Nearly 100 World Trade Organization member countries and entities could potentially swing behind a proposal by India and South Africa to enact a wide-ranging waiver of complex World Trade Organization requirements on the use of patented products, trade secrets and copyrights on health products during the pandemic, asserted the Médecins Sans Frontières (MSF) Access Campaign on Thursday.

MSF on Thursday called upon governments to support what it called “this game-changing step” that would allow countries worldwide to opt out of the granting and enforcement of patents and other IP related to COVID-19 drugs, vaccines, diagnostics and other health technologies for the duration of the pandemic.

The proposal for a “TRIPS Waiver” of the WTO’s requirements by India and South Africa, along with co-sponsors Eswatini and Kenya, is due to be discussed informally tomororw by WTO members, after a formal discussion last month at the WTO TRIPS Council.

The Council administers the complex rules around adherence to patent laws in international trade – Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as so-called TRIPS flexibilities that allow countries to disregard some patent rules, under certain conditions, during health emergencies.

But proponents say that the rules don’t go far enough in loosening the reins of IP control – so that low- and middle-income countries could rapidly gear up, produce and export generic or biosimilar versions of new up-and-coming drugs, such as monoclonal antibodies. Ditto for the barriers to producing COVID-19 vaccines using cutting-edge technologies like mRNA, which seem to have proved themselves in the results of Phase 3 clinical trials unveiled this week by both Moderna and Pfizer. 

Both sets of trials, involving tens of thousands of people found that the mRNA vaccines were about 95% effective in protecting people against COVID-19.  Almost as important was news that the Pfizer vaccine, developed jointly with BioNTech was 94 % effective in preventing COVID infections among older people, who are much more vulnerable to the disease.  

Race For Vaccine Distribution Set To Begin – Where, How & When ?

Pfizer is now poised to submit its vaccine for emergency use approval to the United States Food and Drug Administration by Friday, with Moderna to follow soon afterward.  With the prospects the vaccines may be approved by the FDA as early as December, the race will be on to roll out production and distribution – and the questions of who gets what vaccines first – will become all the more acute.  

But due to the huge logistics and financial challenges involved, vaccine distribution could very well prove to be even more challenging than the research itself. And low- and middle-income countries with long experience in getting the shorter end of the stick, when it comes to quickly getting access to new drug treatments, are becoming more and more anxious. 

According to an MSF background brief, based on informal polling and statements made at the 15-16 October TRIPS Council meeting, a majority of WTO members, some 99 countries, already support the waiver proposal either fully or in principle.  Those expressing full support, include: Argentina, Bangladesh, Egypt, Indonesia, Mali, Mauritius, Mozambique, Nepal, Nicaragua, Pakistan, Sri Lanka, Tunisia, and Venezuela. 

Perhaps more significant, however, is the growing list of countries that have “welcomed” the proposal and said it should be discussed further. Those include: global giant China, Turkey; Pacific influencers like the Philippines and Thailand; Latin America’s Chile, Colombia, Costa Rica, Ecuador, El Salvador, and Jamaica; and African powerhouses like Nigeria, Senegal and Tanzania. 

In addition, according to the MSF count, seen by Health Policy Watch, support has been expressed in principle by dozens of other countries as members of various WTO trade alliances, including: 

• The “African Group”, including Botswana, Cabo Verde, Congo, Cote d’Ivoire, Democratic Republic of Congo, Ghana, Morocco, Namibia, Seychelles, Togo and Tunisia;  
• Organization of African, Carribean and Pacific countries, specifically Antigua and Barbuda, Barbados, Belize, Cuba, Dominica, the Dominican Republic; Fiji, Ghana, Grenada, Guyana, Papua New Guinea, Saint Kits and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, Solomon Islands, Suriname, Tonga, Trinidad and Tobago, Vanuatu, the Bahamas, Comoros; Equatorial Guinea, Ethiopia, Sao Tomé and Principe, and Somalia.
• Chad on behalf of most other members of the WTO’s “Least Developed Countries group not already supporting the proposal individually.  The group includes some 45 other African and Asian countries, as well as small island states; 

Against that growing wall of low- and middle-income country opinion,  most of the world’s developed countries have lined up against the waiver proposal, led by the United States, the United Kingdom, Australia, Japan and the European Union – but also including Switzerland, Brazil, Norway and Canada. 

Developed countries have largely grouped behind the WHO co-sponsored ACT Accelerator, including its COVAX facility – a procurement network that now includes 186 countries. COVAX aims to secure and distribute sufficient vaccinedoses to immunize health workers and at-risk populations globally by pooling large vaccine purchase orders to pharma, without upending patent rules. Similar schemes are underway, under the broader ACT umbrella, to pool and procure orders for the large-scale purchase of COVID medicines and diganostics.

European Union, South Africa, Norway and WHO Issue Call to G20 for Billions in Funding 

But that scheme still requires some US$ 28 billion in funds to ensure that some 92 countries that cannot afford to buy pricey new COVID vaccines, medicines and tests will obtain the products that they need. At the Paris Peace Forum last week, European leaders along with WHO issued an urgent appeal for money. On Thursday, WHO issued yet another high-level appeal ahead of this weekend’s planned G-20 Summit, being hosted  by Saudia Arabia, asking the Group of 20 most industrialized countries to “fully fund” the initiative, including an immediate $US 4.5 billion allocation of funds.

The letter, jointly authored by Norway’s Prime Minister, Erna Solberg, South African President Cyril Ramaphosa, President Ursula Von der Leyen of the European Commission and WHO’s Director General, Dr Tedros Adhanom Ghebreyesus, underlined that funds are now needed immediately to “lay the groundwork for mass procurement and delivery of COVID-19 tools around the world.

“We need the G20 to continue to lead, not only in securing the necessary resources to end the COVID-19 pandemic, but also in addressing the crisis from a strategic macroeconomic perspective that transcends national and sectoral interests and demonstrates joint global action.”

In other words, if  rich countries step up to the bat with massive funding – and big pharma actively joins the ACT initiative with massive offers of voluntary licenses to expand needed vaccines and medicines production – then a polarizing debate at the WTO might be avoided. But if funds fall short, and low and middle income countries can’t access new, lifesaving technologies – then the WTO option may become much more attractive. And its sponsors have already suggested that they might even take the measure to a vote at the WTO – shattering the tradition of decision by consensus.

The Hurdle of Fair Distribution Of Patented Vaccine Supplies

Even if funds become available to purchase brand-name vaccines produced by Moderna, Pfizer and others through the ACT Accelerator, the next problem will be the rapid scale-up of vaccine manufacturing and thus supplies. 

Rich countries have already snapped up huge quantities, if not the lions share, of all of the vaccines that Moderna and Pfizer are planning to manufacture next year. And to hedge their bets further, those same countries have also made pre-orders of vaccine doses from other pharma companies which have other front-running candidates in final stage trials.

Moderna’s vaccine is particularly relevant to low and middle income countries because the vaccine can be stored at 2 ° to 8 ° C (36 ° to 46 ° F) for up to 30 days, for longer at around -20 C ° (-4 F °). In comparison, Pfizer’s vaccine needs ultra-cold storage temperatures of -70 C ° or below. 

The Boston-based Moderna has said that it is on track to manufacture 1 billion vaccine doses in 2021 in collaboration with the Swiss-based manfacturing firm Lonza, at sites in the USA and Visp, Switzerland.

But with pre-orders for some 300.5 million doses, and options to purchase another 480 million more doses – high income countries already have a corner on the market for 780.5 milion out of the 1 billion doses to be produced by Moderna in 2021. Countries with the largest pre-orders and options include the United States, the European Union, Canada, Switzerland and Japan.

That would mean up to 78% of Moderna’s available vaccine supply would go to countries representing just 12% of the world’s population, as a coalition of NGOs recently pointed out.

Another issue being raised by access groups is the potential price tag companies will put on their vaccines, versus the public subsidies that the same vaccine R&D has already received.  Leading pharma firms developing COVID vaccines have so far received some US$ 12 billion in public funds, according to MSF. That includes Moderna’s receipt of some US$ 2.48 billion in United States government public funds. And yet Moderna’s reported price tag for the two-dose vaccine at $US 50-60 per course is the reported to be the “highest cited for a potential vaccine so far.”

Moderna’s ‘No Patents Enforcement’ – MSF Says Its Not Enough 

Against the background of the pandemic, Moderna, as well as other pharma companies have already made gestures indicating that they would not try to do business as usual.

AstraZeneca, another firm with a vaccine in Phase 3 trials, has pledged to sell its vaccine, if approved,  on a not-for-profit basis for as long as the pandemic continues. The company, which co-developed its vaccine with researchers at the UK’s Oxford University, also recently signed a licensing agreement with Brazil’s world-class public research institution, Fundação Oswaldo Cruz (Fiocruz) to produce 100 million vaccine doses. But critics point out that, despite these moves, the no-profit clause may only be good until July, 2021.

Moderna, for its part, has pledged “not to enforce our patents” on its novel mRNA vaccine technology for the duration of the pandemic. In theory, this could mean that other vaccine manufacturers with capacity to make biosimilar versions  (the biological equivalent of generics) could theoretically step into the vacuum, as soon as the Moderna vaccine wins FDA approval, to scale up production much more. 

But access advocates say that Moderna’s pledge so far has not included any commitment to actually license its novel mRNA technology to other manufacturers, so that they could acquire the know-how to produce the novel vaccine.  

While pharma voices point out that many low- and middle-income countries don’t even have the capacity to handle sensitive vaccine technologies, some do. They include India, which is the other key co-sponsor of the WTO initaitive. 

And for countries like India, with significant pharma export potential, a WTO waiver could be far easier to manage, sources say, than the current IP “flexbilities” offered by the TRIPS system in cases of public health emergencies.

Those TRIPS flexibilities largely revolve around Article 31 and 31bis of the TRIPS agreement, which stipulate that countries may issue “compulsory licenses” for patented products.  But, they must do so on a case-by-case basis, and for use primarily in domestic markets.  MSF sums up the rules, and their limitations, like this: 

• Article 31 requires that compulsory licenses are issued on a case-by-case basis and used predominantly to supply domestic markets, thereby limiting the ability of manufacturing countries to export to countries in need.
• Article 31bis 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.

Concludes the MSF brief, despite the “no enforcement” pledge, Moderna, Pfizer and other large pharma firms engaged in promising vaccine trials would need to go much further with voluntary steps to really make a difference in the yawning demand that will open up as soon as new vaccines and drugs are approved: 

“Moderna must share all IP, including the necessary technology, data and know-how, so that other manufacturers can scale up production of these potentially lifesaving vaccines. Many COVID-19 vaccine developers, including Pfizer/BioNTech, have taken no steps towards licensing or transferring IP-protected technologies to enable increased global manufacturing capacity and supply.” 

-Menaka Rao contributed to this story. 

Image Credits: WTO, Moderna TX, United Nations Photo, National Institutes of Health (NIH) .