BILL ANALYSIS                                                                                                                                                                                                    



                                                                    AB 2531


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          CONCURRENCE IN SENATE AMENDMENTS


          AB  
          2531 (Burke)


          As Amended  August 19, 2016


          Majority vote


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          |ASSEMBLY:  |65-3  |(April 28,     |SENATE: |      |(August 29,      |
          |           |      |2016)          |        |26-11 |2016)            |
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          Original Committee Reference:  HEALTH


          SUMMARY:  Repeals the ban on compensation for women providing  
          human oocytes (eggs) for research, and instead allows a woman  
          providing eggs for research to be compensated for her time,  
          discomfort, and inconvenience in the same manner as other  
          research subjects.


          The Senate amendments require that a woman providing eggs for  
          research be provided with a summary of health and consumer  
          issues associated with assisted oocyte production (AOP) and  
          informed consent requirements, and to be informed that ongoing  
          studies will continue to assess the long-term health impacts of  
          ovarian stimulation and egg retrieval.


          FISCAL EFFECT:  None.










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          COMMENTS:  According to the author, this bill promotes medical  
          research in California while ensuring research participants are  
          fairly treated by removing the prohibition on compensation for  
          women participating in egg donation for medical research.  The  
          author states that we all benefit from those willing to  
          participate in research, and the current processes in place are  
          designed to appropriately reward participants, while protecting  
          them from abusive or coercive practices.  The author notes that  
          this bill ensures that women are treated equally to all other  
          research subjects - allowing them to actively evaluate their  
          participation in research studies and be paid for their time,  
          trouble, and inconvenience when they do participate.  The author  
          concludes, given that compensation is allowed in 47 other  
          states, and there is no evidence of abuse, it's time to  
          reconsider our ban, just as New York did.


          Research using donated eggs.  Embryonic stem cells are a unique  
          discovery with the power to unlock causes of and treatments for  
          many human illnesses.  Diseases and disabilities such as heart  
          disease, spinal cord injuries, juvenile diabetes (Type I  
          diabetes), amyotrophic lateral sclerosis (ALS or Lou Gehrig's  
          disease), Parkinson's disease, and Alzheimer's disease afflict  
          millions of Americans.  These are some of the most debilitating  
          diseases known to modern medicine in that they often severely  
          limit the activity of the affected individual, cause painful  
          degeneration of normal bodily functions, bring on premature  
          death, and cause immense suffering for the individual and his or  
          her family.


          Potential benefits of embryo research include an improved  
          understanding of fertilization, implantation, and early  
          pregnancy biology and, with this understanding, possibly fewer  
          undesired outcomes, such as miscarriage.  For infertile couples,  
          embryo research offers the possibility of more effective  
          therapies:  research efforts helped optimize conditions for  
          intracytoplasmic sperm injection, embryo culture, and  
          cryopreservation, for example.  For others at risk for heritable  
          genetic disease who feel pregnancy termination is undesirable or  
          inappropriate, embryo research has led to the possibility of  
          early, accurate genetic diagnosis.  Preimplantation genetic  








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          diagnosis provides diagnostic results at a point before  
          implantation, so pregnancy termination can be avoided.  In  
          addition to these benefits of embryo research in general, stem  
          cell research promises additional potential benefits, for such  
          work may lead both to a better understanding of the processes  
          leading to tissue differentiation and function and to possible  
          therapies by creating lines that can replace diseased or  
          nonfunctioning tissues.


          SUPPORT.  The American Society for Reproductive Medicine (ASRM)  
          is the sponsor of this bill and states, in the United States and  
          California there is a fundamental principle that all research  
          participants deserve just compensation for their contribution to  
          research that entails some risk and much time, trouble, and  
          inconvenience.  ASRM contends the lack of compensation deters  
          participants and stalls research.  The sponsor notes, women  
          considering ovarian stimulation and oocyte retrieval are capable  
          of informed decision making as to the risks of compensated  
          participation in research, just as they do for now for  
          fertility.  ASRM concludes that fairness requires research  
          participants receive the same compensation fertility donors  
          presently receive, and allowing compensation for fertility  
          purposes while banning it for research serves a false value,  
          subordinating research to fertility.


          The American Congress of Obstetricians and Gynecologists,  
          District IX - California (ACOG) writes that all other research  
          subjects are compensated for their time, trouble, and  
          inconvenience related to participating in research, except for  
          this population.  ACOG notes that this bill ensures that women  
          are treated equal to all other research subjects - allowing them  
          to actively evaluate their participation in research studies.


          OPPOSITION.  The Center for Genetics and Society (CGS) is  
          opposed to this bill stating, that women providing eggs are not  
          research subjects, and egg retrieval is very different from a  
          clinical trial.  CGS notes that, in clinical trial,  
          investigators study the reactions and health outcomes of  
          subjects who take a drug, use a device, or undergo a procedure,  








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          however, in the case of egg harvesting, investigators are not  
          studying, or seeking to understand the effects of the procedures  
          on women.  CGS also notes that many experts remain concerned  
          about the long-term risks of these drugs, especially their  
          potential impact on infertility and various cancers, and that  
          follow-up research on egg providers, which could establish the  
          frequency and severity of these adverse outcomes, and best  
          protocols for avoiding them, is widely recognized to be grossly  
          inadequate.  CGS also references the Institute of Medicine  
          report, "Assessing the Medical Risks of Human Oocyte Donation  
          for Stem Cell Research (2006)," and that it concluded that one  
          of the striking facts about ovarian stimulation is just how  
          little is known about long-term health outcomes for women.


          We Are Egg Donors indicates that with no provisions in this bill  
          to protect the health of women who would be providing these  
          oocytes, based on their collective experiences as egg providers,  
          they feel it would be imprudent to pass this bill because women  
          cannot give informed consent when there is a lack of information  
          about the risks.


          Analysis Prepared by:                                             
                          Lara Flynn / HEALTH / (916) 319-2097  FN:  
          0004769