SB16 Alabama 2018 Session

Summary

Primary Sponsor

Gerald H. AllenSenator

Republican

Session

Regular Session 2018

Title

Health, stem cells, availability of certain investigational treatments, record keeping requirements, penalties, Steve Bowman Act

Summary

SB 16 would allow certain patients with severe chronic or terminal illnesses to access investigational stem cell treatments under strict medical oversight and consent.

What This Bill Does

It would let eligible adults access investigational stem cell treatments if their doctor determines FDA-approved options are unavailable or unlikely to help and prescribes a specific class of treatment. Written informed consent is required, and treatment must be administered by a certified physician with oversight from an institutional review board at a licensed hospital or affiliated teaching facility. The act also requires record-keeping and annual de-identified public reports to the Alabama Board of Medical Examiners, and it creates penalties for illegal purchase or sale of adult stem cells for investigational use. The act would take effect three months after passage and is designed to be exempt from local-funding requirements because it defines a new crime, under the Steve Bowman Act.

Who It Affects

• Patients with severe chronic diseases or terminal illnesses who may access investigational stem cell treatments under the act.
• Physicians, hospitals/ambulatory surgical centers, and institutional review boards involved in administering, overseeing, and reporting on the treatments.

Key Provisions

• Provides availability of investigational stem cell treatments for eligible patients with terminal or severe chronic illness.
• Eligibility requires the treating physician to attest illness, consider FDA-approved options, and prescribe a specific class of investigational stem cell treatment.
• Informed consent is required in writing; guardians may consent for minors or those lacking capacity; the Department may adopt a consent form.
• Treatment must be administered by a physician certified under the act and overseen by an institutional review board affiliated with a licensed hospital or accredited medical school.
• IRBs must keep records of treatments and outcomes; annually report de-identified findings to the Alabama Board of Medical Examiners, with public access to the reports.
• It is unlawful to buy/sell/transfer adult stem cells for investigational use except for specified reimbursements and usual medical expenses; violations are Class A misdemeanors.
• The act clarifies it cannot violate other laws and the Board of Medical Examiners cannot revoke a license solely for treatment recommendations that meet the act’s requirements.
• Defines terms (adult stem cell, investigational stem cell treatment, severe chronic disease, terminal illness) and sets implementation rules via the Department of Public Health.

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

Subjects

Health