On April 29, 2025, the Montana Legislature introduced Senate Bill 535, a significant piece of legislation aimed at regulating the informed consent process for patients seeking experimental treatments. The bill seeks to address the growing concerns surrounding the use of investigational drugs, biological products, and devices, particularly in the context of patient autonomy and safety.

The primary purpose of Senate Bill 535 is to establish a comprehensive framework for obtaining informed consent from patients before they undergo experimental treatments. Key provisions of the bill include requirements for healthcare providers to provide detailed descriptions of potential outcomes, including the possibility of new or worsening symptoms. Additionally, the bill mandates that consent forms must be signed by the patient or their legal guardian and attested by the treating healthcare provider and a witness. Notably, the bill emphasizes that experimental treatments cannot be used to hasten a patient's death, reinforcing the ethical boundaries of such interventions.

Debate surrounding Senate Bill 535 has highlighted concerns from various stakeholders. Proponents argue that the bill enhances patient rights and ensures that individuals are fully informed about the risks associated with experimental treatments. However, some opponents express worries that the stringent consent requirements may hinder access to potentially life-saving therapies, particularly for patients with terminal illnesses who may have limited options.

The implications of Senate Bill 535 extend beyond patient consent. Economically, the bill does not expand insurance coverage for experimental treatments, which could limit financial support for patients seeking these options. Socially, the legislation raises questions about the balance between patient safety and access to innovative medical therapies. Politically, the bill reflects a growing trend among states to regulate experimental treatments more closely, potentially influencing similar legislative efforts in other jurisdictions.

As the legislative process unfolds, experts suggest that the outcomes of Senate Bill 535 could set a precedent for how states approach the regulation of experimental treatments in the future. The bill's focus on informed consent may lead to increased scrutiny of healthcare practices and a reevaluation of how patients are educated about their treatment options. The next steps for the bill will involve further discussions and potential amendments as it moves through the legislative process.