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Patent Waiver : The Way Forward?

Patent Waiver The Way Forward?

INTRODUCTION

Following the Biden administration’s public expression of support to the patent waiver request filed by India and South Africa at the World Trade Organisation (WTO), several leading magazines and newspapers have published articles and editorials regarding the effectiveness of such a measure. Given the importance of the topic, we present a sequel to last week’s article which discussed the issue in brief.

Closely on the heels of the announcement, the Director General of the World Health Organisation (WHO) applauded the move as reflective of the moral leadership in the United States (US) and as a “monumental moment in the fight against COVID-19.” The waiver would be a decision affecting not just intellectual property rights and public health but also economics as seen by reports that on the day of the announcement, major vaccine manufacturing companies like Moderna and Pfizer saw a marked drop in their share prices. While 130 countries including the US have now endorsed the waiver, important countries such as the UK and Germany have blocked the move.

It is pertinent to note that several scientists in the UK have stated that the patents and allied IP rights are creating a major obstacle in the administration of vaccines at the national level. It has been warned that the government is acting towards production of variants and not vaccines, by continuing to enforce patent rules parallel to the vaccination program. Vaccination against COVID-19 and the bottlenecks therein are an interconnected global problem like the pandemic itself and not endemic to the poorer nations. The longer poorer countries take in fully vaccinating their population, the more other countries will have to deal with variants amidst their respective populace. Furthermore, if the current rate of infection in the lower income countries is allowed to progress unchecked, the virus would undergo enough mutations to render the existing vaccines ineffective and wholly redundant. This implies that countries will have to look beyond their own economic interests to foster public health across the globe in order to make long term gains against the pandemic. While the offer made by countries to “donate” vaccines may seem benevolent, it is important to remember that what is being offered is only ten percent of the global requirement and therefore, increasing vaccine production by expanding manufacturing units seems to be the prudent step.

Opposition to the patent waiver is manifold but not without strong counter arguments. An argument often made is that the higher income countries like the US and Germany have invested money, carried out research and succeeded in finding a vaccine and vaccine nationalism dictates that their citizens are entitled to a pre-emptory right on the medicine. However, this moral defense does not stand strong. The TRIPS contains numerous provisions which enjoin upon developed countries to promote technology transfer to the least developed counties. For example, Article 7 states that “the protection and enforcement of IP rights should contribute to the promotion of technological innovation and the transfer and dissemination of technology, to the mutual advantage of producers and users of technical knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.” Similarly, Article 66.2 also mandates the developed countries to transfer technologies to LDCs to enable them to create a sound and viable technological base. It is notable that the Low to Middle Income Countries promptly opened their markets and amended domestic patent laws favouring developing countries’ products against this promise of technology transfer.

Another argument against the proposed TRIPS waiver is that a waiver would not increase the manufacturing of COVID-19 would be vaccines. It is undeniable that a lack of manufacturing capacity in the global south is a significant factor of the vaccine shortage. While a TRIPS waiver would not result in an immediate increase of manufacturing capacity, it would be the first step and set the trail ablaze. A waiver of TRIPS would mean teh relaxation of export blockages and import restrictions of not just the finished vaccine medicine but also the various raw materials required in the production of the packed vials of vaccine preparation. Existing barriers in international trade harm the overall output of the vaccine supply chain. A TRIPS waiver followed by consequent relaxation of the bottlenecks would incentivise more governments and companies to invest in repurposing their facilities.

Similarly, arguments such as that generic manufacturing of vaccines that require complex production processes would jeopardise quality, have also been proven wrong in the past. For instance, in the early 1990s, when Indian company Shantha Biotechnics approached a Western firm for a technology transfer of Hepatitis B vaccine, the firm responded that India cannot afford such high technology vaccines and the scientists would not understand recombinant technology in the least. Later, Shantha Biotechnics developed its own vaccine at $1 per dose, and the UNICEF (United Nations Children’s Emergency Fund) mass inoculation programme uses this vaccine against Hepatitis B. In 2009, Shantha sold over 120 million doses of vaccines globally.

India also produces high-quality generic drugs for HIV/AIDS and cancer treatment and markets them across the globe. Now, a couple of Indian companies are in the last stage of producing mRNA (Messenger RNA) vaccines. Similarly, Bangladesh and Indonesia claimed that they could manufacture millions of COVID-19 vaccine doses a year if pharmaceutical companies share the know-how. Recently, Vietnam also said that the country could satisfy COVID-19 vaccine production requirements once it obtains vaccine patents. Countries like the United Arab Emirates (UAE), Turkey, Cuba, Brazil, Argentina and South Korea have the capacity to produce high-quality vaccines but lack technologies and know-how. However, Africa, Egypt, Morocco, Senegal, South Africa and Tunisia have limited manufacturing capacities, which could also produce COVID-19 vaccines after repurposing.

CONCLUSION

The COVID-19 vaccine IPR runs across the entire value chain – vaccine development, production, use, etc. A mere patent waiver may not be enough to address the issues related to its production and distribution. What is more important here is to share the technical know-how and information such as trade secrets. Therefore, the existing TRIPS flexibilities, such as compulsory and voluntary licensing, are insufficient to address this crisis. Further, compulsory licensing and the domestic legal procedures it requires is cumbersome and not expedient in a public health crisis like the COVID-19 pandemic.

Thus an immediate global response to start the process of technology transfer along with relaxation of patent and other IPR barriers would help in efficient mitigation of the pandemic.

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