Relating to right to try individualized treatments
Summary
SB594 creates a new article in West Virginia law establishing a “right to try individualized treatments” for certain patients with life-threatening or severely debilitating illnesses. The bill defines an eligible patient as someone who has exhausted FDA-approved options, has a physician recommendation, and gives written informed consent. It also defines the kinds of products covered, including individualized investigational drugs, biological products, and devices made uniquely for a single patient, such as personalized gene therapies, antisense oligonucleotides, and neoantigen vaccines.
The bill allows manufacturers operating within an eligible facility to make these individualized treatments available to eligible patients, but it does not require them to do so. It also permits manufacturers to provide the treatment without compensation or to charge the patient for manufacturing and related costs. The bill includes detailed informed-consent requirements, including warnings about risks, hospice implications, and the patient’s responsibility for costs. If the patient dies, heirs are shielded from outstanding debt related to the treatment, including costs tied to lack of insurance coverage.
Impact
SB594 would add a new chapter of state law governing access to highly individualized investigational therapies and would limit state-level barriers to their use. It would prohibit licensing boards from disciplining health care providers solely for recommending access to these treatments, bar Medicare certification actions based only on such recommendations, and prevent state officials from blocking access. The bill also creates liability protections by eliminating a private right of action against manufacturers and others involved in good-faith compliance, while expressly preserving existing clinical-trial coverage obligations under state insurance law. The article would take effect January 1, 2026.
Sentiment
The available record shows no committee transcripts and no recorded votes, so there is no documented debate or formal legislative sentiment in the materials provided. Based on the bill text alone, the measure appears strongly supportive of patient access to experimental, personalized therapies and protective of physicians and manufacturers who participate in that access. The overall tone is permissive and facilitative rather than restrictive.
Contention
The main policy tensions in SB594 are between expanding access to experimental individualized treatments and limiting oversight, liability, and payment obligations. Potential concerns include patient safety, informed consent, the absence of a private right of action, and the fact that patients or their estates may bear treatment costs. Another point of possible contention is the bill’s protection for physicians and manufacturers, which may be viewed as necessary to encourage innovation by supporters but as reducing accountability by critics. The bill also preserves Medicaid denial of coverage as not a violation, which could be a point of concern for access advocates.
Mental health: hospitalization; person requiring treatment; revise, and modify certain procedures for treatment. Amends secs. 401, 427, 430, 461, 468, 472a & 475 of 1974 PA 258 (MCL 330.1401 et seq.).
Mental health: hospitalization; person requiring treatment; revise, and modify certain procedures for treatment. Amends secs. 401, 427, 430, 461, 468, 472a & 475 of 1974 PA 258 (MCL 330.1401 et seq.).