California Legislature 2001-2002

BILL NUMBER: S.B. No. 253
AUTHOR: Ortiz
TOPIC: Stem cells: human tissue: research.

TYPE OF BILL:

Inactive
Non-Urgency
Non-Appropriations
Majority Vote Required
Non-State-Mandated Local Program
Fiscal
Non-Tax Levy

2002
Aug. 12 - From committee with author's amendments. Read second time. Amended. Re-referred to committee.
Aug. 14 - From committee: Do pass. (Ayes 16. Noes 7.)
Aug. 15 - Read second time. To third reading.
Aug. 15 - Read third time. Amended. Re-referred to Coms. on HEALTH and APPR. pursuant to Assembly Rule 77.2.
Aug. 19 - From committee: Do pass, but first be re-referred to Com. on APPR. (Ayes 13. Noes 2.) Re-referred to Com. on APPR.
Aug. 22 - From committee: Do pass as amended. (Ayes 15. Noes 4.)
Aug. 23 - Read second time. Amended. To second reading.
Aug. 24 - Read second time. To third reading.
Aug. 26 - Read third time. Passed. (Ayes 46. Noes 27. Page 8169.) To Senate.
Aug. 27 - In Senate. To unfinished business.
Aug. 30 - Senate concurs in Assembly amendments. (Ayes 23. Noes 10. Page 6014.) To enrollment.
Sept. 6 - Enrolled. To Governor at 2 p.m.
Sept. 22 Approved by Governor.
Sept. 22 Chaptered by Secretary of State. Chapter 789, Statutes of 2002.

SB 253

Date of Hearing: August 16, 2002

ASSEMBLY COMMITTEE ON HEALTH
Helen Thomson, Chair
SB 253 (Ortiz) - As Amended: August 15, 2002

POLICY QUESTIONS :

1)Should the policy of California be required to be that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells, including somatic cell nuclear transplants, is required to be permitted and that full consideration of the ethical and medical implications of this research be given?

2)Should any individual receiving infertility treatments, be required to be provided information to allow the individual to make an informed and voluntary choice regarding the disposition of human embryos remaining following the infertility treatment?

3)Should an embryo or cadaveric fetal tissue be prohibited from being purchased or sold?

SENATE VOTE : Not relevant

SUBJECT : Stem cells: human tissue: research.

SUMMARY : Requires the policy of California to be that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells, including somatic cell nuclear transplants, is required to be permitted and that full consideration of the ethical and medical implications of this research be given. Requires any individual receiving infertility treatments, to be provided information to allow the individual to make an informed and voluntary choice regarding the disposition of human embryos remaining following the infertility treatment. Specifically, this bill :

1) Requires the policy of California to be:

a) That research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells , including somatic cell nuclear transplants, is required to be permitted and that full consideration of the ethical and medical implications of this research be given; and

b) That research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells, including somatic cell nuclear transplants, is prohibited from involving early stage embryos after the development of the primitive streak and is required to be permitted by an approved institutional review board.

2) Requires any individual receiving infertility treatments, to be provided timely, relevant, and appropriate information to allow the individual to make an informed and voluntary choice regarding the disposition of human embryos remaining following the infertility treatment.

3) Requires any individual to whom information is provided pursuant to #2 above to be presented with the option of storing the unused embryos, donating them to another individual, discarding the embryos, or donating the remaining embryos for research.

4) Requires any individual who elects to donate embryos remaining after infertility treatments for research to provide written consent.

5) Prohibits an embryo or cadaveric fetal tissue from being purchased or sold. Permits embryos or cadaveric tissue to be donated for research purposes pursuant to this bill.

6) Prohibits a person from knowingly, for valuable consideration, from purchasing or selling embryo or cadaveric fetal tissue for research purposes pursuant to this bill. Specifies that valuable consideration does not include reasonable payment for the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation of a part.

7) Permits embryos or cadaveric fetal tissue to be donated for research purposes.

EXISTING LAW

1) Prohibits, until January 1, 2003, a person from cloning a human being, and from purchasing or selling an ovum, zygote, embryo, or fetus for the purpose of cloning a human being.

2) Specifies that until January 1, 2003, a violation of the prohibitions in #1 above constitutes unprofessional conduct for purposes of the Medical Practice Act, and requires city business licenses and county business licenses to be revoked for violation of these prohibitions.

3) Defines cloning to mean the practice of creating or attempting to create a human being by transferring the nucleus from a human cell from whatever source into a human egg cell from which the nucleus has been removed for the purpose of, or to implant, the resulting product to initiate a pregnancy that could result in the birth of a human being.

FISCAL EFFECT : According to the Senate Appropriations Committee analysis of this bill, the Department of Health Services (DHS) has estimated that the annual ongoing costs of this measure would be approximately $40,000 from the General Fund. These costs are associated with the development of regulations to implement this research policy and continuing enforcement of such regulations.

COMMENTS :

1) PURPOSE OF THIS BILL. According to the author, an estimated 128 million Americans suffer from a variety of chronic and degenerative conditions including Alzheimer's, Parkinson's, and cancer which may be cured or greatly alleviated by stem cell therapies and stem cell research. However, the federal government has significantly limited federal funding available for stem cell research, specifically for human embryonic stem cell research. Various federal proposals would prohibit some types of stem cell research, including somatic cell nuclear transplantation.

The author argues that federal policies and federal proposals have created significant instability in the stem cell research community and have detrimentally affected the availability of funds for human embryonic stem cell research. Limitations or prohibitions on stem cell research would negatively impact California's biomedical industry and deny a third of Americans access to promising medical therapies.

2) SUPPORT. (These positions were received on SB 1272 (Ortiz) which contains the same provisions as this bill.) The Parkinson Association of the Sacramento Valley (PASV) argues that California must fully support all reasonable efforts to reach a cure for Parkinson's as quickly as possible, and that it is incumbent upon the State of California and its legislative representatives to educate themselves and the public as to the science of stem cell research. PASV adds that someone in the United States is diagnosed with Parkinson's every 9 minutes, and that the Legislature must make every effort to provide accurate information in response to continuing misleading, sensational and politicized comments relating to stem cell research.

The Biotechnology Industry Organization states that it is an advocate for somatic cell nuclear transfer research, and it is deeply concerned about restricting scientists' ability to use this potentially life-saving tool. The successful passage of this bill will make California a national policy leader in the arena of scientific research, while also ensuring that cures for devastating diseases continue to be developed.

The California Healthcare Institute (CHI) states that it has been working on the state and federal level for reasonable regulations that will encourage promising biomedical research, and that this bill strikes an appropriate balance by explicitly permitting embryonic stem cell research, while also ensuring that an institutional review board properly evaluates the research. CHI adds that preeminent scientists agree that embryonic stem cell research holds tremendous promise to treat and perhaps even cure many illnesses, including Alzheimer's disease, diabetes, heart disease, various cancers, Parkinson's disease, ALS, and HIV/AIDS.

3) OPPOSITION. (These positions were received on SB 1272 (Ortiz) which contains the same provisions as this bill.) Concerned Women for America states that it is their position that stem-cell research should be focused on the viability of adult stem cells, which it argues have exhibited a lower incidence of both rejection and uncontrolled replication, rather than the use of embryonic cells, which carry with them ethical and moral burdens.

According to the Committee on Moral Concerns (CMC), there is no need to clone human embryos and destroy them for their stem cells. Stem cells from the adult patients themselves are readily available and have shown more promise than stem cells gained by killing embryos, and published studies and findings from accepted medical journals document the successes of adult stem cell work. CMC adds that medical researchers must have legal guidelines to set ethical boundaries, and self-regulation will not work. CMC argues that human embryo research and destruction are neither related to nor justified by abortion, and the legality of abortion is based on the mother's personal right to privacy, which is a right not granted to medical research laboratories.

4) WHAT ARE STEM CELLS? Stem cells are cells that have the ability to divide for indefinite periods and to give rise to specialized cells. They are best described in the context of normal human development. Human development begins when a sperm fertilizes an egg and creates a single cell that has the potential to form an entire organism. This fertilized egg is totipotent, meaning that its potential is total. In the first hours after fertilization, this cell divides into identical totipotent cells. This means that either one of these cells, if placed into a woman's uterus, has the potential to develop into a fetus. Identical twins develop when two totipotent cells separate and develop into two individual, genetically identical human beings.

Approximately four days after fertilization and after several cycles of cell division, these totipotent cells begin to specialize, forming a hollow sphere of cells, called a blastocyst. The blastocyst has an outer layer of cells and inside the hollow sphere, there is a cluster of cells called the inner cell mass. The outer layer of cells will go on to form the placenta and other supporting tissues needed for fetal development in the uterus. The inner cell mass cells will go on to form virtually all of the tissues of the human body. These inner cell mass cells are pluripotent since they can give rise to many types of cells but not all types of cells necessary for fetal development.

The pluripotent stem cells undergo further specialization into stem cells that are committed to give rise to cells that have a particular function. Examples of this include blood stem cells which give rise to red blood cells, white blood cells and platelets; and skin stem cells that give rise to the various types of skin cells. These more specialized stem cells are called multipotent. Therefore, the three basic types of stem cells are, totipotent, pluripotent and multipotent.

5) WHAT IS SOMATIC CELL NUCLEAR TRANSFER? Somatic cell nuclear transfer (SCNT) or therapeutic cloning involves removing the nucleus of an unfertilized egg cell, replacing it with the material from the nucleus of a "somatic cell" (a skin, heart, or nerve cell, for example), and stimulating this cell to begin dividing. Once the cell begins dividing, stem cells can be extracted 5-6 days later and used for research.

6) WHAT ARE EMBRYONIC STEM CELLS? An embryonic stem cell is derived from a group of cells called the inner cell mass, which is part of the early (4 to 5 day) embryo called the blastocyst. Once removed from the blastocyst, the cells of the inner cell mass can be cultured into embryonic stem cells. These embryonic stem cells are not themselves embryos.

7) WHAT IS AN EMBRYONIC GERM CELL? An embryonic germ cell is derived from fetal tissue. Specifically, these cells are isolated from the primordial germ cells of the gonadal ridge of the 5 to 10 week fetus. While embryonic stem cells and embryonic germ cells are both pluripotent, they are not identical in their properties and characteristics.

8) WHAT ARE ADULT STEM CELLS? An adult stem cell is an undifferentiated (unspecialized) cell that occurs in a differentiated (specialized) tissue, renews itself, and becomes specialized to yield all of the specialized cell types of the tissue from which it originated. Adult stem cells are capable of making identical copies of themselves for the lifetime of the organism. Sources of adult stem cells include bone marrow, blood, the cornea and retina of the eye, and the brain.

9) PREEMBRYO VERSUS EMBYRO DISTINCTION. The term "preembryo" is commonly used to describe the stage of cell development from the time an egg is fertilized by sperm until implantation into the uterine wall. Implantation commonly takes place within 10-14 days after fertilization. At the 10-14 day point, a primitive dark streak begins to appear within the otherwise undifferentiated cells. This dark streak will eventually form the neural tube. In modern medical parlance, the appearance of this streak coupled with uterine implantation mark the transition from preembryonic to embryonic status. Those who distinguish the preembryo from the embryo justify that distinction on the basis that prior to the embryonic axis being formed, the cell has no developmental individuality; twinning can occur either naturally or experimentally. The embryonic stage lasts for around eight weeks by which time there is at least rudimentary development of differentiated organs. After that point, the organism is termed a "fetus". This usage, however, is not consistently followed and the terms "embryo" and "preembryo" are often used interchangeably.

10) WHAT KIND OF RESEARCH IS CURRENTLY BEING DONE WITH STEM CELLS? The kind of research that is currently being done using stem cells includes:

a) Diabetes: Scientists are trying to get the stem cells to turn into insulin-producing cells that could then be put inside the body of a person with diabetes;

b) Parkinson's disease: In Parkinson's disease, specific nerve cells in the brain are not working properly. If those cells can be created using stem cells, they can be used to replace the diseased cells;

c) Heart disease: After a heart attack, a portion of the heart muscle dies. Scientists are trying to get stem cells to make heart muscle cells that would replace the damaged part of the heart;

d) Cancer: In many cancers, such as breast cancer, treatments like chemotherapy and radiation can destroy the bone marrow. By using stem cells to re-create the bone marrow, doctors could use more powerful treatments to treat the cancer. Stem cells could also be used to create specific cells that could kill the cancer. If an organ or a chunk of tissue has to be removed or destroyed to get rid of the cancer, stem cells could be used to replace it; and

e) Spinal cord injury: Stem cells have been used to make the nerve cells in the spinal cord. This may help or even cure people who have lost use of their arms or legs because of an injury to their spinal cord.

11) RELATED LEGISLATION. SB 1230 (Alpert), makes various provisions of law relating to prohibitions against cloning a human being, and purchasing or selling an ovum, zygote, embryo, or fetus for the purpose of cloning a human being permanent, by repealing their sunset dates, and requires the Department of Health Services (DHS) to establish an advisory committee for purposes of advising the Legislature and the Governor on human cloning and other issues relating to human biotechnology. SCR 55 (Ortiz), makes various findings and declarations relative to societal and economic value to stem cell research, and establishes a panel to advise the Legislature on stem cell research. SJR 38 (Ortiz), memorializes the President and Congress to reject legislation that impedes the progress of science by impeding stem cell research and to enact legislation that temporarily bans reproductive cloning and permits therapeutic cloning. SB 1230 passed this Committee on June 18th on a 13-3 vote, as well as the Assembly Appropriations Committee on August 7th on a 19-1 vote, and is currently pending on the Assembly Floor. SCR 55 and SJR 38 are scheduled to be heard in this Committee on August 17, 2002.

12) PREVIOUS AMENDMENTS: This bill was amended on August 15, 2002 to delete its previous contents and insert the contents of Senate Bill 1272. SB 1272 passed the Senate on May 2, 2002 by a vote of 21-10.

13) QUESTIONS AND COMMENTS.

a) This bill seeks to establish the policy of California to be that stem cell research is prohibited from involving preembryos after the development of the primitive streak. Should this bill, or DHS, be required to more specifically define at what stage of embryonic development (for example, by number of days) stem cell research is prohibited. Should this prohibition be based on the development of the primitive streak?

b) This bill seeks to permit human embryonic germ cell research, but prohibits this research from involving early stage embryos after the development of the primitive streak. Generally embryonic germ cells are derived from fetal tissue of a 5 to 10 week fetus. The primitive streak is generally developed at the 10-14 day period of embryonic development. Would the prohibition on research involving preembryos after the development of the primitive streak, have the effect of prohibiting research involving human embryonic germ cells?

c) This bill requires any individual receiving infertility treatments, to be provided timely, relevant, and appropriate information to allow the individual to make an informed and voluntary choice regarding the disposition of human embryos remaining following the infertility treatment. The author may wish to clarify who is required to provide this information to the individual.

d) The author may wish to clarify whether any research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells, including somatic cell nuclear transplants, is required to be approved by an institutional review board, or whether the intent is to prohibit any such review board from prohibiting this type of research.

e) Are both of the added Health and Safety Code Sections 24202 and 125117 necessary since both relate to prohibiting the purchase or sale of an embryo or cadaveric tissue?

REGISTERED SUPPORT / OPPOSITION:

Support (These positions were received on SB 1272 (Ortiz) which contains the same provisions as this bill.)

Alzheimer's Association
American College of Obstetricians and Gynecologists
Biotechnology Industry Organization
California Commission on the Status of Women
California Healthcare Institute
California National Organization for Women
Kaiser Permanente
Kirsch Foundation
Older Women's League of California
Parkinson's Action Network
Parkinson Association of the Sacramento Valley
University of California
Women Democrats of Sacramento County
2 individuals

Opposition

(These positions were received on SB 1272 (Ortiz) which contains the same provisions as this bill.)

California Catholic Conference
California ProLife Council California Right to Life Education Fund
California Right to Life Committee, Inc. California Right to Life, Inc.
Capitol Resource Institute
Christian Coalition of California
Committee on Moral Concerns
Concerned Women for America
Crusade for Life, Inc.
Scholl Institute of Bioethics
4 individuals

Analysis Prepared by: David Gonzalez / HEALTH / (916) 319-2097

CHAPTER 789
FILED WITH SECRETARY OF STATE SEPTEMBER 22, 2002
APPROVED BY GOVERNOR SEPTEMBER 22, 2002
PASSED THE SENATE AUGUST 30, 2002
PASSED THE ASSEMBLY AUGUST 26, 2002
AMENDED IN ASSEMBLY AUGUST 23, 2002
AMENDED IN ASSEMBLY AUGUST 15, 2002
AMENDED IN ASSEMBLY AUGUST 12, 2002
AMENDED IN ASSEMBLY JULY 17, 2001
AMENDED IN ASSEMBLY JULY 5, 2001

INTRODUCED BY Senator Ortiz
(Principal coauthor: Assembly Member Wayne)

FEBRUARY 15, 2001
An act to add Article 5 (commencing with Section 125115) to Chapter 1 of Part 5 of Division 106 of the Health and Safety Code, relating to medical research.

LEGISLATIVE COUNSEL'S DIGEST

SB 253, Ortiz. Stem cells: human tissue: research.
Under existing law, it is unlawful for any person to knowingly acquire, receive, sell, promote the transfer of, or otherwise transfer any human organ, for purposes of transplantation, for valuable consideration.
Under existing law, human tissue may be removed in certain circumstances from human remains for the use of the tissue by authorized donees, including, but not limited to, physicians, hospitals, and educational institutions, for transplant, therapeutic, or scientific purposes.
This bill would declare that the policy of the state shall be that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells from any source, including somatic cell nuclear transplantation, shall be permitted, as specified. This bill would require a health care provider delivering fertility treatment to provide his or her patient with specified information. The bill would authorize a donation of a human embryo pursuant to specific requirements and would prohibit the purchase or sale of embryonic or cadaveric fetal tissue for research purposes.

THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

SECTION 1. The Legislature finds and declares all of the following:
(a) An estimated 128 million Americans suffer from the crippling economic and psychological burden of chronic, degenerative, and acute diseases, including diabetes, Parkinson's disease, cancer, and Alzheimer's disease.
(b) The costs of treatment and lost productivity of chronic, degenerative, and acute diseases in the United States constitutes hundreds of billions of dollars every year. Estimates of the economic costs of these diseases does not account for the extreme human loss and suffering associated with these conditions.
(c) Stem cell research offers immense promise for developing new medical therapies for these debilitating diseases and a critical means to explore fundamental questions of biology. Stem cell research could lead to unprecedented treatments and potential cures for diabetes, Alzheimer's disease, cancer, and other diseases.
(d) The United States and California have historically been a haven for open scientific inquiry and technological innovation and this environment, coupled with the commitment of public and private resources, has made the United States the preeminent world leader in biomedicine and biotechnology.
(e) California's biomedical industry is a critical component of the state's economy that provides employment in over 2,500 companies to over 225,000 Californians, pays $12.8 billion in wages and salaries, invests more than $2.1 billion in research, and reports nearly $7.8 billion in worldwide revenue, and would be significantly diminished by limitations imposed on stem cell research.
(f) Open scientific inquiry and publicly funded research will be essential to realizing the promise of stem cell research and to maintain California's worldwide leadership in biomedicine and biotechnology. Publicly funded stem cell research, conducted under established standards of open scientific exchange, peer review, and public oversight, offers the most efficient and responsible means of fulfilling the promise of stem cells to provide regenerative medical therapies.
(g) Stem cell research, including the use of embryonic stem cells for medical research, raises significant ethical and policy concerns, and, while not unique, the ethical and policy concerns associated with stem cell research must be carefully considered.
(h) Public policy on stem cell research must balance ethical and medical considerations. The policy must be based on an understanding of the science associated with stem cell research and grounded on a thorough consideration of the ethical concerns regarding this research. Public policy on stem cell research must be carefully crafted to ensure that researchers have the tools necessary to fulfill the promise of stem cell research. SEC. 2. Article 5 (commencing with Section 125115) is added to Chapter 1 of Part 5 of Division 106 of the Health and Safety Code, to read:

Article 5. Stem Cell Research
125115. The policy of the State of California shall be as follows:
(a) That research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells from any source, including somatic cell nuclear transplantation, shall be permitted and that full consideration of the ethical and medical implications of this research be given.
(b) That research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells, including somatic cell nuclear transplantation, shall be reviewed by an approved institutional review board.
125116. (a) A physician, surgeon, or other health care provider delivering fertility treatment shall provide his or her patient with timely, relevant, and appropriate information to allow the individual to make an informed and voluntary choice regarding the disposition of any human embryos remaining following the fertility treatment.
(b) Any individual to whom information is provided pursuant to subdivision (a) shall be presented with the option of storing any unused embryos, donating them to another individual, discarding the embryos, or donating the remaining embryos for research.
(c) Any individual who elects to donate embryos remaining after fertility treatments for research shall provide written consent.
125117. (a) A person may not knowingly, for valuable consideration, purchase or sell embryonic or cadaveric fetal tissue for research purposes pursuant to this chapter.
(b) For purposes of this section, "valuable consideration" does not include reasonable payment for the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation of a part.
(c) Embryonic or cadaveric fetal tissue may be donated for research purposes pursuant to this chapter.