Vaccine Patent Waivers: A Major Step Towards Ending the Covid-19 Pandemic?

By: Xiang Li

It has been two years now since the World Health Organization (WHO) declared the existence of the COVID-19 global pandemic on March 11, 2020. Through the concerted efforts of healthcare systems, vaccine manufacturers, governments, and members of the public, the world finally has the upper hand in the uphill battle against the COVID-19 pandemic. However, given how infectious the virus is and the speed at which it evolves to escape sufficient human immune response, it is not yet the time to let our guard down and it is critical to redouble efforts to increase global vaccination rates

Importantly, the inequality in vaccination rates seen between low-income countries and the rest of the world remains a prominent problem. As of March 31, 2022, 79.0% of the populations of “high-income” countries have received at least one dose of the COVID-19 vaccine, and so have 81.2% of the populations of upper middle income countries. Approximately 59.2% of the populations of lower middle income countries have received at least one dose. On the other end of the spectrum, only 14.5% of the population of low-income countries have received at least one dose of the vaccine. The disparity is largely caused by the unaffordability of vaccines to people in low-income countries.

To solve this disparity, the national governments of India and South Africa submitted on October 2, 2020 a communication (IP/C/W/669) to the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Council of the WTO, proposing that the obligation of TRIPS members to recognize and enforce patent rights should be temporarily waived with respect to patents relating to COVID-19 vaccines, medicines, and equipment necessary for treating and preventing COVID-19. The patent waiver as proposed is not mandatory, it simply allows TRIPS members to waive patent protection in their own countries, if they choose to do so.

The legal basis of adopting a patent waiver lies in Article IX.3 of the Marrakesh Agreement, which establishes the WTO. Specifically, Article IX.3 provides that the Ministerial Conference of the WTO, with the support of three-quarters of WTO members, may waive an obligation imposed by the TRIPS Agreement.

The waiver proposal has gained support from more than 100 low-income countries, but has encountered obstructions from many high-income countries, including European Union countries, the United Kingdom, and Switzerland. On May 5, 2021, the Biden administration announced support for a patent waiver; however, it was not until recently that major parties of the WTO made progress towards the negotiation of the terms of the waiver. 

Specifically, a news report published on March 16, 2022 indicated that the European Union, the United States, India and South Africa have reached a compromise on the terms of the waiver. Notably, only countries that have exported less than 10% of the total global exports of COVID-19 vaccine doses in 2021 are entitled to invoke the waiver to use the patented materials. These criteria effectively exclude the European Union, China, and the United States from invoking the waiver, since these countries account for 39.3%, 33.7%, and 14.2% of global vaccine exports respectively. 

The United States could have taken a stronger stance on waiving intellectual property protections, but it has not — possibly because a waiver suspending domestic patent protection might violate the Takings Clause of the Fifth Amendment of the United States Constitution. The Supreme Court of the United States has recognized that patent rights are subject to the protection of the Takings Clause, just as property rights in a piece of land. At the same time, the United States has a strong interest in preventing China from obtaining the right to invoke the patent waiver, to make sure China cannot use United States’ proprietary technologies to gain an advantage in vaccine development and other related biotechnology.

This recent compromise on the terms of the waiver might be a significant step towards passing the waiver at the WTO, since the European Union (composed of 28 countries, each having a vote) has been the strongest opponent of the waiver, as indicated by its statements made at several WTO meetings. Many scholars and policy makers believe that passing the waiver is a necessary step to provide equal and affordable access to vaccines to people in low-income countries. If the entire world community is vaccinated before the coronavirus can evolve into other highly contagious and potentially even more deadly variants, the world may be able to finally declare victory over the pandemic.

Telemedicine to the Rescue? Mail Order Abortion in Times of Crisis

By: H.R. Fitzmorris

Since the time of the Comstock Act, reproductive healthcare seekers have turned to networks outside of the traditional doctor’s office to circumvent legal and social obstacles. Almost 60 years after the restriction of mail-order contraception was abandoned, Americans have once again—with the aid of the internet— found themselves relying on the post office to meet reproductive healthcare needs through telehealth. And once again, they face the familiar struggle of navigating complex webs of overlapping regulations and political hostility limiting their access to vital resources and information. However, the healthcare crisis spurred by the COVID-19 pandemic, and the resulting regulatory and legal changes, have helped abortion and reproductive healthcare seekers circumvent some of the most burdensome barriers to access. The question now is whether, together, technological advancement in online telehealth and the relaxation of state and federal regulations will be enough to address the “access crisis” that will ensue if the current onslaught of draconian abortion laws survives legal challenges.

The History of Telehealth and How It Works

The concept of telehealth has existed in some form or another for decades. Telehealth, according to the Mayo Clinic, “is the use of digital information and communication technologies, such as computers and mobile devices, to access health care services remotely and manage your health care.” Some clear advantages of telehealth are the ability to access care without the additional cost and burden of traveling to a doctor’s office, increased access to information and records, and increased speed of communication with healthcare providers.

There are, however, drawbacks. The regulatory system managing telehealth providers is fragmented between state and federal requirements, and insurance coverage of telehealth appointments varies according to location and provider. Licensure requirements currently depend on the location of the patient, so some specialist services or medical providers may not be licensed to provide care to patients in certain locations. Additionally, access to telehealth can be impeded by restrictive interpretations of existing state statutes and regulations. For example, state requirements that clinicians conduct an in-person physical exam of a patient before providing telehealth or issuing a prescription can dramatically impede the utility of telehealth for certain patients.

Currently telehealth makes up a small portion of the health industry as a whole. A study conducted from March 1, 2020 through November 30, 2021 revealed that the vast majority of Americans prefer in-person healthcare, “and the total addressable market for telehealth is less than 1% of the health economy.” However, the lessons learned throughout the COVID-19 pandemic may spur further expansion and increased interest in telehealth.

Covid-19 Changes

The COVID-19 pandemic upended the normal operation of innumerable day-to-day activities for most Americans. Once simple tasks became onerous, if not impossible. Notably, routine healthcare became extremely difficult to schedule when COVID exposure risks closed doctors’ offices, and the industry as a whole buckled under extreme demand. Faced with restricted access to in-person office visits due to lockdown orders and overwhelmed providers, patients turned to telemedicine just as quarantined workers turned to Zoom.

In order to facilitate patient access to healthcare, Congress introduced a myriad of temporary regulatory relaxations and measures such as increased Medicare and Medicaid coverage of telehealth services, HIPAA flexibility, and notably, allowed authorized providers to prescribe controlled substances via telehealth, without the need for an in-person medical evaluation.

This affected not just those with pulled muscles, allergic reactions, or people with other routine but time-sensitive ailments that a quick 15-minute chat with a doctor and a quick prescription would clear up. Those experiencing unwanted pregnancies, who faced the daunting prospect of delayed access to care in understandably time-sensitive situations, also were faced with lockdown and quarantine orders in the most abortion-friendly states. In hostile states, the harm of existing restrictive abortion regulations increased under COVID-19 (such as those requiring multiple in-person clinic visits like mandatory waiting periods and ultra-sound requirements). Additionally, some states that were hostile to abortion seized the opportunity to label abortion care as “non-essential,” thereby entirely restricting abortion access.

These restrictions made early access to safe, reliable, and self-administrable abortion care all the more vital. Medical abortion, which is achieved through the simple administration of a single or multi-dose pill, is available up to 10 weeks from conception. Prior to the COVID-19 pandemic, the reach of medical abortion through telemedicine was limited by “specific restrictions on mifepristone in the United States as well as laws that specifically prohibit telemedicine for abortion.” Specifically, the FDA required that either of the two abortion pills be dispensed in a medical clinic, in-person.

However, with the relaxation of the restrictions placed on telemedicine providers that came with the governmental response to COVID, the FDA relaxed the in-person requirement and allowed abortion pills to be obtained by mail, eliminating the need for a doctor visit and the resulting delay in access. Initially this relaxation was temporary, but in December, 2021, the FDA announced that the change will be permanent. Though a welcome reduction in barriers to safe and effective abortion access, states are still free to place their own restrictions on telemedicine providers that offer their services in their jurisdictions. Currently, 19 states prohibit telemedicine facilitated abortions.

Without these barriers, telemedicine can potentially increase abortion access to abortion seekers in underserved, isolated communities. Telemedicine was, in a limited way, able to address severe need in a crisis that strongly necessitated these services. For abortion seekers in the United States, the crisis is far from over. Current restrictive state statutes and attempts to overturn Roe v. Wade continually threaten access to the constitutional right to choose to terminate a pregnancy. In many states, local access to abortion care could disappear entirely in the coming years. What remains unclear is whether further expansion of access to telemedicine will be able to help fill these gaps and what policy changes will be necessary in order to do so. 

COVID-19 Vaccine Passports: A One-Way Ticket to a Normal Life or a Threat to Individual Privacy and Equality?

By: Kelsey Cloud

As the percentage of fully vaccinated individuals continues to increase globally, countries have begun to consider whether or not to require vaccine passports—digital passes confirming that the owner has been fully vaccinated against COVID-19—in order to attend sporting events, concerts, and other pre-pandemic activities. A simple scan of a QR code on a smartphone or printed paper would allow the flow of international travel to resume, as well as allow consumers access to certain businesses, events, or locations within their home countries. China, New Zealand, Israel, and the United Kingdom have already launched various versions of vaccine passports, with widely varying policies and methods of implementation. For example, the European Union’s Digital Green Certificate collects an individual’s name, birthdate, date of issuance, and vaccine information. Moreover, a multitude of international organizations, including the World Health Organization and International Air Travel Association, have begun launching efforts to coordinate vaccine passport implementation as well.

In the United States, President Biden issued an Executive Order instructing the State Department to collaborate with global health organizations to establish international travel guidelines. However, the administration explicitly stated that the federal government will not issue vaccine passports, nor collect or store personal vaccine data. As such, without a federal mandate, vaccine passport initiatives in the U.S. remain in the private sector, driven by companies such as Microsoft, Salesforce, IBM, and MasterCard. All applications are still in the development stage, and several governors have already issued executive orders banning the use of vaccine passports in their states. The absence of a federally issued vaccine passport, coupled with the lack of uniform digital standards at an international level, create significant implementation issues that stir complicated political and ethical debates surrounding privacy, inequality, discrimination, and fraud.

Private Sector Digital Vaccine Passports Full of Privacy Concerns

The lack of a federal privacy law regulating the collection and use of personal information fosters concern surrounding oversight and control of that information. While companies developing passport applications seek to preserve as much individual privacy as possible, a federal application would likely need to include enough personal and medical information to confirm that someone has been vaccinated, such as name, contact information, and medical records from health care providers. The protections of the Health Insurance Portability and Accountability Act (HIPAA) would not be implicated in most situations, since passport applications could be developed without transmitting information to HIPAA-covered entities such as hospitals.

While some companies claim that their applications have robust privacy protections by encrypting confidential user data, the lack of legal remedies for privacy violations still leaves digital vaccine passports ripe for abuse and vulnerable to privacy breaches. Allowing private companies direct access to medical records raises questions concerning if and how third-party companies will store and use that data. Without oversight from the federal government, those private companies could capture personal health information in ways that create a significant target for hackers.

Current Vaccine Distribution Policies Reinforce Systems of Inequality    

Additionally, restrictive vaccine distribution policies favor  high-   income countries and worsen inequalities domestically and internationally. Globally, most low and middle-income countries still lack access to COVID-19 vaccines, and within high income countries, African Americans and Hispanic individuals continue to be vaccinated at lower rates than White individuals. As of April 15th, only 0.1% of the 841 million administered vaccine doses went to individuals in low-income countries. Joia Mukherjee, Chief Medical Officer of Partners in Health, warns that the world is “creating another superstructure or colonial hierarchy of people from wealthier countries having access and poorer countries not having access.” In the U.S., high poverty and uninsured populations, as well as non-citizen immigrants, share a direct correlation with lower vaccination rates. Moreover, vaccine passports have the potential to discriminate against those who cannot receive vaccinations due to medical or religious reasons. While many vaccine passports, such as the State of New York’s Excelsior Pass, allow for the use of a negative COVID-19 test in place of proof of vaccination, other countries like China exclusively admit vaccinated individuals, increasing the possibility for discrimination.

In addition, those without smartphones, mobile devices, or a reliable mobile data plan would suffer technological discrimination. Vaccine passport applications would disregard those in marginalized communities, such as formerly incarcerated people or undocumented people, who typically hold higher fears of government surveillance of their private health information. Requiring digital passports for travel, both domestically and internationally, could only exacerbate these inequalities.

Towards a Unified Global Approach Vaccine certifications for international travel are not new—many countries currently require proof of yellow fever vaccinations, for example. Mass vaccination initiatives have sprouted throughout history, both in the U.S. and around the world. Prior vaccine initiatives in place before COVID-19 already carry vaccination requirements for attending work, educational institutions, and traveling internationally, which the vast majority of the world complies with. In order to ensure the effectiveness and reliability of COVID-19 vaccination passports, private companies, international organizations, and other entities developing vaccine passports must safeguard the privacy of medical information, prevent fraudulent vaccination data, and implement anti-discriminatory policies that lessen global inequalities.