STAND. COM. REP. NO. 449

Honolulu, Hawaii

RE: S.B. No. 857

S.D. 1

Honorable Ronald D. Kouchi

President of the Senate

Thirty-Second State Legislature

Regular Session of 2023

State of Hawaii

Sir:

Your Committee on Health and Human Services, to which was referred S.B. No. 857 entitled:

"A BILL FOR AN ACT RELATING TO ACCESS TO TREATMENT FOR TERMINALLY ILL PATIENTS,"

begs leave to report as follows:

The purpose and intent of this measure is to authorize manufacturers of investigational drugs or biological products to make available their drugs and products to eligible terminally ill patients under certain conditions.

Your Committee received testimony in support of this measure from four individuals. Your Committee received comments on this measure from the Department of Health.

Your Committee finds that terminally ill patients do not have access to potentially lifesaving investigational drugs or biological products awaiting final approval by the United States Food and Drug Administration. For this reason, the federal government and forty-one states have enacted "right-to-try" legislation that makes available experimental drugs and products that have not received Food and Drug Administration approval to terminally ill patients with no other medication or treatment options. With this measure, Hawaii would join the vast majority of the nation in granting terminally ill patients access to potentially lifesaving investigational drugs and biological products.

Your Committee notes the testimony submitted by the Department of Health recommending data collection to determine the efficacy of a "right-to-try" system based on voluntary participation, in particular a system that involves for-profit entities incorporated outside of the State. Your Committee therefore requests that manufacturers of investigational drugs and biological products that make their drugs and products available pursuant to this measure share applicable data with the Department of Health to assess the "right-to-try" system's efficacy.

Your Committee has amended this measure by:

(1) Inserting an effective date of December 31, 2050, to encourage further discussion; and

(2) Making technical, nonsubstantive amendments for the purposes of clarity and consistency.

As affirmed by the record of votes of the members of your Committee on Health and Human Services that is attached to this report, your Committee is in accord with the intent and purpose of S.B. No. 857, as amended herein, and recommends that it pass Second Reading in the form attached hereto as S.B. No. 857, S.D. 1, and be referred to your Committees on Commerce and Consumer Protection and Judiciary.

Respectfully submitted on behalf of the members of the Committee on Health and Human Services,

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JOY A. SAN BUENAVENTURA, Chair