SB1163 Summary

• Allows eligible patients with life-threatening diseases or severely debilitating illnesses to access individualized investigational treatments (drugs, biological products, or devices) based on their genetic profile, including gene therapy, antisense oligonucleotides, and neoantigen vaccines.

• Requires eligible patients to meet specific conditions: have a life-threatening condition or severely debilitating illness, exhaust FDA-approved treatment options, receive physician recommendation based on genomic analysis, and provide written informed consent with detailed disclosures.

• Permits manufacturers operating within eligible facilities to provide individualized investigational treatments without compensation or require patients to pay all manufacturing costs; does not obligate health plans or hospitals to cover these treatments.

• Protects patient heirs from liability for unpaid treatment debts if the patient dies during individualized investigational treatment.

• Prohibits state officials from blocking eligible patients' access to individualized investigational treatments while allowing physicians to provide medical counseling or recommendations consistent with care standards; creates no private cause of action against manufacturers or care providers complying in good faith with the law.