A small number of pharmaceutical companies, with the support of governments in developed countries, have invested billions of dollars in research and development of COVID-19 vaccines, related drugs and technologies, including mRNA, DNA, RNA, viral vector, protein subunit and test material as well as their manufacture and dissemination. To recoup the huge investment, they claim intellectual property, including patents and trade secrets, restrict vaccine production in their respective territories, and control global supply despite huge sums of public money spent on the whole. of the process. Not only that, they are also implementing vaccine nationalism by securing doses of the vaccine that are many times greater than their population and prioritizing their local markets before vaccines are exported overseas.
In order to maintain the balance between the exclusive right of the vaccine patent holder to manufacture, use, distribute, import or sell the vaccine and the public or societal interest, the pool of access to COVID-19 technology (COVAX) initiated by the WHO program has been established. In high-income countries, 1 in 4 people are vaccinated compared to 1 in 500 people in the poorest countries and as of March 4, at least 47 countries have not yet vaccinated anyone. Without improving this ratio, these countries will have to see disease and death of their unvaccinated people until 2023 or later, as predicted by the New York Times.
However, no pharmaceutical company has come forward within a year to share their intellectual property, know-how and technology through COVAX. Most have not even entered into licensing agreements with other countries to produce the vaccines locally, with the exception of some companies like AstraZeneca whose contracts allow CSL in Australia and the Serum Institute of India to manufacture its vaccines. and to increase production and supply around the world. With meager donations from countries, businesses and philanthropic organizations, including the Bill and Melinda Gates Foundation, COVAX is acquiring vaccines instead of helping countries access technology. It now sets the main objective of delivering 2 billion doses by the end of 2021 and aims to cover at least 20% of the population of developing countries and emerging economies.
Although COVAX vaccines are reaching countries, developing and least developed countries (LDCs) are struggling to fill the void amid the deteriorating coronavirus crisis. To respond to the pandemic, Bangladesh, for example, has prioritized the plan to cover 40% of the population in the first phase of vaccination. As part of this plan, she took out a loan of $ 500 million from the World Bank. The funding will cover the cost of storage and distribution of vaccines acquired through COVAX because the latter has promised to vaccinate about 20% of the population free of charge and the cost of purchasing vaccines directly for 11% of the population from manufacturers or via COVAX, and the costs of administering the vaccination. The government is also procuring vaccines using its own funds to cover an additional 9% of the population according to its initial vaccination plan.
To respond to the pandemic with additional COVID-19 vaccines, low- and middle-income countries led by South Africa and India, in October 2020, requested a temporary waiver of their intellectual property, in accordance with the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS) before the TRIPS Council made up of the 164 members of the WTO. They argued that it would help them produce not only COVID-19 vaccines, but all the drugs, technologies and other related medical products to fight the pandemic, such as treatments, diagnostic tests and medical equipment in the locations where manufacturing facilities exist. For example, countries like Bangladesh, South Korea and Canada have claimed to have manufacturing capacity and are interested in producing COVID-19 vaccines on patent waiver.
However, it is uncertain whether the request for a temporary intellectual property exemption will include the transfer of vaccines, drugs and related technologies and know-how from pharmaceutical companies, financial incentives for these companies and the supply of raw materials. and ingredients such as plastic bags, filters and glass vials used in vaccine production.
Proponents of the waiver proposal expect the temporary suspension of patents and other intellectual property rights relating to vaccines and other related technologies to reduce legal formalities for compulsory licenses or facilitate parallel imports.
On the other hand, pharmaceutical lobbies argue that a simple patent waiver does not help low- and middle-income countries speed up vaccine production unless they have their own time-consuming manufacturing capacities. and a considerable investment. Supporting the pharmaceutical lobby, critics – particularly Bill Gates, who recently narrowly reversed his stance amid criticism and seeing horrific deaths in India and Brazil – also argue that many developing countries and LDCs failed to manufacturing capacities needed to produce vaccines cannot benefit from the transfer. technologies unless they receive aid to build the infrastructure with grants and technological assistance from developed countries. So instead of giving up patents, they suggest voluntary licenses, technology transfer agreements and more doses to be delivered to these countries via COVAX.
One way forward is the Biden administration’s statement focused primarily on vaccine patent waivers, Australia and New Zealand approval, and the EU’s willingness to discuss the US proposal. but it must be decided by consensus in the TRIPS Council, which already has 100 WTO members on board. . At the last council meeting held on April 30, 2021, the temporary suspension was not approved, but members agreed to continue reviewing the proposed temporary waiver of certain TRIPS obligations in response to COVID-19 when of its next meeting to be held on June 8-9, 2021. In an effort to bring together each other’s positions, the sponsors of the proposal have announced that they will present a revised proposal to the text submitted earlier which requested a waiver intellectual property rights for vaccines, drugs, diagnostics and treatments.
So, if the short-term patent exemption decision for COVID-19 vaccines is granted, it will directly help developing countries with patent information for vaccines to allow local pharmaceutical companies to produce vaccines and license them. supply at home and abroad, including LDCs like Bangladesh. However, if the decision for temporary patent exemption for COVID-19 vaccines includes the transfer of vaccine technology, know-how and raw materials on more flexible terms than those taken for the Doha Declaration on Public Health in 2001, this will directly benefit Bangladesh by producing vaccines.
The writer is a professor of law at the University of Dhaka.