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Montana Legislature passes SB 535 to regulate experimental treatment centers

April 29, 2025 | Enrolled Senate Bills, 2025 House and Senate Bills, Montana Legislation Bills, Montana


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Montana Legislature passes SB 535 to regulate experimental treatment centers
Montana's 69th Legislature has introduced Senate Bill 535, a significant piece of legislation aimed at revising laws related to experimental treatments. Introduced on April 29, 2025, the bill seeks to establish a framework for licensing experimental treatment centers, amending the existing Right to Try Act, and creating a Health Freedom and Access requirement for these centers.

The primary purpose of SB 535 is to regulate the operation of experimental treatment centers, ensuring they meet specific standards before being allowed to operate. The bill mandates that these centers obtain a license from the state, which requires detailed information about the center's management and its compliance with health access requirements. The Department of Health will have the authority to approve or deny applications within 90 days, streamlining the process for potential operators.

Key provisions of the bill include the establishment of an Insurance Premium Support Account, which aims to assist patients seeking experimental treatments. This financial support mechanism is designed to alleviate some of the economic burdens associated with accessing unapproved therapies, potentially expanding patient access to innovative medical options.

The introduction of SB 535 has sparked notable discussions among lawmakers and stakeholders. Proponents argue that the bill enhances patient autonomy and access to potentially life-saving treatments, while critics express concerns about the safety and efficacy of unregulated experimental therapies. Amendments to the bill are expected as it moves through the legislative process, reflecting the ongoing debate about balancing patient rights with public health safeguards.

The implications of SB 535 are significant, as it could reshape how experimental treatments are accessed in Montana. Experts suggest that if passed, the bill may lead to increased patient participation in clinical trials and greater innovation in treatment options. However, the potential for misuse or exploitation of vulnerable patients remains a critical concern that lawmakers will need to address.

As the bill progresses, its impact on the healthcare landscape in Montana will be closely monitored, with advocates and opponents alike preparing for further discussions in the coming weeks. The immediate effective date of the bill, should it pass, underscores the urgency surrounding the need for regulated access to experimental treatments in the state.

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