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Committee approves amendment to Senate Bill 250 requiring notice and consent for new commercial uses of patients' biospecimens
Summary
A Senate committee approved an amended version of Senate Bill 250 to define “biospecimen,” require patient or estate notice and consent when a biospecimen is reused, and require disclosure and consent before any profit is realized, including a profit-sharing agreement or contract benefiting the patient or estate.
A Senate committee approved an amended version of Senate Bill 250 on a voice vote, advancing changes that define "biospecimen" and require patient or estate notification, consent and disclosure for commercial uses of a patient's biological materials.
The amendment, presented to the committee, would insert a definition for "biospecimen" as "biological materials obtained from living or deceased human subjects." It would require that if a patient's biospecimen is used, or requested for use by an eligible facility for any purpose other than individualized investigative treatment of that patient, the patient or the patient's estate must be notified of the intended use and asked to consent. A separate subsection would require that, before any profit is realized from products developed from a patient's biospecimen, an eligible facility must disclose each potential commercial application to the patient or estate and obtain consent for each application; consent must include a profit-sharing agreement or other contractual obligations benefiting the patient or the estate.
Representative Carpenter recounted the historical example of Henrietta Lacks and the HeLa cell line as background for the amendment, noting the Lacks family received no remuneration although the cells produced extensive research and commercial activity. Senator Hulshear backed the amendment, saying, "I very much appreciate this amendment, knowing the history of Henrietta Lacks and what happened and how, the family was not aware of the situation and, were not entitled to any profits, for many, many years. Like I said, I do appreciate the flavor of the amendment, so thank you for bringing it forward." Other members indicated concurrence, and the chair called the question; the committee approved the amended bill by voice vote.
The amendment also redesignates subsections to accommodate the new language on biospecimens, notification and commercial disclosure. The committee recording did not name a mover or seconder for the motion to approve the amended bill on the record, and no roll-call tally was provided; the approval was recorded by voice vote.
The transcript does not specify subsequent steps beyond the committee approval.
