Stem Cell and Regenerative Therapy Regulation Advisory Group.

Existing law, including, among other laws, the Medical Practice Act, the Osteopathic Act, and the Nursing Practice Act, provides for the licensure and regulation of various health care practitioners by various boards within the Department of Consumer Affairs, including the Medical Board of California, the Osteopathic Medical Board of California, and the Board of Registered Nursing. Existing law requires licensed health care practitioners who perform stem cell therapies that are subject to regulation by the United States Food and Drug Administration (FDA) , but are not FDA approved, to communicate to their patients specified information regarding the therapies in a notice and in writing prior to providing the initial stem cell therapy. Existing law requires the State Department of Public Health to establish and maintain an anonymous registry of embryos that are available for research. Existing law makes it the policy of the state that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells shall be reviewed by a stem cell research oversight committee. The California Stem Cell Research and Cures Act, an initiative measure approved by the voters at the November 2, 2004, statewide general election as Proposition 71, establishes the California Institute for Regenerative Medicine (CIRM) , the purpose of which is, among other things, to make grants and loans for stem cell research, for research facilities, and for other vital research opportunities to realize therapies, protocols, and medical procedures that will result in the cure for, or substantial mitigation of, diseases and injuries. Existing law prohibits amendment of Proposition 71 by the Legislature unless the amendment is approved by the voters, or the amendment is accomplished by a bill introduced after the first 2 full calendar years and approved by a vote of 70% of both houses, and only if the amendment enhances the ability of the institute to further the purposes of the grant and loan programs. Existing federal law creates an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) and establishes current good tissue practice and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/Ps. Existing federal law requires the FDA to register, list, and regulate HCT/Ps for these purposes. This bill would require the Medical Board of California, no later than February 1, 2020, to establish the Stem Cell and Regenerative Therapy Regulation Advisory Group comprised of specified members, including 3 members appointed by the CIRM, as specified. By imposing a duty on the CIRM to appoint members to the Stem Cell and Regenerative Therapy Regulation Advisory Group, the bill would require for passage a 70% vote. The bill, on or after July 1, 2020, would authorize the board to make the appointments that CIRM fails to make. The bill would require the advisory group to convene a series of stakeholder meetings to review the Medical Practice Act, the Osteopathic Act, and the State Department of Public Health's current licensing and certification laws and procedures to determine whether those laws and procedures provide for adequate consumer protection for the use of stem cell therapies in clinics and other practice settings, to make recommendations to the Legislature, on or before July 1, 2020, regarding how to improve state oversight of licensees offering or providing stem cell therapies to patients, and to make recommendations to the board for the adoption of emergency regulations, as specified. The bill would authorize the board to adopt those recommended emergency regulations, as specified. The bill would repeal these provisions on January 1, 2024.