   
  
IP/C/W/672  
 
15 January  2021 
(21-0501) Page: 1/30 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION , 
CONTAINMENT AND TREATMENT OF COVID -19 – RESPONSES TO QUESTIONS  
COMMUNICATION FROM THE PLURINATIONAL STATE OF BOLIVIA, ESWATINI, INDIA, KENYA, 
MOZAMBIQUE, MONGOLIA, PAKISTAN, SOUTH AFRICA, 
THE BOLIVARIAN  REPUBLIC  OF VENEZUELA AND ZIMBABWE  
The following communication, dated 14 January 2021, is circulated at the request of the delegations 
of the Plurinational State of Bolivia, Eswatini, India, Kenya, Mozambique, Mongolia, Pakistan, 
South  Africa, the Bolivarian Republic of Venezuela and Zimbabwe .  
_______________  
 
This document contains responses to questions raised on the waiver proposal in the TRIPS Council 
meetings on 16 October, 20  November, 3 and 10 December 2020.  
1  ANSWERS TO QUESTIONS RAISED FROM FLOOR IN THE FORMAL MEETING OF TRIPS 
COUNCIL ON 16 OCTOBER 2020  
1.1  We heard the refrain from the EU and others that the TRIPS Agreement is fit for 
purpose and its fl exibilities are usable without limitation or any problem? We once again 
contest this notion.  
1.  Delegations that have taken the floor to condemn this waiver proposal claim that TRIP S 
flexibilities already include the option to issue compulsory licenses where  necessary.  
2.  The proposal for a waiver on certain IP provisions offers an expedited, open and automatic global 
solution that allows for uninterrupted collaboration in development and scale up of production and 
supply and that collectively addresses the glob al challenge facing all countries. Countries should 
continue to use TRIPS flexibilities to safeguard public health, including issuing compulsory licenses 
and placing limitations on or making exceptions to exclusive rights.   
3.  However, the "case by case " or "product by product " approach required when using flexibilities 
to address IP barriers at the national level could be limiting during the pandemic. Some countries 
also face limitations with respect to their national laws, pressures from their trading partn ers, or 
lack the practical and institutional capacity required to exercise TRIPS flexibilities during the 
pandemic quickly and effectively. The existing mechanisms for compulsory licenses under Article31 
and Article 31 bis of the TRIPS Agreement contain ter ritorial and procedural restrictions that make 
the practice of issuing product -by-product compulsory licenses a complex process, making it difficult 
for countries to collaborate. Article 31 requires that compulsory licenses are issued on a case -by-
case bas is and used predominantly to supply domestic markets, thereby limiting the ability of 
manufacturing countries to export to countries in need.  
4.  Article 31 bis requires that any product produced and exported under a compulsory license be 
identified with specific packaging and quantities, which can lead to unnecessary delays in the context 
of COVID -19 where countries need urgent access to medical tools. There is even less experience in 
areas such as industrial designs, trade secrets, algorithms and copyright, applying compulsory 
licenses to such areas may be legally complicated and novel.  IP/C/W/672  
 
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  5.  Pressure  from two delegations that oppose the waiver proposal have taken ac tion to ensure that 
countries do not use compulsory licenses, for example:  
• the European Union (EU) IP enforcement report 2020, issued right before the COVID -19 
pandemic, put a number of developing countries, including India, Indonesia, Turkey, 
Ecuador, und er the spotlight of criticism for their laws allowing the use of compulsory 
licenses if patent holding companies do not fulfil the obligation of supporting production of 
medicines locally;  and 
• the United  States  Trade  Representative (USTR) 2020 Special 301 report, issued right in the 
middle of the COVID -19 pandemic, continue to condemn countries who improve their laws 
on compulsory license or make use of compulsory licenses – countries specifically pressured 
for their law or their use of compulso ry license include Chile, Indonesia, Colombia, Egypt, 
India, Malaysia, the Russia n Federation , Turkey, Ukraine, El Salvador.  
1.2  Voluntary Licenses are somehow touted as the solution for COVID -19! This is not the 
case.  
6.  IP rights can be exercised by their owner s to decide on whether to grant a license or withhold 
from licensing the technology, designs and knowhow required for manufacturing or for further 
developing the products required for COVID -19. By enforcing exclusive rights backed by IP, such as 
patents, p harmaceutical companies slow down research and innovation. The use of restrictive 
voluntary license terms limits the catching up and innovation made by generic competitors.  
7.  Nine months into the pandemic voluntary approaches have proven to be insufficient. For instance, 
despite receiving significant public funding of at least US D 70.5 million, Gilead has signed secretive 
bilateral licenses for Remdesivir (a therapeutic for COVID -19 treatment) with a few generic 
companies of it choosing that excludes nearly h alf of the world 's population from its licensed 
territories. Much of Gilead 's supply has also been reserved for very rich nations. As a result, to date, 
most developing countries have barely received any supply of Remdesivir. The prices of Remdesivir 
are also prohibitively high.   
8.  On the other hand, to date not a single company has committed to the voluntary COVID -19 
Technology Access Pool of WHO.   
9.  In cases where companies have made such commitments to issue voluntary licenses, the lack of 
transparency of license agreements for products to treat COVID -19 is substantial. These initiatives 
are ad hoc  and are not a sustainable way of addressing IP barriers.  
10.  While such companies can limit the production, quantity and export of products produced under 
license to  certain geographical areas thereby excluding large parts of the world population. Nonprofit 
undertakings are time bound, while such companies will decide when they think the pandemic is 
over.  
11.  If we are serious to address access issues, production cannot be concentrated in the hands of 
only a few manufacturers, in order to scale up production, governments have a critical role to play.  
1.3  Various Members have asserted that the waiver proposal will impede innovation and 
that it is improper and ill -conceived on  the side of the co-sponsor to bring a waiver 
proposal at this critical time.  
12.  Never has there been a weaker case for the granting of monopolies.  Governments have been 
funding the development of COVID drugs and vaccines, and no company is able to meet the global 
demand. In the context of COVID -19, despite the billions of taxpayer  dollars invested in R&D, and 
announcements that COVID -19 vaccines shou ld be considered a public good, no government has 
openly stated committed to this undertaking.  
13.  Monopoly -based and market -driven R&D in biomedical sector ignores unmet health needs - no 
new medicine was developed for more than 40 years on TB; no effective R&D in addressing IP/C/W/672  
 
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  antimicrobial resistance (AMR) despite of the constant increasing of number of IP – patents granted 
in pharmaceutical sector globally for zero value add.  
14.  The R&D of drugs is often a joint multi -stakeholder effort, benefitting from signif icant amounts 
of public taxpayer money. For COVID -19, the search for an effective treatment or vaccine is a global 
effort involving by multiple actors – it is not the result of the pharmaceutical industry 's efforts alone. 
Governments and public funding age ncies around the world have poured billions of US dollars of 
public money to support COVID -19 R&D, especially for drugs and vaccines. However, by and large 
no conditions for access or affordability have been included as a precondition to any of that fundin g. 
Governments must attach strings to any public money given for COVID -19 medical tools to 
guarantee that, if they prove safe and effective, they are available to everyone. Today some 
Members have admitted that some conditions had been set on companies, bu t none of it goes far 
enough to ensure that IP rights assigned to companies benefiting from taxpayer money do not abuse 
such rights down the line.  
1.4  It was professed by Members that voluntary cooperative approaches will solve the 
COVID -19 crisis through gene rous pledges to multi -stakeholder collaborative platforms. 
We thank the EU and other delegations for their generous support for these initiatives, 
including the donation of vaccines and access to COVAX -facility to cooperate in the 
purchase of future vaccin es for the benefit of vulnerable countries.  
• The co-sponsors agree that global cooperation and collaboration is key to addressing the 
COVID -19 pandemic, initiatives such as the COVAX facility are helpful but insufficient . Our 
waiver proposal is designed to  work synergistically with such initiatives by enabling the rapid 
scaling of production by multiple producers across many countries, enabling the sharing of 
knowledge and transfer of technology with the aim of addressing the pandemic . 
• COVAX at best provide s very short -term, limited access to vaccines. Its approach is not 
sustainable in the medium and long term. The global needs are massive and can only be 
addressed with global sharing of technology, knowledge and related IP. Not by artificially 
limiting com petition and supply which in turn only results in high prices in the medium and 
long term.  
• Notably wealthy nations representing just 13 % of the world 's population have already 
cornered more than half (51 %) of the promised doses of leading COVID -19 vaccine  
candidates1. This creates significant uncertainty for universal access.  
o The EU together with some other wealthier nations and regions, have already 
pre-booked more than 51% of the global supply capacity of the potential future 
COVID -19 vaccines – leaving limited share for developing countries and least  
developed countries to share. It is this conduct that has created huge uncertainty to 
the guarantee of universal access to COVID -19 medical tools and products . 
• Global equitable allocation and donatio n are separate issues from the waiver proposal that 
we put on the table . 
• While some initiatives such as COVAX is aiming to address the initial shortage of supply of 
medical tools for COVID -19 treatment and prevention, its effects can be limited due largely  
to the following factors:  
• The model and the conducts reinforce the deep inequality in the global health 
architecture and do not provide a sustainable solution;  
• Both the investment to COVAX and donation commitment cannot solve the issue of 
the need to di versify, to the maximum level the global capacity of development, 
manufacturing and supplying COVID -19 medical tools; and 
• COVID -19 reveals the deep structural inequality in access to medicines globally, and 
one of the root causes is that IP sustains dominating industry 's interests at the cost 
of lives.  
 
1 https://www.oxfam.org/en/press -releases/small -group -rich-nations -have-bought -more-half-future -
supply -leading -covid-19 IP/C/W/672  
 
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  1.5  We heard some Members saying that intellectual property is not a hindrance but a 
help to end COVID -19; …. Suspending key protections of the TRIPS Agreement would send 
the wrong message to indus try investors.  
• Huge public funding has been poured into R&D for COVID -19 – more than USD 70 billion 
mostly from governments including many developing countries governments; it is taxpayers 
in different countries who have invested the COVID -19 R&D;  
• People a round the world who are taking huge risk of joining in and supporting the 
unprecedented R&D process and clinical trials;  
• The incentive for people to take substantial risks in supporting and joining clinical trials has 
nothing to do with IP, but the conscie nce and common sense of contributing to the finding 
of a cure for all ; and  
• Industry has asked governments to take over their liability and request for indemnity so that 
industry does not have to bear the risk but can make all the profit without much value add. 
15.  We also heard that intellectual property has enabled collaboration between bio -pharmaceutical  
innovators and governments, universities and other research partners to speed up progress on our 
most pressing unmet medical needs, however the co-sponsors s trongly contest this notion.   
• It is the pandemic – not IP – that has mobilized collaboration of multiple stakeholders.  
• It is knowledge and skills held by scientists, researchers, public health experts and 
universities that have enabled the cross -country collaborations – not IP!  
• It is public funding, again, that facilitated these collaborations – not IP!  
2  ANSWERS TO QUESTIO NS RAISED FROM FLOOR IN THE INFORMAL MEETING OF 
TRIPS  COUNCIL ON 20 NOVEMBER 2020  
2.1  Some Members argue that the TRIPS Agreement, strikes the right balance and 
provides for the necessary means and remedies to allow the use of protected products.  
16.  TRIPS flexibi lities, including those confirmed in the Doha Declaration on TRIPS and Public 
Health, have undoubtedly, played a crucial role in promoting access to medicines. However the 
present COVID -19 global pandemic presents exceptional circumstances. After all, coun tries all over 
the world have had to put in place extraordinary measures to contain COVID -19, ranging from 
putting in place emergency legislations and lockdowns to seeking military help. But, when it comes 
to IP, these same countries shy away from even rec ognizing the evidence that IP is a barrier, let 
alone mustering the global cooperative effort required to scale up manufacturing by addressing the 
IP issues for ensuring timely, equitable and affordable access to COVID -related therapeutics, 
vaccines and ot her goods for all.  
17.  In our view, though the TRIPS flexibilities do allow limited policy space for public health, they 
were never designed to address a health crisis of this magnitude. Invoking them for a range of health 
products and technologies, required f or treatment and prevention of COVID -19, is not a feasible 
option, because:  
18.  Understanding of TRIPS flexibilities is usually in the context of patents. However, as explained 
before, various types of intellectual property rights i.e. patents, copyrights, ind ustrial designs and 
trade secrets pose a barrier towards an effective response to the COVID -19 as the pandemic requires 
access to various commodities, involving multiple IP rights. Flexibilities in other categories of IPRs 
than patents, are less understood  and rarely implemented before. Therefore, options available to 
Members through existing TRIPS flexibilities are limited.  
19.  Many countries lack the institutional capacities to utilize such flexibilities.  
20.  Moreover, compulsory licenses are issued on a countr y by country, case by case and product 
by product basis, where every jurisdiction with IPs would have to issue compulsory license, 
practically making collaboration among countries for the development and manufacturing of medical 
products (where different c omponents are sourced from different countries) extremely onerous.  IP/C/W/672  
 
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  21.  Further Article 31 bis mechanism established to support countries with insufficient or no 
pharmaceutical manufacturing capacity has even in normal times been widely criticised for its 
cumber some procedures. The mechanism includes procedures such as specific labelling or marking 
of products; special packaging and/or special colouring/shaping of products, making it practically 
meaningless. The procedure being used only once, since its inception  in 2006, itself testifies 
difficulties associated with its use.  
22.  Finally, very often the implementation and use of flexibilities is accompanied by pressures from 
trading partners as well as other stakeholders.  
23.  We encourage the use of TRIPS flexibilities by Members. Members that have the capacity to 
implement flexibilities in a timely manner should continue to do so. Furthermore, those Members 
who think that TRIPS flexibilities are enough for COVID -19 response and they do not need the 
waiver, can choose to  not implement the waiver in their domestic legislations, but they should not 
come in the way of international collaboration with respect to development, production and supply 
of needed healthcare products for COVID -19 that we seek to achieve through the T RIPS Waiver. The 
waiver is more than just a legal mechanism, it is a statement of intent by all countries that they 
accord highest value to protecting human lives rather than protecting private profits.  
2.2  Some Members argue that initiatives such as ACT -Accel erator (ACT -A) and COVAX  
Advance Market Commitment (AMC) including donations to these initiatives are sufficient 
to address global need for vaccines and therapeutics.  
24.  We welcome the global cooperation initiatives, including ACT -A and COVAX  AMC and encourag e 
funding by Members to these initiatives. Every effort towards achieving an equitable access for 
COVID -19 products should be supported. However, in our view, these would not be sufficient to 
ensure timely and equitable access to COVID -19 products and technologies. The aim of ACT -A 
including the COVAX  AMC is to provide two billion vaccine doses (for one billion people if we consider 
two-dose vaccine regimen) to the world by the end of 2021. It is designed to address only the initial, 
acute phase of the pandemic to forestall health service collapse and thus to deliver only 20% or less 
of LMICs ' need. Even these acute, minimal goals of the ACT -Accelerator may not be met because it 
has currently raised only about 15% of its funding needs2. These initiatives are obviously inadequate 
to meet the medium and long term needs of the 7.8 billion people of this world.  
25.  In the immediate term, even with these initiatives, there is visible disparity in access between 
the developed countr y Members  and th e rest of the world. Developed countr y Members  have been 
able to leverage their financial position and enter into increasing number of bilateral deals securing 
preferential access creating uncertainty for universal timely and affordable access. As Kenya ha s 
pointed out, majority of the doses of recently announced effective vaccine, based on initial data, 
have reportedly been reserved by high -income countries. On one hand, these countries are buying 
up as much of the limited supply as they can, leaving no va ccines in the pie for developing and least  
developed countries. On the other hand, and very strangely, these are the same countries who are 
arguing against the need for the waiver that can help increase the global manufacturing and supply 
to achieve not ju st equitable, but also timely and affordable access to such vaccines for all countries.  
26.  The global needs are massive and can only be addressed with global sharing of technology, 
knowledge and related IP, which is what our waiver proposal seeks to achieve.  We believe it would 
be naïve for any country to think that it can win over a virus, which knows no boundaries, by simply 
vaccinating their own population. We would like to conclude by saying that we all need to rise up to 
the demands of this crisis and show to the world that WTO is still relevant and very much capable 
of responding to the global need of saving lives and livelihoods, at least during a health crisis like 
COVID. We are open to the suggestions from Members on the text of the Proposal, includ ing its 
scope and coverage, duration or any other aspects and look forward to a constructive discussion.  
 
2 https://www.who.int/news/item/13 -11-2020-access -to-covid-19-tools-accelerator -commitments -
reach -us-5.1billion -following -new-contributions -including -at-paris-peace -forum   IP/C/W/672  
 
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  2.3  Some Members  that are of the view that they will not benefit from the waiver or do 
not need the waiver.  
27.  It is important to note that the adoption of a waiver at the international level does not obligate 
implementation of the waiver at the national level.  
28.  In addition, national implementation of the waiver depends on a country 's political and/or 
constitutional arrangement. There is no one size fits all ap proach to national implementation. For 
instance emergency, disaster management legislations or any other relevant legislation may be 
relied upon for executive action to operationalise the waiver at the national level. We want to stress 
that the proposed wa iver would be applicable only to COVID -19. The waiver is limited and does not 
suggest a waiver from all possible TRIPS obligations, nor does it suggest a waiver beyond what is 
needed for COVID -19 prevention, containment and treatment.  
29.  The waiver should co ntinue until widespread vaccination is in place globally, and the majority 
of the world 's population has developed immunity hence we propose an initial duration of [X] years 
from the date of the adoption of the waiver. The Waiver does not imply any change of the substantive 
treaty obligations; it only temporarily suspends their operation for a period to be agreed by Members 
and thus will be time -bound. As already indicated, our proposal demonstrates the existence of 
exceptional circumstance that justifies o ur request for a waiver decision and clear terms and 
conditions governing the application of the waiver.  
2.4  Those opposing the waiver proposal have repeatedly suggested that voluntary 
approaches offer the best solution.  
30.  As would have been emphasized, the TRIPS waiver proposal is supportive of any voluntary 
licenses issued by companies, however the terms of such  licenses are often such that they may 
restrict access or reserve supply only for wealthy nations. Amidst a global pandemic, Gilead signed 
secretive bilateral licenses for Remdesivir with a few generic companies of its choosing that excludes 
supply to near ly half of the world 's population including many developed and developing countries.  
31.  Similarly, for vaccines, bilateral deals are being signed by pharmaceutical companies with 
specific governments; but the details of these deals are mostly unknown. Usuall y, these agreements 
are for manufacturing of limited amounts and solely supplying a country 's territory or a limited 
subset of countries. Many companies have not signed any agreements to expand manufacturing and 
supply, meaning that during the time of vacc ine development when such supply bottlenecks could 
have been addressed, companies are refusing to share intellectual property in a responsible fashion. 
This turns countries against each other to compete for supply in lieu of working together to defeat 
the pandemic. For instance, 82% of the recent Pfizer/BioNtech vaccine that is claimed to be 90% 
effective has been pre -booked by developed countr y Members  representing 14% of the global 
population , and no public commitment has been made in support of sharing its COVID -19 vaccine 
knowledge, technology and related intellectual property to boost supply, reduce price and enhance 
equity.  
32.  Some argue that pharmaceutical companies have made a "no-profit pledge " during the 
pandemic. But even this pledge is suspect giv en the absence of transparency on actual costs of 
research and development and that pharmaceutical companies may unilaterally declare an end to 
the pandemic, as early as July 2021, according to at least one agreement with a manufacturer. 
Some companies are  not offering prices at a not -for profit price, charging anywhere from USD 20 to 
an estimated USD 40 per dose , which would cost governments billions of dollars. Pfizer and 
BioNTech are expected to make at least USD 13 billion from their vaccine the following  year.  
33.  Some point to the unilateral non -enforcement announcement of Moderna as an example of the 
success of voluntary approaches. In October, Moderna announced that "while the pandemic 
continues, Moderna will not enforce our COVID -19-related pate nts against those making vaccines 
intended to combat the pandemic " adding that "we are also willing to license our intellectual property 
for COVID -19 vaccines to others for the post pandemic period ". This announcement does not provide 
other manufacturers m uch legal certainty as to freedom to operate and does not include other forms 
of intellectual property protected information and technology needed to produce the vaccine such as 
cell lines and know -how. Furthermore, with respect to future intentions, it is  unclear what period is IP/C/W/672  
 
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  intended by "while the pandemic continues " and what licensing arrangements will be applicable 
post-pandemic, which territories will be covered etc.  
34.  In sum, the global pandemic response cannot be dependent on the possibility of such  
ineffectual, ad hoc  announcements.  
35.  Voluntary licenses offered by patent -holding pharmaceutical corporations also tend to exclude 
millions of people from access to more affordable treatments. For instance, the Medicines Patent 
Pool licenses normally exclu de many developing countries and all high -income countries from being 
supplied under the licenses. There are also several other restrictions attached to voluntary license.  
Some voluntary licenses even exclude the manufacturing countries from supplying thei r home 
country markets.  Hence, conventional voluntary licenses do not offer a sustainable path to resolving 
the COVID -19 pandemic.  
2.5  Some have suggested that there is no evidence that intellectual property is a barrier 
to accessing vaccines, treatments, or technologies in the global response to COVID -19.  
36.  Cases involving potential intellectual property infringements emerged early on in the pandemic 
revealing the complex legal implications of producing copies of life -saving medical products or parts 
thereof a s well as impact on access.  
Therapeutics  
37.  A number of therapeutics are under investigation. Some of the therapeutics are presently 
off-patent but as its use is explored for COVID -19 treatment, the filing of new patent applications 
extending to secondary uses of these therapeutics can be expected.  Several other therapeutics under 
examination are patented in multiple jurisdictions.  Attached please refer to a selected patent 
landscape of priority therapeutics. Some of the candidate have patents fil ed and/or granted in nearly 
50 developing and least developed countries.  
38.  The case of Remdesivir best sums up the how patents can block access to therapeutics. The 
primary patent on the base compound of Remdesivir has been granted to Gilead in more than 70  
low-and middle -income countries, hence potentially blocking access to generic alternatives until 
2031. Civil society called for non -enforcement of Gilead 's patents, but this call went unheeded.  
Instead Gilead signed secretive voluntary licenses with a few  generic manufacturers of its choosing 
to supply countries as determined by Gilead. As a result, other manufacturers in countries with 
patents were excluded from manufacturing and nearly half of the world 's population were prevented 
from being supplied by the licensee and hence denied from accessing more affordable generics. 
While more recently WHO has declared Remdesivir to be ineffective in the treatment of COVID -19 , 
this case study is a striking example of inequities that will replay should the internat ional community 
fail to take steps to address intellectual property barriers.  Such inadequacy of supply also allowed 
Gilead to bid up the price of the treatment for those countries that were excluded from a voluntary 
license agreement, and to use the lack of supply to persuade some countries, such as the 27 Member 
States of the European Union, to sp end more than one billion euros  on the drug even though the 
WHO was about to disclose that through its own trials the drug was not effective.  
39.  In therapeutics, m onoclonal antibodies (mAbs) holds promise for curbing COVID -19. Many 
mAbs are currently in development for treatment and prevention of COVID -19. Even prior to the 
spread of COVID -19, access to mAbs was highly unbalanced, with Europe, US and Canada accounti ng 
for 80% of global sales.  Prices also remain prohibitively expensive.  
40.  Many of the monoclonal antibody candidate therapeutics such as tocilizumab, sarilumab, 
bevacizumab are under patent protection in many developing countries. Secondary patents on new 
uses or formulations of an existing mAb product could further strengthen the patent holder 's market 
monopoly, also the primary reason for delayed introduction of biosimilars in some markets including 
in the US.   
41.  Disparity in access is certain unless concret e steps are taken to address intellectual property 
barriers. Competition to lock up existing capacity is already intense. For instance, it is reported that 
Regeneron signed a US D 450 million deal in July to sell to the US enough doses of its antibody 
treatment, REGN -COV2, to treat around 300,000 people.  Similarly Eli Lily has announced an IP/C/W/672  
 
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  agreement with the U.S. government for US D 375 million to supply 300,000 vials of bamlanivimab 
(LY-CoV555) 700 mg, an investigational neutralizing antibody, granted an Eme rgency Use 
Authorization (EUA) by the U.S. Food and Drug Administration (FDA).  
Diagnostics  
42.  In March 2020, it came to light that Netherlands was not able to do mass testing for COVID -19 
as most Dutch testing laboratories work with Roche equipment and depen d on Roche for supplies of 
the liquid buffer needed to run the tests, and there was a shortage of this buffer. Initially, Roche 
refused to provide the recipe for the buffer.  With the recipe, labs would be able to quickly make their 
own solution and ramp up  their testing capability. Eventually however as public pressure mounted 
and the European Commission considered investigating Roche for possible abuse of its market 
position, Roche agreed to release the recipe to the Dutch authorities.  
43.  Shortages of testin g materials in developing countries have also been widely reported as most 
supplies are destined for the US or Europe.  In May 2020, South Africa, my home country, faced 
similar challenges as its diagnostic infrastructure also depends on the use of proprietary test 
materials – including reagents, consumables and cartridges. A virologist with the South African 
National Healt h Laboratory Service explained "that commercial diagnostic manufacturers develop 
their own tests, containing proprietary reagents and unique consumables and packing. As a result, 
the tests cannot be interchanged between different diagnostic systems " adding  that "even we don 't 
know what is in the proprietary reagents ", as the specific formulations are protected as trade 
secrets ". This situation prevents laboratories from making their own test materials or procuring test 
materials from sources other than the diagnostic machine 's manufacturer.  
44.  MSF in its analysis  has found that "major diagnostics companies hold a considerable number of 
patents, often bundled into thickets for various instrumentation, assays, methods and software, 
related to different aspects of  the technologies, methodologies and devices ", concluding that "the 
overall business model for diagnostics results in multiple dominant closed diagnostics systems (since 
each major diagnostics company develops both the device and the consumable parts – for example 
the reagent kits or reagent -loaded integrated cartridges – specifically tailored to that device), making 
competition extremely difficult. The high cost and burden of switching between systems results in a 
"locked -in" effect for end users since the y have no choice but to buy both the device and the assays 
from the same company ".  
45.  Testing is a crucial aspect of containing the spread of COVID -19 especially in the absence of 
effective therapeutics and vaccines, and some countries are now moving to a mo del of mass testing 
of the entire population, either at once or on a regular basis, as a route out of the pandemic.  
46.  And yet, the disparity in testing between developed countr y Members  and other countries is 
vast. As of 11th November, reported tests for ev eryone million population, was approximately 
342000 in developed countries, 81000 in developing countries and 9700 in LDCs. In other words, 
high income countries are testing its population at nearly 35 times the rate of the world 's poorest 
countries.  When new tests come onto the market, only a few countries rapidly purchase all of the 
existing supply or put forward large sums of capital to claim all supply. More supply is needed, and 
such supply requires multiple manufacturers unhindered by any barriers to production. Intellectual 
property has proven to be a barrier in the scaling up of testing for COVID -19. Existing manufacturers 
are unable to keep up the needed global supply, hence negatively impacting a country 's ability to 
screen samples for COVID -19 – an essential part of controlling the pandemic.  
Vaccines  
47.  45 vaccine candidates are in human trial, while about ten are in or entering phase III trials. The 
candidate vaccines are of various types – virus vaccines using live attenuated virus, viral vector 
vaccines, protein - based vaccines, and nucleic acid or RNA and DNA vaccines, which are completely 
new platforms.  
48.  The effects of patents in hindering the introduction of affordable vaccines in developing 
countries have been published by MSF.  While the focus is on pneumococcal conjugate vaccines (PCV) 
and the human papillomavirus (HPV) vaccine, the paper reveals the expansive patent claims applied 
for or granted across the entire spectrum of vaccine development, production and use including on IP/C/W/672  
 
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  vaccine -production materials such as chemical reagents, host cells, vectors, and DNA/RNA 
sequences; vaccine compositions; process technologies; vaccination age groups; methods of using 
vaccines; and vaccine schedules and presentations. These patents increa sed uncertainty, costs, 
delayed competition, leading to high prices in developing countries and hindering access. In 
2016-2017, MSF filed a patent opposition and later a writ petition to challenge Pfizer 's vaccine 
composition patent that blocked developmen t of alternative versions of Pfizer 's PCV13 vaccine. 
Equivalent patent granted in South Korea, compelled a Korean vaccine developer to close their 
production of PCV13. The patent invalidation proceeding launched by MSF towards Pfizer remains 
open in India concerning PCV13.  
49.  A similar situation will materialise with COVID -19 vaccines unless concrete steps are taken to 
address the intellectual property barriers. Research already discloses many patent filings and grants 
such as more than 100 patents on mRNA pl atform technologies that are used for COVID -19 vaccines.   
Other Medical Products  
50.  In March 2020 in the Lombardy region in Northern Italy, one of the areas which was hit hardest 
by the pandemic an Italian hospital ran out of ventilator valves (which cost USD 11,000 each), and 
their regular supplier could not produce them on time.  Two local engineers reverse engineered and 
3D printed replacement valves for the cost of about USD 1. It is reported that the original 
manufacturer declined to share the blueprints a nd even threatened patent infringement and that 
potential legal implications stopped the engineers from distributing the digital design file more 
widely, despite receiving hundreds of requests for the 3D -printed valves ".  
51.  Following this case, a law firm warned "[m]anufacturers should be aware of the complex 
intellectual property issues concerned with this 3D printing technology. Parts such as valves or other 
medical devices and equipment are capable of protection by patent and/or registered design. 
Unregistered design rights and copyright will also apply to the part itself and/or the digital model or 
CAD file. Some or all of these rights might apply in respect of a single component ". The firm 
cautioned "In scanning a compone nt such as a valve, and manufacturing a part using 3D printing 
equipment, there is a risk that this action will infringe an existing patent, design or copyright which 
protects the component, leading to an injunction or claim from the rights holder for dama ges or 
other remedies (such as delivery up of infringing parts) ". Notably in In March 2020, WHO noted a 
shortage of ventilators around the world.  
52.  In another case, the Governor of Kentucky has called on multinational company 3M to release 
its patent for th e N95 respirator — a desperately needed type of protective gear that 's difficult to 
get during the coronavirus pandemic — so that more manufacturers can start making it.  The N95 is 
considered top -of-the-line face protection for the professionals on the fro nt lines of this pandemic. 
The Governor is reported as saying "The procurement is incredibly difficult, as is the manufacture 
because it 's under patent. I 'd like to see the people with that patent, which is 3M, provide that to 
the nation under a license fo r this period of time, " adding that "I believe it 's their patriotic duty, and 
they should put it out there so everybody else can manufacture it, " he said of 3M. "That hasn 't 
happened. " 
Intellectual Property Disputes  
53.  Emerging intellectual property disputes already threaten the development and supply of 
COVID -19 medical products.  In one dispute Regeneron and vaccine developers Pfizer and BioNTech 
are facing a lawsuit from Allele Biotechnology and Pharmaceuticals alleging that their coronavirus 
produc ts were developed using Allele 's mNeonGreen fluorescent protein without the company 's 
permission.   
2.6  Considerations, in connection to EU 's emphasis on the TRIPS flexibilities.  
54.  We welcome EU 's emphasis on the TRIPS flexibilities. However, in the E. Commission  Report on 
the protection and enforcement of intellectual property rights in third countries of 2020, developing 
countries are criticized for improving the criteria for granting compulsory licenses on the basis it 
undermines  "effective patent protection " although the 2001 Doha Declaration on TRIPS and Public 
Health states in paragraph 5(b) that "Each Member has the right to grant compulsory licenses and 
the freedom to determine the grounds upon which such licenses are granted ". For instance it states IP/C/W/672  
 
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  "stake holders report that very broad, vague and arbitrary criteria are applied for granting 
compulsory licenses, which undermine the effective patent protection in Ecuador, India, Indonesia 
and Turkey, notably for pharmaceuticals and chemicals " and in relation t o India criticizes its use of 
TRIPS flexibilities including compulsory license.  
2.7  United States of America : How do proponents envision that Members  would return to 
compliance with their TRIPS  obligations after the waiver expires?  
2.8  United States of America : What effect do the proponents think that the waiver will 
have on innovation related to products that address the prevention containment and 
treatment of COVID -19? What would be the long -term  implications for innovators 
willingness to participate in future pandemic response efforts?  
55.  Some Members have queried what would happen when the waiver ends and what would be the 
impact on future innovations. After the waiver ends, WTO Members  will revert  to the application of 
the relevant TRIPS provisions.   
56.  With respect to the impact of the waiver on innovations and innovators ' willingness to participate 
in future pandemic response efforts, we reiterate that most of the R&D is driven by public 
investments . In addition, should we not be more concerned about how our failure to take prompt 
action will prolong this pandemic and consequently the suffering of people all over the world? 
Moreover, in a global pandemic, innovation must be open and accessible to the  global community, 
and not be the monopoly of one or a few companies or countries.  
2.9  United States of America : If the waiver were to be implemented, how long do the 
proponents think it will take for there to be an impact in the prevention containment or 
treatment of COVID ? What data are proponents relying on to reach this conclusion?  
57.  The proponents have also been asked, if the waiver were granted, how long it will take for there 
to be an impact on the prevention, containment or treatment of COVID -19, and wha t data has been 
relied on to reach such a conclusion.  
58.  The impact of the waiver will depend on many factors. Presently there are many unknowns, as 
we are dealing with a completely novel pathogen. The science of COVID -19 is constantly evolving, 
and we are l earning new things about this virus on a daily basis. Even with the therapeutics and 
vaccines that are showing promise, there are many unknowns including their immediate and 
long-term impact. We also do not know how long the vaccines will remain effective,  how much 
immunity will be conferred, and how logistical issues will be overcome, among others. We see many 
measures being taken in the absence of any concrete data. Even the approvals of the current 
vaccines are based on interim data.  
59.  Hence the impact de pends on a variety of factors such as the kind of technology that is involved, 
and information available about the technology. What is clear however is that if WTO Members 
decide to work together to share knowledge, technology and related IP with the aim t o diversify and 
expand supply options, the journey to the end of the pandemic will be faster as we do know that 
removing IP monopoly and improving freedom to operate for manufacturers can introduce 
competition, expand supply and reduce prices. This is the experience we have had in handling the 
HIV/AIDS epidemic.  
60.  I hope that these responses provide more clarity to some of the specific questions posed by the 
Members.  
61.  If there is anything that COVID -19 has taught us, it is that the only way to urgently conta in this 
threat to humanity is for the world to come together in new ways to defeat it. COVID -19 is a test of 
our global solidarity, and we can pass this test only if we work together for the sake of humanity. 
The co -sponsors, once again, call upon the WTO Members to rise to the collective call of defeating 
the pandemic and saving lives by supporting this proposal for temporary waiver. This will help in 
truly achieving equitable, timely and affordable access for COVID -19 products by removing the IP 
barriers to scale up the global production and supply.  IP/C/W/672  
 
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  2.10  United States of America : What are the expected impacts on Members ' commercial 
and economic interests as a result of the waiver? (Japan & the European Union also claim 
there would be a negative impact on investment and cooperation on future R&D) . 
2.11  United States of America : Could the proponents explain how the waiver is a 
proportionate response to COVID -19?  
2.12  Brazil: What are the expected impacts on authors, inventors and other creators?  
2.13  Brazil: We would like  to ask the proponents to share their views on possible effects 
of a waiver on small and medium enterprises.  
62.  Several questions were posed to the proponents as to how the waiver will affect WTO Members ' 
commercial and economic interests as well as its impac t on authors, inventors and other creators 
and SMEs.  
63.  COVID has wreaked havoc on national and global economies. As per WTO data, global trade is 
expected to drop by about 9% in 2020.3 While trade is expected to rebound in 2021, there is a lot 
of uncertain ty as it depends on the evolution of the pandemic.4  
64.  The COVID -19 pandemic has hit hardest the informal economy and hundreds of millions of 
enterprises worldwide. As per the ILO estimates global labour income has declined nearly 11% or 
USD 3.5 trillion in  the first three quarters of 2020 and as a result, the World Bank estimates that as 
many as 150 million people could be pushed into extreme poverty by 2021.5 
65.  MSMEs are particularly exposed to COVID -19 pandemic 's economic impact because of their size 
and their prevalence in the economic sectors most affected by the pandemic, such as accommodation 
and food services, cultural and creative sectors, and wholesale and retail services. MSMEs in almost 
all countries have been and continued to be most severely  hit by the pandemic. In developing 
countries, as per the World Bank estimates, sales fell for about 84% of firms relative to the same 
period in 2019. The average decline was 49% and has been strikingly persistent.6  
66.  Even in the pharma sector, many MSMEs have manufacturing capacity but hindered by IP 
barriers they are not able to manufacture and supply COVID -19 medical products.  
67.  With regards to the question on expected impacts on authors, inventors and other creators , it 
depends on what the creation or invention is  being talked about. If it is not related to COVID -19, 
then they will not be anyway impacted by this waiver, as the copyright being waived under the 
proposal is only in the context of rights hindering the response to COVID -19.  
68.  Evidently the longer the pandemic continues, with governments having to continue with 
measures such as lockdowns and quarantine, national and global economies will continue to suffer, 
with many more millions pushed into poverty. Every country is trying to redu ce the impact of 
pandemic and come out of it. Our proposal for waiver from certain provisions of TRIPS Agreement, 
is one part of this effort. It is, therefore, in our mutual interest to collaborate, to help diversify and 
expand the supply of vaccines, ther apeutics and other COVID -19 health products to curb this 
pandemic as soon as possible.  
69.  Some of the opponents of the waiver proposal may consider that they will be safe, since they 
have large quantities of vaccines pre -booked. But, if COVID  remains unaddre ssed in any one country, 
it will affect all other countries, with serious consequences for society and the economy.  
70.  Some Members have argued that recent announcements from industry of the success of some 
vaccines, showed that the intellectual property sys tem as a framework that provides incentives to 
invest and innovate has delivered. We disagree with this claim. We believe that without the huge 
 
3 https://www.wto.org/english/news_e/pres20_e/pr862_e.htm  
4 https://www.wto.org/english/news_e/pres20_e/pr862_e.htm  
5 https://blogs.worldbank.org/psd/firms -struggle -stay-afloat -after-losing -half-sales-still-keep-workers  
6 https://blogs.worldbank.org/psd/firms -struggle -stay-afloat -after-losing -half-sales-still-keep-workers  IP/C/W/672  
 
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  state funding, these vaccines would probably not have been developed so speedily. Therefore, it is 
not the IP sy stem that has delivered, but the public funding and institutional support in terms of 
research contributions by public universities and the global sharing of sequence and public health 
information that has led to the development of successful vaccines in r ecord time.  
71.  We need to respond to COVID  with cooperation, solidarity, and equity. The aim of the waiver is 
to restrain the spread of COVID -19, and in the context of the current scale of devastation, the impact 
of the waiver would be positive. The current "business as usual " approach which is narrowly focused 
on supplying a few rich countries artificially limiting global supplies and competition is a greater 
threat to WTO Members ' social, economic and commercial interests.   
72.  The proponents have been asked ho w the waiver is a proportionate response to COVID -19. 
Every country has been taking extraordinary and unprecedented measures, unheard of before. This 
includes requiring weeks and months of lockdowns, imposing quarantine, nationalising private 
hospitals7, mandating wearing of masks, seeking military help etc. So, waiver is definitely a 
proportionate demand.  
73.  If we work together to waive relevant IP and enable access to knowledge and technology, we 
will swiftly bring the pandemic under control and save the w orld economy from further avoidable 
damage.  
2.14  Brazil: How Members  facing legal and institutional difficulties when using 
flexibilities would automatically and expeditiously overcome legislative and institutional 
barriers for the successful implementation of  a waiver?  
2.15  Whether a waiver could reveal instead to be cumbersome and difficult to implement 
considering that most Members  would have to submit it to their national parliaments and 
delve into the specific rights in each of the IP domains that would fall in to the scope of 
the measure.  
2.16  Brazil: A waiver would hardly be a global solution if we consider that several 
Members  may not implement it either because they choose not to or are unable to due to 
the already mentioned legislative and institutional difficul ties or because they are also 
bound by bilateral or regional agreements.  
2.17  United Kingdom (UK) : How would such a waiver even operate;  how would it be 
implemented into national legislation?  
74.  Proponents have been asked how the waiver can be a global solution if  some countries do not 
implement it. If a waiver is adopted, all WTO Members  would be encouraged to utilise it. The proposal 
we have made follows what is allowed within the parameters of Art icle IX of the WTO  Agreement.  
75.  As to national implementation, we have addressed this issue at the last informal TRIPS Council. 
National implementation of the waiver depends on a country 's political and/or constitutional 
arrangement. There is no one size fits all approach to national imp lementation. However, once the 
waiver proposal is approved, emergency, disaster management legislations or any other relevant 
legislative methodology may be relied upon to provide for executive action to operationalise the 
waiver at the national level. Man y governments are already using executive action to put in place 
lockdowns, quarantine and other measures to curb the spread.  
76.  With respect to institutional and legal difficulties when using flexibilities, this is a real challenge 
facing many countries. Fo r instance, countries that have never utilised compulsory license or the 
Article 31bis mechanism will have to consider what are the national procedures for doing so, what 
to do if procedures do not exists, who should request this license, who should issue the license, what 
would be the adequate remuneration to be paid, what are the requirements of Art icle 31bis, can an 
importing country that has not implemented Art icle 31bis in its national law utilise the provision, 
 
7 https://publicservices.international/resources/news/spain -nationalises -all-private -hospitals -uk-rents-
hospital -beds?id=10645&lang=en  
 IP/C/W/672  
 
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  what are the Art icle 31bis requirements for the exporting country, what are the national law 
requirements in the exporting country. Many a times, countries also have to deal with pressures 
from other countries and from pharmaceutical companies while dealing with such issues. Moreover, 
compulsory  licenses are to be issued on product by product and country by country basis, making 
collaboration between countries near impossible. Given the urgency to save lives and the time it 
takes to get a compulsory license implemented on ground in most of develo ping countries, use of 
this flexibility in context of COVID -19 pandemic does not present an expedited solution. In any case, 
it cannot be any body 's case that such flexibilities were even designed keeping in view a crisis of 
this magnitude.  
77.  All of this ca n be avoided and millions of lives can be saved, if Members here agree to a 
temporary waiver from certain provisions, which can then be made use of by Member countries 
using emergency legislative provisions at their disposal to address the challenges posed  by once in 
a millennium pandemic like COVID.  
2.18  United States of America : How do proponents plan to suspend rights that exist 
without formal government registration such as copyrights?  
78.  We have been asked repeatedly about how the waiver will be implemented including how 
proponents plan to suspend rights that exist without formal government registration such as 
copyrights.  
79.  As we have mentioned, national implementation should be left to na tional governments as each 
operates within its own legal system. One size does not fit all. We also think that in many cases 
implementation may be done through executive action, relying on existing national legislation or 
through use of emergency legislati ve provisions.  
80.  More specifically, if a IP right exists such as a patent has been granted or a person is entitled 
to copyright protection (with or without registration) which is related to prevention, containment 
and treatment of COVID -19, a country may ta ke executive action suspending enforcement of the 
protection conferred by the patent or copyright law to it for the duration of the waiver.  
81.  To the countries who have argued against the need of the Waiver, we would like to pose the 
following questions:  
1. Do the opponents have any data regarding how the waiver would demonstrably have 
negative impact on Members ' economies, if any?  
2. Public funding has been driving COVID -R&D. In addition, billions of dollars are spent on 
purchasing the vaccine. Given the demand vo lumes, pharma companies will anyway make 
profits. So why is there a need for IP as an incentive, in a global pandemic situation?  
3. Can the opponents provide data as to how voluntary licensing approaches and existing global 
cooperation mechanisms, including ACT Accelerator, the COVAX  facility and COVAX  AMC, 
would be sufficient to address the vaccine requirements of 7.8 billion people i n the world?  
4. If voluntary mechanisms work, why has the pharmaceutical industry collectively rejected 
participation in the World Health Organization (WHO)  COVID -19 Technology Access Pool 
(C-TAP), an initiative that encourages voluntary contribution of IP, t echnology and data to 
support global sharing and scale -up of manufacturing and supply of COVID - 19 medical and 
pharmaceutical products?  
 
82.  We hope that our intervention addresses the concerns raised by Members. Moreover, the 
proponents are ready to engage wi th the Members, should there be any further questions. But the 
objective, as stated earlier, is to reach to a common ground as early as possible, so that a large 
proportion of world population is not left behind in the quest for a timely, equitable and aff ordable 
access to successful vaccines and therapeutics. WTO Membership needs to act now to ensure that 
the pandemic should not be  needlessly prolonged, only because we fail to act collectively at this 
juncture.  IP/C/W/672  
 
- 14 - 
 
  2.19  United States of America : Could the proponent s provide data that establishes that 
the identified TRIPS  obligations have systematically hindered or blocked the prevention, 
containment or treatment of COVID -19?  
2.20  United States of America : No explanation why compliance with each of the identified 
TRIPS obligation creates an identifiable and undue hardship such that waiver is 
necessary . 
2.21  Brazil: Further elaborate the rationale for including industrial designs in the 
proposal.  
2.22  Brazil: Further specify the cases in which waiver in copyright could be pertinent for 
preventing containing or treating COVID -19. 
83.  Several questions were posed as to why the scope of the waiver extends to patents, trade 
secrets, copyright and industrial des igns and what is the evidence that waiver of these aspects are 
important to contain, prevent and treat COVID -19.  
84.  In formulating the proposal, the starting point was to consider what products are needed to 
curb COVID -19 and what are the barriers to diversi fying suppliers and scaling up manufacturing. 
Several key medical products crucial for curbing COVID -19 include ventilators, N95 masks and other 
personal protective equipment, diagnostics, therapeutics and vaccines. Global shortages of these 
medical produc ts have been widely reported. Shortages are also expected as vaccines are rolled out. 
Due to the limited voluntary license issued by Gilead, the world also witnessed shortages of 
remdesivir a therapeutic once thought to hasten recovery. As new therapeutics  are approved, 
shortages are further expected. For instance, antibody treatments by Regeneron and Eli Lilly have 
recently been approved by the US Food and Drug Authority for COVID -19 treatment, shortages are 
already expected in the US8, while how the rest  of the world will get sufficient access to these 
treatments remains unclear.  
85.  Disparity in access is the ugly reality of this pandemic that we cannot and must not ignore. The 
challenges of access are visible in developed countr y Members , but disproportion ately affects le ast 
developed countries. We have provided concrete evidence of the staggering inequality in access to 
essential products between developed countries and le ast developed countries.   
86.  According to UNCTAD, "since the onset of the pandemic, each  resident of high -income countries 
has benefited, on average, from an additional US D 10 per month of imports of COVID -19-related 
products. This number is much lower for middle income countries - at about US D 1, and lower still 
for low -income countries – a mere US D 0.10. In other words, per capita imports of the medical 
goods essential to mitigate the COVID -19 pandemic have been about 100 times larger in high income 
countries in comparison to low -income countries. While it should be expected that the increase  of 
per capita imports of COVID -19 products would be larger for wealthier countries, the sheer difference 
is staggering. "9 
87.  A solution to this challenge is to diversify and increase production and supply. This requires 
addressing the legal barrier of IP th at prevents diversification and production. Not all categories of 
IP are implicated. To prevent, contain, and treat COVID -19, and more specifically for the medical 
technologies required, the relevant categories of IP are patents, trade secrets, industrial designs and 
copyright.  
88.  Several delegations have queried why the proposal includes industrial designs and copyright 
within the scope of the waiver.  
 
8 https://uk.reuters.com/article/us -health -coronavirus -lilly/u -s-hospitals -to-restrict -lilly-covid-19-
antibody -treatment -due-to-limited -supply -idUKKBN27X1EU ; https://www.bostonherald.com/2020/11/22/fda -
allows -emergency -use-of-antibody -drug-trump -received/  
9 https://unctad.org/system/files/official -document/ditcinf2020d4_en.pdf  
 IP/C/W/672  
 
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  89.  We would like to clarify. As mentioned, the starting point of the proposal is what tools are 
important to c urb COVID -19. This question is what led us to investigate which categories of IP would 
be relevant? Industrial design and copyright protection can become barriers to reproduction of the 
products. We have highlighted the case in Italy where two local engine ers 3D printed ventilator 
valves to supply a local hospital as the regular supplier could not supply the valves, and faced IP 
barriers.   
90.  Following the case a legal firm cautioned "In scanning a component such as a valve, and 
manufacturing a part using 3D p rinting equipment, there is a risk that this action will infringe an 
existing patent, design or copyright which protects the component, leading to an injunction or claim 
from the rights holder for damages or other remedies (such as delivery up of infringin g parts) ".10 
91.  For medical products such as ventilators, personal protective equipment and other technologies 
that may be relevant to curbing the spread of COVID -19, copyright and/or industrial design can be 
a barrier, in addition to patents and trade secrets.  
92.  At the la st informal TRIPS Council meeting, the co -sponsors provided examples of IP barriers 
hindering development, production and supply of COVID -19 products.  
93.  The TRIPS Agreement sets minimum standards for patents, trade secrets, copyright and 
industrial design, that WTO Members except for LDCs have to comply with or be subject to WTO 's 
dispute settlement mechanism. And these standards do limit the policy space available for countries 
to take the measures necessary to collaborate, manufacture and supply addressing  the shortages 
mentioned. Where flexibility exists, in some cases there is also uncertainty as to its scope, while in 
other cases, the use of flexibility is subject to conditions and procedures. As mentioned before, since 
the entry into force of the TRIPS Agreement, developing countries have faced constant pressures 
from their trading partners to limit the use of flexibilities, often criticising actions that may be taken 
to simplify the use of flexibilities.  
2.23  United States of America : How the waiver would d irectly resolve issues related to 
COVID -19 prevention, containment or treatment in a Member . 
2.24  United States of America : Do the proponents have any data that would show how a 
waiver would demonstrable reduce COVID -19 prevalence or impact during the acute 
phase of the pandemic. We note that new pharmaceutical manufacturing capacity 
typically cannot be established quickly.  
2.25  United States of America : If the waiver were to be implemented how long do the 
proponents think it will take for there to be an impact in the prevention containment or 
treatment of COVID ? What data are proponents relying on to reach this conclusion?  
2.26  United Kingdom : How would this  help countries like in manufacturing capacities and 
even if limited in time the waiver creates long -term uncertainty and undermines the 
system for the future including future pandemics.  
94.  Several questions were posed as to how the waiver would resolve issue s related to COVID -19 
prevention, containment and treatment and what is the evidence?  
95.  It is important to note that neither the waiver alone nor any other mechanisms or policy 
intervention on its own, can resolve all challenges we face. Different legal and policy measures are 
needed to respond to different problems. The waiver by offering policy space can help leverage the 
full capacity globally for production and supply. We have clearly demonstrated the limitations of 
voluntary measures by companies. Some c ompanies only choose to work with one or two other 
multinational corporation despite manufacturing capacity being available in different countries. With 
such an approach of course there will still be severe supply shortages.    
 
10 https://www.shoosmiths.co.uk/insights/articles/3d -printing -social -responsibility -vs-legal-risks  
 IP/C/W/672  
 
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  96.  Some delegates may argue that  in those circumstances, compulsory license can be used, 
including Art31 bis license. However, as we articulated earlier, TRIPS rules today do not facilitate a 
collective use of compulsory license by multiple countries on all components needed to produce a 
medical product. Both Art icle 31 and Art icle 31bis licenses are territorial and used on a case -by-case 
basis raising difficulty of using them to leverage all untended capacity in different countries together. 
The waiver provides a practical alternative in the context of the pandemic so that countries can be 
better coordinated.  
97.  In addition, manufacturing capacity in this pandemic need to be discussed at the global level. 
Not all countries can produce everything by themselves and no single country can sustainably supply 
the whole world with their existing ma nufacturing capacity. The proposal on the table suggests that 
we look at a global picture of manufacturing and supply capacity and consider ways to coordinate 
and enable access to knowledge and technology. For countries that do not have manufacturing 
capac ity at all at this moment in time on certain medical technologies, the waiver could open up 
more supply options while they do not have to stick with one or two perceived solutions and avoid 
being held hostage by any individual companies.  
98.  The challenges we  face in this pandemic are novel as we are dealing with an unknown pathogen. 
We are constantly learning what works and does not work. Nationally as well governments are 
experimenting with different measures, to see what works and what does not, adapting an d 
modifying as lessons are learned and new information becomes available. Most measures have been 
put in place without demonstrable evidence as to the efficacy of the measures. For instance, early 
on in the pandemic, many experts thought face coverings wer e not effective.11 Now the guidance 
has changed, with most countries recommending or mandating the wearing of masks.   
99.  Similarly, early on in the pandemic several WTO Members such as Canada12, Germany,13 
Hungary14 took pre -emptive steps to amend their law t o simplify the procedures for issuing CL, 
should they need to use it to override the patent barrier.  Several other countries such as Chile15, 
Colombia16 and Ecuador17 have issued resolutions or decree to set the stage for the issuance of 
compulsory license s.  
 
11 https://www.independent.co.uk/life -style/health -and-families/face -masks -coverings -coronavirus -do-
they-work-shops -transport -a9617666.html  
12 Canada has passed emergency legislation entitled An Act Respecting Certain Measures in Response to 
COVID -19. Part 12 of Bill C -13 amends the Patent Act so that, among other things, upon the application of the 
Minister of Health the Commissioner must authorize the Government of Canada and any person specified in the 
application to make, construct, use and sell a  patented invention to the extent necessary to respond to a public 
health emergency that is a matter of national concern. Source: https://www.wipo.int/covid19 -policy -
tracker/#/covid19 -policy -tracker/access  
13 With the Act for the Protection of the Population in the Event of an Epidemic Situation of National 
Significance of 27 March 2020, the Federal Ministry of Health was authorized to issue orders under Section 13, 
subsection 1 of the Patent Act. Section 13 was already contained in the Patent Act before the COVID -19 
pandemic. The Section stipulates that a patent shall have no effect in a case where the Federal Government 
orders that the invention is to be used in  the interest of public welfare (Section 13, subsection 1, sentence 1). 
Source: https://www.wipo.int/covid19 -policy -tracker/#/covid19 -policy -tracker/access  
14 According to Government Decree 212/2020 (May 16, 2020), compulsory licensing is available for 
patented medicinal products, active substances and medical devices, exclusively for meeting domestic demand. 
This regulation will remain in force until the state o f danger declared by way of Government Decree 40/2020 
(March 11, 2020) is lifted. However, draft legislation is already in front of Parliament that will modify Act No. 
XXXIII of 1995 on the Protection of Inventions by Patents to allow for the continued iss uing of compulsory 
licenses for products and technologies used for pandemic relief. Source: https://www.wipo.int/covid19 -policy -
tracker/#/covid19 -policy -tracker/a ccess  
15 On March 17, the Chilean parliament approved a resolution (896/2020)  declaring that the COVID -19 
pandemic justifies the use of compu lsory licenses for COVID -19 technologies, which can facilitate the 
procedure for compulsory licenses to be issued in the country.  Unofficial English  
16 On March 25, Colombia approved a decree  allowing the Ministry of Health to declare of public interest 
all medicines, medical devices, vaccines an d other health technologies related to COVID -19. The declaration of 
public interest is a necessary step prior to the grant of a compulsory license. The decree also the flexibilization 
of the rules regarding registration and importation of health technologi es in the country.  
17 On March 20, the Committee of Education, Culture and Science and Technology of the National 
Assembly of Ecuador approved a resolution  asking the Minister of Health to issue compulsory licenses on all 
patents related to COVID -19 technologies, as well as access to test data. 17 Unofficial English . IP/C/W/672  
 
- 17 - 
 
  100.  The waiver opens up policy space for WTO Members to take steps required to initiate 
manufacturing of pharmaceutical products. It is well -proven that when IP such as patents are not a 
barrier and a country has manufacturing capacity, generic manufacturi ng can and does take place. 
We have seen this for many products even before the pandemic. Hence the freedom to operate 
offered by a waiver will prove to be invaluable in expanding supply options and capacity.  
2.27  United States of America : Waiver is broad. Unc lear what measures would fall within 
or outside the scope of the waiver. With respect to scope that the proponents explain how 
Member s would determine whether a measure is "related to the prevention containment 
or treatment of COVID -19 and this falls withi n the scope of the proposed waiver ". For 
example, if a measure waives an intellectual property right covering a given product or 
book or work with the product or work have to be directly related to the prevention 
containment or treatment of COVID -19 in order to fall within the scope of this  waiver 
proposal. Could the product or work be indirectly related, how indirectly related and who 
would make this determination.   
2.28  United States of America : How is the waiver proposal targeted considering it 
implicates the suspension of at le ast 34 provisio ns of the TRIPS Agreement?   
101.  The co -sponsors have been asked which measures would fall within the scope of the waiver 
and whether measures that are indirectly related would also be included within the scope of the 
waiver and who would make this determinatio n.  
102.  The issue is not whether a measure is directly related or indirectly related. It is a matter of 
what is needed to prevent, contain and treat COVID -19. Any measure that is not in relation to 
COVID -19 would not be covered by the scope of the Waiver. For instance, a therapeutic for cancer 
treatment would not fall within the scope of the waiver.  
103.  Each country will need to decide what is needed nationally to curb COVID -19 and the 
parameters of implementation of the waiver. The needs and conditions of each co untry varies, hence 
prescribing a one size fits all approach will not be beneficial.  We should recall that the 
WTO Agreements including the TRIPS Agreement already provides governments discretion on how 
to implement their commitments and implementation of the waiver is no different. If a country 
decides that the waiver is inappropriately implemented in another country, it may pursue its case 
under the WTO dispute settlement mechanism that would continue to be available to the 
WTO Members .  
104.  In addition, it h as been suggested by an opposing country, that the waiver proposal implicates 
suspension of at least 34 provisions of the TRIP S Agreement. We are of the view that this 
misrepresents the waiver proposal.  
105.  The waiver proposal is very specific to COVID -19, it s prevention, containment and treatment; 
and therefore, is proportionate. It does not apply to other diseases, although we are aware of severe 
access challenges in other disease areas as well. It does not apply to other sectors. We have also 
been particula r in excluding protection of Performers, Producers of Phonograms (Sound Recordings) 
and Broadcasting Organizations under Article 14 of the TRIPS Agreement, although it falls within the 
ambit of copyright, as it would not be relevant to the prevention, cont ainment and treatment of 
COVID -19. The waiver proposal does not cover all aspects of the TRIPS Agreement, for example it 
does not include GIs, trademarks, layout of integrated circuits etc.  
106.  In short, the waiver is very narrow and specific to the circumsta nce of COVID -19 and the key 
aspects of the TRIPS Agreement that can affect a country 's ability to prevent, contain and treat 
COVID -19.  
107.  I am sure we all agree that COVID -19 presents an extraordinary, unprecedented challenge for 
the world, and no one is saf e until everyone is safe, hence the call for a waiver from certain TRIPS 
obligations with respect to COVID -19.  IP/C/W/672  
 
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  2.29  Mexico, the Republic of Korea, Ecuador, and Israel : Waiver proposal is not clear 
enough as regards its scope and implementation and its possible implications. Additional 
information why current provisions are not sufficient to address concerns. ACT -A & COVAX 
exists.  
2.30  Canada remains the only Member to have  used this special compulsory licensing 
system under Article  31bis and can thus observe on the basis of concrete experience that 
this system has worked as intended. Article 31 bis only used once does not suggest that 
the system is inadequate rather Canada b elieves that this suggests that the overall TRIPS  
regime works as part of the broader international framework that provides Member s with 
sufficient latitude and flexibility such as there has been limited or no need to issue 
compulsory licenses under Articl e 31bis. 
108.  Some countries have queried why TRIPS flexibilities and COVAX  are insufficient to address the 
challenge of access posed by COVID. We have addressed this matter extensively at the previous  
TRIPS  Council. We reiterate that the targets set by Act -A including the COVAX is to provide two 
billion vaccine doses (for one billion people) to the world by the end of 2021, 245 million courses of 
treatment and 500 million diagnostic tests to LMICs (excluding many developing countries) in 2021 
are insufficient t o meet global needs of the 7.7 billion people of this world. At best, these initiatives 
offer short -term and very limited access to diagnostics, therapeutics and vaccines. The insufficiency 
of ACT -A and COVAX is apparent with the current wide disparity in access between the developed 
countries and the developing countries. For vaccines, it only aims to provide up to 20% of the needs 
of developing countries, which is insufficient to build global immunity. In addition, to date only 15% 
of the needed funding h as been raised. ACT -A and COVAX also do not extend to other tools needed 
during a pandemic such as masks, ventilators etc.  
109.  With respect to TRIPS flexibilities, as mentioned in our previous statement, these flexibilities 
have played an important role in promoting access but were never designed to address the access 
challenge of a pandemic. As explained an effective response to the COVID -19 pandemic requires 
access to various commodities and various types of intellectual property that is patents, copyrights, 
industrial designs and trade secrets may pose a barrier to the manufacturing and supply of these 
commodities.  
110.  At the infor mal TRIPS Council meeting of 20th November, the co -sponsors circulated patent 
status of several priority therapeutics for COVID -19. These therapeutics are likely to be patent 
protected in many jurisdictions. Let me explain how cumbersome the process will b e to diversify and 
scale-up manufacturing simply relying on the issuance of CLs by way of Art icle 31 and Art icle 31bis 
of the TRIPS Agreement.  
111.  Assuming country X with manufacturing capacity decides to override the patent barriers to 
expand supply. It will have to issue a compulsory license based on national procedures, a process 
that can take weeks if lucky, but perhaps even months or years, if n ational laws have additional 
requirements or if trading partners and pharmaceutical industry interfere to dissuade its use. Some 
countries have special CL procedure for government use, which can help to accelerate the process 
but not all countries have suc h a fast -track procedure.  
112.  If this country X requires to source patented ingredients from multiple jurisdictions, each of 
these jurisdictions will also need to issue a CL. Each of these CLs will be limited by the condition of 
Article 31(f) that it has to b e predominantly for the supply of the domestic market. At this juncture, 
country X with manufacturing capacity, although able to supply, is likely to be hindered due to the 
number of CLs required, and the conditions imposed. Even if country X overcomes thi s challenge 
and manufactures the product under a CL, country X will not be able to export widely to supply even 
neighbouring countries due to the limitation in Art icle 31(f) that a CL has to be predominantly for 
the supply of the domestic market. Instead, the manufacturing country X and each and every 
importing country will have to issue a CL if there is a patent and utilise the procedures of Article  31bis 
that includes among others specific notification to the WTO by importing and exporting countries 
specifying the quantities to be imported and exported. As more quantities are imported and 
exported, more notifications may be needed, in addition to other requirements such as specific 
labelling or marking of products; special packaging and/or special colourin g/shaping of products.  IP/C/W/672  
 
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  113.  It is also worth noting that whether or not a manufacturing takes place is very much dependent 
on whether economies of scale exist. Countries may have capacity to manufacture but lack 
economies of scale hence making manufacturing an  unattractive option.  
114.  The country by country, case by case approach offered by CLs hinders north -south, 
south -south, regional and international collaboration to achieve economies of scale and ramp -up 
global manufacturing and supply. The waiver will remove  the legal barriers and facilitate 
collaboration at the regional and global level, allow economies of scale to be achieved, motivating 
further manufacturing, and consequently lower prices. With a waiver, the administrative and 
procedural delays and conditi ons linked to Article 31 and 31 bis will be avoided, meaning that 
countries will have full freedom to collaborate, manufacture and supply the required products.  
115.  Canada asserts that its experience shows that the Art icle 31bis mechanism has worked as 
intende d and that it shows that the overall TRIPS  regime works and that there has been limited or 
no need to issue compulsory licenses under Article  31bis. 
116.  We believe this assessment does not reveal the depth and complexity of the access to 
medicines problem faci ng the international community including in developed countr y Members  even 
before the COVID -19 pandemic. To date the CLs issued have generally been by countries with 
manufacturing capacity for their own use or to import from countries that have manufacturi ng 
capacity but where patent was not a barrier. India for instance did not put in place pharmaceutical 
product patent protection until 2005, meaning that many pharmaceutical products were not patented 
in India, allowing other countries to import available generics for many years post 2005 without any 
concern. Several of the patent applications have also been opposed and challenged in India, and 
where this has been successful, generics have managed to enter the market after some years. These 
scenarios do not  create a conducive environment to address the challenges of this pandemic, as the 
COVID -19 products are likely to be widely patented in countries with manufacturing capacity.  
117.  For many patented medicines, generic alternatives are still not available, and the originator 
products simply unaffordable to patients. In addition, trading partners and pharmaceutical 
companies have placed immense pressure on countries with manufacturing capacity, discouraging 
the issuance of CL. Hence even before the pandemic, many  medicines that can save lives, remains 
out of reach of the patients that needed them. This reveals the limitations of the options provided 
by the TRIPS Agreement including Article 31 bis, more so in this current pandemic.  
118.  In the case of Canada 's implementation of the 30th August 2003 decision, we note that MSF 
was involved in the Jean Chr étien Pledge to Africa (JCPA) passed in May 2004, which  implements 
the August 2003 decision which is now translated into Article 31 bis. MSF notes in a paper on i ts 
experience with respect to the Act that it "contains over 19 sections and over 100 clauses and 
sub-clauses ".18 If this is indeed the case, we fail to see how such a mechanism delivers expeditious 
access.   
119.  MSF goes on to say that "Simply understanding th e legislation requires legal training or 
support. Significant financial and human resources are necessary for a government to analyse and 
use this legislation – resources which are limited in many developing and least  developed countries ". 
The MSF paper al so quotes Tanzania 's High Commissioner to Canada, His Excellency Ombeni Sefue, 
which noted "It's not that we don 't want to do it. It 's just that we haven 't because... all the 
bureaucratic, administrative, and legal requirements take a lot of time...The sys tem is too 
complicated... " 
120.  We fail to see how such a mechanism can be a reliable to deliver access in this pandemic. 
Canada can insist it works, despite evidence to the contrary, but the failure of Canada and other 
WTO Member s to take action will cost many  lives especially in the developing world.   
 
18 https://msfaccess.org/neither -expeditious -nor-solution -wto-august -30th-decision -unworkable  IP/C/W/672  
 
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  2.31  United States of America : How would the waiver of each of the identified TRIPS 
obligations be implemented by a Member ? For example, how would the waiver of 
obligations related to undisclosed information be implemented, does proponent intend to 
implement legislation that would release undisclosed information submitted for 
regulatory purposes for undisclosed information such as Trade Secrets. Will the 
proponents suspend their laws on trade secre t theft? Have the proponents considered 
whether this would result in an increase in trade secret theft?  
121.  US posed questions on trade secret, how would it be implemented, would suspension of laws 
give rise to trade secret theft  
122.  In several common law countri es, there is no dedicated  legislation for trade secret protection, 
instead trade  secrets are enforced through contract or tort law.19 Hence the issue of suspending 
trade secret protection does not arise. What is relevant in the context of facilitating acce ss to COVID 
medical products is to diversify and expand the production of medical products. In this context, a 
waiver of Article 39 of the TRIPS Agreement can be enabling.  
123.  We understand that the trade secret regime in US and EU recogni ze disclosure to adv ance 
public interest. The Re -Statement (Third) Of Unfair Competition, §40, Comment C recognized a 
limited privilege to disclose trade secrets, stating:  
Depends upon the circumstances of the particular case, including the nature of the 
information, the pur pose of the disclosure, and the means by which the actor acquired 
the information. A privilege is likely to be recognized, for example, in connection with 
the disclosure of information that is relevant to public health or safety, or to the 
commission of a crime or tort, or to other matters of substantial public concern.20 
124.  Subsequent legislations explicitly recogni zes the exception. For instance, the Economic 
Espionage Act of 1996 provides two such exceptions. Section 1833 of the Act states:  
Exceptions to p rohibitions ''this chapter does not prohibit —''(1) any otherwise lawful 
activity conducted by a governmental entity of the United States, a State, or a political 
subdivision of a State "; or 
"(2) the reporting of a suspected violation of law to any governme ntal entity of the 
United States, a State, or a political subdivision of a State, if such entity has lawful 
authority with respect to that violation " 
125.  The Defend Trade Secret Act which amends the Economic Espionage Act adds the following 
important exception s along with other exceptions:  
''(i) IMMUNITY. —An individual shall not be held criminally or civilly liable under any 
Federal or State trade secret law for the disclosure of a trade secret that — ''(A) is 
made — ''(i) in confidence to a Federal, State, or lo cal government official, either directly 
or indirectly, or to an attorney; and '' 
(ii) solely for the purpose of reporting or investigating a suspected violation of law;  
126.  Further, Court remedying anticompetitive aspects of a merger in U.S. v. Bazaarvoice , Inc, had 
an agreement not to enforce n its trade secret restrictions on current and past employees who were 
hired by the divestiture acquirer.21 
 
19 https://www.dlapiperintelligence.com/goingglobal/intellectual -property/index.html?t=trade -
secrets&s=legal -framework  
20 Peter S Mennel Et all, Intellectual Property in the New Technological Age: 2016, 
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2780190 , p.128.  
21 https://www.ftc.gov/system/files/attachments/us -submissions -oecd-2010-present -other -
international -competition -fora/ip_licensing_us -oecd.pdf  IP/C/W/672  
 
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  127.  Similarly, Article 5 of th e EU Directive on Trade Secret22 provides exceptions to trade secret 
protection:  
Member States shall ensure that an application for the measures, procedures and 
remedies provided for in this Directive is dismissed where the alleged acquisition, use 
or dis closure of the trade secret was carried out in any of the following cases:  
a. for exercising the right to freedom of expression and information as set out in the 
Charter, including respect for the freedom and pluralism of the media;  
b. for revealing miscon duct, wrongdoing or illegal activity, provided that the 
respondent acted for the purpose of protecting the general public interest;  
c. disclosure by workers to their representatives as part of the legitimate exercise 
by those representatives of their funct ions in accordance with Union or national law, 
provided that such disclosure was necessary for that exercise; and  
d. for the purpose of protecting a legitimate interest recognized by Union or national 
law. 
128.  This clearly shows that disclosure to public autho rities or disclosure to advance a public policy 
goal is well permitted under the laws of the US and EU. However, in many countries including the 
US the scope of public policy exception is determined by the court taking into account the facts and 
circumstan ces. This is time consuming and can delay the required result in pandemic time. In the 
present circumstances the waiver will bring the legal clarity with regard to the scope of exception to 
trade secret.  
129.  We would also quote an Associate Professor of Law David Levine from the US who has said 
"not all secrets deserve unwavering protection, and not all alleged "trade secrets " are actual trade 
secrets. As difficult, time -consuming, and expensive as it may be, because information may not 
qualify as a trade secr et upon closer inspection and because public needs may need to trump private, 
profit -maximizing interests, we should always question, interrogate, and weigh any designations of 
untrammeled trade secret protection over valuable information. If it turns out that an alleged "trade 
secret " is actually a trade secret, then a harder question must be asked: Should the trade secret be 
shared anyway? In the COVID context, certain trade secrets might serve society more thoroughly 
through wider access, allowing full t echnology transfer that would foster rapid expansion of needed 
manufacturing capacity and reduced pricing ".23  
2.32  Which measures would fall within the scope of the waiver and whether measures 
that are indirectly related would also be included within the scope of the waiver and who 
would make this determination.  
130.  We clarified that the issue is not whether a measure is directly related or indirectly related. It 
is a matter of what is needed to prevent, contain and treat COVID -19. Any measure that is not in 
relation to COVID -19 would not be covered by the scope of the Waiver. For instance, a therapeutic 
for cancer treatme nt would not fall within the scope of the waiver. The waiver proposal is very 
specific to COVID -19, its prevention, containment and treatment; and therefore, is proportionate. It 
does not apply to other diseases, although we are aware of severe access chal lenges in other disease 
areas as well. It does not apply to other sectors. We have also been particular in excluding protection 
of Performers, Producers of Phonograms (Sound Recordings) and Broadcasting Organizations under 
Article 14 of the TRIPS Agreement , although it falls within the ambit of copyright, as it would not be 
relevant to the prevention, containment and treatment of COVID -19. The waiver proposal does not 
cover all aspects of the TRIPS Agreement, for example it does not include GIs, trademarks,  layout 
of integrated circuits etc.  
 
22 https://eur -lex.europa.eu/legal -content/EN/TXT/PDF/?uri=CELEX:32016L0943&from=EN  
23 http://infojustice.org/archives/42493  
 IP/C/W/672  
 
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  2.33  Further clarification about safety, quality counterfeit medicines . 
131.  The Waiver request does not extend to trademark and "counterfeit trademark good " as defined 
in Article 51, footnote 14 of the TRIPS Agreement. And hence  TRIPS provisions in relation to these 
continue to be applicable.  
132.  The grant of IP or being an IP holder does not provide any assurance that the protected subject 
matter is of a particular quality, efficacy of safety standard. Even originator products of m ultinational 
pharmaceutical companies have been recalled in the past for failing quality standards, therefore 
regulatory oversight is required. This shows that the grant of IP has nothing to do with quality.  
133.  All medical products marketed in a country has to obtain marketing authorisation from the 
national medicine regulatory agency which provides authorisation after proper quality checks. The 
issue of quality of a diagnostic, therapeutic or vaccine is determined by the national medicine 
regulatory authorit ies and not the IP system. At the international level, WHO has a Member 
mechanism that also looks at substandard and falsified medical products.  
134.  We urge WTO Members  not to confuse and conflate issues of quality of a product with issues 
of intellectual pro perty of medical products. These are separate issues. In the past such conflation 
has led to seizure of quality generic medicines by the custom authorities such as at European ports, 
hindering inter alia  international aid programmes and public health.  
2.34  Some  Members  have queried why TRIPS flexibilities and COVAX  are insufficient to 
address the challenge of access posed by COVID.  
135.  We have addressed this matter extensively at the last TRIPS Council. We reiterate that the 
targets set by Act -A including the COVAX  is to provide two billion vaccine doses (for one billion 
people) to the world by the end of 2021, 245 million courses of treatment and 500 million diagnostic 
tests to LMICs (excluding many developing countries) in 2021 are insufficient to meet global need s 
of the 7.7 billion people of this world. As we seen vaccine rollouts in the developed world, we cannot 
but continue to wonder when equitable and timely access will become a reality, with more than 90% 
of all future production of likely vaccine candidates  being reserved for rich developed countries.  
136.  With respect to TRIPS flexibilities, as mentioned in our previous statement, these flexibilities 
have played an important role in promoting access but were never designed to address the access 
challenge of a pa ndemic.  
2.35  Some delegations (Brazil, the European Union , and Switzerland ) have referred to  
document  IP/C/W/670 and asserted at the 3 December informal meeting that the mere 
existence of patent or patent applications does not amount to a barrier. The 
European  Union mentioned that it would be interested to know more about these 
medicines.  
137.  Document IP/C/W/670 presents a preliminary non -exhaustive snapshot of the patent filing 
and granting status on five selected therapeutics candidates that are under review by the WHO 
Access to COVID -19 Tools Accelerator (ACT -A) therapeutics pillar. Due to the interv al between the 
time of patent filing and publication, which can take up to 18 months, new patent applications that 
might have been filed this year may emerge in the coming months.  
138.  The first table shows a patent for Regeneron 's new monoclonal antibody REGN1 0993 + 
REGN10987 granted in the US in June 2020, and which expires only in 2040. Information on patent 
applications filed globally should emerge in several months. The access strategy of Regeneron on 
this therapy remains unknown.  
139.  Document IP/C/W/670 also r eveals high levels of patent filing and granting on other COVID -19 
candidates. Merck 's Molnupiravir (MK -4482) has primary patent applications filed in at least 28 
jurisdictions, including two regional patent offices, expiring between 2035 and 2038. Atea 
pharmaceutical 's AT-527 has primary and secondary patents filed or granted in nearly 60 
jurisdictions, expiring between 2036 and 2038. Incety Corp 's baricitinib has primary and secondary 
patents filed or granted in nearly 50 jurisdictions, expiring in 2029. Roche 's monoclonal antibody IP/C/W/672  
 
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  therapy tocilizumab has primary and secondary patents filed or granted in nearly 30 jurisdictions, 
expiring between 2022 and 2028.  
140.  Document IP/C/W/670 also presents the patent landscape for Pfizer/BioNTech and Moderna 
vaccines.  
141.  Patents confers its holder exclusive rights. With this monopoly the patent holder is able to 
prevent other competent manufacturers from producing and supplying the patented subject matter, 
as well as to charge exorbitant prices for the patented medicines,  hence hindering the timely access 
to affordable treatment.  
142.  The patent landscape in  document  IP/C/W/670 is a warning shot of the existing and emerging 
patent barriers to access and the need for the international community to take urgent action to 
overcome  these barriers so that supply may be diversified and scaled -up. Access to this type of 
information is critical to ensure further transparency and accountability. Up the hill at 
World  Intellectual Property Organization (WIPO) , we hear that the United State s of America, has 
objected to the update of WIPO 's review of existing research on patents and access to medical 
products and health technologies to extend the publication period of studies up to 2020. In light of 
the destruction wrought by the COVID -19 pan demic, one wonders what the United States concerns 
would be regarding an updated report by the WIPO Secretariat.  
2.36  The European Union  has queried what would the domestic implementation of the 
waiver entail and why would it be easier to carry out than introdu cing fast -track 
procedures for compulsory licensing on the basis of the existing system?  
143.  Under the TRIPS Agreement, the flexibilities available are simply insufficient to address the 
global access challenges that we are facing. In the informal sessions, we  have elaborated on this 
point. With respect to fast -track procedure, under Art icle 31 of TRIPS Agreement, there is the option 
to issue compulsory license on grounds of national emergency or other circumstance of extreme 
urgency without engaging in prior negotiations with the patent holder. However in practice, its use 
is dependent on re quirements contained in national laws and regulations. Importantly this 
compulsory license is limited by the condition of Art icle 31(f) that it has to be predominantly for the 
supply of the domestic market, meaning only very limited export is allowed.  
144.  To export, the requirements of Art icle 31bis have to be followed, and this includes issuing 
compulsory licenses in importing and exporting countries, and compliance with other procedures.  
145.  The importing country will in its notification to the Council for TRIP S: 
i. specify the names and expected quantities of the product(s) needed ;  
ii. confirm that the eligible importing Member in question, other than a least developed 
countr ies, has established that it has insufficient or no manufacturing capacities in the 
pharmaceu tical sector for the product(s) in question in one of the ways set out in the 
Appendix to the Annex of the TRIPS Agreement; and  
iii. confirm that, where a pharmaceutical product is patented in its territory, it has granted 
or intends to grant a compulsory licen ce in accordance with Articles 31 and 31 bis of this 
Agreement and the provisions of the Annex to the TRIPS Agreement.  
146.  The exporting Member shall notify the Council for TRIPS of the grant of the licence, including 
the conditions attached to it. The informa tion provided shall include the name and address of the 
licensee, the product(s) for which the licence has been granted, the quantity(ies) for which it has 
been granted, the country(ies) to which the product(s) is (are) to be supplied and the duration of 
the licence. The notification shall also indicate the address of the website whereby before the 
shipment, the licensee is required to post information about the quantities being supplied to each 
destination and the distinguishing features of the product(s).   IP/C/W/672  
 
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  147.  Products produced under the licence have to be clearly identified as being produced under the 
system through specific labelling or marking and suppliers should distinguish such products through 
special packaging and/or special colouring/shaping of the pr oducts themselves.  
148.  These are just some requirements of Art icle 31bis. National laws may include other 
requirements.  
149.  These conditions cannot be referred to as a fast -track process. In fact the process of issuing 
CLs will have to be repeated again as more effective medical technologies enter the market. They 
are also not conducive to achieving economies of scale, which are crucial to motivate large scale 
manufacturing and lower prices of medical products. The current circumstances are especially 
problematic  for countries with insufficient manufacturing capacity.   
150.  Also worth recalling that Art icle 31 and 31 bis only addresses patent barriers while there are 
also challenges with respect to protection of undisclosed information, a barrier which remains 
unaddress ed. On this , especially Art icle 39.3, the European Union , US and other developed countr y 
Members  constantly criticise other WTO Members  especially developing countries for using flexibility 
allowed by the provision to promote public health. Given this kind  of action undermines the ability 
of governments to respond to a pandemic, a waiver is justified for it would provide all governments 
legal certainty.  
151.  Further if the waiver is adopted, it is a one -time implementation, and may be achieved through 
executive action. It swiftly addresses all relevant IP barriers. And with its implementation, legal 
barriers to collaboration, development, production and supply are lifted . A waiver provides legal 
certainty as to freedom to operate, economies of scale can easily be  achieved and with supply 
expanded, substantial price reduction may be expected, leading to timely affordable access.   
152.  Strangely, developed countr y Members  are placing emphasis on use of TRIPS flexibilities, but 
why is pressure been applied on developing countries for implementing public health safeguards in 
their intellectual property laws and policies, through European Union 's annual IP enforcement report 
and US ' annual "Special 301 Report ", released in the midst of a raging COVID -19 pandemic.  
2.37  Some delegates (e.g., US) asked for data regarding how certain obligations have 
systematically hindered prevention, treatment, and containment of COVID -19 so that a 
waiver is needed.  
153.  We consider the discussion of the current proposal is to acknowledge the limitation of the 
existing legal options and to provide additional flexibility at the international level. We have 
presented the examples and indications sufficient  for Members  to consider endorsing the waiver 
proposal, including illustrative examples as per our earlies interventions, and would like to thank 
Indonesia for sharing its national experiences in this regard – we call on other Members  to do the 
same. Impro ving the readiness of law can be done based on due consideration of the probabilities 
of events. This has been reflected by a few Members  who quickly amended domestic laws to get 
ready based on such probabilities. We would like to ask Canada, Germany and H ungary, when they 
decided to swiftly amend national laws to enable quicker use of compulsory license, what kind of 
data was relied upon at that time - demonstrating the necessity of revising the laws? [we refer to 
the Secretariat note and compilation of CO VID-19 measures.]   
154.  TRIPS flexibilities are important to increase access to medicines and other medical product not 
just in a pandemic. Why has pressure  been applied on developing countries for implementing and 
supporting public health safeguards in their i ntellectual property laws and policies  under  the 
European Union 's annual IP enforcement report  and the  annual  "Special 301 Report ", which was 
released even amidst the COVID -19 pandemic!  
155.  Several delegations highlight TRIPS flexibilities, particularly compulsory license under 
Article 31 and Art icle 31bis, as important and need to be used. We recalled how developing countries 
have been under pressures and discouraged from using those flexibilities for a long time. The 
European Union  and Switzerland both highlight the flexibiliti es as the key measures for Members  to 
use, does it mean the European Union  and Switzerland will from now on commit not to pressure 
developing countries when they improve their laws on compulsory license and other TRIPS IP/C/W/672  
 
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  flexibilities or make use of compulso ry license? Would the European Commission from now on 
exclude compulsory license and other TRIPS flexibilities from its IP enforcement report? Would the 
United  States  Trade  Representative (USTR)  do the same to its Special 301 report?   
156.  We notice the recent IP action plan and pharmaceutical strategy published by the 
European  Commission which urges European Union  Members  to use fast track compulsory license 
and explore coordinated compulsory license in the European Union . In launching the Pharmaceutical 
Strate gy for Europe , Vice President Schinas  underscored the importance that the transparency of 
R&D costs plays in ensuring access to affordable  medicines.24 In his remarks to the press on 
25 November 2020, Vice -president Schinas said,   
"Equally important, ensuring affordability of medicines will be guaranteed through 
bolstering transparency on R&D costs and expenditure on medicines in healthcare 
systems, finding a consensus on costing principles and addressing aspects that impede 
the competitive functioning of the markets impacting on affordability. " 
157.  This principle resonates well with our submission to the October 2019 TRIPS Council and the 
WHO Transparency Resolution (WHA72.8). Could the European Union provide more details on how 
it intends to ensure  the "affordability of medicines " through the "bolstering of R&D costs "? 
158.  The European Union  IP Action Plan, released on 25 November 2020, reiterates the exigent 
need to deploy COVID -19 technologies, "not only in Europe but also on a global basis. "To this end, 
the European Union  IP plan c alls for "voluntary pooling and licensing of intellectual property related 
to COVID -19 therapeutics and vaccines, in line with the recent resolution of the World Health 
Assembly to promote equitable global access as well as a fair return on investment. " Can the 
European Union elucidate further on how they intend to transform this lofty rhetoric into concrete 
action?  The European Union  IP Action Plan notes that the Commission is "working on mechanisms 
that would enable and incentivise the rapid pooling of cr itical IP in times of crisis ". Could the 
European Union please explicate on these mechanisms that would enable the "rapid pooling of critical 
IP in times of crisis. " 
159.  Following on from President Ursula von der Leyen 's State of the Union call for the 
establishment of an European Union  BARDA, the European Union 's IP action calls for the 
development of an "effective framework for march -in rights, that should guarantee that publicly 
funded IP is available in case of critic al shortages ". Could the European Union please provide details 
on the design of these march -in rights?  
160.  We would counter the European Union 's assertion, repeated once again today, that compulsory 
licensing should be used as  "means of last resort and a safet y net when all other efforts to make IP 
available have failed. " Nonetheless, could the European Union please provide further details on the 
European Union  IP Action Plan 's recommendation that European Union  Member "establish fast -track 
procedures to issue compulsory licenses in emergency situations "? 
161.  The Commission will explore with Members the possibility of creating an emergency 
co-ordination mechanism, to be triggered at short notice when Members consider issuing a 
compulsory license. What is the rationa le behind this policy decision?   
2.38  In the European Union, data exclusivity and on certain products market exclusivity 
are granted. How does the EC want to make effective use of CL in this pandemic with these 
non-patent barriers in place?  
162.  As the European Unio n has opted out of Article 31 bis of the TRIPS Agreement, how would the 
European Union  Members with no or insufficient manufacturing capacities make effective use of the 
compulsory licensing provisions of the TRIPS Agreement,  especially in light of the IP A ction Plan 's 
emphasis on establishing  "fast-track procedures to issue compulsory licenses in emergency 
situations "? 
 
24 https://ec.europa.eu/commission/presscorner/detail/en/speech_20_2212 . IP/C/W/672  
 
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  2.39  Brazil: International collaboration and voluntary licensing could and should be used 
for the purposes of scaling up production of medical products and guaranteeing sufficient 
and affordable supply.  
2.40  United Kingdom : Voluntary licensing is supporting the ava ilability of medical 
equipment and existing mechanisms that facilitate the sharing of Ip and know how are 
being geared to address COVID -19. 
163.  Several countries have repeatedly suggested that voluntary licensing should be used or is 
being used to scale -up pro duction suggesting that such voluntary licensing (VLs) are providing 
sufficient affordable supply and facilitating the sharing of IP to address COVID -19.  
164.  We find these assertions to be completely divorced from reality. Nine months into the 
pandemic, VLs h ave proven to be either non -existent or insufficient.  
165.  For instance, in the case of Remdesivir , despite receiving significant public funding, Gilead 
signed secretive bilateral licenses with a few generic companies of its choosing that excludes supply 
to nearly half of the world 's population including many developed and developing countries such as 
Brazil and Mexico.25Its limited supply has also been reserved mainly for wealthy nations.26 WHO has 
recently delisted the medicine from COVID -19 treatment, but th is shows a typical negative example 
of VL.  
166.  VLs where they exist are shrouded in secrecy. Usually, their scope is limited to specific amounts 
or for a particular country or for a limited subset of countries, thereby encouraging nationalism 
rather than inte rnational collaboration. Notably some companies have not signed any agreements 
to expand manufacturing and supply. Each country is in race with others to secure supply. This is 
the antithesis of international collaboration. For example, at least 82% of the  recent Pfizer/BioNtech 
vaccine that is claimed to be 90% effective has been pre -booked by developed countr y Members  
representing 14% of the global population27. To date, there is no public commitment to share its 
vaccine knowledge, technology and related intellectual property, so that affordable supply may be 
expanded.28 
167.  Moderna announced that "while the pandemic continues, it will not enforce our 
COVID -19-related patents against those making vaccines intended to combat the pandemic " adding 
that "we are also willing to license our intellectual property for COVID -19 vaccines to others for the 
post pandemic period ".29 While this announcement is a step forward, manufacturers will need a 
firmer commitment for the sake of legal certainty. Some other companies also hold mRNA technology 
patents, and Moderna 's non -enforcement announcement alone is not sufficient to provide legal 
certainty.30 There is also no commitment to share know -how that would also be protected. 
Uncertainty also prevails o ver what is meant by "while the pandemic continues " and what licensing 
arrangements will be applicable post -pandemic etc.  
168.  We are extremely concerned that these ad hoc , non-transparent and unaccountable initiatives 
only lead to artificially limit supply and  competition. In a global pandemic, these "business as usual " 
approaches will surely cost more lives.   
169.  Earlier this year, WHO launched a solidarity call to action that calls on holders of knowledge, 
intellectual property or data to existing or new therapeu tics, diagnostics and vaccines to voluntarily 
license such rights on a non -exclusive and global basis or voluntary non -enforcement of intellectual 
property rights, to facilitate the wide scale  production, distribution, sale and use of such health 
 
25 https://www.citizen.org/news/remdesivir -should -be-in-the-public -domain -gileads -licensing -deal-
picks-winners -and-losers/  
26 https://edition.cnn.com/2020/07/01/health/remdesivir -drug-supply -us-intl/index.html  
27 https://www.independent.co.uk/news/health/covid -pfizer -vaccine -doses -latest -uk-supplies -
b1721162.html  
28 A shot at recovery Mea suring corporate commitments towards a free, fair, and accessible COVID -19 
vaccine, https://www.oxfamamerica.org/explore/research -publications/shot -recovery/  
29 https://investors.modernatx.com/news -releases/news -release -details/statement -moderna -
intellectual -property -matters-during -covid-19 
30 https://www.nature.com/articles/d41573 -020-00119 -8 IP/C/W/672  
 
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  technolog ies throughout the world. About 41 governments and several international agencies have 
supported this initiative, but such collaboration has been spurned by the pharmaceutical industry. 31  
170.  We have to ask ourselves, how we can  sincerely say that this curre nt situation amounts to 
international collaboration.  
2.41  United Kingdom (UK) : On test data and other undisclosed information or to Article  
39.3 of the TRIPS  Agreement sets out that undisclosed test for other data shall be 
protected against disclosure unless necessary to protect the public.  
2.42  United Kingdom : It is also important to note that the way the regulatory framework 
is inextricably linked to the IP framework and has an integral role to play in ensuring the 
efficacy and safety of COVID -19 treatments as they are developed. How would a waiver 
be able to  ensure that these standards particularly safety and quality standards or 
maintain an essential question relevant to another pressing challenge vaccine hesitancy.  
171.  The UK mentioned that the regulatory framework is linked to the IP framework and plays a 
role in ensuring efficacy and safety of COVID -19 treatment and queried how a waiver would ensure 
standards of safety and efficacy and address vaccine hesitancy.  
172.  We would like to clarify that the objective of the regulatory system is to ensure quality, safety,  
and efficacy of medical products. But IP has nothing to do with quality, safety and efficacy of a 
product. For instance, the grant of a patent does not guarantee quality, safety or efficacy. The 
primary purpose of IP  is to prevent third parties from using  the protected subject matter without 
the permission of the IP holder.  
173.  The waiver would greatly contribute in ensuring transparency in COVID clinical trial data which 
in turn will increase confidence in the use of COVID therapeutics and vaccines especiall y vaccines 
hesitancy. Art icle 39.3 of the TRIPS  Agreement  states "Members shall protect such data against 
disclosure, except where necessary to protect the public, or unless steps are taken to ensure that 
the data are protected against unfair commercial us e.". While disclosure is allowed to protect the 
public, there is constant pressure from trading partners and the pharmaceutical industry to limit the 
flexibility allowed under TRIPS Article 39.3.  
174.  The 2020 EU Report on the protection and enforcement of int ellectual property rights in third 
countries, finds that "[a]nother area of continued concern reported by right holders is the absence 
of an effective system for protecting undisclosed test and other data generated to obtain a marketing 
approval for pharma ceuticals […….] This problem affects the European industry mainly in Argentina, 
Brazil, China, India, Indonesia, Malaysia, the Russia n Federation , the Kingdom of Saudi Arabia, 
Ukraine and the United Arab  Emirates. "32 
175.  Similar pressures have been seen from the US as well.  
176.  In view of this, from the perspective of public health, the waiver would be a very positive 
development. It would give regulatory agencies the confidence to disclose clinical trial and other 
relevant d ata in the public interest which in turn generates confidence in using the relevant 
diagnostics, therapeutics and vaccines. This is especially important given the rapid processes 
involved in the development and approval of therapeutics and vaccines that  may give rise to vaccine 
hesitancy and other uncertainty over the safety and efficacy of a product . 
2.43  Some delegations have argued that the IP system provides the necessary incentives 
for development and commercialization of the products.  
177.  We have addressed th is point in significant detail during the informal discussions.  
178.  It is a fact that R&D for emerging infectious diseases has typically depended on public funding 
and not the IP system. And COVID -19 is not different. Billions of public money has been spent o n 
 
31 https://www.ft.com/content/9ed5ca5 e-9360-11ea-899a-f62a20d54625  
32 https://trade.ec.europa.eu/doclib/docs/2020/january/tradoc_158561.pdf  IP/C/W/672  
 
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  R&D and manufacture of the vaccines. For instance, in the case of Pfizer/BioNtech vaccine, there 
has been USD 546 million of public investment33, and more than USD 6  billion has been spent on 
supply deals. It is also reported that Moderna 's R&D is mostly  publicly funded and it has received 
commitments of over USD 1 billion for purchase of the vaccine.34 AstraZeneca has gone so far as to 
state that the development of the vaccine will have no financial implications for the company since 
"expenses to progres s the vaccine are anticipated to be offset by funding by governments and 
international organisations. "35  
179.  Given this reality, in a global pandemic, we fail to see the logic of maintaining IP monopolies 
that limit global supply and competition, and require taxpayers to repeatedly bear the cost of these 
IP monopolies.  
2.44  Some delegations argued that a waiver will bring great uncertainty to the IP system 
and will impact the incentives, while some others have argued that existing flexibilities 
under TRIPS  Agreement are sufficient to address the pandemic and the waiver is not 
necessary. Also, there have been questions as to what the national implementation of the 
waiver will entail.  
180.  In the situation of unprecedented social, health and economic crisis t hat we are facing today, 
insufficient supply and inequitable access to COVID -19 health products, heightens the sense of 
insecurity and uncertainty. The existing flexibilities under the TRIPS Agreement were never designed 
keeping in view a crisis of this ma gnitude and are woefully inadequate in context of COVID -19 
pandemic. We had explained the rationale behind this argument in significant detail over the 
previous  meetings. However, I would like to reiterate some points raised earlier in our intervention.  
181.  Article 31 compulsory licenses are issued on a case by case, country by country basis according 
to national patent law procedures and practices. It is an impractical option, if one takes into 
consideration the need for regional and international collaboratio n to scale up supply, the need to 
source materials from various countries and the need for economies of scale to make manufacturing 
viable. We have already highlighted the limitations associated with the use of Article 31 bis. Countries 
that have never util ised compulsory license or the Article 31 bis mechanism will have to consider 
what are the national procedures for doing so, what to do if procedures do not exists, who should 
request this license, who should issue the license, what would be the adequate re muneration to be 
paid, what are the requirements of Article 31 bis, can an importing country that has not implemented 
Article31 bis in its national law utilise the provision, what are the Article 31 bis requirements for the 
exporting country, what are the nat ional law requirements in the exporting country. Many a times, 
countries also have to deal with pressures from other trading partners and from pharmaceutical 
companies while dealing with such issues. Given the urgency to save lives and the time it takes to  
get a compulsory license implemented on ground in most of developing countries, use of this 
flexibility in context of COVID -19 pandemic does not present a viable solution.  
182.  With regard to the question on national implementation, we have addressed this issu e at the 
last informal meetings. National implementation of the waiver depends on a country 's political and/or 
constitutional arrangement. There is no one size fits all approach to national implementation. 
However, once the waiver proposal is approved, eme rgency, disaster management legislations or 
any other relevant legislative methodology may be relied upon to provide for executive action to 
operationalise the waiver at the national level. Implementation of waiver at the national level can 
also be done in  the same way as the unprecedented steps, like lockdowns, quarantine and other 
measures, put in place to curb the COVID spread.  
183.  In contrast to the waiver bringing uncertainty to the IP system, we are of the view that a 
waiver once implemented will provide greater certainty to manufacturers by providing them freedom 
to operate, and for governments to collaborate to increase supply options. Waiver being sought for 
a limited period and that too only from some specific TRIPS provisions in the context of COVID d oes 
 
33 https://assets.oxfamamerica.org/media/documents/A_Shot_at_Recovery.pdf ; 
https://www.reuters.com/article/us -health -coronavirus -eu-pfizer-exclusiv -idUSKBN2800IC ; 
https://www.thesun.co.uk/news/13169692/pfizer -covid-vaccine -cost-uk-600million -ten-oxford -jab/ 
34 https://assets.oxfamamerica.org/media/documents/A_Shot_at_Recovery.pdf  
35 https://www.astrazeneca.com/media -centre/press -releases/2020/covid -19-vaccine -azd1222 -showed -
robust -immune -responses -in-all-participants -in-phase -i-ii-trial.html  IP/C/W/672  
 
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  not increase uncertainty for the IP system. Instead it shows that in exceptional circumstances, the 
IP system can be flexible and accommodating. On the contrary, a rigid IP system that prioritizes IP 
monopolies and profits over peoples ' lives, would pr esent a greater uncertainty to the world today 
in addressing the COVID crisis.  
2.45  The European Union  has sought an explanation as to how the waiver could operate 
with regard to the vaccine production, including the transfer of the required technology 
and kno w-how and how it would affect the existing licensing mechanisms and COVAX in 
general.  
184.  In the area of vaccines, there are two primary barriers, patents and protection of undisclosed 
information. Patents are used to protect various aspects of the underlying technology as well as the 
product itself. Document IP/C/W/670 presented by South Africa, presents a preliminary non -
exhaustive snapshot of the patent filing and granting status on selected therapeutics candidates. As 
the new vaccines emerge, we are likely to see many more patent applications concerning all aspects 
of vaccines in the coming months.  
185.  In addition, manufacturing know -how, test data, and cell lines are needed to facilitate 
diversification of vaccine production. Hence the importance of addressing  protection of undisclosed 
information under Article 39 of the TRIPS Agreement.  
186.  The wide range of patents and patent applications as well as exclusivity related to undisclosed 
information creates a complex and uncertain legal environment for scaling up va ccine development, 
production and supply. The waiver, if granted, would provide potential manufacturers the freedom 
to operate and achieve economies of scale, thereby incentivizing production and supply of 
therapeutics and vaccines . 
187.  We also need to recogni ze that to date most multinational corporations holding COVID -19 
vaccine IP have not shown any willingness to openly license or transfer technologies to all competent 
vaccine developers globally. The pharma industry has objected to participation in WHO 's COVID -19 
Technology Access Pool. Existing licenses are non -transparent, restricted and limited. We have 
addressed this matter extensively in the informal consultations.  
188.  The waiver is about lifting the legal barrier, it does not preclude the possibility of companies 
agreeing to voluntary licenses. COVAX will also benefit from the Waiver as production will expand 
with more manufacturers engaged in manufacturing. With robust competition, prices can also be 
expected to be substantially reduced.  
189.  In the present meeting, the European Union has reiterated that transfer of technology and 
know -how should be encouraged through licensing. We would like to know how the European Union  
plans to persuade pharma companies to enter into transparent, non -exclus ive global open licenses, 
where all manufacturers can be engaged without any restrictions, and also what steps the 
European  Union  is taking to ensure full transparency and accountability in the cost of R&D and in 
licensing agreements.  
190.  According to the WHO, nearly one third (32%) of vaccines have fewer than four suppliers. We 
would like to ask the WTO Membership how these limited suppliers will be able to cater to the needs 
of 7.8 billion global population and if at all, they can, then after how many mon ths and years, after 
how many more deaths, will everyone get access to vaccines and treatments. These are some 
pertinent questions, which we all need to reflect upon, and that can be answered only through true 
solidarity and global cooperation. Our waiver is the only possible solution to scaling up global 
production to address the pandemic, and considering the urgency of the crisis, we need to take 
time-bound action now rather than limiting ourselves to indefinite debate. We also note the 
COVID -19 and Beyon d: Trade and Health initiative by the European Union , Switzerland, Canada and 
few others, which talks about enhanced preparedness to fight against current and future pandemics. 
History will not judge us kindly if we fail to find an expeditious solution to the current pandemic while 
claiming to prepare for the future ones. We hope the Membership can rise to the demand of this 
crisis and demonstrate that WTO can actually deliver on timely, equitable and affordable access for 
all, by agreeing to the waiver. Wo rld will remember the contribution of WTO during the pandemic 
for generations to come. We now have the opportunity to prove that when the situation demands, IP/C/W/672  
 
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  WTO can indeed deliver. Certainly the pace of other ongoing negotiations at WTO that have 
continued  for more than 20 years, should not be a benchmark for this proposal.  
2.46  It was mentioned during informal consultations and today that advance purchase 
agreements contributed to expanding production calling on companies to use licensing 
mechanisms to maximise  production. Reference was made to Astra Zeneca 's license with 
Serum Institute. We would like to take this opportunity to address some of the points 
raised by a delegation in the last meeting. Do such agreements actually expand global 
production; and do th ey enable equitable and timely access?  
191.  In our view, the race to secure vaccine supplies through advance purchase agreements is in 
fact, reinforcing inequitable access to vaccines. Even if production is being expanded, it seems to be 
for the benefit of a fe w wealthy nations. As reported openly, all of Moderna 's vaccine and 96 % of 
Pfizer/BioNTech 's has been acquired by rich countries. It has also been reported that wealthy nations 
representing just 14 % of the world 's population have bought up fifty -three (53 %) of all the most 
promising vaccines so far. According to several reports, some countries have already made 
arrangements to acquire up to nine doses per person, while among 70 developing or poor countries, 
only one out of every ten people will be vaccinate d by the end of 2021 given the limitations of the 
COVAX  facility. It is also estimated that many lower income countries could have to wait until 2023 
or 2024 for vaccination.  
192.  This situation reveals a lack of global cooperation and solidarity to ensure equi table access and 
allocation. More specifically, IP monopolies are limiting vaccine production and equitable access. 
Regarding Astra Zeneca 's license, it must be emphasised that the license is limited, and insufficient 
to meet global need. Their pledge to p rovide doses to developing nations, can only reach 18 % of 
the world 's population next year at most. Besides, Astra Zeneca 's CEO has reportedly opposed any 
public sharing of technology and IP.  
193.  While we appreciate the idea of asking companies to voluntarily  license and maximise 
production, the strategy does not deliver access. A recent study on the lessons learned from 
voluntary licensing also demonstrates that IP -holding corporations tend to apply restrictive licensing 
terms such as limited geographic cover age of supply and other conditions that limit the benefits of 
competition and global supply. We have already seen this happening during the pandemic. The 
global pharma industry has also objected to participation in WHO 's COVID Technology Access Pool.  
 
__________  