President Donald Trump is looking to regain a significant political and economic victory by capitalizing on the upcoming U.S.-Mexico-Canada Agreement (USMCA) review process. During his first term, the administration, led by U.S. Trade Representative Robert Lighthizer, worked closely with Mexico and Canada to secure several intellectual property (IP) concessions, particularly in the area of biologic medicines. These measures were intended to protect American innovators from foreign rivals, ensure fair competition, and incentivize investment in research and development. However, a key provision—requiring Canada and Mexico to provide 10 years of regulatory data protection for cutting-edge biologics—was excluded from the final version of the agreement at the last minute, despite being a key part of the original negotiations.
The removal of this provision was likely a result of pressure from then-House Speaker Nancy Pelosi, whose backing was essential for passing the USMCA’s implementing legislation through Congress. Despite these setbacks, the new Congress provides a renewed opportunity for the administration to push for the original terms of the agreement. By revisiting the USMCA during its review process, the administration aims to restore the protections that would prevent foreign manufacturers from freeloading on American biotech innovators, ultimately helping to reduce drug prices for U.S. patients.
The article emphasizes that the removal of the regulatory data protection provision would have significantly undermined the intent of the USMCA. By allowing foreign companies to use clinical trial data from U.S. biologic developers, the provision would have eroded the ability of American innovators to recoup their massive investments in research. This would have limited the development of new treatments for patients and reduced incentives for firms to invest in the biotechnology sector. The article argues that restoring these protections would not only help American companies innovate and compete globally but also lead to lower drug prices for American consumers.
Additionally, the Trump administration has placed Mexico on the Special 301 Priority Watch List, highlighting its long-standing failure to meet its intellectual property commitments under the USMCA. Mexico has been found to lack essential patent-enforcement systems, have poor copyright enforcement, and allow rampant trademark counterfeiting and copyright piracy. These failures have undermined the protections that American innovators were expected to gain through the trade pact. The administration now seeks to address these issues through the upcoming USMCA review, which offers an opportunity to hold Mexico accountable for its commitments and restore the intended benefits of the agreement for U.S. interests.
The article concludes that stronger intellectual property protections are critical not only for the biotechnology sector but also for the broader U.S. economy. By securing these protections, the administration could foster innovation, create high-paying jobs, and maintain the United States’ leadership in critical 21st-century industries. The upcoming USMCA review, therefore, presents a pivotal moment for the Trump administration to address past shortcomings and reassert American economic and technological leadership.