HB0158 98TH GENERAL ASSEMBLY

LRB098 04087 RPM 34110 b

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.

A BILL FOR

AN ACT concerning health.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

Section 1. Short title. This Act may be cited as the Human Tissue Transfer Act.

Section 5. Definitions. As used in this Act, and unless the context requires otherwise:

"Human tissue specimen" means any biological material originating within and taken from a living donor (i) as designated exclusively by items (6) and (7) of subsection (b) of Section 12-20 of the Criminal Code of 2012 and (ii) not to be transplanted directly into another human body.

"Informed consent" means a living person's agreement to a medical procedure in which tissue will be removed, which is based upon complete disclosure of facts required to proceed intelligently with that medical procedure, and which includes disclosure of a physician's financial and commercial interests in the removed tissues.

"Living donor" means the viable natural person from whom a human tissue specimen is physically and permanently removed.

"Medical procedure" means an act accomplished upon a human body for therapeutic or diagnostic purposes.

"Ownership" means the maximum collection of rights to enjoy property, including the rights to transfer property to others, as well as to control, handle, and dispose the property, and including the right to use the property to the exclusion of others.

"Possession" means the detention, control, or manual custody of property so that one can exercise power over property to the exclusion of others.

"Successors in interest" includes those persons who own or obtain ownership interests in a decedent's assets subsequent to the decedent's death.

Section 10. Ownership of human tissue specimens.

(a) The living donor from whom the human tissue specimen was physically removed is the owner of that human tissue specimen prior to removal.

(b) To transfer ownership of a human tissue specimen from a living donor to another party requires the written agreement as set forth in Section 40 of this Act if that other party is a physician.

(c) 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 Section 40 of this Act if that party is a physician.

(d) When the agreement set forth in Section 40 of this 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.

Section 15. Misappropriation. Misappropriation of human tissue specimens occurs whenever:

(1) there was no written informed consent for commercialization of the human tissue specimens prior to physical removal of the tissue specimen from the living donor;

(2) there was no written authorization from the living donor to sell, license, or otherwise use the tissue specimens for commercial advantage;

(3) human tissue specimens were otherwise unlawfully obtained and commercially exploited by misrepresentation, breach of a confidential relationship, or breach of a fiduciary duty; or

(4) unlawful taking occurred by a person who knew or had reason to know that the human tissue specimens were unlawfully obtained or derived from a person who utilized improper means to acquire or use them.

Section 20. Remedies.

(a) Misappropriation, or imminent misappropriation, of human tissue specimens may be enjoined by a court of appropriate jurisdiction.

(b) If the court determines that it would be unreasonable to prohibit future use due to an overriding public interest, an injunction may condition future use and possession upon payment of a reasonable royalty to the living donor successors in interest.

(c) The living donor successors in interest may recover profits or a reasonable royalty, as well as attorney's fees, upon proof of misappropriation.

Section 25. Actions for misappropriation. An action for misappropriation must be brought within 2 years after the misappropriation is discovered, or by reasonable diligence should have been discovered. For the purposes of this Act, a continuing misappropriation of human tissue specimens from a single living donor constitutes a single claim.

Section 30. Applicability.

(a) Except as provided in subsection (b) of this Section, this Act supersedes conflicting tort restitution and other laws of this State that provide civil remedies for conversion and misappropriation of personal property.

(b) This Act does not affect:

(1) criminal remedies for misappropriation;

(2) the definition of misappropriation contained in any other Act of this State;

(3) remedies available for invasion of privacy or wrongful taking of genetic or other health information pursuant to federal or State law;

(4) laws for organ donations;

(5) laws for cadavers; or

(6) violations of the Illinois Anatomical Gift Act.

Section 35. Scope of the agreement. The agreement in Section 40 of this Act is not effective or intended for persons and entities outside the scope of living donors and physicians.

Section 40. Agreement; form. A human tissue transfer agreement between a living donor and a physician shall be in substantially the following form:

"............(hereinafter 'Physician'), a natural person doing business at ............, and ............, a natural person residing at ............ (hereinafter 'Living Donor'), enter into the following Agreement:

1. Living Donor's body contains a rare kind of ...............(hereinafter 'human tissue specimen').

2. Physician requests that Living Donor physically transfer a human tissue specimen and ownership thereof to Physician.

3. Physician will apply the human tissue specimen potentially for commercial purposes in addition to research purposes.

4. Living Donor consents to the physical transfer and Physician's ownership of a human tissue specimen solely for these purposes.

5. Physician will compensate Living Donor for physical transfer and ownership of a human tissue specimen with the statutory fee of $2,000 upon physical transfer of the human tissue specimen to Physician. In the alternative, if Living Donor so requests, Physician will negotiate a reasonable fee for physical transfer and ownership of the human tissue specimen.

6. After Living Donor relinquishes physical possession of the human tissue specimen, Physician acquires all rights, title, and ownership in that human tissue specimen after signing this Agreement and payment of either fee of Item 5.

7. If Living Donor becomes deceased after this Agreement is executed, but before the human tissue specimen has been physically transferred to Physician, this Agreement is null and void.

8. If Living Donor becomes deceased after this Agreement is executed, and after the human tissue specimen has been physically transferred to the Physician, Physician agrees to compensate successor(s) in interest pursuant to Item 5.

9. Notwithstanding Item 5 above, Living Donor may voluntarily and affirmatively opt out from the requirements of Item 5. Living Donor hereby affirmatively donates the human tissue specimen without the statutory or negotiated fee by initialing and dating this Item 9: ................

10. Notwithstanding other provisions in this Agreement, Living Donor or Deceased Donor's successor(s) in interest retain(s) all ownership rights to human tissue which remain integrally part of Living Donor body, and they may provide human tissue specimens therefrom to other parties, including by donating organs or tissue pursuant to the Illinois Anatomical Gift Act.

11. This Agreement is not applicable to persons or entities who are not physicians, Living Donors, or successors in interest of Deceased Donors.

12. Physician's financial and commercial interests in the removed human tissue and in any medical laboratory, research facility, or any other entity that may make use of the removed tissue are as follows: --------------------------------------- ------------------------------

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13. This Agreement does not supersede confidentiality and access restrictions for tissue banks, or other medical and genetic information restrictions under Illinois or federal law.

14. This Agreement is governed by the laws of the State of Illinois, including conflicts of laws.

.................. Date:............. Living Donor - Signature

.................. Date:............. Physician - Signature

By signing this Agreement, Physician verifies that he or she has made a full disclosure of all financial and commercial interests in the removed human tissue specimen and in any medical laboratory, research facility, or any other entity that may make use of the removed human tissue specimen.".