STAND. COM. REP. NO.  205-16

Honolulu, Hawaii

                , 2016

RE:   H.B. No. 254

      H.D. 1

Honorable Joseph M. Souki

Speaker, House of Representatives

Twenty-Eighth State Legislature

Regular Session of 2016

State of Hawaii

Sir:

     Your Committee on Health, to which was referred H.B. No. 254 entitled:

"A BILL FOR AN ACT RELATING TO MEDICINES,"

begs leave to report as follows:

The purpose of this measure, as received by your Committee, is to establish a biosimilars working group tasked with the consideration of issues relating to state regulation of biosimilar medicines and the making of recommendations regarding such issues to the Legislature.

     For the purposes of a public hearing on this bill, your Committee circulated a proposed H.D. 1 of H.B. No. 254 (Proposed Draft), and notified the public that it would be accepting testimony on the Proposed Draft.  Among other things, the Proposed Draft:

     (1)  Removed provisions establishing the biosimilars working group;

     (2)  Amended the Hawaii Food, Drug, and Cosmetic Act, as well as state laws regulating drug product selection and formulation, to allow for pharmacist offerings of and substitutions for interchangeable biological products; and

     (3)  Established notification and information-sharing requirements among pharmacists, patients, and prescribing physicians for the disbursement of certain biological products.

Your Committee received testimony from the following organizations and individuals on H.B. No. 254, as received by your Committee, and on the Proposed Draft:

H.B. No. 254. The Hawaii Medical Service Association and American Cancer Society Cancer Action Network testified in support of this measure.  The Walgreen Company and an individual provided comments.

Proposed Draft.  The American Cancer Society Cancer Action Network, Alliance for Safe Biologic Medicines, Global Healthy Living Foundation, National Hispanic Medical Association, International Cancer Advocacy Network, Express Scripts, National Psoriasis Foundation, Alliance for Patient Access, Lupus and Allied Diseases Association, Pharmaceutical Research and Manufacturers of America, and an individual testified in support of the Proposed Draft.  The Hawaii Medical Service Association and CVS Health provided comments on the Proposed Draft.

     Upon careful consideration, your Committee has amended this bill by deleting its substance and inserting the provisions found in the Proposed Draft.

     As affirmed by the record of votes of the members of your Committee on Health that is attached to this report, your Committee is in accord with the intent and purpose of H.B. No. 254, as amended herein, and recommends that it pass Second Reading in the form attached hereto as H.B. No. 254, H.D. 1, and be referred to your Committee on Consumer Protection & Commerce.

Respectfully submitted on behalf of the members of the Committee on Health,

____________________________

DELLA AU BELATTI, Chair