About TRIPS

• The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all the member nations of the World Trade Organization (WTO).
• The Agreement, which came into effect on 1 January 1995, is a comprehensive multilateral agreement on intellectual property.
• The TRIPS Agreement is often described as one of the three “pillars” of the WTO, the other two being trade in goods and trade in services.
• To facilitate the implementation of the TRIPS Agreement, the Council for TRIPS concluded with WIPO an agreement on cooperation between WIPO and the WTO, which came into force on 1 January 1996. 

Why in News?

• According to top government officials, the proposal of India and South Africa on providing temporary patent waiver at the WTO to deal with the pandemic has achieved ‘tremendous’ progress as the member-countries have agreed to start text-based negotiations.
• The TRIPS Council of the WTO has agreed to start the negotiations on a proposal submitted by India and South Africa seeking patent waivers.

What was the earlier proposal from India and South Africa?

• In October 2020, India and South Africa had asked the WTO to waive certain conditions of the TRIPS Agreement that could impede timely access to affordable medical products to combat Covid-19. 
• The countries had asked the TRIPS Council to recommend, as early as possible, a waiver on the implementation, application and enforcement of four sections in the second part of the agreement. 
• These sections — 1, 4, 5, and 7 — pertain to copyright and related rights, industrial designs, patents, and the protection of undisclosed information. 

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 is the argument in favour of relaxing TRIPS rules?

• The broader context for emergency action aimed at rapidly increasing vaccine availability across the world is the sharp surge in COVID-19 cases in India and Brazil. 
• Global concern also stems from the risk that the Indian variant, believed to be driving a second wave of devastating intensity in the country, could potentially fuel second or third waves across the world, causing a setback to the progress made in controlling transmission across the U.S. and EU. 
• Additionally, the Brazil and South African variants still pose a threat in some pockets. Across many affected nations, vaccine availability has emerged as a bottleneck impeding progress. 
• In this context, a fierce debate has been underway, pitting global-vaccine-access advocates against vaccine developers and pharmaceutical firms that rely on patented technology, usually of a highly specialised nature, to produce vaccines. 

Besides patents, what are the other roadblocks to scaling up production?

• The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has pointed to other “real challenges” in scaling up production and distribution of Covid-19 vaccines. These include trade barriers, bottlenecks in supply chains, scarcity of raw materials and ingredients in the supply chain, and the unwillingness of rich countries to share doses with poorer nations.
• The scarcity of raw materials has been a growing issue for ramping up production; several manufacturers have been relying on specific suppliers, and alternatives are limited. Also, 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.
• This led to a delay in the production of Covid vaccines by some companies in India. 
• Also, there may be serious issues associated with manufacturing vaccines, for example, with those based on messenger RNA (mRNA) technology, if there is just an easing of the associated intellectual property rights rules but no further support to generic pharmaceutical firms in countries such as India and South Africa. This is because a “tech transfer” is also needed for the latter to actually commence production, especially for mRNA vaccines, including the ones produced by Moderna and Pfizer along with BioNTech. To illustrate, Pfizer has pointed out that its vaccine requires the use of 280 components from 86 suppliers and highly specialised manufacturing equipment. 
• There is also a strong likelihood that it will take a considerable amount of time, even several years, for generic producers’ plants to become operational at optimal capacity. This raises the question of whether today’s vaccines would even be relevant at that point in time, especially if new variants prove resistant to vaccine formulations currently available.
• Finally, there is the classic counter-argument to calls for patent relaxations, that such policies could discourage pharmaceutical companies from investing in producing next-generation vaccines. Though many, including Mr. Biden, have argued that humanitarian need trumps the profit motive during a pandemic, the decision to waive all TRIPS rules should be preceded by a rigorous analysis of the effects such a policy would have on the biotechnology sector and global supply chains for its products.

Reference:

1. https://economictimes.indiatimes.com/news/international/world-news/wto-inches-forward-in-covid-vaccine-patent-waiver-talks/articleshow/83390518.cms