Patent waiver is not a silver bullet

Posted: Posted Date – 11:40 PM, Mon – 18 Jul 22

By Mark Davison

When members of the World Trade Organization (WTO) agreed in June to ease patent rules on Covid-19 vaccines, they did not give up patent protection. While vaccines poured into some parts of the world at the end of 2020, bringing relief, hope and a ticket out of lockdown, vaccination rates in other countries lagged far behind. This inequality has given voice to supporters of a waiver of the patent. But other issues are at stake.

It may come as a surprise that vaccination rates do not necessarily correlate with a country’s wealth. Argentina, Bangladesh, Bhutan, Brazil, Cambodia, Chile, China, Colombia, Cuba, Ecuador, Iran, Laos, Malaysia, Nepal, Peru, Sri Lanka , Thailand, Uruguay and Vietnam all have higher or similar vaccination rates than the UK, US, France, Netherlands and Germany.

Legal agreement

On the other hand, no African country comes close to a Western country on this point. An international legal agreement requires WTO members to protect patents on new inventions, including vaccines. Patents last for 20 years, and during that time only the patent holder or its licensees can manufacture the vaccine in question, unless otherwise agreed.

A number of developing economies have proposed a WTO patent waiver for Covid-19 medicines, including vaccines. After the June ruling, if a WTO member issues a compulsory license for a patent, the patent holder is still entitled to payment for vaccines made using the patent. What the patent holder cannot do is prevent the grant of the compulsory license to manufacture and distribute the vaccine.

Patent protection aims to provide a financial incentive to invent new products such as Covid-19 vaccines. Various Covid vaccines are the product of technological advances that occurred more than a decade ago, which is why vaccines could be produced so quickly after the emergence of Covid-19. Without these technological advances, the world could still be waiting for any Covid-19 vaccine, with devastating implications for death rates.

Vaccines are also the product of expensive and time-consuming work that has to be done by someone, regardless of who owns a patent on the vaccine. All three phases of vaccine trials are conducted long after patent applications are filed, but are necessary to assess the safety and effectiveness of vaccines. Not all patented vaccines will be commercialized or receive broad regulatory approval, so the cost and risk of vaccine development and testing must be borne with no guarantee of financial success. If patent rights are taken away, it’s hard to see why a pharmaceutical company would invest in vaccine development in future pandemics.
As critics of patent law have pointed out, some of the funding for technological advances comes from government grants rather than from private enterprise alone. Some of the research leading to the development of the Moderna vaccine was conducted by US government agencies or by those agencies in conjunction with Moderna. Similarly, the research behind the AstraZeneca vaccine was undertaken at the University of Oxford with government assistance.

Yet public funding for such research may be insufficient to succeed in the absence of private funding. The precise role and required extent of government funding is unclear and simply impossible to know before an actual health crisis. Vaccine creators AstraZeneca’s book ‘Vaxxers’ explains the role of private venture capital in sustaining the research agenda that was in place years before Covid-19.

Additionally, if a particular government is paying for new vaccines, there is no guarantee that it will share them with other governments rather than seeking exclusive access to first-produced vaccines. Therefore, it is unclear which alternative model to the patent system would achieve an optimal result.

The flip side

On the other hand, exclusive control of vaccines via patents can lead to insufficient vaccine production or lack of access to vaccines in countries where governments cannot afford to pay for them. Likewise, it can be expensive for individuals.

In the early stages of Covid-19 vaccine production, some claimed that patent protection meant that production levels were insufficient to meet global requirements and that developed countries were hoarding vaccines and contractual rights over future production.

But it is no longer the case that there is a lack of production of Covid-19 vaccines, even though there are clear disparities in the distribution between nations. Some of this disparity may be due to intellectual property protection, but other important factors come into play. These include distribution difficulties due to refrigeration requirements, especially for mRNA vaccines, the lack of transport infrastructure, other logistical difficulties and skepticism towards vaccines in some places. Other diseases such as measles also have high death rates every year, especially among young children, even though patents on measles vaccines expired many years ago.

Small rationale

Another difficulty is to assert that Covid-19 vaccines should be an exception to any general intellectual property protection provisions. The vast majority of those dying from Covid-19 are elderly, and the death rate among young people is extremely low. Countries with older populations tend to be among those with the highest death rates, and countries with older populations tend to be wealthier.

It would be difficult to justify an exception for Covid-19 but not for diseases like malaria and Ebola since they disproportionately affect the youngest and poorest populations.

The end result is that it is difficult to identify the precise mix of private financial incentives needed for technical innovation, the appropriate degree and nature of public investment in research, and the need to improve equity. access to this innovation and this research.

Any substantial change to the current system must ensure a superior outcome for the poorest nations, but it is not immediately clear what this substantially changed system should be, even if it were possible to reach agreement on this alternative to the WTO. What is evident is that several effective vaccines against Covid-19 have been produced faster than any other vaccine in human history under current legal arrangements.

(The author is an adjunct professor at Monash University School of Law. 360info)

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