The Stem Cell Research Enhancement Act (H.R. 810) of 2005 and was reintroduced in 2007 and again vetoed by the president.
There is currently little federal legislation regarding the actual research of human embryonic stem cell (hESC) in the United States. The most recent federal actions only regulate the eligibility of this research for federal funding rather than the research itself.
In 2001, President George W. Bush ruled that federal funds may only be used for hESC research using specified pre-existing lines, now known as the ‘presidential’ hESC lines, and that no federal funds may be used to create new hESC lines.
The Stem Cell Research Enhancement Act of 2005 (H.R. 810) was passed by the House of Representatives in May 2005 and the Senate in July 2006, but was rapidly vetoed by President Bush (July 2006). A two-thirds majority, or super-majority vote must follow in both the House of Representatives and the Senate to overturn a Presidential veto. This level of support was not garnered and the veto was sustained.
The limited number of formally listed cell lines derived before August 9, 2001 remain the only eligible lines for U.S. federal support. These stem cell lines, of which there are only 21 and their sub-clones are only available for use in federally funded research programs and to provide technical support to the hES cell research community. The National Stem Cell Bank distributes cells to researchers in academic and non-profit institutions worldwide.
In January 2007, H.R. 3, the Stem Cell Research Enhancement Act of 2007, a reintroduction of the bill H.R.810, went before the House of Representatives. The bill was passed by the House on January 11, 2007 with a majority of 253-174. On April 11, 2007, the U.S. Senate voted 63-34 in support of S. 5, a variant of H.R. 3. While S. 5 differed slightly from H.R. 3 that passed the House in January, 2007, this particular version of the bill returned to and passed the House of Representatives in June, 2007. The legislation once again appeared before President Bush and was again vetoed and the restrictions to funding remain in place.
Despite limited legislation at the federal level, the issue of hESC research has been taken up individually by many states, and policies vary greatly across those states. Currently only the states of CA, CT, IL, MA, and NJ even permit research that is not federally funded. Other states continue to look at the feasibility of funding such research. And some states, such as AR, IN, ND, and SD have gone so far as to ban research.
Changes to US policy on hESC research:
THE WHITE HOUSE
Office of the Press Secretary
_________________________________________
For Immediate Release March 9, 2009 EXECUTIVE ORDER - - - - - - -
REMOVING BARRIERS TO RESPONSIBLE SCIENTIFIC RESEARCH INVOLVING HUMAN STEM CELLS
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1. Policy. Research involving human embryonic stem cells and human non-embryonic stem cells has the potential to lead to better understanding and treatment of many disabling diseases and conditions. Advances over the past decade in this promising scientific field have been encouraging, leading to broad agreement in the scientific community that the research should be supported by Federal funds.
For the past 8 years, the authority of the Department of Health and Human Services, including the National Institutes of Health (NIH), to fund and conduct human embryonic stem cell research has been limited by Presidential actions. The purpose of this order is to remove these limitations on scientific inquiry, to expand NIH support for the exploration of human stem cell research, and in so doing to enhance the contribution of America's scientists to important new discoveries and new therapies for the benefit of humankind.
Sec. 2. Research. The Secretary of Health and Human Services (Secretary), through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.
Sec. 3. Guidance. Within 120 days from the date of this order, the Secretary, through the Director of NIH, shall review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH guidance on such research that is consistent with this order. The Secretary, through NIH, shall review and update such guidance periodically, as appropriate.
Sec. 4. General Provisions. (a) This order shall be implemented consistent with applicable law and subject to the availability of appropriations. (b) Nothing in this order shall be construed to impair or otherwise affect: (i) authority granted by law to an executive department, agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Sec. 5. Revocations. (a) The Presidential statement of August 9, 2001, limiting Federal funding for research involving human embryonic stem cells, shall have no further effect as a statement of governmental policy.
(b) Executive Order 13435 of June 20, 2007, which supplements the August 9, 2001, statement on human embryonic stem cell research, is revoked.
BARACK OBAMA
THE WHITE HOUSE,
March 9, 2009.
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