BILL ANALYSIS                                                                                                                                                                                                    



                                                                    SB 1408


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          Date of Hearing:   May 25, 2016


                            ASSEMBLY COMMITTEE ON HEALTH


                                   Jim Wood, Chair


          SB  
          1408 (Allen) - As Amended May 23, 2016


          SENATE VOTE:  34-0


          SUBJECT:  Organ donation.


          SUMMARY:  Allows for the transplantation of organs into the body  
          of a person when the donor of the organ has human  
          immunodeficiency virus (HIV).  Specifically, this bill:  


          1)Deletes the prohibition in existing law on the transplantation  
            of tissue from a donor with HIV and instead permits such  
            transplantation if the physician and surgeon performing the  
            transplantation has ensured that the organ from an individual  
            who has been found reactive to HIV may be transplanted only  
            into an individual who satisfies both of the following:


             a)   The individual has been found reactive for HIV before  
               receiving the organ; and, 

             b)   The individual is either participating in clinical  
               research approved by an institutional review board (IRB)  
               pursuant to federal requirements, or if the United States  
               Secretary of Health and Human Services (HHS) determines  
               that participation in this clinical research is no longer  







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               warranted as a requirement for transplants, as specified.



          2)Exempts the donation of organs from HIV positive individuals  
            from specified criminal penalties.


          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)Provides that the Medical Board of California (MBC) will not  
            take disciplinary action against a licensee who performs organ  
            transplants in compliance with this bill.


          EXISTING STATE LAW:  


          1)Makes it a felony punishable by imprisonment of two, four, or  
            six years for any person who knows that he or she has acquired  
            immonodeficiency syndrome (AIDS) and donates blood, tissue, or  
            semen to any medical center.


          2)Provides that no tissues be transferred into the body of  
            another person by means of transplantation, unless the donor  
            of the tissues has been screened and found nonreactive by  
            laboratory tests for evidence of infection with HIV, agents of  
            viral hepatitis (HBV and HCV), and syphilis.  


          3)Allows the Department of Public Health (DPH) to adopt  
            regulations requiring additional screening tests of donors of  
            tissues when, in the opinion of DPH, the action is necessary  







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            for the protection of the public, donors, or recipients.


          4)Allows a recipient of sperm to consent to the use of sperm in  
            assisted reproductive technologies if the sperm donor is found  
            reactive for HBV, HCV, syphilis, HIV, or human T-lymphotropic  
            (HTLV) if the sperm donor is the spouse of, partner of, or  
            designated donor for that recipient.  (The HTLV family of  
            viruses are a group of human retroviruses that are known to  
            cause a type of cancer called adult T-cell leukemia/lymphoma).


          5)Provides for an exception to the ban on transplantation of  
            tissue from a donor who has not been screened or tested, with  
            the exception of HIV and HTLV, or has been found reactive for  
            the infection diseases listed in 2) above, or for which DPH  
            has, by regulation, required additional screening tests, if  
            both of the following conditions are satisfied:


             a)   The physician performing the transplantation has  
               determined any one or more of the following:


               i)     Without the transplant the intended recipient will  
                 most likely die during the period of time necessary to  
                 obtain other tissue or to conduct the required tests;


               ii)    The intended recipient already is diagnosed with the  
                 infectious disease for which the donor tested positive;  
                 or,


               iii)   The symptoms from the infectious disease for which  
                 the donor has tested positive will most likely not appear  
                 during the intended recipient's likely lifespan after  
                 transplantation with the tissue or may be treated  
                 prophylactically if they do appear; and, 








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             b)   Consent for the use of the tissue has been obtained from  
               the recipient, if possible, or if not possible, from a  
               member of the recipient's family, or the recipient's legal  
               guardian.  


          6)Establishes the Medical Practice Act which gives the MBC the  
            authority to license and regulate the practice of medicine.
          EXISTING FEDERAL LAW establishes the HIV Organ Policy Equity  
          (HOPE) Act which allows for research into transplanting organs  
          from HIV-positive donors into HIV-positive recipients.


          FISCAL EFFECT:  None.


          COMMENTS:


          1)PURPOSE OF THIS BILL.  According to the author this bill would  
            greatly improve the life expectancies of people living with  
            HIV who need organ transplants by removing California's  
            prohibition on donating organs while HIV-positive.  The author  
            notes that under current state law, it is illegal for an  
            HIV-positive person to donate organs under any circumstance.   
            The author points out this law was enacted nearly 20 years ago  
            at a time when very little was known about HIV and AIDS, and  
            that recent 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 are safe.  The  
            author continues, 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 and increasing the number  
            of eligible donors for HIV-positive individuals will save  
            lives.  The author concludes that his request for expedited  
            consideration of this bill is based on hearing from the  







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            University of California, San Francisco (UCSF) that two  
            HIV-positive patients are in immediate need of the bill's  
            passage in order to have the surgeries performed.

          2)BACKGROUND.  





             a)   Ban on HIV-positive organ donations.  According to an  
               article published in September of 1987 in the journal  
               Transfusion, an estimated 12,000 people in the United  
               States contracted HIV from blood transfusions between 1978  
               and 1984, leaving the public fearful.  In response, the  
               U.S. passed a ban on organ collection from HIV-positive  
               donors in 1988.  However, by the late 1990s screening  
               procedures for HIV had become accurate enough to eliminate  
               this worry, and simultaneously, the development of  
               effective antiretroviral drugs meant that HIV-infected  
               people could expect to live to a relatively old age, and  
               also develop the disorders that come with advancing age.

             b)   Research on HIV-positive organ transplantation.  In 1999  
               UCSF transplant surgeon, Dr. Peter Stock received a $3  
               million grant from the state of California for a pilot  
               study transplanting uninfected livers and kidneys into  
               HIV-positive recipients.  The 37 patients appeared to do  
               well overall and were only slightly more likely to reject  
               organs than HIV-negative recipients were.  In 2004, Dr.  
               Stock and his colleagues published an article in the New  
               England Journal of Medicine, "Outcomes of Kidney  
               Transplantation in HIV-Infected Recipients."  The article  
               discussed the results of another trial in which 150  
               patients underwent kidney transplants between November 2003  
               and June 2009.  According to the article, the trial showed  
               that kidney transplantation appears to be a feasible  
               therapy in carefully selected HIV-infected patients.









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             In 2008, a doctor in South Africa who followed Dr. Stock's  
               work, Elmi Muller, transplanted two HIV-positive patients  
               with kidneys from a single HIV-positive donor, and shortly  
               thereafter a young man and his mother who had been turned  
               down for dialysis.  At that time in South Africa, patients  
               with HIV could not access dialysis treatments, resulting in  
               certain death.  After much controversy Dr. Muller's work  
               was allowed to proceed and in 2010 she published her first  
               round of results showing that her patients thrived two  
               years after the surgery. 

             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 in the  
               US, performed by surgeons at Johns Hopkins University  
               Medical Center in Baltimore Maryland.  The surgeons who  
               performed the transplants at Johns Hopkins conducted  
               research, published in The American Journal of  
               Transplantation in 2011 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 save about 1,000 lives each year.

             c)   Federal HOPE Act.  On November 21, 2013, President Obama  
               signed into law the HOPE Act, which allowed for scientists  
               to carry out research into organ donations from one person  
               with HIV to another.  On November 21, 2015, the Secretary  
               of HHS finalized the Organ Procurement and Transplantation  
               Network (OPTN) standards of quality for the recovery and  
               transplantation of organs from HIV-positive donors as  
               required by the HOPE Act.  The Secretary also developed and  
               published criteria for research relating to transplantation  
               of organs from donors infected with HIV into individuals  
               who are infected with HIV, allowing the HOPE Act to take  
               effect.  The research criteria specifies that organs from  
               individuals infected with HIV may be transplanted only into  
               individuals who were infected with HIV before receiving  
               such organs and are participating in clinical research  
               approved by an IRB.







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             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 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.  

             Currently there are four hospitals who have met the criteria  
               to participate in HOPE Act transplant research:  Johns  
               Hopkins Hospital in Baltimore, Maryland (liver and kidney  
               programs), Hahnemann University Hospital in Philadelphia,  
               Pennsylvania (liver and kidney programs), Mount Sinai  
               Medical Center in New York, New York (liver and kidney  
               programs), and UCSF Medical Center, San Francisco,  
               California (liver {deceased and living donor} and kidney  
               {deceased donor} programs). 



             d)   Transplantation in California.  California law makes it  
               a felony to donate blood, organs or other tissue, or semen  
               by a person with AIDS.  With the passage of the federal  
               HOPE Act, UCSF is the only transplant program on the west  
               coast that is qualified to participate; however current  
               state law prohibits and penalizes such transplants.   
               According to UCSF, two HIV-positive patients are in dire  
               need of transplants and would benefit from the speedy  
               passage of this bill.  One patient with liver failure and  
               cancer has a living donor ready and waiting.  There are an  
               additional 65 HIV-positive patients waiting for kidney or  
               liver transplants at UCSF who would benefit if the HOPE Act  
               could be implemented in California. 








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             e)   Other States.  Sixteen other states and one territory  
               have laws prohibiting HIV-positive organ donations and  
               transplantation:  Delaware, Florida, Georgia, Idaho,  
               Illinois, Kansas, Kentucky, Michigan, Minnesota, Missouri,  
               North Carolina, South Carolina, South Dakota, Tennessee,  
               Virginia, and the U.S. Virgin Islands, although Michigan,  
               Minnesota, Missouri, and Virginia have exceptions for  
               medical research.



             f)   Who gets a transplant?  OPTN allocation policies must,  
               among other factors, be based on sound medical judgment,  
               seek to achieve the best use of donated organs, and shall  
               not be based on a candidate's place of residence or listing  
               except to the extent required to satisfy other factors.   
               For liver disease, the Model for End-Stage Liver Disease  
               (MELD) is a scoring system used to measure illness severity  
               in liver transplant candidates.  The system is used in the  
               allocation of livers to adults and was established in  
               February 2002.  The MELD system calculates a score based on  
               the clinical severity of illness that predicts the risk of  
               death within three months on the waiting list.  Livers are  
               allocated to waitlisted patients with chronic liver disease  
               based upon this score.  The sicker the patient, the higher  
               the score, and the more likely to receive a transplant.   
               However, according to Dr. Stock, patients with HIV do not  
               have the same survival on the wait list, they deteriorate  
               at a significantly higher rate and therefore the MELD  
               scoring system does not serve them well.



               According to OPTN there are currently 123,288 people in the  
               U.S. waiting for a life-saving organ transplant, and every  
               10 minutes another person is added to that list.  Each day  
               an average of 22 patients die waiting for an organ.   
               According to the United Network for Organ Sharing,  
               approximately 23,000 Californians are on the waiting list  
               for an organ transplant.  Of the close to 31,000 organ  







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               transplants performed annually in the U.S., those involving  
               organs from HIV-infected donors will remain a small  
               minority.  Experts at Johns Hopkins estimate that each  
               year, 500 to 600 HIV-positive people will die under  
               circumstances that would make their organs available for  
               transplant. 



          3)SUPPORT.  AIDS Project Los Angeles, Equality California, Los  
            Angeles LGBT Center, and the Positive Women's Network are the  
            cosponsors of this bill and note that permitting HIV-positive  
            individuals to donate their organs and tissue to HIV-positive  
            patients in dire need has the potential to save the lives of  
            hundreds of HIV-positive patients each year, as well as  
            shortening the waiting list for all individuals awaiting  
            transplants.



          The University of California (UC) supports this bill stating  
            UCSF is qualified and ready to proceed with life-saving  
            transplants using HIV-positive donors, but cannot do so unless  
            California's ban is lifted.  UC notes that more than 60 UCSF  
            patients who are HIV-positive are waiting for transplants that  
            could ensure they live longer, healthier lives.
          4)PREVIOUS LEGISLATION.  AB 2356 (Skinner), Chapter 699,  
            Statutes of 2012, permits the recipient of sperm donated by  
            her sexually intimate partner for reproductive use to waive a  
            second or repeat testing of that donor for HIV, agents of  
            viral hepatitis, syphilis, and HTLV, if the recipient is  
            informed of existing donor testing requirements and signs a  
            written waiver.  Exempts physicians or tissue banks that  
            provide insemination or assisted reproductive technology  
            services from liability and disciplinary actions, as  
            specified.


          5)SUGGESTED AMENDMENT.  As currently drafted this bill clarifies  
            that the MBC will not take disciplinary action against a  







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            physician or surgeon who transplants an organ from an  
            HIV-positive donor into an HIV-positive patient.  In order to  
            clarify that physicians and surgeons performing such  
            transplants are following required standards of care this bill  
            should be amended as follows:


            (b)  Subdivision (a) shall not apply to an organ transplant  
            performed  within the standard of care  and in compliance with  
            subdivision (d) of Section 1644.5 of the Health and Safety  
            Code.


          REGISTERED SUPPORT / OPPOSITION:




          Support


          
          AIDS Project Los Angeles (cosponsor)
          Equality California (cosponsor)
          Los Angeles LGBT Center (cosponsor)
          Positive Women's Network (cosponsor)
          Attorney General Kamala D. Harris
          AIDS Healthcare Foundation
          Donate Life California
          Donor Network West
          Lifesharing
          OneLegacy
          Sierra Donor Services
          University of California


          Opposition










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          None on file.


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