BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AJR 16| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- 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; AJR 16 Page 2 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 AJR 16 Page 3 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 AJR 16 Page 4 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 AJR 16 Page 5 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 AJR 16 Page 6 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. AJR 16 Page 7 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 **** END ****