BILL ANALYSIS Ó AB 2531 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 2531 (Burke) As Amended August 19, 2016 Majority vote -------------------------------------------------------------------- |ASSEMBLY: |65-3 |(April 28, |SENATE: | |(August 29, | | | |2016) | |26-11 |2016) | | | | | | | | | | | | | | | -------------------------------------------------------------------- Original Committee Reference: HEALTH SUMMARY: Repeals the ban on compensation for women providing human oocytes (eggs) for research, and instead allows a woman providing eggs for research to be compensated for her time, discomfort, and inconvenience in the same manner as other research subjects. The Senate amendments require that a woman providing eggs for research be provided with a summary of health and consumer issues associated with assisted oocyte production (AOP) and informed consent requirements, and to be informed that ongoing studies will continue to assess the long-term health impacts of ovarian stimulation and egg retrieval. FISCAL EFFECT: None. AB 2531 Page 2 COMMENTS: According to the author, this bill promotes medical research in California while ensuring research participants are fairly treated by removing the prohibition on compensation for women participating in egg donation for medical research. The author states that we all benefit from those willing to participate in research, and the current processes in place are designed to appropriately reward participants, while protecting them from abusive or coercive practices. The author notes that this bill ensures that women are treated equally to all other research subjects - allowing them to actively evaluate their participation in research studies and be paid for their time, trouble, and inconvenience when they do participate. The author concludes, given that compensation is allowed in 47 other states, and there is no evidence of abuse, it's time to reconsider our ban, just as New York did. Research using donated eggs. Embryonic stem cells are a unique discovery with the power to unlock causes of and treatments for many human illnesses. Diseases and disabilities such as heart disease, spinal cord injuries, juvenile diabetes (Type I diabetes), amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), Parkinson's disease, and Alzheimer's disease afflict millions of Americans. These are some of the most debilitating diseases known to modern medicine in that they often severely limit the activity of the affected individual, cause painful degeneration of normal bodily functions, bring on premature death, and cause immense suffering for the individual and his or her family. Potential benefits of embryo research include an improved understanding of fertilization, implantation, and early pregnancy biology and, with this understanding, possibly fewer undesired outcomes, such as miscarriage. For infertile couples, embryo research offers the possibility of more effective therapies: research efforts helped optimize conditions for intracytoplasmic sperm injection, embryo culture, and cryopreservation, for example. For others at risk for heritable genetic disease who feel pregnancy termination is undesirable or inappropriate, embryo research has led to the possibility of early, accurate genetic diagnosis. Preimplantation genetic AB 2531 Page 3 diagnosis provides diagnostic results at a point before implantation, so pregnancy termination can be avoided. In addition to these benefits of embryo research in general, stem cell research promises additional potential benefits, for such work may lead both to a better understanding of the processes leading to tissue differentiation and function and to possible therapies by creating lines that can replace diseased or nonfunctioning tissues. SUPPORT. The American Society for Reproductive Medicine (ASRM) is the sponsor of this bill and states, in the United States and California there is a fundamental principle that all research participants deserve just compensation for their contribution to research that entails some risk and much time, trouble, and inconvenience. ASRM contends the lack of compensation deters participants and stalls research. The sponsor notes, women considering ovarian stimulation and oocyte retrieval are capable of informed decision making as to the risks of compensated participation in research, just as they do for now for fertility. ASRM concludes that fairness requires research participants receive the same compensation fertility donors presently receive, and allowing compensation for fertility purposes while banning it for research serves a false value, subordinating research to fertility. The American Congress of Obstetricians and Gynecologists, District IX - California (ACOG) writes that all other research subjects are compensated for their time, trouble, and inconvenience related to participating in research, except for this population. ACOG notes that this bill ensures that women are treated equal to all other research subjects - allowing them to actively evaluate their participation in research studies. OPPOSITION. The Center for Genetics and Society (CGS) is opposed to this bill stating, that women providing eggs are not research subjects, and egg retrieval is very different from a clinical trial. CGS notes that, in clinical trial, investigators study the reactions and health outcomes of subjects who take a drug, use a device, or undergo a procedure, AB 2531 Page 4 however, in the case of egg harvesting, investigators are not studying, or seeking to understand the effects of the procedures on women. CGS also notes that many experts remain concerned about the long-term risks of these drugs, especially their potential impact on infertility and various cancers, and that follow-up research on egg providers, which could establish the frequency and severity of these adverse outcomes, and best protocols for avoiding them, is widely recognized to be grossly inadequate. CGS also references the Institute of Medicine report, "Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research (2006)," and that it concluded that one of the striking facts about ovarian stimulation is just how little is known about long-term health outcomes for women. We Are Egg Donors indicates that with no provisions in this bill to protect the health of women who would be providing these oocytes, based on their collective experiences as egg providers, they feel it would be imprudent to pass this bill because women cannot give informed consent when there is a lack of information about the risks. Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0004769