109th Congress

Human Embryonic Stem Cells Research

H.R. 162, H.R. 810/S. 471, H.R. 2541, H.R. 2574, H.R. 3144/S. 1557, H.R. 3444, S. 2754, S. 3504

Background

In November 1998, two groups of scientists reported the successful isolation and culture of human embryonic stem cells. Referred to as pluripotent stem cells within the scientific community, human embryonic stem cells can develop into most of the specialized cells and tissues in the human body and divide indefinitely in culture. Because these cells can become many different types of cells, including muscle, nerve, heart, and blood cells, their derivation represents a major advance in human biology. This research holds great promise for advances in health care and has generated interest among scientists, patients and their advocates, and the public.

The Clinton Administration published guidelines governing the use of human embryonic stem cells in the Federal Register on August 23, 2000. On April 25, 2001, a scheduled review of pending grant applications was postponed to provide President George W. Bush and the new Administration with the opportunity to review the issue. On August 9, President Bush authorized funding for stem cell research using existing pluripotent stem cells that were derived from human embryos before August 9. At that time, it was estimated that there were 78 derivations that would be eligible for funding. Research using these derivations is eligible for Federal funding if the following criteria are met: 1) there must have been informed consent from the donors, 2) the embryos must have been created for reproductive purposes and in excess of clinical need, 3) there must not have been any financial inducements to the donors, and 4) the embryos must not have been created for research purposes.

Although there was little congressional activity on stem cells during the first session of the 108th Congress, some Members and many patient advocacy groups continued to express concern that the President’s policy hinders the progress of stem cell research. After the approximate number of currently available stem cell lines was revised to 20, several Members of Congress introduced bills in the spring of 2004 that would have required funding for human embryonic stem cell research, notwithstanding the President’s 2001 policy. On April 28, more than 200 Members of the House sent a letter to the President urging an expansion of the policy; a similar letter from the Senate followed. Former President Ronald Reagan’s death from Alzheimer’s disease on June 5 and former First Lady Nancy Reagan’s subsequent pleas to expand the policy led to significant media coverage during the summer of 2004. The issue of stem cell research also figured prominently in the 2004 presidential election.

When the 109th Congress convened, several Members of Congress reintroduced legislation that had been introduced during prior Congresses. Actions by several States to authorize and fund human embryonic stem cell research placed additional pressure on Congress to consider legislation in this area. In fact, in an effort to support State actions related to human embryonic stem cell research, Representative Nancy L. Johnson (R-CT) introduced H.R. 1650, the Stem Cell Research Investment Act of 2005. The bill would have allowed States to issue $30 billion worth of zero-interest bonds to fund stem cell research, giving bondholders Federal tax credits in lieu of interest payments.

On May 24, 2005, the House passed H.R. 810, the Stem Cell Research Enhancement Act of 2005, by a vote of 238 to 194. The bill, strongly opposed by the Administration, would have effectively overturned the policy established by President Bush in August 2001. The vote was particularly significant because included among the 50 Republican Members who voted in favor of the bill were the chairs of 7 committees and 13 subcommittees.

During the summer of 2005, Members of Congress expressed interest in exploring scientific techniques reported by the media that could potentially produce human pluripotent stem cells without destroying embryos. On July 12, the Senate Appropriations Subcommittee on Labor, Health and Human Services (HHS), Education and Related Agencies held a hearing to discuss several alternative approaches to deriving such stem cells. The Senate Majority Leader publicly stated his intent to bring a package of stem cell bills to the floor during the spring of 2006. It was unclear how the news reports describing scientific misconduct by a leading South Korean stem cell researcher might affect the Senate’s consideration of stem cell legislation.

Nevertheless, in the second session of the 109th Congress, Senator Bill Frist (R-TN) scheduled H.R. 810, S. 2754, and S. 3504 for floor action in late July 2006. S. 2754 would have required the National Institutes of Health (NIH) to fund research on alternative methods for deriving pluripotent stem cells, and S. 3504 would prohibit the transfer or receipt of fetal tissue if a pregnancy was initiated for the purpose of obtaining such tissue. H.R. 810 passed the Senate by a vote of 63 to 37 on July 18, thus having received the support of both the House and Senate. On July 19, President Bush vetoed H.R. 810, the first veto of his presidency. By a vote of 235 to 193, the House failed to override the presidential veto (two-thirds required for a successful override motion). S. 2754 was unanimously passed by the Senate but failed to pass in the House under suspension of the rules, by a vote of 273 to 154 (two-thirds required for passage). S. 3504 was unanimously passed by both the Senate and House.

On July 19, President Bush signed S. 3504 into law as P.L. 109-242. This law prohibits soliciting or knowingly receiving or accepting a donation of human fetal tissue, knowing that a pregnancy was initiated for the purpose of providing such tissue. The law also prohibits receiving cells obtained from a human embryo gestated in the uterus of a nonhuman animal.

Provisions of the Legislation/Impact on NIH

H.R. 162—Stem Cell Replenishment Act of 2005

The bill would have:

• Permitted Federal funds to be used for research on human embryonic stem cells regardless of when the derivation of the stem cell line was begun or completed
• Required NIH to review and revise the guidelines published in 2000 to ensure the availability of not fewer than 60 stem cell lines that are scientifically fit for distribution for research purposes

H.R. 810/S. 471—Stem Cell Research Enhancement Act of 2005

The bills would have:

• Required the Secretary of HHS to conduct and support research using human embryonic stem cells
• Required that the following criteria be met: 1) the stem cells must be derived from embryos that were created for fertility purposes, in excess of clinical need, and donated from in vitro fertilization clinics, 2) prior to consideration of embryo donation, it must be determined that the embryos would never be implanted in a woman and would otherwise be discarded, and 3) donation must be made with written informed consent and without any financial or other inducements
• Required the Secretary, in consultation with NIH, to promulgate guidelines within 60 days
• Required the Secretary to submit an annual report to Congress on activities carried out under the bill

H.R. 2541—Joe Testaverde Adult Stem Cell Research Act of 2005

The bill would have:

• Required NIH to expand, intensify, and coordinate adult stem cell research
• Required NIH to establish not fewer than five Centers of Excellence for conducting basic and clinical research regarding “qualifying adult stem cells”
• Required NIH to provide for a program under which samples of tissues and genetic materials that would be of use in qualifying stem cell research are donated, collected, preserved, and made available for such research
• Required NIH to provide a means through which the public can obtain information on NIH’s activities with respect to adult stem cell research and provide comments on such activities to NIH
• Defined “qualifying adult stem cell” as “a human stem cell obtained from a human placenta, umbilical cord blood, an organ or tissue of a living or deceased human being who has been born, or an organ or tissue of unborn human offspring who died of natural causes (such as spontaneous abortion)”

H.R. 2574—Respect for Life Embryonic Stem Cell Act of 2005

The bill would have:

• Required NIH to conduct and support basic and applied animal research to “develop techniques for the derivation of stem cells from embryos that do not harm the embryos”
• Required NIH to develop techniques for storing such cells in the eventuality that a therapy is developed that uses the stem cells of an animal to adapt the therapy to that particular animal

H.R. 3144/S. 1557—Respect for Life Pluripotent Stem Cell Act of 2005

This legislation is a revised version of H.R. 2574. It would have:

• Required NIH to conduct and support research to derive pluripotent stem cells without destroying embryos. This research would have been conducted using either animal or human cells, but without using human embryos.
• Included within the Public Health Service Act a definition of “embryo.” This would have effectively codified the definition that is included as a yearly amendment to the Labor, HHS, Education and Related Agencies appropriations bill (see P.L. 108-447, Section 509).
• Prohibited research conducted under the provisions of this legislation from using or creating human embryos

H.R. 3444—Cures Can Be Found Act of 2005

The bill would have:

• Provided a personal tax credit to individuals who provide either funds or umbilical cord blood to an eligible facility for research purposes or storage for clinical use
• Defined an “eligible facility” as one that neither conducts embryonic stem cell research nor stores embryonic stem cells
• Provided a business tax credit to umbilical cord blood storage facilities

S. 2754—Alternative Pluripotent Stem Cell Therapies Enhancement Act of 2006

The bill would have:

• Required NIH to fund research to develop techniques for the isolation and production of pluripotent stem cells without deriving such cells from human embryos
• Required the Secretary of HHS, in consultation with the Director of NIH, to issue guidelines within 90 days of the bill’s enactment that would have outlined and prioritized such research

S. 3504—Fetus Farming Prohibition Act of 2006

The bill:

• Prohibits soliciting or knowingly receiving or accepting a donation of human fetal tissue, knowing that a pregnancy was initiated for the purpose of providing such tissue
• Prohibits receiving cells obtained from a human embryo gestated in the uterus of a nonhuman animal

Status and Outlook

H.R. 162 was introduced by Representative Juanita Millender-McDonald (D-CA) on January 4, 2005, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 109th Congress.

H.R. 810 was introduced by Representative Michael Castle (R-DE) on February 15, 2005, and was referred to the House Committee on Energy and Commerce. H.R. 810 was passed by the House on May 24 by a vote of 238 to 194. The bill was passed by the Senate on July 18, 2006, by a vote of 63 to 37. President Bush vetoed the bill on July 19.

S. 471, a companion bill to H.R. 810, was introduced by Senator Arlen Specter (R-PA) on February 28, 2005, and was referred to the Senate Committee on Health, Education, Labor and Pensions (HELP). No further action occurred on this legislation during the 109th Congress.

H.R. 2541 was introduced by Representative Peter King (R-NY) on May 23, 2005, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 109th Congress.

H.R. 2574 was introduced by Representative Roscoe Bartlett (R-MD) on May 24, 2005, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 109th Congress.

H.R. 3144 was introduced by Representative Bartlett on June 30, 2005, and was referred to the House Committee on Energy and Commerce. No further action occurred on this legislation during the 109th Congress.

H.R. 3444 was introduced by Representative Ron E. Paul (R-TX) on July 26, 2005, and was referred to the House Committee on Ways and Means. No further action occurred on this legislation during the 109th Congress.

S. 1557, a companion bill to H.R. 3144, was introduced by Senator Tom Coburn (R-OK) on July 29, 2005, and was referred to the Senate HELP Committee. No further action occurred on this legislation during the 109th Congress.

S. 2754 was introduced by Senator Rick Santorum (R-PA) for himself and Senator Specter on May 5, 2006, and was referred to the Senate HELP Committee. The bill was passed unanimously by the Senate on July 18. It failed to pass the House under suspension of the rules, by a vote of 273 to 154 (two-thirds required for passage). No further action occurred on this legislation during the 109th Congress.

S. 3504 was introduced by Senator Santorum for himself and Senator Sam Brownback (R-KS) on June 13, 2006, and was referred to the Senate HELP Committee. The House and Senate both passed the measure unanimously on July 18. On July 19, President Bush signed S. 3504 into law as P.L. 109-242.