IPR Waiver For Covid 19 Vaccines
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Synopsis:

The US is now supporting the plea of developing countries for granting an IPR waiver to Covid-19 vaccines. The waiver would allow the countries to speed up the production process without the permission of manufacturing company. However, significant roadblocks exist that may prevent the grant of waiver.

Background:
  • The US has shown its willingness to an IPR waiver for Covid-19 vaccines. It would be pursuing text-based negotiations on the waiver at the World Trade Organization (WTO).
    • Under text-based negotiations, negotiators exchange their preferred texts and then try to develop a consensus over them.  
  • Experts believe that US support is based on an October 2020 proposal given by India and South Africa in the WTO. 
    • However, the October proposal called for a waiver on all Covid-19 interventions. This includes testing, diagnostics, and novel therapeutics.
About Patents and Intellectual Property:

    • A patent is a type of intellectual property right. It is an exclusive right that a government grants to an inventor for a limited, pre-specified time. 
    • It provides an enforceable legal right to prevent others from copying the invention.
  • Types of Patents:
    • Product Patent: No person can manufacture the patented product without the consent of the patent holder even if he/she uses an alternative process.
    • Process Patent: Under this only the process is protected. A person can manufacture the patented product using an alternate process.
  • Type of regime in India:
    • India moved from product patenting to process patenting in the 1970s. This enabled it to become a significant producer of generic drugs on a global scale.
    • It allowed companies like Cipla to provide Africa with anti-HIV drugs in the 1990s.
    • However, due to obligations arising out of the TRIPS Agreement, it had to amend the Patents Act in 2005. This made a switch to a product patents regime across the pharma, chemicals, and biotech sectors.
The October 2020 proposal:
  • India and South Africa had asked the WTO to waive certain conditions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.
  • The countries wanted a waiver over sections 1, 4, 5, and 7 that could impede timely access to affordable medical products to combat Covid-19. 
    • The sections relate to copyright and related rights, industrial designs, patents, and the protection of undisclosed information.
Need of IPR waiver:
  • Boost Production: Currently, most production is concentrated in high-income countries. With a waiver, the middle-income countries would be able to manufacture covid vaccines with emergency use authorisations (EUA). This includes vaccines developed by Pfizer, Moderna, AstraZeneca, Novavax, Bharat Biotech, etc.
  • Reducing Cost of Production: The manufacturing in middle-income companies is currently happening through licensing or technology transfer agreements. The companies which grant the license, charge a hefty price for it. The companies would not need a license after an IPR waiver.
  • Avert legal Difficulties: The developing countries may face institutional and legal difficulties when using flexibilities available in the TRIPS Agreement. The waiver would help in averting this problem.

Roadblocks in granting IPR waiver:

  • Procedure Complexities: The nature of text-based negotiations can delay the process. Further, even one country can veto the waiver as granting requires consensus among all 164 members of WTO. 
  • Disincentivization of Companies: Waiver may reduce the earning potential of companies. They may be disincentivized to do more research on tackling new variants. This may undermine the global response to the pandemic.  
  • Erosion of Public Trust: People may not trust the quality and efficacy of vaccines manufactured in a middle-income country. 
  • Production barriers: Ramping up production capacities will be a lengthy process. The developing countries that are currently producing Covid 19 vaccines are able to do so with the extensive support and grant of developed countries. 

Other Challenges concerning the production and distribution of Covid vaccines in developing countries:

  • Scarcity of Raw Material: It has been a growing issue for ramping up production. Several manufacturers have been relying on specific suppliers, and alternatives are limited.
  • Trade Barriers: US has blocked exports of critical raw materials used in the 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.
  • Acquisition Capability of Developed World: They have a higher propensity to purchase the vaccine. This has enabled them to acquire most of the supplies.
Way Forward:
  • Firstly, the developed countries should understand the plight of developing countries under the current extraordinary circumstances. The recent intention of the EU to support the U.S proposal should be materialised in reality.
  • Secondly, other covid related interventions including testing, diagnostics, and novel therapeutics should be made part of IPR waiver proposal.
  • Thirdly, the developing world should be given an opportunity to develop cheap and efficacious vaccines. They have already shown their manufacturing capabilities by developing good quality generic medicines in the past. 

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