BILL ANALYSIS                                                                                                                                                                                                    Ó




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          |SENATE RULES COMMITTEE            |                        SJR 26|
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                                    THIRD READING


          Bill No:  SJR 26
          Author:   De León (D), et al.
          Amended:  8/9/16  
          Vote:     21  

           SUBJECT:   Blood donations


          SOURCE:    Author


          DIGEST:          This resolution calls upon the President of the United  
          States to encourage the Secretary of the United States  
          Department of Health and Human Services (HHS) to adopt policies  
          to repeal the current discriminatory donor suitability policies  
          of the United States Food and Drug Administration (FDA)  
          regarding blood donations by men who have had sex with another  
          man and, instead, direct the FDA to develop science-based  
          policies such as criteria based on risky behavior in lieu of  
          sexual orientation.
          Senate Floor Amendments of 8/9/16 add a provision relating to  
          the FDA's blood donor deferral policies, make a technical  
          change, and add coauthors.


          ANALYSIS:   This resolution makes the following legislative  
          findings:


          1)Since 1983, the FDA, an agency under the HHS, had prohibited  
            the donation of blood by any man who has had sex with another  
            man (MSM) at any time since 1977.


          2)In December 2015, based on recommendations from the HHS  








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            Advisory Committee on Blood and Tissue Safety and  
            Availability, the FDA promulgated revised regulations to allow  
            an MSM to donate blood only if he has not been sexually active  
            for the past 12 months.  Despite these recent steps toward a  
            policy change, a double standard would still exist under the  
            policy as it is proposed to be revised because it would still  
            treat gay and bisexual men differently from heterosexual men.


          3)The FDA currently does not allow gay and bisexual men in  
            committed relationships to donate blood because, while one  
            partner may be monogamous, that individual cannot guarantee  
            that the other partner is monogamous.  The FDA does not apply  
            this same logic to heterosexual relationships, which in effect  
            discriminates against gay and bisexual men.


          4)The FDA is in the process of again reevaluating and  
            considering updating its blood donor deferral policies as new  
            scientific information becomes available, including the  
            feasibility of moving from the existing time-based deferrals  
            related to risk behaviors to alternate deferral options, such  
            as the use of individual risk assessments.


          5)The American Public Health Association has stated that no  
            specific scientific rationale is provided to justify the  
            12-month deferral policy.  The technology can identify within  
            7 to 10 days with 99.9 percent accuracy whether or not a blood  
            sample is HIV-positive, and the chance of the blood test being  
            inaccurate within the 10-day window is about 1 in 2,000,000.


          6)The Williams Institute of the University of California at Los  
            Angeles School of Law estimates that, based on the population  
            of eligible and likely donors among the MSM community, lifting  
            the federal lifetime deferral policy on blood donation by an  
            MSM would result in 4.2 million newly eligible male donors, of  
            which 360,600 would likely donate, generating 615,300  
            additional pints of blood.  Applying national estimates to the  
            California population, the Institute further estimates that  
            lifting the ban on MSM blood donations would add an additional  








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            510,000 eligible men to the current blood donor pool, of which  
            43,917 would likely donate, resulting in an additional 74,945  
            donated pints in California.


          This resolution calls upon the President of the United States to  
          encourage the Secretary of the United States Department of  
          Health and Human Services to adopt policies to repeal the  
          current discriminatory donor suitability policies of the FDA  
          regarding blood donations by men who have had sex with another  
          man and, instead, direct the FDA to develop science-based  
          policies such as criteria based on risky behavior in lieu of  
          sexual orientation.


          Background


          Technological Advances in Blood Testing.  One important factor  
          in developing blood donation deferral policies is the length of  
          the window period.  The window period is the time span between  
          when a person contracts HIV and when an HIV test can detect the  
          virus within the person's body.


          There are two main types of tests which can be used to test  
          blood for HIV:  the antibody test and the nucleic acid test  
          (NAT).  The antibody test assesses whether any HIV-targeted  
          antibodies are in a person's body.  The NAT test looks for HIV  
          in the blood.  The NAT test is what is generally used to test  
          donated blood because it has a shorter window period than the  
          antibody test does.  For most people, the window period for the  
          antibody test is between two to eight weeks with an average of  
          twenty-five days.  Meanwhile, the window period for the NAT test  
          is only nine to 11 days long.


          In part because of recent advances in testing technology, the  
          risk of transmitting HIV through blood donation has decreased to  
          1 in 1.47 million.  Since the NAT test can detect HIV in blood  
          samples within such a short span of time, this diminishes the  
          need for a yearlong ban on MSM.  Instead, the deferral period  








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          for individuals who have been deemed high-risk through a  
          risk-assessment test can be reduced to a shorter timespan.  Only  
          those who have participated in high-risk activity would be  
          deferred, and the time for which they would be deferred would be  
          based on advancements in the technology used to test donated  
          blood.


          Comments


          Why support a risk-assessment approach? According to the author:


            An individual risk-assessment approach would evaluate the  
            risk-level of behaviors of potential donors instead of banning  
            entire "at-risk" groups from donating, such as MSM.  Some  
            higher risk activities which could be screened for using this  
            model are whether or not a potential donor has engaged in  
            unprotected anal sex, had sex with a person of an unknown HIV  
            status in the past three months, or has had unprotected sex  
            with multiple partners in the past three months, amongst other  
            potentially risky behaviors.


            While this list of risky sexual acts can apply to the MSM  
            community, it also demonstrates that heterosexual donors could  
            be engaging in high-risk sexual or recreational activity which  
            puts them at a greater risk of contracting HIV.  Having  
            blanket deferral policies not only spreads a false  
            misconception that heterosexual sex is safe from HIV exposure,  
            but it also does not educate donors about what behaviors put  
            one at a greater risk.  Adding these risk assessment questions  
            further protects the blood supply because it bans high-risk  
            activities that any donor, no matter their race, sexual  
            orientation, or gender, could partake in.


          Prior Legislation


          AJR 16 (Eduardo Garcia, Resolution Chapter 194, Statutes of  








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          2015) called upon the President of the United States to  
          encourage the Secretary of the HHS to adopt policies to repeal  
          the current and upcoming discriminatory donor suitability  
          policies of the FDA regarding blood donations by men who have  
          had sex with another man and, instead, direct the FDA to develop  
          science-based policies such as criteria based on risky behavior  
          in lieu of sexual orientation.


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


          SUPPORT:   (Verified8/5/16)


          APLA Health
          Access Support Network of San Luis Obispo and Monterey Counties
          Equality California
          Project Inform


          OPPOSITION:   (Verified8/5/16)


          None received





          Prepared by:  Karen Chow / SFA / (916) 651-1520
          8/10/16 15:40:28


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