BILL ANALYSIS                                                                                                                                                                                                    Ó




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          |SENATE RULES COMMITTEE            |                       SB 1408|
          |Office of Senate Floor Analyses   |                              |
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                                UNFINISHED BUSINESS 


          Bill No:  SB 1408
          Author:   Allen (D), et al. 
          Amended:  5/26/16  
          Vote:     27 - Urgency

           SENATE HEALTH COMMITTEE:  8-0, 4/27/16
           AYES:  Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan,  
            Roth, Wolk
           NO VOTE RECORDED:  Hall

           SENATE FLOOR:  34-0, 5/16/16
           AYES:  Allen, Anderson, Bates, Beall, Berryhill, Block,  
            Cannella, De León, Fuller, Gaines, Galgiani, Glazer,  
            Hernandez, Hertzberg, Hill, Huff, Jackson, Lara, Leno, Leyva,  
            Liu, McGuire, Mitchell, Monning, Moorlach, Morrell, Nguyen,  
            Nielsen, Pavley, Roth, Stone, Vidak, Wieckowski, Wolk
           NO VOTE RECORDED:  Hall, Hancock, Hueso, Mendoza, Pan, Runner

           ASSEMBLY FLOOR:  Not available

           SUBJECT:   Tissue donation


          SOURCE:   AIDS Project Los Angeles
                    Equality California
                    Los Angeles LGBT Center
                    Positive Womens NetworkUSA



          DIGEST:   This bill allows for the transplantation of organs  
          into the body of a person, as specified, when the donor of the  
          organs is found reactive for human immunodeficiency virus (HIV),  
          and removes penalties for organ donors who are found reactive to  
          HIV, as specified.








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          Assembly Amendments: 




          1)Narrow this bill to apply to the transplantation of organs, as  
            defined, between donors and recipients who are found to be  
            reactive for HIV.




          2)Define "organ" for purposes of organ transplantation and  
            research purposes in compliance with the federal HIV Organ  
            Policy Equity (HOPE) Act, as specified.




          3)Exempt from tissue bank licensure the collection, processing,  
            storage, or distribution of any organ, as specified, within a  
            single general acute care hospital, as defined, operating a  
            Medicare-approved transplant program.


          4)Add a provision to prohibit disciplinary action by the Medical  
            Board of California (MBC) against a licensee who performs  
            organ transplants within the standard of care and in  
            compliance with this bill.


          5)Add an urgency clause for this bill to take effect immediately  
            in order to provide for organ donations and transplants to  
            occur at the earliest opportunity.


          6)Add coauthors.









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          ANALYSIS: 


          Existing law:


          1)Prohibits the transfer of any tissues, as defined, into the  
            body of another person by means of transplantation, unless the  
            donor of the tissues has been screened and found nonreactive  
            for evidence of infection with HIV, agents of viral hepatitis  
            (HBV and HCV), human T lymphotropic virus (HTLV), and  
            syphilis, except as provided.


          2)Authorizes the transplantation of tissue from a donor who has  
            not been tested for specified infectious diseases or, with the  
            exception of HIV and HTLV, has been found reactive, if  
            specified conditions are satisfied, including obtaining  
            consent from an intended recipient or the recipient's family.  
            Defines "family" as a spouse, adult son or daughter, either  
            parent, adult brother or sister, or grandparent.


          This bill:


          1)Allows for the transplantation of organs into the body of a  
            person who is found to be reactive for HIV when the donor of  
            the organs is also found reactive for HIV and both of the  
            following conditions are satisfied:


             a)   The individual receiving the organs has been found  
               reactive for HIV before receiving the organ. 


             b)   The individual is either participating in clinical  
               research approved by an institutional review board under  
               the criteria, standards, and regulations described in  
               subsections (a) and (b) of Section 274f-5 of Title 42 of  
               the United States Code (USC), or, if the United States  








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               Secretary of Health and Human Services determines under  
               subsection (c) of Section 274f-5 of Title 42 of the USC  
               that participation in this clinical research is no longer  
               warranted as a requirement for transplants, the individual  
               is receiving the transplant under the standards and  
               regulations under subsection (c) of Section 274f-5 of Title  
               42 of the USC, which requires the Secretary to, among other  
               things, review the results of scientific research in  
               conjunction with the Organ Procurement and Transplantation  
               Network to determine whether the results warrant revision  
               of the standards of quality.


          2)Removes specified penalties for donors included in 1) above  
            and sperm donors, as specified, for the donation of blood or  
            tissue by a person who knows that he or she has been found  
            reactive for HIV, or for a person afflicted with any  
            contagious, infectious, or communicable disease who willfully  
            exposes himself or herself to another person.


          3)Defines "organ," for purposes of this bill, as a human kidney,  
            liver, heart, lung, pancreas, or intestine (including the  
            esophagus, stomach, small or large intestine, or any portion  
            of the gastrointestinal tract), or vascularized composite  
            allograft, and associated blood vessels recovered from an  
            organ donor during the recovery of such organ.


          4)Exempts from tissue bank licensure the collection, processing,  
            storage, or distribution of any organ, as specified, within a  
            single general acute care hospital, as defined, operating a  
            Medicare-approved transplant program.


          5)Prohibits disciplinary action by the MBC against a licensee  
            who performs organ transplants within the standard of care and  
            in compliance with this bill.


          6)Provides that this bill is an urgency statute in order to  
            provide for organ donations and transplants to occur at the  








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            earliest opportunity.


          Background


          On November 21, 2013, President Obama issued a statement that  
          announced he signed the bipartisan-supported HOPE Act, which  
          allowed for scientists to carry out research into organ  
          donations from one person with HIV to another. As noted in the  
          statement, such organ transplants were deemed illegal for  
          decades. However, with growing effective treatments for HIV and  
          by signing the HOPE Act, successful life-saving organ donations  
          for people living with HIV could eventually be realized. On  
          November 22, 2013, Donate Life California issued a statement  
          applauding the President's signing of the HOPE Act, stating that  
          the change in policy had the potential to save 1,000  
          HIV-infected transplant patients each year, as well as  
          shortening the list for uninfected people awaiting transplants. 
          
          A March 30, 2016, article in the Los Angeles Times announced the  
          first organ transplantation from a deceased HIV-positive donor  
          to two HIV-positive recipients, performed by surgeons at Johns  
          Hopkins University Medical Center. Physicians involved with the  
          transplantation believe that many HIV-infected donors are likely  
          healthy enough to donate an organ without great risk to their  
          health. Also noted in the article is the expectation that each  
          year 500 to 600 HIV-positive people will die under circumstances  
          that would make their organs available for transplant, which has  
          the potential to make hundreds and potentially thousands of  
          transplantable organs available each year to HIV-infected people  
          with end-stage diseases of the kidneys, heart, liver, and lungs.

          Currently there are four hospitals who have met the criteria to  
          participate in HOPE Act transplant research: Johns Hopkins  
          Hospital in Baltimore, MD (liver and kidney programs); Hahnemann  
          University Hospital in Philadelphia, PA (liver and kidney  
          programs); Mount Sinai Medical Center in New York, NY (liver and  
          kidney programs); and UCSF Medical Center, San Francisco, CA  
          (liver [deceased and living donor] and kidney [deceased donor]  
          programs).









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          Comments


          Author's statement. According to the author, this bill will  
          greatly improve the life expectancies of people living with HIV  
          who need organ or tissue transplants by removing California's  
          prohibition on donating organs or tissue while HIV-positive.  
          Under current state law, it is illegal for an HIV-positive  
          person to donate organs or tissues under any circumstance. This  
          existing law was enacted nearly 20 years ago at a time when very  
          little was known about HIV and AIDS. Research made possible by  
          the passage of the federal HOPE Act of 2013 found that organ  
          donations from HIV-positive donors to HIV-positive recipients do  
          not have a detrimental effect. Major advances in the treatment  
          of HIV and AIDS mean that HIV-positive individuals are living  
          longer, and like other older Americans, they too are developing  
          medical conditions that require organ transplants. However, the  
          number of individuals in need of organ transplants far exceeds  
          the availability of healthy organs. Increasing the number of  
          eligible organ and tissue donors for HIV-positive individuals  
          will save lives.
          
          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:NoLocal:    No


          SUPPORT:  (Verified  5/26/16)


          AIDS Project Los Angeles (co-source)
          Equality California (co-source)
          Los Angeles LGBT Center (co-source)
          Positive Women's Network-USA (co-source)
          Access Support Network of San Luis Obispo and Monterey Counties
          AIDS Healthcare Foundation
          American Civil Liberties Union of California
          Familia: Trans Queer Liberation Movement
          Health Officers Association of California
          Lambda Legal
          Law Foundation of Silicon Valley
          San Francisco AIDS Foundation
          Two individuals








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          OPPOSITION:   (Verified5/26/16)


          None received


          ARGUMENTS IN SUPPORT:   The sponsors and other supporters argue  
          that this bill will bring state law into conformity with federal  
          law, ending a policy that was enacted at a time when very little  
          was known about HIV and AIDS. Supporters argue that with  
          advances in HIV understanding and treatment, HIV-positive  
          individuals are living longer and developing medical conditions  
          later in life for which organ transplants are the standard of  
          care treatment. Supporters state that this bill will help  
          alleviate waiting times on donor lists for all people awaiting  
          organ transplants, and that studies have shown that transplants  
          from one HIV-positive person to another do not have a  
          detrimental effect nor negatively affect patient outcomes.





          Prepared by:Reyes Diaz / HEALTH / (916) 651-4111
          5/27/16 9:35:26


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