GS-2: Effect of policies and politics of developed and developing countries on India’s interests, Indian diaspora
GS-2: Government policies and interventions for development in various sectors and issues arising out of their design and implementation.
Intellectual property waiver for Covid-19 vaccines
Context: The United States recently announced support for waiving intellectual property protection for Covid-19 vaccines, saying extraordinary circumstances call for extraordinary measures.
All 164 WTO members must agree on the draft, and any one member can veto it. The European Union, which had earlier opposed the waiver, has now stated its intent to discuss the US-backed proposal.
What are patents and IP rights?
A patent represents a powerful intellectual property right, and is an exclusive monopoly granted by a government to an inventor for a limited, pre-specified time.
It provides an enforceable legal right to prevent others from copying the invention.
Patents can be either process patents or product patents.
A product patent ensures that the rights to the final product is protected, and anyone other than the patent holder can be restrained from manufacturing it during a specified period, even if they were to use a different process.
A process patent enables any person other than the patent holder to manufacture the patented product by modifying certain processes in the manufacturing exercise.
India moved from product patenting to process patenting in the 1970s, which enabled India to become a significant producer of generic drugs at global scale, and allowed companies like Cipla to provide Africa with anti-HIV drugs in the 1990s.
But due to obligations arising out of the TRIPS Agreement, India had to amend the Patents Act in 2005, and switch to a product patents regime across the pharma, chemicals, and biotech sectors.
What does the intellectual property waiver for Covid-19 vaccines mean?
Increased Production: Most production is currently concentrated in high-income countries. The IP waiver might open up space for production of Covid vaccines with emergency use authorisations (EUA) on a larger scale in middle-income countries. production by middle-income countries has been happening through licensing or technology transfer agreements.
Countries including Canada, South Korea, and Bangladesh have shown interest in making Covid vaccines if they can get a patent waiver
Role by India: The US support for an IP waiver stems from a proposal by India and South Africa in the WTO last year. That proposal had, however, called for a waiver on all Covid interventions, including testing diagnostics and novel therapeutics.
What are the deterrents for the waiver?
Undermine R&D Investment: Pharma companies including Pfizer and AstraZeneca have opposed the proposed waiver — saying eliminating IP protections would undermine the global response to the pandemic, including the ongoing R&D efforts to tackle new variants.
Doubts on Safety from new facilities: Pharma Companies also argued that waiving IPR & opening production facilities in developing countries could also undermine public confidence in vaccine safety and create a barrier to information sharing.
Besides patents, what are the other roadblocks to scaling up production?
Trade barriers: Countries like the US had blocked exports of critical raw materials used in the production of some Covid-19 vaccines using regulations like the American Defence Production Act.
Bottlenecks in supply chains
Scarcity of raw materials and ingredients in the supply chain
Unwillingness of rich countries to share doses with poorer nations.
