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India's Covid choices - Waiver in TRIPS Waiver versus Compulsory Licencing
Read more on - Polity | Economy | Schemes | S&T | Environment
- The story: India and South Africa brought a proposal to request waiver on key provisions of the TRIPS agreement on Covid-19 vaccines, drugs, therapeutics, and related technologies. This proposal was later backed by the U.S also, in a major shift of stance.
- What would waiver do: The TRIPS waiver proposal would give immunity to member countries from a legal challenge at the WTO if their domestic Intellectual Property Regulation (IPR) laws suspend or do not enforce IP protection. The idea is that the IPR should not become barriers in scaling up production of medical products essential to combat Covid-19. But experts feel this TRIPS waiver alone may not help India. Instead of obtaining an IP waiver, the Indian government must enable vaccine manufacturers expand production through compulsory licensing & reduce inefficiencies in procurement & distribution.
- TRIPS Agreement & Indian Law: The TRIPS agreement was negotiated in 1995 at the WTO, and requires all its signatory countries to enact domestic patents law in consonance with it. It thereby guarantees minimum standards of IP protection. The idea is that such legal consistency enables innovators to monetise their intellectual property in multiple countries.
- From Doha to 2021 - In 2001, the WTO signed the Doha Declaration, which clarified that in a public health emergency, governments could compel companies to license their patents to manufacturers, even if they did not think the offered price was acceptable.
- This provision is “compulsory licensing”, was already built into the TRIPS Agreement and the Doha declaration only clarified its usage.
- Under Section 92 of the 1970 Indian Patents Act, the central government has the power to allow compulsory licenses to be issued at any time in case of a national emergency or circumstances of extreme urgency.
- Why wavier not a panacea: The process of vaccine development and manufacturing has several steps, and involves a complex intellectual property mechanism. Different types of IP rights apply to different steps and there is no one kind of IP that could unlock the secret to manufacturing a vaccine. The expertise to manufacture it may be protected as a trade secret, and the data from clinical trials to test vaccine safety and efficacy may be protected by copyright. Then, manufacturing vaccines will need to design the process for manufacturing the vaccines, source necessary raw materials, build production facilities, and conduct clinical trials to get regulatory approvals. The manufacturing process itself has different steps, some of which may be subcontracted to other parties. So a patent waiver alone does not empower manufacturers to start vaccine production immediately.
- Go for 'Compulsory Licensing': The richest countries have cornered about 80 percent of vaccine supplies so far! While India needs to supplement its output to ensure that a population of over 900 million which is above 18 years of age gets about 1.8 billion doses at the earliest. So compulsory licensing can be used to augment the supply of drugs and other therapeutics. An assertive posture on compulsory licences would also have the advantage of forcing several pharmaceutical companies to offer licences voluntarily. Licensing Covaxin widely would enable India to live up to its reputation of being the ‘pharmacy of the world’ and also put pressure on developed countries to transfer their vaccine technology to developing countries. By unlocking its vaccine technical know-how to the world, India would demonstrate its resolve to walk the talk on the TRIPS waiver.
- Summary: India has played a key role in mainstreaming TRIPS flexibilities like the compulsory licence at the WTO. In this global emergency, the government should urgently make use of compulsory licences. Otherwise, shortages may linger long enough to kill thousands more Indians.
- Knowledge centre:
- Indian Patents Act 1970 - The Patents Act 1970, along with the Patent Rules 1972, came into force on 20 April 1972, during the Indira Gandhi regime, replacing the Indian Patent and Design Act 1911. The Patent Act is based on the recommendations of the report Justice Iyengar Committee headed by Rajagopala Iyengar. One of the recommendations was the allowance of process patents in relation to inventions related to drugs, drugs, food and chemicals. Again The Patents Act, 1970 was amended by the Patents (Amendment) Act, 2005 regarding extending product patents in all areas of technology including food, medicine, chemicals and microorganisms. Following the amendment, provisions relating to exclusive marketing rights (EMR) have been repealed, and a provision has been introduced to enable the grant of compulsory licenses. Provisions related to pre-grant and anti-post protests have also been introduced.
- Product and process patents - A product patent protects a particular product, so no one can copy it. It offers high protection to the original inventor to reduce the competition for the same product. A process patent protects the process through which one manufactures the product and not the product. It reduces the element of monopoly in the market, because reverse engineering is possible.
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