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 so-called “TRIPS Waiver” of the WTO’s requirements by India and South Africa, along with co-sponsors Eswatini and Kenya, was first discussed last month by 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.

[huge_it_slider id=”15″]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 versions of new up-and-coming drugs, such as monoclonal antibodies. Ditto for the barriers to producing “biosimilar” versions of 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 of |FDA vaccine approvals by December, the race will be on to roll out production and distribution – and the questions of who gets what vaccines first – 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 more and more anxious.

According to the new MSF briefing paper, based on informal polling, a majority of WTO members could indeed already support the waiver proposal either fully or in principle.  Those expressing full support, include a mix of middle-high to low-income countries: 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 reportedly “welcomed” the proposal and say it should be discussed. 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, obtained by Health Policy Watch, support has been expressed in principle expressed 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 support,  most of the world’s developed countries have lined up against, led by the United States, the United Kingdom, Australia, Japan and the European Union – but also including Switzerland, Brazil, Norway and Canada.

‘No Patents Enforcement’

Moderna has already pledged “not to enforce our patents” on its COVID-19 vaccine for the duration of the pandemic – meaning that manufacturers of biosimilar versions (the biological equivalent of generics) could step in very soon after the vaccine is approved by regulatory authorities to support massive production.

The company also 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 medicines advocates have said that is not nearly enough. For starters, Moderna’s pledge so far has not included a critical promise to “license” its novel mRNA technology to other vaccine manufacturers in the developing world, particularly India, which would have the capacity to handle sensitive vaccine technology.

States the MSF brief despite the “no enforcement” pledge, Moderna needs to go further: , “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.”

The Hurdle of Fair Distribution Of Patented Supplies

Rich countries have already snapped up huge quantities, if not the lions share, of next year’s projected vaccine supply from Moderna and Pfizer, as well as other companies with front-running vaccine candidates in final stage trials.

In the case of Moderna’s vaccine, for instance, high income countries have already made pre-orders for some 300.5 million doses, and have options to purchase another 480 million more – for a total of 780.5 milion out of the 1 billion doses to be produced in 2021. Countries with large 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.

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 °). This, in comparison to Pfizer’s vaccines which needs ultra-cold storage temperatures of -70 C ° or below. That makes Moderna’s vaccine much more accessible to developing countries with limited cold-chain capacity – and even to rural regions of high-income countries.

Image Credits: Moderna TX.