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F I S C A L I M P A C T R E P O R T

SPONSOR Ryan

ORIGINAL DATE

LAST UPDATED

02/17/07

HB

SHORT TITLE

EMBRYONIC STEM CELL BIOMEDICAL RESEARCH

SB 894

ANALYST Hanika Ortiz

ESTIMATED ADDITIONAL OPERATING BUDGET IMPACT (dollars in thousands)

FY07

FY08

FY09 3 Year

Total Cost

Recurring

or Non-Rec

Fund

Affected

Total

$.1 see

narrative

(Parenthesis ( ) Indicate Expenditure Decreases)

SOURCES OF INFORMATION

LFC Files

Responses Received From

Department of Health (DOH)

Administrative Office of the Courts (AOC)

SUMMARY

Synopsis of Bill

Senate Bill 894 expands the scope of prohibited activities addressed in the current Maternal,

Fetal and Infant Experimentation Act and enacts the “Biomedical Research Act", permitting

biomedical research on certain embryonic stem cells while at the same time attempting to

prohibit human reproductive cloning. Punishment for violation of the new covered activities is a

misdemeanor.

Sections 1 and 2: cites the title of the Act as the “Biomedical Research Act" and purpose of the

Act which states the benefits of human embryonic stem cell and other biomedical research.

Section 3: Defines terms used in the Act, including:

•

“embryo" is an organism of the species Homo sapiens formed by fertilization, somatic

cell nuclear transfer, parthenogenesis or other means;

•

“human adult stem cell" is an undifferentiated cell found in differentiated tissue that can

renew itself and differentiate to yield specialized cell types;

•

“human reproductive cloning" is the asexual genetic replication of a human being by

transferring a pre-implantation embryo created by somatic cell nuclear transfer,

parthenogenesis or by other asexual means into a uterus or uterine-like environment with

the purpose of creating a human fetus or human child;

Senate Bill 894 – Page

2

•

“pre-implantation embryo" is an embryo formed and maintained outside the human body,

whether by in vitro fertilization, somatic cell nuclear transfer, parthenogenesis or other

asexual means that has not experienced more than fourteen days of development, not

including time in suspension, such as through freezing.

Section 4: Permits certain research and clinical applications involving the use of pre-implantation

human embryonic stem cells, including somatic cell nuclear transfer, human stem cells and

umbilical cord stem cells. The research shall only be conducted in accordance with guidelines

and policies promulgated by the National Research Council and the Institute of Medicine of the

National Academies. The Act prohibits research involving in vitro culture of an intact human

embryo for longer than 14 days or until formation of the primitive streak begins, whichever is

first.

Section 5: Prohibits human reproductive cloning; attempted human reproductive cloning;

purchasing, selling, transferring or obtaining human embryonic, gametic or cadaveric tissue for

the purpose of reproductive cloning; and, creating an embryo with the sole intent of research.

This subsection allows the creation of a pre-implantation embryo formed by asexual means for

research purposes.

Section 6: Exempts an employee from the conduct of research, experimentation or study if it

conflicts with their sincerely held religious practices or beliefs.

Section 7: Provides that violation of the Act is a misdemeanor and shall be punishable by a fine

of up to $25,000 or imprisonment for not more than 1 year or by both.

Section 8: Amends Section 24-9A-1 NMSA 1978, the Maternal, Fetal and Infant

Experimentation Act; and, excludes from the definition of “fetus" products of conception

produced by in vitro fertilization technology and targeted for disposal or deemed excess tissue.

FISCAL IMPLICATIONS

There is no appropriation or agency directed to establish policies and procedures needed to

implement the Biomedical Research Act and amend the Maternal, Fetal and Infant

Experimentation Act. This activity has the potential to require a general fund appropriation.

The National Institute of Health (NIH) is the Federal government's leading biomedical research

organization. The NIH funds research scientists to conduct research on existing human

embryonic stem cells and to explore the enormous promise of these unique cells, including their

potential to produce breakthrough therapies and cures. Scientists are working with the NIH and

the research community to establish a research infrastructure to ensure the successful handling

and use of these cells in the laboratory. The bill creates guidelines for researchers studying

human stem cells in New Mexico toward the goal of fostering such biomedical research within

New Mexico.

SIGNIFICANT ISSUES

Stem cells formed in the earliest embryos are powerful because they can form any kind of cell.

Scientists want to study them to find ways to better help the body repair itself. The use of human

embryonic stem cells, which can be made either from embryos left over from fertility clinics or

Senate Bill 894 – Page

3

by using cloning technology is controversial because of concerns about the sanctity of human

life, and is restricted in some countries.

DOH notes that the public literature on stem cells considers “somatic cell nuclear transfer"

(SCNT) and “parthenogenesis" synonymous with cloning activity.

Proposals to use SCNT techniques in human stem cell research raise a set of concerns beyond the

moral status of any created embryo. One concern is that blastula creation in human stem cell

research will lead to the reproductive cloning of humans (most researchers believe that in the

foreseeable future it will not be possible to use this technique to produce a human clone that will

develop to term). A second concern is the appropriate sourcing of the eggs that are needed.

SCNT requires human eggs, which can only be obtained from women. The most common source

of these eggs today are eggs that are produced and in excess of the clinical need during in vitro

fertilization. This is a minimally invasive procedure, but it does carry some health risks.

Parthenogenesis is another form of asexual reproduction in which female eggs develop without

fertilization by a male. The cells can be closely matched to the immune system of the recipient

making them a potential source for transplants. In theory, the process could be used to reproduce

humans but only after extensive testing and perfection.

The bill also amends the Maternal, Fetal and Infant Experimentation Act and excludes “products

of conception produced by in vitro fertilization technology and targeted for disposal or deemed

excess tissue" from the prohibitions on research; and, has the potential for serious ethical debate.

PERFORMANCE IMPLICATIONS

AOC comments that The National Conference of State Legislatures website, in discussing state

embryonic and fetal research laws posted the following:

“State laws may restrict the use of embryonic stem cells from some or all sources or

specifically permit certain activities. State laws on the issue vary widely. Approaches to

stem cell research policy range from statutes in California, Connecticut, Maryland,

Massachusetts and New Jersey and an Executive Order in Illinois which encourage

embryonic stem cell research; to South Dakota's law, which strictly forbids research on

embryos regardless of the source. States that specifically permit embryonic stem cell

research have established guidelines for scientists such as consent requirements and

approval and review processes for projects."

ADMINISTRATIVE IMPLICATIONS

The bill is unclear which State agency is responsible to address ethical and legal issues including

applicable federal laws; create standardized procedures to

ensure that persons providing cells

gave informed consent

; and, establish criteria for the use of embryos and human eggs for

research purposes and by whom.

TECHNICAL ISSUES

Section 3; defines “embryo" without a limitation upon the age of the organism. An embryo is

considered to be from conception up to 8 weeks of age. Furthermore, DOH notes that the

definition of fetus currently in the Maternal, Fetal and Infant Experimentation Act does not

distinguish between embryonic and fetal stages (greater than 8 weeks).

Senate Bill 894 – Page

4

Section 4(C); the bill does not contain a definition of “primitive streak". The bill restricts

research involving an in vitro culture of an intact human embryo if older than fourteen days or

until formation of the “primitive streak" begins, which ever occurs first. The primitive streak is

an important concept in bioethics, where some experts have argued that experimentation with

human embryos is permissible only until the primitive streak develops, generally around the

fourteenth day of existence. The development of the primitive streak is taken, by such

bioethicists, to signify the creation of a unique, potential human being.

OTHER SUBSTANTIVE ISSUES

DOH comments that human stem cells are believed to hold promise for the understanding and

treatment of many major acute and chronic developmental and degenerative diseases. Because of

their potential to divide and specialize into many different cells types, stem cells have great

potential for use in repairing damaged tissues to recover lost function. The ability of stem cells

to be re-directed toward the development of different cells varies depending upon the source of

the stem cell, with adult cells appearing to have more limited potential than embryonic, placental

and amniotic stem cells.

ALTERNATIVES

Initiate a “New Mexico Advisory Committee on Human Cloning" in an effort to provide useful

advice to lawmakers by laying out the background on the issues, analyzing the arguments, and

presenting recommendations. In addition, the State should create a more permanent body to

provide advice and expertise on other important ethical, legal, and policy issues that will arise

from our increased understanding of human biology.

WHAT WILL BE THE CONSEQUENCES OF NOT ENACTING THIS BILL

Page 4, line 23 after the period insert “and the New Mexico department of health.

AHO/nt