Biotech-related Executive and Legislative Action
During the 94th Illinois General Assembly

Dawn M. Willow, J.D.
Legal Fellow
Institute on Biotechnology and the Human Future and the Center on Nanotechnology and Society at Chicago-Kent College of Law/Illinois Institute of Technology

Last year, Illinois Governor Rod Blagojevich issued Executive Order No. 6 (2005),¹ creating the Illinois Regenerative Medicine Institute for Stem Cell Research (IRMI), directing the Illinois Department of Public Health (IDPH) to award $10 million in research grants - thereby making Illinois the fourth state in the nation to commit public funds to stem cell research - and instructing IDPH to adopt rules that would be subject to legislative approval. Earlier in 2005, Representative Tom Cross (R) sponsored HB 3815² and Senator Jeffrey Schoenberg (D) sponsored SB 2100³, initiatives of the Comptroller that would have established a stem cell research institute in Illinois; both bills remained in the Rules Committees and did not receive further consideration. On February 10, 2006, Governor Blagojevich issued Executive Order No. 3 (2006),⁴ amending his 2005 Executive Order. The new Executive Order eliminates the requirement that IDPH adopt rules that would be subject to legislative approval.

The function of IRMI is to issue grants, support all stages of research and development - from bench science in the laboratory through clinical trials - and establish regulatory standards for research and facilities development. Each grant recipient is required to provide IDPH with semi-annual and annual reports of research progress and to report to their respective institutional review board. In order to evaluate the 24 grant applications that have been submitted, IDPH created a grant review panel composed of two bioethicists and six medical professionals with expertise in stem cell research.⁵ And, in April 2006, IDPH issued the following grants:⁶

• $870,000 to Guillermo A. Ameer at Northwestern University for stem cell-based vascular tissue engineering to enable the development of replacement blood vessels and eliminate the need to harvest existing blood vessels from the patient;
  
• $800,000 to George H. DeVries at the University of Illinois at Chicago for stem cell therapy for recovery from ischemic stroke;
  
• $1,999,944 to Mary J. Hendrix at Children's Memorial Hospital for reversal of disease progression by stem cells;
  
• $1,990,309 to Ronald Hoffman at the University of Illinois at Chicago's Center for the Development of Stem Cell Therapies for Human Diseases to focus on the use of human embryonic stems cells and adult tissue-specific stem cells in the treatment of blood disorders, lung diseases, and heart repair;
  
• $800,000 to Gwendolyn L. Kartje at Hines VA Hospital for human adult bone marrow-derived stem cell therapy for recovery from ischemic stroke;
  
• $250,000 to Stephen J. Kaufman at the University of Illinois at Urbana/Champaign for therapeutic implementation of mesoangioblast stem cells in muscular dystrophy to advance stem cell therapy for muscle and neurodegenerative disease and injury, and to provide a mechanism for repairing a variety of diseased tissues;
  
• $473,212 to Dorothy A. Sipkins at the University of Chicago for mechanisms of hematopietic stem cell homing in normal and disease states with the goal of understanding the molecular signals that blood-producing cells use to travel to specific areas where these cells can survive and regenerate;
  
• $1,400,000 to Patrick J. Stiff at Loyola University for exploring the clinical potential of umbilical-cord-blood-derived stem cells to use as both blood cells, as well as other tissues, including the heart muscle and nerves;
  
• $564,512 to Xiaozhong A. Wang at Northwestern University for genetic control of pluripotency and differentiation in embryonic stem cells to control the self-renewal and multipotency of such cells; and
  
• $591,322 to Matthew B. Wheeler at the University of Illinois at Urbana/Champaign for mesenchymal stem cells using a high-speed robot to culture, screen, and differentiate stem cells, as well as to assess their suitability as an alternative to bone marrow as a source of adult stem cells in tissue-engineered devices for the clinical reconstruction of bone and soft-tissue defects using human-patient-derived fat.

In response to these awards, House Resolution 1151,⁷ sponsored by David Reis (R), was adopted on May 4, 2006; the resolution "urges" Governor Blagojevich and IDPH to disclose: how current appropriations for IRMI are being expended; comprehensive information regarding grantees; the process by which grantees were selected; information on those grant applications that were rejected and the reasons for rejection; and any and all other information pertinent to the status and operation of IRMI, including, but not limited to, the oversight and reporting processes in place.

Several other pieces of legislation were introduced during the 94th General Assembly on biomedical research, the use of state funds, and embryos - none of which were passed. Specifically, Representative Randall M. Hultgren (R) introduced HB 4162⁸ last year; this bill would have created the Human Embryo Protection Act, and would have barred the state, units of local government, school districts, and community college districts from using public funds, property, or credit for certain human embryo research activities, including stem cell extraction. This year, Senator Bill Brady (R) sponsored similar legislation, SB 2344.⁹ However, both bills remained in the Rules Committees and did not receive further consideration. In 2005, Representative Randall Hultgren (R) introduced HB 4162,¹⁰ which would have created the Human Cloning and Adult Stem Cell Research Act, and would have made it a Class A misdemeanor (with civil penalties) to intentionally or knowing: (1) performance or attempted performance of human cloning; (2) transfer or receipt of a cloned human embryo for any purpose; (3) transfer or receipt, in whole or in part, of any oocyte, human embryo, fetus, or human somatic cell, for the purpose of human cloning; or (4) participation in the performance or attempted performance of human cloning. Additionally, this session, Senator Dale Righter (R) introduced SB 3176,¹¹ (Public Support Standards for Biomedical Research Act), which would have prevented the state, units of local government, school districts, and community college districts from using public funds, property, or credit for certain human cloning activities; prohibited grant recipients from acquiring, receiving, or otherwise transferring any human fetal tissue for valuable consideration; and required IDPH to report to the legislature on research grants. Finally, a similar cloning bill, HB 4156,¹² was introduced by Representative David Reis, but it was tabled in the House.

Dawn M. Willow, J.D., is a legal fellow at the Institute on Biotechnology and the Human Future and the Center on Nanotechnology and Society at Chicago-Kent College of Law/Illinois Institute of Technology. During the Spring 2006 Legislative Session, she served as Legislative Counsel, Office of the Speaker of the Illinois House of Representatives.

¹Available at http://www.illinois.gov/gov/execorder.cfm?eorder=39.Earlier in 2005, Representative Tom Cross (R) sponsored HB 3815 (available at http://www.ilga.gov/legislation/fulltext.asp?
DocName=&SessionId;=50&GA;=94&DocTypeId;=HB&DocNum;=
3815&GAID;=8&LegID;=20609&SpecSess;=&Session;=), and Senator Jeffrey Schoenberg (D) sponsored SB 2100 (available at http://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId;=50&GA;=94&DocTypeId;=HB&DocNum;=
3815&GAID;=8&LegID;=20609&SpecSess;=&Session;=) - initiatives of the Comptroller that would have established a stem cell research institute in Illinois. However, both bills remained in the Rules Committees and did not receive further consideration.
²Available at http://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId;=50&GA;=
94&DocTypeId;=HB&DocNum;=3815&GAID;=8&LegID;=20609&SpecSess;=&Session;=.
³Available at http://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId;=50&GA;=
94&DocTypeId;=SB&DocNum;=2100&GAID;=8&LegID;=20555&SpecSess;=&Session;=.
⁴Available at http://www.illinois.gov/gov/execorder.cfm?eorder=46.
⁵In an attempt to minimize conflicts of interest, these experts include individuals from states other than Illinois - including an expert from Ireland.
⁶Available at http://www.illinois.gov/PressReleases/ShowPressRelease.
cfm?SubjectID=1&RecNum;=4799.
⁷Available at http://www.ilga.gov/legislation/fulltext.asp?
DocName=09400HR1151enr&GA;=94&SessionId;=50&DocTypeId;=HR&LegID;=
25653&DocNum;=1151&GAID;=8&Session;=. ⁸Available at http://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId;=50&GA;=94&DocTypeId;=SB&DocNum;=2344&GAID;=
8&LegID;=23048&SpecSess;=&Session;=.
⁹Available at http://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId;=50&GA;=94&DocTypeId;=SB&DocNum;=
2344&GAID;=8&LegID;=23048&SpecSess;=&Session;=.
¹⁰Available at http://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId;=50&GA;=94&DocTypeId;=HB&DocNum;=
4162&GAID;=8&LegID;=22103&SpecSess;=&Session;=. If the bill had passed, a violation of these provisions would have results in a Class A misdemeanor and civil penalties. Additionally, the bill would have encouraged research involving the derivation and use of adult stem cells and stem cells derived from umbilical cord blood and from the placenta.
¹¹Available at http://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId;=50&GA;=94&DocTypeId;=SB&DocNum;=
3176&GAID;=8&LegID;=25388&SpecSess;=&Session;=. This bill remained in the House Rules Committee and did not receive further consideration.
¹²Available at http://www.ilga.gov/legislation/fulltext.asp?DocName=&SessionId;=50&GA;=94&DocTypeId;=HB&DocNum;=
4156&GAID;=8&LegID;=22079&SpecSess;=&Session;=. This bill would have created the Public Support Standards for Biomedical Research Act.