WHEREAS, the 144th General Assembly considers it essential
that the State of Delaware establish a responsible, ethical policy regarding
the rapidly emerging science of regenerative medicine, human reproductive
cloning and stem cell research conducted within the State of Delaware; and
WHEREAS, stem cell research is a key area of regenerative
medicine that offers immense promise for developing new medical therapies and
potential cures for such conditions as juvenile diabetes, diabetes, cancer,
cardiovascular disease, Sickle Cell disease, Alzheimer’s disease, Parkinson’s
disease, spinal cord injuries, birth defects, Osteoporosis, severe burn
injuries, Multiple Sclerosis and HIV/AIDS; and
WHEREAS, stem cell research also offers a critical means to
explore fundamental questions of biology and disease development; and
WHEREAS, stem cells may one day serve as test models for
pharmaceutical development; and
WHEREAS, all reputable forms of stem cell research should be
pursued, including adult, umbilical cord blood, amniotic and embryonic stem
cells, because one is not a replacement for another and because new information
resulting from one avenue of research may be key to advances in another area;
and
WHEREAS, in recognition of the medical potential of adult
stem cells and stem cells derived from umbilical cord blood, the State provided
funding in the Fiscal Year 2007 grant-in-aid bill for a one-time appropriation
to the Brady Kohn Foundation, a Delaware-based nonprofit organization, to help
fund its community outreach initiative to educate members of the public on the
lifesaving potential of umbilical cord blood; and
WHEREAS, stem cell research raises significant ethical and
policy issues that must be carefully considered; and
WHEREAS, the establishment of an ethical policy that
encourages the pursuit of state-of-the-art scientific research in the field of
regenerative medicine, while guarding against its possible misuse, will help to
ensure the long-term health and well being of Delawareans; and
WHEREAS, public policy on stem cell research must balance
ethical and medical considerations, and said policy must be based on an
understanding of the science associated with stem cell research and grounded on
a thorough consideration of the ethical concerns regarding this research;
and
WHEREAS, public policy on stem cell research must be
carefully crafted to ensure that researchers have the tools necessary to
fulfill the promise of stem cell research; and
WHEREAS, many prestigious scientific societies and leading
research institutions in the United States, including, among others, the
American Medical Association, the American College of Surgeons , the American
Society for Cell Biology, the American Association for Cancer Research, the
Society for Neuroscience, the Salk Institute for Biological Studies, Columbia
University, Harvard University, Johns Hopkins University, the University of
Pennsylvania, Yale University and Washington University in St. Louis, endorse
stem cell research, including responsible and ethical embryonic stem cell
research; and
WHEREAS, numerous societies and organizations dedicated to
curing diseases that affect Delawareans and other Americans, such as the
American Diabetes Association, the National Multiple Sclerosis Society, the
Paralyzed Veterans of America, the Parkinson’s Disease Foundation, and the
Foundation Fighting Blindness, endorse stem cell research, including
responsible and ethical embryonic stem cell research; and
WHEREAS, Delaware is home to such respected organizations as
the University of Delaware, Delaware State University, the Nemours Foundation,
the Alfred I. du Pont Hospital for Children, the Helen F. Graham Cancer Center,
the Delaware Biotechnology Institute, and the Delaware Technology Park; and
WHEREAS, the State of Delaware, with its rich legacy of world
leadership in scientific research and discovery, is actively promoting the
development of biotechnology enterprises because of their potentially great
importance to the health of our citizens as well as to the state’s economy; and
WHEREAS, the 144th General Assembly is desirous of fostering
research that will advance the state of medical and scientific knowledge, and
will offer enormous potential to save human lives and treat heretofore
incurable diseases, and which will also allow the State of Delaware to have a
significant role in the emerging biomedical technology field, to the benefit of
all of its citizens;
NOW THEREFORE:
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:
Section
1. Amend Title 16, Delaware Code, by inserting a new Chapter as follows:
“Chapter
30D. The Delaware
Regenerative Medicine Act.
§ 3001D. Findings and purpose.
The 144th General Assembly
considers it essential that the State of Delaware establish a responsible,
ethical policy regarding the rapidly emerging science of regenerative medicine,
human reproductive cloning and stem cell research conducted within the State of
Delaware. Stem cell research is a key area of
regenerative medicine that offers immense promise for developing new medical
therapies and potential cures for many serious and previously incurable
diseases and conditions. Moreover, it
offers a critical means of exploring fundamental questions of biology and
disease development.
The General Assembly believes that all
reputable forms of stem cell research must be explored, including adult,
umbilical cord blood, amniotic and embryonic, because knowledge gained from one
form of stem cell research may be key to advances in another area. However, stem cell research raises
significant ethical and policy issues that must be carefully considered. Not the least of these considerations is the
misuse of these procedures for human reproductive cloning, which this Chapter prohibits,
and the process of obtaining embryonic stem cells for research purposes, which
practice this Chapter strictly limits.
It also establishes severe penalties for violations of prescribed procedures
to ensure that the process occurs in a moral and ethical manner.
Public policy on
stem cell research must balance ethical and medical considerations. Such policy must be based on an understanding
of the science associated with stem cell research and grounded on a thorough
consideration of the ethical concerns regarding this research. Public policy on stem cell research must be
carefully crafted to ensure that researchers have the tools necessary to
fulfill the promise of stem cell research.
It is the policy of the State of Delaware to foster research that will
advance the state of medical and scientific knowledge, and will offer enormous
potential to save human lives and treat heretofore incurable diseases, and
which will also allow the State of Delaware to have a significant role in the
emerging biomedical technology field, to the benefit of all of its citizens.
§
3002D. Human reproductive cloning
prohibition.
(a) As used in this section, the
term (human reproductive cloning) means implanting or attempting to implant the
product of nuclear transplantation into a uterus or the functional equivalent
of a uterus. This does not include
somatic cell nuclear transplantation into eggs or embryonic stem cells for
research or therapeutic purposes that do not involve implantation to initiate a
pregnancy.
(b) A person who knowingly
engages or assists, directly or indirectly, in the cloning of a human being is
guilty of a Class E felony and shall be subject to a fine not to exceed
$1,000,000.00 for each offense.
§ 3003D.
Human embryonic stem cell research.
(a)
Human embryonic stem cells shall be eligible for use in research in the
State of Delaware
if the cells meet each of the following:
(1)
the stem cells were derived from human embryos that have been donated
from In Vitro Fertilization clinics, were created for the purposes of fertility
treatment, were in excess of the clinical need for individuals seeking such
treatment, and are less than the developmental age of 14 days;
(2)
prior to the consideration of the embryo donation and through
consultation with the individuals seeking fertility treatment, it was
determined that the embryos would never be implanted in a woman and would
otherwise be discarded;
(3) the individuals seeking fertility treatment donated the
embryos with written informed consent and neither the individuals nor the clinic
will receive any financial or other inducements to make the donation; and
(4) throughout the process, the
individuals who created the embryos must be educated regarding their options
with respect to any excess embryos, including embryo adoption, and may at any
time up until the point of donation, change their minds.
(b) Any person, including any physician or
fertility clinic who knowingly sells or attempts to sell an embryo is guilty of
a Class E felony and shall be subject to a fine not to exceed $100,000.00 for
each offense.
§ 3004D.
Review of human embryonic stem cell research required.
(a) There is hereby established a
Human Stem Cell Research Advisory Committee consisting of thirteen (13) members
appointed by the Governor. Members of the initial Committee shall be
appointed to staggered terms of one (1) to two (2) years, and thereafter all
terms of appointment shall be four (4) years. The Committee shall consist
of the following members:
(1)
five (5) scientists, including at least two (2) from the private
research sector with experience and training in biomedical and/or clinical
research in the fields of cell differentiation, nuclear reprogramming, tissue
formation and regeneration, cell biology, stem cell biology, developmental
biology, regenerative medicine or related fields;
(2)
two (2) medical ethicists;
(3)
two (2) persons licensed to practice law with backgrounds in legal
issues related to human embryonic stem cell research, in vitro fertilization,
or family law, as it applies to the donation of blastocysts and oocytes;
(4)
one (1) member of the Delaware
disabilities community; and
(5)
three (3) members of the public.
(b)
Such staff assistance as may be required by the Committee for its
operations shall be provided by the staff of the Delaware Health Care
Commission.
(c)
The Committee shall adopt guidelines for research involving the
derivation or use of human embryonic stem cells in Delaware within six (6) months of enactment
of this legislation. Such guidelines shall be consistent with established
Federal guidelines, including (i) the guidelines for research using human
pluripotent stem cells developed by the National Institutes of Health published
in August 2000, and corrected in November 2000, and (ii) guidelines for
research issued by the National Research Council and the Institute of Medicine
of the National Academies, published in April, 2005. After adoption of
the initial guidelines, the Committee may revise the guidelines or issue
advisory opinions, as necessary, to account for developments in research and
medicine as they may affect the research and ethical considerations associated with
the use of human embryonic stem cells.
(d)
Any such guidelines adopted or advisory opinions issued by the Committee
shall only apply to research that is publicly funded by the State of Delaware.
(e)
Whenever the Committee is asked to issue an advisory opinion as to
whether proposed research meets Delaware’s
guidelines, the Committee may, at its direction, obtain the assistance of a
Scientific Review Panel, at the expense of the party seeking the advisory
opinion. The members of the Scientific Review Panel are to be recommended
by the University
of Delaware and are
subject to the approval by the Committee. The Scientific Review Panel
shall submit a written report to the Committee containing the Panel’s findings
and recommendations.
(f)
The Committee shall issue an annual written report on its activities to
the Governor, the Delaware General Assembly and the Director of the Delaware
Division of Public Health on or before the first day of April of the year
following any calendar year in which such activity has occurred.
(g)
Any person, including any individual or legal entity of any kind who
knowingly violates the guidelines adopted by the Committee shall be subject to
a civil penalty not to exceed $500,000.00.”
