On May 5, the Biden administration, hoping to provide more equitable healthcare access both within the country and to lower-income nations, released a statement in support of waiving patents for COVID-19 vaccines. “The Administration believes strongly in intellectual property [IP] protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,” U.S. Trade Representative Katherine Tai announced. However, as expected from a country embroiled in the fierce debate between private and public health, this decision drew backlash from pharmaceutical companies looking to protect their IP (and profits).
This initiative took root in October 2020 when India and South Africa approached the World Health Organization (WHO) with a proposal to temporarily lift IP protections for COVID-19 treatment. This motion cited previous agreements under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) that address pharmaceutical patents in consideration of public health crises. In emergency situations, the World Trade Organization (WTO) may grant compulsory licenses allowing countries to disclose medical technology and information to third-party manufacturers. First put into practice in August 2003 and formally incorporated into the TRIPS Agreement in December 2005, this exists primarily to provide essential medicines to countries that lack the resources to research, produce, or distribute treatment on their own.
Only 16 countries have reached the 70% minimum vaccination benchmark required for herd immunity. As of September 24, 2021, 55% of the U.S. is fully vaccinated, with this shortcoming stemming largely from anti-vaccine sentiments. A similar trend can be observed in other wealthy countries such as Switzerland and Norway. However, for lower-income countries, the issue lies not in vaccine hesitancy but rather in a severe shortage of vaccines. According to the United Nations Office for the Coordination of Humanitarian Affairs (OCHA), “Africa had administered 59% of its vaccine supply [by June 2021], which translates to only 1.86% and 0.51% of the population receiving the first and second doses of the COVID-19 vaccine respectively.” The WHO further reported that Africa will be receiving 25% fewer vaccines than expected, preventing the continent from reaching its goal to inoculate 10% of its population by September.
India and South Africa intended for the vaccine waiver to mitigate this widening disparity, arguing that the legal formalities of IP protection would prevent the vaccine from reaching those who need it most, especially in such a time-sensitive situation. The longer it takes for IP-protected medicine to roll out, the more hospitalizations become deaths.
Developed countries—including the U.S.—rebutted that IP protection was only one of several hindrances to rollout. It would take another several months for the Biden administration to back the initiative, and a revised proposal was eventually submitted on May 25.
Some companies predicted these barriers to access beforehand and have already licensed their vaccines for worldwide manufacturing. As early as February 2021, AstraZeneca, a British-Swedish pharmaceutical business, promised to deliver up to 3 billion doses to governments around the world, as well as to international partnerships (WHO and Coalition for Epidemic Preparedness Innovations).
U.S. companies were more reluctant to echo such actions, but following lengthy negotiations with the Biden administration in June, Pfizer-BioNTech agreed to donate 500 million doses for rollout to 92 lower-income countries. Just one week ago, the company announced plans to expand this initiative to include a total of one billion donated doses. Rather than license their formula for third-party manufacturing, though, Pfizer will sell these vaccines to the government at a not-for-profit price. The government will then manage the distribution overseas.
Despite receiving an initial $2.5 billion from the federal government and $955 million from the Biomedical Advanced Research and Development Authority (BARDA) to fund vaccine research, Moderna has not cooperated with efforts to share this technology or donate doses. The Moderna vaccine is also significantly more expensive than its competitors, reaching $32 to $37 per dose. In comparison, Pfizer-BioNTech costs $19.50 per dose and AstraZeneca costs a mere $3 to $4.
Like Pfizer and Moderna, the Pharmaceutical Research and Manufacturers of America (PhRMA) disapproves of the Biden administration’s push for patent waivers, claiming that lifting IP protections will dilute the quality of vaccines. Even if the formulas are licensed for third-party production, the countries that do not have the money for research also will not have the capacity nor experience to manufacture vaccines efficiently. “[This proposal] will undermine our global response to the pandemic and compromise safety […], further [weakening] already strained supply chains and [fostering] the proliferation of counterfeit vaccines,” PhRMA CEO Stephen J. Ubl stated. In addition, he argues that waiving their IP rights will erode America’s strong position in the biopharmaceutical industry.
Further criticism stems from the government’s seemingly selfish allocations for funding. Some believe that as an economic superpower, the U.S. has the moral responsibility to provide for the less fortunate. While the U.S. is making an effort to accelerate global inoculation, it has also been channeling resources towards booster shots for Americans when front-line workers in other countries are still awaiting their first dose. In August 2021, the WHO issued a moratorium on boosters, justifying that there is no immediate need for a third shot because the original doses still provide sufficient protection. Vaccine development was at the forefront of concern at the beginning of the pandemic, but the priority now turns to fair, global distribution.
The economics regarding vaccines highlights the clash between pharmaceutical monopolies and public health. Medicine has life-saving potential, but because IP-patented drugs are so exclusive, it is often inaccessible to the ill. Generic manufacturers must wait for patents to expire before they can mass produce more affordable options, but time is sensitive in emergency crises such as the COVID-19 pandemic. The billions of lives on the line begs the question of whether IP protections allow pharmaceutical companies to perpetrate abuse upon their customers, but for now, U.S. support for the vaccine patent waiver signifies a shift towards prioritizing the greater good over profit.
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