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Vaccine Regulation and IP

Vaccine regulation and IP

In October 2020, India and South Africa presented a request in the World Trade Organisation (WTO) for suspension of IP rights in medicines and medical equipment used in the prevention, diagnosis and treatment of COVID-19. The debate while sparking a debate on the general IP framework and its morality also placed special focus on the topic of vaccine regulation since vaccines are the most effective method of preventing loss of life to the pandemic.

The proposal has been supported by as many as 100 countries with the latest addition being an announcement from the United States Trade Representative Katherine Tai who stated that while the Biden Administration has a strong belief in protection of intellectual property and their related rights, we are living in extraordinary circumstances that call for extraordinary measures. If a waiver is decided upon, the negotiations that follow will be a long and complex process of its own. This is because the institution of the WTO is consensual in nature and the issue is of substantial complexity.

There has also been tremendous opposition to the move as intellectual property rights are seen as instruments to incentivise further innovation and research. Another argument is that the unavailability of vaccines is due to manufacturing bottlenecks and not due to patent monopolies. So, can the waiver of IP rights really help in global access to vaccines?

This is a complex question and to answer it in simple terms would be unwise. While it is agreed that IP rights are partly responsible for the worldwide shortage in vaccine availability. The logic is that a more extensive production base globally would result in exponentially increased vaccine protection, which is irrefutable. However, several caveats remain.

The first issue is regarding transfer of technology. If patent monopolies are suspended countries are definitely permitted to produce generic versions of the medicine. However, without the necessary technology transfer, an easing of IP rules would not provide the necessary support to pharmaceutical manufacturers. Makers of generic medicine cannot commence production without such support. For example, Pfizer has explained that the making of their vaccine requires the use of 280 components from 86 suppliers and highly specialised manufacturing equipment.

Second, it is very likely that it would take up to several years for generic producers to setu up production plants and operate them at optimal capacity. This raises the question of whether today’s vaccines would even be relevant at that point in time, especially if new variants prove resistant to vaccine formulations currently available.
Finally, we come to the most often cited argument to resist such patent relaxations, discouragement to pharmaceutical companies from investing in producing next-generation vaccines. Though many, including Mr. Biden, 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.

This raises the question, what then, could possibly be the next step?

No significant steps forward will be possible until other major member nations of the WTO sign on, including the EU. The speed of potential action will also be dampened by the fact that in parallel to the waivers, a transfer of personnel, raw materials and equipment to developing nations will be necessary.

However, there is another possibility: Mr. Biden may either intend to release more of the existing U.S. vaccine stockpile to other countries to meet emergency needs and seek the cooperation of pharmaceutical companies in that mission, or he may be using the threat of the TRIPS waivers to nudge U.S. vaccine producers to ramp up their production and donate more doses to countries like India and Brazil.

Either way, it would be unwise for countries like India to rely on such single country based initiatives for an increase in vaccine supply. A more concerted effort on the global level as well as way of introducing more plants within India to manufacture more vaccines at least of the domestic COVAXIN would yield better results.

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