RESTRICTED  
  
IP/C/M/84/Add.1  
 
10 Februar y 2017  
(17-0827) Page: 1/14 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
MINUTES OF MEETING  
HELD IN THE CENTRE W ILLIAM RAPPARD ON 30  JANUARY 2017  
Chairperson: Ambassador Mero (United Republic of Tanzania)  
Addendum  
The present document contains the statements made durin g the Council for TRIPS meeting on 
30 January 2017 . 
 
_____ __________  
 
 
Subjects discussed  
 
1   THE PROTOCOL AMENDIN G THE TRIPS AGREEMEN T – STATUS UPDATE  ......................  3 
2   OTHER BUSINESS  ................................ ................................ ................................ ...... 14 
 
 IP/C/M/84/Add.1  
 
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  INDEX OF THE STATEMENTS MADE  UNDER AGENDA ITEM 1   
AT THE MEETING OF THE COUNCIL FOR TRIPS 30 JANUARY  2017 * 
 
Argentina , 13 
Australia , 6 
Bangladesh , 4 
Benin, on behalf of the LDC Group , 3 
Botswana , 9 
Brazil , 9 
Canada , 3 
Chile , 11 
China , 10 
European Union , 5 
India: , 12 
Japan , 14 Kenya: , 7 
Korea, Republic of , 6 
Morocco, on behalf of the African Group , 8 
Norway , 13 
Peru, 12 
Singapore on behalf of ASEAN , 12 
South Africa , 8 
Switzerland , 10 
Chinese Taipei , 13 
Tanzania , 11 
UNCTAD Secretariat , 14 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
___________________  
* A record of statements as delivered in the formal session of the Council. Some statements have been lightly 
edited as appropriate to ensure the consistency of presenta tion. 
 IP/C/M/84/Add.1  
 
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1  THE PROTOCOL AMENDIN G THE TRIPS AGREEMEN T – STATUS UPDATE  
1.1 Canada  
1.  The WTO has reached an important milestone with the coming into force of the Protocol 
Amending the TRIPS Agreement. Not only is this the first time that one of the original WTO 
agreements has been amended, but more importantly, Members can now enjoy the certainty that 
the system of compulsory licensing that was envisaged all the way back in the Doha Declaration 
on the TRIPS Agreement and Public Health is a permane nt and integral feature of the TRIPS 
Agreement.  
2.  It is worth quoting the Declaration, because it is stated that "We recognize the gravity of the 
public health problems afflicting many developing and least developed countries, especially those 
resulting fro m HIV/AIDS, tuberculosis, malaria and other epidemics. We stress the need for the 
WTO TRIPS Agreement to be part of the wider national and international action to address these 
problems." In our view, this Amendment facilitate s one of the key objectives of  the Declaration: 
namely promoting access to afford able medicines for developing and least developed countries. As 
has been pointed out, Members must ensure that they effectively implement the Amendment in 
their law for it to fulfil its potential. As the f irst country to introduce a system of compulsory 
licensing for export based on the Doha Declaration, and to date the only country to have exported 
medicine s pursuant to the temporary waiver, a three -drug anti -retroviral AIDS cocktail, Canada 
has always bee n a strong proponent of the Amendment. We stand ready to share our experiences 
and lessons learned in implementing our own system with any Member who wishes to learn more.  
3.  It is important to remember that no single factor is responsible for preventing acc ess to 
medicine s. As the Declaration emphasizes, the WTO is part of the wider action required to improve 
access to medicines. This is why Canada relies on a variety of measures to promote access to 
medicines. For example, we support partnerships such as th e Global Fund to fight AIDS, 
tuberculosis and malaria, the Global Drug Facility, and GAVI, the Vaccine Alliance. We also provide 
tax incentives for donations of medicines to developing countries.  
4.  For Canada, this is an occasion worth celebrating. While th e road to get here was long, we 
consider this Amendment to be a demonstration of the fact that the multilateral system can and 
does contribute to the well -being of our citizens.  
1.2 Benin  
5.  The LDC Group would like  to offer our thanks for having convened this meeting of the Council 
for TRIPS, and we would like to offer our thanks to the Director -General for his important message 
he gave us this morning regarding the link between IPRs, TRIPS, trade and public he alth. The 
Chair, Members of the WTO and the international community have worked hard in supporting an 
approach based on consensus in order to come up with legal solutions for access to medicines 
affecting people throughout the world, particularly in poor countr ies and LDCs, and Paragraph 6 of 
the Doha Declaration of 2001 focused on this particular issue.  
6.  The WTO Members then continued and , in August of 2003 , adopted the Decision linked to the 
fundamental objective of promoting public health , followed in 2005 by the Protocol Amending the 
TRIPS Agreement . The TRIPS Amendment has created a legal structure that is going to allow 
access to medicines for the poorest countries and LDCs who depend on imports of pharmaceutical 
products. The LDC Group therefore welcomes th e entry into force on 23 January 2017 of the 
Protocol to the TRIPS Agreement. We believe this marks a significant step forward for the 
Members of the WTO, both developed, developing and LDC Members and demonstrates the way in 
which development is being add ressed through the principles governing international trade . We 
believe that we need to continue down this path in order to ensure that we have good 
implementation and coordination action in order to get the desired results. The LDC Group would 
like to off er our thanks to all players at all levels, the Director -General, and the WTO Secretariat's 
team, all of whom have worked very hard in order to achieve this significant result , working 
towards achieving the Sustainable Development Goals for 2030.  Let me co nclude by offering my 
thanks to you and my congratulations on behalf of the LDC Group for the significant contribution 
you have made to our work during your mandate here in Geneva, and I refer to the negotiations IP/C/M/84/Add.1  
 
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  and consultations that have taken place in different fora in the WTO, including in the TRIPS 
Council. Therefore the LDC Group would also like to wish you all the very best for the future of 
your career.  
1.3 Bangladesh  
7.  I want to say, at the very outset, that I fully agree with t he Director -General for the metaphor 
he used to describ e this epoch -making event of the TRIPS Agreement entering into force. It is 
truly an historic measure that has been taken, the first ever amendment to the WTO Agreements 
that enters into force. We have  proved that trade policies can truly complement other vital public 
policy goals and that, at the WTO , we can negotiate smart solutions for real problems affecting our 
lives. I also thank the Director -General and all officials at the WTO who made continuo us efforts 
towards reaching the  required number of ratifications. Let me take this opportunity to make a few 
observations.  
8.  First, we have recently seen tremendous advancements, including fundamental innovation in all 
sectors of science and technology, inclu ding in  ICT and medicine. Unfortunately, not all countries 
of the world share and enjoy this benefit in the same way. On the one hand, some are enjoying all 
the advantages of scientific progress, and on the other, for many countries the existing digital 
divide continues to widen and we are having ever enlarging gaps between basic requirements and 
real availability of treatments and medicines required to treat communicable and non -
communicable diseases.  
9.  Our Ministers were very right in making a judgement ca ll under paragraph 6 of the Doha 
Declaration regarding the real difficulties of WTO Members with insufficient or no manufacturing in 
the pharmaceutical sector in making effective use of compulsory licensing under the TRIPS 
Agreement. Their kind concern pro mpted today's momentous decision of the Members, and for 
that, we congratulate all of them.  
10.  Secondly, after food, medication for the cure of diseases is a primary need for people living in 
developed, developing and least developing countries. Health is a precondition for an outcome, 
and indicator of all dimensions of sustainable development, and it demands, we believe, persistent 
attention. The right to the enjoyment of the highest attainable standard of physical and mental 
health was first articulated in the Preamble of the WHO constitution of 1948, the right to health is 
also enshrined in the Article 25 of the Universal Declaration of Human Rights on 1948 and 
Article  12 of the International Covenant on Economic, Social and Economic Rights and in the 
Human  Rights Council Resolution entitled "Right of Everyone to the Enjoyment of the highest 
attainable standard of physical and mental health". Now the WTO TRIPS Agreement with its new 
Article 31bis ranks alongside these important international instruments to e nsure health and 
happiness for all.  
11.  Let us recall that this provision was already in place through the temporary Waiver, and was 
only used once, between Rwanda and Canada, to which the Canadian Ambassador made 
reference. However, our experience from that case proves that we have to work on the process 
further, to make it more effective, and requiring effort, since we now have the legal certainty, we 
have to find ways which can best suit everybody's requirement . For national governments this can 
actually be  a very effective procurement tool. We also call upon all developed countries and 
multinational  companies  to extend all possible assistance expeditiously when any such notification 
for compulsory licensing is made  by any developing country or any LDC, and  request them to 
remove any potential administrative or procedural barrier. In future , we may discuss under the 
auspices of the TRIPS Council in any form, the possible problems and prospects of this System, so 
that countries are encouraged to use this impo rtant provision. You are probably aware, that , with 
the help of TRIPS flexibilities for LDCs, Bangladesh has invested heavily in the pharmaceutical 
sector, and is almost self -sufficient as regards the supply of medicine s for its 160million people. It 
even exports medicines to more than 70 countries of the world. Bangladesh would be very happy 
to extend its production capacity in the aid of any future requirement by any developing country or 
any LDC.  
12.  Thirdly, although the private sector is the principle hol der of patents, and the burden of 
access to medicines and treatment is increasing every day, strong political commitment is now 
needed to address the challenges of financing , creating and enabling the environment at all levels IP/C/M/84/Add.1  
 
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  for the success of this System. When global leaders adopted the Sustainable Development Goals 
including SDG3, to "ensure healthy lives and promote well -being for all at all ages" they 
pronounced a commitment that no -one would be left behind, that no goal can be achieved unless 
it is a chieved for all. We at the WTO expect no less than this vision and goal.  
13.  To conclude, we would like to place on record our profound appreciation again to all Members 
and Observers in this Organization, in relevant UN organizations, all the academics, NGOs  and 
activists who have written, campaigned and raised awareness in support of this idea. We are 
profoundly grateful and humbled by the generosity and concern. Bangladesh aligns itself with the 
statement made by Benin as LDC Coordinator.  
1.4 European Unio n  
14.  The European Union welcomes the entry into force of the Amendment of the TRIPS 
Agreement. We all agree that it is essential to secure access to medicines for those in need, 
wherever they are. This development is important not only  because it formalises better access to 
medicines, but it is equally important because it demonstrates that the WTO is capable of 
responding in an adequate way to essential needs beyond trade policy. Th is shows that when there 
is the real necessity to chan ge the rules at the WTO, to defend the fundamental interests of 
developing countries, it can, and will be done.  
15.  We delivered our part early on, our instrument of acceptance was deposited with the WTO 
Director -General on 30 November 2007, that is almost 10  years ago. In the WTO, the EU has 
stressed its political commitment to ensuring that domestic implementation of the 2003 Waiver, 
and the Amendment to the TRIPS by Members is facilitated in that the right conditions are in place 
for its operation and effic ient application. We would like to thank in particular the WTO Secretariat 
and the Director -General for its work on that matter.  
16.  The current innovation model, based on patents, has delivered consistent progress in global 
public health, continuously leadin g to important new and improved treatments , as well as much 
extended life expectancy, both in developed and developing countries. Medicines are created not 
by public authorities, but by the pharmaceutical industry. As all industries, its needs an adequate 
return on investments to finance innovation . The challenges  are how to use all levers available to 
public authorities to promote affordable access to medicine s without affecting negatively the R&D 
by the pharmaceutical industry, and therefore the availabil ity of new and innovative medicines. Let 
us also recall that evidence shows that , indeed , there are many different significant causes of lack 
of access to medicines, which renders it misleading to attribute a problem merely to or even 
principally IPR aspec ts. In fact, IPR issues seem to play a minor role in the problem, but a 
disproportionately large role in the debate. This has also been echoed in a join report from the 
WHO, WTO and WIPO stating that the lack of access to medical technologies is rarely due  to a 
single isolated factor. Additionally , it should be mentioned that currently most medicines on the 
WHO list of essential medicines, that is 98.6% , are available in a generic format, either because 
they were never protected by a patent or because prote ction has expired. Still these medicines do 
not reach all in need, in fact many countries apply tariffs, taxes and substantial mark -ups to 
medicines and lack an efficient procurement and health care system, with the result that medicines 
are not available to the population or at least not at an affordable price.  
17.  However, the EU has never shied away from serious and constructive debate in the IPR 
context. From the outset, the EU has been at the forefront of debates on TRIPS and access to 
medicines. In the W TO, the EU has played an active role, with the aim of bringing together the 
almost irreconcilable positions of the opposing sides, including on the latest LDC Waiver. We have 
also consistently supported the use, when necessary and justified, of the flexibi lities provided in 
the TRIPS Agreement and the Doha Declaration by developing countries in the objective of 
ensuring effective access to medicines for their populations.  
18.  The TRIPS Agreement provides for a number of flexibilities that can be used to take i nto 
account public health needs. In particular the TRIPS Agreement provides for the possibility under 
certain conditions of issuing a compulsory licence for domestic production and consumption of 
medicines. Sometimes the mere possibility of using compulsor y licences has led to companies 
granting voluntary licences and price reductions in situations where such an approach was 
justifiable by systemic public health needs. However, the original TRIPS Agreement left one issue IP/C/M/84/Add.1  
 
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  unresolved; specifically by stating that compulsory licences could only be issued to satisfy 
domestic consumption, it left out countries with no manufacturing capacity for pharmaceuticals. 
These countries could not credibly make the argument of granting a compulsory licence and 
produce local ly generic medicines. Paragraph 6 of the Doha Declaration instructed the TRIPS 
Council to find an expeditious solution to this problem.  
19.  The Decision of 2005 to transform the 2003 Waiver Decision into a permanent Amendment of 
the TRIPS Agreement was that s olution. The Amendment to the TRIPS Agreement allows any WTO 
Member to export pharmaceutical products made under a compulsory licence for the purpose of 
supplying developing countries with insufficient manufacturing capacities. It does ensure a legally 
secure, predictable, effective and sustainable solution for those countries which want to use the 
system to get affordable medicines they need. We therefore see 23 January 2017 as an important 
milestone for the WTO, and a successful proof that , when there is the real need to change rules to 
defend the interests of developing countries, it can, and will be done.  
1.5 Australia  
20.  Australia welcomes the entry into force of the Protocol Amending the WTO Agreement on 
Trade -Related Aspects of Intell ectual Property Rights on 23 January 2017. Along with many others, 
Australia actively encouraged acceptance of the Protocol by all WTO Members. We congratulate 
Members including Burkina Faso, Liechtenstein, Nigeria, United Arab Emirates and Viet Nam on 
their recent acceptances. This outcome 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, and this in turn will support imp roved health outcomes for some of 
the world's poorest people.  
1.6 Korea, Republic of  
21.  As the Director -General said, we have just celebrated Chinese New Year which is the Year of 
the Rooster, but this year it is specifically the yea r of the red rooster, and in Korea, a red rooster 
represents a fighting spirit . We have many things to fight against this year, including protectionism 
and an attack on multilateralism, so I hope that the spirit of the red rooster will help us fight us 
these misguided movements.  
22.   I would like to join the previous speakers in welcoming this historic moment of the entry into 
force of the Protocol Amending the TRIPS Agreement. I would also like to extend my sincere 
appreciation to you, Mr Chairman, for your ex cellent leadership in the Council, and also to the 
Director -General and the Secretariat for their hard efforts in encouraging Members to accept the 
Amendment. On a personal note, I participated in the initial phase of the discussion on this issue 
in 2003, so it is particularly rewarding to see the initial efforts from ten years ago finally bearing 
fruit.  
23.  While we celebrate this moment, we should not think that this is the end of the story. I would 
like to m ake three points in this regard:  
 Firstly, we urge the remain ing one third of Member s who are yet to accept the Amendment 
to do so.  
 Secondly, we should make our new mechanism work by amending domestic laws and 
regulations in accordance with the Amendment. Korea amended its Patent Act and related 
provision s when it accepted the Amendment in 2007. We hope that those Members who 
accepted the Amendment, but have not properly amended their domestic laws  or who have 
not notified them to the WTO, do so promptly.  
 Thirdly, Members should reflect on the implication s of the Amendment which clearly shows 
how trade can contribute to non-commercial values, including public health. Trade is deeply 
involved with every corner of our life, and can make substantial contributions to it. Given the 
growing anti -trade sentiment throughout the world, the potentials of trade in making our life 
better should continue to be explored. I firmly believe that public health may not be the only 
area trade can contribute to.  IP/C/M/84/Add.1  
 
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  24.   Once again I would like to congratulate all the Members on the en try into force of the TRIPS 
Amendment and hope that millions of people suffering from diseases in countries with limited or 
no production capacity will benefit from the new mechanism.  
1.7 Kenya  
25.  Today is a day of celebrations, we are celebrat ing the New Year for China, and also the 
achievement of this particular milestone. Having served in Geneva for the last few years, Chair, 
and then looking forward to a new appointment, I would like to acknowledge and appreciate that 
this is a very welcome achievement as you leave for the dining hall that is New York, people say 
that Geneva is the kitchen and New York is the dining, so I congratulate you for your new 
appointment.  
26.  Kenya readily welcomes the entry into force on 23 January 2017 of the Protocol  Amending the 
TRIPS Agreement. Kenya recalls very well the journey towards access to medicines by WTO 
Members to help them address the grave and tragic time of 2003, really a critical time for public 
health problems that were afflicting the world at that t ime. AIDS was devastating and this was a 
timely decision, especially in the area of HIV /AIDS, tuberculosis and malaria , taken under  
intellectual property rights in the WTO context, within the TRIPS Agreement , which  is a big 
achievement.  
27.  Kenya, like many o ther WTO Members held, and still holds that intellectual property rights 
should be exercised coherently to the mutual benefit of the right holders and also the consumers. 
Thus, the TRIPS Agreement should ensure a balance of rights and of the duties of righ t holders 
vis-à-vis the poor people of the world.  
28.  The journey, as has been mentioned by others, to this Amendment was not smooth for many 
WTO Members and other stakeholders. I do remember the story from my predecessor who was 
here in those days, who was t he Ambassador, and currently the Foreign Minister, the long nights 
and hours they had to hold with some of the delegations here to get this to pass, so Kenya shared 
this experience. The road was rough, winding and full of speed governance – bumps and ramps . 
Some travellers had to change course, while others abandoned like -minded colleagues and others 
gave up. However , Kenya is happy , that with many other WTO Members and other stakeholders , 
we turned the challenges and threats encountered during the journey into this milestone 
opportunity.  
29.  Now that the Protocol Amending the TRIPS Agreement has entered into force, Kenya urges 
WTO Members, the WTO Secretariat and all the stakeholders including civil society, to take 
practical steps in order to make this procur ement tool deliver concrete results to patients in need 
of affordable medicines. Further, Kenya urges WTO Members who have not accepted the Protocol 
to consider doing so as soon as possible.  
30.  The Director -General mentioned that January is a month of reflec tion, we look forward and we 
look backward. I do recall July of 2015 when I came to the realisation that Kenya had actually not 
ratified this particular Protocol, and I was filled with horror. So as we reflect backwards and 
forwards, let us ask ourselves w hy should it take this long for some of us to do these things ? The 
DG has congratulated us, the Ambassadors who have taken the role and moved these things and 
made them possible . However, as we reflect, let us ask ourselves 'could we have done better?'. 
Some of us who have signed late are also some of the people who needed it most. The EU signed 
in 2007, we signed almost ten years later, the big question and the challenge to those of us on this 
floor is why? Could we have made a difference?  
31.  The Paragraph 6 System set  out in the Decision and the Protocol has been doubted by some 
that it does not fully help to address the difficulties faced by WTO Members with insufficient or no 
manufacturing capacity in the manufacturing sector in making effective use of comp ulsory 
licensing under the TRIPS Agreement. In this view, and this is an important point, Kenya is ready 
to support any efforts that would improve the System  to make it more practically viable. The 
practical applicability of what we have achieved has been questioned in some for a.  
32.  Kenya will continue to actively play its part, for it believes that effective and efficient 
utilisation of the System established under paragraph 6 of the Doha Declaration could boost the IP/C/M/84/Add.1  
 
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  government's effort in meeting its intelle ctual property rights and health obligations under the 
Kenyan constitution. I thank you Mr Chairman, and I wish you well.  
1.8 Morocco, on behalf of the Africa n Group  
33.  The African Group welcomes the Amendment o f the TRIPS Agreement which entered into 
force on 23 January 2017, after two -thirds of the Members accepted the Protocol Amending the 
TRIPS Agreement, thereby replacing the Decision of the General Council of 30 August 2003. The 
entry into force has provide d legal certainty to our quest for affordable medicines under the TRIPS 
Agreement. The Doha Declaration on the TRIPS Agreement and Public Health recognizes the 
difficulty that countries with insufficient or no manufacturing capacity in the pharmaceutical s ector 
faced in making effective use of compulsory licences under the TRIPS Agreement. The General 
Council Decision of 30 August 2003 has given Members the opportunity to overcome these 
difficulties. The Amendment has made it easier for access to pharmaceut ical products that would 
help alleviate the suffering of our people who are effected by  HIV/AIDS, tuberculosis, malaria and 
other epidemics. The African Group is therefore pleased with the entry into force of the 
Amendment.  
34.  The Africa n Group notes the imp lementation of the System  by some Members through the 
amendments of their national legislation , in particular , the patent law . However, a large majority 
of others have not done so. In this context, the implementation would depend on the provision of 
meanin gful technical assistance to our countries so that we can implement the Amendment  into 
our legislation. To achieve th is we believe that targeted technical assistance in , inter alia . 
legislative reform, public awareness and institution reforms would assist our Members in the 
effective use of the Amendment. We note the trilateral cooperation between WTO, WIPO and WHO 
on intellectual property and public health with the aim of strengthening cooperation on the 
interface between intellectual property and public h ealth as part of increasing international efforts 
to improve the ability of developing countries and LDCs to have access to medicines and to ensure 
the availability of new and more effective medicines. The three institutions have also provided 
technical as sistance to our Members in this area, and other international organizations and 
Members are also involved in the provision of technical assistance . However, it appears that there 
is a need for coordination among the providers of technical assistance. To th at end , the African 
Group would like to propose the establishment of some form of mechanism that would ensure 
effective coordination of technical assistance.  
35.  Finally, the African Group would like to extend our thanks to the Members for their support 
from the time we came to the TRIPS Council in 2001 when we asked for a discussion on the 
interpretation and application of the relevant provisions of the TRIPS Agreement with a view to 
clarifying the flexibilit ies to which Members were entitled under the Agreem ent, and on the 
relationship between the TRIPS Agreement and affordable access to medicines. This discussion led 
to the Doha Declaration on TRIPS and Public Health, and the Amendment. Our special thanks also 
go to the Secretariat for their tireless work du ring and after the negotiations.  
1.9 South Africa  
36.  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 preparedne ss 
of the Organization to take up the problems faced by the poor in developing and least developed 
countries. Almost one -third of the world's population lacks access to essential medicines. These 
are generally defined as those medicines and medical prescri ptions that satisfy the priority 
healthcare needs of the population. Developing countries continue to face special challenges 
combating infectious and chronic disease. For them, the societal burden of disease is compounded 
by the effect of low -per-capita i ncome, weak institutional governance structures and poor access 
to health treatment and prevention.  
37.  In light of the above -mentioned, this delegation welcomes the entry into force of the Protocol 
Amending the TRIPS Agreement. The entry into force of the Pro tocol is an important signal to 
everyone that this Organization  is not only about trade liberalization, but espouses an inclusive 
vision that seeks to leave no one behind. The System is, however, not a panacea to solve all public 
health -related problems, r ather it is part of a broader picture which includes other important 
aspects that have an impact on innovation and access, such as infrastructure, tariffs, innovative IP/C/M/84/Add.1  
 
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  financing mechanisms, partnerships and cooperation, including at a regional level to whic h this 
Amendment also applies, and regulatory frameworks. We also note the content of the High Level 
Panel recommendations to make the Paragraph 6 System more effective . Inter alia , it posits that 
governments should adopt and implement legislation that fac ilitates the issuance of compulsory 
licence. Such legislation must be designed to effectuate quick, fair, predictable and implementable 
compulsory licences for legitimate public health needs, and particularly with regard to essential 
medicines. The use of compulsory licences must be based on provisions found in the Doha 
Declaration and the grants for issuance of compulsory licences  is left to the discretion of 
governments. This delegation looks forward to further discussions to refine the Paragraph 6 
System  as implemented by the Protocol in order to ensure optimal use of this very important tool.  
38.  In closing, this delegation would like to thank you for the services that you have rendered to 
this Council, I daresay that the TRIPS Council will never be the sam e, since you have implemented 
uncanny and unconventional approaches to long -standing issues that have forced Members to 
think outside of the box. We wish you well in your further career, and in no small way, realize the 
indelible mark that you have left on  us all.  
1.10 Brazil   
39.  Brazil joins other Members in celebrating the entry into force of the Protocol Amending the 
TRIPS Agreement, which consolidates a legal framework for Paragraph 6 of the Doha Declaration. 
We take this opportunity to ac knowledge you, Chair, the DG and the Secretariat as well as all 
those who contributed to this process. The Brazilian Foreign Minister himself , Mr José Serra, in his 
former capacity as Health Minister, was a proponent of the 2001 Doha Declaration. This is i ndeed a 
landmark development for the multilateral trading system. It shows that trade rules can and must 
contribute to addressing people's needs. It enhances the legitimacy of the WTO, it is a vital 
contribution of the implementation of the 2030 Agenda and  it sends a strong message about the 
capacity of the international community to reach consensus decisions. DG Azevêdo stated that 
Members should ensure that trade policies compliment other vital public policies such as public 
health. Brazil fully endorses this. TRIPS flexibilities which are an inherent part of the intellectual 
property system serve this purpose. The Amendment is now a very concrete and very positive 
example of an appropriate balance between protecting innovation through patents and 
safeguar ding public health.  
40.  Now we must look ahead, the entry into force of the Protocol raises the challenge of its 
effective implementation. As stated by the DG, Members should make effective use of the 
Amendment as a procurement tool to ensure pharmaceutical s upplies. We can build upon the 
experience of the first and so far only case of use of the mechanism, the one between Canada and 
Rwanda, which has already been highlighted today. Discussions in previous sessions of this Council 
could also provide inputs for  the way ahead. In this context, Brazil would like to make three 
preliminary suggestions : 
a. Brazil considers that the WTO Secretariat could provide technical assistance to countries 
in their domestic procedures to incorporate the Protocol into their legal sy stems , 
including with regard to implementing legislation.  
b. Awareness -raising activities are also important. The low level of use of the Paragraph 6 
System so far could be related to lack of information, among other reasons. Brazil 
proposes therefore that th e next session of the TRIPS Council includes a presentation by 
the Secretariat on the notification system currently in place.  
c. Another suggestion relates to the need of capacity building activities with officers 
responsible for intellectual property in WTO  Members. Brazil would be ready to 
contribute to such an initiative.  
41.  I thank you Chair and I wish you well in your next endeavours.  
1.11 Botswana  
42.  I will be making some remarks to compliment the statement made on behalf of the Africa n 
Group . I join colleagues in expressing our gratitude for the coming into force of the Protocol IP/C/M/84/Add.1  
 
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  Amending the TRIPS Agreement. Celebration is , indeed , in order, especially as occasions for 
celebration have been very few and far between. Let me also thank the DG f or his open ing 
remarks.  
43.  The rationale which gave rise to the 2003 General Council Decision as well as the Protocol 
Amending the TRIPS Agreement of 2005 remains valid today. Many of our countries carry heavy 
disease burdens of all kinds, and in addition ne ither do we have the capacities to produce our own 
medicines nor do we have financial resources to acquire them.  
44.  I was fortunate to serve as the Chairperson of the TRIPS Council in 2014, during which time I 
encouraged Members in different configurations t o complete the acceptance of the Protocol 
Amending the TRIPS Agreement. I also convened a meeting between the DG and the Africa n 
Group to discuss the benefits of the Protocol and map the way forward. I say this to say that 
hopefully the needle did move pos itively to conduit the work that we are recognizing today.  
45.  Botswana ratified the Amendment  in 2014 and incorporated their flexibilities in its revised 
intellectual property rights legislation. We are very grateful that the Protocol Amending the TRIPS 
Agreement has finally entered force. Yes, it has taken us over a decade to conclude something 
which has been in our interest. Now that it is done, implementation can then reveal how well it 
works, regarding remedial measures as necessary.  
46.  The Secretariat unde r the leadership of the DG deserve s recognition for the tremendous work 
they put into this issue. Similarly your own contribution, Mr Chairman, also deserves our 
recognition.  
1.12 Switzerland  
47.  Switzerland welcomes the entry into force of the Amendment to the TRIPS Agreement. Our 
particular thanks go to the Director -General for his personal effort to achieve this goal , as well as 
to the WTO Secretariat, and especially the IP Division for their tireless support to Members in this 
endeavou r.  
48.  Switzerland was among one of the first WTO Members in September 2006 to deposit its 
instrument of ratification at the WTO and to put in place the necessary legislation at the national 
level to enable the use of the System.  Bringing the waiver solution formally into the TRIPS 
Agreement offers an important added value, especially with respect to the legal certainty needed 
by beneficiary countries when making use of the Paragraph 6 mechanism. Moreover, this added 
TRIPS flexibility is an important contribut ion by the WTO to support developing countries faced 
with public health problems , such as HIV /AIDS, tuberculosis and malaria. Let me close by noting 
that this contribution is just one piece of the much larger challenge of ensuring affordable access 
to medi cines in a sustainable way, in particular in LDCs. Other requirements notably include 
adequate and effective intellectual property protection in order to promote the development of new 
and innovative medicines which are still in great need.  
1.13 China  
49.  First I would like to wish you all a lucky Chinese New Year of the Rooster. China welcomes the 
entry into force of the Protocol Amending the TRIPS Agreement. It marks the first time since 1995 
that WTO accords have been amended and also shows o ur joint efforts to address public health 
issues, especially in developing and least developed countries. Public health is one of the most 
important elements in the UN 2030 Agenda and has attracted great attention from global leaders.  
50.  WTO Members are enco uraged to take full use of flexibilities identified under the TRIPS 
Agreement and the Doha Declaration on TRIPS and public health in order promote access to 
medicines. In this regard, China would like to continue to work with all WTO Members to make the 
System practically available and also keep the proper balance between protecting IP rights and 
securing public health. I would like to conclude by thanking you for your endeavours and 
contribution to the work of the Council.  IP/C/M/84/Add.1  
 
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  1.14 Chile  
51.  Chile w ould like to join previous speakers in endorsing what the DG said and what other 
delegations have said about the significance of this Protocol in the WTO system . We recognise that 
it is important looking ahead to the future. We are currently living in chal lenging times . As WTO 
Members , it is our responsibility to face these challenges and to demonstrate that global trade can 
give impetus to be complementary to significant areas in countries . It can be a development tool, 
and it can create both economic and social well -being. Our delegation was firmly behind this idea 
and we believe that this important Amendment is proof of this because it outlines clearly that 
intellectual property standards can and should be in harmony with other significant objectives such  
as ensuring access to healthcare. Chile was one of the Members who was part of the consensus to 
ensure that this Amendment came into force . We deposited our instrument in 2013, responding to 
the call by  the DG . We would like to acknowledge his contributio n and commend him for placing 
the significance of this Amendment at the highest level, offering assistance to Members who have 
still not ratified it.  
52.  If we look at all the efforts that have gone into ensuring that this Amendment comes into 
force, we see t hat we have a further demonstration that this house is interested in finding creative 
solutions to significant issues in the area of international trade and we have had a new impetus 
that has arisen in recent years. Beginning in 2015 , we had the Sustainabl e Development Goals 
which are going to require efforts by the multilateral trading system, in other words efforts from 
Members . What this means is that all stakeholders by 2030 need to meet certain objectives , 
including the Sustainable Development Goal 3, providing welfare for everybody of all ages . This 
includes achieving access to vaccines and medicines that are safe, accessible and of quality, in 
other words, access for everybody and we certainly look forward to this. Likewise, following an 
initiative by  the Secretary General of the UN, a group of experts met in a High Level Panel on 
Access to Medicines, and we took note of the report that was released in 2016. We are aware that 
this has been an initiative that did not originate with Member states . We see  that our attention is 
called for, this is an invitation for us to consider the recommendations that derive from this report, 
it does  not necessarily mean that we need to adopt all of the report's content.  
53.  However , we do need to consider its content becau se we could glean important ideas in 
improving access to medicine s. Looking at the idea from different angles, in particular, the report 
could be subject to assessment here, in the WHO or WIPO or we could do it co -jointly along the 
lines of what has been d one in the past. Therefore i f we look at the challenge that lies ahead we 
see that we do not  only need to use the flexibility that has now come into force and which is going 
to facilitate the availability of medicines and offer access to health care in our  countries. In 
addition to that, we need to continue to address the issue of flexibilities in the TRIPS Agreement, 
looking at other areas of public policy which are significant for all Members. Chair, we would like to 
wish you all the best in your future c areer.  
1.15 Tanzania  
54.  At the outset, I align my statement to that of the African Group. My delegation would like to 
take this opportunity to welcome the entry into force of the TRIPS Amendment here referred to as 
the Paragraph 6 System. We  appreciate the efforts made by this Council and the Member s, 
particularly those who have deposited their instruments of acceptance of the Protocol Amending 
the TRIPS Agreement. We thank and congratulate you , Chair, your predecessors, the 
Director -General and the Secretariat for your collective efforts in facilitating and sensitising 
Members to raitify the Protocol. As a result today we are celebrating the entry into force of the 
Amendment.  
55.  The importance of this Amendment cannot be over emphasized. Having  this System in place 
assures accessibility of affordable medicines through the imports to the developing and least 
developed country Members with insufficient or no production capacity in the pharmaceutical 
industry. This is an ethical and a critical cont ribution of the WTO to the call of the United Nations 
to ensure the interest of public health, secured sustainably, as stated in the 2030 Agenda.  
56.  While we are celebrating the entry into force of the Paragraph 6 System, we call upon the 
TRIPS Council to re main open in future to any further improvement of the System. We believe this 
instrument is well -balanced and therefore should be embraced by all Member s. IP/C/M/84/Add.1  
 
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  1.16 Singapore, on behalf of ASEAN  
57.  I am making this statement o n behalf ASEAN Member states to congratulate Members on the 
entry into force of the Protocol Amending the TRIPS Agreement. We are especially pleased that 
ASEAN has contributed collectively to this effort. All ten ASEAN Members have ratified the Protocol. 
This is a tangible demonstration of ASEAN's commitment to the multilateral trading system. The 
entry into force of the Protocol is an important development for the facilitation of access to 
medicines in developing countries and especially LDCs. It also repr esents a significant achievement 
for WTO Members as a whole. We hope that with the legal certainty that this Amendment offers, 
more WTO Members will consider making use of the provision.  
1.17 Peru  
58.  Peru welcomes the fact that this Protocol is  entering into force. Last September we deposited 
our instrument of acceptance. We would like to offer our thanks for the efforts of Members and 
you, Chair, and the support we received by the Secretariat on this issue. As other Members have 
said, and the D irector -General himself, we believe that this instrument is the first time that a WTO 
agreement has been amended. Nonetheless , its significance is far more reaching because this is a 
response t o ensuring that there is access  to medicine s which is in line w ith achieving the 
Sustainable Development G oal. This underscores the importance that global trade plays in this 
issue now and the link with development. We are not just signing theoretical agreements, but 
rather we want agreements that offer pragmatic solu tions to daily problems. In this case , we are 
talking about guaranteeing access to  medicine s. We hope that Members that are yet to accept the 
Amendment will maintain their commitment in order to ensure that this does enter into force 
effectively  for them .  
59.  Looking ahead to the next Ministerial Conference with regard to the goal 14.6 about fisheries 
subsidies, we also hope that commitments will be maintained for that. Looking at the Amendment 
to the TRIPS Agreement , we feel that we are well on our way . We believe that it is important that 
Members seek conscientiously to deal with the implementation of this Amendment . We feel that it 
would be important for Members to share experiences about the implementation of this new 
System in order to look at its potentia l, and the challenges we are going to face in using it. We 
believe that this issue could be dealt with in the next TRIPS Council in June together with other 
suggestions that have been made this morning.  
1.18 India  
60.  India welcomes the entry in to force of the Protocol Amending the TRIPS AGremeent which is 
the first multilateral treaty since the WTO Agreement came into force in 1995. India attaches high 
importance to the Doha Declaration on TRIPS and Public Health, the Paragraph 6 System, as 
established under th e 2003 waiver Decision and the Protocol. India was one of the first countries 
that notified its acceptance of the Protocol in March 2007. We would like to congratulate Burkina 
Faso, Nigeria, Liechtenstein, the United Arab Emirates and Viet Nam for depositing their 
instruments of acceptance of the Protocl recently and making possible the entry into force of the 
Protocol.  
61.  India has always been of the view that the Doha Declaration on TRIPS and Public Health 
constituted a major landmark in the  history of the WTO because it recognized the primacy of 
public health needs and the preparedness  of the Organization to address the problems in access to 
medicines faced by poor and developing countries. The 2003 waiver Decision was expected to 
address pu blic health problems faced by Members with insufficient or no manufacturing capacities 
in the pharmaceutical sector. It might have sounded prophetic at that time when India raised 
certain apprehensions in the General Council meeting of August 2003. I quote  "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 t he benefit of the people. In order to make the 
system successful, a sincere collective effort is required on the part of all Members and the entire 
pharmaceutical industry".  
62.  Regrettably we have been proven right. The export of HIV /AIDS medicines by the Ca nadian 
pharmaceutical company Apotex to Rwanda in September 2008 has been the first and only use of IP/C/M/84/Add.1  
 
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  the System so far. The Trilateral S tudy by WTO, WHO and WIPO on Promoting Access to Medical 
Technologies and Innovation: Intersections between Public Health , Intellectual Property and Trade 
highlights some of the issues that need to be addressed for any meaningful utilisation of the 
System. We need to consider those issues carefully so that this measure does not remain confined 
to paper only.  
63.  The UNSG High L evel Panel on Access to Medicines in its report of September 2016 also 
recognises that the Paragraph 6 System is complex and cumbersome. It recommended that "WTO 
Members should revise the Paragraph 6 System in order to find a solution that enables a swift and 
expedient export of pharmaceutical products produced under compulsory licences. WTO Members 
should, as a necessity, adopt a waiver and permanent revision of the TRIPS Agreement to enable 
this reform."  
64.  During an event held on the side lines of the last  TRIPS Council meeting in November 2016, 
several participants also highlighted that the System is not workable in its current form, especially 
because it is too complex, cumbersome and administratively unwieldly to use and is also 
commercially not viable f or companies to supply medicines. We urge the membership to 
constructively engage on the question of improving the Paragraph 6 System to make it more 
workable and effective so that it can benefit Members with insufficient or no manufacturing 
capacities in the pharmaceutical sector.  
65.  Some Members who notified their acceptance of the Protocol have not yet incorporated the 
System into their national laws. We encourage these Members to take necessary steps to 
incorporate the System into their national laws. Som e Members with insufficient or no 
manufacturing capabilities are yet to accept the Protocol. We also encourage Members who are yet 
to notify their acceptance of the Protocol to do so by the end of this year. We also urge the 
Secretariats of WTO and WIPO to  continue providing technical assistance for the implementation 
and use of the Paragraph 6 System by Members. Finally , I conclude by wishing you well in your 
appointment.  
1.19 Chinese Taipei  
66.   On behalf of my delegation, I would like  to welcome the entry into force of the Amendment to 
the TRIPS Agreement. We also congratulate you on this occasion of the deposits made by Viet 
Nam, Burkina Faso and other Members to bring to two -thirds the Members of WTO. We believe 
that this Amendment w ill help developing countries and LDC Members to solve public health 
problems. Special thanks for the hard work of the Chair, the Director -General and the Secretariat 
on this matter.  
1.20 Argentina  
67.  Argentina welcomes the coming into for ce of the Protocol. This Amendment is clearly a major 
flexibility to protect public health, enabling moving towards the Goal 3 of Agenda 2030. As part of 
trade policy, it is an example of WTO responding to  the people that we are talking about, and 
shows th e importance of the multilateral trading system for developing countries. We do hope that 
this system will not require a red fighting rooster to survive, but more cooperation, as mentioned 
by the Ambassador of Brazil.  
1.21 Norway  
68.  Norway att aches great importance to tackling global health challenges, including providing 
access to affordable medicine s for all. Norway was one of the first Members to formally accept the 
Protocol of Amendment to the TRIPS Agreement. We are pleased that we have no w reached the 
necessary threshold for the entry into force of the Protocol. The Amendment is an excellent 
example of how WTO Members can deliver on topics of great importance to developing countries 
and LDCs alike. It is also an excellent example of how th e WTO can contribute to reaching other 
public policy goals, like public health. Norway remains a strong supporter of the Amendment and 
hopes that Members will find practical ways to make use of it, in order to facilitate access to 
medicines for the world's  poorest. We further encourage all Members who have not yet accepted 
the Protocol of Amendment to do so as soon as possible.  IP/C/M/84/Add.1  
 
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  1.22 Japan  
69.  The delegation of Japan would like to show appreciation to the Chair, and the Secretariat for 
all their efforts in facilitating the entry into force of this Amendment . This delegation would like to 
congratulate Nigeria, Burkina Faso, Liechtenstein, United Arab Emirates and Viet Nam for 
depositing their instruments of acceptance of the Protocol most recently.   
70.  Japan recognises that access to medicines is important in order to deal with this issue. The 
Government of Japan has been working on important projects with UNDP and JFIT funds and so 
on. The joint research conducted by WHO, WIPO and WTO clearly suggeste d that this issue has 
been due to a combination of many factors , including sustainable financing and supply systems 
and so on. Japan welcom es the entry into force of the Protocol, as one of the Members that 
accepted the Amendment. I wish you all the best f or your new position in New York.  
1.23 UNCTAD Secretariat  
71.  UNCTAD welcomes the entry into force of the Amendment to the TRIPS Agreement which 
makes permanent the System for the facilitation of export of medicines produced under 
compulsory licence to WTO Members with insufficient domestic manufacturing capacities. UNCTAD 
has followed this process with particular interest, due to the fact that one element of our IP -related 
technical assistance consists of a programme that seeks to p romote the local production of 
pharmaceutical products in developing countries and LDCs.  
72.  While the Paragraph 6 System has only been used once, its potentially most beneficial 
element has never been put into practice so far. I refer to the specific waiver for Regional Trade 
Agreements, made up mostly of LDCs to facilitate the trade in and production of medicines under 
compulsory licence in those regions. Under this RTA waiver, producers located in one of the parties 
to such a regional agreement are not rest ricted by quantity of production and certain notification 
and labelling requirements that usually apply in the context of the System. This may be an 
important tool to incentivise local production and economies of scale in regional trading blocs like 
for ex ample , the East African Community. UNCTAD, in its 2011 'Guide to Using TRIPS Flexibilities 
to Stimulate Local Pharmaceutical Production' , recommended the establishment of regional 
pharmaceutical supply centres under  those regional agreements that would com plement the RTA 
waiver. These centres would pool national procurement capacities and offer the regional market to 
pharmaceutical producers that are willing to engage on an affordable price. The new RTA waiver in 
the TRIPS Agreement could be of specific ben efit to those producers that are located in a 
developing country that is part of a mostly LDC -composed RTA. Under a compulsory licence firms 
could produce considerable quantities of medicines for a regional supply centre at affordable prices 
without the us ual quantitative restrictions. In order for regional agreements to benefit from the 
new TRIPS provision, however, it is important to not treat IP rules in isolation.  
73.  Enabling pharmaceutical production is a cross -sectoral task, and requires close coordinat ion 
and even harmonization of policies related to IP, drug regulation, procurement and inter -regional 
tariffs. As UNCTAD's work on local production shows, local producers in many developing countries 
struggle to meet drug regulatory requirements related to  quality, safety and efficacy of medicines. 
Building local capacities to meet those standards is therefore key to any local production policy. 
Governments need to provide conducive frameworks for foreign and domestic investors to transfer 
technology and kn ow-how to local producers under mutually beneficial agreements. The new RTA 
waiver in the TRIPS Agreement may make a contribution to this effect. UNCTAD will be pleased to 
cooperate with developing countries, LDCs and the WTO Secretariat to help countries reap the 
benefits of this new TRIPS provision.  
2  OTHER BUSINESS  
No statements were made under this Agenda item.    
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