IP/C/76  
 
23 November  2016 
(16-6445) Page: 1/17 
Council for Tr ade-Related Aspects of  
Intellectual Property Rights    
 
  ANNUAL REVIEW OF THE  DECISION ON THE IMPL EMENTATION  
OF PARAGRAPH 6 OF TH E DOHA DECLA RATION  ON 
THE TRIPS AGREEMENT AND PUBLIC HEALTH  
REPORT TO THE GENERA L COUNCIL  
1.  Paragraph 8 of the Decision on the Implementation of Paragraph 6 of the Doha Declaration on 
the TRIPS Agreement and Public Health of 30 August 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 r eport on its operation to the 
General  Council. This review is deemed to fulfil the review requirem ents of Article  IX:4 of the 
WTO Agreement.   
2.  The Council for TRIPS undertook the twelfth annual review in October 201 5. The General 
Council took note of the re port of the Council for TRIPS (IP/C/ 72) at its meeting on 30 November 
and 7 December  2015 (WT/GC/M/ 160, paragraph 8.12). The present report covers the period 
since October  2015. 
3.  At its meeting of 8-9 Novem ber 201 6, the Council undertook the t hirteenth  annual review. 
Annex  1 and Appendix 1 to this report record the review and the statements made by delegations. 
The paragraphs below set out factual information regarding the implementation and use of the 
2003 Decision and the acceptance of the Protocol Amendin g the TRIPS Agreement.  
1  INFORMATION ON IMPLE MENTATION AND USE OF  THE SYSTEM ESTABLISH ED UNDER 
THE DECISION  
4.  Since the last annual review, Canada has  notified  the Council for TRIPS of  an amendment to its 
legislation implementing the System into domesti c law.1 An overview of all notified implementing 
laws and regulations, including hyperlinks to the legal texts, is available on a dedicated page on 
the WTO website at http://www.wto.org/eng lish/tratop_e/trips_e/par6laws_e.htm . 
5.  During the period covered by the present report, 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.  The 2013 WHO -WIPO -WTO study on "Promoting Access to Medi cal Technologies and 
Innovation  – Intersections Between Public Health, Intellectual Property and Trade" offers 
explanato ry background material on the implementation and use of the System.2 In addition, a set 
of model notifications is available  on the WTO's webpage dedicated to public health in order to 
further facilitate the use of the System.3 
                                                
1 WTO Document IP/N/1/CAN/P/12; see also the information provided by the Delegation of Canada at 
the TRIPS Council meeting on 7 -8 June 2016, WTO Document IP/C/M/82/Add.1, paras.  24 to 27 . 
2 See pages 177 to 180 and Annex II of the study, available at the three organizations' respective 
websites:  https://www.wto.org/english/res_e/publications_e/who -wipo-wto_2013_e.htm ; 
http://www.wipo.int/edocs/pubd ocs/en/global_challenges/628/wipo_pub_628.pdf ; 
http://www.who.int/phi/PAMTI_WHO -WIPO -WTO.pdf . 
3 http://www.wto. org/english/tratop_e/trips_e/par6_modelnotifs_e.htm .  IP/C/76  
 
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  2  DECISION ON THE AMEN DMENT 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 201 7 or such later date as may be decided by 
the Ministerial Conference (WT/L/ 965). 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.  
8.  At the Council's meetings in February, June and November, the Chair of the Council for TRIPS, 
H.E. Ambassador Al -Otaibi from Saudi Arabia and H.E. Ambassador Mero from the United Republic 
of Tanzania respectively , updated Members on the state of play of acceptances that had been 
submitted and e ncouraged delegations tha t were yet to accept the TRIPS A mendment to take the 
necessary steps so that the domestic procedures could be completed as soon as possible.  
9.  As of 30 September  2016, the following Members have notified their acceptance:  
 United Stat es, 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 Communities4, 30 November 2007, WT/Let/608;  
 Mauritius, 16 April 2008, WT/Let/619;  
                                                
4 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 Ar ticle 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 the European Community, of the Protocol amending 
the Agree ment 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 Representative                The President of the Council  
        of the European Union"  IP/C/76  
 
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   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/L et/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, Kingdom of, 4 August 2009, WT/Let/652;  
 Colombia, 7 August 2009, WT/Let/650;  
 Zambia, 10 Au gust 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 D ecember 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/Le t/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;  IP/C/76  
 
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   Dominican Republic, 23 May 2013, WT/Let/884;  
 Chile, 26 July 2013, WT/Let/888;  
 Montenegro, 9 September 2013, WT/Let/893;  
 Trinidad and Tobago, 19 September 2013, WT/Let/894;  
 Central African Republic, 13 January 2014, WT/Le t/920;  
 Turkey, 14 May 2014, WT/Let/949;  
 Botswana, 18 June 2014, WT/Let/953;  
 Uruguay, 31 July 2014, WT/Let/984;  
 Brunei Darussalam, 10 April 2015, WT/Let/1037;  
 Moldova, 7 July 2015, WT/Let/1048;  
 Kenya, 21 July 2015, WT/Let/1052;  
 Saint Kitts and Nevis, 27 Jul y 2015, WT/ Let/1055 ; 
 Sri Lanka, 9 September 2015, WT/Let/1080;  
 Lao, People's Democratic Republic, 29 September 2015, WT/Let/1084;  
 Iceland, 12 October 2015, WT/Let/1088;  
 Grenada, 8 December 2015, WT/Let/1107;  
 Malaysia, 10 December 2015, WT/Let/1108;  
 Myanmar , 16 December 2015, WT/Let/1114;  
 Lesotho, 4 January 2016,  WT/Let/1122;  
 Mali, 20 January 2016, WT/Let/1129;  
 Thailand, 28 January 2016, WT/Let/1132;  
 South Africa, 23 February 2016, WT/Let/1134;  
 Nepal,  11 March 2016, WT/Let/1138;  
 Tanzania, United Republic of,  14 March 2016, WT/Let/1139;  
 Ukraine, 16 March 2016, WT/Let/1142;  
 Qatar, 6 April 2016, WT/Let/1147;  
 Samoa, 21 April 2016, WT/Let/1153;  
 Saint Lucia, 2 May 2016, WT/Let/1156;  
 Tajikistan, 23 May 2016, WT/Let/1164;  
 Seychelles, Republic of, 8 June 2016, WT/Let/1168;  IP/C/76  
 
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   Papua New Guinea, 22 June 2016, WT/Let/1173 ; 
 Peru, 13 September  2016, WT/Let/1196  and 
 Belize, 15 September 2016, WT/Let/1197.  
10.  Information on the status of acceptances of the Protocol can be found on a dedicated webpage 
which is regularly updated by t he WTO Secretariat.5 
_______________  
 
 
                                                
5 http://www.wto.org/english/tratop_e/t rips_e/amendment_e.htm .  IP/C/76  
 
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  ANNEX 1  
EXCERPT FROM THE MIN UTES OF THE COUNCIL' S MEETING OF 8-9 NOVEM BER 201 6 
(TO BE CIRCULATED AS IP/C/M/8 3) 
6. REVIEW UNDER PARA GRAPH 8 OF THE DECIS ION ON THE IMPLEMENT ATION OF 
PARAGRAPH 6 OF TH DO HA DECLARATION O N THE TRIPS AGREEMEN T AND PUBLIC 
HEALTH  
1.  The Chairman  said that Paragraph 8 of the Decision required the Council to review the 
functioning of the System annually, with a view to ensuring its effective operation. The Council 
was also required to report annua lly on its operation to the General Council. This review was 
deemed to fulfil the requirements of Article IX:4 of the WTO Agreement.  
2.  He suggested that the Council start with an exchange of views between Members about the 
functioning of the System. He encou raged Members to engage in a constructive discussion which 
could usefully build on the records of earlier reviews which continued to provide a unique and 
valuable resource for understanding this important measure. The reviews in 2010 and 2011 had 
taken the  form of a structured debate on the basis of lists of topics for the discussion that had 
been agreed in advance. The General Council's Aide Mémo ire circulated on 20 February 2 015 
(WT/GC/W/696) was also a useful resource; it set out the expected benefits of  the Paragraph 6 
System and provided a model instrument of acceptance.  
3.  After that discussion, the Council could then consider the report to the General Council. A draft 
cover note modelled on previous years' reports had been circulated as JOB/IP/18.  
4.  The Chairman  updated the Council on the status of acceptances of the Protocol Amending the 
TRIPS Amendment (WT/L/641). The current period for acce pting the Protocol ran until 
31 December 2017. Fifteen  instruments of acceptance had been deposited in 2016, includi ng 
instruments from Papua New Guinea, Peru, and Belize since the Council's meeting in June 2016. 
All Members that had notified their acceptance were listed in the cover note of the draft report 
prepared by the WTO Secretariat, as well as the dedicated WTO webpage that was regularly 
updated. Only five more instruments of acceptance were needed to trigger entry into force.  
5.  He strongly encouraged those Members who were yet to complete their acceptance procedures 
to do as soon as possible. His call upon these Members echoe d the multiple efforts 
Director -General Azevêdo and his predecessors had made since 2015 to secure the entry into force 
of the Protocol. The Director -General in his contacts regularly emphasized that this was not only a 
priority for the WTO, b ut represented a concrete contribution that WTO Members could make to 
global efforts to strengthen the legal framework for access to medicines. Providing the necessary 
legal certainty for the export of much needed medicines through the permanent incorporat ion of 
the Paragraph 6 System into the TRIPS Agreement would, in particular, also respond to many calls 
for its timely implementation and entry into force that emanated from the multilateral system, 
including most recently the Political Declaration on HIV and AIDS that had been adopted by the 
UN General Assembly in June 2016.  
6.  He invited the WTO Secretariat to update the Council on the Paragraph 6 System, including on 
capacity building and on the process of acceptance.  
7.  The representative of the Secretariat  took the floor.  
8.  The representatives of India, Brazil , Canada , Bangladesh , South Africa , the European Union , 
Australia , Japan , Chinese Taipei , Switzerland , the United States , and Panama  took the floor .  
9.  The Council took note  of the statements made.  
10.  Turning  to the Council's report to the General Council, t he Chairman  said that the Secretariat 
had prepared a draft cover note for the report which was modelled on previous years' reports and IP/C/76  
 
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  had been circulated as JOB/IP/18. It contained factual information on t he implementation and use 
of the System, and the status of acceptances of the amendment Protocol. As for past reports, an 
extract from the Council's minutes on this agenda item might  be attached to the cover note.  
11.  The Chairman  proposed that the Council agr ee on the cover note to the report contained in 
JOB/IP/ 18 and also that the Council minutes containing the record of the discussion be attached to 
it. 
12.  The Council  so agreed . 
_______________  
 
 IP/C/76  
 
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  APPENDIX 1  
EXCERPT FROM THE ADD ENDUM TO THE MINUTES , CONTAINING  THE STATEMENTS MADE 
DURING THE COUNCIL'S  MEETING HELD ON 8-9 NOVEM BER 201 6 
(TO BE CIRCULATED AS IP/C/M/8 3/ADD.1)  
6. REVIEW UNDER PARAGRA PH 8 OF THE DECISION  ON THE IMPLEMENTATIO N OF 
PARAGRAPH 6 OF THE D OHA DECLARATION ON T HE TRIPS AGREEMENT A ND PUBLIC 
HEALTH 
6.1 Secretariat  
1.  We have observed a steady rise in the rate of acceptances of the Protocol Amending the TRIPS 
Agreement in the course of this year. As you have noted , Mr Chair, to date already 15  Members 
have accepted the Protocol in this year  alone . It is worth observing that if it were not for the very 
welcome fact of new Members acceding to the WTO in this period, the Protocol would have already 
entered into force some time ago earlier this year.  
2.  We are providing technical assistance on request to Members  who are in the process of 
accepting  the Protocol  – and a number of Members have told us that they are at the final stages of 
their domestic processes . We are at the disposal of any delegation  or Member who would need 
practical support in the acceptance pr ocess. A s a very general observation, it often takes Members 
by surprise how straightforward and simple the process is. It is not a difficult procedure and we 
have the necessary model instruments of acceptance to facilitate the  process.  
3.  The other aspect o f the report concerns technical assistance for implementation . Document 
IP/C/W/618 is the regular annual report of the Secretariat's technical assistance activities in the 
area of TRIPS in general . We will be introducing that report briefly under that sepa rate item later 
in this meeting. However, as for previous annual reviews of the Paragraph 6 System, because this 
has been a matter of particular focus and particular attention for technical assistance, we give a 
more focu sed update under this  agenda  item.  
4.  In general, TRIPS flexibilities with specific refe rence to p ublic health have long formed a 
consistent element of our technical assistance activities. A strong impetus in this direction was 
given by the Doha Declaration on the TRIPS Agreement and Public H ealth; this  flows through to 
the practical level o f technical assistance in the TRIPS area.  
5.  This element of TRIPS implementation is also extensively covered in the Trilateral Study 
published jointly by WHO, WIPO and the WTO in 2013 , which  includes specific  material on 
flexibilities for health and  in particular  the System of compulsory licences for export of medicines 
(also known as the "Paragraph 6 " System ). 
6.  This mechanism has also been a focus of an annual series of W orkshops dealing with TRIPS and 
Public Health since 2005. These Workshops were conceived as cross -cutting programmes directed 
at a blend of health, t rade and IP officials. As this series  evolved over the years, it maintained 
coverage of the key issues concerning medicines, innovation and access  to medicines from  a TRIPS 
perspective, especially  the use of TRIPS flexibilities . In addition, because of the demand received 
from Members , it provided an increasing focus on public health policy within  a wider range of 
disciplines, including the human ri ghts dimension.  
7.  Specifically looking at the use of TRIPS flexibilities and the implementation of the Paragraph 6 
System  of compulsory licensing for export , these capacity -building W orkshops have evolved in line 
with progress in the domestic implementation  of the System in many Members. In recent years , 
many more Members have introduced export provisions into their laws to facilitate the System as 
a tool for export. Accordingly, more recently, the Workshops have  turned from looking at 
legislative implementa tion towards a more detailed look at how to make effective use of this 
additional procurement tool in practice so that  affordable medicines do reach patients.  IP/C/76  
 
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  8.  The most recent session of these series of Workshops, the WTO Workshop on Trade and Public 
Health, was held here in Geneva in October . The W orkshop included updated capacity -building 
material on making effective use of special compulsory licences for export as a procurement tool 
for medicines. This material was tailored exactly for the mix of public health, trade and intellectual 
property officials that took part in the Workshop . The feedback and practical guidance provided by 
those officials will, as ever , guide us in updating and improving  our technical assistance  activities 
and programmes  to enhanc e its practical relevance .  
9.  Some of the general points that we have made in the Workshop  are touched upon in an annex 
to the Secretariat report  (IP/C/W/618 ). This notes as an important recent development that the 
significant increase in pharmaceutical expo rting countries that are putting in place the necessary 
legislation to use the System  for export. This has gone literally from one Member, at the time of 
the first use of the System, to over 52 today . By informal estimates , the System now  cover s about 
80% of current  global  medicines export capacity. It also mentions that t he practical context of the 
System is such that it applies when the best option for access to a medicine is production 
especially for export under a compulsory licence in a foreign country . It need not apply for 
instance when lower cost medicines are available by other means through regular generic 
production, voluntary licensing or whe n some of the production under regular compulsory licences 
could be exported. For example, if a compulsory  licence is applied to serve a relatively large home 
market this could, in principle, be used to serve also a smaller export market.  
10.  A key element in the use of the System concerns notifying expected demands for medicines . 
It was noted that this could be done early in the procurement process , so as to open up a wider 
range of potential suppliers and potentially enable the pooling of demand by different Members 
with similar needs. Notification under the System could also be used at this early stage to ident ify 
all possible sources of supply so as to ensure the most competitive and sustainable range of 
options for access to medicines.  
11.  The important point of economies of scale has been considered and discussed. The need for 
economies of scale was foreseen in  the design of the System and would  clearly be a factor when 
the needs of relatively small populations are concerned. On that note, it was observed that the 
System makes it clear that an export compulsory licence can serve the needs of multiple Members . 
When countries do share the same needs and the same constraints, for example, in the same 
region, this could be an opportunity to pool demand  so as to use the System more effectively . This 
would be especially effective if their regulatory requirements were si milar or compatible, for 
example, through the WHO prequalification programme.  
12.  Discussion has also covered  how the System could be used as part of efforts to build local 
production capacity, especially when this would enable one country 's production to ser ve several 
countries in the same region , enabling economies of scale and thus lower cost , and to support  
more sustainable production of medicines.  
13.  The Workshop on Trade and Public Health also considered the human rights dimension of 
access to medicines wi th a participation of a range of international organizations , including the 
Office of the United Nations High Commission er for Human Rights . The Secretariat of the UN 
Secretary General's High-Level P anel on Access to Medicines presented the Panel Report wh ich will 
be the subject of a separate agenda item in this session of the Council . We would like to record our 
warm gratitude to our colleagues from across the multilateral system for their invaluable 
contributions to this essential capacity -building dialog ue.  
14.  Participating experts in the procurement field and other related fields explored a range of 
practical questions in the course of the  Workshop discussion  on the use of the System. They 
mentioned  the need for awareness -raising of the practical possibili ties of use of this mechanism 
within domestic agencies and other programmes responsible for medicines procurement. More 
generally, they also looked at the practicalities of situating the System as an integral part of 
procedures for access to medicines, inc luding procurement processes and other processes such as 
needs identification, procurement policies and the regulation of medicines for safety and efficacy. 
Other points raised by the experts included the possible choices for effective implementation of th e 
System at the domestic and regional level s and, in particular , how to make the System more 
streamlined in its practical use in those countries that are most likely to be producers and 
exporters u nder the System . Further points discussed concerned the inf ormation needs of potential 
importing countries about potential sources of supply and how to facilitate the forecasting of IP/C/76  
 
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  expected needs which in turn would enable early notification under the System and more capacity 
to aggregate demand of similar ne eds. 
15.  A final point that has come up in a range of our activities concerning this matter is a question 
of economic viability , or commercial sustainability, given the significance recognized in the System 
of boosting economies of scale, how to use the System for  greater predictability  for potential 
suppliers , and the pooling and aggregation of demand so as to ensure that its use is commercially 
sustainable for producers seeking to export under this System.  
16.  We look forward to continuing cooperation with multilate ral partners on our capacity building 
work in this area and again warmly thank our colleagues for their invaluable contribution s to this 
work. 
6.2 India  
17.  India attaches high importance to the Doha Declaration on Public Health, the Paragraph 6 
System as est ablished under the 2003 waiver decision and the 2 005 Protocol Amending the 
TRIPS  Agreement. India had notified its acceptance of the Protocol in March 2007. We would like 
to congratulate Papua New Guinea, Peru and Belize who have deposited their instrument s of 
acceptance of the Protocol since the last TRIPS Council meeting held in June 2016.  So far, over 
64% of WTO Members have submitted their instruments of acceptance for the TRIPS Protocol and 
five more Members have to submit their instruments of acceptan ce for entry into force of the 
2005 Protocol Amending the TRIPS Agreement.   
18.  We have always been of the view that the Doha Declaration on TRIPS 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 preparedness of the Organization to take up the problems faced by the 
poor in developing countries. Along with several other Members, India had worked relentlessly on 
the Doha Declaration and the Decision. The Decision establ ished a framework for special 
compulsory licences, which is an additional flexibility aimed at enabling exports of medicines to 
WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector. 
However, the export of HIV/AIDS medic ines by the Canadian pharmaceutical company Apotex to 
Rwanda in September 2008 ha s been the first and only use of the S ystem so far.  
19.  The side event which was held today to discuss the challenges and problems associated with 
this Paragraph 6 Mechanism and t he comments by expert s has broadened our understanding on 
aspects related to  the P aragraph 6 System, especially as regards its  implementation  so far, the 
challenges and opportunities involved , as well as the ways of improving the System to make it 
effectiv e and meaningful.  
20.  Ms. Yuanqiong Hu from Medicines Sans Frontiers said that her organization had requested the 
HIV/AIDS  medicines from Canada to supply Rwanda, but it had taken three years for the whole 
process to deliver because there were delays associat ed with regulatory approval,  as well as  
discussions with  patent holders which  took a lot of time. A t the same time, the HIV /AIDS  
medicines were available and supplied by Indian generic  companies before Rwanda accorded 
supplies from the Canadian company Apo tex.  
21.  The r epresentative  from Canada  who spoke at the side event confirmed  that th e regulatory 
approval had taken  close to six months , as compared to one year  under the normal procedure , to 
ensure  the quality, safety and efficacy of the drugs. The company had made  losses and had 
supplied  the tablets at a very cheap rate . He was also informed by some compa nies that they 
would never venture into providing medicines under this special compulsory licensing scheme.  
22.  Mr. Denis B roun, the representative of CIPLA, shared the experiences of a generic producer to 
manufacture under the System . There was no way to achieve economies of  scale because  of the 
limited quantities of  medicines to be  procured by the importing countries . He also noted  
requirements like special l abelling and markings and the need for the generic company to  host a 
special website and  to pay  remuneration to the patent holder. According to him, there was so 
much red tape built into the  System that it was difficult for the  Paragraph 6 Mechanism to ach ieve 
its intended purpose . Unless the procedures we re simplified , his company would  never use th e 
System .  IP/C/76  
 
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  23.  Ms. Suerie Moon, Director of Research, Global Health Centre, Graduate Institute of 
International and Development St udies opined that this was  not a g ood System . It should be 
renegotiated before it entered  into force as it was not workable. She also said that patenting in 
exporting countrie s like India wa s on the rise . In her vi ew, the Paragraph 6 System needed  to be 
made more workable for it to be used  by countries.  
24.  Based on the experts opinion at the side event held today, we reiterate our concern that the 
Paragraph 6 System is too complex, cumbersome and administratively unwieldy for further use. I 
conclude by quoting the recommendation on the special  compulsory license mechanism by the 
UN Secretary General's High -Level Panel on Access to M edicines in its report release d in 
September . The recommendation was also endorsed  by many experts at the side event . 
Recognizing the Paragraph 6 S ystem as complex a nd cumbersome, the UNSG High -Level Panel on 
Access to Medicines ha s recommended that "WTO Members should revise the Paragraph 6 Decision 
in order to find a solution that enables a swift and expedient export of pharmaceutical products 
produced under compuls ory licence. WTO Members should, as necessary, adopt a waiver and 
permanent revision of the TRIPS Agreement to enable th is reform."  
6.3 Brazil  
25.  The Paragraph 6 System represents the recognition of the importance of international 
solutions for public health emergencies. In the Doha Declaration, Members of the WTO recognize 
that countries with insufficient or non -manufacturing capacities in the pharmaceutical sector could 
face difficulties in making effective use of compulsory licences under the TRIPS Agreemen t. The 
System that implement s the Decision has only been used once in 13 years. According to the 
Report of the UN Secretary General's High -Level Panel on Access to Medicines, "some note that 
multilateral health financing has removed the need for resource c onstraint countries to use it. 
Others argue that it is too complex to be used. The only time the mechanism was used it proved to 
be complex and cumbersome and serious questions remain as to i ts effectiveness. More than 
ten years after WTO Members agreed to  transform the temporary waiver into an amendment of 
the TRIPS Agreement, the amendment is yet to be accepted by two -thirds of the WTO Members. 
At a time of increased political commitments to enhance local pharmaceutical production in 
developing countries,  attention should be paid to incorporating an efficient easy -to-use compulsory 
licensing provision  into domestic legislation".  
26.  We would like to  highlight the importance of  this periodic review of the implementation of the 
Paragraph 6 Mechanism which will become even more necessary after the entry into force of the 
TRIPS Amendment. We were glad to be co -sponsors of the South Centre initiative to host a side 
event to the TRIPS Council on the subject. We had the opportunity to hear from representatives 
from i ndustry, government, non -governmental organizations and academia thei r assessment of 
the System. W e will continue to contribute constructively to discussions on the improvement of the 
System.  
6.4 Canada  
27.  Providing access to medicines to populations in need is one of the key priorities of our 
Government.  Canada is a global leader in supporting partnerships such as the Global Fund to Fight 
AIDS, Tuberculosis and Malaria, the Global Drug Facility, and Gavi, the Vaccine Alliance, which 
strengthen health systems and provide targeted programming to increase access to medicines and 
vaccines.  
28.  Canada hosted the Fifth Replenishment Conference of the Global Fund to Fight AIDS, 
Tuberculosis and Malaria in Montreal on 16-17 September 2016.  Canada pledged $804 million, fo r 
2017 to 2019, to the Global Fund, an increase of 23% over its previous commitment of 
$650 million for 2014 -2016.  Canada is the 6th largest donor to Gavi, the Vaccine Alliance, having 
pledged $520 million for the 2016 -2020 period bringing Canada's contrib ution to over $1 billion 
since 2002.  
29.  In addition, Canada has introduced tax incentives for donations of medicines to developing 
countries. The Government of Canada's Donations of Medicine Eligibility Program ensures that only 
Canadian charities with suffic ient expertise can participate in this scheme.  IP/C/76  
 
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  30.  Canada's Access to Medicines Regime  (CAMR) , which implements Paragraph 6 of the Doha 
Declaration on the TRIPS Agreement and Public Health, is another measure Canada uses to 
promote access to medicines. Canada continues to believe that CAMR is a useful and effective tool 
to enhance access to medicines in the specific circumstances the System was designed to address. 
Last year , Canada amended the list of medications covered by CAMR to add three new 
antiretroviral  drugs. Canada notified this amendment to the TRIPS Council in June 2016.  
31.  I mention all of these program mes to illustrate that the Government of Canada takes a holistic 
approach to promoting access to medicines. Our view is that only by addressing all of t he factors 
affecting access to medicines can we end the tragedy of people suffering from treatable illnesses.  
32.  To this end, Canada is open to having a discussion of how best to promote access to 
medicines that considers all relevant factors. We would cautio n against treating certain factors, 
such as IP rights, in isolation, as doing so would risk overlooking effectiv e tools to promote access. 
Canada looks forward learning more about the views of other Members on this issue, including 
with respect to Member e xperiences, challenges, and other considerations.  
33.  We consider it essential that the Protocol Amending the TRJPS Agreement be brought into 
force as soon as possible. We are only a handful of countries away from that goal and Canada 
urges all Members who hav e not already done so to accept the Protocol without delay.  
6.5 Bangladesh  
34.  We thank the WTO Membership for this historic decision ; they deserve every accolade for this. 
The intention to help developing countries which lack the necessary capacity to produce  medicines  
is both honest and genuine. We thank Members who have recently accepted the amendment and 
hope that the remaining five ratifications that are needed  for the entry into force of this 
amendment of the TRIPS Agreement  will soon be deposited . 
35.  During  the side even t today , we have  learnt about diff erent limitations which hinder  the 
widespread use of the System. After the entry into force , we may find suitable ways to overcome 
the administrative and supply  side constraints so that this wonderful mechani sm is utilized and not 
wasted. This would pave the way for future necessary amendments of the TRIPS Agreement that 
our Members advocate for other important issues.  
6.6 South Africa  
36.  The Doha Declaration stresses that TRIPS can and should be interpreted and implemented to 
support the right to health and promote access to medicines for all. The Sustainable Development 
Goal target of achieving universal health coverage by 2030, requires strong government and  
international leadership  to effectively implement acc ess to essential medicines.  
37.  South Africa notes that the number of notifications required for the entry into force of the 
Protocol Amending the TRIPS Agreement is now fewer than ever . We would encourage all Members 
who have not yet done so to deposit their notifications in order for the Protocol to enter into force.  
This will mark a significant landmark toward the realization of access to essential medicines.  
38.  As the sources of generic drugs are substantially depleted over time, the most effective 
method by which a country with insufficient or no manufacturing capacity may obtain certain 
medicines at competitive prices is through the use of the Paragraph 6 System . In addition, the 
Paragraph 6 S ystem may prove to be increasingly important for HIV/AIDS patients  who need to 
shift to second -line or third -line treatments. Studies indicate that at least 22% of people on 
treatment would have to switch over to second -line treatment wit hin a five -year period. 
Second - and third -line treatments are substantially more exp ensive, costing up to four to eleven 
times as much as first -line treatments. For these treatments and other widely patent protected 
treatments, the Paragraph 6 System may prove to be an important mechanism for obtaining a 
bulk of the medicine at a competit ive price.  
39.  Having said this, it is indeed not the end of the story since the Paragraph 6 System has been 
reviewed since 2004. During this time a rich debate has emerged between Members regarding 
their experiences of the use of the S ystem. This review mech anism continues to provide Members IP/C/76  
 
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  with an opportunity to exchange their views and to devise ways to make the S ystem more 
effective. As already mentioned by India and Brazil, the side event hosted this afternoon (of which 
South Africa is a co-sponsor), cle arly outlined many criticisms associated with the Paragraph 6 
System including the length of time it takes to use  it. Procedural and other substantive 
complexities make it difficult to effectively  use the System , while many developing countries face 
severe  political pressures when they consider using  it. Raising these criticism s is not an attempt to 
undermine the System, but is indeed an attempt to fully understand the challenges that countries 
face when they want to use it .  
40.  The review should not be an opp ortunity for delegations to repeat longstanding arguments. 
Our focus should be to ensure that the System does not remain a flexibility that is consigned to a 
piece of paper, but to move forward to a substantive review of the System and its functioning, 
including through the more systematic collection and sharing of information. The world has 
changed since the System was first introduced. M any more factors now influence its operation , 
including the introduction of many so -called access initiatives that are l ikely to limit the need to 
use the System; the steady increase in the number of voluntary licences that  can make its use 
redundant; while developments under RTAs may furth er erode the actual use of the S ystem.  
41.  In concluding, we further note that the Repor t of the United Nations Secretary -General's 
High-Level Panel on Access to Medicines, recommends that  WTO Members should revise the 
Paragraph  6 decision in order to find a solution that enables a swift and expedient export of 
pharmaceuti cal products produce d under special compulsory licens e. South Africa looks forward to 
hear other Members ' views in this respect and remain s available for any further discussion on the 
points raised in the High -Level Panel Report.  
6.7 European Union  
42.  The European Union believes  that the entry into force of the Protocol will be an important 
signal that will ensure a legally secure, predictable, effective and sustainable solution for those 
countries wishing to use the TRIPS flexibilities to get affordable medicines.  
43.  Therefore, th e European Commission will continue to encourage and work with the remaining 
WTO Members so that they accept this Pro tocol and allow the amendment  of the TRIPS Agreement 
to enter into force as soon as possible.  
44.  We have much appreciated a series of side ev ents regarding this issue, including the one we 
assisted  today. We are pleased  to note  that, as we pointed out a number of times, these events 
are extremely useful to have discussions about the issues that are addressed more formally here 
in the TRIPS Coun cil. They are very  valuable and allow good debates with people from the outside, 
with other stakeholders , and to hear different  opinions.  
45.  We certainly appreciate clarifications that were presen ted today according to which the 
Paragraph  6 System  is very muc h a last resort option which is most useful at the end of a long list 
of alternatives. Alternatives like the ones that were mentioned by my colleague of South Africa a 
few minutes ago, but also negotiating alternatives .  
46.  That takes us to another  event that  we consider extremely valuable for the debate, i.e. the 
Workshop that was  organized by the Secretariat.  We participate d with pleasure and a lot of 
interest . The part of th e Workshop that I assisted was very valuable. We saw presentations of 
issues that ha ve not been raised today and that are rarely raised in this venue,  including  how 
countries use the Paragraph 6 System as a negotiating mechanism . This takes us back to the fact 
that it is a last resort mech anism. We heard experiences of officials saying ho w in the discussion 
process with a right holder the possible use of this mechanism was there as an additional strong 
negotiating tool and how in most cases , and increasingly so in recent  years, this ha d led to a good 
agreement with the right holder  without  necessarily  triggering the formal steps of the mechanism.  
47.  This being said, in Europe we have put in place legislation for this already in 2007. It has 
never been used so it is very difficult  to assess . I see with some surprise how people are so certain 
that the System does  not work based on  only one case of use . In Europe, as far as we are aware 
because compulsory licences are managed at Member State level, there was never any attempt to 
use this System . We therefore wonder  how people  can state that it is  burdensome  and impossible IP/C/76  
 
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  to use. Th is debate is maybe a little bit more complex than it is sometimes presented and certainly 
proposals to review the Paragraph 6  System  are way too premature at this stage.  
6.8 Australia  
48.  Australia supports the TRIPS Protoc ol's entry into force as soon as possible. This will benefit 
Members by providing a permanent legal basis for countries to import medicines to address their 
public health needs if they  have limited capacity to produce those medicines. The Protocol's entry 
into force will reinforce the WTO's ability to deliver practical developme nt-oriented outcomes.  
49.  Australia commends Members from every region and at every stage of development that have 
already accepted it. We welcome the recent acceptances of the Pr otocol since the previous 
TRIPS  Council meeting by Papua New Guinea, Belize and Peru.  
6.9 Japan  
50.  The delegation of Japan would like to reiterate the importance of access to m edicine, which 
needs to be discussed in a broader context, taking into account not only t he Paragraph 6 System 
but also various other relevant measures and factors such as procurement and tariffs.  
51.  Japan supports the Paragraph 6 System as established under the 2003 waiver decision and 
the 2005 Protocol Amending the TRIPS Agreem ent. The very obj ective of the S ystem is to support 
WTO Members in obtaining greater access to medicines, specifically Members that have either 
insufficient or no pharmaceutical manufacturin g capacity. Compulsory licenses , whether granted 
under the Paragraph 6 System or otherwise , are just one of the potential policy tools that can be 
utilized for th is objective. T herefore, the Paragraph 6 System should not be considered as the only 
solution, but rather as just an option we could consider.  
52.  Lastly, we need to understand and analyse the specific concerns of potential importing 
Members who would or who might use the Paragraph 6 System. Japan hopes that these Members 
will share their concerns and experiences with us. Japan believes that it would be beneficial for this 
Council to  hear specific comments by potential importing Members.  
6.10 Chinese Taipei  
53.  My delegation  thank s the WTO Secretariat for the excellent work done on the draft report on 
this subject.  
54.  My delegation strongly supports the System provided for under Paragraph 6 as it was 
established by the  2003 W aiver Decision  and the 2005 Protocol. We would like to congratulate 
Peru, the Republic of Tajikistan and other Members who formally accepted the amendme nt this 
year. We would also like to say how much we welcome the Secre tariat's efforts aimed at ensuring 
that instruments of acce ptance of the amendment are  deposited.  
55.  Finally, we wish to take the opportunity to highlight the positive efforts made by the 
Secretariat in this r espect. W e would draw delegates' attention to the WTO webpage which is 
devoted to the TRIPS Agreement where  Members can find a link to a guide on notifications under 
the System laid down in Paragraph 6 . We certainly found that guide very useful.  
56.  We would like to stress how important it is that we ensure that the TRIPS Agreement fits into 
the broader framework which exists nationally and internationally and which is aimed at dealing 
with public health problems. We should also underline the fact that the Agreement does not stop 
Members from taking measures which are aimed at protecting public health and in particular 
taking measures which would promote access to medicines for everyone.  
6.11 Switzerland  
57.  I would like to add the thanks from my delegation to my neighbour who has just intervened 
and to the Direct or-General and to yourself and the WTO Secretariat for all your efforts to secure 
the necessary number of acceptances of the Protocol during this year. We certainly commend 
those 15 WTO Members who have completed  their acceptance procedure so far  this year . IP/C/76  
 
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  58.  We also thank the WTO Secretariat for holding its 12th Workshop on Trade and Public Health , 
as noted in its annual report in document  IP/C/W/618 , as a capacity -building W orkshop to raise 
awareness about the System and to help Members make effective use o f it.  
59.  Switzerland was among the first WTO Members to put in place the necessary legislation to 
enable the System at the national level and use of the mechanism for export. According to 
information available from the WTO Secretariat , more than 52 WTO Membe rs have done so by 
today covering about 80% of current medicines export capacity. This  was done  on the basis of the 
waiver solutions agreed in 2003 , and in spite of the fact that the TRIPS Amendment has not yet 
entered into force. This demonstrates the com mitment and the support of WTO Members for the 
use of the Paragraph 6 System . In the Paragraph 6 Review in the TRIPS Council , Members have 
confirmed this political support and encouragement for use of the System.  
60.  I would like to refer  to two points that h ave been mentioned by preceding speakers. One was 
the complexity and cumbersomeness of the System that was claimed. However, in our 
recollection , in past reviews in this Council of  the Paragraph 6 Syste m, we have not heard, at least  
not from potential bene ficiary Members , of cases where the System needed to be used, but was 
not used or dropped because it was too complex , or that the process of making it proved to be not 
workable at any  specific stage of the System . 
61.  When we look at the System it seems quite straightforward. The WTO Secretariat is assisting 
Members who may want to use the Paragraph 6 System very helpfully through all the information 
and the special dedicated website on the WT O site. N otification s certainly should not pose a 
problem.  
62.  Concerns were raised with regard to the need of having to mark medici nes that are produced 
under special compulsory licence. Switzerland has argued in earlier reviews that such special  
marking of  medicines is in the very interest of the potential b eneficiary countr y because it will 
ensure that the medicines produced under such a special licence reach the people who need these 
medicines.  
63.  Also, the requirement for the generic producer under such a licence to put up a  website has 
been described as cumbersome. Howe ver, I believe hosting a website for a generic manufacture 
capable of actually assisting under this System should not pose an  unsurmountable hurdle 
nowadays.   
64.  Having said this, compulsory licences are as such not an easy and quick -fix solution to 
address the b roader problem of sustainable access to affordable medicines – whether in 
developing countries or any other WTO Member. Implementing a compulsory licence , and again I 
refer to normal or special compulsory licences even once granted , pose their own challeng es. A 
generic manu facturer needs to be found who  is ready, willing and available to produce the 
medicine needed and the quantities needed wi thin a short time -period at an affordable and 
competitive price and at the requ ired quality and safety standards. Th is demonstrates that a 
compulsory licence is never a quick -fix solution  and this cannot be remedied by the Paragraph 6 
System or by revising it for that matter.  
65.  Also, the fact that the System has only been used once so far  was taken as evidence that the 
System is not workable . However, I believe it is important  to note, as stated by the EU , that  the 
Paragraph 6 System does not have result in the grant of  an export licence. One of its key benefits 
is to give all WTO Members, including those wit hout manufact uring capacity in the pharmaceutical 
market, the negotiation leverage when they need to address  a specifi c public health problem and 
to negotiate with potential manufacturers the price and any delivery  conditions for receiving the 
needed  medicine. That was  the very basis of the mandate that Ministers gave the TRIPS Council in 
the Doha Declaration on the TRIPS Agreement and Public Health . Their intention was  to ensure 
that this policy flexibility that was identified and confirmed in th e Doha Declaration would be 
available to all WTO Members equally.  
66.  The case of Canada -Rwanda  was the first one and was not an easy one . Always when you do 
a thing for the first time, you learn lessons. Therefore, we do believe that the Paragraph 6 Review, 
within this Council, is extremely beneficial for Members to exchange and share experiences made , 
raise concerns so that  all can learn for any next use of the  Paragraph 6 System.  IP/C/76  
 
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  67.  We hav e also heard that  in many cases the Paragraph 6 System might not have been needed 
since medicin e was available from a country or manufacturer in a country where this medicine was 
still available off patent. It has also been mentioned in that context that in the future this might be 
less often the case . In my delegation's view , this only raises the i mportance of the Paragraph 6 
System in the future . Therefore , we very much welcome the discussions in this Council under the 
Paragraph 6 Review so that we can learn how to make  this System and its application in practice 
more useful to potential beneficiar y countries.  
6.12 United States of Ameri ca 
68.  The United States fully associates ourselves with the delegation and the intervention from 
Switzerland. We also want t o thank the Secretariat for the  update regarding the status of  
acceptance s of the 2005 Protoco l Amending the TRIPS Agreement.  
69.  The United States strongly supports the Paragraph 6 Syste m as established under the 
2003 waiver decision and the 2005 Protocol.  
70.  The United States congratulates the significant number of countries who have formally 
accepted t he amendment since last year's review. This is a significant achievement. We encourage 
other Members to notify their acceptance of the amendment so that it can enter into force.  
71.  Finally, again, we want to welcome the Secretariat's efforts, I think Chinese Taipei also 
referred to it, and draw delegations' attention to the WTO TRIPS webpage where Members can find 
an "Illustrative guide to notifying under the Paragraph 6 System." This is quite a helpful document. 
We have taken a look at it. It is easy and it i s very understandable so we commend the 
Secretariat's work in this regard and join Chinese Taipei in that respect.  
72.  There are multiple avenues available for promoting access to medicines. The Paragraph 6 
System is of course important, but it is not alone. A s raised through the Trilateral Public Health 
Worksho p held at the WTO the week of 17  October as referenced by the European Union, there are 
many mechanisms that governments can use to promote access. Such improvements are the 
building blocks for a sustain able healthcare system. Th ese include, as cited in the 
October  Workshop:  
 strong and effective procurement systems and processes;  
 supply chain management, including reliable data regarding actual demand;  
 improvements in notification systems and coordination  with producers;  
 strong and efficient regulatory control of assured quality of medicines;  
 eliminating retail mark-ups through more efficient distribution and dispensing systems ; 
 advance policies that combat substandard and spurious, falsely labelled, falsi fied; or 
 counterfeit (SSFFC) medicinal products that displace innovative and generi c drugs; and  
 eliminating taxes and tariffs.  
73.  For example, taxes or tariffs may be levied - often in a non -transparent manner - on imported 
medicines and the increased expense  associated with those levies is then passed directly to 
healthcare institutions and patients. For example, in a review of tariffs as applied and bound on 
medicinal products , we see ranges of 25% to 40% on tar iffs at the border with respect to 
pharmaceutic al products. We see applied levels of 10% or 7.5% but that is not the end of the 
analysis. We see an additional 13% by some Members added as other duties and taxes creating an 
applied rate of 21% on pharmaceuticals.  
74.  We continue to believe that the access t o medicines issue is multidimensional. Making 
lifesaving medicines available requires transparency and a commitment to address measures that 
unduly delay patients from getting the treatments they need.  
6.13 Panama  
75.  As one of your predecessors , Chair, who has had many opportunities to speak with on this 
matter , I would like to urge Members just as the Director -General has to ratify this A mendment. 
The map that you showed on the screen is very revealing and is very interesting in the sense that 
if we look at t he countries which still have to ratify we see that most of them are in fact developing IP/C/76  
 
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  countries. The other countries are economies in transition if I am not mistaken. This was a 
measure that was promoted by developing countries to the benefit of developi ng countries . I 
believe that we as developing countries need to make a big effort to achieve this as soon as 
possible to ensure that we reach the necessary number of ratifications so that the measure can 
come into force. We will spare no efforts just as th ose who came before us did not either. This is 
an important measure as has been said by many . To be honest I have never understood the 
reason behind the delays other than perhaps a lack of understanding regarding what the 
ratification process involved.  
76.  The Secretariat has made a lot of effort providing technical assistance and I would like to 
congratulate the Secretariat for all these efforts. Perhaps the most important detail that a 
government can take into consideration and which can inform the decisions made by delegations 
and authorities is that acceptance of the Protocol does not mean a change to national legislation. 
What it does is accept that other Members of the WTO can use this mechanism. In other words, 
this could be a very simple decision, a very  simple instrument because there is always the 
possibility of drafting a more complex national law within domestic legislation in order to apply it, 
but this is not necessary. This could be a subsequent step after acceptance.  
77.  Once again, I would like to th ank the Secretariat and I would like to thank all our 
predecessors who have fought very much for this measure . I hope that we will achieve the 
necessary number of acceptances.  
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