BILL ANALYSIS                                                                                                                                                                                                    



                                                                    AB 2531


                                                                    Page  1





          Date of Hearing:   April 5, 2016


                            ASSEMBLY COMMITTEE ON HEALTH


                                   Jim Wood, Chair


          AB 2531  
          (Burke) - As Introduced February 19, 2016


          SUBJECT:  Reproductive health and research.


          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.  Specifically, this bill:  


          1)Prohibits payment received for providing eggs for research  
            from being for the eggs themselves, or predicated on the  
            number obtained, including if none are obtained.


          2)Requires the proposed compensation amount to be determined by  
            a human subject research panel or institutional review board  
            (IRB).


          3)Specifies, in the event that a human subject research panel or  
            IRB determines that a proposed compensation amount is  
            inappropriate, the panel or board to determine an appropriate  
            compensation amount.










                                                                    AB 2531


                                                                    Page  2





          4)Requires the IRB, if a woman is compensated for providing eggs  
            for the purpose of infertility treatment, and any eggs or  
            embryos in excess of those needed for fertility are offered  
            for research, to disregard the amount of compensation if all  
            of the following conditions are met:


             a)   The clinic performing egg retrieval is a member of the  
               Society for Assisted Reproductive Technology;


             b)   The procurement and disposition for research purposes of  
               eggs initially provided for reproductive uses, either for  
               use by the donor or another woman, shall 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 eggs for  
               her own reproductive success; and, 


             e)   The donation of eggs for research is done without  
               valuable consideration.  Valuable consideration does not  
               include reasonable payment for the removal, processing,  
               disposal, preservation, quality control, and storage of  
               eggs or embryos.


          5)Makes various legislative findings and declarations, stating  
            that concerns that women will be exploited if compensated for  








                                                                    AB 2531


                                                                    Page  3





            providing human eggs for research have not been borne out in  
            the states where compensation is allowed, and that sufficient  
            protections are in place to treat women providing human eggs  
            for research, similar to any other research subject, and that  
            women are competent and able to make decisions for themselves.
          EXISTING LAW:  


          1)Defines "oocyte" as a female egg or egg cell of a human  
            female, and defines "assisted oocyte production" (AOP) as  
            surgical extraction of oocytes following pharmaceutically  
            induced manipulation of oocyte production through the use of  
            ovarian stimulation.





          2)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.



          3)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.



          4)Requires a physician, prior to providing AOP for the purposes  
            of medical research, to obtain written and oral informed  
            consent for the procedure from the subject, and requires this  
            informed consent to comply with the requirements of the  
            Protection of Human Subjects in Medical Experimentation Act  
            (Act), as specified.









                                                                    AB 2531


                                                                    Page  4







          5)Requires a physician, prior to obtaining informed consent from  
            a subject for AOP for the purpose of procuring eggs for  
            research, to provide to the subject a standardized medically  
            accurate written summary of health and consumer issues  
            associated with AOP.   Requires this summary to include  
            medically accurate disclosures concerning the potential risks  
            of AOP, including the risks associated with the surgical  
            procedure and with using the drugs, medications, and hormones  
            prescribed for ovarian stimulation during the AOP process.



          6)Requires an IRB to require research programs or projects under  
            its review that involve AOP 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. 



          7)Requires a research program that involves AOP to ensure that a  
            written record is maintained that includes specified  
            components, including the demographics of subjects,  
            information regarding every egg that has been donated or used,  
            and a record of all adverse health outcomes resulting from the  
            AOP.



          8)Prohibits a physician performing the AOP from having a  
            financial interest in the outcome of the research.



          9)Establishes the Act, which provides various statutory  
            protections for Californians involved in medical experiments,  
            including a detailed requirement for what constitutes  








                                                                    AB 2531


                                                                    Page  5





            voluntary informed consent, and includes penalties for  
            violations of this Act.



          10)Establishes, in the California Constitution, via the passage  
            of Proposition 71 in 2004, the California Stem Cell Research  
            and Cures Act and the California Institute for Regenerative  
            Medicine (CIRM), to provide $3 billion in bond funding over a  
            period of 10 years to fund stem cell research.  Requires the  
            Independent Citizens Oversight Committee of CIRM to establish  
            certain standards for the use of the funds provided by the  
            Act, including a prohibition against compensation to donors or  
            participants of the research, beyond reimbursement of  
            expenses.



          FISCAL EFFECT:  None.


          COMMENTS:  





          1)PURPOSE OF THIS BILL.  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  








                                                                    AB 2531


                                                                    Page  6





            inconvenience when they do participate.



          The author continues, 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 eggs, just as any other research  
            subject, to make an informed decision as to participation, and  
            justly compensate them for doing so. The author concludes 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.
          2)BACKGROUND.  


             a)   Egg production, retrieval, and donation.  Over the past  
               two decades, millions of women have had eggs collected for  
               the purpose of assisted reproduction.  Most of these were  
               women undergoing in vitro fertilization (IVF) with their  
               own eggs; however, a significant minority were donating  
               their eggs to help other women get pregnant.  In the egg  
               donation process, hormones are used to basically trick the  
               body into producing many mature eggs, instead of the normal  
               single egg per menstrual cycle.  The donation process  
               involves the woman self-injecting a mix of hormones over  
               the span of a month that stimulate the growth of ovarian  
               follicles, stop the normal ovulation cycle, and affect egg  
               maturation.  When the eggs are ready, the woman is brought  
               into surgery, where she receives intravenous sedation, and  
               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.


             b)   Compensation of egg donors.  Under California law, the  
               prohibition against compensation to egg donors applies only  
               to donors for research purposes, not to assist someone else  








                                                                    AB 2531


                                                                    Page  7





               in getting pregnant.  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.  The  
               oocyte donor compensation guidelines of the ASRM, adopted  
               in 2007, 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 eggs, the number or quality  
               retrieved, or the donor's ethnic or other personal  
               characteristics.  The guidelines stated that total payments  
               to donors in excess of $5,000 require justification, and  
               sums above $10,000 are not appropriate.





               According to the author, besides California, only  
               Massachusetts and South Dakota specifically prohibit  
               compensation for egg donors.



             c)   Institutional Review Boards.  An IRB is a committee that  
               has been formally designated to approve, monitor, and  
               review biomedical and behavioral research involving humans  
               conducted under the auspices of the institution with which  
               it is affiliated.  IRBs are regulated by the federal Office  








                                                                    AB 2531


                                                                    Page  8





               for Human Research Protection, and are required to have at  
               least five members, including at least one member who is  
               not otherwise affiliated with the institution.  IRBs have  
               the authority to approve, require modifications in, or  
               disapprove all research activities under its review.  Under  
               California law, regarding any research project involving  
               AOP, the IRB is required to ensure that the research  
               program comply with specified requirements, including the  
               following:

               i)     That the research program provide the subject with  
                 an objective and accurate statement about the existing  
                 state of the research for which the subject is providing  
                 oocytes; 

               ii)    That the research program performs psychological and  
                 physical screening for all subjects prior to the oocyte  
                 retrieval procedure;



               iii)   That the research program ensures, after conducting  
                 AOP retrieval on a subject, that the subject be given a  
                 post-procedure medical examination at a time within the  
                 standard of care to determine if the subject has  
                 experienced an adverse health effect that is a result of  
                 the procedure, and to inform the subject of the right to  
                 a second opinion if she has any medical concerns;



               iv)    That the research program ensures that the subject  
                 has access to and coverage for medically appropriate  
                 medical care that is required as a direct result of the  
                 procedure, and to ensure that payment or coverage of  
                 resulting expenses is provided at no cost to the subject;  
                 and,










                                                                    AB 2531


                                                                    Page  9






               v)     That the research program provides disclosure if the  
                 physician and his or her immediate family members have  
                 any professional interest in the outcome of the research  
                 or of the oocyte retrieval procedure.



             d)   Institute of Medicine Report.  Following passage of  
               Proposition 71 in 2004, CIRM asked the Institute of  
               Medicine (IOM) and the National Research Council to convene  
               a committee of experts to ascertain the medical risks of  
               oocyte donation for stem cell research.  A workshop was  
               convened in 2006, and issued a report in 2007 entitled  
               "Assessing the Medical Risks of Human Oocyte Donation for  
               Stem Cell Research" (IOM Report).  According to the IOM  
               Report, years of experience with assisted reproduction have  
               identified a number of potential risks associated with egg  
               donation, falling into three main categories:  i) the  
               potential risks arising from the hormone regimen that women  
               are given to stimulate egg production, including ovarian  
               hyper-stimulation syndrome (OHSS), problems with long-term  
               fertility, breast, ovarian, and endometrial cancers; ii)  
               the risks associated with the surgical procedure, including  
               the anesthesia, which involves many of the same issues that  
               anyone having surgery faces; and, iii), the potential risks  
               that are psychological in nature, including anxiety, mood  
               swings, and post-donation adjustment.  

               However, the IOM Report stated that there was a need for  
               more and better data.  According to the report, 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 IOM 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 IOM Report did acknowledge that the  
               available data come primarily from IVF patients and not  








                                                                    AB 2531


                                                                    Page  10





               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 IOM Report, is that there  
               is a great deal of uncertainty about the potential health  
               risks for egg donation.



             e)   National Academy of Sciences.  The National Academy of  
               Sciences' (NAS) Guidelines for Human Embryonic Stem Cell  
               Research state that women who undergo hormonal induction to  
               generate eggs 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 eggs  
               directly and solely to research for the time, risk, and  
               burden 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."

             f)   Research using donated eggs.  Embryonic stem cells are a  








                                                                    AB 2531


                                                                    Page  11





               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  
               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.
          3)SUPPORT.  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  








                                                                    AB 2531


                                                                    Page  12





            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.

          The National Center for Lesbian Rights (NCLR) asserts that only  
            through research - through translating science from the  
            laboratory to clinical practice - can treatment options and  
            patient outcomes be improved.  NCLR states that without  
            compensation for oocyte donations, few women participate in  
            research, creating barriers to reproductive and other  
            biomedical research that could benefit all women.  NCLR  
            concludes a lack of fertility research affect LGBT people in  
            particular because assisted reproduction is essential for many  
            LGBT people to become parents and build families.
          4)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, however, in the case of egg harvesting,  








                                                                    AB 2531


                                                                    Page  13





            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 IOM 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.

          The California Catholic Conference, Inc. opposes this bill  
            stating that it would put women's health in jeopardy by  
            creating and, in effect, result in a marketing dynamic  
            designed to exploit women who are most in need of resources -  
            including college students, immigrants, and women with  
            economic challenges.
          5)PREVIOUS LEGISLATION.  


             a)   AB 926 (Bonilla), vetoed by Governor Brown in 2013, was  
               substantially similar to this bill.  AB 926 would have  
               lifted the prohibition on compensation for egg donations  
               for medical research, and would have established guidelines  
               for the use of IRBs relative to egg donations and  
               compensation.  Governor Brown's veto message read:









                                                                    AB 2531


                                                                    Page  14






                 Not everything in life is for sale nor should it be.





                 This bill would legalize the payment of money in  
                 exchange for a woman submitting to invasive  
                 procedures to stimulate, extract and harvest her  
                 eggs for scientific research.





                 The questions raised here are not simple; they touch  
                 matters that are both personal and philosophical. 





                 In medical procedures of this kind, genuinely  
                 informed consent is difficult because the long-term  
                 risks are not adequately known. Putting thousands of  
                 dollars on the table only compounds the problem.





                 Six years ago the Legislature, by near unanimity,  
                 enacted the prohibition that this bill now seeks to  
                 reverse. After careful review of the materials which  
                 both supporters and opponents submitted, I do not  
                 find sufficient reason to change course. 










                                                                    AB 2531


                                                                    Page  15








                 I am returning this bill without my signature.


             b)   AB 1317 (Block), Chapter 523, Statutes of 2009, required  
               that all advertisements for egg donations for fertility  
               (non-research) purposes to include a warning that there is  
               a screening process, that not all potential donors are  
               selected, and that not all selected donors receive the  
               compensation amount advertised.  AB 1313also requires the  
               advertisement to include a warning that there may be risks  
               involved, and required egg donors for fertility purposes to  
               be provided with the same risk information required to be  
               provided to donors for research purposes, and to comply  
               with the same informed consent requirements.


             c)   SB 1260 (Ortiz), Chapter 483, Statutes of 2006,  
               establishes various requirements related to the donation of  
               eggs for research.  The prohibition against compensating  
               donors beyond reimbursement of direct costs, which this  
               bill is seeking to repeal, was among the provisions  
               established by SB 1260.


          6)POLICY COMMENT.  In 2013 the Governor vetoed AB 926 which  
            included similar provisions to those contained in this bill.   
            The Committee may wish to ask the author her plans to address  
            the Governor's veto message.


          REGISTERED SUPPORT / OPPOSITION:




          Support








                                                                    AB 2531


                                                                    Page  16







          American Society for Reproductive Medicine (sponsor)


          American Congress of Obstetricians and Gynecologists, District  
          IX - California


          California Chronic Care Coalition


          California Cryobank
          Equality California
          Fertile Action
          National Center for Lesbian Rights


          RESOLVE:  The National Infertility Association


          Opposition


          California Catholic Conference, Inc.


          California Right to Life Committee, Inc.


          Center for Genetics and Society
          We Are Egg Donors
          Several individuals





          Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097








                                                                    AB 2531


                                                                    Page  17