Indiana House Bill HB1158

Indiana 2023 Regular Session

• Introduced: 1/10/23
• Refer: 1/10/23

Caption

Breakthrough therapies.

Impact

The implementation of HB 1158 is expected to amend existing Indiana health laws regarding investigational treatments. By allowing physicians to administer treatments that have completed Phase I clinical trials, the bill enhances the treatment avenues available to patients with serious health conditions. Furthermore, the bill provides legal protections for both manufacturers and healthcare providers by specifying that no civil or criminal cause of action can arise from potential harms related to these investigational treatments, thus encouraging more healthcare providers to utilize these therapies in practice.

Summary

House Bill 1158, titled 'Breakthrough Therapies', aims to facilitate access to investigational drugs, biological products, and medical devices for patients diagnosed with terminal diseases or conditions. By designating certain therapies as 'breakthrough therapies' under federal law, this bill provides a framework for physicians to offer such treatments as part of patient care. This is particularly significant in cases where conventional treatment options are limited or unavailable. The bill introduces an important provision for patients by allowing qualified individuals to receive potentially life-saving treatments that are still undergoing clinical trials but have already shown promise in early stages of research.

Contention

One notable point of contention surrounding HB 1158 involves the ethical implications of allowing access to investigational therapies. Critics argue that prioritizing breakthrough therapies might expose patients to unknown risks without sufficient safeguards in place. The lack of liability for healthcare providers and manufacturers concerning adverse outcomes raises concerns about accountability and informed consent. Moreover, questions about whether such treatments would be covered by insurance remain, as the bill specifies that insurers are not obliged to provide coverage beyond existing contractual terms, potentially affecting access for some patients.