On July 6, 2009, the National Institutes of Health (NIH) issued final guidelines for human stem cell research (National Institutes of Health Guidelines for Human Stem Cell Research). The guidelines implement President Barack Obama’s March 9, 2009 Executive Order 13505, “Removing Barriers to Responsible Scientific Research Involving Human Stem Cells,” which effectively overturned the prior administration's policy restricting the use of public funds for research using embryonic stem cell lines created after August 9, 2001. More than 49,000 comments from patient advocacy groups, scientists, private citizens, Members of Congress, and medical and religious organizations were received and considered by the NIH after publication of draft guidelines.
Greater Clarity for Researchers
The final guidelines apply to funds for research using human embryonic stem cells (hESCs) and certain uses of induced pluripotent stem cells (iPSCs). hESCs, for the purpose of the guidelines, are cells derived from the inner cell mass of blastocyst-stage human embryos, are capable of dividing without differentiation for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. To the end of ensuring funding of the greatest number of derived hESCs, the guidelines are divided into several sections that apply specifically to embryos donated in the United States and foreign countries, both before and on or after the July 7, 2009 effective date of the guidelines.
Common among the eligibility requirements are that the hESCs are derived from human embryos: 1) that the embryos were donated with the informed consent of the embryo donor, to include confirmation that the donation was made without any restriction or direction regarding who may receive medical benefit form the use of the derived hESCs, 2) that the cell lines were derived from embryos from in vitro fertilization (IVF) for reproductive purposes, and that the embryos were no longer required for that purpose, and 3) that the donor will not receive financial or other benefit from use of the donated material. If the embryo was donated before the July 7, 2009 effective date and the applicant cannot comply with all aforementioned requirements, materials establishing informed consent and derivation of the cell line from an embryo from IVF may be submitted to a working group that, in turn, would make a recommendation regarding eligibility to the NIH director, who ultimately decides funding eligibility.
The guidelines also mandate the creation of a registry listing hESCs eligible for NIH funding research. When endorsing applications and progress reports submitted to the NIH for projects using hESCs, funding recipients also must provide assurances that the cells are listed on the NIH registry.
Funding Exclusions Spelled Out
Specifically excluded from funding is research in which hESCs (even if derived from embryos donated in accordance with the guidelines) or human iPSCs are re-introduced into non-human primate blastocyst, and research involving the breeding of animals where the cells contribute to the germ line. The guidelines also make specific mention that funds cannot support research involving the derivation of stem cells from human embryos pursuant to Section 509, Omnibus Appropriations Act, 2009, Pub. L. 111-8, March 11, 2009, also known as the Dickey-Wicker Amendment, or support research where the hESCs are derived from other sources such as somatic cell transfer, parthenogenesis, and/or IVF embryos created for research purposes.
Enhanced Funding Opportunities
The NIH guidelines provide access to federal monies and add to the currently available state grants. More than $30 billion is distributed annually by the NIH in support of medical research. A little over $10.4 billion has been allocated for biomedical research to the NIH in the economic stimulus package. More than 10 state initiatives and referendums — such as California’s Proposition 71 — pledge state funds to support adult and embryonic stem cell basic and translational research. We anticipate that these and additional activities will continue to provide revenue-generation opportunities for public sector entities (e.g., state educational institutions) and private sector entities (e.g., commercial companies) — opportunities that could be realized through forthcoming grant and contract awards or the execution of other funding agreements.
While the implementation of President Obama’s Executive Order, as promulgated by the new NIH guidelines, does not remove the challenges to realizing the promise of the use of stem cells to treat disease, it does offer hope for researchers and patients that additional federal funding support for research will continue to move the frontier of discovery ahead. Researchers and industry representatives are advised to monitor further developments at the federal level and state level, which also are trending in a favorable direction.
Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and our colleagues. If you have any questions about this update or would like to discuss this topic further, please contact your Foley attorney or the following:
Antoinette F. Konski
Partner, Biotechnology & Pharmaceutical Practice
Palo Alto, California
Jeffrey S. Newman
Partner, Government Procurement Practice
Robert C. Geist, Jr.
Director, Government & Public Policy Practice