H.B. No. 810
 
 
 
 
AN ACT
  relating to the provision of certain investigational stem cell
  treatments to patients with certain severe chronic diseases or
  terminal illnesses and regulating the possession, use, and transfer
  of adult stem cells; creating a criminal offense.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  This Act shall be known as Charlie's Law.
         SECTION 2.  Chapter 1003, Health and Safety Code, is amended
  by designating Sections 1003.001, 1003.002, and 1003.003 as
  Subchapter A and adding a subchapter heading to read as follows:
  SUBCHAPTER A. GENERAL PROVISIONS
         SECTION 3.  Chapter 1003, Health and Safety Code, is amended
  by adding Subchapter B to read as follows:
  SUBCHAPTER B. PROVISION OF INVESTIGATIONAL STEM CELL TREATMENTS TO
  PATIENTS WITH CERTAIN SEVERE CHRONIC DISEASES OR TERMINAL ILLNESSES
         Sec. 1003.051.  DEFINITIONS. In this subchapter:
               (1)  "Investigational stem cell treatment" means an
  adult stem cell treatment that:
                     (A)  is under investigation in a clinical trial
  and being administered to human participants in that trial; and
                     (B)  has not yet been approved for general use by
  the United States Food and Drug Administration.
               (2)  "Severe chronic disease" means a condition,
  injury, or illness that:
                     (A)  may be treated;
                     (B)  is never cured or eliminated; and
                     (C)  entails significant functional impairment or
  severe pain.
               (3)  "Terminal illness" means an advanced stage of a
  disease with an unfavorable prognosis that, without
  life-sustaining procedures, will soon result in death or a state of
  permanent unconsciousness from which recovery is unlikely.
         Sec. 1003.052.  RULES. The executive commissioner shall
  adopt rules designating the medical conditions that constitute a
  severe chronic disease or terminal illness for purposes of this
  subchapter.
         Sec. 1003.053.  PATIENT ELIGIBILITY. A patient is eligible
  to access and use an investigational stem cell treatment under this
  subchapter if:
               (1)  the patient has a severe chronic disease or
  terminal illness listed in the rules adopted under Section 1003.052
  and attested to by the patient's treating physician; and
               (2)  the patient's physician:
                     (A)  in consultation with the patient, has
  considered all other treatment options currently approved by the
  United States Food and Drug Administration and determined that
  those treatment options are unavailable or unlikely to alleviate
  the significant impairment or severe pain associated with the
  severe chronic disease or terminal illness; and
                     (B)  has recommended or prescribed in writing that
  the patient use a specific class of investigational stem cell
  treatment.
         Sec. 1003.054.  INFORMED CONSENT. (a)  Before receiving an
  investigational stem cell treatment, an eligible patient must sign
  a written informed consent.
         (b)  If the patient is a minor or lacks the mental capacity to
  provide informed consent, a parent, guardian, or conservator may
  provide informed consent on the patient's behalf.
         (c)  The executive commissioner by rule may adopt a form for
  the informed consent under this section.
         Sec. 1003.055.  TREATMENT REQUIREMENTS; TEXAS MEDICAL BOARD
  RULES. (a) Treatment provided under this subchapter must be:
               (1)  administered directly by a physician certified
  under Subsection (c);
               (2)  overseen by an institutional review board
  described by Subsection (d); and
               (3)  provided at:
                     (A)  a hospital licensed under Chapter 241;
                     (B)  an ambulatory surgical center licensed under
  Chapter 243; or
                     (C)  a medical school, as defined by Section
  61.501, Education Code.
         (b)  A physician administering an investigational stem cell
  treatment under this subchapter shall comply with all applicable
  Texas Medical Board rules.
         (c)  An institutional review board described by Subsection
  (d) may certify a physician to provide an investigational stem cell
  treatment under this subchapter.
         (d)  An institutional review board that oversees
  investigational stem cell treatments administered under this
  subchapter must be affiliated with:
               (1)  a medical school, as defined by Section 61.501,
  Education Code; or
               (2)  a hospital licensed under Chapter 241 that has at
  least 150 beds.
         (e)  The Texas Medical Board may adopt rules regarding
  institutional review boards as necessary to implement this section.
         Sec. 1003.056.  EFFECT ON OTHER LAW. (a) This subchapter
  does not affect the coverage of enrollees in clinical trials under
  Chapter 1379, Insurance Code.
         (b)  This subchapter does not affect or authorize a person to
  violate any law regulating the possession, use, or transfer of
  fetal tissue, fetal stem cells, adult stem cells, or human organs,
  including Sections 48.02 and 48.03, Penal Code.
         Sec. 1003.057.  ACTION AGAINST PHYSICIAN'S LICENSE
  PROHIBITED. Notwithstanding any other law, the Texas Medical Board
  may not revoke, fail to renew, suspend, or take any action against
  a physician's license under Subchapter B, Chapter 164, Occupations
  Code, based solely on the physician's recommendations to an
  eligible patient regarding access to or use of an investigational
  stem cell treatment, provided that the care provided or
  recommendations made to the patient meet the standard of care and
  the requirements of this subchapter.
         Sec. 1003.058.  GOVERNMENTAL INTERFERENCE PROHIBITED. (a)
  In this section, "governmental entity" means this state or an
  agency or political subdivision of this state.
         (b)  A governmental entity or an officer, employee, or agent
  of a governmental entity may not interfere with an eligible
  patient's access to or use of a stem cell treatment authorized under
  this subchapter.
         Sec. 1003.059.  INSTITUTIONAL REVIEW BOARD DOCUMENTATION;
  REPORT. (a) An institutional review board overseeing an
  investigational stem cell treatment under this subchapter shall
  keep a record on each person to whom a physician administers the
  treatment and document in the record the provision of each
  treatment and the effects of the treatment on the person throughout
  the period the treatment is administered to the person.
         (b)  Each institutional review board overseeing an
  investigational stem cell treatment under this subchapter shall
  submit an annual report to the Texas Medical Board on the review
  board's findings based on records kept under Subsection (a). The
  report may not include any patient identifying information and must
  be made available to the public in both written and electronic form.
         SECTION 4.  Chapter 48, Penal Code, is amended by adding
  Section 48.03 to read as follows:
         Sec. 48.03.  PROHIBITION ON PURCHASE AND SALE OF ADULT STEM
  CELLS FOR CERTAIN INVESTIGATIONAL TREATMENTS. (a) In this
  section:
               (1)  "Adult stem cell" means an undifferentiated cell
  that is:
                     (A)  found in differentiated tissue; and
                     (B)  able to renew itself and differentiate to
  yield all or nearly all of the specialized cell types of the tissue
  from which the cell originated.
               (2)  "Investigational stem cell treatment" means an
  adult stem cell treatment that:
                     (A)  is under investigation in a clinical trial
  and being administered to human participants in that trial; and
                     (B)  has not yet been approved for general use by
  the United States Food and Drug Administration.
         (b)  A person commits an offense if the person knowingly
  offers to buy, offers to sell, acquires, receives, sells, or
  otherwise transfers any adult stem cells for valuable consideration
  for use in an investigational stem cell treatment.
         (c)  It is an exception to the application of this section
  that the valuable consideration is:
               (1)  a fee paid to a physician or to other medical
  personnel for services rendered in the usual course of medical
  practice or a fee paid for hospital or other clinical services;
               (2)  reimbursement of legal or medical expenses
  incurred for the benefit of the ultimate receiver of the
  investigational stem cell treatment; or
               (3)  reimbursement of expenses of travel, housing, and
  lost wages incurred by the donor of adult stem cells in connection
  with the donation of the adult stem cells.
         (d)  It is an exception to the application of this section
  that the actor engaged in conduct authorized under Chapter 162,
  Health and Safety Code.
         (e)  A violation of this section is a Class A misdemeanor.
         SECTION 5.  As soon as practicable after the effective date
  of this Act, the executive commissioner of the Health and Human
  Services Commission shall adopt rules necessary to implement
  Subchapter B, Chapter 1003, Health and Safety Code, as added by this
  Act.
         SECTION 6.  This Act takes effect September 1, 2017.
 
 
  ______________________________ ______________________________
     President of the Senate Speaker of the House     
 
 
         I certify that H.B. No. 810 was passed by the House on May 12,
  2017, by the following vote:  Yeas 141, Nays 0, 1 present, not
  voting; that the House refused to concur in Senate amendments to
  H.B. No. 810 on May 26, 2017, and requested the appointment of a
  conference committee to consider the differences between the two
  houses; and that the House adopted the conference committee report
  on H.B. No. 810 on May 28, 2017, by the following vote:  Yeas 145,
  Nays 0, 1 present, not voting.
 
  ______________________________
  Chief Clerk of the House   
 
         I certify that H.B. No. 810 was passed by the Senate, with
  amendments, on May 24, 2017, by the following vote:  Yeas 31, Nays
  0; at the request of the House, the Senate appointed a conference
  committee to consider the differences between the two houses; and
  that the Senate adopted the conference committee report on H.B. No.
  810 on May 28, 2017, by the following vote:  Yeas 30, Nays 0.
 
  ______________________________
  Secretary of the Senate   
  APPROVED: __________________
                  Date       
   
           __________________
                Governor