BILL ANALYSIS Ó
SB 1408
Page 1
Date of Hearing: May 25, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
SB
1408 (Allen) - As Amended May 23, 2016
SENATE VOTE: 34-0
SUBJECT: Organ donation.
SUMMARY: Allows for the transplantation of organs into the body
of a person when the donor of the organ has human
immunodeficiency virus (HIV). Specifically, this bill:
1)Deletes the prohibition in existing law on the transplantation
of tissue from a donor with HIV and instead permits such
transplantation if the physician and surgeon performing the
transplantation has ensured that the organ from an individual
who has been found reactive to HIV may be transplanted only
into an individual who satisfies both of the following:
a) The individual has been found reactive for HIV before
receiving the organ; and,
b) The individual is either participating in clinical
research approved by an institutional review board (IRB)
pursuant to federal requirements, or if the United States
Secretary of Health and Human Services (HHS) determines
that participation in this clinical research is no longer
SB 1408
Page 2
warranted as a requirement for transplants, as specified.
2)Exempts the donation of organs from HIV positive individuals
from specified criminal penalties.
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)Provides that the Medical Board of California (MBC) will not
take disciplinary action against a licensee who performs organ
transplants in compliance with this bill.
EXISTING STATE LAW:
1)Makes it a felony punishable by imprisonment of two, four, or
six years for any person who knows that he or she has acquired
immonodeficiency syndrome (AIDS) and donates blood, tissue, or
semen to any medical center.
2)Provides that no tissues be transferred into the body of
another person by means of transplantation, unless the donor
of the tissues has been screened and found nonreactive by
laboratory tests for evidence of infection with HIV, agents of
viral hepatitis (HBV and HCV), and syphilis.
3)Allows the Department of Public Health (DPH) to adopt
regulations requiring additional screening tests of donors of
tissues when, in the opinion of DPH, the action is necessary
SB 1408
Page 3
for the protection of the public, donors, or recipients.
4)Allows a recipient of sperm to consent to the use of sperm in
assisted reproductive technologies if the sperm donor is found
reactive for HBV, HCV, syphilis, HIV, or human T-lymphotropic
(HTLV) if the sperm donor is the spouse of, partner of, or
designated donor for that recipient. (The HTLV family of
viruses are a group of human retroviruses that are known to
cause a type of cancer called adult T-cell leukemia/lymphoma).
5)Provides for an exception to the ban on transplantation of
tissue from a donor who has not been screened or tested, with
the exception of HIV and HTLV, or has been found reactive for
the infection diseases listed in 2) above, or for which DPH
has, by regulation, required additional screening tests, if
both of the following conditions are satisfied:
a) The physician performing the transplantation has
determined any one or more of the following:
i) Without the transplant the intended recipient will
most likely die during the period of time necessary to
obtain other tissue or to conduct the required tests;
ii) The intended recipient already is diagnosed with the
infectious disease for which the donor tested positive;
or,
iii) The symptoms from the infectious disease for which
the donor has tested positive will most likely not appear
during the intended recipient's likely lifespan after
transplantation with the tissue or may be treated
prophylactically if they do appear; and,
SB 1408
Page 4
b) Consent for the use of the tissue has been obtained from
the recipient, if possible, or if not possible, from a
member of the recipient's family, or the recipient's legal
guardian.
6)Establishes the Medical Practice Act which gives the MBC the
authority to license and regulate the practice of medicine.
EXISTING FEDERAL LAW establishes the HIV Organ Policy Equity
(HOPE) Act which allows for research into transplanting organs
from HIV-positive donors into HIV-positive recipients.
FISCAL EFFECT: None.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author this bill would
greatly improve the life expectancies of people living with
HIV who need organ transplants by removing California's
prohibition on donating organs while HIV-positive. The author
notes that under current state law, it is illegal for an
HIV-positive person to donate organs under any circumstance.
The author points out this law was enacted nearly 20 years ago
at a time when very little was known about HIV and AIDS, and
that recent 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 are safe. The
author continues, 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 and increasing the number
of eligible donors for HIV-positive individuals will save
lives. The author concludes that his request for expedited
consideration of this bill is based on hearing from the
SB 1408
Page 5
University of California, San Francisco (UCSF) that two
HIV-positive patients are in immediate need of the bill's
passage in order to have the surgeries performed.
2)BACKGROUND.
a) Ban on HIV-positive organ donations. According to an
article published in September of 1987 in the journal
Transfusion, an estimated 12,000 people in the United
States contracted HIV from blood transfusions between 1978
and 1984, leaving the public fearful. In response, the
U.S. passed a ban on organ collection from HIV-positive
donors in 1988. However, by the late 1990s screening
procedures for HIV had become accurate enough to eliminate
this worry, and simultaneously, the development of
effective antiretroviral drugs meant that HIV-infected
people could expect to live to a relatively old age, and
also develop the disorders that come with advancing age.
b) Research on HIV-positive organ transplantation. In 1999
UCSF transplant surgeon, Dr. Peter Stock received a $3
million grant from the state of California for a pilot
study transplanting uninfected livers and kidneys into
HIV-positive recipients. The 37 patients appeared to do
well overall and were only slightly more likely to reject
organs than HIV-negative recipients were. In 2004, Dr.
Stock and his colleagues published an article in the New
England Journal of Medicine, "Outcomes of Kidney
Transplantation in HIV-Infected Recipients." The article
discussed the results of another trial in which 150
patients underwent kidney transplants between November 2003
and June 2009. According to the article, the trial showed
that kidney transplantation appears to be a feasible
therapy in carefully selected HIV-infected patients.
SB 1408
Page 6
In 2008, a doctor in South Africa who followed Dr. Stock's
work, Elmi Muller, transplanted two HIV-positive patients
with kidneys from a single HIV-positive donor, and shortly
thereafter a young man and his mother who had been turned
down for dialysis. At that time in South Africa, patients
with HIV could not access dialysis treatments, resulting in
certain death. After much controversy Dr. Muller's work
was allowed to proceed and in 2010 she published her first
round of results showing that her patients thrived two
years after the surgery.
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 in the
US, performed by surgeons at Johns Hopkins University
Medical Center in Baltimore Maryland. The surgeons who
performed the transplants at Johns Hopkins conducted
research, published in The American Journal of
Transplantation in 2011 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 save about 1,000 lives each year.
c) Federal HOPE Act. On November 21, 2013, President Obama
signed into law the HOPE Act, which allowed for scientists
to carry out research into organ donations from one person
with HIV to another. On November 21, 2015, the Secretary
of HHS finalized the Organ Procurement and Transplantation
Network (OPTN) standards of quality for the recovery and
transplantation of organs from HIV-positive donors as
required by the HOPE Act. The Secretary also developed and
published criteria for research relating to transplantation
of organs from donors infected with HIV into individuals
who are infected with HIV, allowing the HOPE Act to take
effect. The research criteria specifies that organs from
individuals infected with HIV may be transplanted only into
individuals who were infected with HIV before receiving
such organs and are participating in clinical research
approved by an IRB.
SB 1408
Page 7
An IRB is a committee that has been formally designated to
approve, monitor, and review biomedical and behavioral
research involving humans conducted under the auspices of
the institution with which it is affiliated. IRBs are
regulated by the federal Office for Human Research
Protection, and are required to have at least five members,
including at least one member who is not otherwise
affiliated with the institution. IRBs have the authority
to approve, require modifications in, or disapprove all
research activities under its review.
Currently there are four hospitals who have met the criteria
to participate in HOPE Act transplant research: Johns
Hopkins Hospital in Baltimore, Maryland (liver and kidney
programs), Hahnemann University Hospital in Philadelphia,
Pennsylvania (liver and kidney programs), Mount Sinai
Medical Center in New York, New York (liver and kidney
programs), and UCSF Medical Center, San Francisco,
California (liver {deceased and living donor} and kidney
{deceased donor} programs).
d) Transplantation in California. California law makes it
a felony to donate blood, organs or other tissue, or semen
by a person with AIDS. With the passage of the federal
HOPE Act, UCSF is the only transplant program on the west
coast that is qualified to participate; however current
state law prohibits and penalizes such transplants.
According to UCSF, two HIV-positive patients are in dire
need of transplants and would benefit from the speedy
passage of this bill. One patient with liver failure and
cancer has a living donor ready and waiting. There are an
additional 65 HIV-positive patients waiting for kidney or
liver transplants at UCSF who would benefit if the HOPE Act
could be implemented in California.
SB 1408
Page 8
e) Other States. Sixteen other states and one territory
have laws prohibiting HIV-positive organ donations and
transplantation: Delaware, Florida, Georgia, Idaho,
Illinois, Kansas, Kentucky, Michigan, Minnesota, Missouri,
North Carolina, South Carolina, South Dakota, Tennessee,
Virginia, and the U.S. Virgin Islands, although Michigan,
Minnesota, Missouri, and Virginia have exceptions for
medical research.
f) Who gets a transplant? OPTN allocation policies must,
among other factors, be based on sound medical judgment,
seek to achieve the best use of donated organs, and shall
not be based on a candidate's place of residence or listing
except to the extent required to satisfy other factors.
For liver disease, the Model for End-Stage Liver Disease
(MELD) is a scoring system used to measure illness severity
in liver transplant candidates. The system is used in the
allocation of livers to adults and was established in
February 2002. The MELD system calculates a score based on
the clinical severity of illness that predicts the risk of
death within three months on the waiting list. Livers are
allocated to waitlisted patients with chronic liver disease
based upon this score. The sicker the patient, the higher
the score, and the more likely to receive a transplant.
However, according to Dr. Stock, patients with HIV do not
have the same survival on the wait list, they deteriorate
at a significantly higher rate and therefore the MELD
scoring system does not serve them well.
According to OPTN there are currently 123,288 people in the
U.S. waiting for a life-saving organ transplant, and every
10 minutes another person is added to that list. Each day
an average of 22 patients die waiting for an organ.
According to the United Network for Organ Sharing,
approximately 23,000 Californians are on the waiting list
for an organ transplant. Of the close to 31,000 organ
SB 1408
Page 9
transplants performed annually in the U.S., those involving
organs from HIV-infected donors will remain a small
minority. Experts at Johns Hopkins estimate that each
year, 500 to 600 HIV-positive people will die under
circumstances that would make their organs available for
transplant.
3)SUPPORT. AIDS Project Los Angeles, Equality California, Los
Angeles LGBT Center, and the Positive Women's Network are the
cosponsors of this bill and note that permitting HIV-positive
individuals to donate their organs and tissue to HIV-positive
patients in dire need has the potential to save the lives of
hundreds of HIV-positive patients each year, as well as
shortening the waiting list for all individuals awaiting
transplants.
The University of California (UC) supports this bill stating
UCSF is qualified and ready to proceed with life-saving
transplants using HIV-positive donors, but cannot do so unless
California's ban is lifted. UC notes that more than 60 UCSF
patients who are HIV-positive are waiting for transplants that
could ensure they live longer, healthier lives.
4)PREVIOUS LEGISLATION. AB 2356 (Skinner), Chapter 699,
Statutes of 2012, permits the recipient of sperm donated by
her sexually intimate partner for reproductive use to waive a
second or repeat testing of that donor for HIV, agents of
viral hepatitis, syphilis, and HTLV, if the recipient is
informed of existing donor testing requirements and signs a
written waiver. Exempts physicians or tissue banks that
provide insemination or assisted reproductive technology
services from liability and disciplinary actions, as
specified.
5)SUGGESTED AMENDMENT. As currently drafted this bill clarifies
that the MBC will not take disciplinary action against a
SB 1408
Page 10
physician or surgeon who transplants an organ from an
HIV-positive donor into an HIV-positive patient. In order to
clarify that physicians and surgeons performing such
transplants are following required standards of care this bill
should be amended as follows:
(b) Subdivision (a) shall not apply to an organ transplant
performed within the standard of care and in compliance with
subdivision (d) of Section 1644.5 of the Health and Safety
Code.
REGISTERED SUPPORT / OPPOSITION:
Support
AIDS Project Los Angeles (cosponsor)
Equality California (cosponsor)
Los Angeles LGBT Center (cosponsor)
Positive Women's Network (cosponsor)
Attorney General Kamala D. Harris
AIDS Healthcare Foundation
Donate Life California
Donor Network West
Lifesharing
OneLegacy
Sierra Donor Services
University of California
Opposition
SB 1408
Page 11
None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097