Chapter 14. Acquired Immune Deficiency Syndrome (aids) Clinical Trial Grant Award For The Prevention Of Maternal Transmission Of Human Immunodeficiency Virus (hiv) Infection of California Health And Safety Code >> Division 105. >> Part 4. >> Chapter 14.

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.

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.

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.

(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.

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

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.

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.

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.