Bill > HB543

This bill establishes a framework for providing access to individualized investigational drugs, biological products, or devices for patients with life-threatening or severely debilitating illnesses, defining key terms like "eligible facility" (an institution adhering to federal human subject protection rules) and "eligible patient" (someone with a serious illness who has exhausted approved treatments and provided informed consent, or whose guardian has). Manufacturers operating within eligible facilities can offer these unique, patient-specific treatments, which are developed based on an individual's genetic profile, and can either provide them at no cost or require the patient to cover expenses. Importantly, if a patient dies during such treatment, their heirs are not liable for any outstanding costs, and healthcare provider licensing boards cannot penalize professionals for recommending these treatments. The bill also prevents state officials from obstructing patient access and shields manufacturers and others involved from lawsuits for harm caused by these treatments, provided they acted with reasonable care and in good faith. However, this legislation does not mandate health insurance coverage for these experimental treatments or require hospitals to offer new services.

Health and Social Services

https://apps.legislature.ky.gov/record/26RS/hb543.html