SENATE PUBLIC AFFAIRS COMMITTEE SUBSTITUTE FOR

SENATE BILL 313

51st legislature - STATE OF NEW MEXICO - first session, 2013

AN ACT

RELATING TO HEALTH; ENACTING THE BIOMEDICAL RESEARCH ACT; PERMITTING BIOMEDICAL RESEARCH ON LIMITED CATEGORIES OF HUMAN EMBRYONIC STEM CELLS; REQUIRING OVERSIGHT; PROHIBITING HUMAN CLONING; IMPOSING PENALTIES; AMENDING THE MATERNAL, FETAL AND INFANT EXPERIMENTATION ACT; MAKING THE DEFINITION OF "EMBRYO" THE SAME UNDER BOTH ACTS.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF NEW MEXICO:

     SECTION 1. [NEW MATERIAL] SHORT TITLE.--Sections 1 through 7 of this act may be cited as the "Biomedical Research Act".

     SECTION 2. [NEW MATERIAL] DEFINITIONS.--As used in the Biomedical Research Act:

          A. "cell lines" means a permanently established cell culture that will proliferate indefinitely given the appropriate laboratory conditions;

          B. "embryo" means a fertilized human egg from the time that cell division begins to the end of the eighth week after conception;

          C. "fertilization" means the process whereby the male sperm and female ovum unite to form an embryo;

          D. "human adult stem cell" means an undifferentiated cell found in differentiated tissue that can renew itself and differentiate to yield specialized cell types;

          E. "human reproductive cloning" means the asexual creation of an embryo;

          F. "in vitro" means in a laboratory or clinical environment, including a test tube or culture medium, and also refers to a process or reaction occurring in a laboratory or clinical environment;

          G. "in vitro fertilization" means an assisted reproduction technique in which fertilization is accomplished outside the human body;

          H. "placental cells" means cells obtained from the placenta;

          I. "pre-implantation embryo" means an embryo formed and maintained outside the human body, by in vitro fertilization, that has not experienced more than fourteen days of development, excluding time the embryo was cryopreserved or frozen; and

          J. "umbilical cord stem cells" means cells derived from an umbilical cord.

     SECTION 3. [NEW MATERIAL] BIOMEDICAL RESEARCH PERMITTED--LIMITATIONS--RESEARCH PROHIBITIONS.--

          A. Research and clinical applications conducted in accordance with the Biomedical Research Act that involve the derivation and use of pre-implantation human embryonic stem cells are permitted; provided that they are derived from:

                (1) embryos that are produced by in vitro fertilization clinics and designated for destruction;

                (2) stem cell lines;

                (3) human adult stem cells from any source;                 (4) umbilical cord stem cells; and

                (5) placental cells.

          B. Research involving the derivation of human embryonic stem cells, as permitted by Subsection A of this section, shall only be conducted with the informed consent of the original progenitors or recipients pursuant to a sperm or egg donation agreement and in accordance with guidelines and policies promulgated by an institutional review board as provided in Section 4 of the Biomedical Research Act, which shall take into account the recommendations of the United States department of health and human services' office for human research protections, the national research council and the institute of medicine of the national academies.

     SECTION 4. [NEW MATERIAL] INSTITUTIONAL REVIEW BOARD OVERSIGHT REQUIRED.--A person or institution conducting stem cell research shall submit its activities to the oversight of an institutional review board. The institutional review board shall:

          A. provide oversight over all issues related to derivation and use of stem cells;

          B. review and approve the scientific merit of research protocols;

          C. review compliance of all stem cell research with all relevant regulations and guidelines; and

          D. perform such other activities as may be necessary or appropriate and consistent with nationally recognized institutional review board standards or protocols or as may be provided by law.

     SECTION 5. [NEW MATERIAL] HUMAN REPRODUCTIVE CLONING PROHIBITED.--

          A. It is unlawful to knowingly engage or assist in human reproductive cloning or attempted human reproductive cloning of a human being.

          B. A person shall not knowingly purchase, sell, transfer or otherwise obtain human embryonic, gametic or cadaveric tissue for the purpose of human reproductive cloning.

     SECTION 6. [NEW MATERIAL] SCIENTIFIC RESEARCH--EXEMPT

EMPLOYEES.--An employee shall not be required to conduct scientific research, experimentation or study that involves the creation or use of pre-implantation embryos in relation to human embryonic stem cell research to the extent that such research conflicts with the sincerely held religious practices or beliefs of the employee.

     SECTION 7. [NEW MATERIAL] PENALTIES.--Violation of a provision of the Biomedical Research Act is a misdemeanor and shall be punishable by a fine of not more than twenty-five thousand dollars ($25,000) or imprisonment for not more than one year or both.

     SECTION 8. Section 24-9A-1 NMSA 1978 (being Laws 1979, Chapter 132, Section 1, as amended) is amended to read:

     "24-9A-1. DEFINITIONS.--As used in the Maternal, Fetal and Infant Experimentation Act:

          A. "viability" means that stage of fetal development when the unborn child is potentially able to live outside the mother's womb, albeit with artificial aid;

          B. "conception" means the fertilization of the egg of a human female by the sperm of a human male;

          C. "health" means physical or mental health;

          D. "clinical research" means any biomedical or behavioral research involving human subjects, including embryos, conducted according to a formal procedure. The term is to be construed liberally to embrace research concerning all physiological processes in human beings and includes research involving human in vitro fertilization, but shall not include diagnostic testing, treatment, therapy or related procedures conducted by formal protocols deemed necessary for the care of the particular patient upon whom such activity is performed and shall not include human in vitro fertilization performed to treat infertility; provided that this procedure shall include provisions to ensure that each living fertilized ovum, zygote or embryo is implanted in a human female recipient, and no physician may stipulate that a woman must abort in the event the pregnancy should produce a child with a disability; and provided further that emergency medical procedures necessary to preserve the life or health of the mother or the fetus shall not be considered to be clinical research;

          E. "subject at risk", "subject" or "at risk" means any person who may be exposed to the likelihood of injury, including physical or psychological injury, as a consequence of participation as a subject in:

                (1) any research, development or related activity that departs from the application of those established and accepted methods deemed necessary to meet the person's needs;

                (2) controlled research studies necessary to establish accepted methods designed to meet the person's needs; or

                (3) research activity that poses a significant risk to the subject;

          F. "significant risk" means an activity that is likely to cause disfigurement or loss or impairment of the function of any member or organ;

          G. "embryo" means a fertilized human egg from the time that cell division begins to the end of the eighth week after conception;

          [G.] H. "fetus" means the product of conception from the [time of] end of the eighth week after conception until the expulsion or extraction of the fetus or the opening of the uterine cavity, but shall not include the placenta, extraembryonic membranes, umbilical cord, extraembryonic fluids and their resident cell types, [and] cultured cells or products of conception produced by in vitro fertilization clinics and designated for destruction;

          [H.] I. "live-born infant" means an offspring of a person that exhibits heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles or pulsation of the umbilical cord if still attached to the infant ex utero; provided that the Maternal, Fetal and Infant Experimentation Act does not apply to a fetus or infant absent the characteristics set forth in this subsection;

          [I.] J. "infant" means an offspring of a human being from the time it is born until the end of its first chronological year;

          [J.] K. "born" means the time the head or any other part of the body of the fetus emerges from the vagina or the time the uterine cavity is opened during a caesarean section or hysterotomy; and

          [K.] L. "in vitro fertilization" means [any fertilization of human ova that occurs outside the body of a female, either through admixture of donor human sperm and ova or by any other means] an assisted reproduction technique in which fertilization is accomplished outside the human body."

     SECTION 9. Section 24-9A-7 NMSA 1978 (being Laws 1979, Chapter 132, Section 7) is amended to read:

     "24-9A-7. SHORT TITLE.--[Sections 1 through 7 of this act] Chapter 24, Article 9A NMSA 1978 may be cited as the "Maternal, Fetal and Infant Experimentation Act"."

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