IP/C/W/693  
 
1 November 2022  
(22-8189) Page: 1/4 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
 
TRIPS COUNCIL DISCUSSIONS ON COVID -19 THERAPEUTICS AND DIAGNOSTICS: 
EVIDENCE AND QUESTIONS ON INTELLECTUAL PROPERTY CHALLENGES EXPERIENCED 
BY MEMBERS  
COMMUNICATION FROM MEXICO AND SWITZERLAND  
_______________  
 
 
1  INTRODUCTION  
1.  Even though we are not in the same place as we were in 2020, COVID -19 is still prevalent. With 
its new mutations, the COVID -19 pandemic continues to demand a high toll, first and foremost with 
regard to its humanitarian costs but also with regard to its economi c and social costs. It is therefore 
of utmost importance that we continue to seek holistic solutions that allow us to rein in the COVID -19 
pandemic and to be better prepared for future pandemics. Ensuring global, equitable, affordable and 
rapid access to h ealth technologies is one element of such solutions. To that end and with regard to 
our mandate on whether or not to extend the MC12 Decision to include COVID -19 therapeutics and 
diagnostics, basing our discussions on the concrete situation regarding acces s to COVID -19 
therapeutics and diagnostics is key.  
2  EVIDENCE  
2.1  Supply and Demand Landscape  
2.  Available information shows that no shortage of therapeutics exists. Instead, large parts of 
innovators ' production capacity remain idle due to a lack of demand. Accord ing to Airfinity data1, 
Pfizer would be able to produce 120 million doses of its Paxlovid therapeutic in 2022. The contracted 
supply stood in August 2022 at only 41.5 million doses, i.e. at 35% of the production capacity. The 
situation is similar with MSD 's Molnupiravir, where demand amounted to a mere 45% of the 
company 's production capacity. Governments and NGOs have purchased 35 million COVID -19 
treatments for LMIC for 2022 but have only been able to administer 10 million as of September this 
year.2 
3.  Global demand for tests has reduced and there is no evidence to suggest that supply is 
constrained relative to actual demand.3 Diagnostics companies working closely with WHO, and 
providing them with sample collection kits, have reported there is a high le vel of product surplus to 
order. This involves issues with logistics and distribution, which are not IP -related, but that need to 
be addressed. The Access to COVID -19 Tools Accelerator (ACT -A) Working Group Paper on 
Therapeutics and Diagnostics4 noted tha t recurring challenges for access to therapeutics and 
diagnostics  are regulation, manufacturing, allocation, funding, procurement and deployment, 
forecasting, and demand. The paper recommended actions including assessment of national 
 
1 "Key Figures: COVID -19 Treatments and Diagnostics " prepared for IFPMA by Airfinity, 30.08.2022.  
2 "Expanding the TRIPS Waiver Is Unnecessary and Harmful " prepared for PhRMA by Airfinity, 
September 2022.  
3 'Key Figures: COVID -19 Treatments and Diagnostics ', Airfinity, 30th August 2022  
4 "Report of Access to COVID -19 Tools Accelerator Facilitation Council Working Group on Diagnostics 
and Therapeutics ", WHO, September 2022, available at https://www.who.int/docs/default -
source/coronaviruse/act -accelerator/council -working -group -on-diagnostics -and-therapeutics -
v4.pdf?sfvrsn=920f4bf9_2&download=true   IP/C/W/693  
 
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  strategies, closer mul tilateral collaboration including on licensing and technology transfer and 
financing initiatives, and improving regulations. It is therefore clear to see that access to therapeutics 
and diagnostics  requires a holistic response to addressing these factors.  
2.2  Voluntary Licensing  
4.  The fight against the COVID -19 pandemic is a global effort. As of 11 October 2022, 138 bilateral 
or Medicines Patents Pool -based voluntary licensing agreements comprising some of the most highly 
demanded treatments, have been signed bet ween innovators and companies all over the world 
enabling them to join this fight by producing therapeutics.5 These agreements cover more than 127 
countries collectively.  
5.  The MPP -licenses are royalty -free. Thanks to these agreements, 191 production sites for 
COVID -19 therapeutics exist worldwide, i.a. in India, Bangladesh, the Philippines, Brazil, Paraguay, 
Egypt, South Africa or Kenya .6 
a. MSD's agreement with the MPP for its oral COVID -19 antiviral medicine Molnupiravir allows 
for sublicensing deals to sup ply to 106 low - and middle -income countries.7 Agreements 
have been signed with 31 companies located in 10 countries.  
b. Pfizer 's agreement with the MPP covers 95 countries8, and the MPP has signed sublicensing 
agreements for the generic version of Pfizer 's oral COVID -19 treatment with 38 
manufacturers in 13 countries.  
c. Japanese company Shionogi has also just agreed to voluntarily license its product via the 
MPP.9 
6.  In the case of MSD, 31 voluntary license agreements across 10 LMIC countries provide 
Molnupiravir availability in 106 LMICs.10 38 companies produce generic versions of Pfizer 's Paxlovid 
for 95 LMIC.11 
7.  In May 2020, Gilead entered voluntary licensing agreements with nine generic pharmaceutical 
manufacturers based in India, Pakistan, and Egypt to manufacture and supply Remdesivir to 127 
LMICs.12 These licenses are currently royalty -free, and licensees receive Gilead 's technology 
transfer. The licenses enable the manufacture of generic Remdesivir by generics companies and 
subcontractors in any co untry.  
2.3  Affordability and Accessibility  
8.  Innovators bring their products to the different markets of the world based on a tiered -pricing 
system, like that offered by Pfizer and MSD. Therefore, prices for the same product are significantly 
lower in LMIC than  they are in developed countries – in many cases the products are being offered 
for a non -profit price.13 International organizations and NGOs also support LMICs with the 
procurement and distribution of COVID -19 therapeutics to ensure fair and equitable ac cess. MSD 
 
5 "Key Facts and Figures: Thera peutics " prepared for IFPMA by Airfinity, October 2022.  
6 "Key Facts and Figures: Therapeutics " prepared for IFPMA by Airfinity, October 2022.  
7 "Molnupiaravir (MOL)", Medicines Patent Pool, available at https://medicinespatentpool.org/licence -
post/molnupiravir -mol  
8 "Nirmatrelvir ", Medicines Patent Pool, available at https://medicinespatentpool.org/licence -post/pf -
07321332   
9 "Ensitrelvir Fumaric ACID ", Medicines Patent Pool, available at 
https://medicinespatentpool.org/licence -post/ensitrelvir   
10 "EFPIA Factsheet on COVID -19 Therapeutics ", September 2022, efpia, 29.09.2022.  
11 "Covid -19 Therapies at the Crossroads ", Katherine E. Bliss and J. Stephen Morrison, CSIS, 
06.07.2022, available at https://www.c sis.org/analysis/covid -19-therapies -crossroads   
12 "Voluntary Licensing Agreements for Remdesivir ", available at 
https://www.gilead.com/purpose/advancing -global -health/covid -19/voluntary -licensing -agreements -for-
remdesivir?_sm_au_=iVV3rM63ZjssVkHrvMFckK0232C0F . See also "Key Facts and Figures: Therapeutics " 
prepared for IFPMA by Airfinity, October  2022.  
13 "Pfizer to share license for covid -19 pill, potentially opening up treatment to millions in low -income 
nations ", Adam Taylor and Claire Parker, The Washington Post, 16.11.2021, available at 
https://www.washingtonpost.com/world/2021/11/16/pfizer -license -covid-pill-paxlovid/   IP/C/W/693  
 
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  has made available 3 million units of Molnupiravir for shipment through UNICEF.14 The first shipment 
by UNICEF took place in August – more than 20,000 units to Cambodia15, the first of 14 countries 
that placed orders through them.  
9.  In March 2022, Pfizer signed a supply agreement with UNICEF for procurement of up to 4 million 
treatment courses for distribution to 95 LMICs.16 In September 2022, Pfizer signed a deal with The 
Global Fund for the procurement of up to 6 million treatment courses for supp ly to 132 Global Fund -
eligible countries (subject to regulatory authorization).17 Through 'the Accord for a Healthier World ', 
Pfizer is offering its patent -protected medicines and vaccines filed in EU or US on a not -for-profit 
basis to 45 LMICs, alongside collaborating with country governments and global health organizations 
to remove barriers to access for these products, e.g. lack of diagnostics, training, and storage.18 
3  CONCLUSION  
10.  The information provided above is a non -exhaustive snapshot of t he current landscape. It aims 
at providing a foundation for further discussion on whether or not an extension is required to improve 
access. The Doha Declaration confirms that "the TRIPS Agreement does not and should not prevent 
Members from taking measure s to protect public health, " and that it "can and should be interpreted 
and implemented in a manner supportive of WTO Members ' right to protect public health and, in 
particular, to promote access to medicines for all ". Mexico and Switzerland stand by these  
commitments. If a systemic problem regarding the access to COVID -19 therapeutics and diagnostics 
is demonstrated conclusively and such lack of access is caused by the current IP system, steps have 
to be taken to improve the situation to ensure unimpeded a ccess. However, based on the information 
laid out above, we do not face a situation where we have an IP -induced lack of access to or a lack 
of manufacturing capacity of COVID -19 therapeutics and diagnostics. As a consequence, no 
adjustments to the IP syste m seem to be required. If the decision were extended nonetheless, it 
would even have a detrimental effect and leave us ill -equipped to fight the COVID -19 pandemic and 
potential future pandemics effectively. This is because inventors would have no incentive  to shoulder 
the risks and costs associated with R&D of such products. It would also jeopardize the further 
development and the production of many of the over 1,800 COVID -19 therapeutics that are currently 
in different stages of the R&D -pipeline.19 Mexico and Switzerland therefore respectfully submit the 
following questions to proponents of an extension of the MC12 TRIPS Decision for their consideration 
and response.  
4  QUESTIONS  
1. Against the background of the demonstrated availability of therapeutics like Moln upiravir and 
Paxlovid, especially with regard to the idle production capacity, what would be the added 
benefit of an extension of the MC12 TRIPS decision?  
2. Given that already 138 bilateral or MPP -based voluntary licensing agreements have been 
signed, many with LMICs, no systemic hurdles seem to exist that prevent other companies 
from also signing voluntary licensing agreements. Why do proponents of an extension consider 
 
14 "Merck and Ridgeback Announce New Data For Investigational LAGEVRIO™ (molnupiravir) From 
Phase 3 MOVe -OUT Study ", Merck press release, 07.06.2022, available at 
https://www.merck.com/news/merck -and-ridgeback -announce -new-data-for-investigational -lagevrio -
molnupiravir -from-phase -3-move -out-study/   
15 "UNICEF Executive Director Catherine Russell 's remarks at the event on ending the COVID -19 
pandemic through equitable access to vaccines, tests, and treatments ", UNICEF, 23. 09.2022, available at 
https://www.unicef.org/press -releases/unicef -executive -director -catherine -russells -remarks -event -ending -
covid-19-pandemic   
16 "UNICEF signs supply agreement with Pfizer for oral COVID -19 treatment ", UNICEF, 22.03.2022, 
available at https://www.unicef.org/cuba/en/press -releases/unicef -signs-supply -agreement -pfizer -oral-covid-
19-treatment   
17 "The Global Fund Signs Agreement with Pfizer to Expand Access to PAXLOVIDTM Antiviral ", The Global 
Fund, 22.09.2022, available at https://www.theglobalfund.org/en/news/2022/2022 -09-22-the-global -fund-
signs-agreement -with-pfizer -to-expand -access -to-paxlovid -antiviral/ . See also " The Global Fund Signs Letter 
of Intent with Pfizer for Oral COVID -19 Treatment ", The Global Fund, 20.05.2022, available at 
https://www.theglobalfund.org/en/news/2022/2022 -05-20-global -fund-signs-letter -of-intent -with-pfizer -for-
oral-covid-19-treatment/   
18 "Pfizer Launches 'An Accord for a Healthier World ' to Improve Health Equity for 1.2 Billion People 
Living in 45 Lower -Income Countries ", Pfizer, 25.05.2022, available at https://www.pfizer.com/news/press -
release/press -release -detail/pfizer -launches -accord -healthier -world -improve -health   
19 "EFPIA Factsheet on COVID -19 Therapeutics ", September 2022, efpia, 29.09.2022.  IP/C/W/693  
 
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  it necessary to facilitate the issuing of compulsory licenses that do not contain techno logy 
transfers, training and other benefits that come with most voluntary license agreements?  
3. Given that already a large number of producers for therapeutics and their generic versions 
exist and that these producers face declining demand for their product s, why do proponents 
consider it necessary to facilitate the issuing of compulsory licenses so that additional 
producers can produce for an already saturated and shrinking market?  
4. As the market for therapeutics is already saturated and served by many comp anies including 
producers for generic versions of therapeutics, the profit margins are small. How likely do the 
proponents consider it that a company bestowed with a compulsory license would be willing 
to make large upfront investments just to have very mo dest returns on investment and a 
break -even point in the very distant future?  
5. For many months, we have discussed a potential waiver and whether such a waiver is 
necessary to improve access to COVID -19 vaccines. Yet, since the adoption of the MC12 
Decision,  no country has made use of the possibilities provided for by the Decision to grant a 
compulsory license for the export of COVID -19 vaccines. Against this background and taking 
into consideration that supply of therapeutics exceeds their demand, how do the  proponents 
of an extension justify the need for such extension?  
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