Why the TRIPS Waiver Should Include More than Just Vaccines

By Rachel Thrasher

Nearly eight months after an initial proposal from India and South Africa, the United States surprised the world by making a public declaration of support for a Trade-Related Aspects of Intellectual Property (TRIPS) Waiver for COVID-19 vaccines at the World Trade Organization (WTO). Since then, proponents have been advocating for a waiver that is sufficiently broad in scope, coverage and duration to do the work of increasing equitable access to vaccines as well as other COVID-19 related products.

Unfortunately, the waiver still does not appear to have the global support needed to get past the WTO practice of consensus-based decision-making. The focus from G7 countries on donating doses and funding COVAX continues to keep vaccine access to a conversation about how much of their slice of pie rich countries are willing to give away, rather than expanding the pie altogether. And while the TRIPS Waiver is targeted at increasing vaccine production, the broader scope of the original proposal is cognizant of the complexity of this public health crisis by including other products that are crucial to the fight against the virus.

Arguments in favor of and against a TRIPS Waiver remain largely, and frustratingly, unchanged as the pandemic rages on. Opponents prioritize concerns that removing intellectual property protection during the pandemic will backfire and potentially make companies less likely to contribute to innovation during future pandemics. Supporters argue the COVID-19 pandemic is not the time to operate business-as-usual, where patents on tests, treatments and vaccines hinder access to critical products and put everyone at risk – “no one is safe until everyone is safe.”

WTO members should support a broad-scope TRIPS Waiver, applicable to a myriad of inventions and forms of intellectual property for two key reasons. First, millions more people are likely to contract COVID-19 and need treatment and care in the next few years, as the realities of vaccine production make it difficult to replicate in time to ramp up production in other countries quickly. Second, many products related to that treatment and care are potentially patent-protected, so a TRIPS Waiver could promote enhanced access to better care for sick people, even if the vaccines are not imminently available.

What exactly does the TRIPS Waiver say?

The most recent version of the proposal put forth by the African Group, India and others, lays out a broad-based waiver of the rules governing IP rights listed in Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement, as well as the enforcement of those rules (Part III). This covers the protection of copyrights, industrial designs, patents and undisclosed information (e.g., trade secrets).  The effect of such a waiver would be to allow countries to temporarily waive their domestic intellectual property laws which protect these types of knowledge and innovation. In countries where IP protection is waived, domestic producers could begin to manufacture and sell patent-protected products, for example, without negotiating a license with the originator firm, and without fearing domestic or international legal repercussions.

The waiver would also cover all “health products and technology…[for] the prevention, treatment or containment of COVID-19.” This includes diagnostics, therapeutic medicines, vaccines, devices, personal protective equipment and “all materials and components as well as methods and means of manufacture” of those products. The proposed waiver would be in place for three years with annual reviews by the WTO General Council and an additional review at the end of the three years to determine if the “exceptional circumstances” still apply and if the waiver should be extended.

Much less is known about the exact United States stance on the waiver text, except to note that public statements about the waiver have been limited to vaccines and their associated patents – making it less a bona fide TRIPS Waiver and more of a narrow vaccine patent waiver.

A TRIPS Waiver is necessary, but not sufficient to end the pandemic

It has been widely acknowledged that the proposed TRIPS Waiver would not be sufficient to end the pandemic. A waiver of IP rights does not magically provide the money for developing country manufacturers to build factories overnight. It does not transfer the expertise for COVID-19 vaccines automatically and, by itself, it cannot re-route supply chains to send the needed inputs to new locations.

One of the biggest obstacles highlighted by opponents of the waiver is the simple fact that many of the newest biopharmaceuticals, especially including the mRNA vaccines, would require more than a simple patent-based “recipe” to replicate – it would require technology and know-how transfer. It is this reality that causes some to fear that a waiver would make originators less likely to cooperate voluntarily:  if governments can’t guarantee some protection of their trade secrets in the future, then why would they be willing to share them now?

Even its most ardent proponents argue that negotiating a TRIPS Waiver is only the first step toward equitable access. The uncertainty about cooperation from vaccine originators is further complicated by varying expectations on just how much of an impact the TRIPS Waiver will really have. If pessimistic projections for vaccination rates are accurate, then some countries will not be fully vaccinated before the end of 2024, leaving the waiver plenty of time to make a difference for vaccine access. Some argue that more optimistic projections are accurate and most countries will have majority vaccination rates by the end of 2022, meaning the waiver’s impact on vaccines would be negligible.

COVID-19 variants, booster shots and patent protected treatments offer support for a broad waiver

The landscape of the debate is changing even further, however, as some experts predict that even if the initial vaccination campaigns take place quickly, there is a strong likelihood that booster shots will be required, possibly on an annual basis, like the flu. Additionally, the appearance of variants that are more transmissible or deadly may require a long-term strategy for ramping up vaccine production.

Ultimately, the focus on vaccines distracts from the countless other ways that ramping up production of COVID-19 products can save lives through increasing access to diagnostics, treatments, oxygen and personal protective equipment, and much more. In 2020, there was a surge in patent filings related to COVID-19 covering everything from personal protective equipment and testing, to treatment and vaccination. Of those filings, only 20 to 30 percent were related to vaccines. The waiver debate becomes carelessly futile when experts tread the same, narrow arguments and ignore that this is about much more than just vaccines.

This evidence shows a broad-scope TRIPS Waiver will be essential to increasing access to initial vaccinations, and it will also greatly expand access to follow-up booster shots, new treatments and improved patient care as the vaccine landscape evolves. With realistic production timelines and current predictions of future vaccine demand, the TRIPS Waiver is likely to shorten the wait time for citizens in developing countries.

Perhaps even more importantly, the TRIPS Waiver would also provide greater access to the best treatment options while they are waiting.