RESTRICTED  
  
IP/C/M/101/Add.1  
 
18 January 2022  
(22-0369) Page: 1/64 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
 
MINUTES OF MEETING  
HELD IN THE CENTRE WILLIAM RAPPARD ON 20 JULY 2021  
Chair: H.E. Ambassador Dagfinn Sørli  (Norway)  
Addendum  
The present document contains the statements made during the Council for TRIPS meeting held on 
20 July 2021.  
 
_______________  
 
Table of Contents  
 
1   PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS 
AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF 
COVID -19 ................................ ................................ ................................ ............  3 
2   DRAFT GENERAL COUNCIL DECLARATION ON THE TRIPS AGREEMENT AND 
PUBLIC HEALTH IN THE CIRCUMSTANCES OF A PANDEMIC  ..............................  45 
3   OTHER BUSINESS  ................................ ................................ .........................  63 
 
 
  IP/C/M/101/Add.1  
 
- 2 - 
 
  INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF THE COUNCIL FOR TRIPS 20 JULY 2021*  
 
Bolivia, Plurinational State of  
Waiver - COVID -19................................  7 
Brazil  
Waiver - COVID -19..............................  26 
Chad on behalf of the LDC Group  
EU Proposal for Draft GC Declaration  ..... 57 
Waiver - COVID -19................................  5 
China  
Waiver - COVID -19..............................  18 
Cuba 
Waiver - COVID -19..............................  18 
European Union  
EU Proposal for Draft GC Declaration  ...  45, 
59, 62  
Waiver - COVID -19................................  8 
India 
EU Proposal for Draft GC Declaration  ..... 59 
Waiver - COVID -19..............................  32 
Indonesia  
Waiver - COVID -19..............................  27 
Jamaica on behalf of the OACP Group  
Waiver - COVID -19................................  8 
Japan  
Waiver - COVID -19..............................  28 
Korea, Republic of  
Waiver - COVID -19..............................  29 
Maldives  
Waiver - COVID -19................................  7 
New Zealand  
Waiver - COVID -19..............................  30 
Pakistan  Waiver - COVID -19 ...............................  7 
Paraguay  
EU Proposal for Draft GC Declaration  ..... 57 
Waiver - COVID -19 .............................  29 
Saudi Arabia, Kingdom of  
Waiver - COVID -19 .............................  28 
Singapore  
EU Proposal for Draft GC Declaration  ..... 57 
Waiver - COVID -19 .............................  30 
South Africa  
EU Proposal for Draft GC Declaration  ..... 57 
Waiver - COVID -19 ...............................  3 
Switzerland  
EU Proposal for Draft GC Declaration  ..... 56 
Waiver - COVID -19 .............................  19 
Chinese Taipei  
Waiver - COVID -19 .............................  28 
Tanzania on behalf of the African Group  
Waiver - COVID -19 ...............................  6 
Turkey 
EU Proposal for Draft GC Declaration  ..... 57 
Waiver - COVID -19 .............................  31 
United Kingdom  
Waiver - COVID -19 .............................  17 
United States of America  
Waiver - COVID -19 .............................  31 
Venezuela, Bolivarian Republic of  
Waiver - COVID -19 .............................  30 
World Intellectual Property Organization  
Other Business  ................................ ... 63 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_______________  
* 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 presentation.  
  IP/C/M/101/Add.1  
 
- 3 - 
 
   
1  PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR 
THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID -19 
1.1  South Africa  
1.  I would like to thank you for the transparency report that you delivered just a few minutes ago. 
I think this is very much in line with the activities and the processes that were carried out during 
this period and certainly the references to the meetings o f 30 June, 6 July, 14 July and to 20 July , 
the formal meeting. We would also just like to stress that the arrangement that you referred to in 
terms of small group meetings which were convened on the 22 , 24 and 28 June and also 9 July, 
enabled us to have di scussions on various proposals presented. I think, as you have already pointed 
out, going forward it would be useful, beyond this period, to revisit some of the issues that we ha ve 
discussed including those around product and IP scope with respect to vacci nes and diagnostics and 
therapeutics, as well as trade secrets and technology transfer, including the treatment of regulatory 
data under Article 39.3. With regard to your draft oral status report, which has now been adopted, 
my delegation believes that it is an objective assessment of the process up to this point. We would 
like to thank Members for their constructive engagement in the small group process, both on 19 and 
20 July , in trying to finalise and clear some of the language that you have just read ou t. This is a 
testament to the type of compromise that we can achieve, as Members, when we are united in the 
goals that we try to achieve and from this perspective . I think it bodes well for our further 
discussions.  
2.  Allow me to make  a few comments in respe ct of our deliberations, given the fact that this is a 
formal meeting, and so for the record we would like to raise some issues. The co -sponsors have 
argued that the TRIPS waiver is a necessary, targeted and a time -bound proportionate measure 
directed at a ddressing intellectual property rights, in so far as they represent barriers to access . 
Passing this waiver will allow companies to ramp up and cooperate on the production of COVID -19 
health products and to use health technologies without the fear of infri nging another 's IP rights and 
the attendant threat of litigation. Furthermore, passing this waiver will also act as an important 
political, moral and economic lever towards encouraging solutions and get global equitable access 
to COVID -19 health products a nd technologies including vaccines, therapeutics and diagnostics.  
3.  The urgency of passing this waiver has not abated. We are now very close to 4.1  million fatalities, 
as of 19 July, and as we previously indicated, many jurisdictions are now entering a thir d wave with 
drastic increases of infections and mortalities due to new variants. The W orld Health Organization 
(WHO)  has also confirmed globally that cases, and death s have increased by 10 % and 3% 
respectively the previous week, and this is also the case f or five out of the six WHO regions, while 
the delta variant is now in 111 countries. We also observe that 76% of vaccinations have taken place 
in only ten countries, with 1.4 % in Africa, 9.6% in Asia, and in the European Union we see 42.6%, 
the U nited Kingdom  is at 53%, the U nited States is at 48.2% , and Switzerland is at 43%. This puts 
things into stark perspective, given the fact that only 13% of the world 's population is fully 
vaccinated, and this leaves much room for varian ts to emerge and this puts lower income countries 
at greater risk.  
4.  In the last nine months, the waiver proposal has been discussed extensively, and co -sponsors 
have responded to questions and requests from WTO Members, including the E uropean Union. We 
have noted recently that the European parliament has approved a resolution calling for support of a 
pro-active, constructive and text -based negotiations for a temporary waiver at this Organization. 
We also would have seen in the previous  week, the waiver gett ing support from at least 100 IP 
academics in an open letter which was addressed to relevant organizations. We have to also realize 
that intellectual property rights are not absolute, they are granted and recognised under a condition 
that they serve the pu blic interest, and right now, it is in the global public interest to provide access 
to vaccines, therapeutics, diagnostics and other technologies that will assist us to defeat the scourge 
of COVID -19. This is a global, not a local pandemic, and we will hav e to keep this in mind as we see 
viruses spreading and the emergence of new variants.  
5.  Let me come back to some of the points that we would have raised in some of the meetings. We 
had an opportunity to have in -depth discussions on various aspects of the wa iver proposal, including 
on the product scope of the waiver. We have explained that the waiver covers so -called health 
products and technologies and in these discussions we pointed to the fact that these terms are used 
in many organizations including in th e terminology that the WHO uses . For instance , the term health IP/C/M/101/Add.1  
 
- 4 - 
 
  product is inspired by the WHO  Resolution on Improving Transparency of Markets for Vaccines, 
Medicines and Other Health -Related Products, which also include medicines, vaccines, medical 
devices  as well as diagnostics and other assistive products which include both cell and gene -based 
therapies and other health technologies. Furthermore, we have emphasised the fact that testing is 
critical to detect cases and to investigate clusters of infections  and certainly also to ascertain whether 
a particular approach to disease management is appropriate and successful. So it has become 
increasingly clear that there is also a need to expand genomic surveillance and testing for new 
COVID -19 variants , both to identify those variants of concern, but also to start to build vaccines and 
therapeutics that can prevent or treat infections. Having an arsenal of complementary means to 
address COVID -19 is both necessary and practical and certainly we see that this type of approach is 
also supported by some of the global approaches. If we look at the WHO 's list of priority medical 
devices for COVID -19, it describes a list of medical devices and equipment that would be needed to 
address COVID -19, and these include devices such as pulse oximeters, equipment for medical 
imaging, oxygen concentrators , and also includes specialised medical and surgical masks.  
6.  The waiver proposal does not only deal with finished products, but it also covers so -called 
intermediate products, whic h cover materials, all their components, the methods and means of 
production. IP protection can prevent the supply of raw materials, components, machines and 
equipment, part of those machines and processes of production. So, for instance, we have recalled 
that raw materials are active and inactive ingredients of drug  substances that are used in the 
formulation of therapeutics or vaccines , and reagents as i n the case of diagnostics for the detection 
and screening of diseases, can all be subject to IP protection , which could make it much more difficult 
to access these particular products. We have pointed these out, and I will not repeat them , in our 
landscape document IP/C/W/670 . We will also note, as an update, that the WHO has recently 
authorised tocilizumab and sarilumab for patients w ith severe, or critical COVID -19 infection and 
both these are highly priced and limited in supply in developing countries . These are  subject to very 
high pricing , and as a result they will remain inaccessible resulting from intellectual property 
protection . 
7.  We have also discussed, as we have indicated, the IP scope  – and as we indicated  – copyright, 
industrial designs, patents and protection of undisclosed information are all categories included in 
the waiver proposal. These categories of intellectual prope rty rights are relevant, not only to the 
production but also to the supply and access to COVID -19 health products and technologies. 
Co-proponents have made several submissions to highlight  the relevance of addressing existing and 
potential IP issues in the  area covered by these particular IP rights. The COVID -19 landscape is 
rapidly changing, and we have seen that there is an under -supply currently in respect of vaccine 
demand, we have seen that producers have estimated  that there would be a demand between ten 
to 14 billion doses. We have now seen just over 3.4 billion doses having been produced. Now of 
course, this situation is also subject to additional doses, so -called booster doses , will be needed. We 
have also seen jurisdictions starting to vaccinate ch ildren. All of this puts additional stress on supply 
and as a result we can expect supply shortages to continue . We have also seen that , in the absence 
of vaccines, we may want to ramp up production of diagnostics treatments, oxygen, personal 
protective eq uipment , in order to save lives.  
8.  We have also discussed the fact that the IP issues which we are faced with are complex in nature, 
and as a result , the waiver proposal is not just limited on patents. The revised text that we have 
discussed during the  previous month or so also includes other types of IPRs which are essentially 
directed to ramp up production. We have also looked at issues around trade secrets. We, as 
co-sponsors, believe that lifting trade secret protection is essential for expanding and div ersifying 
global protection . For instance, by waiving trade secret protection we can start to share regulatory 
dossiers with potential manufacturers, and this would essentially enable existing capacity to be 
increased. Co -sponsors have already set out this  particular dimension in document IP/C/W/673 . 
9.  We have also clarified the issue of duration and we have indicated that since the SARS -CoV-2 is 
a new virus, there are still  many uncertainties that can affect , how the disease evolves. In order to 
tailor the duration of the waiver to the prevailing circumstances and the uncertainties attached 
thereto, the co -sponsors have specified a period of duration of three years from the date of decision 
and we have indicat ed that the waiver would not automatically terminate after three years, but only 
upon a review of the General Council. We have not specified any specific criteria, this is difficult to 
do, given the current complexity and novelty of this virus . Nonetheless , we do know that tailoring 
the period of a minimum of three years does accommodate at least some perspectives where it is 
assessed that some developing countries may have to wait three to seven years to access vaccines, IP/C/M/101/Add.1  
 
- 5 - 
 
  so this takes these factors into ac count. We have also explained the relationship between the 
mechanisms to determinate the waiver in paragraph 2 and the early review by the General Council 
in paragraph 5. These two elements do not contradict each other, they can also be found in other 
waivers that would have been issued, for example, the waiver in document WT/L/971 with respect 
to the waiver of Article 70.8 and Article 70.9 of the TRIPS Agreement for LDCs . It can also be found 
in decision of 30 August 2003 which waived Article 31 .f and 31.h of the TRIPS  Agreement.  
10.  On the implementation, we have also emphasised that we have a diversity of legal systems, 
and hence national implementation would have to take account of a country 's political and 
constitutional arrangements. So, similarly, the pa rameters for implementation of the waiver would 
be subject to national decision s. We have indicated that there is a difference of approach between 
those jurisdictions that apply a so -called mon ist approach, and those that apply dualist approach. 
In the mon ist system international law applies directly in the national system, whereas in a dualist 
system, countries would still have to implement those particular provisions into their national laws, 
but we have seen that during this time, countries have been abl e to take decisions and to amend 
laws based either on state of the emergency that would have been declared, or disaster management 
legislation or the amendment of existing laws, so that it should be no different for implementing a 
waiver when it is passed.  
11.  Let me conclude by saying that we believe, as co -sponsors, that the previous cycle of small 
group meetings and informal meetings of the TRIPS Council was very useful and informative. We 
believe a similar process can be convened after the summer break to t ake up issues that we have 
not been able to complete, or to get back to topics that require more attention . Similarly, let me 
take this opportunity to thank you Chair for your stewardship and leadership in this process, and for 
your continued support for a n inclusive and transparent process.  
1.2  Chad on behalf of  the LDC Group  
12.  I would like to congratulate South Africa on the presentation of the revised document and the 
proposal that was just voiced, reg arding the small group work that was carried out . This is very 
important when it comes to bringing our discussions and negotiations forward. We support this 
approach whole -heartedly. My delegation, on behalf of the LDC Group , would like to recall that 
South  Africa and India have submitted , already nine months ago, in October  2020, a proposal  for a 
waiver for certain provisions of the TRIPS Agreement for the prevention and treatment and 
containment of COVID -19. It is a joint pr oposal IP/C/W/669  and the Group  has co-sponsored this, 
calling for a temporary waiver. The existing flexibilities that we find within the framework of the 
TRIPS Agreement at present are not sufficient to face the very swift evolution of COVID -19. They 
are limited to pharmaceutical products a nd were not designed to be able to rise to the unique 
challenge of such a widespread, far -reaching pandemic. If you look at the ventilators, respirators 
that are essential to save lives, lives that are threatened by the unfolding pandemic . These are not 
covered by the existing flexibilities. Moreover,  the demands, the requirements of the compulsory 
licensing regime are complex, cumbersome, onerous and slow, and they are not able to provide for 
a swift and efficient response in response to the urgency of the  challenge that is currently under 
way. That is the reason why, as we see it, the temporary waiver which is being proposed is a very 
relevant proposal.  
13.  When it comes to scope and application, products and technologies such as test kits, masks, 
therapeutics , vaccines, respirators and components , such as the valves which are used in the 
manufacturing of the respirators, are very important, and are crucial when it comes to a swift and 
efficient response . These technology products are protected by four types of  intellectual property 
rights that spring from the four sections of the TRIPS Agreement. Of course,  there are patents, 
authors rights, copyrights, industrial designs, designs and the protection of undisclosed information. 
There is coherence of these variou s elements , when it comes to products and technologies that have 
been protected. This proposal was given a momentum when the trade representative Catherine Tai 
of the U nited States of America  declared on 5 May 2021, that her delegation was favourable for a 
waiver for COVID -19 vaccines and that she would commit herself in the text -based negotiations to 
this end. At the same time , the co -author of the proposal, on 21  May 2021 also submitted a re vised 
text in  document  IP/C/W/669/Rev.1  in order to reflect the comments that had been voiced, to 
maintain the momentum under way , and engage in text -based negotiations. In the meeting on 
8 June 2021, the TRIPS Council examined the revised proposal and decided to launch a negotia tion 
process on the text, and we would like , Chair, to thank you for having held a number of meetings IP/C/M/101/Add.1  
 
- 6 - 
 
  and for having seen to it that the deliberations of the Members of the Council could be brought 
forward very quickly.  
14.  There has been progress, it is true , but there are still some divergences of views at this time, 
and this also includes the approach to be used when it comes to responding to the pandemic. We 
would urge the Members of this Council to commit themselves in a more intense fashion, commit 
thems elves to this process, bring it forward so that you , Chair, can also continue facilitating the work 
for a very swift conclusion of the work of this process , to bring this home. We are discussing this 
here in the Council . The discussions here have given ris e to broad -based and in -depth attention, so 
we are all sharing in the destiny. In the new wave of COVID caused by the Delta variant, even 
countries that have vaccinated high number of their population  are seeing their health situation 
worsen and the outloo k for economic recovery look ing remote at this time. We have to provide the 
international  community with a respons e that is very strong, very swift and very efficient. In the 
interests of our populations, populations which are mainly living in countries wh ich are the poorest 
and which, at the same time, must face up to the same scourge with very limited resources, which 
must be strengthened. It is a source of encouragement  that, in less than nine months after the 
beginning of the COVID -19 pandemic, the  scientific community  was able to design vaccines . It is 
difficult to accept that 18 months after the start of this pandemic , and nine months after the 
submission of this proposal , we still are not able to see to it that these discoveries are accessible to 
all, and still not provide a response that can rise to this public health challenge. Therefore,  what we 
are focusing on here is the relevance of the multilateral trading system. T his is what is at stake here, 
and this is in the interest of the WTO as well.   
15.  Finally,  we would like to thank you for your report that has just been adopted. Indeed,  we 
received  the initial preliminary version in  document  JOB/IP/47, even though these docu ments are 
not yet available in French, we work in both English and French in the LDC Group. The LDC Group 
would, at this time, like to thank you for the very fact -based approach you adopted when it comes 
to the substance  and the content of the report . We once again would like to voice our concern and 
our regrets regarding the fact that the delays that are encountered because of the discussions in the 
WTO will expand the urgency of our needs, which concern all corners of the earth.  
1.3  Tanzania on behalf of the  African Group  
16.  First and foremost, the African Group would like to express its gratitude to you Chair for having 
guided Members well while steering the work of the Council on this subject m atter. The African  Group 
welcomes the Council 's draft report to the General Council. We found the report reflecting the 
progress and the state of play. Since May 2021, we have had an opportunity to exchange views i n 
various meetings and configurations, rig ht after the start of the text -based process.  The 
African  Group has frequently expressed in the Council meetings , that COVID -19 is our biggest 
challenge , which we must address. It is disrupting the long and hard-earned social economic 
progress built over the decades.  
17.  African countries , like many other developing countries , are also grappling to contain the 
pandemic in order to lessen its effect. Recently, it has been reported by W orld Health Organization  
that the  African continent has recorded the highest number of new COVID -19 cases. The third wave 
of COVID -19 seems to be a more deadly and contagious variant.  However, irrespective of the 
resurgence of infections, the vaccination rate in Africa is still not satisf actory. For example, until the 
second week of July 2021, only a total of 50 million doses were administered in Africa, accounting 
for only 1.6% of doses globally. It has been further reported that only 16 million people in Africa are 
now fully vaccinated, accounting  for less than 2%, leaving nearly 98% of people vulnerable to 
COVID-19 infection.  
18.  COVID -19 cases in Africa now have reached 5.7 million and 146,000 people have died, up to 
the 14 July report. The situation is worryin g. To prevent and contain the  pandemic from worsening 
further, we need a strong international commitment for collective efforts and collaboration for 
meaningful solutions. The African Group believes the proposed waiver will significantly contribute to 
the scaling up of production and supply of vaccines, diagnostic kits and therapeutics globally.  The 
African Group has since been advocating for a swift adoption of the waiver to save the lives of many 
people vanishing due to COVID -19 pandemic. We still hope that Members will exercise more  
flexibility for adoption of the waiver soon. The African Group is ready to continue with engagement 
on the waiver under any arrangement and configuration for its conclusion.  IP/C/M/101/Add.1  
 
- 7 - 
 
  1.4  Maldives   
19.  As we know , COVID -19 is continuing to spread around the world, and many countries seem to 
be entering yet another wave. According to the news, the new Delta variant has been confirmed in 
more than 100 countries, with the possibility of increasing in the upcoming weeks. Tren ds show that 
the pandemic is not over yet, and we have more waves coming our way. As a small  island state, the 
Maldives depends on a fair and equitable distribution and supply of vaccines to fight this disease. 
More than a year into the pandemic, we are grateful to have vaccines as well as seeing the 
willingness from countries to donate vaccines through dose -sharing and COVAX. Though this has 
helped many countries, it is not enough. Too many people in the least  develop ed countries, as well 
as other parts of the world, are still waiting for either their first or second dose of vaccines to protect 
them from COVID -19. Furthermore, these countries also need more supplies and therapeutics to 
address the needs of the increasing number of patients.  
20.  To meet the g lobal vaccine requirement, it is vital to address the intellectual property 
challenges. We believe that an exceptional waiver will assist in equitable and timely access to 
affordable medical products including vaccines and medicines for all , and most impor tantly so we 
can scale up the production of vaccines across the globe and have equitable and timely access.  
Maldives,  as a co -sponsor of the proposed temporary waiver from certain provisions of the 
TRIPS  Agreement , welcomes the progress of text -based negot iations. We are hopeful that all 
WTO Members will work together in global solidarity and agree on moving forward on this matter, 
with the aim of providing universal access to COVID -19 vaccines, treatments, testing and other 
products to control the pandemic , and to reach the Sustainable Development Goals in a timely 
manner.  
21.  In this regard, I would like to echo previous speakers in calling for accelerated efforts to achieve 
a positive, substantive and constructive outcome with regard to the proposed waiver i n the interest 
of time.  
1.5  Bolivia, Plurinational State of  
22.  First and foremost,  we would like to thank the Chair  for the efforts you have deployed to arrive 
at a consensus to move ahead on the negotiat ions. However , we see that the advance is still very 
slow. We have seen in recent weeks that COVID -19 victims ha ve increased and the delta variant is 
spreading. We see all too often that there is limited capacity for production , as well . There has been 
intensive work by the proponents and co -sponsors to try and bring this forward, and this text has 
more clarity in terms of the scope and objectives , and prevention is the main approach used here. 
Notwithstanding  all of this, this proposal is broken down very often into questions and answers and 
proposals , and all too often it has been very difficult to arrive at tangible concrete results to save 
lives. We would like to thank all for the various proposals that hav e been made . We stand ready to 
discuss these, we will have to see how the proposal of the E uropean Union will make it possible to 
rise to the challenge.  
23.  We are in the process of notification,  which was started in May . We have made progress, but 
we have  not seen any encouraging result and we are still seeing a lot of the deficiencies of the 
system. We think that public health is extremely important, and this shows that the mechanism that 
had been built into the organization is not effective , and we do  not have a true political will. 
Intellectual property is the barrier, not the only barrier to ramping up production , but it is one of the 
most important ones. We have to open up pathways to increase production , to call on all the 
Members to accelerate their constructive discussion to arrive at a consensus before MC 12 starting 
in November. We would like to thank you for the report, Chair, which we see as very balanced and 
we see as a good way forward.  
1.6  Pakistan  
24.  We wish to thank you for your work and for your continued efforts in advancing the work of this 
Council . Thank you as well for your status report on the process held so far. We wish to al ign 
ourselves with the statement made by South Africa on behalf of the co -sponsors. Th e pandemic is 
far from over and new variants are emerging and spreading quickly. Not all countries have equitable 
access to medicines and therapeutics for COVID -19. The statistics provided by W orld Health 
Organization  describe a large d ivide between vaccine supply and requirements in poor countries. IP/C/M/101/Add.1  
 
- 8 - 
 
  The data also show the wide gap  in health therapeutics. The co -sponsors of the waiver have provided 
comprehensive answers to all concerns raised by Members. All Members have agreed to enter 
text-based nego tiations in good faith. We therefore call on Members to meaningfully engage on the 
actual text -based elements of the waiver proposal and support it , as time is of the essence here. 
Through our collective efforts we can demonstrate the relevance of the WTO to provide a global 
response to address this pandemic.  
1.7  Jamaica  on behalf of the OACP Group   
25.  The ACP Group supports the draft oral status report to be delivered at the upcoming 
General  Council. As would have been requested by Members, the report gives a factual and succinct 
status update on the developments relating to the ongoing discussions in the Council. The report is 
also consistent with the format of previous reports delivered in the Genera l Council on this matter. 
The ACP Group wishes to express our commendation for your concerted efforts and dedication to 
this process. Over the past weeks, under your leadership, the small groups and informal open -ended 
meetings have facilitated deeper disc ussions and provided the opportunity for continued constructive 
engagement s amongst WTO Members. It is only through such constructive engagements that 
significant progress will be achieved.  
26.  The ACP Group remains concerned the rate of vaccination for many members of our Group 
continues to be very slow. The Group is also concerned that some countries are currently 
experiencing another wave of the virus, and some are dealing with the impacts of new strains and 
variants. If members of the ACP Group and other d eveloping countries are to experience herd 
immunity and be in a position to start rebuilding their economies, there has to be an increase in the 
rate of vaccination. The discussions within the TRIPS Council are of critical importance in finding an 
appropri ate response aimed at increasing access to vaccines to combat the spread of the virus.  
27.  It is evident that all Members within the WTO agree that the Organization has a role to play in 
the response to this pandemic, but divergences remain on the best approa ch. The ACP Group is 
however encouraged by the robust discussions and exchanges on the waiver proposal , particularly 
as it relates to issues concerning scope, duration and implementation. Through these exchanges, 
Members have been able to have a better und erstanding of the various concerns of some delegations 
and they will serve as the basis for further discussions. The ACP Group again takes this opportunity 
to encourage all WTO Members to continue engaging in the various configurations with the aim of 
arriving at landing zones on this issue.  
1.8  European Union  
28.  Thank you for your continued efforts on advancing the discussion on this important topic and 
on your report from our discussions.  We fully support this report , both the factual and objective 
reflection of the complex situation that we are dealing with in this debate. We are also ready to 
continue the debate  after the summer break in a similar manner as we have organised our exchanges 
in the last couple of weeks . The EU continues to be committed to achieving our common goal to 
continue ramping up production to share COVID -19 vaccines and medicines more widely and faster , 
and to ensure equitable access to these products  for low - and middle -income countries. We already 
see incredible progress in the total global production of COVID -19 vaccines. According to Airfinity , a 
billion doses were produced by 12 April, another billion were produced by 26 May and the third billion 
by 22 June. It is clear , that the producti on is accelerating,  and it is therefore realistic to expect that 
some ten billion doses will be produced by the end of 2021. For comparison, the total global output 
of all vaccines was only five billion doses.  
29.  But this is not enough . We need to continue o ur efforts to further ramp up production and to 
ensure equitable distribution of COVID -19 vaccines and medicines. In this context , we must focus 
our efforts where they can deliver best results in the shortest possible time. Setting up and ramping 
up the pr oduction of vaccines is a highly  complex process which requires adequate facilities, trained 
personnel, raw materials and other inputs. It is a complex issue that cannot be solved by one simple 
solution. The overall strategy is not only within the WTO eith er. The W orld Health Organization , 
other organizations, institutions and initiatives  such as the COVAX Facility are working on these 
solutions . In the WTO , we are collectively looking at possible measures to support the increased 
production of COVID -19 vac cines and medicines to the extent it is possible in the context of the WTO 
framework.  IP/C/M/101/Add.1  
 
- 9 - 
 
  30.  The intensive discussions in this Council, as well as in other fora have demonstrated that limited 
manufacturing capacity and restricted access  to raw materials and othe r inputs  are the main 
bottlenecks as regards the production and distribution  of COVID -19 vaccines. In addition, having 
the required know -how is key due to the complexity  of the production process of these vaccines. 
Information collected by the WTO on the b ottlenecks regarding critical COVI D-19 products indicate 
that one common theme emerges and that is that essential goods and inputs need to flow efficiently 
and expeditiously to support the rapid scaling up of COVID -19 production  capacity worldwide. The 
delay of a single component may significantly slow down or even halt vaccine production given the 
globally integrated supply chains that underpin COVI D-19 vaccine manufacturing. This is where we 
should focus our efforts because these are the real -life problem s and in -points when it comes to the 
production of COVID -19 vaccines and medicines. And this is where trade -related measures, if agreed 
swiftly, could make a real difference.  
31.  In order to deal with these bottlenecks with the use of trade -related measures at our disposal 
at the WTO, the  EU believes a multi -pronged approach is needed. We need to look into export 
restrictions, minimize barriers to trade and put forward trade facilitation measures. The 
European  Union, together with other  Members had been at the forefront of these efforts fo r a number 
of months in the context of the Trade and Health Ini tiative by the Ottawa  Group. This Initiative 
provides pragmatic proposals on these issues  as well as on enhancing partnerships between 
innovative companies and manufacturers with adequate produ ction capacity. We would like all WTO 
Members to join this initiative. In addition, building on the idea also presented in the trade and 
Health Initiative on 4 June the European Union submitted to the WTO General Council a 
communication on urgent trade pol icy responses to the COVID -19 crisis, document WT/GC/231, 
calling for a multilateral and comprehensive response by trade -related measures  to the COVID -19 
pandemic.  
32.  Given the nature of the identified bottlenecks and particularly the fact that they are not related 
to intellectual property, we do not believe that the full suspension of the TRIPS Agreement is the 
appropriate and effective measure to increase production and enhance the global, equitable and 
affordable access to COVID -19 vaccines and medicines. It is a false path, not only it will not increase 
production of vaccines and medicines as it will not address any of the existing bottlenecks, but also 
it will have counter -productive effects on our common efforts to enhance access to COVID -19 
vaccines and  medicines. In addition,  it may have harmful effects going forward, when it comes to 
fighting future pandemics and overall,  on the incentives for innovation . Vaccine research and 
production is generally not profitable and IP incentives are key to maintain ing research in this area , 
in particular for the benefit for many lower -income countries where infectious  diseases  remain a 
significant problem.  We will not repeat today all the arguments that we have put forward on multiple 
occasions, and in that regard, w e ask the Secretariat to add all the EU statements made in informal 
TRIPS Council meetings to this statement, so that all these arguments are properly recorded.  
33.  Today we would like to recall the most important shortcomings of the proposed waiver. F irst of 
all, as already mentioned, the waiver focuses on intellectual property while the real bottlenecks lay 
elsewhere. In other words, the waiver has a wrong target . Second, it would operate against what 
should be our priority now, that is, to enhance transfer o f technology. As mentioned, we are dealing 
with a highly  complex manufacturing  process, there is no other way to go about this manufacturing 
than knowing the exact recipe. This is crucial to be able to produce vaccines that are both effective 
and safe. The  part of the recipe that is revealed in patent applications, which by the way have not 
even been published yet with regard to the relevant products, is far from sufficient to start a 
manufacturing process. A real collaboration  needs to take place between t he vaccine developer and 
the manufacturer. We have examples of multiple  such ongoing collaborations, exceeding anything 
we kn ow from the past. All these collaborations  are based on one and the same framework, the 
protection provided by intellectual propert y. This platform provides for guarantees , a safe 
framework, and in this way helps in building trust between various actors. It is clear what happens 
when this platform is taken away – the framework falls apart and the relationships built on trust are 
broke n.  
34.  The waiver proponents never answered the question as to how an action that undermines the 
existing collaborations,  and the transfer of technology can be at all beneficial under the current 
circumstances. We all agree that we need to enhance transfer of  technology to increase the 
manufacturing capacity for vaccines and medicines, also taking into account the preparedness for 
future pandemics . But this is a process that needs to be built on voluntary collaboration and trust, 
it is not by lifting intellectual property and inviting disclosures  of information , that would constitute IP/C/M/101/Add.1  
 
- 10 - 
 
  breaches under  agreements entered into between vaccine developers  and various manufacturers , 
that such collaboration and trust are built. This is the wrong and very short -sighted approach that 
will not bring any benefit but  introduce confusion and a lack of legal certainty. We need to create 
conditions that will invite the transfer of technology, strengthening manufacturing capacities and 
resilience of the health systems of lower - and middle -income  countries, creating conditions for 
investment, including via adequate regulatory frameworks , in order to attract the private  sector 
where their technology is crucial.  
35.  In that regard we would like to give an example of the Team  Europe Initiative, an integrated 
and comprehensive support package that will tackle barriers to manufacturing and access to health 
products and technolo gies in Africa from all angles.  This initiative encompasses three dimensions: 
supply side, demand side and enabling environment of the health system. On the supply side the 
initiative will incentivise and de -risk investment into local pharmaceutical and bi otech companies. 
The Team Europe Initiative  will support technology transfer and develop a number of regional 
manufacturing hubs in alignment with the African Union and the Africa Centre for Disease Control 
and Preventions which recently launched  the Partn erships for African Vaccine Manufacturing. On the 
demand side the Initiative will work with African leaders and communities to tackle the fragmentation 
of local markets and help consolidate demand, facilitate market integration and the use of locally 
produ ced goods. The Initiative  will substantially strengthen pharmaceutical and health systems , thus 
creating an enabling environment for sustainability. It will contribute to developing human resources 
by investing in skills and education, by increasing Africa  research capacities and by enhancing 
scientific cooperation between the two continents. This Initiative will also address the problem of 
falsified products and boost confidence in local goods by strengthening regulatory frameworks. The 
European Commission  is also willing to support digital solutions , for example , to trad ing vaccines 
and medicines across the supply chain. The Team Europe support and funding for vaccine production 
is also under way in a number of countries in Africa.  
36.  To improve the vaccine supply we are also working with industry to optimise the use of our 
existing capacity while building more capability. This will allow us to address the needs of EU citizens 
as well assist supply to third countries and low-and middle -income  economies. We ar e doing that 
through the Taskforce for Industrial Scale -up of COVID -19 vaccine production, set up in 
February  2021. The Taskforce, operating under Commission er Breton 's responsibility, ramps up 
production capacity for vaccines in Europe and acts as a one -stop-shop for manufacturers in need 
of support. The Taskforce work includes mapping European vaccine production capacities throughout 
the supply chain, identifying, addressing and eliminating production bottlenecks in terms of capacity 
and supply chain  issues, and promoting partnerships through matchmaking events for vaccine and 
therapeutics production.  
37.  The third shortcoming of the proposed waiver is the fact that it does not in any way specif y 
what measures Members will be permitted to introduce as a resul t of the waiver. It is the normal 
practice with waivers that certain provisions  are listed in order to allow specified measures. Here we 
are dealing with a situation where the TRIPS Agreement is lifted almost in its entirety and there is 
no clarif ication  as to what measures can be taken in what manner. This causes enormous risks that 
we have pointed to in the previous meetings, ranging from invalidation  of existing patents which 
could result in  the impossibility of restoring protection even after the waiv er expires , the denial of 
new patent applications which could result in product and processes losing the possibility of being 
patented in the future, invalidation of voluntary agreements licensing patents , and therefore a 
chilling effect on collaborations by removing incentives of the developers of the original products to 
provide know -how and technology to manufacturers of biosimilars and so on. In short,  a great legal 
uncertainty with potential ly long-lasting negative effects as regards production, distri bution and 
access to vaccines and medicines.  
38.  We are ready to continue to discuss , to present our arguments in more detail, but also given 
the important shortcomings of the waiver proposal , the EU made an alternative proposal to this 
Council, the objective  of which is to ensure that IP is an enabler for the use of the available and 
adequate manufacturing capacity as regards COVID -19 vaccines and medicines. We will say more 
about this proposal under the next agenda point and  would like to encourage further e ngagement 
of Members. We are looking forward to advancing on this proposal and finding a common ground 
that would allow us to ensure that IP plays an enabling role in enhancing access to COVID -19 
vaccines and medicines.  IP/C/M/101/Add.1  
 
- 11 - 
 
  European Union 's statement at the informal meeting held on 17 June 2021  
39.  The European Union would like to thank you for convening small -group consultations on the 
manner in which to take the text -based process forward. We have presented our position on the 
modalities of this process in the course of the small -group consultations. We would like to recall the 
main points and reiterate our position on the matter.  
40.  As stated at the previous  meeting of the TRIPS Council, the European Union is ready to 
constructively engage in the text -based su bstantive process to find a way forward in this discussion 
on the role of intellectual property in enhancing access to affordable COVID -19 vaccines and 
therapeutics , and to proceed with concrete and pragmatic short- and medium -term solutions to 
enhance uni versal access to COVID -19 vaccines and therapeutics at affordable prices.  
41.  This discussion is part of a comprehensive approach to the crisis presented by the 
European  Union in a communication on "Urgent trade policy responses to the COVID -19 crisis ", 
docum ent WT/GC/231, calling for a multilateral and comprehensive response by trade -related 
measures to the COVID -19 pandemic. We would like to emphasise that it is the view of the 
European  Union that only a multi -pronged approach addressing the identified bottl enecks such as 
limited manufacturing capacity and access to raw materials can bring about a real change.  
42.  We are ready to immediately start a discussion based on the proposal set out in our 
communication on "Urgent trade policy responses to the COVID -19 cri sis – intellectual property ", 
document IP/C/W/680 , submitted to this Council on 4 June, and intend to follow up in the coming 
days with a more elaborated text. We would like to thank you, Chair, for planning for a date for 
presenting our proposal.  
43.  At the same time, as mentioned at the previous  meeting, the EU is ready to continue discussing 
the revised waiver proposal though we are not convinced that the broad waiver proposed by a 
number of WTO Members is the right response to the pandemic.  
44.  This is  why the EU wants to include in this discussion our different and more targeted approach. 
We hope that we will be able to convince Members that our approach, including the components that 
will be addressed in the General Council, represents the best way to  respond to the crisis in the short 
term in an effective and pragmatic manner.  
45.  We would like to recall that our proposal is based on the discussions that we have had in this 
Council over the last couple of months. In the course of these discussions , we hav e been examining 
various ways in which intellectual property can help in enhancing access to affordable COVID -19 
vaccines and therapeutics. One of the results of these discussions is that a number of WTO Members 
identified aspects related to the use of com pulsory licensing that, in their view, limit the use of this 
tool. The EU proposal aims to address these aspects, provide more legal certainty and enhance the 
effectiveness of the compulsory licensing system.  
46.  We note that our proposal has been welcomed by a number of delegations as a constructive 
contribution to the ongoing discussion. The revised proposal on the waiver and the EU proposal 
represent different approaches to the problem of the availability of COVID -19 vaccines and 
therapeutics and are based o n different premises. We are of the opinion that it is key that Members 
can benefit from having a possibility of discussing these two approaches alongside one another and 
we request that our proposal is treated and discussed on an equal footing with the re vised proposal 
on the waiver.  
47.  We also note that in the previous  meeting the Chair recognised that there are still divergent 
views both on the underlying assumptions of the revised waiver proposal and on the specifics. There 
is no agreement among Members th at the waiver can achieve our common goal, i.e. enhancing 
access to affordable COVID -19 vaccines and therapeutics.  
48.  In order to take account of all these considerations, to provide for an opportunity to discuss all 
pertinent issues and to facilitate the exa mination of both the revised proposal on the waiver and the 
EU proposal, we request a theme -based approach for our process that we would like to reiterate 
here for consideration of all Members. This approach would be based around the following themes:  IP/C/M/101/Add.1  
 
- 12 - 
 
  Scope – under which we would examine  
a. Provisions of the TRIPS Agreement covered:  
i. which provisions are affected and why – this for us is the first priority for setting the 
basis for our discussion; and  
ii. we would also compare waiving entire sections of the TRIPS A greement to the targeted 
approach proposed by the EU.  
Effects short -, medium - and long -term – under which we would examine effects of each proposal  
a. on vaccine/medicine production;  
b. on transfer of technology;  
c. on legal certainty as to which IP rights continue  to apply - effects on the current and future 
cross-licensing; and  
d. on ongoing partnerships and concluded agreements.  
Products – under which we would discuss the products covered by each proposal including issues 
such as  
a. How the link with COVID is determin ed; and  
b. Definition of a pharmaceutical product in the Annex to the TRIPS Agreement.  
Duration – under which we would examine for each proposal  
a. End date  
b. Restoration, where applicable, (by type of IP right)  
c. Compatibility with the WTO rules  
Implementation in national law – under which we would discuss  
a. Which measures are needed domestically to implement each of the proposals  
b. How will these measures relate to the current legislation on compulsory licensing?  
c. Effects on procedures of national IP  offices  
Links of the proposals with other international obligations  
49.  Of course, the sub -points are not exhaustive but are meant to indicate the aspects that we find 
the most pertinent for our discussion.  
50.  As regards the proposed calendar of meetings, we ag ree to the proposed schedule of weekly 
TRIPS Council informal sessions. We are also ready to discuss the use of small groups and will also 
engage bilaterally with Members to present our proposal.  
51.  As regards the proposed meetings in a small  group starting next week, we would have preferred 
it to be scheduled after our proposal is presented on 24 June and ask for this request to be 
considered, but should that not be possible, we request that our proposal is discussed in this small 
group meeting on an equal f ooting with the revised proposal on the waiver.  
52.  We would like to thank you, Chair, for your efforts to find a pragmatic manner in which to 
organise the process before us and we remain committed to constructively engaging with all 
Members to find a pragmat ic, inclusive and effective way forward.  IP/C/M/101/Add.1  
 
- 13 - 
 
  European Union 's statement at the informal meeting held on 6 July 2021  
53.  Chair, thank you for your efforts in advancing our discussions. We would also like to welcome 
Deputy -Director General Gonzalez and thank her for devoting her time and attention to this 
important matter. Enhancing equitable access to COVID -19 vaccines is the priority for the European 
Union and this is our objective in this discussion.  
54.  The European Union appreciated the possibility provided by th e small group meeting to explain 
in more detail the EU proposal and to discuss the revised waiver proposal. We would like to thank 
all the delegations that engaged in the discussions and hope that the input provided by the 
European  Union has been helpful i n taking this discussion forward.  
55.  The European Union remains fully committed to this process and to finding the best way forward 
to ensure that the intellectual property system plays an enabling role in the context of deploying 
existing capacity or creatin g new capacity for the production of COVID -19 vaccines and medicines 
while keeping intact the necessary incentives that the intellectual property system provides to 
researchers of new vaccines and medicines to fight against the current and future variants of the 
virus that causes COVID -19. We will continue to engage constructively and are open to discuss ing 
all approaches that contribute to enhancing access to affordable COVID -19 vaccines and medicines 
and can bring results in an urgent manner.  
56.  Even though the discussions on the duration and implementation and especially on the 
implementation have not been finalised in our meeting of yesterday, the European Union would like 
to use this opportunity to recall some of the most pertinent, in our view, points tha t have been raised 
and which, in our view, deserve further discussion at the next small -group meeting.  
57.  Starting with the EU proposal for a General Council Declaration on the TRIPS Agreement and 
Public Health in the Circumstances of a Pandemic, document IP/C/W/681 , the EU has provided 
explana tions on the duration and implementation of the EU proposal:  
a. As regards the duration, the EU proposal clarifies certain requirements of the compulsory 
licensing system for the circumstances of a pandemic, therefore these clarifications will 
apply not only  in the times of this pandemic but also in other such cases – as we said 
previously, this is of course without prejudice to other situations of 'national or extreme 
urgency ' that Members may decide on in accordance with the TRIPS Agreement . 
b. As regards the implementation, we would like to recall that we believe that one of the 
advantages of the EU proposal is that it can be adopted swiftly; the proposal clarifies 
certain provisions in Articles 31 and 31 bis and the Annex of the TRIPS Agreement. As we 
do not a im to amend these articles, we will not require lengthy debates and procedures. 
The scope of these provisions will remain the same but agreeing on a declaration will 
remove legal uncertainty about their application and support those WTO Members who 
wish to  use them. No implementation at national level will be required. This is how we can 
advance quickly and have immediate results on the ground.  
On the duration aspect of the revised proposal on the waiver  
58.  We believe that any discussion about the duration of a measure needs to be preceded by a 
reflection on the impacts on the various stakeholders affected by the measure. In that respect, the 
discussion around the duration of the measures to enhance equitable access to COVID -19 vaccines 
and medicine s also needs to be preceded by a reflection on the impacts in the short -, mid - and 
long-term, both in terms of benefits and negative impacts.  
59.  First, we need to make sure that the measure proposed is effective to achieve our common 
objective. This is a con dition to accept any measure that could have negative impacts on various 
stakeholders or on incentives to innovate and research as well as on public health.  
60.  Second, only if the measure is effective, we need to make sure that the negative impacts of the 
measure are as limited as possible, both in terms of scope and duration, and that the benefits offset 
these negative impacts.  IP/C/M/101/Add.1  
 
- 14 - 
 
  61.  In the case of the EU proposal, we remain convinced that the clarification on the use of 
compulsory licensing under the TRIPS Agreeme nt is effective to enhance equitable access to 
COVID -19 vaccines and medicines, together with other trade -related measures that are part of the 
comprehensive approach that the EU has proposed. Moreover, the duration is limited to what is 
necessary ( "in the  circumstances of a pandemic ") in order to reduce the negative impacts of 
compulsory licensing on patent holders e.g. waiving the requirement to negotiate with the patent 
holder before issuing a compulsory licensing may result in missing opportunities of a greeing on 
voluntary licences – however this fast -track procedure is applied in the specific circumstances of a 
health emergency and not as norm, therefore the negative impacts of our proposal remain limited, 
as they keep intact the necessary incentives to  continue research and innovation on vaccines and 
medicines against COVID -19 and other diseases.  
62.  With respect to the waiver proposed in document IP/C/W/669/Rev.1 , we maintain our 
fundamental concerns about the lack of effectiveness of this measure to achieve our common goal 
of en hancing equitable access to COVID -19 vaccines and medicines. Moreover, we believe that a 
discussion on the duration of the potential waiver can only take place once the effects of the proposal 
in the short -, mid- and long -term are analysed and discussed, i n particular:  
a. the impacts on transfer of technology required to produce the existing vaccines against 
COVID -19; 
b. the impacts on research and innovation of new vaccines and medicines against the existing 
and future variants of COVID -19 or against future pand emics; and  
c. the impacts on public health (especially in the mid - and long -term if the incentives to 
innovation are removed).  
63.  We have had some exchanges on some of these issues yesterday but not in an exhaustive 
manner and we think it is important that we co ntinue discussing these topics in the next session of 
the small -group meeting.  
64.  For example, the proponents of the waiver indicated that the waiver would enhance 
collaborations among vaccine developers and manufacturers and therefore would also enhance 
technology transfer. We question how the measure that takes away the platform on which 
collaboration and technology transfer can occur and introduces legal uncertainty as to the licensing 
agreements could have this effect. We would like to ask the proponents o f the waiver to elaborate 
on this aspect of their proposal. Transfer of technology, as we know, is absolutely essential in our 
efforts to ramp up production and therefore understanding how exactly in practice the waiver would 
affect this transfer is key fo r assessing the effectiveness of the measure. We understand that this 
and similar questions will be discussed in the next sessions of the small -group meetings.  
65.  Without prejudice to the discussion on the effects of the measure and the links with the duratio n, 
we also note that the provision on the duration of the waiver is proposed in a manner that does not 
indicate the date on which the waiver would be terminated. Following three years and subject to 
exceptional circumstances ceasing to exist, the General C ouncil would determine the date of 
termination of the waiver. As explained at yesterday 's meeting by the waiver proponents, the 
General Council may or may not decide on the termination in such circumstances. This would indicate 
that the waiver could stay i n force for an undefined period of time after the exceptional 
circumstances, which are presented as those justifying the waiver, cease to exist.  
On the implementation of the revised waiver proposal  
66.  The proposed waiver does not contain any indications of the mechanisms of implementation at 
the national level, in contrast with , for instance,  the provisions of the Annex to the TRIPS Agreement 
applying Art. 31 bis.  
67.  The proposed waiver is currently being discussed as though it would be directly applicable to all 
Members and produce immediate effects. The assumption seems to be that if the waiver is adopted 
and Members avail themselves of it, the relevant IP rights will be suspended, without any further 
action being required. But this is not the c ase. Each waiver of the provisions of the TRIPS  Agreement 
requires national implementation in national systems which are aligned with the TRIPS Agreement 
requirements – which is the case for most of our systems. The broader and less targeted the waiver, IP/C/M/101/Add.1  
 
- 15 - 
 
  the more complex implementation is required. The discussions we had yesterday confirm that the 
need for the national implementation would mean that whatever effects the proponents count on, 
would not materialise in the short term at all.  
68.  First, a national le gal infrastructure would in many cases need to be created by the Members to 
enact measures permitted under the waiver, and in particular, to:  
a. determine which IP rights would be deemed to fall under the ambit of the waiver; and  
b. create a legal instrument and  procedures to effect the suspensions and circumscribe their 
scope to the purposes provided in § 1 of the waiver.  
69.  In that regard we asked the proponents to explain how they see the waiver being implemented 
and how long this would take. Other delegations in dicated that , considering that the corresponding 
domestic procedures often take time and may be complex, it is questionable how the waiver would 
provide a quick solution for the Members.  
70.  Further, the waiver provides no framework to establish clarity and tr ansparency regarding the 
status of individual IP rights within the respective WTO Member s – this creates a risk of  additional 
legal uncertainty and further damage to the incentive function of the patent system as pointed out 
by a number of delegations in t he course of yesterday 's meeting.  
71.  The waiver provides no description of measures to be adopted by Members under the waiver. 
No measures are indicated or prescribed. There are no set boundaries to the measures which can 
be taken. The proponents explain that  the 'waiver is permissive ' and that 'the choice of measures is 
left to the Members '. 
72.  The lack of defined measures is, in our view, highly problematic and results in high risk as 
regards the effects of the waiver. The lack of any boundaries means that Memb ers would be free to 
take any measures they deem appropriate without any accountability or scrutiny, and regardless of 
the impact of the waiver on incentives for innovation.  
73.  While the positive effects of the waiver are not proven and clearly questioned by  many 
delegations, its effect in the short-term is likely impossible due to the need for the national 
implementation, the lack of defined measures and the permissiveness of the waiver proclaimed by 
the proponents is creating risks of harmful effects that w ould continue beyond the time of application 
of the waiver. It is not only about what procedure is used by Members – based on emergency 
prerogatives of the state or other – it is, beyond all, about the substance of these measures and 
their effects.  
74.  The fi rst one concerns invalidation of existing patents: In the absence of TRIPS obligations to 
protect patents, Members may choose to invalidate existing patents on COVID -19 related products 
or processes. This would result in curtailing the patent protection wi thout any compensation or the 
possibility of restoration of the right. Importantly, this could impact not only inventions that are 
specific to COVID -19, but also "dual-use" inventions that are relevant to both COVID -19 and other 
existing and future disease s. This protection would be impossible to restore once the invention would 
be in the public domain.  
75.  The second one concerns the possibility of rejecting pending patent applications: In the absence 
of TRIPS obligations to protect patents, Members may choose  to provide that pending applications 
for new patents for all COVID -19-related technologies or for all products and processes relevant to 
the manufacture of vaccines, medicines and medical devices can be rejected. This would mean that 
new inventions relate d to these products and processes will not have patent protection and can be 
freely copied. In such a case such products/processes could not be patented going forward as, once 
known, they would lose their novelty characteristic which is one of the conditio ns of patent 
protection. In this respect, the explanations provided yesterday seem to assume that this condition 
of novelty could be ignored after the expiry of the waiver, but the TRIPS Agreement requires novelty 
to grant patents, as the novelty requireme nt is essential for the patent system to work properly.  IP/C/M/101/Add.1  
 
- 16 - 
 
  76.  In that regard we would like to discuss how proponents of the waiver suggest to guarantee that 
no measures may be taken with regard to patents or patent applications (the same goes for other 
registere d rights) which will continue to produce effects once the waiver has terminated?  
77.  The other set of effects that need to be analysed are the effects on voluntary licence agreements  
and open licensing schemes: If existing patents are invalidated, this may in consequence also result 
in invalidation of the voluntary agreements licensing those patents, depending on how the new rules 
are implemented, under the terms of the contract and the applicable contract law. This would mean 
that the licensees would be free o f licence conditions in their use of the invention. This would clearly 
undermine the ongoing collaborations and efforts to enhance production of COVID -19 vaccines.  
78.  As regards the collaborations based on voluntary agreements, compulsory licences or open 
licensing schemes, the question is – why would a waiver apply to these situations where obviously 
there is no barrier to access? Generally, where licences have been granted or the willingness to 
license has been expressed, does this not constitute evidence  that the IP right in question is not a 
barrier to access for health products? Should the consequence be that such an IP right does not fall 
within the ambit of the waiver?  
79.  There were a number of other questions raised by various delegations including on s afeguards 
for the holders of undisclosed information – in cases where such information enters the public 
domain, how exactly the proponents of the waiver suggest to protect the interests of such holders 
in the time after the waiver expires . It seems that i f protection of undisclosed information is once 
disclosed, such information loses protection permanently, even after the waiver ceases to apply. 
This is another example of why negative impacts on holders of undisclosed information need to be 
carefully asse ssed. 
80.  We would also have additional questions about the implementation of the waiver that we hope 
to discuss today or during the meeting on 9 July.  
81.  We understand that the intention of the proponents of the waiver is to remove intellectual 
property protecti on from COVID -19 vaccines, medicines and medical goods for the purposes of 
making them public goods, so that they can be made accessible more widely to the vulnerable 
populations. This should entail, in practice, that the use of these inventions has a huma nitarian and 
not a commercial objective. However, whereas the waiver takes away the obligation to remunerate 
the holders of intellectual property rights, we do not find any mechanism in the proposed waiver to 
ensure that the access to products covered by t he waiver would be ensured in line with the stated 
objective of the waiver and not for the economic benefit of manufacturers relying on the waiver. In 
contrast, the EU proposal explicitly provides for a mechanism aiming to keep patent holders ' 
remuneration  in line with the non -for-profit manufacture and supply of vaccines and medicines. 
Therefore, we would like to ask the proponents of the waiver for an expla nation : Will it be acceptable 
that entities benefitting from the waiver reap profits on the manufact ure and distribution of health 
products during the pandemic, when such authorisation to use the invention has been granted under 
exceptional circumstances in the interest of public health? If not, how do they propose to avoid it in 
practice?  
82.  As is clear fr om the text of the waiver, the suspension of the IP rights should be solely for the 
purposes set out in § 1. Any further uses unrelated to the prevention, treatment or containment of 
Covid -19 shall not be covered by the waiver, and IP rights will deploy th eir full effects in this regard. 
At the same time, as discussed in the course of previous  week, the waiver covers many products 
which are not limited to treating COVID -19 – how are proponents suggesting to guarantee that the 
permitted use of the invention under the waiver does not encompass use for other purposes or 
diseases or simply nullifies patents that are relevant for other areas?  
83.  The discussions we have had so far , rather than dispel ling our concerns about the effects of the 
proposed waiver, confirm  the merit of these concerns. We look forward to further discussions as a 
number of questions are still unanswered. For instance, the proposed duration, seems to us to be 
based on a certain assumption rather than evidence and underestimates the negative ef fects of the 
waiver on the system that has allowed researchers and innovation to develop various vaccines in an 
unprecedented time. On implementation, it seems to us that the assumption that the waiver does 
not require lengthy and complex implementation un derestimates the challenges of implementing the 
waiver proposal in practice. Moreover, the approach according to which the choice of measures to IP/C/M/101/Add.1  
 
- 17 - 
 
  implement the waiver is left entirely to Members, without any boundaries that would take account 
of necessity a nd proportionality raises concerns on the long -term effects of the waiver not only on 
the IP system but on its disruptive effects for access to COVID -19 vaccines and medicines.  
84.  The EU is looking forward to further discussions on these points and is always  ready to respond 
to any questions on the EU proposal.  
85.  As was mentioned by a number of delegations, the EU believes that Members should focus on 
solutions which are targeted, pragmatic and that can bring results in the short -term. We invite 
Members to discussions on the EU proposal , which in our view fulfils these requirements. As indicated 
in the previous meetings, the EU is also ready to discuss other aspects of compulsory licensing 
system that would merit clarification to enhance efforts to scale up the production of COVID -19 
vaccines, therapeutics and diagnostics. Finally, we would like to emphasise that the IP -related 
discussion is only a part of the multi -pronged approach proposed by the EU. We call on all Members 
to engage in discussions on all el ements of this approach as only this way we will be able to 
adequately respond to the current crisis.  
European Union 's statement at the informal meeting held on 14 July 2021  
86.  Chair, we would like to thank you for your continuous efforts in advancing our di scussions. 
Enhancing equitable access to COVID -19 vaccines and medicines is a priority for the European Union 
and this is our objective in this discussion. The European Union appreciated the possibility provided 
by the small -group meeting of 9 July to expl ain in more detail the EU proposal and to discuss the 
revised waiver proposal.  
87.  The European Union remains fully committed to this process and to finding the best way forward 
to ensure that the intellectual property system continues to contribute to enhanc ing equitable access 
to COVID -19 vaccines and medicines. We remain convinced that the current intellectual property 
system can play an enabling role in deploying existing capacity or creating new capacity for the 
production of COVID -19 vaccines and medicin es while keeping intact the necessary incentives for 
innovation. We will continue to engage constructively and are open to discuss all approaches that 
contribute to enhancing access to affordable COVID -19 vaccines and medicines and can bring results 
in an urgent manner. The discussions on implementation during our last two meetings have been 
helpful to understand the positions of various delegations, in particular of those who have put 
forward text -based proposals.  
1.9  United Kingdom  
88.  The United Kingdom welcomes the text of the oral status report and is content for it to be 
delivered at the upcoming General Council. We believe this report is factual, objective, and 
accurately reflects developments made by this Council si nce the General Council was last updated 
in May, and we thank other delegations for their engagement.  
89.  The United Kingdom would like to extend our gratitude to you and the Secretariat for 
successfully organising several informal TRIPS Council sessions and s mall-group consultations, to 
help Members advance discussions on substantive topics in a transparent manner. Our delegation 
has engaged in good faith throughout this process, asking questions conducive to healthy discussion, 
and has found the exchange of v iews from Members useful. However, as reflected in the status 
report, this Council has been finding it difficult to move towards consensus. We once again reiterate 
our long -held view that a discussion on fundamental areas of disagreement would help guide 
discussions towards pragmatic solutions. It is only by developing a common understanding of these 
underlying principles, that we will be able to meaningfully move forward in this process.  
90.  We will continue to actively engage in all discussions and review the  merits of any proposal 
submitted to the TRIPS Council. Responding to the question of vaccine equity necessitates a 
multifaceted response underpinned by pragmatic action, including voluntary licensing and 
technology transfer agreements for vaccines, suppor t for COVAX, and solutions for production 
bottlenecks and supply chain issues. We will continue to support action in this regard, and we look 
forward to our future discussions.  IP/C/M/101/Add.1  
 
- 18 - 
 
  1.10  China  
91.  We appreciate your leadership  and great efforts in organising  the text -based process for the 
past couple of weeks. We fully support your oral report to the General Council which we believe is a 
balanced and objective report and also a factual reflection  of the status quo  of our discus sions so 
far. The days and weeks since have witnessed Members active and constructive discussions both in 
small group consultations  and informal session on some important and specific issues in the waiver 
proposal focusing on the product  scope , the scope o f the IP rights, duration of the waiver , 
implementation -related considerations and regulatory data measures . Members have also touched 
upon some of the elements in the E uropean Union proposal. These rounds of intensive discussions 
have provided opportuniti es for Members to clarify each other 's positions and concerns and further 
understand the key issues in the proposal which has laid a sound foundation for our future work.  
92.  However, we are also awa re that Members are still divided over some key elements in the 
waiver proposal, most notably the role  of IP waiver in ramping up the production  of vaccine s and  
the scope and duration of the waiver as well. We realize that time is not on our side. If we do expect 
a good harvest in this regard before MC12 we may nee d to consider the possible landing zone as 
early as possible. The recent spread of delta variant s has put developing countries  with low 
vaccination rate s in even greater danger. It is an urgent call for the international community to  work 
together to expan d the COVID vaccines manufacturing capacity and to ensure the fair and equitable 
access to COVID vaccines for developing countries .  
93.  At the APEC informal economic leaders meeting on 16 July, Chinese President Xi Jinping said 
that China has overcome the cha llenges of his own mass vaccination programme and provided more 
than 500  million doses of vaccines to other developing countries. In another package , international  
aid worth USD 3 billion will be delivered over the next three years to support COVID -19 response 
and economic and social recovery in other developing countries. It is notable that the President Xi 
reiterates China 's support on the proposal of waiving intellectual  property rights on COVID -19 
vaccines a nd expects an early decision in the WTO.  
94.  Having said that, China will continue to actively engage in all forms of discussion at the 
TRIPS  Council with other Members aiming to reach a balanced and effective solution from the 
perspective of IP, so as to pro mote the accessibility and affordability of vaccines for developing 
countries  in the near future.  
1.11  Cuba  
95.  We would like to congratulate you  Chair  on the way in which you have conducted our debates 
and for your efforts on these  topics. Also, we acknowledge the work of all the colleagues that have 
been involved in informal discussions and other activities in relation to this topic. COVID -19 has led 
to a crisis with serious effects at a global level. Its implication goes well beyo nd the health sector 
and affects all sectors. The global system is complex, cases are still increasing,  and the unfair and 
unequal distribution of vaccines is hampering our efforts to put an end to this epidemic. In this 
context, the WTO has been discussin g the need to increase the capacities of our trading system to 
deal with the emergency in terms of public health. In this crucial time for humanity , it is absolutely 
vital that we find formulae to provide solutions that are comprehensive to all the aspects  relating to 
comprehensive vaccinations  in developing countries. We need to lift current restrictions on imports 
of vaccinations, for example, as well as medical products indispensable for the production of 
vaccines. Often it is only companies that are bas ed in large, industrialized  countries that produce 
these vaccines. It also means lifting the coercive  measures that are unilateral and that are set up 
against developing countries which affect the access and distribution of vaccines.  
96.  It is undeniable that  a large majority of developing countries have no vaccine production 
capacity and even if patents were to be facilitated, they do not have the necessary resources, 
technological, human or other resources  necessary. We need firm commitments on behalf of 
industrialised countries for the capacity -building , funding and transfer of technology to developing 
countries . No less important are the health networks in various territories with storage and transport 
capacity and su fficient health personnel to carry out mass vaccination campaigns  as swiftly as 
possible. Either way , most developing countries lack all of this and we need to work on building them 
or strengthening them whatever the case may be. We know that there is stil l much to be discussed 
given the impact of these topics and the timeframe  we need greater analysis and more in -depth IP/C/M/101/Add.1  
 
- 19 - 
 
  analysis. We m ust overlook no aspect, we must carry out comprehensive analyses to ensure a global 
solution to the global problem ensuring a ffordability and access to vaccines, equipment and other 
inputs. We need to work on a consensus -based  approach with our organization and the binding 
nature of its commitments and agreements. We reaffirm the need to work on immunizing  against 
COVID -19 and e nsuring a swift, equitable access to vaccines, equipment .  
97.  To come back to this pandemic, Cuba will continue in this vein to work on bilateral agreements, 
south-south cooperation, triangular cooperation , or cooperation through international organizations. 
We will support, as we have done since the very beginning of the pandemic  in dozens of countries 
any campaign of vaccination and will assist in training health staff. The United States Government 
attitude against Cuba is only leading to a more difficult si tuation in our country. This is also having 
an impact on citizens of many other nations including US citizens . In the previous  years , the 
economic situation of our country has significantly worsened given the measures taken by the 
United  States , with over 300 measures having been taken during the presidency of President Trump 
and President Biden is leaving them intact. The Government of the United States identified the 
pandemic virus as an opportunity to strengthen these measures for political reasons and u se the 
strongest measures possible to act against Cuba. This has been deliberate, cruel, and opportunistic . 
They have made the most of a pandemic to try and strangle our economy. In Cuba there were 
disturbances, protests on 11 July, they were very limited,  and they were caused by communication 
that had been prepared a long time ago from the outside of the country. It is unfortunate that the 
United States  Government is directly involved in this and  is very much responsible for the incidents 
that happened on that day. Their goal is to create disturbance and instability, making the most of 
the difficulties that we are facing due to the pandemic. In the context of t he measures  taken by the 
United States and by President Trump there is a lot of fake news and misi nformation against Cuba, 
we have proof of this. I denounce the measure taken by the US against Cuba and the terror carried 
out against it.  
1.12  Switzerland  
98.  At the outset, let me clarify that our statement covers both, agenda items 1 and 2.  
99.  My delegation would like to thank you, Chair for your efforts in this process and for the 
consultations you held to find consensus on the status report to the General Council. It is important 
that this report reflects correctly and comprehensively the discussions the Council has held in the 
various formats on all the proposals made by Members, in an objective and factual manner. This 
includes, of course, in addition to the waiver request, also the proposal from the EU in document  
IP/C/W/681 . 
100.  As you reported to this  Council and will to the G eneral Council , Chair, Members have intensified 
work over past weeks and have held substantive discussions on the proposals on the table. 
Switzerland remains committed to engage in the Council 's discussions and the need to conside r all 
the proposals when we resume that work.  
101.  My delegation requests the Secretariat to include its statements from the informal meetings 
since the Council met formally the last time in the minutes of this Council . At last week 's meeting, 
my delegation no ted the many questions posed by Members to the  proponents  and their TRIPS 
waiver proposal. These concerned in particular questions in relation to the national implementation 
and the impact and negative effects such a waiver risks to have on the ongoing int ernational efforts 
to scale up the manufacturing of COVID -19 vaccines. The discussions show that there is still no 
consensus that a waiver is the adequate approach to achieve our shared goal of making global and 
equitable access to COVID -19 vaccines and th erapeutics happen in the shortest time possible. Nor 
have we been presented with evidence that the TRIPS Agreement would indeed be a barrier to 
access. On the contrary, we see, in many examples, that it works as an enabler.  
102.  My delegation referred previous ly to the more than 300 voluntary agreements and 
partnerships that so far have been established internationally and are working currently on scaling 
up manufacturing of COVID -19 vaccines or work on the development of vaccines adapted to the new 
variants an d respective health technologies. And new ones are announced almost every day. These 
partnerships are based on the international regulatory framework in place, of which the WTO 
TRIPS  Agreement is a key component.  IP/C/M/101/Add.1  
 
- 20 - 
 
  103.  The case example of Lonza illustrates this , a Swiss pharmaceutical and biotech company with 
considerable experience and existing solutions facility, covering the complete biopharmaceutical 
lifecycle , ranging from preclinical to commercial stages, from drug substance to the final drug 
product:  
104.  The US vaccines developer Moderna and Lonza announced in May 2020 a ten-year agreement 
to support the manufacturing of Moderna 's COVID -19 vaccine. Under this Agreement, Lonza provides 
drug substance manufacturing capacity for Moderna 's mRNA COVID -19 vaccine. O n the basis of their 
cooperation agreement, the two partners established a close collaboration:   
a. They exchanged skilled personnel which are the holders of respective experience and 
knowhow, transferred technology and materials for the manufacturing of the product, 
handling instructions, protocols of production standards, other documentation necessary 
to maintain the properties of such materials for the performance of their service.  
b. They established a Joint steering committee in charge of overseeing, review ing, approving 
and coordinating the activities of the Parties under their cooperation agreement.  
c. A joint manufacturing team was set up to oversee the services under each stage of 
production.  
d. Licensing and confidentiality agreements were prepared in relat ion to trade secrets and 
manufacturing know -how to be exchanged.  
e. Setting up such a complex manufacturing capacity of this scale would normally take up to 
two years till production is operational. Thanks to their close collaboration, sharing of 
knowhow and  the focus they set to respond to the urgency of the pandemic, the two 
partners managed to start the first of three production lines after eight months ' time. Not 
of the entire vaccine, of course, but as mentioned of the drug manufacturing substance. 
Moder na works with many more partners to produce and get the finished and filled 
vaccines ready for inoculation.  
f. At the end April of this year, Moderna and Lonza announced that they intend to double the 
manufacturing capacity of Lonza, hoping to get three addi tional production lines going by 
spring 2022.  
g. A major and urgent concern for Lonza remains finding sufficient qualified specialist staff, 
from vaccines researchers to other expert employees to implement this project and adhere 
to the set time schedule for  establishing and scaling up its manufacturing capacity. This is 
particularly challenging today, in the time of the pandemic, where in the field of vaccines 
science the market for qualified research and other experts is almost dried up, and this at 
the int ernational level. In this state of emergency, the Swiss Federal Government started 
to dispatch temporarily qualified experts from its own federal and from university staff to 
support the ramping up of Lonza 's manufacturing capacity. Lonza itself contacted other 
Swiss companies to see whether they could loan specialists to step on a temporary basis.  
105.  We can take away a few lessons from this case example:  
a. The close cooperation between Moderna , the vaccine developers , and Lonza , the qualified 
manufacturer , was quintessential for the scale -up of manufacturing to succeed. And to 
succeed within a timeline to matter for the fight against this pandemic.  
b. Voluntary collaboration, exchange of expert personnel, transfer of their know -how and 
technology were key ingredi ents of their success.  
c. Even with partners willing to collaborate, to contribute, exchange and share - it took time 
to get this up and running. This cannot be done at the push of a button.  
d. Many operational challenges need to master : recruitment of the required number of 
qualified specialists, access to needed raw materials and getting the right supply chains in IP/C/M/101/Add.1  
 
- 21 - 
 
  place to secure the manufacturing process from sourcing raw materials to fill and finish 
the vaccines.  
e. Last but certainly not  least: protection of their trade secrets and manufacturing know -how 
were a given for both partners to enter into a partnership. For this, the two partners relied 
on the well -established and trusted international regulatory framework, part of which is 
the TRIPS Agreement. Had there been no international regulatory IP framework or had 
TRIPS been suspended, this international partnership, just one of many examples, would 
not have come about.  
106.  Against this backdrop, my delegation reiterates its concern that th e proposed TRIPS waiver 
would jeopardize the partnerships and collaborations such as the one between  Lonza and Moderna 
currently engaged in the manufacturing of COVID -19 vaccines, adapting them to new virus variants 
or the development of novel therapeutics  against the Sars Cov2 virus. It also risks preventing  the 
establishment of new partnerships and would thus have a counterproductive impact on our 
achieving, as soon as possible, the goal of broad and equitable access to COVID -19 vaccines.   
107.  We agree, that , at this juncture, in many countries we still face a severe shortage of vaccines, 
equitable access to it , and a lack of efficient vaccination strategies to inoculate populations. In this 
regard, we reiterate that a holistic approach is needed, that notably  addresses trade measures and 
the real bottlenecks affecting access to COVID -19 vaccines and relevant health technologies. The 
WTO has an important role to play, and we welcome the trade policy actions identified by more than 
50 of its Members on 15 July 2 021 in the communication "COVID -19 and beyond: Trade and Health ".  
108.  In addition, to ensure more equitable access to vaccines in the immediate term, countries 
disposing of sufficient doses must now share surplus vaccines quickly. Vaccine 's production and 
sharing in cooperation with WHO 's COVAX must be oriented with high priority to the needs of those 
countries with the most acute shortage.  
109.  Governments also need to boost local and regional vaccines production to be better prepared 
for future pandemics, includ ing in Africa. But this is not a goal that can be achieved at once. Nor 
through a TRIPS waiver. This goal must be pursued in the medium and long term. Cooperation, 
capacity -building  and manufacturing partnerships will be a prerequisite for this to happen 
successfully - the TRIPS regulatory framework will contribute again as an enabler. We took note with 
interest of the new initiative of WHO to establish a vaccine technology transfer hub mechanism. 
Switzerland has already been in touch with the person respon sible at WHO to pledge our support.  
110.  On the further discussions and work of the TRIPS Council after the recess, Switzerland remains 
committed to contribute actively and constructively with the aim to find adequate solutions that can 
truly support us in ach ieving our shared goal that unites  this Council.  
Switzerland 's statement at the informal meeting held on 17 June 2021  
111.  In order to respond efficiently to the COVID -19 pandemic, many measures are needed. These 
range from the support and facilitation of partnerships between innovative companies and qualified 
manufacturers with adequate production capacity, to removing export  restrictions and minimizing 
barriers to trade. This is why a holistic approach is best suited to harness the contribution of trade 
to an effective response to fight the pandemic. In this regard, Switzerland would like to recall that 
the "Trade and Health " initiative by the Ottawa Group, and supported by other Members, provides 
pragmatic proposals on these issues. Switzerland actively supports this initiative and encourages all 
WTO Members to consider it positively.  
112.  My delegation reiterates its openness to examine all proposed measures by WTO Members 
which contribute - effectively - towards the goal of expanding the production of COVID -19 vaccines 
and health technologies and facilitates prompt and equitable access to them. Regarding the way 
forward, we would  like to thank you Chair for holding small group consultations on this matter on 
16 June  as well as on 11 June . 
113.   In light of the various ideas on the table and the different perceptions of the best way forward, 
Switzerland believes that all the proposals a nd potential future proposals, which are all working 
towards the same goal, have to be discussed on an equal footing in this process. This means, 
irrespective of their current form, at the same time and with equal intensity.  IP/C/M/101/Add.1  
 
- 22 - 
 
  114.  Chair, we would like to thank you for your suggested calendar of meetings. This calendar, 
which contains indicatives dates, is very intensive, but we are ready to engage on this. We 
understand that in the stocktaking meeting on 30 June, Members will have an opportunity to review 
this s chedule and whether the rhythm and thematic structure of meetings seems appropriate. We 
also welcome the approach to have dedicated meetings to discuss specific topics. As mentioned by 
the U nited Kingdom , which remarks on calendar we fully support, we need  a pragmatic, 
solution -oriented and problem -based approach. To that effect, we need to look at specific topics and 
how the individual proposals would address them. Effectiveness, short, medium and long -term 
effects or national implementation are also important elements to discuss.  
115.  In order to ensure that all propo sals can be treated on an equal footing, we would like to 
express our support to the E uropean Union's suggestion to hold the first small group meeting only 
after the EU was given an opportunity to present its proposal on the 24 June. We are currently 
analy sing proposals in documents IP/C/W/669/Rev.1  and IP/C/W/680  and would welcome to be able 
to benefit from sufficient time to allow in -depth study of these proposals. We agree to discuss all 
proposals that have the objective of ramping -up production and ensuring access, inter alia  proposal 
document IP/C/W/669/Rev.1 , including the draft text . Nevertheless, this is without prejudice to the 
Swiss position as to the TRIPS waiver proposal as such. Indeed, as we have clearly stated in our 
previous statements, we have not been convinced and do not believe that IP is a barrier to global 
access and t hat the suspension of the TRIPS Agreement would be an effective measure to ensure a 
global, equitable, affordable and timely access. Doing so could have counterproductive effects for 
reaching our common goal, fighting this and futures pandemics.  
116.  Switzerlan d will continue to actively contribute to the ongoing efforts at the WTO in order to 
reach our common goal of quickly scaling up global manufacturing capacity for equitable access to 
COVID -19 vaccines and other medical technologies.  
Switzerland 's statement  at the informal meeting held on 24 June 2021  
117.  My delegation would like to thank you for organizing this open -ended informal meeting. As 
this Council is dedicated to proposal document IP/C/W/681 , we will not repeat today our well -known 
position and refer on that point to our previous statements. We would like to thank the 
European  Union for presenting its new proposal document IP/C/W/ 681. As this document was 
circulated four days ago, we are currently analysing it in capital.  
118.  Allow us, Chair, to make some preliminary comments and ask the distinguished delegation of 
the EU a question. Switzerland appreciates that proposal document IP/C/W/ 681 is part of a broader 
holistic approach reflected in the EU proposal WT/GC/231 on urgent trade policy responses to the 
COVID -19 crisis. We fully share the EU 's views that the holistic approach is the right way in order t o 
reach our common goal of expanding the production of COVID -19 vaccines and health technologies 
and facilitates prompt and equitable access to them. This approach is necessary not only to facilitate 
trade and address export restrictive measures, but also to enhance harmonious and trust -based 
collaborations as well as mutual exchange of know -how and technology.  
119.  Thanks to a holistic approach and to efforts based on the tools provided for under the 
multilateral framework we believe that manufacturing capacit y will ramp up. As already stated, 
Switzerland fully acknowledges that compulsory licen ces are a flexibility that Members can use under 
Article 31 of the TRIPS Agreement, as also confirmed in the separate Doha Declaration on the 
TRIPS  Agreement and Public Health. Under Article 31, a compulsory licen ce can be issued promptly 
and in the case of an emergency, like the COVID -19 pandemic, even without prior negotiations with 
the right holder.  
120.  We encourage Members facing practical challenges when making use of co mpulsory licen ces 
to bring this quickly to the attention of the TRIPS Council. Switzerland remains open to discuss 
solutions to concrete challenges. In our view, clarifying the application of existing provisions of the 
TRIPS  Agreement concerning certain as pects of compulsory licensing, in the circumstances of a 
pandemic as suggested in proposal document IP/C/W/ 681, is a constructive approach. We believe 
that solutions should and can be found building on existing multilateral IP rules.  
121.  We welcome the fact that proposal document IP/C/W/ 681 underlines the need to provide and 
preserve appropriate incentives for investments in research and development of COVID -19 vaccines. 
We also share the view expressed in the communication that legal certainty on the flexibilities IP/C/M/101/Add.1  
 
- 23 - 
 
  provided for in the TRIPS Agreement is essential when making use o f compulsory licen ces in the 
context of a pandemic. Our delegation would be interested to know if diagnostics are also covered 
by the proposal since they are not explicitly mentioned. As already stated several times, Switzerland 
believes that all existing and future proposals on these matters should be discussed on an equal 
footing. We look forward to discussing  in an open -minded and inclusive way all proposals – including 
the present one – on 28 June  at the small group consultation on IP rights.  
Switzerlan d's statement at the informal meeting held on 30 June 2021  
122.  Our delegation would like to thank you for convening this important meeting, which gives 
Members the opportunity to take stock of the discussions, review the process 's schedule, pace and 
thematic structure, as well as discuss the next steps. Allow us, Chair, firstly to reiterate that 
Switzerland is fully convinced that the IP system is part of the solution to fight the pandemic. IP 
rights are namely key for existing and forthcoming collabo rations and partnerships between various 
stakeholders because they offer safe environment for know -how and technology transfer.  
123.  In a timesaving manner, we will not repeat our position and refer to all our previous statements 
made at the TRIPS Council. Howe ver, we would like to recall that there is no silver bullet to address 
the challenges we face in the current pandemic: Only a holistic approach can bring us closer to our 
common goal of increasing global manufacturing capacity for equitable and affordable access to 
COVID -19 health technologies. In the context of a holistic approach, we stand ready to discuss IP 
and in particular possible solutions to practical challenges that Members would face. We believe that 
Members need to adopt a pragmatic, targeted so lution -oriented and problem -based approach, and 
that solutions can and should be found within the rules -based multilateral IP system.  
124.  Currently, two proposals – respectively documents IP/C/W/ 681 and IP/C/W/ 669/Rev.1 – are 
on the table, proposing different approaches in order to reach our common goal. There is curre ntly 
no consensus among Members as to which approach should be pursued. We are convinced that it is 
therefore necessary to continue discussing all proposals on an equal footing. We appreciated the 
holding of the two small group consultations related to the  scope of products and IP rights. Indeed, 
they gave Members the opportunity to discuss proposals documents IP/C/W/ 681 and 
IP/C/W/ 669/Rev.1 in a constructive, interactive and inclusive way.  
125.  In these meetings my delegation was in particular interested to understand better why existing 
TRIPS flexibilities are not suf ficient to adequately address potential problems arising and how the 
approach suggested in document IP/C/W/ 669/Rev.1  would achieve the objective of ramping up 
manufacturing, in particular with regards to the question how a suspension of the protection of trade 
secrets would encou rage technology transfer. We certainly agree with proponents of document 
IP/C/W/ 669/Rev.1  on the importance of know -how and technology transfer, but still fail to 
understand how this would be facilitated with a suspension of the protection of trade secrets.  
126.  We believe that it is  our collective responsibility as Members of the WTO and as Parties to the 
TRIPS Agreement to search for solutions based on existing multilateral IP rules, rather than simply 
suspending these rules. In this regard, we reiterate our call to Members facing p ractical challenges 
when making use of TRIPS flexibilities such as compulsory licen ces to bring this quickly to the 
attention of the TRIPS Council.  
127.  Considering the number of open questions, Switzerland believes that it would be important to 
continue these  discussions, with the aim to better understand the challenges concretely faced and 
identify the best way forward to achieve our collective goal. During the last small group meeting, 
Members touched upon the issue of implementation several times. We would therefore propose that 
the next small group consultation focuses on how the proposals would be implemented in domestic 
law, as this is a key aspect which has not been sufficiently addressed.  
128.  Furthermore, topics such as systemic implications, short, medium  and long -term effects also 
seem very pertinent to us. We also support the suggestion that came up in the meeting on 28 June  
to have a dedicated small group consultation on technology transfer. Regarding the way forward in 
July and in order to manage time carefully, we suggest keeping the same rhythm of meetings as 
described in your communication dated 16 June. We are of the vi ew that one small group 
consultation per week on a specific topic allows Members to adequately prepare for them and 
provides predictability. In this regard, we would also appreciate if you could indicate in a 
communication the dates for the small group con sultations to be held in July.  IP/C/M/101/Add.1  
 
- 24 - 
 
  129.  As indicated in your communication dated 16 June, Chair, we have noted that you have the 
intention to convene three TRIPS Councils in the coming month: on 6, 14 and 20 July. These 
open-ended  meetings would allow Members to t ake stock of the discussions and to prepare the 
status report for the General Council meeting of 27 and 28 July. Our delegation would appreciate to 
get more clarity on the structure on these open -ended TRIPS Councils. As envisaged in your 
communication Cha ir, we support the idea of holding one of the three meetings mentioned above as 
a formal meeting, in order to adopt the status report to the General Council. Let me reiterate, Chair, 
that Switzerland remains fully committed to engage actively in order to f ind with all Members a 
pragmatic solution to reach our common goal.  
Switzerland 's statement at the informal meeting held on 6 July 2021  
130.  My delegation would like to thank you for convening this open -ended meeting. We would like 
to start our statement by mak ing an announcement: we are pleased to inform Members that the 
Swiss Federal Council decided, on 30 June , to transfer 4 million of vaccines doses to the COVAX 
Facility. To us, the COVAX facility is a key international initiative to reach the goal of equal and 
equitable access to COVID -19 vaccines. Indeed, it brings together Members, international 
organizations and other public and private stakeholders as partners to work together towards the 
goal of global access to COVID -19 vaccines.  
131.  Partnerships are key to fight this pandemic, also with regard to ramping up production. The IP 
system also brings together various stakeholders as partners to continue research and development 
of COVID -19 health technologies to fight the current pandemic. IP is thus part of th e solution and is 
not a barrier. Therefore, and as mentioned in our previous statements at the TRIPS Council, we are 
convinced that Members should address the pandemic in a holistic and sustainable manner and 
within the rules -based multilateral IP system i n order to overcome this crisis quickly.  
132.  As for the small group consultations on 22 and 28 June, we observed on 5 July  that the 
consultation enabled Members to discuss proposals documents IP/C/W/ 681 and IP/C/W/ 669/Rev.1 
in a constructive, interactive and inclusive way. The day before , we were especially interested  to 
obtain more information on how a waiver would concretely be implemented. Unfortunately, many of 
our questions remain unanswered. For instance, we still fail to understand how a waiver would be a 
quick solution for all Members, if Members wishing to imp lement it would need to amend their 
domestic legislations. We also do not understand how waiving obligations of the TRIPS Agreement 
would be consistent with other international obligations. Finally, we also fail to see how predictability 
and transparency w ould be ensured with regard to the implementation of the waiver.  
133.  Regarding the duration of the effects of a waiver, we still do not understand how confidential 
information, which would be disclosed during the application of a waiver, would be protected af ter 
its end. Indeed, the conditions of Art icle 39 § 2 of the TRIPS Agreement would not been fulfilled 
anymore; that means that once disclosed, such confidential information would lose protection 
forever. Related to this, let me add one follow -up question t o the discussion  on 5 July : If our 
understanding is correct, safeguards could be built in to ensure confidentiality under the waiver? 
How would this work and what would then be the reason to suspend the legal certainty and 
confidentiality we have now with TRIPS Agreement in the first place?   
134.  While these small group discussions have been helpful in deepening our exchanges also with 
a view on the status report for the July General Council, Members views on the issues such as scope, 
duration or implementation are still diverging and it seems that  we did not come closer to reaching 
consensus so far. Switzerland is ready to continue these discussions and will engage constructively.  
135.  Regarding the schedule, Chair, we understand that your intention is to convene another 
consultation on 9 July . We reit erate what we have explained at the TRIPS Council on 30 June and 
hope that you will consider it: namely that to us, one small group consultation per week on a specific 
topic is appropriate to allow Members to prepare adequately. We believe that having more  than one 
consultation per week would weaken the quality of our discussions and take us away from our 
common goal.  
136.  With respect to the meeting  on 9 July , we are ready to engage with the understanding that 
we will continue our discussion on implementation,  as we have not had enough time on 5 July  to 
discuss this topic. In order to structure our discussions in line with a pragmatic, targeted 
solution -oriented and problem -based approach, we propose to discuss topics such as systemic IP/C/M/101/Add.1  
 
- 25 - 
 
  implications and short, me dium and long -term effects at the small group consultations. We also 
reiterate our support to the suggestion made by Brazil to have a dedicated consultation on transfer 
of technologies and know -how.  
137.  We thank the proponents of proposal document IP/C/W/ 669/Rev.1 for reaching out b ilaterally 
to discuss the way forward. In that meeting, Switzerland indicated its willingness to engage in this 
text-based process by continuing discussions on all proposals that have the objective of ramping -up 
production and ensuring access under the Cha ir-led process. This is without prejudice to the Swiss 
position as to the TRIPS waiver proposal as such. We also reiterated our view on the importance of 
voluntary cooperation in particular with a view to enable the crucial transfer of technologies and 
know-how for the complex production of vaccines. A Swiss manufacturer is producing drug 
substance. We therefore have first -hand experience on how important the collaboration between IP 
holder and manufacturer is. In this respect, we fail to understand how thi s cooperation could still 
work, not to mention be even better, without the legal certainty granted by the existing multilateral 
IP framework.  
138.  Switzerland remains ready to discuss with all Members how we can ensure a global and prompt 
access to COVID -19 he alth technologies with the aim to better understand the challenges concretely 
faced and identify the best way forward based on existing multilateral rules to achieve our common 
objective.  
Switzerland 's statement at the open-ended informal meeting held on 1 4 July 2021  
139.  My delegation would like to thank you for convening this open -ended informal meeting to 
inform the Council about your recent consultation and to consider next steps.  
140.  Switzerland constructively engages in these consultations and the Council 's discussion of the 
proposals made by Members, based on proposed draft texts. We reiterate that this is without 
prejudice to Switzerland 's position - that a waiver such as the one proposed in document 
IP/C/W/669/Rev.1  is not a useful means to achieve our shared goal of ramping up manufacturing 
capacity for COVID -19 vaccines to enable global and equitable access as quickly as possible and 
encourage the development of new health technologies against COVID -19. 
141.  My delegation would l ike to thank you, Chair, for allocating time in the most recent small group 
consultations to discuss questions and concerns raised by Members in relation to the potential 
implementation of the proposed waiver. Switzerland and other delegations questioned c laims that a 
waiver would – or even could – be swiftly implemented by Members. Members are bound by 
international IP treaties other than the WTO TRIPS Agreement. These treaties are outside the realm 
of the WTO and would not be subject to such a TRIPS waive r. Then, there is the national dimension: 
the domestic regulatory framework would need to be amended which cannot be achieved simply or 
swiftly.  
142.  While possible safeguards that could be built in a waiver have been mentioned by proponents 
of proposal in doc ument IP/C/W/ 669/Rev.1, our questions and concerns on this important issue have 
so far remained unanswered. Why would the legal certainty we now have with TRIPS then be given 
up in the first place? Members in the consultations reiterated their concerns with respect to the legal 
uncertainty resulting from the suspension of large parts of the TRIPS Agreement. This would throw 
into jeopardy more than 300 voluntary agreements and partnerships that engage so far 
internationally in ramping up manufacturing of COVID -19 vaccines and in de veloping respective 
health technologies. It would also have a chilling effect on the establishment of new such 
partnerships.  
143.  An implementation of the waiver in a permissive way, such as advocated by the proponents 
of proposal in document IP/C/W/669/Rev.1 , does not mitigate these  concerns. Indeed, a situation 
where every Member decides whether, how and to what extent it would apply such a waiver would 
result in even more uncertainty. The various stakeholders would have no idea under what conditions 
to operate transnationally – as opposed to the current situation where the minimum standards of 
the TRIPS  Agreement provided a safe point of reference and necessary guidance.  
144.  A number of delegations raised questions and reiterated concerns on the 
short-/mid-/long-term effects of the pro posed waiver. We disagree with the claim that a waiver IP/C/M/101/Add.1  
 
- 26 - 
 
  would have no negative effects and we believe that the Council should continue its consideration on 
the potential effects of such a waiver in relation to all three -time dimensions.   
145.  At the Council 's informal meeting the previous  week, my delegation mentioned the case of a 
Swiss manufacturer engaged in the fight against the current pandemic. We would like to provide 
more detailed information. The Swiss company Lonza provides drug substance manufacturing 
capacity to the US company Moderna for its COVID -19 vaccine. Lonza and Moderna announced in 
May 2020 a ten-year strategic collaboration agreement to support the manufacturing of Moderna 's 
COVID -19 vaccine. With this collaboration agreement between them, it  took the two companies eight 
more months of close collaboration, intense cooperation, innumerable contacts and exchange of 
skilled personnel as well as the sharing of know -how and transfer of technology before production 
of drug substance could start at L onza's site in Visp.  
146.  On the basis of this successful cooperation, Moderna and Lonza announced last April their 
intention to double production by building three additional production lines . Lonza hopes that with 
the close support of Moderna to have these n ew lines in operation in the course of spring of 2022. 
This target date is only feasible thanks to Lonza 's existing solutions facility, which covers the 
complete biopharmaceutical lifecycle (ranging from preclinical to commercial stages, from drug 
substance to drug product).  
147.  A major and urgent concern in this context is to find the necessary qualified specialist staff, 
from vaccines researchers to other expert employees to implement this project and adhere to the 
set time schedule. This is particula rly challenging today, in times of the pandemic, where in the field 
of vaccines science the market for qualified research and other experts is close to dry out, and this 
at an international level. In this state of emergency, the Swiss Federal Government st arted to 
dispatch temporarily qualified employees from its own federal and university staff to support the 
ramping up of Lonza 's manufacturing capacity.  
148.  This example demonstrates how quintessential the close collaboration between vaccine 
developers and qu alified manufacturers is, how the success of their partnership depends on 
voluntary transfer of technologies and know -how to become operational in a reasonable and useful 
timeframe in order to be still relevant for fighting this pandemic together. It also highlights that a 
range of other complex challenges related more to operational matters need to be mastered also 
successfully. And yes, it also demonstrates that this is still demanding work in progress.  
149.  Against the backdrop of this case example, my deleg ation is clearly of the view that the 
proposed TRIPS waiver would put into jeopardy existing transnational partnerships and 
collaborations engaged in the manufacturing of new vaccines and the development of novel 
therapeutics. It also risks to prevent the establishment of new partnerships as the existing 
international regulatory framework, important part of which is the WTO 's TRIPS Agreement, could 
no longer provide the required regulatory basis.  
150.  Turning to the status report to the General Council of 27 an d 28 July: We agree that the two 
previous status reports can serve as its basis. We have discussed in various formats how best to 
achieve our common objective and the role of IP for the past weeks. While we had intensive 
consultations, including text -based  discussions on documents IP/C/W/669/Rev.1  and IP/C/W/ 681, 
Members ' views on the best approach to achieve our common goal are still diverging. There is no 
consensus on the approach to take or on the solutions contained in documents IP/C/W/669/Rev.1  
and IP/C/W/681 . Clearly, the status report must refer to all proposals (including document 
IP/C/W/681 ) on the table that were subject of the recent consultations  and the Council 's discussions, 
and that in the absence of a consensus, the Council will continue its discussions.  
1.13  Brazil  
151.  We want to thank you for your report and for your stewardship in this process. The intense 
schedule of consultations and informal open -ended meetings held in the past week have helped us 
delve deeper in the technical aspects of both the waiver and the E uropean Union proposals. As many 
delegations and you, Chair, have pointed out, there are other  aspects to explore and some others 
to revisit.  Brazil wants meaningful, timely and comprehensive solutions that empower all Members 
in their response to the challenges we are currently facing. In that spirit, we have been engaging in 
a constructive manner  regarding all proposals on the table and are open also to discuss any other IP/C/M/101/Add.1  
 
- 27 - 
 
  idea put forward by Members. We urge all to approach these negotiations with the necessary mix of 
flexibility, urgency and pragmatism.  
152.  We hope that discussions to follow will cont inue to show the same frank spirit of engagement.  
We have been carefully listening to the different voices in this debate. Some Members do not feel 
sufficiently reassured of their margin of manoeuvre  within the IP system to take measures to boost 
productio n of life -saving drugs and vaccines to fight the pandemic. If it is not sufficiently clarified 
that flexibilities in all domains of IP rights can and should be used to protect public health, we should 
provide that assurance to Members.  Discussions have als o shed light on certain areas of the 
Agreement that could be amenable to improvement. Simplifying packaging requirements and 
enhancing the scope of products covered by the Article 31 bis could be a way forward to empower 
Members in the use of flexibilities for this and future pandemics.  
153.  All in all, we are convinced there is a landing zone for these discussions, and we are committed 
to working with Members to find common ground and to finalizing this negotiation with an important 
legacy for IP and Public Heal th. As we move forward in our discussions and as previously suggested 
by my delegation, we would like to see a more in -depth discussion on transfer of technology and 
know -how. It is Brazil 's priority to augment the productive capacity of developing countri es in the 
pharmaceutical and health sectors. To that end, it is important that we continue to explore ways to 
disseminate crucial technology and know -how. While ramping -up production, we must also 
deconcentrate it.  
154.  We welcome Director -General 's Dr Ngozi Ok onjo-Iweala  initiative to hold , together with the 
Director -General of the WHO, Tedros Adhanom, the High -Level Dialogue on "Expanding COVID -19 
Vaccine Manufacturing to Promote Equitable Access ". We hope these and future discussions, within 
the DG 's "third w ay approach ", might provide an enhanced understanding of the progress made and 
the prospects for further expansion of productive capacity in developing countries.  
155.  We welcome current efforts from the WTO, WHO and WIPO to enhance their trilateral 
cooperation  and invite them to continue to explore innovative ways to support Member s, each in 
their respective areas of expertise, to attain our common goal of ensuring fair and equitable access 
to medicines, vaccines and other health products worldwide.  
1.14  Indonesia  
156.  Indonesia would like to join others in thanking you Chair for convening this meeting and for 
your leadership during the course of many discussions of the waiver proposal. The discussions have 
been very in sightful and it made us even more convinced on the immediate necessity of having the 
TRIPS waiver. In this opportunity we would also like to reiterate our support for  the Chair's report 
to the General Council . The report captures factual information objectively. Regret tably, Indonesia 
would also like to state its profound disappointment to the WTO Members for not being able to  reach 
consensus on this very important issue despite the situation we are facing right now. The TRIPS 
waiver should not be considered as only a p ossible deliverable for MC12 , but it is something that we 
should pursue  and conclude immediately.  
157.  However, we also appreciate the constructive engagement by all Members during the course 
of the negotiations guided skilfully by you , Chair. Furthermore,  Indonesia supports the statement 
made by other co -sponsors in this regard. The waiver is crucial in addressing one of the key barriers 
to the global access of health products and health technologies for the prevention, containment,  and 
treatment of the COVID -19 pandemic. The COVID -19 pandemic is still continuing and even in many 
parts of the world, including in my country , is still getting worse due to the mutation of the virus. 
As of today , we have reached 244,000 new cases during the last seven days. Our sit uation is not 
because we have not made efforts to obtain enough vaccines for people, we have used bilateral as 
well as multilateral avenues in this regard, but still we have not obtained enough vaccines for our 
300 million people because there are not enou gh vaccines available. Our situation  is also not because 
we do not have the industry to produce vaccine, but it is more due to the barriers regarding the 
access to the supply of vaccine raw materials, IP obstacles as well as transfer of technology barriers .  
158.  There are not many voluntary licensing agreements in developing countries,  and it is making 
things very difficult for developing countries to produce its own vaccine. The situation is reflected 
from the WHO Emergency Use Listing Procedure (EUL) on COVID -19 vaccines; from five vaccines IP/C/M/101/Add.1  
 
- 28 - 
 
  which have been given EUL, only one is applied in a developing country, the rest are applied in 
high-income countries. The fact is that there are 70 manufacturers in middle - and low -income 
countries  having the capabilities to produce vaccines, but they do not have the access to such 
voluntary licensing. COVAX, as a multilateral system, have only been able to distribute around 
90 million doses of COVID -19 vaccines during the past six months, while the global need of vaccines  
is around 11  billion doses. It is inevitable that we immediately pursue and conclude a TRIPS waiver 
to address such IP obstacles.  
159.  We share the view of our colleagues from South Africa that IP rights are not absolute, they 
are subject to public interest, a nd such interest in such public interest exists now. The TRIPS waiver 
is the Members ' way to uphold public interest and the livelihood of so many. We believe that the 
TRIPS  waiver addresses many concerns of Members and it is not reasonable that it provides a 
minimum condition in our efforts for ramping up the conditions for diagnostic, therapeutics and 
vaccines for the prevention, containment and treatment of the COVID -19 pandemic. The 
TRIPS  waiver proposal now has a clear scope and duration. The sc ope is now limited to health 
products and technologies necessary for the prevention, containment and treatment of COVID -19 
pandemic as per the WHO list of priority medical devices. Of course,  we are committed to continuing 
negotiation with a view to arrivi ng at an agreement on the TRIPS waiver decision that could be 
acceptable noting that the waiver propos al is targeted, time -bound and proportionate.  
160.  We believe that the waiver offer ed by the proposal will be one key solution in addressing the 
COVID -19 glob al pandemic, especially in helping global access of vaccines and medical products 
especially for the developing and least  developed countries and will leave a legacy which all 
WTO Members could be proud of one day.  
1.15  Chinese Taipei  
161.  I would like to start by thanking you, Chair, on behalf of my delegation, for the efforts you 
have made to convene this meeting in order that we can address the important and difficult issues 
we are all facing today and will continue to en counter if no multilateral action can be found.  
162.  We also want to thank you for the status report you issued early last week, and to express our 
support for the suggested actions contained therein. The report, which is both neutral and 
fact-based, in our vi ew provides an accurate summary of the discussion as it stands at the moment. 
We would also like to thank all the Members that have tabled their proposals and engaged in 
constructive discussions.  
163.  I am sure we all agree that the extraordinary circumstances  caused by the COVID -19 pandemic 
require a rapid, effective and coordinated response. The ultimate goal of this particular multilateral 
approach should be to expand the production and supply of vaccines and other medical products, so 
as to address the crit ical shortages in a timely and efficient manner. We sincerely hope and trust 
that WTO Members, working together, will be able to find a practical and mutually agreed solution 
to achieve this common goal as soon as possible.  
1.16  Saudi Arabia, Kingdom of  
164.  First of all, the Kingdom of Saudi Arabia offers its condolences to all families who lost their 
loved ones all over the world. We recall our previous statements and emphasize that the situation 
is extremely seri ous. People are dying and getting hospitalized, and there is no time to lose. What 
we are facing now is urgent need to take action. We urge all Members to cooperate and show the 
necessary flexibility to provide timely and secure access to safe and affordab le vaccines for all. 
Globalisation teaches us many lessons, and one important lesson is that no one is safe until everyone 
is safe.  
1.17  Japan  
165.  The delegation of Japan appreciates the efforts made by the Chair and the Secretariat  to 
convene this TRIPS Council meeting and to make and finalize the draft oral status report. We support 
the draft reflecting and based on discussions in previous meetings  IP/C/M/101/Add.1  
 
- 29 - 
 
  166.  In order to overcome COVID -19, it is important to promote equitable access to vaccin es 
throughout the world. Japan co -hosted the COVAX AMC Summit and contributed to securing the 
funds which exceeded the target amount of USD 8.3 billion. Also, Japan announced a financial 
contribution of USD 800 million in addition to existing contribution of USD 200 million. In addition 
to financial contribution to COVAX, Japan announced that it will provide around 30 million doses of 
vaccines manufactured in Japan to various countries and regions, including through the COVAX 
Facility. Japan also will make steady progress in establishing cold chains, as "Last One Mile Support " 
to ensure vaccination down to the last person. Japan will continue to work towards securing equitable 
access to safe, effective and quality -assured vaccines through various support s, responding to the 
needs of worldwide countries , including developing cou ntries, in cooperation with relevant countries 
and international organizations.  
167.  Japan will constructively discuss various issues and measures with Members in order to expand 
the production of safe and effective vaccines and ensure globally fair and equitab le distribution 
toward an early convergence. From this perspective, any ideas and proposals, which aim at 
improving the IP system as a means to overcome COVID -19, should be considered . However , these 
ideas or proposals should be effective in achieving thes e goals. We have a variety of issues to 
consider, such as 'scope ' or 'duration '. However, we would like to stress that any uncertainty or 
delay of achieving these goals should not be caused by 'implementation ' of any proposals.   
168.  We appreciate the proposal from E uropean Union for the purpose of legal certainty of the 
compulsory licen ce system. The delegation of Japan notes its interest in the EU 's proposal, and will 
continue to consider the proposal with WTO Members.  
169.  The small -group consultations and informa l open -ended meetings were helpful in sharing 
Members ' opinions . However, consideration has not yet been completed from a technical 
perspective . We appreciate again the efforts made by the Chair and the Secretariat to convene these 
meetings. Japan will con tinue to exchange views on the waiver proposal and the EU proposal closely 
with WTO  Members, and at the same time, Japan remains committed to tackling various problems 
caused by COVID -19, together with the international community.  
1.18  Paraguay  
170.  My delegation would like to thank you for your efforts in guiding this process, and for the draft 
report to the General Council which we support. Similarly,  we would like to thank the proponents of 
the waiver as well as the European Uni on for their impeccable work in presenting and defending 
their various proposals. The discussions of the last few weeks have been extremely useful to clarify 
different aspects of the various approaches. To be brief , we shall make a one single statement on 
both items 1 and 2 of the agenda together.  
171.  Paraguay has followed the debate very closely and with great interest and is open to discussing 
in a constructive manner all the proposals that have a comprehensive approa ch, the main goal of 
which is to increase the production of vaccines as well as guaranteeing equitable access and 
distribution in the short term.  
172.  In the case of our country we repeat, as we have done in the past, the fact that we do not 
have any local vac cine production capacity and we depend on imports. Paraguay will consider 
positively any consensual solution that includes additional elements such as greater transparency 
on contracts, measures on facilitation to trade, elimination of restrictions to expo rts, cooperation in 
terms of transport and logistics, facilities to import for those countries which use any of the two 
approaches, including through the COVAX facility mechanisms which we believe could improve the 
equitable distribution between regions. T his is why my delegation reiterates its interest in achieving 
a joint objective which consists in saving lives and hopes to be able to continue discussing other 
aspects in future sessions of the Council such as the example issue of technology transfer and 
know -how, exchange of relevant data and increasing local production capacity.  
1.19  Korea, Republic of  
173.  Thank you Chair for the status report . We appreciate your continued efforts to give this process 
transparency. Ko rea finds the status report objectively reflecting the actual discussion at the 
TRIPS  Council since the last status report. At the TRIPS Council , both the TRIPS waiver proposal and IP/C/M/101/Add.1  
 
- 30 - 
 
  the E uropean Union proposal delegations exchanged views and sought clarific ation through 
consultation in various formats. As indicated in the report it seems obvious that, given the divergent 
views expressed by Members , this Council needs to continue its deliberations on these two proposals, 
and others, if any.   
174.  As reiterated sev eral times previously, we believe that any discussions on IP -related issues at 
the TRIPS Council should serve as a process leading up to the broader package of the WTO overall 
response to the need for increased production and equitable distribution of vacc ines. Korea hopes 
that Members will continue to discuss this and other proposals in an open and constructive manner 
and my delegation will also actively engage with others with a view to helping build consensus.  
1.20  Singapore  
175.  Let me begin by expressing Singapore 's appreciation for your able stewardship of the 
discussions this far. Singapore supports your oral status report to the General Council which is 
objective and factual. In the interest of time, Singapore als o delivers one intervention addressing 
both agenda items 1 and 2.  
176.  Singapore would like to thank the proponents of the TRIPS waiver proposal and the 
European  Union's proposal for your detailed explanations and clarifications over the course of the 
various meetings. The discussions you have had on the proposals have been valuable , and have 
given us much to reflect on. First, we must bear in mind right from the start that all of us have a 
shared objective of increasing vaccine production and enhancing equitable vaccine distribution. We 
have heard in past meetings in statements about the high rate of COVID -19 infections and death, 
especially in developing countries and LDCs. We are faced with a crisis that requires an urgent 
response and Singapore believes the equitable and universal access to COVID -19 vaccines is 
essential to contain the pande mic and for global economic recovery.  
177.  We must keep an open mind in exploring all possible pathways for us to achieve this shared 
objective. Technically, this crisis demands a holistic approach,  and we must identify and use all 
available tools at our dispos al. As such, it is important that the TRIPS Council continues its 
consideration of all proposals in achieving this objective. We note that there have been questions 
and concerns raised on the proposals which have yet to be addressed, such as on the impleme ntation 
timelines or the operationalisation of the proposals. Singapore looks forward to sharing answers to 
these in subsequent meetings.  
178.  We must exercise greater flexibility if we want to achieve an acceptable outcome. Fundamental 
differences persist as to whether IP is indeed a barrier to increasing the production and distribution 
of vaccines and other medical supplies or whether the clarification of the existing TRIPS Articles is 
necessary. In order to achieve an outcome by MC12, Members must continue to  engage 
constructively to address these differences and reach an agreement on a mutually acceptable way 
forward. Singapore reiterates our commitment to contribute constructively to the discussions on all 
proposals.  
1.21  Venezuela, Bolivarian Republic of  
179.  Thank you Chair, we welcome your efforts and think that the draft report is a correct 
assessment of the situation. We join those who have complained about the slow progress made 
despite our meetings It is unfortunate that we are in a third wave with delta variant, with suffering 
of the poorest, most vulnerable countries with no more than 20% vaccination whereas industrialized 
countries have almost vaccinated their entire population. In a pandemic , in a context marked by 
limited capacity of production this far into the pandemic , it is unfortunate that we are still at this 
stage with no prospect of moving forward to enable us to save lives. We , lastly , would like to join 
what was said by the distinguished Ambassador of Cuba about the restrictions on imports on vaccines 
which should also look at the validity  of measures that are unilateral and affect access to vaccines. 
This is necessary on behalf of industrialized countries to ensure universal access to vac cines.  
1.22  New Zealand  
180.  New Zealand is very happy to endorse the status report that was circulated , for which we 
provide our thanks for all the hard work that has been put into it. New Zealand has been pleased IP/C/M/101/Add.1  
 
- 31 - 
 
  with the lev el of detailed engagement which has taken place recently through the combination of 
the Chair 's consultations  and the formal and informal meetings of the TR IPS Council . The elements 
of the waiver proposal have been thoroughly discussed and a wide range of perspectives have been 
canvassed. Discussions of this detail was key, allowing us to reach a common understanding of the 
means by which we can achieve o ur common objective, providing timely  and secure access to 
high-quality, safe, efficacious,  and affordable vaccines and medicines for all.  
181.  While the upscale of manufacturing is happening at pace, more must be done on the 
manufacture and in particular the distribution side to enable us to meet our common goal. 
New Zealand continues to support the co nclusion of a waiver in relation to vaccines. This will form 
a key part of the overall WTO response to the pandemic in the pursuit of our common objective s. 
While further discussion is needed on the detail on product scope, coverage of disciplines, duratio n 
and the practicality of implementation, we are much further along the path than we were a month 
ago. It is our hope that we will be able to reach agreement in the coming months . The COVID -19 
pandemic continues to create tragedy, hardship and loss for mil lions around the world. This Council, 
with the will of the Members, can contribute to the easing of those hardships.  
1.23  Turkey  
182.  We would like to join other colleagues in expressing our support to your status report and our 
appreciation for your leadership and efforts. My statement will cover both proposals on the Council 's 
agenda today.  
183.  We very much value discussions at the WTO on how to respond and contribute to the global 
fight against the COVID -19 pandemic. We observe that Members continue to be divided between 
two different approaches for delivering a swift response to possible IP -related issues. While a large 
group of Members are supporting a wide -ranging waiver on TRIPS Agreement for efforts to tackle 
the pandemic, others  propose facilitation of the use of existing flexibilities provided in Articles 31 
and 31 bis of the TRIPS Agreement. We also take note of the divergent views among Members with 
respect to the advantages of these two different approaches and the concerns ex pressed about 
them.  
184.  We are of the view that both approaches proposed by the Members have their own merits and 
they are not necessarily alternatives to each other. We believe that we should continue our 
deliberations on both proposals, namely , the proposed  waiver and the facilitation of the existing 
flexibilities, for reaching a meaningful and effective outcome to address the IP -related issues in the 
fight against the pandemic. For this purpose, we invite all Members, including the proponents of the 
proposa ls, to engage constructively in discussions for addressing the concerns raised about the 
existing proposals , and bridging the gap between Members.  
185.  While we believe that the proposed waiver may provide Members with important policy -space 
on IP -related issue s during the fight against the pandemic, the product scope and the termination 
of the waiver still need further clarifications. We think that an intensified and focused text -based 
discussion may bring a common -ground on those matters.  
186.  On the other hand, we  would like to thank the E uropean Union for its preliminary answers to 
our questions on its proposal during the informal deliberations of the Council. While we continue to 
reflect on these answers, we still believe that further clarifications are needed on  this proposal with 
regard to the extension it brings on the existing flexibilities in Articles 31 and 31 bis of the 
TRIPS  Agreement. Turkey is ready to engage in discussions with all Members to reach a meaningful, 
relevant and timely answer to the possible  IP-issues in the fight against the pandemic.  
1.24  United States  of America  
187.  I would like to say that we appreciate the efforts of India, South Africa and the other waiver 
proponents, as well as the European Union in putting forward proposals. We are grateful for the 
Chair 's work in facilitating various small -group, informal and formal meetings of the TRIPS Council 
membership to engage on these proposals. The United States believes that it is importan t that all 
formal proposals be given due consideration by the TRIPS Council and we welcome additional 
proposals from other Members. We continue to urge Members to focus on proposals that are 
pragmatic and that gain consensus from the TRIPS Council in a tim ely manner. With respect to the IP/C/M/101/Add.1  
 
- 32 - 
 
  proposed report by the Chair to the General Council on this agenda item, we support the proposed 
language as it provides a factual description of the process and status since the last report.  
1.25  India  
188.   At the outset my delegation would like to thank you for your endeavours in taking this process 
forward . We would also thank Members who have unequivocally supported the waiver proposal . The 
past year -and-a-half ha s been unprecedented in the history  of this Organization  with regards to 
where we have reached on the wavier and our continuous engagement on the proposal , and more 
so because of the waning enthusiasm to finalise it. Since the previous  formal TRIPS Council meeting 
on 8 and 9 June 2021, we have had several rounds of small -group meetings and informal TRIPS 
Council meetings to take stock of the progress made. These meetings gave the opportunity to 
Members to discuss in detail key elements of the waiver proposal like the scope of products as we ll 
as the scope of IP, implementation issues, the duration for which the waiver would be in place and 
other relevant elements .  
189.  I also take this opportunity to inform Members on the outreach undertaken by the proponents 
of the waiver proposal. In continuat ion of our outreach to Members on this proposal in the previous  
two weeks, proponents have engaged bilaterally with several Members and have explained in detail 
the reason and rationale behind the proposal, with an aim to respond to all their concerns. In these 
discussions we have proposed to a few Members to engage bilaterally on the text and iron out the 
differences in a focused manner. However , there seems to be little enthusiasm among these 
Members to engage bilaterally on detailed text negotiation. Generally,  we have seen Members have 
been receptive of such bilateral s during fisheries negotiations. The lack of enthusiasm substantiates 
our fear that a few Members have agreed for the text -based negotiations, but not with an intent of 
concluding  it. Most o f the questions and concerns raised by these Members with regards to the 
waiver text were repetitive and had already been answered in detail , and those responses are 
contained in the docu ments IP/C/W/670 , IP/C/W/672 , IP/C/W/673  and IP/C/W/674 . The 
co-sponsors have engaged positively and responded to these questions at the small -group meetings. 
However, such beating around the bush has only led to losing precious time that also means losing 
lives. Clearly, and sadly indeed, the delaying tactics of these few Members has worked, and that 
entails that we will not be able to deliver the outcome by end of July.  
190.  For the sake of time, my delegation will n ot repeat the detailed responses and statements 
made in the small group and open -ended meetings, and provide these as my written statement to 
the Secretariat to be incorporated in the minutes of the present formal meeting.  
191.  As the challenges posed by the pandemic are still unfolding, we would still need to work 
towards collaborative efforts to combat COVID -19. In this regard, while discussions are moving 
forward on various proposals seeking to combat the crisis and enhance pr eparedness for future 
pandemics, it is our firm belief that the TRIPS waiver proposal remains at the core of our response 
and preparedness. It is also important that we agree on the waiver as it aims at relieving the supply 
side constraints. The waiver ent ails enhancing the production and the supply of vaccines and other 
COVID -related products. This is addressing the root cause of most problems with respect to 
distribution, access and affordability. The past ten months have been s pent discussing the waiver, 
we have lost three million more people with new variants adding to the uncertainties surmounting 
us.  
192.  Only 2% of the least developed countries that represent 14% of the world population  and 23% 
of developing countries that repres ent 70% of the world population  have received at least a single 
shot as of June 2021, compared to 46% of the developed world. With less than 1% of vaccines 
administered in low -income nations, increasingly we see that a two -track pandemic is developing, 
with richer countries having access , while poorer nations being left behind. Each nation 's fate is 
entwined with that of the other , while developed countr y Members  have outpaced developing and 
LDCs in vaccinations, and have also secured supplies for future do ses, such a differential approach 
will not help us in ending the pandemic, as the virus does not different iate and discriminate in 
affecting people.  
193.  Despite Members agreeing to the collective goal of saving lives and the consequen t need of 
augmenting prod uction of vaccines, therapeutics and diagnostics needed to combat  COVID-19, we 
see a lack of urgency and enthusiasm by a few Members to reach a conclusive decision on the waiver. IP/C/M/101/Add.1  
 
- 33 - 
 
  Time is of the essence . We should not miss the opportunity of finalising the waiver. The extraordinary 
circumstances of the pandemic demand more than a moderate collective response, and everyone in 
a position to contribute must do so. Members have agreed to pursue different approaches 
simultaneously in this regard, and without prej udice to each other. The co -sponsors of the waiver 
proposal have reiterated that they welcome all proposals. However,  this understanding from the 
co-sponsors have been construed differently. What we intend to say is that each proposal should be 
considered on its own merit and follow its own course , and agreeing on the waiver does not mean 
that we cannot agree on anything else or vice versa.  
194.  We have also clearly stated in several meetings earlier that the two proposals  cannot be 
clubbed together as they fol low different procedures and legal approaches and with this 
understanding,  we have engaged in discussions on the E uropean Union proposal in good faith, but 
this has not been reciprocated . We have never said that there could only be one approach which 
could deliver. No single mechanism will be able to provide  a perfect solution for this crisis .  
195.  There  have been questions with regards to the uncertainty that the waiver may bring. On the 
contrary, we understand that in fact the waiver would provide more companies with the freedom to 
operate  and to produce more without the fear of infringing on other  parties ' rights and the threat of 
litigation. From what has been reiterated often by a few Mem bers, that they do not see the waiver 
as a response to the crisis, this argument compels us to think that perhaps we do not share the 
urgency, severity and need for quick solutions to put an end to the pandemic. The waiver is 
necessary at this time as the existing flexibilities  in the TRIPS Agreement have not proved to be 
sufficient in the context of the pandemic. Additionally,  the insufficient voluntary mechanism and 
engagement by pharmaceutical companies to scale up manufacturing makes the waiver an impor tant 
policy response for radically increasing manufacturing capacity and thus ensuring sufficient supplies 
and facilitating pathways to achieve equitable access.  
196.  The waiver will be a critical ingredient of the multi -pronged approach to combat the pandemic . 
The proponents have argued previously on many occasions how flexibilities provided in the 
TRIPS  Agreement are inadequate in responding to the pandemic of this magnitude. The limited policy 
space provided by the TRIPS Agreement flexibility to address mono poly actions through the issuing 
of compulsory licences would not be a feasible option in a pandemic. Beyond patents, other IP rights 
including trade secrets, industrial designs , copyrights etc . also pose barriers. Compulsory  licensing 
does not address the  barriers posed by these rights . In fact, these limitations posed by compulsory 
licensing can be addressed by the waiver. The waiver , once approved and applied , would provide 
countries with an effective and expeditious way to remove IP barriers that scuttl e the use of latent 
capacities.  
197.  Lastly, it is imperative of us that we logically and meaningfully conclude what we started. It is 
important that the waiver proposal is taken forward constructively and finalised expeditiously . The 
discussions that were hel d in the small -group meetings on the draft of the oral report of the Chair 
to the General Council do not reflect our position. Such a report to the G eneral Council  by a subsidiary 
body, mandated by Article 9.3 should contain only deliberations with respect  to the waiver and other 
discussions on the TR IPS Council on other proposals could be reflected separately. However,  in the 
spirit of compromise this was agreed to have a report to the G eneral  Council  and also to help move 
the process forward. It is our vi ew tha t any other discussions on other proposal s should be looked 
at separately and are not mutually exclusive or clubbed together with the waiver proposal.  
198.  While we have been painstakingly creat ing this rules -based system, it is to our dismay that 
the rules here get selectively interpreted and run con trary to our understanding of the rule of law. 
These derogations would not help in our efforts of restoring the credibility of this Organization in the 
midst  of the pandemic . This cannot be achieved without delivering on the solutions that would help 
scale up production of life -saving vaccines, therapeutics and diagnostics and ensure access for all.  
India's statement at the small -group meeting held on 22 June 2021  
199.  Let me begin by thanking Members for their continuous engagement on this critical issue, I 
also thank the Chair for his tireless efforts and guidance in bringing this together to this point where 
today we begin substantive discussions on the text, we have come a long way in these nine months, 
wherein we have engaged and discussed the waiver  propos al thoroughly and have now achieved 
concurrence on a range of crucial issues that are pertinent in formulating the solutions to the 
pandemic. We have acknowledged  the existence of supply side problems and therefore the need for IP/C/M/101/Add.1  
 
- 34 - 
 
  expanding manufacturing, we have recognised that there is idle and latent capacity that needs to 
be harnessed, we agree that different aspects of IP and IP -related barriers are impeding the 
availability and accessibility of vaccines and other products required for prevention, treatme nt and 
containment of COVID -19, we are also looking at the limitations of existing TRIPS flexibilities in a 
pandemic situation especially the need to improve upon compulsory licences . This summarises our 
work so far and would be the basis to continue discu ssions on the text with a view to finalise it before 
the next G eneral Council .  
200.  Chair as the proponents of the proposal and as suggested by you Chair in the previous  informal 
meeting, we will begin by discussing the scope. The scope comprises of two elements i.e. the scope 
of products covered by the waiver and the scope of different aspects of IP, it would be prudent to 
focus the discussions today on scope of the produ cts.  
201.  Let me take this opportunity to briefly reiterate and explain the rationale behind the proposed 
Scope. The operative paragraph 1 of revised waiver  text in document IP/C/W/669 /Rev 1. has been 
revised to add specificity to the decision text in response to the concern that the ori ginal decision 
text was too broad. Hence the revised text addresses this concern by focusing the language in the 
paragraph on "health products and technologies " as the prevention, treatment or containment of 
COVID -19 involves a range of products, their mat erials or components, as well as their methods and 
means of manufacture.  
202.  The TRIPS waiver proposal is motivated by the need for swift ramping up of manufacturing, to 
address alleviate the  supply side concerns for timely availability, accessibility and aff ordability of the 
required products to prevent, treat and contain COVID -19.  
203.  Hence, the starting point in determining the scope of health products and technologies to be 
covered by the text is to determine what is needed to prevent, treat, or contain COVID -19. Any 
strategy that does not address these three elements simultaneously would fall short of yielding any 
positive results.  
204.  We have learnt from experiences of the past year and a half that it is critical to scale up 
production and access to personal pr otective equipment (PPE), masks, testing kits, ventilators, 
diagnostics, therapeutics apart from vaccines to prevent the spread and to treat the disease and 
prevent deaths. These resources have been in acute shortage in many countries leading to limited 
accessibility. It became clear that the prevention, containment and treatment of COVID -19 involves 
a range of health products and technologies. It  is clear that vaccines are necessary but not sufficient 
to respond to the pandemic in the short term  
205.  The scope of products is also reflected in the national COVID -19 response strategies, of many 
countries that acknowledge the need to ensure equitable access to critical COVID -19 PPE, tests, 
therapeutics, and vaccines. For example, one of the therapeutic strategy sta tes "vaccines will not 
eliminate the disease overnight and therapeutics will still be needed for patients in hospitals and at 
home, including people suffering from 'long COVID ' (the long -term effects of COVID -19 infection). 
For these reasons, therapeutics will continue to play a significant role in the response to COVID -19.  
206.  In a similar vein another Member recognizes antiviral medicines as part of the 
whole -of-government strategy. What these statements reveal is that therapeutics  are expected to 
play a rol e in addressing the response gaps in the pandemic. WHO 's consultations on COVID -19 
therapeutics reveals that a range of therapeutics will be required including "drug combinations 
targeting specific aspects of infection, as well as suites of treatments targ eting different disease 
processes (such as antivirals, immunomodulators and anti -coagulants) "1. Thus , one cannot ignore 
therapeutics, diagnostics or other health technologies relevant and required to combat COVID -19.  
207.  Equally critical are diagnostics, as the ACT -A strategy recognizes that "Testing is a critical 
element in the armoury of tools needed to defeat COVID -19. Without it, the spread of the virus 
cannot be tracked or contained, patients cannot access the care th ey need, the efficacy of vaccines 
cannot be assessed, nor the emergence of new variants detected. Major gaps in testing are still 
putting lives at risk and threatening progress to end the pandemic. There is an urgent need to scale 
up testing and ensure imm ediate, equitable access to diagnostic tools in every country across the 
 
1 Pg. 5 https://cdn.who.int/media/docs/default -source/blue -print/06_therapeutics_full -achievements -
report.pdf?sfvrsn =d6cdb802_3&download=true . See also p ages 12 and 13.  IP/C/M/101/Add.1  
 
- 35 - 
 
  world. In high -income countries there are 603 tests per 100  thousand  of population compared to 
about 100 tests in middle income countries and about five tests in low -income countries.2 We stress 
that the disparity in testing is hindering efforts to control the pandemic. No country can afford to 
adopt only one intervention in this pandemic. Vaccination and test and treat strategies are needed 
alongside other interventions.  
208.  In this con text, it is justified that the revised text extends to "health products and technologies 
including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their 
materials or components, and their methods and means of manufactur e for the prevention, 
treatment or containment of COVID -19." Having said that Chair, we would like to hear from 
delegations their views on the scope of products proposed by the co -sponsors in the revised decision 
text. 
India's statement at the small -group meeting held on 28 June 2021  
209.  On 22 June, discussions were held on the scope of products and the co -sponsors provided 
justification for the scope of products proposed in the revised decision text.  Today the discussion 
would be focussed on the scope of IP wi th regards to these products. Therefore, the proposal calls 
for a waiver of the application, implementation, and enforcement of TRIPS provisions on copyright 
(Section 1), industrial designs (Section 4), patents (Section 5) and protection of undisclosed 
information (Section 7).  
210.  These categories of intellectual property are relevant to the production, supply, and access to 
COVID -19 health products and technologies. We also point out that Paragraph 3 of the revised text 
makes explicit that the waiver will not  apply to the protection of Performers, Producers of 
Phonograms (Sound Recordings) and Broadcasting Organizations under Article 14 of the 
TRIPS  Agreement.  
211.  The proponents have made several submissions highlighting the relevance of addressing 
existing and potential IP issues in copyright, industrial designs, patents, and protection of 
undisclosed information.  
212.  Let me also reiterate here that the proponents at no point have argued against the Intellectual 
Property rights in fact most of us have robust domestic frameworks protecting Intellectual property 
rights. We must bear in mind that the proposal calls for a limited period waiver from these four 
sections and is an exceptional measure for exceptional circumstances like these.   
Patents  
213.  The patent landscape usually varies from product to product and country by country. In the 
case of COVID -19, the patent landscape remains quite uncertain as many pat ent applications are 
yet to be published.  
214.  In the case of mRNA vaccines there is a complex web of patent holdings. While larger 
companies involved in product development may have a patent portfolio, the patents portfolio to the 
underlying technology is hel d by numerous other academic labs or small biotech companies. This 
reveals the complex patent landscape that exists with respect to mRNA technology.   
215.  In the case of therapeutics, in  document  IP/C/W/670  the co -sponsors have presented a 
preliminary patent landscape that offers a non -exhaustive  snapshot of the patent filing and granting 
status on five selected therapeutics candidates. However, many more therapeutics are being 
investigated and evaluated for efficacy against COVID -19. Some of the therapeutics under 
investigation are presently off -patent but as its use is explored for COVID -19 treatment, the filing 
of new patent applications extending to secondary uses of these therapeutics is expected. A similar 
situation exists with respect to other health products and technologies as well.  
Trade  Secret Protection  
216.  In addition to patents trade secret protection is another hurdle to access various health 
products and technologies. With respect to vaccines and bio -therapeutics, the manufacturing 
methods and techniques (know -how) tend to be protected by trade secrets. This includes dossiers 
 
2 http://www.finddx.org/covid -19/test -tracker/  IP/C/M/101/Add.1  
 
- 36 - 
 
  to obtain regulatory approval that will usually include robust information regarding the 
manufacturing process, formulation and dosage, method of delivery, storage conditions, indicated 
uses along with safety and ef ficacy information. Hence the importance of addressing protection of 
undisclosed information under Art icle 39 of TRIPS.   
217.  Lifting trade secret protection is essential to expanding and diversifying global production. For 
instance, by waiving trade secret pro tection, and as a start facilitating the sharing of regulatory 
dossiers especially with potential manufacturers, existing production capacity especially in 
developing countries can be mobilised. And as demonstrated sufficiently now most recently by the 
event hosted on the 14 April where interaction with several pharmaceutical companies did show that 
several unused capacities do exist in several developing countries.  
218.  The slow roll out of vaccination in developing countries is testament to the fact that the c urrent 
system of production and supply is not working to deliver equitable access. Numerous examples 
have been reported of the industry turning down offers of help from other drug makers, including 
those from developing countries, to boost global manufactu ring and supply. There have been and 
continue to be similar experiences in developing countries and least developed countries. We have 
also provided other examples in para graph  43 of  document  IP/C/W/672  and para graph  65 in 
document IP/C/W/673 . 
219.  These numerous examples show how in a pandemic we cannot rely solely on ad hoc , 
non-transparent and unaccountable voluntary mechanisms. The existing mechanisms are not 
delivering and artificially constraining supply, at the expense of prolonging the pandemic, lives and 
live hoods around the world. A pandemic by nature of its spread, s everity and uncertainty needs 
global collaboration and extraordinary measures.  
220.  We need supply now and at least in the near future and we need supply at affordable prices. 
With developed countr y Members  prebooking future supply for boosters and additional rounds of 
vaccination, we urgently need to ramp up manufacturing and this requires the lifting of trade secret 
protection. Expanding manufacturing of health products is crucial not only for this pandemic but also 
for future pandemics. The waiver, if grante d, would provide potential manufacturers the freedom to 
operate and achieve economies of scale, thereby incentivizing production and supply of therapeutics 
and vaccines.  
Copyright and Industrial Designs  
221.  Copyright and Industrial Designs are also categories of IP that may hinder production and 
supply. Copyright issues may also arise in other situations such as with respect to software in medical 
devices, compilation of data and algorithms, product information documents or product labelling, 
diagnostic kits, a nd digital technologies , etc. 
222.  In document IP/C/W/673 , the co -sponsors responded in detail from para graph  54 to 63 on the 
industrial design and copyright challenges faced by Members in procurement or of seeking local 
manufacture or production of COVID -19 diagnostics, equipment, therapeutics o r vaccines. In the 
same document the co -sponsors illustrated the case where a hospital ran out of ventilator valves 
and had 3D -printed replacement valves at a much lower cost, but it was stymied by threats of IP 
infringement.  
223.  These instances elucidate tha t complex intellectual property issues are involved in the 
manufacture and supply of needed health technologies and their parts, and these issues go beyond 
patents.  
224.  The proponents and the co -sponsors of the waiver have these four elements in scope of IP a s 
we believe that rather than entering discussions on the nitty -gritties of the relevance of each section 
we must work towards the final objective that is to ramp up production and save lives. We must list 
out all possible elements of IP that may be a barr ier in achieving our final goal.  
225.  Finally, would like to draw attention to the fact that we often tend to overlook the lessons 
learned from the HIV/AIDS crisis where an absence of IP landscape did enable augmenting 
production of life saving generic drugs, t hereby enhancing both accessibility and affordability of ARVs 
and FDCs which helped saved millions of lives. The current pandemic is far worse, severe and 
unprecedented, the waiver would be an enabler to boost the production of vaccines, therapeutics IP/C/M/101/Add.1  
 
- 37 - 
 
  and o ther health products needed to combat the virus. Increased production coupled with robust 
competition; we see a substantial reduction in prices. Here would give an example of a study that 
shows that for products with a single generic producer, the generic Average Manufacture Price is 
39% lower than the brand AMP before generic competition, with two competitors, that generic prices 
are 54% lower with four competitors the generic prices are 79% less than the brand drug price 
before generic entry and with six or more competitors, generic prices show price reductions of more 
than 95% compared to brand prices.  
226.  Thus, the waiver would aid in ramping up production, fill the supply side gaps, and this 
augmented supply would ensure both accessibility and affordabilit y. We are of the view that a waiver 
once implemented will provide greater certainty to manufacturers by providing them freedom to 
operate, and for governments to collaborate to increase supply options. Waiver being sought for a 
limited period and that too only from some specific TRIPS provisions in such testing times does not 
increase uncertainty for the IP system. This is not an ideological debate on the IP regime per say. 
Instead, it shows that in exceptional circumstances, the IP system can be flexible a nd 
accommodating and one that can be manoeuvred to suitably address the unprecedented challenges 
posed by the pandemic. We have heard from some Members in the recent meetings that they do 
not see waiver  as a part of the solution, and do not see how IP is a  barrier even for vaccines 
production. Had that been the case why have these Members agreed to engage in the text -based 
negotiations on the waiver proposal which was clear from the previous  formal meeting held on 
8-9 June 2021. Was this the case such Members should be more forthcoming during the discussions 
on whether to start the text -based negotiations or not. Or is it an attempt to filibuster the entire 
process? And hopefully if that is not the case, we would urge Member s to engage constructively and 
in good faith on the waiver  text under consideration with an aim to finalise it.  
227.  It will be presumptuous to think that the co -proponents do not believe in IPR, some Members 
have argued that they do not see waiver of IP resul ting in augmenting manufacturing or as a 
measure easing supply side constraints, or having impact outside voluntary licensing mechanisms , 
on the other hand they firmly believe and argue that this proposal will cause significant damage to 
commercial intere sts of IP rights holders so both arguments cannot be true at the same time, we 
cannot have the cake and eat it too. And if the proposal seriously damages the commercial interests 
of a few private entities by ramping up production then we are on our way to achieve our objective. 
And if the waiver fails to succeed as some Members say there will be no harm to commercial interests 
and this could be another tool in the WTO policy toolkit.  
228.  We have agreed to work on a multipronged approach to tackle the crisis an d finalising the 
waiver is a step forward towards our end goal of saving lives. Thus, discussions must be continued 
in a constructive and focussed manner on the waiver text towards achieving this. Other proposals 
will be considered separately and not in ta ndem with the waiver proposal.  
229.  These elaborate explanations provide the basis of including in the revised decision text the 
relevant parts of the TRIPS Agreement within the scope of IP, that should be waived to ramp up 
production and supply.  
India's stat ement at the informal meeting held on 30 June 2021  
230.  Chair, I thank you for your summary of the discussions that took place in the small group 
meetings held on 22 and 28 June  2021. There were several questions posed and answers provided 
both on the scope of products as well as on the scope of IP. While all Members have committed to 
engage in text-based negotiations it is disappointing to note that some Members are not willing to 
contribute to the waiver text with an aim to finalize it.   
231.  In the past nine months we all have invested our time and energy in discussing the waiver 
proposal in various formats formal informal at the TRIPS Council, in small group meetings as well as 
in bilateral engagements. All Members have concurred that there is  a dire need to enhance the 
production of health products including vaccines, diagnostics, and therapeutics to ensure timely and 
equitable access. All Members have further agreed that various ways can be pursued simultaneously 
and without prejudice to each  other. Furthermore, Members including the proponents and 
co-sponsors of the waiver proposal have said that they welcome all proposals, and it is only fair to 
say that each proposal should be considered on its own merit and as to what it brings on the tabl e 
as a part of the solution. The waiver has been a standalone agenda item and cannot be clubbed 
together with any other proposal, the waiver proposal will follow a different procedural course under IP/C/M/101/Add.1  
 
- 38 - 
 
  Article  IX.3 of the Marrakesh Agreement. Its therefore not  clear as to how the waiver and the 
European Union proposal stand on equal footing.  
232.  From what has been reiterated often by some Members that they do not see waiver as a 
response to the crisis, well more than half of the membership does see waiver as a leg itimate policy 
option that could be used to offset the supply side constraints. This argument compels us to think 
that perhaps we are not on the same boat and the urgency, severity, and the need for quick solution 
in the form of waiver would depend on the vantage point of the Member, whether you are the one 
who has secured access to vaccines, therapeutics medicines or you are part of the scramble.  
233.  On the EU proposal, notwithstanding the fact that compulsory licences  and other TRIPS 
flexibilities are import ant, but the limited policy space provided by the TRIPS Agreement flexibilities 
to address egregious monopoly actions through issue of compulsory licen ces has not until now 
proved to be a feasible and expeditious option in a pandemic of this scale and magn itude.  
234.  Invoking compulsory licen ces across a wide range of medical products, that too on a "case by 
case" or "product by product " basis is a cumbersome and time -consuming process, severely limiting 
their effectiveness, in the context of products and technologies required for fighting the virus. 
Beyond patents, other IP rights, including trade secrets, industrial designs, copyrights,  etc. also pose 
barriers. Compulsory Licensing does not address the barriers posed by these rights.  The 
understanding and implementation of TRIPS flexibilities in IPRs other than patents are limited 
making their use to address the supply side constraints f or products required for dealing with ongoing 
pandemic not a viable option.  
235.  Additionally, the medical technologies required for C OVID -19 response are surrounded by a 
thicket of patents and other intellectual property rights. Practically, operating within the current 
system means that each country is obligated to use its stretched human resources to identify which 
of the patents and other IPRs are relevant and thus should become the object of a compulsory 
licence. The accompanying delays in such a process a re unacceptable in an emergency like this.  
236.  Furthermore, Article 31 bis which allows export to countries with insufficient or no 
manufacturing capacity, is subject to extremely cumbersome and lengthy procedures, rendering it 
meaningless and impractical to use especially in a pandemic where each delay costs several lives. 
Simply put, there are currently no provisions in TRIPS Agreement  to allow countries to act more 
expeditiously in a global crisis to use Article 31 compulsory licensing to export without limitation on 
quantity and other additional procedural requirements. In fa ct, these limitations posed by the 
compulsory licences  can be easily addressed by the waiver . Moreover, the EU proposal does not 
bring any value add to the existing flexibilities rather a fundamental flexibility enjoyed by WTO 
Members to determine any grou nds for compulsory licensing as explicitly affirmed by 
Doha Declaration, the proposal however as an unintended consequence asks for an agreement to 
be reached to allow WTO Members to use the pandemic as a ground for issuing compulsory licensing 
thereby red ucing the existing flexibility enjoyed by all WTO Members.  
237.  I stated in an earlier discussion Chair, that if a particular prescription is not effective in treating 
a disease then, it is only logical and prudent to find a new prescription, we do not continu e following 
the old prescription.  
238.  Chair, lastly, it is imperative upon us that we logically and meaningfully conclude what we 
started, it is important that the waiver  proposal is taken forward constructively and finalized 
expeditiously. We look forward to  intensive discussions on other elements of the waiver text 
including the implementation issues and duration in the upcoming TRIPS Council  meetings.  
239.  The credibility of this organization will not be successfully reinstated if it overlooks vital policy 
options like the waiver  that acts as an enabler, a policy option among the many options being 
discussed, for Members to use as per their own needs and circumstances. We owe this not just to 
ourselves but to our future generations as well.  
240.  Members have often sa id this crisis is unprecedented, we need extraordinary measures, we 
need concerted multilateral efforts, saving lives is a priority, no one is safe until everyone is safe 
well the time to act on this is now. Now is the time Chair for us to walk the talk.  IP/C/M/101/Add.1  
 
- 39 - 
 
  India's statement at the small -group  meeting held on 5 July  2021 
241.  The WHO COVID -19 dashboard of 4 July 2021 shows that there have been over 184 million 
confirmed cases of COVID -19, including 3.9 million deaths, reported to WHO. As of 1 July 2021, a 
total of 2.95 billion vaccine doses have been administered. 75 % of these doses, however, have been 
administered in the developed countr y Members . Only about 1 % of people in low -income countries 
have received at least one dose. Until June not more than 3 bi llion vaccines have been produced, it  
is difficult to fathom how without taking exceptional measures, like agreeing to the waiver  proposal, 
will we be able to reach an output of even 10 billion doses by the end of the current year. Again, we 
often forget t hat it's not just the availability of supply but also the vast inequity both in accessibility 
and affordability of these supplies.  
242.  Previously as well, in several discussions the proponents of the waiver  proposal have presented 
their understanding and rati onale behind the proposed implementation and duration of the waiver . 
We are grappling with a novel pathogen, and this novelty brings with it many uncertainties. There 
are emerging variants and mutations and while we are better off in our understanding of t he virus 
than the previous  year still many unknowns remain with respect to the duration of immunity provided 
by the vaccines, effectiveness of these vaccines against new variants, whether or not there will be 
a need for a booster dose, or the requirement f or an annual vaccination.  
243.  All these elements such as the duration of immunity conferred, need for booster doses, 
effectiveness of vaccines against new variants, and the need of vaccines for children will determine 
the scale of manufacturing needed and sup ply that will be needed to control the pandemic, and this 
is just for the vaccines. Production for therapeutics, diagnostics and other COVID 19 related health 
products will also need to be ramped up in order to diagnose and treat people as subsequent waves  
continue infecting people across the globe.  
244.  Therefore, with regards the time or duration of the waiver the revision text states that the 
waiver  shall be in force for at least three  years from the date of this decision. And the uncertainties 
and reasons t hat we just cited along with the concerns raised by Members in earlier meetings on the 
original text, the proponents have proposed this, this also clearly captures the temporary nature of 
the waiver . Furthermore, the General Council shall determine the dat e of termination of the waiver, 
once the exceptional circumstances justifying the waiver cease to exist.  
245.  What needs to be guiding us while deciding on the timeline therefore is that the duration also 
has to be practical for manufacturing to be feasible and  viable. The complexities and uncertainties 
related to the pandemic suggest the need for a practical and flexible duration. Hence it is proposed 
that the General Council assesses the existence of the exceptional circumstances justifying the 
waiver after a minimum period to determine the date of termination. The proposed language is 
based on Article IX (4) of the WTO Agreement. Importantly, in accordance with the provisions of 
paragraph 4 of Article IX of the WTO Agreement, the waiver  shall be reviewed by th e General Council 
not later than one year after it is granted, and thereafter annually until the waiver terminates.  
246.  Now coming to the implementation of the waiver , we have reiterated that the waiver is not a 
prescriptive tool, it 's an enabler. National imp lementation of the waiver depends on a country 's 
political and/or constitutional arrangement. There is no one size fits all approach to national 
implementation. However, once the waiver proposal is approved, emergency, disaster management 
legislations or a ny other relevant legislative methodology may be relied upon to provide for executive 
action to operationalise the waiver at the national level.  Many governments have/are already using 
executive action to put in place lockdowns, quarantine, and other measu res to curb the spread of 
present pandemic.  
247.  As we have mentioned, at several meetings earlier on this issue the national implementation 
should be left to national governments as each operates within its own legal system. We also believe 
that in many cases  implementation may be done through executive action, relying on existing 
national legislation or through use of emergency legislative provisions.  
India's statement at the informal meeting held on 6 July 2021  
248.  Chair let me thank you for your efforts in taking this process forward, the past few meetings 
in the small group format were quite helpful in taking these discussions forward and inputs from 
Members does help in improving the text and arriving at a landing  zone.  IP/C/M/101/Add.1  
 
- 40 - 
 
  249.  Chair before coming to the substantive part of the intervention, as suggested by you yesterday 
Chair, I take this opportunity to inform Members on the outreach undertaken by the proponents of 
the waiver  Proposal. In continuation of our outreach to Members on this proposal in the last two 
weeks proponents have engaged bilaterally with several Members and have explained in detail the 
reason, rationale behind the proposal, with an aim to respond to all concerns raised. In these 
discussions we proposed to some Members to engage bilaterally on the text and iron out the 
differences in a focused manner, however, there seems to be little enthusiasm among these 
Member s to engage bilaterally to discuss the text. Generally, Member s have been receptive of such 
bilateral during fisheries negotiations, chair this lack of enthusiasm substantiates our fear that some 
Member s have agreed for TBN but not with an intent of concluding it.  
250.  Chair in the short time span when we have begun 13 million people have got further infected,  
and 430 thousand more lives have been lost. In total so far there have been over 184 million 
confirmed cases of COVID -19, including 3.9 million deaths, reported to WHO as per the WHO 
COVID -19 dashboard of 4th July 2021. Chair , time is of the esse nce we do not want to miss the 
opportunity of finalizing the waiver  in July and get going on finding modalities for ramping up 
production for COVID -19 related health products.  
251.  As of 1 July 2021, a total of 2.95 billion vaccine doses have been administered . 75% of these 
doses, however, have been administered in the developed countr y Members . Only about 1 % of 
people in low -income countries have received at least one dose. Until June not more than 3 billion 
vaccines have been produced, it is difficult to fath om how without taking exceptional measures, like 
agreeing to the waiver  proposal, will we be able to reach an output of even 10 billion doses by the 
end of the current year. Again, we often forget that it is not just the availability of supply but also 
the vast inequity both in accessibility and affordability of these supplies.  
252.  Previously as well, in several discussions the proponents of the waiver  proposal have presented 
their understanding and rationale behind the proposed implementation and duration of the waiver . 
We are grappling with a novel pathogen, still many unknowns remain with respect to the duration 
of immunity provided by the vaccines, whether there will be a need for a booster dose, or the 
requirement for an annual vaccination also there are v arying reports on how long it will take to roll 
out vaccination globally to ensure immunity. Demand in developed countr y Members  for booster 
doses and vaccines for teens and children will further impact supply in developing countries. And 
even more importa ntly, vaccines will not only be needed in 2021 but also beyond. Some developed 
countr y Members  have already reserved vaccines right up to 2025.  
253.  Among all these uncertainties one thing is certain and clear to us that wherever vaccination 
rates are higher t he severity of the disease in the form of hospitalization and mortality is lower. 
Augmenting the manufacturing of vaccines as of now seems to be the only way to save lives and 
therefore we should aim for producing 14 billion doses by the end of 2021.  
254.  Chair, apart from vaccines production for therapeutics, diagnostics and other COVID -19 related 
health products will also need to be ramped up to diagnose and treat people as subsequent waves 
continue infecting people across the globe. The pandemic has already gone on for 1.5 years and 
right now no end in sight with infections rising in most countries. While the pandemic continues 
unabated it would be unwise for us to have a short time frame for a TRIPS waiver.  
255.  What needs to be guiding us while deciding on the timeline therefore is that the duration of 
the waiver  must be practical to scale up manufacturing a noticeably short time might not be feasible 
and viable for the intended purpose of ramping up manufacturing.  
256.  With these reasons in mind the proponents in t he revision text have proposed that the waiver  
shall be in force for at least three  years from the date of this decision. This also was in response to 
concerns raised by Member s in earlier meetings on the original text, this duration also clearly 
captures the temporary nature of the waiver . The duration of three  years is also reflective of the 
fact that co proponents at no point in time have intended for the waiver to be of an indefinite nature.  
257.  Further it is proposed that the General Council assesses the existence of the exceptional 
circumstances justifying the waiver after a minimum period to determine the date of termination. 
The proposed language is based on Article IX (4) of the WTO Agreement. Importantly, in accordance 
with the provisions of paragraph  4 of Article IX of the WTO Agreement, the waiver  shall be reviewed IP/C/M/101/Add.1  
 
- 41 - 
 
  by the General Council not later than one year after it is granted, and thereafter annually until the 
waiver terminates. And as was discussed in the small group meeting yesterday we are op en to 
deliberate on these aspects further based on any suggestions.  
258.  Now coming to the implementation part of the waiver  and responding to the concerns raised 
by Member s with respect to lack of guidance or mechanism in the text on the domestic 
implementation of the waiver , we have reiterated that the waiver is not a prescriptive tool, it is an 
enabler and therefore national implementation of the waiver depends on a count ry's political and/or 
constitutional arrangement. There is no one size fits all approach to national implementation. 
However, once the waiver proposal is approved, emergency, disaster management legislations or 
any other relevant legislative methodology ma y be relied upon to provide for executive action to 
operationalise the waiver at the national level.  Many governments have/are already using executive 
action to put in place lockdowns, quarantine, and other measures to curb the spread of present 
pandemic.  
Rebuttal  
259.  TRIPS flexibilities have played a crucial role in promoting access to medicines. The use of such 
flexibilities and the waiver are not mutually exclusive. However, the global pandemic presents 
exceptional circumstances for the international community that demands an exceptional global 
solution. After all, countries all over the world have had to put in place extraordinary measures to 
contain COVID -19.  
260.  Compulsory licen ces are issued on a country by country, case by case and prod uct by product 
basis, where every jurisdiction with patents would have to issue compulsory licen ce, practically 
making collaboration among countries for the development and manufacturing of medical products 
(where different components are sourced from diff erent countries) onerous.   
261.  Further Article 31 bis mechanism (that waives the condition in Article 31(f) that a compulsory 
licence should be predominantly for the supply of the domestic market) established to support 
countries with insufficient pharmaceutica l manufacturing capacity has been found to be cumbersome 
like the mechanism includes procedures such specific labelling or marking of products; special 
packaging and/or special colouring/shaping of products. Moreover, the E.U proposal does not bring 
any va lue add to the existing flexibilities, it seeks to clarify something that is not in dispute on the 
contrary could limit existing flexibility.   
262.  Much has been said about "business as usual voluntary licensing " as the way out of this 
pandemic and yet more tha n a year on, this "business as usual " approach premised on voluntary, 
secretive, limited and restrictive licensing has failed to leverage global expertise and capacity to 
scale-up manufacturing and deliver equitable access. Instead, this approach has limit ed competition, 
and is artificially constraining global supply.  
263.  These "business as usual " approaches championed by some Member s is not the global solution 
but really the root cause of why to date we have less than 1 % of people in low -income countries 
that have received at least one dose.  
264.  The global needs are massive and can only be addressed with global sharing of technology, 
knowledge and related IP, which is what our waiver proposal seeks to achieve. We believe it would 
be naïve for any country to think  that it can win over a virus, which knows no boundaries, by securing 
vaccinating their own population. By putting boundaries to and limit Member s policy options in 
combating the virus that knows no boundary seems to be counterintuitive .  
265.  A recurring conce rn against the waiver proposal is the impact on the incentives for the 
development of diagnostics, therapeutics and vaccines.  Generally , R&D in emerging infectious 
diseases (EIDs) has been driven by public investment. The narrow emphasis on maintaining 
intellectual property to increase resources for private pharmaceutical R&D, disregards the fact that 
rapid development of COVID -19 diagnostics, therapeutics and vaccines is the sum of public funding 
and global collaboration. The waiver is more than just a leg al mechanism, it is a statement of intent 
by all countries that they accord highest value to protecting human lives rather than protecting 
private profits.  IP/C/M/101/Add.1  
 
- 42 - 
 
  266.  The TRIPS waiver is a necessary, proportionate, and temporary legal measure for clearing IP 
barriers  paving the way for more companies to produce COVID -19 vaccines and other health 
products and technologies by providing them freedom to operate without the fear of infringement of 
IP rights or the threat of litigation.  
267.  Chair, to conclude we would say we al l need to rise to the demands of this crisis and show to 
the world that WTO is still relevant and very much capable of responding to the global need of saving 
lives and livelihoods, at least during a health crisis like COVID -19. We have been open to the 
suggestions from Members on the text of the Proposal and look forward to subsequent discussions 
in small group meetings or other formats including further discussion on elements like undisclosed 
information, duration or any other aspects and look forward t o a constructive discussion in small 
group meetings.  
India's statement at the small -group meeting held on 9 July 2021  
268.  Chair let me begin by some comments on the implementation aspect of the waiver. Among 
WTO Member s there is a diversity of legal systems, h ence national implementation of waiver depends 
on a country 's political and/or constitutional arrangement. Similarly, the parameters and conditions 
of implementation should be a national decision. Each country will need to decide what is needed 
nationally to curb COVID -19 and the parameters of implementation. One size does not fit all as the 
legal systems, needs and conditions varies from country to country. In fact, the IP systems instituted 
in Member  countries differ from each other. Therefore, the propon ents of the waiver  have not 
prescribed definite set of rules or methods as far as national implementation of the waiver is 
concerned.  
269.  In order to expeditiously implement the TRIPS waiver  each Member should decide what is the 
best approach in the context o f their legal system and this need not involve an amendment of the 
intellectual property laws.  
270.  Some countries have invoked emergency provisions or enacted legislation to implement the 
wide range of measures required for effective response to the COVID19. Such legislation may also 
provide governments the discretion to implement measures with respect to existing laws or 
privileges and such provisions could be used for the implementation of the TRIPS waiver. In some 
country 's emergency legislations has been u tilised to make changes to intellectual property 
legislation.   
271.  Apart from the emergency powers the executive may also have certain powers under the 
Constitution to issue orders suspending or amending the legal provisions. For instance, I can give 
an exampl e for India where if both houses of the parliament are not in session, to avoid delay in 
passing a legislation the executive can give effect to the waiver decision through an ordinance. Under 
Article 123 of the Constitution "the President is satisfied that  circumstances exist which render it 
necessary for him to take immediate action, he may promulgate such Ordinances as the 
circumstances appear to him to require ". The ordinance can then be tabled for the approval of both 
house of parliament within six months from the date of its promulgation and becomes law after the 
obtainment of the assent of the parliament. WTO Members may also have disaster management 
laws to organise an effective response to disasters including a pandemic. These laws may also 
contain p rovisions providing powers to the government to suspend the operation of legislations to 
take effective measures.  There is also the option of amending national intellectual property 
legislations. Such an amendment need not be a time -consuming exercise. In this pandemic we have 
seen governments fast tracking enactment of legislation and taking extraordinary measures for 
controlling the pandemic.  
272.  Since the outbreak of the pandemic, almost every country has implemented or is still 
implementing lockdown in som e form or other to contain the spread of COVID -19. That does not 
mean that authorities of these countries were against the fundamental rights of "freedom of 
movement " of their citizens. Governments worldwide have also introduced fiscal packages to the 
tune of trillions of US dollars to help the recovery of ailing economies. That does not mean that they 
have deviated from their stated objective of fiscal consolidation towards fiscal profligacy. In the 
same light, the temporary waiver from certain provisions of TRIPS Agreement does not mean that 
the co -sponsors are against the Intellectual Property Rights but  are arguing only for a temporary 
departure therefrom to ensure enhanced manufacture, timely supply and enhanced accessibility as 
well as affordability of  health products essential for prevention, treatment and control of COVID -19. IP/C/M/101/Add.1  
 
- 43 - 
 
  The global community has resorted to exceptional measures in the exceptional circumstances of 
pandemic, and the waiver  should be seen in a similar vein. The proposed waiver requi res a one -time 
implementation and, for the duration of the waiver, will remove legal barriers, create freedom to 
operate facilitating collaboration at the regional and global levels, allow economies of scale to be 
achieved, motivating further manufacturing , and consequently lower prices. With a waiver, the 
administrative and procedural delays and conditions linked to Article 31 and 31 bis will be avoided, 
meaning that countries will have full freedom to collaborate, manufacture and supply the required 
products.  
273.  Some arguments from Member s portray that it is the IP system and the incentives that accrue 
from this system that has driven all innovation and R&D. However, it cannot be denied that it was 
public funding, the institutional support in terms of research contributions by public universities, the 
global collaboration in sharing of genome sequencing data and public health information th at has 
led to the development of successful vaccines in record time. We respect the intellectual property 
rights and their value as incentives for innovation, but for the COVID -19 pandemic research and 
innovation has mostly been spearheaded by massive publ ic funding, expedited regulatory approvals, 
and global collaboration. While millions of lives have already been lost, and no respite is in sight , 
where the only thing certain is the uncertainty , we cannot just rely on endeavours and voluntary 
mechanisms of  a handful of private companies to secure an end to this pandemic. The proponents 
have always argued that the waiver  is not standing in the way of any other solution or way that we 
could pursue, it is one of the many ammunitions in the policy arsenal of Members that can be 
deployed to fight the virus. The waiver  is a collective response to a collective crisis; this should not 
be viewed as a zero -sum game.  
Duration  
274.  Let me quickly reiterate our understanding and rationale behind the proposed duration of the  
waiver . We are combating a novel virus . There are emerging variants and mutations that lead to  
uncertainty with respect to the duration of immunity provided by the vaccines, the effectiveness of 
these vaccines against these new variants, whether or not th ere will be a need for a booster dose, 
or the requirement for an annual vaccination, the need and efficacy of vaccines for children and 
teens, and the duration of immunity conferred by them. All these factors determine the scale of 
manufacturing needed and  supply that will be needed to control the pandemic, and this is just for 
the vaccines. Production for therapeutics, diagnostics and other COVID 19 related health products 
will also need to be ramped up in order to diagnose and treat people as subsequent w aves continue 
infecting people across the globe.  
275.  Therefore, with regards to the time or duration of the waiver the revision text states that the 
waiver  shall be in force for at least three  years from the date of this decision.  
276.  While deciding on the timel ine or the duration one has to keep in sight that this duration is 
practical, feasible and viable for scaling up manufacturing, however , as said in last small group 
meeting as well proponents are open to constructive suggestions on the duration and would r ather 
have Members provide an alternative to this formulation than raising similar question on the 
duration.  
India's statement at the informal meeting held on 14 July 2021  
277.  Chair, thank you for your opening remarks summarizing the discussions that took place in the 
small group meetings. Also Chair I take this opportunity to thank you for your efforts in organizing 
and taking forward these discussions.  Since the previous  formal TRIPS Council meeting on the 8 -
9th June  2021 we have had several rounds of sma ll group meetings and informal Council meetings 
to take stock of the progress made. These meetings gave further opportunity to Member s to discuss 
in details key elements of the waiver  proposal like the scope of products as well as on the scope of 
IP, imple mentation issues, the duration for which the waiver  would be in place and other elements.  
278.  I thank South Africa for their comprehensive summary on these discussions that were held in 
these small group meetings . It is helpful for the information of the larger membership participating 
today.  
279.  Chair, briefly , as you suggested we would inform on our outreach with Member s. Chair, in the 
last few weeks the proponents have continued their outreach to Member s and have engaged IP/C/M/101/Add.1  
 
- 44 - 
 
  bilaterally with several Member s explai ning in detail the reason, rationale, and our understanding 
behind the proposal, and have responded to the many concerns raised. In these discussions we 
proposed to some Member s to engage bilaterally on the text and iron out the differences in a focused 
manner, however, there seems to be little enthusiasm among these Member s to engage bilaterally 
to discuss the text. Generally, Member s have been receptive of such bilateral s during fisheries 
negotiations . Chair, this lack of enthusiasm substantiates our fear  that some Member s while agreeing 
for text-based negotiations in 8-9 June TRIPS Council meeting , have shown lack of interest when 
the actual process started thus not allowing a text-based negotiation .  
280.  The Pandemic will not wait for MC12 . Its spread will continue unabated negatively impacting 
lives and livelihood s. Also the virus will not take a break or pause while we go for our summer break 
and come back to the issue of scaling up manufacturing and ensuring equitable access in September 
after whilin g away our time in July and taking a break in August. As responsible Member s we have 
responsibility to conclude this if we all agreed to start it and reach a minimal understanding on the 
text by July end.  
281.  Chair, in the past nine months that we spent discussing the waiver  we have lost 3 million more 
people, with new variants adding to the uncertainties surmounting us, only 2% of least developed 
countries (that represent 14% of the world population) and 23% of deve loping countries (that 
represent 70% of the world population) have received at least one shot as of 23 June 2021 compared 
to 46% of developed world receiving a shot. This huge disparity and gap in accessibility and 
affordability of vaccines must be a drivi ng force for us to deliver an outcome in the form of waiver .  
282.  Despite Member s agreeing to the collective goal of saving lives and the consequent need for 
augmenting production of vaccines, therapeutics and diagnostics needed to combat COVID -19 we 
see lack of urgency and enthusiasm in some Member s to reach a conclusive decision on the waiver . 
Chair , time is of the essence we should not miss the opportunity of finalizing the waiver  in July and 
get going on finding modalities for ramping up production for COVI D-19 related health products.  
283.  Each nations ' interests are entwined with that of the other, while developed countr y Members  
have outpaced developing and LDCs in vaccinations and have also secured supplies for future doses 
such differential approach will no t yield results of ending the pandemic, as the virus will not 
differentiate and discriminate in affecting people.  
284.  The extraordinary circumstances of the pandemic demand more than a minimal or even 
moderate collective response and everyone in a position to  contribute must do so. Members have 
agreed to pursue different approaches simultaneously in this regard and without prejudice to each 
other. The co -sponsors of the waiver proposal have reiterated that they welcome all proposals, and 
that each proposal sho uld be considered on its own merit and follow its own course. And we have 
engaged in discussions on the E.U proposal as well in good faith. We have never said that there 
could be only one approach which could deliver, no single mechanism will be able to pr ovide a perfect 
solution for this crisis. There have been questions with regards the uncertainty that waiver  may 
bring on the contrary Chair we understand that in fact the waiver  would provide more companies 
with freedom to operate to produce more without the fear of infringing another party 's rights and 
the threat of litigation.  
285.  While Member s have been undertaking extraordinary measures domestically in the form of 
lockdowns, quarantine and restricting movement of its people thereby essentially curtailing their 
fundamental human rights, for the larger and greater good. We have seen there has been no problem 
in the implementation of such extreme measures. Similarly, the economic stimulus packages that 
many Member s have provided to their domestic industries w ithout a prerequisite of this stimulus not 
being used to target exports which can potentially distort global trade.  All these extraordinary 
measures were taken, and no questions were raised as to their compatibility with WTO agreements 
or Member s' internat ional obligations . The waiver  should also be viewed in a similar vein as a 
temporary and extraordinary measure.  
286.  From what has been reiterated often by some Member s that they do not see the waiver  as a 
response to the crisis. This argument compels us to th ink that perhaps we do not share the urgency, 
severity, and the need for quick solution to put an end to the pandemic. The waiver  is necessary at 
this time as the existing flexibilities in the TRIPS Agreement  have not proved to be sufficient in the 
context  of the pandemic. Additionally, the insufficient voluntary mechanisms and engagements by IP/C/M/101/Add.1  
 
- 45 - 
 
  pharmaceutical companies to scale up manufacturing makes the waiver  much needed for radically 
increasing manufacturing capacity and thus ensuring sufficient supplies a nd facilitating pathways to 
achieve equitable access. The waiver  will be a critical ingredient of the multi -pronged approach to 
combat the pandemic.   
287.  The EU proposal talks only about compulsory licen ce under Article 31 and Article 31 bis of the 
TRIPS Agreement . These Articles are confined to the issue of patents. Hence, the proposal by the 
EU attempts to address only patent barriers and not intellectual property barriers in general in 
responding to the pandemic. Issues such as trade secret, copyright, industrial designs, etc which 
are equally important barriers are out of the purview of this proposal. The proposals by the EU are 
confusing and repeat what is already addressed under Article 31, Article 31 bis and the Doha 
declaration on public health. Impo rtantly, the proposal by the EU contains only 'may obligations ' 
which makes these proposals even more redundant in addressing the COVID -19 pandemic.  The EU 
proposal even fails to address the problems with current Compulsory Licensing procedures under 
the TRIPS Agreement  such as requirement under Article 31 bis for mandatory differential packaging 
and colouring of products under the compulsory licences . Also, requirements of notification of 
quantities and other details under Annex of the TRIPS Agreement  which  delays the process of 
exporting compulsory licences  products instead of simplifying it are important.  What the proposal 
covers is a reiteration of existing provisions of TRIPS Agreement . We wish to know how these 
reiterations of existing provisions result  in ensuring augmentation of production of vaccines, 
therapeutics and diagnostics for the treatment, prevention and containment of the pandemic, how 
will these secure access to vaccines for developing countries and the LDCs.  Additionally , we would 
like to know what will be the legal enforceability of this declaration, since it does not change the 
existing Agreement, how will Member s use this declaration to procure more vaccines, therapeutics, 
PPEs, masks etc for their  population.   
288.  The proponents of the waiver proposal have argued previously on many occasions how 
flexibilities provided in the TRIPS Agreement  are inadequate in responding to a pandemic of this 
magnitude. The limited policy space provided by the TRIPS Agreement flexibilities to address 
monopoly actions through issue of compulsory licen ces would not be a feasible option in a pandemic. 
Beyond patents, other IP rights, including trade secrets, industrial designs, copyrights, etc. also pose 
barriers. Compulsory Licensing does not address the barriers  posed by these rights. In fact, these 
limitations posed by the compulsory licences  can be easily addressed by the waiver . The waiver once 
approved and applied would provide countries with an effective and expeditious way to remove key 
IP barriers that scu ttle the use of existing idle capacities.   
289.  Chair, lastly, it 's imperative upon us that we logically and meaningfully conclude what we 
started, it is important that the waiver  proposal is taken forward constructively and finalized 
expeditiously. The report to the G eneral Council  should convey both the importance and urgency to 
conclude the discussions and finalize the waiver . Any other discussions on other proposals should 
be looked at parallelly and not as mutually exclusive to the waiver  proposal.  
290.  We talk of restoring the credibility of this organization, but this cannot be achieved without 
delivering on the solutions that would help scale up production of life saving vaccines, therapeutics 
and diagnostics and ensure access for all.  
2  DRAFT GENERAL COUNC IL DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC 
HEALTH IN THE CIRCUMSTANCES OF A PANDEMIC  
2.1  European Union  
291.  Thank you for providing the European Union with this opportunity to follow up on the 
discussions on our proposal as submitted to the Council in document IP/C/W/ 681. The 
European  Union would first like to recall that our proposal is part of a wider comprehensive approach 
to the COVID -19 crisis, an approach that is based on the use of trade -related measures at the 
disposal of the WTO to address the real bottlenecks that affect the production and distribution of 
COVID -19 vaccines and medicines. The European Union set out this approach in the communication 
on "Urgent Trade Policy Responses to the COVID -19 Crisis ", document WT/GC/231 which we 
submitted to the WTO General Council on 4 June 2021. In that communication the intellectual 
property component is one ele ment of the solution, as explained in a dedicated communication on IP/C/M/101/Add.1  
 
- 46 - 
 
  "Urgent Trade Policy Responses to the COVID -19 Crisis – Intellectual Property " document IP/C/680 , 
which the European Union submitted to the Council for TRIPS on 4 June 2021.  
292.  As set out in that communication , the intellectual property component focuses on the 
clarifications and facilitation of TRIPS Agreement flexibilities relating to compulsory licence s. The 
European Union believes that our discussion  in the TRIPS Council should concentrate on how the IP 
system can contribute towards increasing the manufacturing capacity and equitable access to 
vaccines around the world.  
293.  When we discussed the role, that intellectual property plays to solve the COVID -19 crisis, we 
should not underestimate the role that it has already played and will continue to play. The current 
system has provided the necessary incentives for vaccine developers to research and invest in the 
existing vaccines that exist against COVID -19. The world has obtained not only one, but several 
vaccines against COVID -19 in an unprecedented time. Researchers count on the IP incentives . We 
still need more effective vaccines, not only for the existing variants but also for the future ones. 
Therefore , we must make the most of the existing IP system, while maintaining incentives that ha ve 
proven effective. With our proposal for a General Council declaration on the TRIPS Agreement and 
Public Health in the circumstances of a pandemic, the EU would like t o find a pragmatic approach on 
the role of the intellectual property in enhancing access to affordable COVID -19 vaccines and 
medicines with concrete short - and medium -term solutions that can have quick results on the 
ground.  
294.  We agree that intellectual pro perty rights  do not and  should not stand in  the way of deploying 
existing capacity or creating new capacity or of ensuring that access to COVID -19 vaccines and 
medicines is equitable. The EU believes that it is possible to achieve this objective while at t he same 
time maintaining the protection required for incentivising technology transfer and investment in 
innovation so that we can fight against new strains of COVID -19 and any future diseases . In our 
view, this can be done by using the compulsory licensin g system that the TR IPS Agreement provides 
for and the use of which is supported by the Doha Declaration on the TRIPS Agreement and Public 
Health. This system provides for an IP solution to a situation when there is a producer having the 
ability to produce  the particular product but  does not have a licence from the patent holder to 
proceed with the production. The system can be used for domestic needs, this is the case where the 
country grants a compulsory licence to a manufacturer established in its terr itory, and the product 
will be predominately sold within the same country, but more importantly, under the current 
circumstances, it can also be used for exports. In situations where the product cannot be produced 
domestically at all or in sufficient quantit ies due to lack of capacity and where the producer having 
the ability to produce and willing to produce the product is located in a country where a patent is in 
force on that product and needs a compulsory licence in that country to produce for export.  
295.  When it comes to the potential IP -related obstacles , this system can work effectively, also in 
times of a pandemic. It actually has elements inbuilt  specifically for the circumstances of an 
emergency and a pandemic is clearly such a circumstance. In the disc ussions in the Council we have 
heard Members assert that this is not the case. These assertions were based on seeing the system 
as too complex. This is precisely where the EU proposal  comes in. We believe that t he compulsory  
licensing system provides for t ools that can be used in the times of the pandemic. It also provides 
enough legislative space to apply the system in a swift manner. The EU proposal is meant to clear 
any doubts that persist about the use of the system and to indicate ways in which the sys tem can 
be used in a manner that is full adapted to the challenges of the pandemic. The EU proposal is based 
on a number of clarifications that have as their objective to facilitate and increase the effectiveness 
of the use of the system. We have proposed clarifications on the elements that we find most relevant 
for the situation of the pandemic and these are the fast -track procedure, the support for 
manufacturers wishing to supply to low and middle -income countries at discounted prices, and a 
simple single  notification of the exporting country.  
296.  We have provided details on these three elements in our interventions in the informal meetings 
of this Council.  We would like to ask the Secretariat to add all these interventions to the current 
statement for comple teness of the information .  
297.  In our view, clarifications on the proposed aspects would provide the necessary legal certainty 
to Members that have the possibility of using the existing capacity or increasing their capacity to 
produce COVID -19 vaccines and medicines. They would also promote production and supply of those IP/C/M/101/Add.1  
 
- 47 - 
 
  products to low -and middle -income countries at affordable prices including via the COVAX facility 
and this should be our priority right now.  
298.  In sum mary, the declaration to be adopted by the General Council would be based on the 
following premises:  
a. First, it keeps entire necessary incentives that the intellectual property system provides 
to fight against  the current and future variants of the virus t hat causes COVID -19.  
b. Second, it builds upon the existing flexibilities in the TRIPS Agreement and content of the 
Doha Declaration .  
c. Third, it provides legal certainty on those areas related to compulsory licencing that 
WTO Members have identified as disco uraging them from using this possibility due to risk 
of being in being in breach of their obligations under the TRIPS Agreement.  
d. Fourth, it contributes to our global efforts to ensure equitable access to COVID -19 in 
low-and middle -income countries through  the COVAX facility.  
e. Fifth, it addresses not only the ongoing COVID -19 crisis, but also future pandemics.  
299.  Finally, a declaration is a pragmatic solution that can be adopted swiftly. We need to act 
urgently. As the proposal does not amend Articles 31 and 31 bis and the Annex of the 
TRIPS  Agreement , we will not require lengthy procedures. In addition, the clarification that we 
propose can also be applied in a national legislation swiftly, with none or minimal changes to the 
current system as it uses the space and the flexibility provided by the system. This means that the 
declaration could have immediate or almost immediate results on the ground.  
300.  We would like to recall that our proposal emerges from the discussions that we have had in 
the Council over t he last months. In  the course of those discussions,  we examined various ways in 
which intellectual property can help in enhancing access to affordable COVID -19 vaccines and 
medicines. One of the results of these discussions is that a number of WTO Members identified 
aspects related to the use of compulsory licensing that in their view limit their use of this tool.  
301.  We thank all Members for their engagement on our proposal and for their contributions, 
questions,  and thoughts on it so far. We have discussed o ur proposal in open -ended informal 
meetings of the TRIPS Council as well as in all small group meetings that the Chair has organised. 
We have received valuable feedback and we are pleased to see the interest of various delegations 
in continuing and explori ng this approach. We have also  heard suggestions from Members on other 
aspects of the compulsory licensing system that would, in their view, deserve further examination 
and eventually be included among the elements to be clarified, for example, issues rela ted to 
labelling and packaging, as well as broader notification issues.  
302.  We are currently analysing these proposals and are ready to discuss these issues in more 
detail. We remain also open to discussing which other requirements concerning compulsory licen sing 
can be clarified to facilitate the use of the system. We look forward to our continued discussion on 
these matters. We are confident that all WTO Members c an agree with the clarifications contained 
in our proposal as well as those that it might be app ropriate to add. It is necessary and timely, and 
it can have immediate impact on the ground and apply also for future situations of a similar kind. 
Therefore, we believe that, with the commitment of all WTO Members, we should be able to find 
convergency ra pidly on how to clarify and facilitate the use of the compulsory licensing system.  
European Union 's statement at the informal meeting held on 24 June 2021  
303.  Chair, thank you for providing us with this opportunity to present our proposal as submitted 
to this  Council in document IP/C/W/681 . We continue to be committed to achieving our common 
goal: to continue ramping up production, to share COVID -19 vaccines more widely and faster and 
to ensure equitable access to low - and middle -income countries. Equity for us does not only mean 
access but also access at affordable prices.  IP/C/M/101/Add.1  
 
- 48 - 
 
  304.  We already see incredible progress in the total global production of COVID -19 vaccines with 
more than 10 billion doses to be produced by the end of 2021. For comparison, the total global 
output of all vaccines before COVID -19 was only 5 billion doses. However, further ramping up the 
production and, most importantly, ensuring equitable distribution of COVID -19 vaccines remain 
essential in the fight against time in this pandemic.  
305.  Setting up and ramping up the pro duction of vaccines is a highly complex process which 
requires adequate facilities, trained personnel, raw materials and other inputs. It is a complex issue 
that cannot be solved by one simple solution. The overall strategy is not within the WTO only eithe r. 
The World Health Organization, other organi zations, institutions and initiatives – such as the COVAX 
Facility – are working on these solutions. In the WTO, the Members must collectively find ways to 
address the current delays and shortages in vaccine pr oduction to the extent that is possible in the 
WTO framework.  
306.  Following the intense discussions in this Council as well as in other fora and events organised 
by the Director General of the WTO, Dr Ngozi Okonjo -Iweala, it is our assessment that limited 
manufacturing capacity and restricted access to raw materials and other inputs are the main 
bottlenecks as regards the production and distribution of COVID -19 vaccines. In addition, having 
the required know -how is key due to the complexity of the production p rocess of these vaccines.  
307.  In order to deal with these bottlenecks with the use of trade -related measures at our disposal 
at the WTO, the EU believes a multi -pronged approach is needed. This is why , on 4 June , the 
European  Union submitted to the WTO Genera l Council a Communication on "Urgent trade policy 
responses to the COVID -19 crisis ", document WT/GC/231, calling for a multilateral and 
comprehensive response by trade -related measures to the COVID -19 pandemic.  
308.  In that communication, the EU proposes that W TO Members agree as soon as possible on a 
global trade initiative for equitable access to COVID -19 vaccines and  therapeutics encompassing the 
following three components: 1) trade facilitation and disciplines on export restrictions; 2) concrete 
actions to e xpand production and ensure supply of vaccines at affordable prices to low and middle 
income countries during the pandemic and; 3) clarification and facilitation of TRIPS  Agreement 
flexibilities relating to compulsory licences.  
309.  While the EU considers that the General Council should be the forum to address all three 
components in a comprehensive manner, the third component on intellectual property is in the remit 
of the Council for TRIPS. For this reason, on 4 June 2021 the EU also submitted a dedicated 
comm unication on "Urgent trade policy responses to the COVID -19 crisis – intellectual property ", 
document IP/C/W/680 , to the Council for TRIPS.  
310.  Further to that communication, on Monday the EU submitted to the TRIPS Council  our proposal 
for a General Council declaration on the TRIPS Agreement an d Public Health in the circumstances of 
a pandemic (document IP/C/W/681) . We are pleased to present this proposal today. The proposal 
submitted to the TRIPS Council is part of a broad, comprehensive proposal of the EU on the urgent 
response to the COVID -19 crisis.  
311.  We believe that our disc ussion in the TRIPS Council should concentrate on how the IP system 
can contribute towards increasing the manufacturing capacity and the equitable access to vaccines 
around the world. When we discuss the role that intellectual property plays to solve the C OVID -19 
crisis we should not underestimate the role that it has already played and will continue to play. The 
current system has provided the necessary incentives for vaccine developers to research and invest 
in the existing vaccines and medicines against COVID -19. The world has obtained and had access 
to not only one , but several vaccines against COVID -19 in an unprecedented time, less than one 
year. Researchers count on the IP incentives to continue developing vaccines against COVID -19. We 
still need more  effective vaccines, not only for the existing variants, but also for future ones. 
Therefore, we must make the most of the existing IP system while maintaining incentives that have 
proven effective.  
312.  With this proposal the EU would like to find a way forwa rd in the discussion on the role of 
intellectual property in enhancing access to affordable COVID -19 vaccines and medicines, with 
concrete short - and medium -term solutions.  IP/C/M/101/Add.1  
 
- 49 - 
 
  313.  Firstly, we would like to recall that in addition to ensuring the uninterrupted flo w of raw 
materials and inputs for the vaccine production, the key issue for increasing access to COVID -19 
vaccines is to enhance the transfer of COVID -19 vaccine technology. Contrary to simple chemical 
medicines that are relatively easy to replicate, COVID -19 vaccines involve a complex biological 
process which requires the relevant know -how.  
314.  Voluntary licences are the most effective instrument to facilitate the sharing of know -how. 
Intellectual property framework provides a platform that incentivises colla boration and transfer of 
know -how. It is thanks to the intellectual property system that knowledge and technology are 
disseminated. It is our view that the question as to which measures incentivise transfer of technology 
and which have the opposite effect , is one of the key questions in this debate.  
315.  This is why we would like to reiterate our view on this matter : in the context of the novel 
vaccine production, collaboration and licensing are key for the transfer of know -how. It may be a 
very different situat ion for simpler pharmaceutical products. In the current case, the authorisation 
to use a patent is only one side of the coin, but it is not enough. The patent holder, that is, the 
inventor of the vaccine, also needs to share its know -how with the manufactu rer; and only a 
voluntary licence provides the ideal framework for this transfer of know -how. This is one of the key 
premises of our proposal. Setting up the manufacturing infrastructure to produce vaccines not only 
requires this know -how, but also time an d resources. And this is also why Europe committed EUR 1 
billion to create , with our African partners and our industrial partners , manufacturing hubs in 
different regions in Africa. These solutions must go hand in hand.  
316.  We agree that intellectual property rights should not stand in the way of deploying existing 
capacity or creating new capacity or of ensuring that access to COVID -19 vaccines and medicines is 
equitable. The EU believes that it is possible to achieve this objective while at the same time 
maintaining the protection required for incentivising technology transfer and investment in 
innovation, so that we can fight against new strains of COVID -19 and any future diseases.    
317.  The Doha Declaration on the TRIPS Agreement and Public Health affirms that t he 
TRIPS  Agreement does not and should not prevent Members from taking measures to protect public 
health. It further affirms the flexibilities contained in the TRIPS Agreement, including specific 
flexibilities related to compulsory licences. The Doha Decla ration states that each Member has the 
right to grant compulsory licences and the freedom to determine the grounds upon which such 
licences are granted. It also states that each Member has the right to determine what constitutes a 
national emergency or oth er circumstances of extreme urgency which includes public health crises.  
318.  We would like to contribute to the discussion we are having in this Council with a targeted 
approach. We hope that we will be able to convince Members that our approach, including the  key 
components that will be addressed in the General Council, represents the best way to respond to 
the crisis in a short term in an effective and pragmatic manner.  
319.  We would like to recall that our proposal is based on the discussions that we have had in  this 
Council over the last months. In the course of these discussions,  we have been examining various 
ways in which intellectual property can help in enhancing access to affordable COVID -19 vaccines 
and medicines. One of the results of these discussions i s that a number of WTO Members identified 
aspects related to the use of compulsory licensing that, in their view, limit the use of this tool. The 
EU proposal is a response to these comments.  
320.  We propose a declaration to be adopted by the General Council tha t would be based on the 
following premises:  
a. First, it keeps intact the necessary incentives that the intellectual property system provides 
to researchers on new vaccines and medicines to fight against the current and future 
variants of the virus that caus es COVID -19.  
b. Second, it builds upon existing flexibilities under the TRIPS Agreement and reaffirms the 
content of the Doha Declaration.  IP/C/M/101/Add.1  
 
- 50 - 
 
  c. Third, it provides legal certainty on those areas related to compulsory licensing that 
WTO Members have identified as discouraging them from using this possibility due to risk 
of being in breach of their obligations under the TRIPS Agreement.  
d. Fourth, it contributes our global efforts to ensure equitable access to COVID -19 vaccines 
and medicines in low - and middle -income countries thorough the COVAX Facility.  
e. Finally, it addresses not only the ongoing COVID -19 crisis but also future pandemics.  
321.  Consequently, in order to address comments raised in the context of our discussions, provide 
more legal certainty an d enhance the effectiveness of the system, the EU considers that all 
WTO Members should be ready to agree on the following clarifications of the compulsory licensing 
system set out in Articles 31 and 31 bis and in the Annex of the TRIPS Agreement:  
a. the pandemic is a circumstance of national emergency and therefore the requirement to 
negotiate with the right holder may be waived;  
b. to support manufacturers ready to produce vaccines or medicines at affordable p rices, 
especially for low - and middle -income countries, on the basis of a compulsory licence, the 
remuneration for patent holders should reflect such affordable prices; and  
c. the compulsory licence could cover any exports destined to countries that lack 
manufacturing capacity, including via the COVAX Facility.  
322.  Clarifications on these aspects would, in our view, provide the necessary legal certainty to 
Members that have the possibility of using the existing capacity or increasing their capacity to 
produce COV ID-19 vaccines and medicines. They would also promote production and supply of those 
products to low - and medium -income countries at affordable prices, including via the COVAX Facility. 
And this should be our priority right now.  
323.  We would like to recall tha t an additional value added of our proposal is that it can be adopted 
swiftly. The proposal clarifies certain provisions in Articles 31 and 31 bis and the Annex of the 
TRIPS  Agreement. As we do not aim to amend these articles, we will not require lengthy de bates 
and procedures. The scope of these provisions will remain the same, but agreeing on a declaration 
will remove legal uncertainty about their application and support those WTO Members who wish to 
use them.  
324.  The first element is to clarify that in a cir cumstance of a pandemic, governments can proceed 
quickly and they do not have to engage in the negotiations with patent holders, which normally is 
the longest part of the procedure. Some WTO Members raised doubts as to whether this 'fast-track' 
procedure c an be used only in the case of compulsory licences for domestic use or also with regard 
to the, crucial now, licences for exports. We want to make it absolutely clear that this possibility 
applies also to licences for exports. Therefore, we propose to clar ify that WTO Members may waive 
the requirement of making efforts to obtain authorisation from the right holder, provided for in 
Article 31(b) of the TRIPS Agreement, for the purposes of issuing a compulsory licence not only for 
domestic use, under Article 31, but also for exports, under Article 31 bis.  
325.  The second element concerns remuneration for patent holders. This is a crucial element of a 
compulsory licence and we need to promote those manufacturers that are ready to produce at 
affordable prices for low - and middle -income countries and to provide supplies to COVAX. This means 
different levels of discounted prices, e.g., supplies at cost or at lower prices to low- and 
middle -income  countries. The clarification would provide legal certainty that in such ca ses 
manufacturers will be supported by governments setting the remuneration for patent holders 
reflecting these discounted prices, in order to ensure that the remuneration does not become a 
blocking factor in enhancing production. Therefore, we propose to clarify that WTO Members may 
provide, for the purposes of determining the remuneration to be paid to the right holder under a 
compulsory licence for domestic use (Article 31 .h) or for exports (Article 31 bis paragraph 2), that 
the remuneration reflects the price charged by the manufacturer of the vaccine or medicine produced 
under the compulsory licence.  IP/C/M/101/Add.1  
 
- 51 - 
 
  326.  The third element deals with an often -raised, procedural problem of country -to-country 
application of compulsory licence. We want to make sure that a willi ng manufacturer can easily 
export to all eligible countries, including via COVAX, under a single simple procedure. Therefore, we 
propose to clarify that the notification procedure in paragraph 2.c) of the Annex to the 
TRIPS  Agreement allows WTO Members to submit a single notification that includes the list of all 
countries to which the vaccines and medicines are to be supplied. We also propose to clarify that 
this notification is valid not only when the exporting Member exports the vaccines directly, but al so 
when it does so through the COVAX Facility. COVAX is already supplying vaccines to many countries 
of the world, many of which are eligible importing Member s under the Annex to the 
TRIPS  Agreement. Therefore, we propose that WTO Members agree that, where  a WTO Member 
provides COVAX with vaccines produced under a compulsory licence, it is understood that COVAX 
distributes those vaccines to the eligible importing Member s included in the notification submitted 
by the exporting Member.  
327.  We are talking about a  substantial reinforcement of the TRIPS flexibilities and of the legal 
certainty required for their use. It is our objective to bring all sides of the discussion closer together 
on this approach and find solutions quickly while also fully engaging on other  aspects of our 
comprehensive proposal which are key, in our view, to make a real difference on the ground. We 
invite all Members to consider our proposal and engage on this approach. We are of course open to 
discuss which other requirements concerning com pulsory licensing can be clarified to facilitate the 
use of the system.  
328.  We are confident that all WTO Members can agree that the clarifications contained in our 
proposal are necessary and timely and can have an immediate impact on the ground and apply als o 
for future situations of the similar kind. Therefore, we believe that, with the commitment of all 
WTO Members, we should be able to rapidly find convergence on how to clarify and facilitate the use 
of the compulsory licensing system.  
European Union 's statement at the informal meeting held on 30 June 2021  
329.  The European Union much appreciated the possibility provided by the small group meetings 
to explain in more detail the EU proposal and to discuss the revised waiver proposal. We would like 
to thank all the delegations that engaged in the discussions and hope that the input provided by the 
European Union has been helpful in taking this discussion forward.  
330.  The European Union remains fully committed to this process and to finding the best way 
forward to  ensure that the intellectual property system plays an enabling role in the context of 
deploying existing capacity or creating new capacity for the production of COVID -19 vaccines and 
medicines while keeping intact the necessary incentives that the intelle ctual property system 
provides to researchers of new vaccines and medicines to fight against the current and future 
variants of the virus that causes COVID -19. We will continue to engage constructively and are open 
to discuss all approaches that contribute  to enhancing access to affordable COVID -19 vaccines and 
medicines and can bring results in an urgent manner.  
331.  The European Union would like to use this opportunity to recall some of the most pertinent, in 
our view, points that have been raised in the discu ssion in small groups on the scope of products 
and provisions covered.  
332.  Starting with the EU proposal for a General Council Declaration on the TRIPS Agreement and 
Public Health in the Circumstances of a Pandemic, document IP/C/W/681 , the EU have provided 
explanations on the scope of its propo sal.  
333.  As regards the scope of products covered by the EU proposal, we have explained that:  
a. The EU proposal emerges from the discussions that WTO Members have had in the 
TRIPS  Council since the COVID -19 started.  
b. Those discussions have focused on how intell ectual property can contribute to ensuring 
global equitable access to COVID -19 vaccines and medicines.  
c. We are aware that WTO Members use different terms to refer to the products we aim to 
cover e.g., pharmaceuticals, medicines, treatments, therapeutics, d iagnostics, etc. We IP/C/M/101/Add.1  
 
- 52 - 
 
  also understand that intellectual property law does not usually address definitions of terms 
such as medicines.  
d. It is important to recall that our proposal concerns Articles 31 and 31 bis of the 
TRIPS  Agreement and therefore the product  scope as applicable to these articles applies 
also in the context of our proposal. In the case of Article 31 of TRIPS there are no 
limitations to the scope – all products that are patented are covered. Article 31 bis is more 
specific, as it applies to phar maceutical products, which are defined as "patented products, 
or products manufactured through a patented process, of the pharmaceutical sector ".  
e. Therefore, the EU proposal covers all patented products as far as the application of 
Article  31 is concerned and all pharmaceutical products as far as Article 31 bis is concerned. 
The pharmaceutical products under Article 31 bis cover vaccines, therapeutics, diagnostics 
and active ingredients and therefore these products, which are key for tackling the 
COVID -19 cri sis, are covered by the EU proposal. When we speak about 'medicines ' in the 
EU proposal as regards the facilitation of compulsory licences, diagnostics as well as 
therapeutics fall under that term.  
334.  As regards the provisions covered by the EU proposal, the EU has explained that:  
a. The EU proposal to the WTO is a comprehensive proposal as it addresses trade issues 
related to the actual bottlenecks that affect the speed of manufacturing and the fair supply 
of vaccines and medicines in the current pandemic. The component on compulsory 
licensing as proposed for discussion at the TRIPS Council is thus only one element of this 
comprehensive approach. We consider that intellectual property plays an important role 
as an enabler that contributes to our ov erall objective of ramping up production of 
COVID - 19 vaccines and medicines. However, it is not and should not be a barrier to 
achieve this objective. We have been clear that in a global emergency like this pandemic, 
if voluntary licensing fails, compulso ry licensing is a legitimate tool to scale up production. 
This is why we propose to clarify and simplify the use of compulsory licensing in times of 
a pandemic.  
b. If we examine how intellectual property can enable the production of vaccines or 
medicines, th e focus is primarily on patents. We believe that a debate on the entire 
intellectual property system is not necessary and will only delay our urgent action. 
Moreover, the intellectual property framework is already a system of checks and balances. 
There are  relevant exceptions that can be used with regard to every intellectual property 
right, be it copyright, design or protection of undisclosed data.  
c. For example, as regards trade secrets, it is important to note that the TRIPS Agreement 
only protects trade s ecrets against disclosure, acquisition or use in a manner contrary to 
honest commercial practices. Trade secrets do not have to be protected in situations 
concerning disclosure, acquisition or use which is consistent with honest commercial 
practices. This provides for space for governments to provide exceptions e.g. in a health 
emergency situation. The EU Directive on trade secrets provides for an exception 'for the 
purpose of protecting a legitimate interest recognised by Union or national law '.  
d. As regard s regulatory data, we agree that the national provisions on compulsory licensing 
need to be effective and should therefore allow manufacturer s of generics to produce 
them. Regulatory data protection should not be an obstacle to achieve this objective. 
Article 39 paragraph 3 of the TRIPS Agreement allows exceptions 'where necessary to 
protect the public '. The EU uses this exception in its implementation of Article 31 bis of the 
TRIPS  Agreement.   
e. Moreover, we must be realistic as to what the proposed lifting o f the Members ' obligations 
under the TRIPS Agreement can achieve. For example, in the long -discussed case of trade 
secrets, waiving Article 39 of the TRIPS Agreement does not grant access to companies ' 
confidential information, only removes certain minimum  remedies against a 
misappropriation of that information. There seems to be a misunderstanding about this 
fact as some Members indicated possibilities of governments to requisition  and repurpose IP/C/M/101/Add.1  
 
- 53 - 
 
  trade secrets. We would like to emphasise that such measures which may be provided 
under national law of some Members fall outside of the realm of intellectual property.  
335.  Without prejudice to our position on the revised waiver proposal, and in particular the fact that 
we do not believe that it would have the effect o f increasing production and enhancing access to 
COVID -19 vaccines and medicines, in the course of the small group meetings, we have raised a 
number of concerns with regard to this proposal:  
a. As regards the product scope, it was observed that the link betwee n the accessibility of 
the broad list of products and intellectual property is not clear. There is no evidence that 
it is IP that is at the origin of the shortages of these products. The fact that a product is 
protected by an IP right, such as patent, is n ot in itself an indication that there is an IP 
obstacle that limits its accessibility.  
b. Moreover, if an IP would stand in the way of accessibility, it is not clear why the existing 
flexibilities provided in the TRIPS Agreement, and in particular compulsory  licensing, could 
not be used.  
c. In addition to the possibilit y of relying on exceptions which can also be used for public 
purposes, in accordance with the trilateral study by WHO, WTO and WIPO on Promoting 
Access to Medical Technologies and Innovation, numerous private sector companies have 
taken access -oriented acti ons that include: (i) committing to non -exclusive and 
royalty -free licensing or issuing non -enforcement declarations of patent rights in some or 
all jurisdictions; (ii) publishing scientific data on a free -to-use basis; (iii) publishing 
technical specifica tions of vital equipment (e.g. ventilators); and (iv) sharing knowledge 
to enable others to manufacture and use such technologies. In addition, among other 
voluntary actions in support of R&D that have been observed are the permission to use 
text and data mining and machine -learning technologies and to freely access and reuse 
COVID -19 related scientific literature protected by copyright and the making available of 
standards protected by copyright. For example, as part of the Open Covid Pledge, a 
number of p rivate companies and universities are granting free access to patented 
technologies and protected designs related to diagnosing, preventing, containing and 
treating COVID -19. 
d. There are questions as to the establishment of the link between a product and the  
prevention, treatment or containment of COVID -19. While certain products, such as 
vaccines or certain therapies, have been developed and are approved as COVID -19 
products, there are also products that have at the same time different uses, this concerns 
also 'materials and components ' covered by the revised waiver proposal.  
e. As regards the provisions covered, the EU questions the approach under which the entire 
sections of the TRIPS Agreement are subject to the waiver. This includes for example 
provisions on  compliance with the Berne Convention, exceptions and limitations to various 
rights, inventions excluded from patentability, conditions on patent applications or 
provisions on compulsory licensing. Again, the link between these provisions and the 
objective  of the waiver is not clear. This approach points rather to a suspension of the 
TRIPS Agreement than a waiver that should be limited to what is justified and necessary 
in view of its stated objective.  
f. We should not lose sight of our common aim, i.e. enhan cing global access to affordable 
COVID -19-related medical products and addressing global production constraints and 
supply shortages. The EU believes that this objective must inform our discussions. We 
have previously expressed concerns as to the impact of  the proposed waiver on what is 
the core element for expanding the current production of vaccines, i.e. transfer of 
technology.  
g. As already mentioned, Articles 39 paragraphs 1 and 2 of the TRIPS Agreement provide 
only for remedies in case of breach of conf idence or other dishonest commercial practices. 
Waiving these paragraphs does not in any way compel the holder of the trade secret, in 
this case the technology and the know -how, to reveal it. To the contrary, lifting the IP/C/M/101/Add.1  
 
- 54 - 
 
  protection granted by these provisi ons takes away the platform on which such transfer 
can occur with full legal certainty.  
h. Intellectual property rules provide the legal framework for cooperation between companies 
by licensing contracts and partnership agreements. Therefore, IP rights do not  obstruct 
production but are an enabler to enhance production. The most efficient way of knowledge 
sharing is a cooperation on a voluntary basis, that enables a quick exchange of know -how 
needed besides the patent itself.  
i. As regards Article 39 paragraph 3  on regulatory data, it is not clear to us what would 
prevent Members to use undisclosed data by regulatory agencies where necessary to 
protect the public as provided by this Article.  
j. There are further questions regarding the implementation of the waiver, e.g. its impact on 
pending patent applications that would need to be discussed and closely analysed. The 
same concerns medium - and long -term consequences of the waiver . For example it is 
important to note that health products and technologies developed dur ing the waiver 
period would, in all likelihood, not be eligible for patent protection even after the 
termination of the waiver, because they would no longer fulfil the patentability 
requirement of novelty. Finally, there are also questions as regards effec ts of the waiver 
on international obligations of WTO Members under international agreements in the area 
of intellectual property. We are looking forward to further discussions on these points and 
will of course present these aspects also in the context of the EU proposal.  
336.  As was mentioned by a number of delegations, the EU believes that Members should focus on 
solutions which are targeted, pragmatic and that can bring results in the short -term. We invite 
Members to discussions on the EU proposal which in ou r view fulfils these requirements. As indicated 
during the last week 's meeting, the EU is also ready to discuss other aspects of the compulsory 
licensing system that would merit clarification to enhance efforts to scale up the production of 
COVID -19 vaccin es, therapeutics and diagnostics.  
337.  Finally, we would like to emphasise that the IP -related discussion is only a part of the 
multi-faceted approach proposed by the EU. We call on all Members to engage in discussions on all 
elements of this approach as only this way we will be able to adequately respond to the current 
crisis.   
European Union 's statement at the informal meeting held on 14 July 2021  
338.  For the European Union,  the discussions the previous  week allowed us to explain in detail the 
advantages of the E U proposal from the perspective of implementation. We have looked at it from 
two key angles. First, from a procedural angle, the EU proposal for a General Council Declaration on 
the TRIPS Agreement and Public Health in the Circumstances of a Pandemic, docu ment IP/C/W/681  
can be adopted swift ly. Moreover, the clarifications on the use of the existing flexibilities on 
compulsory licensing would normally not require implementation by WTO Members to have 
immediate results - they would remove any legal uncertainty on a number of aspects that 
WTO Members have identified during the last months as unclear.  
339.  Second, the other key angle when we discussed implementation is the substantive angle. The 
EU proposal for a General Council Declaration is targeted and addresses the key aspects of the 
compulsory licensing system that can be clarified or facilitated to make sure that we make the most 
of the system during this and future pandemics. Even if the list of these aspects is extended in the 
course of the negotiations, it will remain targeted and easily app licable. Moreover, if any 
WTO Member actually needs to incorporate these clarifications into its national regime, the 
implementation would be simple due to the targeted approach of the proposal.  
340.  As regards the implementation of the revised waiver proposal:  
341.  The discussions during the last two meetings showed, in our view, that the implementation of 
the waiver would be a very complex exercise and would involve important risks. To begin with, a 
waiver does not have direct application in the national s ystems of WTO Members. All WTO Members 
that have implemented the TRIPS Agreement in their national law would need to adopt national law 
to implement the waiver. This is already an important difference between the waiver and the EU IP/C/M/101/Add.1  
 
- 55 - 
 
  proposal. It is true that , as the proponents have explained, WTO Members having fast -track 
legislative procedures in place could use them to implement the waiver at national level. However, 
if we take into account the second implementation angle we have mentioned, i.e. the substan tive 
angle, further hurdles and concerns appear.  
342.  First, as already mentioned in the previous meeting, the proposed waiver does not contain any 
indication as regards the measures that can be applied by the Members. In other words – it is not 
clear what the Members can do on the basis of the waiver and how they can do it.  
343.  Second, clearly the broader and less targeted the waiver, the more complex implementation 
is required. This means national rules:  
a. to determine which IP rights would fall under the ambit of the waiver, under which 
conditions and with which effects in the short, mid - and long -term; and  
b.  to create a legal instrument and procedures to effect the suspensions and circumscribe 
their scope to the purposes provided in § 1 of the waiver.  
344.  The proponents have explained that the waiver provides no description of measures to be 
adopted by Members un der the waiver. No measures are indicated or prescribed. These means that, 
from the substantive angle, there are no set boundaries to the measures that Members can 
implement. The proponents explain that the 'waiver is permissive ' and that 'the choice of me asures 
is left to the Members '. 
345.  The lack of defined measures is, in our view, highly problematic and results in high risk as 
regards the effects of the waiver. The lack of any boundaries means that Members would be free to 
take any measures they deem appro priate without any accountability or scrutiny, and regardless of 
the impact of the waiver on incentives for innovation. We would like to emphasise here that we are 
talking about the substance of the measures, not their form – the fact that there can be eme rgency 
measures or measures taken in a different procedure does not change the fact that the substance 
of the measures is unknown.  
346.  The proponents have explained that they expect that WTO Members will not use the waiver to 
its full extent, as they should us e it in a targeted manner. The waiver is, in their view, a tool that 
would give freedom to Members to adopt measures in their own way. This does not in any way 
remove the discussed concerns, including those related to:  
a. the invalidation of existing patents,  including in the long term, once the waiver ceases to 
apply;  
b. the possibility of rejecting pending patent applications and its effects on the loss of novelty 
of the products and processes relevant to the manufacture of vaccines, medicines and 
medical devi ces;  
c. the effects of the waiver on existing and future voluntary licence agreements and open 
licensing schemes;  
d. the effects of the waiver on trade secrets, which, if disclosed due to the waiver, would lose 
their secret character and therefore any protectio n, even after the waiver ceases to apply 
– in that regard we also noted certain comments pointing to using the waiver as a vehicle 
for forcing rather than enhancing technology transfer – this increases our concerns about 
this approach;  
e. how to ensure that t he waiver is used exclusively for the announced intention and not for 
commercial purposes;  
f. how to ensure that a COVID -19 related waiver does not affect IP rights that are related to 
other purposes or diseases or are relevant for other areas;  IP/C/M/101/Add.1  
 
- 56 - 
 
  g. the applicatio n of the waiver to enforcement procedures – it is not at all clear what the 
waiver would mean for the application of rules such as that the procedures must be fair 
and equitable, that court decisions must be reasoned and in writing, etc..  
347.  Chair, the discu ssions we had last week showed, in our view, that a reply based on mere 
permissiveness or reliance on Members ' freedom to implement the waiver does not provide an 
answer to these and other questions posed by Members.  
348.  At the very end of the meeting the prev ious week, we also started a discussion on regulatory 
data protection. We did not have much time to discuss this issue , so we look forward to continuing 
our dialogue on this point in the future. The main area to explore, in our view, is the flexibility 
provided by Article 39(3). But as the discussion has not really taken place in the small group meeting, 
we will not comment on these matters at this stage – we have presented our preliminary comments 
on other occasions.  
349.  Chair, we, as other WTO Members, remai n unconvinced about the benefits and concerned 
about the effects of the proposed waiver. On implementation, the discussion we have had so far 
shows that the assumption that the waiver does not require lengthy and complex implementation 
underestimates the c hallenges of implementing the waiver proposal in practice. Moreover, the 
approach according to which the choice of measures to implement the waiver is left entirely to 
Members, without any boundaries that would take account of necessity and proportionality  raises 
concerns on the long -term effects of the waiver not only on the IP system but also as regards access 
to COVID -19 vaccines and medicines. On regulatory data protection, subject to further discussions, 
it seems to us that the existing flexibilities u nder the TRIPS Agreement do not justify a waiver in the 
circumstances of a pandemic.  
350.  We would like to thank again all the delegations that engaged on the EU proposal. We have 
noted the main two additional angles as regards requirements in Article 31 bis – one concerning the 
labelling requirements and one the statements on the lack of manufacturing capacity. We would like 
to invite Members to present views on these two issues. We are all aware of the justification of the 
labelling requirement – which is an an ti-diversion measure. It seems to us that in the case of exports 
to multiple countries there is no need of distinguishing labels depending on the importing country. 
We would be interested to know whether this is also the understanding of the other Members.  It 
would be important to understand which aspect of the labelling requirement is viewed as 
cumbersome so that we can advance on our discussion. The same goes for the requirement to 
indicate the insufficient manufacturing capacity – we would be very intere sted to hear the views of 
Members on this requirement. This would also help us present in more detail a case study as 
suggested by the United Kingdom.  
351.  We are also discussing bilaterally with various delegations to explain our proposal in more 
detail and wi ll continue these efforts.  
352.  Chair, we had important and good exchanges with Members on the EU proposal in the context 
of the text -based process. In view of these exchanges and the great potential of finding solutions 
on the basis of the EU approach, we woul d like to ask you to reflect this fact in the report to the 
General Council. It is, in our view, vital for the next steps that the General Council has the full view 
of the discussions that are taking place in the TRIPS Council and all proposals that are on  the table.  
353.  As was mentioned by a number of delegations, the EU believes that Members should focus on 
solutions which are targeted, pragmatic and that can bring results in the short -term. In this context, 
we invite Members to discussions on the EU proposal . As indicated in the previous meetings, the EU 
is also ready to discuss all aspects of compulsory licensing system that would merit clarification to 
enhance efforts to scale up the production of COVID -19 vaccines, therapeutics and diagnostics.  
354.  Finally, w e would like to emphasise that the IP -related discussion is only a part of the 
multi-pronged approach proposed by the EU. We call on all Members to engage in discussions on all 
elements of this approach as only this way we will be able to adequately respon d to the current 
crisis.  IP/C/M/101/Add.1  
 
- 57 - 
 
  2.2  Switzerland  
355.  [Switzerland made a single statement under agenda items 1 and 2. See the statement 
recorded under agenda item 1]  
2.3  Paraguay  
356.  [Paraguay made a single statement under agenda items 1 and 2. See the statement recorded 
under agenda item 1]  
2.4  Singapore  
357.  [Singapore made a single statement under agenda items 1 and 2. See the statement recorded 
under agenda item 1]  
2.5  Turkey  
358.  [Turkey made a single statement under agenda items 1 and 2. See the statement recorded 
under agenda item 1]  
2.6  Chad on behalf of the LDC Group  
359.  On behalf of the LDC Group allow me to thank the European  Union for this statement that was 
just submitted under  agenda  item 2 . Document  IP/C/W/681  includes a draft declaration which 
provides for three clarificati ons in the framework of this pandemic regarding the mechanism of the 
compulsory licence, Article 31 of the TRIPS Agreement . As we see it , the objectives of these three 
suggestions that were voiced in this draft declaration are useful and we embrace them, w e see them 
in a very positive light. To be more specific first of all , as we see it, it is judicious to facilitate the 
possibility to waive the obligation under Art. 31 (b) before actually moving to compulsory licensing 
agreements , and also to providing that, where vaccines are provided at affordable prices to low -and 
medium -income countries , the renumeration required from the manufacturers  should reflect these 
prices , and t o simplify and streamlin e the notification requirements for the exporting Members . That 
is the current state of play of our thinking with regard to the statements by the European Union  and 
the LDC Group still is assessing these statements -. Bilateral consu ltations will be provided for and 
our Group will fine -tune these various concerns and then refer these to the delegation of the 
European Union.  
2.7  South Africa  
360.  At the outset I want to thank the Europ ean Union for its introduction. I think we are on record 
in many of the meetings indicating  that we believe that the response proposed by the 
European  Union is essentially insufficient. We also note that the proposal is underpinned by an 
assumption that th e laudable and unprecedented progress made in developing COVID -19 vaccines 
was incentivised by IPRs. While recognizing the role of IP to research and development, we also 
have to recognize other factors incentivising the rapid development of COVID -19 vacci nes would 
also apply in this case. We believe that a comm on desire to ameliorate and eliminate an existential 
threat to  the human race in terms of its health and economi c wellbeing is part of that driving force . 
Also, large-scale public investment in resea rch and development amounting to billions of dollars  
have also contributed.  
361.  We would be the first country to acknowledge and appreciate the role that intellectual property 
can play in stimulating innovation  and as we have said in previous statements our IP Policy of 2018  
is testament to this particular aspect. However, we believe that it is important to focus on the facts 
of the matter. In o ur view , an urgent multilateral response to the pandemic requires accelerati on 
and diversification of production of health products and technologies, especially in low- and 
medium -income countries . We see that Africa lags far behind in the global distribution  and access . 
A continent of 1.2 billion people imports 99% of its vaccines. This is unsustainable and something 
that would have to change.  It is therefore critical that we use all the policy tools available to us  to 
achieve this stated purpose to address barriers to production and diversification of production across 
the world. From this perspective we believe that t he TRIPS waiver is a credible response by Members 
that should engage in good faith to achieve th is objective, and that objective would be to save lives. IP/C/M/101/Add.1  
 
- 58 - 
 
  362.  Substantively , we have raised various issues , and I will quickly go through some of these 
points. We be lieve that the proposal which envisages a declaration by the General Council provides 
clarification in relation to the right s of Members that are already clear. Where Members have to use 
compulsory licences, i n reality, all the clarifications that have bee n advanced by the European Union 
are already abundantly clear and t his can be ascertained by a simple reading of the text of 
TRIPS  Article 31 bis, and the Doha Declaration on TRIPS and Public Health  has already given us a 
very clear picture of the right of Members to use compulsory licences . So from that perspective the 
EU proposal seeks to provide a clarification at the level of the General Council to essentially seek 
clarification on so -called nati onal emergency and other circumstances of extreme urgency within the 
meaning of Article 31 .b of the TRIPS Agreement .  
363.  This was never in question. We believe that in addition, the highest decision -making body of 
the WTO clarified in 2001 that for the purpos es of Article 31 .b, "Each Member has the right to 
determine what constitutes a national emergency or other circumstances of extreme urgency ". 
Another concern that we have raised in the deliberations that we have had relates to the clarification 
that the EU  is advancing , which seems to limit the flexibilities provided to WTO Members under 
Article 31 and 31 bis of TRIPS. During a pandemic, compulsory licences can be issued for purposes 
of public non -commercial use as well as to remedy anti -competitive practice s, in which event there 
is also no need to obtain authorization from the right holder.  
364.  A serious concern with EU 's proposal is that it implies that an authoritative interpretation by 
the WTO is required before an event can qualify as a "national emergency or other circumstances of 
extreme urgency ". But this is not the case as - clearly - paragraph  5.c of the Doha Declaration has 
already provided this particular clarifi cation.   
365.  In relation to remuneration , we have also raised the issue that  Article 31 .h of T RIPS allocates 
and states that "the right holder shall be paid adequate remuneration in the circumstances of each 
case, taking into account the economic value of the authorization ". The TRIPS Agreement already 
provides full freedom in terms of the level of  "adequate remuneration " to be paid to the patent 
holder under a compulsory licen ce. From that perspective, un der Art icle 31.j of the 
TRIPS  Agreement, the right holder has the right to appeal such a decision concerning remuneration, 
if the holder is not satisfied. This has also been clarified by work conducted by the Secretariat that 
the decision to set the level of remuneration is that of the national authorities that are competent 
to make such a dec ision.  
366.  The EU's text also implies that remuneration reflecting the generic price is only allowed in 
situations of "addressing the pandemic at affordable prices for low - and middle -income countries " 
and for "vaccine or medicine " although the flexibility to determine adequate remuneration in 
Article 31 is applicable to all WTO Members in all circumstances even beyond pandemics.  
367.  Furthermore,  we would want to say, in short, it is unclear what t he EU proposal  adds to the 
status quo from a substantive perspective . If anything,  it appears that the EU proposal seeks  to limit 
the existing TRIPS flexibilities. Another point that we would very quickly like to raise is that the EU 
proposal treats compulsory licensing of products as a panacea for all IP -related barriers.  In reality , 
this is not the case. As proponents of the TRIPS waiver, we have outlined in detail why compulsory 
licensing of patented products are inappropriate to comprehensively and expeditiously deal with 
COVID -19 in our documents IP/C/W672  and IP/C/W/673 , so I will not repeat those particular aspects 
but merely indicate that  compulsory licences as a response to the pandemic may not be able to 
deliver the results that we are seeking.  
368.  We do believe there is a need to simplify the compulsory licensing system, however we do not 
see how the EU proposal achieves this objective, other than maintaining the status quo. We take 
good note of the intervention by Brazil that looks at issues s uch a s packaging as a further 
simplification , and we believe that this could be useful as an addition to our discussions. From that 
perspective we think that the EU proposal  does not go far enough and certainly , as we have stressed, 
the EU proposal in its curre nt form cannot be seen as an alternative to the waiver proposal, since it 
addresses only very limited issues and so from that perspective,  we think that a further discussion 
could unlock an expansion of the ideas that have been introduced by the European U nion.  
369.  I guess , as we have reiterated, the proposal is certainly limited to compulsory licensing of 
patents. As the waiver proponents have said, i t does not address intellectual property beyond these IP/C/M/101/Add.1  
 
- 59 - 
 
  concerns and so we think that issues around the protecti on of undisclosed information, copyright, 
industrial designs  and so forth are also important responses to deal with the situation that we face 
with COVID -19. On the other hand, as we have reiterated, the waiver proposal comprehensively 
deals in a holistic  manner with all the matters in relation to COVID -19 technologies and intellectual 
property. It is also not clear how the EU proposal will facilitate the transfer of technology and 
know -how. We also note the call by several Members, including the delegation  of Brazil, to have a 
further discussion on this particular issue. The communication also fails to address the major 
underlying concern with respect to compulsory licensing -that is the "case-by-case" or 
"product -by-product " approach which is limiting durin g the pandemic , and that this approach means 
that additional tools are needed to overcome IP barriers.  
370.  At the start of th is discussion on the TRIPS waiver in October 2020, we heard some developed 
country Members referring to C -TAP and COVAX as tools that will deliver equitable access in due 
course. We have always been open to alternative approaches and we have welcomed these as 
alternatives to what we are proposing, but to date these tools have not delivered as much as they 
had promised. We have seen many pharmaceutical companies rejecting CTAP and we have witness ed 
a growing inequality and insufficient supply to COVAX  which as of 19 July 2021 had  only shipped 
129 million doses, 6.5% of the 2  billion doses which will be due by the end of 2021. From that 
perspective it is very clear that we need additional capacity, we need more producers to come online 
to produce vaccines for everyone including for the developing world. We have heard voluntary 
licences is the way to go, but the experience during  this time has indicated that these are extremely 
limiting. We have heard various delegations including the delegation of Indonesia indicating that 
many producers in the developing world requesting licences  have been rebuffed and clearly under 
these circum stances compulsory licences are not delivering the results that we need.  
2.8  European Union  
371.  I just wanted to very quickly thank for the comments, both from the LDC Group and from 
South  Africa. As re gard to the LDC Group we understand that our proposal is being analysed and we 
can look forward to some comments and to some proposals and that is very good news. And we are 
very much looking forward to this discussion. In the same way, regarding comments from 
South  Africa, I think that one strand of these comments is about the fact that in the view of 
South  Africa, the European Union proposal does not go far enough, it has only very limited issues 
included as the delegate said , and that there can be some further expansion of these ideas. That 
again is very good news to us. We are looking forward to this discussion, I think that if there is 
something missing, if there are issues that should be addressed or clarified in the view of 
South  Africa, we want to re iterate our openness to such discussion. We have always emphasized 
that the list of issues that we proposed in our proposal to be clarified i s not exhaustive, and therefore 
we are open to discussions on other issues and other clarifications, so we would li ke to really look, 
if need be, issue by issue, requirement by requirement , to see where there are problems, where 
there is complexity, where the se are cumbersome in view of delegations , and to see what we can 
do to facilitate the use of the system.  
372.  I thin k we had a very broad discussion here and we are struggling as regards the way forward, 
and finding a common ground, but we have to start somewhere. I think we all agreed that patents 
is the most relevant part. What we would suggest is to start the discuss ion with regards to patents, 
let's have a discussion with regards to requirement by requirement and looking at what could be 
clarified, what could be facilitated. I would just like to emphasise that the European Union is very 
ready to have this discussion and with look forward to furthering  discussions.  
2.9  India  
373.  I also thank the E uropean Union delegation for introducing their proposal. I take this 
opportunity to raise certain questions and seek clarifications and explanations from the EU on their 
proposal. It is indeed heartening  to see that the proponents recognise the pandemic to be a global 
and economic crisis that calls for urgent multilateral action which is key to respond to this crisis 
swiftly. It would be useful if EU could clarify what it envisages as the urgent multilateral action and 
what would be the timeline for such an action. We a re glad to see that the main objective of this 
proposal as reflected in the preamble is to ensure fair and equitable distribution of vaccines and 
medicines  to fight against the COVID -19 pandemic and that requires concerted efforts to increase 
manufacturing  capacity and investment as well as supplies at an affordable cost.  IP/C/M/101/Add.1  
 
- 60 - 
 
  374.  It also mentions in a number of places the need for accelerating the production of vaccines 
and medicines and their equitable global distribution. We wish to know and understand how this is 
envisaged in the proposal to achieve equitable distribution of thi s accelerated production of vaccines 
and medicines, especially with the concern over rampant pre -ordering of vaccines by developed 
countr y Members , how will this increased output be equitably distributed.  
375.  The proposal stresses the need for legal certainty  on the flexibilities provided by the 
TRIPS  Agreement and that the established procedures to use compulsory licences for those purposes 
be as efficient and streamlined as possible. It proposes to facilitate the determination of the 
renumeration to be paid under compulsory licences in the circumstances of the pandemic in order 
to support manufacturers ready to produce pharmaceutical products  including vaccines or medicines 
at affordable prices for low - and middle -income countries . It is reassuring that at th is critical time 
the proposal then delivers to reaffirm existing rights emanating from the Doha Declaration on the 
TRIPS  Agreement and Public Health and the TRIPS provisions itself. It would be helpful if the EU 
could share some experiences in this regard.  The proposal desires to facilitate the use of WTO 
notification procedures on compulsory licensing and I would like to state here that it is these 
cumbersome preconditions that render the mechanism impractical in a pandemic situation and these 
need to be r evisited.  
376.  We have heard from a delegation in this meeting itself regarding their first -hand account of 
the difficulties being faced in utilising the compulsory licensing system, especially in the context of 
a pandemic, and we hear that the proponents stil l continue to support their proposal . However, while 
the majority of Member s of the waiver proposal are calling for a waiver, it has not been given a 
chance to prove itself.  
377.  Another pertinent question here would be whether, since its proposal deals with e xplanation 
on the compulsory licensing, the EU is monitoring existing requests on compulsory licensing being 
filed by Members.  
378.  Now let me touch upon the three points mentioned in the operative part of the proposal. Point 
A clarifies that a pandemic is a n ational emergency or other circumstance of extreme urgency, that 
is the meaning of Article 31 .b. We are not clear what elicited such clarification from the EU, since 
this was never in dispute and a pandemic by its definition is a global emergency and that does qualify 
as a national emergency. Additionally,  Article 5 .c of the Doha Declaration on the TRIPS Agreement 
and Public Health clearly states that each Member can determine as to what constitutes a national 
emergency.  Further the second point reads that a Member can set a remun eration that reflects the 
price charged by the manufacturer of the vaccine for medicine produced under the compulsory 
licence. However,  Article 31 .h already provides  for Member s' freedom to set the level of adequate 
remuneration. Point C of the proposal says that the exporting Member may provide in one single 
notification a list of all countries to which vaccines and medicines are to be supplied. What these 
points covered is a rei teration of existing provisions of the TRIPS Agreement. Importantly the 
proposal contains only 'may' obligations which makes these proposals even more redundant in 
addressing the current COVID -19 pandemic. Would the EU elucidate how these reiterations of t he 
existing provisions result in ensuring  production of vaccines, therapeutics and diagnostics for the 
treatment, prevention and containment of the pandemic and how they will secure access to vaccines 
for the developing countries and the LDCs ?  
379.  Finally , we also want to know and understand what the legal enforceability of this declaration 
will be since it does not bring in any change to the existing agreement. How will Members use this 
declaration to procure more vaccines, therapeutics, PPE kits, masks etc . for their population ? The 
proponents of the waiver proposal have argued on many occasions how flexibilities provided in the 
TRIPS  Agreement are inadequate in responding to a pandemic of this magnitude. The limited policy 
space provided by the TRIPS Agreeme nt flexibilities to address monopoly actions through issue of 
compulsory licences would not be a feasible option in a pandemic. Invoking compulsory licences 
across a wide range of medical products , on a case -by-case or product -by-product bas is is a 
cumbers ome and time -consuming process, severely limiting its effectiveness in the context of 
products and technologies required for fighting the virus. Beyond patents, other IP rights including 
trade secrets, industrial designs, copyrights etc . also pose barriers , and the current proposal is silent 
on those issues. Compulsory licen ce does not address these barriers posed by  these rights.   
380.  What is pertinent to note here is that the discussion on improving on existing TRIPS flexibilities 
as well as the 2001 Doha Dec laration on TRIPS and Public Health is crucial and relevant. However, IP/C/M/101/Add.1  
 
- 61 - 
 
  we would also only be deceiving ourselves by believing that a mere reiteration of existing flexibilities , 
with more stringent interpretations , would  make them practical, less cumbersome and effective , and 
provide a timely solution to the pandemic.  
India's statement at the informal meeting held on 24 June 2021  
381.  I thank you Chair for organising this meeting and I also thank the EU for introducing their 
proposal.   
382.  I take this opportunity to raise some questions and seek clarifications and explanations from 
the proponents. It is indeed heartening to note that the proponents recognise the pandemic to be a 
global health and economic crisis that calls for urgent multilateral action  which is key to respond to 
this crisis swiftly. It would be useful if European Union could clarify what it  envisages as urgent 
multilateral action and what would be the timeline for such action?  
383.  Further it reads that pandemic affect s all countries and the refore require s concerted global 
efforts to ensure that all people in all countries have access to safe and effective vaccines and 
medicines as soon as possible. Here again would want to know what is meant by concerted effort 
and what is the understanding of the term 'as soon as possible ' as it lacks specificity.  
384.  We are glad to see that the main objective of this proposal as reflected in the text is to ensure 
fair and equitable distribution of vaccines and medicines to fight against COVID -19 and that requi res 
concerted efforts to increase manufacturing capacity and investment, as well as supplies at an 
affordable cost. The text does mention in a number of places the need for accelerating the production 
of vaccines and medicines and their equitable global di stribution.  
385.  So while the proposal aims for fair and equitable distribution of vaccines and medicines it does 
not recognize that access to diagnostics and therapeutics is equally critical to save lives. Does the 
proposal aim to increase existing manufactur ing capacity of the few players and , if so, could they 
provide evidence as to how increased manufacturing capacity will yield affordable supplies? And 
especially, with rampant pre -ordering of vaccines by developed countr y Members , how will the 
increased ou tput be equitably distributed ?  
386.  The proposal also talks of the need to provide and preserve appropriate incentives for 
investments in research and development of COVID -19 vaccines and medicines, particularly in view 
of the continuing emergence of new varia nts of the virus. What would be an appropriate incentive 
for R&D ? Will it not be prudent to prioritise vaccination of people across the globe, as more 
unvaccinated people would only help the virus incubate and mutate into new variants defeating the 
purpose  of these concerted efforts ?  
387.  The proposal stresses the need for legal certainty on the flexibilities provided by the 
TRIPS  Agreement and that the established procedures to use compulsory licences for those purposes 
be as efficient and streamlined as possi ble. to facilitate the determination of the remuneration to be 
paid under a compulsory licence in the circumstances of a pandemic, in order to support 
manufacturers ready to produce pharmaceutical products, including vaccines or medicines, at 
affordable pr ices for low - and middle -income countries. It is reassuring that at this critical time EU 
proposal endeavours to reaffirm our existing rights emanating from the Doha Declaration on the 
TRIPS Agreement and Public Health and the TRIPS provisions itself. The proposal desires to facilitate 
the use of WTO notification procedures on compulsory licensing , let me state here that it is these 
cumbersome preconditions that render the compulsory licensing  mechanism impractical in a 
pandemic situation and these need to be revisited.  
388.  Now let me touch upon the three points mentioned in the operative part of the proposal point 
a clarifies that pandemic is a national emergency or other circumstances of extreme urgency withing 
the meaning of Article 31.b. We don 't know what elicited such clarification from E.U since this was 
never in dispute and pandemic by its definition is global so a global emergency does qualify as a 
national emergency. Additionally, Article 5.c of the Doha Declaration on TRIPS Agreement and Public 
Health  clearly states that each Member  can determine as to what constitutes a national emergency.   
389.  Further, the second point reads that Member s can set a remuneration that reflects the price 
charged by the manufacturer of the vaccine or medicine produced under t he compulsory licence. IP/C/M/101/Add.1  
 
- 62 - 
 
  However, Article 31.h of TRIPS already provides Member s freedom to set the level of adequate 
remuneration.   
390.  Point c of the proposal says that the exporting Member may provide in one single notification 
a list of all countries to whic h vaccines and medicines are to be supplied. What these points covered 
is a reiteration of  existing provisions of TRIPS Agreement. Could the EU elucidate how these 
reiterations of existing provisions result in ensuring augmentation of production of vaccine s, 
therapeutics and diagnostics for the treatment, prevention and containment of the pandemic, how 
will these secure access to vaccines for developing countries and the LDCs.   
391.  Finally, we would like to hear as to what will be the legal enforceability of th is declaration, 
since it does not change the existing Agreement, how will Member s use this declaration to procure 
more vaccines, therapeutics, PPEs, masks etc . for their population ?   
392.  The proponents of the Waiver proposal have argued previously on many occ asions how 
flexibilities provided in the TRIPS Agreement  are inadequate in responding to a pandemic of this 
magnitude. The limited policy space provided by the TRIPS Agreement flexibilities to address 
monopoly actions through issue of compulsory licen ces would not be a feasible option in a pandemic. 
Invoking compulsory licen ces across a wide range of medical products, that too on a "case by case " 
or "product by product " basis is a cumbersome and time -consuming process, severely limiting their 
effectiveness , in the context of products and technologies required for fighting the virus. Beyond 
patents, other IP rights, including trade secrets, industrial designs, copyrights, etc. also pose 
barriers. Compulsory licence does not address the barriers posed by thes e rights. In fact these 
limitations posed by the compulsory licensing  can be easily addressed by the Waiver. The waiver 
once approved and applied would provide countries with an effective and expeditious way to remove 
key IP barriers that scuttle the use o f existing idle capacities.   
393.  What is pertinent to note , Chair, is that this discussion on improving upon the existing TRIPS 
flexibilities as well as the 2001 Doha Declaration on TRIPS and Public Health is crucial and relevant, 
however, we would only be dec eiving ourselves by believing that a mere reiteration of existing 
flexibilities would make them practical, less cumbersome and effective and provide a timely solution 
to the pandemic.  
2.10  European Union  
394.  I would like to give some first responses  to questions from India. I think we have discussed a 
lot of these issues already in the context of small groups and informal  meetings and of course we 
are ready to discuss again and in more detail. First of all, about the multilateral action and 
multifaceted action, that was the question of India. What is part of this proposal, so here I would 
like to reiterate the engagement of the E U in both the Trade and Health Initiative  that was presented 
by the Ottawa  Group that deals with a number of trade -related policy responses to the COVID -19 
crisis, and also a specific communication on urgent trade policy responses to COVID -19 crisis, 
document WT/GC/231 , that we have submitted to the WTO General Council on 4 June 202 1. The 
approach proposed in these documents is basically to explain that we need a number of trade -related 
measures that deal with identifying bottlenecks. It is to tackle export restrictions , to look at supply 
chains, to look at trade facilitation measure s, that we need to have also a proper cooperation with 
industry and see how we can support collaborations between industry,  and this is where the 
Director -General of the WTO, Dr Ngozi Okonjo -Iweala, has organised a number of events as to how 
to strengthen these collaborations and how to strengthen th is matchmaking.  
395.  The third component of this approach is the intellectual property component where the logic 
of our proposal is , that IP should be an enabler when it comes to increasing capacity and using the 
current adequate capacity . It is all of these components together that work towards accelerating the 
production of vaccines and medicines. None of these elements alone can do it and certainly not the 
element on intellectual property, whether  it is compulsory licensing  or the waiver , cannot achieve it. 
What we need, as we have presented in our intervention, we need discussions, we need investments, 
we need to create conditions, we need to see which facilities can be used, we need to see what 
additions to these facilities have to be made. Switzerland gave a ve ry good example of what had to 
be done to ensure there is skilled personnel, there is a question of access to raw materials , so all of 
this has to come together in order to accelerate production of vaccines and medicines , and as 
South  Africa was saying today, I think that there are clearly things that can be done in the short IP/C/M/101/Add.1  
 
- 63 - 
 
  term and things that can be done in the medium - and long term. And clearly , as the delegate from 
South Africa was referring to, the fact of the dependence of certain regions like Africa on imports of 
pharmaceuticals - I think the delegate referred to 99% of imports - is not a situation that can be 
accepted  going forward. And this is also why the European Union is engaging on supporting what I 
think was included very clearly in our intervention today, on the creation of manufacturing hubs in 
Africa and also strengthening the resilience of health systems. So, to answer the question , all of this 
comes together to produce a set, because it is not by one click or one decision or one change, 
especially in the area which  has nothing to do with the bottlenecks which are identified , that we can 
bring any change.  
396.  All of this is also done in such a way as to maintain incentives and not break the current 
collaboration  – not taking away incentives for transfer of technology and know -how, I think that is 
a crucial part of the EU proposal. Our proposal is proposed in such a way to ensure when IP is an 
obstacle, so when the licence is an obstacle , then the compulsory licences system can be used and 
can respond to this obstacle. At the same time , we are not proposing an approach that undermines 
the current collaborations , that result in a chilling effect on collaboration going forward , and basically 
backfires  and puts into question all our efforts and objectives that we have.  
397.  When it comes to questions about particular clarifications, I think I have referred to this 
already, when replying to the honourable  delegate from South Africa, we are not reiterating what is 
in the TRIPS Agreement or the Doha Declaration, we are giving additional precision, an additional 
comfort regarding these three issues in the circumstances of the pa ndemic. It does not have a 
limiting effect of course, as we have explained many times. The intention  is not to provide 
clarification in a way that limits Members in the use of these flexibilities, on the contrary, it is to 
provide additional comfort, to pr ovide legal certainty to make the system as effective as possible. 
We heard now from India and we hear from a number of delegations that it is does not go far 
enough, that it is inadequate, that there can be other issues . India mentioned notification 
proce dures . There were also references to packaging and labelling requirements . Well, I would say, 
let's discuss  it. Please let us know what else is missing, because moving away, and leaving the 
discussion at the level of 'it is inadequate and cannot work because it does not go far enough ' is not 
helping to go forward . Let's discuss requirement by require ment, what els e is needed, we are very 
open to do that.  
398.  The European  Union has been saying this from the beginning, we have come up with our 
proposal on what we think is most relevant but we are absolutely open to discussing, and this already 
came in a very useful manner last week from the delegation of Turkey, for which w e are very 
grateful . As I explained in our intervention today , we are analysing very closely this proposal . So 
let's discuss it, let 's not just say it is inadequate, let 's not just say it doesn 't go far enough. Please 
put issues forward so that we can look  into this. All of this is open to discussion, we discussed legal 
enforceability, for the time being I can say it is the same as the Doha Declaration . We see how the 
Doha Declaration has been agreed and what kind of impact it has had and continues to have,  and 
we think that our declaration as proposed can have a very similar impact and can be extremely 
useful for the times of a pandemic. I will stop here, but the most important, from my point of view, 
is the invitation to share . We are not limiting our appr oach to the proposal to what we are putting 
on paper . We are open to discussing all requirements and looking at all issues and we think that we 
need to move forward in the discussion, we need to advance, we cannot as has been said many 
times by the propone nts of the waiver, we cannot go in circles . Let's try to find some areas of 
convergence, let 's try to start with something smaller, something relevant, something on which we 
can build convergence and communication between us – and obviously patents is the area which is 
most relevant here . So let's start with this, rather than discuss and not find any solutions, let 's start 
with something that can bring solutions in the short term and make a real difference. That is what 
we would like to invite all Members to do.  
3  OTHER BUSINESS  
3.1  World Intellectual Property Organization  
399.  The global pandemic continues to wreak havoc on the lives and livelihoods of people across 
the globe. While the threat i s coming under control in some countries, many others continue to 
suffer the full force of the pandemic. Winning the battle against COVID -19 is the world 's most 
pressing and immediate challenge. Finding ways to secure global vaccine production to overcome IP/C/M/101/Add.1  
 
- 64 - 
 
  global vaccine shortages is central to that endeavour. Let us not forget that no one is safe until we 
are all safe.  
400.  Human ingenuity offers great hope. Over the last year, we have witnessed the fastest 
development and deployment of vaccines in history. The  anticipated ramp up in COVID -19 vaccine 
production over the coming months promises to bring total production to some 11 billion doses by 
year-end. While this is very good news, there is still much to do to ensure that these life -saving 
vaccines reach all communities in every part of the world.  
401.  Beyond overcoming the pandemic, we also need to come together to support countries as they 
lay the foundations for a post -COVID recovery. Harnessing the innovative and creative capacities of 
our people and  building a balanced and effective global IP ecosystem to support these efforts, will 
be key to building back better. While the important discussions in this forum are proceeding, WIPO 
is committed to taking measures to support our common goal of equitable access to  COVID -19 
vaccines, therapeutics, diagnostics,  and other health technologies. But the challenge ahead is 
complex and multi -faceted and  requires concerted action across agencies.  
402.  This is why we are very pleased that the trilateral cooperation with the WHO and WTO has 
been stepped up. Last month, the Directors -General of WIPO, WHO and WTO met to map out further 
collaboration to tackle the COVID -19 pandemic and other pressing challenges at the intersection of 
public health, IP and trade. The teams from all th ree agencies have since been working hard to 
concretize these aspirations. We have agreed to organize a series of capacity -building workshops to 
enhance the flow of updated information on current pandemic -related development and responses 
to achieve equita ble access to COVID -19 health technologies. Scheduled for September, the first 
workshop will focus on technology transfer and licensing.  
403.  We further agreed to implement a joint gateway for tripartite technical assistance to support 
countries in assessing, p rioritizing , and responding to unmet needs for COVID -19 vaccines, 
medicines and related technologies. Work on this is still ongoing and further details will be shared 
in due course.  
404.  While the Trilateral work is proceeding apace, solely at the WIPO front, the previous  week 
Director  General Daren Tang announced a package of COVID -19 services and measures to support 
Members as they overcome the pandemic and rebuild. The package covers five areas in which WIPO 
has significant experience and expertise, namely, Policy and Legislative Assistance; Technical 
Assistance and Capacity Building; Innovation Support and Technology Transfer; and IP Dispute 
Resolution and Knowledge Resources. Full details can be found on our website and via WIPO 's 
COVID -19 Related Services and Support page.  
405.  The package complements other long -standing WIPO pandemic -response measures, such as 
the COVID -19 Policy Tracker and our work in support of an enabling environment for tech transfer 
and licensing. In fact, today, we are holding a worksho p on The Role of Knowledge Transfer Policies, 
which is the first in a series of seminars focused on Innovation in the Time of COVID -19.  
406.  WIPO has been a longstanding observer at the proceedings of this august Council, and we are 
following the important del iberations of WTO Member governments on COVID -19 related proposals 
in the TRIPS Council very closely. And we stand ready to provide legal and technical assistance in 
line with Article 67 of the TRIPS Agreement, and Article 4 of the WIPO -WTO Agreement.  
407.  We look forward to working with our key partners around the globe to support collective efforts 
to bring the COVID -19 pandemic to an end and to build back in a more inclusive and sustainable 
way. WIPO also wishes to thank you, Chair, for your tireless efforts  in building consensus to achieve 
these shared goals . 
 
__________