Relating to access to individualized investigational treatments for patients with life-threatening or severely debilitating illnesses.
Summary
SB 984 creates a new chapter in the Texas Health and Safety Code to authorize access to “individualized investigational treatments” for patients with life-threatening or severely debilitating illnesses. The bill defines these treatments as patient-specific drugs, biologics, or devices made exclusively for one patient based on that patient’s genetic profile, including individualized gene therapies, antisense oligonucleotides, and neoantigen vaccines.
Under the bill, a patient may access such a treatment only if the patient has a qualifying serious illness, has considered all FDA-approved options, and gives written informed consent. A physician must attest to the patient’s condition and recommend the treatment based on genomic or other molecular analysis. The bill also sets detailed informed-consent requirements, including warnings about uncertain outcomes, possible worsening of symptoms, and the patient’s financial responsibility for treatment-related costs.
Impact
The bill adds Chapter 491 to the Health and Safety Code and establishes a state framework for access to highly individualized experimental therapies. It limits state interference with access, bars licensing boards and HHSC from taking adverse action against providers solely for recommending these treatments, and prevents the chapter from creating a private cause of action against compliant manufacturers or providers. It also clarifies that insurers, third-party administrators, hospitals, and governmental agencies are generally not required to cover or pay for these treatments or related services, though they may choose to do so.
Sentiment
The bill appears to have been broadly supported and noncontroversial in the Legislature. It passed the Senate unanimously and the House overwhelmingly, with no recorded opposition in the final votes. The lack of committee transcript material also suggests there was little publicized debate or visible resistance during the legislative process.
Contention
The main policy tension in the bill is between expanding access to experimental, patient-specific treatments and limiting financial and legal exposure for providers, manufacturers, and public programs. Supporters would likely view the bill as a pathway for patients with terminal or severely debilitating conditions to try promising personalized therapies when conventional options are exhausted. Potential concerns center on safety, uncertain efficacy, informed consent, and cost, but the bill addresses those issues by requiring physician attestation, detailed consent disclosures, no mandatory coverage, and no private right of action for compliant actors.
Health: other; individualized investigational treatment for certain patients suffering from a life-threatening or severely debilitating illness; provide for. Amends title & secs. 1, 2, 3, 4, 5, 6 & 7 of 2014 PA 345 (MCL 333.26451 et seq.) & adds sec. 2a.
To Create The Right To Try Individualized Investigational Treatment Act; And To Ensure That Patients Have Access To Individualized Investigational Treatment.
Health care; creating the Right to Try for Individualized Treatments Act; authorizing individualized investigational treatments for eligible patients. Effective date.
Enacting the right to try for individualized treatments act to permit a manufacturer to make an individualized investigative treatment available to a requesting patient.
Probate: patient advocates; withholding life-sustaining treatment for a patient who is pregnant; allow. Amends secs. 5507 & 5509 of 1998 PA 386 (MCL 700.5507 & 700.5509).