110th Congress

Stem Cell Research

S. 5/S. 997, S. 51, H.R. 3, H.R. 322, H.R. 457, S. 362, S. 363, S. 957, S. 30, H.R. 1892, H.R. 2807

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 represented 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 human embryonic 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. Under the President’s policy, 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. As of spring 2008, there are 21 human embryonic stem cell lines available to National Institutes of Health (NIH)-funded researchers.

There was extensive legislative activity on human embryonic stem cells during the 109th Congress. In July 2006, then-Senate Majority Leader Bill Frist (R-TN) scheduled a package of stem cell bills for floor activity. These included H.R. 810, a bill that would have overturned the President’s policy; S. 2754, a bill that would have required NIH to fund research on alternative methods for deriving pluripotent stem cells; and S. 3504, a bill to prohibit the transfer or receipt of fetal tissue if a pregnancy was initiated for the purpose of obtaining such tissue. H.R. 810 was passed by the Senate by a vote of 63 to 37 on July 18, 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 it 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.

The 110th Congress, controlled by a Democratic majority, made stem cell research one of its top priorities. On January 4, 2007, Senator Harry Reid (D-NV) introduced S. 5, a bill that would have overturned the President’s stem cell policy. On January 5, Representative Diana L. DeGette (D CO) introduced the companion bill, H.R. 3, in the House. The bill was brought to swift floor action in the House and was passed on January 11 by a vote of 253 to 174, despite strong opposition from the Administration.

On January 19, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies (Senator Tom Harkin [D-IA], Chair) and the Senate Committee on Health, Education, Labor and Pensions (HELP) (Senator Edward M. Kennedy [D-MA], Chair) held a hearing to address, among other issues, research involving the presence of multipotent stem cells in amniotic fluid. Dr. Story Landis, Chair of the NIH Stem Cell Task Force, testified at this hearing.

During spring 2007, there was considerable public, congressional, and media interest in scientific research involving the use of methods to derive multipotent and pluripotent stem cells that do not involve human embryos. Opponents of human embryonic stem cell research argued that Federal research dollars should be redirected to explore the viability of these new methods. Proponents of human embryonic stem cell research argued that while research using these alternative methods is important and should proceed, this research should not a be a substitute for human embryonic stem cell research. They argued that all types of stem cell research should be pursued because scientists do not yet know which methods will ultimately prove to be the most promising.

The Senate did not consider stem cell research until April 11, when S. 5 was passed by the Senate by a vote of 63 to 34. The bill was amended prior to passage to include the text of S. 997, a bill that had been introduced on March 27 by Senator Harkin. In addition to overturning the President’s stem cell policy, S. 5, as passed by the Senate, included provisions that would have required the Secretary of Health and Human Services (HHS) to conduct and support research involving methods of obtaining pluripotent stem cells that do not involve the use of human embryos. Despite the presence of these additional provisions, the White House issued a Statement of Administration Policy in opposition to S. 5.

Concurrent with the passage of S. 5, S. 30, a bill that was introduced by Senator Norm Coleman (R MN) on March 29, was passed by the Senate by a vote of 70 to 28. This bill would have required the Secretary of HHS to support research to develop pluripotent stem cells using methods that do not involve the creation of, harm to, or destruction of human embryos. The White House issued a Statement of Administration Policy in support of S. 30. The House has not considered S. 30.

On June 7, S. 5 was passed by the House by a vote of 247 to 176. On June 20, the President vetoed S. 5. At the same time, he issued an Executive Order that requires the Secretary of HHS to enhance funding for research on alternative methods to derive pluripotent stem cells that do not involve human embryos.

In addition to H.R. 3, S. 5, and S. 30, several other stem cell bills were introduced during the first session of the 110th Congress. Many of these bills include provisions that would direct the Secretary of HHS to conduct research to explore whether stem cells that have characteristics similar to embryonic stem cells can be derived either without harming an embryo or without using embryos at all.

Provisions of the Legislation/Impact on NIH

H.R. 3—Stem Cell Research Enhancement Act of 2007

The bill would:

• Require the Secretary of HHS to conduct and support research using human embryonic stem cells (regardless of the date on which the stem cells were derived from a human embryo)
• Require 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
• Require the Secretary, in consultation with NIH, to promulgate guidelines within 60 days
• Require the Secretary to submit an annual report to Congress on activities carried out under the bill

H.R. 322—Alternative Pluripotent Stem Cell Therapies Enhancement Act of 2007

The bill would:

• Require the Secretary of HHS to conduct and support basic and applied research to develop techniques for the isolation, derivation, production, or testing of stem cells that, like embryonic stem cells, are capable of producing all or almost all of the cell types of the body, but are not derived from a human embryo
• Require the Secretary, after consultation with the Director of NIH, to issue guidelines within 90 days of enactment to provide guidance on the next steps required for additional research, taking into account alternative techniques for deriving stem cells outlined by the President’s Council on Bioethics and prioritizing research with the greatest potential for near-term clinical benefit
• Require the Secretary to submit an annual report to Congress describing the activities and research carried out under the Act
• Codify the definition of “human embryo” contained in the annual Labor, HHS, Education, and Related Agencies Appropriation Act

H.R. 457—Cures Can Be Found Act of 2007

The bill would:

• Provide a personal tax credit to individuals who provide either funds or qualified stem cells to an eligible facility for research purposes or storage for clinical use
• Define an “eligible facility” as one that neither conducts embryonic stem cell research nor stores embryonic stem cells
• Provide a business tax credit to storage facilities that store qualified stem cells
• Define “qualified stem cells” as those derived from a “human placenta, umbilical cord blood, amniotic fluid, 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”

H.R. 1892—National Amniotic and Placental Stem Cell Bank of 2007

The bill would:

• Require the Secretary of HHS to establish a National Amniotic and Placental Stem Cell Bank for the purpose of obtaining, storing, and making available for research and treatment human stem cells derived from amniotic fluid or placenta
• Require that the Bank maintain a collection of at least 100,000 samples of such stem cells in order to ensure genetic diversity
• Require that the Bank may obtain such stem cells only if informed consent is provided

H.R. 2807—Patients First Act of 2007

The bill would:

• Require the Secretary of HHS to conduct and support basic and applied research to develop techniques for the isolation, derivation, production, testing, and human clinical use of stem cells, including pluripotent stem cells, provided that such activities do not involve the creation of a human embryo for research purposes, destruction of or risk of injury to a human embryo, or use of any stem cell that has been derived by either creating or harming a human embryo
• Require the Secretary to issue final guidelines within 90 days that would implement the provisions of the bill in a way that ensures that the research is prioritized in terms of potential for near-term clinical benefit in human patients
• Codify the definition of “human embryo” contained in the annual Labor, HHS, Education, and Related Agencies Appropriation Act
• Amend Section 492 of the Public Health Service Act (Peer Review Requirements) to require that the Secretary, acting through the Director of NIH, give priority to conducting the research authorized by the bill. In addition, the bill would require an annual report to Congress that would include the number of research proposals received under the section, the number that were peer reviewed, and a summary and detailed list of the proposals that were not funded, including the reasons why those proposals were not funded.
• Require that the biennial report established by the NIH Reform Act (P.L. 109-482) address stem cell research specifically

S. 5/S. 997—Stem Cell Research Enhancement Act of 2007

The bill would:

• Require the Secretary of HHS to conduct and support research using human embryonic stem cells (regardless of the date on which the stem cells were derived from a human embryo)
• Require 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
• Require the Secretary to conduct and support basic and applied research to develop techniques for the isolation, derivation, production, or testing of stem cells that, like embryonic stem cells, are capable of producing all or almost all of the cell types of the body, but are not derived from a human embryo
• Require the Secretary, after consultation with the Director of NIH, to issue guidelines within 90 days of enactment to provide guidance on the next steps required for additional research, taking into account alternative techniques for deriving stem cells outlined by the President’s Council on Bioethics and prioritizing research with the greatest potential for near-term clinical benefit
• Require the Secretary to submit an annual report to Congress describing the activities and research carried out under the Act

S. 30—Hope Offered through Principled and Ethical Stem Cell Research Act (HOPE Act)

The bill would:

• Require the Secretary of HHS to conduct and support basic and applied research to develop techniques for the isolation, derivation, production, testing, and human clinical use of stem cells, including pluripotent stem cells, provided that such activities do not involve the creation of a human embryo for research purposes, destruction of or risk of injury to a human embryo, or use of any stem cell that has been derived by either creating or harming a human embryo
• Require the Secretary to issue final guidelines within 90 days that would implement the provisions of the bill in a way that ensures that the research is prioritized in terms of potential for near-term clinical benefit in human patients
• Codify the definition of “human embryo” contained in the annual Labor, HHS, Education, and Related Agencies Appropriation Act
• Require the Secretary to submit an annual report to Congress describing the activities and research carried out under the Act
• Require the Secretary to enter into a contract with the Institute of Medicine for a study to be completed within 6 months that would recommend an optimal structure for an amniotic and placental stem cell bank

S. 51—Pluripotent Stem Cell Therapy Enhancement Act of 2007

The bill would:

• Require the Secretary of HHS to conduct and support basic and applied research to develop techniques for the isolation, derivation, production, testing, and human clinical use of stem cells, including pluripotent stem cells, provided that such activities do not involve the creation of a human embryo for research purposes, destruction of or risk of injury to a human embryo, or use of any stem cell that has been derived by either creating or harming a human embryo
• Require the Secretary to issue final guidelines within 90 days that would implement the provisions of the bill in a way that ensures that the research is prioritized in terms of potential for near-term clinical benefit in human patients
• Codify the definition of “human embryo” contained in the annual Labor, HHS, Education, and Related Agencies Appropriation Act
• Require the Secretary to submit an annual report to Congress describing the activities and research carried out under the Act

S. 362—Stem Cell Research Expansion Act

The bill would:

• Authorize the U.S. Department of Health and Human Services (DHHS) to provide funding for research on embryonic stem cell lines that were created prior to January 23, 2006, that does not result in the use of Federal funding to destroy an embryo or embryos

S. 363—Hope Offered through Principled, Ethically-Sound Stem Cell Research Act (HOPE Act)

The bill would:

• Require the Secretary of HHS to conduct and support basic and applied research to develop techniques for the isolation, derivation, production, testing, and human clinical use of stem cells, including pluripotent stem cells, provided that such activities do not involve the creation of a human embryo for research purposes, destruction of or risk of injury to a human embryo, or use of any stem cell that has been derived by either creating or harming a human embryo
• Require the Secretary to issue final guidelines within 90 days that would implement the provisions of the bill in a way that ensures that the research is prioritized in terms of potential for near-term clinical benefit in human patients
• Codify the definition of “human embryo” contained in the annual Labor, HHS, Education, and Related Agencies Appropriation Act
• Require the Secretary to submit an annual report to Congress describing the activities and research carried out under the Act
• Establish a National Stem Cell Research Review Board, comprising both outside experts and community members, that would be responsible for monitoring stem cell research funded by DHHS to ensure that it is in compliance with the provisions of the bill. The Board would also be responsible for ensuring “fair consideration of both embryonic stem cell and adult stem cell research for funding.”
• Prescribe informed consent requirements governing stem cell research funded under the provisions of the bill
• Amend provisions of the National Organ Transplant Act that prohibit the buying and selling of human organs for profit to extend such prohibitions to human ova, human blastocysts, human embryos, and any stem cells derived from human embryos
• Prohibit any individual from receiving valuable consideration for any therapy that “utilizes cells from a human embryo, if the process of deriving such cells destroyed the embryo.” “Valuable consideration” is defined as not including the reasonable production and administrative costs associated with developing a therapy.

S. 957—Amniotic Fluid and Placental Stem Cell Banking Act of 2007

The bill would:

• Require the Secretary of HHS to enter into one-time contracts with qualified amniotic fluid and placental stem cell banks to assist in the collection and maintenance of 100,000 new units of amniotic fluid and placental stem cells to be made available for treatment through the C.W. Bill Young Cell Transplantation and Treatment Program. This program is operated by the Health Resources and Services Administration.
• Require contractors who receive awards to make amniotic fluid and placental stem cell units that are collected, but not appropriate for clinical use, available for peer-reviewed research

Status and Outlook

S. 5 was introduced by Senator Reid on January 4, 2007. It was passed by the Senate on April 11 by a vote of 63 to 34 and by the House on June 7 by a vote of 247 to 176. S. 5 was vetoed by the President on June 20.

S. 51 was introduced by Senator Johnny Isakson (R-GA) on January 4, 2007, and was referred to the Senate HELP Committee. No further action has occurred on this legislation.

H.R. 3 was introduced by Representative DeGette on January 5, 2007, and was referred to the House Committee on Energy and Commerce. It was not considered in Committee. The bill was passed by the House on January 11 by a vote of 253 to 174. No further action has occurred on this legislation.

H.R. 322 was introduced by Representative Roscoe Bartlett (R-MD) on January 9, 2007, and was referred to the House Committee on Energy and Commerce. No further action has occurred on this legislation.

H.R. 457 was introduced by Representative Ron E. Paul (R-TX) on January 12, 2007, and was referred to the House Committee on Ways and Means. No further action has occurred on this legislation.

S. 362 was introduced by Senator Coleman on January 23, 2007, and was referred to the Senate HELP Committee. No further action has occurred on this legislation.

S. 363 was introduced by Senator Coleman on January 23, 2007, and was referred to the Senate HELP Committee. No further action has occurred on this legislation.

S. 957 was introduced by Senator Richard Burr (R-NC) on March 22, 2007, and was referred to the Senate HELP Committee. No further action has occurred on this legislation.

S. 997 was introduced by Senator Harkin on March 27, 2007. It was not referred to any Committee, and its provisions were incorporated into S. 5, prior to passage by the Senate. No further action has occurred on this legislation.

S. 30 was introduced by Senator Coleman on March 29, 2007. It was passed by the Senate on April 11 by a vote of 70 to 28. No further action has occurred on this legislation.

H.R. 1892 was introduced by Representative Dan Lipinski (D-IL) on April 17, 2007, and was referred to the House Committee on Energy and Commerce. No further action has occurred on this legislation.

H.R. 2807 was introduced by Representative Randy Forbes (R-VA) on June 21, 2007, and was referred to the House Committee on Energy and Commerce. No further action has occurred on this legislation.

March 27, 2008