Intellectual Property Rights waiver
- 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 the World Intellectual Property Organization (WIPO) an agreement on cooperation between WIPO and the WTO, which came into force on 1 January 1996.
- As per the TRIPS provisions, the member countries are required to adopt TRIPs provisions in their domestic intellectual property legislations like Patent Act, Copyright Act etc. TRIPs agreement is an effort to bring national legislations under common international rules.
- The areas of intellectual property that TRIPS covers are: copyright and related rights; trademarks; geographical indications; industrial designs; patents; the layout-designs of integrated circuits; and undisclosed information including trade secrets and test data.
- In India, the government has made a major amendment to the 1970 Patent Act in 2005 to accommodate the TRIPS provisions. In 2010, the Copyright Act was amended and enforced from 2012. Other legislations with respect to Industrial designs also have been made.
Why in News?
- India has pitched for an early outcome of the TRIPS waiver proposal for COVID-19 vaccines, therapeutics and diagnostics in the World Trade Organisation (WTO).
- 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.
- In May this year, a revised proposal was submitted by 62 co-sponsors, including India, South Africa, and Indonesia.
- The proposal, if passed by the WTO, could dramatically alter how pharmaceutical companies worldwide access proprietary trade know-how for the production of leading vaccines.
- However, questions remain regarding whether the easing of TRIPS rules for COVID-19 vaccines will lead to a greater supply of efficacious vaccines in countries where they are the most needed, or if less circuitous options to boost supply are more relevant in the present scenario.
What was the earlier proposal from India and South Africa?
- 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.
- 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.
- Also, there may be serious issues associated with manufacturing vaccines 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.
- 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.
- 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 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.
View all comments