Where We Are Now on the COVID-19 TRIPS Proposal—Is an IP Waiver the Right Way to Address Vaccine Inequity?
After over a year of discussions, the World Trade Organization (WTO) proposal to temporarily waive intellectual property (“IP”) protections for COVID-19 vaccines and treatments has seen little progress, even with the backing of over a hundred other countries, including the United States.[1] But is this waiver actually the best way to ensure the equitable distribution of COVID-19 treatments to all?
This idea was first introduced at the WTO Council for Trade-Related Aspects of Intellectual Property Rights, or TRIPS.[2] TRIPS ensures that IP rights acquired in any one WTO member country—including copyright, trademarks, and patents—are recognized in other member countries, who must abide by certain minimum standards of protection.[3] The Council is not only a means for countries to confirm the compliance of other member countries, but also a means for countries to advance concerns and problem-solve with one another.[4]
The COVID-19 waiver was initially advanced in October of 2020 by India and South Africa for the purposes of ensuring that treatments and vaccines for COVID-19 could be shared without hindrance from the enforcement of IP rights.[5] They feared that enforcement of IP rights for these measures would prevent timely provisioning of goods and limit affordability worldwide, and that these problems would be especially difficult to overcome for developing countries.[6] The original proposal ambiguously advocated for the waiver to be in place until the majority of the world had developed immunity to COVID-19.[7]
The proposal was later revised in May of 2021, where, with the support of additional countries, changes were made to reflect a growing concern for COVID-19 variants.[8] The revised proposal also set out a more concrete time frame and stated that IP rights would be waived for at least three years.[9] After concerns about the breadth of the original waiver were brought to light, this revision also narrowed the language of the original proposal to make sure that it encapsulated only health products related specifically to the treatment or containment of COVID-19.[10]
When it was first put forward in 2020, the United States opposed the TRIPS waiver, in part due to the strong disapproval of the pharmaceutical industry.[11] However, an increase in global outbreaks—particularly skyrocketing cases in India at the beginning of 2021—and pressure from Democratic lawmakers caused a reversal of the United States’ position.[12] In May of 2021, the Biden administration announced that it supported a waiver of IP rights, not for all COVID-19 treatments, but exclusively for COVID-19 vaccines.[13] Even though the United States did not fully endorse the proposal, this signaled that it would be willing to participate in negotiations surrounding the waiver.[14]
The support of the United States initially led to hope that talks of adopting the waiver would progress, but little has advanced since then. Many have accused the United States of failing to take a leadership role in advocating for the waiver, empowering other high-income countries like Germany and the United Kingdom to continue to block efforts.[15] Some have also complained that the United States has offered free booster shots to Americans while failing to supply poorer countries with initial doses of the vaccine.[16] In November 2021, the discovery of the Omicron variant in South Africa and mounting criticism led President Biden to urge countries for a quick waiver of IP protections, stating that the pandemic would not end until global vaccinations were achieved.[17] The WTO nations were expected to meet during that time to discuss the waiver, but the meeting was postponed due to travel restrictions caused by the Omicron variant, leaving discussions once again essentially tabled.[18]
Overall, proponents of the waiver argue that the failure of the WTO to act has enabled pharmaceutical companies to determine which countries have access to the treatments they’ve developed and at what price.[19] They state that drugmakers have “us[ed] their intellectual property rights to segment global markets instead of maximizing the scale of generic production.”[20] While over five billion people worldwide have received a dose of a COVID-19 vaccine, most reside in middle- to high-income countries.[21] In low-income countries, only about fifteen percent of the population has received a dose of any COVID-19 vaccine.[22] Licensing for production of the vaccine has mostly occurred in higher income countries, leaving low-income countries to receive doses through an agreement called COVAX, which has faced difficulty providing vaccines due to problems with production, exporting, and stockpiling of vaccines by higher income countries.[23] Dealing with the shortcomings of COVAX and having no access to the IP behind vaccines and treatments, with no waiver, less wealthy nations would be left to the lengthy process of discovering their own treatments, leaving COVID-19 to mutate and cases to worsen.[24]
While all countries agree that an end must be put to the COVID-19 pandemic, not all of them agree that a waiver of IP protection is the best way to go about it, or in fact, if the waiver would help at all.[25] Opponents of the waiver agree that abandoning IP protections would do little to address the underlying issue of vaccine inequity because they feel that it has not been shown that IP rights have caused vaccine shortages.[26] They note that technology transfer has been facilitated since the pandemic began, with the world’s largest patent offices readily providing information on patents available for licensing.[27] Additionally, in the least developed countries, IP rights have not been fully enforced, meaning that these countries are technically already allowed to manufacture the patented vaccines.[28] This could indicate that the problem is not with the existence of IP rights for these treatments, but rather with the lack of manufacturing capacity of many of the countries in the most danger. Many of these countries lack a developed pharmaceutical manufacturing industry and would have a long road ahead to prepare facilities and employees for manufacturing.[29] Even with waived IP rights, these countries would be competing with wealthier countries for raw materials and may face other supply chain issues as well.[30]
Some go so far as to state that waiving IP rights would hurt rather than help the distribution of vaccines.[31] Without IP protections, they argue that it would be more difficult for businesses to invest in research—a necessity to address emerging variants—and also more difficult for would-be competitors to join in contractual manufacturing partnerships—which could be vital for them to continue to produce a high volume of doses.[32] Some countries who have stalled the waiver have opted for alternatives, such as donating vaccines.[33] Germany, for example, believes that IP rights must remain in place, but pledged to donate over twenty million vaccines through COVAX in 2021.[34]
WTO countries seem to be at an impasse regarding the waiver, with both sides making valid arguments. Supporters of the waiver may be correct in that the current voluntary licensing system has allowed pharmaceutical companies to guide the distribution of COVID-19 treatments, with most of them failing to respond to voluntary licensing calls or share technology.[35] However, detractors of the waiver may have rightly noted that its adoption would create problems concerning manufacturing. A solution to this issue may lie somewhere in the middle. One potential answer would be to move from a voluntary licensing system to one that is compulsory for COVID-19 related goods.[36] Compulsory licenses may be supported on public health grounds, and there are national emergency exemptions that would allow them to take effect without the satisfaction of strict prerequisites.[37] Some countries, like Israel and Hungary, have already effectively authorized compulsory licensing for COVID-19 vaccines and treatments.[38] Compulsory licensing may offer a way for countries with the manufacturing capacity to produce more COVID-19 treatments and vaccines, allowing for a higher volume of these products to be donated to less able countries without having to undergo the costly process of implementing manufacturing facilities of their own.
With the pandemic continuing to disproportionately affect less-wealthy countries, it is clear that keeping to the status quo is not an adequate response. However, the TRIPS waiver may not fully address the problem. Overall, it may be time for countries to find new ways to collaborate with one another and globally put an end to the pandemic.
Footnotes
