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					                                  South Carolina General Assembly
                                      117th Session, 2007-2008

S. 173


General Bill
Sponsors: Senator Leventis
Document Path: l:\council\bills\nbd\11075ac07.doc

Introduced in the Senate on January 9, 2007
Currently residing in the Senate Committee on Medical Affairs

Summary: Biotechnology Act


    Date     Body     Action Description with journal page number
12/13/2006   Senate   Prefiled
12/13/2006   Senate   Referred to Committee on Medical Affairs
  1/9/2007   Senate   Introduced and read first time SJ-104
  1/9/2007   Senate   Referred to Committee on Medical Affairs SJ-104


 9                              A BILL
35   Whereas, the General Assembly finds that:
37      (1) human embryonic stem cell research and other research in
38   the life sciences and regenerative medicine present a significant
39   chance of yielding fundamental biological knowledge from which
40   may emanate therapies to relieve, on a large scale, human suffering
41   from disease and injury;

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 1      (2) the biomedical scientists working in South Carolina within
 2   institutions of higher education, research institutes, hospitals,
 3   biotechnology companies, and pharmaceutical companies can
 4   contribute significantly to the welfare of mankind by performing
 5   outstanding research in this field; and
 6      (3) it is the policy of this State to actively foster research and
 7   therapies in the life sciences and regenerative medicine by
 8   permitting research and clinical applications involving the
 9   derivation and use of human embryonic stem cells and umbilical
10   cord cells, and any human adult stem cells, including research and
11   clinical applications involving somatic cell nuclear transplantation.
12   It shall further be the policy of this State to prohibit human
13   reproductive cloning.
15   Be it enacted by the General Assembly of the State of South
16   Carolina:
18   SECTION 1. Title 44 of the 1976 Code is amended by adding:
20                             “CHAPTER 46
22                             Biotechnology
24     Section 44-46-10. This chapter        may    be   cited   as   the
25   ‘Biotechnology Act of 2008’.
27      Section 44-46-20. For the purposes of this chapter, unless the
28   context clearly requires otherwise:
29      (1) ‘Advisory board’ means stem cell research advisory board.
30      (2) ‘Donated to medicine’ means a preimplantation embryo
31   originating from an in vitro process, when, for purposes of
32   biomedical research or medical care or treatment, the persons
33   contributing genetic material do so in the absence of financial
34   inducement and after fulfillment of the requirements of a duly
35   appointed institutional review board concerning informed consent.
36      (3) ‘Fertilization’ means the process whereby the male sperm
37   and the female oocyte unite to form an embryo.
38      (4) ‘Financial inducement’ means any valuable consideration,
39   excluding:
40        (a) reimbursement for reasonable costs incurred in
41   connection with a donation; and
42        (b) reasonable compensation to a donor from whom an
43   oocyte or somatic cell is recovered for the time, burden,

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 1   preparation, and risk of such recovery. Whether costs or
 2   compensation are reasonable must be determined by a duly
 3   appointed institutional review board, provided the determination is
 4   made with due diligence and in good faith.
 5      (5) ‘Human adult stem cell’ means an undifferentiated cell
 6   found in the differentiated tissue in adult humans which can renew
 7   itself and differentiate to yield specialized cell types.
 8      (6) ‘Human embryonic stem cell’ means a pluripotent human
 9   stem cell derived from a preimplantation embryo.
10      (7) ‘Human reproductive cloning’ means creating, or
11   attempting to create, a human being by transferring a nucleus of a
12   human cell from any source into a human or nonhuman egg cell
13   from which the nucleus has been removed for the purpose of
14   creating a human being, and implanting the resulting product into a
15   uterus or uterine-like environment to initiate pregnancy and a
16   possible birth.
17      (8) ‘Informed consent’ means consent for the donation of
18   embryos, consent for participation in vitro fertilization, or consent
19   for any other process where an egg is extracted from a woman, or
20   other participation in research pursuant to this chapter, which
21   complies with requirements of a duly appointed institutional
22   review board, and which follows the procedures stipulated in 45
23   CFR Part 46.116 and 117.
24      (9) ‘Institution’ means any organization, corporation, or
25   institution that conducts human embryonic stem cell research.
26      (10) ‘Institutional review board’ or ‘IRB’ means a board that has
27   a minimum of 5 members who meet regularly to review research
28   applying the standards of 45 CFR Part 46 and 21 CFR Parts 50 and
29   56.
30      (11) ‘In vitro’ means in an artificial environment, referring to a
31   process or reaction occurring therein, as in a test tube or culture
32   medium.
33      (12) ‘In vitro fertilization’ means an assisted reproductive
34   technique in which fertilization is accomplished outside of the
35   body.
36      (13) ‘Parthenote’ means the product of egg development without
37   fertilization.
38      (14) ‘Parthenogenesis’ means the development of an egg
39   without fertilization.
40      (15) ‘Person’ means any natural person, corporation,
41   association, partnership, institute, or other legal entity.
42      (16) ‘Preimplantation embryo’ means any in vitro human
43   embryo whether formed by fertilization, somatic cell nuclear

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 1   transfer or other means, which has not experienced more than
 2   fourteen days of development; provided, that such length of time
 3   does not include any interval in which such development has been
 4   suspended, such as through freezing.
 5      (17) ‘Public institutional review board’ means a board
 6   established in accordance with the requirements of 45 CFR 46
 7   Subpart A, as amended from time to time.
 8      (18) ‘Somatic cell nuclear transfer’ means replacement of the
 9   nucleus of an egg with the nucleus from any other nonreproductive
10   human cell.
11      (19) ‘Uterus’ means a muscular organ of a woman in which the
12   ovum is deposited and the embryo and fetus are developed, or
13   fallopian tube.
14      (20) ‘Uterine-like environment’ means any replicate of the
15   uterus used for the purpose of sustaining an embryo through birth
16   and creating a human being.
18      Section 44-46-30. (A) Research and clinical applications
19   involving the derivation and use of human embryonic stem cells,
20   human adult cells from any source, somatic cell nuclear
21   transplantation and umbilical cord stem cells, parthenotes, is
22   permitted in this State in accordance with this chapter.
23      (B)(1) No person may use a preimplantation human embryo
24   donated to medicine in scientific research or other kind of
25   experimentation or study for the derivation of human embryonic
26   stem cells without the prior written approval, and continuing
27   review on at least an annual basis, of a duly appointed IRB or
28   public IRB setting forth the IRB’s approval of the research,
29   experimentation, or study. The written approval must contain a
30   detailed description of the research, experimentation, or study by
31   attachment of a protocol or other writing, must include written
32   documentation of informed consent, and must be maintained as a
33   permanent record by the IRB or the hospital or other entity for
34   which the IRB acts.
35        (2) No person may knowingly purchase or sell any
36   preimplantation embryo for human embryonic stem cell research
37   for valuable consideration. For purposes of this subsection,
38   ‘valuable consideration’ excludes reasonable payments associated
39   with storage, quality control, preservation, processing, or
40   transportation of such preimplantation embryos donated to
41   medicine.
42      (C) Human reproductive cloning is prohibited. Accordingly, a
43   preimplantation embryo donated to medicine for purposes of

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 1   human embryonic stem cell research, pursuant to this section, must
 2   not be transferred to a uterus or a uterine-like environment.
 3   Nothing in this chapter prohibits or regulates the use of in vitro
 4   fertilization for reproductive purposes.
 5      (D) A person who knowingly violates subsection (B)(1) or
 6   (B)(2) must be imprisoned for not less than one year or more than
 7   two years or fined not more than one hundred thousand dollars. A
 8   person who violates subsection (C) must be imprisoned for not less
 9   than one year or more than two years or fined up to one million
10   dollars.
12      Section 44-46-40. (A) For the purposes of reporting to the
13   Governor, President of the Senate, and Speaker of the House of
14   Representatives on the status of human embryonic stem cell
15   research and proposing modifications to the regulation of this
16   research, there is established the Stem Cell Research Advisory
17   Board. The advisory board shall consist of eight members, all of
18   whom must be residents of this State. The members must be
19   professionally qualified and collectively experienced in the fields
20   of science including, but not limited to, knowledge of cell
21   differentiation, nuclear reprogramming, tissue formation and
22   regeneration, stem cell biology, developmental biology,
23   regenerative medicine, related biomedical and research fields,
24   medical ethics, and biotechnology, and must include one
25   community member. Three members must be appointed by the
26   President of the Senate, three must be appointed by the Speaker of
27   the House of Representatives, and the one community member
28   must be appointed by the Governor. The eighth member must be
29   the Director of the Department of Health and Environmental
30   Control.
31      (B) Original members of the advisory board must have
32   staggered terms of one to three years, and thereafter, members’
33   terms are for three years.
34      (C) A      person     who      conducts    scientific    research,
35   experimentation, or study that involves the creation or use of
36   preimplantation embryos in relation to human embryonic stem cell
37   research shall submit an annual report to the advisory board
38   providing a summary of the research approved during that calendar
39   year and a statement representing that the research was reviewed in
40   accordance with Section 44-46-30. Any disclosure that, in the
41   opinion of the institution or person submitting disclosure, is a trade
42   secret, proprietary, or confidential must be submitted separately
43   from the annual report with a statement explaining the reasons that

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 1   the information should be deemed confidential to the Attorney
 2   General, who shall determine whether the information should be
 3   kept confidential as proprietary. The Attorney General shall submit
 4   all disclosures considered not proprietary to the Stem Cell
 5   Research Advisory Board after notice to the institution or person
 6   submitting the disclosure. All disclosures considered proprietary
 7   must be kept confidential by the office of the Attorney General
 8   and, notwithstanding any law to the contrary, must not be deemed
 9   a public record. The Attorney General may establish procedures to
10   effectively carry out this paragraph.
11      (D) The advisory board shall meet periodically, and no less
12   than twice each year. All meetings must be public.
13      (E) The advisory board shall keep a public record of all
14   meetings, votes, and other business.
15      (F) The advisory board shall review the annual reports from
16   persons conducting scientific research, experimentation, or study
17   that involves the creation or use of preimplantation embryos in
18   relation to human embryonic stem cell research. The advisory
19   board may require submission of a copy of the federal-wide
20   assurance from the institutions whose IRBs review preimplantation
21   embryo research relating to human embryonic stem cell research.
22      (G) The advisory board shall study the implementation of this
23   chapter and the conduct of research and shall make
24   recommendations to the General Assembly on ways to encourage
25   disproportionately impacted population’s participation in, and
26   benefit from, human embryonic stem cell research, including
27   requiring the IRB to develop methods for such participation.
28      (H) Based on its review of the annual reports submitted, the
29   advisory board shall submit to the Governor, President of the
30   Senate, and Speaker of the House by January 31 of each year an
31   annual report of the current state of preimplantation embryo
32   research relating to human embryonic stem cell research in the
33   State. The advisory board may include recommendations, if any,
34   regarding the modification of regulations concerning human
35   embryonic stem cell research.
36      (I) The advisory board shall receive administrative support
37   from the Department of Health and Environmental Control.
39     Section 44-46-50. (A) An employee may not be required to
40   conduct scientific research, experimentation, or study that involves
41   the creation or use of preimplantation embryos in relation to
42   human embryonic stem cell research to the extent that such

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 1   research conflicts with the bona fide religious practices and beliefs
 2   of the employee.
 3      (B) A physician or other health care provider who treats a
 4   patient for infertility shall provide the patient with timely, relevant
 5   and appropriate information sufficient to allow that patient to make
 6   an informed and voluntary choice regarding the disposition of any
 7   preimplantation embryos remaining following said treatment. The
 8   physician shall present the patient with the options of storing,
 9   donating to another person, donating for research purposes, or
10   otherwise disposing of or destroying any unused preimplantation
11   embryos, as appropriate. The Department of Health and
12   Environmental Control shall prescribe and provide for use by
13   physicians and other health care providers who treat patients for
14   infertility through in vitro or any other process where an egg is
15   extracted from a woman the following two documents:
16        (1) an informational pamphlet, describing the procedure by
17   which an egg is intended to be extracted from the patient,
18   including all short and long-term potential health impacts of the
19   procedure on the patient, any drugs or devices to be used,
20   including whether they have received approval from the United
21   States Food and Drug Administration, the risks involved, any
22   discomfort and side-effects that may be experienced, any
23   alternatives which the patient has and their attendant risks and
24   benefits, medical treatment available to the patient should
25   complications arise, and that the particular treatment may involve
26   currently unforeseeable risks to the patient, embryo, or fetus. A
27   physician or other health care provider treating a woman with any
28   procedure by which an egg is intended to be extracted shall
29   provide the patient with this pamphlet or a legible copy of the
30   pamphlet, and provide any other treatment information which may
31   be specific to the patient’s treatment; and
32        (2) an informed consent form, stating that the patient has
33   been given, has reviewed and understands the informational
34   pamphlet described in item (1), has consulted with her physician or
35   health care provider concerning the general procedures and her
36   specific medical situation, and, understanding the procedure,
37   process, and risks, consents to proceed with the procedure or
38   process. The informed consent form must also contain a ‘Notes’
39   section, to be completed by the physician or health care provider.
40   This notes section must contain any medical information,
41   alternative procedures, medicines, devices, considerations, or risks
42   relevant to the specific patient’s informed consent to proceed and
43   must be completed by the physician or health care provider in each

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 1   case. A physician or other health care provider treating a woman
 2   by any procedure by which an egg is intended to be extracted shall
 3   provide the patient with this form or a legible copy of the form,
 4   and shall keep a signed copy of this document in the patient’s
 5   medical file.
 6      A physician or other health care provider must not provide such
 7   treatment before providing the patient with both the informational
 8   pamphlet and the informed consent form, and receiving in return a
 9   complete and fully-executed informed consent form from the
10   patient. A physician or other health care provider shall seek
11   informed consent only under circumstances that provide the
12   prospective patient reasonable opportunity to consider whether or
13   not to receive such treatment and that minimize the possibility of
14   coercion or undue influence. The information that is given to the
15   patient must be in language understandable to the patient. No
16   informed consent, whether oral or written, may include a waiver of
17   legal rights beyond those specifically acknowledged as waived by
18   the terms of the consent.
19      (C) An institution conducting human embryonic stem cell
20   research shall not take any retaliatory action against its employee
21   because its employee:
22         (1) discloses or threatens to disclose to a manager or a public
23   body an activity, policy, or practice of the institution conducting
24   embryonic stem cell research, or of another institution conducting
25   such research with whom the employee’s institution has a business
26   relationship, that the employee reasonably believes is in violation
27   of Sections 44-46-30 through 44-46-60; or
28         (2) objects to, or refuses to participate in, any activity,
29   policy, or practice that the employee reasonably believes is in
30   violation of Sections 44-46-30 through 44-46-60.
31      (D) For purposes of this section:
32         (1) ‘Retaliatory action’ means the discharge, suspension,
33   demotion, harassment, denial of promotion, layoff, or other
34   adverse action taken against an employee affecting the terms and
35   conditions of employment.
36         (2) ‘Manager’ means an individual to whom an institution
37   conducting human embryonic stem cell research has given the
38   authority to direct and control the work performance of the
39   affected employee, who has authority to take corrective action
40   regarding a violation of a law, rule, regulation, activity, or policy.
41         (3) The protection against retaliatory action does not apply
42   to the public disclosure of confidential or proprietary information,
43   trade secrets, or other confidential materials unless such

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 1   confidential disclosure is made by the employee directly to and
 2   exclusively with the office of the Attorney General or the
 3   Department of Health and Environmental Control.                 The
 4   Department of Health and Environmental Control must not
 5   publicly disclose any such confidential information but shall
 6   submit the information to the Attorney General immediately.
 7      (E) An employee aggrieved by a violation of this section may,
 8   within two years, file a complaint with the Attorney General, who
 9   may bring an action in the name of the State against any institution
10   conducting human embryonic stem cell research that has violated
11   subsection (C).
12      (F) The Department of Health and Environmental Control shall
13   establish a program to educate maternity patients with regard to the
14   subject of ‘cord blood banking’. This program shall provide these
15   patients with sufficient information to make an informed decision
16   on whether or not to participate in a private or public umbilical
17   cord blood banking program including, but not limited to, an
18   explanation of the difference between public and private umbilical
19   cord blood banking, the medical process involved in umbilical
20   cord blood banking, the current and potential future medical uses
21   of stored umbilical cord blood, the benefits and any risks involved
22   in banking umbilical cord blood, and the availability and cost of
23   public or private umbilical cord blood banks.
25      Section 44-46-60. (A) The Department of Health and
26   Environmental Control shall issue a license authorizing an
27   institution to conduct human embryonic stem cell research, within
28   thirty days after the applying institution pays a fee of not more
29   than two hundred dollars to the department, and provides
30   documentation to the department demonstrating that the institution
31   has or has arranged for a duly appointed IRB or a copy of a valid
32   contract between the institution and the public IRB that shall
33   review the institution’s experimentation, study, and procedures
34   involving human embryonic stem cell research.
35      (B) No person may conduct human embryonic stem cell
36   research at any institution that does not have a license issued
37   pursuant to this section.
38      (C) All licenses issued pursuant to this act expire December 31
39   of the third year after the date of issuance. A holder of a license is
40   entitled to have the license renewed for a three-year term by the
41   department, upon the payment of a renewal fee of not more than
42   two hundred dollars. On November 1 of each year, the department
43   shall send written notice to this effect to every licensed institution,

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 1   whose license shall expire that calendar year, and shall enclose
 2   with each notice a proper blank form for such renewal. If the blank
 3   form, properly filled out, together with the fee, is not received
 4   before January 1 of each year by the department from any
 5   institution so notified, the department shall strike from the register
 6   the name of that institution; but at any time thereafter, an
 7   institution, upon submission to the department of proof of
 8   satisfactory compliance with the procedures and guidelines
 9   contained in this section, may have its name restored in the register
10   upon the payment to the department of all accrued renewal fees,
11   together with a reinstatement fee of not more than two hundred
12   dollars.
13      (D) The Department of Health and Environmental Control shall
14   keep an official record of the names of all licensed institutions and
15   of all money received and disbursed by it, and a duplicate must be
16   open to public inspection in the office of the Secretary of State.
17      (E) An institution that applies for a license and complies with
18   subsection (A) must not have its license unreasonably withheld. If
19   thirty days following an application for a license the department
20   has failed to issue the license to an applying institution that is in
21   compliance with this section, the institution is considered to be
22   licensed and the Department of Health and Environmental Control
23   shall issue the license accordingly. If an application is considered
24   by the department to be incomplete, the department shall
25   immediately issue notice to the applicant of any further
26   information or corrections necessary for the issuance of the license
27   pursuant to this section.
29      Section 44-46-70. (A) The         Department       Health      and
30   Environmental Control shall establish and maintain, in partnership
31   with the Medical University of South Carolina and the University
32   of South Carolina School of Medicine, a public bank for umbilical
33   cord and placental tissue for the purpose of collecting and storing
34   umbilical cord blood and placental tissue that is donated by
35   maternity patients in this State. The public bank shall collect any
36   donated umbilical cord blood and placental tissue from
37   participating hospitals and store said blood and tissue, and tissue to
38   be made available for research, pursuant to the provisions of this
39   chapter.
40      (B) Notwithstanding any other provision of law, all licensed
41   hospitals shall inform pregnant patients, not later than thirty days
42   from the commencement of their third trimester of pregnancy, of
43   the opportunity to donate to a publicly accessible certified cord

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 1   blood and placental tissue bank, blood and tissue extracted from
 2   the umbilical cord and placenta following delivery of a newborn
 3   child. Donations for research pursuant to this chapter must be
 4   made at no expense to the donor. Donations must be made without
 5   financial inducement to the donor and after informed consent.
 6      (C) Institutions licensed under Section 44-46-60 may reach
 7   agreement with the public umbilical cord blood bank to acquire
 8   donated umbilical cord blood or placental tissue for the purpose of
 9   conducting research. This agreement shall provide for the payment
10   of the estimated expenses of the collection and storage of the
11   donated umbilical cord blood and placental tissue, as well as any
12   reasonable administrative fees by the institution.
13      (D) Nothing in this section obligates a hospital to collect
14   umbilical cord blood or placental tissue if, in the professional
15   judgment of a physician licensed to practice medicine in all its
16   branches or of a nurse, the collection would threaten the health of
17   the mother or child.
18      (E) Nothing in this section imposes a requirement upon any
19   hospital employee, physician, nurse, or hospital that is directly
20   affiliated with a bona fide religious denomination that includes as
21   an integral part of its beliefs and practices the tenet that blood
22   transfer is contrary to an essential part of its doctrine or beliefs.
24      Section 44-46-80. (A) The Medical University of South
25   Carolina and the University of South Carolina School of Medicine
26   shall jointly establish and maintain a public institutional review
27   board (‘public IRB’). The public IRB shall operate pursuant to the
28   provisions contained in Section 44-46-20. The public IRB must be
29   established not later than one hundred twenty days from this act’s
30   effective date. The public IRB must be available on an ongoing
31   basis to any institution for review of that institution’s
32   experimentation, study, and procedures for the purposes of
33   conducting research pursuant to this chapter. The public IRB must
34   be available to any institution employing 50 or fewer full-time
35   employees.
36      (B) An institution may access the services of the public IRB
37   only through a written instrument of contract. The contract must
38   include the payment to the public IRB of a reasonable fee,
39   calculated pursuant to a methodology approved by the advisory
40   board to account for the costs of operating and maintaining the
41   public IRB and the relevant position of those costs attributable to
42   the particular institution receiving the benefit.”

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 1   SECTION 2. A. The Stem Cell Advisory Board, established
 2   pursuant to Section 44-46-40 of the 1976 Code, together with the
 3   Department of Health and Environmental Control, shall conduct a
 4   feasibility study on the establishment and maintenance of a public
 5   bank for the collection and storage of umbilical cord blood and
 6   cells and placental tissue and cells for the purpose of making these
 7   resources available to donors and their families for individual
 8   medical research and treatment.
 9      B. This study must include, but is not limited to, the
10   development of an appropriate fee structure to be charged to
11   individuals participating in the bank, any necessary eligibility
12   requirements to ensure access to the bank for citizens of all
13   geographic regions of the State, of all levels of income, the costs of
14   operating and maintaining said bank, and any possible need for and
15   appropriateness of public subsidies for those costs, any necessary
16   regulations and protocols to govern donations to the bank and the
17   release and use of banked cells, tissue or blood, the potential for
18   and desirability of additional partnerships in operating the bank,
19   and any ethical considerations involved in its creation and
20   maintenance.
21      C. The board shall report the findings of the study, together with
22   all necessary legislative recommendations for the establishment
23   and maintenance of the bank, to the House of Representatives, the
24   Senate, and the Governor, not later than December 31, 2009.
26   SECTION 3. Any institution currently conducting human
27   embryonic stem cell research in this State has one hundred eighty
28   days from this act’s effective date to comply with the provisions of
29   this act. Research currently being conducted by institutions in this
30   State relative to human embryonic stem cell research is not
31   deemed to be in violation of Section 44-46-30(B)(1) of the 1976
32   Code for one hundred eighty days after this act’s effective date and
33   of Section 44-46-60(B) for one hundred eighty days after this act’s
34   effective date.
36   SECTION 4. This act takes effect July 1, 2008.
37                            ----XX----

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