98TH GENERAL ASSEMBLY
State of Illinois
2013 and 2014
HB0158

 

Introduced 1/16/2013, by Rep. Lou Lang

 

SYNOPSIS AS INTRODUCED:
 
New Act

    Creates the Human Tissue Transfer Act. Sets forth definitions. Provides that the living donor from whom the human tissue specimen was physically removed is the owner of that human tissue specimen prior to removal and that to transfer ownership of a human tissue specimen from a living donor to another party requires the written agreement as set forth in the Act if that other party is a physician. Provides that ownership of human tissue specimens that are physically removed from a living donor resides in the party who has signed and complied with the conditions of the agreement in the Act if that party is a physician. Provides that when the agreement set forth in the Act has been fully executed by the living donor and a physician and the human tissue specimens have been physically removed prior to the death of the living donor, but the payment required by the agreement has not been made prior to the death of the donor, the payment shall be made to the successor in interest. Sets forth provisions concerning the misappropriation of human tissue specimens, remedies, actions for misappropriation, the applicability of the Act, the scope of the human tissue agreement, and the form of the agreement.


LRB098 04087 RPM 34110 b

 

 

A BILL FOR

 

HB0158LRB098 04087 RPM 34110 b

1    AN ACT concerning health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short title. This Act may be cited as the Human
5Tissue Transfer Act.
 
6    Section 5. Definitions. As used in this Act, and unless
7the context requires otherwise:
8    "Human tissue specimen" means any biological material
9originating within and taken from a living donor (i) as
10designated exclusively by items (6) and (7) of subsection (b)
11of Section 12-20 of the Criminal Code of 2012 and (ii) not to
12be transplanted directly into another human body.
13    "Informed consent" means a living person's agreement to a
14medical procedure in which tissue will be removed, which is
15based upon complete disclosure of facts required to proceed
16intelligently with that medical procedure, and which includes
17disclosure of a physician's financial and commercial interests
18in the removed tissues.
19    "Living donor" means the viable natural person from whom a
20human tissue specimen is physically and permanently removed.
21    "Medical procedure" means an act accomplished upon a human
22body for therapeutic or diagnostic purposes.
23    "Ownership" means the maximum collection of rights to enjoy

 

 

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1property, including the rights to transfer property to others,
2as well as to control, handle, and dispose the property, and
3including the right to use the property to the exclusion of
4others.
5    "Possession" means the detention, control, or manual
6custody of property so that one can exercise power over
7property to the exclusion of others.
8    "Successors in interest" includes those persons who own or
9obtain ownership interests in a decedent's assets subsequent to
10the decedent's death.
 
11    Section 10. Ownership of human tissue specimens.
12    (a) The living donor from whom the human tissue specimen
13was physically removed is the owner of that human tissue
14specimen prior to removal.
15    (b) To transfer ownership of a human tissue specimen from a
16living donor to another party requires the written agreement as
17set forth in Section 40 of this Act if that other party is a
18physician.
19    (c) Ownership of human tissue specimens that are physically
20removed from a living donor resides in the party who has signed
21and complied with the conditions of the agreement in Section 40
22of this Act if that party is a physician.
23    (d) When the agreement set forth in Section 40 of this Act
24has been fully executed by the living donor and a physician and
25the human tissue specimens have been physically removed prior

 

 

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1to the death of the living donor, but the payment required by
2the agreement has not been made prior to the death of the
3donor, the payment shall be made to the successor in interest.
 
4    Section 15. Misappropriation. Misappropriation of human
5tissue specimens occurs whenever:
6        (1) there was no written informed consent for
7    commercialization of the human tissue specimens prior to
8    physical removal of the tissue specimen from the living
9    donor;
10        (2) there was no written authorization from the living
11    donor to sell, license, or otherwise use the tissue
12    specimens for commercial advantage;
13        (3) human tissue specimens were otherwise unlawfully
14    obtained and commercially exploited by misrepresentation,
15    breach of a confidential relationship, or breach of a
16    fiduciary duty; or
17        (4) unlawful taking occurred by a person who knew or
18    had reason to know that the human tissue specimens were
19    unlawfully obtained or derived from a person who utilized
20    improper means to acquire or use them.
 
21    Section 20. Remedies.
22    (a) Misappropriation, or imminent misappropriation, of
23human tissue specimens may be enjoined by a court of
24appropriate jurisdiction.

 

 

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1    (b) If the court determines that it would be unreasonable
2to prohibit future use due to an overriding public interest, an
3injunction may condition future use and possession upon payment
4of a reasonable royalty to the living donor successors in
5interest.
6    (c) The living donor successors in interest may recover
7profits or a reasonable royalty, as well as attorney's fees,
8upon proof of misappropriation.
 
9    Section 25. Actions for misappropriation. An action for
10misappropriation must be brought within 2 years after the
11misappropriation is discovered, or by reasonable diligence
12should have been discovered. For the purposes of this Act, a
13continuing misappropriation of human tissue specimens from a
14single living donor constitutes a single claim.
 
15    Section 30. Applicability.
16    (a) Except as provided in subsection (b) of this Section,
17this Act supersedes conflicting tort restitution and other laws
18of this State that provide civil remedies for conversion and
19misappropriation of personal property.
20    (b) This Act does not affect:
21        (1) criminal remedies for misappropriation;
22        (2) the definition of misappropriation contained in
23    any other Act of this State;
24        (3) remedies available for invasion of privacy or

 

 

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1    wrongful taking of genetic or other health information
2    pursuant to federal or State law;
3        (4) laws for organ donations;
4        (5) laws for cadavers; or
5        (6) violations of the Illinois Anatomical Gift Act.
 
6    Section 35. Scope of the agreement. The agreement in
7Section 40 of this Act is not effective or intended for persons
8and entities outside the scope of living donors and physicians.
 
9    Section 40. Agreement; form. A human tissue transfer
10agreement between a living donor and a physician shall be in
11substantially the following form:
 
12"............(hereinafter 'Physician'), a natural person doing
13business at ............, and ............, a natural person
14residing at ............ (hereinafter 'Living Donor'), enter
15into the following Agreement:
 
16    1. Living Donor's body contains a rare kind of
17...............(hereinafter 'human tissue specimen').
 
18    2. Physician requests that Living Donor physically
19transfer a human tissue specimen and ownership thereof to
20Physician.
 

 

 

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1    3. Physician will apply the human tissue specimen
2potentially for commercial purposes in addition to research
3purposes.
 
4    4. Living Donor consents to the physical transfer and
5Physician's ownership of a human tissue specimen solely for
6these purposes.
 
7    5. Physician will compensate Living Donor for physical
8transfer and ownership of a human tissue specimen with the
9statutory fee of $2,000 upon physical transfer of the human
10tissue specimen to Physician. In the alternative, if Living
11Donor so requests, Physician will negotiate a reasonable fee
12for physical transfer and ownership of the human tissue
13specimen.
 
14    6. After Living Donor relinquishes physical possession of
15the human tissue specimen, Physician acquires all rights,
16title, and ownership in that human tissue specimen after
17signing this Agreement and payment of either fee of Item 5.
 
18    7. If Living Donor becomes deceased after this Agreement is
19executed, but before the human tissue specimen has been
20physically transferred to Physician, this Agreement is null and
21void.
 

 

 

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1    8. If Living Donor becomes deceased after this Agreement is
2executed, and after the human tissue specimen has been
3physically transferred to the Physician, Physician agrees to
4compensate successor(s) in interest pursuant to Item 5.
 
5    9. Notwithstanding Item 5 above, Living Donor may
6voluntarily and affirmatively opt out from the requirements of
7Item 5. Living Donor hereby affirmatively donates the human
8tissue specimen without the statutory or negotiated fee by
9initialing and dating this Item 9: ................
 
10    10. Notwithstanding other provisions in this Agreement,
11Living Donor or Deceased Donor's successor(s) in interest
12retain(s) all ownership rights to human tissue which remain
13integrally part of Living Donor body, and they may provide
14human tissue specimens therefrom to other parties, including by
15donating organs or tissue pursuant to the Illinois Anatomical
16Gift Act.
 
17    11. This Agreement is not applicable to persons or entities
18who are not physicians, Living Donors, or successors in
19interest of Deceased Donors.
 
20    12. Physician's financial and commercial interests in the
21removed human tissue and in any medical laboratory, research
22facility, or any other entity that may make use of the removed

 

 

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1tissue are as follows:
2---------------------------------------
3------------------------------
4------------------------------
 
5    13. This Agreement does not supersede confidentiality and
6access restrictions for tissue banks, or other medical and
7genetic information restrictions under Illinois or federal
8law.
 
9    14. This Agreement is governed by the laws of the State of
10Illinois, including conflicts of laws.
 
11..................                Date:.............
12Living Donor - Signature
 
13..................                Date:.............
14Physician - Signature
 
15    By signing this Agreement, Physician verifies that he or
16she has made a full disclosure of all financial and commercial
17interests in the removed human tissue specimen and in any
18medical laboratory, research facility, or any other entity that
19may make use of the removed human tissue specimen.".