Senate Bill sb0750
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Florida Senate - 2007 SB 750
By Senator Geller
31-252A-07 See HB
1 A bill to be entitled
2 An act relating to biomedical research;
3 amending s. 20.435, F.S.; revising uses for
4 funds credited to the Biomedical Research Trust
5 Fund; amending s. 381.86, F.S.; providing that
6 the Institutional Review Board within the
7 Department of Health shall not review certain
8 research within the jurisdiction of the Stem
9 Cell Research Advisory Council; creating s.
10 381.99, F.S.; creating the Florida Better
11 Quality of Life and Biomedical Research Act;
12 providing a short title; providing definitions;
13 creating the Stem Cell Research Advisory
14 Council; providing for appointment, terms, and
15 duties of members; authorizing reimbursement
16 for per diem and travel expenses; requiring a
17 report; requiring the Department of Health to
18 provide administrative support; creating the
19 Biomedical Ethics Advisory Council to regulate
20 research procedures and enforce ethical
21 guidelines; providing for appointment, terms,
22 and duties of members; authorizing
23 reimbursement for per diem and travel expenses;
24 providing duties of the council; providing for
25 a grants-in-aid program for the purpose of
26 conducting embryonic, amniotic, or human adult
27 stem cell research; providing that
28 grants-in-aid shall be provided through funds
29 in the Biomedical Research Trust Fund;
30 restricting the use of such funds for research
31 on certain stem cells; providing requirements
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Florida Senate - 2007 SB 750
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1 with respect to the disposition of human
2 embryos following infertility treatment;
3 requiring the Department of Health to develop
4 and maintain on its Internet website a consent
5 form for the donation of certain embryos;
6 prohibiting purchase or sale of embryonic fetal
7 tissue for research purposes; prohibiting
8 certain acts relating to human reproductive
9 cloning; providing penalties; providing a
10 continuing appropriation; providing an
11 effective date.
12
13 WHEREAS, an estimated 130 million Americans suffer from
14 acute, chronic, and degenerative diseases and there is
15 enormous potential for lifesaving treatment and therapy as a
16 result of recent advances in biomedical research, and
17 WHEREAS, Florida is unique among all states because of
18 the size of the projected net population increase within the
19 next 20 years, which raises significant health care concerns
20 as a new generation of retirees moves to Florida, resulting in
21 a corresponding rise in the number of persons suffering from
22 illnesses such as cancer, heart disease, Alzheimer's Disease,
23 Parkinson's Disease, cerebral palsy, juvenile diabetes,
24 atherosclerosis, Amyotrophic Lateral Sclerosis, AIDS, spinal
25 cord injuries, severe burns, osteoporosis, osteoarthritis,
26 cystic fibrosis, muscular dystrophy, multiple sclerosis,
27 macular degeneration, diabetic retinopathy, retinitis
28 pigmentosa, cirrhosis of the liver, motor neuron disease,
29 brain trauma, stroke, sickle cell anemia, and intestinal
30 diseases, and
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Florida Senate - 2007 SB 750
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1 WHEREAS, in order to maintain a high quality of life
2 for all Floridians, research into stem cell regenerative
3 therapies and treatment should be supported to give hope and
4 relief to the millions of citizens who suffer from
5 degenerative and crippling diseases, and
6 WHEREAS, to reduce the burden on the health care
7 infrastructure, the state must shift its health care
8 objectives from costly long-term maintenance toward prevention
9 and cures, and
10 WHEREAS, to bolster and advance Florida's burgeoning
11 biotechnology industry, the state should provide funds and
12 incentives to encourage private research companies to work in
13 the state, and
14 WHEREAS, the state should advance the goal of
15 scientific and academic discourse in its universities and help
16 bring its public and private universities to the forefront in
17 biomedical research and technology, and
18 WHEREAS, it will benefit the economy of the state to
19 create a wide array of new projects and high-paying jobs
20 relating to biomedical research, and
21 WHEREAS, it will benefit the state to foster
22 cooperation between the state's universities and private
23 sector research in terms of jobs, resources, and academic
24 discourse relating to biomedical research, and
25 WHEREAS, the public funds provided under the Florida
26 Better Quality of Life and Biomedical Research Act are
27 intended to spur innovation and development in Florida's
28 biomedical technology sector, which will be used to treat
29 debilitating chronic diseases, NOW, THEREFORE,
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31 Be It Enacted by the Legislature of the State of Florida:
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Florida Senate - 2007 SB 750
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1 Section 1. Paragraph (h) of subsection (1) of section
2 20.435, Florida Statutes, is amended to read:
3 20.435 Department of Health; trust funds.--
4 (1) The following trust funds are hereby created, to
5 be administered by the Department of Health:
6 (h) Biomedical Research Trust Fund.
7 1. Funds to be credited to the trust fund shall
8 consist of funds deposited pursuant to ss. s. 215.5601,
9 288.955, and 381.99, and any other funds appropriated by the
10 Legislature. Funds shall be used for the purposes of the James
11 and Esther King Biomedical Research Program, and the William
12 G. "Bill" Bankhead, Jr., and David Coley Cancer Research
13 Program, and the Florida Better Quality of Life and Biomedical
14 Research Act as specified in ss. 215.5602, 288.955, and
15 381.922, and 381.99. The trust fund is exempt from the service
16 charges imposed by s. 215.20.
17 2. Notwithstanding the provisions of s. 216.301 and
18 pursuant to s. 216.351, any balance in the trust fund at the
19 end of any fiscal year shall remain in the trust fund at the
20 end of the year and shall be available for carrying out the
21 purposes of the trust fund. The department may invest these
22 funds independently through the Chief Financial Officer or may
23 negotiate a trust agreement with the State Board of
24 Administration for the investment management of any balance in
25 the trust fund.
26 3. Notwithstanding s. 216.301 and pursuant to s.
27 216.351, any balance of any appropriation from the Biomedical
28 Research Trust Fund which is not disbursed but which is
29 obligated pursuant to contract or committed to be expended may
30 be carried forward for up to 3 years following the effective
31 date of the original appropriation.
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1 4. The trust fund shall, unless terminated sooner, be
2 terminated on July 1, 2008.
3 Section 2. Subsection (2) of section 381.86, Florida
4 Statutes, is amended to read:
5 381.86 Institutional Review Board.--
6 (2) Consistent with federal requirements, the
7 Secretary of Health shall determine and appoint the membership
8 of the board and designate its chair, except that a separate
9 Stem Cell Research Advisory Council shall be appointed
10 pursuant to s. 381.99 for the sole purpose of reviewing
11 research funded under that section.
12 Section 3. Section 381.99, Florida Statutes, is
13 created to read:
14 381.99 Florida Better Quality of Life and Biomedical
15 Research Act.--
16 (1) SHORT TITLE.--This section may be cited as the
17 "Florida Better Quality of Life and Biomedical Research Act."
18 (2) DEFINITIONS.--As used in this section, the term:
19 (a) "Adult stem cell" means an undifferentiated cell
20 found among differentiated cells in a tissue or an organ which
21 can renew itself and can differentiate to yield the major
22 specialized cell types of the tissue or organ.
23 (b) "Amniotic stem cell" means a cell extracted from
24 human amniotic fluid or a placenta.
25 (c) "Embryonic stem cell" means a cell obtained from
26 the undifferentiated inner mass of an early-stage embryo.
27 (d) "Human reproductive cloning" means the practice of
28 creating or attempting to create a human being by transferring
29 the nucleus from a human cell into an egg cell from which the
30 nucleus has been removed for the purpose of implanting the
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1 resulting product in a uterus or a substitute for a uterus to
2 initiate a pregnancy.
3 (e) "In vitro fertilization" means a technique by
4 which oocytes are fertilized by sperm outside a woman's body
5 resulting in organisms that are not genetically identical to
6 any one existing human.
7 (f) "Stem cell" means an undifferentiated cell that
8 retains the potential to differentiate into some or all other
9 cell types.
10 (3) STEM CELL RESEARCH ADVISORY COUNCIL.--There is
11 created the Stem Cell Research Advisory Council.
12 (a) The advisory council shall consist of the
13 Secretary of Health or his or her designee, who shall act as
14 chair, and six additional members, who shall be appointed as
15 follows:
16 1. Two persons appointed by the Governor, one of whom
17 shall be an academic researcher in the field of stem cell
18 research and one of whom shall have a background in bioethics.
19 2. One person appointed by the President of the
20 Senate, who shall have a background in private sector stem
21 cell funding and development and public sector biomedical
22 research and funding.
23 3. One person appointed by the Speaker of the House of
24 Representatives, who shall have a background in private sector
25 stem cell funding and development and public sector biomedical
26 research and funding.
27 4. One person appointed by the Minority Leader of the
28 Senate, who shall have a background and experience in either
29 public sector or private sector stem cell research and
30 development.
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Florida Senate - 2007 SB 750
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1 5. One person appointed by the Minority Leader of the
2 House of Representatives, who shall have a background and
3 experience in business and financial investments.
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5 Each member shall serve a term of 2 years commencing on
6 October 1, 2007. No member shall serve for more than two
7 consecutive 2-year terms; however, for the purpose of
8 providing staggered terms, of the initial appointments, three
9 members shall be appointed to a 1-year term and three members
10 shall be appointed to a 2-year term. Any vacancy on the
11 council shall be filled in the same manner as the original
12 appointment. All initial appointments must be made by October
13 1, 2007. The first meeting shall take place no later than
14 November 1, 2007. All meetings are subject to the call of the
15 chair. Members shall meet at least twice a year or as often as
16 necessary to discharge their duties but shall have no more
17 than four meetings during any 12-month period. Members shall
18 serve without compensation but may be reimbursed for per diem
19 and travel expenses in accordance with s. 112.061.
20 (b) The advisory council shall:
21 1. Develop a donated funds program for recommendation
22 to the Secretary of Health to encourage the development of
23 funds other than state appropriations for embryonic, amniotic,
24 and human adult stem cell research in the state.
25 2. Examine and identify specific ways to improve and
26 promote for-profit and not-for-profit embryonic, amniotic, and
27 human adult stem cell and related research in the state,
28 including, but not limited to, identifying both public and
29 private funding sources for such research, maintaining
30 existing embryonic, amniotic, and human adult stem cell
31 related businesses, recruiting new embryonic, amniotic, and
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Florida Senate - 2007 SB 750
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1 human adult stem cell related businesses to the state, and
2 recruiting scientists and researchers in such fields to the
3 state and state universities.
4 3. Develop a biomedical research grant program for
5 recommendation to the Secretary of Health, which shall provide
6 grants-in-aid to eligible institutions for the advancement of
7 embryonic, amniotic, or human adult stem cell research.
8 4. Develop, no later than December 1, 2007, an
9 application for grants-in-aid under this section for
10 recommendation to the Secretary of Health for the purpose of
11 conducting embryonic, amniotic, or human adult stem cell
12 research.
13 5. Review applications from eligible institutions for
14 grants-in-aid on and after December 1, 2007, and provide to
15 the Secretary of Health recommended grant awards.
16 6. Review the stem cell research conducted by eligible
17 institutions that receive such grants-in-aid.
18 (c) The advisory council shall submit an annual
19 progress report on the status of biomedical research in the
20 state to the Florida Center for Universal Research to
21 Eradicate Disease and to the Governor, the Secretary of
22 Health, the President of the Senate, and the Speaker of the
23 House of Representatives by June 30. The report must include:
24 1. The amount of grants-in-aid awarded to eligible
25 institutions from the Biomedical Research Trust Fund.
26 2. The names of the recipients of such grants-in-aid.
27 3. The current status and progress of stem cell
28 research in the state.
29 4. A list of research projects supported by
30 grants-in-aid awarded under the program.
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1 5. A list of publications in peer-reviewed journals
2 involving research supported by grants-in-aid awarded under
3 the program.
4 6. The total amount of biomedical research funding
5 currently flowing into the state.
6 7. New grants for biomedical research that were funded
7 based on research supported by grants-in-aid awarded under the
8 program.
9 8. All other materials the council deems advisable to
10 include.
11 (d) Advisory council members shall disclose any
12 conflict of interest or potential conflict of interest to the
13 Secretary of Health.
14 (e) The Department of Health shall provide
15 administrative staff to assist the advisory council in
16 developing the application for the grants-in-aid, reviewing
17 the applications, preparing the written consent form described
18 in paragraph (6)(b), and performing other administrative
19 functions the advisory council requires.
20 (4) BIOMEDICAL ETHICS ADVISORY COUNCIL.--There is
21 created within the Department of Health the Biomedical Ethics
22 Advisory Council, which shall review the research conducted
23 under s. 381.99.
24 (a) The advisory council shall consist of the
25 Secretary of Health or his or her designee, who shall act as
26 chair, and six additional members, who shall be appointed as
27 follows:
28 1. Two persons appointed by the Governor.
29 2. One person appointed by the President of the
30 Senate.
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1 3. One person appointed by the Speaker of the House of
2 Representatives.
3 4. One person appointed by the Minority Leader of the
4 Senate.
5 5. One person appointed by the Minority Leader of the
6 House of Representatives.
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8 All members must demonstrate knowledge and understanding of
9 the ethical, medical, and scientific implications of
10 embryonic, amniotic, and adult stem cell research and should
11 also demonstrate knowledge of related fields, including, but
12 not limited to, genetics, cellular biology, and embryology.
13 Each member shall serve a term of 4 years commencing on
14 October 1, 2007; however, for the purpose of providing
15 staggered terms, of the initial appointments three members
16 shall be appointed to a 2-year term and three members shall be
17 appointed to a 4-year term. No member shall serve for more
18 than two consecutive terms. Any vacancy on the council shall
19 be filled in the same manner as the original appointment. All
20 initial appointments must be made by October 1, 2007. The
21 first meeting shall take place no later than November 1, 2007.
22 All meetings are subject to the call of the chair. Members
23 shall meet at least twice a year or as often as necessary to
24 discharge their duties but shall have no more than one meeting
25 per month during any 12-month period. Members shall serve
26 without compensation but may be reimbursed for per diem and
27 travel expenses in accordance with s. 112.061.
28 (b) The council shall review all embryonic, amniotic,
29 or human adult stem cell research that is funded or supported
30 in any manner through the Biomedical Research Trust Fund to
31 ensure adherence to ethical and safety guidelines and
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1 procedures as laid out by federal ethical standards
2 established by the United States Department of Health and
3 Human Services.
4 (5) BIOMEDICAL RESEARCH TRUST FUND AND
5 GRANTS-IN-AID.--
6 (a) The Secretary of Health shall make grants-in-aid
7 from the Biomedical Research Trust Fund in accordance with the
8 provisions of this section.
9 (b) The Department of Health shall require any
10 applicant for a grant-in-aid under this section, for the
11 purpose of conducting stem cell research, to submit a complete
12 description of the applicant's organization, the applicant's
13 plans for stem cell research, the applicant's proposed funding
14 for such research from sources other than the state, and the
15 applicant's proposed arrangements concerning financial
16 benefits to the state as a result of any patent, royalty
17 payment, or similar right resulting from any stem cell
18 research made possible by the awarding of the grant-in-aid.
19 The Stem Cell Research Advisory Council shall provide
20 recommendations to the Secretary of Health with respect to
21 awarding such grants-in-aid after considering the
22 recommendations of the Biomedical Ethics Advisory Council.
23 (c) Beginning with the 2007-2008 fiscal year, and for
24 10 consecutive years thereafter, not less than $20 million
25 shall be made available from the Biomedical Research Trust
26 Fund within the Department of Health for grants-in-aid to
27 eligible institutions for the purpose of conducting embryonic,
28 amniotic, or human adult stem cell research pursuant to this
29 section. Up to 15 percent of the funds may be used for
30 administrative costs. Any unexpended funds not used for
31 grants-in-aid during the current fiscal year shall be carried
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1 forward for the following fiscal year to fund the
2 grants-in-aid.
3 (6) USE OF FUNDS; REQUIREMENTS AND RESTRICTIONS
4 REGARDING DISPOSITION OF HUMAN EMBRYOS FOLLOWING INFERTILITY
5 TREATMENT.--
6 (a) Funds provided under this section may be used only
7 for research involving:
8 1. Human adult stem cells, including, but not limited
9 to, adult stem cells derived from umbilical cord blood and
10 bone marrow.
11 2. Human embryonic stem cells taken from donated
12 leftover embryos from in vitro fertilization treatments which
13 would otherwise be thrown away or destroyed.
14 3. Amniotic stem cells extracted from human amniotic
15 fluid or placentas, which are otherwise discarded after birth.
16 (b) A physician or other health care provider treating
17 a patient for infertility shall provide the patient with
18 timely, relevant, and appropriate information sufficient to
19 allow the person to make an informed and voluntary choice
20 regarding the disposition of any human embryos that remain
21 following infertility treatment. The person to whom the
22 information is provided:
23 1. Shall be presented with the option of storing any
24 unused embryos remaining after receiving in vitro
25 fertilization, donating the remaining embryos to another
26 person, donating the remaining embryos for research purposes,
27 or selecting other means of disposition of the remaining
28 embryos.
29 2. Who elects to donate, for research purposes, any
30 embryos remaining after receiving infertility treatment shall
31 provide written consent for that donation on a consent form
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1 provided by the Department of Health and made available to the
2 public on the department's Internet website.
3 3. May not knowingly, for material or financial gain,
4 purchase, sell, or otherwise transfer or obtain, or promote
5 the sale or transfer of, embryonic fetal tissue for research
6 purposes pursuant to this section. Embryonic, amniotic, and
7 adult stem cell material may be donated only for research
8 purposes with the informed consent of the donor. A person who
9 violates any provision of this subparagraph commits a felony
10 of the second degree, punishable as provided in s. 775.082, s.
11 775.083, or s. 775.084.
12 (7) HUMAN REPRODUCTIVE CLONING; PROHIBITION;
13 PENALTIES.--
14 (a) It is unlawful for any person to knowingly:
15 1. Perform or attempt to perform human reproductive
16 cloning;
17 2. Participate or assist in an attempt to perform
18 human reproductive cloning; or
19 3. Ship or receive for any purpose an embryo produced
20 by human reproductive cloning or any product derived from such
21 embryo.
22 (b) A person who violates any provision of paragraph
23 (a) commits a felony of the second degree, punishable as
24 provided in s. 775.082, s. 775.083, or s. 775.084.
25 (8) CONTINUING APPROPRIATION.--Beginning in fiscal
26 year 2007-2008, the sum of $20 million is appropriated
27 annually from recurring funds in the General Revenue Fund to
28 the Biomedical Research Trust Fund within the Department of
29 Health for the purposes of carrying out the provisions of this
30 section. The amount of funds appropriated shall not exceed
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Florida Senate - 2007 SB 750
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1 $200 million for the 10-year period beginning in fiscal year
2 2007-2008 and ending in fiscal year 2016-2017.
3 Section 4. This act shall take effect July 1, 2007.
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