To prevent the Covid-19 pandemic, a small number of companies with the help of their developed country partners invested billions of dollars in research and development of vaccines, vaccine technologies including mRNA, DNA, RNA, inactivated, viral vectors, protein subunits and test materials along with their production and distribution. To shield their huge investments, companies claim intellectual property rights including patents on vaccine products as mentioned in the World Trade Organisation (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) limiting vaccine production to their own territories and taking control of the global supply system. Not only that, they also apply vaccine nationalism policy by stockpiling vaccine doses several times higher than their population, which is only 14 per cent of the world's population, and prioritise their local market before exporting vaccines abroad.
To maintain a balance between the public interest and the exclusive right to commercially manufacture, use, distribute, import or sell vaccines without the consent of the patent owner, the World Health Organisation (WHO) leads the COVID-19 Technology Access Pool (COVAX) since April 2020 for ensuring global equitable access to Covid-19 vaccines on finding 1 in 4 people vaccinated in high?income countries compared to 1 in 500 people in poorer countries. Further, in the last one year, no pharmaceutical company has come forward to transfer its intellectual property, technology, and technology know-how through COVAX. Apart from some companies such as AstraZeneca, they have not entered into licensing agreements with other countries to manufacture vaccines locally; AstraZeneca's agreements allow the CSL in Australia and the Serum Institute in India to develop its vaccines and increase global production and supply. With the help of the Bill & Melinda Gates Foundation, various rich countries, corporations, and philanthropies, COVAX is working to supply collected vaccines to the Caucasus countries instead of ensuring their ability to acquire technology. It has now set a preliminary target of supplying 2 billion doses worldwide by the end of 2021 and is moving toward vaccinating at least 20 per cent of people in 92 developing countries and emerging economies. In addition, it is expecting 1.6 billion doses of vaccines to be supplied to these countries in the first half of 2022.
In addition to COVAX vaccines, developing and least developed countries (LDCs) are receiving some developed countries' surplus vaccines as gifts forming part of their vaccine diplomacy, and some from other sources or through COVAX at a reduced or subsidised rate. However, compared to the population of these countries and the growing coronavirus crisis therein, vaccine supply seems to be inadequate. In such a situation, the government of Bangladesh has given priority to the plan to bring 40 per cent of the people under the vaccination programme in the initial stage of vaccination. As part of this plan, the country has borrowed $500 million from the World Bank. The fund will cover the cost of preserving and distributing vaccines to 20 per cent of the country's population through COVAX, the cost of purchasing vaccines directly from producers or COVAX to 11 per cent of the population, and the cost of vaccine delivery. In addition, according to the initial plan, the government is interested in procuring vaccines using its own funds to bring 9 per cent more people under the vaccine programme. Besides, the recently concluded $940 million loan agreement with the Asian Development Bank will help the government procure more vaccines through COVAX and expand its vaccine activities.
Although COVAX and other sources may provide a temporary relief, low and middle-income countries require to have a long-term and sustainable vaccine solution. On their behalf, South Africa and India submitted a proposal to the WTO's 164-member TRIPS Council in October 2020 to temporarily waive the vaccine patent for locally producing and supplying them. They argue that the waiver will not only help in vaccine production, but also in the fight against the pandemic by producing drugs, related technologies, medical products such as treatments, diagnostic tests, and therapeutical equipment in countries that have the production infrastructure. In this case, countries like Bangladesh, India, South Korea, South Africa, and Canada claim that they have the production capacity, and they are interested in developing the Covid-19 vaccine.
Advocates of the request claim that such temporary waiver will reduce existing legal formalities for compulsory licensing or government use and allow vaccine developers to enter the market more quickly or popularise parallel imports. However, uncertainties remain whether the temporary waiver proposal includes the transfer of vaccines, drugs and related technology, financial incentives to vaccine companies, and the provision of supplying raw materials and ingredients like plastic bags, filters, glass-vials used in vaccine production.
Pharma lobbies, on the other hand, argue that patent waivers alone will not help low- and middle-income countries accelerate vaccine production unless they invest to build their own production capacity in the long run. Many countries and industrialists have joined them; one of them is Bill Gates, who later changed his mind after witnessing terrible Covid-19 deaths. According to them, the transfer of technology will not be of any use to these countries due to lack of their own production capacity and hence they need grants and technical assistance from developed countries to build this infrastructure. So instead of waiving patents, they recommend voluntarily licensing, transferring technology and providing more doses of the vaccine to countries through COVAX.
The Biden administration agreed to the short-term patent waiver request in the face of domestic and international demands. The subsequent support from Australia and New Zealand and the willingness of the European Union to negotiate paved the way. To make a ground for consensus, proponents of the proposal also retreated by shortening some of the request like intellectual property waiver for medicines, diagnostics, and treatments. They also garnered support from more than a hundred countries, but the TRIPS Council's April and June meetings could not reach a consensus. At the same time, other developed countries, including the United Kingdom, advise the supporters to follow the existing TRIPS flexibilities like compulsory licensing, parallel imports, government use or research exceptions, and transition period exempting medicinal patents for the production and supply of vaccines. In such context, supporters are expecting to raise this in the 12th Ministerial Conference to be held later this year in Geneva.
In the meantime, LDCs demanded at the TRIPS Council that the transition for exempting pharma patents be extended as long as they do not migrate to developing countries and those who will soon migrate to developing countries (such as Bangladesh who will get it in 2026) be granted a 12-year patent waiver for medicines. In this context, on June 29, 2021 the TRIPS Council extended the pharmaceutical patent exemption for LDCs until July 1, 2034, or as long as they did not pass to developing countries-- whichever came first. However, in the case of newly graduated developing countries, some countries have agreed to grant short-term concessions, but the TRIPS Council referred it to the WTO General Council as being outside the scope of article 66.1 of the TRIPS.
In this situation, without flexible conditions for transfer of vaccine technology, technical knowledge and raw materials, the drug patent exemption till 2034 or short-term patent exemption will not bring immediate benefit to a country like Bangladesh under the existing TRIPS structure. This is because the country is not currently required to patent drugs as an LDC, nor has any vaccine company applied for a patent by submitting the vaccine information here to enable it issuing compulsory licences. However, the country can easily import vaccines produced in other countries in the wake of temporary patent exemption or under existing TRIPS flexibilities. In addition, the country will be able to collect raw materials and make generics by 2026 after identifying the molecules of vaccines. However, if it graduates to a developing country, the drug patent waiver designed to protect public health in an LDC until 2034, in the absence of agreeing special benefits for a newly graduated developing country, will not be relevant to the country's vaccine accessibility by producing generics.
Dr Mohammad Towhidul Islam is a Professor of Law, University of Dhaka.
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