Welcome to the Roundtable, a forum for incisive commentary and analysis
on cases and developments in law and the legal system.
on cases and developments in law and the legal system.
By Rachel Gu
Rachel Gu is a sophomore in the School of Engineering and Applied Sciences at the University of Pennsylvania studying Bioengineering.
On March 11th, the World Health Organization (WHO) declared COVID-19 a global pandemic. Since then, the number of confirmed cases has risen tenfold from 118,000 cases to over 1.8 million cases worldwide . Of these, the U.S. houses over half a million cases with over 20,000 deaths and counting . However, these numbers only showcase the beginning. Experts predict deaths will increase over threefold to about 70,000 by August when the projected infection curve finally begins to flatten . Not to mention, experts predict a second wave of mass infection as society gradually returns to normalcy . As a result, vaccine development is paramount in combating this global pandemic. However, due to the pressure of rising fatalities and plummeting economies, typical rules and regulations are being bypassed by researchers and regulators. In this race to develop vaccines, safety, liability and patent contention must be considered.
So far, the U.S. Food and Drug Administration has deployed Emergency Use Authorizations (EUA) to allow the rapid development of drugs. Under section 564 of the Federal Food, Drug, and Cosmetic Act, the FDA may allow unapproved medical products to be used in an emergency that has significant potential to affect national security when there are no existing adequate, approved alternatives . In fact, a test developed by Swiss pharma giant Roche was EUA-approved in just one day, and Thermo Fisher’s new diagnostic test was also cleared due to the large deficit in available testing kits both nationally and internationally. Even more radical, the FDA has allowed state-level authorities in New York to coordinate COVID-19 patient testing, eliminating federal oversight entirely .
Given these accelerated deviations from the ordinary course of action, safety and liability issues inevitably arise. However, the Department of Health and Human Services (HHS) declared under the Public Readiness and Emergency Preparedness (PREP) Act that manufacturers and distributors are given liability immunity from medical countermeasures against COVID-19 effective February 4th, 2020, except for claims involving “willful misconduct.” Any diagnostic tests, treatment, or vaccines that are FDA-approved––even under EUA––qualify under this act . However, certain individuals who are seriously injured or die as a direct result of a covered medical countermeasure may be eligible to obtain benefits through the government’s Countermeasures Injury Compensation Program (CICP). This program is a last resort payer who only covers expenses that third-party payers, such as health insurance or Workers’ Compensation programs, do not have an obligation to pay .
With no established cure on the market, panicked citizens can easily fall for treatment and testing dupes. On March 22nd, the first federal action against COVID-19 fraud was announced. The owners of fraudulent website coronavriusmedicalkit.com claimed to offer consumers access to WHO vaccine kits in exchange for a low shipment charge, despite there being no legitimate COVID-19 vaccines. In response, U.S. District Judge Robert Pitman issued a temporary restraining order on this website while the FBI continues to investigate the allegations. Judge Pitman hopes this case inspires responsible web domain registrars to quickly shut down future scamming websites exploiting a national emergency for personal gain .
Along with the race to develop an effective vaccine against COVID-19, a new source of contention emerges: the ownership of the vaccine patent rights. A patent gives the inventor an exclusivity period during which they may control who can use or sell their product. Although there is currently no COVID-19 vaccine, pharmaceutical companies in China, the U.S, and Europe report they are all nearing successful treatment production. While Europe has reassured that a vaccine first developed and patented in Europe will be globally licensed to ensure access to all populations, not every leading nation has ensured the same course of action. Given current tensions between the U.S. and China, critics fear that vaccine patent ownership may be used as a political bargaining chip.
Micro examples of this behavior have already occured. U.S. pharmaceutical laboratory Gilead owns the patent rights to antiviral medication Remesdivir. While this treatment was first developed for Ebola during the outbreak in 2014, it is currently the only known antiviral believed to be effective at treating coronavirus strains such as COVID-19. To test the efficacy of this medication, Gilead donated Remesdivir samples to hospitals in China in response to China’s massive outbreak. After receiving these treatment samples, the Wuhan Institute of Virology filed a competing “method of use” patent for a combination treatment of Remesdivir and chloroquine––a common malaria antiviral. Wuhan Institute issued a statement along with its patent application, declaring that the patent application was filed in the “nation’s interest” and that they would not enforce the patent rights if foreign pharmaceutical companies agreed to collaborate with China in addressing COVID-19 .
Wuhan Institute ostensibly filed for a Remesdevir patent purely as a defensive measure to secure access to a promising treatment in China, indicating a clear mistrust between the two nations. However, this action, along with poor historical evidence of China enforcing American patent rights, could signal to other foreign pharmaceuticals, such as Johnson & Johnson, BioNTech, and CureVac, not to test their treatments in China in fear that their intellectual property rights will not be upheld.
Despite the declaration of a global pandemic with millions of lives at stake, the COVID-19 vaccine could provide leverage to either nation in the escalating trade war between the U.S. and China. Only time will tell if political conflicts will threaten public access to essential medicines: a battle between the prioritization of human lives or political power.
The opinions and views expressed in this publication are the opinions of the designated authors and do not reflect the opinions or views of the Penn Undergraduate Law Journal, our staff, or our clients.
 Ducharme, J. (2020, March 11). The WHO Just Declared Coronavirus COVID-19 a Pandemic. Time. Retrieved from https://time.com/5791661/who-coronavirus-pandemic-declaration/
 Coronavirus Disease 2019 (COVID-19) Situation Report-85. (2020, April 14th). World Health Organization. Retrieved from https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200414-sitrep-85-covid-19.pdf?sfvrsn=7b8629bb_4
 IHME: COVID-19 Projections. (2020, April 13). Institute for Health Metrics and Evaluation. Retrieved from https://covid19.healthdata.org/united-states-of-america
 Xu, S. & Li, Y. (2020, April 8). Beware of the Second Wave of COVID-19. The Lancet. Retrieved from https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30845-X/fulltext
 Emergency Use Authorization. (2020, April 16). U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
 Wentworth, S. (2020, March 25). The legal and regulatory context of R&D during COVID-19. The Pharma Letter. Retrieved from https://www.thepharmaletter.com/article/the-legal-and-regulatory-context-of-r-d-during-covid-19
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary. (2020, February 4). U.S. Department of Health & Human Services. Retrieved from https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx
 Countermeasures Injury Compensation Program. (2017, October). Health Resources & Services Administration. Retrieved from https://www.hrsa.gov/sites/default/files/hrsa/cicp/cicpfactsheet.pdf
 Justice Department Files Its First Enforcement Action Against COVID-19 Fraud. (2020, March 24). United States Department of Justice. Retrieved from https://www.justice.gov/opa/pr/justice-department-files-its-first-enforcement-action-against-covid-19-fraud
 Harasimowicz, R. (2020, March 24). The Global Patent Race for a COVID-19 Vaccine. The National Law Review. Retrieved from https://www.natlawreview.com/article/global-patent-race-covid-19-vaccine
Photo by National Cancer Institute on Unsplash