Vaccine Patents, Their Effect on Developing Countries

Jonathan Qu

Paper Length: 2915 words 15733 characters (no spaces)

Literature Review

With the current “pandemic:” “an outbreak of a disease that occurs over a wide geographic area (such as multiple countries or continents) and typically affects a significant proportion of the population” (“Pandemic”), the war between vaccines as intellectual property, IP, or public property was renewed. What not only the causes, but also the effects of companies like Pfizer, Moderna, and Johnson & Johnson safeguarding information and innovations that could save millions. However, before that, we need to understand some terminology that is used in this field. Under the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS), innovations are considered IP (“Pharmaceutical Patents and the TRIPS Agreement”). IP is split into 3 subcategories: trademarks, “patents”, and copyrights. Trademarks are words or phrases that are original and unique enough that they separate your product from others. Copyrights are for created works like movies or novels. Our discussion will focus on “patents” only for new, unique, and useful inventions, the holder of a “patent” must release information about their product. In return, patent holders receive a certain amount of time to be the sole manufacturer of the product (Trademark, patent, or copyright). However, the WTO can “waive” the rights of this patent, releasing the rights of the patent (Bokohari). In our case, these patents will be over “vaccines”, “biologics that give dynamic, versatile invulnerability against explicit infections and contain drugs that look like the microorganisms that cause infection” (Alshrari). The current two major vaccine manufacturers in the current “pandemic”, are Pfizer and Moderna, their vaccines use mRNA to code for the surface spike proteins on the SARS-CoV-2 S antigen or coronavirus. The vaccine is injected into our arms where our cells will follow the mRNA to construct a spike protein. The mRNA is broken down, but the spike is shown on the outside of the cell. Our immune system spots the foreign object and will produce immune cells to fight off the spike. With this when the real SARS-CoV-2 S enters your body, your immune system will recognize it and stop a serious infection ("Understanding mRNA COVID-19 Vaccines.").

Vaccines are an ancient discovery, with the first on record vaccine being in May 1796, Edward Jenner injected the cowpox disease into an 8yr old boy to build resistance to the deadly smallpox disease (Riedal). However, talk about patents over vaccines is a new topic with the oldest paper being about in the 2000s for illnesses such as influenza (H1N1), hepatitis B and C, HPV, SARS, or HIV (“Recent Patent Applications in Antiviral Vaccines”). Due to how broad the range of innovations that could be considered for a patent, examples being processes that could be useful for a vaccine, or could be useful for something else, when these diseases broke out, due to patent restrictions, only wealthier countries could afford vaccines for its citizens, leaving poorer countries much more susceptible (Kingston). This inequality is not solely created by large outbreaks and pandemics, only highlighted by them. Wealthy countries in 2008 consisted of 20% of the world’s population but took part in 80% of the global pharmaceutical trade (Marques 210).

2008’s situation draws a parallel to today’s, the wealthiest countries are unproportionally vaccinated compared to the rest world. While Covax by the World Health Organization (WHO) and programs like it try to reduce the inequality “by pooling financial and scientific resources, these participating economies will be able to insure themselves against the failure of any individual vaccine candidate and secure successful vaccines in a cost-effective, targeted way” (“Coronavirus") the trench between developed and developing countries becomes more and more prominent. The manufacturers are also striking deals with larger wealthier countries, in early 2021, it was reported that the EU was paying on average $3.50 per dose of the AstraZeneca vaccine, while Uganda was paying $8.50 per dose and South Africa $5.25 leading to an even bigger gap (“Price Check: Nations Pay Wildly Different Prices For Vaccines”). In the U.S. as of the 23rd of February 253.2 million people have at least received one dose of a Covid-19 vaccine. The European Union’s countries as of the 25th of February as administered 313.8 million doses, about 75% of its population has received at least 1 dosage ("COVID-19 Vaccine Tracker"). While Africa as of the 26th of February has 397 million total vaccinations (Kyobutungi) total in contrast to its 1.4 billion people (“African Population (LIVE)”). About only 28.9% of people in Africa are vaccinated, with the disparity in Africa being even more blatant. South Africa as of the 24th of February has a total of 31.3 million vaccinated 52.8% with 48.1M vaccines being bought, 9.27M through Covax and 490k through donations, while the populous Democratic Republic of Congo with 89.6M people (about twice the population of California) as of the 14th of February has 696k vaccinated .8% of its population vaccinated 756k vaccines bought, 5.15M through Covax and 450k donated (Kyobutungi). Some may argue that these gaps are caused independently by wealth, wealth is a factor, but patents are the real roadblock for these developing countries. Patents make it illegal for countries to manufacture their own vaccines, leading to a lower number of total vaccines available, causing both price and demand up. Forcing them to outsource for vaccine options. Even when these patents are waived, the information in the patents is not enough to actually produce the vaccines. Original manufacturers do not have to share “specific manufacturing processes and practices, many of which are not disclosed in a patent” (Rutschman), nor do many of the developing countries have the technology to produce their own vaccines. (Rutschman).

This project will explore pandemics, the effects patents have on the distribution of vaccines during pandemics and outbreaks. Through collecting, analyzing, then synthesizing data from graphs and charts from various outbreaks and scientific journals over pharmaceutical patents and vaccines, to solve whether or not patents over pandemic time vaccines are ethical.

Process Narrative

The pandemic showed the world how truly uncoordinated and unprepared we are for a global health crisis. In the U.S., toilet paper flew off the shelves at your local Walmart and used car prices skyrocketed, it's impossible to believe that we as a developed nation could not handle the pandemic. My thoughts drifted to the vaccine distribution that began as soon as they seemed safe. If we did not even have enough doses for our country yet, how we're developing countries faring? At the beginning of the data collection, I went into the research with the hypothesis that if the IP rights for a vaccine were waived during a pandemic, the developing nations would be able to manufacture their vaccines. That these smaller countries just could not invent new products as quickly as we could due to a lack of funding. I started by searching for the keywords Covid-19 and intellectual property to gain a general knowledge specifically about Covid-19 because it is the most recent/ongoing pandemic.

I then searched for information over IP. The difference between the 3 types of IP, is what is required to be shared for a patent to be approved, the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS), and patent waivers. After building my BoK, I started my research. I knew I could not conduct a survey because my research required quantitative data from past pandemics and current pandemics, so I decided to collect data from previous pandemics and outbreaks through scientific journals and charts, graphs, and maps from credible sources. I approached the project using a qualitative/quantitative data analysis approach to the project, by looking at the major vaccine producers, patents they held, and the % vaccinated in countries during the H1N1 (swine flu) pandemic, H5H1 (avian influenza) scare, and Covid-19.

I decided on the H5N1 and H1N1 alongside Covid-19 outbreaks/pandemics as they were the 3 more recent/current virus outbreaks. I went to the CDC and looked up H5N1 and H1N1. To determine whether a country was developed or developing, I used the GDP per capita (PPP) as a comparison because generally, developed countries have higher PPPs, while developing countries have lower PPPs. I understand this assumption can have exceptions such as China, a country that currently is a major power on the world stage and is highly developed but ranks only 102 in the CIA database based on PPP due to the extreme degree of concentration of wealth in an extremely small elite class. I started with a CIA database of every country’s PPP, while this database was not the most recently updated, the other sources I found used information from Wikipedia which is not always accurate. From the list, I chose the following 4 countries. I chose a mix of high PPP and low, and countries that were more recently updated. Of the three, I started with Covid-19, I searched the keywords, “Covid-19” and “Vaccine production” to find a mapping of Covid testing and production. I focused on my 6 countries, Then I looked at the lockdown policy in each of the countries. While the first 2 countries’ information was found from a credible source who gathered its information from each country’s official guidelines. Iran and Yemen were not on this list. Instead, I found information on the guidelines in these countries from a travel advisor who did not list its sources. I also searched where Yemen and Singapore sourced their vaccines during the pandemic on Reuters.

Next, I went to H5N1, since the avian flu was over 10 years ago, information on the subject was scarce compared to information on Covid-19. Throughout this, I was keeping in mind what the effects of a patent in this situation would be. While looking at databases and news sources, the specific information I compiled for the Covid-19 tables was not available. Of the pages that did cover H5N1 vaccine production, their sources like the WHO had deleted the specific web pages cited. I did find sources, but they did not include the quantitative data I was looking for. I started with EBSCO, searching the keywords, “H5N1”, “Vaccine production”, and “Yemen”, but there were no results. Next, I swapped “Yemen” for “Iran,” the sources that were over the general topic were not what I was specifically looking for. Most results covered trials on mice, whereas I was looking for their vaccine producing capabilities. I started looking at the list of countries on the CIA PPP list that were similar in PPP and had in 2022 a similar amount of trial facilities for Covid-19 vaccines to replace Iran’s data. I found South Africa. It had an $11,500 PPP to Iran’s $12,400 and 26 facilities operational to Iran’s 33 right now. I swapped Iran for “South Africa” in my search options and had 8 results. I then went to a less formal source, Reuters, for South Africa’s Health Minister Aaron Motsoaledi’s opinion over the matter in 2009. While searching, I found a source from the NIH over a dispute between Indonesia and the developed countries of the world over vaccine hoarding. I then searched the FDA’s report on the U.S.’s H5N1 vaccine. I paid specific attention to the dates between when the U.S. had a working vaccine and when the rest of the world did. While specific numbers were not available since H5N1 never truly became widespread and there was not much over it. I focused on the difference between when the U.S. and Singapore had vaccines ready compared to when the 2 developing nations had their vaccines ready.

For my H1N1 research, I decided that seasonal influenza is a much more common and recurring pandemic and the information over production and patents is much more recent as well. I searched for “influenza,” “seasonal flu,” and “vaccine production” and found a study done in Science Direct that surveyed a total of 18 different companies, to find out where they had functioning production plants. I next searched for the number of vaccines each country produced/bought for the 2021-2022 influenza variant H3N2 season. For the U.S., the information was on the CDC. For Singapore, the number of vaccines did not seem to be an issue, but the number of adults who were in the at-risk group reluctant to become vaccinated was an issue. For Iran, the information was found on Iranwire. Yemen also had truly little information on vaccination details. However, I inferred that since they had below 3% of their population vaccinated against Covid-19, there was a similar situation with the current flu H3N2.

Results/Data:

Table 1

GDP per capita of each country

Adapted from: "Country Comparisons Real GDP per capita." The World Factbook, CIA,

www.cia.gov/the-world-factbook/field/real-gdp-per-capita/country-comparison.

Table 2

# Of Covid vaccine trial facilities in each country

Adapted from: Vuillemot, Romain, et al. Vaccine Testing and Testing Mapping. COVID

NMA, 20 Apr. 2022, covid-nma.com/vaccines/mapping/.

Table 3

% Of each country vaccinated

Adapted from: Ritchie, Hannah, et al. "Coronavirus (COVID-19) Vaccinations." Our

World in Data, 2 May 2022, ourworldindata.org/covid-vaccinations

country=OWID_WRL.

Table 4

Restrictions in each country

Adapted from: "Iran." Tripsguard, 28 Apr. 2022,

www.tripsguard.com/destination/iran?origin=united-states&passport=united

states&vaccinated=unvaccinated.

Shoening, Elise, and Lizzie Wilcox. "The Latest Updates on International

Gathering and Travel Restrictions." Northstar Meetings Group, 25 Apr. 2022,

www.northstarmeetingsgroup.com/coronavirus-countries-cities-reopening-COVID-19

new-cases.

"Yemen." Tripsguard, 28 Apr. 2022, www.tripsguard.com/destination/yemen

origin=united-states&vaccinated=unvaccinated&passport=united-states.

Table 5

H3N2 vaccine amounts:

Adapted from: Khoshhal, Pouyan. "Iran About-Turns on Domestic Flu Jab." Iran Wire, 30 Nov. 2021, iranwire.com/en/2020-coronavirus-outbreak/70871.

"Seasonal Influenza Vaccine Supply for the U.S. 2021-2022 Influenza Season." CDC, 26 Aug. 2021, www.cdc.gov/flu/prevent/vaxsupply.htm#:~:text=Flu%20vaccine%20is%20 produced%20by,for%20the%202021-2022%20season.

Sparrow, Erin, et al. "Global production capacity of seasonal and pandemic influenza vaccines in 2019." Science Direct, vol. 39, no. 3, 15 Jan. 2021, pp. 512-20. Science Direct, https://doi.org/10.1016/j.vaccine.2020.12.018.

H5N1 (Swine Flu):

The U.S. had a functional FDA approved vaccine by April 2007 (Schnirring), while the rest of the world was waiting on samples of the virus from Indonesia who was scared developed countries would hoard vaccines made from its samples (Garrett).

Analysis and Conclusions

While my subject was not experimental, for obvious reasons, I cannot start my own pandemic and form patents to stop certain countries from producing vaccines then lift them to compare the difference between the effect the pandemic had on the certain countries, I was still able to form a hypothesis and collect and analyze data to prove it wrong. Patents are ethical. Patents protect intellectual property as they are supposed to; they stop others from stealing the invention to benefit from the work of others. Even during a global crisis, the WTO has measures in place such as the TRIPS 31bis agreement to waiver these rights when deemed necessary. My data shows that while the countries that held private producers with the patent had visible differences between the % vaccinated and the restrictions still in place, I found the number of testing facilities to be more important. Even when these patents are waivered during the pandemic as they are during Covid or even H5N1, these smaller developing countries still struggle to produce their vaccines. These smaller countries not only don’t have the technology to produce these complex mRNA vaccines currently used but even if they did, when waivered, patent holders, either way, don’t have to share enough information to produce their invention. During H5N1, these smaller countries were fearful of larger countries taking their samples to hoard vaccines produced off the samples. These fears were justified because each country ends up fending for itself. During H5N1, the U.S. already produced a working vaccine with very few samples. These developing SE Asian countries had the samples for a much longer time than the U.S. or the rest of the world. They had the samples, but they did not have the facilities to create their vaccines. In the case of Yemen, it’s a war-torn country that does not have the expendable wealth that Singapore has to buy vaccines, so when Covid hit, it couldn’t outsource the vaccine or produce its own. None of these factors had anything to do with patents. The differences that arise during a pandemic are not due to patents restricting developing countries from producing vaccines, but rather due to the fundamental differences between 2nd and 3rd world countries and 1st world countries. That includes but is not limited to differences in capital, private and public research facilities, and political climate between these developing countries and developed countries. To solve these issues, we should not look to fix the patent system, we should look to help these developing countries acquire the infrastructure to catch up with the rest of the pack in the ever-evolving world we live in.

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