BILL ANALYSIS Ó
SJR 26
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Date of Hearing: August 30, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
SJR
26 (De León) - As Amended August 17, 2016
SENATE VOTE: 34-0
SUBJECT: Blood donations
SUMMARY: 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 (MSM) and, instead, direct
the FDA to develop science-based policies such as criteria based
on risky behavior in lieu of sexual orientation. Specifically,
this resolution:
1)Finds that since 1983 the FDA had prohibited the donation of
blood by any MSM at any time since 1977.
2)Finds that in December 2015, based on recommendations from the
HHS 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, and that despite these recent steps
toward a policy change, a double standard exists under the
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policy as revised because it still treats gay and bisexual men
differently from heterosexual men.
3)Finds that California law prohibits discrimination against
individuals on the basis of actual or perceived sex, sexual
orientation, gender identity, and gender-related appearance and
behavior. Finds that Argentina, Italy, Mexico, Poland,
Portugal, Russia, South Africa, South Korea, and Spain 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.
4)Finds that the FDA does not currently 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 and that the FDA does not apply
this same logic to heterosexual relationships, which in effect
discriminates against gay and bisexual men.
5)Finds that 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.
6)Finds that the American Public Health Association has stated
that no specific scientific rationale is provided to justify the
12-month blood donation deferral policy for gay and bisexual
men.
7)Finds that the Williams Institute of the University of
California at Los Angeles School of Law (Institute) estimates
that, based on the population of eligible and likely donors
among the MSM community, lifting the federal lifetime deferral
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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 pints of blood and applying national
estimates to the California population the Institute estimates
lifting the ban would add an additional 510,000 eligible men to
the blood donor pool, resulting in an additional 74,945 pints of
blood in California.
EXISTING LAW: 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.
FISCAL EFFECT: None.
COMMENTS:
1)PURPOSE OF THIS RESOLUTION. According to the author last year,
both houses passed a similar measure, AJR 16 (Eduardo Garcia),
Resolution Chapter 194, Statutes of 2015, on a bipartisan vote,
however, recent events and a new FDA guideline make it important
for the Legislature to go on record again on this issue. The
author states that since 1983 the FDA policy, adopted when the
scientific and medical community knew very little about human
immunodeficiency virus (HIV) transmission, was a lifetime ban on
blood donation for any men who had sex with men, however, last
year, the FDA finally reconsidered, acknowledging that the
policy was not in line with current scientific understanding and
was unnecessarily discriminatory. The author notes in spite of
overwhelming scientific evidence to the contrary, instead of an
individual "risk-assessment" approach, the FDA adopted an
arbitrary one year ban. In late July, the FDA announced that it
is officially reconsidering the blood donations policy and has
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put out a formal request for public comment. The request
specifically states that the FDA wants to ensure that the policy
reflects the most up-to-date scientific knowledge. The author
concludes that the purpose of this resolution is to put the
California Legislature on record with the FDA urging a
scientific-based, individual risk assessment policy.
2)BACKGROUND.
a) Revised Recommendations for Reducing the Risk of HIV
Transmission by Blood and Blood Products. The FDA
recommends that blood establishments defer potential donors
as follows:
i) Defer indefinitely an individual who has ever had a
positive test for HIV;
ii) Defer indefinitely an individual who has ever
exchanged sex for money or drugs;
iii) Defer for 12 months from the most recent contact any
individual who has a history of sex with a person who: has
ever had a positive test for HIV; ever exchanged sex for
money or drugs; or, ever engaged in non-prescription
injection drug use;
iv) Defer for 12 months from the most recent transfusion
any individual who has a history of receiving a
transfusion of Whole Blood or blood components donated by
another person;
v) Defer for 12 months the most recent exposure any
individual who has a history of through-the-skin contact
with the blood of another individual, such as a needle
stick or blood contact with an open wound or mucous
membrane;
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vi) Defer for 12 months from the most recent tattoo, ear
or body piercing;
vii) Defer for 12 months after completion of treatment of
any individual with a history of syphilis or gonorrhea or
with a history of diagnosis or treatment for syphilis or
gonorrhea in the past 12 months;
viii) Defer for 12 months from the most recent contact a
man who has had sex with another man during the past 12
months; and,
ix) Defer for 12 months from the most recent contact a
female who has had sex during the past 12 months with a
man who has had sex with another man in the past 12
months.
b) Technological Advances in Blood Testing. One important
factor in developing blood donation deferral policies is the
length of what is called 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
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period for the antibody test is between two to eight weeks
with an average of 25 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 one 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 for individuals who have been deemed
high-risk through a risk-assessment test can be reduced to a
shorter time span. 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.
c) Individual risk-assessment. The 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.
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d) Current FDA process for reevaluating blood donor deferral
policies. On July 26, 2016, the FDA issued a notice in the
Federal Register titled "Blood Donor Deferral Policy for
Reducing the Risk of Human Immunodeficiency Virus
Transmission by Blood and Blood Products." FDA issued a
Final Guidance in December 2015 that changed the decades-old
indefinite blood donor deferral policy regarding MSM to a
one-year deferral since the last sexual contact with another
man.
This change better aligns the deferral period with that of
other men and women engaging in behaviors that place them at
increased risk for HIV infection (e.g., those who had a
recent blood transfusion or accidental exposure to the blood
of another individual, or had other potential exposure to a
potentially blood borne disease). When this policy was
updated in 2015, the FDA promised to continue to reconsider
the donor deferral policies as new data become available.
The FDA is seeking science-based comments to the newly opened
docket on:
i) 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 assessment;
ii) The design of potential studies to evaluate the
feasibility or effectiveness of such alternative deferral
policy options; and,
iii) Other science-based comments that will help shape
future decisions.
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The public docket will be open for comments until November
25, 2016.
3)SUPPORT. Equality California (EQCA) is the sponsor of this
resolution and states that when more than 50 people were injured
in the shooting at the Pulse nightclub in Orlando in June of
this year, thousands of gay and bisexual men nationwide came
forward to donate blood to help members of their own community,
but were turned away. EQCA notes it should not have taken this
tragedy to call attention to the stigmatizing and unnecessary
FDA policy still in place, which does not reflect modern
detection methods of HIV.
AIDS Project Los Angeles points out currently medical 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 a blood
test being inaccurate within the 10-day window is approximately
one in 2 million.
4)PREVIOUS LEGISLATION. AJR 16 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.
REGISTERED SUPPORT / OPPOSITION:
Support
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Equality California (sponsor)
AIDS Project Los Angeles
AIDS Services Foundation Orange County
Opposition
None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916)
319-2097