Stem Cell Research 'Ban' Lifted in the United States  



July 15, 2009 - (Lang Michener Intellectual Property Brief Summer 2009)

Lang Michener Intellectual Property Brief Summer 2009
Executive Order 13505 signed by President Obama on March 9, 2009 has been widely misunderstood as "lifting a ban on stem cell research." In order to understand what the executive order did and did not do requires an understanding of the "ban" that was in place.

Before getting into the "ban", it is worth pausing to consider why stem cell research is considered to be so important. A stem cell is a type of cell that can become any type of cell in the body, given the right signals to do so. Decoding these signals is one of the key areas of stem cell research, with significant contributions to their understanding being made in Canada. The promise is that, in time, cells that have been destroyed or do not function normally can be replaced with new cells generated from stem cells. Thus, type 1 diabetes could be treated by regenerating pancreatic cells. Spinal cord injuries might be repairable, thus providing paraplegics and quadriplegics some measure of restored function. Many other diseases and disorders, such as cancer, Parkinson's disease, cardiac damage, Multiple Sclerosis and macular degeneration are the subject of stem cell research.

Returning to the "ban" in the United States, firstly it was not a ban in the usual sense of the word. The ban was on the use of federal funds to aid such research. Thus, if a corporation saw fit to conduct a research program based on embryonic stem cells with its own money, it was generally free to do so. Secondly, the "ban" in place related to embryonic stem cells and not to stem cells generally. Indeed, opponents of the use of embryonic stem cells point to advances made in adult stem cell research in the last ten years or so to argue that the use of embryonic stem cells is unnecessary. While there is much promising work in this area, such as the work of Toronto's Dr. Andras Nagy to convert adult skin cells into pluripotent stem cells that was recognized in the June 2009 edition of Scientific American, it is too early to say that embryonic stem cell research is completely unnecessary.

The first element of the "ban" was the Dickey-Wicker amendment to an appropriations bill passed by Congress in 1995, and signed into law by President Clinton. This amendment, which has been added to all subsequent appropriations bills including the Omnibus Appropriations Act, 2009 in substantially the same form, prohibits the use of any of the funds so appropriated for "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero." While funding of research on cell lines which might result from a process in which embryos are destroyed or discarded is not banned, funding of research leading to the creation of such cell lines is. During his first term in office, President George W. Bush issued a Presidential statement declaring that federal funding of embryonic stem cell research based on lines created after August 9, 2001 (the date of the statement) would not be permitted. On June 20, 2007, during his second term, President Bush issued Executive Order 13435 which, among other things, directed The Secretary of Health and Human Services to "conduct and support research on the isolation, derivation, production, and testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of or treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus." This Executive Order complemented the restrictions of the Dickey-Wicker amendment.

In revoking the Presidential statement and Executive Order of President Bush, Executive Order 13505 does not reverse the effects of the Dickey-Wicker amendment, as it is explicitly to be implemented in a manner "consistent with applicable law and subject to the availability of appropriations." While the Secretary of Health and Human Services is permitted to "support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research", she may do so only "to the extent permitted by law."

The signing of Executive Order 13505 raised a concern that the ability of Canada and other countries to attract and keep outstanding stem cell researchers would be adversely affected. These concerns are premature; however, if the new administration's change of policy translates into the repeal (or removal from future appropriations) of the Dickey-Wicker amendment and possibly to additional measures to encourage embryonic stem cell research, such concerns may be merited. In current circumstances, researchers in the United States are now free to carry out federally funded research on embryonic stem cell lines, whether created before or after August 9, 2001, but they still may not use federal funds to create new lines based on human embryos, unless they are able to do so without destroying, discarding or subjecting such embryos to risk of injury or death. In the current state of stem cell knowledge it would be difficult for an applicant for federal funding in the United States to demonstrate that research to create a new embryonic stem cell line did not subject such embryos to risk of injury.

This is not to say that Canadian researchers are unregulated. In March 2002, the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council (NSERC) and the Social Sciences and Humanities Research Council (SSHRC) ("the Agencies") adopted interim Tri-Agency stem cell measures, agreeing that no research with human pluripotent stem cells would be funded without the prior review and approval of the Stem Cell Oversight Committee (SCOC) in conformity with the CIHR guidelines. These guidelines are, not surprisingly, quite detailed, but in general, funding can only be approved under the guidelines where the acquisition of the material (whether embryos, placenta, umbilical cord) has been acquired with informed consent and non-commercially, and in the case of embryos, that they are no longer required for reproduction.

Stem cell research has grown in Canada, and many organizations engaged in this research have formed the Stem Cell Network. This organization has managed to assist Canadian researchers to co-ordinate their work, and to co-operatively develop tools such as Stembase, said to be "the largest stem cell gene expression database in the world, containing data on DNA and gene expression, mostly on human and mouse stem cell samples and their derivatives." The ability to obtain funding for the creation of new cell lines, so long as the guidelines are met, has provided Canada with a solid foundation in stem cell research. This is still a significant advantage Canada has in attracting world-class researchers in this field. However, it is important that we consider what measures would be necessary to prevent these researchers from being lured away to the United States if it were to repeal the Dickey-Wicker amendment and replace it with something similar to the CIHR guidelines. Assisting organizations such as the Stem Cell Network is one way to do so, by providing Canadian researchers with access to useful tools and efficient ways of exchanging data and cell lines. If the Canadian research infrastructure has sufficient value, any researcher considering relocation would have to consider how to manage without that resource. Providing a consistent, stable funding and regulatory environment is also critical. No research project can be guaranteed to obtain results in the lifetime of a Canadian government or a United States administration. An environment in which support for stem cell research changes radically every time the government changes is not conducive to encouraging such research.