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Markkula Center for Applied Ethics

Is it Ethical to Uphold Vaccine Patents during a Global Shortage?

Robby Brock ’22

Michel Euler/AP Photo

Robby Brock is a junior neuroscience major with a Spanish minor and a 2020-21 health care ethics intern at the Markkula Center for Applied Ethics at Santa Clara University. Views are his own. 

While many Americans and Europeans are returning to a life of normalcy, people from other regions are facing massive waves of COVID-19. India has made headlines after setting a global record with a daily infection rate of 314,000, with 4,000 dying from the virus each day. Other countries such as Mexico and Brazil have also faced high infection rates and a shortage of medical resources.

At the beginning of the pandemic, vaccine companies such as Pfizer stated that they would make sure low-income countries “have the same access [to the vaccine] as the rest of the world.” Yet what we are seeing today is a massive global disparity in the allocation of available vaccines. How did this happen?

Once wealthy countries such as the U.S., Canada, and others realized the severity of COVID-19, they engaged in bilateral agreements with the companies producing the vaccines. This secured their place at the front of the line well before the vaccines were available. Efforts to secure vaccines for poorer countries, such as pledges to COVAX, were only formed after these agreements were made. As a result, solid equitable vaccine distribution agreements were too little and too late. 

Is this divide in vaccine access ethically acceptable? If the pharmaceutical companies putting in years of research and development are based in and supported by high-income countries, then shouldn’t those countries have a right to receive their products first? This is a reasonable question in the abstract. However, as it stands, the U.S. has already vaccinated most citizens and is now planning to vaccinate teenagers, who pose a much lower risk of complications from COVID-19. Meanwhile, most countries don’t even have enough vaccines to protect their health care workers, much less their vulnerable elderly populations. Moreover, these countries often lack stable health care systems, and their citizens often lack the ability to work from home. Putting aside the universal interest of reducing variants, there exists a moral imperative to hold vaccine distribution to a level of fairness. 

Ethical allocation of health care resources is crucial for the principle of justice. Lack of foresight, incentives, and political will has caused a serious violation of this principle.  

In light of the divide between rich and poor countries, many government leaders have been pressured to help close the gap. Among the possible solutions is a vaccine patent waiver, which was proposed by India and South Africa back in October of 2020. This would allow other companies, including those in developing countries, to make generic brands of existing vaccines. The U.S. and E.U., as well as countries including the UK, Japan, and Australia among others, opposed the proposal. Over 100 other countries have supported the waiver and on May 5th, President Biden changed U.S. policy, backing the proposal and causing renewed interest. 

So is it ethically permissible to keep these patents in place? Proponents of a waiver make the following argument: 

  1. Vaccine patent waivers would allow other countries to produce generic copies and thus increase the global supply of vaccines.
  2. Increasing the global supply would give developing nations access to vaccines.
  3. Increasing vaccine access would save lives and decrease the prevalence of future Covid variants, which could prolong the pandemic.

From this perspective, the answer seems clear. Maintaining patents violates the principle of beneficence, doing good for others, by deliberately refusing to help countries in dire need. It also violates the principle of non-maleficence, avoiding harm to others, as patents can discourage innovators from other countries from developing a novel vaccine for fear of copyright suits.

There are several precedents for patent waivers. In 2001, the “Doha Declaration on TRIPS and Public Health” eliminated patents on drugs for HIV, allowing for cheaper production and more affordable products. A similar situation took place with the hepatitis B vaccines in the 1980’s. By handing over the “recipe” for existing, highly effective vaccines, other companies can begin producing their own versions. In the case of India, production of these vaccines could take place alongside existing vaccine manufacturing. Removing IP protections could also free innovators to develop entirely new vaccines without fear of copyright infringement due to an overlap of procedures. 

While everyone agrees on the importance of increasing vaccine supply, the method of using a patent waiver has been controversial. Critics of a waiver claim that it would create no immediate increase in supply, as establishing production of a new type of vaccine would take months and require far more assistance from companies than a waiver would provide. Another concern is that waivers would jeopardize existing supply chains. The Pfizer-BioNTech vaccine, for example, requires 280 components from 86 suppliers in 19 countries. Competition for access to the raw materials could slow net production and result in an even lower supply. Finally, critics worry that a waiver would discourage future innovation. The mRNA technology utilized by the Pfizer-BioNTech and Moderna vaccines were only possible through years of research and development from the public and private sector. If companies have no profit incentive to create these new health care products, then we may see investments in the industry drop. This could lead to a decline in new technologies, leaving us unprepared for the next pandemic. 

The clash between these stances has stirred debate about everything from pharmaceutical company power to geopolitical strategy. It's easy to become tangled in the pros and cons of a patent waiver, and there are strong arguments for both sides. What remains clear is that the issues of justice (equitable distribution), beneficence (helping other countries), and non-maleficence (avoiding harm to other countries) are present and pressing. Fortunately, there are other impactful options for adhering to these principles that can be done with or without a waiver. 

One option would be to increase direct patent licensing. This would allow the companies producing vaccines to partner with specific companies to increase production while still protecting their intellectual property. Governments can help with this. In February, the Biden administration negotiated with Johnson & Johnson to partner with Merck to increase production domestically. By March, an agreement was made with federal funding to help prepare new facilities. Internationally, AstraZeneca made a major partnership with the Serum Institute of India early in the pandemic to produce the Oxford-AstraZeneca vaccine from the UK and Switzerland. There is an incredible amount of potential partnerships to be made. These partnerships would allow companies to share their IP on their own terms and better regulate the process.

Another option would be exporting existing vaccines. As of last week, the U.S. had donated only around 1% of the vaccines it has produced. Fortunately, this looks to be changing, as President Biden has pledged to donate 20 million U.S.-made vaccines in addition to the 60 million already- pledged Astra-Zeneca vaccines (which are not currently approved in the U.S.). This was long overdue, as many middle-income countries like China and Russia (and even low-income countries like India) have already exported a significant proportion of their vaccines to other countries. This has caused many in the international community to question the leadership of countries like the U.S.

A final measure would be exporting supplies and technological and medical expertise. This is crucial, as much of the current problem is caused by a lack of materials, weak public health systems, and subpar vaccine distribution in poor countries. In February, President Biden signed the Defense Production Act, which placed an embargo on U.S. exports of medical raw materials. He has now pledged to send out supplies after growing criticism.

Following through with these alternatives could make a huge difference in the global supply and access of vaccines. In a recent interview, Mustaqeem De Gama, the World Trade Organization representative for South Africa who was heavily involved in the original patent waiver proposal, mentioned that it “could just be an incentive for companies to come forward and collaborate.” 

President Biden has already pledged a total of $4 billion to COVAX and has begun to help fund existing vaccine production in India. While these measures are a start, much more will need to be done. We need to take immediate action and plan for systemic changes in order to rectify the lack of justice, beneficence and non-maleficence, and help us win back the trust of other nations. 

May 19, 2021

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