BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 1408|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
UNFINISHED BUSINESS
Bill No: SB 1408
Author: Allen (D), et al.
Amended: 5/26/16
Vote: 27 - Urgency
SENATE HEALTH COMMITTEE: 8-0, 4/27/16
AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan,
Roth, Wolk
NO VOTE RECORDED: Hall
SENATE FLOOR: 34-0, 5/16/16
AYES: Allen, Anderson, Bates, Beall, Berryhill, Block,
Cannella, De León, Fuller, Gaines, Galgiani, Glazer,
Hernandez, Hertzberg, Hill, Huff, Jackson, Lara, Leno, Leyva,
Liu, McGuire, Mitchell, Monning, Moorlach, Morrell, Nguyen,
Nielsen, Pavley, Roth, Stone, Vidak, Wieckowski, Wolk
NO VOTE RECORDED: Hall, Hancock, Hueso, Mendoza, Pan, Runner
ASSEMBLY FLOOR: Not available
SUBJECT: Tissue donation
SOURCE: AIDS Project Los Angeles
Equality California
Los Angeles LGBT Center
Positive Womens NetworkUSA
DIGEST: This bill allows for the transplantation of organs
into the body of a person, as specified, when the donor of the
organs is found reactive for human immunodeficiency virus (HIV),
and removes penalties for organ donors who are found reactive to
HIV, as specified.
SB 1408
Page 2
Assembly Amendments:
1)Narrow this bill to apply to the transplantation of organs, as
defined, between donors and recipients who are found to be
reactive for HIV.
2)Define "organ" for purposes of organ transplantation and
research purposes in compliance with the federal HIV Organ
Policy Equity (HOPE) Act, as specified.
3)Exempt from tissue bank licensure the collection, processing,
storage, or distribution of any organ, as specified, within a
single general acute care hospital, as defined, operating a
Medicare-approved transplant program.
4)Add a provision to prohibit disciplinary action by the Medical
Board of California (MBC) against a licensee who performs
organ transplants within the standard of care and in
compliance with this bill.
5)Add an urgency clause for this bill to take effect immediately
in order to provide for organ donations and transplants to
occur at the earliest opportunity.
6)Add coauthors.
SB 1408
Page 3
ANALYSIS:
Existing law:
1)Prohibits the transfer of any tissues, as defined, into the
body of another person by means of transplantation, unless the
donor of the tissues has been screened and found nonreactive
for evidence of infection with HIV, agents of viral hepatitis
(HBV and HCV), human T lymphotropic virus (HTLV), and
syphilis, except as provided.
2)Authorizes the transplantation of tissue from a donor who has
not been tested for specified infectious diseases or, with the
exception of HIV and HTLV, has been found reactive, if
specified conditions are satisfied, including obtaining
consent from an intended recipient or the recipient's family.
Defines "family" as a spouse, adult son or daughter, either
parent, adult brother or sister, or grandparent.
This bill:
1)Allows for the transplantation of organs into the body of a
person who is found to be reactive for HIV when the donor of
the organs is also found reactive for HIV and both of the
following conditions are satisfied:
a) The individual receiving the organs has been found
reactive for HIV before receiving the organ.
b) The individual is either participating in clinical
research approved by an institutional review board under
the criteria, standards, and regulations described in
subsections (a) and (b) of Section 274f-5 of Title 42 of
the United States Code (USC), or, if the United States
SB 1408
Page 4
Secretary of Health and Human Services determines under
subsection (c) of Section 274f-5 of Title 42 of the USC
that participation in this clinical research is no longer
warranted as a requirement for transplants, the individual
is receiving the transplant under the standards and
regulations under subsection (c) of Section 274f-5 of Title
42 of the USC, which requires the Secretary to, among other
things, review the results of scientific research in
conjunction with the Organ Procurement and Transplantation
Network to determine whether the results warrant revision
of the standards of quality.
2)Removes specified penalties for donors included in 1) above
and sperm donors, as specified, for the donation of blood or
tissue by a person who knows that he or she has been found
reactive for HIV, or for a person afflicted with any
contagious, infectious, or communicable disease who willfully
exposes himself or herself to another person.
3)Defines "organ," for purposes of this bill, as a human kidney,
liver, heart, lung, pancreas, or intestine (including the
esophagus, stomach, small or large intestine, or any portion
of the gastrointestinal tract), or vascularized composite
allograft, and associated blood vessels recovered from an
organ donor during the recovery of such organ.
4)Exempts from tissue bank licensure the collection, processing,
storage, or distribution of any organ, as specified, within a
single general acute care hospital, as defined, operating a
Medicare-approved transplant program.
5)Prohibits disciplinary action by the MBC against a licensee
who performs organ transplants within the standard of care and
in compliance with this bill.
6)Provides that this bill is an urgency statute in order to
provide for organ donations and transplants to occur at the
SB 1408
Page 5
earliest opportunity.
Background
On November 21, 2013, President Obama issued a statement that
announced he signed the bipartisan-supported HOPE Act, which
allowed for scientists to carry out research into organ
donations from one person with HIV to another. As noted in the
statement, such organ transplants were deemed illegal for
decades. However, with growing effective treatments for HIV and
by signing the HOPE Act, successful life-saving organ donations
for people living with HIV could eventually be realized. On
November 22, 2013, Donate Life California issued a statement
applauding the President's signing of the HOPE Act, stating that
the change in policy had the potential to save 1,000
HIV-infected transplant patients each year, as well as
shortening the list for uninfected people awaiting transplants.
A March 30, 2016, article in the Los Angeles Times announced the
first organ transplantation from a deceased HIV-positive donor
to two HIV-positive recipients, performed by surgeons at Johns
Hopkins University Medical Center. Physicians involved with the
transplantation believe that many HIV-infected donors are likely
healthy enough to donate an organ without great risk to their
health. Also noted in the article is the expectation that each
year 500 to 600 HIV-positive people will die under circumstances
that would make their organs available for transplant, which has
the potential to make hundreds and potentially thousands of
transplantable organs available each year to HIV-infected people
with end-stage diseases of the kidneys, heart, liver, and lungs.
Currently there are four hospitals who have met the criteria to
participate in HOPE Act transplant research: Johns Hopkins
Hospital in Baltimore, MD (liver and kidney programs); Hahnemann
University Hospital in Philadelphia, PA (liver and kidney
programs); Mount Sinai Medical Center in New York, NY (liver and
kidney programs); and UCSF Medical Center, San Francisco, CA
(liver [deceased and living donor] and kidney [deceased donor]
programs).
SB 1408
Page 6
Comments
Author's statement. According to the author, this bill will
greatly improve the life expectancies of people living with HIV
who need organ or tissue transplants by removing California's
prohibition on donating organs or tissue while HIV-positive.
Under current state law, it is illegal for an HIV-positive
person to donate organs or tissues under any circumstance. This
existing law was enacted nearly 20 years ago at a time when very
little was known about HIV and AIDS. Research made possible by
the passage of the federal HOPE Act of 2013 found that organ
donations from HIV-positive donors to HIV-positive recipients do
not have a detrimental effect. Major advances in the treatment
of HIV and AIDS mean that HIV-positive individuals are living
longer, and like other older Americans, they too are developing
medical conditions that require organ transplants. However, the
number of individuals in need of organ transplants far exceeds
the availability of healthy organs. Increasing the number of
eligible organ and tissue donors for HIV-positive individuals
will save lives.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:NoLocal: No
SUPPORT: (Verified 5/26/16)
AIDS Project Los Angeles (co-source)
Equality California (co-source)
Los Angeles LGBT Center (co-source)
Positive Women's Network-USA (co-source)
Access Support Network of San Luis Obispo and Monterey Counties
AIDS Healthcare Foundation
American Civil Liberties Union of California
Familia: Trans Queer Liberation Movement
Health Officers Association of California
Lambda Legal
Law Foundation of Silicon Valley
San Francisco AIDS Foundation
Two individuals
SB 1408
Page 7
OPPOSITION: (Verified5/26/16)
None received
ARGUMENTS IN SUPPORT: The sponsors and other supporters argue
that this bill will bring state law into conformity with federal
law, ending a policy that was enacted at a time when very little
was known about HIV and AIDS. Supporters argue that with
advances in HIV understanding and treatment, HIV-positive
individuals are living longer and developing medical conditions
later in life for which organ transplants are the standard of
care treatment. Supporters state that this bill will help
alleviate waiting times on donor lists for all people awaiting
organ transplants, and that studies have shown that transplants
from one HIV-positive person to another do not have a
detrimental effect nor negatively affect patient outcomes.
Prepared by:Reyes Diaz / HEALTH / (916) 651-4111
5/27/16 9:35:26
**** END ****