Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.
The Legislature finds and declares all of the following:
California Health and Safety Code — §§ 121300-121335
Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.
The Legislature finds and declares all of the following:
Amended by Stats. 1997, Ch. 294, Sec. 23. Effective August 18, 1997.
For the purposes of this chapter, the following definitions apply:
Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.
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.
Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.
Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.
No person shall be denied the opportunity to be a research subject because of the inability to pay for medical treatment.
Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.
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.
Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.
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.
Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.
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.