HB463 Alabama 2015 Session

Summary

Primary Sponsor

April WeaverSenator

Republican

Session

Regular Session 2015

Title

Health, terminally ill patients, drugs and devices which have completed phase I trial, right to try under certain conditions

Summary

This bill creates a Right to Try program that lets terminally ill patients use an investigational drug or device that has completed Phase 1 trials under defined conditions.

What This Bill Does

It sets criteria for who is eligible (terminal illness, exhausted approved options, physician recommendation, informed consent, and physician documentation). It allows eligible patients to request an investigational item from the manufacturer, who may provide it without payment or may charge costs, but is not required to do so. It states that insurers, government agencies, hospitals, and providers are not required to cover or expand coverage for such treatments, while also protecting providers from sanctions solely for recommending or providing access, and safeguarding good-faith nonprofit or professional actions. It also protects heirs from being charged for debts related to the treatment, creates restrictions on licensing and Medicare actions based only on access recommendations, and prohibits state officials from blocking access.

Who It Affects

• Terminally ill patients (and their families) who meet the eligibility criteria and choose to pursue an investigational drug or device under the act.
• Health care providers, manufacturers, insurers, and state officials, who are affected by protections against sanctions for recommendations, options about providing or not providing the investigational treatment, and limits on actions based solely on access under this act.

Key Provisions

• Defines eligible patient, investigational drug/biological product/device, terminal illness, and written informed consent with specific required elements.
• Authorizes a manufacturer to provide the investigational drug/biological product/device to an eligible patient if requested, but does not require the manufacturer to do so; costs may be charged or absorbed as allowed.
• States that this act does not require insurer or government coverage or hospital expansion of services, but may allow coverage at their discretion; imposes no new hospital service obligations absent approval.
• Provides protections for health care providers and licensing/Medicare entities from sanctions or license actions solely based on recommendations or access to investigational treatments; prevents blocking access by state officials; allows counseling aligned with medical standards.
• Establishes that heirs are not liable for outstanding debts related to the treatment, and limits private actions against manufacturers or others for harm if they act in good faith.
• Effective date: the first day of the third month after passage and governor approval.

AI-generated summary using openai/gpt-5-nano on Feb 24, 2026. May contain errors — refer to the official bill text for accuracy.

Subjects

Drugs