SB70-AA3,82,10 205. Page 374, line 11: after that line insert:

SB70-AA3,82,11 “ Section 78. 15.07 (3) (bm) 7. of the statutes is created to read:

SB70-AA3,82,13 15.07 (3) (bm) 7. The prescription drug affordability review board shall meet at least 4 times each year.

SB70-AA3,79 Section 79. 15.735 of the statutes is created to read:

SB70-AA3,82,17 15.735 Same; attached board. (1) There is created a prescription drug affordability review board attached to the office of the commissioner of insurance under s. 15.03. The board shall consist of the following members:

SB70-AA3,82,18 (a) The commissioner of insurance or his or her designee.

SB70-AA3,82,22 (b) Two members appointed for 4-year terms who represent the pharmaceutical drug industry, including pharmaceutical drug manufacturers and wholesalers. At least one of the members appointed under this paragraph shall be a licensed pharmacist.

SB70-AA3,82,24 (c) Two members appointed for 4-year terms who represent the health insurance industry, including insurers and pharmacy benefit managers.

SB70-AA3,83,3 (d) Two members appointed for 4-year terms who represent the health care industry, including hospitals, physicians, pharmacies, and pharmacists. At least one of the members appointed under this paragraph shall be a licensed practitioner.

SB70-AA3,83,5 (e) Two members appointed for 4-year terms who represent the interests of the public.

SB70-AA3,83,8 (2) A member appointed under sub. (1), except for a member appointed under sub. (1) (b), may not be an employee of, a board member of, or a consultant to a drug manufacturer or trade association for drug manufacturers.

SB70-AA3,83,13 (3) Any conflict of interest, including any financial or personal association, that has the potential to bias or has the appearance of biasing an individual's decision in matters related to the board or the conduct of the board's activities shall be considered and disclosed when appointing that individual to the board under sub. (1).

SB70-AA3,80 Section 80. Subchapter VI (title) of chapter 601 [precedes 601.78] of the statutes is created to read:

SB70-AA3,83,16 CHAPTER 601

SB70-AA3,83,18 SUBCHAPTER VI Prescription drug

SB70-AA3,83,19 affordability review board

SB70-AA3,81 Section 81. 601.78 of the statutes is created to read:

SB70-AA3,83,21 601.78 Definitions. In this subchapter:

SB70-AA3,83,23 (1) “Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 21 CFR 601.20.

SB70-AA3,83,25 (2) “Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 USC 262 (k) (3).

SB70-AA3,84,2 (3) “Board” means the prescription drug affordability review board established under s. 15.735 (1).

SB70-AA3,84,5 (4) “Brand name drug” means a drug that is produced or distributed in accordance with an original new drug application approved under 21 USC 355 (c), other than an authorized generic drug, as defined in 42 CFR 447.502.

SB70-AA3,84,8 (5) “Financial benefit” includes an honorarium, fee, stock, the value of the stock holdings of a member of the board or any immediate family member, and any direct financial benefit deriving from the finding of a review conducted under s. 601.79.

SB70-AA3,84,9 (6) “Generic drug” means any of the following:

SB70-AA3,84,11 (a) A retail drug that is marketed or distributed in accordance with an abbreviated new drug application approved under 21 USC 355 (j).

SB70-AA3,84,12 (b) An authorized generic drug, as defined in 42 CFR 447.502.

SB70-AA3,84,14 (c) A drug that entered the market prior to 1962 and was not originally marketed under a new drug application.

SB70-AA3,84,17 (7) “Immediate family member” means a spouse, grandparent, parent, sibling, child, stepchild, or grandchild or the spouse of a grandparent, parent, sibling, child, stepchild, or grandchild.

SB70-AA3,84,18 (8) “Manufacturer” means an entity that does all of the following: