BILL ANALYSIS Ó
SJR 26
Page 1
SENATE THIRD READING
SJR
26 (De León)
As Amended August 17, 2016
Majority vote
SENATE VOTE: 34-0
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|Committee |Votes |Ayes |Noes |
|----------------+------+----------------------+---------------------|
|Health |13-0 |Wood, Maienschein, | |
| | |Bonilla, Campos, | |
| | |Chiu, Lackey, | |
| | |Nazarian, Olsen, | |
| | |Ridley-Thomas, | |
| | |Rodriguez, Santiago, | |
| | |Thurmond, Gordon | |
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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:
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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
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
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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
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: 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
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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
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.
1)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:
a) Defer indefinitely an individual who has ever had a
positive test for HIV;
b) Defer indefinitely an individual who has ever exchanged
sex for money or drugs;
c) 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;
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d) 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;
e) 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;
f) Defer for 12 months from the most recent tattoo, ear or
body piercing;
g) 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;
h) Defer for 12 months from the most recent contact a man
who has had sex with another man during the past 12 months;
and,
i) 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.
2)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.
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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 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.
3)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
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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.
4)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,
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iii) Other science-based comments that will help shape future
decisions.
The public docket will be open for comments until November 25,
2016.
Analysis Prepared by:
Lara Flynn / HEALTH / (916) 319-2097 FN:
0005005