HB 966 Summary

• Permits manufacturers of investigational drugs and biological products to provide them to terminally ill patients beginning January 1, 2024, without requiring FDA approval, implementing Hawaii's "right-to-try" law.

• Establishes eligibility requirements for patients: must have a terminal illness certified by treating physician, have exhausted FDA-approved treatment options, be unable to access clinical trials within 100 miles or within one week of application, and provide written informed consent.

• Allows manufacturers to either provide investigational drugs at no cost or require patients to pay manufacturing costs; health insurers are not required to cover these costs but cannot deny coverage for preexisting conditions or previously commenced benefits.

• Protects healthcare providers from licensing board action based on recommendations regarding investigational drug access and prohibits state officials from blocking eligible patients' access to these treatments.

• Provides manufacturers and healthcare providers immunity from private lawsuits for harm resulting from investigational drugs if they comply in good faith and exercise reasonable care.