BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 2531| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: AB 2531 Author: Burke (D) Introduced:2/19/16 Vote: 21 SENATE HEALTH COMMITTEE: 8-1, 6/15/16 AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Pan, Roth, Wolk NOES: Nielsen SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8 ASSEMBLY FLOOR: 65-3, 4/28/16 - See last page for vote SUBJECT: Reproductive health and research SOURCE: American Society for Reproductive Medicine DIGEST: This bill requires women providing human oocytes for research to be compensated for their time, discomfort, and inconvenience in the same manner as other research subjects, as prescribed and determined by a human subject research panel or institutional review board. ANALYSIS: Existing law: 1)Prohibits any payment in excess of the amount of reimbursement of direct expenses incurred as a result of the procedure to be AB 2531 Page 2 made to any subject to encourage her to produce human eggs for purposes of medical research. Prohibits any human egg or embryo from being acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies. 2)Requires an institutional review board (IRB) to require research programs or projects under its review that involve "assisted oocyte production" to comply with certain requirements, including that the research program perform psychological and physical screening for all subjects, and that subjects be given a post-procedure medical examination. This bill: 1)Repeals the ban on compensation in excess of the amount of reimbursement of direct expenses incurred, as specified. Requires compensation amounts to be determined by human subject research panels and IRBs. 2)Requires a woman providing human oocytes for research to be compensated for her time, discomfort, and inconvenience in the same manner as other research subjects. Prohibits this payment from being for the human oocytes themselves or predicated on the number of oocytes obtained, including if no human oocytes are obtained. 3)Requires a human subject research panel or IRB to determine whether a proposed compensation amount is appropriate. Requires the panel or IRB, in the event that a proposed compensation amount is determined to be inappropriate, to determine an appropriate compensation amount. 4)Requires the IRB, if a woman providing human oocytes for the purposes of fertility is compensated, and any human oocytes or embryos in excess of those needed for fertility are offered for research, to disregard the amount of compensation if: a) The clinic performing oocyte retrieval is a member of the Society for Assisted Reproductive Technology; AB 2531 Page 3 b) The procurement and disposition for research purposes of human oocytes initially provided for reproductive uses, either for use by the donor or another woman, does not knowingly compromise the optimal reproductive success of the woman in the infertility treatment; c) The infertility treatment protocol is established prior to requesting or obtaining consent for donation for research purposes and the prospect of donation for research does not alter the timing, method, or procedures selected for clinical care; d) The woman in infertility treatment makes the determination that she does not want or need the oocytes for her own reproductive success; and, e) The donation of oocytes for research is done without valuable consideration, as specified. Background Over the past two decades, millions of women have had oocytes collected for the purpose of assisted reproduction. Most of these were women undergoing in vitro fertilization (IVF) with their own eggs, but a significant minority donate eggs to help other women get pregnant. During the normal ovulation cycle, 10 or 20 egg follicles will begin to grow, eventually leading to one "dominant follicle" producing a single egg, and the other egg follicles dying off. In the process, hormones are used to basically trick the body into keeping the other follicles alive and also produce eggs. The process involves the woman self-injecting hormones to stimulate the growth of ovarian follicles, plus a gonadotropin-releasing hormone (GnRH) agonist to block the normal surge of luteinizing hormone (LH), which could cause the woman to ovulate before the physician retrieves AB 2531 Page 4 the eggs. Typically, GnRH agonists are administered a week before stimulation to control the stimulation cycle and avoid a spontaneous LH surge. The woman subsequently self-injects the hormone chorionic gonadotropin (similar to LH) to affect egg maturation. When the eggs are ready, the woman is brought into surgery, where the eggs are harvested via needle aspiration. A woman who has undergone the usual hormone treatment will have a dozen or so eggs that can be collected. Compensation of oocyte donors. Under California law, the prohibition against compensation to oocyte donors applies only to donors for research purposes, not to assist someone else get pregnant (fertility purposes). According to a March 2010 report by the Hastings Center, a research institution focusing on bioethics, entitled "Self-Regulation, Compensation, and the Ethical Recruitment of Oocyte Donors," the fertility industry in the United States relies heavily on self-regulation, which generally takes the form of guidelines issued by the American Society for Reproductive Medicine (ASRM - the sponsor of this bill) and its affiliated organization, the Society for Assisted Reproductive Technology. The report looked at egg donor recruitment advertisements on college campuses, and found that nearly half offered compensation that exceeded recommended levels. The average compensation offered was approximately $9,000, with a maximum offer of $50,000. ASRM's 2007 donor compensation guidelines state that compensation should be structured to acknowledge the time, inconvenience, and discomfort associated with the process, and should not vary according to the planned use of the oocytes, the number or quality retrieved, or the donor's ethnic or other personal characteristics. The guidelines state that total payments to donors in excess of $5,000 require justification, and sums above $10,000 are not appropriate. Institute of Medicine report. Following passage of Proposition 71 in 2004, the Institute of Medicine and the National Research Council convened a committee of experts to ascertain the medical risks of oocyte donation for stem cell research. The committee issued a report in 2007 entitled "Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research" (IMR report), which stated that years of experience with assisted reproduction have identified a number of potential risks associated with egg AB 2531 Page 5 donation, falling into three main categories: (1) the potential risks arising from the hormone regimen that women are given to stimulate egg production, including ovarian hyperstimulation syndrome, perhaps problems with long-term fertility, and breast, ovarian, and endometrial cancers; (2) the risks associated with the surgical procedure, including the anesthesia, which involves many of the same issues that anyone having surgery faces; and (3), the potential risks that are psychological in nature, including anxiety, mood swings, and post-donation adjustment. However, the IMR Report stated that there was a need for more and better data and that one of the most striking facts about IVF is just how little is known for sure about the long term health outcomes for the women who undergo the procedures. The IMR Report notes that there are no registries that track the health of the people who have taken part, and without such registries to draw from, most of the studies have focused on relatively small groups of people. The IMR Report did acknowledge that the available data come primarily from IVF patients and not from healthy subjects, yet it is healthy women and not those coping with infertility who will be donating eggs for research, which raises the possibility that the existing data overstates the potential risks for healthy donors. The bottom line, according to the IMR Report, is that there is a great deal of uncertainty about the potential risks for oocyte donation for research. National Academy of Sciences. The National Academy of Sciences' (NAS) Guidelines for Human Embryonic Stem Cell Research states that women who undergo hormonal induction to generate oocytes specifically for research purposes should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an IRB. The Guidelines go on to state that "no payments beyond reimbursements, cash or in-kind, should be provided for donating oocytes for research purposes. Similarly, no payments beyond reimbursements should be made for donations of sperm for research purposes." When developing the 2010 amendments to these guidelines (the most recent update), NAS noted that since the prior update in 2008, the ethics committee of the State of New York's Empire State Stem Cell Board adopted a resolution allowing New York State-funded stem cell researchers to compensate women who donate their oocytes directly and solely to research for the time, risk and burden AB 2531 Page 6 involved in donating. Amounts of compensation are to be comparable to those received by women in New York State for similar donations for reproductive purposes. NAS stated that while it "acknowledges that the circumstances surrounding the issue of compensation to oocyte donors continues to evolve, it chose not to change the National Academies' Guidelines." NAS went on to state that while it was leaving its guideline on no payments in place, it recognized that "other states and entities may choose to set their own policies, as New York has done." Comments Author's statement. According to the author, AB 2531 promotes medical research in California while ensuring research participants are fairly treated by removing the prohibition on compensation for women participating in oocyte (egg) donation for medical research. 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. AB 2531 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. 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. Lifting the ban will allow women providing oocytes, just as any other research subject, to make an informed decision as to participation, and justly compensate them for doing so. We should no longer deny a woman's fundamental ability to make informed decisions or think for herself, or tell her if she wants to participate, she can only participate on terms different than for any other procedure. FISCAL EFFECT: Appropriation: No Fiscal Com.:NoLocal: No AB 2531 Page 7 SUPPORT: (Verified 8/1/16) American Society for Reproductive Medicine (source) Adventist Health Alliance for Fertility Preservation American Association of University Women American Congress of Obstetricians and Gynecologists California Chronic Care Coalition California Cryobank California Hepatitis C Task Force California Life Sciences Association Equality California Fair Allocation in Research Foundation Fertile Action Loma Linda University Health National Association of Hepatitis Task Forces National Center for Lesbian Rights Resolve: The National Infertility Association OPPOSITION: (Verified 8/1/16) Alliance for Humane Biotechnology Black Women for Wellness Black Women's Health Imperative Breast Cancer Action California Catholic Conference, Inc. California Nurses for Ethical Standards California Right to Life Committee, Inc. Center for Genetics and Society Friends of the Earth Forward Together Life Priority Network National Women's Health Network Our Bodies Ourselves Pro-Choice Alliance for Responsible Research We Are Egg Donors Seven Individuals ARGUMENTS IN SUPPORT: The American Association of University Women and the American Congress of Obstetricians and AB 2531 Page 8 Gynecologists, District IX (California) (AAUW/ACOG) state that all other research subjects can be compensated for their time, trouble, and inconvenience related to participating in research, except for this population. AAUW/ACOG contend 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 that it will remove barriers to women participating in research that could result in improvement in care for reproductive health, including infertility and cancer care. AAUW/ACOG state that this research could benefit untold numbers of women in the future. The California Life Sciences Association states that California is one of three states banning compensation for oocytes, which ultimately deters participation among women who are willing donors and stalls research excellence. California Cryobank states that to single out egg donors is inherently discriminatory so few, if any women, participate in oocyte research in California, creating barriers to reproductive and other biomedical research that could result in major medical advancements in cancer and degenerative diseases. The National Association of Hepatitis Task Forces, the California Hepatitis C Task Force, and the Fair Allocation in Research Foundation state that the gender inequality regarding women and research will be resolved by having a requirement for women providing human oocytes for research to be compensated. Equality California writes that despite all of the protections to guard against the dangers of exploitation in laws and informed consent procedures, women are the only ones singled out and prohibited from being compensated for research purposes in cases of oocyte donation and that as a result of the prohibition, all research is suffering due to lack of needed tissues. Resolve states that while some fear potential exploitation of women for their oocytes, in the 47 other states which permit compensation there is no evidence of exploitation or abuse. The National Center for Lesbian Rights states that if paying for oocyte donors is an acceptable practice for infertility treatment, it should also be acceptable to compensate donors who provide their eggs for research. The California Chronic Care Coalition writes that this bill will ensure 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. AB 2531 Page 9 ARGUMENTS IN OPPOSITION:Former California State Senator Deborah Ortiz, who authored the legislation that this bill seeks to repeal, states that in 2006, she stood alongside women's health and reproductive rights advocates to call for more studies on the long-term health outcomes for women undergoing egg retrieval. Senator Ortiz states that the health risks to women are not only significant, but there is wide recognition that they are understudied and that the many reports of harm to women who provide eggs in the fertility context should not be ignored. Senator Ortiz further states that the research has advanced very little in the last 10 years, reinforcing the need for more data before expanding the market in eggs and that the absence of data should urge caution, not serve as a rationale to support inducements for medical procedures that carry risks. A number of organizations, including Breast Cancer Action, Black Women for Wellness, Friends of the Earth, and National Women's Health Network write that while they support reimbursing women for the reasonable expenses of egg donation, they oppose paying women over and above those amounts because women providing eggs are not research subjects, and egg harvesting is very different from a clinical trial and the health risks of egg harvesting are substantial, but there is insufficient evidence about their extent and severity to be able to provide true informed consent. These opponents further state that this bill conflicts with recommendations by the National Academy of Sciences, and with policies that apply to California Institute for Regenerative Medicine-funded researchers and are part of the California Constitution. Black Women for Wellness also writes that they are concerned about the lack of oversight to protect vulnerable women from being preyed upon for research purposes, especially with the lack of clarity around the longer term health consequences of egg harvesting. We Are Egg Donors states that they understand that research with human oocytes can contribute to important knowledge that can be used for the greater good, but with no provision in this bill to protect the health of women who would be providing these oocytes, based on their collective experiences as egg providers, feel it would be imprudent to pass it. The Alliance for Humane Biotechnology states that in clinical trials, investigators study the reactions and health outcomes of subjects who take a drug, use a device, or undergo a procedure and that in a case of egg AB 2531 Page 10 harvesting, investigators are not studying, or seeking to understand, the effects of the procedures on women. The Alliance for Humane Biotechnology states that egg providers are thus quite different from research subjects. The California Catholic Conference states that this bill puts women's health in jeopardy by creating and, in effect, resulting in a marketing dynamic designed to exploit women who are most in need of resources, including college students, immigrants and women with economic challenges. ASSEMBLY FLOOR: 65-3, 4/28/16 AYES: Achadjian, Alejo, Arambula, Atkins, Baker, Bloom, Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dodd, Eggman, Frazier, Beth Gaines, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mayes, McCarty, Medina, Mullin, Nazarian, Obernolte, O'Donnell, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Weber, Wilk, Williams, Wood, Rendon NOES: Grove, Harper, Mathis NO VOTE RECORDED: Travis Allen, Bigelow, Brough, Dahle, Daly, Gallagher, Gray, Hadley, Melendez, Olsen, Patterson, Waldron Prepared by:Melanie Moreno / HEALTH / (916) 651-4111 8/3/16 19:10:59 **** END ****