About the author: Philip Alexander is a law student at the National University of Juridical Sciences, Kolkata.
"Pre-Exposure Prophylaxis (PrEP)" by NIAID available here.
Introduction
The United States' Food and Drug Administration (FDA) recently granted Emergency Use Authorization to AstraZeneca’s Evusheld as pre-exposure prophylaxis (PrEP) to COVID-19 for immunocompromised patients. The product will be administered to at-risk patients who are moderately to severely immunocompromised due to a medical condition "or for whom vaccination with any available COVID-19 vaccine… is not recommended due to a history of severe adverse reaction." Although beneficial in preventing the transmission of COVID-19, several questions are raised on the pharmaceutical monopolization of PrEPs, with the HIV/AIDS epidemic as precedent for the inequitable distribution of medication to ethnic and racial minorities.
Gilead Sciences dominates the market for HIV PrEPs in the United States, manufacturing the only two FDA-approved PrEPs, Truvada and Descovy, providing up to 99% protection against HIV infection. However, the drugs are priced at $1500 per month but cost only $6 to manufacture, restricting accessibility to poor minority groups who form a significant percentage of HIV patients - Black and Latino men have the highest and second-highest infection rates. However, despite these disproportionately high rates of infection, only 1% and 3% of PrEPs were prescribed to Black and Latino men, respectively. This disparity in the distribution of HIV medication is attributable to a prominent market monopoly by Gilead Sciences over PrEPs, controlled by restrictive patents on Truvada and Descovy. Recent allegations also indicate that Gilead Sciences entered into several collusive agreements, delaying competition to maintain the exorbitant prices of Truvada. Gilead’s unethical practices over HIV PrEPs is an open secret and has contributed to the loss of millions of lives unable to afford their high prices.
The Right to Health
The ongoing COVID-19 pandemic is witnessing similar trends with a disproportionate impact on minorities in the United States. According to data from the CDC, 21.8% and 33.8% of COVID-19 cases were Black and Hispanic individuals, with these groups forming only 13% and 18% of the U.S. population. Furthermore, minorities were less likely to be vaccinated against COVID-19 and 4.7 times more likely to be hospitalized from infection. Evusheld as a PrEP would be beneficial under such circumstances, protecting at-risk patients from contracting the virus. However, it is concerning that AstraZeneca has recently shifted to a ‘for-profit’ model with multiple commercial agreements for vaccine supply, reneging on its earlier ‘no-profit pledge’ on the sale of its vaccine. The company made over $1.1 billion from its vaccine but intends to sustain ‘modest profitability’ to compete with global vaccine manufacturers. With this, the pharmaceutical giant’s intentions with Evusheld as a PrEP become more transparent. A strict patent regime from AstraZeneca could see an unequal distribution of COVID PrEPs, exacerbating the pandemic’s impact on at-risk individuals belonging to disenfranchised groups.
This is not the first time pharmaceutical companies have prioritized profit over accessibility during the COVID-19 pandemic. The FDA granted Emergency Use Authorization to Gilead’s antiviral drug Remdesivir to treat COVID-19 in patients requiring hospitalization. The drug was priced at $2340 up to $3120, rendering it completely inaccessible to most residents and causing an acute shortage of supply during critical stages of the pandemic. The U.S. Government must prevent this from happening by upholding the core principles recognized under its international human rights obligations.
Although the right to health is not constitutionally recognized, the United States is a signatory to the United Nations Declaration of Human Rights (UNDHR) and the International Covenant on Economic, Social and Cultural Rights (ICESCR). Article 25 of the UNDHR and Article 12 of the ICESCR stipulate that everyone is entitled to enjoy the highest attainable standard of physical and mental health. Furthermore, the ICESCR General Comment No. 14 mandates non-discrimination in healthcare accessibility, stating that ‘health facilities, goods and services have to be accessible to everyone without discrimination.’ It is not uncommon for large pharmaceutical entities to engage in price gouging essential services, depriving minorities and other disenfranchised groups from access to critical medical treatment. AstraZeneca has engaged with price gouging in the past, with poorer countries having to pay several times the price for the Vaxzevria vaccine. This is known as vaccine nationalism, which is described by the World Trade Organization as the prioritization of wealthy nations over poorer nations in vaccine distribution.
Unethical and discriminatory practices thus prevent the equitable distribution of the medication to those who require it. It is not outside the realm of possibility that Evusheld will follow a similar trajectory where immunocompromised Black, Hispanic, Asian and Native American patients are deprived of access to PrEPs. The denial of PrEPs accompanied by the implicit racial bias in the health care system will leave several minority groups in a highly vulnerable position.
Compulsory Licensing
Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) permits the use of intellectual property without the permission of the right holder under specific circumstances. Although member states must make reasonable effort to obtain the authorization of the right-holder, this requirement can be waived during national emergencies. Article 5 of the Doha Declaration grants member states the right to determine what constitutes a national emergency or circumstances of extreme urgency. This is referred to as compulsory licensing where the government has the right to manufacture patented pharmaceuticals at lower prices for the protection of public health. Article 73 of the TRIPS Agreement also permits IPR non-compliance for the protection of a state’s essential security interests. The United States Government could very reasonably take action against a potential monopoly over COVID drugs by exercising its rights under Articles 31 and 73. For example, the Brazilian Parliament amended the Brazilian Patent Statute in early 2021 to include the procedural requirements for compulsory licensing during the pandemic. A framework that sets forth the rules for compulsory licensing during COVID-19 could alleviate the concerns of inaccessibility of COVID PrEPs to marginalized groups by granting an IPR waiver to Evusheld.
Conclusion
The future of COVID medication remains uncertain. Drawing parallels with the HIV/AIDS epidemic and AstraZeneca’s intentions with Evusheld, a limited portion of the population will receive access to COVID PrEPs at the expense of poorer ethnic and racial minorities. The HIV/AIDS epidemic is a stark reminder of the potential human rights transgressions across the pharmaceutical industry, with the monopolization of Truvada and Descovy as precedent for the United States’ health care obligations under its various international human rights instruments. The regulation of its entry into the market, compulsory government licensing, and an intellectual property waiver are just some ways to prevent the monopolization of Evusheld. Although COVID PrEPs will be an invaluable asset during this health care crisis, AstraZeneca must be held accountable for its actions. The failure to do so could prolong the social ramifications of COVID-19 far beyond what is expected.