NC S871

Permits eligible patients with life-threatening or severely debilitating illnesses to access individualized investigational drugs, biological products, and devices produced exclusively for individual patients based on genetic profiles, including gene therapy and neoantigen vaccines.

Requires eligible patients to have physician attestation of their condition, consideration of all FDA-approved treatments, physician recommendation for the investigational treatment, and written informed consent detailing risks, benefits, costs, and potential outcomes.

Prohibits licensing boards and Medicare-certifying entities from disciplining health care providers based solely on their recommendations for access to individualized investigational treatments, and prevents state officials from blocking eligible patient access to these treatments.

Protects manufacturers and involved parties from private lawsuits if they make good-faith efforts to comply with the law and exercise reasonable care; heirs are not liable for outstanding treatment-related debt if the patient dies.

Appropriates $50,000 nonrecurring funding to the Department of Health and Human Services for 2024-2025 to implement the provisions, effective October 1, 2024.