Summary and
Background
The Stem Cell Research
Enhancement Act of 2007, S. 5, would expand the number of human
embryonic stem cells eligible for federally-funded research. Scientists report
that current limitations, established by the Bush Administration in August
2001, are impeding promising research. This bill addresses this problem by
directing the Department of Health and Human Services (HHS) to conduct and
support research on stem cells derived from embryos now stored in fertility
clinics that would otherwise be destroyed.
Human embryonic stem cells
were first isolated in 1998. Researchers are excited about using human
embryonic stem cells because they have the unique ability to develop into
almost any type of cell or tissue in the body. Harnessing this capability
could enable researchers to improve health and save lives. Researchers are
hopeful that research using these cells will eventually lead to new treatments
for serious medical problems, including Parkinson’s disease, diabetes, spinal
cord injuries, autoimmune diseases, cardiovascular disease, and cancer.
On August 9, 2001, President
Bush implemented a policy that made a small number of human embryonic stem cell
lines eligible for federally-funded research. Only those stem cells already in
existence at the time of his announcement are eligible. While the Bush
Administration claimed that 78 embryonic stem cell lines would qualify for
federal funding, the actual number now available to scientists under the
Administration’s policy is only 21. Supporters of stem cell research have
reported difficulty gaining access to eligible stem cell lines and frustration
at not being able to use federal funds for research on newer, more promising
stem cell lines that do not pose the risk of contamination that eligible stem
cell lines do.
An important potential
source of embryonic stem cells that is not now eligible for federally-funded
research are embryos stored in fertility clinics. The process of in vitro
fertilization (IVF) typically produces more embryos than are needed for
fertility treatments. Approximately 400,000 frozen embryos are now stored in
fertility clinics. The vast majority of these frozen embryos will likely be
destroyed. S. 5 would enable these frozen embryos to be donated for
embryonic stem cell research and be eligible for federal research funds.
In addition to expanding the
number of human embryonic stem cell lines eligible for federally-funded
research, S. 5 would also promote research into finding alternative ways
to derive stem cells that do not involve the destruction of an embryo. Current
work on finding alternative sources of stem cells is at its earliest stages and
is largely theoretical. The development of alternative sources of stem cells
is a worthwhile pursuit as a complement to, but not a substitute for, existing
mechanisms for generating embryonic stem cells.
Note that S. 5 is a
modified version of H.R. 810, which 63 Senators supported last year. The
only change from last year’s bill is the inclusion in the current bill of the
text of last year’s Spector-Santorum “alternatives” bill, S. 2754, which
the Senate approved by a vote of 100-0.
Major Provisions
Human Embryonic Stem Cell
Research
S. 5 would direct the HHS Secretary to conduct and
support research that utilizes human embryonic stem cells – regardless of the
date when they were derived from an embryo – that adhere to the following
requirements:
·
The stem cells were derived from
embryos donated from in vitro fertilization clinics, were created for the
purpose of fertility treatment, and were in excess of what was needed for that
fertility treatment;
·
It is determined, through
consultation with the individuals who sought fertility treatment, that the
embryos would never be implanted in a woman and would otherwise be discarded;
and
·
The individuals who donated the
embryos provided their written informed consent and did not receive any
financial or other inducements for making the donation.
The HHS Secretary, in
consultation with the Director of the National Institutes of Health, would be
required to issue final guidelines to carry out this act no later than 60 days
after enactment. These guidelines would ensure that federally-funded
researchers adhere to ethical considerations. The HHS Secretary would also be
required to prepare and submit a report each year to the appropriate
congressional committees that describes the activities performed to carry out
this act, including whether and to what extent research has been conducted.
Alternative Human
Pluripotent Stem Cell Research
With respect to the
development of alternative mechanisms to derive stem cells, S. 5 would
direct the HHS Secretary to conduct and support basic and applied research to
develop techniques for the isolation, derivation, production, or testing of
stem cells that are capable of producing all or almost all of the cell types of
the body but are not derived from a human embryo.
The Secretary, after
consulting with the NIH Director, would be required to issue final guidelines
no later than 90 days after enactment. These guidelines would:
·
Provide guidance on the next
steps required for additional research, including a determination of the extent
to which specific techniques may require additional basic or animal research to
ensure that any research involving human cells using these techniques would
clearly be consistent with the standards established under this section.
·
Prioritize research with the
greatest potential for near-term clinical benefit; and
·
Take into account techniques
outlined by the President’s Council on Bioethics and any other appropriate
techniques and research.
The bill would require the
Secretary to prepare and submit to the appropriate committees of Congress a
report on the activities carried out under this act during the fiscal year,
including a description of research conducted. The reports will be prepared
and submitted no later than January 1 of each year.
The bill authorizes the
appropriation of such sums as may be necessary for each of Fiscal Years 2008
through 2010 to carry out its provisions.
Legislative History
Embryonic stem cell research
has been the focus of numerous hearings by the Senate Appropriations’ Labor-HHS
Subcommittee and the Senate Health, Education, Labor, and Pensions Committee in
recent years.
On May 24, 2005, the House
approved H.R. 810, the Stem Cell Research Enhancement Act, by a vote of
238-194. The Senate approved H.R. 810 on July 18, 2006 by a vote of 63-37, but
the President vetoed the bill on July 19th. On January 11, 2007,
the House passed H.R. 3 (legislation identical to last year’s H.R. 810) by a
vote of 253-174. On March 29, 2007, a unanimous consent agreement was reached,
pursuant to which the Senate will consider two bills: S. 5 (modified as
described above to include both the text of H.R. 3/last year’s H.R. 810, as
well as the provisions of last year’s unanimously-approved “alternatives” bill,
S. 2754), and S. 30, the Hope Offered Through
Principled and Ethical Stem Cell Research Act or HOPE Act. Each
bill will require 60 votes in order to pass. Floor debate is scheduled to
begin on April 10. Debate will be limited to 20 hours, with time divided as
follows:
-
Five hours each under the control
of the Majority and Republican Leaders, or their designees; and
-
Five hours each under the control
of Senators Harkin and Brownback, or their designees.
Amendments
Under the consent agreement,
no amendments will be in order.
Administration Position
The Bush Administration
issued a Statement of Administration Policy stating that it strongly opposed
House passage of H.R. 3, and that if H.R. 3 were presented to the President, he
would veto it. However, the Bush Administration also issued a Statement of
Administration Policy last year stating that it strongly supported S. 2754,
last year’s alternatives bill, which is included in its entirety in the current
version of S. 5. (Again, the current, modified version of S. 5
consists of provisions identical to H.R. 3/last year’s H.R. 810, along with the
provisions of last year’s unanimously-approved “alternatives” bill, S. 2754.)
The Administration has expressed its support for S. 30.
