Introduction to the USTR’s Concerns
The United States Trade Representative (USTR) has highlighted non-tariff barriers in Mexico’s pharmaceutical and telecommunications industries.
Pharmaceutical Industry Delays
Regarding the pharmaceutical sector, the USTR reports delays of 18 to 24 months for the granting of health registrations and import permits.
Although Mexico’s regulatory environment has shown minor improvements, the USTR asserts that structural changes are necessary to facilitate registration in Mexico.
The Federal Commission for Protection against Health Risks (Cofepris) continues working to resolve its backlog, but the USTR argues that companies attempting to register FDA-approved products in Mexico still face delays exceeding one year.
The regulatory delay remains the primary barrier for entering Mexico’s medical device and pharmaceutical product markets, according to the USTR. Cofepris struggles with insufficient staff and capacity to grant health registrations and conduct factory inspections within established timeframes.
Cofepris is implementing trust mechanisms for approvals and inspections, maintaining technical regulatory conversations with the FDA to identify improvement opportunities in their review process.
Telecommunications Industry Concerns
The USTR has expressed concern over Mexico’s telecommunications sector, citing potential barriers for US companies like AT&T.
Three main issues raised by the USTR include:
- Abolition of the Federal Telecommunications Institute (IFT) in 2024 through a constitutional reform for administrative simplification.
- Potential new legal framework establishing sector-by-sector and service-based regulation in telecommunications.
- High tax burden for licensed spectrum usage.
Additionally, the USTR questioned Mexico’s Secretariat of Environment and Natural Resources (Semarnat) for rejecting import permits of chemical products containing glyphosate.
Mexico has not provided public comment opportunities, notified the World Trade Organization (WTO), or offered scientific evidence for these rejections. Glyphosate remains registered for use in Mexico, but a decreed phased elimination of its usage and related products by January 31, 2024, took effect on January 1, 2021.
Intellectual Property Policy Concerns
The USTR has also shown concern over what it perceives as a weak intellectual property protection policy in Mexico.
Mexico was included in the USTR’s “WatchList” in its Special 301 Report of 2024 due to high availability of counterfeit products, digital piracy, and weak law enforcement.
Key Questions and Answers
- What are non-tariff barriers? Non-tariff barriers refer to regulations, standards, and other policies that restrict international trade without directly using tariffs.
- Who is the USTR? The United States Trade Representative (USTR) is an office within the Executive Office of the President responsible for developing and coordinating US international trade, commodity, and direct investment policy.
- What is Cofepris? The Federal Commission for Protection against Health Risks (Cofepris) is a Mexican government agency responsible for overseeing health risks and ensuring compliance with health regulations.
- What is glyphosate? Glyphosate is a widely-used herbicide, primarily for controlling broadleaf weeds and grasses in agricultural settings.
