WORLD TRADE  
ORGANIZATION   
IP/C/61 
18 November 2011 
 (11-6012) 
Council for Trade-Related Aspects of 
Intellectual Property Rights  
 
 
 
ANNUAL REVIEW OF THE DECISION  ON THE  IMPLEMENTATION OF  
PARAGRAPH 6 OF THE DOHA DECLARATION ON THE  
TRIPS AGREEMENT AND PUBLIC HEALTH 
 
Report to the General Council 
 1. Paragraph 8 of the Decision on the Implementati on of Paragraph 6 of th e Doha Declaration on 
the TRIPS Agreement and Public Health of 30 Au gust 2003 (the "2003 Decision") provides that the 
Council for TRIPS shall review annually the functioni ng of the System set out in the Decision with a 
view to ensuring its effective operation and shall annually report on its operation to the 
General Council.  This review is deemed to fulfil the review requirements of Article IX:4 of the WTO 
Agreement. 
2. The Council for TRIPS undertook the seventh annua l review in October 2010.  The General 
Council took note of the report of the Council for TRIPS (IP/C/57 and Corr.1) at its meeting on 
14 December 2010 (WT/GC/M/129, paragraph 90).  The present report covers the period since 
October 2010. 
3. At its meeting on 1 March 2011, the Council fo r TRIPS followed up a set of questions that 
remained open and outstanding issues that arose at the seventh annual review.  It also addressed the 
preparations for the eighth annual review at its  meeting on 7 June 2011.  At its meeting of 
24-25 October 2011, the Council undertook the eighth annua l review.  Annex 1 to this report records 
the statements made in the review.   
4. The paragraphs below set out factual informati on regarding the implementation and use of the 
2003 Decision, discussions on the operation of the System and the acceptance of the Protocol 
Amending the TRIPS Agreement. 
1. Information on implementation and use of the System established under the Decision 
 
5. Since the last annual review, the Republic of Korea has notified its Patent Act and 
Presidential Decree No. 23306 of 26 July 2010 on  "Provisions Regarding the Expropriation and 
Implementation of the Patent Right".  They provide the legal basis for the Republic of Korea to act as 
an exporting Member, as well as an importing Member in situations of natio nal emergency or other 
circumstances of extreme urgency.
1  China has submitted its "Revised Rules for the Implementation 
of the Patent Law 2010"2, which complements its earlier notificati on of the amended Patent Law.  As 
of 30 September 2011, 12 Members, including the European Union (formerly the European Communities), have thus formally notified the Co uncil for TRIPS of the changes made to their 
domestic legal regime in order to implement the 2003 Decision.  An overview of the notified 
implementing laws and regula tions, including hyperlinks to the legal texts, is available on a dedicated 
page on the WTO website at http://www.wto.org/english/tratop_e/trips_e/par6laws_e.htm . 
                                                      
1 IP/N/1/KOR/P/4. 
2 IP/N/1/CHN/P/3. IP/C/61 
Page 2 
 
 
  6. During the period covered by the present repor t, no notifications by importing or exporting 
Members pursuant to paragraphs 1(b), 2(a) and 2(c)  of the 2003 Decision have been made to the 
Council for TRIPS.  As foreseen in the 2003 Decision,  the Secretariat regularly updates a page on the 
WTO website dedicated to this Decision, notably to  ensure the public availability of notifications 
made pursuant to it ( http://www.wto.org/english/tratop_e/trips_e/public_health_e.htm ). 
2. Discussion on the operation of the System established under the Decision 
7. As requested by the Council for TRIPS at its a nnual review in October 2010, the Chair held 
small group consultations on the follow-up to the review on 7 and 15 February 2011.  At these 
consultations, all delegations shared the view that th e seventh annual review had been very useful and 
constructive.  However, at the same time, many delegations felt that the discussion had not yet been 
fully exhausted.  Given the broad support for fo llowing up open questions and outstanding issues, the 
item was put on the agenda of the Council's meeting on 1 March 2011.  In advance of the meeting, the 
Chair faxed to Members a list of issues, both general and specific, that Members had identified at the 
annual review in October 2010 as requiring furthe r discussion or information, so as to help 
delegations to prepare for the follow-up discussion. 
8. At the meeting in March 2011 (IP/C/M/65, pa ragraphs 128-179), Members' expressed their 
readiness to share experiences on the use of the System and to continue practical fact-based 
discussions in order to have a full understanding of its functioning.  In response to a question raised in 
the annual review in October 2010, the delegation of Canada shared further information on the review 
of Canada's Access to Medicines Regime and provi ded an update of its comprehensive strategy to 
fight diseases and improve healthcare worldwide.   A number of other delegations provided 
information in response to the general or specifi c issues on the list relevant to them, including on 
incentives for technology transfer and on ways in which they ensured the safety and efficacy of 
medicines manufactured under compulsory licence for export.  The Secretariats of the WTO, WHO 
and WIPO provided further information on their t echnical co-operation programmes, including their 
trilateral co-operation activities. 
9. As to the operation and review of the System, some delegations reitera ted their concern that 
the System had only been used once since 2003 and th at it had taken some three years to deliver the 
medicines to Rwanda in this context.  They also  noted that only a limited number of Members had 
accepted the Protocol Amending the TRIPS Agreemen t.  Some other delegations noted that the 
System was a useful tool and that its limited use so  far was not an appropriate measure of its success.  
In their view, the use so far had demonstrated that the System could work effectively and that it could 
play a supportive role in the wider effort to impr ove access to essential medicines, which depended on 
numerous trade and non-trade policy issues.  It was al so noted that there could be a need to use the 
System more frequently in the future, in particular  given the introduction of product patent protection 
for pharmaceutical products in developing country Members and the expiratio n of transition periods 
for least-developed country Members. 
10. While agreeing that annual reviews constituted a good platform for sharing experiences and 
evaluating the operation of the System, some delega tions reiterated their proposal to complement 
them by a dedicated workshop to allow for an in-depth study of any potential obstacles to the System's effective and expeditious operation.  In order to gather information on all aspects and 
concerns, the workshop should be open to all re levant stakeholders.  Some other delegations 
maintained that the review of the functioning of  the System was a Member-driven process.  They 
reiterated their invitation to potential importers a nd beneficiaries of the System to report on their 
experience, positive or negative, with the System di rectly to the Council, considering that holding an 
open-ended workshop would be premature.  The C ouncil requested the incoming Chair to continue 
consultations on any further follow-up and on preparations of the next annual review.  IP/C/61 
 Page 3 
 
 
  11. In addition, the Chair drew the Council's attention to two new pages on the WTO website 
providing information on: 
(a) implementing legislation notified by a number of Members to the Council;3 and 
(b) procedures for accepting the Protocol, including a model instrument of acceptance4. 
At the Council's meeting on 7 June 2011, the Chai r recalled this information on the procedural 
requirements for acceptance and clarified that it was not necessary for a Member to introduce 
domestic implementing legislation before accepting the amendment to the TRIPS Agreement as an 
additional flexibility that other Members may choose to make use of. 
12. At the Council's meeting in June 2011, the Chair reported under "Other Business" on the 
small group consultations he  had held.  Delegations reiterated their positions regarding the format of 
future work in this area.  The Ch air indicated that it was his intention to pursue further consultations 
on the preparation for the eighth annual review and the issue of a possible workshop.  He suggested 
that the Council work on the assumption that th e annual review would at least follow a similar 
approach to that which had been widely welc omed by delegations in  October 2010, noting his 
intention to continue consultations with Member s on possible ways of improving and preparing for 
the review (IP/C/M/66, paragraphs 249-265). 
13. At the meetings in March and June 2011, ma ny delegations expressed their appreciation of 
the trilateral symposia that the WHO, WIPO and the WTO had organized on issues connected with 
public health and intellectual property, which had provided us eful background information on a 
complex subject matter that could serve Member s' respective constituencies, and underscored the 
sources of practical experience and empirical da ta that can help support policy debates. 
3. Decision on the Amendment to the TRIPS Agreement 
14. As called for in paragraph 11 of the 2003 Deci sion, the General Council adopted a Protocol 
Amending the TRIPS Agreement, by a Decision of 6 December 2005 (WT/L/641).  The Protocol is 
open for acceptance by Members until 31 December 2011 or such later date as may be decided by the 
Ministerial Conference (WT/L/785).  In accordance with Article X:3 of the WTO Agreement, the 
Protocol will enter into force upon acceptance by two thirds of the WTO Members. 
15. As of 21 October 2011, the following Me mbers have notified their acceptance: 
 United States, 17 December 2005, WT/Let/506; 
 Switzerland, 13 September 2006, WT/Let/547; 
 El Salvador,  19 September 2006, WT/Let/548; 
 Republic of Korea, 24 January 2007, WT/Let/558; 
 Norway, 5 February 2007, WT/Let/563; 
 India, 26 March 2007, WT/Let/572; 
 Philippines, 30 March 2007, WT/Let/573; 
                                                      
3 http://www.wto.org/english/trat op_e/trips_e/par6laws_e.htm . 
4 http://www.wto.o rg/english/tratop_e /trips_e/accept_e.htm . IP/C/61 
Page 4 
 
 
   Israel, 10 August 2007, WT/Let/582; 
 Japan, 31 August 2007, WT/Let/592; 
 Australia, 12 September 2007, WT/Let/593; 
 Singapore, 28 September 2007, WT/Let/594; 
 Hong Kong, China, 27 November 2007, WT/Let/606; 
 China, People's Republic of, 28 November 2007, WT/Let/607; 
 European Union (formerly the European Communities)5, 30 November 2007, 
WT/Let/608; 
 Mauritius, 16 April 2008, WT/Let/619; 
 Egypt, 18 April 2008, WT/Let/617;  
 Mexico, 23 May 2008, WT/Let/620;  
 Jordan, 6 August 2008,WT/Let/630; 
 Brazil, 13 November 2008, WT/Let/636; 
 Morocco, 2 December 2008, WT/Let/638; 
 Albania, 28 January 2009, WT/Let/639; 
 Macao, China, 16 June 2009, WT/Let/645; 
 Canada, 16 June 2009, WT/Let/646; 
 Bahrain, 4 August 2009, WT/Let/652; 
 Colombia, 7 August 2009, WT/Let/650; 
                                                      
5 The text of the instrument of acceptance reads as follows: 
 
"THE PRESIDENT OF THE COUNCIL OF THE EUROPEAN UNION, 
 
HAVING regard to the Treaty establishing the European Community, and in particular Article 133(5) 
in conjunction with the first se ntence of the first subparagraph of Article 300(2) and the second 
subparagraph of Article 300(3) thereof, 
 
NOTIFIES by these presents the acceptance, by th e European Community, of  the Protocol amending 
the Agreement on Trade-Related Aspects of Intellectua l Property Rights (TRIPS), done at Geneva on 
6 December 2005, 
 
CONFIRMS, in accordance with Artic le 300(7) of the Treaty establishing the European Community, 
that the Protocol will be binding on the Member States of the European Union. 
 
The Secretary-General/High Representative                The President of the Council 
      of the European Union"  IP/C/61 
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   Zambia, 10 August 2009, WT/Let/651; 
 Nicaragua, 25 January 2010, WT/Let/663; 
 Pakistan, 8 February 2010, WT/Let/664;  
 Former Yugoslav Republic of Mace donia, 16 March 2010, WT/Let/671; 
 Uganda, 12 July 2010, WT/Let/684; 
 Mongolia, 17 September 2010, WT/Let/684; 
 Croatia, 6 December 2010, WT/Let/747; 
 Senegal, 18 January 2011, WT/Let/753; 
 Bangladesh, 15 March 2011, WT/Let/758; 
 Argentina, 20 October 2011, WT/Let/830; 
 Indonesia, 20 October 2011, WT/Let/831; 
 New Zealand, 21 October 2011, WT/Let/832; and 
 Cambodia, 1 November 2011,WT/Let/833.6 
16. At the Council's meeting on 1 March 2011, the de legation of Kenya informed the Council that 
it was in the process of accepting the Protocol and that the instrument of acceptance would soon be 
deposited.  Nigeria reported to the Council's me eting on 7 June 2011 that Members of the African 
Group were making efforts in order to proceed with the acceptance of the Protocol. 
17. Information on the status of acceptances of the Pr otocol is periodically u pdated in revisions of 
document IP/C/W/490. 
18. Given the present status of acceptances, and th e indications that a number of Members are 
actively progressing their acceptance of the Protoc ol, the Council for TRIPS submits the attached 
proposal to the General Council for a decision to ex tend the period for acceptances of the Protocol.  A 
draft of such a proposal for consideration by the Co uncil is contained in Annex 2 of this document. 
 
                                                      
6 Secretariat note : Cambodia's instrument of acceptance has been  received after approval of the present 
report at the Council's meeting on 24-25 October 2011.  It has been added in order to ensure that the list of 
WTO Members who have notified their acceptance is up-to-date.  IP/C/61 
Page 6 
 
 
  ANNEX 1 
 
Excerpt from the Minutes of the Council's meeting of 24-25 October 2011 
 to be circulated as IP/C/M/671 
 G. R
EVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 
OF THE DOHA DECLARATION ON THE TRIPS  AGREEMENT AND PUBLIC HEALTH  
1. The Chairman said that, as requested by the Counc il, he had held consu ltations with a number 
of Members on how best to structure the Council's di scussions in order to make the review as useful 
as possible.  In light of these consultations, he had faxed to the Members a list of topics and issues for 
discussion on 14 October 2011.  The list merged the list of six topics for discussion prepared for the System's annual review at the Council's meeting in  October 2010 with the list of issues for further 
discussion or information identified by Members whic h the then Chairman had faxed to Members in 
February 2011 to guide the discussion on the follow- up to the annual review at the Council's meeting 
in March.  While the Chairman clarified that wh ile this approach was based on the structure and 
content of the 2010 review and re presented a natural continuation of what was well received at that 
time, it was not necessarily exhaustive.  Members s hould therefore feel free to raise any additional 
issues during the review. 
2. He said that during his consultations, some de legations had reiterated their proposal for an 
open-ended workshop involving all the key stakehol ders.  However, views continued to diverge on 
that proposal.  The last topic on the list, namely "Next steps and recommendations", would enable the 
Council to continue the discussion of this point.   
3. Regarding the purpose of the TRIPS Council's a nnual review and the report to the General 
Council, he said that paragraph 8 of the waiver  Decision provided that the Council would annually 
review the functioning of the System set out in the Decision with a view to ensuring its effective 
operation and annually report on its operation to th e General Council.  Such a review would be 
deemed to fulfil the review requirements of Article IX:4 of the WTO Agreement. 
4. The Secretariat had circulated a draft cover note for the Council's report modelled on previous 
years' reports (JOB/IP/4).  It contained factua l information on the implementation and use of the 
System established under the Decision, discussion s regarding its operation, and the status of 
acceptances of the Protocol Amending the TRIPS Agre ement.  In accordance with the way that the 
Council had prepared its reports in pr evious years, the part of the minutes of the meeting that reflected 
the discussions held under the agenda item could be attached to the cover note. 
5. The Secretariat had also circulated an update to the note on the status of acceptances of the 
Protocol that the Council had requested it to  prepare at its meeting in October 2006 
(IP/C/W/490/Rev.8).  Since the circulation of that  document, Argentina and Indonesia had deposited 
their instruments of acceptance on 20 October, a nd New Zealand had deposited its instrument on 21 
October (WT/Let/830, 831 and 832, respectively).  37 notifications of acceptance of the Protocol, 
including from the European Union (formerly the Eu ropean Communities), had thus been received.  
He reminded Members that the Protocol would ente r into force for the Members concerned when it 
had been accepted by two thirds of the Members.   
6. Turning to the consolidated list of topics a nd questions for discussion in the annual review, 
the Chairman said that this list combined the list of topics for discussion that had been prepared for 
the October 2010 review and the list of issues for further discussion or information identified by 
                                                      
1 The paragraph numbering of this excerpt will not co rrespond with that of the minutes of the TRIPS 
Council meeting but has been included for the convenience of users.  IP/C/61 
 Page 7 
 
 
  Members that had been prepared to guide the fo llow-up discussion at the Council's meeting in March 
2011.  The follow-up questions were grouped un der the appropriate headings.  The footnotes 
indicated the delegations that had posed those foll ow-up questions and the further information that 
had already been provided in response to those questions at the Council's meeting in March.  
Therefore, there was no need to repeat or duplicate what had already been said on the record.  He said 
that structuring the discussion this way should help the Council carry out the review with most 
continuity on the basis already established, and t hus ensure a productive and useful discussion of the 
System that would help Members better unders tand the Paragraph 6 Syst em's operation and any 
concerns related to it. 
1. Experience of Members who have used or considered using the Paragraph 6 System 
2. Implementation of the System into do mestic legislative and regulatory framework 
 7. The representative of Canada said that her dele gation had provided extensive information on 
its experience at the last annual review of th e Paragraph 6 System in October 2010.  She updated 
Members on the status of Bill C-393, which had sought to amend Canada's Access to Medicines 
Regime (CAMR).  It had died on the Order Paper at  the end of the last parliamentary session before 
the May 2011 general federal elections  in Canada.  No similar bill ha d yet been introduced in the new 
session of Parliament.  
8. She recalled that her delegation had asked a numbe r of questions at the Council's meeting in 
October 2010, to which responses remained outstan ding.  The Paragraph 6 System, while a useful 
tool, should not be viewed as a panacea for the co mplex problem of ensuring access to medicines.  
The impact of intellectual property rights on access to  medicines, in particular on their price and on 
healthcare as a whole, had to be viewed as comme nsurate with the role of intellectual property 
alongside other factors that affected the price and availability of medicines.  Those factors included 
infrastructure, rational use of medicines, health  systems, and tariffs on medicines and related 
commodities that merely taxed the sick. 
9. The Paragraph 6 System should therefore not be viewed as the only solution - which it was 
not, and had never been intended to be - but rather as a mechanism that sought to modulate one of the 
factors, i.e. intellectual property rights, which a ffected the price of medicines.  She recalled the 
genesis of the Paragraph 6 System, wherein Ministers had recognized the need for the TRIPS 
Agreement to be part of the "wider national a nd international action" that addressed grave public 
health problems such as HIV/AIDS, malaria and t uberculosis.  The difficult negotiations that had 
ensued resulted in a mechanism th at had not been designed to be a tool to lower medicines prices 
generally, but rather to help address acute public health crises. 
10. She therefore urged Members to focus their efforts on ensuring that the Paragraph 6 System 
worked as it had been intended to and called on all Me mbers that had not already done so to deposit 
their instruments of acceptance of the Protoc ol Amending the TRIPS Agreement.  Innovative 
financing mechanisms, such as pooled procurement and voluntary licensing, should be welcomed.  
Key issues such as the need for prevention strategi es and rational medicine use, the strengthening of 
health systems, and the training of health work ers should also be addressed by WTO Members in the 
WTO and other multilateral fora, such as the WHO, as well as bilaterally. 
11. The representative of China said that public hea lth was a comprehensive issue and intellectual 
property rights were but one element of the framework  that impacted public health.  Given that it was 
difficult for her delegation to conclude that the Pa ragraph 6 System in its present form provided an 
expeditious solution to public health problems, sh e invited the Council to consider whether there was 
room for any improvement that could be made to the System.  Recommendations could also be made 
regarding other factors that could have a role in im proving public health.  Work in the Council would IP/C/61 
Page 8 
 
 
  benefit from looking at any burdensome elements, clarifying the issues and discussing the legal 
framework as established by the System.   
12. Referring to Bill C-393, which had been introdu ced to the Canadian Parliament and had not 
been pursued because of elections in May 2011, sh e wondered whether the domes tic debate in Canada 
had identified burdensome elements in CAMR, which needed to be improved.  A review of those 
elements by the Council could also serve as an example for its work on the functioning of the 
Paragraph 6 System.  She therefore suggested that the delegation of Canada share further information 
with the Council in that regard.  For example, there was a range of conditions established by CAMR which were not required by the Paragraph 6 System, such as the limited list of products to which it 
applied, the two year limit which applied to any compulsory licence granted under CAMR, as well as 
limitations on prices and profit margins for geneti c manufacturers.  Her delegation would like to 
understand whether those elements had been reviewed  in the parliamentary debate in Canada, or 
whether other WTO Members were concerned about  them.  For elements also required by the 
Paragraph 6 System, such as case-by-case decisions on a country-by-country basis or the need to make prior efforts to obtain a voluntary licence firs t, she asked whether they stood in the way of a 
well-functioning mechanism that provided effective and expeditious solutions. 
13. While some of the elements referred to may ha ve been touched upon, it was possible that they 
had not been thoroughly explored.  As her delegation was not sure wh ether this could be addressed by 
the Council and did also not have any experiences to share in this regard, a dedicated workshop with 
the participation of all stakeholders  could be a useful step to answer some of the open questions and to 
gather experiences.  This would allow Members to better understand the functioning of the System. 
14. The annual review had already been conducted ei ght times without reaching a conclusion as 
to whether the System worked well, provided an effective and expeditious solution, or could be 
improved.  Her delegation was open as to how to conduct the review .  If Members agreed that the 
exchange of experiences had been exhausted at thei r level, a dedicated open-ended workshop could be 
conducted in order to better understand the System's functioning and to look at possible 
recommendations to improve it.   
15. The representative of India thanked the delegati on of Canada for its role in initiating the 
implementation of the Paragraph 6 System and s upplying much-needed medicines to Rwanda under 
CAMR.  However, the fact that their actual deliv ery had taken almost three years was a matter of 
concern, as was the lack of any information on whether patients had received the medicines in time.  His delegation had not obtained convincing replies to  a number of basic questions during the System's 
annual reviews which the Council had conducted for several years.  It would be interesting to learn 
more about the debate on Bill C-393 th at had taken place in the Canadian parliament, in particular the 
objections that had been raised.  He wondered whet her the Bill would be reintroduced and whether the 
amendments that had been suggested w ould be reflected in the new version. 
16. In response to the questions raised by the dele gations of China and India, the representative of 
Canada said that Bill C-393 had not been put fo rward or supported by her Government.  Since a 
private member had introduced the Bill, it was not po ssible to predict whether there would be another 
initiative of this kind.  Her Govern ment had no intention of amending CAMR.  It had opposed the Bill 
because it was convinced that CAMR  worked in its present form, reflecting Canada's commitment to 
improving access to medicines.   
17. Taking up the point made by the delegation of India with respect to the time it had taken for 
the medicines to reach Rwanda, she said that gove rnment action had been expedited and the licence 
had been granted within 15 days.  This indicated that the system had worked and that the delay had 
not been caused by lengthy administrative procedures.   IP/C/61 
 Page 9 
 
 
  3. Process of acceptance 
 
18. The representative of New Zealand said that he r Government had deposited its instrument of 
acceptance with the WTO on 21 October 2011.  In 20 08, when the Government had initially agreed to 
the acceptance of the Protocol, it had been made contingent upon the passage of domestic 
implementing legislation.  Provisions that woul d enable New Zealand to become an exporting 
Member under the System had been inserted into th e draft Patent Bill, which currently awaited its 
second reading before Parliament.  Having reached  the understanding that the acceptance of all WTO 
Members' entitlement to use the Paragraph 6 System  was distinct from the domestic implementation 
of the System, her Government had agreed to accept the Protocol in advance of the current deadline 
for acceptance of 31 December 2011.  Her delegation remained fully committed to the principles 
underpinning the Protocol.  By accepting the Pr otocol, it had committed to accepting that the 
additional flexibilities for all WTO Members became an  integral part of the TRIPS Agreement.  She 
encouraged other Members to deposit their instrument s of acceptance in order to reach the two-thirds 
majority required to bring the amendment into force. 
19. The representative of Turkey said that her de legation attached great importance to the 
Paragraph 6 System, which provided additional flex ibilities to facilitate access to medicines under the 
TRIPS Agreement.  It supported the entry into fo rce of the Protocol Amending the TRIPS Agreement 
in order to make the System established under the 2003 Decision a permanent part of the TRIPS 
Agreement.  Her delegation had in itiated domestic procedures for the acceptance of the Protocol and 
hoped to finish them as soon as possible. 
20. The representative of Costa Rica said that his country's legislative assembly had approved the 
acceptance of the Protocol Amending the TRIPS Ag reement on 2 October 2011.  The instrument of 
acceptance would be submitted once the re maining formalities were completed. 
21. The representative of Indonesia said his delega tion had submitted its instrument of acceptance 
of the Protocol Amending the TRIPS Agreemen t to the Director-General of the WTO on 
20 October 2011.  With the WTO Ministerial Conf erence approaching, he invited Members to seize 
the momentum and submit their acceptances. 
22. The representative of the Secretariat updated the Council on the work of the Secretariat in 
supporting Members in the acceptance process.  In view of the interest that had been expressed during 
the System's annual review in the Council's mee ting in October 2010, the Secretariat had provided 
further information in order to help Members draw up their instruments of acceptance of the Protocol, 
based on the discussions that had been  recorded in the minutes of that meeting.  He stated that many 
delegations had sought practical in formation on procedures for the acceptance of the Protocol and that 
similar questions had often arisen in capacity building activities on TRIPS and public health.  The 
Secretariat had therefore developed a webpage which described the acceptance procedure and 
provided a model instrument of acceptance.2   
23. He recalled that a Member could accept the Protocol independent of domestic implementation 
of the Paragraph 6 System as the two actions were clearly distinct. Acceptance of the Protocol was a 
legal act whereby a Member expressed its consent that  all Members were entitled to use the System.  
The process of accepta nce needed to follow both the rele vant Member's own constitutional 
requirements, and the content requirements which applied to the instrument of acceptance.  A 
Member that wished to take advantage itself of the additional flexibilities provided in the Protocol 
might need to put in place implementing laws or regulations through normal domestic legislative and 
regulatory processes.  On the other hand, the a dditional flexibilities under the Paragraph 6 System 
were already available under the waivers that had been provided in the 2003 Decision.  A Member 
                                                      
2 Available at:  http://www.w to.org/english/tratop _e/trips_e/accept_e.htm . IP/C/61 
Page 10 
 
 
  could therefore also choose to put in place domes tic implementing legislati on before having deposited 
its instrument of acceptance. 
24. The representative of Venezuela said that accep ting the Protocol was different from the 
implementation of the System into domestic le gislation, which made the introduction of new 
flexibilities possible.  The fact that his delegation ha d not yet accepted the Protocol reflected a lack of 
trust in the System, which would persist until furthe r clarification was obtained.  The advent of the 
TRIPS Agreement had further complicated access to medicines because of the requirement to provide 
for full patent protection in the pharmaceutical sect or.  He said that the Me mbers who had signed the 
Protocol were the main producers of medicines.  While the System had been established to address 
public health problems in an expeditious manner, th ere was still a need for further clarification of 
issues related to its functioning and the problem s Members were encountering in the process of 
accepting the Protocol.  In support of the delegation of China, he therefore agreed on the importance 
of having an open-ended workshop,  which would involve all key st akeholders, including from civil 
society and industry.  No convincing argument against holding such a workshop had been brought 
forward since last year's annual review. 
4. Capacity building on the Paragraph 6 System and related TRIPS flexibilities 
 
25. The representative of the Secretariat provided an  update on technical assistance activities that 
had been undertaken with a bearing on the Paragrap h 6 System and other flexibilities as they related 
to public health.  The implementation, legal a nd policy context, and the acceptance process of the 
Paragraph 6 System had been a major theme of technical assistance activities conducted by the 
Secretariat in increasingly close collaboration with sister organizations, in particular the WHO and 
WIPO.   
26. A specific example of this co-operation was th e most recent workshop on intellectual property 
and public health held by the Secretariat in co llaboration with WHO and WIPO.  The seventh in its 
series, the workshop had been a specialist progra mme for 23 developing country officials that had 
been convened earlier in the month.  Its focus had be en building the participants' capacity to help their 
countries make use of flexibilities for pharmaceuticals under the TRIPS Agreement.  To this end, the 
workshop had utilized presentations, discussions a nd practical exercises to study the TRIPS 
Agreement and the management of intellectual prope rty rights as applied to concrete health-related 
projects.  Participants had been  familiarized with the key con cepts under the TRIPS Agreement and 
other intellectual property instruments, and how th ose provisions, including the Paragraph 6 System, 
could be implemented in national law.  
27. Among other issues covered had been pricing an d procurement policies as a key element in 
securing access to medicines, as well as ensuring th e safety, efficacy and quality of medicines, 
technology transfer and local production, the role  of competition policy, and intellectual property 
rights provisions in regional or bilateral free trad e agreements and their link to public health.   
28. A diverse range of speakers had shared their practical experiences and views on key issues 
directly relevant to public health, including a wi de range of expertise on legal, policy and economic 
issues from WTO, WHO and WIPO, as well as UNCTAD, representatives from some WTO Members, including Geneva delegations, the Commissioner of the South African Competition 
Commission, the President of the Ecuadorian Institu te of Intellectual Property, the research based and 
generic industries, Médecins sans Frontières (D octors without Borders), the Global Fund, the 
Medicines for Malaria Venture, and Health Acti on International.  These experts had provided a 
well-rounded view of the issues at the crossroad between intellectual property rights and public health.   IP/C/61 
 Page 11 
 
 
  29. He said that TRIPS flexibilities in the area of pub lic health had also figured prominently in 
other WTO national and regional tec hnical cooperation events. In add ition, in order to advance co-
operation between the WTO, WHO and WIPO and to  focus on technical cooperation and enhance 
available information materials, a series of policy symposia were being undertaken.  A third in the 
series was expected early next year.  The working ma terials developed in this  programme of trilateral 
cooperation, along the lines of the themes and content of the first trilateral symposium held in 2010, 
were being developed and collate d in the form of a trilateral study prepared as a resource for 
continuing technical cooperation and capacity buildi ng.  In addition, as a further tool for technical 
assistance, a set of models for notifications under th e Paragraph 6 System had been made available on 
the WTO website.3 
30. The representative of WIPO Secretariat  recalled that the Development Agenda, agreed upon 
by the Member States of WIPO in 2007, containe d 45 recommendations to enhance the development 
dimension of the Organization's activities.  Key am ong those were Recommendations 13, 14, 17, 22 
and 25, focused on enhancing the understanding and use of flexibiliti es in the intellectual property 
system. Since its inception, the Committee on Devel opment and Intellectual Property (CDIP) had met 
twice each year at WIPO to discuss the planning , implementation and mainstreaming of Development 
Agenda projects within WIPO's work. 
31. As regards the implementation of flexibilities unde r the Development Agenda, he said that at 
the fourth session of the CDIP which had been he ld in November 2009 the Committee had, in the 
context of discussions on Recommendation 14, request ed WIPO to prepare a document on flexibilities 
in the area of patents.  Accordingly, WIPO had prepared a document on Patent-Related Flexibilities in 
the Multilateral Framework and their Legislative Impl ementation at the National and Regional Levels 
(CDIP/5/4 Rev.).  At the Committee's request, WIPO  had subsequently prepared the second part of 
the document on flexibilities in patents (CDIP/7/3).  In total, those two documents provided 
information on implementation of ten patent-related flexibilities. 
32. At its fifth session, in April 2010, the Committe e had requested WIPO to prepare a proposed 
future work programme on flexibilities for its consid eration.  At its sixth and seventh sessions, in 
November 2010 and May 2011 respectively, the CDIP had considered a document setting out a future 
work programme on flexibilities at WIPO (CDIP/6/10).  In response to a request made at the seventh 
session, the Secretariat had updated the strategy for implementation of the work programme on 
flexibilities and revised the annex providing details of  WIPO's activities in this area, addressing work 
in the area of patents, and taking stock of WIPO's activities relating to flexibilities in the IP system 
and technical assistance in the use of flexibilities (CDIP/8/5). 
33. He informed the Council of WIPO's implementa tion of the agreed components of the work 
programme on flexibilities. Information on IP fl exibilities had been incorporated in the WIPO 
technical assistance programme.  The Regional Bur eaus and the concerned sectors had been requested 
to ensure that, at the request of member States, information on flexibilities was appropriately included 
in the provision of technical assistance. 
34. Furthermore, a webpage dedicated to flexibilities in the IP system had been developed and 
published in English, French a nd Spanish on the WIPO website.4  As agreed upon by the member 
States, the webpage contained (i) a roadmap pr oviding guidance on WIPO's work on flexibilities in 
the substantive sectors and Committees;  (ii) a da tabase containing provisions  on national legislation 
related to flexibilities in the IP system, draw n from the agreed documents on patent-related 
flexibilities in the IP system;  and (iii) links to literature and resources on flexibilities produced by the 
Secretariat and WIPO-commissioned experts, as well as links to resources on flexibilities produced by 
                                                      
3 Available at:  http://www.wto.org/english/tratop_e /trips_e/par6_modelnotifs_e.pdf . 
4 Available at:  http://www.wipo.int/ip-developm ent/en/agenda/flexibilities/ . IP/C/61 
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  other relevant international organizations, such as  the WTO, the WHO, the FAO, and UNCTAD.  In 
this respect, WIPO was actively collaborating with ot her international organizations involved in work 
related to flexibilities in order to gather informati on and ensure a coordinate d and effective provision 
of resources on the issue to the Member States.  WI PO had researched and provided links to the work 
of such organizations, and would c ontinue this outreach to ensure the most effective use of resources 
in this area. 
35. In addition, steps had been taken through inte rnal communications and briefings to ensure 
that staff involved in providing technical assistance acr oss the sectors of the Secretariat were aware of 
this strategy on the use of flexibilities in intellectua l property, and continued to integrate appropriate 
techniques for diffusion of information to Member States.  Finally, at the request of member States, 
national and regional level seminars  had been organized and were pl anned in future activities with a 
view to exchange practical experiences on the impl ementation of flexibilities.  In this respect, in 
March 2011, a Regional Seminar on the Effective Use of Several Patent-Related Flexibilities had been 
held in Bangkok, Thailand, involving participants  from 16 countries in the Asia and Pacific Region 
for discussions on patent-related flexibilities a nd enabling sharing of experiences on the 
implementation of flexibilities at the national level.   
36. The representative of WIPO said that over time, the joint participation of WHO, WIPO and 
WTO in a number of activities and their participation as observers in respective meetings of the three 
organizations had contributed to building up a we ll-functioning working relationship among the three 
organizations on issues related to public health, intellectual property and trade.  This working 
relationship, which was supported by WIPO's Deve lopment Agenda Recommendation 40 to intensify 
cooperation on IP-related issues with UN agencies, had matured into the informal and practical 
trilateral cooperation his organiza tion had reported in earlier mee tings.  One example of this 
cooperation in the current year was the Workshop on Patent Searches and Freedom to Operate, held 
on 17 February 2011, which had introduced participan ts to the basic concepts involved in carrying out 
patent searches and freedom to operate analyses.5  Other collaborative activities included (i) the Joint 
Technical Symposium on Access to Medicines, Patent  Information and Freedom to Operate, held on 
February 18, 2011,6 which had addressed the growing importa nce of patent information for public 
health with respect to freedom to operate strategi es, procurement of medicines, technology transfer 
and setting of research priorities and strategies;  (ii) the WTO Workshop on Intellectual Property and 
Public Health, organized in Geneva by the WTO Secr etariat in collaboration with the Secretariats of 
WHO and WIPO from 10 to 13 October 2011;  and (iii)  work on a trilateral  study on "Promoting 
Access and Medical Innovation:  Intersections Betw een Public Health, Intellectual Property and 
Trade" that would be combining the three Secret ariats' specific expertise in order to support and 
objectively inform technical cooperation and policy discussions.  
37. He said that the agenda of the 16th session of the WIPO Standing Committee on the Law of 
Patents (SCP)7 from 16 to 20 May 2011 had included an agenda item on Patents and Health.  The 
delegation of South Africa had submitted a proposal to the SCP on behalf of the African Group and 
the Development Agenda Group (SCP/16/7).  The WI PO Secretariat, as well as representatives from 
the WHO and the WTO, had briefed the SCP on work being carried out in relation to that agenda 
item.  The topic would remain on the agenda of the 17th session of the SCP.   
38. He also informed the Council that, as of 13 October 2011, the Access to Research for 
Development and Innovation (A RDI) programme of WIPO had become a full member of 
Research4Life.  Research4Life was a public-priva te partnership between WIPO, WHO, FAO, UNEP, 
the International Association of Scientific, T echnical and Medical Publishers (STM), Cornell 
                                                      
5 http://www.wipo.int/meetings/en/ details.jsp?meeting_id=22342   
6 http://www.wipo.in t//meetings/en/2011/who_ wipo_wto_ip_med_ge_11/   
7 http://www.wipo.int/meetings/en/topic.jsp?group_id=61    IP/C/61 
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  University, Yale University, and several technical partners, including Microsoft.  The goal of the 
partnership was to enable free or low-cost onlin e access in developing and least developed countries 
to critical scientific research, with ARDI provi ding a particular focus on applied science and 
technology. 
39. He drew the Council's attention to the launc h of "WIPO Re:Search – Sharing Innovation in 
the Fight Against Neglected Tropical Diseases"8 on 26 October 2011.  Through WIPO Re:Search, a 
range of public and private sector institutions ha d come together to increase the availability of 
valuable intellectual property assets to the gl obal research community in order to address the 
challenges represented by neglected tropical diseases, particularly the need for more research.  The 
WHO was supporting this initiative by providing tec hnical advice to WIPO.  WIPO Re:Search was 
founded on the belief that intellectual property and knowledge could be used creatively to stimulate 
greater investment in research and development for new health solutions.  The mechanism worked 
entirely on a voluntary basis for all participating parties, namely providers and users, and had no 
impact on any legal instrument.  WIPO Re:Search allowed public and private sector organizations to 
make valuable intellectual property, including co mpounds, compound libraries, unpublished scientific 
results, regulatory data and dossiers, screeni ng technologies, platform technologies, know-how 
licenses and patent licences, available to qualifie d researchers anywhere in the world seeking to 
develop new solutions for neglected tropical diseas es, malaria and tuberculosis.  Licenses for product 
distribution in least developed countries would be royalty-free. 
40. The representative of the WHO Secretariat said that special emphasis had been given in his 
organization's capacity building activities to the im plementation and use of flexibilities in accordance 
with the TRIPS Agreement and the Doha Declarat ion on the TRIPS Agreement and Public Health.  
The aim had been to ensure that public health in terests were adequately taken into account in the 
formulation of national policies and legislation on  trade and intellectual property.  Many of the 
activities, especially in the field of training,  capacity building and technical assistance, thus 
encompassed TRIPS flexibilities.  Support was dire cted towards assisting Member States on how to 
safeguard public health interests while adhering to their obligations under international trade 
agreements.  In particular, this included devel oping public health sensitive patent legislation and 
incorporating TRIPS flexibilities into domestic legisl ation.  Technical support was carried out in close 
collaboration with WHO country and regional offi ces and relevant intern ational organizations. 
41. Turning to specific activities, he reported that in March 2011, WHO, along with the United 
Nations Development Programme (UNDP) and UNAI DS, had published a policy brief on the use of 
TRIPS flexibilities to improve access to HIV/AIDS treatment.  The paper reviewed how countries 
could use and had used TRIPS flexibilities in order to increase access to HIV treatment.  To provide 
ministries of health in the Eastern Mediterranean Re gion with a clear analysis of the public health 
implications of provisions include d in bilateral free trade agreemen ts, the WHO Regional Office for 
the Eastern Mediterranean had also published a po licy guide on "Public health related TRIPS-plus 
provisions in bilateral trade agreements". 
42. In 2011, WHO had taught for the first time a module on "Public health and Intellectual 
Property" in the framework of the Master's Degree in Intellectual Property at the Africa University in 
Zimbabwe, jointly organized by WIPO, the Afri can Regional Intellectual Property Organization 
(ARIPO) and Africa University. 
43. He recalled that WHO had provided substantia l support to the organization of the annual 
WTO "Workshop on Intellectual Property and Pub lic Health" that took place in Geneva in 
October 2011.  The workshop had addressed TRIPS pr ovisions and flexibilities of relevance to public 
health as well as other relevant issues ranging from procurement to regulatory questions and prices of 
                                                      
8 More information available at: http://www.wipo.int/research/en/ . IP/C/61 
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  medicines.  WHO Headquarters and the WHO Eur opean Regional Office had collaborated with WTO 
in the organization of a Regional Workshop for Ce ntral and Eastern European and Central Asian 
Countries on Intellectual Property and Public Policy that  had taken place in Vienna in January 2011.  
WHO Headquarters and regional offices had al so continued providing, upon request and in 
collaboration with relevant intern ational organizations, technical and policy support to favour use and 
management of intellectual property in a manne r that maximized health-related innovation and 
promoted access to medical technologies.  
44. The representative of the European Union said that  it had been reported to his delegation that 
the WTO Workshop on Intellectual Property and Public  Health had provided informative and helpful 
support to those Members seeking to utilize TRIPS fl exibilities.  Specific presentations on pricing had 
been particularly useful.  They had clarified that  there were many components relevant to the pricing 
of pharmaceuticals in addition to intellectual proper ty.  The inclusion of external speakers with 
various backgrounds had stim ulated an open debate. 
45. The representative of Nigeria recognized the work done to build capacity to use the 
Paragraph 6 System, and asked whether there ex isted a model voluntary licensing agreement that 
could be used to guide developing countries in d ealing with companies to establish or enhance their 
local manufacturing capacity.  
5. Any alternatives to the use of Paragraph 6 System to achieve the objective of access to 
medicines, procurement policies, and other rel ated aspects affecting access to medicines 
raised by Members 
 46. The representative of the United States said that his delegation strongly supported the 
Paragraph 6 System as established under the 2003 waiv er Decision and the 2005 Protocol Amending 
the TRIPS Agreement in order to allow medicines to be exported under a compulsory license under 
the terms set out in that decision and the accompanying Chairman's Statement.  His delegation had 
been the first Member to notify its acceptance of  the amendment. Members who had already notified 
their acceptance were developed, developing, a nd least developed countries and that though some 
were pharmaceutical producers, most were not.  He encouraged other Members to notify their acceptance of the amendment so that th e amendment could enter into force. 
47. Although the Paragraph 6 System represented an  important failsafe, it was only one tool for 
addressing the larger issue of access to medicines. In discussions with stakeholders in recent years, his 
delegation had consistently heard that the issue of  access to safe and effective medicines was being 
addressed by a variety of other means.  His Govern ment had also been actively working to address the 
factors that had been shown to reduce access to safe and effective medicines, including tools to deploy 
trade policy to promote trade in, and reduce obstacl es to access, innovative and generic medicines.  It 
had also been supporting the innovation and inte llectual property protection that was vital to 
developing new medicines and achievi ng other medical breakthroughs. 
48. Those tools included (i) enhancing legal certain ty for manufacturers of generic medicines;  
(ii) eliminating tariffs on medicines and medical devices, thereby decreasing costs for hospitals, 
clinics, aid organizations and cons umers, among others;  ( iii) reducing customs obstacles to medicines 
by minimizing import barriers, such as discriminatory, burdensome, and unpredictable customs 
procedures, that impeded access to innovative and generi c medicines;  (iv) curbing trade in counterfeit 
medicines by making customs and criminal enfor cement measures available to prevent medicines 
bearing counterfeit trademarks from entering na tional markets, and thus supporting efforts of 
countries to address the serious risks to patients po sed by such counterfeits;  (v) reducing internal 
barriers to distribution of medicines by  guaranteeing importing, exporting, and distribution rights with 
respect to medicines and minimizing internal barriers that could stand in the way of efficiently 
distributing medicines to those in need;  a nd (vi) minimizing unnecessary regulatory barriers by   IP/C/61 
 Page 15 
 
 
  promoting transparent and nondiscriminatory regulatory structures to facilitate the availability of safe 
and efficacious medicines to the public, while also  improving coherence of future rules across the 
region.  He recalled that his delegation had elabor ated those systemic issues in the Council's annual 
review carried out in 2010 (IP/C/M/57, paragraphs 198 to 201).  The list of other tools demonstrated 
that one policy alone could not solve the challenges relating to access to medicines.  Rather, a variety 
of tools, including the Paragraph 6 System, were needed to promote access to medicines. 
49. Regarding the proposal of some Members to hold a workshop which would include non-
governmental actors, he said that his delegati on did not support the idea of having the Council 
organize such a seminar.  Members were free to bring into the C ouncil's review of the Paragraph 6 
System perspectives they had gleaned from stakehol ders, such as companies or civil society.  What 
Members got out of the review was very much a func tion of what they put into it.  His delegation had 
hoped that Members would provide information on their experiences as input for the Council's 
discussions of the System's functioning at the current  meeting, but it was disappointed by the details 
of experiences that had been provided.  It coul d be that the Paragraph 6 System had not been 
necessary, and for this reason many Members had not implemented it, or that capital-based experts 
from health ministries could simply not attend the Council's meeting because of other competing 
demands.  He reiterated hi s delegation's interest in hearing othe r Members' experiences and views on 
how best to gather additional information. 
50. The representative of Ecuador said that the Syst em was not effective and could be further 
improved. His Government was therefore not ready to proceed with the acceptance of the Protocol. 
His delegation, like other Members, had considered alternatives to the use of the Paragraph 6 System 
by compiling and evaluating other coun tries' practices in respect of the implementation of Articles 30, 
31 and 44 TRIPS.  Those practices were of signi ficant importance in enabling Members to take 
informed policy decisions as they str ove to transform into reality the spirit of the Doha Declaration on 
the primacy and safeguarding of public health and the promotion of access to medicines. 
51. In that context, he requested that the Eur opean Union provide clarification on the Italian 
Competition Authority's granting of three compulsory licences between 2005 and 2007, which 
seemed to have occurred under Article 31(k) of th e TRIPS Agreement.  Under that provision, the 
conditions established in Article 31(f) could be waiv ed if a licence was granted to remedy a practice 
determined after judicial or administrative process to be anti-competitive. 
52. In the first case, the Italian Competition Author ity had launched an inv estigation in February 
2005 regarding the abuse of dominant position by Me rck for its refusal to grant licensing rights in 
respect of the patent-protected active ingredients, which were used to produce the antibiotic Imipenem 
Cilastatin.  On 21 June 2005, the Italian Compe tition Authority had granted a compulsory licence on 
the relevant patents for the active ingredients needed  for the manufacture of the antibiotic concerned.  
The product had been patented only in Italy and not in other European countries.  The Italian generics 
industry had sought a licence to produce and market th e product in the rest of Europe (not for the 
Italian market), where this product had not been protected. 
53. The second case concerned a decision by the Italian Competition Authority of 
8 February 2006 to grant a compulsory licence for the manufacture in Italy of the patent-protected 
active ingredient Sumatriptan Succinate needed to  produce medicines to treat migraine.  The licence 
had been requested by the chemical company Fabbrica Italiana Sintetici SpA  (FIS), following GSK's 
refusal to negotiate a voluntary licence.  Initially, FIS had used the compulsory licence primarily for 
the purpose of supplying the export market by se lling its product to generic companies, which 
marketed it in other countries such as Spain, where th e relevant patent had e xpired.  This had been 
done outside the Paragraph 6 System, from which th e EU and its member States had opted out of as 
beneficiaries. IP/C/61 
Page 16 
 
 
  54. The third case related to the Italian Competiti on Authority call upon Me rck on 21 March 2007 
to "grant free licences to allow the manufacture and sale in Italy of the active ingredient Finasteride 
and related generic drugs two years before th e 2009 expiration of the Supplementary Protection 
Certificate".  Finasteride was th e active ingredient of a drug initially marketed under the brand names 
Proscar and Propecia.  It was used to treat prostatic hypertrophy, prostate cancer and male pattern 
baldness.  The royalty-free compulsory licences is sued by the Italian Competition Authority had 
remedied Merck's refusal to license its patent s to local manufacturers of pharmaceutical active 
ingredients.  Those licences had once again involved exports to other European countries. 
55. He asked the delegation of the European Union to provide the Council with further 
information on these three compulsory licences including, but not limited to, administrative 
procedures, decision-making processes and the legal a nd factual basis for the grant of the licences.  
He also requested that the European Union pr ovide examples of other uses under Article 31(k) 
relating to the export of medical technologies. 
56. The representative of India said that the issue of Members' experiences using alternatives to 
the Paragraph 6 System to achieve the objective of  access to medicines had been raised and discussed 
for several years, but Members were still short of inputs.  He therefore reiterated his delegation's 
demand for a dedicated workshop that would, as the delegation of Ecuador  had mentioned, help 
strengthen the Paragraph 6 System and where Memb ers would have an opportunity to discuss other 
experiences.  The workshop would also help those delegations develop faith in the System who had 
cited a lack of faith as the reason for not accepting the Protocol Amending the TRIPS Agreement.   
57. Turning to the role of compulsory licensing to  provide access to medicines, he recalled that 
Articles 30 and 31 of the TRIPS Agreement provided a mechanism to that extent.  Article 30 was a 
substantive exception which detailed three criteria to  be met for any exception to apply to exclusive 
patent rights.  Article 31, in contrast, was primarily procedural  in nature, detailing a list of 
requirements that applied to other uses without au thorization by the patent right holder.  Both 
provisions taken together defined the scope of limitations to excl usive patent rights available under 
the TRIPS Agreement.  Additionally, Article 44 ou tlined flexibilities with respect to the right to 
provide permanent injunctions.  
58. He drew Members' attention to two particular cases in the Un ited States.  Shedding light on 
those cases could help address the problem of provi ding access to medicines without recurring to the 
complicated Paragraph 6 System.  In eBay v. Me rcExchange, the US Supreme Court had determined 
that the plaintiff in infringement cases had to satisfy  a four-factor test before a court could issue a 
permanent injunction.  This four-factor test incl uded demonstration of the following elements by the 
plaintiff, i.e. that:  (i) he had suffered full and irrepa rable injury;  (ii) remedies  available at law such as 
monetary damages were inadequate to compensate fo r that injury;  (iii) considering the balance of 
hardships between the plaintiff and defendant, a reme dy in equity was warranted;  and (iv) public 
interest would not be disserved by a permanent injunc tion.  In Edwards Lifesciences v. CoreValve, a 
compulsory licence had been granted for manufacturing a medical device in the United States 
exclusively for exportation.  He requested that the United States and other countries where similar 
judgments had occurred explain to Members why the restrictions on exports under compulsory 
licences as established by Article 31 of the TRI PS Agreement did not apply in those cases.   
59. The representative of Switzerland referred to hi s delegation's intervention at the last annual 
review, which was recorded in paragraph 175 of th e Council minutes (IP/C/M/64).  In response to the 
question from the delegation of Ec uador on programmes put in pl ace by his Government to address 
public health problems in developing countries, he not ed that his delegation was active in many such 
programmes.  Public health was one of the focus poi nts of its development work at both the bilateral 
and multilateral levels.  As regards programmes specifi cally linked to intellectual property, he referred 
to the reports that his delegation had submitted on technical cooperation, as well as on the obligation  IP/C/61 
 Page 17 
 
 
  under Article 66.2 to provide incentives to transfer technology to least developed country Members.  
The 2011 report provided more details, in particular  in paragraphs 28, 29 and 34 (IP/C/W/558/Add.5).  
Regarding programmes with a particular focus on de velopment and health, but not specifically linked 
to intellectual property, more information could be accessed on the website of the Swiss Federal 
Agency for Development and Cooperation.9 
60. With respect to any alternativ es to the use of the Paragraph 6 System, he referred to his 
delegation's intervention at last year's annual revi ew (IP/C/M/64, paragraphs 285 to 287).  Turning to 
the proposal for an open-ended workshop to be held to gather information on the functioning of the 
System, which had been made by some delegations who considered that the exchange of experiences 
among Members had been exhausted,  he maintained his delegation's view that holding such a 
workshop at this stage was premature.  So far, it had not heard much from countries that were 
potential beneficiaries under the Paragraph 6 System.  Most countries that had intervened were either 
potential exporting countries or countries with manufacturing capacity.  However, those were not the 
countries that WTO Members had had in mind when  devising the Paragraph 6 System.  While his 
delegation was not in principle against the idea of holding a workshop, it was important to first 
establish within the Council the problems that potenti al beneficiaries had encountered, as well as their 
concerns with respect to the Paragraph 6 System.  Before having heard thos e concerns, it would be 
difficult to even decide who should be invited to such a workshop and what specific problems should 
be highlighted and discussed.   
61. The representative of Japan recalled that the Paragraph 6 System aimed at enhancing access 
to medicines in Members with insufficient or no manufacturing capacities in the pharmaceutical 
sector. He noted that according to the information th at had been provided at the trilateral Symposium 
on "Access to Medicines: Pricing and Procurement pr actices" that had been organized by the WHO, 
WIPO and WTO in July 2010, only 5% of the medi cines on the WHO list of essential medicines were 
protected by patents.  Therefore, the Paragraph 6 System was only one of many tools to address public 
health problems.  Other important elements incl uded the procurement of medicines and tariffs.  
62. The specific concerns of potential importing Me mbers were indispensable parts of the review. 
Those Members were best qualified to share thei r experiences with the Council regarding specific 
obstacles or concerns faced, but only a few Memb ers had done so.  Until discussions within the 
Council were completed, it would be premature to  hold a workshop on the Paragraph 6 System.  
63. The representative of Cuba shared the con cerns expressed by other delegations on the 
implementation of the Paragraph 6 System.  As re gards the acceptance of the Protocol Amending the 
TRIPS Agreement, she noted that it was the respons ibility of Members to create suitable rules that 
provided a lasting solution and did not require frequent revision. In that context, it was important that 
further discussions be held in the Council before  Members rushed to accept the Protocol.  Those 
should aim at clarifying any doubts about the Syst em's functioning, and address the reasons why it 
had been rarely used.  To this end, the organiza tion of a workshop would be desirable in order to 
provide greater clarity on the effectiveness of the implementation and operation of the System. 
64. The representative of the European Union said that access to essential medicines for 
developing countries was of utmost importance to his delegation.  This explained why it had taken an 
active part in the negotiations that had led to the 2003 waiver decision and to the TRIPS amendment. 
Subsequently, it had taken the necessary steps to impl ement the Paragraph 6 System at the EU level 
and to accept the amendment.  He st ressed the need to make the Syst em work, as well as the fact that 
his delegation was committed to do so.  Rather than  reopening a debate on the System as a whole, it 
was important to have a focused discussion within the framework of the Council's annual review.  To 
that extent, the list of issues for discussion which th e Chairman had circulated was helpful.  However, 
                                                      
9 http://www.deza.admin.ch/en/home/themes/health  IP/C/61 
Page 18 
 
 
  his delegation was disappointed about the debate, as it had hoped to learn more about the reasons why 
the developing countries for whom the System had been designed, apart from Rwanda, had not used 
it.  He disagreed with those Members that claimed that the operation of the System would be hindered 
by legal, procedural, commercial and other obstacl es.  There were few conditions required for the 
System to work properly. 
65. Several reasons could explain why the System ha d not been used more often.  These included 
the fact that 90 per cent of essential medicines were in the public domain.  Least developed countries 
were also not obliged to implement any TRIPS obligations with respect to patents and test data protection in the area of pharmaceuticals until 1 Janua ry 2016.  Moreover, ther e were other channels 
developing countries could use to get access to chea p medicines, including, for instance, through the 
use of existing TRIPS flexibilities and direct negotiation with pharmaceutical companies. The 
Paragraph 6 System was equally effective when it w as used as when it was not used due to its effect 
as both a negotiating chip and a strong deterrent.  It  would be interesting to hear more about the 
System's impact on negotiations and on pricing since it had been put in place.   
66. In his delegation's view, those who criticized the System as being too burdensome without 
real life experience of the matter were discourag ing developing countries from using an instrument 
which could help them secure access to affordable medicines.  Positions taken by some countries like 
Ecuador who had said that they would not accept the System were unfair, since those countries had 
domestic manufacturing capacities that other countries that really needed the System lacked. 
67. In response to the questions which the delegati on of Ecuador had addressed to his delegation, 
he said that it was not clear whether those were mean t to demonstrate how the System had been put in 
place or whether they were addressing an unrelated matter, such as the use of compulsory licences 
under normal circumstances.  He clarified that, in any event, European countries were not using the 
System as importers.  Addressing those issues would require some research, but his delegation would 
be prepared to do so under the relevant agenda item. 
68. As regards the two judicial decisions referred to  by the delegation of India, the representative 
of the United States clarified that those decisions had specifically addressed procedural aspects of the 
provision on injunctive relief.  The findings in those cases were therefore limited and the analysis 
which the delegation of India had made of them wa s not necessarily within the scope of the matters 
before the courts.  
69. Noting his country's experience regarding the import of generic medicines under the 
Paragraph 6 System, the representative of Rwanda  supported the permanent incorporation of the 
System through the proposed amendment to the TRIPS Agreement.  He informed the Council that his 
Government would ratify the Protocol Amending th e TRIPS Agreement no later than by the extended 
deadline for acceptance. 
70. Taking note of the response given by the delega tion of the European Union, the representative 
of Ecuador further clarified the issues he had raised  in his earlier statement.  The Paragraph 6 System 
constituted one of the mechanisms to waive the otherwise applicable c ondition under Article 31(f) 
TRIPS and to issue compulsory licences for export pu rposes.  Other provisions that could also assist 
Members who faced difficulties with the restric tive condition established by Article 31(f) included 
Article 31(k) which permitted unauthorized usage to remedy a practice determined after a judicial or 
administrative process to be anti-competitive.  In th e three cases he had referred to before, compulsory 
licences had been granted under Article 31(k).  Hi s delegation would welcome learning more about 
such practice, which seemed to represent a valid an d useful alternative to overcome problems posed 
by the implementation of Article 31(f).  IP/C/61 
 Page 19 
 
 
  6. Next steps and recommendations  
 
71. The Chairman said that the discussion of this topic should provide the Council with an 
opportunity to discuss whether there was a need for a follow-up to the annual review, and, if so, what 
it should be.  
72. The representative of Venezuela noted that ma ny Members who had intervened on the issue 
were developed countries who had stated that th ere was no need to re-open the discussion on the 
System's functioning.  His delegation's concern was that Members who had not yet accepted the 
Paragraph 6 System and thus could not share their e xperiences were reluctant to  speak on the issue.  
The fact that they had not implemented the Syst em combined with their silence indicated the 
existence of unaddressed concerns and the need for greater clarity.  
73. The representative of Turkey said that, in the interest of understanding the Paragraph 6 
System well, holding a workshop open to all st akeholders could provide a good opportunity to 
introduce it to potential users.  Such a forum w ould allow the civil society, the pharmaceutical 
industry, exporting Members and least developed co untry Members to share their views, experiences, 
and questions on the implementation of the System.  
74. The representative of China said that the Counc il needed to make a decision regarding the 
follow-up to the eighth annual review.  There app eared to be a lack of consensus among Members on 
whether the legal procedures or commercial stake holders prevented developing countries from using 
the Paragraph 6 System. Her delegation therefore st rongly supported that an open-ended workshop for 
all stakeholders be held. It would help achieve greater transparency, promote a holistic understanding, 
and perhaps a solution to the current deadlock.  
75. The representative of Canada supported the delega tions of Switzerland and Japan in that it 
would be useful to hear more specific views a nd experiences from potential beneficiaries regarding 
any obstacles posed by the System.  It was not clear what could be gained from an open-ended 
workshop that could not be gained through discussi ons in the Council. Delegations could gather 
information from stakeholders and share it with the Council.  
76. The representative of the European Union said th at his delegation shared the views expressed 
by the delegations of Canada, the US, Japan, and Switzerland.  Experiences with the System heard so 
far either indicated that the System had worked, th at it had had some impact even when it had not 
been used in the end, or that it had been a usef ul negotiating chip.  Holding an open-ended workshop 
would therefore be premature and unnecessary. 
77. The Chairman suggested that he consult on next steps, including the issue of a possible 
workshop. 
78. The Council took note of the statements made and so agreed. 
79. Turning to the draft report to the General C ouncil on the annual review  of the Paragraph 6 
System, the Chairman recalled that the Secretariat had circulated a draft cover note for the Council's 
report modelled on previous years' reports (JOB/I P/4).  It contained factual information on the 
implementation and use of the System establishe d under the Decision, discussions regarding its 
operation, and the status of acceptances of the Protocol Amending the TRIPS Agreement.  In 
accordance with the way that  the Council had prepared its reports in the previous years, the portion of 
the minutes of the meeting that reflected the discu ssions held under the specific agenda item could be 
attached to the cover note. IP/C/61 
Page 20 
 
 
  80. As regards paragraph 15 of th e report, he recalled that Argentina, Indonesia and New Zealand 
had recently accepted the Protocol.  There was also  a minor error in the paragraph, namely that 
Uganda should have been included in the list of Members that had notified their acceptance.  This 
paragraph would be updated and corrected accordingly.  
81. The Protocol had originally been open fo r acceptance by Members until 1 December 2007. 
Upon proposals by the TRIPS Council, the General C ouncil had twice extended that period for further 
two-year periods.  The period for acceptance was currently due to expire on 31 December 2011.  
Given the proximity of that date, the Chairman s uggested that the Council consider again submitting a 
proposal to the General Council for a decision to ex tend the period for the acceptance of the Protocol.  
For that purpose, a draft decision that could be  submitted to the General Council for adoption was 
included in Annex 2 to the draft report.  It did not yet contain a new deadline for the extended period for acceptances.  In the light of the consultations he  had held on this matter, he suggested that the 
Council propose to extend the period by a further two years until 31 December 2013. 
82. The representative of Turkey supported the appro ach suggested by the Chairman.  This would 
also provide her delegation with additional tim e to complete its internal procedures.  
83. The Chairman proposed that the Council ag ree on forwarding to the General Council the 
proposal for a decision to extend the period of accep tance by Members of the Protocol Amending the 
TRIPS Agreement until 31 December 2013.  He suggested  that the last paragraph of the draft decision 
by the General Council contained in Annex 2 to the draft report (JOB/IP/4) be complemented by 
inserting this date.  He also proposed that the Counc il agree to the cover note to the report contained 
in JOB/IP/4, and also that the Council minutes contai ning the record of the discussion be attached to 
it. 
84. The Council took note of the statements made and so agreed. 
  IP/C/61 
 Page 21 
 
 
  ANNEX 2 
 
 
WORLD TRADE  
ORGANIZATION   
WT/L/… 
 
 (11-0000) 
  
 
 
AMENDMENT OF THE TRIPS AGREEMENT – THIRD EXTENSION OF THE PERIOD 
FOR THE ACCEPTANCE BY MEMBERS OF THE PROTOCOL AMENDING 
THE TRIPS AGREEMENT 
 
Draft Decision of [date] 
 
 The General Council, 
 
 Conducting  the functions of the Ministerial Conference in the interval between meetings  
pursuant to paragraph 2 of Article IV of the Marrakesh Agreement establishing the World Trade 
Organization (the "WTO Agreement"); 
 
 Having regard to paragraph 2 of the Decision of the General Council of 6 December 2005 on 
the Amendment of the TRIPS Agreement (the "TRI PS Amendment Decision") and paragraph 3 of the 
Protocol Amending the TRIPS Agreement (the "Protocol")1, which provide that the Protocol shall be 
open for acceptance by Members until 1 December 2007 or  such later date as may be decided by the 
Ministerial Conference;  
 Recalling that the General Council, by its d ecision of 17 December 2009 (the "2009 
Extension Decision")
2, extended the period for acceptances of the Protocol by Members for the 
second time until 31 December 2011 or such later date as may be decided by the Ministerial 
Conference;  
  Recalling also that, pursuant to paragraph 3 of the TRIPS Amendment Decision and 
paragraph 4 of the Protocol, the Protocol shall take effect and enter into for ce in accordance with the 
provisions of paragraph 3 of Article X of the WTO Agreement;  
 Noting  that acceptance of the Protocol by two th irds of the Members in accordance with 
paragraph 3 of Article X of the WTO Agreem ent is taking longer than initially foreseen; 
 
 Having considered the proposal to further extend the period for acceptances of the Protocol 
submitted by the Council for TRIPS (IP/C/..); 
 
 Decides  as follows: 
 
 The period for acceptances by Members of the Protocol Amending the TRIPS Agreement 
referred to in paragraph 2 of the TRIPS Amendm ent Decision and paragraph 3 of the Protocol, 
                                                      
1 WT/L/641. 
2 WT/L/785. IP/C/61 
Page 22 
 
 
  and extended by the 2009 Extension Decision, shall be further extended until 31 December 2013 
or such later date as may be decided by the Ministerial Conference. 
 
__________