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Pending Stem Cell Research and Legislation

Background

In November 1998, two different groups of scientists reported the successful isolation and culturing of human embryonic stem cells. Generally referred to as pluripotent stem cells, these cells have the ability to develop into most of the specialized cells or tissues in the human body and can divide for indefinite periods in culture. Because these cells can give rise to many different types of cells, such as muscle cells, nerve cells, heart cells, blood cells, and others, they are enormously important to science and hold great promise for advances in health care.

The establishment of human pluripotent stem cell lines represents a major step forward in human biology. This advance has generated interest among scientists, the public, and patients and their advocates, especially with regard to the ethical issues related to stem cell research.

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 his new Administration an opportunity to review the issue. On August 9, 2001, President Bush issued a long-awaited decision on stem cell research. He authorized funding of stem cell research using existing pluripotent stem cell lines that were derived from human embryos before August 9. Such research is eligible for Federal funding if the following criteria are met: 1) there must have been informed consent of 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. During fiscal year (FY) 2002, the National Institutes of Health (NIH) funded the first grants to conduct human embryonic stem cell research, including both new grants and supplements to existing grants.

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108th Congress, House Bills

H.R. 534—Human Cloning Prohibition Act of 2003

On February 27, 2003, the House voted 241 to 155 in favor of H.R. 534, the Human Cloning Prohibition Act of 2003. H.R. 534 would prohibit both reproductive and therapeutic cloning, and includes a criminal penalty of up to 10 years for violation of the provisions of the bill. A less restrictive substitute measure offered by Representative Jim Greenwood (R-PA), which would have prohibited reproductive cloning only, failed by a vote of 231 to 174.

HR 534 was introduced on February 5, 2003, by Representative Dave Weldon (R-FL). The was reported favorably by the House Committee on the Judiciary with a vote of 19 to 12 on February 12.

H.R. 801—Cloning of Humans

On February 13, 2003, Representative Jim Greenwood (R-PA) introduced H.R. 801, a bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the cloning of humans, and for other purposes. Although the text of the bill is not available, it is reported that it would prohibit reproductive cloning but permit therapeutic cloning. The bill was referred to the House Committee on Energy and Commerce.

H.R. 916—Human Cloning Research Prohibition Act

On February 25, 2003, Representative Cliff Stearns (R-FL) introduced H.R. 916, the Human Cloning Research Prohibition Act. The intent of the bill is to prohibit the expenditure of Federal funds to conduct or support research on human cloning. The bill would require the Director of the National Science Foundation to contract with the National Research Council for a review of the implementation of the Act. H.R. 916 would also express the sense of Congress that other countries should establish similar provisions. The bill was referred to the House Committees on Energy and Commerce and on Science.

H.R. 938—Human Cloning Prevention Act of 2003

On February 26, 2003, Representative Ron Paul (R-TX) introduced H.R. 938, the Human Cloning Prevention Act of 2003. The bill would prohibit any Federal agency from making any grant, contract, or other payment to any entity that "within the past year has engaged in human cloning." The phrase "human cloning" is defined to include somatic cell nuclear transfer technology for the purpose of deriving stem cells. The bill was referred to the House Committee on Energy and Commerce.

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108th Congress, Senate Bills

S. 245—Human Cloning Prohibition Act of 2003

On January 29, 2003, Senator Sam Brownback (R-KS) introduced S. 245, the Human Cloning Prohibition Act of 2003. The bill would prohibit both therapeutic and reproductive cloning, and is similar to H.R. 234, introduced by Representative Dave Weldon (R-FL). The bill was referred to the Senate Committee on Health, Education, Labor and Pensions.

S. 303—Human Cloning Ban and Stem Cell Research Protection Act of 2003

On February 5, 2003, Senator Arlen Specter (R-PA) introduced S. 303, the Human Cloning Ban and Stem Cell Research Protection Act of 2003. The bill would prohibit reproductive cloning but would specifically permit therapeutic cloning, as long as certain ethical requirements are met.

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107th Congress Stem Cell Research

H.R. 2059/S. 723, H.R. 2096/S. 1349, H. Con. Res. 17, H.R. 2747, H.R. 2838, H.R. 2863, and H.R. 4011

The Senate Appropriations Subcommittee on Labor, Health and Human Services (HHS) and Education (Senator Tom Harkin [D-IA], Chairman) held four hearings on the issue during the 107th Congress—July 18, 2001; August 1, 2001; October 31, 2001; and September 25, 2002. The July 18 hearing focused on the release of a comprehensive report prepared by NIH that described the current state of the science on stem cells derived from human embryos, fetal tissue, and adult tissue. In addition, several Senators holding pro-life views testified in support of stem cell research. The August 1 hearing focused on intellectual property issues and ethical issues. The October 31 hearing focused on testimony from the various derivers of the existing stem cell lines. The September 25 hearing was held to provide the new Director of NIH with an opportunity to update the Subcommittee on the implementation of the President's stem cell decision by NIH, and to hear from researchers on their efforts to obtain the eligible stem cell lines listed in the NIH Stem Cell Registry. The Senate Health, Education, Labor and Pensions Committee (Senator Edward M. Kennedy [D-MA], Chairman) held one hearing on this topic on September 5, 2001. The hearing focused on the quality and viability of the existing stem cell lines. The Secretary of HHS, Tommy G. Thompson, testified.

The House was not particularly active on this issue as a body. The House Committee on Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources held one hearing on this issue on July 17, 2001, which focused on testimony from individuals who had adopted frozen embryos from in vitro fertilization clinics.

H.R. 2059 and S. 723, the Stem Cell Research Act of 2001, were introduced by Representative Jim McDermott (D-WA) and Senators Arlen Specter (R-PA) and Harkin, respectively, to amend the Public Health Service Act to provide for human embryonic stem cell generation and research.

H.R. 2096 and S. 1349, the Responsible Stem Cell Research Act of 2001, were introduced by Representative Christopher H. Smith (R-NJ) and Senator John Ensign (R-NV), respectively, to require the Secretary of HHS to maintain a stem cell donor bank containing stem cells derived from adult tissue, placentas, and umbilical cord blood.

H. Con. Res. 17 was introduced by Representative Carolyn Maloney (D-NY) to express the Sense of Congress regarding pluripotent stem cell research.
H.R. 2747 was introduced by Representative Diana L. DeGette (D-CO) to codify the Clinton Administration's guidelines governing research using human pluripotent stem cells.

H.R. 2838 was introduced by Representative Juanita Millender-McDonald (D-CA) to require NIH to conduct human embryonic stem cell research and repeal the Human Embryo Research Ban contained within the Labor, HHS, and Education Appropriations Act.

H.R. 2863 was introduced by Representative McDermott to require the establishment of an additional Food and Drug Administration (FDA) Advisory Committee to make recommendations on the field of cell development, including human embryonic stem cell research and therapeutic cloning.

H.R. 4011 was introduced by Representative Maloney to establish a Stem Cell Research Board within the legislative branch to conduct research on the effects of the President's August 9, 2001, stem cell policy.

While no further action on this legislation occurred during the 107th Congress, stem cell research continues to be a source of considerable controversy and discussion within Congress. As many predicted, there was considerable debate on this issue when the Senate considered H.R. 3061, the Departments of Labor, HHS, Education, and Related Agencies Appropriation Act of 2002. Rather than passing new legislation, most Members of Congress appeared willing to accept the President's policy and await the results of its implementation before determining whether any specific legislative remedies were needed. It is possible, however, that if the 108th Congress considers the Labor, HHS, Education, and Related Agencies Appropriations bill this spring, rather than one omnibus spending bill, stem cell amendments may be added. It is also possible that Members of Congress who have been active on this issue, such as Senator Specter and Senator Sam Brownback (R-KS), will introduce legislation to either expand or limit the President's policy. Given comments by the Senate majority leader during debate on the Labor, HHS, Education, and Related Agencies appropriations bill, it is possible that Senator Specter's bill will be the subject of debate when the Senate considers this issue again in spring 2003.

The Senate Report to the FY 2003 Labor, HHS, Education, and Related Agencies Appropriations bill currently contains language that would 1) require DHHS to submit a report to Congress explaining how the Agency plans to encourage more stem cell grant applications and make more stem cell lines available to researchers, 2) encourage NIH to expand the stem cell registry to include more detailed information regarding the availability and characteristics of the existing lines, and 3) encourage NIH to consider developing a stem cell repository.

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Provisions of the Legislation/Impact on NIH

S. 723/H.R. 2059—Stem Cell Research Act of 2001

These bills would have permitted the U.S. Department of Health and Human Services (DHHS) to fund both the derivation and use of human pluripotent stem cells. Section 2 of the bills would have added a new section (489C) to the Public Health Service Act, which would have stipulated the following:

H.R. 2096/S. 1349—Responsible Stem Cell Research Act of 2001

These bills would have required the Secretary of HHS to establish a stem cell donor bank containing stem cells derived from umbilical cord blood, placental tissue, and adult tissues. The bills contained the following key provisions:

H. Con. Res. 17—Support for Pluripotent Stem Cell Research

H.R. 2747—Stem Cell Research for Patient Benefit Act of 2001

The bill would have codified the NIH guidelines for research using human pluripotent stem cells. The bill contained the following key provisions:

H.R. 2838—New Century Health Advantage Act

The bill contained the following key provisions:

H.R. 2863—Cell Development Research Act of 2001

The bill contained the following key provision:

H.R. 4011—Science of Stem Cell Research Act

The bill would have established a Stem Cell Research Board within the legislative branch to conduct research on the effects of the President's August 9, 2001, stem cell policy. The bill contained the following key provisions:

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Status and Outlook

On April 5, 2001, Senator Specter introduced S. 723, the Stem Cell Research Act of 2001. The bill had 18 cosponsors and was referred to the Senate Health, Education, Labor and Pensions Committee. A series of amendments to the bill were also referred to the Committee in June and July. An identical companion measure, H.R. 2059, was introduced by Representative McDermott on June 5. H.R. 2059 had 31 cosponsors and was referred to the House Energy and Commerce Committee. On June 18, the bill was referred to the House Energy and Commerce Subcommittee on Health.

On June 7, 2001, Representative Smith introduced H.R. 2096, the Responsible Stem Cell Research Act of 2001. The bill had 70 cosponsors and was referred to the House Energy and Commerce Committee. On June 18, H.R. 2096 was referred to the House Energy and Commerce Subcommittee on Health. An identical companion measure, S. 1349, was introduced by Senator Ensign on August 3. S. 1349 had three cosponsors and was referred to the Senate Health, Education, Labor and Pensions Committee.

On January 30, 2001, Representative Maloney introduced H. Con. Res. 17. The resolution had 85 cosponsors and was referred to the House Energy and Commerce Committee. On February 14, the resolution was referred to the House Energy and Commerce Subcommittee on Health.

On August 2, 2001, Representative DeGette introduced H.R. 2747, the Stem Cell Research for Patient Benefit Act of 2001. The bill had 15 cosponsors and was referred to the House Energy and Commerce Committee.

On September 5, 2001, Representative Millender-McDonald introduced H.R. 2838, the New Century Health Advantage Act. The bill had no cosponsors and was referred to the House Energy and Commerce Committee.

On September 6, 2001, Representative McDermott introduced H.R. 2863, the Cell Development Research Act of 2001. The bill had 17 cosponsors and was referred to the House Energy and Commerce Committee.

On March 20, 2002, Representative Maloney introduced H.R. 4011, the Science of Stem Cell Research Act. The bill had 25 cosponsors and was referred to the House Energy and Commerce Committee.

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