WeVote
Log In

Bill

Bill

S 5316

BINSA Act

119th Congress Introduced by Pete Ricketts and 1 co-sponsor

Biotechnology moves into the DPA’s prohibited/notifiable framework, tightening review and restrictions on cross-border biotech licensing, JV, and equity transactions.

Introduced in Senate
1
WeVote Research Nonpartisan
Bill Summary · S 5316

Summary of Bill S.5316, the Biotech Investment National Security Act of 2026 (BINSA Act)

Purpose and intent

  • The BINSA Act amends title VIII of the Defense Production Act of 1950 to explicitly include biotechnology within the scope of “prohibited technology” and “notifiable technology.”
  • The overarching goal is to address national security and strategic vulnerability risks associated with U.S. capital flows, licensing, joint ventures, and equity investments in biotechnology activities that could bolster the People's Republic of China (PRC) biotechnology capabilities, particularly in pharmaceutical development, biologics manufacturing, and related clinical research and development.

Key provisions and changes

1) Definitions and scope
- Biotechnology is added to the definitions relevant to prohibited and notifiable transactions under the Defense Production Act (DPA), covering:
- Pharmaceutical products (as defined by the FD&C Act)
- Biological products (as defined in the Public Health Service Act)
- Therapeutic compounds and related areas, including drug discovery platforms, clinical R&D capabilities, biologics manufacturing, and related intellectual property and know-how

2) Inclusion in prohibited and notifiable transactions
- The act updates Section 809 of the DPA to include licensing of prohibited technology and, separately, biotechnology-related transactions (as defined above) within the prohibited and notifiable technology categories.
- The changes are designed to capture licensing, joint ventures, and equity investments involving biotechnology with covered foreign persons (as defined by the statute).

3) Rulemaking and definitions
- The Secretary of the Treasury must issue a rule within 1 year of enactment to further define the parameters of “biotechnology” for the purposes of the notifiable/prohibited technology definitions.
- The rulemaking process must:
- Involve consultation with the Secretaries of Health and Human Services, Defense, and the DNI.
- Prioritize considerations around licensing of IP, drug discovery platforms, clinical R&D capabilities, and biologics manufacturing know-how to covered foreign persons.
- Assess transactions (licensing, joint ventures, equity investments) involving drug discovery platforms, clinical development, and biologics manufacturing as priority categories for both prohibited and notifiable tiers.
- Evaluate the degree of transfer of pharmaceutical innovation capacity to entities under PRC direction/control.
- Avoid overbroad definitions that would inappropriately sweep in agricultural biotechnology, unrelated industrial fermentation, or basic academic research without pharmaceutical/therapeutic application.

4) Reporting requirement
- Within 60 days after enactment, the Department of Defense must provide an unclassified (with possible classified annex) report to specified congressional committees assessing whether U.S. capital flows into the PRC biotechnology sector (including licensing transactions with PRC firms) undermine U.S. national security and military readiness.

5) Scope of committees
- The bill specifies which congressional committees are considered “appropriate congressional committees” for the reporting obligations: Armed Services, Banking/Financial Services, Intelligence, and related select committees in both the House and Senate.

Who/what would be affected

  • Biotechnology firms involved in:
    • Pharmaceutical products, biological products, and therapeutic compounds
    • Drug discovery platforms, clinical development capabilities, and biologics manufacturing
    • Intellectual property and know-how related to therapeutic compounds
  • Foreign entities, especially those subject to PRC direction or control, that participate in licensing, joint ventures, or equity investments with U.S. persons
  • U.S. entities engaging in outbound licensing, investments, or collaborations that could transfer pharmaceutical innovation capacity to covered foreign persons

Procedural and timeline aspects

  • Introduction date: August 6, 2026
  • Immediate action: Bill is referred to the Senate Committee on Banking, Housing, and Urban Affairs
  • Rulemaking timeline: Treasury to issue a defining rule within 1 year of enactment
  • Reporting timeline: DoD to deliver an unclassified report within 60 days of enactment
  • Additional procedural notes: The act codifies findings and sense of Congress emphasizing national security considerations related to biotechnology and its linkage to China’s strategic objectives

Practical implications to watch

  • Expanded DPA coverage: Biotechnology would move into the prohibited and notifiable transactions framework, affecting outbound investments and certain licensing arrangements involving biotech-related IP and capabilities.
  • Regulatory uncertainty during rulemaking: The forthcoming Treasury rule will define the practical boundaries of what constitutes “biotechnology” for DPA purposes, shaping which activities trigger notification or prohibitions.
  • National security emphasis: The bill reinforces a tighter screening regime on cross-border biotech flows, aiming to reduce potential dependency and IP leakage that could affect therapeutic innovation and domestic readiness.

Compiled from official sources — confirm details with the bill’s official record.

Sign in to ask a question.