BILL ANALYSIS                                                                                                                                                                                                    Ó






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          |SENATE RULES COMMITTEE            |                        AJR 16|
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                                   THIRD READING 


          Bill No:  AJR 16
          Author:   Eduardo Garcia (D), et al.
          VersionAmended:6/25/15 in Assembly
          Vote:     21  

           SENATE HEALTH COMMITTEE:  7-2, 7/15/15
           AYES:  Hernandez, Hall, Mitchell, Monning, Pan, Roth, Wolk
           NOES:  Nguyen, Nielsen

           ASSEMBLY FLOOR:  62-6, 6/25/15 - See last page for vote

           SUBJECT:   Blood donations


          SOURCE:    Equality California

          DIGEST:   This resolution requests the President and the U.S.  
          Department of Health and Human Services to adopt science-based  
          policies that repeal current U.S. Food and Drug Administration  
          policies that prohibit men who have had sex with men from  
          donating blood.

          ANALYSIS: 
          
          Existing law:

          1)Pursuant to U.S. Food and Drug Administration (FDA) blood  
            donation policies regarding screening and deferral of  
            potential donors:

             a)   Requires that potential donors are informed about the  
               risk of transmitting infectious diseases through blood  
               donation;








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             b)   Requires potential donors to be asked screening  
               questions about their health status, health behaviors, and  
               other factors that are associated with an increased risk of  
               being infected with transmissible disease, in order to help  
               persons identify themselves as potentially at higher risk  
               for transmitting infectious diseases and defer from  
               donating on their own accord, rather than unknowingly  
               donating blood that may be infected;

             c)   Requires that the minimum information presented to  
               potential donors at every visit indicate clearly that  
               persons meeting certain criteria should not donate blood,  
               including, but not limited to, men who have had sex with  
               other men (MSM) even one time since 1977; and

             d)   Prohibits blood donation establishments from allowing  
               MSM, even one time since 1977, to donate blood, even when  
               such a donor does not wish to self-defer.  

          2)Provides that all persons within the jurisdiction of this  
            state are free and equal. Prohibits discrimination based on  
            sex, race, color, religion, ancestry, national origin,  
            disability, medical condition, marital status, or sexual  
            orientation with respect to accommodations, advantages,  
            facilities, privileges, or services in all business  
            establishments of every kind.

          This resolution:

           1) Finds that, since 1983, the FDA has prohibited blood  
             donation by MSM at any time since 1977.

           2) Finds that in December 2014, based on recommendations from  
             the U.S. Department of Health and Human Services (USHHS)  
             Advisory Committee on Blood and Tissue Safety and  
             Availability, the FDA announced its intent to promulgate  
             regulations to allow MSM to donate blood only if he has not  
             been sexually active for the past 12 months. Declares that a  
             double standard still exits under this proposed policy  
             because it still treats gay and bisexual men differently from  
             heterosexual men.

           3) Declares that California law prohibits discrimination  







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             against individuals on the basis of actual or perceived sex,  
             sexual orientation, gender identity, and gender-related  
             appearance and behavior.

           4) Finds that Spain, Italy, Russia, Mexico, and Portugal have  
             adopted blood donor policies that measure risk against a set  
             of behaviors, sexual and otherwise, rather than the sex of a  
             person's sexual partner or partners.

           5) Finds that the FDA 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. Declares that the FDA  
             does not apply this same logic to heterosexual relationships,  
             which in effect discriminates against gay and bisexual men.

           6) Finds that a 12-month deferral policy for gay and bisexual  
             men to donate blood is overly stringent given scientific  
             evidence, advanced testing methods, and safety and quality  
             control measures in place within the different FDA-qualified  
             blood donating centers. Declares that technology can identify  
             within seven to 10 days with 99.9% accuracy whether or not a  
             blood sample is HIV-positive, and the chance of the blood  
             testing being inaccurate within the 10-day window is about 1  
             in 2,000,000.

           7) Finds that the General Social Survey conducted by NORC at  
             the University of Chicago estimates that 8.5% of men in the  
             U.S. have had at least one male sexual partner since 18 years  
             of age; 4.1% report at least one male sexual partner in the  
             last five years; and 3.8% report a male sex partner in the  
             last 12 months.

           8) Finds that an estimated 45.4% of men (or 54 million) in the  
             U.S. are eligible to donate blood, but only 8.7% actually do.  
             Declares that there are 15.7 million donations of blood per  
             year made by 9.2 million donors, yielding approximately 1.7  
             donations per donor.

           9) Finds that the Williams Institute (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 donations by an MSM would  







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             result in 4.2 million newly eligible male donors, of which  
             360,600 would likely donate, generating 615,300 additional  
             pints of blood.

           10)Finds that applying national estimates to the California  
             population, the Institute further estimates that lifting the  
             ban on MSM blood donations would add an additional 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.  

           11)Calls upon the President of the U.S. to encourage the USHHS  
             Secretary to adopt policies to repeal the current and  
             upcoming discriminatory donor suitability policies of the FDA  
             regarding blood donations by MSM and, instead, direct the FDA  
             to develop science-based policies, such as criteria based on  
             risky behavior in lieu of sexual orientation.

           12)Requests the Chief Clerk of the Assembly to transmit copies  
             of this resolution to the President and the Vice President of  
             the U.S., to the USHHS Secretary, to the Speaker of the House  
             of Representatives, to the Majority Leader of the Senate, and  
             to each Senator and Representative from California in the  
             U.S. Congress.

          Comments
          
          1)Author's statement.  According to the author, this measure  
            would call upon the President of the U.S. to encourage the  
            USHHS Secretary to adopt policies to repeal the current and  
            upcoming discriminatory donor suitability policies of the FDA  
            regarding blood donations by MSM and, instead, direct the FDA  
            to develop science-based policies, such as criteria based on  
            risky behavior in lieu of sexual orientation.

          2)Background.  Blood banks now test donated blood by both  
            serologic (antibody) testing and the more recently developed  
            nucleic acid test method before the blood can be used in a  
            transfusion or contaminate other blood supplies. Both methods  
            allow detection of HIV-infected donors between 10 and 21 days  
            after exposure. When blood testing may not be able to detect  
            low levels of HIV is known as the critical window period. 

            According to the FDA, any man who has had sex with another man  







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            even once since 1977 has been deferred as a blood donor  
            because, as a group, MSM are at increased risk for HIV,  
            hepatitis B, and other infections that can be transmitted by  
            blood transfusion. The year 1977 was chosen because it marked  
            the beginning of the AIDS epidemic in the U.S.  Although the  
            FDA policy uses the term "deferral," the policy in effect acts  
            to prohibit, in all cases, any man who has had sex with  
            another man even once since 1977 from donating blood. The FDA  
            has had a donor deferral policy for MSM since 1983, when the  
            risk of AIDS from transfusion was first recognized. 

            On April 23, 1992, the FDA issued a memorandum to all blood  
            donation establishments, titled "Revised Recommendations for  
            the Prevention of HIV Transmission by Blood and Blood  
            Products," to those in the regulated community to provide  
            guidance and more detailed instruction on how to comply with  
            federal law and regulations. The specific rules in such a  
            memorandum can and often do have the effect of agency policy.  
            In this case, the current FDA policy deferring blood donation  
            by MSM traces back to that 1992 memorandum and has remained in  
            effect ever since. The FDA has stated that it would change its  
            MSM deferral policy only if supported by scientific data  
            showing that a change in policy would not present a  
            significant and preventable risk to blood recipients. 

          3)Recent Announcement of Proposed Change.  On December 23, 2014,  
            the FDA announced that it would recommend changing the donor  
            deferral period for MSM from a lifetime deferral to a period  
            of one year after last sexual contact, and would issue a draft  
            guidance recommending this proposed change in 2015, including  
            an opportunity for public comment.  In the announcement, the  
            FDA states that over the past several years, in collaboration  
            with other government agencies, the FDA has carefully examined  
            and considered the available scientific evidence relevant to  
            its blood donor deferral policy for MSM, including the results  
            of several recently completed scientific studies and recent  
            epidemiologic data. Following this review, and taking into  
            account the recommendations of advisory committees to the  
            USHHS and the FDA, the agency will take the necessary steps to  
            recommend a change to the blood donor deferral period for MSM  
            from indefinite deferral to one year since the last sexual  
            contact. This recommended change is consistent with the  
            recommendation of an independent expert advisory panel of the  
            HHS Advisory Committee on Blood and Tissue Safety and  







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            Availability, and will align the deferral period with that of  
            other men and women at increased risk for HIV infection. 

            In May 2015, the FDA issued its draft guidance document,  
            titled "Revised Recommendations for Reducing the Risk of HIV  
            Transmission by Blood and Blood Products."  The document  
            contains nonbinding recommendations to entities that collect  
            blood donations, including the recommendation of deferral for  
            12 months after the most recent contact of any MSM during the  
            past 12 months, or any female who has had sex during the past  
            12 months with an MSM.
          
          FISCAL EFFECT:   Appropriation:    No          Fiscal  
          Com.:NoLocal:    No


          SUPPORT:   (Verified8/7/15)


          Equality California
          City of West Hollywood



          OPPOSITION:   (Verified8/7/15)


          None received


          ARGUMENTS IN SUPPORT:     Equality California (EQCA), the  
          sponsor, argues that medical organizations like the American Red  
          Cross, the American Association for Blood Banks, America's Blood  
          Centers, and the American Medical Association have called for a  
          reevaluation and/or repeal of FDA's existing and proposed new  
          policy, citing its excessively broad nature and advances in  
          blood testing. EQCA also argues that the FDA policy creates  
          stigma without any justifiable public health imperative and  
          results in negative attitudes to blood donor eligibility  
          criteria and in blood collection facilities. EQCA further states  
          that the proposed new FDA blood donor guidelines continue to  
          discriminate against MSM.









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          ASSEMBLY FLOOR:  62-6, 6/25/15
          AYES:  Achadjian, Alejo, Baker, Bloom, Bonilla, Bonta, Brown,  
            Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu,  
            Cooley, Cooper, Dababneh, Daly, Dodd, Eggman, Frazier,  
            Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez,  
            Gonzalez, Gordon, Gray, Hadley, Roger Hernández, Holden,  
            Irwin, Jones-Sawyer, Lackey, Levine, Linder, Lopez, Low,  
            Maienschein, Mayes, McCarty, Medina, Mullin, Nazarian,  
            O'Donnell, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez,  
            Salas, Santiago, Mark Stone, Thurmond, Ting, Weber, Wilk,  
            Williams, Wood, Atkins
          NOES:  Brough, Beth Gaines, Grove, Harper, Wagner, Waldron
          NO VOTE RECORDED:  Travis Allen, Bigelow, Dahle, Gallagher,  
            Jones, Kim, Mathis, Melendez, Obernolte, Olsen, Patterson,  
            Steinorth

          Prepared by:Reyes Diaz / HEALTH / 
          8/13/15 13:24:38


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