The Biden administration and other World Trade Organization members are considering expanding the harmful and unnecessary waiver of intellectual property (IP) protections under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) beyond COVID-19 vaccines. These governments should approach this decision with a clear understanding of one of the most significant consequences of that action: compromised public health, especially in lower-income countries.
Simply put, expanding the TRIPS waiver to include treatments would compromise global public health and the safety of patients. That’s because, unlike through voluntary licensing agreements between U.S. biopharmaceutical innovators and foreign manufacturers, neither the U.S. government nor biopharmaceutical companies would be able to ensure the safety, quality or effectiveness of medicines manufactured abroad under this waiver.
If a foreign manufacturer were to utilize the TRIPS waiver to produce a COVID-19 vaccine or treatment, then the U.S. government and original innovating company would have no oversight over that production. The TRIPS waiver could enable bad actors to take advantage of this less regulated environment to supply adulterated, substandard or counterfeit treatments and vaccines. Unfortunately, we saw the proliferation of counterfeit COVID-19 vaccines during the pandemic. Further weakening commitments to protect IP could exacerbate this issue.
By forfeiting additional American innovation to countries and other entities, any expansion of the TRIPS waiver would jeopardize the safety of patients in low- and middle-income countries since they are most likely to take these medicines produced without the benefit of oversight by the innovator company. The innovator has the most knowledge, know-how and safety and effectiveness data about the product.
The World Health Organization has noted already that developing countries are vulnerable — an estimated 1 in 10 medical products in low- and middle-income countries is substandard or falsified. IP protections help support and enable the voluntary partnerships and collaborations that have provided, and will continue to provide, the globe with safe and effective COVID-19 vaccines and treatments. Rejecting any expansion of the TRIPS waiver is critical to support continued innovation and will help keep people safe.
To read more about the harms of TRIPS waiver expansion, click here.