BILL ANALYSIS                                                                                                                                                                                                    Ó




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          |SENATE RULES COMMITTEE            |                       AB 2531|
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                                   THIRD READING 


          Bill No:  AB 2531
          Author:   Burke (D) 
          Amended:  8/19/16 in Senate 
          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.


          Senate Floor Amendments of 8/19/16 (1) require that an  
          institutional review board (IRB) to require a research project  
          that includes oocyte retrieval to inform the research subject  
          that ongoing studies will continue to assess the long-term  
          health impacts of ovarian stimulation and oocyte retrieval; (2)  
          require that a woman providing human oocytes for research to be  
          provided with a summary of health and consumer issues associated  
          with assisted oocyte production and informed consent  








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          requirements, as specified; (3) make any research program that  
          offers compensation to women providing human oocytes for  
          research subject to specified existing law, including, but not  
          limited to, coverage for medically appropriate medical care that  
          is required as a direct result of the procedure for research  
          purposes, regardless of the level of compensation offered; and  
          (4) make other conforming and technical changes.


          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  
            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 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  








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            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; 


             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  








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               valuable consideration, as specified.





          5)Requires that an IRB to require a research project that  
            includes oocyte retrieval to inform the research subject that  
            ongoing studies will continue to assess the long-term health  
            impacts of ovarian stimulation and oocyte retrieval.





          6)Requires that a woman providing human oocytes for research to  
            be provided with a summary of health and consumer issues  
            associated with assisted oocyte production and informed  
            consent requirements, as specified.



          7)Makes any research program that offers compensation to women  
            providing human oocytes for research subject to specified  
            existing law, including, but not limited to, coverage for  
            medically appropriate medical care that is required as a  
            direct result of the procedure for research purposes,  
            regardless of the level of compensation offered.  


          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  








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          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  
          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.

           NOTE:  Please see the Senate Health Committee analysis for more  
                 detailed background information on this subject.


          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.








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          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:NoLocal:    No

          SUPPORT:    (Verified  8/22/16)


          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 
          California National Organization for Women
          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
          Secular Coalition for California

          OPPOSITION:  (Verified  8/22/16)


          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








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          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  
          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  








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          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.

          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  








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          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  
          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
          8/22/16 23:18:48


                                   ****  END  ****


          








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