S 0771 General Bill, By Leventis, Drummond, Jackson, Ford, Hutto and Mescher
 A BILL TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING CHAPTER 46
 TO TITLE 44 ENACTING THE "BIOTECHNOLOGY ACT OF 2006" SO AS TO AUTHORIZE STEM
 CELL RESEARCH IN THIS STATE, AND AMONG OTHER THINGS, TO REQUIRE APPROVAL FROM
 AN INSTITUTIONAL REVIEW BOARD TO CONDUCT SUCH RESEARCH, TO PROHIBIT PURCHASING
 OR SELLING PREIMPLANTATION EMBRYOS FOR HUMAN EMBRYONIC STEM CELL RESEARCH, AND
 TO PROHIBIT HUMAN CLONING AND TO PROVIDE PENALTIES, TO PROVIDE FOR THE
 DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL TO LICENSE INSTITUTIONS
 CONDUCTING STEM CELL RESEARCH, TO FURTHER PROVIDE FOR THE REVIEW AND
 REGULATION OF SUCH RESEARCH, TO PROVIDE THAT AN EMPLOYEE OF AN INSTITUTION MAY
 NOT BE REQUIRED TO CONDUCT SUCH RESEARCH OR RELATED ACTIVITIES IF IT IS IN
 CONFLICT WITH THE EMPLOYEE'S RELIGIOUS BELIEFS, TO REQUIRE INFORMED CONSENT
 FOR DISPOSITION OF PREIMPLANTATION EMBRYOS FOR PATIENTS BEING TREATED FOR
 INFERTILITY, AND TO REQUIRE INFORMATION TO BE PROVIDED ON UMBILICAL AND
 PLACENTA DONATIONS.

   04/19/05  Senate Introduced and read first time SJ-6
   04/19/05  Senate Referred to Committee on Medical Affairs SJ-6

TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING CHAPTER 46 TO TITLE 44 ENACTING THE "BIOTECHNOLOGY ACT OF 2006" SO AS TO AUTHORIZE STEM CELL RESEARCH IN THIS STATE, AND AMONG OTHER THINGS, TO REQUIRE APPROVAL FROM AN INSTITUTIONAL REVIEW BOARD TO CONDUCT SUCH RESEARCH, TO PROHIBIT PURCHASING OR SELLING PREIMPLANTATION EMBRYOS FOR HUMAN EMBRYONIC STEM CELL RESEARCH, AND TO PROHIBIT HUMAN CLONING AND TO PROVIDE PENALTIES, TO PROVIDE FOR THE DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL TO LICENSE INSTITUTIONS CONDUCTING STEM CELL RESEARCH, TO FURTHER PROVIDE FOR THE REVIEW AND REGULATION OF SUCH RESEARCH, TO PROVIDE THAT AN EMPLOYEE OF AN INSTITUTION MAY NOT BE REQUIRED TO CONDUCT SUCH RESEARCH OR RELATED ACTIVITIES IF IT IS IN CONFLICT WITH THE EMPLOYEE'S RELIGIOUS BELIEFS, TO REQUIRE INFORMED CONSENT FOR DISPOSITION OF PREIMPLANTATION EMBRYOS FOR PATIENTS BEING TREATED FOR INFERTILITY, AND TO REQUIRE INFORMATION TO BE PROVIDED ON UMBILICAL AND PLACENTA DONATIONS.

Whereas, the General Assembly finds that:

(1)    human embryonic stem cell research and other research in the life sciences and regenerative medicine present a significant chance of yielding fundamental biological knowledge from which may emanate therapies to relieve, on a large scale, human suffering from disease and injury;

(2)    the biomedical scientists working in South Carolina within institutions of higher education, research institutes, hospitals, biotechnology companies, and pharmaceutical companies can contribute significantly to the welfare of mankind by performing outstanding research in this field; and

(3)    it is the policy of this State to actively foster research and therapies in the life sciences and regenerative medicine by permitting research and clinical applications involving the derivation and use of human embryonic stem cells and umbilical cord cells, and any human adult stem cells, including research and clinical applications involving somatic cell nuclear transplantation. It shall further be the policy of this State to prohibit human reproductive cloning.

Be it enacted by the General Assembly of the State of South Carolina:

SECTION    1.    Title 44 of the 1976 Code is amended by adding:

Section 44-46-10.    This chapter may be cited as the 'Biotechnology Act of 2006'.

Section 44-46-20.    For the purposes of this chapter, unless the context clearly requires otherwise:

(1)    'Advisory board' means stem cell research advisory board.

(2)    'Donated to medicine' means a preimplantation embryo originating from an in vitro process, when, for purposes of biomedical research or medical care or treatment, the persons contributing genetic material do so in the absence of financial inducement and after fulfillment of the requirements of a duly appointed institutional review board concerning informed consent.

(3)    'Fertilization' means the process whereby the male sperm and the female oocyte unite to form an embryo.

(4)    'Financial inducement' means any valuable consideration, excluding:

(a)    reimbursement for reasonable costs incurred in connection with a donation; and

(b)    reasonable compensation to a donor from whom an oocyte or somatic cell is recovered for the time, burden, preparation, and risk of such recovery. Whether costs or compensation are reasonable must be determined by a duly appointed institutional review board, provided the determination is made with due diligence and in good faith.

(5)    'Human adult stem cell' means an undifferentiated cell found in the differentiated tissue in adult humans which can renew itself and differentiate to yield specialized cell types.

(6)    'Human embryonic stem cell' means a pluripotent human stem cell derived from a preimplantation embryo.

(7)    'Human reproductive cloning' means creating, or attempting to create, a human being by transferring a nucleus of a human cell from any source into a human or nonhuman egg cell from which the nucleus has been removed for the purpose of creating a human being, and implanting the resulting product into a uterus or uterine-like environment to initiate pregnancy and a possible birth.

(8)    'Informed consent' means consent for the donation of embryos, consent for participation in vitro fertilization, or consent for any other process where an egg is extracted from a woman, or other participation in research pursuant to this chapter, which complies with requirements of a duly appointed institutional review board, and which follows the procedures stipulated in 45 CFR Part 46.116 and 117.

(9)    'Institution' means any organization, corporation, or institution that conducts human embryonic stem cell research.

(10)    'Institutional review board' or 'IRB' means a board that has a minimum of 5 members who meet regularly to review research applying the standards of 45 CFR Part 46 and 21 CFR Parts 50 and 56.

(11)    'In vitro' means in an artificial environment, referring to a process or reaction occurring therein, as in a test tube or culture medium.

(12)    'In vitro fertilization' means an assisted reproductive technique in which fertilization is accomplished outside of the body.

(13)    'Parthenote' means the product of egg development without fertilization.

(14)    'Parthenogenesis' means the development of an egg without fertilization.

(15)    'Person' means any natural person, corporation, association, partnership, institute, or other legal entity.

(16)    'Preimplantation embryo' means any in vitro human embryo whether formed by fertilization, somatic cell nuclear transfer or other means, which has not experienced more than fourteen days of development; provided, that such length of time does not include any interval in which such development has been suspended, such as through freezing.

(17)    'Public institutional review board' means a board established in accordance with the requirements of 45 CFR 46 Subpart A, as amended from time to time.

(18)    'Somatic cell nuclear transfer' means replacement of the nucleus of an egg with the nucleus from any other nonreproductive human cell.

(19)    'Uterus' means a muscular organ of a woman in which the ovum is deposited and the embryo and fetus are developed, or fallopian tube.

(20)    'Uterine-like environment' means any replicate of the uterus used for the purpose of sustaining an embryo through birth and creating a human being.

Section 44-46-30.    (A)    Research and clinical applications involving the derivation and use of human embryonic stem cells, human adult cells from any source, somatic cell nuclear transplantation and umbilical cord stem cells, parthenotes, is permitted in this State in accordance with this chapter.

(B)(1)    No person may use a preimplantation human embryo donated to medicine in scientific research or other kind of experimentation or study for the derivation of human embryonic stem cells without the prior written approval, and continuing review on at least an annual basis, of a duly appointed IRB or public IRB setting forth the IRB's approval of the research, experimentation, or study. The written approval must contain a detailed description of the research, experimentation, or study by attachment of a protocol or other writing, must include written documentation of informed consent, and must be maintained as a permanent record by the IRB or the hospital or other entity for which the IRB acts.

(2)    No person may knowingly purchase or sell any preimplantation embryo for human embryonic stem cell research for valuable consideration. For purposes of this subsection, 'valuable consideration' excludes reasonable payments associated with storage, quality control, preservation, processing, or transportation of such preimplantation embryos donated to medicine.

(C)    Human reproductive cloning is prohibited. Accordingly, a preimplantation embryo donated to medicine for purposes of human embryonic stem cell research, pursuant to this section, must not be transferred to a uterus or a uterine-like environment. Nothing in this chapter prohibits or regulates the use of in vitro fertilization for reproductive purposes.

(D)    A person who knowingly violates subsection (B)(1) or (B)(2) must be imprisoned for not less than one year or more than two years or fined not more than one hundred thousand dollars. A person who violates subsection (C) must be imprisoned for not less than one year or more than two years or fined up to one million dollars.

Section 44-46-40.    (A)    For the purposes of reporting to the Governor, President of the Senate, and Speaker of the House of Representatives on the status of human embryonic stem cell research and proposing modifications to the regulation of this research, there is established the Stem Cell Research Advisory Board. The advisory board shall consist of eight members, all of whom must be residents of this State. The members must be professionally qualified and collectively experienced in the fields of science including, but not limited to, knowledge of cell differentiation, nuclear reprogramming, tissue formation and regeneration, stem cell biology, developmental biology, regenerative medicine, related biomedical and research fields, medical ethics, and biotechnology, and must include one community member. Three members must be appointed by the President of the Senate, three must be appointed by the Speaker of the House of Representatives, and the one community member must be appointed by the Governor. The eighth member must be the Director of the Department of Health and Environmental Control.

(B)    Original members of the advisory board must have staggered terms of one to three years, and thereafter, members' terms are for three years.

(C)    A person who conducts scientific research, experimentation, or study that involves the creation or use of preimplantation embryos in relation to human embryonic stem cell research shall submit an annual report to the advisory board providing a summary of the research approved during that calendar year and a statement representing that the research was reviewed in accordance with Section 44-46-30. Any disclosure that, in the opinion of the institution or person submitting disclosure, is a trade secret, proprietary, or confidential must be submitted separately from the annual report with a statement explaining the reasons that the information should be deemed confidential to the Attorney General, who shall determine whether the information should be kept confidential as proprietary. The Attorney General shall submit all disclosures considered not proprietary to the Stem Cell Research Advisory Board after notice to the institution or person submitting the disclosure. All disclosures considered proprietary must be kept confidential by the office of the Attorney General and, notwithstanding any law to the contrary, must not be deemed a public record. The Attorney General may establish procedures to effectively carry out this paragraph.

(D)    The advisory board shall meet periodically, and no less than twice each year. All meetings must be public.

(E)    The advisory board shall keep a public record of all meetings, votes, and other business.

(F)    The advisory board shall review the annual reports from persons conducting scientific research, experimentation, or study that involves the creation or use of preimplantation embryos in relation to human embryonic stem cell research. The advisory board may require submission of a copy of the federal-wide assurance from the institutions whose IRBs review preimplantation embryo research relating to human embryonic stem cell research.

(G)    The advisory board shall study the implementation of this chapter and the conduct of research and shall make recommendations to the General Assembly on ways to encourage disproportionately impacted population's participation in, and benefit from, human embryonic stem cell research, including requiring the IRB to develop methods for such participation.

(H)    Based on its review of the annual reports submitted, the advisory board shall submit to the Governor, President of the Senate, and Speaker of the House by January 31 of each year an annual report of the current state of preimplantation embryo research relating to human embryonic stem cell research in the State. The advisory board may include recommendations, if any, regarding the modification of regulations concerning human embryonic stem cell research.

(I)    The advisory board shall receive administrative support from the Department of Health and Environmental Control.

Section 44-46-50.    (A)    An employee may not be required to conduct scientific research, experimentation, or study that involves the creation or use of preimplantation embryos in relation to human embryonic stem cell research to the extent that such research conflicts with the bona fide religious practices and beliefs of the employee.

(B)    A physician or other health care provider who treats a patient for infertility shall provide the patient with timely, relevant and appropriate information sufficient to allow that patient to make an informed and voluntary choice regarding the disposition of any preimplantation embryos remaining following said treatment. The physician shall present the patient with the options of storing, donating to another person, donating for research purposes, or otherwise disposing of or destroying any unused preimplantation embryos, as appropriate. The Department of Health and Environmental Control shall prescribe and provide for use by physicians and other health care providers who treat patients for infertility through in vitro or any other process where an egg is extracted from a woman the following two documents:

(1)    an informational pamphlet, describing the procedure by which an egg is intended to be extracted from the patient, including all short and long-term potential health impacts of the procedure on the patient, any drugs or devices to be used, including whether they have received approval from the United States Food and Drug Administration, the risks involved, any discomfort and side-effects that may be experienced, any alternatives which the patient has and their attendant risks and benefits, medical treatment available to the patient should complications arise, and that the particular treatment may involve currently unforeseeable risks to the patient, embryo, or fetus. A physician or other health care provider treating a woman with any procedure by which an egg is intended to be extracted shall provide the patient with this pamphlet or a legible copy of the pamphlet, and provide any other treatment information which may be specific to the patient's treatment; and

(2)    an informed consent form, stating that the patient has been given, has reviewed and understands the informational pamphlet described in item (1), has consulted with her physician or health care provider concerning the general procedures and her specific medical situation, and, understanding the procedure, process, and risks, consents to proceed with the procedure or process. The informed consent form must also contain a 'Notes' section, to be completed by the physician or health care provider. This notes section must contain any medical information, alternative procedures, medicines, devices, considerations, or risks relevant to the specific patient's informed consent to proceed and must be completed by the physician or health care provider in each case. A physician or other health care provider treating a woman by any procedure by which an egg is intended to be extracted shall provide the patient with this form or a legible copy of the form, and shall keep a signed copy of this document in the patient's medical file.

A physician or other health care provider must not provide such treatment before providing the patient with both the informational pamphlet and the informed consent form, and receiving in return a complete and fully-executed informed consent form from the patient. A physician or other health care provider shall seek informed consent only under circumstances that provide the prospective patient reasonable opportunity to consider whether or not to receive such treatment and that minimize the possibility of coercion or undue influence. The information that is given to the patient must be in language understandable to the patient. No informed consent, whether oral or written, may include a waiver of legal rights beyond those specifically acknowledged as waived by the terms of the consent.

(C)    An institution conducting human embryonic stem cell research shall not take any retaliatory action against its employee because its employee:

(1)    discloses or threatens to disclose to a manager or a public body an activity, policy, or practice of the institution conducting embryonic stem cell research, or of another institution conducting such research with whom the employee's institution has a business relationship, that the employee reasonably believes is in violation of Sections 44-46-30 through 44-46-60; or

(2)    objects to, or refuses to participate in, any activity, policy, or practice that the employee reasonably believes is in violation of Sections 44-46-30 through 44-46-60.

(D)    For purposes of this section:

(1)    'Retaliatory action' means the discharge, suspension, demotion, harassment, denial of promotion, layoff, or other adverse action taken against an employee affecting the terms and conditions of employment.

(2)    'Manager' means an individual to whom an institution conducting human embryonic stem cell research has given the authority to direct and control the work performance of the affected employee, who has authority to take corrective action regarding a violation of a law, rule, regulation, activity, or policy.

(3)    The protection against retaliatory action does not apply to the public disclosure of confidential or proprietary information, trade secrets, or other confidential materials unless such confidential disclosure is made by the employee directly to and exclusively with the office of the Attorney General or the Department of Health and Environmental Control. The Department of Health and Environmental Control must not publicly disclose any such confidential information but shall submit the information to the Attorney General immediately.

(E)    An employee aggrieved by a violation of this section may, within two years, file a complaint with the Attorney General, who may bring an action in the name of the State against any institution conducting human embryonic stem cell research that has violated subsection (C).

(F)    The Department of Health and Environmental Control shall establish a program to educate maternity patients with regard to the subject of 'cord blood banking'. This program shall provide these patients with sufficient information to make an informed decision on whether or not to participate in a private or public umbilical cord blood banking program including, but not limited to, an explanation of the difference between public and private umbilical cord blood banking, the medical process involved in umbilical cord blood banking, the current and potential future medical uses of stored umbilical cord blood, the benefits and any risks involved in banking umbilical cord blood, and the availability and cost of public or private umbilical cord blood banks.

Section 44-46-60.    (A)    The Department of Health and Environmental Control shall issue a license authorizing an institution to conduct human embryonic stem cell research, within thirty days after the applying institution pays a fee of not more than two hundred dollars to the department, and provides documentation to the department demonstrating that the institution has or has arranged for a duly appointed IRB or a copy of a valid contract between the institution and the public IRB that shall review the institution's experimentation, study, and procedures involving human embryonic stem cell research.

(B)    No person may conduct human embryonic stem cell research at any institution that does not have a license issued pursuant to this section.

(C)    All licenses issued pursuant to this act expire December 31 of the third year after the date of issuance. A holder of a license is entitled to have the license renewed for a three-year term by the department, upon the payment of a renewal fee of not more than two hundred dollars. On November 1 of each year, the department shall send written notice to this effect to every licensed institution, whose license shall expire that calendar year, and shall enclose with each notice a proper blank form for such renewal. If the blank form, properly filled out, together with the fee, is not received before January 1 of each year by the department from any institution so notified, the department shall strike from the register the name of that institution; but at any time thereafter, an institution, upon submission to the department of proof of satisfactory compliance with the procedures and guidelines contained in this section, may have its name restored in the register upon the payment to the department of all accrued renewal fees, together with a reinstatement fee of not more than two hundred dollars.

(D)    The Department of Health and Environmental Control shall keep an official record of the names of all licensed institutions and of all money received and disbursed by it, and a duplicate must be open to public inspection in the office of the Secretary of State.

(E)    An institution that applies for a license and complies with subsection (A) must not have its license unreasonably withheld. If thirty days following an application for a license the department has failed to issue the license to an applying institution that is in compliance with this section, the institution is considered to be licensed and the Department of Health and Environmental Control shall issue the license accordingly. If an application is considered by the department to be incomplete, the department shall immediately issue notice to the applicant of any further information or corrections necessary for the issuance of the license pursuant to this section.

Section 44-46-70.    (A)    The Department Health and Environmental Control shall establish and maintain, in partnership with the Medical University of South Carolina and the University of South Carolina School of Medicine, a public bank for umbilical cord and placental tissue for the purpose of collecting and storing umbilical cord blood and placental tissue that is donated by maternity patients in this State. The public bank shall collect any donated umbilical cord blood and placental tissue from participating hospitals and store said blood and tissue, and tissue to be made available for research, pursuant to the provisions of this chapter.

(B)    Notwithstanding any other provision of law, all licensed hospitals shall inform pregnant patients, not later than thirty days from the commencement of their third trimester of pregnancy, of the opportunity to donate to a publicly accessible certified cord blood and placental tissue bank, blood and tissue extracted from the umbilical cord and placenta following delivery of a newborn child. Donations for research pursuant to this chapter must be made at no expense to the donor. Donations must be made without financial inducement to the donor and after informed consent.

(C)    Institutions licensed under Section 44-46-60 may reach agreement with the public umbilical cord blood bank to acquire donated umbilical cord blood or placental tissue for the purpose of conducting research. This agreement shall provide for the payment of the estimated expenses of the collection and storage of the donated umbilical cord blood and placental tissue, as well as any reasonable administrative fees by the institution.

(D)    Nothing in this section obligates a hospital to collect umbilical cord blood or placental tissue if, in the professional judgment of a physician licensed to practice medicine in all its branches or of a nurse, the collection would threaten the health of the mother or child.

(E)    Nothing in this section imposes a requirement upon any hospital employee, physician, nurse, or hospital that is directly affiliated with a bona fide religious denomination that includes as an integral part of its beliefs and practices the tenet that blood transfer is contrary to an essential part of its doctrine or beliefs.

Section 44-46-80.    (A)    The Medical University of South Carolina and the University of South Carolina School of Medicine shall jointly establish and maintain a public institutional review board ('public IRB'). The public IRB shall operate pursuant to the provisions contained in Section 44-46-20. The public IRB must be established not later than one hundred twenty days from this act's effective date. The public IRB must be available on an ongoing basis to any institution for review of that institution's experimentation, study, and procedures for the purposes of conducting research pursuant to this chapter. The public IRB must be available to any institution employing 50 or fewer full-time employees.

(B)    An institution may access the services of the public IRB only through a written instrument of contract. The contract must include the payment to the public IRB of a reasonable fee, calculated pursuant to a methodology approved by the advisory board to account for the costs of operating and maintaining the public IRB and the relevant position of those costs attributable to the particular institution receiving the benefit."

SECTION    2.    A.    The Stem Cell Advisory Board, established pursuant to Section 44-46-40 of the 1976 Code, together with the Department of Health and Environmental Control, shall conduct a feasibility study on the establishment and maintenance of a public bank for the collection and storage of umbilical cord blood and cells and placental tissue and cells for the purpose of making these resources available to donors and their families for individual medical research and treatment.

B.    This study shall include, but is not limited to, the development of an appropriate fee structure to be charged to individuals participating in the bank, any necessary eligibility requirements to ensure access to the bank for citizens of all geographic regions of the State, of all levels of income, the costs of operating and maintaining said bank, and any possible need for and appropriateness of public subsidies for those costs, any necessary regulations and protocols to govern donations to the bank and the release and use of banked cells, tissue or blood, the potential for and desirability of additional partnerships in operating the bank, and any ethical considerations involved in its creation and maintenance.

C.    The board shall report the findings of the study, together with all necessary legislative recommendations for the establishment and maintenance of the bank, to the House of Representatives, the Senate, and the Governor, not later than one hundred eighty days after this act's effective date.

SECTION    3.    Any institution currently conducting human embryonic stem cell research in this State has one hundred eighty days from this act's effective date to comply with the provisions of this act. Research currently being conducted by institutions in this State relative to human embryonic stem cell research is not deemed to be in violation of Section 44-46-30(B)(1) of the 1976 Code for one hundred fifty days after this act's effective date and of Section 44-46-60(B) for one hundred eighty days after this act's effective date.

SECTION    4.    This act takes effect upon approval by the Governor.