What happened: Last week, the U.S. Chamber of Commerce submitted comments to the U.S. Trade Representative voicing concerns about the state of intellectual property (IP) protections and market access obligations under the United States-Mexico-Canada Agreement (USMCA). The Chamber’s comments underscore the importance of robust IP enforcement and transparent regulatory practices to support innovation, cross-border trade, and fair market access.
What was raised: Among other key issues, the main concerns for industry are:
- Regulatory Data Protection: Mexico has yet to implement meaningful regulatory data protection (RDP) for biologics and small molecules, despite commitments under USMCA. The Chamber believes it will be critical to restore the RDP provisions originally negotiated in the agreement to bring Canada and Mexico closer to the high standard set in U.S. law.
- Patent Protection and Enforcement: Mexico has yet to establish a meaningful patent enforcement mechanism, despite the government’s claim that listing the use of patents satisfies Mexico’s USMCA obligations. In Canada, difficulties securing effective patent term adjustment forces innovators to initiate costly and lengthy judicial proceedings to protect their patent rights.
- Market Access Barriers: U.S. firms face prolonged delays when seeking regulatory approvals and pricing decisions in Mexico and Canada, particularly in the health sector. In Mexico, COFEPRIS has inconsistently used the expedited review pathway, resulting in long approval delays that prevent market access. Meanwhile, in Canada, the government’s pricing policies artificially devalue innovative medicines and delay patient access to new medicines.
- Copyright & Digital Trade: While the Mexican Supreme Court upheld the USMCA copyright provisions, clear implementing regulations have yet to be issued. In Canada, the government has implemented new discriminatory digital measures targeting U.S. companies.
Why it matters: Effective implementation of USMCA provisions can raise the bar for IP protection, strengthening the framework for innovation and creativity throughout North America and setting an example for other regions to follow. The U.S. government can utilize the joint review of USMCA to address outstanding practices that undervalue American innovation and discriminate against U.S. innovators and creators. The Chamber supports the continued success of the Agreement which will help level the playing field for IP-intensive industries across the region.
Read the Chamber's submission:
