Economist Joseph Stiglitz believes that the difference between developing and developed countries stems not only from resource gaps but also from knowledge gaps. Middle-and-low-income countries have low levels of innovation and patenting, and thus struggle with the affordability of life-saving drugs due to artificial scarcity caused by intellectual property rights. The generic pharmaceutical industry has been instrumental in making life-saving drugs affordable to these countries. Ninety-four percent of the medicines used by Médecins Sans Frontières for the treatment of tuberculosis, malaria, HIV, and other infectious diseases are generics, of which two-thirds are produced in India. India grew in reputation as a ‘pharmacy of the developing world’ and has been at loggerheads with the ‘big-pharma companies’ of the West due to reverse engineering of drugs, leading to non-payment of royalty to patent-holders. The patent debate reignited in the backdrop of the ongoing coronavirus pandemic. The race to the procurement of the vaccines and the subsequent gatekeeping of the know-how by high-income nations have highlighted the dualism in the world order. 

In October 2020, India and South Africa requested the World Trade Organisation for temporary suspension of intellectual property rights on vaccines to make them accessible and affordable to low and middle-income countries. The proposal calls for deferring enforcement of certain provisions under Trade-Related Aspects of Intellectual Property Rights (TRIPS) concerning copyrights, industrial designs, patent rights, and protection of undisclosed information. 

The supporters of the waiver have cited reasons of low production and vaccination rates, and affordability and accessibility in low- and middle-income countries. According to WHO’s estimation, approximately 1.1 billion vaccine doses were administered as of May 5^th, of which 80% were administered in high and upper-middle-income countries. Further, India’s ambassador to WTO, Brajendra Navnit highlighted the need to ramp up production citing the difference between required and actual production, which stands at 1.5 billion doses per month and 400-500 million doses per month respectively. The enormous amounts of investments by the public sector in the innovation process have set off arguments against the privatization of profits. The instrumentality of IPR waivers in combating HIV-AIDS in the 1990s has been cited in favor of the waiver. It led to a subsequent decrease in the paralyzing price by 99%, and widely increased the reach of the drug.

The opposers of the waiving-off of the patents have raised issues with the disincentivizing of research and development, indeterminate time period of the waiver, and available capacity in the developing countries. The argument of available capacity and expertise in the developing countries holds little merit as Indian pharmaceutical companies produced Hepatitis B vaccines, Tamiflu, and Remdesivir against speculations of manufacturing and knowledge incompetencies. The chair of WHO Solidarity Trial of COVID-19 treatments, John-Arne Rottingen, says “IP is the least of the barriers” and is supported by Developing Countries Vaccine Manufacturers Network. Vaccines are biological products and are more complex and costly in terms of quality assurance, delivery systems, and regulatory approvals. Further, the reproduction of the process may be dependent on implicit knowledge not mentioned in patent documents. 

The French Minister for Industry, Agnes Pannier-Runacher, declared the IP waiver to be a ‘false good idea’, taking into consideration the time required for industrialization of vaccines, which ranges between 12 to 30 months. The time required for capacity building and regulatory checks would delay the immunisation process. Further, as the world braces for subsequent mutants, disincentivizing private investments would stifle medical innovation. In 2001, WTO signed the Doha Declaration which allowed the member countries to issue ‘compulsory license’ in the event of public health emergencies. An assertive stand on compulsory licensing would nudge companies to extend voluntary licenses. Manufacturing and supply-chain should be strengthened guided by Article 66.2 of the TRIPS Agreement, which obliges governments of developed countries to incentivize institutions and enterprises for technology transfer. Voluntary licensing and regulatory measures against super-normal profits will greatly contribute to achieving mass-immunization targets and reinforce PM Modi’s call for ‘One World, One Health’. 

References

1. 2015. Access Campaign. April 28. https://msfaccess.org/spotlight-pharmacy-developing-world.
2. Archyde. 2021. Remove patents on vaccines? A “false good idea” for Pannier-Runacher. February 7.
3. Iacobucci, Gareth. 2021. “Covid-19: How will a waiver on vaccine patents affect global supply?” The BMJ. doi:10.1136/bmj.n1182.
4. Mantri, Geetika. 2021. The News Minute . May 6. https://www.thenewsminute.com/article/why-removing-patents-covid-19-vaccines-need-hour-148408.
5. Thambisetty, Siva. 2021. Vaccines and patents: how self-interest and artificial scarcity weaken human solidarity. LSE British Politics and Policy, February 9. https://blogs.lse.ac.uk/politicsandpolicy/vaccines-and-patents/.
6. UNAIDS. 2016. Intellectual property and access to health technologies. May 27.
7. Usher, Ann Danaiya. 2020. “South Africa and India push for COVID-19 patents ban.” The Lancet 396 (10265): 1790-1791. doi:https://doi.org/10.1016/S0140-6736(20)32581-2.

This blog is written by CPPR interns, Nidhi John & Akhila P Mony.

Views expressed are personal and need not reflect or represent the views of Centre for Public Policy Research.

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