Relating To Terminal Illnesses.
SB49 creates a Hawaii “right-to-try” framework for terminally ill patients to access investigational drugs or biological products that have completed phase one of FDA-approved clinical trials but are not yet approved for general use. The bill defines who qualifies as an eligible patient, requiring a terminal diagnosis, exhaustion of approved treatment options, inability to access a clinical trial within specified limits, a provider recommendation, and informed consent. It also requires detailed disclosure of risks, alternatives, and financial responsibilities before access is granted.
The bill authorizes manufacturers to make investigational products available either at no cost or by charging manufacturing costs, and it allows health insurers to cover those costs if they choose. It also addresses related care issues by permitting insurers to deny coverage for a limited period after use begins, while protecting preexisting-condition coverage and benefits already in place. The bill further shields health care providers from professional discipline for recommending access, bars state officials from blocking access, and limits liability by preventing claims against manufacturers and others who comply in good faith with the chapter. The measure is set to take effect on December 31, 2050.
SB49 would add a new chapter to the Hawaii Revised Statutes governing access to investigational drugs and biological products for terminally ill patients. It would create new definitions, patient eligibility standards, informed-consent requirements, provider protections, insurer rules, and liability limitations, while also overriding conflicting law in section 328-17 for this purpose. The bill would affect terminally ill patients, treating providers, manufacturers of investigational therapies, health insurers, hospice and home-care arrangements, and state licensing boards.
The available voting history suggests generally favorable sentiment toward the bill in committee: the Senate Health and Human Services Committee passed it with amendments by a 5-0 vote. The bill’s findings and structure also indicate a supportive policy rationale centered on patient access, end-of-life options, and alignment with similar laws in other states. No committee transcript is available here, so the record does not show detailed debate or opposition arguments.
The main points of potential contention are patient safety, informed consent, insurance coverage, and liability. Supporters are likely to emphasize compassionate access for terminally ill patients who cannot wait for FDA approval, while critics may worry about unproven treatments, the possibility of harm or false hope, and the financial burden on patients and insurers. The bill also raises questions about whether insurers should be allowed to limit coverage after a patient begins using an investigational product, and whether providers and manufacturers should receive broad immunity from discipline or lawsuits when acting in good faith.