California stem cell laws boost the stem cell industry by funding stem cell research, but the product side of industry is largely in the hands of the FDA.
To understand California stem cell regulation, let’s take a step back to Proposition 71.
Prop 71’s Creation of the Institute for Regenerative Medicine
Proposition 71 (the California Stem Cell Research and Cures Initiative) created the California Institute for Regenerative Medicine, California’s state-funded stem cell agency, to make grants and loans for stem cell research, support the development of stem cell-based therapies to cure diseases, and to establish appropriate regulatory standards and oversight bodies for research and facilities development. Prop 71 added Article XXXV to the California Constitution (Medical Research) and Chapter 3 (starting with Section 125290.10) to Part 5 of Division 106 of the California Health & Safety Code.
While much of California law applicable to the health and wellness industries consists of rules in the Business & Professions Code or Health & Safety Code that are arcane and nested, here, the rules are fairly straight-forward.
California stem cells are referenced in one helpful California government website, the Human Stem Cell Research Program, within the California Department of Public Health. CDPH notes:
The California Legislature mandated the California Department of Public Health (CDPH) in Health and Safety Code Section 125118 to develop a comprehensive set of guidelines, which would fully address the ethical, legal, and social aspects of stem cell research as well as ensure the systematic monitoring and reporting of human stem cell research activity in California that is not fully funded by Proposition 71 money granted through the California Institute for Regenerative Medicine (CIRM) (Senate Bill 322, Chapter 506, Statutes of 2003; Senate Bill 1260, Chapter 483, Statutes of 2006). To fulfill this intent, a diverse group of 13 national and international specialists were enlisted to serve on a Human Stem Cell Research (HSCR) Advisory Committee established to advise the Department in the development of statewide guidelines for human stem cell research and the update of these guidelines.
The California Department of Public Health will monitor human stem cell research conducted within the State by collecting reporting forms from all Stem Cell Research Oversight (SCRO) Committees overseeing human embryonic stem cell research that is not fully funded by CIRM. CDPH will also monitor all research projects that are using assisted oocyte production (AOP) to harvest human eggs for research by collecting reporting forms from review committees overseeing research involving human oocyte retrieval for research or the development of medical therapies.
Notice that the focus here is on research, and not on what private industry can do.
California Health & Safety Code 125518 provides authorization for CDPH to develop guidelines for research involving the derivation or use of human embryonic stem cells in California. It is part of the California Stem Cell Research and Cures Act (H&S 1252901.01 et seq., which implements Article XXXV of the California Constitution).
California Institute for Regenerative Medicine Regulations
The California Institute for Regenerative Medicine has published regulations governing stem cell research grants. These deal with such things as: conflicts of interest, scientific and medical accountability, intellectual property and revenue-sharing arrangements, and grants administration policies. The Institute’s authority to adopt regulations comes from Health & Safety Code 125290.40.
The California Stem Cell and Biotechnology Education and Workforce Development Act of 2009
This is a separate statute (California Education Code Section 33475 et seq.), whose purpose is “establish stem cell and biotechnology education and workforce development as a state priority and to promote stronger links among these industry sectors, the California Institute for Regenerative Medicine, and California public schools.”
Industry Developments
Human Longevity, Inc. recently announced $70 million in backing to pursue genomics and cell therapy-based diagnostics and therapeutics, focused on extending health human life span.
The California Institute for Regenerative Medicine writes about stem cell therapy research developments on its stem cell agency blog. For example, early research suggests that stem cells (which share some properties with cancer cells) can be turned into fat cells – suggesting that perhaps some day cancer cells can be turned into fat cells.
California regulation of blood banks, cord blood banks and collection centers, and other biologics is separate (see CDPH, Blood Bank and Biologics). For California law governing cosmetics, dietary supplements, and medical devices, we look to the Sherman Food, Drug & Cosmetic Laws.
With FDA being somewhat ambiguous about its posture regarding stem cell therapies, anti-aging and longevity therapies blooming in the era of personalized medicine, and legal decisions testing FDA’s authority, we can expect additional California and other state regulators to step in, in the future.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
