HB 1065

1
A bill to be entitled
2An act relating to stem cell research; creating s. 381.99,
3F.S.; providing a short title; providing definitions;
4creating the Stem Cell Research Advisory Council and
5Biomedical Ethics Advisory Council within the Department
6of Health; providing for membership and terms; providing
7duties and responsibilities; requiring the Secretary of
8Health to make grants-in-aid from the Biomedical Research
9Trust Fund for stem cell research; providing requirements
10relating to applications for and awards of such grants-in-
11aid; providing specifications for moneys to be made
12available from the trust fund for stem cell research
13grants-in-aid; providing restrictions and requirements for
14uses of funds from such grants-in-aid; providing
15prohibitions relating to human cloning; providing for
16penalties; providing an appropriation; amending s. 20.435,
17F.S.; revising references; amending s. 381.86, F.S.;
18providing an exception to the Institutional Review Board
19for the Stem Cell Research Advisory Council and Biomedical
20Ethics Advisory Council; providing an effective date.
21
22Be It Enacted by the Legislature of the State of Florida:
23
24     Section 1.  Section 381.99, Florida Statutes, is created to
25read:
26     381.99  Florida Hope Offered through Principled, Ethically
27Sound Stem Cell Research Act.--
28     (1)  SHORT TITLE.--This section may be cited as the
29"Florida Hope Offered through Principled, Ethically Sound Stem
30Cell Research Act."
31     (2)  DEFINITIONS.--As used in this section, the term:
32     (a)  "Adult stem cell" means a cell found within
33differentiated tissue or an organ that can renew itself and give
34rise to the major cell types of the tissue or organ. This
35includes cells from the fetal to adult stages of development.
36     (b)  "Amniotic stem cell" means a cell extracted from human
37amniotic fluid or a placenta.
38     (c)  "Embryonic stem cell" means a cell obtained from the
39undifferentiated inner mass of an early stage embryo.
40     (d)  "Human cloning" means human asexual reproduction,
41accomplished by introducing nuclear material from one or more
42human somatic cells into a fertilized or unfertilized oocyte the
43nuclear material of which has been removed or inactivated so as
44to produce a living organism at any stage of development that is
45genetically virtually identical to an existing or previously
46existing human organism.
47     (e)  "Stem cell" means a cell that retains the potential to
48generate some or all other cell types.
49     (3)  STEM CELL RESEARCH ADVISORY COUNCIL.--There is created
50the Stem Cell Research Advisory Council within the Department of
51Health.
52     (a)1.  The advisory council shall consist of the Secretary
53of Health or his or her designee, who shall act as chair, and
54six additional members, who shall be appointed as follows:
55     a.  Two persons appointed by the Governor, one of whom
56shall be an academic researcher in the field of stem cell
57research and one of whom shall have a background in bioethics.
58     b.  One person appointed by the President of the Senate,
59who shall have a background in private-sector stem cell funding
60and development or public-sector biomedical research and
61funding.
62     c.  One person appointed by the Speaker of the House of
63Representatives, who shall have a background in private-sector
64stem cell funding and development or public-sector biomedical
65research and funding.
66     d.  One person appointed by the President of the Senate,
67who shall have a background and experience in either public-
68sector or private-sector stem cell research and development.
69     e.  One person appointed by the Speaker of the House of
70Representatives, who shall be an executive of a biotech company,
71or his or her designee.
72     2.  Each member shall serve a term of 2 years commencing on
73October 1, 2007. No member shall serve for more than two
74consecutive 2-year terms; however, for the purpose of providing
75staggered terms, of the initial appointments, three members
76shall be appointed to a 1-year term and three members shall be
77appointed to a 2-year term. Any vacancy on the advisory council
78shall be filled in the same manner as the original appointment.
79All initial appointments shall be made by October 1, 2007. The
80first meeting shall take place no later than November 1, 2007.
81All meetings are subject to the call of the chair. Members shall
82meet at least twice a year or as often as necessary to discharge
83their duties but shall have no more than four meetings during
84any 12-month period. Members shall serve without compensation
85but may
86be reimbursed for per diem and travel expenses in accordance
87with s. 112.061.
88     (b)  The advisory council shall:
89     1.  Develop a donated funds program for recommendation to
90the Secretary of Health to encourage the development of funds
91other than state appropriations for human adult stem cell
92research in the state.
93     2.  Examine and identify specific ways to improve and
94promote for-profit and not-for-profit human adult stem cell and
95related research in the state, including, but not limited to,
96identifying both public and private funding sources for such
97research, maintaining existing human adult stem cell-related
98businesses, recruiting new human adult stem cell-related
99businesses to the state, and recruiting scientists and
100researchers in such fields to the state and state universities.
101     3.  Develop a biomedical research grant program for
102recommendation to the Secretary of Health that shall provide
103grants-in-aid to eligible state institutions for the advancement
104of human adult stem cell research.
105     4.  Develop, no later than December 1, 2007, an application
106for grants-in-aid under this section for recommendation to the
107Secretary of Health for the purpose of conducting human adult
108stem cell research.
109     5.  Review applications from eligible institutions for
110grants-in-aid on and after December 1, 2007, and provide to the
111Secretary of Health recommendations for grant awards.
112     6.  Review the stem cell research conducted by eligible
113institutions that receive such grants-in-aid.
114     (c)  The advisory council shall submit an annual progress
115report on the status of biomedical research in the state to the
116Florida Center for Universal Research to Eradicate Disease and
117to the Governor, the Secretary of Health, the President of the
118Senate, and the Speaker of the House of Representatives by June
11930. The report must include:
120     1.  The amount of grants-in-aid awarded to eligible
121institutions from the Biomedical Research Trust Fund.
122     2.  The names of the recipients of such grants-in-aid.
123     3.  The current status and progress of stem cell research
124in the state.
125     4.  A list of research projects supported by grants-in-aid
126awarded under the program.
127     5.  A list of publications in peer-reviewed journals
128involving research supported by grants-in-aid awarded under the
129program.
130     6.  The total amount of biomedical research funding
131currently flowing into the state.
132     7.  New grants for biomedical research that were funded
133based on research supported by grants-in-aid awarded under the
134program.
135     8.  All other materials the advisory council deems
136advisable to include.
137     (d)  Advisory council members shall disclose any conflict
138of interest or potential conflict of interest to the Secretary
139of Health.
140     (e)  The Department of Health shall provide administrative
141staff to assist the advisory council in developing the
142application for the grants-in-aid, reviewing the applications,
143preparing the written consent form described in paragraph
144(6)(b), and performing other administrative functions as the
145advisory council requires.
146     (4)  BIOMEDICAL ETHICS ADVISORY COUNCIL.--There is created
147within the Department of Health the Biomedical Ethics Advisory
148Council.
149     (a)1.  The advisory council shall consist of the Secretary
150of Health or his or her designee, who shall act as chair, and
151six additional members, who shall be appointed as follows:
152     a.  Two persons appointed by the Governor.
153     b.  One person appointed by the President of the Senate.
154     c.  One person appointed by the Speaker of the House of
155Representatives.
156     d.  One person appointed by the Minority Leader of the
157Senate.
158     e.  One person appointed by the Minority Leader of the
159House of Representatives.
160     2.  All members must demonstrate knowledge and
161understanding of the ethical, medical, and scientific
162implications of stem cell research and should also demonstrate
163knowledge of related fields, including, but not limited to,
164genetics, cellular biology, and embryology. Each member shall
165serve a term of 4 years commencing on October 1, 2007; however,
166for the purpose of providing staggered terms, of the initial
167appointments, three members shall be appointed to a 2-year term
168and three members shall be appointed to a 4-year term. No member
169shall serve for more than two consecutive terms. Any vacancy on
170the advisory council shall be filled in the same manner as the
171original appointment. All initial appointments shall be made by
172October 1, 2007. The first meeting shall take place no later
173than November 1, 2007. All meetings are subject to the call of
174the chair. Members shall meet at least twice a year or as often
175as necessary to discharge their duties but shall have no more
176than one meeting per month during any 12-month period. Members
177shall serve without compensation but may be reimbursed for per
178diem and travel expenses in accordance with s. 112.061.
179     (b)  The advisory council shall review all stem cell
180research that is funded or supported in any manner through the
181Biomedical Research Trust Fund to ensure the adherence to
182ethical and safety guidelines and procedures as set forth by
183federal ethical standards established by the United States
184Department of Health and Human Services.
185     (5)  BIOMEDICAL RESEARCH TRUST FUND AND GRANTS-IN-AID.--
186     (a)  The Secretary of Health shall make grants-in-aid from
187the Biomedical Research Trust Fund in accordance with the
188provisions of this section.
189     (b)  The Department of Health shall require any applicant
190for a grant-in-aid under this section, for the purpose of
191conducting stem cell research, to submit a complete description
192of the applicant's organization, the applicant's plans for stem
193cell research, the applicant's proposed funding for such
194research from sources other than the state, and the applicant's
195proposed arrangements concerning financial benefits to the state
196as a result of any patent, royalty payment, or similar right
197resulting from any stem cell research made possible by the
198awarding of the grant-in-aid. The Stem Cell Research Advisory
199Council shall provide recommendations to the Secretary of Health
200with respect to awarding such grants-in-aid after considering
201the recommendations of the Biomedical Ethics Advisory Council.
202     (c)  Beginning with the 2007-2008 fiscal year, and for 10
203consecutive years thereafter, not less than $20 million shall be
204made available annually from the Biomedical Research Trust Fund
205within the Department of Health for grants-in-aid to eligible
206institutions for the purpose of conducting adult stem cell
207research pursuant to this section. Up to 15 percent of the funds
208may be used for administrative costs. Any unexpended funds not
209used for grants-in-aid during the current fiscal year shall be
210carried forward for the following fiscal year to fund the
211grants-in-aid.
212     (6)  USE OF FUNDS; REQUIREMENTS AND RESTRICTIONS.--
213     (a)  Funds provided under this section may only be used for
214research involving:
215     1.  Human adult stem cells, including, but not limited to,
216adult stem cells derived from umbilical cord blood and bone
217marrow. Funding for research may be given for human adult stem
218cells derived from postmortem tissues, other than from medically
219induced abortions. Funds may be used for studies of human adult
220stem cells obtained from either normal or transformed tissues.
221     2.  Amniotic stem cells extracted from human amniotic fluid
222or placentas that are otherwise discarded after birth.
223     (b)  Amniotic and adult stem cell material may only be
224donated for research purposes with the informed consent of the
225donor.
226     (c)  No funds shall be used for research with human
227embryonic stem cells that are derived by a process entailing the
228donor embryo's death or destruction.
229     (7)  HUMAN CLONING; PROHIBITION; PENALTIES.--
230     (a)  It is unlawful for any person to knowingly:
231     1.  Perform or attempt to perform human cloning;
232     2.  Participate or assist in an attempt to perform human
233cloning; or
234     3.  Ship or receive for any purpose an embryo produced by
235human reproductive cloning or any product derived from such
236embryo.
237     (b)  A person who violates paragraph (a) commits a felony
238of the second degree, punishable as provided in s. 775.082, s.
239775.083, or s. 775.084.
240     (8)  CONTINUING APPROPRIATION.--Beginning in fiscal year
2412007-2008, the sum of $20 million is appropriated annually from
242recurring funds in the General Revenue Fund to the Biomedical
243Research Trust Fund within the Department of Health for the
244purpose of carrying out the provisions of this section. The
245amount of funds appropriated shall not exceed $200 million for
246the 10-year period beginning in fiscal year 2007-2008 and ending
247in fiscal year 2016-2017.
248     Section 2.  Paragraph (h) of subsection (1) of section
24920.435, Florida Statutes, is amended to read:
250     20.435  Department of Health; trust funds.--
251     (1)  The following trust funds are hereby created, to be
252administered by the Department of Health:
253     (h)  Biomedical Research Trust Fund.
254     1.  Funds to be credited to the trust fund shall consist of
255funds deposited pursuant to ss. s. 215.5601, 288.955, and 381.99
256and any other funds appropriated by the Legislature. Funds shall
257be used for the purposes of the James and Esther King Biomedical
258Research Program, and the William G. "Bill" Bankhead, Jr., and
259David Coley Cancer Research Program, and the Florida Hope
260Offered through Principled, Ethically Sound Stem Cell Research
261Act as specified in ss. 215.5602, 288.955, and 381.922, and
262381.99. The trust fund is exempt from the service charges
263imposed by s. 215.20.
264     2.  Notwithstanding the provisions of s. 216.301 and
265pursuant to s. 216.351, any balance in the trust fund at the end
266of any fiscal year shall remain in the trust fund at the end of
267the year and shall be available for carrying out the purposes of
268the trust fund. The department may invest these funds
269independently through the Chief Financial Officer or may
270negotiate a trust agreement with the State Board of
271Administration for the investment management of any balance in
272the trust fund.
273     3.  Notwithstanding s. 216.301 and pursuant to s. 216.351,
274any balance of any appropriation from the Biomedical Research
275Trust Fund which is not disbursed but which is obligated
276pursuant to contract or committed to be expended may be carried
277forward for up to 3 years following the effective date of the
278original appropriation.
279     4.  The trust fund shall, unless terminated sooner, be
280terminated on July 1, 2008.
281     Section 3.  Subsection (1) of section 381.86, Florida
282Statutes, is amended to read:
283     381.86  Institutional Review Board.--
284     (1)  The Institutional Review Board is created within the
285Department of Health in order to satisfy federal requirements
286under 45 C.F.R. part 46 and 21 C.F.R. parts 50 and 56 that an
287institutional review board review all biomedical and behavioral
288research on human subjects which is funded or supported in any
289manner by the department, except that a separate Stem Cell
290Research Advisory Council and Biomedical Ethics Advisory Council
291shall be appointed under s. 381.99.
292     Section 4.  This act shall take effect July 1, 2007.


CODING: Words stricken are deletions; words underlined are additions.