RESTRICTED  
  
IP/C/M/97/Add.1  
 
7 April 2021 
(21-2922) Page: 1/38 
Council for Trade -Related Aspects of  
Intellectual Property Rights    
 
MINUTES OF MEETING  
HELD IN THE CENTRE WILLIAM RAPPARD ON 23 FEBRUARY 2021 
Chair: H.E. Ambassador Xolelwa Mlumbi -Peter 
Addendum  
The present document contains the statements made during the Council for TRIPS held on 
23 February 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 ....... 2 
2   OTHER BUSINESS  ................................ ................................ ................................ ...... 38 
  IP/C/M/97/Add.1  
 
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  INDEX OF THE STATEMENTS MADE  
AT THE MEETING OF COUNCIL FOR TRIPS 23 FEBRUARY 2021*  
 
 
 
Australia  
Waiver - COVID -19..............................  36 
Bangladesh  
Waiver - COVID -19................................  9 
Canada  
Waiver - COVID -19..............................  35 
Chad on behalf of the LDC Group  
Waiver - COVID -19................................  7 
Chile  
Waiver - COVID -19................................  3 
China  
Waiver - COVID -19..............................  17 
Colombia  
Waiver - COVID -19................................  6 
Egypt  
Waiver - COVID -19................................  6 
El Salvador  
Waiver - COVID -19..............................  13 
European Union  
Waiver - COVID -19..............................  18 
Holy See  
Waiver - COVID -19..............................  36 
India  
Waiver - COVID -19..............................  10 
Indonesia  
Waiver - COVID -19..............................  12 
Japan  
Waiver - COVID -19..............................  36 
Mali 
Waiver - COVID -19..............................  34 Mozambique  
Waiver - COVID -19 ..............................  10 
Namibia  
Waiver - COVID -19 ..............................  16 
Nepal  
Waiver - COVID -19 ..............................  16 
Nigeria  
Waiver - COVID -19 ..............................  16 
Norway  
Waiver - COVID -19 ..............................  29 
Pakistan  
Waiver - COVID -19 ...............................  8 
Singapore  
Waiver - COVID -19 ..............................  34 
South Africa  
Waiver - COVID -19 ...............................  4 
Sri Lanka  
Waiver - COVID -19 ..............................  14 
Switzerland  
Waiver - COVID -19 ..............................  29 
Tanzania on behalf of the Afri can Group  
Waiver - COVID -19 ...............................  3 
United Kingdom  
Waiver - COVID -19 ..............................  35 
United States of America  
Other business  ................................ .... 37 
Waiver - COVID -19 ..............................  28 
Venezuela, Bolivarian Republic of  
Waiver - COVID -19 ..............................  13 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_______________  
* 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/97/Add.1  
 
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  1  PROPOSAL FOR A WAIVER  FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR 
THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID -19 
1.1  Chile  
1.  Chile would like to acknowledge those who have referred to its work during the discussions on 
this subject, and  express its gratitude for the facilitation of the discussion and the search for 
consensus. Our delegation can support the draft report that has been presented, in that it provides 
a factual presentation of the discussions that have been held in this commi ttee. 
2.  Chile reiterates its position on this matter and would like to emphasize from its report to the 
General Council that the member ship shares the objective of achieving timely and secure access to 
effective, reliable and high quality vaccines and medici nes for all. This point in its report is not 
insignificant and should be the starting point for the search for creative solutions within the IP system 
that are able to tackle the issue. It also allows us to be open to considering the possibility of seeking  
solutions together with the pharmaceutical industry that enable the production and distribution of 
vaccines to be increased worldwide.  
3.  For Chile, the WTO is a relevant actor and an appropriate forum that could promote a dialogue 
with the industry, especia lly now that we have a new Director General.  
1.2  Tanzania on behalf of the African Group  
4.  On behalf of the African Group I would like you to thank you for your efforts and the manner in 
which you are inspiring the way of this Council. Also let me take this opportunity to congratulate the 
LDC Group for also joining the proponents as  the co-spons ors of this propos ed waiver, as the African 
Group has also done.  
5.  The world is faced with the insurmountable challenge of COVID -19 pandemic and it is not 
predictable when this challenge will cease. Economic strides achieved by Members over a decade are 
being now slumped. Governments are struggling to protect the lives of their citizens in the midst of 
this economic crunch.   
6.  It is of interest to all Members to prevent COVID -19 from continuing to spread the damage it is 
causing which is already epic. To win t his battle, WHO has called for international solidarity and 
cooperation, as the only effective way to fight COVID -19, particularly by scaling up research and 
production of vaccines, medical kits and medicines for COVID -19. As we have previously mentioned, 
the WTO has an essential role in this fight, as the custodian of the multilateral  TRIPS  Agreement. 
During the pandemic more flexibilities of TRIPS Agreement are needed in addition to the existing 
ones. The current exiting flexibilities have clear limitatio ns as the proponents have explained in the 
past. Therefore, intellectual property should not become a barrier for scaling up production of 
vaccine s, medical kits and medicines for COVID -19.  
7.  In the previous TRIPS Council meetings, the African Group has sup ported the proposal for a 
waiver of certain provisions of TRIPS Agreement for the prevention, containment and treatment of 
COVID -19. We also informed the Council that the Group was consulting internally with a view of 
co-sponsoring the proposal. This matter was taken to the highest level of engagement and discussed 
during the Assembly of the African Union held from 6  to 7 February 2021. Consequently, a decision 
was taken that due to the exceptional circumstances we are faced with, Members of the Africa n 
Union should support the proposed waiver. Following that decision and considering the mounting 
challenges that Africa is facing today on COVID -19 vaccines, we are joining the proponents as 
co-sponsors in seeking a swift decision on the waiver at the TRIP S Council and ultimately the 
General  Council.  
8.  In the last TRIPS Council meeting, many delegations including the African group, indicated the 
need to move to a text -based negotiation. We want to once again reiterate the call for an urgent 
shift from discus sion to text -based negotiations. Further delay of a decision on the proposed waiver 
is inappropriate as the death tolls across the globe caused by COVID -19, are rising.  IP/C/M/97/Add.1  
 
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  1.3  South Africa  
9.  We thank you for your report on th e activities of the TRIPS Council 's consideration of the 
Waiver  Proposal and further consultations you held in small group formation as well as the details 
put forward in the proposed oral report to be presented to the General Council in March 2021. We 
would like to welcome the African Group and LDC Group to the fold of co -sponsors, the increase d 
number s of delegations in our ranks demonstrate the growing importance of the Waiver  Proposal 
and the need to scale up production  in order to ensure equitable a nd timely access to COVID -19 
medical products, including vaccines, therapeutics, diagnostics and other equipment.  
10.  Moving forward, discussions cannot continue to be mired in the evidentiary loop that we have 
been engaged in over the last few months . Co-sponsors have also made it clear that we want to 
move to text -based discussions, we stand ready to discuss the scope and duration of our proposal 
in light of comments and observations that Members have made.  
11.  A pandemic like COVID -19 has not been seen in a cen tury, and much remains unknown and 
evolving about the situation and the virus that causes it. While many regard  the virus as a sort of 
black swan, it was not entirely unexpected and was preceded by several other viruses and 
semi-global pandemics in recent times. As much as we may hope that something like this will not 
happen again, the probability is there that the next event may be even more cataclysmic. Many of 
the most serious global threats today involve a high degree of uncertainty. Under such conditio ns, 
people are notoriously unwilling to make sacrifices for others when the benefits are uncertain. A 
good example of this type of behaviour is vaccine nationalism, which denotes self -prioritization to 
the exclusion of others, as many rich government have done on the assumption that individual action 
can yield results on its own. However, this is not the case, the idea that a vaccine rollout will be the 
deus ex machina  is misplaced, we cannot put the virus back into its bottle, we just cannot go back 
to the  old normal.  
12.  According to available data, the United States , the United Kingdom  and the E uropean Union 
account for about 50% of the over 200 million vaccines administered globally as at 22 February . 
Countries opposing the TRIPS  Waiver  Proposal  account for  60% of the globally administered 
COVID -19 vaccines. Reportedly, just ten countries have administered 75 % of all COVID -19 vaccines. 
More than 130 countries have not received a single dose. The WTO has to pay heed to the caution 
of the Director General of W HO: "The longer it takes to suppress the virus everywhere, the more 
opportunity it has to change in ways that could make vaccines less effective – an opportunity to 
mutate ".1  
13.  Sir Jeremy Farrar, the head of Wellcome  Trust has also highlighted that "Immunising a lot of 
people in a few countries while leaving the virus unchecked in large parts of the world would simply 
allow more variants to emerge in these places. And the more that happens, the higher is the risk 
that the virus will evolve to an extent that our vaccines, treatments and tests are no longer effective " 
adding that "We've got to understand this is a global problem that must be dealt with globally. "2 Our 
TRIPS Waiver  offers a global solution. The world is facing its worst ever crisis since perhaps 
World  War II, and the response of WTO Members opposing the Waiver  Proposal  is to engage in 
"business as usual " approaches, and for WTO to do nothing to address IP monopolies  around the 
technology and know -how, to scale up production and to bring this crisis to an end.  
14.  Many of the opposing WTO Members , under pressure from their pharmaceutical industry have 
for more than two decades, been known to dissuade developing countries  from incorporating TRIPS 
flexibilities in their national law and using such flexibilities to promote access, and yet now insistently 
assert  that such sufficient flexibilities exist, although we have presented concrete arguments against 
it.   
15.  These same W TO Members stress on "business as usual voluntary licensing " as the way out of 
this pandemic and yet one 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 limited competition, 
 
1 https://www.who.int/director -general/speeches/detail/who -director -general -s-opening -remarks -at-
munich -security -conference ---19-february -2021 
2 https://www.theguardian.com/world/2021/jan/31/jeremy -farrar -until-we-are-all-safe-no-one-is-safe-
covid-is-a-globa l-problem  IP/C/M/97/Add.1  
 
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  and is artificially constraining global supply. These "business as usual " approaches championed by 
opposing countries is not the global solu tion but really the root cause of why to date we have 
vaccinations that are "wildly uneven and unfair " as pointed out by the UN Secretary General.3 At the 
current vaccination rate, it will take an estimated 4.8 years to cover 75% of the population with a 
two-dose vaccine, according to Bloomberg on the path to immunity around the world4. And sadly, 
this is probably an optimistic scenario. Co -sponsors have often called for the open sharing of vaccine 
manufacturing technology, IP and know -how through the COV ID-19 Technology Access Pool (CTAP).  
16.  We want to clarify that as co-sponsors of the Waiver  Proposal, we have always said that we 
welcome global multilateral cooperative initiatives such as the ACT -Accelerator. The objective of 
COVAX, its vaccine arm, is la udable, as are financial contributions from WTO Members to this end. 
However, we have to confront the limits of the architecture of such an approach, it is not meant to 
address all the needs of developing and least developed countries. A rather large gap e xists between 
what COVAX or ACT -A can deliver and what is required in developing and least developed countries. 
In this case demand -side requirements outstrips supply -side constraints. Irrespective of the amount 
of money any of the donor country may throw at the problem, the model of donation and 
philanthropic expediency cannot solve the fundamental disconnect between the monopolistic model 
it underwrites and the very real desire of developing and least developed countries to produce for 
themselves. The problem with philanthropy is that it cannot buy equality. Yesterday the DG of WHO 
warned that:  "Money is not the only challenge we face. If there are no vaccines to buy, money is 
irrelevant. Even if we have the funds, we can only deliver vaccines to poore r countries if high -income 
countries cooperate in respecting the deals COVAX has done, and the new deals it is doing. "5 Even 
in light of all the additional pledges of monetary support, the ACT Accelerator still faces a gap of at 
least 22.9 billion dollars  to fully financed.  
17.  The Waiver  Proposal constitutes a very real compromise that will immediately enable countries 
to tap into unused production capacity by accessing spare capacity in the developing world which 
will satisfy the ongoing demand for COVID -19 vaccines (including therapeutics and diagnostics) and 
will also negate the need for any donations from rich countries. Take the Africa n continent for 
example : as a whole , Africa currently imports more than 80 % of its pharmaceutical and medical 
consumables.  This is unsustainable and puts the continental population of 1.3 billion people at the 
mercy of a few monopolistic companies. This is a recipe for disaster as we have witnessed not only 
with the COVID -19 pandemic but with all other diseases and pandemics that continue to affect the 
continent.   
18.  We recalled in our intervention of 4 February 2021, in which we quoted a study commissioned 
by the international Chamber of Commerce (ICC) Research Foundation which found that the global 
economy stands to lose as mu ch as USD 9.2 trillion if governments fail to ensure developing country 
economies access to COVID -19 vaccines. We have already argued that there are good moral and 
legal grounds, as recognized under the TRIPS A greement, to pass the Waiver  Proposal . In addi tion, 
this study underscores the importance of ensuring access by developing countries to effective 
vaccines in order to mitigate the economic  and social consequences in the years ahead. We have 
already indicated that the artificial shortage of vaccines is  primarily caused by the inappropriate use 
of intellectual property rights . This cannot be allowed to continue. It is now apparent that poor 
countries would have to wait a long time to access vaccines, during this time the virus will mutate 
giving rise to strains that will undermine the efficacy of existing vaccines. COVID -19 does not respect 
national borders; nor does it care about the gross domestic product of a country, no country in the 
world can insulate itself, even the best plans will be laid to wast e. Let us ensure that everyone has 
access to effective vaccines in the shortest possible time.  
19.  In closing, as many co -sponsors have reiterated, we are ready to go to a text -based discussion 
in order to arrive at an immediate solution. This will not only s ave lives but also enable us to return 
to a situation of relative normalcy. No one is safe until everybody is safe.  
 
3 https://news.un.org/en/story/2021/02/1084962  
4 https://www.bloomberg.com/graphics/covid -vaccine -tracker -global -distribution/  
5 https://www.who.int/director -general/speeches/detail/who -director -general -s-opening -remarks -at-
the-media -briefing -on-covid-19-22-february -2021 IP/C/M/97/Add.1  
 
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  1.4  Egypt  
20.  At the outset, Egypt aligns itself with the statement to be delivered by Tanzania on behalf of 
the African Group and we welcome the African and the LDCs groups as co -sponsors of the 
Waiver  Proposal . We also would like to thank you Madame Chair for the oral report and we support 
its adoption by the TRIPS Council .  
21.  Many countries , even in the develope d world , have been reporting shortages of COVID -19 
vaccines and had to suspend their immunizations – or slow them for lack of doses. These shortages 
in supply of vaccines, coupled with vaccine nationalism and export controls, mean that the vast 
majority of  people especially in developing and least -developed countries will not be able to access 
a COVID -19 vaccine in 2021, and possibly for multiple years ahead. It is clear that we are facing a 
huge problem especially in the production and distribution of COVID-19 vaccines that will hinder the 
global fight against this pandemic.  
22.  We believe that we cannot continue to ignore the severity of the current crisis and we urge all 
Member s to engage constructively in text -based negotiations in this house in order to rea ch 
consensus on this Waiver  Proposal  as soon as possible to prove that this organization can make a 
difference during this unprecedented crisis. The adoption of the TRIPS Waiver  will be beneficial to 
the global economy, as it help s ramping up the global pr oduction of vaccines in order to put an end 
to this pandemic.  
1.5  Colombia  
23.  Colombia reiterates its thanks to the co -sponsors of document IP/C/W/6 69 for bringing the 
attention of all Members to the effects on the public health and  the economies of countries caused 
by the SARS COV 2 virus ( COVID -19), and for encouraging the global review of possible alternative 
action to be taken in relation to intellectual property which could help overcome the crisis that we 
are experien cing. 
24.  Bearing in mind the impact of the decisions taken on this subject, it is crucial to comprehensively 
review the proposal for a "Waiver  from certain provisions of the TRIPS Agreement for the Prevention, 
Containment and Treatment of COVID -19", while exp loring how to use the flexibilities enshrined in 
this Agreement without fear of retaliation or excessive costs.  As stated on previous occasions, it is 
essential for the Colombian Government to ensure a coordinated international response on access 
to inputs , treatments and vaccines. Achieving the desired level of immunity requires all countries to 
stop the spread of the virus.  
25.  We believe that the discussion that has been generated is constructive and we again call for 
special attention to be given to the str engthening of production and supply, vaccines, inputs, and 
medicines, as it is on the weakness of production and supply chains that we must focus our actions. 
We need to better understand the relationship between intellectual property and weak production 
and supply chains in order to have better tools to strengthen them and thus ensure the effective, 
expeditious and universal distribution of vaccines and other inputs in times of crisis.  
26.  For this reason, it is important to discuss alternatives to address sud den surges in demand for 
medicines, vaccines or other goods needed to address an emergency, based on the transfer of 
information, knowledge and technology to ensure that all populations meet their needs. It is desirable 
to find a concerted and voluntary wa y to share information and make legitimate use of intellectual 
property rights in the midst of this pandemic.  
27.  The decision whether or not to grant a  waiver should be based on a thorough review of the 
benefits and implications that it may have. The knowledg e and technology needed to respond to an 
emergency must be easily accessible to all countries, especially during times of calm, which is when 
they must prepare for crises. This is a decision of the utmost importance, as we must always bear 
in mind that we must not only respond to current crises, we must also ensure a sustainable system 
that allows for innovation in order to address future crises.  
28.  We would also like to express our support for the proposed oral report to be submitted to the 
General Council, w hich represents the progress made in the discussions.  IP/C/M/97/Add.1  
 
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  29.  I wish to conclude by reiterating Colombia 's willingness to continue the discussion in a 
constructive manner, while remaining open to all options to ensure access to goods that improve the 
health of the  population.  
1.6  Chad on behalf of the LDC Group  
30.  On behalf of the LDC Group, I would like to reiterate our gratitude to the authors of the proposal 
for this initiative on the "Waiver  from certain provisions of the TRIPS Agreement for the prevention, 
containment and treatment of COVID -19". 
31.  The objective of this proposal concerns us all: developed countries, developing countries and 
least developed countries. Life has meaning only when you are in good health. If you are sick and 
you do not have access to health care, then you can expect the worst.  We must save lives and ensure 
that the COVID -19 pandemic does not further exacerbate the current situation, claiming a large 
number of victims , forcing states to take measures that restrict the movement of people and goods, 
slowing down global activity and global demand, disrupting economies , and causing turmoil and 
uncertainty for economies and world trade.  
32.  The Director General of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, 
warned last January that "the world is on the brink of a catastrophic moral failure – and the price of 
this failure will be paid with lives and livelihoods in the worl d's poorest countries ". 
33.  The trends that we are observing are deeply concerning, and we often say that no one will be 
safe until everyone is safe. Vaccine nationalism will not work, as COVID will resurface through 
variants, as we can already see.  
34.  We must th erefore ensure that everyone has affordable access to vaccines, medicines and other 
new technologies needed to control the pandemic. It is necessary for everyone 's safety and it is the 
vital challenge before us.  
35.  Voluntary transfer through initiatives by co mpanies has produced limited results. Vaccine 
manufacturing agreements with some enterprises lack transparency on costs, and other companies 
have shown no interest in licensing or transferring technology for their patented products. We will 
only be able to  provide an effective response to this global challenge through multilateralism. Our 
collective interest depends on it.  
36.  It is clear that this proposal is aimed at the common good and meets the expectations of world 
opinion. The debate, the reactions, the p ositions and the proposals that it has generated throughout 
the world are proof of this. The very fact that world opinion has taken up the matter demonstrates 
the need for WTO Members to find a consensual solution to this situation.  
37.  The proposed Waiver  is an opportunity to take concrete measures to help prevent another tragic 
repetition with regard to access to life saving treatments.  
38.  The debate within the Council for TRIPS must enable all to ensure that barriers to accessing 
these types of products and tra ding in them are minimized, in order to make our economies and 
populations more resilient to such a pandemic crisis, but also to build a fairer, more equitable, 
transparent and inclusive system that truly responds to global public health needs. And this is  what 
the communication seeks to do.  
39.  We must ensure that intellectual property rights do not create barriers to timely access to 
affordable medical products, including vaccines, or to increased research, development, 
manufacturing or provision of medical p roducts that are essential for combating COVID -19. 
40.  Since the emergence of the COVID -19 pandemic, many developing countries and LDCs have 
become more vulnerable and have had difficulty accessing medical supplies. The significant 
imbalance between countries raises serious concerns about the availability and accessibility of 
medical products needed to tackle COVID -19. IP/C/M/97/Add.1  
 
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  41.  In these exceptional circumstances, we believe it is important to remove potential barriers 
related to intellectual property rights. It is impor tant to take all the necessary steps to ensure that 
everyone has access to affordable medicines and/or vaccines.  
42.  Moreover, the LDC Group, having spoken with the authors of the proposal and received feedback 
from our various capitals on the importance of th is proposal, joins the proponents as co -sponsors of 
the communication on the "Waiver  from certain provisions of the TRIPS Agreement for the 
prevention, containment and treatment of COVID -19". 
43.  In light of the significant health challenges before us, the LDC  Group calls for a swift decision 
by the Council for TRIPS and the General Council.  
1.7  Pakistan  
44.  Pakistan would like to thank you for convening this meeting, and to commend you on your hard  
work to allow open exchange on this topic. Pakistan has no objection to the draft report you have 
presented. At the outset, we wish to welcome the new co -sponsors, in the entire African group and 
the LDC group. The growing support for this proposal, is te stament to the importance and urgency 
of this proposal in present times. We therefore wish to recall all our previous statements in the formal 
and informal meetings of this Council on the issue.  
45.  Since we started debating this issue last year, significant t ime has elapsed. During this time, we 
have seen that the assurances given by those who opposed this Waiver , that the COVAX facility 
would take care of vaccine dissemination to developing countries; that partnerships and voluntary 
licenses were the only way  and would adequately cover the needs of the large developing country 
populations; those assurances have fallen flat. Instead, vaccine hoarding has now become 
established. At the same time, supply constraints have emerged even in developed countries that 
had secured enough doses to vaccinate one person many times over. Most recently, reports have 
surfaced that export restrictions on vaccines may be placed by countries that have them and control 
their supply.  
46.  According to a latest estimate, a handful of ric h countries have secured over three  billion doses 
of the available vaccines, which is over one billion more than the collective requirement of these 
countries put together.  
47.  Meanwhile, the disease remains rampant. New mutant strains are being reported ever y day, 
and there are no signs of abatement. The consequences of such developments, are noteworthy. Only 
last night, it was reported that the richest country in the world has now suffered half a million deaths 
due to the disease. This, on top of the fact th at this country has one of the best healthcare delivery 
systems in the world. An extrapolation of this number as a percentage of the population across the 
entire globe would present unimaginable and alarming numbers in the coming months, if the vaccines 
do not become available to the poorer countries in time.  
48.  Other than the loss of lives, and as mentioned in the statement by South African earlier, it is 
estimated in a recent study by the International Chamber of Commerce, that the global economy is 
set to l ose as much as USD 9.2 trillion if developing countries ' access to COVID -19 vaccines cannot 
be ensured. The study further finds that no economy, even in the developed world, can fully recover 
from the effects of the pandemic unless vaccines are equally acc essible in all developing countries.  
49.  While developing countries are making a strong case for access to vaccines, we are already 
hearing mentions of COVID  or vaccine passports in those that have access to vaccines. Such steps, 
in a very preliminary underst anding, could only lead to more restrictions on already restricted travel, 
seriously affecting supply chains and curtailing movement of natural persons. Economies dependent 
on such movements could face serious damage. We fear that the world would create ye t another 
divide between the vaccinated and non -vaccinated. Only this time, the effects would be felt by 
everyone, regardless of their development status.  
50.  A good solution is what we , the co -sponsors , have proposed. To remove this artificial vaccine 
famine we must utilise all the production capacity in various countries in the Global South, and allow 
them to manufacture vaccines and other essential medicines and equipment en masse  by removing IP/C/M/97/Add.1  
 
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  the various IP restrictions. This would allow us to reach the figu res required to break the chain of 
the virus spread and avoid the impending crises.  
51.  We have made a very robust and thorough case for this Waiver . We have provided detailed 
explanations regarding its necessity, scope, and applicability. We have also put for th detailed 
evidence on how and why this Waiver  is necessary. We have stressed in our explanations that the 
quest to perpetuate monopoly power using IP, especially trade secrets, must be abandoned, in order 
to massively scale up the production of vaccines within the shortest possible time.  
52.  In opposition, we have heard among other things that, intellectual property is not barrier. At 
the same time, the same Members have argued that the real barrier is the transfer of technology 
and know -how and that the unde rlying IP is required for purposes of licensing. These are 
contradictory statements, at best.   
53.  It is a known fact that much of the vaccine and monoclonal anti -body technology and know -how 
is protected by intellectual property, particularly patents and trad e secrets. We have detailed in 
documents IP/C/W/671 and IP/C/W/673 this known patent landscape for therapeutics and vaccines. 
While patents are obtained on many aspects of vaccine technologies, trade secrets work to deny 
access to the biomaterials and manu facturing processes. Patent information, therefore, is insufficient 
to facilitate non -originator manufacturing of COVID -19 vaccines. Additionally, as pointed out before, 
compulsory licenses under TRIPS Article  31 are only applicable for patents, and are no t explicitly 
provided for under Article 39 of TRIPS.  
54.  Lifting IP monopolies around technology and know -how will facilitate the sharing of such 
technology, expedite production, and also give potential manufacturers legal certainty and freedom 
to operate. It is, therefore, important to ask whether the regulatory agencies of the developed 
countries are ready to share the vaccine regulatory dossiers to scale up vaccine production.  
55.  Based on the foregoing, it is high time that we conclude the debate, and move towa rds concrete 
text-based solutions to the Waiver  to be put it into effect. Endless deliberation to stall this issue will 
only cause further problems for the entire globe. As we have indicated before, we are ready to 
explore possibilities on the text of the proposal to make sure that it adequately addresses the 
challenges we face.  
1.8  Bangladesh  
56.  The delegation of Bangladesh supports the draft statement presented in this meeting  which will 
be further delivered orally at the General Council by the TRIPS Council Chair.  
57.  My delegation endorses the statement delivered by Chad on behalf of the LDCs. Wit h all the 
co-sponsoring Members , including the LDC group, Bangladesh attaches high importance and 
welcomes discussion of the proposal contained in document IP/C/W/669. My delegation once again 
thanks the proponents for their previous submissions with evide nces and explanations.  
58.  We live in an interdependent and interconnected world, and therefore, my delegation believes 
that the issues of public health are concerns for everyone in the world. A threat to public health in 
one society puts humanity at risk everywhere. As we have noti ced, the ongoing pandemic is primarily 
a health issue, but evidently has far reaching impact on our societies and economies. No one is 
certain when this pandemic will end actually. Enough damage ha s already happened to the world, 
and as consequences, the L DCs particularly are becoming the worst victims. In addition, the new 
variants of the virus are threatening us. We need collective efforts to support each other, irrespective 
of our development status, for the interest of our survival.  
59.  My delegation earli er stated that unconditional, affordable, equitable and timely access to 
vaccine and other curative measures against the virus must be a priority of the time. Production and 
distribution of vaccine and other medical equipment for prevention, containment, a nd treatment of 
COVID -19 must be open to all, so that people of the world can easily access these facilities. The 
TRIPS or any other regulatory framework should not be brought as a hindrance to the most urgent 
needs of the humanity today.   IP/C/M/97/Add.1  
 
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  60.  The proposal ha s clearly presented its objectives. Members have also discussed the contents of 
this submission in several occasions and heard each other loud and clear. This is a high time now, 
to start a text -based discussion. The delegation of Bangladesh looks forward to engaging 
constructively with Members and once again requests a favourable  consideration of the proposal.  
1.9  Mozambique  
61.  From December 2019 to February 2021, more than 2.4 million of people have died from 
COVID -19, out o f more than 110 million who contracted the virus.  As is well-known, this virus does 
not only affect health, but all other aspects related to human life, in the social and economic area.  
The world is facing an unprecedented challenge that calls for unpreced ented collective measures.  
62.  As the world is now organized, it will not contain the spread of the virus only with public health 
measures. We reiterate the need to put in place other measures to guarantee that billions of vaccine 
doses are produced and made a vailable to everyone, at affordable prices and in a short period of 
time. 
63.  The developing countries have already been left behind and the way out is the Waiver  certain 
provisions of the TRIPS A greement for prevention, containment and treatment of COVID -19, to 
ensure that the intellectual property rights do not restrict rapid scaling up of manufacturing and do 
not hinder an equitable and affordable access for diagnostics, medicines, vaccines and other 
necessary goods.  
64.  The application of this measure would not invalidate existing IP rights, and would open space 
for further collaboration and transfer of technology.  My delegation would like to remind that behind 
the figure of 2.4 million deceased, there are health workers, care givers, teach ers, fathers and 
mothers, a long list of professionals who left an empty hole in their communities, and we need to 
put urgently an end to this pandemic.   
65.  We reiterate our appeal to Member s to avoid putting in place restrictive measures to exports at 
a time they are needed most.  Since this dialogue started, many Member s have positively engaged. 
We commend and welcome the proposals put forward so as to move this dialogue ahead.  We 
welcome the proposal for a text based dialogue.  We thank and welcome all new c o-sponsors this 
initiative, so valuable to assist and respond to all needs.  
1.10  India  
66.  We would like to thank you for your report, which is factual and reflects the developments that 
have taken place since the last report to G eneral Council  in December 2020. We look forward to the 
discussions in the General Council on the report. We would like to thank and welcome the Africa 
Group and the LDC Group as the latest co -sponsors of the Waiver  Proposal. The Proposal now reflects 
the vo ice of 57 WTO Members with many more supporting from the floor since its introduction in this 
Council in October 2020.  
67.  So far around 200 million vaccine doses against COVID 19 have been administered worldwide. 
The UN Secretary General, in his press briefing  last week6 noted that the progress on vaccinations 
has been wildly uneven and unfair, more than 130  countries have not received a single dose.   He 
warned "If the virus is allowed to spread like wildfire in the global South, it will mutate again and 
again  and that this can prolong the pandemic significantly, enabling the virus to come back to plague 
the global North. "  
68.  When we introduced the Waiver  last year, we had cautioned against such a scenario and 
therefore made the case for removing IP barriers temp orarily to ramp up rapid global manufacturing. 
It is unfortunate that our apprehensions, subsequently supported by evidences, were dismissed as 
hypothetical as the vaccines were yet to arrive at that time. We are not feeling happy about being 
proven right in raising concerns in advance. Today our fears have not only proven to be true but the 
very Members who dismissed our argument in this Council that there would be shortages of vaccines 
if manufacturing remains limited, are themselves facing shortages in t heir jurisdictions even after 
 
6 https://www.un.org/press/en/2021/sc14438.doc.htm   IP/C/M/97/Add.1  
 
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  having successfully negotiated advance purchase agreements of volume way beyond their need. 
That the situation could be this worse, even the proponents of Waiver  did not predict.  
69.  On its part, India has supplied 28.84 million v accine doses to 26 countries as on 
21 February  2021 under its "Vaccine Maitri " i.e. Vaccine Friendship Initiative. 48 more countries will 
be supplied in the coming days ranging from Europe, North America, Latin America, and Caribbean 
to Africa, SE Asia and the Pacific Islands. India has also gifted 200,000 doses for the 
UN Peacekeep ers. The UN Secretary General has stated that India has been a global leader in 
pandemic response efforts having provided critical medicines, diagnostic kits, ventilators and 
personal protective equipment to more than 150 countries. Despite scarce resource s and a 
population of more than 1.3 billion, we are doing our bit towards equitable delivery of vaccines. If 
the existing global manufacturing capacity can be used for mass manufacturing by providing legal 
certainty to manufacturers over use of COVID -related IP, which is the chief objective of the Waiver , 
then humanity can accelerate the fight to win over the virus.  
70.  As we reiterated at the past meeting, proponents answered all questions posed in various 
sessions of the TRIPS Council, yet certain delegations  have this tendency to ask further questions 
and delay the start of text -based negotiations. With the experience learnt during the last four months 
after the first emergency use authorisation of vaccines, we need to close the evidentiary loop and 
get down to textual negotiations that can further refine the Waiver  Proposal  that we tabled. What 
we have seen in last few meetings is a repetition of similar questions and maybe answers to some 
of those questions lie in text -based negotiations. M oving to a text -based negotiation may appear to 
be yielding from the high moral ground of being the sole protectors of IP rights for some Member s, 
but not doing so means a willingness to stand by a poor choice, devoid of ground realities and just 
opposite to what is the nee d of the hour.   
71.  The delegations that oppose the Waiver  have argued on one hand that the Waiver , if granted, 
will not result in augmenting the manufacturing capacity and on the other hand, they argue that the 
Waiver  will impact the commercial interests of e xisting IP holders as lot of manufacturing could come 
into play without agreement with the IP holders. We would like to understand this dichotomy that if 
the Waiver  will not lead to an increase in manufacturing capacity, meaning, no new manufacturers 
will enter into production of COVID  products even with the proposed Waiver  in place, then how will 
the commercial interests of existing IP holders be impacted? On the other hand, if manufacturing is 
going to increase significantly and are thereby impacting comm ercial interests of IP right holders, 
then are we not agreeing that final objective in the present scenario is to increase manufacturing.  
72.  Moving on to COVAX  - even its creators have admitted the issues with the mechanism like lack 
of funding and its inadeq uacy to address supply side constraints. DG, WHO in a recent statement7 
said and I quote, 'The ACT Accelerator and COVAX Facility were created to increase equity. But with 
every passing day, that goal is at risk. ' He called on all countries to respect COV AX contracts and 
not compete with them. He also mentioned that 'we need an urgent scale -up in manufacturing to 
increase the volume of vaccines '. There is no alternative to augmenting manufacturing to address 
supply side constraints of goods critical for pr evention, containment and treatment of COVID -19, 
and allocation of money alone for securing such supplies would not suffice. The Waiver  Proposal, 
which seeks to address supply -side bottlenecks, will thus further help the COVAX mechanism to 
achieve its goal.  
73.  Regarding the proportionality of the Waiver , almost every country implemented lockdown in 
some form or other to curtail the spread of  COVID . That does not mean that authorities were against 
the principle of "right to freedom of movement ". Similarly, government s worldwide intervened to 
suspend air transport and restrict mobility in order to prevent the spread of coronavirus. Sectors like  
civil aviation, travel and tourism, hospitality and even small business activities are facing continued 
restrictions and thereby being severely impacted by such state interventions. These sectors are also 
important for the global economy, for growth, for employment. Certainly, governments are not 
against the interest of these sectors. We would like to ask the member ship that why commercial 
interests of only few companies are so sacrosanct?  If it is to preserve incentives to innovate, then 
such commercial loss, to the tune of few tens of billions of USD at the maximum, can always be 
compensated by further incentives through public funding. In any case, such loss to few companies 
is significantly lower than the overall loss to global economy, estimated to be  USD 9.2 trillion if the 
 
7 https://www.who.int/director -general/speeches/detail/who -director -general -s-introductory -remarks ---
act-accelerator -4th-facilitation -council   IP/C/M/97/Add.1  
 
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  international community fails to ensure developing economy access to COVID -19 vaccines, as per 
the study by International Chamber of Commerce.  The global community has resorted to exceptional 
measures in the exceptional circumstan ces of COVID  pandemic, and the Waiver  should be seen in 
similar vein.  
74.  The TRIPS Agreement has been in force since 1995. But never, in the history of medical science, 
have vaccines been developed in such a short span of time of less than one year. This prov es that it 
is not the IP system alone that has delivered, but also the 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 info rmation that has led to the development of successful vaccines 
in record time. The proponents respect the intellectual property rights and their value as incentives 
for innovation, but COVID 19 pandemic being unprecedented as it is, where research and innov ation 
has mostly been spearheaded by massive public funding, expedited regulatory approvals, and global 
collaboration, we need to put lives before private profits.  
75.  Some Members have questioned that how fast manufacturing can be ramped up once the Waiver  
is granted. Once the Waiver  is in place, the existing manufacturing capacity worldwide can be put to 
immediate use for production of COVID  products. Our past experience suggests that if supported 
with adequate regulatory framework, vaccines are relatively qu ick and inexpensive to make. The 
other option is to scale up the existing capacity through brown -field investments which can be done 
in a few months.  Yet another option is to invest in creating new capacity through green -field 
investments, a matter of a f ew quarters.  
76.  Some other countries have questioned that how the abuse of Waiver  would be avoided and how 
would it be ensured that it does not become permanent. We are seeking a temporary Waiver , and 
we have left the time period to be negotiated by Members in TRIPS Council. Moreover, Waiver , once 
granted, will be reviewed annually by the General Council. The duration could be some fixed number 
of years together with a conditional criteria for termination. We want to have frank discussions on 
the text of the Waiver , relating to both its duration and scope, in order to find answers to these 
questions and to find a landing zone to operationalise the Waiver  in the shortest possible time. We 
cannot continue to engage in endless discussions while millions of lives are lost to the coronavirus 
pandemic. We need concerted efforts by all WTO Members to ensure that the WTO makes a 
meaningful contribution to defeat COVID -19. COVID -19 has shown that our fates are inextricably 
linked. Whether we win or lose, we will do so t ogether. The Waiver  provides an opportunity to make 
a winning attempt, and we hope Members will make that attempt.  
1.11  Indonesia  
77.  We join other s in thanking you, Madam Chair , for convening this meeting and your leadership 
during the course of the discussion of this proposal. The discussion has been very insightful to 
broaden our understanding of the proposal tabled by India and South Africa.  
78.  We also would like to thank you, Madam Chair, for the draft of Status Report in 
document  JOB/IP/42. We fully support the draft status report as now been revised to reflect 
additional co -sponsors .   
79.  As the discussions have been extensively rolling in the Council, we collectively understand that 
IP creates a visible barrier in the access of vaccines, therapeutics, and diagnostics for the prevention, 
containment, and treatment of COVID -19. The WTO, as the only umbrella which governs the 
balancing of IP protect ion and public health through TRIPS flexibilities, arguably is believed to be the 
solution to address this problem. However, in practice, such flexibilities are not easily acquired by 
countries.  
80.  In the previous meeting, Indonesia shared our experience on t he difficulties of using voluntary 
licensing of Remdesivir. We failed to convince the patent holder to extend the production to Indonesia 
to address shortages and the product 's high price. Relying on importation alone will add more time 
and cost, creating an obstacle for our government to provide essential medicines in a timely and 
affordable manner.  
81.  As we have addressed in previous meetings, the patent approach is not enough in combating 
the COVID -19 pandemic. Many countries experienced shortages in medica l equipment such as IP/C/M/97/Add.1  
 
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  ventilators, respirators, and test kit, causing the price to increase and create massive turbulence in 
the market. This is a clear example that the lack of flexibility in these products ' IP areas should be 
addressed.  
82.  International colla boration present today is a breath of fresh air and a form of global solidarity. 
Still, the lack of transparency, equitability, and accessibility, in the system might create uncertainty 
for developing countries and LDCs to have equitable access of medicine s and medical equipments. 
These collaborations might also face limitations primarily due to the voluntary system being adopted.  
83.  In this part, we believe the Waiver  offered by the proposal will be a possible solution of these 
issues by eliminating certain IP barriers and scaling up the production. The Waiver  will also prevent 
the possible monopoly created by the IP system and will provide a larger access of medical products 
to people in dire needs.  
84.  Therefore Indonesia would like to reaffirm our position to  support the discussion of a possible 
Waiver  until we find concrete solutions that are certain, transparent, equitable, and accessible to 
combat the world catastrophe created by the COVID -19 Pandemic.  
85.  Finally we urge those Member s who are still against th e proposal to also provide written replies 
to the questions posed by co -sponsors in document IP/C/W/674 to reflect our intention to move 
forward with this proposal.    
1.12  El Salvador  
86.  As we stated at the outset of the dis cussion of this proposal, El Salvador considers the 
comprehensive handling and management of the COVID -19 health crisis to be of vital importance. 
The Government of El Salvador has stepped up its efforts to support affected sectors of the 
population in ter ms of health, as well as the harsh economic and social impact that has affected most 
of the population.  
87.  In this context, our country has been analysing in detail the proposal in question from a social 
and health perspective, as well as from a legal perspec tive. El Salvador has legal institutions that 
afford protection for all areas of intellectual property at the national level, in addition to our 
international commitments in this area, of which we are faithful guarantors.  
88.  Promoting and incentivizing innova tion as a tool for boosting and accelerating our country 's 
development is a top national priority. El Salvador 's scientific and technological progress and 
modernization are becoming increasingly important in these times of crisis and for economic 
recovery. In this context, we find it difficult to reconcile such a broad Waiver  in the application of 
intellectual prop erty rights with the objectives that we have set as a country.  
89.  We consider that the discussions that we have held on this proposal, provide important inputs 
for a practical and profound dialogue within the competence of this Council, to improve the 
intelle ctual property system, while identifying the specific barriers that some Members have faced in 
addressing their priorities and seeking solutions within the multilateral system.  
90.  We consider it essential to continue to intensify dialogue and cooperation amon g Members on 
this important subject in order to find a balanced solution for all partners. El Salvador will continue 
to engage constructively in this discussion.  
1.13  Venezuela, Bolivarian Republic of  
91.  We would like to begin by reiterating our appreciation of the manner in which you have 
conducted the work of this Committee, which is reflected in the report that we have adopted in this 
meeting  for consideration by the General Council.  
92.  We would also like  to welcome the African Group and the LDC Group, as co -sponsors of this 
proposal. The large increase in co -sponsors of this proposal is a clear indication of its importance. 
We would like to take this opportunity to call on those countries that approve of the proposal to also 
take a step forward.  IP/C/M/97/Add.1  
 
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  93.  Under your leadership, we have held a number of consultations that now enable us to be clear 
about the concerns of those countries that oppose it, as well as the objectives of those who are 
co-sponsoring it. As a r esult, we consider that it is now time to move to text -based negotiations. We 
could start with the scope and duration of the proposal, taking into account the comments and 
recommendations received, in the best spirit of compromise and reconciliation of pos itions. We must 
rise to the current challenges and be ready to provide options for responses aimed at ridding the 
world of this COVID -19 pandemic and its variants.  
1.14  Sri Lanka  
94.  First my delegation wishes to extend its cong ratulations to the African Group and the LDCs for 
joining India, South Africa and other original co -sponsors in co -sponsoring the Waiver  Proposal .  
95.  While my delegation is strongly contemplating to join others as a co -sponsor of this 
Waiver  Proposal , it has been strongly supporting the initiative and urging all Member s to be on board 
in addressing the issues, which are very well presented and justified in the proponents ' proposals 
aimed at prevention, containment and treatment of COVID -19.  
96.  The bigge st aim right now should be to vaccinate and prevent the deaths caused by the virus, 
as the medical research undertaken so far by many countries indicate s that it not only guarantees 
the slowing down the spread of the virus among the communities, but also b uilds the required 
immunity in the persons who get vaccinated, so that their symptoms get milder and it prevents the 
persons from hospitalization or dying from the virus.  
97.  New strains of the coronavirus could be more infectious. This therefore requires Sri  Lanka and  
all those countries which have declared having the presence of various mutated form s of COVID  
virus to go back to aggressive measures of testing, contact tracing, and isolating infections, while 
pursuing a vigorous vaccination programme in thei r countries.   
98.  As per the recent revelations, the UK and California variants of the coronavirus appear to have 
combined into a heavily mutated hybrid, sparking concern that we may be entering a new phase of 
the COVID -19 pandemic.  
99.  Two variants of the SARS -CoV-2 coronavirus that causes COVID -19 have combined their 
genomes to form a heavily mutated hybrid version of the virus. The "recombination " event was 
discovered in a virus sample in California, provoking warnings that we may be poised to enter a new 
phase  of the pandemic.  
100.  The hybrid virus is the result of recombination of the highly transmissible B.1.1.7 variant 
discovered in the UK and the B.1.429 variant that originated in California and which may be 
responsible for a recent wave of cases in Los Angeles because it carries a mutation making it resistant 
to some antibodies.  
101.  Recombination could lead to the emergence of new and even more dangerous variants, 
although it isn 't yet clear how much of a threat this first recombination event might pose. 
Recombination commonly occurs in coronaviruses, because the enzyme that replicates their genome 
is prone to slipping off the RNA strand it is copying and then re-joining  where it left off. If a host cell 
contains two different coronavirus genomes, the enzyme can repeatedly jump from one to the other, 
combining different elements of each genome to create a hybrid virus.  
102.  The recent emergence of multiple variants of the new coronavirus may have created the raw 
material for recombination because people can be infe cted with two different variants at once. The 
scientists predict that such recombination  could allow the virus to have coupled a more infectious 
virus with a more resistant virus.  
103.  We are also concerned that though the vaccines will continue to be effectiv e against the new 
variants of the virus, their efficacy might be less. Despite these setbacks, getting vaccinated is a 
must.  IP/C/M/97/Add.1  
 
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  104.  Though Sri Lanka began to witness cases a t a very slow pace, since 4 October 2020, it has 
been witnessing the spread of the virus i n an unprecedented speed creating serious concerns as to 
whether it has gone out of control.  
105.  During the period of 4 October 202 0 to 22 February 2021, the total number of cases ha s surged 
from 3,402 to 80,517 recording 2,267 % increase, active cases from 13 1 to 4,957 recording 3,784 
% increase and overall deaths from 13 to 450 recording 3,362 % increase. These data are very 
disturbing for a small country such as mine.   
106.  Thanks to the generosity of the Government of India, Sri Lanka received 500,000 doses of the 
Oxford –AstraZeneca COVISHIELD vaccines in late January 2021. The vaccination drive in Sri Lanka 
began on 29 January 2021. As of yesterday, a total number of 302,857 vaccines out of these 500,000 
vaccines have been administered.  
107.  Sri Lanka is expecting a  further 1.6 million vaccines of the Astra Zeneca variety under the 
WHO'S COVAX facility which are expected arrive in the country in three  to four batches commencing 
from early March 2021.  
108.  Sri Lanka is also working closely with India to sign agreements to purchase a further ten million 
doses from the Serum Institute in India using the funds that have been allocated by the government 
especially for this purpose. Once confirmations are receive d, an agreement will be signed between 
the Serum Institute in India and the Sri Lanka Pharmaceutical Corporation who will procure the 
vaccines for Sri Lanka. These  ten million vaccines will be utilized to vaccinate five million people, 
under the first phas e.   
109.  Since the tourism sector contributes substantially to the backbone of the economy, Sri Lanka 
took a very bold, but a painful decision to open the country to foreign tourists since 21 January 2021 
under strict guidelines, despite the rising number of i nfections within the country.  Accordingly, 
Sri Lanka has also decided to include the personnel served in the tourism industry and directly 
interacting with the foreign tourists in the priority list of the vaccination programme enabling them 
to receive the  vaccines first, before including other non -vulnerable population groups in the 
programme.  Under this programme, around 1,500 airport staff including security personnel at the 
Bandaranaike International Airport has been vaccinated as of yesterday.  
110.  These are some of the initiatives taken by Sri Lanka to face the many economic challenges of 
the pandemic, but it is concerned whether it is likely to face serious setbacks after hearing the news 
from Serum Institute of India (SII), which is the world 's biggest vaccine maker by volume, on Sunday 
asking for patience from foreign governments awaiting their supply of COVID -19 shots, saying it had 
been directed to prioritise India 's requirements.  
111.  Many low -and middle -income countries, ranging from Bangladesh to Brazil , are depending on 
SII's AstraZeneca vaccine, branded COVISHIELD by the Indian company. But demand is growing, 
including from Western countries like Canada, where Serum Institute has promised to deliver the 
COVISHIELD vaccine in the coming months.  
112.  In the m eantime, Britain 's drug regulator is also auditing manufacturing processes at SII, 
potentially paving the way for the COVISHIELD vaccine to be shipped from there to the UK and other 
countries.  
113.  All these developments indicate that the scarce supply of vacc ines and drugs and other 
personal protective equipment used in combating COVID -19 pandemic around the world have 
precarious effects mostly on the developing countries and LDCs. South Africa indicated this aspect 
very eloquently today with empirical data. M y delegation concurs with the facts presented by 
South  Africa and others in this regard.  
114.  We have had sufficient and lengthy debate on the issue of the Waiver . The co -sponsors made 
the case in great detail describing the various challenges and problems whi ch necessitate this Waiver . 
They have also listened and provided elaborate answers to all questions, concerns and clarifications 
in writing. They have also in turn, asked certain questions. These detailed answers and questions 
have been compiled in various  documents before us.  IP/C/M/97/Add.1  
 
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  115.  In view of the continuously evolving situation, it is high time we learn lessons from our past, 
where we ignored the health care needs of millions in developing countries in the interest of 
maximizing profits for a few companies, and  we do not repeat the same mistakes. The time is now 
ripe for a more forthright, solution -finding approach. This will be the most significant contribution 
that the WTO could make towards fighting the pandemic and saving human lives.  
116.  The proposal is seekin g a limited -time, and limited -scope Waiver  from certain obligations under 
the TRIPS A greement only to deal with the global pandemic. It promises to help large populations in 
developing countries and particularly countries such as mine not having manufactur ing capacity 
which hence is compelled to rely on imports, but would also allow export of medicines and medical 
equipment to developed countries where demands could remain unfulfilled otherwise.  
117.  It is high time we listen to the countless calls outside the W TO premises from all walks of life, 
for global solidarity and cooperation to help fight the pandemic which threatens humanity.  We are 
open and look forward to more meaningful engagement from Member s at this juncture, that aims at 
finding constructive solut ions to address this issue.  
1.15  Namibia  
118.  Let me take this opportunity to thank you, for your report and for directing the proceedings 
for the present  TRIPS Council meeting and also thank the co-sponsors for this proposal.  
119.  On the outset, Namibia aligns itself with the statement which was delivered  by Tanzania on 
behalf of the African Group. My delegation fully supports a call to move the discussions to text -based 
negotiations with a view to achieve a balanced outcome of the Waiver  on certain provisions of the 
TRIPS Agreement for the prevention, con tainment and treatment of COVID -19. 
120.  COVID -19 has no boundaries, therefore the longer we take in ensuring equitable access to 
medicine for all, the more we prolong the catastrophic health effect and rise in death rate globally 
due to COVID -19. 
121.  The current r ate of the vaccine production and distribution calls for concern, a number of 
countries introduced export restriction on medicine and medical supplies causing havoc to 
non-producers of vaccines. We need to find an urgent solution to rapid scaling up of man ufacturing 
to address capacity and supply constraints of the COVID -19 vaccine.  
122.  As net importer of medicine, Namibia reiterates its position in support of the proposal of the 
TRIPS Waiver . In addition,  we implore other Members as a matter of urgency to supp ort this proposal 
mindful that time is of the essence in addressing or suppressing the spread of COVID -19 virus in 
order to save human lives.  
1.16  Nepal  
123.  My delegation wishes to associate itself with the statement delivered by Ch ad on behalf of the 
LDC group.  First, my delegation thanks you, Madam Chair, for your draft report and supports the 
report.  
124.  I would like to refer to Nepal 's statements delivered earlier in various meetings on this 
Waiver  Proposal  and reiterate our full support to this proposal for the benefit of the people at large 
across the globe. It would help save life of millions of people across the world and also cont ribute to 
the global economy. Therefore, the proposal has merit and deserves support of all WTO Member s. 
1.17  Nigeria  
125.  At the outset we would like to thank the co -sponsors of this proposal of which we are happy 
to be joined as co -sponsors.  
126.  More vulnerable countries continue to face challenges in ensuring timely, sufficient and 
affordable medicines, vaccines, diagnostics and other essential medical tools. These challenges are 
even heightened by the new corona virus vari ants discovered first in December 2020. Research has 
shown that it is the nature of RNA viruses such as the coronavirus to evolve and change gradually, IP/C/M/97/Add.1  
 
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  in other words mutate. A renowned professor in the field of medicine , Robert Bollinger , states that 
there is some preliminary evidence that it  is more contagious due to the presence of a surge identified 
by scientists of cases in areas where the new strain appeared.  
127.  The Waiver  Proposal  presents an important opportunity for all governments to unite and stand 
up for public health, global solidarity, and equitable access through a concrete step at the 
international level that can provide an automatic and expedited solution to address IP and technology 
challenges. Governments need to take back the drive r's seat a nd fulfil their core obligations of 
protecting public health and ensuring access to medicines for all. This Waiver  is accessible to all 
Member s and this should come as a good news since COVID -19 is a global pandemic and therefore 
a global issue. Withholdin g access to any region will definitely affect other parts of the world no 
matter the protective efforts in place.  
128.  In Nigeria for instance, we are already experiencing a second wave of the virus and this was 
seen to affect many of our citizens including per sons from age  ten to 35. Health authorities in Nigeria 
have currently confirmed a total of 130,000 cases of COVID -19, including 1,600 deaths. Up till now, 
Nigeria is still expecting to actually receive the first batch of doses of the new vaccines. Our 
government has requested for 41 million doses of a combination of COVID -19 vaccines and also, an 
additional 16 million doses of the AstraZeneca vaccine are expected this February from the COVAX  
program me which is backed by the World Health Organization. As Nig eria fights a second wave of 
COVID -19, officials are looking to multiple sources to secure more vaccines to inoculate its enormous 
population. Nigeria`s population is around 186 million, therefore from the statistics I have given, 
the quantity of vaccines are not nearly enough to fight the spread of the disease in Nigeria.  
129.  Some Member s say IP is not a barrier for COVID -19 related tools, and therefore question the 
need for a Waiver . While we appreciate the concrete steps that owners of IP and rich countries have 
been making to ensure distribution of the vaccine to regions like Africa, we disagree with this claim 
because both past and present experiences have shown concretely that IP does pose a challenge in 
ensuring global equitable access to the effective to ols needed in response to COVID -19, including 
vaccines. Governments have faced IP barriers over drugs, masks, ventilator valves and reagents for 
testing kits. In addition, more than 100 patents have been filed for the mRNA technology that is 
being used to develop a vaccine. A report by MSF found that patents pose a serious threat to access 
to affordable versions of newer medicines.  
130.  To address domestic need, countries are turning to local/regional production as a sustainable 
solution. However, multiple IPRs could pose barriers to such sol utions. The existence of patents on 
products or processes generally prevents the acquisition of pharmaceutical products at low prices or 
in sufficient quantities. WTO Member s have a role to play in striking an acceptable balance between, 
on the one hand, p reserving the health of our populations and on the other, saving the lives of our 
people.  
131.  The TRIPS flexibilities contained in Articles 31 and 31 bis were not designed to address a global 
pandemic of this level. For instance, the challenges of implementing the compulsory license system 
include the cumbersome procedures of actually acquiring the license at the national level. Similarly, 
a voluntary licensing system is not transparent, and oftentimes have stringent clauses that do not 
contribute to our global commitment of ensuring that Vaccines and COVID -related tools are 
accessible in a timely and cost -efficient manner. Also, in a voluntary licensing system, the licensee 
is oftentimes at the mercy of the IP owner.   
132.  Finally, w e urge all Member s who are yet to  co-sponsor the proposal to do so as soon as 
possible. As South Africa and Norway has mentioned, no one is safe until everyone is safe. We 
encourage all Member s to proceed to text based discussions in order to arrive at an acceptable 
outcome.  
1.18  China  
133.  China would like to join others in thanking Madame Chair for convening this meeting and your 
hard work in steering the consultations on the Waiver  Proposal  during the past few months.  
134.  We have seen the development and deployment o f COVID  vaccines at an unprecedented speed. 
However, to ramp up the COVID  vaccines manufacturing capacity and ensure fair and equitable IP/C/M/97/Add.1  
 
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  access to COVID  vaccines for all Member s is still an urgent call for global community. And if we 
cannot provide the feas ible solutions within a reasonable but short period of time, the "vaccination 
gap" will further increase the "development gap ". 
135.  So the Waiver  Proposal  is important in the sense that it constitute s a possible way to solve the 
problem. Though consensus has not been reached yet, the discussion of the proposal in the 
TRIPS  Council demonstrates that Members share the common goal of ensuring the accessibility and 
affordability of COVID  vaccines. China wi ll continue to actively engage in further discussions in 
whatever format that could help forge the consensus on this important issue.   
136.  China believes the most feasible solution, to increase the accessibility and affordability of 
COVID  vaccines, i f not the  sole one, is through multilateral cooperation. China notes that by 
19 February  2021, public and private entities have committed 10.3 billon dollars to the 
WHO ACT-Accelerator, and 190 countries have joined the COVAX.  
137.  For China, as we stated at various oc casions, we are committed to making COVID  vaccines 
global public goods and we have made best efforts to honour  this commitment. For example, China 
joined COVAX and decided to provide  ten million doses of Chinese vaccines, mainly to meet the 
urgent demands of developing countrie s. We have also supplied vaccines to a number of developing 
countries through bilateral cooperation.  
138.  Containing the coronavirus is still the most pressing task for Member s. China hopes Member s 
can strengthen the cooperation, we will continue to work with all parties to tackle the production and 
distribution deficit of vaccines, and strengthen the global solidarity in your fight against the 
pandemic.  
1.19  European Union  
139.  Madame Chair, we would like to thank you, the Secretariat and all the delegations for the 
constructive engagement on the status report, which we fully support.  
140.  We would like to recall our statements made in the formal and informal meetings of the 
TRIPS  Council, including the answers we provided to the questions that have been posed to us.   
141.  There is no doubt that all WTO Members agree on the objective in this global fight against the 
COVID  pandemic: to rapidly develop and manufacture safe and effective t herapeutics and vaccines 
and to distribute them equitably across the world as soon as possible. However, our extensive 
discussions have shown that our views as to the best way of achieving this objective are far apart.  
142.  I would like to emphasise  that achie ving the objective of equitable access to vaccines is a top 
priority of the EU. We believe that the main global mechanism to achieve such equitable access is 
the COVAX Facility. It just has received a major financial boost following the G7 meeting the prev ious 
week. We very much welcome the important financial contribution to the COVAX Facility made by 
the United States as well as additional contributions made by Japan and Canada.  
143.  The European Union has also announced an additional EUR 500 million for the COVAX Facility, 
doubling its contribution to date. These new pledges bring us closer to achieving COVAX 's target to 
deliver 1.3 billion doses for 92 low and middle income countries by the end of 2021. Team Europe is 
one of the lead contributors to COVAX wi th over EUR 2.2 billion, including EUR 900 million pledged 
by Germany last week.  
144.  It is clear that this is only the start and that we will need to mobilise additional support as we 
move forward. It is not the time to find flaws in the COVAX Facility, the o nly viable solution we have 
to deliver the vaccines globally, it is time to support it and encourage the industry to step up and 
make their vaccines available and affordable to COVAX, so that there can be a timely global rollout.  
145.  Novavax, for example, ann ounced last week that it signed a Memorandum of Understanding 
with Gavi, The Vaccine Alliance, to provide COVAX with 1.1 billion cumulative doses of its vaccine 
candidate. COVAX continues to actively negotiate with various suppliers to reserve three  billion doses 
in 2021 -2022, seeking to diversify the vaccine portfolio and to ensure the minimum coverage in all 
participating countries.  IP/C/M/97/Add.1  
 
- 19 - 
 
  146.  However, we see clearly that having a vaccine developed and reserved is not enough. The 
actual delivery of vaccines will depend on a number of factors which include timely regulatory 
approvals, country readiness, logistics and other factors. In the last fe w weeks, several emergency 
or conditional regulatory approvals of different COVID  vaccines in the EU and across the world were 
granted.  
147.  Since our last meeting, two versions of the AstraZeneca/Oxford COVID -19 vaccine have been 
given WHO Emergency Use Listi ng (EUL). This follows the Emergency Use Listing for Pfizer/BioNTech 
vaccine. This announcement means that two versions of the AstraZeneca/Oxford vaccine, produced 
by AstraZeneca -SK Bioscience (AZ -SKBio) and the Serum Institute of India (AZ -SII), are now 
available for global rollout through the COVAX Facility. This is crucial for the functioning of its 
COVAX 's distribution mechanism and we hope to see more vaccines approved for emergency use 
soon.  
148.  Other challenges related to actually delivering the vaccine  to the people remain enormous and 
depend a lot on country readiness, including for example creating priority lists for vaccination, 
organising vaccination centres, with conditions such as storage at very low temperatures. Despite 
the efforts of everyone i nvolved, this is not easy for any country.  
149.  At the moment, however, we are all still facing one major challenge – ensuring rapid and 
predictable production of the new vaccines, while simultaneously increasing levels of that production 
and maintaining the s upply of all other medicines and vaccines.  
150.  We all agree that the ramping up of manufacturing capacity is a clear priority now. Any 
available manufacturing capacity anywhere in the world should be used to the full extent. Any 
indication of where underused capacity exists as indicated by some Members would be very welcome.  
151.  As set out in the Communication Towards HERA: making Europe 's bio-defence capacities fit to 
deal with SARS -CoV-2 variants, the EU is taking action to facilitate the production of COVID -19 
vaccines and to allow for a ramping up of production in the shortest possible time. The 
European  Commission will continue to address potential bottlenecks in production and supply of raw 
materials and other essential input required for vaccines manufactur ing. It will build on the ongoing 
mapping of existing industrial capacities for vaccine production in Europe, as well as facilities which 
can be potentially repurposed to produce vaccines.  
152.  Where such capacity exists and can be deployed quickly, the best wa y of using it to the fullest 
is by disseminating the technology and know -how of those who developed the vaccines through a 
collaboration with other companies that can contribute to the developers ' manufacturing capacity. 
Intellectual property is a key fact or in providing a framework that enables this collaboration.  
153.  This is because the IP system is crucial in providing a legal framework for the collaboration 
and dissemination of any new technology. The objective of an IP system is not merely to create 
exclus ivity for the owner of intellectual property, but also to ensure the publication and dissemination 
of research results when otherwise they would remain secret. And this dissemination is precisely 
what we need now. The IP system enables commercialisation of  the research results and their 
transfer through licensing agreements. Developers of vaccines can enter into manufacturing 
agreements, transfer technology and expand production with their licensees.  
154.  The increase of production capacity is happening, as deve lopers of vaccines are entering into 
manufacturing agreements with producers, and are expanding global production by transferring their 
technology to licensees. We see this being done by AstraZeneca, Johnson & Johnson and we hope 
to see these collaboration s grow and intensify.  
155.  No doubt more needs to be done in the weeks and months ahead, but, as we have already 
mentioned previously, there are many examples of collaboration and licensing to producers in the 
developing countries.  
156.  As was said before, we full y agree that all adequate manufacturing capacity must be used 
where possible. However, in this forum we have disagreed on the best way to tap into that potential 
manufacturing capacity. The proponents of the Waiver  suggested that the Waiver  would in fact IP/C/M/97/Add.1  
 
- 20 - 
 
  achieve that objective. We do not think that this is the case. It is through collaboration and the rapid 
transfer of technology and know -how that we can get there.  
157.  We consider that the TRIPS Agreement and the principles of the Doha Declaration can play a 
role in addressing this crisis, as they reflect a careful balance between protecting intellectual property 
on one hand, which is a crucial incentive to innovation, and promoting widespread access to 
medicines and health care, on the other hand.  
158.  As indicate d in previous meetings, we believe that the concerns that have been raised in the 
current discussion can be addressed through the combination of, on the one hand, licensing and 
expanding manufacturing capacity via manufacturing agreements and, on the other  hand, the 
framework of the TRIPS Agreement and the flexibilities it offers. These flexibilities are absolutely 
legitimate tools for Members in need as many are in the midst of this pandemic.  
159.  We have noted carefully the difficulties conveyed by some Membe rs with regard to the 
implementation of these flexibilities, and we are very ready to discuss ways of overcoming them. 
Administrative burdens should not stand in the way of manufacturing and delivering vaccines to 
where they are needed. It is important to note that the TRIPS Agreement also provides for flexibilities 
and exceptions in relation to other relevant IP rights, not only patents. This includes copyright, 
industrial design and regulatory data protection. The principles of the Doha Declaration on the  
TRIPS  Agreement and public health that direct countries to interpret the TRIPS Agreement in a 
manner supportive of their right to protect public health and to promote access to medicines for all 
are equally applicable to all types of IP rights.  
160.  Since ques tions have been posed to us on this matter, we would like to emphasise that the 
TRIPS Agreement does not stand in the way of the consistent application of the patent and regulatory 
data protection provisions to enable the application of compulsory licences . The EU, just as any other 
Member of the WTO, has the possibility of framing its legislation in this manner.  
161.  One of the main concerns with the suspension of intellectual property rights like the proposed 
TRIPS Waiver  is that it will not enhance the ongoin g voluntary collaboration and the needed transfer 
of technology and know -how. To the contrary, the lack of a framework that guarantees protection 
can effectively block such transfer, to the detriment of all at a time when we need it most.  
162.  In this forum, o ur focus is on intellectual property. However, as we have highlighted, 
intellectual property is only a small part of a broader massive financial, manufacturing and logistical 
response to COVID -19. The EU and its Members have been in the forefront of this r esponse.  
163.  I would like to recall what we have already said on the role of public financing and its impact 
on the need to protect IP. Public financing does not mean that there is no financing or risk carried 
by private investors. In some cases, private fina ncing may significantly exceed public support. IP 
makes possible licensing agreements in the pharmaceutical sector (which requires multiple partners) 
and the creation of partnerships. Pharmaceutical development requires trials, manufacturing 
developments a nd deployment -related logistics that are not necessarily publicly funded (or public 
funding is not enough), in this context IP does not only make licensing activities possible, but it is a 
critical loan collateral to obtain private financing.  
164.  We have also  already said that, as part of their national or regional health and research policy, 
every Member has the right to attach certain conditions to the public funding it provides to 
pharmaceutical companies.  
165.  As a last remark, I would like to mention the agre ements that the EU has entered into for 
purchasing of vaccines and I would underline again that we have invested in manufacturing capacity 
not only to guarantee vaccines for the EU citizens but also so that vaccines are more rapidly available 
to everyone, everywhere.  
166.  We are all facing significant difficulties during these first weeks of 2021. However, we are also 
hopeful that the situation will gradually improve with more vaccines coming to the market and more 
production of the already approved vaccines ma terialising. On 19 January, the European Commission 
announced that –- we are ready to set up an EU vaccine sharing mechanism, based on the "Team 
Europe " approach. This would allow the sharing of access to some of the vaccine doses secured by IP/C/M/97/Add.1  
 
- 21 - 
 
  the EU. Specia l attention would be given to the Western Balkans, our Eastern and Southern 
neighbourhood and Africa. This could primarily benefit health workers, as well as humanitarian 
needs. Details of that mechanism are currently being worked out.  
167.  As we have already s aid before, the EU is committed to an open and comprehensive dialogue 
with all WTO Members to explore how the multilateral rules -based trading system can best support 
universal and equitable access to COVID -19 vaccines and treatments as we seek to provide for a 
robust, rapid and universal response to the pandemic.  
168.  In that regard, and in order to facilitate a consensual, constructive and evidence -based 
discussion, we fully support document  IP/C/W/671 submitted by the delegations of Australia, 
Canada, Chile and Mexico and the approach to the current discussion presented in this 
communication. We are ready to work together with the sponsors of this communication and all other 
Members to contribute to such an evidence -based discussion.  
169.  We have already indicate d our willingness to discuss problems with the implementation and 
the use of the TRIPS flexibilities, in particular how the use of the flexibilities such as compulsory 
licensing can be facilitated. It is important that these flexibilities can be used when the need arises 
and are not hampered by administrative hurdles.  
170.  We are committed to cooperation mobilising the global manufacturing, trade, and delivery 
response that will end this crisis and help build a more resilient system for the future. We would als o 
like to ask the Secretariat to add our previous statements to the minutes of this meeting.  
European Union 's statement at the informal meeting held on 4 February 2021  
171.  During the last four months, we had an intense schedule of exchanges in various formats of 
the TRIPS Council as well as the December General Council of the WTO. There is no doubt that all 
WTO Members agree on the objective in this global fight against the COVID  pandemic: to rapidly 
develop and manufacture safe and effective therapeutics and vaccines and to distribute them 
equitably across the world as soon as possible. However, our extensive discussions have shown that 
our views as to the best way of achiev ing this objective are far apart.  
172.  I would like to repeat once again that achieving the objective of equitable access to vaccines 
is a top priority of the EU. We believe that the main global mechanism to achieve such equitable 
access is the COVAX Facility.  The EU so far has been the COVAX 's biggest donor with more than 
EUR 850 million provided by the EU and its Members. The larger Coronavirus Global Response 
beyond vaccines also remains crucial. For this purpose, a global recovery package of EUR 38.5 billio n 
delivered under a common "Team Europe " approach has been supporting partner countries with 
emergency response to humanitarian needs, strengthening health systems and crucial health 
services, and assisting economic recovery and social support.  
173.  It is clear  that this is only the start and that we will need to mobilise additional support as we 
move forward. We welcome the United States ' recent decision to join COVAX and strongly encourage 
other WTO Members to help address the remaining financing needs.  
174.  The C OVAX Facility is now well placed with nearly two billion doses of COVID -19 vaccine 
candidates reserved for 2021. COVAX continues to actively negotiate with various suppliers to 
reserve three  billion doses in 2021 -2022, seeking to diversify the vaccine port folio and to ensure the 
minimum coverage in all participating countries.  
175.  However, we see clearly that having a vaccine developed and reserved is not enough. The 
actual delivery of vaccines will depend on a number of factors which include timely regulatory  
approvals, country readiness, logistics and other factors. In the last few weeks, several emergency 
or conditional regulatory approvals of different COVID  vaccines in the EU and across the world were 
granted. However, only one vaccine – Pfizer/BioNTech – has so far completed the World Health 
Organisation Emergency Use Listing Procedure (EUL). The procedures for other vaccines are still 
pending, including those reserved by COVAX. This is crucial for the functioning of its COVAX 's 
distribution mechanism.  IP/C/M/97/Add.1  
 
- 22 - 
 
  176.  Other challenges related to actually delivering the vaccine to the people remain enormous and 
depend a lot on country readiness, including for example creating priority lists for vaccination, 
organising vaccination centres, with conditions such as storage at  very low temperatures. Despite 
the efforts of everyone involved, this is not easy for any country.  
177.  At the moment, however, we are all still facing one major challenge – ensuring rapid and 
predictable production of the new vaccines, while simultaneously i ncreasing levels of that production 
and maintaining the supply of all other medicines and vaccines.  
178.  We all agree that the ramping up of manufacturing capacity is a clear priority now. Any 
available manufacturing capacity anywhere in the world should be us ed to the full extent. Any 
indication of where underused capacity exists as indicated by some Members would be very welcome.  
179.  However, the EU still considers that if such capacity exists and can be deployed quickly, the 
best way of using it to the fullest i s by disseminating the technology and know -how of those who 
developed the vaccines through a collaboration with other companies that can contribute to the 
developers ' manufacturing capacity. Intellectual property is a key factor in providing a framework 
that enables this collaboration.  
180.  This is because the IP system is crucial in providing a legal framework for the collaboration 
and dissemination of any new technology. The objective of an IP system is not merely to create 
exclusivity for the owner of intelle ctual property, but also to ensure the publication and dissemination 
of research results when otherwise they would remain secret. And this dissemination is precisely 
what we need now. The IP system enables commercialisation of the research results and thei r 
transfer through licensing agreements. Developers of vaccines can enter into manufacturing 
agreements, transfer technology and expand production with their licensees.  
181.  The increase of production capacity is happening, as developers of vaccines are enterin g into 
manufacturing agreements with producers, and are expanding global production by transferring their 
technology to licensees.  No doubt more needs to be done in the weeks and months ahead, but, as 
we have already mentioned previously, there are many ex amples of collaboration and licensing to 
producers in the developing countries.  
182.  As was said before, we fully agree that all adequate manufacturing capacity must be used 
where possible. However, in this forum we have disagreed on the best way to tap into t hat potential 
manufacturing capacity. The proponents of the Waiver  of the TRIPS Agreement suggested that the 
Waiver  would in fact achieve that objective. We do not think that this is the case.  
183.   We consider that the TRIPS Agreement and the principles of th e Doha Declaration can play a 
role in addressing this crisis, as they reflect a careful balance between protecting intellectual property 
on one hand, which is a crucial incentive to innovation, and promoting widespread access to 
medicines and health care, on the other hand.  
184.  As indicated in previous meetings, we believe that the concerns that have been raised in the 
current discussion can be addressed through the combination of, on the one hand, licensing and 
expanding manufacturing capacity via manufacturi ng agreements and, on the other hand, the 
framework of the TRIPS Agreement and the flexibilities it offers. These flexibilities are absolutely 
legitimate tools for Members in need as many are in the midst of this pandemic.  
185.  We have noted carefully the diff iculties conveyed by some Members with regard to the 
implementation of these flexibilities, and we are very ready to discuss ways of overcoming them. 
Administrative burdens should not stand in the way of manufacturing and delivering vaccines to 
where they are needed. It is important to note that the TRIPS Agreement also provides for flexibilities 
and exceptions in relation to other relevant IP rights, not only patents. This includes copyright, 
industrial design and regulatory data protection. The principles  of the Doha Declaration on the 
TRIPS  Agreement and public health that direct countries to interpret the TRIPS Agreement in a 
manner supportive of their right to protect public health and to promote access to medicines for all 
are equally applicable to all  types of IP rights.  
186.  Since questions have been posed to us on this matter, we would like to emphasise that the 
TRIPS Agreement does not stand in the way of the consistent application of the patent and regulatory IP/C/M/97/Add.1  
 
- 23 - 
 
  data protection provisions to enable the app lication of compulsory licences. The EU, just as any other 
Member of the WTO, has the possibility of framing its legislation in this manner.  
187.  One of the main concerns with the suspension of intellectual property rights like the proposed 
TRIPS Waiver  is that  it will not enhance the ongoing voluntary collaboration and the needed transfer 
of technology and know -how. To the contrary, the lack of a framework that guarantees protection 
can effectively block such transfer, to the detriment of all at a time when we need it most.  
188.  In this forum, our focus is on intellectual property. However, as we have highlighted, 
intellectual property is only a small part of a broader massive financial, manufacturing and logistical 
response to COVID -19. The EU and its Members have been in the forefront of this response.  
189.  I would like to recall what we have already said on the role of public financing and its impact 
on the need to protect IP. Public financing does not mean that there is no financing or risk carried 
by private investo rs. In some cases, private financing may significantly exceed public support. IP 
makes possible licensing agreements in the pharmaceutical sector (which requires multiple partners) 
and the creation of partnerships. Pharmaceutical development requires trial s, manufacturing 
developments and deployment -related logistics that are not necessarily publicly funded (or public 
funding is not enough), in this context IP does not only make licensing activities possible, but it is a 
critical loan collateral to obtain p rivate financing.  
190.  We have also already said that, as part of their national or regional health and research policy, 
every Member has the right to attach certain conditions to the public funding it provides to 
pharmaceutical companies. Beyond the financing , it is also clear that without the researchers and 
the industry we would not have the vaccines that we have at the moment.  
191.  As a last remark, I would like to mention the agreements that the EU has entered into for 
purchasing of vaccines and I would underli ne again that we have invested in manufacturing capacity 
not only to guarantee vaccines for the EU citizens but also so that vaccines are more rapidly available 
to everyone, everywhere.  
192.  We are all facing significant difficulties during these first weeks o f 2021. However, we are also 
hopeful that the situation will gradually improve with more vaccines coming to the market and more 
production of the already approved vaccines materialising. On 19 January, the Commission 
announced that – in addition to our con tribution to COVAX - we are ready to set up an EU vaccine 
sharing mechanism, based on the "Team Europe " approach. This would allow the sharing of access 
to some of the vaccine doses secured by the EU. Special attention would be given to the Western 
Balkans , our Eastern and Southern neighbourhood and Africa. This could primarily benefit health 
workers, as well as humanitarian needs. Details of that mechanism are currently being worked out.  
193.  As we have already said before, the EU is committed to an open and co mprehensive dialogue 
with all WTO Members to explore how the multilateral rules -based trading system can best support 
universal and equitable access to COVID -19 vaccines and treatments as we seek to provide for a 
robust, rapid and universal response to the  pandemic.  
194.  We have already indicated our willingness to discuss problems with the implementation and 
the use of the TRIPS flexibilities, in particular how the use of the flexibilities such as compulsory 
licensing can be facilitated. It is important that t hese flexibilities can be used when the need arises 
and are not hampered by administrative hurdles.  
195.  We are committed to cooperation mobilising the global manufacturing, trade, and delivery 
response that will end this crisis and help build a more resilient  system for the future. European 
Union 's statement at the informal meeting held on 4 February 2021.  
196.  I refer to the statements made by this delegation in the discussion under this ad hoc  agenda 
item in the TRIPS Council 's past five formal and informal meeti ngs. IP/C/M/97/Add.1  
 
- 24 - 
 
  On procedure and the follow up:  
a. We are flexible on the presentation of the status report of the TRIPS Council to the General 
Council, as long as  the report presents the state of discussions in a factual and succinct 
manner; and  
b. The EU is ready to engage in the discussions following the suggested format of small group 
consultations.  
EU Vaccine export authorisation  
197.  This decision is a reaction to a p ossible breach of contracts signed with the EU, as doses that 
were initially targeted for the EU may have been exported to third countries. This would be a clear 
and unacceptable violation of legal obligations by the companies in question, while delaying t he 
vaccination of EU citizens.   
198.  In order to prevent such violation, the Commission has decided that all vaccine manufacturers 
should declare exports to third countries. From 30 January, the customs authorities are checking all 
vaccine export declarations.  They may also control the products and trace their origin to ensure that 
they do correspond to third countries purchase contracts. These checks and controls will ensure 
transparency in a sensitive market, and avoid reselling, litigations and traffics. The y will be conducted 
in a speedy manner to avoid unnecessary additional delays.  
199.  These obligations are strictly targeted to vaccine manufacturers and are applicable until end 
of March 2021. They will be proportionate and will not slow down the vaccine trade  between the EU 
and third countries.  
200.  These measures have been designed in a targeted manner to limit the impact on our trade 
partners and on the most -vulnerable countries. The legal decision adopted today explicitly rules out 
exports:  
a. to the EEA countries , the Western Balkans, the Neighbourhood countries;  
b. the 92 low - and middle -income countries covered by the COVAX facility, as well as those 
delivered through COVAX, UNICEF and PAHO to any COVAX participating country, as well 
as;  
c. in the context of a humani tarian emergency response.  
201.  With these provisions, the EU stands to its commitments towards its partners.  
European Union 's statement at the informal meeting held on 19 January 2021  
202.  It is very clear, following the earlier discussions in the TRIPS Council and the exchanges in the 
General Council of the WTO, that in this global fight against the COVID  pandemic, we all share one 
objective: to rapidly develop safe and effective therapeuti cs and vaccines, to manufacture them in 
required quantities as soon as possible and to distribute them equitably across the world. What we 
are discussing is the best way of achieving this objective.  
203.  We thank the delegations of from the Plurinational State  of Bolivia, Eswatini, India, Kenya, 
Mozambique, Mongolia, Pakistan, South Africa, the Bolivarian Republic of Venezuela and Zimbabwe 
for their contributions to the debate presented in documents IP/C/W/672, IP/C/W/673 and 
IP/C/W/674. We are still studying t he provided information and may come back with questions at a 
later stage. A number of questions have been posed in these documents to the European Union and 
we will do our best to respond to all of them.  
204.  I would like to repeat that delivering on the obje ctive of equitable access to vaccines is a top 
priority of the EU. Out of the EUR 16 billion provided to the Coronavirus Global Response, nearly 
EUR 12 billion was pledged by the Members of the European Union, the European Commission and 
the European Inves tment Bank.  IP/C/M/97/Add.1  
 
- 25 - 
 
  205.  The EU and its Members have so far provided more than EUR 800 million to the COVAX Facility 
- which makes the European Union COVAX 's biggest donor.  
206.  In the second half of December we received a good news from COVAX which confirmed that it 
had a rrangements in place to access nearly two billion doses of COVID -19 vaccine candidates, on 
behalf of 190 participating economies. These arrangements will enable all participating economies 
to have access to doses in the first half of 2021, with first deliv eries anticipated to begin in the first 
quarter of 2021.  
207.  This is a very good news but, to answer one of the questions, it is not enough. We are aware 
that this is only the start and that we will need to mobilise additional support as we move forward. 
We ar e working hard with our partners to procure the needed funding. We strongly encourage other 
WTO Members to help address the remaining financing needs, as underlined in the G20 Riyadh 
Leaders Declaration.  
208.  Over the last weeks, we received some good news on t he regulatory approvals of several 
COVID  vaccines in the EU and across the world. Particularly optimistic is the fact that the AstraZeneca 
vaccine enters the market, including in India, as this vaccine can be stored in a normal fridge 
temperature making it  much more accessible to the developing countries. Importantly, a significant 
share of the AstraZeneca vaccine actually goes to the developing countries and the COVAX Facility.  
209.  The Novavax vaccine, the lion 's share of which, we understand, is designated fo r the 
developing countries (according to reports Novavax reached an agreement with the Serum Institute 
of India that could enable them to produce as many as two billion doses a year) has not been 
approved yet but it began a last phase trials in December in  the United States. The results from the 
last phase trials of the Johnson & Johnson vaccine are expected later this month. At the same time, 
it is clear that we will have to wait for a number of vaccines before they are ready to enter the 
market.  
210.  As we kno w, having a vaccine developed and approved is not enough. The challenges related 
to actually delivering the vaccine to the people remain enormous, in particular producing the vaccines 
at an unprecedented scale and then distributing them, organising vaccina tion centres, with 
conditions such as storage at very low temperatures.  
211.  Many countries face systemic and financial challenges such as fragile and underfunded 
healthcare and procurement systems, a limited number of health workers or inadequate cold chain 
equipment. These are, in addition to manufacturing, the main hurdles in the access to and the roll -out 
of the vaccines.  
212.  The TRIPS Agreement and the principles of the Doha Declaration can play a role in addressing 
this crisis, as they reflect a careful balan ce between protecting intellectual property on one hand, 
which is a crucial incentive to innovation, and promoting widespread access to medicines and health 
care, on the other hand.  
213.  A question has been asked about the role of public financing and its impa ct on the need to 
protect IP. We believe that we have answered this question in our previous statements. Just to recall 
that public financing does not mean that there is no financing or risk carried by private investors. It 
is the researchers and the indus try with their know -how, previous and current investment that are 
delivering the new vaccines, including the running of clinical trials in parallel with investing in 
production capacity to be able to produce millions, or even billions, of doses of a succes sful vaccine.  
214.  We have already provided the example of the vaccines based on the mRNA technology which 
would not reach the market so quickly were it not for decades of work and investment in this novel 
technology undertaken at high risk of failure by resea rchers and companies. Finally, as part of their 
national or regional health and research policy, every Member has the right to attach certain 
conditions to public funding it provides to pharmaceutical companies.  
215.  As indicated in the previous meetings, we believe that the concerns that have been raised in 
the current discussion can be addressed through the combination of licensing, expanding 
manufacturing capacity via manufacturing agreements with the TRIPS Agreemen t and the flexibilities 
it offers. These flexibilities are absolutely legitimate tools for Members in need as many are in the IP/C/M/97/Add.1  
 
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  midst of this pandemic. I want to be very clear on the fact that the European Union never questioned 
the use of compulsory licence s in the times of need.  
216.  We have noted carefully the difficulties conveyed by some Members with regard to the 
implementation of these flexibilities, and we are very ready to discuss ways of overcoming them. 
Administrative burdens should not stand in the wa y of manufacturing and delivering vaccines to 
where they are needed. We note a question in this regard addressed to some of our Members as to 
what data they relied upon when they decided to amend national laws to enable quicker use of 
compulsory licence.  
217.  We have in the past explained the nature of the amendments introduced in Hungary so will 
not repeat these details but would like to make certain clarifications regarding the changes in the 
law of the Federal Republic of Germany as the question posed is ref lecting a factual 
misunderstanding. Last year, Germany did not modify the conditions for the granting of compulsory 
licences. The Patent Law was only amended to change the competence for the issuance of a 
government order (and again not the conditions for the issuance of a government order). Previously, 
a government order for the use of medicinal/pharmaceutical inventions required a decision by the 
Federal Cabinet (Kabinett -Beschluss). This has been changed. It is now the Ministry for Health which 
can issue  such an order, provided that the (unchanged) requirements have been met.  
218.  More generally, we would like to clarify that the TRIPS Agreement requires no data or special 
justification to introduce rules on compulsory licensing, including fast track procedur es in Member 's 
legislation. Each Member has the right to have these rules.  
219.  It is important to note that the TRIPS Agreement also provides for flexibilities and exceptions 
in relation to other relevant IP rights, not only patents. This includes copyright, i ndustrial design and 
regulatory data protection. The principles of the Doha Declaration on the TRIPS Agreement and 
public health that direct countries to interpret the TRIPS Agreement in a manner supportive of their 
right to protect public health and to pr omote access to medicines for all are equally applicable to all 
types of IP rights. Since questions have been posed to us on this matter, we would like to emphasise 
that the TRIPS Agreement does not stand in the way of the consistent application of the pat ent and 
regulatory data protection provisions to enable the application of compulsory licences. The EU, just 
as any other Member of the WTO, has the possibility of framing its legislation in this manner.  
220.  It seems that we all agree that what is most needed now, beyond developing vaccines, is the 
ramping up of manufacturing capacity, and a seamless follow through by the transport and 
distribution sectors. The best way of achieving that is by disseminating the technology and know -
how of those who developed the  vaccines through a collaboration with other companies that can 
contribute to the developers ' manufacturing capacity. Intellectual property is a key factor in providing 
a framework that enables this collaboration.  
221.  This is because the IP system is crucial i n providing a legal framework for the collaboration 
and dissemination of any new technology. The objective of an IP system is not merely to create 
exclusivity for the owner of intellectual property, but also to ensure the publication and dissemination 
of research results when otherwise they would remain secret. And this dissemination is precisely 
what we need now. The IP system enables commercialisation of the research results and their 
transfer through licensing agreements. Developers of vaccines can enter  into manufacturing 
agreements, transfer technology and expand production with their licensees.  
222.  The increase of production capacity is already happening, as developers of vaccines are 
entering into manufacturing agreements with producers, and are expanding  global production by 
transferring their technology to licensees.  No doubt more needs to be done in the weeks and months 
ahead, but I would note that we have many examples of companies that have either accepted to 
produce at cost for citizens in developing  countries or licensed production to producers in the 
developing countries. And then there are other examples of collaboration among different players.  
223.  A number of questions regarding the terms of licensing or manufacturing agreements have 
been posed by th e proponents of the Waiver . We do not know the details of the terms of these 
agreements so cannot answer but can share our understanding of the situation. On the concern 
related to the choice of manufacturers – it is our understanding that the production o f a vaccine is a 
very complex process and not all pharmaceutical manufacturers can step up to such production. This IP/C/M/97/Add.1  
 
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  is why in the EU, new production facilities are being set up and efforts are being made to use the 
facilities that can be used for the produ ction of vaccines to the maximum.  
224.  We believe that constant close coordination between governments and the pharmaceutical 
industry is required to ensure that all the adequate manufacturing capacity is used where possible. 
The potential use of compulsory li censing is of course also a leverage that governments have in that 
regard.  
225.  One of the main concerns with the suspension of intellectual property rights like the proposed 
TRIPS Waiver  is that it will not enhance such collaboration, that it will not enhance  the needed 
transfer of technology and know -how. To the contrary, the lack of a framework that guarantees 
protection can effectively block such transfer, to the detriment of all. In this forum, our focus is on 
intellectual property. However, intellectual p roperty is only a small part of a broader massive 
financial, manufacturing and logistical response to COVID -19. 
226.  This response includes close coordination with pharmaceutical companies, creating and 
maintaining complex, international supply chains to import  crucial raw materials and equipment (in 
parallel to the production of vaccines, supplies of vials, syringes, and other ancillary materials must 
remain adequate). There may be a need for pharmaceutical companies globally to reallocate critical 
materials am ong themselves. Where some vaccines development projects fail, as they are bound to 
do, successful vaccines producers should be able to use the manufacturing capacity, glass vials, and 
other ancillary materials that had originally been reserved for failed projects. Where surplus of 
vaccines may occur, it would be important to set up arrangements allowing the reallocation of doses. 
The flows of the required raw materials and vaccines cannot be hampered by export restrictions and 
other impediments affecting s upply chains.  
227.  In that regard I would like to recall again the work undertaken by the EU in the WTO to 
safeguard global supply chains. Under our "Trade and Health Initiative " WTO Member s would jointly 
agree on a number of actions in response to the current crisis that would ensure free flow of essential 
goods which would facilitate an effective response to this and any future crisis.  
228.  A lot has been said in this forum about the agreements that the EU has entered into for 
purchasing of vaccines. We have invest ed in manufacturing capacity not only to guarantee vaccines 
for the EU citizens but also so that vaccines are more rapidly available to everyone, everywhere. 
Today in the European Parliament, the Commission informed on the ongoing work to propose a 
mechani sm to share vaccines with other countries. We hope to be able to provide more detail soon.  
229.  We would also like to thank South Africa, India, Mozambique and Pakistan for their detailed 
questions and interest in the EU 's policy developments, in particular two  recent strategy documents: 
the Pharmaceutical Strategy for Europe and the IP Action Plan (both published very recently, on 
25 November 2020). Both strategy documents are ambitious roadmaps covering a wide variety of 
issues and objectives to be attained in  the short and mid -term. A number of concrete actions must 
be still agreed upon and their details worked out. But, to the extent possible, we are happy to provide 
more detail on the intentions and the objectives of the Commission.  
230.  Among its objectives, the  Pharmaceutical Strategy indeed has a goal of ensuring access to 
affordable medicines – this goal is shared globally. It also focuses on addressing the unmet medical 
needs of patients, strengthening of the EU pharmaceutical industry, and enhancing EU 's crisis 
preparedness. This strategy document sets out the priorities of the EU 's future action in this area. 
Concrete steps will follow with all the necessary details, including on the creation of the new EU 
Health Emergency Response Authority which would b e responsible for strategic investments for 
research, development, manufacturing, deployment, distribution and use of medicines. Details on 
any march -in rights or other conditions for receiving support from the new agency are also still to 
be worked out.  
231.  The Pharmaceutical Strategy proposes actions at EU level to promote the affordability of 
medicines and the sustainability of health systems. The Commission will support cooperation 
between national authorities on pricing, payment and procurement policies, t o improve the 
affordability, cost -effectiveness of medicines and health system 's sustainability. The Commission will 
also help improving transparency on methods used for establishing the R&D costs of medicines. Over 
the next years, this will help national public authorities to improve their capacities and take better IP/C/M/97/Add.1  
 
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  decisions. But it will also help the producers of high valued products to better make their case, and 
the EU patients to access cost -effective medicines in a timely, equitable and affordable wa y. 
232.  Closely linked and in complete synergy with the Pharmaceutical Strategy, the IP Action Plan 
outlines concrete areas of priority in the field of intellectual property for the EU. It highlights that 
intellectual property is a key driver for economic growt h as it helps companies to valorise their 
intangible assets.  
233.  The IP Action Plan also highlights that the IP system must be balanced, meaning that access 
to critical technologies, where and when necessary, while ensuring an adequate return on investment 
for innovators, must be ensured. Therefore, the IP Action Plan fully supports all avenues of voluntary 
licensing in relation to COVID  technologies, as endorsed in the World Health Assembly 's Resolution 
of May last year. We believe that existing and effective  patent pooling initiatives should be supported 
in the face of this crisis.  
234.  The Commission has recently signed a Memorandum of Understanding with the Medicines 
Patent Pool – the most known, experienced and effective public health organisation delivering 
medicines to low and middle income countries through licensing contracts. We will explore all ways 
to help the Medicines Patent Pool to continue delivering in the COVID  crisis as well. Many pharma 
companies are supporting the Medicines Patent Pool with free  or cost -based licensing. Medicines 
Patent Pool is one of the actors mentioned in the C -TAP initiative that calls upon holders of 
knowledge, intellectual property or data to existing or new therapeutics, diagnostics and vaccines to 
voluntary license and pr ovide access to their proprietary assets. We note that MPP is an organisation 
with the working history and experience in pooling IP and concluding licensing agreements with 
pharma companies and a one that can deliver results, gather support.  
235.  In the EU, com pulsory licences are regulated and granted by the EU Members. With the IP 
Action Plan, the Commission encouraged the EU Members to assess their domestic legislation and to 
make sure that the all the tools are indeed available.  
236.  Since the competence for comp ulsory licences remains national, the Commission considers 
that early coordination and information among the Members would secure maximum benefits whilst 
at the same time avoiding excessive distortions. This is a specific issue in the EU which other WTO 
Members may not face. As concerns the EU 's status under Article 31 bis of the TRIPS Agreement (i.e. 
the procedure set up for cases of insufficient manufacturing capacity), it must be noted that the EU 
possesses very extensive manufacturing capacity for pharma ceutical products. Nevertheless, we 
closely and constantly monitor the situation, together with our Members, to be able to address any 
issues that may arise.  
237.  The EU is committed to an open and comprehensive dialogue with all WTO Members to explore 
how the multilateral rules -based trading system can best support universal and equitable access to 
COVID -19 vaccines and treatments as we seek to provide for a robust, rapid and universal response 
to the pandemic.  
238.  We have already indicated our willingness to disc uss problems with the implementation and 
the use of the TRIPS flexibilities, in particular how the use of the flexibilities such as compulsory 
licensing can be facilitated. It is important that these flexibilities can be used when the need arises 
and are n ot hampered by administrative hurdles.  
239.  Only international cooperation can mobilise the global manufacturing, trade, and delivery 
response that will end this crisis and help build a more resilient system for the future. We are 
committed to such cooperation . 
1.20  United States of America  
240.  With respect to the Council 's status report to the General Council for next week 's meeting, the 
United States supports the compromise language reached.  
241.  As reflected by President Biden 's pledge to COVAX last week, the United States is committed 
to working with international partners to end the devastating public health and economic effects of 
this pandemic. Furthermore, the United States will work with partners to identif y practical ways to IP/C/M/97/Add.1  
 
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  catalyse  the needed capacity to end this pandemic and respond to the next one. It is paramount that 
we collectively increase access to and facilitate equitable distribution of COVID -19 vaccines and that 
we support policies that drive th e rapid development of new vaccines, medicines, and other health 
products.  
242.  The United States is committed to working constructively with Members to tackle this 
unprecedented global health crisis and end this pandemic.  We look forward to engaging in furthe r 
fact-based discussions on the questions that a number of Members have raised about the proposal, 
with the aim of finding multilateral solutions to amplify the public health and humanitarian responses 
to the ongoing crisis, while bearing in mind the impor tance of incentives for innovation.    
1.21  Norway  
243.  Thank you, Chair, for having facilitated discussions on this important topic and for having 
secured consensus for your oral report to the General Council.  
244.  Norway agrees, and I do not think any Member disagrees, that nobody 's safe until everybody 's 
safe. Ensuring a fair and equitable distribution of vaccines, diagnostics and medicines should have 
our highest priority. Norway is working hard to make this happen through various int ernational 
cooperative efforts.  
245.  As to the issue at hand, we have listened carefully to the views expressed by Members in both 
formal and informal settings. We would like to thank those Members who have presented concrete 
questions to the proponents, and w e would like to thank the proponents for their response.  We 
consider this engagement to be promising and hope that we can continue our deliberations in a 
constructive mode.  
246.  In this context, we have taken note of statements from proponents that they are willing to 
discuss the scope and duration of the Waiver . It would therefore be interested to learn from the 
proponents whether they are considering presenting a revised proposa l as a basis for further 
deliberations.    
1.22  Switzerland  
247.  Switzerland would like to thank you, Chair, for the consultations you held to build consensus 
on your oral report to the General Council .  
Introduction  
248.  In the vie w of Switzerland, the proposed TRIPS Waiver  would not facilitate global access to 
COVID -19 vaccines. On the contrary, we consider suspending large parts of the TRIPS Agreement 
would be counterproductive. It would undermine the efforts currently ongoing, to  scale up 
manufacturing to achieve such global access.  
249.  We have set out our main arguments, explaining our view in past meetings, including in those 
of 19 January and 4 February 2021. We ask the Secretariat to include our statements from those 
two meetings in the present  minutes.  
Scale up manufacturing  
250.  Roughly 12 months after the world entered the pandemic, in record time, the first few vaccines 
have been developed and tested for their efficacy and safe use. Scaling up their manufacturing is 
the most import ant challenge now, as they are not available in sufficient quantities, yet. This comes 
not unexpected, as alleged by the delegation of India. It was hardly avoidable. Never before have 
such novel and highly complex biotech vaccines had to be made available  to the whole of the world 
population in such a short time. This is a pioneering challenge. Progress is made, but we stand only 
at the beginning of this process.  
251.  The partnerships engaged in this manufacturing scale -up are built also on the 
TRIPS  Agreement . By enabling licensing agreements, patents and other IPRs help to build bridges IP/C/M/97/Add.1  
 
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  between the various stakeholders and connect these partnerships, offering safe passages for 
know -how and technology transfer, thereby accelerating the manufacturing scale up.   
252.  If we were to suspend large parts of the TRIPS Agreement now, we would also suspend the 
bridges between these partnerships. The collaborations mentioned would be thrown into legal 
uncertainty, slowed down in their efforts and risk to stop functioning pro perly. Precious time would 
be lost and harm done to the fight against this pandemic, costing lives.  
253.  Negative impacts might be felt also on the international initiatives underway, such as ACT -A 
and COVAX, in which WHO, specialized organizations and the pri vate sector are partnering up for 
making vaccines available for low and middle income countries.  
254.  Last week, the WHO listed a first COVID -19 vaccine for emergency use, giving the green light 
for these vaccines to be rolled out globally through COVAX. The v accines are produced by SK Bio of 
South Korea and the Serum Institute of India, under licensing agreements from the vaccine innovator 
Astra Zeneca. With WHO 's emergency use listing obtained, the joint UN -led COVAX initiative can now 
start to deliver vaccin es to recipient countries.  
255.  In a recent interview in the newspaper The Guardian, Adar Poonawalla, the CEO of the Serum 
Institute of India was asked, whether the reason for the roll out having been slow was because of 
the developers who hold the patents on the vaccines having licensed too few manufacturers to make 
the vaccines. His answer was plain and simple: No – He said: "There are enough manufacturers, but 
the scale up simply takes times. " 
Mid and long term consequences of the TRIPS Waiver  
256.  Fighting this pandemic successfully is a marathon. We are on the way, but nowhere near 
crossing the finish line. There is worrying news about mutations of the virus and new variants, 
potentially more contagious or dangerous. Existing vaccines might have to be adapted, a nd new 
ones to be developed   to fight this pandemic successfully. This requires keeping  all stakeholders 
engaged and build on the existing innovation regulatory framework, of which the TRIPS Agreement 
is a key component.  
257.  Accordingly, the incentive to continue research and development, also during the pandemic, 
must be preserved in order for  innovative activity to be able to contribute to the fight against 
COVID -19; Suspending the TRIPS Agreement at this critical stage would have serious consequences, 
for the fight against this pandemic and for world pandemic preparedness in the future.  
258.  Switzerland reiterates its openness to discuss with WTO Members how we can ensure a global, 
equitable and timely access to COVID -19 vaccines, treatments and diagnostics within the multilateral 
legal framework.  
Responding to India  
259.  Just to note that India posed a number of questions including in relation to the statement of 
my own delegation from this morning. We will come back with answers to these questions at our 
next meeting, to do justice to them.  
260.  One question posed by India I would like to answer right away, however: India asked "on what 
side Switzerland really stands… ":  
261.  It goes without saying, that Switzerland stands on the side of all those who want this pandemic 
to end as soon as possible, to p revent further loss of lives and to end the social and economic misery 
caused by this pandemic. Switzerland 's position in the Council 's discussion on the Waiver  Proposal  
is to be seen and understood exactly on this background.  
Switzerland ' statement at the  informal meeting held on 4 February 2021  
262.  I refer to the statements made by this delegation in the discussion under this ad hoc  agenda 
item in the TRIPS Council 's past five formal and informal meetings.  Thus, I will not repeat our 
well-known position on the proposed Waiver  request at length. Indeed, our position has not changed.  IP/C/M/97/Add.1  
 
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  263.  We do not support the Waiver  Proposal  because we firmly believe that it would not help us to 
achieve the goal of expeditious global access, that goal we all sha re. Much more, we are convinced 
that it would undermine the efforts currently under way to reach this objective. It is thus not a matter 
of prioritizing IP protection over expeditious and equitable global access to COVID -19 therapeutics, 
but simply a matte r of the supposed solution not solving the problem.  
264.  My delegation would like to focus on the following arguments raised by proponents in 
documents IP/C/W/672, 673 and 674.  Proponents argue that public research and also public funding 
have been key in the R &D of COVID -19 vaccines and other therapeutics. Accordingly, pharmaceutical 
companies would not deserve any patent rights on the resulting therapeutics.  
265.  My delegation agrees that cooperation between universities, public research institutions and 
pharmaceu tical R&D companies have been instrumental in successfully developing an innovative 
vaccine or therapeutics in the current pandemic. We can now start to mass produce safe, quality and 
effective vaccines or therapeutic products to administer to patients and  work towards immunity 
against COVID -19, mainly thanks to close collaboration and partnership between a wide range of 
stakeholders from the public and the private sectors.  
266.  Public universities, which deliver basic research, often lack the capacity and the finances to 
turn their basic scientific results into applied research and most often to develop them into tested, 
safe, effective, approved and marketable products. For this reason, they enter partnerships with 
other stakeholders, including those from the private sector, each contributing his or her particular 
expertise to this joint venture. And it is IPRs and thus the TRIPS Agreement which are a key 
prerequisite for these stakeholders being able and willing to do so.  
267.  Accordingly, IP rights and the TRIPS Agreement are not solely a privilege for R&D 
pharmaceutical companies to recoup the investment for their contribution to the resulting innovative 
COVID -19 vaccines or therapeutics, but are similarly used by public sector institutions engaged in 
such partne rships.  
268.  Governments that are funding such partnerships can, by fixing contractual arrangements about 
resulting novel vaccines or therapeutics, set the relevant terms and conditions about the ownership 
of respective IP right or determine other factors, lik e those concerning the affordable pricing or the 
distribution of these products.  
269.  By suspending large parts of the TRIPS Agreement - and thus the linchpin of the international 
IP system - we would deprive these partnerships of a key basis for their collabo ration. Proponents 
also claim that the TRIPS Agreement and IP rights are a barrier to global access.  We have not been 
presented with convincing evidence of this actually being the case in this pandemic.  
270.  Shortages in supply and issues in manufacturing proc esses were to be expected at the initial 
stage of mass production of vaccines, only very recently market approved in the first few countries.  
271.  Vaccines in general, and in particular novel vaccines from biotechnology, are highly complex 
products and bringin g them from the laboratory to the process of mass manufacturing is a highly 
complex task, which is fault -prone, incurs huge responsibility and thus represents an enormous 
challenge.  
272.  This applies not just for their mass production, but also for their storag e, international and 
domestic distributions, which includes the dispensing of these products to patients. Therefore, the 
collaboration of many stakeholders is needed for these production and delivery chains to work. The 
IP system builds essential bridges b etween various stakeholders, rather than constituting a barrier 
to access.  
273.  By waiving obligations under the TRIPS Agreement, we would suspend these bridges and this 
at a crucial juncture where numerous stakeholders are working together towards achieving g lobal 
access. It is important to note that intellectual property protection is essential because it also allows 
the patent holder of the concerned health technology to guarantee for the quality and safety of its 
products.  IP/C/M/97/Add.1  
 
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  274.  Due to high quality requirements and patient safety, it must be thoroughly examined on a 
case-by-case basis, whether a licensee is at all capable of producing the respective product at the 
required quality standards, within a reasonable period and at an acceptable price. Furthermore, the 
licensee must have the necessary infrastructure to produce as well as to distribute the product.  
275.  Another argument mentioned by the proponents to which we would like to revert is the 
following: The TRIPS Agreement and IPRs would be barriers to the transfer  of technology, sharing 
of know -how, and undisclosed information. Again, my delegation believes that this claim stands in 
stark contrast and contradiction to what we have experienced in reality, including in this pandemic.  
276.  In order to allow newly discover ed innovations to be turn into marketable products, transfer 
of technology is crucial. Transfer of technology is not only crucial, but highly complex and requires 
a large number of specialized skills. This transfer of know -how takes place through partnersh ips 
between the originator companies and the generic manufacturers.  
277.  Waiving international obligations concerning intellectual property rights without securing the 
necessary technology transfer is like letting the well run dry: the required health technolo gies will 
hardly be able to get reproduced in a timely manner. Moreover, future incentives into the research 
and development of health technologies will be deterred.  
278.  It is exactly because the TRIPS Agreement and the IP system enable sharing of technology,  
know -how and trade secrets in a legally safe environment, that research and manufacturing 
partnerships are entered into and that such transfer and sharing actually happen.  
279.  Parties do so only if they feel safe and comfortable and if they can rely on a tru stworthy national 
and international regulatory framework. Against this background, our delegation believes that 
suspending large parts of the TRIPS Agreement would not facilitate technology transfer and sharing 
of know -how. If now, in the midst of this tra gic pandemic, the WTO should suspend a key component 
of the international regulatory framework – and moreover – its very own regulatory framework, we 
would do harm and no good.  
280.  Finally, my delegation would like to respond to the question raised in documen t IP/C/W/674 
specifically addressed to Switzerland. Switzerland fully acknowledges that compulsory licenses are a 
flexibility that the TRIPS Agreement provides in its Article 31 for Members ' use, as also confirmed in 
the separate Doha Declaration on the TR IPS Agreement and Public Health.  
281.  Under this Article , a compulsory license can be issued promptly and in the case of an 
emergency, like the COVID -19 pandemic, even without prior negotiations with the right holder.  This 
being said, Switzerland is of the vie w that in most situations where there is a prompt need for access 
to an innovation, voluntary licensing agreements, e.g. through contractual licensing, are a more 
expeditious and more efficient approach to access and manufacture an invention still under pa tent 
protection.  
282.  Transfer of technology and know -how are regularly an important part of such licensing 
agreements. They are key components of actual and effective access to an innovation – and of the 
partnership entered into through such agreements.  Switz erland takes this view not only in the WTO, 
but it shares it consistently with its partners at the multilateral level as well as the bilateral level.  
283.  To sum up: Switzerland remains open to discuss with all WTO Members how we can ensure a 
global and fast a ccess to COVID -19 vaccines, treatments and diagnostics. This is indeed an enormous 
challenge, and we should address it in a holistic and sustainable manner, and within the rules -based 
multilateral trading system.  
284.  On the process, Switzerland remains open f or discussions on how to best address the actual 
challenges that would be identified. This could be considered in a short, factual status report to the 
General Council to be held in March. Switzerland is ready to engage in the process leading us to such 
a report.  IP/C/M/97/Add.1  
 
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  Switzerland ' statement at the informal meeting held on 19 January 2021  
285.  There is positive news since we first started discussing under this ad hoc  agenda item in the 
Council – there are now a number of  vaccines in the manufacturing and rollout stage and a few more 
in the pipeline. Dozens of countries, both developed and developing, have launched mass vaccination 
programmes.  
286.  Only a couple of months ago, we would not have thought such quick progress poss ible as 
concerns new vaccines. Of course, this is only the beginning of overcoming the pandemic. The 
challenges ahead are enormous: to scale up manufacturing with a view to expeditiously respond to 
global needs, the logistics of distribution and safe and e fficient administration.  
287.  Still, that we are at this point now, having tools available to combat the pandemic effectively, 
roughly one year after its breakout, is the result of unprecedented efforts and collaboration of many 
stakeholders involved: governme nts, international organisations, universities, scientists, research 
institutions, both public and private, public -private partnerships and the private sector. They are 
joining forces to address this global public health crisis.  
288.  IPRs and thus the TRIPS Ag reement help build bridges between these stakeholders, help 
establish, organize and manage these partnerships. What is true for the research and development 
of the vaccines, is true for the tasks of scaling up manufacturing, distributing and administering the 
vaccines over the next few months and throughout 2021.  
289.  An example of such a partnership is the licensing agreement between Oxford University, the 
pharmaceutical company AstraZeneca (AZ) and the Indian generic manufacturer Serum Institute of 
India (SII ). The SII produces the AstraZeneca vaccine in India. According to SII, millions of doses 
have already been stockpiled, and are ready for distribution to vaccination centres in India.  
290.  These are welcome news, and only one example of many that I could cite here from the past 
few weeks. Since these vaccines have only recently been approved for market entry and only in 
some Members, scaling up production will take time, naturally. As of today, we are still far from the 
goal that I understand we all share: fast est possible and equitable access to the new, safe and 
effective vaccines at global scale. We will only reach this goal through continued joint efforts and 
committed collaboration of all the stakeholders already engaged in this undertaking.  
291.  During the col lective race towards this goal, we must not suspend these rules. Suspending 
large parts of the TRIPS Agreement would result in considerable legal uncertainty, disrupt existing 
partnerships and hamper the establishment of new ones. The bridges between the s takeholders I 
mentioned IPRs help to build, would be jeopardized. A safe regulatory framework has and will help 
them guide their collaboration. It will make it predictable and accountable.  
292.  The TRIPS Agreement underpins licensing agreements such as the one  mentioned between 
Oxford University, AZ and the Serum Institute of India. It supports technology and know -how 
transfer. We need confidence in down -stream financing and delivery capacity for rollout of products, 
including in low and middle income countries ). 
293.  I mentioned that the arrival of new vaccines against the novel coronavirus is positive news. 
There is also worrying news since we last met. News about the novel coronavirus mutating and 
building new variants, potentially more dangerous and contagious. T his shows that the fight against 
COVID -19 is not a one -time effort. Rather, it is an ongoing challenge for months and years to come. 
And there will be future pandemics.  
294.  Therefore, we must ensure a safe, reliable, rule -based environment that encourages - today 
and in the future - the research and development of new vaccines and medicines, adapting existing 
ones to respond to mutations of viruses and develop innovative therapeutic products and diagnostics 
against them. The TRIPS Agreement is a key component of such a reliable regulatory environment. 
Our focus now is COVID -19, we must collectively mobilize and join forces in the fight against this 
pandemic. While doing this, we must keep in mind that our actions today will have an important 
impact on medical i nnovation tomorrow, including on our preparedness for a next pandemic.  IP/C/M/97/Add.1  
 
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  295.  In sum: The concern of fast and equitable access to those new vaccines and medicines for all 
is one my delegation fully shares with the proponents of the TRIPS Waiver  request. Yet, my 
delegation has not been convinced and does not believe that suspending large parts of the 
TRIPS  Agreement will help us meet this goal. On the contrary, we think it would prevent us from 
doing so. It is essential that we take into account all relevant factor s that determine access, and 
continue to address the challenges that we are facing in a holistic and sustainable manner, and within 
the rules -based multilateral trading system. It is a global pandemic and there is no alternative to 
overcoming it together.  
296.  We thank the proponents for their three  submissions with answers to questions raised in the 
Council 's past discussion and questions of their own posed to other Members. We received these 
submissions late last Friday and are still examining them. As alread y stated, Switzerland is open to 
discuss concrete challenges related to IP with regard to access to health technologies relevant to 
COVID -19. We will come back on questions posed at our next meeting.  
1.23  Mali 
297.  Mali would like to thank you, Madam Chair, for organizing this important meeting and we would 
like to thank all Members who have supported the proposal, which is no longer a South African or 
Indian proposal but is becoming universal. We hope that, at the next TRIPS Council m eeting, an 
important decision will be taken to ensure affordable access to medicines and vaccines against 
COVID -19. As we have seen, national borders are no obstacle to COVID -19. We have seen 
discussions on "vaccine passports " in many countries and this wo uld be a restriction on the right to 
freedom of movement.  
298.  In our view, we must implement Article 66.2. of the TRIPS Agreement effectively and we 
believe that if we are an effective organization, we will provide major support for our countries. Mali 
is a co-sponsor of this proposal, and we have suggested that all Members of the African Group and 
the LDC Group also support it individually because all African countries are Members of the African 
Group and all LDCs are in Africa, and this would give it more wei ght. 
299.  What we also suggest is that another meeting of the TRIPS Council be held and specifically 
dedicated to technology transfer and that provision be made for this under TRIPS Article 66.2; we 
believe that this will be an important step. Mali thanks all t he countries that have supported the 
proposal.   
1.24  Singapore  
300.  Thank you very much, Madam Chair, for convening the TRIPS Council so that Members can 
continue to deepen our evidence -based discussions on the Waiver  Proposal . Allow me to make three 
points.  
301.  First, there is no doubt that Members recogni ze that there are real and ongoing challenges in 
ensuring equitable and timely access to COVID -19 diagnostics, vaccines and therapeutics (DVTs). 
But what is less clear i s whether IP rights have been the actual obstacle. There is evidence that IP 
rights have played a key role in fostering an ecosystem that promotes continuous innovation by 
allowing the key stakeholders such as governments, researchers and pharmaceutical co mpanies to 
collaborate in developing and producing COVID -19 vaccines. This has led to several collaboration 
success stories, including the Serum Institute of India (SII), which has become the largest COVID -19 
vaccine manufacturer in the world.  
302.  My Swiss co lleague has already reference d the interview in The Guardian but  let me share the 
content again because I think it is worth the while. The CEO of SII, Adar Poonawalla said in a recent 
Guardian interview which posed the following question, and I quote: "Some people think the reason 
that rollout has been slow in many countries is because the developers who hold the patents on the 
vaccines have licensed too few manufacturers to make them. Do you agree? " Listen to what 
Poonawalla said, and I quote: "No. There a re enough manufacturers, it just takes time to scale up. 
And by the way, I have been blown away by the cooperation between the public and private sectors 
in the last year, in developing these vaccines. " What Poonawalla said is significant because he has 
emphatically debunked the notion that vaccine developers have withheld licensing their patent rights 
to manufacturers. In other words, IP rights are not, and have not, been an obstacle. Hence, Members IP/C/M/97/Add.1  
 
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  would welcome more detailed information from the proponen ts on the tangible hurdles that their 
manufacturers have faced, which can be attributed to constraints posed by IP rights.  
303.  Second, and relatedly, it is not clear that waiving IP rights will provide a "silver bullet " to solve 
the challenges surrounding the  complex issue of equitable and timely access to vaccines.  There are 
still significant challenges in producing or ramping up production of vaccines in many countries, but 
these challenges have more to do with limited healthcare infrastructure, domestic re gulatory 
deficiencies and supply chain blockages rather than IP rights. I believe that every Member agrees 
that ensuring equitable and timely access to vaccine is a crucial element of the global fight against 
the COVID -19 pandemic because no one is safe un til everyone is safe. But if we are serious in finding 
a solution, we must avoid reducing the multi -faceted challenges to a single dimension that focuses 
only on IP rights. Instead, we must address systemic and deep -seated issues that require a holistic 
and comprehensive approach to find the right and effective solution.  
304.  Third, as new Director -General, Dr Ngozi Okonjo -Iweala, had rightly highlighted at the Special 
General Council (GC) meeting on 15 February  2021, we must find a "third way to broaden access ". 
Rather than just focussing on a Waiver  of IP rights, Members should seriously consider Dr  Ngozi 's 
call to "facilitate technology transfer within the context of multilateral trade rules, so as to encourage 
research and innovation, while at the same time allowing licensing agreements that help scale up 
manufacturing of medical products ". We must pay close attention to Dr Ngozi 's remarks as she brings 
extensive experience and deep understanding of the issue as former Chair of the Global Alliance for 
Vaccine s and Immunisation (GAVI). Additionally, we must improve different aspects of the 
ecosystem by addressing supply -chain disruptions and encouraging more stakeholder partnerships, 
including between governments and industries to facilitate distribution of vac cines to those who need 
them.  
305.  Let me end by expressing Singapore 's support for the draft of your oral status report to the 
General Council and we look forward to further productive discussions on this issue.  
1.25  Canada  
306.  Canada is pleased that Members were able to agree to a way ahead for this important 
discussion, to which we remain fully committed with a view to identifying consensus -based solutions 
to any specific issues arising from the TRIPS Agreement in relation to COVID -19 diagnostics, 
therapeutics, vaccines, devices and equipment.  
307.  Canada would like to reiterate that it has not rejected the Waiver  Proposal , and remains 
interested in understanding the specific nature and scope of any concrete IP challenges experienced  
by Members, related to or arising from the TRIPS Agreement, in their responses to COVID -19, such 
that concrete, consensus -based solutions can be found.  
308.  Canada would again like to thank the Waiver  co-sponsors for their engagement on the 
questions posed by Canada and other Members, including through document IP/C/W/671, and their 
engagement such as through document IP/C/W/673. Pursuant to the oral status report of the 
TRIPS  Council, and the direction of the General Council, we look forward to further discuss ion on 
these important issues, with a view to concretely identifying any IP -related challenges experienced 
by Members in their efforts to address COVID -19, including with respect to the operation of the 
TRIPS  Agreement.  
309.  As noted at our most recent meeting on 4 February 2021, Canada took note of the indications 
by some Members that there currently unused or underutilized COVID -19 vaccine -production 
capacity. While acknowledging that this topic involves a range of complex considerations that may 
involve inter national bodies outside this Council, Canada looks forward to further discussion on any 
TRIPS or otherwise IP -related challenges faced in this area, and that Members could not address 
through the existing TRIPS Agreement flexibilities, or otherwise, and th at have thus led to facilities 
being unused or underutilized. This, in our view, would help foster enhanced, mutual understanding 
of challenges faced by Members, and help guide us toward the most appropriate, consensus 
approaches. Canada would also be plea sed to share our own experiences with respect to the 
utilization of manufacturing capacity, to help inform these discussions. We look forward to further 
discussion at the upcoming 10-11 March session of the TRIPS Council in this regard.  IP/C/M/97/Add.1  
 
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  1.26  United Kingdom  
310.  The United Kingdom welcomes the text of the status report and is content for it to be delivered 
at the upcoming General Council. The UK thanks delegations for continued discussion on how to best 
deliver our shared obje ctive of equitable, affordable, and timely access to COVID -19 related 
technologies and supplies.  
311.  Reiterating our position from the 4 February  2021 informal Council, we encourage Members to 
identify where idle capacity exists that can be utilised to addres s manufacturing demands, how IP is 
related to supply shortages, and how the proposed Waiver  would be an immediate solution to 
identified production shortages. We are also interested in hearing responses to the queries we, and 
other delegations, raised at t he previous informal Council.  The UK stands ready to engage in 
continued evidence -based discussions.  
1.27  Australia  
312.  We made a lengthy intervention at the last informal meeting on 4 February  2021. I do not plan 
to reiterate all of what we said on that occasion.   
313.  It seems to us that much of the discussion in this Council has been focussed on issues on which 
the membership appears to be in fierce agreement – including the scale of the health and ec onomic 
challenge presented by COVID -19, particularly to developing countries, the need to scale up 
manufacturing to ensure timely and widespread access to vaccines, and the need for ongoing 
innovation to respond to variants and future pandemics.   
314.  To us, t he key issue appears to be whether the international IP regime is itself a significant 
barrier to widespread access to health products, including vaccines, and therefore whether this 
proposed Waiver  would assist in achieving these shared objectives. With a  view to focussing 
discussion on this key issue, on 4 February, we asked the proponents to identify with specificity any 
underutilised global vaccine manufacturing capacity, and whether it is IP rules that are responsible 
for this underutilised capacity.  We have also previously asked the proponents to clarify exactly what 
actions they would like to take, or could need to take, that they feel they are currently unable to 
take as a result of their obligations under the TRIPS Agreement and its flexibilities.  
315.  We look forward to receiving any further information the proponents are able to provide in this 
regard, and stand ready to engage with the proponents, including informally, at any time.  
1.28  Japan  
316.  The delegation of Japan appreci ates the efforts made by the Chair and the Secretariat to 
convene this TRIPS Council meeting and coordinate the draft status report to the General Council. 
We support the status report which reflects the discussion at the previous meetings.  
317.  Japan believes that ensuring timely, fair and equitable access to vaccines and medical 
treatments throughout the entire world is essential in the fight against COVID -19. Japan has put 
emphasis on Universal Health Coverage in response to COVID -19, and Japan is contributin g to 
multilateral schemes such as the ACT Accelerator, including the COVAX Advance Market Commitment 
and Global Fund. The immediate challenge facing the ACT -Accelerator is to meet its financial needs. 
To achieve this goal, Japan announced at the fourth Fac ilitation Council meeting of ACT -Accelerator 
held on 9 February 2021 that Japan would increase its commitment and contribute USD 200 million 
in total to the COVAX Advance Market Commitment. Furthermore, Japan is going to contribute to 
the Medicines Patent Pool through Unitaid for promoting the distribution of medical products. We are 
convinced that these efforts are practical and effective for achieving timely, fair and equitable access 
to medical products.  
318.  Japan 's position remains unchanged. If there were  concrete challenges relating to the 
TRIPS  Agreement experienced by Members in procuring COVID -19 vaccines, therapeutics, 
diagnostics and other medical products, we are prepared to have an evidence -based discussion.  
Japan remains committed to combatting COVID-19, together with the international communities.  IP/C/M/97/Add.1  
 
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  1.29  Holy See  
319.  "The COVID -19 pandemic unexpectedly erupted, exposing our false securities. Aside from the 
different ways that various countries responded to the crisis, their inability to work together became 
quite evident. For all our hyper -connectivity, we witnessed a fragmentation that made it more 
difficult to resolve problems that affect us all ".8 
320.  As emerged during the recent Executive Board of the World Hea lth Assembly, "the world is on 
the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and 
livelihoods in the world 's poorest countries ".9 Over the last weeks, we have experienced how some 
countries and companies continue to prioritize bilateral deals, driving up prices and attempting to 
jump to the front of the queue. Pope Francis warned about the risk of prioritizing access to the 
vaccine to the richest: "It would be sad if this vaccine were to become the propert y of this nation or 
another, rather than universal and for all ".10 
321.  On the one hand, most countries of the world are experiencing delays in vaccine rollout 
programmes. Such situations have resulted from insufficient product manufacturing and the 
consequent lack of availability of the required number of vaccine doses. On the other hand, in many 
countries, a large number of manufacturing facilities, with proven capacity to produce safe and 
effective vaccines, are unable to utilize those capacities, due, inter alia, to IP barriers.  
322.  The financing of research has been provided by different sources, including investment of 
resources by states, and contributions from private entities. In the context of COVID -19, despite the 
billions of taxpayer dollars invested in R&D, and announcements that COVID -19 vaccines should be 
considered a public good, no government has openly made such a public commitment.   
323.  Nonetheless, given the absolute necessity of COVID -19 vaccines during this global public health 
emergency, it is app ropriate to consider such vaccines "as a good to which everyone should have 
access, without discrimination, according to the principle of the universal destination of goods 
highlighted by Pope Francis . 'We [cannot] allow the virus of radical individualism  to get the better 
of us and make us indifferent to the suffering of other brothers and sisters… letting the law of the 
marketplace and patents take precedence over the law of love and the health of humanity '".11 
324.  The existing mechanisms for compulsory licenses under Article 31 and Article 31 bis of the 
TRIPS Agreement contain territorial and procedural restrictions that make the practice of issuing 
product -by-product compulsory licenses a complex process, thus causing difficulties for collabor ation 
among countries. TRIPS flexibilities allow limited policy space for public health, but they never were 
designed to address a global health crisis, such as the one we are experiencing at present. Even 
during "normal " times, the Article 31 bis mechanism , which was established to support countries with 
insufficient or no pharmaceutical manufacturing capacity, has been widely criticised due to its 
cumbersome procedures. In addition, the fact that it was used only once since its inception, in 2006, 
gives am ple evidence of the difficulties associated with its use.  
325.  Policies and laws should maintain a perspective that is focused on the respect for, and 
promotion of, human dignity, in a spirit of solidarity within and among nations. This implies, 
inter alia, that, while recognizing the value of protecting intellectual property rights, we should focus 
on the purpose of such rights and on the limitations and potential negative consequences of the 
current system.  
326.  In his Urbi et Orbi Christmas message,  Pope Francis  stated that vaccines, if they are "to 
illuminate and bring hope to all, need to be available to all… especially for the most vulnerable and 
needy of all regions of the planet ". The principles of justice, solidarity  and inclusiveness, must be the 
basis of any specific and concrete intervention in response to the pandemic. The decision of granting 
a Waiver  from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II 
of the TRIPS Agreement  in relation to prevention, containment or treatment of COVID -19 would be 
 
8 Pope Francis, Encyclical Letter Fratelli tutti, para 7.  
9 Dr. Tedros Adanhom Ghebreyesus, Director General, World Health Organization, address to 148th 
meeting of the WHO Executive Board, 18 January 2021.  
10 Pope Francis, General Audience, 19 August 2020.  
11 Note of the Vatican Covid -19 Commission in collaboration with the Pontifical Academy for Life "Vaccine 
for all. 20 points for a fairer and healthier world ", para. 7, 29 December 2020.  IP/C/M/97/Add.1  
 
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  a strong signal demonstrating real commitment and engagement and thus moving from declaration 
to action in favour  of the entire human family.  
2  OTHER BUSINESS  
2.1  United States of America  
327.  Under the discussions of the TRIPS Council at the February and October 2020 sessions and the 
upcoming March m eeting concerning the theme of making MSMEs competitive through IP and 
Innovation, the Friends of  IP and Innovation are organizing a virtual side event.  
328.  The event is on 9 March 2021 at 4-6 p.m. on the WTO Zoom platform.   A registration link was 
sent around to the membership last week and is still open.  
329.  The event will have engaging speakers and moderat ors, focusing on how IP supports MSMEs 
in becoming more competitive in the green tech space and also focusing on LDC and LMIC 
partnerships to catalyse  innovation and drive diffusion of technologies in the green tech field.  
330.  In an updated notice, more detail s will be provided on the speakers, including those from:  
• The Climate Technology Center and Network through the UNFCCC ; 
• Ecotech Quebec ; 
• Cutting edge SME innovation in the green tech space, including their program mes and 
partnerships ; 
• IP office of the Unite d Kingdom; and  
• WIPO directors in the SME and green tech sectors as moderators for the event . 
331.  We look forward to seeing you virtually on  9 March at 4 p .m. 
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