HB1275: HB1275 Medical practice; ensure that stem cell therapies are used to advance medical treatments and improve patient outcomes in an ethical manner that does not involve stem cells derived from aborted fetuses

26 HB 1275/AP House Bill 1275 (AS PASSED HOUSE AND SENATE) By: Representatives Newton of the 127th, Hawkins of the 27th, Cooper of the 45th, Au of the 50th, and Taylor of the 173rd A BILL TO BE ENTITLED AN ACT To amend Article 2 of Chapter 34 of Title 43 of the Official Co de of Georgia Annotated,1 relating to medical practice, so as to ensure that human stem c ell therapies are used to2 advance medical treatments and improve patient outcomes in an ethical manner that does not3 involve human stem cells derived from aborted fetuses; to provide for definitions; to provide4 for the designation of a physician assistant or nurse practitio ner; to provide for certain5 requirements and patient protections; to provide for notice; to provide for consent; to provide6 for certain exceptions; to provide for the use of Georgia facil ities; to provide for statutory7 construction; to provide for related matters; to provide for le gislative findings; to repeal8 conflicting laws; and for other purposes.9 BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:10 SECTION 1.11 The General Assembly finds that:12 (1) Significant potential of human stem cell therapies in advancing medical treatments and13 improving patient outcomes exists;14 H. B. 1275 - 1 - 26 HB 1275/AP (2) Protections need to be established to ensure that such the rapies are provided using15 umbilical cord human stem cells obtained in an ethical manner that does not involve human16 stem cells derived from aborted fetuses;17 (3) Medical innovation should be fostered while upholding ethical standards that respect18 the sanctity of life; and19 (4) By encouraging the use of human stem cell sources such as adult human stem cells;20 umbilical cord Wharton's jelly mesenchymal human stem cells; and other ethically obtained21 human cells, tissues, or cellular or tissue based products, the state will advance regenerative22 medicine in a manner consistent with the values of this state.23 SECTION 2.24 Article 2 of Chapter 34 of Title 43 of the Official Code of Geo rgia Annotated, relating to25 medical practice, is amended by adding a new Code section to read as follows:26 "43-34-49.27 (a) As used in this Code section, the term:28 (1) 'FDA' means the United States Food and Drug Administration.29 (2) 'Human cells, tissues, or cellular or tissue based products' means articles containing30 or consisting of human cells or tissues that are intended for implantation, transplantation,31 infusion, or transfer into a human recipient. Such term does not include:32 (A) Vascularized human organs for transplantation;33 (B) Whole blood or blood components or blood derivative products; or34 (C) Secreted or extracted human products, such as milk, collag en, and cell factors,35 other than semen.36 (3) 'Human stem cell therapy' means a treatment involving the use of afterbirth placental37 perinatal human stem cells, or human cells, tissues, or cellular or tissue based products,38 which complies with the regulatory requirements provided in thi s Code section. Such39 H. B. 1275 - 2 - 26 HB 1275/AP term shall not include treatment or research using human cells or tissues that were40 derived from an aborted fetus or embryo.41 (4) 'Minimally manipulated' means:42 (A) For structural tissue, processing that does not alter the original relevant43 characteristics of such tissue relating to the tissue's utility for reconstruction, repair, or44 replacement; and45 (B) For cells or nonstructural tissues, processing that does n ot alter the relevant46 biological characteristics of such cells or tissues.47 (5) 'Nurse practitioner' means a registered professional nurse licensed pursuant to48 Article 1 of Chapter 26 of this title and authorized by the Geo rgia Board of Nursing to49 engage in advanced practice registered nursing as a nurse practitioner.50 (6) 'Physician' means a physician licensed under this article acting in the course and51 scope of his or her employment.52 (7) 'Physician assistant' means a person licensed as a physici an assistant pursuant to53 Article 4 of this chapter, the 'Physician Assistant Act.'54 (8) 'Umbilical cord Wharton's jelly mesenchymal human stem cells' or 'Wharton's jelly'55 means highly potent, multipotent human stem cells derived from gelatinous connective56 tissue surrounding the umbilical cord vessels.57 (b) A physician or, following a lawful designation from such p hysician, a physician58 assistant or nurse practitioner, may perform human stem cell therapy that is not approved59 by the FDA if such therapy is used for treatment or procedures that are within the scope of60 practice of the physician, physician assistant, or nurse practitioner, so long as the patient61 is advised and signs a consent form.62 (c) To ensure that the retrieval, manufacture, storage, and us e of human stem cells used63 for therapies conducted under this Code section meet the highes t standards, any human64 stem cells used must fall under one of the following categories:65 H. B. 1275 - 3 - 26 HB 1275/AP (1) Be retrieved, manufactured, and stored in a facility that is registered with the FDA66 and located in Georgia, another state in the United States, or another country; or67 (2) Be retrieved, manufactured, and stored in a facility located in Georgia, another state68 in the United States, or another country and that is certified and accredited by one of the69 following entities:70 (A) World Marrow Donor Association;71 (B) Association for the Advancement of Blood and Biotherapies;72 (C) American Association of Tissue Banks; or73 (D) Such other entity as the Department of Public Health may determine appropriate.74 (d) A physician or his or her designee performing human stem cell therapy shall not obtain75 human stem cells for therapies from a facility engaging in the retrieval, manufacture, or76 storage of human stem cells intended for human use under this C ode section unless the77 facility maintains a valid certification or accreditation as required by subsection (c) of this78 Code section.79 (e) The facility described in this Code section shall notify t he physician within 30 days80 after any change in certification or accreditation status, incl uding renewal, suspension,81 revocation, or expiration, occurs.82 (f) In the performance of any procedure using or purporting to use human stem cells or83 products containing human stem cells, the physician or his or her designee shall use human84 stem cell therapy products obtained from facilities that adhere to the applicable current85 good manufacturing practices for the collection, removal, proce ssing, implantation, and86 transfer of human stem cells, or products containing human stem cells, pursuant to the87 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 301, et seq.; 52 Stat. 1040 et88 seq.; and 21 C.F.R. Part 1271, Human Cells, Tissues, and Cellul ar and Tissue-Based89 Products.90 (g) A physician or his or her designee who conducts human stem cell therapy pursuant to91 this Code section shall include the following in any form of advertisement:92 H. B. 1275 - 4 - 26 HB 1275/AP 'THIS NOTICE MUST BE PROVIDED TO YOU UNDER GEORGIA LAW. This93 physician or his or her designee performs one or more human ste m cell therapies that94 have not yet been approved by the FDA. You are encouraged to c onsult with your95 primary care provider before undergoing any human stem cell therapy.'96 (h) The notice required under subsection (g) of this Code section must be clearly legible97 and in a type size no smaller than the largest type size used i n the advertisement of the98 human stem cell therapy services being offered.99 (i) A physician or his or her designee who conducts human stem cell therapy pursuant to100 this Code section shall obtain a signed consent form from the p atient before performing101 such human stem cell therapy.102 (j) The consent form shall be signed by the patient or if the patient is not legally103 competent, the patient's representative, and shall state all of the following in a language the104 patient or his or her representative may reasonably be expected to understand:105 (1) The nature and character of the proposed treatment;106 (2) The fact that the proposed human stem cell therapy has not yet been approved by the107 FDA if it has not been approved at such time; and108 (3) The anticipated results of the proposed treatment.109 (k) This Code section does not apply to the following:110 (1) A physician who has obtained approval for an investigation al new drug or device111 from the FDA for the use of human cells, tissues, or cellular or tissue based products and112 is operating under such approval; or113 (2) A physician or his or her designee who performs human stem cell therapy under an114 employment or other contract on behalf of an institution certified or accredited by any of115 the following:116 (A) The Foundation for the Accreditation of Cellular Therapy;117 (B) The Blood and Marrow Transplant Clinical Trials Network;118 (C) The Association for the Advancement of Blood and Biotherapies; or119 H. B. 1275 - 5 - 26 HB 1275/AP (D) An entity with expertise in human stem cell therapy as det ermined by the120 Department of Public Health.121 (l) A violation of this Code section may subject the physician or his or her designee to122 disciplinary action by the licensee's respective professional board.123 (m) Nothing in this Code section shall be construed to regulate, restrict, or prohibit stem124 cell research or the derivation, banking, or use of human stem cell lines for research or125 therapeutic research purposes, conducted in accordance with fed eral law, including126 research overseen by an institutional review board or embryonic stem cell research127 oversight committee."128 SECTION 3.129 All laws and parts of laws in conflict with this Act are repealed.130 H. B. 1275 - 6 -