The World Trade Organization (WTO) and its related agreements, specifically the Trade-Related Aspects of Intellectual Property Rights (TRIPS), have come into focus recently due to the ongoing Covid-19 pandemic. A recent disclosure by Geneva Health Files, a specialized publication based in Switzerland, highlighted that a handful of WTO members were considering exempting Indian and Chinese drug manufacturers from the intellectual property rights obligations outlined under TRIPS. This has sparked discussions concerning patent waivers and the implications for the global fight against Covid-19.
The TRIPS Agreement and Its Connection with Indian Patent Law
Negotiated in 1995 within the WTO framework, the TRIPS agreement mandates all signatory countries to formulate domestic laws aiming to protect intellectual property rights. These protections enable inventors to reap profits from their innovations across countries.
A crucial moment in this context came in 2001 when WTO members agreed upon the Doha Declaration. This declaration clarified that governments could compel businesses to license their patents to manufacturers in public health emergencies, even if the firms found the offered price unacceptable. This provision, known as “compulsory licensing,” was already incorporated in the TRIPS agreement, and the Doha declaration simply clarified its application. Under Section 92 of the 1970 Indian Patents Act, India’s central government can authorize compulsory licenses in national emergencies or situations of extreme urgency.
Why Invoking Compulsory Licensing is Necessary
With the richest countries having secured approximately 80% of the world’s vaccine supplies, there is a pressing need to increase production. Compulsory licensing can facilitate the augmentation of drug supply. Moreover, a firm position on compulsory licenses could potentially persuade pharmaceutical companies to provide voluntary licenses.
India, dubbed the ‘pharmacy of the world,’ could bolster this reputation by licensing Covaxin widely, thereby putting pressure on developed nations to share their vaccine technology. This could also encourage the Indian government to transfer Covaxin’s technology to domestic pharmaceutical companies, thereby boosting national supplies and offering it to foreign corporations as well. Such a move would demonstrate India’s determination to uphold the TRIPS waiver.
Challenges Associated with TRIPS Waiver
However, implementing a TRIPS waiver is not without its difficulties. Vaccine development and manufacturing involve multiple stages and a convoluted intellectual property mechanism, with different types of IP rights applicable to different phases.
Moreover, the complex nature of vaccine production includes designing the production process, sourcing raw materials, constructing production facilities, and obtaining regulatory approvals through clinical trials. Consequently, a patent waiver alone wouldn’t enable manufacturers to launch vaccine production immediately.
Favorable Regulatory Environment
To address these challenges and instill trust in India’s ability to handle the supply and distribution of vaccines, the government must provide reliable commitments. Alongside this, expedited processes for vaccine approval can assist India in addressing its supply shortfall promptly. By doing so, the country can forge a path towards establishing a more favorable regulatory environment and strengthen its position as a critical player in the global pharmaceutical landscape.