BILL ANALYSIS
SB 164
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SENATE THIRD READING
SB 164 (Migden)
As Amended August 27, 2007
Majority vote
SENATE VOTE :35-1
HEALTH 13-1 JUDICIARY 7-1
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|Ayes:|Dymally, Nakanishi, Berg, |Ayes:|Jones, Evans, Feuer, |
| |De Leon, Emmerson, | |Krekorian, Laird, Levine, |
| |Hancock, Hayashi, | |Lieber |
| |Hernandez, Huff, Jones, | | |
| |Lieber, Ma, Salas | | |
| | | | |
|-----+--------------------------+-----+--------------------------|
|Nays:|Gaines |Nays:|Adams |
| | | | |
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APPROPRIATIONS 11-2
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|Ayes:|Leno, Caballero, Davis, |
| |DeSaulnier, Huffman, |
| |Karnette, Krekorian, |
| |Lieu, Ma, Nava, Solorio |
| | |
|-----+--------------------------|
|Nays:|Walters, La Malfa |
| | |
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SUMMARY : Makes changes to the Birth Defects Monitoring Program
(Program) related to the research use of prenatal blood samples
and the fees to be charged in support of the Program.
Specifically, this bill :
1)Adds "Biomedical Resources" to the name of the Program,
renaming it as the Birth Defects Monitoring and Biomedical
Resources Program.
2)Clarifies Department of Public Health (DPH) is required to
charge an additional $10 fee for prenatal screening to support
the Program.
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3)Requires DPH to collect fees from research investigators
conducting studies using prenatal blood samples, to cover DPH
and Program costs associated with data linkage, storage,
retrieval, processing, data entry, reinventory, related data
management, and shipping of prenatal blood samples, or its
components, that are based in part on protocols developed by
the California Health and Human Services Committee for the
Protection of Human Subjects (CHHS CPHS) to protect the
privacy and confidentiality of mothers and infants who donate
samples, to which DPH, the Program, and researchers are
required to adhere. Requires that these fees be deposited
into a Special Program Fund that is also created by this bill.
4)Requires researchers wanting to conduct research using
prenatal blood samples, to first receive approval from DPH and
from the CHHS CPHS and requires an approved for-profit
investigator to enter into an agreement to pay specified
amounts as a condition of accepting the sample.
5)Establishes strict procedural requirements for researchers who
also want identifying personal information for each individual
who provided a prenatal blood sample, which will be enforced
by the CHHS CPHS.
6)Requires the Program to develop blood specimen collection,
processing, storage, and disposal standards and protocols.
Requires the Program or another DPH authorized entity, to
store the prenatal blood for research purposes from all or a
statistically representative sample of prenatal blood
specimens from pregnant women who have provided a positive
consent for the use of their samples for research.
7)Establishes the Birth Defects Monitoring and Biomedical
Resources Fund to sustain the Program through the collection
of fees and allows the user fee to be adjusted to meet any
increased costs to the program.
Specifies that the funds to be used for the Program are to be
appropriated from the Special Program Fund by the Legislature.
EXISTING LAW establishes within DPH, a statewide program to
conduct prenatal testing for genetic disorders and birth
defects. Requires $10 of the fee charged to hospitals when each
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infant is born (or the parent or parents in case of a home
birth) to be used to support activities associated with prenatal
blood sample testing, storage, and research.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, this bill will have unknown Special Program Fund fee
revenues to the extent researchers access Program blood samples
and according to fee schedules established by this bill.
Assuming a fairly low demand for samples initially, the Program
could collect between $25,000 and $100,000 in Special Program
Funds annually. This estimate assumes 50 to 200 researchers per
year would request five blood samples each at a cost of $100 per
sample. Any fee revenue collected would be used to support the
Program.
COMMENTS : According to the author, this bill, sponsored by the
March of Dimes, is a companion bill to last year's SB 1555
(Speier), Chapter 484, Statutes of 2006, which, among many
maternal and child health reforms, allows the state to store
both prenatal and newborn screening samples in a state database
to be used for birth defects research. This bill directs DPH to
establish protocols that enable researchers throughout the
United States and internationally to access these blood samples
for the purpose of birth defects prevention and treatment
research. The goal is that these blood samples can be
confidentially shared with researchers worldwide to accelerate
the discovery of disease causes and develop of targeted
treatment solutions and prevention strategies-without the
unnecessary risk of inappropriate public disclosure of any
individual who has contributed a sample to the Program.
In 2006, the Institute of Medicine in the United States
Department of Health and Human Services, reported the annual
cost of premature birth to be nearly $26 billion, or over
$51,000 per infant. The Program found that tobacco smoking
during pregnancy is associated with cleft lip and palate.
Prevention strategies based on these two research findings have
resulted in savings of at least $78.5 million per year in
California. In 1995, the Program's research found that folic
acid, taken at the time of conception, prevents birth defects of
the brain.
Analysis Prepared by : M. Anne Powell / HEALTH / (916)
319-2097FN: 0002506
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