SECTIONS 121250-121280 - California Statutes

HEALTH AND SAFETY CODE

SECTION 121250-121280

121250. The Legislature finds and declares all of the following:
(a) The rapidly spreading AIDS epidemic poses an unprecedented
major public health crisis in California, and threatens, in one way
or another, the life and health of every Californian.
(b) The best hope of stemming the spread of the AIDS virus among
the general public is the development of an AIDS vaccine to develop
an immunity to exposure.
(c) No vaccine has yet been fully developed, tested, or approved
for AIDS. An effective vaccine, especially when directed at high-risk
groups of unexposed persons, will virtually eliminate the risk of
contracting AIDS, just as the risk of contracting polio and smallpox
have been virtually eliminated by earlier vaccine development,
production, and use among the general public.
(d) Private industry today has the capability of conducting the
vaccine research, biological research, immunology, and genetic
engineering of appropriate viral components needed to formulate,
develop, produce, and test an AIDS vaccine. Whenever these and other
appropriate expertise cannot be found within a single company, the
formation of multiinstitutional research groups should be encouraged
and prioritized, as it is in the public interest to encourage efforts
toward vaccine production.
(e) It is of the highest importance and in the public interest to
maximize public protection by developing an AIDS vaccine and by
establishing high levels of immunization, initially among high-risk
populations.
(f) The continuous spread of AIDS and especially the threat of
infection spreading among population groups previously considered
low-risk demands that the highest of priorities be given to the
development of a universal immunoprophylaxis.
(g) The use of vaccines to control the spread of infectious
pathogens is recognized as one of the genuinely decisive technologies
of modern medicine. Recent advances in pharmaceutical technology
combined with better understanding of the immune process offer the
hope of an AIDS vaccine that is effective, safe, relatively
inexpensive, and relatively easy to administer.
(h) Utilization of this new science may be forestalled, however,
by problems that have recently deterred the development of vaccines
by traditional means. These problems must be resolved before the full
public health benefits of new approaches to vaccine development can
be fully and expeditiously realized.
(i) The marketplace conditions facing vaccine manufacturers and
developers today have changed considerably over the past 30 years.
Private manufacturers and developers of vaccines cannot be forced to
produce vaccines, and may choose, under the free enterprise system,
not to produce them if marketplace conditions are unfavorable.
(j) Certain market conditions are slowing and threatening to halt
the development of an AIDS vaccine. Any delay in the discovery,
testing, approval, and production of the vaccine because of these
secondary considerations may cost tens of thousands of human lives
annually, unnecessary pain and suffering for hundreds of thousands of
infected Americans, and billions of dollars in medical costs and in
lost productivity.
(k) Resource constraints in the public and private sectors and the
time required to bring vaccines to market presently limit
investments in vaccines research and development. Although
universities constitute a significant resource in AIDS research in
particular and vaccines research in general, university funding
limitations and conflicting research priorities make reliance on the
resources and expertise of the private pharmaceutical industry a
necessary supplement to public funding of AIDS research.
( l) There has been a decrease in the willingness of
pharmaceutical companies to become involved in vaccine research,
development, and manufacturing because of uncertain profitability and
perceived and actual marketplace risks and disincentives.
(m) It is clearly in the public interest to provide appropriate
and necessary incentives toward the timely development and production
of an effective and safe AIDS vaccine.
(n) The development of an AIDS vaccine provides an exceptionally
important benefit, making its availability highly desirable. However,
certain conditions may preclude that development, including the
following:
(1) There is a high cost for capital expenditures for vaccine
development (estimated to be from ten million dollars ($10,000,000)
to thirty million dollars ($30,000,000)). Testing costs of clinical
trials (twenty million dollars ($20,000,000) per vaccine, by some
estimates) are particularly burdensome, especially for smaller firms.
(2) There is an uncertain market demand for a vaccine once
development costs have been invested and FDA marketing approval has
been secured.
(o) Without state intervention to assure minimal profitability of
an AIDS vaccine, inadequate incentives may exist for the private
sector to commit resources and expertise to the accelerated
development of an AIDS vaccine.
(p) In light of the dangers inherent in the AIDS epidemic to the
general public of California, it is crucial that to the extent
possible any serious obstacles to the development of a vaccine be
removed.
(q) Because an AIDS vaccine provides an exceptionally important
public benefit, it is in the public interest to take uncommon action
to facilitate the development and production of a vaccine.
(r) It is as well in the public interest to assure fair
compensation, if necessary at public expense, to any innocent victim
who may be injured by an AIDS vaccine, as a part of implementing the
socially beneficial policy of establishing high levels of AIDS
immunization.
(s) In light of the high incidence of AIDS amongst Californians,
the California Legislature must lead our country into the 20th
century in this effort.
(t) It is therefore fitting and proper that the State of
California enact uncommon and exceptional legislation in order to
prevent the further spread of the AIDS epidemic.

121255. The Legislature further finds and declares all of the
following:
(a) Acquired immune deficiency syndrome (AIDS) is caused by the
virus human T-cell lymphotropic virus, type III (HTLV-3) that
initially cripples the body's immune system and eventually leaves the
body open to an array of lethal opportunistic infections.
(b) So far, there is no known cure for AIDS and once a person is
AIDS infected, the virus remains throughout the rest of his or her
life.
(c) The AIDS virus has a three-to-seven year incubation period,
making it one of the most difficult diseases to combat and trace.
(d) An easily administered blood test can determine whether a
person has been exposed to the AIDS virus.
(e) In 1979, when AIDS was first diagnosed in the United States,
the number of newly diagnosed victims was doubling every six to nine
months; today the number of people diagnosed with AIDS doubles each
year.
(f) Nationally, between 500,000 and 2,000,000 Americans are
estimated to have been exposed to the AIDS virus. Of those exposed,
between 25,000 and 500,000 persons (5 percent-25 percent) may be
expected to die of AIDS.
(1) Another 25,000 to 500,000 persons may be expected to develop
AIDS Related Complex (ARC). The range of illnesses these individuals
will suffer from may range from minor ailments to brain damage.
(2) The remaining majority of those exposed may never suffer its
consequences, but may carry and transmit the disease unknowingly.
(3) Some experts estimate as many as 1,000 additional people are
exposed daily.
(g) The department, in its report to the Legislature (March 1986)
estimated conservatively that over 30,000 Californians shall have
contracted AIDS by 1990, about 50 percent having succumbed. The
disease is believed to be fatal within 18 months of diagnosis. To
date, more than half the 16,000 people with AIDS in the United States
have died.
(h) The AIDS virus is transmitted primarily through sexual
contact, and also through the sharing of hypodermic needles,
contaminated blood transfusions, and during pregnancy to the fetus.
(i) While the earliest spread of the AIDS virus was primarily
among homosexuals, the virus is now found and spreading among
heterosexuals as well.
(j) Additionally, drug abusers are highly susceptible to the AIDS
virus since the drugs diminish the ability of the body's immune
system to function. Intravenous drug abusers traditionally come into
contact with the virus from sharing hypodermic needles.
(k) Persons sexually active in the heterosexual community are also
at risk. Until a vaccine is developed, the AIDS virus will cross
over from the high-risk groups to the lower risk groups. At this
time, it is not known how fast the AIDS virus will penetrate other
population groups, but it is not expected to be nearly as rapid. To
date, partners of high-risk groups (bisexual men and intravenous drug
users) are considered the main means of transmitting the AIDS virus
to the heterosexual population. Other means include pregnant women
who pass the infection on to the child and prostitutes who pass on
the infection to their clients.
( l) Of the first 9,000 AIDS cases diagnosed in the United States,
almost 1,000 were women. Fourteen percent of these women developed
AIDS through sexual contact. Recent studies have demonstrated that
the virus can be transmitted by women to their male sexual partners.
Sexual contact with an infected partner may transmit the virus and
fatally infect the partner.

121260. The Legislature further finds and declares all of the
following:
(a) The average cost per patient in the treatment of AIDS until
death is now one hundred fifty thousand dollars ($150,000). It is
estimated that total costs including health care of the first 10,000
AIDS cases in the United States totaled more than six billion three
hundred million dollars ($6,300,000,000). By 1990, according to the
department, Californians will spend almost five billion dollars
($5,000,000,000) in medical costs alone in care and treatment of
30,000 AIDS patients, with no realistic hope for their remission or
cure. This cost does not include money spent on education, research,
and lost income.
(b) To date, the costs of caring for people with AIDS related
complex (ARC) has not been officially calculated. However, it is safe
to assume the costs are substantial over time. Experts fear that the
illnesses of ARC patients, although they may not be fatal, are
severe. For example, the virus invades the brain rendering the
patients incapable of caring for themselves. It is, therefore,
plausible that a percentage of ARC patients will need to be
institutionalized.
(c) The Legislature intends by this chapter to take uncommon
action to remove the impediments to the expeditious development of an
AIDS vaccine.
(d) It is further the intent of the Legislature to provide to any
person, whose injury is proximately caused by the use of the vaccine,
except to the extent the injuries are attributable to the
comparative negligence of the claimant in the use of the vaccine, all
of the following:
(1) Compensation for related medical costs associated with the
care and treatment of the injury.
(2) Compensation for the loss of any and all earnings caused by
the injury.
(3) Compensation for pain and suffering caused by the injury,
except that in no action shall the amount of damages for noneconomic
losses exceed five hundred fifty thousand dollars ($550,000).
(e) It is further the intent of the Legislature to establish the
AIDS Clinical Trials Testing Fund that will be available to not more
than three California manufacturers of an AIDS vaccine approved by
the federal Food and Drug Administration (FDA) or the department
pursuant to Part 5 (commencing with Section 109875) of Division 104
for clinical trials with humans.
(f) The AIDS Vaccine Research and Development Advisory Committee
shall review requests from California manufacturers for funds from
the AIDS Clinical Trials Testing Fund and shall make recommendations
to the department regarding the award of funds, including the
appropriate amount of funding. The department, taking into
consideration the committee's recommendations, may allocate the funds
to the manufacturers specified in the protocol approved by the FDA
or the department pursuant to Part 5 (commencing with Section 109875)
of Division 104 for administering the clinical trials.
(g) A California manufacturer seeking the approval of the FDA,
rather than the department, for administering clinical trials of an
AIDS vaccine may apply while FDA approval is pending to the AIDS
Vaccine Research and Development Advisory Committee for the committee'
s recommendation that the manufacturer receive funds from the AIDS
Clinical Trials Testing Fund upon FDA approval.

121265. "State," as used in this chapter, has the same meaning as
set forth in Section 900.6 of the Government Code.

121270. (a) There is hereby created the AIDS Vaccine Victims
Compensation Fund.
(b) For the purposes of this section, the following definitions
apply:
(1) "AIDS vaccine" means a vaccine that (A) has been developed by
any manufacturer and (B) is approved by the FDA or the department
pursuant to Part 5 (commencing with Section 109875) of Division 104
as a safe and efficacious vaccine for the purpose of immunizing
against AIDS.
(2) "Board" means the California Victim Compensation and
Government Claims Board.
(3) "Damages for personal injuries" means the direct medical costs
for the care and treatment of injuries to any person, including a
person entitled to recover damages under Section 377 of the Code of
Civil Procedure, proximately caused by an AIDS vaccine, the loss of
earnings caused by the injuries, and the amount necessary, but not to
exceed five hundred fifty thousand dollars ($550,000), to compensate
for noneconomic losses, including pain and suffering caused by the
injuries.
(4) "Fund" means the AIDS Vaccine Victims Compensation Fund.
(c) The board shall pay from the fund, contingent entirely upon
the availability of moneys as provided in subdivision (o), damages
for personal injuries caused by an AIDS vaccine that is sold in or
delivered in California, and administered or dispersed in California
to the injured person except that no payment shall be made for any of
the following:
(1) Damages for personal injuries caused by the vaccine to the
extent that they are attributable to the comparative negligence of
the person making the claim.
(2) Damages for personal injuries in any instance when the
manufacturer has been found to be liable for the injuries in a court
of law.
(3) Damages for personal injuries due to a vaccination
administered during a clinical trial.
(d) An application for payment of damages for personal injuries
shall be made on a form prescribed by the board within one year of
the date that the injury and its cause are discovered. This
application may be required to be verified. Upon receipt, the board
may require the submission of additional information necessary to
evaluate the claim.
(e) (1) Within 45 days of the receipt of the application and the
submission of any additional information, the board shall do either
of the following:
(A) Allow the claim in whole or part.
(B) Disallow the claim.
(2) In those instances of unusual hardship to the victim, the
board may grant an emergency award to the injured person to cover
immediate needs upon agreement by the injured person to repay in the
event of a final determination denying the claim.
(3) If the claim is denied in whole or part, the victim may apply
within 60 days of denial for a hearing. The hearing shall be held
within 60 days of the request for a hearing unless the injured person
requests a later hearing.
(f) At the hearing, the injured person may be represented by
counsel and may present relevant evidence as defined in subdivision
(c) of Section 11513 of the Government Code. The board may consider
additional evidence presented by its staff. If the injured person
declines to appear at the hearing, the board may act solely upon the
application, the staff report, and other evidence that appears on the
record.
(g) The board may delegate the hearing of applications to hearing
examiners.
(h) The decision of the board shall be in writing and shall be
delivered or mailed to the injured person within 30 days of the
hearing. Upon the request by the applicant within 30 days of delivery
or mailing, the board may reconsider its decision.
(i) Judicial review of a decision shall be under Section 1094.5 of
the Code of Civil Procedure, and the court shall exercise its
independent judgment. A petition for review shall be filed as
follows:
(1) If no request for reconsideration is made, within 30 days of
personal delivery or mailing of the board's decision on the
application.
(2) If a timely request for reconsideration is filed and rejected
by the board, within 30 days of personal delivery or mailing of the
notice of rejection.
(3) If a timely request for reconsideration is filed and granted
by the board, or reconsideration is ordered by the board, within 30
days of personal delivery or mailing of the final decision on the
reconsidered application.
(j) The board shall adopt regulations to implement this section,
including those governing discovery.
(k) The fund is subrogated to any right or claim that any injured
person may have who receives compensation pursuant to this section,
or any right or claim that the person's personal representative,
legal guardian, estate, or survivor may have, against any third party
who is liable for the personal injuries caused by the AIDS vaccine,
and the fund shall be entitled to indemnity from that third party.
The fund shall also be entitled to a lien on the judgment, award, or
settlement in the amount of any payments made to the injured person.
(l) In the event that the injured person, or his or her guardian,
personal representative, estate, or survivors, or any of them, bring
an action for damages against the person or persons liable for the
injury or death giving rise to an award by the board under this
section, notice of institution of legal proceedings and notice of any
settlement shall be given to the board in Sacramento except in cases
where the board specifies that notice shall be given to the Attorney
General. All notices shall be given by the attorney employed to
bring the action for damages or by the injured person, or his or her
guardian, personal representative, estate, or survivors, if no
attorney is employed.
(m) This section is not intended to affect the right of any
individual to pursue claims against the fund and lawsuits against
manufacturers concurrently, except that the fund shall be entitled to
a lien on the judgment, award, or settlement in the amount of any
payments made to the injured party by the fund.
(n) There is hereby created the AIDS Vaccine Injury Compensation
Policy Review Task Force consisting of 14 members. The task force
shall be composed of 10 members appointed by the Governor, of which
two shall be from a list provided by the California Trial Lawyers
Association, one from the department, the Director of Finance, one
unspecified member, and one attorney with experience and expertise in
products liability and negligence defense work, two representing
recognized groups that represent victims of vaccine induced injuries
or AIDS victims, or both, and two representing manufacturers actively
engaged in developing an AIDS vaccine. In addition four Members of
the Legislature or their designees shall be appointed to the task
force, two of which shall be appointed by the Speaker of the Assembly
and two of which shall be appointed by the Senate Committee on
Rules. The chairperson of the task force shall be appointed by the
Governor from the membership of the task force. The task force shall
study and make recommendations on the legislative implementation of
the fund created by subdivision (a). These recommendations shall at
least address the following issues:
(1) The process by which victims are to be compensated through the
fund.
(2) The procedures by which the fund will operate and the
governance of the fund.
(3) The method by which manufacturers are to pay into the fund and
the amount of that payment.
(4) The procedural relationship between a potential victim's claim
through the fund and a court claim made against the manufacturer.
(5) Other issues deemed appropriate by the task force.
The task force shall make its recommendations to the Legislature
on or before June 30, 1987.
(o) The fund shall be funded wholly by a surcharge on the sale of
an AIDS vaccine, that has been approved by the FDA, or by the
department pursuant to Part 5 (commencing with Section 109875) of
Division 104, in California in an amount to be determined by the
department. The surcharge shall be levied on the sale of each unit of
the vaccine sold or delivered, administered, or dispensed in
California. The appropriate amount of the surcharge shall be studied
by the AIDS Vaccine Injury Compensation Policy Review Task Force,
which shall recommend the appropriate amount as part of its report,
with the amount of the surcharge not to exceed ten dollars ($10) per
unit of vaccine. Expenditures of the task force shall be made at the
discretion of the Director of Finance or the director's designee.
(p) For purposes of this section, claims against the fund are
contingent upon the existing resources of the fund as provided in
subdivision (o), and in no case shall the state be liable for any
claims in excess of the resources in the fund.

121275. (a) Because the development of a vaccine now costs
somewhere between twenty million dollars ($20,000,000) and forty
million dollars ($40,000,000), and because the last vaccine produced
and marketed did not sell well, vaccine manufacturers are hesitant to
proceed to invest their resources in a risky venture. It is,
therefore, in the public health interest of California to assure that
manufacturers proceed to develop this vaccine and protect
Californians against this dread disease and protect the State of
California against the enormous fiscal costs of treatment for persons
getting AIDS. It is a sound and worthwhile investment to provide a
guarantee of a market to lessen the risk of loss and assure the
development of an AIDS vaccine.
It is anticipated that this AIDS vaccine will consist of a
three-unit series. The State of California is willing to guarantee
that at least 175,000 persons will be vaccinated, and to guarantee
the purchase, within three years after the FDA or the department
pursuant to Part 5 (commencing with Section 109875) of Division 104
approves marketing of an AIDS vaccine, of at least 500,000 units, at
a cost of no more than twenty dollars ($20) per dosage, by all
companies, anywhere in the United States.
Therefore, the State of California, by moneys to be appropriated
later through the Budget Act, commits itself to purchasing, at the
end of three years after the FDA or the department pursuant to Part 5
(commencing with Section 109875) of Division 104 has approved the
marketing on a competitive basis, at not more than twenty dollars
($20) per dosage, the difference between 500,000 units and the actual
amount sold, delivered, administered, or dispensed by all companies
throughout the United States, including units sold to or reimbursed
by Medi-Cal, Medicare, or other public programs, providing that fewer
than 500,000 units are sold, delivered, administered, or dispensed.
(b) The AIDS Vaccine Guaranteed Purchase Fund is hereby
established and shall be administered by the department, which may
develop necessary regulations to carry out the purpose of this
section.
(c) The department may carry out this section, when those funds
are appropriated through the State Budget. In determining which
vaccine shall be purchased by the state from among those
manufacturers selling or distributing in California, an AIDS vaccine
approved by the FDA or the department pursuant to Part 5 (commencing
with Section 109875) of Division 104, the department shall take into
consideration at least all of the following factors:
(1) The length of time each AIDS vaccine has been in the
marketplace in California.
(2) Each AIDS vaccine's history of efficacy since approval by the
FDA or the department.
(3) Each AIDS vaccine's history of side effects experienced by
previous recipients of the vaccine.
(4) The relative cost of each competing manufacturer's AIDS
vaccine.

121280. (a) In enacting this section the Legislature finds and
declares:
(1) It is in the interest of the people of California to develop a
vaccine that will prevent the infection of HIV, the agent that
causes AIDS.
(2) In order to develop that vaccine, a prototype vaccine must be
first given to HIV-negative people to determine the following:
(A) The vaccine's toxicity.
(B) The vaccine's efficacy.
(C) The human immune response to the vaccine.
(3) These studies are currently impossible because vaccine
manufacturers fear that, by inoculating HIV-negative individuals with
an experimental vaccine, they will elicit a positive immune response
as measured by an enzyme linked immunosorbent assay (ELISA), western
blot or other federal Food and Drug Administration approved in vitro
diagnostic test, thereby placing vaccine volunteers at risk for
denial of health or life insurance by insurance carriers as a
consequence of their participation.
(4) Insurers need a reliable mechanism by which they can verify
the insurability of a vaccine trial participant.
(b) No health care service plan, disability insurer, nonprofit
hospital service plan, self-insured employee welfare benefit plan, or
life insurer may withhold any settlement or coverage of an
individual solely because of his or her participation in an AIDS/HIV
vaccine clinical trial studied under an investigational new drug
application effective pursuant to Section 312 of Title 21 of the Code
of Federal Regulations, or Section 111595.
(c) The sponsor of any such trial shall make a confidential
certificate with all the necessary particulars, which shall be
determined by the department, for each enrollee and then submit it to
the department, which shall endorse it and return it to the vaccine
recipient. A copy of this confidential certificate shall be kept on
file indefinitely by both the study sponsor and the department.
(d) Release of a confidential certificate shall be by written
authorization of the enrollee named in the certificate. If the
enrollee is unable to provide the written authorization, a person
designated in the certificate by the enrollee may provide the written
authorization. The written authorization shall include the name of
the person or entity to whom the disclosure would be made.
Disclosure as used in this section means to release, transfer,
disseminate or otherwise communicate all or part of any confidential
certificate orally, in writing, or by electronic means to any person
or entity.