TX HB3318

Allows patients with life-threatening or severely debilitating illnesses to access individualized investigational treatments—including personalized gene therapies and neoantigen vaccines—that are uniquely produced based on the patient's genetic profile

Requires patients to have considered all FDA-approved treatment options, provide written informed consent, and obtain a physician attestation confirming eligibility and recommending treatment based on genomic analysis

Health care facilities must operate under federal human subjects protection assurance (42 U.S.C. Section 289(a) and 45 C.F.R. Part 46) to provide these treatments

Protects manufacturers and health care providers from private lawsuits for harm resulting from treatments if acting in good faith and with reasonable care; prohibits state licensing boards from taking action against providers solely for recommending these treatments

Health insurers, third-party administrators, and government agencies are not required to cover treatment costs; patients are liable for all expenses, though heirs are protected from treatment-related debt if the patient dies during treatment