The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing. We hope our contribution will assist the United States Trade Representative’s (USTR) efforts in strengthening President Biden’s Build Back Better agenda by preserving strong intellectual property (IP) protections for United States’ innovators, companies and workers internationally. The annual Special 301 Review presents a key opportunity for the U.S.-based innovative biotechnology research community to share with USTR and the broader U.S. Government interagency stakeholders the main intellectual property (IP) challenges in trading partner countries abroad that harm the competitiveness of our member companies and their workers. The examples provided throughout this submission of the absence of adequate and effective protection of U.S. IP rights serve to illustrate how the ability of U.S.-based biotech enterprises, collectively employing over 1.87 million workers in the United States,1 that rely heavily on their IP rights to export and operate overseas is frustrated by certain policies put in place by key trading partners.

On Thursday, January 27th, BIO submitted comments in response to the World Health Organization’s (WHO) recently published white paper on the regulation of Cell and Gene Therapy Products (CGTPs). First and foremost, BIO acknowledged that the publication of this white paper is a major milestone in the global recognition and regulation of such products. The paper, while only an initial step in driving regulatory convergence, achieves the appropriate balance in providing key principles for the “state of the art”, without being overly prescriptive. In the comments submitted, BIO expressed agreement that the development and adoption of harmonized regulatory requirements based on sound science and risk-based principles is important to ensure that safe and effective CGTPs are accessible to all patients in a timely manner. Additionally, BIO emphasized the importance of industry-regulator dialogue throughout the product lifecycle and urged WHO, along with other regulatory authorities, to carefully consider the small patient population enrolled in clinical trials for regenerative medicine products as well as the adverse impact duplicative import/export release testing for advanced therapy medicinal products (ATMPs) could have on these patients. Furthermore, BIO noted that future guidelines could contemplate the utility of waivers or other flexible tools in assuring a balanced and risk-based approach. In addition to a number of redline edits, lastly, BIO suggested that the paper could be strengthened by introducing terminology early-on and by grouping definitions and categories together.