HB 555

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 Stem Cell Research Advisory
8Council; creating s. 381.99, F.S.; creating the Florida
9Better Quality of Life and Biomedical Research Act;
10providing a short title; providing definitions; creating
11the Stem Cell Research Advisory Council; providing for
12appointment, terms, and duties of members; authorizing
13reimbursement for per diem and travel expenses; requiring
14a report; requiring the Department of Health to provide
15administrative support; creating the Biomedical Ethics
16Advisory Council to regulate research procedures and
17enforce ethical guidelines; providing for appointment,
18terms, and duties of members; authorizing reimbursement
19for per diem and travel expenses; providing duties of the
20council; providing for a grants-in-aid program for the
21purpose of conducting embryonic, amniotic, or human adult
22stem cell research; providing that grants-in-aid shall be
23provided through funds in the Biomedical Research Trust
24Fund; restricting the use of such funds for research on
25certain stem cells; providing requirements with respect to
26the disposition of human embryos following infertility
27treatment; requiring the Department of Health to develop
28and maintain on its Internet website a consent form for
29the donation of certain embryos; prohibiting purchase or
30sale of embryonic fetal tissue for research purposes;
31prohibiting certain acts relating to human reproductive
32cloning; providing penalties; providing a continuing
33appropriation; providing an effective date.
34
35     WHEREAS, an estimated 130 million Americans suffer from
36acute, chronic, and degenerative diseases and there is enormous
37potential for lifesaving treatment and therapy as a result of
38recent advances in biomedical research, and
39     WHEREAS, Florida is unique among all states because of the
40size of the projected net population increase within the next 20
41years which raises significant health care concerns as a new
42generation of retirees moves to Florida, resulting in a
43corresponding rise in the number of persons suffering from
44illnesses such as cancer, heart disease, Alzheimer's Disease,
45Parkinson's Disease, cerebral palsy, juvenile diabetes,
46atherosclerosis, Amyotrophic Lateral Sclerosis, AIDS, spinal
47cord injuries, severe burns, osteoporosis, osteoarthritis,
48cystic fibrosis, muscular dystrophy, multiple sclerosis, macular
49degeneration, diabetic retinopathy, retinitis pigmentosa,
50cirrhosis of the liver, motor neuron disease, brain trauma,
51stroke, sickle cell anemia, and intestinal diseases, and
52     WHEREAS, in order to maintain a high quality of life for
53all Floridians, research into stem cell regenerative therapies
54and treatment should be supported to give hope and relief to the
55millions of citizens who suffer from degenerative and crippling
56diseases, and
57     WHEREAS, to reduce the burden on the health care
58infrastructure, the state must shift its health care objectives
59from costly long-term maintenance toward prevention and cures,
60and
61     WHEREAS, to bolster and advance Florida's burgeoning
62biotechnology industry, the state should provide funds and
63incentives for private research companies to work in the state,
64and
65     WHEREAS, the state should advance the goal of scientific
66and academic discourse in its universities and help bring its
67public and private universities to the forefront in biomedical
68research and technology, and
69     WHEREAS, it will benefit the economy of the state to create
70a wide array of new projects and high-paying jobs relating to
71biomedical research, and
72     WHEREAS, it will benefit the state to foster cooperation
73between the state's universities and private sector research in
74terms of jobs, resources, and academic discourse relating to
75biomedical research, and
76     WHEREAS, the public funds provided under the Florida Better
77Quality of Life and Biomedical Research Act are intended to spur
78innovation and development in Florida's biomedical technology
79sector, which will be used to treat debilitating chronic
80diseases, NOW, THEREFORE,
81
82Be It Enacted by the Legislature of the State of Florida:
83
84     Section 1.  Paragraph (h) of subsection (1) of section
8520.435, Florida Statutes, is amended to read:
86     20.435  Department of Health; trust funds.--
87     (1)  The following trust funds are hereby created, to be
88administered by the Department of Health:
89     (h)  Biomedical Research Trust Fund.
90     1.  Funds to be credited to the trust fund shall consist of
91funds deposited pursuant to ss. s. 215.5601, 288.955, and
92381.99, and any other funds appropriated by the Legislature.
93Funds shall be used for the purposes of the James and Esther
94King Biomedical Research Program, and the William G. "Bill"
95Bankhead, Jr., and David Coley Cancer Research Program, and the
96Florida Better Quality of Life and Biomedical Research Act as
97specified in ss. 215.5602, 288.955, and 381.922, and 381.99. The
98trust fund is exempt from the service charges imposed by s.
99215.20.
100     2.  Notwithstanding the provisions of s. 216.301 and
101pursuant to s. 216.351, any balance in the trust fund at the end
102of any fiscal year shall remain in the trust fund at the end of
103the year and shall be available for carrying out the purposes of
104the trust fund. The department may invest these funds
105independently through the Chief Financial Officer or may
106negotiate a trust agreement with the State Board of
107Administration for the investment management of any balance in
108the trust fund.
109     3.  Notwithstanding s. 216.301 and pursuant to s. 216.351,
110any balance of any appropriation from the Biomedical Research
111Trust Fund which is not disbursed but which is obligated
112pursuant to contract or committed to be expended may be carried
113forward for up to 3 years following the effective date of the
114original appropriation.
115     4.  The trust fund shall, unless terminated sooner, be
116terminated on July 1, 2008.
117     Section 2.  Subsection (2) of section 381.86, Florida
118Statutes, is amended to read:
119     381.86  Institutional Review Board.--
120     (2)  Consistent with federal requirements, the Secretary of
121Health shall determine and appoint the membership of the board
122and designate its chair, except that a separate Stem Cell
123Research Advisory Council shall be appointed pursuant to s.
124381.99 for the sole purpose of reviewing research funded under
125that section.
126     Section 3.  Section 381.99, Florida Statutes, is created to
127read:
128     381.99  Florida Better Quality of Life and Biomedical
129Research Act.--
130     (1)  SHORT TITLE.--This section may be cited as the
131"Florida Better Quality of Life and Biomedical Research Act."
132     (2)  DEFINITIONS.--As used in this section, the term:
133     (a)  "Adult stem cell" means an undifferentiated cell found
134among differentiated cells in a tissue or an organ that can
135renew itself and can differentiate to yield the major
136specialized cell types of the tissue or organ.
137     (b)  "Amniotic stem cell" means a cell extracted from human
138amniotic fluid or a placenta.
139     (c)  "Embryonic stem cell" means a cell obtained from the
140undifferentiated inner mass of an early stage embryo.
141     (d)  "Human reproductive cloning" means the practice of
142creating or attempting to create a human being by transferring
143the nucleus from a human cell into an egg cell from which the
144nucleus has been removed for the purpose of implanting the
145resulting product in a uterus or a substitute for a uterus to
146initiate a pregnancy.
147     (e)  "In vitro fertilization" means a technique by which
148oocytes are fertilized by sperm outside of a woman's body
149resulting in organisms that are not genetically identical to any
150one existing human.
151     (f)  "Stem cell" means an undifferentiated cell that
152retains the potential to differentiate into some or all other
153cell types.
154     (3)  STEM CELL RESEARCH ADVISORY COUNCIL.--There is created
155the Stem Cell Research Advisory Council.
156     (a)  The advisory council shall consist of the Secretary of
157Health or his or her designee, who shall act as chair, and six
158additional members, who shall be appointed as follows:
159     1.  Two persons appointed by the Governor, one of whom
160shall be an academic researcher in the field of stem cell
161research and one of whom shall have a background in bioethics.
162     2.  One person appointed by the President of the Senate,
163who shall have a background in private sector stem cell funding
164and development and public sector biomedical research and
165funding.
166     3.  One person appointed by the Speaker of the House of
167Representatives, who shall have a background in private sector
168stem cell funding and development and public sector biomedical
169research and funding.
170     4.  One person appointed by the Minority Leader of the
171Senate, who shall have a background and experience in either
172public sector or private sector stem cell research and
173development.
174     5.  One person appointed by the Minority Leader of the
175House of Representatives, who shall have a background and
176experience in business and financial investments.
177
178Each member shall serve a term of 2 years commencing on October
1791, 2007. No member shall serve for more than two consecutive 2-
180year terms; however, for the purpose of providing staggered
181terms, of the initial appointments, three members shall be
182appointed to a 1-year term and three members shall be appointed
183to a 2-year term. No member shall serve for more than two
184consecutive terms. Any vacancy on the council shall be filled in
185the same manner as the original appointment. All initial
186appointments must be made by October 1, 2007. The first meeting
187shall take place no later than November 1, 2007. All meetings
188are subject to the call of the chair. Members shall meet at
189least twice a year or as often as necessary to discharge their
190duties but shall have no more than four meetings during any 12-
191month period. Members shall serve without compensation but may
192be reimbursed for per diem and travel expenses in accordance
193with s. 112.061.
194     (b)  The advisory council shall:
195     1.  Develop a donated funds program for recommendation to
196the Secretary of Health to encourage the development of funds
197other than state appropriations for embryonic, amniotic, and
198human adult stem cell research in the state.
199     2.  Examine and identify specific ways to improve and
200promote for-profit and not-for-profit embryonic, amniotic, and
201human adult stem cell and related research in the state,
202including, but not limited to, identifying both public and
203private funding sources for such research, maintaining existing
204embryonic, amniotic, and human adult stem cell related
205businesses, recruiting new embryonic, amniotic, and human adult
206stem cell related businesses to the state, and recruiting
207scientists and researchers in such fields to the state and state
208universities.
209     3.  Develop a biomedical research grant program for
210recommendation to the Secretary of Health, which shall provide
211grants-in-aid to eligible institutions for the advancement of
212embryonic, amniotic, or human adult stem cell research.
213     4.  Develop, no later than December 1, 2007, an application
214for grants-in-aid under this section for recommendation to the
215Secretary of Health for the purpose of conducting embryonic,
216amniotic, or human adult stem cell research.
217     5.  Review applications from eligible institutions for
218grants-in-aid on and after December 1, 2007, and provide to the
219Secretary of Health recommended grant awards.
220     6.  Review the stem cell research conducted by eligible
221institutions that receive such grants-in-aid.
222     (c)  The advisory council shall submit an annual progress
223report on the status of biomedical research in the state to the
224Florida Center for Universal Research to Eradicate Disease and
225to the Governor, the Secretary of Health, the President of the
226Senate, and the Speaker of the House of Representatives by June
22730. The report must include:
228     1.  The amount of grants-in-aid awarded to eligible
229institutions from the Biomedical Research Trust Fund.
230     2.  The names of the recipients of such grants-in-aid.
231     3.  The current status and progress of stem cell research
232in the state.
233     4.  A list of research projects supported by grants-in-aid
234awarded under the program.
235     5.  A list of publications in peer-reviewed journals
236involving research supported by grants-in-aid awarded under the
237program.
238     6.  The total amount of biomedical research funding
239currently flowing into the state.
240     7.  New grants for biomedical research that were funded
241based on research supported by grants-in-aid awarded under the
242program.
243     8.  All other materials the council deems advisable to
244include.
245     (d)  Advisory council members shall disclose any conflict
246of interest or potential conflict of interest to the Secretary
247of Health.
248     (e)  The Department of Health shall provide administrative
249staff to assist the advisory council in developing the
250application for the grants-in-aid, reviewing the applications,
251preparing the written consent form described in paragraph
252(6)(b), and performing other administrative functions as the
253advisory council requires.
254     (4)  BIOMEDICAL ETHICS ADVISORY COUNCIL.--There is created
255within the Department of Health the Biomedical Ethics Advisory
256Council, which shall review the research conducted under s.
257381.99.
258     (a)  The advisory council shall consist of the Secretary of
259Health or his or her designee, who shall act as chair, and six
260additional members, who shall be appointed as follows:
261     1.  Two persons appointed by the Governor.
262     2.  One person appointed by the President of the Senate.
263     3.  One person appointed by the Speaker of the House of
264Representatives.
265     4.  One person appointed by the Minority Leader of the
266Senate.
267     5.  One person appointed by the Minority Leader of the
268House of Representatives.
269
270All members must demonstrate knowledge and understanding of the
271ethical, medical, and scientific implications of embryonic,
272amniotic, and adult stem cell research and should also
273demonstrate knowledge of related fields, including, but not
274limited to, genetics, cellular biology, and embryology. Each
275member shall serve a term of 4 years commencing on October 1,
2762007; however, for the purpose of providing staggered terms, of
277the initial appointments, three members shall be appointed to a
2782-year term and three members shall be appointed to a 4-year
279term. No member shall serve for more than two consecutive terms.
280Any vacancy on the council shall be filled in the same manner as
281the original appointment. All initial appointments must be made
282by October 1, 2007. The first meeting shall take place no later
283than November 1, 2007. All meetings are subject to the call of
284the chair. Members shall meet at least twice a year or as often
285as necessary to discharge their duties but shall have no more
286than one meeting per month during any 12-month period. Members
287shall serve without compensation but may be reimbursed for per
288diem and travel expenses in accordance with s. 112.061.
289     (b)  The council shall review all embryonic, amniotic, or
290human adult stem cell research that is funded or supported in
291any manner through the Biomedical Research Trust Fund to ensure
292the adherence to ethical and safety guidelines and procedures as
293laid out by federal ethical standards established by the United
294States Department of Health and Human Services.
295     (5)  BIOMEDICAL RESEARCH TRUST FUND AND GRANTS-IN-AID.--
296     (a)  The Secretary of Health shall make grants-in-aid from
297the Biomedical Research Trust Fund in accordance with the
298provisions of this section.
299     (b)  The Department of Health shall require any applicant
300for a grant-in-aid under this section, for the purpose of
301conducting stem cell research, to submit a complete description
302of the applicant's organization, the applicant's plans for stem
303cell research, the applicant's proposed funding for such
304research from sources other than the state, and the applicant's
305proposed arrangements concerning financial benefits to the state
306as a result of any patent, royalty payment, or similar right
307resulting from any stem cell research made possible by the
308awarding of the grant-in-aid. The Stem Cell Research Advisory
309Council shall provide recommendations to the Secretary of Health
310with respect to awarding such grants-in-aid after considering
311the recommendations of the Biomedical Ethics Advisory Council.
312     (c)  Beginning with the 2007-2008 fiscal year, and for 10
313consecutive years thereafter, not less than $20 million shall be
314made available from the Biomedical Research Trust Fund within
315the Department of Health for grants-in-aid to eligible
316institutions for the purpose of conducting embryonic, amniotic,
317or human adult stem cell research pursuant to this section. Up
318to 15 percent of the funds may be used for administrative costs.
319Any unexpended funds not used for grants-in-aid during the
320current fiscal year shall be carried forward for the following
321fiscal year to fund the grants-in-aid.
322     (6)  USE OF FUNDS; REQUIREMENTS AND RESTRICTIONS REGARDING
323DISPOSITION OF HUMAN EMBRYOS FOLLOWING INFERTILITY TREATMENT.--
324     (a)  Funds provided under this section may only be used for
325research involving:
326     1.  Human adult stem cells, including, but not limited to,
327adult stem cells derived from umbilical cord blood and bone
328marrow.
329     2.  Human embryonic stem cells taken from donated leftover
330embryos from in vitro fertilization treatments that would
331otherwise be thrown away or destroyed.
332     3.  Amniotic stem cells extracted from human amniotic fluid
333or placentas, which are otherwise discarded after birth.
334     (b)  A physician or other health care provider treating a
335patient for infertility shall provide the patient with timely,
336relevant, and appropriate information sufficient to allow the
337person to make an informed and voluntary choice regarding the
338disposition of any human embryos that remain following
339infertility treatment. The person to whom the information is
340provided:
341     1.  Shall be presented with the option of storing any
342unused embryos remaining after receiving in vitro fertilization,
343donating the remaining embryos to another person, donating the
344remaining embryos for research purposes, or selecting other
345means of disposition of the remaining embryos.
346     2.  Who elects to donate, for research purposes, any
347embryos remaining after receiving infertility treatment shall
348provide written consent for that donation on a consent form
349provided by the Department of Health and made available to the
350public on the department's Internet website.
351     3.  May not knowingly, for material or financial gain,
352purchase, sell, or otherwise transfer or obtain, or promote the
353sale or transfer of, embryonic fetal tissue for research
354purposes pursuant to this section. Embryonic, amniotic, and
355adult stem cell material may only be donated for research
356purposes with the informed consent of the donor. A person who
357violates any provision of this subparagraph commits a felony of
358the second degree, punishable as provided in s. 775.082, s.
359775.083, or s. 775.084.
360     (7)  HUMAN REPRODUCTIVE CLONING; PROHIBITION; PENALTIES.--
361     (a)  It is unlawful for any person to knowingly:
362     1.  Perform or attempt to perform human reproductive
363cloning;
364     2.  Participate or assist in an attempt to perform human
365reproductive cloning; or
366     3.  Ship or receive for any purpose an embryo produced by
367human reproductive cloning or any product derived from such
368embryo.
369     (b)  A person who violates any provision of paragraph (a)
370commits a felony of the second degree, punishable as provided in
371s. 775.082, s. 775.083, or s. 775.084.
372     (8)  CONTINUING APPROPRIATION.--Beginning in fiscal year
3732007-2008, the sum of $20 million is appropriated annually from
374recurring funds in the General Revenue Fund to the Biomedical
375Research Trust Fund within the Department of Health for the
376purposes of carrying out the provisions of this section. The
377amount of funds appropriated shall not exceed $200 million for
378the 10-year period beginning in fiscal year 2007-2008 and ending
379in fiscal year 2016-2017.
380     Section 4.  This act shall take effect July 1, 2007.


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