121300-121335

HEALTH AND SAFETY CODE
SECTION 121300-121335




121300.  The Legislature finds and declares all of the following:
   (a) Nearly 90 percent of the cases of pediatric AIDS in the United
States occur as a result of maternal infant transmission.
   (b) It is estimated that from 13 to 45 percent of infants born to
HIV-infected mothers will acquire HIV either in utero, during
delivery, or postpartum.
   (c) In 1990, the number of cases of AIDS in women in the United
States increased by 34 percent compared to an increase of 18 percent
in men. As a consequence of this increased dissemination of HIV in
women, there has been a concomitant increase in the number of HIV
infected infants.
   (d) Approximately 6,000 children were born to HIV-infected women
in the United States in 1990. This resulted in 1,500 to 2,000 newly
infected infants. Internationally, it is estimated that one million
children acquired HIV through maternal transmission in 1990.
   (e) HIV infection that is transmitted maternally progresses more
rapidly than HIV infection in adults, with most infants developing
advanced symptoms of infection within 18 months. Costs for care of
infants infected with HIV have been estimated to be comparable or
higher than the cost of treating HIV-related illness in adults.
Currently, limited data exists for the costs of treating HIV-infected
children. A recent estimate for those costs is as follows:
   (1) For the mean lifetime hospital costs per child: ninety
thousand dollars ($90,000).
   (2) For the mean annual cost per child hospitalized all year: two
hundred nineteen thousand dollars ($219,000). A significant portion
of pediatric hospital costs may be due to a prolonged hospitalization
because of the lack of foster homes for children.
   (3) For the estimated annual medicaid cost: eighteen thousand
dollars ($18,000) to forty-two thousand dollars ($42,000).
   (4) In comparison, recent estimates of the national cost of
treating an adult with HIV and without AIDS is five thousand dollars
($5,000) per year and the average cost of treating an adult person
with AIDS is thirty-two thousand dollars ($32,000) per year of that
twenty-four thousand dollars ($24,000) is inpatient costs and eight
thousand dollars ($8,000) for other services.
   (f) AIDS vaccines are now available for testing in FDA-approved
clinical trials in HIV-infected pregnant women for the purpose of
protecting against HIV transmission from mother to child.
   (g) Manufacturers are hesitant to conduct these trials because of
the combined threat of liability and the limited market to reimburse
the research and clinical trial investment.
   (h) The California Legislature wishes to encourage FDA-approved
AIDS vaccine clinical trials to protect against maternal HIV
transmission from mother to child, that may also provide a
therapeutic effect in the HIV-infected mother. It is appropriate to
mandate that grants be made to encourage qualified manufacturers to
conduct these trials for the benefit of California citizens.




121305.  For the purposes of this chapter, the following definitions
apply:
   (a) "AIDS" means acquired immune deficiency syndrome.
   (b) "An HIV-positive individual" means an individual who is
infected with the AIDS virus.
   (c) "Committee" means the AIDS Vaccine Research and Development
Advisory Committee.
   (d) "Grant award" means an AIDS Vaccine Clinical Trial Grant Award
for the Prevention of Maternal Transmission of HIV Infection.
   (e) "AIDS vaccine," for the purposes of this chapter, means a
vaccine that has been developed by a manufacturer and is being tested
and administered for the purposes of determining whether
immunization of HIV-infected pregnant women will protect against
maternal transmission of the AIDS virus. Clinical trials must be
conducted under an investigational new drug (IND) application on file
with the federal Food and Drug Administration (FDA).
   (f) "Research subject" means a person who is administered an AIDS
vaccine, or a fetus of a woman administered an AIDS vaccine, or a
child born to a woman administered an AIDS vaccine during pregnancy.
   (g) "Researcher" means a person employed by or affiliated with a
manufacturer or a research institution, who participates in the
development or testing or administration of an AIDS vaccine, or who
is involved in the diagnosis and treatment of a research subject.




121310.  A manufacturer, research institution, or researcher shall,
prior to the administration of an AIDS vaccine to a research subject,
obtain that woman's informed consent, that shall comply with all
applicable statutes and regulations.
   (a) The informed consent shall contain a statement that
significant new findings developed during the course of the research
that may relate to the subject's willingness to continue
participation will be provided to the subject.
   (b) A copy of the informed consent shall be maintained with the
woman's medical records.



121315.  (a) A manufacturer, research institution, or researcher
shall not be strictly liable for personal injury or wrongful death
resulting from the administration of any AIDS vaccine to a research
subject participating in the clinical trials described in this
chapter.
   (b) It is the intent of the Legislature in enacting this section
to confer upon manufacturers, research institutions, and researchers
participating in the clinical trials described in this chapter an
immunity from liability to the same extent as conferred upon
specified pharmaceutical manufacturers under Brown v. Superior Court,
44 Cal. 3d 1049.
   (c) No immunity shall be conferred to the extent that the injury
or death was caused by the negligence, gross negligence, or reckless,
willful, or wanton misconduct of the manufacturer, research
institution, or researcher or the manufacturer, research institution,
or the researcher has failed to comply with Section 121310.
   (d) The immunity provided by this section shall not apply to a
manufacturer, research institution, or researcher who intentionally
provided false information to the FDA in connection with an IND
application.
   (e) Notwithstanding the immunity provided by this section, nothing
in this section shall be construed to affect the inapplicability or
applicability of the holding in Brown v. Superior Court, 44 Cal. 3d
1049 to other situations involving the same or similar conduct.



121320.  No person shall be denied the opportunity to be a research
subject because of the inability to pay for medical treatment.



121325.  There is hereby created the AIDS Vaccine Clinical Trial
Grant Award for the Prevention of Maternal Transmission of HIV
Infection. Moneys within the AIDS Clinical Trials Testing Fund,
established in accordance with Section 121260, shall, upon
appropriation by the Legislature, be available to the department for
the purposes of this chapter, that shall include a one-time amount of
sixty thousand dollars ($60,000) for the department to develop and
process the request for proposal as specified in subdivision (a).
Grant awards shall be made available to not more than three
manufacturers of an AIDS vaccine approved by the FDA for clinical
trials in HIV-positive pregnant women. The purpose is to expedite the
completion of an AIDS vaccine to prevent maternal transmission of
HIV. The funds are to be used for FDA approved clinical trials.
   (a) The department shall issue a request for proposal (RFP) for
the clinical trials of an AIDS vaccine to prevent maternal
transmission of HIV infection.
   (1) The RFP shall be based on the criteria provided in subdivision
(d).
   (2) Upon issuing the RFP, the department shall publish this fact
along with the deadline for grant proposals in the newspapers with
the greatest circulation in the major cities of the state, as
determined by the department. Additionally, upon issuing the RFP, the
same information shall be transmitted to the Secretary of the Senate
and the Chief Clerk of the Assembly for publishing in the respective
journals of each house of the Legislature.
   (b) Any manufacturer may submit a proposal for the grant award in
the response to the RFP issued by the department.
   (c) The department, taking into consideration the committee's
recommendations, shall, for purposes of this chapter, award grants to
no more than three California manufacturers after receiving the
committee's recommendations.
   (d) The department, making use of an RFP, shall include a clear
description of the criteria to be used to select the projects that
will receive funding pursuant to this chapter. The committee shall
make recommendations to the department regarding the content of the
RFP. The criteria shall include, but not be limited to, the
following:
   (1) The potential of the grant recipient to develop a vaccine for
the prevention of maternal transmission of HIV infection.
   (2) The financial, technical, and managerial commitment of the
grant recipient to the development of the vaccine.
   (3) The commitment of the grant recipient to agree to provide
medical treatment, either directly or through reasonable health
insurance coverage, to the participant for any injury caused by the
AIDS vaccine in the clinical trial. This agreement shall also be
included as part of the participant's informed consent pursuant to
Section 121305.
   (e) Grant awards may be made without limitation on the amount of
funding from the AIDS Clinical Trials Testing Fund that may be
allocated to a single manufacturer, provided that the committee has
determined that the grant award is in the public interest.



121330.  If a manufacturer that is a grant recipient sells,
delivers, or distributes an AIDS vaccine that has received FDA
approval for use by the general population and that was developed in
whole or in part using a grant awarded pursuant to this chapter, the
State of California shall be reimbursed for the grant as provided in
this section.
   Until the total amount of the grant is repaid, repayments in the
amount of one dollar ($1) per dose from the sale of the AIDS vaccine
shall be deposited by the grant recipient into the General Fund. Upon
payment in full of the grant amount into the General Fund, a royalty
on the sale of the vaccine from the grant recipient shall be
deposited into the General Fund. The percentage amount of the royalty
shall be negotiated at the time of the grant award.




121335.  It is the intent of the Legislature for the department to
make every effort possible to insure a comprehensive and diverse
expert representation on the committee. It is the intent of the
Legislature to ensure that expert members of the committee include,
but are not limited to, ethnic minorities and women.