SB 49 Hawaii Senate · 2025 Regular Session

RELATING TO TERMINAL ILLNESSES.

Summary

Authorizes manufacturers of investigational drugs or biological products that are pending approval by the United States Food and Drug Administration to make the drugs or products available to terminally ill patients under certain conditions. Effective 12/31/2050. (SD1)

Issues: ✓ Healthcare

Bill status in committee 1 of 4 stages cleared

Introduction

Jan 2025

Committee Review

Floor Vote

Governor

Introduced Jan 8, 2025 Last action Feb 7, 2025

Maddy AI version diff · 1 comparison

What changed between versions

SB49 → SB49_SD1 · 6 edits

MODERATE

This bill was reformatted from a standard legislative document to a structured digital format (SB49_SD1), but the substantive policy content remains largely unchanged. The bill establishes a 'right-to-try' program allowing terminally ill patients to access investigational drugs before FDA approval, with provisions for patient eligibility, manufacturer liability protections, and health insurance coverage rules.

Scope change

The bill's scope and applicability remain the same; only the document formatting and metadata structure changed from a traditional legislative text format to a structured digital template.

TECHNICAL

Document format changed from traditional legislative text to structured digital metadata format with timestamps, revision numbers, and template identifiers.

DEFINITION

New formal definitions added for 'eligible patient', 'health care provider', 'informed consent', 'investigational drug or biological product', and 'terminal illness' to clarify program requirements.

REQUIREMENT

Added specific requirements for informed consent documentation that must list existing FDA-approved treatments and describe possible outcomes of investigational treatments.

ELIGIBILITY

Eligibility criteria expanded to include patients unable to participate in clinical trials within 100 miles of home or not accepted to clinical trials within one week of application.

ENFORCEMENT

Added protections preventing licensing boards from taking action against healthcare providers who recommend investigational drug access to eligible patients.

TIMELINE

Added effective date of December 31, 2050, which appears to be a placeholder or error date rather than an intentional policy change.

Floor votes

How they voted

No floor votes recorded yet.

Full legislative history

Actions timeline

Total actions

Key actions

Committee

Feb 7, 2025

Committee

Reported from HHS (Stand. Com. Rep. No. 90) with recommendation of passage on Second Reading, as amended (SD 1) and referral to CPN/JDC.

upper

Jan 29, 2025

Upper · Passed

The committee(s) on HHS recommend(s) that the measure be PASSED, WITH AMENDMENTS. The votes in HHS were as follows: 5 Aye(s): Senator(s) San Buenaventura, Aquino, Hashimoto, Keohokalole, Fevella; Aye(s) with reservations: none ; 0 No(es): none; and 0 Excused: none.

upper

Jan 24, 2025

Upper · Passed

The committee(s) on HHS has scheduled a public hearing on 01-29-25 1:00PM; Conference Room 225 & Videoconference.

upper

Jan 16, 2025

Committee

Referred to HHS, CPN/JDC.

upper

Jan 15, 2025

Introduced

Introduced and passed First Reading.

upper

Jan 8, 2025

Introduced

Pending Introduction.

upper

3 primary · 0 co-sponsors