On April 29, 2025, the Montana Legislature introduced Senate Bill 535, a significant piece of legislation aimed at regulating the use of investigational drugs, biological products, and devices for patients seeking experimental treatments. The bill seeks to establish a framework for informed consent, ensuring that patients and their legal guardians are fully aware of the implications of opting for such treatments.

Key provisions of SB 535 include a requirement for written informed consent from patients, which must detail several critical aspects. These include an explanation of currently approved treatments for the patient's condition, an attestation that conventional treatments are unlikely to yield desired outcomes, and a clear identification of the investigational treatment being sought. Additionally, the bill mandates that patients be informed about the potential financial implications, including the possibility that their health plans may not cover costs associated with the experimental treatment.

Notably, the bill addresses the intersection of experimental treatments and hospice care, stipulating that a patient's eligibility for hospice may be revoked if they pursue curative treatment with an investigational product. This provision has sparked discussions among healthcare providers and patient advocacy groups, raising concerns about the potential impact on patients' end-of-life care options.

The introduction of SB 535 has not been without controversy. Critics argue that the stringent requirements for informed consent may deter patients from exploring potentially life-saving treatments. Supporters, however, contend that the bill is essential for protecting patients from the risks associated with unproven therapies. The debate surrounding the bill reflects broader concerns about patient autonomy, healthcare access, and the ethical implications of experimental treatments.

Economically, the bill could have significant implications for the pharmaceutical industry and healthcare providers in Montana. By clarifying the responsibilities of both patients and providers, SB 535 aims to create a more transparent environment for experimental treatments, potentially influencing the decisions of patients considering such options.

As the legislative process unfolds, stakeholders are closely monitoring SB 535 for its potential to reshape the landscape of experimental treatment access in Montana. The bill's progression will likely continue to evoke strong opinions from various sectors, highlighting the ongoing tension between innovation in healthcare and the need for patient protection.