Vaccine patent waiver debate, COVAX and Bangladesh

A small number of pharmaceutical companies with the support of developed country governments invested billions of dollars in research and development of COVID-19 vaccines, related medicines, and technologies including mRNA, DNA, RNA, viral vector, protein subunit and testing materials along with their production and distribution. To recoup the huge investment, they claim intellectual property including patents and trade-secrets therein, restrict the vaccine production to their respective territories and control the global supply despite the huge amounts of public money directed into the whole process. Not only that, they also implement vaccine nationalism by securing vaccine doses several times higher than their population and prioritising their local markets before vaccines are exported overseas.

In order to maintain the balance between the vaccine patent owner's exclusive right to make, use, distribute, import, or sell the vaccine and the public interest or the interest of the society, the WHO-initiated COVID-19 Technology Access Pool (COVAX) programme has been put in place. In high-income countries 1 in 4 people are vaccinated compared to 1 in 500 people in poorer countries and as of 4 March at least 47 countries are yet to vaccinate anyone. Without improving this ratio, such countries will have to see sickness and death of their unvaccinated people until 2023 or later as the New York Times predicts.

However, no pharmaceutical company has come forward within one year to share its intellectual property, know-how, and technology through the COVAX. Most have not even entered licensing contracts with other countries to locally produce the vaccines except some companies like the AstraZeneca whose contracts allow the CSL in Australia and the Serum Institute of India to make its vaccines and increase the production and supply worldwide. With the meagre donation of countries, corporations, and philanthropies including the Bill and Melinda Gates Foundation, the COVAX acquires vaccines instead of helping countries access the technologies. It now sets the primary target to deliver 2 billion doses by the end of 2021 and aims to cover at least 20% of people in developing countries and emerging economies.

Although the COVAX vaccines are reaching countries, developing and least developed countries (LDCs) are struggling to fill the gap amid the deteriorating coronavirus crisis. To respond to the pandemic, Bangladesh, for example, has prioritised the plan of covering 40% of the population in the first phase of vaccination. As part of this plan, it has taken a loan of $500 million from the World Bank. The funding will cover the cost of storing and distribution of the vaccines acquired through the COVAX as the latter promised to freely vaccinate about 20% of the population and the direct vaccine procurement cost of 11% of the population from manufacturers or through the COVAX, and the costs related to administering the vaccination. The government is also acquiring vaccines using its own funds to cover another 9% of the population as per 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, sought for a temporary waiver of intellectual property thereof as enshrined in the World Trade Organisation (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS) before the TRIPS Council consisting of all 164 WTO members. They argued that it would help them produce not only COVID-19 vaccines, but all related medicines, technologies, and other medical products to fight the pandemic such as treatments, diagnostic tests, and medical equipment in places where manufacturing facilities exist. For example, countries like Bangladesh, South Korea and Canada have claimed that they have the manufacturing capacity, and they are interested to produce COVID-19 vaccines on waiver of patents.

However, it is not certain whether the temporary intellectual property waiver request will include the transfer of pharmaceutical companies' vaccine, medicines, and related technology and know-how, financial incentives for such companies, and supply of raw materials and ingredients like plastic bags, filters, and glass-vials used in the vaccine production.

Sponsors of the waiver proposal expect that temporary suspension of patents and other intellectual property rights relevant to vaccines and other related technologies will curtail legal formalities for compulsory licensing or facilitate parallel imports.

On the other hand, pharma lobbies argue that a simple patent waiver does not help low and middle-income countries accelerating the vaccine production unless they have their own manufacturing capabilities requiring huge time and investment. Supporting the pharma lobby, critics – especially Bill Gates, who recently narrowly reversed his position amidst criticisms and seeing the horrendous deaths in India and Brazil – also submit that many developing countries and LDCs lacking the manufacturing capacities required to produce vaccines cannot benefit with the transfer of technologies unless they receive help to build the infrastructure with grants and technological assistance from developed countries. So, instead of waiving patents, they suggest voluntary licensing, technology transfer arrangements, and more doses to be delivered to these countries through the COVAX.

The Biden administration's statement centring primarily on waiver of vaccine patents, Australia and New Zealand's endorsement thereto and the EU's readiness to discuss the US proposal are a way forward, but it must be decided by consensus in the TRIPS Council having already 100 WTO members on board. In the last council meeting held on 30 April 2021, the temporary suspension was not approved but members agreed to continue consideration of the proposal for a temporary waiver of certain TRIPS obligations in response to COVID-19 in its next meeting due to be held on 8-9 June 2021. In a bid to bring together each other's positions, sponsors of the proposal announced they would come up with a revised proposal of the text submitted earlier that requested intellectual property waiver for vaccines, medicines, diagnostics, and treatments.

The writer is a Professor of Law at the University of Dhaka.