BIO's 2019 Special 301 Submission

Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual property protections or fair and equitable market access to U.S. persons who rely on IP protection. As part of the 2019 Special 301 Review process conducted by USTR, Justin Pine prepared BIO’s formal submission and presented oral testimony to USTR and the interagency Special 301 subcommittee highlighting the IP issues facing our members in key markets around the world.

The principal concerns highlighted in BIO’s submission are: i) global compulsory licensing trends; ii) lack of adequate or any regulatory data protection; iii) restrictive patentability frameworks; and iv) market access concerns associated with drug pricing controls.