With vaccine trials on overdrive, India has rightly taken the lead in invoking TRIPS flexibilities

| Updated on July 30, 2020 Published on July 30, 2020

India’s indigenous vaccine manufacturers can utilise flexibilities built into TRIPS to facilitate access to essential health technologies and products with the same sterling effect that they did for Hepatitis B vaccine

Encouraging results from clinical trials for Covid-19 vaccines have raised hopes for an end to the pandemic crisis. However, they have also raised concerns about equitable access, amidst concerns over price gouging. As many as six vaccines have entered phase III of clinical trials for efficacy and safety of the candidates. But already, the propensity to be first in the queue and undermine global cooperation in combating the disease is becoming evident in the US Government’s Operation Warp Speed vaccine programme; under this, vaccines are to be speed-developed and procured en masse for American use. The US Health and Human Secretary Alex Azar announced a $1.95 billion deal to buy 100 million doses of a vaccine developed by Pfizer which began a late-stage trial involving 30,000 volunteers this week. Another frontrunner for vaccine development, Moderna Inc, as also Johnson & Johnson have cut similar deals to mass-produce the vaccine even before the completion of clinical trials. Charting a similar course, Britain announced this week that it had secured access to 90 million experimental vaccines. Corporations, while investing in R&D, have justifiably been assured of a return on their investment. However, the issue here is of putting into effect the flexibilities in TRIPS agreed upon in the 2001 Doha Declaration of the WTO, so that patents do not run against the interests of public health and access in times of a pandemic. At a virtual general council meeting of the WTO early June, India reiterated its commitment to this principle. The resolution adopted by member states on May 18-19 in the 73rd World Health Assembly, the decision-making body of WHO, is a critical instrument. India has joined other countries in pushing a resolution that calls for “equitable access to and fair distribution of all essential health technologies and products to combat the virus”.

India’s indigenous vaccine manufacturers can utilise flexibilities built into TRIPS to facilitate access with the same sterling effect that they did for Hepatitis B vaccine. Shantha Biotechnics broke into global monopoly pricing (the vaccine was being sold at $23 a dose), bringing it within the reach of Indian families by pricing it at $1. This enabled low-cost mass vaccination globally through UNICEF. The role of Indian generic manufacturers in supplying anti-retroviral medicines to other developing countries has been exemplary. India has simultaneously shown the capacity to achieve self- reliance in the area of diagnostics for Covid-19.

Its drug manufacturers have already geared up to produce and distribute the antiviral remdesivir under a licence, although the price is arguably steep. The time is ripe for leveraging global platforms and legal mechanisms to pre-empt monopoly pricing. Apart from invoking TRIPS flexibilities under Article 31, the government should create a consensus under WHO to reduce licensing costs, so that manufacture and mass procurement can proceed smoothly.

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Published on July 30, 2020
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