HB 233

1
A bill to be entitled
2An act relating to biomedical research; amending s.
320.435, F.S.; revising uses for funds credited to the
4Biomedical Research Trust Fund; amending s. 381.86, F.S.;
5providing that the Institutional Review Board within the
6Department of Health shall not review certain research
7within the jurisdiction of the Biomedical Research and
8Ethics Oversight Council; creating s. 381.99, F.S., the
9Florida Better Quality of Life and Biomedical Research
10Act; providing definitions; providing legislative
11findings; creating the Biomedical Research Advisory
12Council; providing for criteria, appointment, and terms of
13members; authorizing reimbursement for per diem and travel
14expenses; providing duties of the advisory council,
15including a report to the Governor, the President of the
16Senate, and the Speaker of the House of Representatives;
17requiring the Department of Health to provide
18administrative support; creating the Biomedical Research
19and Ethics Oversight Council to regulate research
20procedures and enforce ethical guidelines; providing for
21criteria, appointment, and terms of members; authorizing
22reimbursement for per diem and travel expenses; providing
23duties of the oversight council; providing for a grants-
24in-aid program for the purpose of conducting embryonic or
25human adult stem cell research; providing that grants-in-
26aid shall be provided through funds in the Biomedical
27Research Trust Fund; restricting the use of such funds for
28research on certain stem cells; providing requirements
29with respect to the disposition of human embryos following
30infertility treatment; requiring the Department of Health
31to develop and maintain on its Internet website a consent
32form for the donation of certain embryos; prohibiting
33purchase or sale of embryonic fetal tissue for research
34purposes; prohibiting certain acts relating to human
35reproductive cloning; providing penalties; providing an
36effective date.
37
38Be It Enacted by the Legislature of the State of Florida:
39
40     Section 1.  Paragraph (h) of subsection (1) of section
4120.435, Florida Statutes, is amended to read:
42     20.435  Department of Health; trust funds.--
43     (1)  The following trust funds are hereby created, to be
44administered by the Department of Health:
45     (h)  Biomedical Research Trust Fund.
46     1.  Funds to be credited to the trust fund shall consist of
47funds deposited pursuant to ss. s. 215.5601, 288.955, and
48381.99. Funds shall be used for the purposes of the James and
49Esther King Biomedical Research Program as specified in ss.
50215.5602 and 288.955 and the purposes of the Florida Better
51Quality of Life and Biomedical Research Act as specified in s.
52381.99. The trust fund is exempt from the service charges
53imposed by s. 215.20.
54     2.  Notwithstanding the provisions of s. 216.301 and
55pursuant to s. 216.351, any balance in the trust fund at the end
56of any fiscal year shall remain in the trust fund at the end of
57the year and shall be available for carrying out the purposes of
58the trust fund. The department may invest these funds
59independently through the Chief Financial Officer or may
60negotiate a trust agreement with the State Board of
61Administration for the investment management of any balance in
62the trust fund.
63     3.  Notwithstanding s. 216.301 and pursuant to s. 216.351,
64any balance of any appropriation from the Biomedical Research
65Trust Fund which is not disbursed but which is obligated
66pursuant to contract or committed to be expended may be
67certified by the Governor for up to 3 years following the
68effective date of the original appropriation.
69     4.  The trust fund shall, unless terminated sooner, be
70terminated on July 1, 2008.
71     Section 2.  Subsection (1) of section 381.86, Florida
72Statutes, is amended to read:
73     381.86  Institutional Review Board.--
74     (1)  The Institutional Review Board is created within the
75Department of Health in order to satisfy federal requirements
76under 45 C.F.R. part 46 and 21 C.F.R. parts 50 and 56 that an
77institutional review board review all biomedical and behavioral
78research on human subjects which is funded or supported in any
79manner by the department except for research within the
80jurisdiction of the Biomedical Research and Ethics Oversight
81Council, which shall be reviewed pursuant to the provisions of
82s. 381.99.
83     Section 3.  Section 381.99, Florida Statutes, is created to
84read:
85     381.99  Florida Better Quality of Life and Biomedical
86Research Act.--
87     (1)  SHORT TITLE.--This section may be cited as the
88"Florida Better Quality of Life and Biomedical Research Act."
89     (2)  DEFINITIONS.--As used in this section, the term:
90     (a)  "Adult stem cell" means an undifferentiated cell found
91among differentiated cells in a tissue or an organ that can
92renew itself and can differentiate to yield the major
93specialized cell types of the tissue or organ.
94     (b)  "Asexual reproduction" means reproduction not
95initiated by the union of oocyte and sperm.
96     (c)  "Embryonic stem cells" means cells obtained from the
97undifferentiated inner mass of an early stage embryo.
98     (d)  "Human reproductive cloning" means the practice of
99creating or attempting to create a human being by transferring
100the nucleus from a human cell into an egg cell from which the
101nucleus has been removed for the purpose of implanting the
102resulting product in a uterus or substitute for a uterus to
103initiate a pregnancy.
104     (e)  "In vitro fertilization" means a technique in which
105oocytes are fertilized by sperm outside of a woman's body
106resulting in organisms that are not genetically identical to any
107one existing human.
108     (f)  "Oocyte" means an immature egg cell of the human
109ovary.
110     (g)  "Stem cells" means undifferentiated cells which retain
111the potential to differentiate into some or all other cell
112types.
113     (3)  LEGISLATIVE FINDINGS.--The Legislature finds that:
114     (a)  An estimated 130 million Americans suffer from acute,
115chronic, and degenerative diseases and that there is enormous
116potential for lifesaving treatment and therapy as a result of
117recent advances in biomedical research.
118     (b)  Florida is unique among all states for its large
119projected net population increase within the next 20 years. This
120increase, in turn, raises significant health care concerns as a
121new, larger generation of retirees moves to Florida, resulting
122in a corresponding rise in the number of persons suffering from
123illnesses such as cancer, heart disease, Alzheimer's Disease,
124Parkinson's Disease, cerebral palsy, juvenile diabetes,
125atherosclerosis, amyotrophic lateral sclerosis, AIDS, spinal
126cord injuries, severe burns, osteoporosis, osteoarthritis,
127cystic fibrosis, muscular dystrophy, multiple sclerosis, macular
128degeneration, diabetic retinopathy, retinitis pigmentosa,
129cirrhosis of the liver, motor neuron disease, brain trauma,
130stroke, sickle cell anemia, and intestinal diseases.
131     (c)  In order to maintain a high quality of life for all
132Floridians, research into stem cell regenerative therapies and
133treatment should be supported to give hope and relief to the
134millions of citizens who suffer in silence from degenerative and
135crippling diseases.
136     (d)  To reduce the burden on the health care
137infrastructure, the state must shift its health care objectives
138from costly long-term maintenance toward prevention and cures.
139     (e)  To bolster and advance Florida's burgeoning
140biotechnology industry, the state should provide funds and
141incentives for private research companies to work in the state.
142     (f)  The state should advance the goal of scientific and
143academic discourse in our universities and help bring its public
144and private universities to the forefront in biomedical research
145and technology.
146     (g)  It will benefit the economy of the state to create a
147wide array of new projects and high-paying jobs relating to
148biomedical research.
149     (h)  It will benefit the state to foster cooperation
150between the state's universities and private sector research in
151terms of jobs, resources, and academic discourse relating to
152biomedical research.
153     (i)  The public funds provided under this section are
154intended to spur innovation and development in Florida's
155biomedical technology sector, which will be used to treat
156debilitating chronic diseases.
157     (4)  BIOMEDICAL RESEARCH ADVISORY COUNCIL.--There shall be
158established a Biomedical Research Advisory Council.
159     (a)  The advisory council shall consist of the Secretary of
160Health, who shall act as chair, and six additional members, who
161shall be appointed as follows:
162     1.  Two persons appointed by the Governor, one of whom
163shall be an academic researcher in the field of stem cell
164research and one of whom shall have a background in bioethics.
165     2.  One person appointed by the President of the Senate,
166who shall have a background in private sector stem cell funding
167and development and public sector biomedical research and
168funding.
169     3.  One person appointed by the Speaker of the House of
170Representatives, who shall have a background in private sector
171stem cell funding and development and public sector biomedical
172research and funding.
173     4.  One person appointed by the Minority Leader of the
174Senate, who shall have a background and experience in either
175public or private sector stem cell research and development.
176     5.  One person appointed by the Minority Leader of the
177House of Representatives, who shall have a background and
178experience in business and financial investments.
179
180Members shall serve for terms of 2 years each commencing on
181October 1, 2006. No member shall serve for more than two
182consecutive 2-year terms. All initial appointments must be made
183by October 1, 2006. The first meeting shall take place no later
184than November 1, 2006. Members shall meet at least twice
185annually, but no more than four times annually. Members shall
186serve without compensation but shall be reimbursed for per diem
187and travel expenses in accordance with s. 112.061.
188     (b)  The members of the advisory council shall work to
189provide an environment fostering the advancement of embryonic
190and human adult stem cell research. The advisory council shall:
191     1.  Develop a donated funds program for recommendation to
192the Secretary of Health, to encourage the development of funds
193other than state appropriations for embryonic and human adult
194stem cell research in the state.
195     2.  Examine and identify specific ways to improve and
196promote for-profit and not-for-profit embryonic and human adult
197stem cell and related research in the state, including, but not
198limited to, identifying both public and private funding sources
199for such research, maintaining existing embryonic and human
200adult stem cell related businesses, recruiting new embryonic and
201human adult stem cell related businesses to the state, and
202recruiting scientists and researchers in such fields to the
203state and state universities.
204     3.  Develop a biomedical research grant program for
205recommendation to the Secretary Health, which shall provide
206grants-in-aid to eligible institutions for the advancement of
207embryonic or human adult stem cell research.
208     4.  Develop, no later than December 1, 2006, an application
209for grants-in-aid under this section for recommendation to the
210Secretary of Health for the purpose of conducting embryonic or
211human adult stem cell research.
212     5.  Receive applications from eligible institutions for
213grants-in-aid on and after December 1, 2006, and provide to the
214Secretary of Health recommended grant awards.
215     6.  Monitor the stem cell research conducted by eligible
216institutions that receive such grants-in-aid.
217     (c)  The advisory council shall submit an annual progress
218report on the state of biomedical research in the state to the
219Florida Center for Universal Research to Eradicate Disease and
220to the Governor, the Secretary of Health, the President of the
221Senate, and the Speaker of the House of Representatives by June
22230. The report must include:
223     1.  The amount of grants-in-aid awarded to eligible
224institutions from the Biomedical Research Trust Fund.
225     2.  The recipients of such grants-in-aid.
226     3.  The current status and progress of stem cell research
227in the state.
228     4.  A list of research projects supported by grants-in-aid
229awarded under the program.
230     5.  A list of publications in peer-reviewed journals
231involving research supported by grants-in-aid awarded under the
232program.
233     6.  The total amount of biomedical research funding
234currently flowing into the state.
235     7.  New grants for biomedical research that were funded
236based on research supported by grants-in-aid awarded under the
237program.
238     8.  All other materials the council deems advisable to
239include.
240     (d)  Advisory council members shall disclose any conflict
241of interest or potential conflict of interest to the Secretary
242of Health.
243     (e)  The Department of Health shall provide administrative
244staff to assist the advisory council in developing the
245application for the grants-in-aid, reviewing such applications,
246making recommendations to the advisory council, preparing the
247written consent form described in paragraph (7)(b), and
248performing other administrative functions as the advisory
249council requires or as is deemed necessary.
250     (5)  BIOMEDICAL RESEARCH AND ETHICS OVERSIGHT
251COUNCIL.--There shall be established a Biomedical Research and
252Ethics Oversight Council.
253     (a)  The oversight council shall consist of seven members,
254of which the Secretary of Health shall act as chair. The
255additional members shall be appointed as follows:
256     1.  Two persons appointed by the Governor.
257     2.  One person appointed by the President of the Senate.
258     3.  One person appointed by the Speaker of the House of
259Representatives.
260     4.  One person appointed by the Minority Leader of the
261Senate.
262     5.  One person appointed by the Minority Leader of the
263House of Representatives.
264
265All members must demonstrate knowledge and understanding of the
266ethical, medical, and scientific implications of embryonic and
267adult stem cell research and should also demonstrate knowledge
268of related fields, including, but not limited to, genetics,
269cellular biology, and embryology. At least three members shall
270have practical research experience in stem cell research or
271related fields. Members shall serve for terms of 4 years each
272commencing on October 1, 2006. No member shall serve for more
273than two consecutive 4-year terms. All initial appointments must
274be made by October 1, 2006. The first meeting shall take place
275no later than November 1, 2006. Members shall meet at least
276twice annually, but no more than four times annually. Members
277shall serve without compensation but shall be reimbursed for per
278diem and travel expenses in accordance with s. 112.061.
279     (b)  The oversight council shall review all embryonic or
280human adult stem cell research which is funded or supported in
281any manner through the Biomedical Research Trust Fund to ensure
282the adherence to ethical and safety guidelines and procedures as
283laid out by federal ethical standards established by the United
284States Department of Health and Human Services.
285     (6)  BIOMEDICAL RESEARCH TRUST FUND AND GRANTS-IN-AID.--
286     (a)  The Secretary of Health shall make grants-in-aid from
287the Biomedical Research Trust Fund in accordance with the
288provisions of this section.
289     (b)  The Department of Health shall require any applicant
290for a grant-in-aid under this section, for the purpose of
291conducting stem cell research, to submit a complete description
292of the applicant's organization, the applicant's plans for stem
293cell research, the applicant's proposed funding for such
294research from sources other than the state, and the applicant's
295proposed arrangements concerning financial benefits to the state
296as a result of any patent, royalty payment, or similar rights
297resulting from any stem cell research made possible by the
298awarding of such grant-in-aid. The Biomedical Research Advisory
299Council shall provide recommendations to the Secretary of Health
300with respect to awarding such grants-in-aid after considering
301recommendations from the Biomedical Research and Ethics
302Oversight Council.
303     (c)  Beginning with the 2006-2007 fiscal year, and for 10
304consecutive years thereafter, not less than $15 million shall be
305made available annually from the Biomedical Research Trust Fund
306for grants-in-aid to eligible institutions for the purpose of
307conducting embryonic or human adult stem cell research as
308directed by the Biomedical Research Advisory Council. Any
309balance of such amount not used for such grants-in-aid during a
310fiscal year shall be carried forward for the fiscal year next
311succeeding for such grants-in-aid.
312     (7)  FUNDING.--Funds provided under this section may only
313be used for research involving:
314     (a)  Human adult stem cells, including, but not limited to,
315adult stem cells derived from umbilical cord blood and bone
316marrow.
317     (b)  Human embryonic stem cells taken from donated leftover
318embryos from in vitro fertilization treatments that would
319otherwise be thrown away or destroyed.
320     1.  A physician or other health care provider who is
321treating a patient for infertility shall provide the patient
322with timely, relevant, and appropriate information sufficient to
323allow the person to make an informed and voluntary choice
324regarding the disposition of any human embryos that remain
325following infertility treatment.
326     2.  A person to whom information is provided pursuant to
327subparagraph 1. shall be presented with the options of storing
328any unused embryos, donating them to another person, donating
329the remaining embryos for research purposes, or selecting other
330means of disposition.
331     3.  A person who elects to donate, for research purposes,
332any embryos remaining after receiving infertility treatment
333shall provide written consent for that donation in a consent
334form provided by the Department of Health and made available to
335the public on the department's Internet website.
336     4.  A person may not knowingly, for material or financial
337gain, purchase, sell, or otherwise transfer or obtain, or
338promote the sale or transfer of, embryonic fetal tissue for
339research purposes pursuant to this section. Embryonic and adult
340stem cell material may only be donated for research purposes
341with the informed consent of the donor. A person who violates
342any provision of this subparagraph commits a felony of the
343second degree, punishable as provided in s. 775.082, s. 775.083,
344or s. 775.084.
345     (8)  HUMAN REPRODUCTIVE CLONING; PROHIBITION; PENALTIES.--
346     (a)  It is unlawful for any person to knowingly:
347     1.  Perform or attempt to perform human reproductive
348cloning.
349     2.  Participate or assist in an attempt to perform human
350reproductive cloning.
351     3.  Ship or receive for any purpose an embryo produced by
352human reproductive cloning or any product derived from such
353embryo.
354     (b)  A person who violates any provision of paragraph (a)
355commits a felony of the second degree, punishable as provided in
356s. 775.082, s. 775.083, or s. 775.084.
357     Section 4.  This act shall take effect July 1, 2006.


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