By Brave Well Mawthoh
It is a tremendous achievement in the history of humankind that within one year since the beginning of the pandemic, scientists across different countries have come up with several vaccines to combat the coronavirus pandemic. However, vaccines are unevenly manufactured and distributed worldwide, with the rich and vaccine manufacturing countries inoculating a significant percentage of their population. In contrast, people of low and middle-income countries (LMICs) could not access these vaccines and other related medical products. As a result, they have been haplessly gazing and waiting in the queue to receive their share of the vaccines. Recently with the backing of the US, the demand to temporarily remove intellectual property (IP) protection and patent rights on coronavirus vaccines has gained steady momentum. The European Union and numerous countries have also joined in reconsidering their decision to waive IP protections and patents on coronavirus vaccines.
The demand was initially put forward by India and South Africa to WTO in October 2020 to waive intellectual property rights (IPRs) on vaccines, therapeutics and other allied medical supplies required to fight against the coronavirus pandemic. They argued that LMICs might also have adequate access to the vaccines by waiving IP protections and patents. More than 100 developing countries have supported this proposal. France and Russia have also abetted the waiving of IP protections and patents on vaccines. However, the manufacturing of vaccines is exclusively and predominantly controlled by few big firms located in high-income countries (HICs). As a result, there is a substantial gap in the number of vaccines received by LMICs and HICs. Earlier, most HICs such as the UK, US, Hungary, and the EU have rejected this move, insisting that waiving IP protections and patents will harm competitiveness since intellectual property rights and patent rights drive innovations, research, and development. They also disagreed that IP protection and patents act as a constraint in the manufacturing, supply chain and distribution of the vaccines. The WTO is likely to take up the matter in its next ministerial conference in November this year. Typically, WTO makes decisions through consensus, and voting is infrequent.
Only a few countries such as the US, China and India have administered the maximum number of doses to their citizens. India being a country with an enormous population, has vaccinated less than 14.7% of its populace. Nearly a dozen countries have succeeded in fully vaccinating more than 50% of their masses. However, the vaccination drive worldwide is biased, with HICs vaccinating a more significant percentage of their population. Some of these countries, such as the US, also hoard vaccines in large quantities more than their required capacity. Many LMICs received a petty share or could not have access to these vaccines. Therefore, advanced countries should shift their excess doses to countries in desperate need of vaccines. The coronavirus situation is significantly more acute in many Asian and African countries. There are incidences of under-reporting of the number of cases and death tolls. A remarkably few percentages of its population have vaccinated against the coronavirus. The shortage arises because the production and distribution of the vaccines are managed only by few colossal firms located in a few HICs. Many of them have engaged in a bilateral contract with these firms placing orders in bulk.
Several agencies and countries belonging to HIC groups have sponsored these firms in the initial stages of research and development. Hence, these countries impel firms to meet the demand made by them first. However, since they are yet to fulfil the order placed by most HICs, they cannot carry out the orders and distribution of vaccines set by LMICs. Many developing countries hinge on supply from rich countries since they cannot produce the vaccines independently. By waiving IP protections and patents on vaccines, it will permit manufacturing by countries such as Canada, South Korea and Bangladesh who have expressed their intention. It will enable manufacturers in middle-income countries to enter the race and speed up the production on a large scale and ensure even distribution of the vaccines to all nations. It will also ensure that all countries get access to the necessary vaccines vital to fighting the coronavirus. Thus, we can combat the virus and overcome the devastation caused by it in a shorter period.
Earlier, many HICs have challenged the proposal saying that waiving patent on vaccines may impede research and development on vaccines in the future, which is vital to innovations. Leading pharmaceutical vaccine manufacturers also opposed the move, asserting that waiving patent on vaccines is not the solution. The real challenge which may impact vaccines supply, according to them, include trade barriers, bottlenecks in supply chains, scarcity of raw materials and ingredients in the supply chains and hesitancy on the part of the rich countries to share the vaccines with poorer countries. In addition, there is a scarcity of raw materials, which hinder the production process. Experts also claimed that removing patents on the vaccines may instead be detrimental. Also, there are likelihoods that manufacturers may compromise on the safety and quality standards of the vaccines in a rush to produce them in large quantities. They argued that manufacturers in LMICs might not have the required know-how and technology. They may not have the essential raw materials to make the vaccines even if there is a patent waiver. Earlier, several countries, like the US with the required raw materials, controlled their supply using the American Defence Production Act. It has affected countries like India which depend on the US for raw materials.
There are many other ways for vaccine manufacturers in LMICs to boost the vaccine supply. They may do so by voluntary licenses, contract manufacturing and proactive technology transfers. In the case of a voluntary license, a patent-holding company will give authorisation to a generic company. The patent holder company will monitor the quality and safety of the vaccines and also their supply. In contract manufacturing, the patent holder company will hire a contract manufacturer. Like in the case of a voluntary license, the patent holder company will monitor the quality and safety of the vaccines. In case of technology transfer, the patent holder company will share the knowledge, skills, expertise, and technology and know-how to a company in LMICs to ensure that the vaccines are accessible and constantly monitor their production.
Countries can also produce vaccines under the WTO’s TRIPS flexibilities via compulsory licensing, enabling LMICs to issue compulsory licenses to vaccine manufacturers to produce them for domestic uses without the permission of the patent holder company. The LMICs can also collectively purchase the patent rights from these vaccine producing firms and use them to rapidly increase the supply of vaccines and supply them equitably to all countries across the world. In all these cases, they should financially recompense vaccine manufacturing firms for acknowledging their efforts and encouraging them to invest in research and development in the future. It will also lessen the risk of investment in the research and development of vaccines, thus assuring investment stability in research and investment in vaccines and other medicinal products. Many countries, including India, have already produced the vaccines using either one or some of these alternatives.
The temporary waiving of intellectual property rights is not only the answer to speed up vaccines supply. The waiver may not help ramp up the production of vaccines because many LMICs may not have the production capacity. Also, the vaccine manufacturers cannot meet the global demand in a short span. Hence, what is required is a global proactive co-action, collaboration and collective responsibility. The vaccine manufacturers and government of different countries should work together to ensure that vaccines supplies are ramped up and at the same time ensure that safety and quality standards are maintained. They need to identify manufacturers in LMICs who can produce and collectively work to meet global demands and ensure equitable access to vaccines for all. We should approach this race of ramping up vaccine production as a global fight against the coronavirus pandemic. The world will swiftly emerge out of this pandemic only when enough vaccines are available and all countries have vaccinated their population fully within a shorter span.
(The writer is Assistant Professor, Don Bosco College, Tura: Email [email protected])