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By now, you have heard about President Biden’s decision to support a waiver of the Trade-Related Intellectual Property Rights (TRIPs) agreement at the World Trade Organisation (WTO). The waiver backed by the US would suspend intellectual property rights on vaccines.

You have also probably seen the response to the President’s decision. From support and celebration from many Democratic leaders to alarm and concern from the biopharmaceutical industry, investment, and other business community members. 

So why is the President’s decision so alarming, and why should you be concerned? Here is what you need to know. 


Background

In October 2020, India and South Africa first proposed the waiver as a vital tool to address the availability of COVID-19 vaccines, diagnostic tools, and therapeutic treatments. 

India is currently in the midst of a devastating deadly second-wave COVID outbreak. By mid-May, about 23 million infections had been confirmed, and roughly 250,000 people were dead.

On May 5th President Joe Biden announced his support to waive intellectual property rights for COVID-19 vaccines, bowing to mounting pressure from Democratic lawmakers. The President’s comment was followed by a statement from his top trade negotiator, Katherine Tai, who backed negotiations at the World Trade Organization.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in a statement amid growing concern that significant outbreaks in India could allow the rise of vaccine-resistant strains of the deadly virus, undermining a global recovery.

Until the announcement, the US, alongside the European Union, Norway, Canada, Australia, the UK, Switzerland, Brazil, and Japan, had been steadfast in their position that stringent patent protection is key to vaccine supply and the global effort to tackle COVID-19.

In response to the US announcement, German chancellor Angela Merkel voiced her opposition through a government spokesperson, who stated that the ruling would cause “severe complications” for the production of vaccines.


Impact on Vaccine Availability

The President’s decision to support an IP waiver reflects a common misconception from other democratic leaders that patents are a critical hurdle to expanding the production of the COVID Vaccine. 

Biopharmaceutical manufacturers are fully committed to providing global access to COVID-19 vaccines. We have seen unprecedented collaboration in our industry to achieve this goal, including more than 200 manufacturing and other partnerships to date. Click here to see an updated list of partnerships. 

Every global facility that is capable of producing the COVID vaccine is doing so. Instead, the waiver will cause more problems to vaccine production.

“Currently, infrastructure is not the bottleneck for us manufacturing faster,” Bourla wrote in a dear colleague letter posted on LinkedIn. “The restriction is the scarcity of highly specialized raw materials needed to produce our vaccine.”

Pfizer’s vaccine requires 280 different materials and components that are sourced from 19 countries around the world, Albert Bourla said. He contended that without patent protections, entities with much less experienced than Pfizer at manufacturing vaccines will start competing for the same ingredients.

Craig Garthwaite, a professor of strategy at the Kellogg School of Management at Northwestern University, similarly noted to the Times that “People think you’re going to pick up this patent and read it like a cheesecake recipe, and make this awesome cheesecake,” he says. “You really want Moderna and Pfizer helping you.”


Concerns about IP

Another common misconception is that this is a “limited waiver,” both in duration and scope. That may be the intent, but in reality, when you open that door, you can’t close it. 

First, the mRNA vaccine is a platform technology. It is currently being used for COVID, but the future possibilities of leveraging this platform to address other therapeutic areas, including oncology. Providing access to this technology may be intended for COVID, but its implications are far-reaching. 

Second, even if the waiver is only granted to a couple of countries, it is unrealistic to expect that the protected information will remain in that country and not be abused by global biopharmaceutical competitors. 

The president’s decision flies in the face of his stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery. It sets a dangerous precedent for America to consent to strip away patents on lifesaving COVID vaccines that cost businesses billions of dollars to develop and reward countries like China with access to US innovation for a world pandemic.


What can be done to improve vaccine availability?

  1. Focus on priority access. Some countries (including ours) are stockpiling or blocking the shipment of vaccine doses, impeding their global distribution, and choosing to vaccinate their low-risk populations before focusing on higher-risk patients abroad. The U.S. and other countries should prioritize the distribution of vaccines to the most at-risk patients wherever they may be in the world. 
  2. The WTO needs, with U.S. leadership, to play a central role in ensuring that global supply chains for vaccines are open and resilient and avoiding restrictive nationalist policies that restrict the flow of inputs in global supply chains and vaccines across borders to patients.
  3. Instead of the forced cession of U.S. vaccine manufacturing capacity abroad, promote the development of such capacity here in the US. This would build valuable US manufacturing jobs and benefit patients worldwide, aligning to a top priority under President Biden’s “Build Back Better” program. 
  4. President Biden made an important start in engaging and leading in global efforts to spur vaccine manufacturing and distribution when it joined the COVAX facility and re-engaged with the WHO. But so much more can and should be done. The United States should devote significantly more resources to multilateral and unilateral efforts to procure vaccines for low-and middle-income countries, and to support weak and under-resourced health care systems in these countries so that they can be quickly and effectively distributed. In addition, the U.S. can increase their support of the implementation of the WHO’s No Fault Compensation (NFC) program and COVAX indemnification program. Many low- and middle-income countries are in need of both expertise and financial support as they stand up their national programs. This will help protect patients, healthcare providers and many others as vaccination programs increase in more countries. 
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