On April 28 2018 the Office of the United States Trade Representative (USTR) issued its Special 301 Report, which is the result of:

"an annual review of the state of IP protection and enforcement in U.S. trading partners around the world, which the Office of the United States Trade Representative (USTR) conducts pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988, the Uruguay Round Agreements Act, and the Trade Facilitation and Trade Enforcement Act of 2015 (19 U.S.C. § 2242)."(1)

Section I.A.1 of the report concerns pharmaceutical and medical device innovation and market access and:

  • calls on Mexico – as a US trading partner – to address pharmaceutical and medical device IP-related challenges;
  • lists the steps that it can take in order to open its markets to IP-intensive pharmaceutical products and medical devices; and
  • encourages it to recognise the value of innovation in these fields and contribute its fair share to the research and development of new treatments and cures.

Whereas Mexico has a relatively strong IP protection system for pharmaceutical products (which includes broad criteria on patentable subject matter, linkage between patents and marketing authorisations and limited regulatory data exclusivity), market access has been the subject of continuous public policy debate and adjustment.

In Mexico, several institutions provide public health services (the main ones being the Mexican Social Security Institute, the Institute for Social Security and Services for State Workers and Seguro Popular). Pharmaceutical products and devices are acquired predominantly through direct purchase through tendering processes, but complex listing must occur before a product can be tendered.

For further information on this topic please contact Juan Luis Serrano-Leets at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.


(1) Special 301 Report, page 2.