The proposed legislation significantly impacts state laws concerning the use and administration of investigational drugs and treatments. By establishing this fund, it encourages research initiatives within Indiana, fostering collaboration between healthcare providers and research institutions. The bill also outlines conditions under which patients may receive these investigational products, specifically emphasizing informed consent and the assessment of risks by healthcare providers. This could facilitate earlier access to innovative treatments for patients with critical health issues, thereby improving health outcomes.
House Bill 1184 aims to establish a Breakthrough Therapies Research Fund, providing financial assistance aimed at researching breakthrough therapies for serious mental illnesses. It allows drugs, biological products, or medical devices designated as breakthrough therapies under federal law to be provided to qualified patients by physicians as part of their medical treatment. This provision is crucial as it seeks to enhance access to potentially life-saving treatments that may not yet have full approval from the federal Food and Drug Administration (FDA).
Despite its potential benefits, HB 1184 may face scrutiny and opposition regarding the liabilities associated with providing unapproved treatments. While the bill states that it does not create civil or criminal causes of action against manufacturers or healthcare providers for harm that qualified patients may experience from these investigational therapies, concerns could arise regarding patient safety and the ethics of offering treatments that are still under investigation. Additionally, the lack of insurance coverage for these therapies, as specified in the bill, could limit access for many patients, raising questions about equity in healthcare provision.