   
  
IP/C/W/684  
 
30 September  2021 
(21-7337) Page: 1/9 
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 
COMMUNICATION FROM THE AFRICAN GROUP, THE PLURINATIONAL  STATE OF BOLIVIA, EGYPT, 
ESWATINI, FIJI, INDIA, INDONESIA, JORDAN, KENYA, THE LDC GROUP, MALAYSIA, MALDIVES, 
MOZAMBIQUE, MONGOLIA, NAMIBIA, PAKISTAN, SOUTH AFRICA, VANUATU, 
THE BOLIVARIAN  REPUBLIC OF VENEZUELA AND ZIMBABWE  
1  INTRODUCTION  
1.  On 21 May, the co -sponsors presented a revised decision text in document IP/C/W/669/Rev.1 
(waiver proposal) with respect to the proposal to waive the application, implementation, and 
enforcement of TRIPS provisions on copyright (Section 1), industrial designs (Section 4), pa tents 
(Section 5) and protection of undisclosed information (Section 7) circulated in  document  IP/C/W/669 
and co -sponsored by 63 WTO Members.  
2.  Co-sponsors introduced  document  IP/C/W/669/Rev.1 during an informal TRIPS Council meeting 
on 31 May 2021 and the formal meeting on 8 -9 June 2021. In the context of text -based negotiations, 
informal open -ended meetings were held on 17 June, 30 June, 6 July and 14 July, and between 
these meetings, small -group consultations took place.  
3.  This communication contains a sum mary of the co -sponsors' interventions in explaining the basis 
for the waiver proposal. The co -sponsors of the waiver proposal have engaged positively and 
responded in detail to questions raised by some WTO Members.  
2  CONTEXT  
4.  The extent of the current healt h crisis posed by COVID -19 is as undeniable as the current global 
response is untenable. Given the ongoing absence of sufficient engagement by the pharmaceutical 
industry to voluntarily and openly allow the use of their intellectual property rights, data a nd 
know -how with all possible manufacturers, to address the pandemic, mechanisms are needed to 
remove existing and potential legal barriers to scale up manufacturing and diversify sources of 
supply.  
5.  The WTO needs to act now to arrest the rising human toll  and economic strain from the COVID -19 
pandemic. Global solidarity is required to ramp up and diversify global production of vaccines, 
therapeutics and diagnostics to effectively deal with the spread of the COVID -19 virus and to 
leverage the under -utilized  manufacturing capacity in developing countries. Sustainable global 
economic recovery will only be possible when we end the health crisis. Ending the pandemic in a 
timely manner should be the overarching priority for the WTO. There is an overwhelming ethic al, 
epidemiological, and economic case for urgent collective action and hence the motivation for the 
TRIPS waiver proposal.  
6.  The waiver proposal is a necessary, timebound and proportionate legal measure directed at 
addressing intellectual property (IP) bar riers in a direct, transparent and efficient fashion, which is 
consistent with the WTO legal framework. Waivers are part and parcel of the WTO toolbox. Adopting 
this waiver allows companies the world over the freedom to operate and to produce covered 
COVID -19 health products and to use health technologies without the fear of infringing another 
party's IP rights and the attendant threat of litigation. Furthermore, adoption of a TRIPS waiver acts 
as an important political, moral and economic lever towards enc ouraging solutions aimed at global IP/C/W/684  
 
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  equitable access to COVID -19 health products and technologies including vaccines, therapeutics and 
diagnostics, which is in the wider interest of the global public. This outcome is also consistent with 
the Covenant on Eco nomic, Social and Cultural Rights, especially Article 12 which recognizes the 
"human right of everyone to the enjoyment of the highest attainable standard of physical and mental 
health " and obligating the taking of steps to fully realize this right, includ ing "those necessary for ... 
the prevention, treatment and control of epidemics, endemics, ... and other diseases ".  
7.  In the context of COVID -19 and the 2030 Sustainable Development Goals, SDG 3 was adopted 
by UN Member States to ensure health and well -being for all, including a bold commitment to end 
the epidemics of AIDS, tuberculosis, malaria and other communicable diseases by 2030. It also aims 
to achieve universal health coverage, and provide access to safe and effective medicines and 
vaccines for all.  
8.  Right now, billions of people in Asia, Africa and Latin America remain unvaccinated and have no 
prospect of being vaccinated in the foreseeable future. There can be no solution to the global crisis 
in access to health products and technologies including va ccines, therapeutics and diagnostics, 
unless we waive intellectual property rights to lift the legal monopoly over the technology in order 
to have more manufacturing everywhere.  
3  PRODUCT SCOPE OF THE WAIVER  
9.  The TRIPS waiver proposal is motivated by the need  for swift ramping up of manufacturing, to 
alleviate the supply side concerns for timely availability, accessibility and affordability of the required 
products to prevent, treat and contain COVID -19. Hence, the starting point in determining the scope 
of health products and technologies to be covered by the decision text is to determine what is needed 
to prevent, treat, and contain COVID -19. Any strategy that does not address these three elements 
simultaneously would fall short of yielding any positive resul ts.  
10.  We have learnt from the experiences of the past year and a half that it is critical to scale up 
production and access to personal protective equipment (PPE), masks, diagnostics, ventilators, and 
therapeutics, apart from vaccines, to prevent the spread  and to treat the disease and prevent deaths. 
These resources have been in acute shortage in many countries leading to very limited accessibility. 
The scope of products is also reflective of national COVID -19 response strategies of many countries 
that ackn owledge that the prevention, treatment and containment of COVID -19 involves a range of 
health products and technologies. Vaccines are necessary but not sufficient to respond to the 
pandemic. No country adopts only one intervention in this and any pandemic.  Vaccinations, test and 
treat strategies and their related health products and technologies are urgently needed alongside 
other interventions.  
3.1  'Health products and technologies'  
11.  The waiver proposal covers "health products and technologies" for COVID -19 as there is a range 
of products and technologies that are critical for the prevention, treatment and containment of 
COVID -19, such as those listed in WHO's list of priority medical devices for COVID -19 response.1 
This list describes the range of priority medical devices required for the clinical management of 
COVID -19 and WHO's Emergency Global Supplies Catalogue (COVID -19)2 includes the range of 
health products and technologies cr itical to respond to the COVID -19 global health emergency.  
12.  Notably, WHO's COVID -19 Strategic Preparedness and Response Plan pillars 5, 7 and 10 
underline the importance of diagnostics, therapeutics, vaccines and other supplies for an effective 
COVID -19 re sponse.3 
13.  The term "health products" is inspired by the World Health Assembly Resolution on "Improving 
the transparency of markets for medicines, vaccines, and other health products"4 which defines 
health products to "include medicines, vaccines, medical devices, diagnostics, assistive products, 
cell- and gene -based therapies, and other health technologies".  
 
1 https://www.who.int/publications/i/item/WHO -2019-nCoV-MedDev -TS-O2T.V2  
2(https://www.who.int/publications/m/item/emergency -global -supply -chain -system -covid-19-catalogue ) 
3 (https://www.who.int/publications/i/item/WHO -WHE-2021.02 ) 
4 https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_R8 -en.pdf  IP/C/W/684  
 
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  14.  Based on the above it is quite clear that the concept of health products and technologies is well 
understood and used within the international health  lexicon.  
3.2  Diagnostics  
15.  Pillar 5 of WHO's Strategic Preparedness and Response Plan for COVID -19 considers testing to 
be the cornerstone of the management of the COVID -19 pandemic. Testing is critical to detect cases 
and investigate clusters of cases so that  public health actions can be rapidly taken to isolate those 
infected, quarantine contacts and break chains of transmission. Testing allows for new COVID -19 
variants to be identified to begin to build vaccines and therapeutics that can prevent or treat 
infection.  Major gaps in testing are still putting lives at risk and threatening progress to end the 
pandemic. In high -income countries there are 603 tests per 100  thousand  of population compared 
to about 100 tests in middle income countries and about five tests in low -income countries.5 There 
is an urgent need to scale up testing and ensure immediate, equitable access to diagnostic tools in 
every country across the world.  
16.  The co -sponsors have provided examples highlighting IP challenges in previous TRIPS Council 
meetings (see paragraphs 42 -46 of document IP/C/W/672 as well as paragraph 65 of document 
IP/C/W/673).  
3.3  Therapeutics  
17.  The spectrum of medical therapies to treat COV ID-19 is growing and evolving rapidly. It includes 
antivirals, monoclonal antibodies, immunomodulators, antithrombotic therapies.6 WHO's 
consultations on COVID -19 therapeutics reveals that "[d]espite the great success of COVID -19 
vaccine development, ther apeutics are still urgently required" and that a range of therapeutics will 
be required including "drug combinations targeting specific aspects of infection , as well as suites of 
treatments targeting different disease processes (such as antivirals, immuno modulators and 
anti-coagulants)"7.  
18.  The EU COVID -19 therapeutic strategy also states that " vaccines will not eliminate the disease 
overnight and therapeutics will still be needed for patients in hospitals and at home, including people 
suffering from 'long  COVID' (the long -term effects of COVID -19 infection). For these reasons, 
therapeutics will continue to play a significant role and complement the EU strategy for vaccines ." 
Notably, several therapeutics have been approved, registered and have received nat ional Emergency 
Use Authorization or qualified for the WHO Emergency Use Listing.  
19.  Since the currently available vaccines are not able to prevent infections (which may be the case 
for second or third generation vaccines) – therapeutics play an important ro le in our effort to contain  
and treat COVID -19. Further, therapeutics are also important to address animal virus spill over and 
possible resurgence of virulence in humans.8 
20.  In document IP/C/W/670, the co -sponsors have presented a preliminary patent landsc ape 
providing a non -exhaustive snapshot of the patent filing and granting status of five selected 
therapeutics candidates for COVID -19. In document IP/C/W/672 (e.g. paragraphs 37 -41) and in 
document IP/C/W/673 the co -sponsors have highlighted IP -related ch allenges in the area of 
therapeutics and how restrictive voluntary licensing practices continue to pose supply challenges for 
countries .  
3.4  Vaccines  
21.  As noted above, the disparity in access to vaccines remains vast as supply remains constrained. 
Eight vaccine  manufacturers are listed in WHO's Emergency Use Listing. Of these five are from OECD 
countries.9 According to the UNICEF dashboard 137 manufacturing agreements have been signed, 
 
5 http://www.finddx.org/covid -19/test -tracker/  
6 https://www.covid19treatmentguidelines.nih.gov/therapies/   
7 Pg. 5 https://cdn.who.int/media/docs/default -source/blue -print/06_therapeutics_full -achievements -
report.pdf?sfvrsn =d6cdb802_3&download=true . See also pgs 12 and 13.  
8 https://www.thelancet.com/journals/ebiom/article/PIIS2352 -3964(21)00082 -7/fulltext   
9 https://www.who.int/news/item/01 -06-2021-who-validates -sinovac -covid-19-vaccine -for-emergency -
use-and-issues -interim -policy -recommendations   IP/C/W/684  
 
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  out of which 73 are contract manufacturing agreements. 64 agreements are cla ssified as technology 
transfer, but 28 agreements are from just one company.10 Details of the agreements are unknown 
but this shows the heavy concentration of production and supply of COVID -19 vaccines. Prices of 
COVID -19 vaccines also remain high within a  range of US D 2-40 per dose.11 There is an urgent need 
to bring down the price through competition, which can be achieved by diversifying production.  
22.  The emerging landscape of both background and foreground IP on key vaccine technologies, 
and the IP dispu tes (see para 53 of document IP/C/W/672) that have already occurred during the 
pandemic, underline evident IP challenges in ensuring legal certainty for vaccine development and 
supply, especially when some of the main vaccine producers continue to pursue monopolistic 
approaches in their IP management. Past experience12 shows that patents can hinder the 
introduction of affordable vaccines in developing countries as generally broad patent claims are 
applied for or granted across the entire spectrum of vaccine development, production and use, 
including in relation to vacci ne-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. The impacts of these pate nts 
are documented and create legal uncertainty and costs which ultimately result in delayed 
competition, insufficient supplies and high prices which hinder access.  
3.5  'Medical devices, personal protective equipment'  
23.  The WHO's list of priority medical devices  for COVID -19 response describes the  range of priority 
medical devices required for the clinical management of COVID -19.13 It describes priority medical 
devices required for the clinical management of COVID -19, selected and prioritized according to  the 
latest available evidence and guidelines. For example, beginning from clinical assessment, medical 
imaging, clinical laboratory, clinical care and protective equipment, the list identifies priority medical 
devices that are needed, including pulse oximeters, e quipment for medical imaging, oxygen 
concentrators, patient monitors, various types of ventilators such as for transport, for acute care 
and for sub -acute care, infusion and suction pumps, medical/surgical mask etc.  
24.  The WHO's Emergency Global Supplies Cat alogue (COVID -19)14 lists the following medical 
devices in its catalogue: oxygen delivery devices – nasal cannula and catheters; oxygen delivery 
devices – masks; various types of patient monitors, pulse oximeters and infrared thermometer for 
monitoring; ox ygen therapy sources including the oxygen concentrator and its accessory the flow 
splitter; various types of ventilators and related accessories; protective equipment such as various 
types of apron/gowns, gloves, face shield, goggles, respirator, mask FFP2 /KN95, Biohazard Bag, 
sample collection kits, PCR machines, rapid diagnostics, power accessories.  
25.  Clearly what is specified in the waiver proposal finds international support for the clinical 
management of COVID -19 based on the latest available evidence a nd guidelines.  
26.  In document IP/C/W/672 (paragraphs 50 - 52), the co -sponsors have provided examples of IP 
barriers to medical devices and protective equipment such as masks and ventilator valves.  
3.6  'Their materials or components, and their methods and means of manufacture'  
27.  The rationale of the revised decision text is to address any IP constraints in the way of scaling 
up of the production of COVID -19 health products and technologies. IP protection can prevent the 
supply of raw materials, components, machiner ies and equipment, parts of machinery and 
equipment, process of production etc.  
28.  Materials and components refer to parts of the health products and technologies. These include, 
for instance, raw materials, active and inactive ingredients of the drug substa nces used in the 
formulation of therapeutics or vaccines and reagents in the case of diagnostics used for the detection 
or screening of a disease. While in the case of medical devices and other health technologies it would 
 
10 https://www.unicef.org/supply/covid -19-vaccine -market -dashboard   
11 https://www.unicef.org/supply/covid -19-vaccine -market -dashboard   
12 https://msfaccess.org/sites/default/files/2018 -
06/VAC_ report_A%20Fair%20Shot%20for%20Vaccine%20Affordability_ENG_2017.pdf  
13 (https://www.who.int/publications/i/item/WHO -2019-nCoV-MedDev -TS-O2T.V2 . 
14 https://www.who.int/publications/m/item/emergency -global -supply -chain -system -covid-19-catalogue  IP/C/W/684  
 
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  refer to parts of the products or  technology such as ventilator valves. IP constraints may emanate 
in the following context, which are addressed in the revised text, for example:  
• the raw materials for the production of vaccines, diagnostics or therapeutics such as lipids for 
mRNA vaccine s, adjuvants for vaccines, starting materials for the active pharmaceutical 
ingredient of therapeutics, chemical reagents and solutions for diagnostics etc. (The word 
"materials" cover this aspect);  
• components used for the production of medical devices su ch as electronic or mechanical 
components required for the production of medical devices including ventilators, oxygenators, 
oximeter etc. (The word "components" covers this aspect);  
• machineries and equipment used for the production of various health prod ucts (the words 
"method and means of production" cover this aspect);  
• parts of the machinery and equipment deployed for the production process such as bio -bags, 
bio-reactors, equipment for lipid coating etc. (the words "method and means of production" 
cover  this aspect); and 
• technologies used for the production of these health products such as mRNA technology, 
diagnostic techniques like improvements on PCR technology etc. (the word "technologies" 
covers this aspect).  
29.  Methods and means of manufacture refer t o the process and equipment used for the 
manufacture of the health products and technologies covered by the scope of products.  
3.7  '… the prevention, treatment or containment of COVID -19' 
30.  Prevention  refers to products and technologies to prevent the infection of COVID -19. Treatment  
refers to products and technologies to treat a patient who has been infected with COVID -19. 
Containment  refers to products and technologies to control the spread of COVID -19.  
4  INTELLECTUAL PROPERTY SCOPE OF THE WAIVER  
31.  The proposal ca lls for a waiver of the application, implementation, and enforcement of TRIPS 
provisions on copyright (Section 1), industrial designs (Section 4), patents (Section 5) and protection 
of undisclosed information (Section 7). The waiver proposal only focuses o n categories of intellectual 
property that are relevant to the production, supply, and access to COVID -19 health products and 
technologies. The co -sponsors have pointed out to paragraph 3 of the revised decision text which 
makes explicit that the waiver wi ll not apply to the protection of Performers, Producers of 
Phonograms (Sound Recordings) and Broadcasting Organizations under Article 14 of the 
TRIPS  Agreement.   
32.  The co -sponsors have made several submissions highlighting the relevance of addressing 
existing and potential intellectual property issues in the area of copyright, industrial designs, patents 
and protection of undisclosed information. In  document  IP/C/W/673 the co -sponsors responded 
to eight questions raised in  document  IP/C/W/67 1 by Australia, Canada, Chile and Mexico. Examples 
of IP challenges and barriers are detailed in document IP/C/W/670 , in which both the emerging 
IP landscape of pipeline medical products and limited, restrictive voluntary licensing practices have 
presented  ongoing challenges for the prediction, preparation and management of procurement 
options for countries. Document IP/C/W/672  contains interventions of the co -sponsors in 
responding to questions raised with respect to the proposal including on the scope of IP.  
33.  Patents  grant monopoly rights over a protected subject -matter, preventing other 
manufacturers from using the patented s ubject -matter. The patent status of each product and 
components of the product will vary country by country with a single product often involving a large 
number of patent applications and grants, that differs from country to country. In the case of 
COVID -19, the patent landscape remains quite uncertain as many patent applications have yet to 
be published because  patent applications are not typically made public for 18 months.  A recent paper 
in the International Journal of Biological Sciences15 has observed that there has been a rapid increase 
in human coronavirus patents, especially COVID -19 patents; "treatment and prevention" accounting 
 
15 Kunmeng et al "Global landscape of patents relat ed to human coronaviruses. " 2021; 17(6): 1588 –
1599. [published online 2021 Apr)] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8071764/  IP/C/W/684  
 
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  the largest proportion (57.89%), followed by "diagnosis of viral infection" (20.64%), "disinfection" 
(8.12%), "medical dev ices" (7.00%), and "virus cultivation" (1.32%).  
34.  The patent system contains flexibilities such as opposition systems and compulsory licenses. 
However, challenging each and every patent application or grant everywhere they may exist is not 
a practical or su stainable option. The co -sponsors have also on numerous occasions illustrated in 
significant detail the inadequacies and difficulties in relying on Article 31 and 31 bis of the 
TRIPS  Agreement (see paragraphs 28 -53 of document  IP/C/W/673) to scale up manufa cturing. It is 
even more so, when dealing with a complex global web of patent holding. For instance, in the case 
of mRNA vaccines larger companies involved in product development may have a patent portfolio, 
but the patent portfolio to the underlying techn ology is held by numerous other academic 
laboratories or small biotech companies.16 
35.  Protection of Undisclosed Information  is another hurdle to access various health products 
and technologies. With respect to vaccines, and bio -therapeutics in particular, th e manufacturing 
methods and techniques (know -how) tend to be protected by trade secrets. This includes regulatory 
dossiers submitted for purposes of obtaining marketing approval. These dossiers will usually include 
robust information regarding the manufact uring process, formulation and dosage, method of 
delivery, storage conditions, indicated uses along with safety and efficacy information. Hence the 
importance of addressing protection of undisclosed information required under Article 39 of the 
TRIPS Agreem ent.  
36.  Lifting trade secret protection would facilitate expanding and diversifying global production. For 
instance, by waiving trade secret protection, and as a start facilitating the sharing of regulatory 
dossiers with potential manufacturers, existing pro duction capacity especially in developing countries 
can be mobilised. As demonstrated by the event hosted on 14 April 2021 by the Director -General of 
the WTO, Dr Ngozi Okonjo -Iweala , whereby interaction with several pharmaceutical companies 
revealed unused  capacities in several developing countries.17 
37.  The slow roll out of vaccination in developing and least developed countries is testament to the 
fact that the current system of production and supply is not working to deliver equitable access. 
Numerous examp les have been reported of the industry turning down offers of help from other drug 
makers, including those from developing countries, to boost global manufacturing and supply.18  
38.  In the case of diagnostics, s hortages of testing materials in developing coun tries cannot be 
overcome as the formulation used for diagnostic testing is protected as a trade secrets, preventing 
laboratories from making their own test materials or procuring test materials from sources other 
than the diagnostic machine's manufacturer (see para 43 of document IP/C/W/672 and para 65 in 
document IP/C/W/673).  
39.  In document  IP/C/W/673 paragraphs 66 -69, the co -sponsors have raised the issue of 
developing countries constantly facing pressure from developed country members, advocating 
restricti ve interpretations of Article 39 and hampering the use of flexibilities. Hence there is a lack 
of clarity with regard to available flexibility provided by Article 39, which creates a chilling effect on 
its use. As such, a waiver will support countries to t ake appropriate actions with respect to 
COVID -19. 
40.  Copyright and industrial designs  are also categories of IP that may hinder production and 
supply. In document  IP/C/W/673, the co -sponsors responded in detail from paragraphs 54 to 63 on 
the industrial design and copyright challenges faced by members in production of COVID -19 
products. Copyright issues may also arise in other situations such as with respect to sof tware in 
medical devices, diagnostic kits, compilation of data, algorithms, product information documents or 
product labelling. For instance in India, Roche asserted copyright infringement with respect to use 
of the product information of the originator pr oduct Herceptin (breast cancer treatment) on the 
package insert and carton of a biosimilar product19  
 
16 A network analysis of COVID -19 mRNA vaccine paten ts 
https://www.nature.com/articles/s41587 -021-00912 -9 
17 https://www.wto.org/english/news_e/spno_e/spno9_e.htm  
18 https://www.politico.eu/article/vaccine -producers -reject -offers -to-make -more-jabs/ 
19 https://indiankanoon.org/doc/99133603/?type=print  IP/C/W/684  
 
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  41.  In paragraphs 59 -63 of document IP/C/W/673, the co -sponsors have pointed out that the 
exceptions in Article 13 and Article 26 of TRIPS are inadequate and there is uncertainty as to their 
application to protect public health. In addition, identifying the various IP claims involved with 
respect to a particular product or technology, and negotiating the terms of use involve a costly, 
time-consuming and complex  process as products and technologies involve multiple IP holders. IP 
holders may also simply refuse to license their IP. In times of an emergency, such legal issues should 
not hinder an urgent public health response.  
42.  The waiver being sought is for a limit ed period and that too only from some specific TRIPS 
provisions. This is not an ideological debate on the IP regime per say. Instead, it shows that in 
exceptional circumstances, the IP system can be flexible and accommodating, and one that can be 
appropria tely invoked to address the unprecedented challenges posed by the pandemic.  
5  DURATION  
43.  The rationale for the proposed duration has been clarified in the revised decision text contained 
in document  IP/C/W/669/Rev.1. Since SARS -CoV-2 is a new virus, there ar e still many uncertainties. 
There are emerging variants and mutations and while we are better off in our understanding of the 
virus than last year, still many unknowns remain such as the duration of immunity provided by the 
vaccines, effectiveness of these  vaccines against new variants, effectiveness of vaccines on children, 
the need for a booster dose or annual vaccination . All these elements will determine the scale of 
manufacturing and supply needed to control the pandemic and this is just for the vaccin es. 
44.  In order to tailor the waiver duration to prevailing circumstances and the uncertainties attached 
thereto, the co -sponsors have specified a minimum duration period of three  years from the date of 
the decision. Thereafter, the waiver will be reviewed by  the General Council to determine whether 
exceptional circumstance justifying the continuation of the waiver still exist. The difficulty with 
setting criteria is the uncertainty of the situation as explained above.  
45.  There is also very little WHO guidance o n the situation of a pandemic and when that situation 
comes to an end. The International Health Regulations (IHR) of the WHO does not use or define the 
term "pandemic". It uses the term "public health emergency of international concern" (PHEIC). In 
determi ning whether an event constitutes a PHEIC, the WHO Director -General , 
Dr Tedros  Adhanom  Ghebreyesus , considers the advice of an Emergency Committee convened for 
the purpose. If a PHEIC is recommended, the WHO Director -General has the final authority to make  
a declaration, taking all information into account.  
46.  Article 49 (6) of the IHR states the following:  "The Director -General shall communicate to States 
Parties the determination and the termination of a public health emergency of international concern, 
any health measure taken by the State Party concerned, any temporary recommendation, and the 
modification, extension and termination of such recommendations, together with the views of the 
Emergency Committee."  
47.  It does not provide concrete guidance as to wha t factors should be taken into account and 
seems to operate on a case -by-case approach. The declaration of PHEIC under the IHR has drawn 
significant criticism.20 The recent Independent Panel for Pandemic Preparedness and Response has 
recommended that the definition of a new suspected outbreak with pandemic potential needs to be 
refined.21 
48.  With COVID -19, several considerations and uncertainties have to be taken into account for 
example:  
• What proportion of the population needs to be vaccinated for herd immuni ty from COVID -19? 
The proportion of the population that must be vaccinated against COVID -19 to begin inducing 
herd immunity is not known . This is an important area of research and will likely vary according 
to the community, the vaccine, the populations prioritized for vaccination, and other factors. It 
would be difficult to reach herd immunity without vaccinating children in countries wit h young 
demographics.  
 
20 https://www.thelancet.com/journals/laninf/article/PIIS1473 -3099(20)30401 -1/fulltext  
21 Pg. 26, https://theindependentpanel.org/wp -content/uploads/2021/05/COVID -19-Make-it-the-Last-
Pandemic_final.pdf  IP/C/W/684  
 
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  • How long  do COVID -19 vaccines protect people? Is it eight months, 12 months or longer? This 
information is not yet known. If boosters are needed, it is still unknown how often they will be 
needed. On this point the WHO in December 2020 said " we don't actually know for how long the 
protection of these vaccines wi ll last... But by necessity, they've only been able to follow up 
people for a period of months following their immunization. We really do need to know whether 
or not these vaccines last for only a period of months in terms of their protection or potentiall y 
years…."22 
• On the question of the need for booster shots, a few examples of various diseases may suffice. 
Measles does not change, so does not need booster vaccines for variants. Influenza needs a new 
vaccine each year because of variants. " Now for SARS -CoV-2 we're still learning, we're still 
observing things and our knowledge is evolving. . . the more we give it a chance to spread and 
to multiply within humans, the more chances it's going to have to keep changing itself, that's its 
natural property ."23 And "there's some data coming showing that vaccines may be less effective 
in preventing against some of these variants ."24 
• How much COVID -19 vaccine production capacity exists? Most developing countries are nowhere 
near the levels of vaccination required to  address their basic needs. Halfway through 2021 
COVAX has only managed to deliver 95 million doses to date25, i.e. 4.8% of the 2 billion doses 
to be delivered in 2021. The supply gap justifies the duration proposed. If countries are already 
procuring 'boo ster' doses to deal with new variants or have moved to vaccinating children, the 
waiting period for sufficient vaccination in developing countries will be much longer. There are 
varying reports on how long it will take to roll out vaccination globally. Som e reports suggest 
that based on the current rate of vaccination, it may take five to seven  years for global 
vaccination to be realized.26 But the situation is even more complex. Emergence of new highly 
transmissible variants can at any time render any of t he currently registered vaccines ineffective.  
49.  The complexities of the current pandemic as well as learning from the past, suggest the need 
for a practical and flexible duration, and one that creates an enabling environment for the scale -up 
of manufacturin g and diversifying suppliers. It is noteworthy that the 30 August 2003 decision that 
waived Article 31(f) and (h) of TRIPS contained in document WT/L/540 does not contain a specific 
timeframe, instead it states the duration of the waiver is until " the date  on which an amendment to 
the TRIPS  Agreement replacing its provisions takes effect for that Member ".  
50.  Co-sponsors have been asked the relation between the mechanism to terminate the waiver in 
paragraph 2 and the yearly review in the General Council in par agraph 5. The annual review is a 
requirement under Article IX.4 when waivers are granted for a period of more than a year whereas 
paragraph 2 is for determining the date of termination of a waiver. It is common for waiver decision 
to contain these two aspe cts. For instance, see decision text WT/L/971 with respect to the waiver of 
Article 70.8 and 70.9 of TRIPS for least developed countries with respect to pharmaceutical products.  
6  IMPLEMENTATION ISSUES  
51.  Among WTO Members there is a diversity of legal systems , hence national implementation of a 
waiver depends on a country's constitutional and or administrative arrangement. Similarly, the 
parameters and conditions of implementation should be a national decision. Each country will need 
to decide what is needed n ationally to curb COVID -19 and the parameters of implementation of the 
waiver. One size does not fit all as the legal systems, needs and conditions vary from country to 
country.  
52.  Generally, the relationship between international law and national law is bas ed on theories of 
monism and dualism. In monist countries international law is applicable nationally, without 
intervention of the legislature and international law may take precedence over national law. On the 
 
22 https://www.who.int/emergencies/diseases/novel -coronavirus -2019/media -resources/science -in-
5/episode -15---vaccine -distribution  
23 https://www.who.int/emergencies/diseases/novel -coronavirus -2019/media -resources/science -in-
5/episode -20---covid-19---variants -vaccines  
24 February 2021, https://www.who.int/emergencies/diseases/novel -coronaviru s-2019/media -
resources/science -in-5/episode -27---vaccines -variants -herd-immunity  
25 https://www.gavi.org/covax -facility  
26 https://www.aljazeera.com/news/2021/2/19/vaccine -nationalism -why-hoarding -shots -could -prolong ; 
https://www.smh.com.au/politics/federal/it -will-be-six-years -before -the-world -is-vaccinated -against -covid-19-
experts -20210210 -p5718i.html  IP/C/W/684  
 
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  other hand, in dualist systems, international laws need to be translated into national law for them 
to be applicable. In some countries this distinction tends to be blurred.  
53.  The diversity of legal systems is apparent. In order to expeditiously implement the waiver each 
WTO Member should decide on wha t is the best approach in the context of their respective legal 
systems and this need not involve an amendment of their intellectual property laws.  
54.  For instance, countries could use emergency powers. Some countries have invoked emergency 
provisions or ena cted legislation to implement the wide range of measures required for effective 
response to COVID -19. According to ICNL, 108 countries declared emergency as part of an effective 
COVID -19 response.27 Such legislation may also provide governments the discretion to implement 
measures with respect to existing laws or privileges, and such provisions could be used for the 
implementation of the TRIPS waiver. In some countries, emergency legislation has been  utilised to 
make changes to intellectual property laws.  
55.  Apart from emergency powers the executive may also have certain powers under the 
Constitution to issue orders suspending or amending the legal provisions. WTO Members may also 
have disaster manageme nt laws to organise an effective response to disasters including a pandemic. 
These laws may also contain provisions providing powers to the government to suspend the 
operation of legislation to take effective measures. For instance, India invoked provision s of the 
Disaster Management Act to respond to COVID -19.  
56.  There is also the option of amending national intellectual property legislation. Such an 
amendment need not be a time -consuming exercise. Indeed in this pandemic governments have 
fast tracked enactm ent of legislation as required for controlling the pandemic.  
57.  Governments have taken extraordinary measures such as lockdowns, quarantine, nationalising 
private hospitals, border closures and other measures to curb the spread of COVID -19. Addressing 
intellectual property concerns should not be any different. These are just some possibilities for the 
implementation of the TRIPS waiver. Each Member will have to decide for itself what is the most 
expeditious approach for implementation. As mentioned, in some l egal systems international law 
may directly be applicable at the national level.  
__________  
 
27 https://www.icnl.org/covid19tracker/?location=&issue=5&date=&type=n  