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) 
          Vote:     21 

           SENATE HEALTH COMMITTEE:  8-1, 6/15/16
           AYES:  Hernandez, Nguyen, Hall, Mitchell, Monning, Pan, Roth,  
           NOES:  Nielsen


           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.


          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  


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            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  

          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; 


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             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.


          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  


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          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  


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          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  


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          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."


          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


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          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  


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          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.


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          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  


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          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

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