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.
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.
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.
Under the consent agreement, no amendments will be in order.
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.