WORLD TRADE  
ORGANIZATION  RESTRICTED 
IP/C/M/69 
15 May 2012  
 
(12-2635) 
Council for Trade-Related Aspects of 
Intellectual Property Rights  
 
 
 
MINUTES OF MEETING 
 
Held in the Centre William Rappard on 28-29 February 2012 
 
Chairperson:  Ambassador Dacio Castillo (Honduras)  
 
  The present document contains the record of the discussion which took place during the 
Council for TRIPS meeting held on 28-29 February 2012. 
 
_______________ 
  
Subjects discussed Page nos. 
A.  ELECTION OF THE CHAIRPERSON  ................................................................................................ 2  
B.  NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  ......................................................... 5  
C.  REVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  .............................................................. 8  
D.  REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) ..................................................................... 8  
E.  RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE RELATIONSHIP BETWEEN 
THE TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY  .......................... 8  
F.  PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  ................................................... 8  
G.  NON-VIOLATION AND SITUATION COMPLAINTS  ...................................................................... 18  
H.  REVIEW OF THE IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1 ........... 20  
I.  REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHIC 
INDICATIONS UNDER ARTICLE 24.2 .......................................................................................... 20  
J.  FOLLOW -UP TO THE NINTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION 
ON THE IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  ............................... 21  
K.  TECHNICAL COOPERATION AND CAPACITY BUILDING  ............................................................. 21  
L.  LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO 
IMPROVE THE TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER 
INFORMATION FLOWS  ............................................................................................................... 25  
M.  AUSTRALIA :  TOBACCO PLAIN PACKAGING BILL 2011  AND ITS COMPATIBILITY WITH 
THE TRIPS  AGREEMENT  ........................................................................................................... 26  
N.  IP ENFORCEMENT TRENDS  ........................................................................................................ 41  
O.  INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO .............................. 55  
P.  OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  ............... 56  
Q.  OTHER BUSINESS  ...................................................................................................................... 56  
 IP/C/M/69 
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  A. E
LECTION OF THE CHAIRPERSON  
1. The representative of the Secretariat recalled that the Chairman of the TRIPS Council 
Ambassador Federico González had informed the Ge neral Council at its December 2011 meeting that 
he had relinquished the post because of his return  to the capital to take up new responsibilities.  The 
normal practice of the TRIPS Council was that the out going Chair held office until the end of the first 
meeting of each year.  The new Chair was then normally  elected at the end of that meeting.  Since the 
Chair had already relinquished his post, the Council would this time need to start by electing a new 
Chair. 
2. At its meeting of 24 February 2012, the Genera l Council had noted the consensus on a slate of 
the names of chairpersons for WTO bodies.  On the basis of the understanding reached, he proposed 
that the Council for TRIPS elect H.E. Mr. Daci o Castillo from Honduras as its Chairperson for the 
coming year by acclamation.   
3. The Council so agreed. 
Adoption of the agenda  
4. In proposing the agenda for adoption, the Chairman said that  item M on "Australia:  Tobacco 
Plain Packaging Bill 2011 and Its Compatibility with the TRIPS Agreement" had been put on the 
proposed agenda at the written request of the dele gation of the Dominican Republic.  Item N on "IP 
Enforcement Trends" had been put on the agenda at the written request of the delegations of 
Australia, Canada, the European Un ion, Japan, Korea, Mexico, New Zealand, Singapore, Switzerland 
and the United States. 
5. The representative of India said that he was su rprised to see that an item on IP enforcement 
had again been proposed on the agenda.  At it s October 2011 meeting, the Council had had on its 
agenda a similar item at the beh est of the Anti-Counterfeiting Trade Agreement (ACTA) participants.  
At that time, Members had said that the idea had been to circulate the ACTA text.  The item had no place on the agenda of this meeting, since the Counc il was not a forum to discu ss such an agreement.  
He therefore opposed the adoption of the proposed agenda. 
6. The representative of China said that that her first concern was that there was an 
inconsistency between the proposed age nda item and the supporting documentation .  While IP 
enforcement was a broad issue on which Members ha d various views, the document provided for the 
item was solely focused on ACTA.  In her view, AC TA could not represent IP enforcement trends in 
general.  She said that she did not understand th e intention of the proponents and could not accept the 
proposed item as such.  
7. Secondly, the Council had been instructed  and mandated by Ministers at Doha and 
Hong Kong to focus its discussion on implementation-related issues.  Wh ile those issues remained not 
fully resolved, it would not be appropriate for the Council to deviate from those instructed topics.  
Thirdly, the proposed item had already been on the agenda of the Council's last regular meeting and detailed presentations had been made on various pa rts of ACTA.  A repetitive exercise would be 
redundant, except if there were further explanations.  Finally, she emphasized that ACTA was not part 
of the TRIPS Agreement.  It went beyond the en forcement requirements of the TRIPS Agreement and 
was a TRIPS-plus provision.  It was conclude d only between some Members of the WTO and 
therefore was neither a multilateral agreement among  the whole WTO membership nor a plurilateral 
agreement as listed Annex 4 to the WTO Agreement.  Therefore the content of ACTA should not be a 
topic for TRIPS Council meetings.  If the proponent s wished to share information on ACTA with 
other WTO Members, they could do so under item Q on "Other Business" or make a notification 
under Article 63 of the TRIPS Agreement.  IP/C/M/69 
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  8. The representative of Ecuador said that item N ha d already been dealt with at the Council's 
last meeting and should not become a permanent ite m of its agenda.  ACTA was only one vision of IP 
trends, did not represent best practices and was not within the TRIPS framework.  The item could be 
dealt with under "Other Business". 
9. The representative of Egypt said that he did not accept item N on the agenda, although the 
matter could be dealt with under "Other business".  The Council should not be a forum to promote 
TRIPS-plus issues and should stick to  the mandate set up by Ministers. 
10. The representative of the Plurinational State of  Bolivia said that it was not appropriate to 
review ACTA as an item of the agenda.  If the propone nts wished to carry out a transparency exercise, 
that should be done under an appropria te agenda item.  Furthermore, ACTA did not represent the best 
trends. 
11. The representative of Cuba said that ACTA was not a relevant issue for the Council and did 
not agree that it be included on the agenda.  Initiatives aiming at plurilateralism should not be 
analysed in the Council except under "Other business". 
12. The representative of Brazil said that the discu ssion of enforcement at the WTO should be 
confined to matters related to the TRIPS Agreem ent and its implementation.  There was no mandate 
to discuss TRIPS-plus measures in the Council. 
13. The representative of the Bolivarian Republic of Venezuela said that he was against including 
item N on the agenda. ACTA went far beyond the TRIPS Agreement and therefore should not be 
raised in the Council.  It was difficult to carry out  a transparency exercise with something that had 
started without transparency.  Most importantly, ACTA was not part of the multilateral context. 
14. The representative of the United States said that , given that enforcement was the subject 
matter of Part III of the TRIPS Agreement, item N wa s perfectly consistent with the mandate of the 
Council.  The delegations who had requested this agenda item had me t all the procedural requirements 
for filing an item and consensus had been reached  on the item title in October 2011 as well as on 
including the item on the agenda of the Octobe r Council meeting.  If Members had questions 
regarding the subject-matter of the item, which was evident from the previous interventions, he would 
welcome the discussion.   
15. As indicated in October, Members had raised  questions in the past and there had been 
requests for additional information at the Octobe r meeting as well.  Transparency lay at the 
foundation of the agenda item.  Many Members, and not only proponents of the item, had explicitly 
supported the objective of promoting transparency at the Council's last meeting, and they had done so 
at the present meeting by suggesting that the ite m be discussed under "Other business".  This was 
reflected in paragraphs 5 through 31 of th e minutes of the October TRIPS Council meeting 
(document IP/C/M/67).  To call for transparency and yet to oppose the proposed agenda item was 
curious and internally inconsistent.  To deny a response from the ACTA participants to Members who 
had asked questions and sought  additional information was difficult to reconcile.  
16. He said that "Other business" was inappropria te since the proposed agenda item was not 
limited to an announcement, as was the purpose of "Other business".  He also referred Members to 
Rule 25 of the Rules of Procedures, which confirme d this point.  Instead, this item was a substantive 
item in nature and intended to promote a good exchange of views.  With respect to the reference made 
to past ministerial statements, he recalled para graph 3 of the statement of Ministers from the 
December 2011 Ministerial Conference (document WT/MIN(11)/W/2), where "Ministers underline 
the importance of the work of regular WTO bodies including their role in the oversight of 
implementing existing Agreements;  dispute avoi dance;  transparency through monitoring and IP/C/M/69 
Page 4  
 
  reporting and as a forum for the consideration of trade-related issues raised by Members".  In his 
view, the proposed agenda item was fully in line with  the intent of Ministers.  In contrast, it was 
difficult to understand how opposing th is item fulfilled that intent.   
17. The representative of Japan said that the prop osed agenda item should be addressed in the 
Council because IP enforcement was a relevant  issue for it.  Furthermore, the Government of Japan 
had hosted a signing ceremony of ACTA in January 2012.  He believed that the item was a useful 
opportunity to share on new developments since the Council's last meeting. 
18. The representative of the European Union said th at enforcement was an extremely important 
element of IP and of the TRIPS Agreement.  It therefore made sense to have a discussion.  He 
intended to talk about IP enforcement trends , inter alia,  ACTA, and he looked forward to having that 
discussion at the present meeting under the relevant agenda item. 
19. The representative of Canada said that she we lcomed an informed discussion on enforcement 
issues in the Council, as counterfeiting and piracy  posed serious threats to the global economy.  
Effective enforcement of IPRs was a fundamental aspect of the TRIPS Agreement and it should be 
addressed in the ambit of the Council.  It was not only a matter of establishing procedures and 
remedies but also of improving cooperation, capacity building and communication among Members. 
20. The representative of Australia said that his in tention was to continue the discussion that had 
started at the Council's last meeting and had not been  completed.  It certainly would not be the first 
time that ACTA had been discussed in the Council.  It  had been raised a number of times previously.   
21. The representative of New Zealand said that the proposed agenda item was appropriate and 
that it would provide an opportunity for a useful tr ansparency exercise and to continue discussion on 
some questions remaining from the October meeting. 
22. The representative of Switzerland said that the proponents of the agenda item had fully 
ensured compliance with the pro cedural requirements.  Furthermore, the title had already been 
adopted in October 2011.  ACTA was not the enfo rcement trend but obviously one development in 
the sphere of enforcement trends.  The purpose of the discussion would be to give further 
explanations, as ACTA had been the subject of a fair amount of discussion on Internet blogs and the 
press, and there had also been misleading and wrong in formation about it.  Accordingly, he felt that it 
was his obligation to correct and rectify that in formation and provide answers that Members had 
posed in earlier Council meetings. 
23. The representative of Thailand said that that IP  enforcement was a very important issue.  
However, if the Council were to discuss IP enforcem ent trends or any TRIPS-plus standard setting, it 
should move in very small steps.  As agreed by  many Members in the General Council meeting earlier 
that month, the Council should be pragmatic and avoid a dogmatic approach. 
24. The representative of Mexico said that th e proposed agenda item was important for 
transparency and he wished to continue in that direction with other delegations. 
25. The representative of China said she could go along with Members who had said that the 
intention was to strengthen the regulative body of the WTO.  At the Council's October meeting, the 
previous Chair had successfully facilitated a compromise among Members on this item.  If the 
proponents would insist on the agenda to be adopted as proposed, the discussion under that agenda item should not be limited to ACTA, but Members should be entitled to raise other enforcement 
trends.  In a spirit of collaboration and to avoid bl ocking the adoption of the agenda, she was ready to 
adopt the agenda with the proposed item with th e understanding that it was a temporary item.   IP/C/M/69 
 Page 5 
 
 
  26. The representative of Korea said that the pr oposed agenda item fulfilled all the procedural 
requirements and fell within the Council's mandate.  Moreover, several questions had been raised 
relating to the matter and not addressed at the Council's  last meeting.  She said that she could go along 
with China's constructive suggestion. 
27. The representative of India said that, since ther e was no consensus regarding the inclusion of 
the proposed agenda item, it should be  dealt with under "Other business". 
28. The Chairman noted two points made by delega tions, namely that the proposed agenda item 
should not become a standing item on the Council agenda , and that the request that the item be put on 
the proposed agenda did meet the procedural requi rements for its inclusion.  On that basis, he 
suggested that the Council take note of the st atements made and adopt the proposed agenda. 
29. The Council so agreed. 
B. NOTIFICATIONS UNDER PROVISIONS OF THE AGREEMENT  
30. The Chairman said that, since its meeting in October 2011, the Council had received a 
number of supplements and updates to earlier notif ications of laws and regulations notified under 
Article 63.2 of the Agreement: 
 Georgia had notified its laws on patents, co pyright and neighbouring rights, trademarks, 
designs, appellations of origin and geographi cal indications of goods, topographies of 
integrated circuits, new breeds of animals and new varieties of plants, as well as a law on border measures relating to intellectual property and certain resolutions related to industrial 
property; 
 Colombia had notified certain provisions of a law establishing the Nati onal Development Plan 
2010-2014 that concerned the transfer of IP Rs generated under services or employment 
contracts, or in research projects funded by the national budget;  
 Japan had notified its Unfair Competition Prevention Act;  and 
 the United States had notified its Trademark Rul es of Practice, and Trademark Technical and 
Conforming Amendments. 
31. These notifications would be circulated in th e IP/N/1-series of documents, which contained 
two types of documents.  The base document for each notification contained the list of laws and 
regulations that a Member had notified and any explan ations relating to them.  The actual texts of the 
laws and regulations were circulated in a law series of documents.  The base document provided a 
reference to each of these law series documents that c ontained the full texts of laws and regulations.   
32. While the Secretariat would share under "Other  business" information on the implementation 
of the recommendations for savings and more e fficient use of resources made by the Budget 
Committee and adopted by the General Council and how  this affected the TRIPS Council's work, he 
wished to already mention one element of the im plementation of these recommendations.  While the 
Secretariat was continuing to circulate base docum ents both in hard copy and electronic form, the 
actual texts of laws in the sub-series of documents would only be circulated in electronic form on the 
Documents Online database.  This procedure also  responded to the feedback from users that the 
routine circulation of hard copies of texts of laws  and regulations did not, on the whole, facilitate 
access to these materials.  To the contrary, feedback  from users showed that, overwhelmingly, the first 
point of access was the on-line version of the documen t, not separate collections of hard copies.   IP/C/M/69 
Page 6  
 
  33. As regards notifications of contact points unde r Article 69 for the exchange of information 
and cooperation on trade in infringing goods, he said that, since the Council's meeting in October, 
updates to contact points notified earlier have b een received from Georgia and Ukraine.  The 
information on the Members' transparency t oolkit page had been updated accordingly. 
34. The representative of Paraguay said that, since th e entry into force of the TRIPS Agreement, 
Paraguay had made significant progress in the area of  IP protection, not only with regard to the 
updating of legislation, but in work relating to the implementation of the Agreement.  The following areas were those in which work had been carried  out, activities organized, and measures taken.   
35. In 2008, Paraguay had carried out a legi slative reform whereby, pursuant to 
Law No. 3.440/2008 amending various provisions of th e Criminal Code, the penalties for IP offences 
had been increased and custodial sentences of two to  eight years had been introduced.  The Office of 
the Public Prosecutor had also been reorganized into  units, with the creation of a specialized unit for 
IP offences ( Unidad Especializada de Delitos C ontra la Propiedad Intelectual ).  This Unit's specific 
function was to combat the copying or plagiarism  of copyright protected works.  The prosecution 
department employed four prosecutors.  In  July 2010, the Unit's operations manual ( Manual de 
Funciones ) had been approved.  This manual had help ed to optimize the functioning of the area 
concerned by ensuring the appropriate distribution of  tasks and proper coordination.  In addition, 
training and updating activities were continuously be ing organized for the prosecutors involved.  A 
prosecution department was also responsible for IP offences in Ciudad del Este, which was one of the 
most problematic areas in Paraguay.   
36. In 2011, the Supreme Court of Justice ruled, by means of Decision ( Acordada ) No. 676, that a 
criminal court for economic offences ( Juzgado Penal de Garantías en Delitos Económicos ), 
responsible for addressing issues relating to  economic crimes, would take charge of, inter alia , issues 
pertaining to the infringement of IPRs and in doing  so speed up legal proceedings relating to such 
matters.  The Supreme Court of Justice had also creat ed an Intellectual Property Directorate within the 
judiciary with a view to supporting th e work carried out in this area.   
37. With a view to preventing piracy and counterfeiting and protecting copyright 
(Decree No. 603/2003), special measures had been taken to create the Register for Importers of Magnetic and Optical Media and Raw Mate rials Used in the Production thereof ( Registro de 
Importadores de Soportes Magnéticos y Ópticos  y Materias Primas para su Producción ).  In this 
respect, natural or legal persons that imported audiovisual recorded materials, videograms, films, 
musical and audiovisual compact discs and software, or the raw materials used to manufacture these 
products, required prior authorization from the Ministry of Industry and Trade. 
38. In February 2010, the National Customs Direct orate had created a trademark registration 
department ( Sección de Registro de Marcas ) to facilitate the identification of IPR infringing goods 
and to raise further awareness of the IPRs regist ered with the Directorate-General of Industrial 
Property at the Ministry of Industry  and Trade.  To this end, officials working in this department 
received on-going training and were brought up to  date on procedures and techniques for identifying 
goods that infringe IPRs.   
39. The national police force now had a departme nt for economic and financial offences 
(Departamento de Delitos Económicos y Financieros ) which was responsible for issues relating to 
IPR protection within its remit.  A specialized technical unit ( Unidad Técnica Especializada  - UTE) 
was responsible for investigating and providing su pport in operations involving the seizure of goods 
related to alleged IPR offences.   
40. The system for exchanging data between institu tions involved in IP protection was currently 
undergoing a complete overhaul with a view to  establishing a data and statistics centre ( Centro de  IP/C/M/69 
 Page 7 
 
 
  Datos y Estadísticas ).  This centre would enable institutions , through their competent authority, to 
provide better information on procedures and seizures,  and ensure accurate and timely information on 
IP-related issues.  The Research and Data Ce ntre would also improve  coordination between 
institutions.   
41. The Directorate-General of Intellectual Property at the Ministry of Industry and Trade was 
also working on the creation of a National Intellectual Property Directorate.  The draft law 
establishing the National Intellectual Property Dir ectorate (DINAPI) had been submitted to the 
Chamber of Deputies in December 2011 and was cu rrently being examined by various committees 
within this legislative body.  The purpose of estab lishing this National Directorate was to strengthen 
the body responsible for the administration and prot ection of IPRs and to raise awareness of these 
rights at the national level.  In terms of infrastru cture, the Office of the Public Prosecutor had been 
modernized and the Directorate-General of Intellectual Property was undergoing reform. 
42. Another important aspect was the raising of awareness of legislation on trademark rights, 
copyright and patents through the publication of  a compendium of key laws and decrees on 
intellectual property ( Leyes y Decretos Esenciales en Materia de Propiedad Intelectual ).  This 
publication was distributed free of charge on a gene ral basis to universities and legal professionals.  
Talks were also being given in colleges and universities throughout Paraguay with a view to 
introducing the subject of IPRs to around 10,000 yo ung people.  An agreement had also been signed 
by the Directorate-General of Intellectual Property and the Ministry of Education and Culture (MEC), under which a subject entitled "Intellectual Property"  would be introduced into the school curriculum 
for final year students.   
43. Combatting piracy was important to Paraguay, as was preventative action.  The population 
was not fully aware of what IP was, which presente d the Government with a considerable task, given 
the poor economic status of the country.  Emph asis was being placed on the complex awareness-
raising process in an attempt to prevent IP o ffences from increasing and getting worse.   
44. Statistics had increased in recent years, in particular since 2005, which highlighted the 
considerable increase in the number of trademarks and patents registered nationally.  This implied that 
the private sector had understood how important the intangible assets acquired by registering trademarks and products were for companies.  Para guay, as a developing country, considered it very 
important to highlight the intensive efforts that it had been making to introduce changes and move 
forward as regards IP, and to emphasize its firm  commitment to continue making progress with its 
work in this area. 
45. The representative of Colombia said that, on 13 January 2012, Colombia had deposited its 
instrument of accession to the World Intellectua l Property Organization Trade Law Treaty and that 
this treaty would enter into force in Colombia on 13 April 2012.  A notification would be made to the 
attention of all Members. 
46. The Chairman thanked those Members who have  notified new and revised laws and thus 
contributed to the goal, set by the General Council,  of improving the timeliness and completeness of 
notifications across the Organization.  This was an  important practical reminder of the value of a 
comprehensive and up to date set of notifications .  He therefore urged those Members whose initial 
notifications of laws and regulations remained inco mplete to submit the outst anding material without 
delay.  He also reminded other Members of thei r obligation under the TRIPS Agreement to notify any 
subsequent amendments of their laws and regulations  without delay after their entry into force.  He 
especially encouraged Members to notify changes made  to their laws and/or regulations to implement 
the Decision on TRIPS and public health. 
47. The Council took note of the statements made. IP/C/M/69 
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  C. R
EVIEWS OF NATIONAL IMPLEMENTING LEGISLATION  
48. The Chairman said that, as regards the reviews of national implementing legislation that had 
been initiated at the Council's m eetings since April 2001, the reviews of three Members remained on 
the Council's agenda, namely those of C uba;  Fiji;  and Saint Kitts and Nevis. 
49. The representative of Cuba informed the Council of the recent enactment of 
Decree Laws Nos. 290, 291 and 292 relating to legi slation on inventions and industrial designs, the 
protection of plant varieties, and layout-designs of integrated circuits.  Once published, these 
Decree-Laws would be notified to the WTO.  By th e Council's next meeting in June, the Secretariat 
would also have received replies to the questions put forward by Members. 
50. The Chairman recalled that, at its meeting in October 2011, the Council had agreed to review 
the national implementing legislation of Maldives at its next meeting scheduled for 5-6 June, and set 
the following target dates for the submission of quest ions and answers:  questions should be submitted 
to Maldives, with a copy to the Secretariat, by 27 March at the latest;  and responses to questions 
posed within that deadline should be submitted by 8 May at the latest. 
51. The Council took note of the statements made. 
D. REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) 
E. RELATIONSHIP BETWEEN THE TRIPS  AGREEMENT AND THE RELATIONSHIP BETWEEN THE 
TRIPS  AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY  
F. PROTECTION OF TRADITIONAL KNOWLEDGE AND FOLKLORE  
52. The Chairman suggested that the Council conti nue to discuss the three agenda items together 
on the basis of contributions by Members as had been the practice at past meetings.  He recalled that, 
at its meeting in October 2011, the Council had re quested the Chair to continue consulting on the 
suggestion that the CBD Secretariat be invited to  brief the Council on the outcome of the Nagoya 
meeting.  He said that he would be ready to co ntinue his predecessor's consultations on that matter 
prior to the Council's meeting in June 2012.    
53. The representative of Indonesia said that, as a proponent of document TN/C/W/52, her 
delegation remained of the view that all Members sh ould take bold steps to address the issue so that 
the Council not only produced fruitful result but also contributed to substantive progress.  Given the fact that the protection of genetic resources, traditional knowledge and folklore was crucial for 
developing countries, she reiterated the urgency of enhancing disclosure requirements.  The 
implementation of the disclosure requirements woul d ensure the success of development, as the 
potential of genetic resources and associated tr aditional knowledge could become one of the key 
elements for economic welfare for people in deve loping countries, especially that of mega-diverse 
countries.  
54. As the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing 
of Benefits Arising from Their Utilization (Nag oya Protocol) had been adopted, she urged all 
Members, especially those who did not share her view, to seriously consider the importance of the issue and the matter at stake.  It would be in Members' best interest to articulate through the TRIPS Agreement the aim to afford sufficient level of pr otection to genetic resources and to provide a fair 
practice for their use.  
55. Referring to the 20
th session of the WIPO's Intergovernmental Committee on Intellectual 
Property and Genetic Resources, Traditional Knowle dge and Folklore (IGC), she said that her  IP/C/M/69 
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  delegation, together with the group of like-minde d countries, had successfully come up with a draft 
text on the protection of genetic resources.  That text was far from complete, since the negotiation on 
genetic resources, unlike that on traditional knowle dge and traditional cultural expression, was not 
text-based, being still considered merely on the basis of draft objectives and principles.  Against that 
background, she viewed the underlying importanc e of making a concrete connection between the 
discussions in the Council and in other forums, most  notably within WIPO, to be crucial.  She 
informed the Council that the Government of Indo nesia would host an international symposium on 
defensive protection of genetic resources and trad itional knowledge and folklore back-to-back with 
the meeting of the group of like-minded countries in Bali before the coming summer season. 
56. The representative of the Plurinational State of  Bolivia said that, in March 2011, Bolivia had 
submitted document IP/C/W/554, entitled "Article 27 .3(b) and the Legalization of Biopiracy:  Trends, 
Impacts and Why It Needs to be Amended", to c ontribute to the work programme of the Council and 
to continue the process of reviewing and amending on e of the most controversial articles of the TRIPS 
Agreement.  The document demonstrated how biopiracy  had surged since the adoption of that article, 
turning what had previously been a number of isol ated cases into a veritable race to patent genetic 
resources and their derivatives.  The field of biotech nology could not be treated in a same manner as 
other areas of human knowledge.  The patenting of lif e forms or parts thereof as genetic resources or 
their derivatives had serious implications for the liv elihoods, beliefs and values  of many populations 
and cultures in numerous parts of the world, and in  particular those of the indigenous peoples of 
Bolivia.  
57. The negative aspects of the TRIPS provision were not just limited to ethical questions.  As 
stated in document IP/C/W/554, there was an adver se impact on various sectors of human activity at 
the global level, including agriculture, health a nd food, owing to the conc entration of gene and 
technology patents in the hands of some ten multinational companies globally, which held a 
monopoly in that regard.  If that was what Member s were hoping to develop with the IP system, then 
they were heading for trouble.  For the above reasons , he reiterated the imperative need to review the 
aforementioned Article as proposed in documents  IP/C/W/554 of March 2011 and IP/C/W/545 of 
February 2010. 
58. The representative of Brazil supported the introduction of a mandatory disclosure of origin 
requirement in the TRIPS Agreement.  He said that this was an important step to make the IP system 
supportive of international provisions on that matte r, such as the CBD and the Nagoya Protocol.  A 
multilateral mandatory disclosure requirement would be the most efficient way to address the 
international problem of misappr opriation of genetic resources and traditional knowledge as it would 
allow tracking down the country providing genetic  resources and associated traditional knowledge 
through patent applications.  The disclosure requireme nt would demand patent a pplicants to reveal the 
country providing genetic resources and associated  traditional knowledge, as well as to provide 
evidence of compliance with the principles of prior informed consent and access and benefit sharing.  
Brazil supported the proposal to invite the CBD Secret ariat to make a briefing on the Nagoya Protocol 
in the Council.  
59. The representative of China said that, as patents were closely related to the utilization of 
genetic resources and/or associated traditional kno wledge, WTO Members should take appropriate 
and effective measures in patent applications to prevent misappropriation of genetic resources and to 
avoid erroneous patents.  The TRIPS Agreement, the CBD and the Nagoya Protocol should operate in 
a mutually supportive way.  In the view of some  Members, contractual arrangements and prior art 
requirements were enough to achieve the objectives of harmony and synergy between the CBD and 
the TRIPS Agreement, while many others believed th at the mandatory disclosure requirement of prior 
informed consent and benefit sharing in patent applications was indispensable to achieve those 
objectives.  In the view of China, contractua l arrangements and the novelty requirement in 
patentability were not enough for the protection of ge netic resources because contractual arrangement IP/C/M/69 
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  depended on voluntary behavior and fulfillment of pa rties to contracts, and the novelty requirement 
played a secondary role in preventing erroneously gr anted patents.  Databases and other information 
that patent examiners might have access to before  granting a patent were limited compared to the 
large quantity of genetic resources existing in the world.  As one genetic resource could generate 
several patents, it would not be enough to rely upon  patent examiners to prevent the use of genetic 
resources without prior informed consent and access and benefit-sharing requirements.  The 
responsibility to respect the sovereign right over ge netic resources should re ly upon legal or natural 
persons who accessed or used the genetic resour ces and associated traditional knowledge in the first 
place.  As one of the co-sponsors of documents TN/C/W/52 and TN/C/W/59, China believed the mandatory disclosure requirement would improve the transparency of utilization of genetic resources 
and/or associated traditional knowledge, and would help to achieve the goals.  The disclosure 
requirement was consistent with the transparency  principle established in the multilateral trading 
system.  It would not be burdensome for the patent a pplicant to fill in a form with the information of 
prior informed consent and access and benefit sharing as indicated in document TN/C/W/59, considering the legitimate objective it would achieve. 
60. She noted that the Eighth Ministerial Conf erence had agreed that "Ministers remain 
committed to work actively, in a transparent a nd inclusive manner, towards a successful multilateral 
conclusion of the Doha Developmen t Agenda in accordance with its mandate" and that "Ministers 
maintain that, in their negotiations, they will conti nue their work based on the progress already made".  
The issues of TRIPS-CBD and GI extension were  outstanding implementation-related issues in the 
Doha Round. Negotiations on those issues must be an  integral part of the Work Programme, and the 
outcome of the negotiations must be treated as part  of the Single Undertaking.  She hoped that the 
Director-General would continue his consulta tions based on a legal text, in pace with the 
arrangements for other Doha negotiations.  She suppor ted the proposal to invite the CBD Secretariat 
to make presentations in the Council from a perspective different from CBD members.  The 
presentation would help to improve Members' unde rstanding of the Nagoya Protocol, and contribute 
to the cooperation between WTO and ot her international organizations.  
61. The representative of Ecuador said that there were a number of reasons for preserving and 
protecting Ecuador's biological wealth and associat ed knowledge, one of them being the fact that 
Ecuador was one of the world's 12 mega-diverse countries.  Despite being the smallest of the 
12 countries, Ecuador was home to more species and pl ants than countries 30 times its size.  In short, 
Ecuador had the highest density of species diversit y in the world.  In addition to environmental 
aspects and the spiritual and cultural value of preserving biodiversity and associated elements, 
economic assessments carried out in Ecuador had estimated that in the west of the country, the value 
of a  square kilometer of land as a provider of poten tial new medicines could be US$9,177.  It would 
therefore seem, according to those studies, that that region was one of the most valuable for 
bio-prospecting in relation to 18 other world biodiv ersity hotspots.  Furthermore, recent scientific 
studies showed that more than 35 per cent of the ne w medicines marketed in the last 20 years derived 
from natural products. Such scientific studies had dete rmined, for example, that 74 per cent of the 
135 species of microscopic fungi and bacteria living in the plants and tropical forests of the Amazon region shared by Ecuador and Peru were bioactive,  i.e. of potential use to human beings.  For 
example, fifteen years ago a new alkaloid called ep ibatidine had been extracted from the skin of tiny 
poisonous frogs (species Epipedobates ) living in the tropical forests of Ecuador.  That molecule was 
found to have painkilling properti es 200 times more effective than morphine, despite being far less 
addictive.  The same studies showed that more th an 100 traces of alkaloids had been detected in frog 
skin extracts, the utility of whic h remained to be established. 
62. All of those aspects made it clear why develo ping countries were so keen to promote 
sustainability and legitimate access to biodiversity and associated traditional knowledge by ensuring 
adequate protection at multilateral level in the field of  IP.  In that context, it was essential to bear in 
mind document TN/C/W/59 of 19 April 2011, which contained the minimum legal elements to be  IP/C/M/69 
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  incorporated into the TRIPS Agreement.  It woul d ensure legal protection for legitimate and fair 
access to biodiversity resources and associated traditi onal knowledge, i.e. (i) di sclosure of the source 
and country of origin in accordance with the CBD;  (ii) presentation of a copy of an internationally 
recognized certificate of compliance of prior informed  consent and fair and equitable benefit sharing, 
or, where that was not applicable in the provi ding country, provision of relevant information 
regarding compliance with prior informed consent and fair and equitable benefit sharing;  (iii) 
adoption of appropriate, effective and proportionate measures so as to permit effective action against 
non-compliance with the obligations set out in poi nts (i) and (ii);  (iv) non-processing of patent 
applications that did not comply with the discl osure obligations listed above;  (v) adoption of 
measures establishing administrative sanctions, crim inal sanctions, fines and adequate compensation 
for damages in cases where non-compliance with points (i) and (ii) was discovered after the approval 
of a patent application;  and (vi) adoption of me asures which made it possible to determine other types 
of sanctions, including revocation of the patent  due to non-compliance with points (i) and (ii). 
63. In conclusion, he emphasized that while progress had been made in other multilateral 
negotiating forums, e.g. the Nagoya Protocol and the recently concluded 20th session of the IGC, 
which had resulted in the drafting of a document c ontaining legal texts on that subject, part of the 
multilateral work was the contribution that WTO Members could make to ensuring adequate 
protection. It was therefore important for the Council to make progress in that respect. 
64. The representative of Peru supported the statemen ts made by Indonesia, Brazil and China on 
the three agenda items and the propo sal to invite the CBD Secretariat.  The international IP system as 
established in the TRIPS Agreement needed to be impr oved so as to ensure a fair and balanced regime 
for the protection of folklore and traditional knowle dge and to avoid misappropriation and biopiracy.  
Since 2003, Peru, together with other WTO Member s, had submitted 11 relevant working documents 
in the Council.  Peru had also submitted four documents, which analyzed biopiracy cases and 
provided legal and practical arguments on the need for disclosure requirements in the patent system.  
The IP system could be adapted to the provisions  of the CBD and the Nagoya Protocol through the 
amendment of the TRIPS Agreement.  The disclos ure requirements made it possible to identify the 
country of origin and to ensure that prior informed consent and benefit sharing were respected.  In that 
context, a large number of WTO Members had su bmitted document TN/C/W/59, which proposed to 
include Article 29 bis into the TRIPS Agreement with a view to establishing disclosure requirements.  
The proposal would not hamper the access to or use of genetic resources, but would protect genetic resources against biopiracy and ensuring their sustai nable use.  Unfortunately, the proposal had not 
been examined and discussed in the context of the Doha Round.  He said that a successful conclusion 
of the negotiations in the WTO should include results in that area, and the interests of the developing 
countries should be reflected in the outcomes, in pa rticular when it came to the protection of genetic 
resources, folklore and traditional knowledge.  Only  a solution that dea lt with the problem of 
biopiracy would enable Members to establish a proper balance in the patent system and the IP system 
in general for the benefit of all, particularly the indigenous peoples of the developing countries. 
65. The representative of the Bolivarian Republic of  Venezuela supported Bolivia's proposal to 
review Article 27.3(b) of the TRIPS Agreement. Do mestic legislation, especially Articles 124 and 127 
of the Constitution of the Bolivarian Republic of Ve nezuela banned the registration of patents on all 
life forms.  Review of Article 27.3(b), as provided fo r in the last sentence of Article 27.3(b) and as 
required by the Ministerial Conference, was part of  the Doha mandate. Under Article 27.3(b), it was 
possible for Members to exclude from patentability pl ants and animals other than micro-organisms, 
and essentially biological process for the production of  plants or animals other than non-biological 
and microbiological processes, which was against Ve nezuela's Constitution, and contradicted the 
principles related to food safety, values of the co untry, and the protection of indigenous peoples' 
knowledge and folklore, genetic resources and ancestral knowledge.  Therefore, it was time for 
Members to modify or clarify Article 27.3(b).  In  addition to the constitutio nal and legal concerns 
over the patenting of life forms, there was also an ethical concern.  While highlighting the sovereignty IP/C/M/69 
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  of the State and indigenous peoples over their biologi cal resources, he said that the authority to 
determine the access to the genetic resources la y with national governments and was subject to 
national legislation.  In other words, genetic resources and traditional kn owledge should not come 
within the IP framework as it was agai nst the sovereignty of Venezuela.  
66. The representative of New Zealand said that her country had a high degree of endemic flora 
and fauna, and therefore her delegation had a strong interest in preventing the misappropriation of its 
genetic resources and associated traditional knowledg e.  As a party to the CBD, New Zealand was 
committed to the effective implementation of its th ree objectives, including the third objective related 
to the fair and equitable sharing of benefits aris ing from the utilization of genetic resources.  New 
Zealand also had a systemic interest in the stability  of the patent system.  Measures which prevented 
the granting of erroneous patents were critical to ma intaining the integrity of that system.  There was 
widespread agreement amongst Members over the n eed to prevent the misappropriation of genetic 
resources and associated traditional knowledge.  Th ere was, however, still much disagreement over 
the appropriate policy responses that would best achieve that objective.  
67. New Zealand's domestic policy was still evol ving in the area, but it was committed to 
engaging constructively in relevant  international forums to address it.  The IGC was undertaking a 
detailed consideration of the rela tionship between IP and genetic resources, as well as traditional 
knowledge and traditional cultural expressions.  The IGC was currently working on the text of an 
international instrument or instruments on the prot ection of the three subject matters.  New Zealand 
considered that the IGC was an appropriate foru m to discuss in detail the IP issues relating to 
traditional knowledge and genetic re sources because it was able to l ook at those issues in a holistic 
and coordinated way.  New Zealand was active and constructive in the IGC and was committed to the 
fulfillment of the IGC mandate.  She noted that th e IGC had met in February 2012 with the focus on 
genetic resources issues and had agreed to a single draft text.  While the draft text contained a number of divergent policy objectives and policy options , it was nonetheless a positive step forward.   
68. The representative of Turkey said that, due to its geographical location and climate, Turkey 
had rich animal and plant biodiversity.  As a c ountry having a high degree of unique endemic flora, 
Turkey had an interest in preserving its genetic resources, preventing the misappropriation of genetic 
resources and associated traditional knowledge, and pr eventing the grant of erroneous patents.  She 
welcomed the progress made in the IGC, particular ly the recent consolidated legal text on IP and 
genetic resources.  She supported the introduction of a mandatory disclosure requirement, and was 
open to the introduction of the principles of prior in formed consent, and access and benefit sharing.  
69. The representative of Korea said that the review of Article 27.3(b) should be of a procedural 
nature and should not lead to a revision of the TRI PS Agreement.  He did not subscribe to the idea of 
prohibiting the patenting of all life forms.  Instead, he  said that inventions in all fields of technology, 
including biotechnology, deserved to be incentivized through adequate patent protection.  Given the 
huge potential benefits of biotechnology to all hum ankind, research and development in that field 
should be encouraged.  His delegation did not su pport the proposal of introduction of a mandatory 
disclosure requirement, which would create legal uncertainties and would be too burdensome for 
patent applicants as well as for patent authorities.  Further, it would not seem feasible to reach consensus among Members on a manageable definition of source and country of origin.  Given the 
substantive progress made in the IGC, he said that the IGC was the right forum for further 
discussions.  In addition, he was not convinced th at the issues of TRIPS-CBD and GI should be 
discussed in parallel, as they were completely unrelat ed to each other and shou ld not be linked in any 
form in the discussion. 
70. The representative of India said that the issue of incorporating the CBD provisions into the 
framework of the TRIPS Agreement demanded mu ch greater involvement of WTO Members, 
especially after the signing of the Nagoya Protocol by 193 countries.  The first Conference of Parties  IP/C/M/69 
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  in the UN Decade on Biodiversity to be hosted by India in October 2012 would be the first milestone 
to assess the progress in the implementation of the Nagoya Protocol, and the work in the Council 
could significantly contribute to its success.  The disclosure of origin had been successfully 
implemented in India and in many  developing countries.  It was indeed a workable solution which 
motivated developing countries to make submissions to the Council in order to have an international 
architecture that could protect their interests.  The latest proposal contained in document TN/C/W/59 
submitted in April 2011 was a major step forward from the proposal contained in document TN/C/W/52 and it incorporated the provisions of the Nagoya Protocol.  The proposal was compatible with the TRIPS Agreement and did not  diminish the rights of the patent holder as 
provided for in the TRIPS Agreement.   
71. He said that the Indian Patent Law had inco rporated the disclosure requirements within 
Section 10 specifying clear and complete disclosur e requirements.  While Section 10(4)(a) embodied 
the enablement and written description requirements, Section 10(4)(b) provided for the disclosure of 
the best mode of performing the invention.  Furthe r Section 25 of India's Pa tent Law provided for pre-
grant and post-grant opposition that helped in avoida nce or revocation of erroneous patents for failure 
of the patent applicant to meet the disclosure requirements.  The prior approval of the National 
Biodiversity Authority was require d for any invention based on r esearch/information on biological 
resources.  In addition, India' s Traditional Knowledge Digital Library (TKDL) was an important 
contribution to prevent misappropriation of traditio nal knowledge at international patent offices.  
Today, the TKDL was capable of protecting about 2. 5 lakh medicinal formulations similar to those of 
neem and turmeric.  Access to the TKDL had been gi ven to eight internationa l patent offices as of 
now.  
72. Challenging patents at international patent offices was a long drawn process and was very 
expensive.  For example, Mexico had been able to get the patent on enola bean  at the United States 
Patent and Trademark Office cancelled in July 2009 after more than 10 years of legal battle.  
Similarly, the Monsanto soybean patent was cance lled at the European Patent Office in July 2007 
after 13 years of legal battle.  India's limited initiativ e in the form of the TKDL could only prevent 
erroneous patents in the limited field of traditional Indian medicine.  The TKDL enabled the cancellation/withdrawal of wrong patent  applications at zero cost and in a time period of a few weeks. 
In sharp contrast, in the absence of the TKDL, it had taken 10 years (1995-2005) to get neem patent 
invalidated for antifungal properties at the European  Patent Office. The TKDL's impact on biopiracy 
was already visible.  The references to TKDL as prior art had led to significant outcomes towards 
achieving the goal of preventing misappropriation of  Indian traditional knowledge.  Beginning in 
July 2009, the TKDL team had submitted 571 prior art references, resulting so far in 88 patent 
applications of the pharmaceutical companies of the United States, the United Kingdom, Japan, Spain, 
Italy, China, etc. being set aside or withdrawn/ca ncelled or declared as dead patent applications.  
According to a recent study, there had been a sharp fall (44%) in patent appli cations filed at the EPO 
concerning Indian systems of medicines.  While th e disclosure obligation ensured that the applicant 
had provided accurate and adequate information on  the source of the traditional knowledge, the 
TKDL enabled in identifying prior art and to as certain the novelty in the claims.  With the 
development of databases similar to the TKDL by other developing countries and their extensive use 
by the international patent offices, it was possible to avoid grant of erroneous patents in future in areas 
where the databases had been developed.  Hen ce incorporating the disclosure provision was an 
appropriate measure that would bring in uniformity  in the practice of patent offices in using such 
databases and coherence in ascertaining the validity of  patent claims involvi ng traditional knowledge 
and/or associated genetic resources. 
73. 
In conclusion, he reiterated that the TR IPS-CBD issue was one of the outstanding 
implementation issues and the Council should take a serious note of the compliance issues under the 
Nagoya Protocol to deal with internalizing the re lationship between access a nd benefit sharing and IP 
protection to become an important deliverable of the Round for developing countries.  Exhaustive IP/C/M/69 
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  discussions alone on the TRIPS-CBD issue over the l ast ten years were not enough if Members sought 
a positive outcome on the issue.  Members needed c onstructive engagement in the Council, which was 
sadly missing on part of some developed country Memb ers.  He noted with considerable concern that 
some Members could not agree to a presentation by the CBD Secretariat on the Nagoya Protocol in spite of the fact that 193 countries had already adopt ed the Nagoya Protocol.  It was unfortunate that 
the same Members who opposed a presentation by th e CBD Secretariat in the WTO had no problems 
with the CBD being present in the WIPO or WHO.   
74. The representative of Cuba endorsed the arguments  put forward by Bolivia and the statements 
made by Ecuador and Venezuela on critical aspects of implementation.  She reiterated Cuba's long 
held position on the need to amend Article 29 of th e TRIPS Agreement so that Members had the right 
to request patent applicants to disclose the sour ce and country of origin of inventions based on 
biological materials and to provide evidence of pr ior informed consent and benefit sharing among the 
parties receiving the consent to investigate and e xploit genetic resources, as well as the publication of 
applications relating to biological material. 
75. The representative of Colombia supported the st atements made by some other co-sponsors of 
document TN/C/W/52.  She said that the IP syst em was a mechanism for promoting innovation and 
investment. Patents should not have negative impact s on the protection of genetic resources and their 
derivatives.  Not only the inventor but also the States providing the resources should receive the 
benefits arising from the use of the genetic r esource.  Members needed implementing tools for 
monitoring compliance with the provisions on access and benefit sharing.  She supported the proposal 
to invite the CBD Secretariat to present the Nagoya Protocol to the Council.  
76. The representative of Chile said that the three main requirements for patentability established 
under Article 27.1 of the TRIPS Agreement, i.e. no velty, inventive step and industrial applicability 
should be fully implemented by IP offices and, were that to happen, there should be no contradiction 
or conflict with the appropriation of naturally o ccurring life forms.  It was vital for national and 
regional patent offices to have access to all the info rmation available so as to avoid granting erroneous 
patents.  Databases could be of great use in th at regard.  As Chile had endemic unique genetic 
resources, it was looking into the development of a system that would regulate those resources in compliance with its international commitments.  In th at context, Chile was analyzing the benefits of 
the disclosure requirement.  He welcomed the work be ing carried out on that issue in other forums, in 
particular the IGC, and hoped an increase in the nu mber of the meetings of the IGC in 2012 would 
allow for major progress in that regard. 
77. The representative of South Africa said that ther e were three fundamental conflicts between 
the TRIPS Agreement and the CBD according to thei r respective spirit and the objectives.  Firstly, 
Article 3 of the CBD provided that states had sovere ign rights over their biological resources while 
the TRIPS Agreement overlooked states' soverei gnty but recognized private IPRs over those 
resources.  Secondly, the CBD provided states with an  opportunity to demand sharing of the benefits 
arising from commercial use of biological resource s while the TRIPS Agreement negated that legal 
authority.  Thirdly, the CBD was aimed at reducin g biopiracy by requiring prior informed consent 
whereas the TRIPS Agreement did not contain su ch a requirement, which meant that patent 
applications could be submitted over biological resources or knowledge of certain local communities 
in any other countries.  The TRIPS Agreement recognized patent rights on the basis of novelty which did not take into account traditiona l knowledge and cultural practices.  There was a need to avoid 
erroneous grant of patents for inventions that in volved the use of genetic resources and related 
traditional knowledge.  There was also a need to  secure compliance with national access and benefit-
sharing regimes in the relevant Member's jurisdiction.   It was clear that the application of the TRIPS 
Agreement might threaten the preservation of biological resources and traditional knowledge.   IP/C/M/69 
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  78. The three conflicts were what Article 16.5 of th e CBD advised against, which read that IPRs 
must not be in conflict with sustainable use of biodiversity.  What could aid in reconciling the two agreements was a proper legal review of both agreem ents with the aim of making amendments where 
necessary to ensure mutually supportive application.   Under the review of Article 27.3(b) of the 
TRIPS Agreement, amendments c ould be made to incorporate the CBD objectives into the TRIPS 
Agreements in order to preserve biodiversity, pr event biopiracy and include protection of local 
community rights in accordance with th e spirits and purport of the CBD. 
79. The representative of Japan stressed the importance of considering the problem of 
misappropriation of genetic resources by dividing it into two aspects: erroneously granted patents and 
CBD compliance.  An appropriate solution should be  considered in each case, bearing in mind that 
such solutions should accomplish each objective in a manner that would not have an adverse effect on 
the IP system.  Japan had proposed the establishmen t of one-click databases to prevent erroneously 
granted patents.  His delegation attached a great deal of importance to the Nagoya Protocol and 
expected that Members' efforts to implement it would have international effects.  With regard to the 
Bolivian proposal, he reiterated that the patent sy stem provided a critical incentive for technological 
development in all the fields, including biotechnolog y, which was crucial for the world at large.  
80. The representative of Australia said that, as a mega-diverse country with a unique indigenous 
culture, his delegation had a strong interest in a balance between holders  and users of genetic 
resources and associated traditional knowledge.  Australia had signed the Nagoya Protocol on 
20 January 2012, and was currently  undertaking internal processes to consider its ratification.  
Australia had already implemented an access and be nefit-sharing system in relation to genetic 
resources and associated traditional knowledge, consis tent with its obligations under the CBD.  His 
delegation considered that the TRIPS Agreement and the CBD were consistent and could be and were 
implemented in a mutually supportive manner, but was willing to consider appropriate solutions to 
address misappropriation of genetic r esources and erroneously granted pa tents.  Australia had strong 
interest in the issue and welcomed the significant progress made at the 20th session of the IGC, which 
had focused on IP and genetic resources and had de veloped a single negotiating text in accordance 
with its mandate.  Australia would continue its ac tive and constructive engagement in the IGC, which 
was best placed to consider that complex IP issue.  
81. The representative of Nigeria said that the TRIPS Agreement and the CBD should be 
implemented in a mutually supportive and consis tent manner.  Members should require patent 
applicants to disclose the source of the biological material that constituted input in an invention and 
the evidence of benefit sharing through their do mestic laws.  There was an emerging consensus 
among Members that the amendment of the TRIPS Ag reement would ensure prior informed consent 
and sharing of the benefits arising from the use of the genetic resources and associated traditional 
knowledge and therefore avoid erroneously grante d patents.  The amendment would fulfill the 
objectives and principles provided in Articles 7 and 8 of the TRIPS Agreement, thereby establishing 
an adequate and effective coor dination between the TRIPS Agreement and the CBD.  The proposal 
contained in document TN/C/W/59 would enhance international action to ensure the mutual 
supportiveness between the TRIPS Agreement and the CBD.  It would also help to avoid potential conflict in the application and practice of the two agreements.  The African Group wished the 
Director-General to resume his consultations on that  issue in line with paragraph 39 of the Hong Kong 
Ministerial Declaration. 
82. The representative of Canada said that his delegation could not agree to negotiate an 
amendment to the TRIPS Agreement to establish st ronger protection for genetic resources and/or 
associated traditional knowledge, including imposing a mandatory disclosure requirement for patent 
applications involving genetic resources and/or  associated traditional knowledge.  Canada was 
committed to work to secure compliance with legi slative and regulatory ob ligations under national 
access and benefit-sharing policies for obtaining prior informed consent and negotiating mutually IP/C/M/69 
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  agreed terms for access to gene tic resources, as well as traditional knowledge associated with genetic 
resources.  Canada was also committed to work to a void the grant of erroneous patents and to ensure 
that patent offices have at their disposal the appr opriate information required to make proper decisions 
on patent grant.  She encouraged Members to cons ider other non-patent-based mechanisms to protect 
biodiversity and prevent misappropr iation of genetic resources, su ch as developing broader, more 
globally accessible and functional prior art databases, e. g. India's TKDL, using mutually agreed terms 
in material transfer agreements, licensing, c odes of conduct and contracts between users and 
providers.  She said that the TRIPS Agreement and the CBD were mutually supportive and therefore there was no need to amend the TRIPS Agreement. 
83. Canada continued to believe th at WIPO remained the best forum for technical discussions of 
IP-related aspects of the protection of genetic res ources, traditional knowledge and traditional cultural 
expressions.  The IGC had been given a clear, rene wed mandate to undertake text-based negotiations 
to reach an agreement on the text of one or more international instruments to ensure the effective 
protection of genetic resources, traditional knowledge  and traditional cultural expressions.  At the 20
th 
session of the IGC, participants had prepared a cons olidated document dedicated to genetic resources. 
Canada welcomed the progress made, notably that - in the spirit of the renewed mandate that called 
for accelerated work - members had a consolidated a nd structured text on genetic resources that was 
similar to the texts on traditional knowledge and traditional cultural expressions.  While that text 
represented work in progress and was without prejudi ce to the positions of the participants, she was 
confident that the consolidated text would prov ide a sound basis for future work.  Canada looked 
forward to participating in future IGC sessions. 
84. She said that the review of Article 27.3(b) was meant to focus on Members' implementation 
issues rather than on revising the content of that  article.  Flexibility should be maintained in 
Article 27.3(b) to allow Members to im plement it domestically as appropriate. 
85. The representative of Chinese Taipei said that th e flexibilities provided for in Article 27.3(b) 
allowed Members to implement rele vant domestic provisions appropria tely and to take into account 
their own needs and interests.  Me mbers were able to take advantag e of those flexibilities to suit their 
particular unique domestic conditions.  The review of  Article 27.3(b) should not lead to any lowering 
of the level of patent protection for biotechnological  inventions.  She said that the TRIPS-CBD issue 
concerned a number of different stakeholders.  On-going discussions and consultations should take 
those interests into consideration.  The attempt to  make a linkage between three TRIPS issues and to 
include them as part of the Single Undertaking was not helpful.  Each issue should be discussed on its 
own merits. 
86. The representative of Switzerland took note of the substantive and constructive discussion on 
IP and genetic resources in the IGC and said that  the work in the WTO was of a complementary 
nature.  Switzerland had submitted several proposal s concerning the Patent Cooperation Treaty and 
Patent Law Treaty in the WIPO.  Switzerland ha d also co-sponsored document TN/C/W/52 in the 
WTO, in which a large coalition representing more  than two thirds of WTO membership had 
proposed modality wording for three outstanding im plementation issues:  the issues of TRIPS-CBD, 
GI extension and GI register.  Switzerland associated itself with the statement by China on the need to 
continue the work on those three i ssues in the course of 2012.  Switzerland was of the opinion that a 
non-burdensome disclosure requirement in patent applications relating to the source of genetic 
resources or traditional knowledge on which the inve ntion was directly based could contribute to 
enhancing transparency in access and benefit-shari ng regimes and could enha nce legal certainty and 
patent examination standards.  Genetic resources were particularly relevant in the context of 
biotechnological inventions.  A disclosure requirement in the TRIPS Agreement could help to promote the understanding of the importance a nd benefit of biotechnology for mankind and the 
understanding of the role of patents in the fields  of public health or food security.  Switzerland was 
convinced of the importance of patents as a tool  to incentivize and disseminate innovation, and  IP/C/M/69 
 Page 17 
 
 
  therefore patents should be available and enjoyable in  the field of biotechnology.  Article 27.3(b) of 
the TRIPS Agreement provided sufficient flexibiliti es, which allowed Members to take into account 
their specific needs. 
87. The representative of the United States said that , as referred to by other Members, the IGC 
had held its 20th session in early February.  As evidence of its constructive engagement at that session, 
the United States, together with Canada, Japan, Ko rea, and Norway, had made a proposal for a Joint 
Recommendation on Genetic Resources and A ssociated Traditional Knowledge (Joint 
Recommendation).  Providing a few highlights of the Joint Recommendation, which incorporated Members' shared interest in addressing erroneously  granted patents, he said that the objectives and 
principles of the Joint Recommendation were that "Member States, in protecting genetic resources 
and traditional knowledge associated with genetic res ources, should aim to:  (a) prevent patents from 
being granted erroneously for inventions that ar e not novel or inventive with regard to genetic 
resources and traditional knowledge ass ociated with genetic resources;  (b) protect indigenous peoples 
and local communities from the limitations of the traditional use of genetic resources and their traditional knowledge associated with genetic resour ces that might result from the erroneous patenting 
thereof;  (c) ensure that patent offices have the appropriate available information on genetic resources 
and traditional knowledge associated with genetic r esources needed to make informed decisions in 
granting patents;  and (d) maintain the incentiv es for innovation provided by the patent system." 
88. He highlighted a number of important developm ents in the IGC, including the development of 
improved search tools and classification systems for patent examiners who examined patent applications, including applications that claimed genetic resources;  the creation of a database of 
illustrative examples of mutually agreed terms c oncerning access and benefit sharing, which served as 
a capacity-building tool, and helped to inform the policy debate;  and the drafting of guidelines on the 
IP aspects of equitable benefit-sharing arrangements.  
89. In addition, mindful of the concerns being addressed at the IGC, the WIPO Patent 
Cooperation Treaty Working Group had establishe d additional tools to improve the quality 
information available to patent examiners.  Tho se tools included a supplemental international search 
mechanism and a mechanism for third parties to submit prior art to be considered during the 
international search and preliminary examination.  The US Patent and Trademark Office had a similar 
mechanism in place.   
90. Furthermore, the International Authorities under the Patent Cooperation Treaty had decided to 
expand the list of periodicals that were part of  the PCT Minimum Documentation by adding the 
Korean Journal of Traditional Knowledge, the Indi an Journal of Traditiona l Knowledge, and other 
periodicals.  The PCT Minimum Documentation was th e patent publications a nd non-patent literature 
that a patent examiner should search in conducting a search or preliminary examination of a PCT application.  National authorities had created add itional tools, such as patent prosecution highways 
and databases of information related to genetic  resources and associated traditional knowledge.   
91. He said that although the IGC had not yet finished its work, it had made significant 
contributions to addressing Members' shared con cerns.  He hoped that WIPO would adopt the Joint 
Recommendation and thereby demonstrate to the in ternational community Members' commitment to 
prevent patents from being erroneously granted, in cluding by creating and usi ng relevant databases, 
and by encouraging compliance with relevant access  and benefit-sharing and prior informed consent 
laws and regulations.   
92. The representative of Egypt recalled the mandate given by Ministers to the Council, which 
had instructed the Council, in pursuing its work programme including under the review of 
Article 27.3(b), to examine, inter alia , the relationship between the TRIPS Agreement and the CBD, 
the protection of traditional knowledge and folklore .  The Council was therefore the best place to IP/C/M/69 
Page 18  
 
  conduct that work.  He said that the disclosure requirement had been implemented by several 
developing and developed countries, where it worked very well in terms of contributing to innovation 
and not creating a burden on stakeholders.  As high lighted by Switzerland, it was important to ensure 
legal certainty, confidence and credibility of the pa tent system. Regarding the IGC, he said that as 
long as databases did not lose the confidentiality, it c ould be supportive to the objective of avoidance 
of erroneous patents.  He endorsed the request ma de by China and the African Group to invite the 
Director-General to continue his consultations  on the TRIPS-CBD issue to ensure the mutual 
supportiveness between the TRIPS Agreement, the CBD and the Nagoya Protocol.   
93. The Chairman suggested that the Council request  the Chair to continue consulting on the 
suggestion that the CBD Secretariat be invited to  brief the Council on the outcome of the Nagoya 
meeting.  
94. The Council took note of the statements made under those three agenda items and so agreed.   
G. NON-VIOLATION AND SITUATION COMPLAINTS  
95. The Chairman recalled that, at its meeting on  17 November 2011, the Council had agreed to 
recommend that the Eighth Session of the Ministeria l Conference to be held in December 2011 extend 
the moratorium on TRIPS non-violation and situation complaints.  Pursuant to that recommendation, 
Ministers had directed the Council to continue its examination of the scope and modalities for 
complaints of the types provided for under subpara graphs 1(b) and 1(c) of Article XXIII of GATT 
1994 and to make recommendations to their next Sessi on, which they had decided to hold in 2013.  It 
was agreed that, in the meanti me, Members would not initiate such complaints under the TRIPS 
Agreement.  The Decision of the Eighth Session of th e Ministerial Conference had been circulated in 
document WT/L/842. 
96. The representative of Venezuela said that, in  his view, it was not possible to apply 
subparagraphs 1(b) and 1(c) of  Article XXIII of GATT 1994 without the agreement of all Members 
established under Article 64(3) of the TRIPS Agreement.   No such consensus had been reached in the 
Council.  The lack of possible cases presented for the Council's assessment was clear proof that IP 
could not be dealt with as a good.  The reasons for this were clearly set out in document IP/C/W/385 
co-sponsored by Venezuela.   
97. The representative of Cuba said that non-violati on and situation complaints, as provided for in 
subparagraphs 1(b) and 1(c) of  Article XXIII of the GATT 1994, were not applicable as grounds for 
dispute settlement within the framework of th e TRIPS Agreement.  All of the Agreement's 
flexibilities would be undermined if non-violation and situation complain ts were to be applied to it, 
since countries could be exposed to complaints with out having violated the Agreement in any way.  
An automatic extension of the doctrine and GATT concepts to the scope of the TRIPS Agreement 
would bring about legal uncertainty rather than providing security and predictability within the 
system. 
98. The representative of Nigeria, speaking on behalf of the African Group, believed that 
non-violation complaints were inapplicable under the TRIPS Agreement.  He recalled that the Council 
Chair had considered four options in May 2003 for a possible recommendation, namely (i) banning 
non-violation complaints in the TRIPS Agreement co mpletely;  (ii) allowing the complaints to be 
handled under the WTO's dispute settlement sy stem as applied to goods and services cases;  
(iii) allowing non-violation complaints but subject  to special modalities;  and (iv) extending the 
moratorium.  In response, most Members had favour ed banning non-violation complaints completely 
or extending the moratorium.  To date, no con sensus had been reached, but the moratorium had 
fortunately been extended until the next Minister ial Conference in 2013.  To avoid any legal 
uncertainty, the African Group therefore urged remain ing Members to join the consensus that would  IP/C/M/69 
 Page 19 
 
 
  allow the Council to recommend banning non-violati on complaints under the TRIPS Agreement.  He 
requested the Chair to continue consultations with  a view to exploring how to resolve the issue. 
99. The representative of Ecuador supported the statem ents by Nigeria, Cuba and Venezuela, and 
reiterated Ecuador's view that non-violation and situation compla ints did not fall under the TRIPS 
Agreement.  The specific arguments cont ained in document IP/C/W/385 of October 2002 
co-sponsored by Ecuador continued to be prev alent and remained unchanged.  Even though the 
moratorium had again been extended, he believed th at it was necessary to make a final decision that 
there was no legal basis for such comp laints under the TRIPS Agreement.  
100. The representative of Peru associated himself with  the previous statements.  In 2002, Peru had 
co-sponsored document IP/C/W/385, together with  14 other Members, outlining its position on the 
issue of non-violation and situation complaints.  As  set out in that document, Peru believed that 
non-violation complaints were unnecessary to prot ect the rights and obligations stemming from the 
TRIPS Agreement, because they were reflected in  the main obligations and flexibilities of the 
Agreement.  Furthermore, the Agreement explicitl y provided that Members were not compelled to 
apply broader protection.  He, th erefore, believed that that non-vi olation and situation complaints 
were inapplicable to the TRIPS Agreement. 
101. The representative of China welcomed the Mi nisterial Conference decision to extend the 
moratorium.  The TRIPS Agreement differed from GA TT 1994 both in nature and in structure.  The 
application of non-violation and situation co mplaints under the TRIPS Agreement would be 
inappropriate and problematic.  It  would cause fundamental concerns and might also limit the use of 
flexibilities under the Agreement.  
102. The representative of Brazil welcomed the exte nsion by the Eighth Ministerial Conference of 
the moratorium for further two years.  He consid ered that non-violation and situation complaints 
should be determined inapplicable to the pr ovisions of the TRIPS Agreement.  The TRIPS 
Agreement, unlike other WTO Agreements, was a sui generis  agreement.  It was not designed to 
protect market access or the balance of tariff con cessions, but rather to establish minimum standards 
of IP protection.  One of the consequences of the application of non-violation and situation complaints 
could be that developing countries might be prevented from successfully using the flexibilities 
contained in the Agreement, including those re lated to the protection of public health.   
103. The extension of the non-violation remedy to the TRIPS Agreement might also entail 
consequences for the predictability  and security of the multilateral tr ading system.  He believed that 
the definition of Members' rights and obligations, ba sed on the text of the Agreement, would become 
more difficult, leading to impacts on important public policies in the areas of public health, 
biodiversity protection and transfer of technology. 
104. The representative of the United States said that it was entirely appropriate for non-violation 
and situation complaints to be applicable to the TRIPS Agreement and, further, that the moratorium 
should expire at the next Ministerial conferen ce.  He supported Nigeria's proposal for further 
consultations the issue. 
105. The representative of India supported the statements by Brazil, China and other Members.  
Non-violation complaints had no place under the TRIPS Agreement as it would undermine the 
flexibilities provided by the Agreement.  
106. The representative of Colombia said that th e introduction of non-violation and situation 
complaints in the TRIPS Agreement was unnecessar y and incompatible with the interests of 
Members.  That belief was consistent with the pos itions already expressed by the various co-sponsors 
of document IP/C/W/385.  Any advantage stemming from the Agreement could appropriately be IP/C/M/69 
Page 20  
 
  protected by applying the text of the Agreement in line with the principles of international law 
without introducing the uncertain notion of non- violation and other situation complaints.  
Non-violation complaints should therefore be dete rmined inapplicable under the TRIPS Agreement. 
107. The representative of the European Union said that non-violation and situation complaints 
were inapplicable under the TRIPS Agreement.  Since the moratorium had been extended until the 
end of 2013, the Council had almost another two year s to reflect on the matter.  His delegation was 
open to having a debate and to lis tening to arguments by others that might come forward with 
convincing reasons and good examples on why non-viola tion complaints should be applicable to the 
TRIPS Agreement. 
108. The representative of Switzerland said that, for reasons of consistency both from a systemic 
and legal point of view, he considered that non viol ation and situation complain ts were applicable to 
the TRIPS Agreement, like to the two other pilla rs under the WTO Agreements.  The fact that a 
moratorium had been agreed in the Uruguay Roun d for the purpose of examining the desirability of 
additional modalities for the application of such comp laints in the TRIPS context spoke in favour of 
the principle that such complaints were actually applicable in the TR IPS context.  He believed that the 
Dispute Settlement Understanding provided suffi cient guidance.  Switzerland had joined the 
consensus at the last Ministerial Conference to extend the moratorium once more in order to give those Members who believed that additional modaliti es in the TRIPS context were necessary the time 
and room to have a discussion and to come forward with proposals. 
109. The representative of the Plurinational State of  Bolivia considered that non-violation and 
situation complaints were inapp licable in the TRIPS context. 
110. The Chairman suggested that he consult on how the Council should organize its continued 
examination of the scope and modalities for non-violation and situation complaints. 
111. The Council so agreed. 
H. REVIEW OF THE IMPLEMENTATION OF THE TRIPS  AGREEMENT UNDER ARTICLE 71.1 
112. No statements were made  under this agenda item. 
113. The Council agreed to revert to the matter at its next meeting. 
I. REVIEW OF THE APPLICATION OF THE PROVISIONS OF THE SECTION ON GEOGRAPHIC 
INDICATIONS UNDER ARTICLE 24.2 
114. The Chairman recalled that Article 24.2 provided that the Council shall keep under review the 
application of the provisions of the GI section of the TRIPS Agreement.  The principal tool used to 
coordinate the review process had been a Check list of Questions contained in document IP/C/13 
and Add.1, which a number of Memb ers had submitted, but many had so far not completed.  In 
addition, at its meeting in March 2010, the Co uncil had agreed to encourage Members to share 
information on and notify to the Council bilateral ag reements related to the protection of geographical 
indications, which they have entered into.  That exercise had already resulted in some useful and 
informative material. 
115. As the question of GI protection remained a c ontinuing interest, he ur ged those delegations 
that had not yet done so to provide responses to the Checklist of Questions.  Equally, those Members 
that had already provided respon ses could provide updates to the extent there had been any significant 
changes to the way they provided protection to ge ographical indications.  There was considerable  IP/C/M/69 
 Page 21 
 
 
  benefit in having up-to-date, accurate and geographi cally more representative material available as the 
basis of the on-going review process.   
116. In line with the Council's recommendation of Ma rch 2010, he also encouraged any Member 
that was party to any bilateral agreements related to the protection of GIs to share information on 
them with the Council if they had not yet done so. 
117. The representative of the European Union refe rred to the additional information on EU 
technical co-operation activities in document IP/C/W /568, which he would introduce under item K of 
the agenda.  At this stage, he shared some info rmation in the document on technical assistance on GIs.  
This work had been carried out by TradeCom a nd the Business Climate facility (BizClim), which 
were joint initiatives of the European Commissi on and the ACP Group of States, with funding from 
the European Development Fund (EDF).  The initiatives utilized consultancy companies and 
independent consultants, recruited in accordance with the 10th EDF rules and procedures.  This 
assistance, like all assistance provide by the European Union, was demand-driven. 
118. Some examples of the work in the last th ree years included the following:  a Regional 
Workshop on the Development Benefits of Geographi cal Indications Protection for ACP States (June 
2009, Trinidad and Tobago);  a Regional Workshop  on the Development Bene fits of Geographical 
Indications (GIs) Protection for the ACP States (April 2010, Cameroun);  a Regional Workshop on the Development Benefits of Geographical Indica tions Protection for the ACP States (May 2010, 
South Africa);  a Regional Workshop on the Devel opment Benefits of Geogr aphical Indications and 
Traditional Knowledge Protection for the Pacific member countries of the ACP States (August 2010, Fiji);  a Technical Workshop on GIs as a Tool for E nhancing Value to African Union Farmers in the 
Agri-Food Chain (November 2011, Uganda);  and Technical Assistance to Saint-Lucia and the 
Organisation of Eastern Caribbean States Secretary on a GI Strategy (September 2011 – March 2012). 
119. The Council took note of the statements made and agreed to revert to the matter at its next 
meeting. 
J. FOLLOW -UP TO THE NINTH ANNUAL REVIEW UNDER PARAGRAPH 2 OF THE DECISION ON THE 
IMPLEMENTATION OF ARTICLE 66.2  OF THE TRIPS  AGREEMENT  
120. The Chairman recalled that, at its meeting in  October 2011, the Council had taken up its ninth 
annual review of developed country  Members' reports on their implem entation of Article 66.2 of the 
TRIPS Agreement.  In concluding the item, the Chair had indicated that delegations would be 
provided an opportunity at the present meeting to make further comments on the information submitted for that meeting that they had not yet been able to study. 
121. No statements were made  under this agenda item. 
K. T
ECHNICAL COOPERATION AND CAPACITY BUILDING  
122. The Chairman recalled that, at its meeting in October 2011, the Council had taken up its 
annual review of technical cooperation.  Sin ce then, the European Union had provided a 
communication entitled "Technical Cooperation Activ ities and Assistance for Least-Developed 
Countries" (IP/C/W/568), which complemented the information the European Union had provided in 
September 2011 for the Council's annual review (IP/C/W/560/Add.7).  It contained further 
information regarding specific IP technical assistan ce that the European Union had provided to least 
developed countries, including in response to a number of priority needs identified by them.  
123. He also recalled that paragraph 2 of the Council's 2005 decision on the "Extension of the 
Transition Period under Article 66.1 for Least-Dev eloped Country Members" provided that "with a IP/C/M/69 
Page 22  
 
  view to facilitating targeted technical and fina ncial cooperation programmes, all the least-developed 
country Members will provide to the Council for TR IPS, preferably by 1 January 2008, as much 
information as possible on their individual priority needs for technical and financial cooperation in order to assist them taking steps necessary to im plement the TRIPS Agreement".  To date, such 
information had been received from six Member s, namely Sierra Leone, Uganda, Bangladesh, 
Rwanda, Tanzania and Senegal.   
124. The Council's 2005 decision also provided that de veloped country Members were required to 
provide technical and financial cooperation in accordance with Artic le 67 in order to effectively 
address the needs identified by the least developed c ountries.  Furthermore, the decision called for the 
WTO to enhance its cooperation with  WIPO and other relevant inte rnational organizations with a 
view to making technical assistance and capacity building as effective and operational as possible. 
125. At the Council's October 2011 meeting, Nigeria had made a suggestion that, if acceptable to 
it, the Secretariat would prepare a note aimed at indicating areas that had been implemented in those LDCs that had submitted their need s assessments, as well as the outst anding areas.  Since another 
delegation had indicated that it needed further time for consideration, the Counc il had agreed to revert 
to that suggestion at the present meeting. 
126. The representative of the European Union said that the Council October meeting had followed 
a symposium organized by the WTO Secretariat on LDC priority needs for technical and financial 
cooperation.  His delegation had we lcomed that opportunity to enga ge further with other Members 
and international organizations on how to assist  the LDCs with TRIPS implementation.   
127. Following its annual notifications of techni cal assistance under TRIPS Article 67, the 
European Union had undertaken to provide furthe r and more detailed information on the technical 
assistance work it had recently carried out specifically in relation to LDCs in the area of IP.  That 
information had now been set out in document IP /C/W/568.  It provided an overview of recent 
specific projects, including those being undertaken  in Bangladesh, Uganda and Zambia, as well as 
regional work being carried out in conjunction w ith COMESA, OAPI and ARIPO.  It also provided 
information on the way the European Union delive rs technical assistance and how its various bodies 
work together with recipient countries and other organizations. 
128. The document provided information on EU funding of technical assistance, in particular in 
relation to the European Development Fund and th e Development Cooperation Instrument.  It also 
described how LDCs could obtain technical assistan ce, including an explanation of how Country and 
Regional Strategy papers functioned;  these were three annual plans that framed the way technical 
assistance was provided. 
129. Technical assistance was also available for de veloping countries, as well as for developed 
countries.  In that regard, he referred to the latest annual notification under Article 67 
(IP/C/W/560/Add.7), which contained numerous examples of those programmes.   
130. The representative of the United States thanke d the European Union for the paper it had 
presented.  With respect to the proposal from the October 2011 Council meeting regarding a report to 
be produced by the Secretariat, his delegation was still in the process of considering that internally. 
131. The representative of Nigeria thanked the US delegation and noted its request for more time 
to consider the proposal.  The issue of LDC prior ity needs for technical and financial cooperation was 
being discussed in the Council and elsewhere, and it w ould be in the interest of all the LDCs, and 
especially the African Group which had 33 LDC memb ers, if that factual information could be 
prepared by the Secretariat.  It would also serve  to give the Council a perspective on how to move 
forward.    IP/C/M/69 
 Page 23 
 
 
  132. The representative of Rwanda supported Nigeria' s proposal that the Secretariat prepare a note 
indicating the areas implemented in LDCs based on their needs assessments.  The objective should be 
to make an actual assessment of what was or w as not being done, which would provide a basis for 
both LDCs and their development partners to  continue working on pending issues.  
133. The representative of China supported the suggestio n to request the Secretariat to prepare a 
note under Article 66.2 to have a ge neral review of the situation of  technology being or having been 
transferred to LDCs.  China believed that th e questions posed by the LDC Group in document 
IP/C/W/562 were beneficial to improving the me chanisms for ensuring the monitoring and full 
implementation of Article 66.2.  In addition to r esponding to those questions, she believed it would be 
highly beneficial if developed country Members co uld take the concerns of the LDC Members into 
account and improve these reports in the future. 
134. The representative of the Secretariat provided a brief update to the Council on the work that 
the Secretariat was undertaking in relation to th e needs communication, resource mobilization and 
coordination process focused on the individual prior ity needs of LDC Members.  He said that the 
2005 Council Decision concerning the implementa tion period for LDCs and the process for 
communication of individual priority needs and c oordination on fulfilment of those needs included a 
requirement for the Secretariat to step up its coordination efforts.  At the Council's October 2011 meeting, he had reported at length on the step s taken, under the guidance of the LDC Group of 
countries, to promote greater coordination of that process.  Those steps had culminated in a workshop 
held in Geneva prior to that meeting. 
135. The biennial technical assistance and training programme (document 
WT/COMTD/W/180/Rev.1 circulated on 3 February 2012) for the 2012-2013 biennium gave priority 
to the LDCs as a fundamental principle.  Specifi c support was earmarked for needs assessments as 
such; and LDC needs assessments and trade policy revi ews (TPRs) were integrated.  reports for least 
developed and developing countries incl uded a section on Aid for Trade which, inter alia , covered the 
country's TA needs and priorities, as identified du ring the review in cooperation with the Member 
concerned.  That pointed to some of the on-going system-wide work that could be undertaken to 
support the specific needs-assessment pr ocess identified by the Council.   
136. The TA plan included over the biennium two further Geneva Symposia scheduled for both 
2012 and 2013 on LDC needs assessment concerning implementation of the TRIPS Agreement. The 
planning and consulting on these Symposia would be undertaken in close coordination and under the 
direction of the LDC Group of countries in particul ar, and Members in general.  They offered a key 
opportunity to move towards a more focused, prac tical coordination of needs communicated and any 
updates of LDC needs.  The TA programmes and r esources of the WTO itself, other IGOs such as 
WIPO and UNCTAD, and bilateral programmes r un by developed country Members and other 
providers of TA resources, many of which they knew from past consultations, were indeed already 
actively addressing the needs identified in that process.   He underscored the benefit of such practical 
exchange of information and coordination that past workshops had focused on, and had been a 
particular feature of the October 2011 workshop. 
137. In order to assist in the coordination process, the WTO webpage on the LDC needs 
assessment process already included  practical information and resources on the process.  It also 
included the full needs assessment s themselves as submitted by LDC Members.  There was also an 
additional section containing information from deve loped country Members on technical and financial 
cooperation provided to LDC Members, including in r esponse to any priority needs identified by LDC 
Members.  The recent submission by the European  Union in document IP/C/W/568, as described by 
the EU delegation, was the first entry on that new section. IP/C/M/69 
Page 24  
 
  138. In addition, he noted that under the biennial  TA programme, resources were earmarked for 
national activities under the general heading " assisting beneficiaries in conducting Needs 
Assessment".  These resources might potentially be drawn upon by individual LDC Members to 
support the process, if they so required, in line w ith the general demand-driven approach to national 
TA activities. 
139. In order to support LDCs, both in undertaking th eir needs assessments as required and in their 
coordination with providers of te chnical and financial resources to  fulfil those needs, a guidebook was 
in the process of being curated through various  phases of the work programme, including through 
regional workshops and Geneva-based workshops.  He expected that resources would be available to 
support LDCs in undertaking that process in the course of the biennium exercise. 
140. It was important to note, bearing in mind the direction from the Council towards greater and 
improved coordination in that area, that other international organizations had been active in 
supporting LDCs in identifying their priority developm ent needs in relation to the IP system and the 
TRIPS Agreement in particular.  Among intern ational organizations, WIPO and UNCTAD were 
notable in that regard.  It was also worth bear ing in mind that existing needs assessments had been 
prepared with the support of such organizations , underscoring the necessity and the benefits of 
improved coordination between international or ganizations and other resource providers and 
programmes, in particular as that took on a more pr actical accent.  He believed that such enhanced 
coordination would continue to be a focus of the WTO Secretariat's efforts and expressed his 
appreciation for the collegial and collaborative a pproach of colleagues, notably in WIPO, UNCTAD 
and, on health-related TA matters, the WHO.  Additi onally, a number of international experts and the 
ICTSD had also worked on the needs assessment pr ocess in a number of countries and the informal 
consultation and coordina tion network also include d such active players. 
141. He said that the Secretariat's work would con tinue to be guided by the directions given by 
Members and, in particular, those Members most concerned, i.e. the LDC Group and individual LDC Members.  This also took a lead, as outlined earlie r, from the Technical Assistance Plan approved by 
Members, which stressed the priority for support for LDCs and in particular for needs assessment 
activities.   
142. The representative of Switzerland expressed his appreciation for the Secretariat's efforts to 
facilitate the process under Article 67 of the TR IPS Agreement and support for the LDC needs 
assessment process.  Switzerland had participated in the regional workshop for Asian, Pacific and 
Caribbean Countries organized by the WTO in the second half of 2010 in Dakar, as one means of 
assisting and supporting the LDC needs assessment pro cess.  It had reported to the Council after that 
workshop that bilateral contacts between Banglad esh and Switzerland had taken place on the occasion 
of that workshop.  As a result of those continuing contacts, a technical co-operation project had been agreed between the two countries, commencing with  an inception mission the following week.  This 
was intended to be a technical co-operation project  based on the priority needs assessment submitted 
by Bangladesh to the Council.  It was a project that would span two years and amounted to financial 
support of some CHF 1 million.  Switzerland was looking forward to the implementation of the 
project in partnership with Bangladesh and looked forward to the support of its authorities.  His 
delegation would update the Council with  further details and relevant de velopments with regard to the 
progress of the project in future meetings.  
143. The representative of the United States said that in a spirit of moving forward, his delegation 
would support consultations on that issue.  His delegation was in the process of carrying out an 
extensive review of its programmes in support of ne eds assessments and it would be helpful to discuss 
the issue before the next meeting.    IP/C/M/69 
 Page 25 
 
 
  144. The Chairman urged all least developed country Members that had not yet provided 
information on their individual priority needs for tec hnical and financial cooperation to do so.  He said 
that the Council would revert to Nigeria's proposal on the work to be carried out by the Secretariat at 
its next meeting.  In the meantime, he intended to discuss with delegations on how the Council could 
best proceed. 
145. The Council took note of the statements made. 
L. LETTER FROM THE CHAIR OF THE GENERAL COUNCIL CONCERNING WAYS TO IMPROVE THE 
TIMELINESS AND COMPLETENESS OF NOTIFICATIONS AND OTHER INFORMATION FLOWS  
146. The Chairman recalled that, at its past few mee tings the Council had had on its agenda a letter 
from the Chair of the General Council concerning wa ys to improve the timeliness and completeness 
of notifications and other information flows in the ar ea of its responsibility.  In order to facilitate the 
Council's consideration of that issue, the Secret ariat had presented at the October 2009 meeting a 
factual background note (IP/C/W/543) prepared at the Council's request, summarizing the relevant procedures and providing information on the use of those procedures.  The document further 
contained suggestions for the Council's consider ation on how to improve the transparency and 
user-friendliness of the notification system.  At th e subsequent meetings, the Secretariat had provided 
oral reports on further developments in that area.  At  its last meeting, the Council had agreed to revert 
to that agenda item at the present meeting, so as to provide Members with a further opportunity to 
share any comments and allow the Secretariat to in form the Council of any further enhancements to 
its services improving the transparency and u ser-friendliness of the notification system. 
147. The representative of the Secretariat said that the work of the Secretariat on the process was 
very much guided by the directions in the lette r from the Chairman of the General Council and the 
background note IP/C/W/543.  The core objective of the work on timeliness and completeness of 
notifications and other information flows continued to  be the goal of making that material available in 
a more user-friendly way, and thus to make it more straightforward for Members to prepare and 
submit their notifications, in short to reduce th e burden on Members.  This included both the 
documentary burden on Members to fulfil their notif ication obligations and ma king it easier to consult 
the information in a way that corresponded more dir ectly with the actual needs of stakeholders.  On a 
number of the substantive agenda items before the Council, the Secretariat continued to hold 
discussions with delegations very informally w ho expressed some uncertainty about how to obtain 
even some of the basic tools, i.e. some of the basic notifications.  This underscored the continuing 
need for that work.   
148. This was an area where the very considerable  expense involved in processing those materials 
could be addressed, in response to the recommenda tions for savings and more efficient use of 
resources in the area of documentation recently ma de by the budget committee and adopted by the 
General Council.  The focus was on a number of official documents.  Some of the lengthy documents involved considerable effort, both in their prep aration and in their handling, distribution and 
translation.   
149. He stressed that the exercise was simply about practical document management.  It was being 
undertaken entirely within the para meters already set by the Counc il's own decisions and the TRIPS 
Agreement and it continued to follow directly the outline set out in document IP/C/W/543.  The work 
continued to review the body of existing notifi cations, a collection of over 15 years' worth of 
heterogeneous documents, of immen se potential practical use, but at the same time presenting a major 
information management challenge.  As it worked through the outline already reported to the Council, 
the increasing focus of the Secretariat was at present on examining ways of using appropriate information technology tools to improve the usabil ity and the accessibility of those data to reduce 
wasteful and expensive paper-based approaches,  where appropriate.  In addition, improved IP/C/M/69 
Page 26  
 
  accessibility and usability of data would ensure that it could contribute to the broader effort across the 
Secretariat towards a more integrated holistic a pproach to managing notifications and other trade 
policy information.  In this regard, he referred to the Integrated Trade Intelligence Portal (I-TIP), 
announced at the margins of the 2011 December Ministerial Conference. 
150. An immediate need was to address the backlog of  notified material that was not yet available 
in readily accessible text-searchable form.  The Secret ariat was currently working on a stocktake of all 
notification materials provided since the Council ha d commenced its work, so  as to measure exactly 
the scale of the task of making that material mo re readily accessible and useable, in line with the 
directions set by the letter of the Chair of the Gene ral Council.  The next step was to consider how to 
provide more user-friendly web tools for access ing and using the information contained in 
notifications, building on the pilot work already repor ted to the Council.  Cons ideration should further 
be given to making use of such tools as the comm on portal established with WIPO for the submission 
of legislative texts and exploring further coope ration along those lines, given the overlapping 
responsibilities between the WTO and WIPO that we re recognized in the TRIPS Agreement itself. 
151. Other avenues that could be explored in the area of practical document management, rather 
than determining new notification approaches, might include (i) facilitating the submission of texts for 
regular notifications, other than legislative texts,  through a notification tool;  and (ii) a continued 
focus on suggested standard notification formats to  facilitate both the preparation of notification 
materials and indeed their handling and disseminati on.  The Secretariat would seek to consult with 
delegates and other users of that information th rough informal workshops and technical assistance 
activities and aimed to develop appropriate tools that corresponded to the actual needs of actual 
stakeholders, particularly delegations.  The work w as very much at an early stage and further details 
would be reported to subsequent meetings of the Council as the preliminary work continued. 
152. Notification materials were now routinely u sed to inform the Secretariat's technical 
cooperation activities, in response to the demand fro m Members for information at a very practical 
level and in a factual way about the approaches take n by Members in relation to various areas of IP 
law and policy.  Further technical assistance activ ities would concentrate on more effective use of 
notification processes, so as to advance the objec tives set out by the General Council concerning the 
timeliness and completeness of notifications unde r the TRIPS Agreement as well as user-friendly 
access to and use of those materials. 
153. The Chairman suggested that the Council agree to  revert to that agenda item at its next 
meeting so as to afford Members a further opport unity to make their comments on the subject and 
allow the Secretariat to inform the Council on any further improvements to its services aimed at 
enhancing transparency and use-frie ndliness of the notification system. 
154. The Council took note of the statements made and so agreed. 
M. AUSTRALIA :  TOBACCO PLAIN PACKAGING BILL 2011  AND ITS COMPATIBILITY WITH THE 
TRIPS  AGREEMENT  
155. The Chairman said that this item had been put  on the agenda at the written request of the 
delegation of the Dominican Republic. Since its me eting in October, the Council has received two 
documents relating to this matter.  At the request  of the delegation of the Dominican Republic, the 
statement it made at the Council's meeting in Oc tober 2011 under item N on "Australia's Tobacco 
Plain Packaging Bill 2011" had been circulated in document IP/C/W/565.  The Council had also 
received a communication from Moldova entitled "Aus tralia's Tobacco Plain Packaging Bill 2011", 
which has been circulated in document IP/C/W/567.    IP/C/M/69 
 Page 27 
 
 
  156. The representative of the Dominican Republic said that his delegation wished to reiterate its 
serious concern at the plain packaging measures for tobacco products adopted by Australia.  The 
Dominican Republic had already expressed its concern both to the Council and to the TBT 
Committee, and several other WTO Members had al so questioned these unprecedented measures.  He 
said that so far, Australia had not responded satisf actorily to these concerns but had only provided 
incomplete replies that failed to show the existe nce of any solid evidence used as a basis for these 
measures. 
157. He said that Australia's plain packaging measure s were a threat to many IPRs which were 
vital for international trade and should be a matt er of concern to each and every Member.  In 
particular, these measures were inconsistent with  Australia's obligations under the TRIPS Agreement 
and the Paris Convention, which form ed part of the TRIPS Agreement. 
158. He said that, for any product that could be lawfully sold for consumption, registered 
trademarks, geographical indications and other elem ents that formed part of a product's packaging 
played an important role in providing information on products and producers, which was essential for 
consumers, as such information enabled consumer s to differentiate and choose between competing 
products. 
159. Australia's plain packaging measures would elimin ate practically all the distinctive features of 
tobacco sector products by banning designs and trademarks, as well as by requiring packaging for 
different tobacco products to be virtually identical .  These measures would, therefore, negate IPRs, 
preventing consumers from obtaining basic information on products they could lawfully purchase, thereby creating confusion in the market and lessening the opportunities for competition among 
imported tobacco products. 
160. He said that, at the same tim e, these measures would not succeed  in promoting public health 
goals.  On the contrary, it was expected that th ey would have serious negative consequences.  
Tobacco consumption might increase, instead of decreasing, as prices fell because all tobacco 
products would look virtually the same.  Furtherm ore, plain packaging would make it easier to 
counterfeit products and market them. 
161. It was his delegations view that, instead of a dopting such inappropriate and extreme measures 
to reach the objectives sought, Australia should fo cus on other available measures that would be 
effective in promoting public health.  Such measures would not negate IPRs re lated to lawful products 
and would not undermine the benefits gi ven to consumers by such rights. 
162. The Dominican Republic believed that Austra lia's plain packaging measures for tobacco 
products would violate Articles 20, 22.2(b) and 24. 3 of the TRIPS Agreement, as well as Article 10 bis 
of the Paris Convention. According to Article 20 of  the TRIPS Agreement, the "use" of registered 
trademarks relating to tobacco products would be "encumbered" by "special requirements" 
determined by Australia's plain packaging measure s for tobacco products.  Australia intended to 
prohibit the use of any design feature of the regist ered trademark, allowing only mention of the brand 
name and the variety in a predetermined location, in a predetermined font style and size on an 
identical background.  These special requirements aut horized the use of registered trademarks only in 
a "special form" that was "detrimental to [the trademark's] capability to distinguish the goods or 
services of one undertaking from those of other undertakings". 
163. He said that Australia had contended on several  occasions that the measures in question were 
justified by public health objectiv es, and had referred to a number of studies.  His delegation wished 
to reiterate that in its understanding the factua l and scientific evidence for these measures had been 
challenged in public documents that had been subm itted to the Australian Government in a timely IP/C/M/69 
Page 28  
 
  manner.  Australia had still not explained to Member s how it justified the plain packaging measures in 
view of the lack of evidence. 
164. Moreover, he said, Australia's plain packag ing measures would also violate Article 10 bis of 
the Paris Convention, which prohibited "all acts of such  a nature as to create confusion by any means 
whatever with the establishment, the goods, or the industrial or commercial activities, of a 
competitor".  The plain packaging measures posed  a serious risk of confusion among competing 
tobacco products because Australia would impose the us e of virtually identical packaging for all such 
products.  For similar reasons, the plain packaging m easures would also violate Article 22.2(b) of the 
TRIPS Agreement - which referred back to Article 10 bis of the Paris Convention - by creating 
confusion in relation to geographical indications. 
165. He said that the Dominican Republic had also incorporated into its domestic legislation 
protection for geographical indications that wa s available under TRIPS, in order to provide 
competitive advantage to traditional products that were well known in domes tic and international 
markets.  His delegation had the pleasure of informing the Council that the Tobacco Institute 
(INTABACO), the Republic's cigar producers, togeth er with the National Industrial Property Office 
(ONAPI), had developed the Dominican Repub lic's first geographical indication, " Cigarros 
Dominicanos ", which was the fruit of two years of join t work.  It was intended to identify and 
highlight the quality of Dominican cigars throughout the world. Against this background his delegation considered that Australia's plain packag ing measures would also violate Article 24.3 of the 
TRIPS Agreement, which prohibited WTO Memb ers from "[diminishing] the protection of 
geographical indications that existed in that Member immediately prior to the date of entry into force 
of the WTO Agreement [1 January 1995]".  By elim inating the right to use geographical indications 
for the retail sale of tobacco products, Australia w ould violate this obligation as the plain packaging 
measures would be detrimental to this  geographical indication in Australia. 
166. He said that, for the foregoing reasons, the Do minican Republic urged Australia to honour its 
obligations under the TRIPS Agreement. 
167. The representative of Australia said that her de legation welcomed the continued interest of 
other Members in its initiative to require the pl ain packaging of tobacco products.  She thanked 
Members for their questions and the support Aust ralia had received for these important measures and 
wished to provide an update on the status of the legislation and its implementation. 
168. She said that Australia had addressed the various  issues raised by Members in relation to its 
Tobacco Plain Packaging legislation at previ ous Council meetings a nd had comprehensively 
responded to all the claims made by the Dominican Re public and others.  In order not to repeat those 
responses today, her delegation requested that Austra lia's previous interventions on its Tobacco Plain 
Packaging Bill, as recorded in previ ous minutes be included in the record. 
169. Since this Council last met in October 2011, the Tobacco Plain Packaging Act 2011 and the 
Trade Marks Amendment (Tobacco Plain Packagi ng) Act 2011 had been passed by the Australian 
Parliament and had received Royal Assent on 1 December 2011.  The Tobacco Plain Packaging 
Bill 2011 had passed the Australian Parliament on 21 November 2011, which included amendments to 
(i) extend the implementation timeframes and provide  an additional two weeks for retailers to sell 
through ('flush-through') any product in non-co mpliant packaging before the retail offences 
commence; and (ii) address a technical implemen tation issue identified by tobacco companies to 
permit rounded corners to be used on the inside lip  of cigarette packs.  The associated Trade Marks 
Amendment (Tobacco Plain Packaging) Bill 2011 had passed the Parliament on 10 November 2011.   
170. She said that all tobacco products manufactured  or packaged in Australia would now be 
required to be in plain packaging by 1 October 2012 (previously 20 May 2012 ). All tobacco products  IP/C/M/69 
 Page 29 
 
 
  would now be required to be sold in plain pack aging by 1 December 2012 (previously 1 July 2012). 
The final regulations as they related to cigarette products, which contained the specific details on how 
the plain packaging requirements were to be im plemented, had been approved on 7 December 2011 
and were publicly available. These regulations ha d been revised in response to comments from the 
industry on previous drafts. 
171. She said that regarding non-cigarette tobacco pr oducts - including cigars, loose-leaf tobacco 
and bidis - the Government had issued a c onsultation paper on 30 September 2011 for public 
comment. Consultations had closed on 28 Oct ober 2011, with 33 submissions received. The 
Government had released draft regulations incorpor ating the specifications for plain packaging of 
non-cigarette tobacco products on 23 December 2011,  for a public consulta tion period which ended 
on 20 January 2012.   
172. The Government had revised the draft regulati ons in response to comments and was currently 
considering responses to the most recent consulta tion in finalising the Amendment Regulation, and 
planned to seek approval of the Amendm ent Regulation in the coming weeks.  
173. She said that, as had been outlined at the previ ous meeting of the Counc il, her delegation was 
implementing this legislation in the interests of pr omoting public health. Her delegation was confident 
that, as part of a comprehensive package of tobacco  reforms, it would make an effective contribution 
to reducing smoking, and thereby reduce the health impacts of smoking on Australian individuals and 
the community at large. 
174. Australia was and would continue to be fully committed to its interna tional obligations to 
protect IPRs, including the rights of trade mark owners. In framing its policy on plain packaging, 
Australia had paid full regard to its obligations u nder the TRIPS Agreement and would ensure that the 
new policy was implemented in a manner consistent with that Agreement. 
175. She said that plain packaging was a legitimat e measure designed to achieve a fundamental 
objective – the protection of public  health. It was based on a broad range of studies and reports, and 
was supported by leading Australian and internati onal public health experts. Australia had been 
responsive to comments from trading partners and ot her stakeholders. Prior to the introduction into 
Parliament of the Bills, the Australian Government  had consulted widely with trading partners, 
including through a series of outreach meetings to explain the proposed measures. These comments 
had been taken into account  and had led to changes to the Bill a nd draft regulations where the changes 
were in line with the Government's policy objectiv es. This included responding to concerns about the 
protection of the rights of trademark owners, with changes made to ensure their effective operation. 
176. She said that amendments to the Tobacco Plai n Packaging Bill had been proposed to ensure 
trademark owners' ability to protect their trademar ks from use by other persons, and the ability to 
register and maintain the registration of a trad emark had been preserved. A parallel Trade Marks 
Amendment Bill had been introduced and passed to allow the Government  to strengthen those 
protections should any uncertainty arise. 
177. Australia had also removed import offences fo r non-compliant tobacco products, in response 
to submissions received in public consultations. This change would allow tobacco products to be 
imported into Australia in non-comp liant retail packaging, and then repackaged for retail sale in 
Australia.  The Bill required compliance with pl ain packaging requirements from the first on-sale 
(whether wholesale or retail) of imported products in the supply chain in Australia.  Australia had 
further adjusted the measures to allow a greater  timeframe for implementation and to address a 
technical concern raised by industry to avoid retooling of machinery.  IP/C/M/69 
Page 30  
 
  178. In closing, her delegation wished  to reiterate that Australia's Plain Packaging legislation was a 
legitimate and appropriate measure which would ma ke a significant contribution to protecting the 
health of Australians. 
179. As requested, the statement her delegation made  at the Council's meeting in June 2011 is 
reproduced below
1. 
"The representative of Australia said that he r delegation welcomed the interest of other 
Members in its proposed legislation on the plain packaging of tobacco products and the 
support received for these important measures.  Since the last meeting of the TRIPS Council in June 2011, the Tobacco Plain P ackaging Bill 2011 and the associated Trade 
Marks Amendment (Tobacco Plain Packaging)  Bill 2011 had been introduced into the 
Australian Parliament on 6 July 2011.  Both Bills had passed the House of 
Representatives on 24 August 2011 with no amen dments and were expected to be 
considered by the Senate before the end of 2 011.   She said that Australia's Minister for 
Health and Ageing, Nicola Roxon, had i ssued a media release on 12 October 2011, 
indicating that as a result of the delays in passing the Bill, the Government was now reconsidering implementation timelines in the context of which representations from 
industry about the timelines were also being considered. 
She said that in recent months her delegati on had met with all WT O delegations that 
had raised this issue in previous TR IPS Council and TBT Committee meetings to 
explain the purpose and details of the pr oposed measures and to provide detailed 
information in relation to the questions raised.  
With regard to the purpose of the measures, her delegation had outlined at the previous 
meeting of the Council that Australia was impl ementing this legislation in the interests 
of promoting public health and in partic ular in the area of reducing tobacco 
consumption.  She said that three million Au stralians still smoked, and 15,000 of them 
died every year causing a staggering bill of $A 36 billion to the Australian tax payer.  In 
that context, her delegation was confident th at, as part of a comprehensive package of 
tobacco reforms, the bill would make an e ffective contribution to reducing smoking, and 
thereby reduce the health impact of smoking on Australian individuals and the community at large.  Tobacco packaging was one of the last remaining forms of tobacco 
advertising in Australia and the plain pack aging legislation was therefore the next 
logical step in Australia's tobacco control efforts. 
She said that the effect of the legislati on would be that tob acco company branding, 
logos, symbols and other images that might have  the effect of advertising or promoting 
the use of the tobacco product would not be able to appear on tobacco products or their 
packaging.  The brand name and variant name would continue to be allowed on 
packaging, as would be information required by  other legislation or regulations, such as 
trade descriptions and graphic health warnings.  
The plain packaging of tobacco products w as designed to reduce the attractiveness and 
appeal of tobacco products to consumers, particularly young people; to increase the 
noticeability and effectiveness of mandated hea lth warnings; to reduce the ability of the 
tobacco product and its packaging to mislea d consumers about the harms of smoking;  
and, through the achievement of these aims in the long term, as part of a comprehensive 
suite of tobacco control measures, contribute to efforts to reduce smoking rates.  She 
said that plain packaging needed to be consid ered in the context of Australia's long term 
                                                      
1 Paragraphs 426-436 of IP/C/M/67.  IP/C/M/69 
 Page 31 
 
 
  efforts on tobacco control.  Over the past  30 years Australia had implemented a number 
of measures to reduce smoking rates, incl uding extensive and continuing public 
education campaigns on the dangers of smoking; age restrictions on tobacco purchase;  pricing measures through excise and customs duties;  comprehensive bans on tobacco advertising, promotion and s ponsorship; bans on smoking in certain places to reduce the 
impact of second hand smoking; bans and rest rictions on the retail display of tobacco 
products; mandatory graphic health warnings  on tobacco product packaging; and 'quit 
smoking' support services including free coun selling and subsidi sed pharmaceutical 
products. 
Guidelines agreed by the Conference of th e Parties to the WHO Framework Convention 
on Tobacco Control (FCTC) in 2008 for the implementation of Articles 11 and 13 of the 
FCTC recommended that Parties consider the introduction of plain packaging.  The 
proposed legislation was consistent with recommendations made to the Government by 
Australia's National Preventative Health T askforce which had been based on extensive 
research evidence that explored the impact s of tobacco packaging and tested the 
reactions of respondents exposed to differe nt packaging options under experimental 
conditions.  The weight of the evidence indicat ed that a plain packaging requirement, as 
part of a comprehensive suite of tobacco  control measures, would help to reduce 
smoking rates.  Her delegation wished to ur ge Members to examine carefully any so-
called evidence to the contrary which was funde d by the tobacco industry.  She said that 
her delegation had been responsive to co mments from trading partners and other 
stakeholders, and that Australia remain ed fully committed to its international 
obligations to protect IPRs, including the rights of trademark owners.  
Her delegation had notified the measures to the WTO on 8 April 2011.  As noted by 
Ukraine in its intervention, the Australian Government had undertaken extensive public 
consultation on the proposed legislation.  Prio r to the introduction into Parliament of the 
Bills, the Australian Government had also consulted widely with trading partners, 
including tobacco exporting de veloping countries, through a series of outreach meetings 
to explain the proposed measures.  These comments were taken into account and had 
led to changes to the Bill and draft regulati ons where the changes were in line with the 
Government's policy objectives.  This in cluded responding to concerns about the 
protection of the rights of trademark owne rs, with changes made to ensure their 
effective operation. 
Amendments to the Tobacco Plain Packaging Bill had been propo sed to ensure the 
trademark owners' ability to protect their tr ademarks from use by other persons, and the 
ability to register and maintain the registra tion of a trademark had been preserved.  A 
parallel Trade Marks Amendment Bill had been  introduced to allow the Government to 
strengthen those protections should uncerta inty arise. The import offences for non-
compliant tobacco products had also been  removed from the bill in response to 
submissions received and public consultations .  This change allowed tobacco products 
to be imported into Australia in non-complia nt retail packaging, and then repackaged 
for retail sale in Australia.  She said that  the bill required compliance with plain 
packaging requirements from the first on-sale (whether wholesale or retail) of imported 
products in the supply chain in Australia.  
She said that her delegation did not accept claims that Australia's plain packaging 
proposal would have a significant impact on illic it trade in tobacco products.  Trade in 
illicit tobacco in Australia was low and her dele gation did not expect this to change as a 
result of these measures.  It was important  to understand that counterfeiters now seemed 
to have little trouble replicating branded t obacco packages and it was worth repeating IP/C/M/69 
Page 32  
 
  that smoking of any tobacco product, whethe r licit or illicit, was fundamentally harmful 
to human health.  Nevertheless, given con cerns were expressed about counterfeiting and 
illicit trade in tobacco products, allowances ha d been made to ensure that protective 
markings could be used for anti-counte rfeiting purposes.  These included the use of 
unique alphanumeric code markings on each pack and cigarette stick, and covert 
markings in compliance with other aspects of the Bills. 
With respect to the applicability of the m easure to other products she said that the 
proposed plain packaging legislation rela ted only to tobacco products and retail 
packaging of those products and the Austra lian Government did not consider extending 
the measure to other products.   
According to the World Health Organizati on, "tobacco is the only legal consumer 
product that kills up to half of those w ho use it as intended and recommended by the 
manufacturer." She said that tobacco products cause extraordinary harm and require appropriate measures.  At the same time, sh e said that Australia was fully committed to 
its international obligations to protect IPRs , including the rights of trademark owners.  
She said that, in framing its policy on plain pack aging, Australia had paid full regard to 
its obligations under the TRIPS Agreement a nd would ensure that the new policy was 
implemented in a manner that cons istent with that Agreement." 
180. In addition, the representative of Australia requ ested that the statement made in the June 2011 
meeting be included.
2 
"The representative of Australia said that her delegation welcomed the opportunity to 
discuss this extremely important public h ealth issue in the TRIPS Council and to 
explain the health policy underpinnings of the Australian Government's proposal.  In order to provide some context for Members,  she said it was worth noting that some 
3 million Australians continued to smoke daily, that smoking killed over 15,000 
Australians per year and that the cost to Australia's society and economy was over 
$31.5 billion per annum.  This was the policy context in which the Australian 
Government approached this issue.  She said that, on 7 April 2011, the Australian Minister for Health and Ageing had released for public comment the Consultation Paper and dr aft legislation to mandate 
the plain packaging of tobacco products.  The consultation period had closed on 
6 June 2011.  The comments lodged were curre ntly being considered by the Australian 
Government.  She said that Australia had been  a global leader in tobacco control over 
the past 30 years and had implemented a co mprehensive range of measures to reduce 
smoking rates.  These included extensive a nd continuing public education campaigns 
on the dangers of smoking;  age restrictions  on tobacco purchase;  comprehensive bans 
on tobacco advertising, promotion and s ponsorship;  bans on smoking in workplaces 
and enclosed public places;  bans on smoking in cars with children and increasingly in 
open air public places where children may be  exposed to second hand smoke;  bans 
and restrictions on the retail display of t obacco products;  pricing measures through 
excise and customs duties;  and mandatory  graphic health warnings on tobacco 
product packaging. 
 
She said that tobacco packaging was one of  the last remaining forms of tobacco 
advertising in Australia and the plain packagi ng legislation was the next logical step in 
Australia's tobacco control efforts.  Guide lines agreed by the Conference of the Parties 
                                                      
2 Paragraphs 177-182 of IP/C/M/66.  IP/C/M/69 
 Page 33 
 
 
  to the WHO Framework Convention on Tobacco Control (FCTC) in 2008 for the 
implementation of Articles 11 and 13 of th e FCTC recommended that Parties consider 
the introduction of plain packaging.  The legislation proposed by Australia was 
expected to commence on 1 January 2012, and would require all tobacco products 
offered for retail sale on or after 1 July 2012 to be compliant.  The proposed 
legislation was part of a comprehensive p ackage of new reforms to combat smoking 
announced by the Australian Government in  April 2010.  Other elements of the 
package were a 25 per cent increase in tobacco  excise - Australia's tobacco excise and 
excise-equivalent duty was already high by international standards and now amounted 
to A$8.40 on a packet of 25 cigarettes, and A$10.09 on a packet of 30;  increased 
investment in anti-smoking social marketi ng campaigns;  and legislation to bring 
restrictions on tobacco advertising on the Inte rnet into line with restrictions in other 
media and at retail points of sale.  She said that these measures had been r ecommended by Australia's leading public 
health experts on the National Preventativ e Health Taskforce, and accepted by the 
Australian Government.  The Taskforce had considered that plain packaging would 
improve public health by reducing the attrac tiveness and appeal of tobacco products to 
consumers;  reducing the ability of tobacco packaging to mislead consumers about the 
harmful effects of smoking;  increasing the noticeability and effectiveness of mandated health warnings. 
 
She said that her delegation had noted the comments from the Dominican Republic 
referring to an alleged lack of scientific evidence to indicate that a plain packaging 
requirement would work.  She observed, however, that there was a body of peer-reviewed literature on the public record indi cating that a plain packaging requirement 
would contribute to Australia's objectives.  All of that literature was available on the 
preventative health website, the details of  which she would be happy to furnish to 
Members.  Australia did not consider that the plain packaging proposal would have a significant impact on the illicit trade in tobacco products since already branded products were quickly and readily counterfe ited.  Nevertheless, she said that anti-
counterfeiting markings would be  allowed to be used on the packaging provided those 
markings were not linked to tobacco marke ting or promotions and did not interfere 
with graphic health warnings.  She said th at the Australian Government considered 
that the smoking of any tobacco products, whether licit or illicit, was fundamentally harmful to human health.  
She said that Australia was, and would continue to be, fully committed to its 
international obligations to protect IPRs, including the rights of trademark owners.  
She assured all Members that, in framing its policy on plain packaging, Australia had paid full regard to the TRIPS Agreement and would ensure that the new policy was 
implemented in a manner that was c onsistent with that Agreement." 
 
181. The representative of Cuba said that the Austra lian bill had created te nsion between the right 
of governments to protect human health, and the commercial interests associated with tobacco 
consumption.  She said that the requirement of st andard packaging with no distinguishing trademark 
features would have an impact on advertising and consumption, which would in turn affect 
commercial interests.  This was not the first time that tensions between commercial interests and the 
right to health had appeared.   
182. She said that Cuba was recognized internationa lly as a staunch defender of the right to life 
and health, which it viewed as a supreme human right , and had maintained a c onsistent and proactive 
position with respect to this principle.  Scien tific and technological de velopments had provided IP/C/M/69 
Page 34  
 
  irrefutable proof that tobacco consumption affects not only human health but life expectancy, and her 
delegation recognized that government s were responsible for protecting the health of their citizens.  
The Cuban Government was also adopting measures in this regard, thus applying the principle set 
forth in Article 8.1 of the TRIPS Agreement wher eby Members had the right to adopt measures to 
protect public health, provided that such measur es were consistent with the provisions of the 
Agreement.  
183. Nevertheless, she said, Cuba shared the con cerns expressed by other countries regarding the 
measure's impact on trademark law and, in particular, the legislation's impact on the capacity of 
registered trademarks to distinguish one company's goods and services from those of another.  If registered trademarks could not be used and disp layed because of this legislation's plain packaging 
requirements, this did not bode well for the future  as it undoubtedly generated some expectation for 
legislation on distinctive signs in business activities. 
184. As Australia had affirmed that the legisla tion's measures had been properly examined to 
ensure consistency with the TRIPS Agreement, he r delegation would be interested to know how 
Australia had assessed not only the problem of usi ng a trademark in a form that differs from the 
design of the registered trademark, but also the i ssue of potential trademark infringements, where such 
trademarks, regardless of their registered design, appeared on plain packaging merely as words.  The 
question was whether, under the plain packaging, it  was possible to display the trademark as it had 
been registered, which was after all a trademark's function in the market. 
185. In her delegation's view it would be appropriate  for Australia to explain why it believed that 
these measures were the best way of meeting the propo sed objective.  Australia should also share with 
Members its analysis regarding these measures' consistency with the provisions of the TRIPS 
Agreement, as well as the measures available to right  owners to minimize the risks of counterfeiting 
and unfair competition, given that plain packaging in volving the brand name in standard size and font 
was so easy to reproduce. 
186. She said that Cuban cigars had been the target  of counterfeiting for many years and in many 
markets, forcing the industry to adopt various me asures to minimize this problem.  These measures 
were not advertising measures but measures to highli ght the origin and authenticity of the products.  
Plain packaging defeated all those measures.  For example, it would no longer be possible to use the 
"Habanos " designation of origin seal or the national guarantee of origin seal used by the Republic of 
Cuba on all its cigars since almost 100 years.  Nor would it be possible to use the ring on the upper part of each cigar bearing the brand name  and place of origin, La Habana, Cuba. 
187. The representative of El Salvador said that hi s delegation wished to reiterate a number of 
systemic observations on Australia's Tobacco Plain Packaging Bill 2011 and its compatibility with the 
TRIPS Agreement.  In line with the objectives se t forth in Article 7 of the TRIPS Agreement, 
El Salvador believed that IP belonged to a set  of trade policy tools designed to promote the 
development of the economy.  It allowed Members, inter alia , to add value to goods and services in a 
way that ensured their distinctiveness and afforded  them due protection in transactions on both the 
El Salvadorian and destination markets.  
188. In his view, the IPRs system constituted a ba lance between guaranteed rights for IPR holders 
and exceptions to allow states to  safeguard their legitimate public  policy objectives, such as the 
protection of health, education, safety and market competition.  In this context, El Salvador had 
concerns about how Australia's measure might unduly affect trade and create non-tariff barriers.  His 
delegation was also concerned that  this type of measure could set a precedent for other goods and 
services.  Against this background, his delegati on wished to ask Australia a few questions.    IP/C/M/69 
 Page 35 
 
 
  189. With regard to Article 8 of the TRIPS Agre ement, could Australia please provide the basic 
information that it used to determine that the measure was necessary to protect public health and 
explain how it is consistent with the provisions of this Agreement?  With reference to Article 20 of 
the TRIPS Agreement, to what extent did Australia view its measure as detrimental, or otherwise, to 
the capability of trademarks to distinguish the goo ds - in this case tobacco - of one undertaking from 
those of other undertakings?  With regard to th is same Article, if Australia was undermining the 
distinctive capacity of trademarks, would it please id entify its specific justifications for restricting 
trademark use in relation to the goods covered by th e measure?  In light of Article 22.2 of the TRIPS 
Agreement, what was Australia doing to ensure that  owners of geographical indications could prevent 
the measure from potentially undermining their right to use this category of IPR to render their goods 
distinctive - as in the aforementioned cases?  Fi nally, when applying the measure, did Australia 
consider alternatives in order to avoid potential c ontradictions with WTO law and a possible impact 
on private rights?  If so, his delegation would like to know what those alternatives were.  
190. He said that El Salvador would continue to monitor Australia's measure, including within the 
framework of the WTO Committee on Technical Barriers to Trade. 
191. The representative of Norway thanked the Aust ralian delegation for the update on the status 
of the tobacco plain packaging legislation and its  implementation.  Norway had expressed its support 
for the Australian measures at previous meetings of the Council and wished to reiterate its view that 
the TRIPS Agreement provided Members the flexibility  to adopt measures necessary to protect public 
health.  Following the information provided by th e Australian delegation in this matter, Norway 
remained confident that the measu res described would be implemented in a manner consistent with 
Australia's WTO obligations.  
192. The representative of Honduras said that her dele gation shared the concerns raised by the 
Dominican Republic and others regarding the plain tobacco packaging measures adopted by Australia 
in the Tobacco Plain Packaging Act 2011 No. 148 and the law on trademarks No. 149 of 2011.  The 
regulations on plain tobacco packaging for cigare ttes and cigarette packaging had been adopted on 
7 December 2011 as the public consultations on ci gar regulations and the regulations for other 
tobacco products had now ended. 
193. She said Honduras was concerned by the lack of comprehensive responses from Australia to 
the concerns expressed by Members, and the lack of  evidence that supported the measure, as well as 
the effective prohibition of the use of trademarks as regards logos, designs, colours and brands on the 
packaging of all tobacco products, both cigars and ci garettes.  Her delegation feared that under these 
measures, producers and importers of related t obacco products would be obliged to adopt 
standardized packaging and would at the same time be prevented from using their legitimate IPRs on 
the packaging, preventing consum ers from having access to important information on the product that 
they were buying.   
194. Honduras believed that this requirement would violate Article 20 of the TRIPS Agreement, 
which clearly established that the use of a trademar k could not be unjustifiably encumbered in trade 
operations by specific requirements such as the use wi th another trademark, the use in a special form, 
or use in a manner which could undermine the abilit y for the brand to distinguish the goods or 
services of one company from those of other compani es.  It was her delegation's view that plain 
packaging represented a special requirement of th e type listed in Article 20 and was therefore by 
definition an unjustified encumbrance of the use of  a trademark.  Although Australia's intention in 
adopting this type of measure was understandable,  her delegation believed that the end could not 
justify the means.  Such measures had to be ba sed on proof and had to meet the requirements and 
objectives of public interest.  In this case, she said, there was not sufficient proof to guarantee that this 
plain packaging was really effective in discouraging consumption.   IP/C/M/69 
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  195. Her delegation believed, on the contrary, that plain packaging measures created a serious risk 
of confusion between competing to bacco products.  These measures would also violate Article 22.2(b) 
of the TRIPS Agreement which referenced Article 10 bis of the Paris Convention, because it generated 
confusion with respect to geographi cal indications.  Lastly, Article 10 bis of the Paris Convention 
itself would be violated, as this Article prohibited any act that could create confusion through 
whatever means regarding this establishment, th e products, or the industrial trade activity of a 
competitor.   
196. The representative of Ukraine said that his delegation had expressed serious concerns 
regarding Australia's proposed Tobacco Plain Packag ing Bill 2011 at the Council's previous meetings 
in June and October 2011.  Ukraine and others had noted that, if the proposed legislation were enacted 
into law as drafted, the plain packaging requirements set forth in the legislation would violate a 
number of Australia's WTO obligations, including ob ligations under the TRIPS Agreement, as well as 
provisions of the Paris Convention for the Protection of Industrial Property that had been incorporated 
into the TRIPS Agreement.   
197. He said that, at the time of the Council's m eeting in October 2011 when the Bill had passed 
Australia's House of Representatives and was pendi ng before its Senate, Ukraine had expressed its 
hope that Australia's Senate would amend the bill to bring it into compliance with Australia's 
obligations under the TRIPS Agreement. Since the C ouncil's last meeting, there had been a number of 
important and highly troub ling developments in Australia with re gard to the Tobacco Plain Packaging 
Bill 2011. The legislation had passed Australia's Senate on 10 November 2 011 without substantive 
amendments and received Royal Assent on 1 Dece mber 2011, thus becoming Australian law as the 
Tobacco Plain Packaging Act 2011.   
198. He said that Australia had also implemented the final Tobacco Plain Packaging Regulations 
2011 relating to cigarettes on 7 December 2011, an d had proposed amendments to these regulations 
concerning non-cigarette tobacco products, includ ing cigars and other products.  It was his 
delegation's understanding that Australia intended to implement these regulations in the course of the 
coming month.  
199. He said that Ukraine wished to reiterate its strong concern that the Tobacco Plain Packaging 
Act 2011 and its implementing regulations violate sev eral provisions of the TRIPS Agreement, such 
as Article 20, Articles 15 and 16 and Article 8.1, as well as provisions of the Paris Convention as 
incorporated into the TRIPS Agreement.  Serious c oncerns about the lack of consistency of the Act 
and its regulations with fundamental  international rules on the protection of IP had been echoed by a 
number of other Members and leading internati onal IP and business organizations throughout the 
world, as referenced in detail at the Council's last meeting. 
200. He said that the delegation of Ukraine appreci ated Australia's intention to develop and 
implement policies for the health of its citizens.  Ukraine strongly supported the implementation of 
rational, effective, evidence-based measures to achie ve health-related goals.  It was merely requested 
of Australia, like of all other Members, to formul ate health policies in a manner consistent with 
international obligations, including those under the TRIPS Agreement.  Article 8.1 of the TRIPS 
Agreement expressed the very same principle in no unclear language: Members may of course impose 
measures that are necessary to protect health, provided  that they are consistent with the obligations 
under the TRIPS Agreement.  Unfortunately, Australia 's measure appeared to be neither necessary to 
protect health, nor consistent with  the provisions of the TRIPS Agreement.  His delegation was deeply 
disappointed to have received no responsive information from Au stralia regarding these critical 
points. 
201. He said that Ukraine would continue to fo llow in the most serious manner the further 
implementation of this measure and reiterated its request that Australia reconsider the Plain Packaging  IP/C/M/69 
 Page 37 
 
 
  Act 2011 and revise the measure as needed to ensure the conformity with Australia's international 
treaty obligations, including tho se under the TRIPS Agreement. 
202. The representative of New Zealand said that her delegation welcomed the Australian 
Government's decision to legislate for the plain p ackaging of tobacco products.  The negative effects 
of smoking, which was the leading preventable cause  of early death in New Zealand, could not be 
overstated.  It was within a Member's right to im plement necessary measures in order to protect public 
health. Her delegation noted the clear assurances by Australia that it had paid close attention to and 
respected its WTO obligations in developing its plain packaging proposal. She further noted the 
numerous scientific studies which demonstrated that plain packaging of tobacco products could lead 
to positive public health outcomes by reducing the a ttractiveness and desirability of smoking and by 
increasing the prominence of public health warni ngs.  It was her delegation's view that plain 
packaging, as part of a comprehensive suite of toba cco control measures, could contribute to efforts to 
reduce smoking rates. 
203. The representative of Uruguay said that his de legation's position regarding the law on plain 
packaging was well known.  In summary, his dele gation believed that Australia had acted in 
accordance with the TRIPS Agreement and its objec tive of public health protection, and Uruguay 
therefore respected the legisl ative initiative by Australia. 
204. The representative of Chile said that, in the thr ee meetings in which this issue had been on the 
agenda of the TRIPS Council, Chile had highlight ed the systemic importance of this discussion, 
particularly in relation to the legitimate use of flexibilities in the area of public health, and regarding 
the protection of IPRs and the legal certainty necessar y in international trade.  His delegation wished 
to reiterate that the right of WTO Members to regulate and protect public health, which was made 
abundantly clear in Article 8 of the TRIPS Agreement and the Doha Declaration, was not in dispute.  
The discussion did therefore not concern the legitim acy of measures to protect public health, nor 
should it be seen as a dispute opposing those for and against the protection of public health. 
205. Nevertheless, it was clear that any measure take n by Members to protect public health had to 
be consistent with the relevant in ternational trade agreements.  In th is case, they had to be consistent 
with provisions and recognized rights in the area of IP.  They also had to comply with TBT provisions, in particular with Article 2.2 of the TBT Agreement, which stipulated that technical 
regulations shall not be more trade restrictive than necessary to fulfil a legitimate objective. 
206. He said that Members did not dispute that tobacco had a harmful effect on health.  However, 
was there no other measure to reduce cigarette cons umption less onerous than prohibiting the use of 
trademarks, thereby undermining their capability to  distinguish the goods and services of one 
undertaking from those of other undertakings? The provisions of the TRIPS Agreement were clear in this respect, in particular Article 20, which specifica lly stated that the use of a trademark shall not be 
unjustifiably encumbered by special requirements,  such as use in a special form. If the plain 
packaging measure were deemed consistent with the TRIPS Agreement, did this then mean that every 
time a product was considered harmful to health, trademark owners coul d be stripped of their right to 
use their registered trademark, or that they might be  obliged to use their trad emark in such a way that 
it loses its distinctive character, and consequently its value? 
207. Chile believed that this issue related neither to tobacco nor to public health, but rather to the 
regulation of international trade in accordance w ith the WTO Agreements.  His delegation did not 
dispute the legitimacy of the objective sought by the Australian authorities, nor Australia's right to 
take measures to protect public health.  Howeve r, his delegation had serious doubts that imposing 
plain packaging for cigarettes was the least trade re strictive measure and that it was consistent with 
certain provisions of the TRIPS Agreement, in particular Article 20.  IP/C/M/69 
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  208. The representative of Canada said that her de legation followed with  interest the on-going 
international developments regarding the plain packaging of tobacco products, and how such a 
measure interacted with both IP and public h ealth.  She said that Canada had adopted and 
implemented the WHO Framework Convention on T obacco Control (FCTC) and encouraged other 
Members to consider doing so.  Canada had been  a pioneer in packaging requirements for tobacco 
products and her delegation recogni zed how challenging it was to introduce tobacco control measures 
that had never been implemented before.  Canada ha d been in a similar situation a decade ago when it 
had introduced pictorial health warnings on tobacco  packages.  This measure had been put in place 
after extensive research had suggested that it was effective at increasing public awareness of health 
effects and hazards.  It was her understanding that Australia had also conducted serious research to 
support the introduction of their new measure. 
209. She said that the information Australia had provi ded, and its experience with plain packaging, 
would help WTO Members gain a better understanding of the complex issues at stake.  She thanked 
Australia for updating the Council on the implementa tion of its plain packaging initiative, and its 
various implications, and was confident that Australi a, in the elaboration of its Bill, had taken into 
account the importance of respec ting international obligations. 
210. The representative of Zimbabwe said that her de legation shared the concerns expressed by the 
Dominican Republic and other dele gations as regards the likely c onsequences for consumers and 
producers of tobacco products of the plain packagi ng measures being put in place by Australia.  It was 
her delegation's view that Australia, like any othe r Member, was obliged to protect and advance the 
public health of its citizens within the limits of its undertakings and commitments under the WTO 
TRIPS Agreement. 
211. The representative of Mexico said that her delegation was sensitive to the legitimate 
objectives sought by Australia, which se rved as a basis for its plain pack aging bill.  At the same time, 
Mexico shared the concerns regarding potential co mmercial implications, and particularly the possible 
negative systemic implications of such a measure  as expressed in the statement by Chile.  The 
discussion on this measure did not just concern public health and tobacco, it was a more systemic 
issue and Mexico would continue to follow the deve lopments in the implementation of this bill very 
closely and analyse its consistency with both the TRIPS and the TBT Agreement.  
212. The representative of China said that her delegati on noted that the Draft Bill of Australia had 
the legitimate objective to protect human health by  introducing the requirement of plain packaging on 
tobacco products, with the aim to reduce their a ppeal to consumers and increase the effectiveness of 
health warnings.  With regard to the utilization of trademarks, Sections 20 and 22 of Tobacco Plain 
Packaging Act 2011 provided a general prohibition on marks appearing on retail packaging of tobacco 
products and on the wrapper.  Section 21 of the Act set out requirements for the appearance of brand, 
business, company and variant names on cigarette p acks and cigarette cartons, including the surfaces 
on which the names may appear and where the names may appear on those surfaces.  Division 2.4 of 
Tobacco Plain Packaging Regulations 2011 added to those requirements, and specified the typeface, 
font size, colour and capitalization of the bran d, business, company and variant names.  The 
Regulation prohibited any permitted tr ademarks or marks obscuring rele vant legislative requirements, 
or constituting or providing access to t obacco advertising and promotion.   
213. She said that without touching the legal natu re of these provisions, her delegation believed 
that these public health measures were also related to  IPR protection.  Members of WTO needed to be 
cautious and strike a balance between the protection of IP right holders and the public interest in 
general.  Her delegation believed that such measure s should not contravene in ternational obligations 
under TRIPS Agreement.   IP/C/M/69 
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  214. The representative of Brazil said that his delegation's position on the matter was well known. 
It believed that the existing international rules on IP should be supportive of public policy measures 
designed to protect public health within Members.  For Brazil, a balance had to be found with a view 
to guaranteeing the legitimate interests of right hol ders and, at the same time, ensuring that public 
health policies could be duly implem ented in our countries. Article 8 of the TRIPS Agreement and the 
Doha Declaration on TRIPS and Public Health s hould guide the interpretation of the applicable 
provisions on trademarks of the Agreement. 
215. The representative of Switzerland said that his delegation was supportive of public health 
measures in the area of anti-smoking as long as such measures were implemented in a manner 
consistent with the TRIPS Agreement and also the Pa ris Convention.  This meant that such measures 
needed to be both effective and proportionate, taking  into account the various interests at stake in a 
balanced manner.  It was against this background th at Switzerland had posed a question to Australia at 
the last meeting.  It referred to the consu ltation paper on the plain packaging amendment the 
Australian Government had submitted to interested st akeholders for comments in spring 2011.  This 
paper mentioned a caveat to the full ban of us ing the trademark, meaning that under certain 
circumstances the trademark could be used on the pa ckaging of the product under the new legislation, 
albeit under restrictions imposed by a regulation.  His delegation wished to ask whether Australia 
could clarify to the Council what the final vers ion of the Tobacco Plain Packaging Bill Act and 
implementing regulations, as they had now been approved, provided in that respect.   
216. The representative of Ecuador said that his delegation understood the concerns expressed by 
Members regarding the possible commercial and social  effects of the plain packaging bill.  This 
concerned especially the local farming communiti es as such a measure would seem to constitute an 
obstacle to a product exported by developing countries. 
217. With respect to the WHO taking the floor, th e Dominican Republic said that his delegation 
had no objection a statement to be made by the WHO Secretariat, as long as the statement focused on 
the health aspect and did not touch on aspects wh ich fell under the responsibility of the WTO.  He 
wished to repeat that the Dominican Republic did not deny the harm tobacco  caused to health, but 
what was of concern to his delegation was that a Pandora's box could be opene d which would have an 
impact on any products which countri es considered harmful to health. 
218. The representative of the World Health Organiza tion (WHO) said that tobacco use was one of 
the greatest threats to public health the world had ev er faced, and the single most preventable cause of 
death in the world today.  Globally, tobacco c onsumption killed nearly six million people a year 
through both direct use and the deadly effects of  second-hand smoke, more than 70 per cent of whom 
reside in low- and middle-income countries. Tob acco also represented the leading modifiable risk 
factor in the fight against the growing epid emic of non-communicable diseases (NCDs).  NCDs, 
primarily cancers, diabetes, cardiovascular a nd chronic lung diseases, currently accounted for 
63 per cent of all deaths worldwide.  These diseas es killed an astounding 36 million people each year, 
with nearly 80 per cent of deaths occu rring in low- and middle-income countries. 
219. He said that, as necessary tobacco control measures continued to be implemented in 
developed countries, the tobacco industry, throug h aggressive marketing and interference practices, 
had shifted its focus to new markets in the de veloping world some time ago.  As a result, 
tobacco-attributable mortality was rapidly increasing in  developing countries, and, by 2030, more than 
80 per cent of the world's tobacco deaths would occu r in low- and middle-income countries.  He said 
that, given that smoking caused 30 per cent of all ca ncers, including greater than 70 per cent of all 
lung cancers, 40 per cent of chronic respiratory diseases, and nearly 10 per cent of all cardiovascular diseases, it was a critical moment in the global effort  to curb the tobacco ep idemic for the introduction 
of necessary public health interventions under th e WHO Framework Convention on Tobacco Control 
(FCTC), like the measure under consideration in this Council.   IP/C/M/69 
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  220. He said that the economic costs of tobacco u se were equally as devastating as the public 
health costs.  Though the tobacco industry routin ely cited the economic contribution of tobacco, the 
reality was that tobacco use put an enormous financ ial burden on countries, in addition to the fact that 
tobacco and poverty were inextricably linked at the i ndividual level.  Nationally, the costs of tobacco 
use encompassed increased health-care costs, lost productivity du e to illness, premature death, and 
widespread environmental damage.  Thus, as tob acco consumption rates and tobacco-related illnesses 
increased in developing countries, so did tobacco-relate d healthcare costs.  Additionally, conservative 
estimates suggested that tobacco 's more than US$500 billion drain on the world economy exceeded 
total annual health expenditures in low- and middle-income countries.   
221. He said that the economic burden of NCDs, with  tobacco representing the largest risk factor, 
was also staggering. Recent macroeconomic simula tions suggested that, over the next two decades, 
cardiovascular disease, chronic respiratory disease,  cancer, and diabetes, would cause a cumulative 
output loss of more than US$30 trillion, representing 48%  of global GDP in 2010.  This in turn would 
push millions of people across the planet below the poverty line.  Because NCDs would result in long-
term macroeconomic impacts on labour supply, capit al accumulation and GDP worldwide, with the 
consequences most severe in developing countries, strong public health interventions, like the plain 
packaging measure, were relevant in addr essing both health and ec onomic concerns.   
222. He said that the WHO wished to draw the atten tion of delegations to the fact that the impact 
of tobacco and NCDs on both public  health and country economies ha d been highlighted at the recent 
United Nations High-Level Meeting of the General Assembly on the Prevention and Control of Non-Communicable Diseases, held in September 2011 in New York.  There, the UN General 
Assembly, comprised of Heads of State, had a dopted a Political Declaration which recognized the 
fundamental conflict of interest between the tobacco  industry and public health, and wherein Member 
States unanimously committed to advancing the implementation of multi-sectoral, cost-effective, population-wide interventions in order to reduce the impact of NCD risk factors.   
223. He said that the WHO was of the view that  the implementation of plain tobacco product 
packaging, representing a legitimate tobacco contro l measure, would have a substantial impact on 
tobacco consumption, was fully in line with the spir it and intent of the outcome of the UN High-Level 
Meeting, and was in accordance with internati onal legal obligations under the FCTC.     
224. Another representative of the WHO said that the FCTC consisted of a series of obligations to 
undertake tobacco control measures and that the pa rties to the WHO FCTC largely overlapped with 
WTO membership.  She said Members could refer to the comments WHO had made at the two 
previous Council meetings but she wished to draw the attention of the Council to an upcoming event 
that it the FCTC Secretariat was planning at th e WHO headquarters.  This event stemmed from a 
decision by the Conference of the Parties, the supreme governing body of the FCTC, to collaborate with and cooperate with the WTO Secretariat in terms of information shar ing and exploration of 
trade-related tobacco control measures and issues arising therefrom.   
225. The FCTC Secretariat was hosting on 15-16 Marc h a workshop at the WHO headquarters in 
order to promote the sharing of knowledge and in formation amongst representatives of countries that 
are parties to the FCTC and also Members of the WTO.  The primary goal was to invite health 
attachés and trade attachés of Permanent Missions in  Geneva to this works hop so as to examine the 
issues of intersection between tobacco control meas ures and trade-related issues.  She said that the 
FCTC Secretariat would very much welcome the pa rticipation by Members of the TRIPS Council and 
other WTO bodies.  
226. The representative of South Africa said that, althou gh there had been an opportunity to speak 
before the WHO took the floor, his delegation preferre d to reserve its comments.  This was an issue 
that South Africa had previously taken the floor on, and would continue to do so.  He said that the  IP/C/M/69 
 Page 41 
 
 
  discussion Members were having in the Council w as a very sensitive discussion that involved a 
tension between public health and a legitimate ri ght to trademark protection.  His delegation 
recognised the sensitivity of the issue even if it did not have a view one way or the other.  His delegation did, however, believe that the remit of  the TRIPS Council went beyond the issues that the 
representatives of the WHO had correctly raised and which were substantively the same as had been 
heard before.  
227. South Africa had no difficulty as a delegation with what it had heard.  He did, however, 
consider it worth recalling that Members' responsibility  was both to the questions of public health, and 
to the trade and commercial aspects of the issue.  Therefore, although his delegation appreciated the 
WHO's angle, it considered it worthwhile reca lling the presentation from Chile, which he believed 
had been very balanced and had brought forwar d precisely the responsibilities that Members had in 
the Council.  His delegation wished therefore to ur ge the WHO, in going forward, to also appreciate 
that Members' mandate in this body was broader than  the issues WHO had to consider.  He said that 
his delegation had expressed this particular concern at  the Council's last meeting, and would continue 
to do so, also in stronger terms if  necessary, as it was important that this Council be allowed to have 
an in-depth debate on this issue that was within the framework of its mandate. 
228. The representative of the Dominican Republic sai d that what the WHO had requested would 
amount to allowing it to hold debates on the functions of this organization. He said that the WHO 
event could be helpful, given that the WHO had exte nded invitations to a series of seminars including 
on tobacco consumption as well as on alcohol consumpti on, both of which were harmful to health and 
had a high cost burden throughout the world.  
229. The Council took note of the statements made.  
N. IP ENFORCEMENT TRENDS  
230. The Chairman said that this had been put on the agenda at the written request of the 
delegations of Australia, Canada , the European Union, Japan, Korea, Mexico, New Zealand, 
Singapore, Switzerland and the United States.  They had also requested that the text of the Anti-
Counterfeiting Trade Agreement (ACTA) be circulated  to Members.  He recalled that the text had 
already been circulated in advance of the Counc il's October 2011 meeting in document IP/C/W/563 
entitled "Enforcement of Intellectual Property Rights". 
231. The representative of Japan reported on develo pments on ACTA since the Council's last 
meeting.  On 26 January 2012, the European Un ion and 22 of its member States had signed the 
agreement in Tokyo.  It was hoped that other par ticipants to the agreement who had not yet signed it 
would soon be able to do so.  No instrument of ratification, acceptance or approval had been deposited 
so far with the Government of Japan in its capacity as the agreement's Depositary.  
232. ACTA represented a modest but important step fo rward in order to deal with infringement of 
IPRs, in particular given the proliferation of co unterfeiting and piracy in the current technological 
environment, as well as the diversification and refineme nt of IP infringing activities.  This had led to a 
substantive expansion of counterfeiti ng and piracy at the global level since the entry into force of the 
TRIPS Agreement.  The purpose of circulating the te xt of ACTA was to clarify what was provided for 
and what was not covered by the agreement, as we ll as to give an overview of the many optional 
provisions included therein.  Some Members might thus realize that they had already legislative 
measures in place that were similar to those pr ovided under ACTA.  To address certain concerns 
expressed about the potential impact of ACTA, he underlined that the agreement explicitly provided 
for its implementation to be done in a manner that avoided the creation of new barriers to legitimate 
trade. IP/C/M/69 
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  233. The representative of the United States welcom ed the opportunity to discuss enforcement of 
IPRs, which could serve to dispel some mispercepti ons about IP enforcement in general and ACTA in 
particular.  In his delegation's view, the effectiv e enforcement of IPRs was critical to sustaining 
economic growth across all industries and globally .  The proliferation of counterfeit and pirated 
goods, as well as of services that distributed infring ing material, undermined legitimate trade and 
sustainable development of the world economy, cau sed significant financial losses for right holders 
and for legitimate businesses, and, in some cases,  provided a source of revenue for organized crime 
and otherwise posed risks to the public.  Eff ective IPR enforcement benefited from enhanced 
international cooperation and more effective international enforcemen t.  He said that principles 
regarding effective IPR enforcement thus formed part of the bedrock of ACTA. 
234. To help promote a dialogue among Members, his delegation wanted to address some of the 
issues that had been raised at the Council's last meeting in October 2011.  In response to the question 
asked by the delegation of Zimbabwe about the "lacunae" in the TRIPS Agreement which ACTA 
sought to address, he provided a few examples.  First,  ACTA provided a forum for its participants to 
work cooperatively together to protect and enfor ce IP.  The ACTA cooperation provisions were more 
extensive than those in the TRIPS Agreement, but as  with the rest of ACTA, they were fully TRIPS-
consistent. ACTA further provided that Parties to the Agreement had to authorize their border 
enforcement authorities to act on their own initia tive against trademark counterfeit and copyright 
pirated goods.  This addressed a gap in existi ng standards under which customs officials were 
sometimes powerless to take action against fake and pirated goods. Applic ation of this stronger 
standard would help protect consumers.  Fina lly, ACTA included new commitments on the seizure 
and destruction of fake goods, on the seizure of  the equipment and materials used in their 
manufacture, and on the seizure of the criminal proceeds from piracy and counterfeiting offenses.  This ensured that police and prosecuto rs would be able to take away both ill-gotten gains and the tools 
of illicit trade. 
235. When the TRIPS Agreement had been negotiated almost 20 years ago, the type of complex 
distribution webs encountered today had not existed.   ACTA was intended to ensure that enforcement 
authorities had the legal tools to address the new sophisticated ways by which illegal, and often 
deadly, products were distributed.  The examples pr ovided to the delegation of  Zimbabwe reflected an 
effort to provide appropriate tools.  Government s had to modernize their approaches to adapt to 
evolving illegal activities, especially  to keep up with criminals.  
236. Turning to concerns expressed about the impact of ACTA on generic medicines, the 
representative of the United States clarified that ACTA  did not target such medicines. Among others, 
ACTA did not require border enforcement of pate nts.  On the other hand, border enforcement of 
trademarks constituted an important element of prot ecting the public.  In the United States, authorities 
had, for example, recently uncovered a significant problem of fake cancer drugs in the domestic 
supply chain.  Among other things, such fake  drugs sometimes bore counterfeit trademarks.  
Empowering border authorities to act in regard to such fake trademarks could have real health 
benefits. 
237. As noted by the delegation of Japan, Article 13 of ACTA provided, similarly to the TRIPS 
Agreement, that barriers to legitimate trade should be avoided.  Furthermore, ACTA also protected 
against abuse.  Like the TRIPS Agreement, it sti pulated that IP enforcement procedures "shall be 
applied in such a manner so as … to prov ide for safeguards against their abuse." 
238. With respect to questions regarding transparen cy which were raised at the Council's last 
meeting, he said that ACTA was not secret.  A draft had been released in April 2010, while 
negotiations had still been ongoing.  A near-final text had been published in Oc tober 2010, as well as 
the final text in December 2010.  In May 2011, Fren ch and Spanish translations had been published. 
The final English text had thus been public for more than a year.    IP/C/M/69 
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  239. The representative of Switzerland said that a fair amount of misleading, if not wrong, 
information was circulating about ACTA.  His delegation was therefore pleased to seize this 
opportunity to clarify a number of points and, in particular, to address the objectives of ACTA, including the benefits which ACTA Parti es hoped to derive from the agreement.   
240. He emphasized that ACTA dealt with measure s to effectively enforce IPRs and more 
specifically to combat counterfeiting and piracy.  ACTA  was thus not ratcheting up higher levels of IP 
protection, but rather aimed at enforcing more effe ctively existing standards of protection. It focused 
on large scale, commercially-oriented counterfeiti ng and piracy.  Those activities, which were 
constantly growing, had a significant negative im pact on the world economy, on legitimate business 
and on the public's health and safety. 
241. ACTA had not been negotiated by 38 like-minde d Parties to bypass multilateral institutions.  
On the contrary, his delegation, like the other AC TA Parties, would have preferred to address the 
growing problem of counterfeiting and piracy, includ ing ways and means how best to counter that 
trend, in multilateral fora like the WTO or WIPO.  There had been numerous attempts to do so in the 
past, during which it had been clarified that th e purpose of such a discussion was not about finger 
pointing but to take up a challenge that all Memb ers faced jointly and which should therefore be 
addressed jointly.  However, there had been strong opposition from a number of countries to even raise or discuss the subject in these fora. 
242. Counterfeiting and piracy was a challenge of tr ansnational character to which efforts at 
national level could not provide an effective solu tion. ACTA Parties had therefore opted for the 
second best alternative, i.e. to take a step forward among a group of like-minded countries. Since 
countries depended on each other in order to ad dress the issue of counterfeiting and piracy, 
cooperation was in their mutual interest. This responded to a challenge which not only created 
enormous economic damage, but also represented in ma ny instances serious safety and health risks for 
their citizens. 
243. Switzerland had adopted a range of measures to  combat counterfeiting and piracy at the 
national level.  The Swiss anti-counterfeiting and piracy platform, called STOP PIRACY, represented 
such an instrument.  It allowed for enhan ced coordination and cooperation among competent 
government agencies as well as between the public and private sector. 
244. Enhanced cooperation between the ACTA Partie s, as provided for in Chapter IV of the 
agreement, could reinforce such national efforts by  adding the international dimension.  It thus 
contributed to efforts to address the growing prol iferation of counterfeiting and piracy in a more 
effective manner than could be done at the national level.  ACTA represented an effort by a group of 
like-minded countries, both developing and developed,  to cooperate with a view to supporting each 
other in their efforts to more effectively combat counterfeiting and piracy. 
245. The representative of Singapore welcomed the opportunity to discuss IP enforcement trends, 
particularly to provide clarifications on issues rela ted to ACTA.  It was important to base discussions 
on ACTA on the actual provisions in the final text, rather than on proposed la nguage which had been 
deleted or on provisions which were  misattributed to ACTA, or extr apolations of ACTA provisions.  
246. In reaction to concerns that ACTA could re duce the freedom of access to the Internet and 
impede cross-border trade, in particular as regards the movement of generic medicines across borders, 
she said that ACTA would not interfere with a signato ry's ability to ensure that citizens continued to 
enjoy ease of legitimate access to the Internet.  Sim ilarly, ACTA did not limit the ability of signatories 
to exercise flexibilities that exis ted within the TRIPS Agreement, nor did it prevent signatories from 
protecting or enforcing IPRs in a manner conduciv e to social and economic welfare. Nothing in 
ACTA imposed a requirement on signatories to introduce a specific measure, such as a graduated IP/C/M/69 
Page 44  
 
  response (three strikes) or site-blocking policy, ag ainst copyright infringement.  ACTA also did not 
compel Internet service providers to monitor Internet users' traffic.  
247. As a small country with a strong interest in  international trade, Singapore placed great 
importance on a multilateral rules-based system. A key pr iority had therefore been to ensure that the 
enforcement measures in ACTA were consistent with  existing international IP agreements and did not 
create new barriers to trade. Nothing in ACTA  derogated from the TRIPS Agreement, which 
established minimum  standards for IP protection.  ACTA was built on existing TRIPS flexibilities. 
Nothing in ACTA obliged border authorities to search  travelers' baggage or their personal electronic 
devices for infringing materials.  As regards more  specifically access to medicines, there were no 
provisions in ACTA which hindered the cross-border tr ansit of legitimate generic medicines.  Patents 
were not covered in the section on border meas ures.  ACTA was consistent with the TRIPS 
Agreement and respected the Declaration on TRIPS and Public Health. 
248. The representative of Canada said that th e ACTA partners had been committed to 
transparency throughout the negotiations.  Since Augu st 2008, they had issued joint public statements 
after each round or meeting.  Her delegation, lik e other ACTA negotiating partners, had undertaken 
consultations with stakeholders throughout the ne gotiations.  As agreed during the sixth round of 
negotiations that had taken place in Seoul in Nove mber 2009, the participants to ACTA negotiations 
had published the agenda for each round in advance of the meeting.  They had published a summary 
of elements under discussion in the ACTA negotiations in April 2009.  A fact sheet prepared by the participants to the negotiations had been made av ailable to the public in April 2010.  Following the 
round of negotiations in New Zealand, they had re gularly released a revised negotiating text to the 
public with a view to increasing transparency and to providing accurate information to the public 
about the negotiations.  She also stressed that, in en couraging higher standards, there was no intention 
to exclude any country from joining efforts to co mbat counterfeiting and piracy. The agreement had 
been negotiated with a view to being inclusive and attracting accessions from other countries.   
249. The representative of New Zealand said that ques tions had been raised for some time about 
the challenge of enforcing IPRs in the digital e nvironment.  In recent months, there had been many 
misleading statements about possible negative impacts of ACTA.  For example, ACTA had been unfairly accused of posing a threat to freedom of expression on the Internet, stifling innovation, and 
negatively affecting indi viduals' abilities to access and use the Inte rnet.  Freedom of speech, fair 
process and privacy were core values for her dele gation.  These values applied in both the physical 
world and on the Internet.   Freedom of speech did not mean, however, that a person had a right to 
engage in unauthorized reproduction, distribution and sale of copyright-protected works over the 
Internet. 
250. All WTO Members were required to provide co pyright protection as set out in Articles 9 
to 14 of the TRIPS Agreement.  Pursuant to Article  41, procedures for enforcement of IPRs, including 
copyright, had to be effective and remedies to infri ngement had to constitute a deterrent to further 
infringements.  The TRIPS Agreement did not allow its Members to turn a blind eye to copyright 
piracy that was increasingly occurring over the Inte rnet.  Accordingly, Article 27 of ACTA obliged 
each Party to ensure that enforcement provisions were available under their laws so as to permit 
effective action against copyright infringements in the digital environment. 
251. She noted that a common fiction perpetuated about ACTA by critics was an unsubstantiated 
allegation that ACTA interfered with civil rights an d in particular freedom of expression.  Article 27 
contained clear and unequivocal language that a Party was not required to interfere with either civil 
rights or freedom of expression.  It stated that "procedures shall be implemented in a manner that avoids the creation of barriers to legitimate activ ity, including electronic commerce, and, consistent 
with that Party's law, preserves fundamental prin ciples such as freedom of expression, fair process, 
and privacy".    IP/C/M/69 
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  252. Another common fiction perpetuated about AC TA was that it required the blocking of 
Internet access as a result of copyright infringement.  She clarified that the ACTA text did not contain 
a requirement to block access to the Internet, nor  did it require the criminalization of illegal 
downloading.  In her delegation's view, ACTA struck  an appropriate balance between the rights and 
interests of rights holders, Internet service providers and users of online content, while also explicitly 
preserving fundamental principles such as freedom of expression, fair process, and privacy. 
253. The representative of Australia said that AC TA was an important initiative to address 
growing international trade in counterfeit trademar k and pirated copyright goods.  Concerns raised 
during previous discussions in the Council and else where that the enforcement provisions in ACTA 
could undermine the balance in the TRIPS Agreem ent were unwarranted. Participants to ACTA 
negotiations had worked hard to achieve a balanc ed agreement. The final text stroke a balance 
between use and protection  of IP and affirmed, and built on, the balance and flexibilities in the TRIPS 
Agreement. 
254. In particular, all TRIPS flexibilities were preser ved because ACTA made specific reference, 
in Article 1, to not derogating from any obligation of  a Party, with respect to any other Party, under 
existing agreements, including under the TRIPS Agre ement.  Furthermore, Article 2(3) of ACTA 
explicitly stated that the objectives and principles in Part 1 of the TRIPS Agreement, in particular its 
Articles 7 and 8, were applicable to ACTA.  Article  7 addressed the balance in IP systems, i.e. the 
rights and obligations of producers and users, a nd Article 8 provided flexibilities for Members in 
formulating and amending legislation and regulations in the public inter est.  In addition, Article 6 of 
ACTA incorporated the standards in TRIPS Article  41 dealing with "enforcement obligations" and 
those in Article 46 dealing with "other remedies ".  Amongst other things, ACTA Article 6 required 
that (i) enforcement procedures be applied "in such  a manner as to avoid the creation of barriers to 
legitimate trade and to provide fo r safeguards against their abuse", (ii) procedures implementing the 
provisions of the chapter be "fair and equitable", (iii) Parties provide "for the rights of all participations subject to such procedures be appr opriately protected", and (iv) Parties "take into 
account the need for proportionality between the seri ousness of the infringement, the interests of third 
parties and the applicable measures, remedies and pe nalties".  Therefore, the ACTA text explicitly 
preserved and affirmed the important balance and flexibilities contained in the TRIPS Agreement. 
255. The representative of the European Union said th at businesses based on creativity required the 
protection and enforcement of IPRs.  The most conservative estimates put the size of the global 
counterfeiting and piracy industry at €200 billion a y ear.  But that estimate excluded all Internet 
piracy, as well as any act of counterfeiting and piracy where the product was sold in the country of 
production.  The EU had a comprehensive system to protect and enforce IPRs which had been 
implemented in its 27 member States together with national enforcement authorities.  When 
elaborating its IPR regime, the rights of citizen s to free speech, data protection and access to 
information had been safeguarded, as well as the rights of Internet service providers and other 
intermediaries who dealt with protected goods.  These  two goals were compatible and even mutually 
supportive. 
256. IPR enforcement in the EU was evolving to b ecome increasingly effective.  The EU customs 
enforcement legislation, which had already resulte d in annual detentions of more than one hundred 
million fake objects, was currently being reviewed.  There were also plans to revisit the civil 
enforcement legislation.  Furthermore, a European  Observatory on the protection of IPRs had been 
established. Its primary goal was to obtain factual and accurate information that was needed to better 
substantiate new policy measures and to optimize resources. 
257. In addition to the work in the area of enforcement, the European Commission was also 
preparing initiatives to make digital content more acc essible to citizens.  For instance, a pan-European 
licence for music, easier licensing for "orphan works" , and the creation of online digital libraries were IP/C/M/69 
Page 46  
 
  under consideration. Such initiatives sought to give  consumers and users better access to cultural 
content while allowing for new business models to thrive.   
258. He said that ACTA was another important tool to  ensure more effective IP enforcement at the 
international level.  It was an enforcement tr eaty which dealt with civil, criminal and border 
enforcement.  It also set out some basic prin ciples for Internet enforcement and encouraged 
international cooperation between 38 countries.  While not covering the details of what was legal and 
what was illegal, ACTA addressed procedures for ensu ring that what was illegal could be redressed. 
ACTA thus simply meant that companies and indivi duals who wished to protect their ideas so as to 
defend their livelihoods would find it easier to do so in the 38 countries that had participated in the 
negotiations.  
259. His delegation would have preferred that ACTA be negotiated at a global level, but this had 
not been possible.  Thus, ACTA constituted a significan t first step by a nucleus of countries that were 
committed to the highest standards of IPR enforcem ent.  This nucleus was expected to grow.  
Countries joining the agreement would see the benefits  of effective enforcement measures in terms of 
increased investment and innovation, as well as more  generally economic growth and the creation of 
quality jobs.  For example, the OECD  had found that an increase of 1 pe r cent in the strength of patent 
rights led to an increase of 1.7 per cent in foreign direct investment flows in developing countries. 
260. The representative of the European Union gave  examples of misconceptions about ACTA.  
As regards access to medicines, there were no provis ions in ACTA that could directly or indirectly 
affect the legitimate trade in generic medicines or , more broadly, global public health.  On the 
contrary, ACTA contained unequivocal language  safeguarding access to medicines and expressly 
referred to the Doha Declaration on the TRIPS Ag reement and Public Health.  ACTA also excluded 
patents from criminal and border measures.  
261. As regards concerns expressed about the transpar ency of the negotiating process, he said that 
ACTA had not been negotiated in secret.  The text  of ACTA had been made publicly available since 
April 2010.  It had already been made public duri ng the negotiations.  His delegation had organized 
four stakeholder conferences on ACTA, which had b een open to all stakeholders, including citizens, 
industry, NGOs and press.  Negotiators had also met and extensively debriefed NGOs, academia and 
representatives from political parties in public debates he ld as side events in the margins of the last 
four rounds of negotiations. 
262. The representative of Mexico said that he r Government recognized that piracy and 
counterfeiting had had a very significant impact worldwide, calling for solutions that required 
effective international coordination, including the establishment of higher standards for the 
enforcement of IPRs through agreements such as ACTA .  With a view to the implementation of more 
effective measures to combat IPR violations, her de legation was convinced that active involvement in 
the development of mechanisms for cooperation am ong countries would make it possible to ensure 
better protection of IPRs. 
263. The representative of Korea addressed the relati onship of ACTA with the TRIPS Agreement. 
In her view, ACTA was a legal framework for coun tries to more effectively combat counterfeiting 
and piracy, which built on the TRIPS Agreement but  did not supplant nor undermine it. It thus 
complemented the TRIPS Agreement in terms of IPR enforcement and was fully consistent with it.  
The TRIPS Agreement set minimum standards fo r IPR protection, which granted its Members 
flexibilities to choose effective measures and procedures to implement its objectives.  
264. As regards concerns about a possible conf lict between ACTA and basic human rights, 
including freedom of speech and privacy, namely by changing the role of Internet service provider, 
she emphasized that ACTA stroke a fair balance between the need to protect innovation on the one  IP/C/M/69 
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  hand and the rights of consumers and public inter ests on the other hand.  It had all the necessary 
safeguards to shield freedom of speech, piracy and data protection.  This was expressly stipulated in 
Article 27.  In addition, ACTA only focused on IPR infringement on a commercial scale, not on 
private, non-commercial activities of individuals.  It  did not affect the free flow of non-pirated 
information, nor did it require Internet service providers to monitor individuals.  
265. While ACTA sought to strengthen the level of  IPR protection in general, it provided its 
Parties with enough discretion on the measures to be  taken domestically.  The reason was that each 
country had different legal system and the balance to  be struck between the protection of right holders 
and public interests varied from one country to an other.  Such flexibilities in ACTA could enable 
more countries to join the agreement in the future .  In her view, ACTA provided for a well-balanced 
and flexible legal framework for Members to be tter achieve the objectives of IPR protection, as 
stipulated in the TRIPS Agreement, through comba ting counterfeiting and pira cy.  ACTA could thus 
contribute to a sounder multilateral trading system.  She hoped to work closely with all Members in 
the Council on how to best protect IPRs in an effective and balanced manner. 
266. The representative of Malaysia said that Members' views differed on whether the current level 
of IP enforcement under the TRIPS Agreement was sufficient or whether additional measures needed 
to be taken.  This underlined the need for and im portance of preserving flexibilities in determining the 
appropriate level of enforcement obligation.  The TRIPS Agreement provided such flexibility, as it 
imposed minimum standards, while recognizing Memb ers' right to adopt higher standards.  This 
flexibility should not be restricted, neither by ra ising the floor on what had to be done, nor by 
imposing a ceiling on what could be done. 
267. The representative of India recalled that, at th e Council's meeting in October, his delegation 
had pointed out that TRIPS-plus provisions in plurilateral agreements like ACTA and TPP could 
undermine the flexibilities and disturb the delicate ba lance provided by the TRIPS Agreement, thus 
adversely affecting access to health in the deve loping countries.  This issue equally affected 
developing and develope d countries.  The unprecedented econom ic and financial crisis in the 
developed world and the austerity measures that ha d been taken by many countries, had adversely 
affected their health budgets.  In such a situation,  it was essential that access to affordable medicines 
did not get circumscribed by agreements like ACTA  and TPP, which were motivated by the interests 
of pharmaceutical companies.  
268. For instance, reports on the situation in Gr eece had highlighted how its extensive public 
health care system, under which care had been taken of every need of its people, had been pushed 
hard for dramatic cost savings in order to cut back on the deficits.  These measures were taking a 
brutal toll on the system and on the country's growing number of poor and unemployed, who could 
neither afford high health insurance premiums nor  high cost of drugs applied by the pharmaceutical 
companies.  Similar austerity measures in other parts of Europe were beginning to affect access to medicines for patients. 
269. He said that the post-TRIPS era had seen a reduction in the policy space required for 
designing IP policy.  It had witnessed an enormous increase in cost of essential medicines and the countries that lacked manufacturing capacity were in  a further difficult situation.  For the last few 
years, barriers had been created, even to import ge neric medicines, through their seizure during their 
transshipment at European ports.  Attempts were al so made through bilateral,  regional and plurilateral 
agreements to stifle the manufacturers of generic medi cines that were a life line for billions of poor in 
the developing countries.  In his delegation's view , the Council would be better advised to deliberate 
on how the TRIPS Agreement could promote access to health for the billions of  needy people rather 
than discuss the IP agenda of a few countries. IP/C/M/69 
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  270. Despite the statements made by ACTA signa tories and their reassurance that ACTA would 
not affect access to medicines in developing countries, his delegation was nevertheless afraid that, once ACTA comes into force, the ACTA border meas ures, which were currently limited to some parts 
of Europe, could be extended to the territories of other ACTA signatories.  This would further stifle the supply of generic medicines to the needy countries .  The very need of ACTA remained unclear in 
the absence of reliable estimates of  the extent of counterfeiting and piracy and the exact impact of 
such activities on domestic industry.  Various industry  estimates had been criticized for being based 
on downright incorrect data and at best dubious met hodology to the extent that some estimates relied 
on failure to meet targeted sales as evidence of piracy and counterfeiting. 
271. He referred to several ACTA provisions which might be worrisome for developing countries 
despite the ostensible removal of "patents" from th e ambit of border measures.  First, ACTA was not 
limited to 'counterfeiting', as defined in the TRIPS Agreement.  Even while admitting that the term 
'counterfeit' applied to trademarks only, the agreemen t had extended it to all forms of IPRs as covered 
under the TRIPS Agreement, including data, copyrights, pa tents, etc.  Stating th at patents were not the 
subject matter of the Agreement would be inappropria te.  For example, while patents (and undisclosed 
information) were kept outside the scope of borde r measures, the application of civil enforcement 
measures was preserved on an optional basis in the agreement.  This represented a marked increase 
over the TRIPS Agreement which limited itself to counterfeit trademark and pirated copyright goods 
only.  In addition, by criminalizing wilful use of trade labels or packaging without authorization by 
the right holder, Article 23.2 of ACTA clearly militated against parallel importation even though the 
relevant domestic law might not expressly forbid it. 
272. As regards border measures, ACTA initially  went much beyond TRIPS Article 51 and 
included all forms of IPRs.  However, in response to criticism voiced during the secret negotiations of 
ACTA, as well as in the light of several incidents of generic drugs in transit seized at European ports, 
the ACTA signatories had finally decided to exem pt patents and undisclosed test data from border 
measures.  While this move had to be welcomed, the mandatory application of border measures to 
other forms of IPRs could still affect the trad e in goods transiting through ACTA countries.   
273. The representative of India recalled that in p ast Council meetings, his delegation and other 
Member had highlighted their concerns over the seiz ure of generic medicines in transit at European 
ports when there had been no IP infringement.  Some  consignments had been detained not for patent 
violation but had been suspected of trademark violation.  Based on ACTA's expansion of border measures far beyond "counterfeit trademark or pirated copyright goods", seizures of suspected 
"confusingly similar" trademarks  could be authorized.  Taking a decision on cases of ordinary 
trademark infringement required a comprehensive legal analysis, which was much less straightforward than determining whether goods were  counterfeit.  Such an assessment was typically 
performed by courts or trademark offices, which had the necessary legal expertise, case law, and experience to rely upon.  Imposing this task on cust oms officers was likely to result in a considerable 
increase in seizures and temporary detentions based on right holder allegations that transiting products 
were confusingly similar. 
274. Article 16 of ACTA extended the requirement s with respect to border measures while 
reducing safeguards.  Under ACTA, ex officio seizu res were mandatory, as well as the application of 
border measures to exports.  No reference was made  to a prima facie evidence requirement or limited 
duration of the suspension pending a determination on the merits.  This went much beyond TRIPS 
Article 58 that imposed restrictions on the ability of customs officials to take ex officio action to stop 
goods at the border without any complaint from a right holder.  Further, right holders could also use 
this customs authority to launch harassi ng actions against legitimate competitors. 
275. Finally, the delicate balance established by Artic le 57 of the TRIPS Agreement with respect 
to the right of inspection and information was up set by Article 22 of ACTA which favoured right  IP/C/M/69 
 Page 49 
 
 
  holders vis-a-vis the importer of goods.  This provi sion could be used by right holders to discover 
details on distribution chains of generic companies on the basis of alleged infringement rather than 
proven infringement.  These companies could then mount aggressive and expensive litigation against 
suppliers and intermediaries to dete r generic entry into key markets.  
276. His delegation was also concerned about new be nchmarks for international standards on IP 
enforcement being established by ACTA.  These st andards were likely to become the bedrock of 
future negotiations between de veloped and developing countri es in various RTA negotiations 
currently under way.  As the lure of immedi ate market access was a potent one, many of the 
developing countries might end up accepting these st andards as their own.  This would severely 
inhibit South–South trade since it would impose ob ligations on the importing countries to follow the 
new standards of enforcement. 
277. Another matter of concern was the impact of AC TA on digital goods a nd Internet freedom. In 
this regard, ACTA obligations with respect to the enforcement of copyright were not only of 
particular interest, but also problematic.  Tho se included digital rights management and technology 
protection measures, which were coupled with ne w norms for damages for infringement, such as the 
suggested retail price of goods being the determinant factor for the injury.  This could have a severe 
impact on the efforts towards literacy and access to knowledge and information that had been at the 
core of the aspirations of the developing world to  convert themselves into information societies and 
knowledge economies.  In these areas, consumers in the US and the EU were rightfully concerned, 
because ACTA was fundamentally hostile to consumers, by systematically excluding consumer interests from having meaningful roles in the ACTA negotiations.  This practice was expected to be 
continued by the ACTA Committee, which was under no obligation to operate in a transparent, open 
and inclusive manner. 
278. He concluded by reiterating his delegation's concern that the adverse effect of TRIPS-plus 
enforcement provisions contained in ACTA and other plurilateral agreements could affect developing 
countries and developed countries likewise.  It was th erefore essential that co llective efforts be made 
to protect the policy space needed not only to ensu re access to affordable medicines but also to 
provide freedom to mankind. 
279. The representative of Ecuador said that, in his view ACTA was an agreement that sought to 
create a form of basic general framework which went  beyond the TRIPS Agreement in terms of levels 
of enforcement in the multilateral sphere.  It also see med to be more targeted at developing countries.  
The main participants in the ACTA negotiations  were developed countries which most probably 
already had similar legal enforcement standards in place while many developing countries did not 
have such standards in their domestic legislation fo r reasons relating to inte rnal sovereign decisions 
and economic and social development.  In his view , ACTA violated the basic principles of the United 
Nations Declaration on the Right to Development insofar as the Declaration clearly established the 
primacy of self-determination and the principle of inclusive participation in multilateral 
decision-making processes affecting people's economic and social development. 
280. More specifically, the measures introduced in Article 9 of ACTA on damages might make 
natural and legal persons more cautious in their leg itimate activities because of the risk of not meeting 
these very high legal standards, w ithout really achieving the objec tive of preventing undesirable illicit 
activities.  In the area of copyright, in particular, effective solutions to extensive infringements, which 
occurred both in developing and developed countries, would be better based on improved access 
through content that was legitimately licensed at re asonable prices.  His was concerned about ACTA's 
new and much more aggressive rules on damages which would severely weaken the legitimate TRIPS 
flexibilities provided for in Article 44.1 and 44.2 on in junctions.  Its rules on civil liability would not 
only be much harder to implement, but would actually  be inconsistent with the current national legal 
systems of most WTO Members. IP/C/M/69 
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  281. He said that the increase in civil liability re quirements in ACTA in relation to possible 
infringements could create a bias in favour of IP ri ght holders, to the detriment of the rights of 
consumers and users.  By granting special rights to right holders, including specific rights authorizing 
such holders to elaborate extensive theories before courts on damages, hitherto unheard of in legal 
systems and case law, ACTA appeared to attempt to increase the level of risk involved in any activity 
where there was the slightest possibility of committing an offence.  For this reason, ACTA was most 
probably inconsistent with the objectives of Article  7 and the principles of Article 8 of the TRIPS 
Agreement which guaranteed:  (i) a balance of  rights and obligations between producers and 
consumers of IP;  (ii) the promotion of the public interest in sectors of importance for countries;  and 
(iii) the prevention of the abuse of IPRs by right holders. 
282. The representative of Egypt said that the TRIPS Council should not be a forum to promote 
TRIPS-plus standards.  ACTA had created a heated  controversy in many countries that had signed the 
agreement.  In some cases, this had led countries to freeze the verification process, driven by fears 
that ACTA might be constraining access to informati on, knowledge and health.  Such trends in IP 
enforcement could accentuate the tension between IP and public policies and should therefore be dealt 
with very carefully.  He said that the Council' s discussion on IP enforcement trends should be 
informed by development considera tions and imperatives, instead of  looking into the narrow scope of 
police, customs and judicial measures.  Issues re lated to affordability and availability, even of 
protected subject-matters, needed to be considered so as to ensure effective enforcement of the IP 
standards contained in the TRIPS Agreement.  IPR enforcement had to be ad dressed in the context of 
broader interests, taking into account development- oriented concerns, as stipulated by the TRIPS 
Agreement according to which "the protection and enforcement of IPRs should contribute to the 
promotion of technological innovation and to the tr ansfer and dissemination of technology, to the 
mutual advantage of producers and users of t echnological knowledge and in  a manner conducive to 
social and economic welfare, and to a balance of rights and obligations". 
283. The representative of Bangladesh drew Members' attention to the fact that LDC countries 
were entitled to TRIPS flexibilities in  order to create a level playing field for their infant industries 
and also to give them time to develop necessary infrastructure of enforcement.  If higher standards 
than those set by the TRIPS Agreement were put in  place, LDCs would find it difficult to exert.  
Besides the possible impact of ACTA on LDCs regarding vital issues such as access to generic medicines, various issues regarding access to conten t on the Internet remained unclear.  This would 
put additional burden on LDC enforcement agencies.  Among others, consideration of the role of right 
holders by the judicial authorities in determini ng compensation or damages might lead to undue 
advantage.  While taking note of statements by some delegations according to which ACTA did not 
target generic medicines, he said that mechanisms to differentiate  between generic and counterfeit 
medicines had to be established in order to avoi d unnecessary harassment.  Furthermore, ACTA did 
not seem to take development components of enforcement measures adequately into account. 
284. The representative of Br azil said that IPRs had been nego tiated during the Uruguay Round as 
part of a broader package, which included agricu lture, NAMA, services and other areas.  There was 
no mandate to discuss TRIPS-plus enforcement me asures in the Council.  The discussion of ACTA 
could therefore only be of an informative nature. 
285. IP infringement was a global phenomenon, wh ich affected developing and developed 
countries, albeit in different ways.  Given the comple xities involved, "one size fits all" solutions were 
not the best approach.  Each country required sp ecific solutions.  Only a broad discussion at the 
multilateral level could therefore reflect the different political and social variables. 
286. He drew Members' attention to TRIPS Article 1.1, which allowed Members to determine the 
appropriate method of implementing the provisions of  the Agreement within their own legal system 
and practice.  In addition, Article 41.5 stated that  there was no "obligation to put in place a judicial  IP/C/M/69 
 Page 51 
 
 
  system for the enforcement of intellectual property ri ghts distinct from that for the enforcement of law 
in general (…) ". 
287. ACTA was a plurilateral agreement negotiated with selective participation, which did not 
follow the standards of inclusiveness and transparen cy of multilateral negotiations.  A superficial 
approach risked, among others, that (i) IPRs be a bused;  (ii) obstacles to legitimate commerce be 
erected, which had already led to serious conse quences in the area of public health, with the 
apprehension of medicines in transit;  and (iii) due  process of law be disregarded and civil rights not 
be respected. 
288. A number of analyses questioned the compatib ility of ACTA with the TRIPS Agreement, 
regarding its provisions on border measures, civil a nd administrative procedures and remedies, as well 
as provisional measures.  ACTA only provided repression as the remedy to counterfeiting and piracy.  
There was, however, a growing perception that, in order to face IP infringement, a comprehensive 
policy was necessary, combining repr essive measures, educational effo rts and public policies to foster 
the creation of formal jobs. 
289. The agreement claimed to strike a balance betw een IP enforcement and the rights to freedom 
of expression and privacy, in particular due to the ex istence of some safeguards in the text.  However, 
substantive provisions raised concerns that it was bi ased in favour of IP right holders.  There was no 
guarantee that the implementation of  its substantive provisions woul d not affect fundamental civil 
rights, such as the right to privacy, presumption of innocence, due process of law, proportionality between offenses and sentences, protection of third pa rty interests, participation in the information 
society, etc.  For instance, ACTA allowed for th e identification of internet subscribers in case of 
alleged infringement, upon request by the right holder.  It  also stated that such personal data was to be 
disclosed by an online service provi der.  In the absence of a preci se definition of "online service 
provider", it could be understood in a very broad wa y, ranging from access providers to sites which 
hosted contents, including social networks. 
290. He noted that ACTA had been the object of deep concern of civil society organizations 
around the world, including in the countries that had signed the agreement.  Recently, the EU trade 
Commissioner had announced the European Commissi on's decision to ask the European Court of 
Justice for a legal opinion regarding the conformity of  ACTA with European legislation.  This was an 
indication of the need of promoting a true public  debate on the merits of such an agreement. 
291. The representative of Chile recognized the importan ce of enforcing IPRs.  At the same time, it 
was important to ensure that the system was ba lanced and consistent with the requirements and 
priorities of all countries and their various legal sy stems.  Given that his delegation's position had not 
changed since earlier discussions of the issue, he requested that the following statement made at the 
Council's October 2011 meeting be reproduced:3 
"The representative of Chile said that he recognized the importance of IPRs and upheld 
them accordingly.  IP and its enforcement we re crucial tools in promoting research and 
development, and were subject to growi ng demands and challenges.  However, IP 
enforcement, including civil penalties, possi ble criminal penalties, border measures and 
so forth, could not be considered in isolati on but had to be coherent  and consistent with 
each country's situation.  Enforcement tools ha d to, for example, be in keeping with the 
financial resources available for other areas of primary public necessity, particularly 
given that IPRs were, after all, private rights. 
                                                      
3 Paragraphs 527-529 of IP/C/M/67. IP/C/M/69 
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  Likewise, enforcement measures had to be cons istent with the legal system and could not 
constitute a barrier to the population's leg itimate access to protected works and essential 
goods such as cultural goods and medicines.  In that regard, any provision on enforcement included in bilateral or plurilate ral agreements needed to respect and be 
consistent with the objectives and principles set out in Articles 7 and 8 of the TRIPS 
Agreement.  Those provisions had to, in partic ular, be consistent with ensuring that the 
enforcement of IPRs furthered technology tran sfer that was beneficial to producers and 
users alike.  That had been Chile's focu s in all negotiations on IP enforcement. 
Although ACTA negotiating parties had stated in previous interventions that the 
Agreement was open to any WTO Member to jo in, Article 43.2 of the Agreement, which 
concerned accession, stated that Committee me mbers, the original parties to ACTA, 
could define the terms of accession for each ne w applicant.  He sought clarification on 
whether this referred simply to procedural matte rs such as time limits for entry into force, 
or whether Parties deciding on a new Party's accession could request compliance with substantive measures that would be more stringe nt than those that had been incumbent on 
the original Parties to the Agreement." 
292. The representative of Thailand urged Members to take note of the differences in the level of 
development, the availability of resources as well  as the IP infringement situation in different 
countries.  He concurred with the delegation of Br azil which had stated that there was no "one-size-
fits-all" approach to IPR enforcement.  His dele gation would like to preserve the flexibilities under the 
TRIPS Agreement. 
293. The representative of China referred to her inte rvention at the beginning of the meeting, 
reiterating that information on ACTA  could better be provided under a nother item of the agenda.  She 
also recalled that the Chairman had said at the adop tion of the agenda that this was not a permanent 
item on the Council's agenda.  Given that ACTA did not form part of the WTO legal framework, it 
was not appropriate for the Council to discuss it. 
294. Her delegation recognized that the legal system to protect IPRs should be comprehensive and 
well balanced.  Next to protecting the rights of IPR ho lders, it also had to protect the public and social 
interests.  Although the TRIPS Agreement was setti ng minimum standards, enforcement levels could 
not be raised to the extent that they would c ontravene the TRIPS Agreem ent, in particular the 
flexibilities enshrined in it, nor should the fine balance of rights and obligations in the TRIPS 
Agreement be disturbed.   
295. ACTA broadened the scope  of piracy and counte rfeiting, enhanced the standards of protection 
through criminal, border and civil enforcement meas ures, and set up special disciplines for the digital 
environment. Most of those measures went beyond the TRIPS Agreement.  Even in countries which 
had participated in the ACTA negotiations, there were a lot of controversies over the agreement, 
including concerns on the transparency of negotiatio ns, inconsistency with domestic legislation, and 
its impact on free communication on the Internet and human rights. 
296. She said that, for example, ACTA provisions  on criminal procedures went beyond TRIPS 
Article 61, as they applied at lower thresholds a nd included higher penalties.  The first sentence of 
Article 61 provided that "Members shall provide for criminal procedures and penalties to be applied at 
least in cases of wilful trademark counterfeiting or copyright piracy on a commercial scale".  The 
Panel in China — Measures Affecting the Protection and Enforcement of IPRs (DS362) had found 
that, in quantitative terms, the benchmark for an  activity to qualify as being carried out on a 
commercial scale was "the magnitude or extent of ty pical or usual commercial activity".  Accordingly, 
what constituted counterfeiting or piracy of a pa rticular product in a particular market on a 
commercial scale would depend on the magnitude or exte nt that was typical or usual with respect to  IP/C/M/69 
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  such a product in such a market.  According to the Panel, the negotiators had chosen the word "scale" 
in order to refer to size.  This showed that the limitations in Part III, Section 5 of the TRIPS 
Agreement on criminal procedures reflected an effo rt to address only the more blatant and egregious 
infringements.  On the other hand, the second senten ce of Article 23.1 of ACTA provided that "acts 
carried out on a commercial scale include at least those carried out as commercial activities for direct 
or indirect economic or commercial advantage".  Th is provision read the word "scale" out of the 
context of "commercial scale".  It meant that an y profit-making activity which was not carried out on 
a typical or usual scale would also be subject to cr iminal procedures.  This would lower the threshold 
of criminal procedures and might increase Members' obligation to impose criminal penalties.    
297. She noted that Article 23.3 of ACTA also provided that a party "may provide criminal 
procedures for the unauthorized copying of cinema tographic works from a performance in a motion 
picture exhibition facility generally open to the public".   However, the text did not clarify whether the 
activity had to be "wilful" a nd "on a commercial scale", as required by the TRIPS Agreement. 
According to the second sentence of Article 61 of th e TRIPS Agreement, the legal remedies available 
in criminal procedures had to include imprisonment "a nd/or" monetary fines.  It was therefore left to 
Members' discretion to provide the appropriate re medies.  On the other hand, Article 24 of ACTA 
used the words "as well as", instead of "and/or",  between the words "imprisonment" and "monetary 
fines".  This would limit the flexibility available under the TRIPS Agreement since all ACTA Parties 
had to provide both imprisonment and monetary fines. 
298. With respect to seizure and forfeiture, ACTA provided that the competent authorities shall 
have the authority to order the fo rfeiture or destruction of the assets derived from, or obtained directly 
or indirectly through, the infringing activity, and may have the authority to order the seizure and 
forfeiture of assets the value of which corresponds to  that of the assets derived from, or obtained 
directly or indirectly through, the infringing activit y.  This meant that not only the assets related to the 
infringing activity, but also other assets irreleva nt to the infringing activity could be subject to 
forfeiture.  In contrast, the TRIPS Agreement onl y requested that "the infringing goods and any 
materials and implements the predominant use of wh ich has been in the commission of the offence" 
be seized, forfeited and destructed.  
299. The representative of China referred to Article  26 of ACTA according to which "each Party 
shall provide that, in appropriate cases, its co mpetent authorities may act upon their own initiative to 
initiate investigation or legal action with respect to  the criminal offences."  Recognizing that IPRs are 
private rights, the TRIPS Agreement did not oblig e the competent authorities to initiate criminal 
investigation or act upon their own initiative. 
300. It appeared that ACTA strengthened IP enforcem ent and raised the level of IP protection.  
ACTA Parties had to allocate more resources to IP enforcement, and this despite TRIPS Article 41.5 which provided that Part 3 of the TRIPS Agreemen t on enforcement of IPRs "does not create any 
obligation to put in place a judicial system for the enforcement of intellectual property rights distinct 
from that for the enforcement of law in general, nor  does it affect the capacity of Members to enforce 
their law in general.  Nothing in this Part create s any obligation with respect to the distribution of 
resources as between enforcement of IPRs a nd the enforcement of law in general".   
301. The implementation of ACTA would influence the interests of Members and limit their 
capacity to use the flexibilities provided by the TRI PS Agreement.  She noted that protests against 
ACTA had been held in more than 200 European cities on 11 February 2012.  This was a useful 
reminder that IP protection and enforcement s hould recognize and accomplish the underlying public 
policy objectives, including developmental and t echnological objectives.  Her delegation cautioned 
against the protection and enforcement of IPRs wh ich would contravene the provisions of the TRIPS 
Agreement.  Enforcement procedures should neither b ecome a barrier to legitimate trade, nor create 
distortive effects on legitimate international trade.  IP/C/M/69 
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  302. The representative of Cuba said that her delegation shared many of the concerns that had been 
raised by other Members.  The Council was not  the appropriate forum to discuss ACTA, which 
reduced the flexibilities provided for under the TRIPS Agreement.  It was contradictory that the 
United States did not comply with its obligatio ns under the TRIPS Agreement and nevertheless 
advocated TRIPS-plus standards.  Ten years a go, the Dispute Settlement Body had ruled that 
Section 211 of the US Omnibus Appropriations Act was inconsistent with the TRIPS Agreement and 
the Paris Convention because it undermined the rights of  the owners of Cuban trademarks by enabling 
Bacardi to engage in the fraudulent sale of produc ts under the Havana Club trademark, despite these 
products not being of Cuban origin.  This situati on not only had a negative impact on Cuba, but also 
affected the commercial interests of businesses in other Members, such as those of the French 
company Pernod Ricard. 
303. In response to references made to some incide nts that had taken place in the European Union 
in 2007 and 2008 regarding the detention of pharmaceu ticals in transit, the representative of the 
European Union said that considerable efforts had b een made to ensure that such incidents would not 
occur again. Instead of constantly recalling those case s in the past, it would be worthwhile looking at 
the equally worrying situa tion of counterfeit medicines in the pharmaceutical sector.  According to 
figures published by the EU, 3,200,000 fake pharm aceuticals had been detained by EU customs in 
2010, of which 93.6 per cent had come from India.  This was of concern to consumers and citizens 
and needed to be discussed too. 
304. In response to a point made by the delegation of India with respect to confusingly similar 
trademarks, the representative of the United States sai d that providing for the availability of border 
enforcement against confusingly similar marks was a best practice reflected in the laws of many WTO 
Members, including the United States.  This would,  for example, allow border authorities to take 
action when fake goods bore trademarks that were onl y slightly modified but still confusing.  In his  
view, the determination that, for example, "Sialis" w ith an "S" was confusing with "Cialis" with a "C" 
was not a matter of such profound legal complexity  as to be beyond the abilities of the same border 
enforcement officials entrusted with safeguarding c itizens from all sorts of potential threats.  When 
there were hard cases, the laws of his own country  and those of other countries provided appropriate 
legal means to resolve those issues. 
305. Remarks on "TRIPS-plus" requirements remained somewhat mystifying.  Many WTO 
Members that were not ACTA participants had implemented ACTA-type provisions.  For several 
examples, he referred Members to the minutes of th e Council's last meeting (paragraphs 534 and 535, 
document IP/C/M/67).  He asked why those provisions were acceptable in coun tries' domestic law, 
but not in ACTA.  For example, there was a paradox between the analysis of the criminal provisions of ACTA provided by the delegation of China a nd its own domestic law providing for criminal 
procedures to enforce IPRs. 
306. With respect to the concerns raised by the de legation of India regarding Article 22 of ACTA, 
he noted that paragraph 9 of the "Notification No . 47/2007 – Customs (N.T.)" of the Government of 
India called for the provision of similar informa tion by customs authorities to right holders upon 
request.  The same Notification appeared to implement numerous ACTA provisions, including 
Article 16(1)(a) of ACTA on ex officio authority for customs officials, which was mirrored by 
Article 7(1)(b) of the Notification.  Likewise, the equivalent of Article 15 of ACTA on the provision 
of information from rights holders to customs o fficials could be found in Article 7(5) of the 
Notification.  Furthermore, the Notification cove red copyright, trademark, designs and patents.  IP/C/M/69 
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  307. The representative of the Bolivarian Republic of Venezuela reiterated his delegation's concern 
about the inclusion of the item on the agenda, as well as its opposition against ACTA.  He requested 
that the following statement made at the Council's October 2011 meeting be reproduced:4 
 "The representative of the Bolivarian Republic of Venezuela, supporting the statement 
by Brazil, said that his delegation preferre d multilateralism and transparency.  It was 
his understanding that ACTA would raise IP st andards to a higher level and that it was 
a TRIPS-plus measure.  Recognizing the in formation that was made available, he 
regretted that the process of negotiations had not been transparent." 
308. The representative of Japan said that his dele gation had been one of the advocates of the 
initiative which had resulted in the conclusion of ACTA.  As early as 2005, the Prime Minister of 
Japan had promoted the idea.  This did not merely r espond to the interests of a particular industry, but 
affected a wide range of sectors.  25 per cent of Japanese companies reported that they were suffering 
from counterfeiting and piracy. 
309. As regards the balance between the interests of right holders and those of users, he said that 
ACTA contained the necessary provisions to preven t the abuse of enforcement measures by the right 
holder, for example as regards the initiation of bor der measures.  Under Article 18 of ACTA, right 
holders requesting customs authorities to take action had to provide a security or equivalent assurance, 
depending on Parties' resp ective national legislations. 
310. The Council took note of the statements made. 
O. INFORMATION ON RELEVANT DEVELOPMENTS ELSEWHERE IN THE WTO   
311. The Chairman recalled that, at its meeting in October 2011, the TRIPS Council had agreed to 
forward to the General Council a proposal for a decision to extend the period of acceptance by 
Members of the Protocol Amending the TRIPS Agreement until 31 December 2013 
(document IP/C/58).  Pursuant to this proposal, th e General Council had decided, at its meeting of 
30 November 2011, to further extend the period for acceptances of the Protocol until 31 December 2013 or such later date as may be decided by the Ministerial Conference 
(document WT/L/829). 
312. As regards the status of acceptances of the Protocol Amending the TRIPS Agreement, since 
the Council's meeting in October, the following  Members had deposited their instruments of 
acceptance:  Cambodia, Panama, Costa Rica, Rwa nda and Honduras (documen ts WT/Let/833, 837, 
838, 839 and 843, respectively).  To date, 42 instru ments of acceptance had been deposited, including 
the one from the European Union and its member States.  The Secretariat had circulated an update to 
the note on the status of acceptances of the Pr otocol Amending the TRIPS Agreement in 
document IP/C/W/490/Rev.9. 
313. He urged those Members that had not yet notifie d their acceptance of the Protocol to ensure 
that necessary measures are being taken in capitals to  allow the consideration of the acceptance in a 
timely fashion. 
314. As regards the issue of transition period for LDCs, he recalled that, at its meeting on 
17 November 2011, the TRIPS Council had agreed to submit a text concerning that matter to the 
General Council with the recommendation that it  be forwarded to the Eighth Session of the 
Ministerial Conference for its consideration (paragraphs 3-4 of IP/C/59/Add.2). 
                                                      
4 Paragraph 530 of IP/C/M/67. IP/C/M/69 
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  315. Pursuant to this, Ministers had invited the Council to give full consideration to a duly 
motivated request from least developed country Memb ers for an extension of their transition period 
under Article 66.1 of the TRIPS Agreement, and report thereon to the WTO Ninth Ministerial 
Conference.  This decision of the Eighth Session of the Ministerial Conference had been circulated in 
document WT/L/845. 
316. Noting that no such request had yet been recei ved, he said that he  would naturally be 
available to facilitate work on any su ch request that might be submitted. 
317. As regards accessions to the WTO, he sai d that the General Council had approved the 
accession package of Vanuatu on 26 October 2011.  The Eighth Ministerial Conference held on 
15-17 December 2011 had adopted the packages of accession of the Russian Federation, Samoa and 
Montenegro.  The relevant decisions could be found in documents WT/L/823, 839, 840 and 841, 
respectively.  In keeping with WTO provisions , Vanuatu, the Russian Federation, Samoa and 
Montenegro would become Members 30 days follow ing the dates of their ratification of their 
respective protocols of accession. 
318. The Council took note of the information provided. 
P. OBSERVER STATUS FOR INTERNATIONAL INTERGOVERNMENTAL ORGANIZATIONS  
319. The Chairman said that the list of 15 pending requests for observer status in the Council by 
other intergovernmental organizations was contai ned in document IP/C/W/52/Rev.12.  He recalled 
that, at its meeting in June 2011, the Council had requ ested the Secretariat to contact the international 
intergovernmental organizations whose requests for observer status were pending to request up-to-
date information, including on the nature of their work and the reasons for their interest in being 
accorded observer status.   
320. Since the Council's meeting in October, the Secretariat had received updated information 
from the United Nations Environment Programme (UNEP), faxed to all Members on 3 November.  
Before the October meeting, such information had been received from the European Free Trade 
Association (EFTA), the South Centre and the Confér ence des Ministres de l'Agriculture de l'Afrique 
de l'Ouest et du Centre (CMA/AOC), and the Coope ration Council of the Arab States of the Gulf 
(GCC).  This information was also available for Members on the Members' website. 
321. At its October meeting, the Council had ag reed that the Chair should continue his 
consultations on the issue of observer status, in pa rticular in the light of this updated information 
received from a number of IGOs.  In the absence of a regular Chair, it had not been possible to hold such consultations.  He suggested that he contin ue consultations on the requests for observer status 
with a view to seeing if the Council could ta ke any decisions at its next meeting. 
322. The Council so agreed.  
Q. OTHER BUSINESS  
(i) Improvements in the documentation, sch eduling and management of meetings 
323. The representative of the Secretariat said that, at the meeting of the General Council on 
14 February 2012, the Director-General had shar ed, under "Other Business", information on the 
implementation of the recommendations for savings and more efficient use of resources made by the Budget Committee (WT/BFA/128) and adopted by the General Council.  In providing an update on 
the Secretariat's work in implementing these decisions, he had sought Members' support and cooperation in carrying the work further.  IP/C/M/69 
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  324. The WTO's 2012-13 Budget, approved by the General Council in November 2011, provided 
for zero nominal growth in 2012.  In December , the General Council had approved a number of 
recommendations for savings and more efficient use of resources made by the Committee on Budget, 
Finance and Administration, including the specifi c recommendations containe d in paragraphs 29-31 
of the Budget Committee's report circulated in document WT/BFA/128.   
325. Highlighting just a few actions that immediatel y affect the Council's wo rk, the representative 
of the Secretariat said that the decision provided fo r the discontinuance of the distribution of official 
documents, previously circulated in meeting rooms and at the document centre, as of the beginning of 
2012.  While all Members had already been informed  about the implementation of this change, the 
Secretariat had sent a fax on 24 February reminding TRIPS delegates about this change.  Otherwise 
the daily distribution of documents on paper and electronically on the Documents Online database 
would continue as before.  Documents for this and future Council meetings could also be easily 
accessed through the "Documents for Meetings" modul e on the Members' site.  The fax contained 
further information on this facility. 
326. The recommendations also called for the reduction in  the use of paper in particular as regards 
notifications.  The Chair had already mentioned u nder item A one element of the implementation of 
these recommendations.  While the Secretariat was continuing the circulation of base documents 
containing lists of notified laws and regulations a nd related explanations both in hard copy and 
electronic form, the actual texts of laws in the sub-series of documents would now only be circulated in an electronic form on the Documents Online database.   
327. He suggested, in addition, that more consis tent formats and submission methods for other 
lengthy reporting requirements - such as on techni cal cooperation and Article  66.2, which represented 
a major portion of the Council's formal documentati on and thus its use of resources - could not only 
reduce costs significantly, but would also make the material thus reported more accessible and useful 
for its intended readership.  The S ecretariat would look into the technical aspects, with a view to 
advising Members subsequently on practical possibilities. 
328. The decisions also called for the Chair to explor e ways to further reduce the use of paper and 
to take steps to move towards the online submission a nd distribution of notifications.  He said that the 
report that the Secretariat had provided for Me mbers under item L went into more detail about 
proposed ways of developing its services, so as to make this material more easily accessible and thus more useful.  The process was not only about cutting costs for the sake of it, although an important element as a component of maintaining zero grow th nominal budget, but it also represented an 
opportunity to more effectively respond to the practi cal needs of the users of the system, principally 
WTO Members, and to find ways of servicing their needs more directly, efficiently and in line with the ways that they would choose to access and make  use of that material as well as to prepare and 
submit it.  Hence under the guidance of the Chair and in consultations with Members, the Secretariat would actively be looking to improve ways of ma king that material available.  He encouraged 
interested delegations to consu lt with the Secretariat on how they  preferred to work with those 
materials. 
329. The Chairman thanked the Secretariat for the updated information and said that, as called for 
in the decision, he intended to informally explore with delegations further ways to make the Council's 
work increasingly cost effective. 
330. The Council took note of the statements made. IP/C/M/69 
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  (ii) Invitations to ARIPO and OAPI 
331. The Chairman recalled that, at its meeting in J une 2010, the Council had agreed to grant an 
ad hoc  observer status on a meeting-to-meeting basis to the African Regional Intellectual Property 
Organization (ARIPO) and the African Intellectual Pr operty Organization (OAPI).  He suggested that 
the Council again invite ARIPO and OAPI to atte nd the Council's next formal meeting on an ad hoc  
basis. 
332. The Council so agreed. 
__________