SF 48 — Stem Cell Freedom Act.

SORIGINAL TATE OF W YOMING 26LSO-0142 SENATE ENGROSSED FILE NO.

SF0048 StemENROLLED CellACT FreedomNO. Act.

Sponsored31, by:SENATE SIXTY-EIGHTH LEGISLATURE OF THE STATE OF WYOMING BUDGET SESSION AN ACT relating to public health and safety;

Senator(s) Barlow and Brennan and Representative(s) Clouston and Haroldson A BILL for AN ACT relating to public health and safety;

amending the powers of the Wyoming state board of medicine;

1 SF0048 STATE OF WYOMING 26LSO-0142 Section 1.

4 ARTICLE 11 STEM CELL FREEDOM ACT 7 35-4-1101.

9 This act shall be known and may be cited as the "Stem Cell Freedom Act." 35-4-1102.

(ii)ORIGINAL "InstitutionalSENATE reviewENGROSSED board"FILE meansNO. a group duly constituted and currently registered in accordance with applicable federal law that provides initial approval SF0048 STATE OF WYOMING 26LSO-0142 and continuing oversight of the stem cell therapies being offered under this act, including adverse event reporting and the approval of a form to be used for informed consent between a physician and patient or the patient's legal representative prior to the use of stem cell therapy;

7SF0048 (iii)ENROLLED "InvestigationalACT drug,NO. biological product or device" means a drug, biological product or device that has successfully completed phase one (1) of a clinical trial but has not yet been approved for general use by the United States food and drug administration and remains under investigation in a clinical trial;

31, SENATE SIXTY-EIGHTH LEGISLATURE OF THE STATE OF WYOMING BUDGET SESSION (ii) "Institutional review board" means a group duly constituted and currently registered in accordance with applicable federal law that provides initial approval and continuing oversight of the stem cell therapies being offered under this act, including adverse event reporting and the approval of a form to be used for informed consent between a physician and patient or the patient's legal representative prior to the use of stem cell therapy;

(iii) "Investigational drug, biological product or device" means a drug, biological product or device that has successfully completed phase one (1) of a clinical trial but has not yet been approved for general use by the United States food and drug administration and remains under investigation in a clinical trial;

(v) "Stem cell therapy" means treatment involving the use of autologous mesenchymal stem cells, including but not limited to the collection, processing, cultural expansion, manufacturing, storage and therapeutic SF0048 STATE OF WYOMING 26LSO-0142 use of stem cells.

5 (vi) "This act" means W.S.

8 35-4-1103.

(a)ORIGINAL NotwithstandingSENATE W.S.ENGROSSED FILE NO.

SF0048 ENROLLED ACT NO.

31, SENATE SIXTY-EIGHTH LEGISLATURE OF THE STATE OF WYOMING BUDGET SESSION (a) Notwithstanding W.S.

4 SF0048 STATE OF WYOMING 26LSO-0142 (iii) A physician-patient relationship exists between the physician administering the stem cell therapy and the person receiving the therapy;

5 (iv) The patientphysician oris legallyregistered recognizedwith representativethe Wyoming state board of themedicine patientto hasprovide providedstem writtencell informedtherapy consentpursuant acknowledging:to this act;

9(v) (A) The naturepatient andor characterlegally recognized representative of the proposedpatient stemhas cellprovided therapy;written informed consent acknowledging:

(A) The nature and character of the proposed stem cell therapy;

and (D)ORIGINAL TheSENATE financialENGROSSED responsibilityFILE ofNO. the patient or legally recognized representative of the patient in paying for the stem cell therapy to be received.

5 SF0048 STATEENROLLED OFACT WYOMINGNO. 26LSO-0142 (b) Stem cell therapy provided pursuant to this act shall be administered by a physician or under the direct supervision of a physician.

31, SENATE SIXTY-EIGHTH LEGISLATURE OF THE STATE OF WYOMING BUDGET SESSION (D) The financial responsibility of the patient or legally recognized representative of the patient in paying for the stem cell therapy to be received.

(b) Stem cell therapy provided pursuant to this act shall be administered by a physician or under the direct supervision of a physician.

7 (c) No person authorized under this act to perform stem cell therapy or manufacture stem cells shall be obligated by this act to provide stem cell therapy or stem cells but may do so according to the person's own discretion and judgment.

6 SF0048 STATE OF WYOMING 26LSO-0142 35-4-1104.

4 Notwithstanding any other provision of law, the Wyoming state board of medicine shall not revoke, fail to renew, suspend or take any other action against a physician's license based solely on the physician's recommendations to a patient regarding access to or treatment with stem cell therapyORIGINAL orSENATE theENGROSSED performanceFILE ofNO. stem cell therapy, provided that the recommendations or procedures are consistent with medical standards of care.

SF0048 ENROLLED ACT NO.

31, SENATE SIXTY-EIGHTH LEGISLATURE OF THE STATE OF WYOMING BUDGET SESSION therapy or the performance of stem cell therapy, provided that the recommendations or procedures are consistent with medical standards of care and that the physician is registered with the Wyoming state board of medicine to provide stem cell therapy under this act.

7 SF0048 STATE OF WYOMING 26LSO-0142 This act shall not create a private cause of action against any person involved in the care of anany eligible patient using stem cell therapy or the manufacturing of stem cells if the person is complying with the requirements of this act and medical standards of care.

W.S.

33-26-202(b) by creating a new paragraph (xx) is amended to read:

33-26-202.

Board;

duties;

general powers.

(b) The board is empowered and directed to:

(xx) Operate and publish a public registry of qualified physicians registered to perform stem cell therapy pursuant to the Stem Cell Freedom Act.