IP/C/66  
 
23 October 2013  
(13-5865)  Page: 1/16  
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 Implementa tion of Paragraph 6 of the Doha Declaration on 
the TRIPS Agreement and Public Health of 30 Augu st 2003 (the "2003 Decision") provides that the 
Council for TRIPS shall review annually the functioning 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 th e review requirements of Article IX:4 of the WTO 
Agreement. 
2.  The Council for TRIPS undertook the ninth annual review in November 2012. The General 
Council took note of the report of the Council for TRIPS (IP/C/63) at its meeting on 
11 December 2012 (WT/GC/M/141, paragraph 10.6).  The present report covers the period since October 2012. 
3.  At its meeting of 10-11 October 2013, the Council undertook the tenth annual review. Annex 1 
to this report records the statements made in the review. The paragraphs below set out factual information regarding the implementation and use of the 2003 Decision and the acceptance of the 
Protocol Amending the TRIPS Agreement. 
1  INFORMATION ON IMPLEMENTATION AND USE OF THE SYSTEM ESTABLISHED UNDER 
THE DECISION 
4.  Since the last annual review, Jordan has notified legislation implementing the System into 
domestic law to the Council for TRIPS. An overview of all notified implementing laws and 
regulations, including hyperlinks to the legal text s, is available on a dedicated page on the WTO 
website at http://www.wto.org/english/trat op_e/trips_e/par6laws_e.htm . 
5.  During the period covered by the present re port, 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 ). 
6.  A trilateral study on "Promoting Access to Medical Technologies and Innovation – Intersections 
Between Public Health, Intellectual Property an d Trade", launched by the WHO, WIPO and WTO 
Secretariats in February 2013, offers explanatory background material on the implementation and 
use of the System.1 In addition, a set of model notifications has been provided for illustrative 
purposes on the WTO's webpage dedicated to public health in order to further facilitate the use of 
the System.2 
                                               
1 See pages 177 to 180 and Annex II of the study, av ailable at the three organizations' respective 
websites: http://www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf ; 
http://www.wipo.int/export/sites/www/freepubl ications/en/global_challenges/628/wipo_pub_628.pdf ; 
http://www.who.int/phi/PAMTI_WHO-WIPO-WTO.pdf .  
2 http://www.wto.org/english/tratop_e/trips_e/par6_modelnotifs_e.htm .  IP/C/66 
 
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  2  DECISION ON THE AMENDMENT TO THE TRIPS AGREEMENT 
7.  As called for in paragraph 11 of the 2003 Decision, 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 2013 or such later date as may be decided by 
the Ministerial Conference (WT/L/829). In accordan ce with Article X:3 of the WTO Agreement, the 
Protocol will enter into force upon accept ance by two thirds of the WTO Members. 
8.  As of 30 September 2013, the following Members 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; 
 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 Communities
3, 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;  
                                               
3 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 Europe an Community, and in particular Article 133(5) in 
conjunction with the first sentence 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 Intellectual Property Rights (TRIPS), done at Geneva on 6 December 2005, 
 
CONFIRMS, in accordance with Article 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 Represen tative                The President of the Council 
        o f  t h e  E u r o p e a n  U n i o n "  IP/C/66 
 
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   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; 
 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 Macedonia, 16 March 2010, WT/Let/671; 
 Uganda, 12 July 2010, WT/Let/678; 
 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; 
 Cambodia, 1 November 2011,WT/Let/833; 
 Panama, 24 November 2011, WT/Let/837;  
 Costa Rica, 8 December 2011; WT/Let/838; 
 Rwanda, 12 December 2011, WT/Let/839; 
 Honduras, 16 December 2011, WT/Let/843; 
 Togo, 13 March 2012, WT/Let/848; 
 Saudi Arabia, Kingdom of, 29 May 2012, WT/Let/855; 
 Chinese Taipei, 31 July 2012, WT/Let/870;  
 Chile, 26 July 2013, WT/Let/888; 
 Montenegro, 9 September 2013, WT/Let/893; and IP/C/66 
 
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   Trinidad and Tobago, 19 September 2013, WT/Let/894. 
9.  Information on the status of acceptances of the Protocol can be found on a dedicated webpage 
which is regularly updated by the WTO Secretariat.4 
10.  Given the present status of acceptances, and the indications that a number of Members are 
actively progressing their acceptance of the Protocol, the Council for TRIPS submits the attached 
proposal to the General Council for a decision to extend the period for acceptances of the Protocol. A draft of such a proposal for consideration by the Council is contained in Annex 2 of this 
document. 
                                               
4 http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm . Revisions of document IP/C/W/490 
will no longer be circulated. IP/C/66 
 
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  ANNEX 1 
Excerpt from the Minutes of the Council's meeting of 10-11 October 2013 
to be circulated as IP/C/M/74 
 
 
6  REVIEW 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 suggested that, in light of the consultations he had held on the preparations for 
the tenth annual review under paragraph 8 of the Decision on the Implementation of Paragraph 6 
of the Doha Declaration on the TRIPS Agreement and Public Health, the Council follow the 
standard format in the present review. Accordingl y, after introducing the item and any relevant 
recent developments, the floor would be opened to delegations for comments. This was how the Council had conducted most of the reviews, including the previous review, although in 2010 and 
2011, the Council had had in place more elaborated procedures that had been agreed in advance, 
including a set of topics and qu estions to guide the discussion. 
2.  He said that the records of earlier reviews, including the exchange of questions and responses, 
continued to provide a unique and valuable resource for understanding this important measure and 
could also inform discussions at the present review. He had therefore encouraged delegations to consult this material, recorded in the minutes of previous reviews, and consider whether there was 
any issues they would wish to follow up.  
3.  As regards the purpose of the review, he recalled that paragraph 8 of the waiver Decision 
provided that the Council for TRIPS 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 
the 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/9). It contained factual in formation on the implementation and use of the 
System established under the Decision and on the status of acceptances of the Protocol Amending 
the TRIPS Agreement. In accordance with the way that the Council had prepared its report in previous 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.  Paragraph 8 of the cover note contained a list of Members that had notified their acceptance of 
the Protocol. The Chairman said that Chile an d Montenegro, on 26 July and 9 September 2013 
respectively, had deposited their instruments of acceptance since the Council's last meeting 
in June. In addition, since the circulation of the draft report, Trinidad and Tobago had also accepted the Protocol (WT/Let/894). Paragraph 8 would need to be updated accordingly. 
6.  The Chairman clarified a frequently asked qu estion on how the acceptance of the Protocol 
related to the implementation of the Paragraph 6 System in a Member’s domestic legal framework. 
He said that these were two entirely separate acts, in other words, the Protocol could be accepted independently from adopting domestic implementing legislation. By accepting the Protocol, a 
Member in essence expressed its consent that other WTO Members were entitled to use the 
additional flexibility that the System provided. Should a WTO Member wish to take advantage itself of those additional flexibilities, the adoption of appropriate domestic legislative measures could be 
required. He emphasized that, since these two pr ocesses were entirely separate, a Member could 
choose to deposit an instrument of acceptance of the Protocol without the need to wait for any domestic implementation. In fact, a number of instruments of acceptance that the WTO had 
received had been deposited before the Member in question had adopted any domestic 
implementing legislation. IP/C/66 
 
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  7.  The representatives of the United States, Indi a, Canada, China, Australia, Japan, the European 
Union, Cuba, Switzerland, Chile and El Salvador, as well as of the WTO Secretariat and the WIPO 
Secretariat took the floor under this agenda item.1  
8.  The Council took note of the statements made. 
9.  Turning to the report to the General Council  on the annual review of the Paragraph 6 System, 
the Chairman said that the Secretariat had circulated a draft cover note for the Council's report 
modelled on previous years' reports (JOB/IP/9). It contained factual information on the 
implementation and use of the System establis hed under the Decision and on the status of 
acceptances of the Protocol Amending the TRIPS Ag reement. In accordance with the way that the 
Council had prepared its reports in the previous 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. 
10.  As regards paragraph 8 of the cover note to the report, he recalled that Trinidad and Tobago 
had also recently accepted the Protocol. This paragraph would be updated accordingly. 
11.  The Protocol had originally been open for acceptance by Members until 1 December 2007. 
Upon proposals by the TRIPS Council, the General Council had three times extended that period 
for further two-year periods. The period for acceptance was currently due to expire on 
31 December 2013. Given the proximity of this date, the Chairman suggested that the Council 
consider again submitting a proposal to the General Council for a decision to extend 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 prop ose to extend the period by a further two years 
until 31 December 2015.  
12.  The Chairman proposed that the Council agree on forwarding to the General Council the 
proposal for a decision to extend the period of acceptance by Members of the Protocol Amending 
the TRIPS Agreement until 31 December 2015. He suggested that the last paragraph of the draft decision by the General Council contained in Annex 2 to the draft report be complemented by 
inserting this date. He also proposed that the Council agree on the cover note to the report 
contained in JOB/IP/9, with the update to paragraph 8 concerning Trinidad and Tobago, and also that the Council minutes containing the record of the discussion be attached to it. 
13.  The Council so agreed. 
                                               
1 The statements made by dele gations will be reproduced in an addendum to the minutes 
(IP/C/M/74/Add.1) of which the relevant extracts  are contained in Appendix 1 to this report. IP/C/66 
 
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  ANNEX 2 
  
  
WT/L/  
 
 
(13-0000)  Page: 7/16  
    
AMENDMENT OF THE TRIPS AGREEMENT – FOURTH 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 "TRIPS 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 decision of 5 December 2011 (the "2011 
Extension Decision")
2, extended the period for acceptances of the Protocol by Members for the 
third time until 31 December 2013 or such late r 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 force in accordance with the provisions of paragraph 3 of Article X of the WTO Agreement; 
 
 Noting  that acceptance of the Protocol by two thirds of the Members in accordance with 
paragraph 3 of Article X of the WTO Agreement 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/65); 
 
 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, 
and extended by the 2011 Extension Decision, sh all be further extended until 31 December 2015 
or such later date as may be decided by the Ministerial Conference. 
 
 
                                               
1 WT/L/641. 
2 WT/L/829. IP/C/66 
 
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  APPENDIX 1 
[EXCERPT FROM THE ADDENDUM TO THE MINU TES, CONTAINING THE STATEMENTS MADE 
DURING THE COUNCIL'S MEETING HELD ON 10-11 OCTOBER 2013, TO BE CIRCULATED AS 
IP/C/M/74/ADD.1.] 
AGENDA ITEM 6: REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE 
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH 
6.1 United States   
 The United States strongly supports the Paragraph 6 System as established under the 2003 waiver decision and the 2005 Protocol. 
 
We encourage other Members to notify their acce ptance of the amendment so that it can enter 
into force. I congratulate Montenegro, Chile, Chinese Taipei, Saudi Arabia, and Togo as the most 
recent Members to accept the amendment. 
 We want to take this opportunity as part of toda y's review of the implementation of paragraph 6 of 
the Doha Declaration on the TRIPS Agreement and Public Health to provide some context. As we 
have noted previously, the Paragraph 6 System is one of many tools to address the issue of access 
to medicines. There are other tools to address this important issue, which also merit discussion. As we will describe in greater detail under a separate agenda item, there are numerous barriers to 
access that deserve greater attention in this Council. These include both financial and non-financial 
barriers such as: insufficient legal and regulatory frameworks; insufficient enforcement; financial disincentives; high cost of capital and red tape. Today we would like to focus on tariffs. 
 
Tariffs are applied to medicines, to the components of those medicines, such as active ingredients, 
and medical products. Tariffs imposed by governments are, however, borne by consumers, and 
more specifically, by patients. As we explained in November 2012, in recognition of this reality, 
during the Uruguay Round, the United States joined several other Members in eliminating tariffs on medicines and active ingredients in order to liberalize trade, lower costs, and increase access to these essential products. Since then, the participants in the pharmaceutical zero-for-zero 
agreement have updated it four times in order to include additional inputs for medicines, thereby 
reducing costs of production for medicines. Howeve r, some countries continue to impose relatively 
high tariffs on medicines, inputs to medicines and medical products. As we have previously noted, 
according to an October 18, 2012 paper by the WTO Economic Research and Statistics Division 
entitled "More Trade for Better Health, Internationa l Trade and Tariffs on Health Products", several 
countries continue to maintain relatively high tariff rates on these products, despite a general 
trend toward tariff reduction on these goods. 
 The report concludes by asking "why countries even maintain tariffs on health products. Imposing tariffs typically translates into higher product pr ices, especially in the presence of long supply 
changes. Maintaining tariffs ultimately means taxing  the sick and creating additional costs for the 
health system." Today, we would welcome more insight from those countries identified in the WTO report who continue to maintain the highest tariffs on medicines about the consistency of such 
policies with their commitment to greater access to medicines. 
 6.2 India 
 
India attaches high importance to the Doha Declaration on the TRIPS Agreement and Public Health, the Paragraph 6 System and the Protocol  Amending the TRIPS Agreement of December 
2005. We see from JOB/IP/9 that although 47 Members have accepted the Protocol, we are still far 
away way from the two thirds mark required for its entry into force, i.e. 106 Members.  
 India has always been of the view that the Doha Declaration on the TRIPS Agreement and Public 
Health constituted a major landmark in the short history of the WTO because it recognized the 
primacy of public health needs and the sensitivity of this organization to the problems faced by the poor in the less developed countries.  
 IP/C/66 
 
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  Along with several other Members, India worked relentlessly for the Decision of 30 August 2003 
with the hope that it would genuinely and completely address the problems faced by WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector to address their public health problems. It may have sound ed prophetic at that time when India voiced 
certain apprehensions in the General Council meeting of August 2003. India sounded a word of 
caution and expressed hope that “the results accruing from this mechanism should not be negated by the creation of cumbersome systems that would lead to huge delays in getting medicines across 
at reasonable cost to those that needed them or discourage Members from using the System for 
the benefit of the people. In order to make this System successful, a sincere collective effort was required on the part of all Members and the entire pharmaceutical industry.” Regrettably, we have been proven right.  
 
During the recently held negotiations to extend the TRIPS transition period for the LDCs, we found 
strong resistance from the developed country Members to provide an indefinite extension till the 
LDCs graduated to become developing countries. Since the ability of the LDCs to gain access to 
generic medicines would be directly and severely impaired with the implementation of the TRIPS 
Agreement, we cannot take seriously any prior or current rhetoric by these Members in the context 
of the Paragraph 6 mechanism that these Members are committed to ensuring access to 
medicines. In fact the permanent exemption from  the provisions of the TRIPS Agreement to all 
countries while they are classified as LDCs continues to be the most significant exception to ensure access to low-cost generic medicines in LDCs, though patent barriers in countries with capacity to 
manufacture generic medicines presents and will present a critical barrier that the Paragraph 6 
mechanism was meant to help resolve.   
Let me also recall that our delegation during the last two annual reviews in 2011 and 2012, had 
asked a few questions to some developed country  members around the Paragraph 6 mechanism. 
Regrettably these questions have still remained unanswered. Since the mechanism has been used 
only once for a single product, in favour of a single country and by a single country during the last 
several years and since the Members, especially those who would require this mechanism in future, have several questions, it is necessary that the Council reviews the mechanism comprehensively by taking into account the views of not only the Members but also all 
stakeholders, including patients, legal experts an d civil society organisations. It is therefore 
pertinent that the Council organizes a dedicated workshop on the question of making effective use of compulsory licensing for export under the TR IPS Agreement, including alternatives to the 
Paragraph 6 System involving all relevant stakeholders at the earliest. We are sure that an 
inclusive approach would help in a better review of the mechanism. We also understand that a few Members have blocked the consensus required for holding such a workshop. In fact my delegation 
would urge them to reconsider their position on such a trivial issue to save the lives of thousands 
of people in the countries lacking manufacturing facilities and also lacking resources to import patented products.  
6.3 Canada   
 Canada would be interested in hearing more from Members based on questions we have previously 
raised, including at our November 2012 meeting, as to whether potential importing Members have 
availed themselves of pooled procurement schemes; and whether Members have increased their domestic manufacturing capacities since 2003. We are also concerned that potential importing 
Members still impose tariffs or duties on the products concerned by the 2003 Decision and on 
other products such as antimalarial commodities.  Canada also calls on all Members that have not already done so to deposit their instruments of 
acceptance of the Protocol Amending the TRIPS Agreement.   
 IP/C/66 
 
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  6.4 China  
 The adoption of the 2003 Decision by the General Co uncil had been a historical event for the World 
Trade Organization, as from our understanding, th is is the first amendmen t that has been ever 
made to any of the covered agreements. This has been achieved by the WTO Members through 
consensus and the Doha mandate, by waiving Members' obligation under Article 31(f) of the TRIPS Agreement. The system allows the poorer countries to make full use of TRIPS flexibilities in order 
to deal with diseases that ravage peoples. Thus, China fully supports this Decision. According to 
the trilateral study on "Promoting Access to Medical Technologies and Innovation, Intersections between Public Health, Intellectual Property and Trade" that was prepared by the WTO together 
with the WHO and WIPO, TB and HIV/AIDS are among the leading causes of death in middle-
income countries and people in low-income countries predominantly die of infectious diseases and 
more than a third of all deaths are under the ag e of 15. This indicates that public health and 
access to medicine is still a huge challenge for many Members, yet it is not easy to assess whether 
the System has completely achieved its objectives as  it has been used only once so far. The review 
is therefore necessary in order to understand and try to improve it.  During the past annual reviews, Members had also discussed the broader issues related to innovation and access to 
medicines, including those on the list of topics and issues that had been circulated by the Chair in 
2011. However, the difficulties in using the Syst em and the possible improvements had not been 
clearly identified. Once again, we strongly support that an open-ended workshop for all 
stakeholders be held soon. It would help ac hieve greater transparency, promote a holistic 
understanding and perhaps a solution to the current situation. We take note that this kind of 
workshop has taken place from time-to-time in other WTO bodies, and we do not see the reason 
to oppose such a workshop. We really wish that we could conduct our work for the review in a 
constructive manner. 
 6.5 Australia  
 
Australia supports international measures to improve access to medicines, including the WHO Pandemic Influenza Preparedness Framework fo r sharing of influenza viruses and access to 
vaccines and other benefits (PIP Framework). Australia accepted the TRIPS Protocol in 2007. 
Australia congratulates Chile and Montenegro on their acceptance and encourages others that have 
not yet done so to follow suit.  
Legislation to implement the TRIPS Protocol was introduced to the Australian Parliament in 
May 2013, however was not passed prior to the recent election. Ministers will consider this issue in due course. 
 
6.6 Japan  
 This delegation would like to reiterate the importance to discuss and consider access to medicines 
in a manner so as to take into account not only the Paragraph 6 System but also various other 
elements such as procurement and tariffs. The very objective of the System is to support WTO Members in obtaining greater access to medicines, specifically Members who have insufficient or 
no pharmaceutical manufacturing capacity. Compulsory licenses are just one of the measures 
available to promote this objective. Therefore, the Paragraph 6 System should not be considered 
a s  t h e  o n l y  s o l u t i o n  i n  a n  i s o l a t e d  m a n n e r ,  b u t  as  j u s t  a n  o p t i o n a l  m e a s u r e  w e  c o u l d  c o n s i d e r 
when looking at the whole range of efforts bein g proposed to address this critical problem. 
 We should understand and analyze the specific concerns of potential importing Members who might use the Paragraph 6 System. We hope that such Members would share their experiences 
with us. We believe that it would be beneficial for this Council to hear specific comments by 
potential importing Members.   
Therefore, this delegation is of the view that what we should do first and foremost is to take full 
advantage of this annual review to collect concrete examples of practices, particularly based on the list of topics for discussion prepared by the WTO Secretariat in 2011. To put it another way, 
this delegation has to say that it is premature to hold any workshop at this moment, as proposed 
by some Members.   IP/C/66 
 
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  IP protection is conducive to developing medical technology. Thus, our sincere expectation is, once 
again, to be able to have Members, who have considered using but who have not yet used the 
System, share their experiences and specific concerns.  
6.7 European Union  
 On previous occasions the European Union has expressed its disappointment with the fact that the 
amendments introduced to the TRIPS Agreement have not yet been ratified by the entire 
membership. Today I would simply like to thank the United States for raising a very important point.  It is very difficult to understand how countries who have problems of access to medicines and who clearly point to intellectual property as the main culprit for this, can keep very high 
import tariffs on pharmaceuticals. I assume tha this can only be explained for reasons of 
protection of a domestic industry, but the fact is that this is an obstacle to access to medicines by the poorest layers of society.  
 
6.8 Cuba  
For years now, we have been discussing in the Council the desirability of holding a workshop 
to address the discrepancies in the implementation  of the TRIPS and Public Health decision, which 
was intended to provide the developing countries with guaranteed access to medicines. Unfortunately, because a handful of Members are opposed to it, the workshop, which Cuba also 
wishes to support, has not been able to take place. 
 We are concerned at the way in which the subject of access to medicines is being approached 
when we hear the United States saying that a simple reduction in the tariffs applied to medicines 
would be the solution.  
It is important to note that for more than 50 years, the United States has blocked Cuba's access 
to medicines as well as to any projects or resources vital to our health sector. This is being done on the basis of the criminal economic, financial and commercial blockade it has imposed on Cuba.  
Let me mention a few concrete cases of US hostility designed to deprive the Cuban Government 
of its right of access to medicines that are vital to the Cuban people: most recently, we have seen the decision of the Cantonal Bank of Zurich, und er pressure from the United States, to suspend 
all transfers to Cuba. As a result, cooperation between the non-governmental organization 
MediCuba-Suisse and the Cuban public health authorities in such important areas as the 
fight against cancer, paediatrics and the preventi on of HIV/AIDS, has been undermined. Recently, 
as well, under the usual United States pressure, a Canadian bank held back funding for the 
purchase of flu vaccines for the "Immunization Programme for the Elderly". We believe that 
violations of this type and their impact on access to medicines are issues that could also be addressed in the framework of the Council. 
 
Finally, in spite of the blockade, Cuba is a model to be followed in the health area: its success does not rely on free trade, but rather on the political will of the Cuban Government to establish 
an accessible, universal and free national health system for all Cubans. 
 6.9 Switzerland  
 
Switzerland would first like to congratulate Chile and Montenegro for depositing their instruments of acceptance of the Protocol, adding to the lis t of Members, however, which has not yet reached 
the necessary number for the Protocol to enter into force. My delegation wishes to express 
disappointment that we are looking into the fourth  extension of the deadline for the acceptance of 
the Protocol for it to enter into force. It is even more difficult to understand considering the importance that was attached by so many Member s in the course of the negotiations of this 
Paragraph 6 mechanism, particularly by those WTO Members without manufacturing capacity in 
the pharmaceutical sector. I recall that this was at the very origin of the Paragraph 6 mechanism to put those WTO Members at a level playing field with other WTO Members as concerns Article 31 
of the TRIPS Agreement. This all stands in the context of access to medicines, but it was never the 
purpose of the Paragraph 6 mechanism to actually solve the access to medicines problem on its own. As other delegations have pointed out this morning, a whole range of measures and factors are needed in order to improve the situation in a specific country. Referring again to the Protocol, I 
remember well, after the agreement on the waiver solution in 2003, it was pointed out that the IP/C/66 
 
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  waiver is of course a first step, but that the Paragraph 6 mechanism should be introduced into the 
TRIPS Agreement, and this for the sake of transparency, legal certainty, permanency and also legitimacy of this Paragraph 6 mechanism.  Such legitimacy is important for those Members beneficiaries of this mechanism who want to use it. It is also necessary for those WTO Members 
who are intending to undertake, or have already undertaken to put into place national 
implementing legislation, whether as exporting countries or as potential beneficial countries. Accordingly, my delegation urges all those WTO Members who have not yet done so to proceed as 
fast as possible with the acceptance of the Protocol. There is very helpful information provided by 
the WTO Secretariat on the WTO website about how this ratification and the deposit of instrument of acceptance of the Protocol can be undertake n, and that it is independent from national 
implementing legislation. With regard to the pr oposal by India for a dedicated workshop, I can 
refer to the statement that Switzerland made at the last review in 2012 according to which "we are 
of the opinion that before we go into an exclusive workshop with many other stakeholders outside of this room, we should have first a very thor ough discussion among WTO Members, if there are 
actually concerns or problems that beneficiary countries do meet when trying to make use of the 
Paragraph 6 mechanism, and before we have clarity of this we do think it is, indeed, premature to enlarge the circle of stakeholders for this discussion". 
 
6.10  Chile   
 We take acceptance of the Protocol merely as a matter of assuming responsibility and a signal of 
my country's commitment to the multilateral system and the proper functioning of the 
international intellectual property system. It is also a way of bearing testament to the importance my country attaches to flexibilities in general, but notably those flexibilities relating to public 
health. 
 With regard to the analysis that we are engaged in and the functioning of the System, we are 
concerned that in the course of today's session we have repeated the same ideas, the same 
concerns as were voiced in previous reviews in previous years. We have heard various delegations making appeals for questions to be answered, but as yet we have not heard any delegation interested in providing responses to these concerns, providing input to the discussion. We believe 
that if we genuinely want to make inroads with an  understanding on this matter, we need to adopt 
a fairly pragmatic stance, pragmatism that allowed us in 2005 to come up with this Decision.  We know that this is a complex issue, that has various factors to be considered and various points of 
view, and for that reason we need to take into account all of the aspects that could serve to 
improve our understanding of the issues at stake wi thout excluding a priori any elements from this 
analysis. 
 
6.11 United States  
 The United States wanted to associate itself with the comments made by Switzerland, particularly 
with respect to the questions that remain outstanding and the need to have further insight into 
answers to those questions with respect to the workshop that has been proposed. To put a finer point on some of those questions, I wanted to refer Members back to the report we cited earlier in 
our first intervention, i.e. the Staff Working Paper ERSD-2012-17. One Member identified some 
concerns about the commitment of other delegations to the Paragraph 6 System, and also with respect to the LDC waiver that was agreed unanimously earlier this year, to much acclaim by all 
Members in this Organization beyond just the Council. We may have some differences of views 
about levels of commitment of Members who have been engaged in that process. According to the aforementioned report (see page 24, penultimate paragraph), the Member who raised such questions is the country with the highest tariffs, both MFN and preferential on health products in 
their sample. Let me identify some of the basket  of medicines that were sampled in the survey: 
basket A1 deals with dosified medicines; basket A2 deals with bulk medicines and basket C1, for which that Member also maintains relatively high tariffs are hospital and lab inputs. With a little 
more precision in terms of our request, I think we would be grateful for those Members who are 
identified in this report to explain the consiste ncy of their policies with the commitment to greater 
access to medicines.  
 
6.12 India  
 I would like to thank the delegation of the United States for highlighting this working paper which 
has been prepared by a WTO staff member. We ha ve not gone through this report, but since you IP/C/66 
 
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  mention the high tariffs by India on some medical products in this regard I would like to say that 
the link between access to medicines and tariffs is quite low. We hardly see any linkage between tariffs and access, rather we feel that high tariffs could support developing the local pharmaceutical industry which could help in supplying medicines at a lower cost. We therefore do 
not see any core relation between those issues. If the United States would like to say that by 
lowering the tariffs one can get access, I think they are trying to promote access to patented 
products which would lead to closure of the local pharmaceutical industry, and this will affect 
access to medicines.  
 6.13 China  
 
China is not among the top of those Members whose tariff is very high on pharmaceutical 
products. However, it is unclear what kind of role  tariffs may play in terms of access to medicines, 
and especially in terms of the impact on building the domestic capacity for producing 
pharmaceutical products. That is why China is encouraging Members to consider a proposal that 
has been long pending within this Council - that is to have a workshop to thoroughly discuss all these relevant effects, and to try to find a solution. We are very encouraged to hear from 
Switzerland and the United States, both indicating that, if we could identify possible stakeholders 
to be invited, we may further consider how the wo rkshop could be conducted. We look forward to 
work closely with you on identifying possible candidates that can speak from different perspectives on these complicated matters and to have a successful workshop. 
 
6.14 Switzerland  
 
I would like to briefly react to the intervention of  the distinguished delegate of China. I seem to 
not have expressed myself clearly on the point of the dedicated workshop. I have not so much referred to a choice of stakeholders which should be  looked into further. In our view, we first need 
a thorough discussion of the Paragraph 6 mechanisms in this Council and possible problems or 
concerns that particularly beneficiary countries that wish to make use of the Paragraph 6 mechanisms have actually met when doing so, or a ttempting to do so. We have not really heard or 
discussed this during the many past reviews.  We  have heard no clear arguments or evidence why 
the Paragraph 6 mechanism is actually posing obst acles to being used. This is first and foremost 
the task of the Council and the Members in this room. Once we have this done, that would be the moment to look into further follow up action. 
 
6.15 China  
 
I would like to thank our distinguished delegate from Switzerland, in clarifying his position. China 
also agrees that we need to identify why the Paragraph 6 System has not been used to address this issue.  The only fact before us is that it has been used only once. This is why we propose to have this workshop.  I would like to remind the Members of this Council that the way the WTO 
Members conducted this work is to have informal consultations before the Council, before we have 
an emerging consensus, in having solutions to resolve a matter. In assisting the consultation we may have workshops, to invite expertise, even from international organizations, so that we can all 
sit down to talk about the issue in a detailed manner. It is unlikely that we can resolve a matter by 
just expressing our positions at the TRIPS Council. We therefore encourage to continue to have informal consultations held by the Chair, as the Chair has always done so, but in order to have 
really effective informal consultations, we still st rongly suggest that we have a workshop so that 
we can have all the stakeholders and the expert ise needed in order to try to provide some 
solutions to the issues pending before us.  
6.16 European Union  
 I would like to come back to the statement made by India that the link between tariffs and access 
to medicines is not clear. If I may quote from one of my favourite studies, the very good trilateral 
study made by WIPO, WTO and WHO says on page 77 that "tariffs make imported goods, including medicines, more expensive for consumers. Nevertheless, many countries apply tariffs to bolster 
the competitive position of locally based companies in the domestic market in an attempt to 
preserve employment or promote the development of the industry (e.g. the local production capacities of the pharmaceutical sector), or to maintain a certain level of independence from international markets. For consumers, tariff protection can result in costly outcomes. Tariffs also 
raise revenue for governments, although in the ca se of medicines, the revenue amounts raised are IP/C/66 
 
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  generally not significant." I would add that we have received complaints by non-governmental 
organizations that these tariffs are applied even on pharmaceuticals that are intended for free distribution as part of assistance programmes. When we raise this concern, we are not finding another way to promote the consumption of patented pharmaceuticals, we are just identifying 
another very important obstacle to access to medicines. 
 6.17 India  
 
In responding to the questions raised by the delegate from the EU, I would like to point out that the trilateral study had mentioned about the tariffs, but I would like to state that it is up to every country to decide the kind of tariffs, and on whic h medicines they should be applied. For example, 
if some medicines are manufactured locally it is better for any country to decide the level of tariffs 
depending on the level of production. National go vernments are in a better position to understand 
their access to medicines, if the people in those countries are getting access and how tariffs affect 
access. 
 6.18 WTO Secretariat  
 
This update to previous reports to the TRIPS Counc il will focus on activities to support acceptance 
of the Protocol Amending the TRIPS Agreement, and related technical assistance.   
At the request of the Members concerned, we are providing technical assistance concerning both 
the process for entry into force of the amendm ent, and the implementation and use of the 
Paragraph 6 System which enables the grant of special compulsory licenses for export of 
pharmaceuticals. This also forms part of almost all of our TRIPS related technical assistance, at the 
national, regional and international levels, including annual flagship activities such as the advanced course for government officials, the WIPO-WTO colloquium, and the workshop on IP and public 
health. 
 We have had feedback from a number of Members that acceptance of the Protocol is awaiting 
domestic procedures, in particular concerning national legislation to implement the System. As you 
have noted, Mr Chair, these processes have been considered by many Members to be distinct – 
acceptance of the Protocol is a confirmation that other Members are legally entitled to make use of this additional flexibility if they so wish; and the optional act of separately introducing this System 
into national legislation is a distinct choice to be taken. Actual practice bears this out. On the basis 
of information available to us (including some Members that are yet to notify implementing legislation), an informal review of acceptances of the Protocol indicate that a significant proportion 
of Members, across a wide spectrum, have accepted the TRIPS amendment without having 
introduced domestic implementing legislation. Some then went on subsequently to develop domestic implementing legislation, while others have not taken any steps to implement it domestically. In at least one instance, a Member has initially planned to notify acceptance only 
after introducing domestic implementing legislation. At the request of the Council, the Secretariat 
has developed and made available on a dedicated webpage a simple model for acceptance, with associated information, and we stand ready to work with any delegation wishing to advance this 
process. 
 Since the last annual review of the System, and as reported to previous sessions of the Council, 
the Secretariat has launched a study, prepared with counterparts in WHO and WIPO and intended 
essentially as a resource for technical assistance, entitled "Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade". This report consolidates and makes available the technical assistance resources provided by the 
three Organizations in the course of their technical cooperation relating to health, IP and trade. 
 The report notes how access to essential medicines and the lack of research to address neglected 
diseases have been a major concern for many years. It responds to the needs expressed by health 
policy‑makers for a systematic understanding both of the innovation processes that lead to new 
technologies and of the ways in which these techno logies are disseminated in health systems. This 
study captures a broad range of experience and data in dealing with the interplay between intellectual property, trade rules and the dynamics of access to, and innovation in, medical technologies. 
 IP/C/66 
 
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  The study informs ongoing technical cooperation activities undertaken by the three organizations 
concerning the interplay between health, IP and trade, including activities that address the Paragraph 6 System. Based on many years of field experience in technical cooperation, the study 
has been prepared to serve the needs of policy ‑makers who seek a comprehensive presentation of 
the full range of issues, as well as lawmakers, government officials, delegates to international 
organizations, non ‑governmental organizations and researchers. 
 
The study provides information to support technical assistance relating to TRIPS and public health, describing how the Paragraph 6 System was designed as an additional flexibility to enhance access 
to medicines by removing a potential barrier for countries that need to import medicines. In 
particular, the study outlines the background, co ntext, and scope of use of the System (pages 
177ff), giving an overview of the ongoing policy discussions. It notes that while the reasons for the 
limited use of the Paragraph 6 System are still under consideration, it could be more widely used 
in the future, for example, in the case of a pandemic or some other health security event where effective treatments may be patented in all majo r supplier countries following the introduction of 
the product patent regime since 2005. 
 
The study describes the particular procurement scenario that the System is designed to address, and reviews some of the issues that have been discussed here and in other fora regarding whether 
the System has been used as expected, noting that its operational context is still being mapped.  
 Finally, Annex II provides specific practical information on the operation of the System, its context 
and scope and use, and domestic implementation, as a means of technical assistance to Members 
considering the possible use of the System. It provides references to the model forms for notifications under the System that have been made available on the WTO website, again as a 
technical assistance resource for the benefit of Members considering making use of the System. 
 
6.19 WIPO  
During the period November 2012 – September 2013, legislative and policy advice on patents that 
referred or included considerations regarding the Paragraph 6 System has been provided by the WIPO as follows: 
 
 At the request of four Member States, WIPO  Secretariat drafted laws and/or prepared 
comments on draft laws which included reference to, or implemented, the Paragraph 6 System. 
 In the framework of legislative assistance on patents, matters related to health policies, 
including the Paragraph 6 System, were also addressed in the context of six missions that were 
undertaken in Member States and eight consultations that took place in WIPO headquarters in Geneva. 
 Legislative implementation of patent law matters related to health policies, including the 
implementation of the Paragraph 6 System, were addressed in the following seminars or meetings: 
 
1. WIPO Regional Seminar for Certain African Countries on the Implementation and Use of 
several Patent-Related Flexibilities, Durban, South Africa, 29 to 31 January 2013;  
2. WIPO Sub-Regional Workshop on Patent  Policy and its Legislative Implementation, 
Basseterre, Saint Kitts and Nevis, 10 and 11 April 2013; 
3. WIPO-Organisation Internationale de la Francophonie (OIF) Sub-Regional Workshop on 
Trade of Services for the Economic Community  of Central African States (ECCAS), Douala, 
Cameroon, 6 to 9 August 2013. 
 During the period under consideration, the World Intellectual Property Organization also 
participated at the following WTO Seminars where the topic of patent-related flexibilities, with a 
reference to the Paragraph 6 System, has been dealt with:  
1. WTO Regional Workshop for Latin American Countries on TRIPS and Public Policies, Bogotá, 
Colombia, 16 to 18 April 2013; 
2. WTO National Seminar on TRIPS and Public Health, Luanda, Angola, 10 and 11 July 2013; 3. WTO Regional Workshop on IP and Public Health, Arusha, Tanzania, 29 to 31 May 2013; and 
4. WTO National Workshop on TRIPS Flexibilities, Pretoria, South Africa, August 6 to 8, 2013. 
 IP/C/66 
 
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  WIPO's assistance is consistently based on the multilateral legal framework. More recently, a 
n u m b e r  o f  n a t i o n a l  a u t h o r i t i e s  i n  c h a r g e  o f  d r a f t i n g  l a w s  h a v e  b e e n  s e e k i n g  a d v i c e  f r o m  W I P O  regarding how to use the available multilateral flexibilities so as to accommodate particular national interests that are specific to their countri es. Since the Paragraph 6 System is part of those 
flexibilities which are considered by several countries as part of their access-to-medicine policies, 
this issue is regularly covered by WIPO legislative and policy assistance.  
The following is an update on WIPO Re:Search. One of the world's great global health challenges is 
to overcome the impact of neglected tropical diseases (NTDs), malaria and tuberculosis. These 
diseases negatively affect the lives of more than one billion people, many of whom live in the world's least developed countries. To generate more investment in innovation directed at these 
diseases, the World Intellectual Property Organization in cooperation with public and private sector 
partners launched WIPO Re:Search in 2011. As reported to the TRIPS Council in October 2011 and November 2012, WIPO Re:Search is a platform addressed to catalyze more research in NTDs, 
malaria, and tuberculosis by facilitating the sharing of IP assets and resources among public and 
private sector partners and researchers in this im portant field. By providing a searchable, public 
database of available IP assets (for example,  pharmaceutical compounds, know-how and data 
available for research and development), WIPO Re:Search facilitates new partnerships to support 
organizations that conduct research on treatments for those diseases.  WIPO Re:Search was launched on 26 October 2011, with about 30 members, including 
pharmaceutical companies, research institutions and a range of public and private entities. To 
date, WIPO Re:Search has more than double d its membership, with 76 members currently, 
including more than ten African members from th e academia and the public and private sectors. 
Since our report in 2012 to the TRIPS Council, thanks to WIPO Re:search over 30 collaborations 
have been initiated, and more are in development.   
Also, thanks to a Funds-in-Trust provided to WIPO by the Government of Australia, five scientists 
from five African countries – Cameroon, Egypt, Ghana, Nigeria, and South Africa – are working in research labs of WIPO Re:Search members in In dia, Switzerland and the USA, where they are 
upgrading their R&D management skills and furthering their research work.  
 
WIPO Re:Search is founded on the belief that intellectual property and knowledge can be used creatively to stimulate more investment in research and development for new health solutions. 
Intellectually property should be used to make  a positive contribution. WIPO Re:Search works 
entirely on a voluntary basis of all participating parties and has no impact on any legal instrument. The WIPO Re:Search website http://www.wipo.int/research  provides further information. 
 
6.20 El Salvador  With regard to the reports that were discussed, we  do not have any concrete points to make. We 
are delighted to hear the report by WIPO with re gard to the initiatives mentioned. Our country had 
a field visit in order to make known these initiati ves and in order to make known that project. We 
believe these projects are particularly relevant for developing country Members. 
 
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