the TRIPS
Agreement was not part of the problem, as they had done in the discussions so far, the Council shouldalso be able to be clear and forthright in saying that it was part of the solution, i.e. with language thatIP/C/M/33
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provided the necessary guarantees and clarity to re move the current ambiguities.  Only then the WTO
would be able to move forward with other intern ational organizations, the private sector and all
stakeholders in addressing the current problems.  He agreed with the European Communities that
work should focus more on the operative part than the preamble, but some preambular text was
necessary as well, as proposed by Zimbabwe and its co-sponsors.  While his delegation could agree
that intellectual property rights provided an incenti ve for research and development, it was of the view
that the Council should also acknowledge that certai n practices concerning intellectual property rights
stifled innovation, e.g. broad patents.  Delegations  should not pretend that the current system was
working perfectly.  It also needed to be acknowledged that current research and development was not
focusing on so-called diseases of the poor.  The WTO needed to work with other organizations to
ensure that research was carried out into tropical diseases.  The paper that had been introduced by the
United States fell short of the expectations of his delegation.  It would, however, continue to engage
in consultations with the delegations that had tabled the paper so as to reach a convergence ofpositions.  He hoped that in the coming weeks an agreed text for a separate declaration on this issue
could be forwarded to the General Council.
241. The representative of India, referring to the intervention that had just been made by
Switzerland, said that he still did not understand why it should be agreed that voluntary licences were
preferable to compulsory licences.  Article 31 stood on its own and did not concern an exception tothe normal situation.  Exceptions to patent rights were addressed in Article 30.  He maintained the
view that he had expressed earlier when he had referred to compulsory licences as a tool of industrial
policy by way of example as to how the current exercise could reduce the flexibility under the
Agreement rather than enhance it.  On parallel imports, he admitted that he had misunderstood what
Switzerland had said.  However, when Switzerland was saying that the import of generic copies ofmedicines produced under a compulsory licence into a country where the original product was
patented did not fall under the notion of parallel imports since they were not original products nor had
been put on the market with the authorization of the right holder, he wondered whether it was not true
that, while they were indeed not original products, in the event of a compulsory licence, the right
holder was entitled to adequate remuneration.  Therefore, he questioned that the consent of the rightholder was imperative in such a case.
242. The representative of the World Health Organization said that, for his organization, the
careful and systematic attention which WTO Members had given to the issue of access to medicines
during the 20 June 2001 discussion in the Council for TRIPS and were giving to it at the present
meeting was most heartening.  WHO wished to congratulate WTO Members on the historicimportance of the 20 June 2001 discussion in that this was the first time in the 50-year history of the
multilateral trading system - including GATT and the WTO - that a
 special discussion on access to
drugs had been convened.  The WHO was encouraged by the Chairperson's summary of the 20 June
discussion in which he had indicated that "[...] Members said they [are] committed to ensuring that the
TRIPS Agreement does not stand in the way of access to existing drugs, especially in the poorest
countries […]" and that the Council would "seek common understandings of the flexibility in the
TRIPS Agreement, so as to ensure that all Members have the necessary sense of security and legalcertainty that enable[s] them to use these provisions  to the full".  He also noted with appreciation the
numerous positive references by delegates at the same meeting of the TRIPS Council to the WHO's
work in the area of access to medicines.  He referred to the update WHO had provided to the Council
of its activities in the field of technical cooperation relevant to implementation of the TRIPS
Agreement and access to drugs emphasizing that this update contained WHO's policy perspectives onaccess to drugs.  It also provided information on:  (1) policy guidance and information support;
(2) direct country support and regional awareness meetings;  (3) monitoring and analysis of the
potential impact of globalization on access to drugs;  and (4) cooperation with other international
organizations.  With respect to cooperation with international organizations, the WHO had been
fortunate to co-sponsor joint meetings with the WTO Secretariat, such as the April 2001 Workshop onDifferential Pricing and Financing of Essential Dr ugs.  WHO had also been pleased to have theIP/C/M/33
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participation of the WTO Secretariat in regional briefings on pharmaceuticals and trade.  The WHO
Secretariat had been mandated by the WHO Member States to continue cooperation with international
organizations to support countries.  In this light, the WHO Secretariat looked forward to being of
assistance to WTO Members in whatever way it could.
243. The Chairperson said that the Council for TRI PS would need some guidance from delegations
as to how to proceed.  The discussion had been very rich on this issue of great impact and importance.
It was a universal responsibility to find solutions to the problems raised in terms of health and human
life, and not the responsibility of the WTO only.  However, delegations seemed to agree that the
WTO, from a political point of view, had to say so mething, in particular at the Doha Ministerial
Conference.  In this regard, the oral and written contributions were very useful in that they helped to
clarify the positions.  Views expressed were different in some respects.  The importance of Articles 6,
7, 8 and 31 of the TRIPS Agreement had been highlighted as well as other specific provisions.  Most
delegations were in favour of working towards a separate declaration for Doha.  Others had expressedtheir flexibility in this regard.  On substance, it would seem that some issues were of a highly
technical nature and there complexity might preven t a solution by the time of the coming Ministerial
Conference.  This was how he understood the proposal that had been made to reserve some of the
issues raised for a specific work programme to be approved by the coming Ministerial Conference.
As regards the issue of the scope of the declaration, i.e. "public health and nutrition", "public health","access to medicines in general" or "access to medicines for HIV/AIDS and other pandemics", he
suggested that this be looked at in systemic terms once Members had identified specific language for
the declaration.  The view had been espoused that nothing from the exercise should result in a
limitation of  the existing flexibility, while another view expressed was that it should not result in a
limitation of existing obligations.  He emphasized the importance of approaching the matter in aconstructive way and of addressing the issues raised both in terms of the overriding objective of
securing public health and of the need to preserve the basic framework of rights and obligations in the
TRIPS Agreement.  A number of delegations had pointed out that specific clarifications were needed
of the scope of some provisions of the Agreement and that, therefore, mere "preambular" language
would be insufficient.  On some points, delegations did not seem to disagree.  He stressed that littletime was available prior to the moment towards the end of the month, at which the Chairperson of the
General Council had indicated he intended to circulate a text on the contents of a draft Ministerial
declaration.  It would be helpful if the elements to be included in a declaration on the issues that had
been discussed under the present agenda item could be listed, so as to structure the further discussions
and also assist the Chairperson of the General Council in his reflections as to how to proceed furtherand as to whether he should include something on access to medicines in the text he intended to
submit towards the end of the month.
244. When reverting to the issue on the afternoon of Thursday, 20 September, the Chairperson said
that he had been in touch with the Chairperson of the General Council and stressed that the limited
time available for further work on the issue before the Ministerial Conference would meet in Doha
required making the best possible use of the presence of the experts attending the present meeting.  He
therefore suggested that the Council would meet the ne xt day in informal mode to further discuss the
issue with the aid of a list of the different suggestions that had presented themselves, in the
discussions to date and the contributions submitted, as possible elements for the Ministerial
declaration on the issue.  He would ask the Secretariat to assist in drawing up this list.
245. The representative of Argentina wondered whether the Chairperson was suggesting that this
informal meeting consider the contributions submitted so far on the basis of a document consolidating
them.  If so, she might need to get additional instructions from her capital first.
246. The Chairperson said that the sole purpose of the list that he had suggested might be drawn up
would be to facilitate the discussion on the different suggestions made to date at the suggested
informal meeting.IP/C/M/33
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247. The Council took note of the statements made and agreed  to proceed as suggested by the
Chairperson.
248. The European Commission representative drew the attention of participants to an informal
contribution to the debate that was ma de available outside the meeting room.
O. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO
(i) Accessions
249. The Chairperson said that, on 26 July 2001, Moldova had become the 142nd Member of the
WTO.  Moldova had committed itself to apply full y the provisions of the TRIPS Agreement by the
date of its accession to the WTO, without recourse to a transitional period.  He suggested, in
accordance with the procedures for the reviews of national TRIPS implementing legislation which the
Council had applied thus far in respect of newly acceded Members, that the Council reserve time for
the review of Moldova's legislation at its first meeting in 2002.
250. The Council so agreed.
(ii) Dispute settlement
251. The Chairperson informed the Council that, by means of a communication, dated 5 July 2001,
the United States and Brazil had notified the Dispute Settlement Body that they had reached a
mutually satisfactory solution to the matter rais ed by the Government of the United States in
WT/DS199/1 ( Brazil - Measures Affecting Patent Protection ).  This communication had been
circulated as document IP/D/23/Add.1.
252. On 23 July 2001, the United States and the European Communities had notified to the DSB
their agreement to resort to arbitration pursuant to  Article 25 of the DSU to determine the level of
nullification or impairment of benefits to the EC as a result of Section 110(5)(B) of the US Copyright
Act (see documents WT/DS160/14, 15 and 16).
253. On 6 August 2001, the Report of the Panel on United States – Section 211 of the Omnibus
Appropriations Act of 1998  had been circulated as document WT/DS176/R.
P. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS
254. The Chairperson said that a request had come in from UNAIDS to be admitted as observer to
the present meeting of the Council and only as far as the discussion under agenda item N was
concerned.  If, as at the previous meeting, there was no objection to this request, he would suggest
that UNAIDS be granted observer status for the discussion of this agenda item.
255. The Council so agreed.
256. The Chairperson said that the Council continued to  have before it 15 outstanding requests for
regular observer status, namely from the 15 Organizations listed in document IP/C/W/52/Rev.9.  He
noted that there were no new developments on the issue of these pending requests.IP/C/M/33
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Q. ANNUAL REPORT TO THE GENERAL COUNCIL
257. The Chairperson recalled that the draft Annual Report of the Council had been circulated in
document IP/C/W/307.  He noted that there were no comments on this draft and suggested that the
Secretariat update the text of this draft, so that it would also reflect the work of the Council at its
present meeting, and circulate the revised draft to Members for comments.
258. The Council so agreed.32
____________
                                                     
32 A revised draft was circulated as document IP/C /W/307/Rev.1.  No comments were received on this
revised draft.  The final report was circulated as document IP/C/23 and forwarded to the General Council.