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Section 121280 Of Chapter 13. Acquired Immune Deficiency Syndrome (aids) Immunization From California Health And Safety Code >> Division 105. >> Part 4. >> Chapter 13.
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.
(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.
