Dl2011 Bioethics Legislation

8/7/2019 Dl2011 Bioethics Legislation

1/36

Defending Life 2011

580

HUMAN CLONING PROHIBITION ACT

HOUSE/SENATE BILL No. ______

By Representatives/Senators ____________

Section 1. Title.

This Act may be known and cited as the Human Cloning Prohibition Act.

Section 2. Legislative Findings.

(a) The [Legislature] of the state of [Insert name of State] nds that:

(1) At least one company has announced that it has successfully cloned a human

being at an early embryonic stage of life, and others have announced that theywill attempt to clone a human being using the technique known as somatic cell

nuclear transfer.

(2) Efforts to create human beings through cloning mark a new and decisive step

toward turning human reproduction into a manufacturing process in which

human beings are made in laboratories to preordained specications and,

potentially, in multiple copies.

(3) Creating cloned live-born human children, or cloning-to-produce-children,

begins by creating cloned human beings at the embryonic stage of life, a

process which some also propose as a way of creating human embryos for

destructive research as sources of stem cells and tissues for possible treatment

of other humans, or cloning-for-biomedical-research;

(4) Many scientists agree that attempts at cloning-to-produce-children pose a

massive risk of producing children who are stillborn, unhealthy, or severely

disabled, and that attempts at cloning-for-biomedical-research always result

in the destruction of human beings at the embryonic stage of life when their

stem cells are harvested.

(5) The prospect of creating new human life, solely to be exploited (cloning-

to-produce-children) or destroyed (cloning-for-biomedical-research) in

these ways, has been condemned on moral grounds by many as displaying a

profound disrespect for life.


2/36

581

Americans United for Life

(6) The distinction between so-called therapeutic cloning and reproductive cloning

is a false distinction scientically because both begin with the reproduction of

a human being at the embryonic stage of life, one destined for implantation in a

womb and one destined for destructive farming of its stem cells. Regardless of

its ultimate destiny, all human embryos are simultaneously human beings.

(7) It will be nearly impossible to ban only attempts at cloning-to-produce-

children if cloning-for-biomedical-research is allowed because cloning

would take place within the privacy of a doctor-patient relationship; the

implantation of embryos to begin a pregnancy is a simple procedure; and any

government effort to prevent the implantation of an existing cloned embryo or

to prevent birth once implantation has occurred would raise substantial moral,

legal, and practical issues.

(b) Based on the above ndings, it is the purpose of this Act to prohibit the use of

cloning technology to initiate the development of new human beings at the embryonic stageof life for any purpose.

Section 3. Denitions.

For purposes of this Act:

(a) Human cloning means human asexual reproduction, accomplished by (1)

introducing the genetic material from one or more human somatic or embryonic cells into a

fertilized or unfertilized oocyte whose nuclear material has been removed or inactivated before

or after introduction, so as to produce an organism at any stage of development with a human

or predominantly human genetic constitution; (2) articially subdividing a human embryo atany time from the two-cell stage onward, such that more than one human organism results; or

(3) introducing pluripotent cells from any source into a human embryo, nonhuman embryo, or

articially-manufactured human embryo or trophoblast, under conditions where the introduced

cells generate all or most of the body tissues of the developing organism.

(b) Somatic cell means a cell having a complete set of chromosomes obtained from a

living or deceased human body at any stage of development.

(c) Embryo means an organism of the species homo sapiens from the single cell stage to

eight (8) weeks development.

(d) Fetus means an organism of the species homo sapiens from eight (8) weeks

development until complete expulsion or extraction from a womans body, or removal from

an articial womb or other similar environment designed to nurture the development of such

organism.


3/36

Defending Life 2011

582

(e) Pluripotent cells means stem cells possessing the ability to give rise to most or all of

the various cell types that make up the body. One demonstration of pluripotency is the ability,

even after prolonged culture, to form derivatives of all three embryonic germ layers from the

progeny of a single cell.

Section 4. Prohibitions.

It shall be unlawful for any person or entity, public or private, to intentionally or knowingly:

(a) perform or attempt to perform human cloning;

(b) participate in an attempt to perform human cloning;

(c) transfer or receive the product of human cloning for any purpose; or

(d) transfer or receive, in whole or in part, any oocyte, embryo, fetus, or human somaticcell for the purpose of human cloning.

Section 5. Exceptions.

Nothing in this Act shall restrict areas of scientic research not specically prohibited by this

Act, including in vitro fertilization; the administration of fertility-enhancing drugs; or research

in the use of nuclear transfer or other cloning techniques to produce molecules, DNA, tissues,

organs, plants, animals other than humans or cells other than human embryos.

Section 6. Penalties.

(a) Criminal Penalties:

(1) Any person or entity that violates Sections 4(a) or 4(b) of this Act shall be

guilty of a [Insert appropriate penalty/offense classication].

(2) Any person or entity that violates Sections 4(c) or 4(d) of this Act shall be


(b) Civil Penalty. Any person or entity that violates any provision of this Act and derives

a pecuniary gain from such violation shall be ned [Insert appropriate amount] or twice the

amount of gross gain, or any amount intermediate between the foregoing, at the discretion of

the court.

(c) Unprofessional Conduct. Any violation of this Act shall constitute unprofessional


4/36

583


conduct pursuant to [Insert appropriate statutes for 1) medical doctors and surgeons and

2) osteopathic doctors] and shall result in permanent revocation of the violators license to

practice medicine.

(d) Trade, Occupation, or Profession. Any violation of this Act may be the basis for

denying an application for, denying an application for the renewal of, or revoking any license,permit, certicate, or any other form of permission required to practice or engage in a trade,

occupation, or profession.

Section 7. Severability.

Any provision of this Act held to be invalid or unenforceable by its terms, or as applied to any

person or circumstance, shall be construed so as give it the maximum effect permitted by law,

unless such holding shall be one of utter invalidity or unenforceability, in which event such

provision shall be deemed severable herefrom and shall not affect the remainder hereof or

the application of such provision to other persons not similarly situated or to other, dissimilarcircumstances.

Section 8. Right of Intervention

The [Legislature], by joint resolution, may appoint one or more of its members who sponsored

or co-sponsored this Act, as a matter of right and in his or her ofcial capacity, to intervene to

defend this law in any case in which its constitutionality is challenged.

Section 9. Effective Date

This Act takes effect on [Insert date].


5/36

Defending Life 2011

584

DESTRUCTIVE HUMAN EMBRYO RESEARCH ACT

HOUSE/SENATE BILL No. ____

Sponsored by Representatives/Senators __________

Section 1. Title.

This Act may be known and cited as the Destructive Human Embryo Research Act.

Section 2. Legislative Findings and Purpose.

(a) The [Legislature] of the State of [Insert name of State] nds that:

(1) Human embryos are human beings at the earliest stage of development;

(2) Some human embryos are being created and then destroyed to obtain

stem cells for research;

(3) Destructive human embryo research to obtain embryonic stem cells raises

grave moral, ethical, scientic, and medical issues that must be addressed;

(4) The moral justication of medical or scientic research cannot be

based upon the dehumanizing and utilitarian premise that the end

justies any means; and

(5) Medical research and treatment does not require the destruction of human life,

because it can be ethically pursued in other ways, including the use of adult

stem cells.

(b) Accordingly, it is the purpose of this Act to prohibit destructive human embryo

research.



(a) Human embryo means an organism with a human or predominately human genetic

constitution, from a single cell up to eight (8) weeks of development, that is derived by

fertilization, parthenogenesis, cloning (also known as somatic cell nuclear transfer), or any

other means from one or more human gametes or human diploid cells.


6/36

585


(b) Gamete means a human sperm or unfertilized human ovum.

(c) Destructive research means medical procedures, scientic or laboratory research, or

other kinds of investigation that kill or injure the subject of such research. It does not include:

(1) In vitro fertilization and accompanying embryo transfer to a womans body;

(2) Research in the use of nuclear transfer or other cloning techniques to produce

molecules; deoxyribonucleic acid; or cells other than human embryos, tissues,

organs, plants, or animals other than humans; or

(3) Any diagnostic procedure that benets the human embryo subject to such tests,

while not imposing risks greater than those considered acceptable for other

human research subjects.

Section 4. Prohibitions.

It shall be unlawful for any person to:

(a) Intentionally or knowingly conduct destructive research on a human embryo;

(b) Buy, sell, receive, or otherwise transfer a human embryo with the knowledge that such

embryo will be subjected to destructive research; or

(c) Buy, sell, receive, or otherwise transfer gametes with the knowledge that a humanembryo will be produced from such gametes to be used in destructive research.

Section 5. Sanctions.

(a) Whoever violates Section 4(a) shall be guilty of a [Insert appropriate penalty/offense

classication] for each violation.

(b) Whoever violates Section 4(b) shall be guilty of a [Insert appropriate penalty/offense

classication] for each violation.

(c) Whoever violates Section 4(c) shall be guilty of a [Insert appropriate penalty/offense

classication]for each violation.


7/36

Defending Life 2011

586






the application of such provision to other persons not similarly situated or to other, dissimilar

circumstances.

Section 7. Right of Intervention.




Section 8. Effective Date.



8/36

Defending Life 2011

587

PROHIBITION ON PUBLIC FUNDING OF HUMAN CLONING

AND DESTRUCTIVE EMBRYO RESEARCH ACT

HOUSE/SENATE Bill No.____

By Representatives/Senators______________

Section 1. Short Title.

This Act may be cited as the Prohibition on Public Funding of Human Cloning and

Destructive Embryo Research Act.

Section 2. Legislative Findings and Purpose.


(1) The prospect of creating new human life solely to be exploited or destroyed

has been condemned on moral grounds by many as displaying a profound

disrespect for human life.

(2) Destructive human embryo research reduces the status of human beings from

ends in themselves to a mere means to anothers possible benet.

(3) The moral justication of medical or scientic research cannot be based upon

the dehumanizing and utilitarian premise that the potential ends justify anymeans.

(4) Ethical researchresearch not involving human cloning and destructive

embryo researchhas proven more promising than destructive research.

For example, so-called therapeutic cloning has, thus far, made no valuable

therapeutic advancements, while research with ethically-obtained adult stem

cells has already produced signicant and valuable contributions and improved

patient health. Adult stem-cell contributions have included heart tissue

regeneration; corneal reconstruction; treatment for autoimmune diseases such

as diabetes, lupus, Crohns disease, and multiple sclerosis; and treatment forleukemia and other related bone and blood cancers.

(5) Moreover, recent and promising advances in reprogramming human cells to

behave as if in an embryonic state render controversial cloned human embryos

unnecessary for use in embryonic stem-cell research.


9/36

588


(6) Cloning embryos and destructive embryo research require human egg cells,

which are highly expensive to obtain.

(7) Harvesting human egg cells also poses signicant health risks to women. Such

risks include ovarian hyperstimulation syndrome, damage to internal organs or

blood vessels, infertility, depression, and death.

(8) Harvesting human egg cells for research, whether women are compensated or

not, could result in the commoditization of women.

(9) Public opinion is divided over the deep, conicting moral and ethical concerns

on matters related to payment to women for access to their human egg cells.

Providing public funds to be exchanged in these transactions would be a

misuse of revenue collected by this State.

(10) Public opinion is similarly divided over the deep, conicting moral andethical concerns surrounding the creation and destruction of human embryos.

Providing public funds to such research would be a misuse of revenue

collected by this State.

(b) The [Legislatures] purpose in enacting this ban on taxpayer funding is to further the

important and compelling state interests of:

(1) Respecting life and fostering a culture of life;

(2) Limiting public expenditures;

(3) Directing public expenditures away from funding research that has not

yielded any signicant scientic contributions;

(4) Directing public expenditures toward funding research that has already

yielded signicant contributions for patients;

(5) Relieving the consciences of taxpayers concerned about the possible

exploitation of women that may result from the collection of and payment for

human egg cells; and

(6) Relieving the consciences of those resident taxpayers who object to human

cloning and destructive embryonic stem-cell research.


10/36

Defending Life 2011

589


For the purposes of this Act:

(a) Human cloning means human asexual reproduction, accomplished by (1) introducing

the genetic material from one or more human somatic or embryonic cells into a fertilized orunfertilized oocyte whose nuclear material has been removed or inactivated before or after

introduction, so as to produce an organism at any stage of development with a human or

predominantly human genetic constitution; (2) articially subdividing a human embryo at

any time from the two-cell stage onward, such that more than one human organism results;

or (3) introducing pluripotent cells from any source into a human embryo, nonhuman

embryo, or articially-manufactured human embryo or trophoblast, under conditions where

the introduced cells generate all or most of the body tissues of the developing organism.

(b) Somatic cell means a cell having a complete or nearly complete set of chromosomes

obtained from a living or deceased human body at any stage of development.

(c) Human embryo means an organism with a human or predominately human genetic

constitution, from a single cell up to eight (8) weeks of development, that is derived by

fertilization, parthenogenesis, cloning (also known as somatic cell nuclear transfer), or

any other means from one or more human gametes or human diploid cells.

(d) Embryonic stem cellmeans a stem cell obtained from an embryo of the same species.

(e) Destructive research means medical procedures, scientic or laboratory research, or

other kinds of investigation that kill or injure the subject of such research. It does notinclude:

(1) In vitro fertilization and accompanying embryo transfer to a womans body;

(2) Research in the use of nuclear transfer or other cloning techniques to produce

molecules; deoxyribonucleic acid; cells other than human embryos, tissues,





(f) Pluripotent cells means stem cells possessing the ability to give rise to most or all of

the various cell types that make up the body. One demonstration of pluripotency is the ability,

even after prolonged culture, to form derivatives of all three embryonic germ layers from the


11/36

590


progeny of a single cell.

(g) Public funds means, but is not limited to:

(1) Any monies received or controlled by the State or any ofcial, department,

division, agency, or educational or political subdivision thereof, includingbut not limited to monies derived from federal, state, or local taxes, gifts, or

grants from any source; settlements of any claims or causes of action, public

or private; bond proceeds or investment income; federal grants or payments; or

intergovernmental transfers; and

(2) Any monies received or controlled by an ofcial, department, division, or

agency of state government or any educational or political subdivision thereof,

or to any person or entity pursuant to appropriation by the [Legislature] or

governing body of any political subdivision of this State.

Section 4. Human Cloning and Destructive Embryonic Stem-Cell Research Against

Public Policy.

The [Legislature] declares that public funding of human cloning and destructive embryo

research is against public policy.

Section 5. Prohibition.

(a) No public funds shall be used to nance human cloning or destructive embryo research.

The State, a state educational institution, or a political subdivision of the State may not usepublic funds, facilities, or employees to knowingly destroy human embryos for the purpose of

research or knowingly participate in human cloning or attempted human cloning.

(b) No public funds shall be used to buy, receive, or otherwise transfer a human embryo

with the knowledge that such embryo will be subjected to destructive research;

(c) No public funds shall be used to buy, receive, or otherwise transfer gametes with the

knowledge that a human embryo will be produced from such gametes to be used in destructive

research.

This Section will go into effect notwithstanding any other law in the State.

Section 6. Exceptions.

Nothing in this Act shall restrict the funding of areas of scientic research not specically


12/36


13/36

592


Section 10. Standing.

The provisions of this Act shall inure to the benet of all residents of this State. Any taxpayer of

this State or any political subdivision of this State shall have standing to bring suit against the

State or any ofcial, department, division, agency, or political subdivision of this State, and any

recipient of public funds who or which is in violation of this Act in any court with jurisdiction

to enforce the provisions of this Act.




14/36

Defending Life 2011

593

ASSISTED REPRODUCTIVE TECHNOLOGIES (ART) DISCLOSURE

AND RISK REDUCTION ACT

HOUSE/SENATE BILL No. ______

By Representatives/Senators _____________

Section 1. Title.

This Act may be known and cited as the Assisted Reproductive Technology Disclosure and

Risk Reduction Act.

Section 2. Legislative Findings and Purposes.

(a) The [Legislature] of the State of [Insert name of Sstate] nds that:

(1) Infertility is of grave concern to many couples and individuals who want to be

parents.

(2) Assisted reproductive technology (ART) is a growing, $4 billion annual

industry that serves an increasing number of patients.

(3) ART procedures are expensive. Each [treatment] cycle can cost $10,000 to

$15,000, or more.

(4) Full information about the costs and risks of ART is necessary for patients to

evaluate ART, including the risks associated with multiple gestation.

(5) Only one federal statute, the Fertility Clinic Success Rate and Certication

Act of 1992 (42 USCA 263a-1 et seq), directly regulates ART procedures by

requiring the reporting of clinic success rates.

(6) ART is subject to little state regulation. For example, Connecticut and Virginia

require the disclosure and reporting of ART success rates. New Hampshire

and Pennsylvania impose some regulations on ART clinics, while several statesrequire insurance coverage for ART.

(7) A number of other nations regulate specic aspects of ART, including the

number of embryos that can be created. Brazil, Denmark, Germany, Hungary,

Saudi Arabia, Singapore, Sweden, and Switzerland limit the number of


15/36

594


embryos (from two to four) that can be transferred per treatment cycle.

Specically, Germany, Sweden, Denmark, and Switzerland limit transfers to,

at most, three (3) embryos per treatment cycle. The United Kingdom limits the

number transferred to two (2) embryos per treatment cycle.

(8) Voluntary self-regulation of ART programs is not completely effective. Notall ART programs or facilities are members of professional organizations, like

the Society for Assisted Reproductive Technology (SART) or the American

Society for Reproductive Medicine (ASRM). Moreover, the professional

organizations do not independently conrm that their members follow their

voluntary guidelines.

(9) In most cases, ART involves the creation of multiple embryos, some of which

are not subsequently used in an implantation (transfer) procedure.

(10) This State has an interest in ensuring protection for mothers who undergo ARTand for the future health of children conceived through ART.

(11) Informed consent is one of the core principles of ethical medical practice

and every patient has a right to information pertinent to an invasive medical

procedure. Further, ART is unique because it produces a third party, the

prospective child, who must also be considered and protected.

(12) Thorough recordkeeping and reporting is necessary for public education about

the rates of success and the costs, risks, and benets of ART and to ensure

proper accountability.

(13) One problem associated with ART is high-order multiple pregnancies (three

or more embryos implanting) and their associated health risks to mother

and children, for which the economic burdens for parents and society are

signicant.

(14) Fetal reduction in the event of a high-order multiple pregnancy involves

signicant risks to the mother and to prospective children subsequently born.

(b) Based on the ndings in Subsection (a) of this Section, the purpose of this Act is to:

(1) Protect the safety and well-being of women using ART and the children

conceived through ART;

(2) Establish standards for obtaining informed consent from couples and


16/36

Defending Life 2011

595

individuals seeking ART;

(3) Require adequate reporting for facilities providing ART services;

(4) Stem the proliferation of cryopreserved human embryos being stored in

fertility clinics [and bring the State of [Insert name of State] into line withinternational norms] by limiting the number of embryos that can be created in

any reproductive cycle;

(5) Reduce the risk of high-order multiple gestations and the risk of pre-maturity

and other complications to mothers and children by limiting the number of

embryos transferred in any reproductive cycle;

(6) Reduce the risks of fetal reduction to mothers and children; and

(7) Institute annual reporting requirements to the [Insert name of State healthdepartment or other appropriate agency].


For purposes of this Act only:

(a) Assisted reproductive technology (ART) means all treatments and procedures

which include the handling of human eggs and sperm, including in vitro fertilization, gamete

intrafallopian transfer (GIFT), zygote intrafallopian transfer (ZIFT), and such other specic

technologies as the [Department of Health] may include in this denition.

(b) ART facility or facility means any public or private organization, corporation,

partnership, sole proprietorship, association, agency, network, joint venture, or other entity

that is involved in providing assisted reproductive technology, including but not limited to:

hospitals, clinics, medical centers, ambulatory surgical centers, private physicians ofces,

pharmacies, nursing homes, university medical schools and nursing schools, medical training

facilities, or other institutions or locations wherein assisted reproductive technology is offered

to any person.

(c) ART program or program means all treatments or procedures which include the

handling of both human eggs and sperm.

(d) Department means the state [Insert name of State health department or other

appropriate agency].


17/36

596


(e) Embryo means the developing human organism however generated, beginning with

the diploid cell resulting from the fusion of the male and female pronuclei, or from somatic cell

nuclear transfer, or by other means, until approximately the end of the second (2nd) month of

development.

(f) Gamete means human egg (oocyte) or sperm.

(g) Fetal reduction means the induced termination of one or more embryos or fetuses.

Section 4. Informed Consent.

(a) All ART programs providing assisted reproductive technologies must, at least

twenty-four 24 hours prior to obtaining a signed contract for services, provide patients with

the following information in writing, and obtain a signed disclosure form before services

commence:

(1) Description of the procedure(s)

(2) Outcomes and success:

a. The likelihood that the patient will become pregnant, based on experience

at that particular program with patients of comparable age and medical

conditions;

b. Statistics on the facilitys success rate, including the total number of live

births, the number of live births as a percentage of completed retrieval cycles,the rates for clinical pregnancy and delivery per completed retrieval cycle

bracketed by age groups consisting of women under 30 years of age, women

aged 30 through 34 years, women aged 35 through 39 years, and women aged

40 years and older;

c. The likelihood of the patient having a live-born child based on a forthright

assessment of her particular age, circumstances, and embryo transfer options;

d. The programs most recent outcome statistics, as reported to the Centers for

Disease Control and Prevention (CDC);

e. The existence of, and availability of data from, the Fertility Clinic Success

Rate and Certication Act regarding pregnancy and live-birth success rates

of ART programs, and a copy of the annual report by the ART program to the

CDC pursuant to said Act; and


18/36

Defending Life 2011

597

f. Statistics reported by the program to federal and state agencies are to be

provided to the patient, along with reported statistics from all other clinics in

the state and national ART statistics as reported to the CDC, along with an

explanation of the relevance of the statistics.

(3) Costs:

a. The anticipated price (to the patient) of all procedures, including any charges

for procedures and medications not covered in the standard fee; and

b. Average cost to patients of a successful assisted pregnancy.

(4) Major known risks:

a. All major known risks and side effects to mothers and children conceived,including psychological risks, associated with all ART drugs and procedures

considered;

b. The risks associated with any drugs or fertility-enhancing medications

proposed;

c. The risks associated with egg retrieval and embryo or oocyte transfer; and

d. The risks associated with multiple gestation to mother and child(ren).

(5) Multiple gestation and fetal reduction:

a. The likelihood that fetal reduction might be recommended as a response to

multiple gestation; and

b. A clear explanation of the nature of fetal reduction and the associated risks

for mother and any surviving child.

c. Decisions about embryo conception and transfer, including the patients right

to determine the number of embryos or oocytes to conceive and transfer.

(6) Donor gametes: If relevant, the testing protocol used to ensure that gamete

donors are free from known infection, including human immunodeciency

viruses, and free from carriers of known genetic and chromosomal diseases.


19/36

598


(7) Non-transferred embryos:

a. The availability of embryo adoption for non-transferred embryos and

information on agencies in the State that process embryo adoption;

b. The risks of cryopreservation for embryos, including information concerningthe current feasibility of freezing eggs rather than embryos, and any inuence

that may have on the likelihood of a live-birth;

c. The current law governing disputes concerning excess embryos; and

d. Information concerning disposition of non-transferred embryos that may be

chosen by the patient, and the rights of patients regarding that disposition, and

the need to state their wishes and intentions regarding disposition.

(8) Changes that may affect the contract:a. The effect on treatment, embryos, and the validity of informed consent of

clinic closings, divorce, separation, failure to pay storage fees for excess

embryos, failure to pay treatment fees, inability to agree on fate of embryos,

death of patient or others, withdrawal of consent for transfer after

fertilization but before cryopreservation, incapacity, unavailability of

agreed upon disposition of embryos, or loss of contact with the clinic; and

b. The patients right to revoke consent at any time and that charges will be

limited to only the services provided, with exceptions possibly made for some

shared-risk programs, if relevant.

(b) This information must be discussed with the patient, and the ART program must

provide written documentation that all relevant information required by this Section has been

given to the patient.

(c) Patients shall be informed of the option of additional counseling throughout future

procedures, even if counseling was refused in the past.

(d) Each time a new cycle is undertaken, informed consent must be obtained and

information provided to the patient with the latest statistics and ndings concerning the

patients status.

(e) The [Commissioner of Health or other appropriate ofce/individual] is authorized to

promulgate additional regulations providing more specic guidance for ensuring fully informed

consent to ART.


20/36

Defending Life 2011

599

Section 5. Data Collection & Reporting Requirements.

(a) All ART programs shall condentially collect and maintain the following information,

pertaining to the particular ART program, and condentially report, on such forms as the

Department prescribes, the following information to [Insert name of state health department orother appropriate agency], no later than February 1 following any year such procedures were

performed:

(1) Success rates

a. Rates of success, dened as the total number of live births achieved, the

percentage of live births per completed cycle of egg retrieval, and the numbers

of both clinical pregnancy and actual delivery as ratios against the number of

retrieval cycles completed. These statistics must be broken down into the age

group of patients: 43;

b. Rate of live births per transfer; and

c. Number of live births per ovarian stimulation, broken down into age groups:

43.

(2) Storage: Information regarding the safekeeping of embryos including:

a. Storage location (if stored);

b. Location to which relocated (if transferred to another facility);

c. Purpose for which relocated (if transferred to another facility); and

d. Dime and date of disposal of each patients embryos, if destroyed.

(3) Technologies: Percentage usage of types of ART, including IVF, GIFT, ZIFT,

combination, or other.

(4) Multiples:

a. Percentage of pregnancies resulting in multi-fetal pregnancies, broken down by

number of fetuses; and

b. Percentage of live births having multiple infants.


21/36

600


(5) Fetal reduction:

a. Number of fetal reductions performed, individually reported, identifying the

number of embryos transferred before the reduction;

b. Percentage of transferred embryos that implant;

c. Percentage of premature births per singleton and multiple births; and

d. The use of pre-implantation genetic diagnosis (PGD), if used in the ART

program, including data on it safety and efcacy.

(6) Prematurity and other abnormalities:

a. Percentage of birth defects per singleton and multiple births; and

b. Percentage of fetal reductions that resulted in a miscarriage.

(b) The programs medical director shall verify in writing the accuracy of the foregoing

data.

(c) The [Commissioner of Healthor other appropriate ofce or individual] is authorized

to promulgate additional regulations requiring additional or more specic data collection and

reporting, as needed. [The Commissioner shall make the data available in such form as the

Commissioner prescribes.]

Section 6. Limits on transfer of embryos in any reproductive cycle.

(a) It shall be unlawful for any ART program, ART facility, or its employees to create more

than [two] embryos per reproductive cycle.

(b) In subsequent assisted reproductive cycles, transfer shall rst be attempted with

cryopreserved embryos from previous cycles, if they exist. Only after transfer is attempted

with cryopreserved embryos may new embryos be conceived through ART. [In the alternative,

Section 6(b) could require presenting patients with the option of emphasizing the use of

existing, cryopreserved embryos in future cycles.]

Section 7. Embryo Donation and Adoption

No ART program may limit or inhibit the option or availability by patients of embryo


22/36

Defending Life 2011

601

donation or adoption through psychological evaluations, increased costs or payments, or other

conditions.


(a) Civil Penalty. Any person or entity that violates any provision of this Act and derivesa pecuniary gain from such violation shall be ned [Insert appropriate amount] or twice the

amount of gross gain, or any amount intermediate between the foregoing, at the discretion of

the court [as is just].

(b) Unprofessional Conduct. Any violation of this Act shall constitute unprofessional

conduct pursuant to [Insert appropriate state statutes/regulations for 1) medical doctors/

surgeons and 2) osteopathic doctors] and shall result in sanctions increasing in severity from

censure to temporary suspension of license to permanent revocation of license.

(c) Trade, Occupation, or Profession. Any violation of this Act may be the basis fordenying an application for, denying an application for the renewal of, or revoking any license,

permit, certicate, or any other form of permission required to practice or engage in a trade,


(d) Facility Licensing. Any violation of this Act by an individual in the employ and under

the auspices of a licensed healthcare facility to which the management of said facility consents,

knows, or should know may be the basis for denying an application for, denying an application

for the renewal of, temporarily suspending, or permanently revoking any operational license,

permit, certicate, or any other form of permission required to operate a healthcare facility.







circumstances.

Section 10. Right of Intervention





23/36

602





24/36

Defending Life 2011

603

EGG PROVIDER PROTECTION ACT

HOUSE/SENATE Bill No. _____


Section 1. Title.

This Act may be known as the Egg Provider Protection Act.



(1) Human eggs used for research and fertility treatments are obtained from female

human providers.

(2) Egg providers tend to be young, single women without children.

(3) Egg providers are usually compensated nancially for their eggs or for the

time, pain, and inconvenience of the extraction procedure.

(4) Egg harvesting requires preliminary hormone treatment.

(5) This hormone therapy is accompanied by serious health risks, including an

increased risk of uterine, ovarian, and breast cancers and complications with

future pregnancies.

(6) Many egg providers are not fully informed of the health risks associated with

egg harvesting.

(7) Many egg providers suffer emotionally and psychologically for extended

periods after their eggs are harvested.

(8) Many egg providers will choose to have children sometime after having theireggs harvested.

(b) Based on the ndings in subsection (a) of this Section, it is the purpose of this Act to:

(1) Safeguard the health and welfare of egg providers;


25/36

604


(2) Require fully informed consent that ensures egg providers understand the

physical, psychological, and reproductive risks that accompany egg harvesting;

(3) Prevent egg harvesting institutions from exploiting women and commodifying

womens bodies; and

(4) Establish an egg provider registry in order to contribute to a more accurate and

complete understanding of the effects of egg harvesting on the providers.


For purposes of this Act only:

(a) Compensation means any consideration or payment given to a woman in exchange

for the harvesting and use of her eggs. It does not include reimbursement for time and trouble.

(b) Department means [Insert reference to appropriate State department or agency

responsible for implementing and administering this Act].

(c) Destructive human embryo research means medical procedures, scientic or

laboratory research, or other kinds of investigation that kill or injure the human embryo. It

does not include:

(1) In vitro fertilization and accompanying embryo transfer to a womans body,

(2) Research in the use of nuclear transfer or other cloning techniques to producemolecules; deoxyribonucleic acid; or cells other than human embryos, tissues,





(d) Eggmeans the unfertilized gamete, or oocyte, of a human female.

(e) Egg harvestingmeans the extraction of an egg or eggs from the reproductive organs

of a provider for purposes other than the impregnation of the provider with those same eggs.

(f) Egg provideror providermeans any woman who provides or agrees to provide

her eggs for purposes other than her own impregnation with those same eggs.


26/36


27/36

606


(c) No person or entity shall provide compensation, nancial or otherwise, for eggs or the

egg harvesting procedure.

(d) Any reimbursement for time and trouble to the provider shall not exceed an amount

typically paid to research subjects for their time and trouble in unrelated medical tests at the

institution offering the compensation, or if no other live-subject medical tests are conducted atthat institution, at other medical institutions in the State.

Section 5. Eligibility of Egg Providers.

No physician shall harvest the eggs of an egg provider unless that person:

(a) Is over the age of twenty;

(b) Has never had her eggs harvested by that physician or another person legally or

nancially afliated with that physician; and

(c) Has never had her eggs harvested for reproductive purposes in this State.

Section 6. Solicitation of Egg Providers.

(a) No solicitation of egg providers shall offer compensation, nancial or otherwise, for

eggs or the egg harvesting procedure.

(b) Any solicitation of egg providers shall include a summary of any drug or hormone

treatments involved, the total number of ofce or other visits that a provider must make, andthe intended use of the eggs to be harvested.

Section 7. Informed Consent.

(a) Before conducting any medical procedures on or prescribing any hormones or other

drugs for an egg provider, a physician shall provide the prospective provider with the following

information, described in basic terminology and written in a language understood by the

prospective provider, and shall obtain the providers signed consent on a form that the [Insert

name of State health department or other appropriate agency] shall prescribe.

(1) Procedure

a. Description of all hormones and other drugs to be taken by an egg provider,

including the dosage, frequency of administration, intended biochemical

function of, and likely physiological response to each medication;


28/36

Defending Life 2011

607

b. Whether the hormones and other drugs to be taken by the egg provider

are being administered as tested and approved by the Food and Drug

Administration (FDA);

c. Whether the hormones and other drugs to be taken by the egg provider arebeing administered off-label or according to an evidence-based protocol,

and if so the original intended purpose of the hormone or drug when it was

tested and approved by the FDA;

d. The number of times the egg provider will be expected to visit the physician,

the purpose for each visit, and the duration of each visit, including recovery

time;

e. Description of the procedure to be performed on the egg provider, including all

blood tests, ultrasounds, injections, and egg extractions. The description shallinclude the purpose, duration, and estimated recovery time of each procedure;

and

f. Description of all restrictions the egg provider will be asked to undertake and

their duration, including abstinence from alcohol, cigarettes, illegal drugs,

prescription drugs, and unprotected sexual intercourse, and restrictions on

driving following medication and medical procedures.

(2) Nature of Egg Harvesting

a. The approximate number of eggs to be harvested; and

b. That eggs have the potential to develop into live human persons sharing their

parents DNA, when fertilized by sperm.

(3) Intended Use of Eggs

a. Description of the intended use of the eggs;

b. Whether the eggs may be fertilized by sperm and, if so, how many days the

resulting embryos will be permitted to develop;

c. Whether the eggs may be turned into blastocysts through human cloning or

some means other than fertilization by sperm and, if so, how many days the

resulting entities will be permitted to develop;


29/36

608


d. Whether the eggs may be used for destructive human embryo research;

e. Whether the eggs may be implanted in other persons for reproductive or other

purposes;

f. How many separate recipients may be impregnated with the providers eggs;

g. What information the egg provider will be entitled to learn about any children

produced with her eggs, and what contact she will be allowed to have with

such children; and

h. Whether the eggs may be multiplied to produce more eggs. If so, sections (a)

through (g) of this Subsection also apply to the resulting eggs.

(4) Side Effects

a. Description of any pain that may be experienced as a result of hormones, other

drugs, the egg harvesting procedure, or any related procedure, including the

likely degree and duration of such pain;

b. Description of any other possible physical side effects, including allergic

reaction, ovarian hyperstimulation syndrome, ovary rupture, bleeding,

infection, blood clots, kidney failure, uid build-up in the lungs, damage to

bowel or bladder, and scarring of the fallopian tubes, that may be experienced

as a result of hormones, other drugs, the egg harvesting procedure, or anyrelated procedure, including the likely degree and duration of such physical

side effects;

c. Description of any emotional or psychological side effects, including

depression, stress-related symptoms, and mood swings, that may be

experienced as a result of hormones, other drugs, the egg harvesting procedure,

or any related procedure, including the likely degree and duration of such

emotional or psychological side effects;

d. Information on studies demonstrating an increased likelihood of the egg

provider developing uterine, breast, or ovarian cancer, or any other type of

cancer, after providing eggs, including the percentage of the general female

population that develop each type of cancer, and the percentage of egg

providers that develop each type of cancer; and


30/36

Defending Life 2011

609

e. The adverse effects the hormones, other drugs, the egg harvesting procedure,

and other related procedures have on future attempts of the egg provider to

become pregnant, including scarred fallopian tubes and infection.

f. Acknowledgement that, to date, the process and risks related to egg harvesting

are highly unstudied and unknown compared to other medical procedures andtreatments, and thus the egg provider cannot be completely informed of all

potential risks or effects.

(b) No person other than the egg provider shall consent on behalf of the provider.

Section 8. Data Collection and Reporting and Maintenance of State Registry.

(a) The [Legislature] of the State of [Insert name of State] further nds that there is a

substantial lack of knowledge in regard to the effects and risks of the egg harvesting process.

In order to develop the breadth of knowledge necessary to adequately inform women of therisks involved and better understand the demographic targeted by researchers for egg harvesting

purposes, the Department shall develop and maintain a state registry containing the following

information about each woman who provides eggs to any person or institution within the State:

(1) The age of the egg provider;

(2) The current yearly income of the egg provider;

(3) The city and state of residence of the egg provider;

(4) The number of pregnancies of the egg provider;

(5) The number of live births of the egg provider;

(6) The number of times the egg provider has previously provided or attempted to

provide eggs;

(7) The number of eggs harvested for each time the egg provider has previously

provided eggs;

(8) All hormones and other drugs prescribed or administered to the egg provider,

including dosage and frequency of administration, relating directly or

indirectly to the egg harvesting procedure;

(9) The manner in which the egg provider was instructed to administer the


31/36

610


hormones and drugs prescribed;

(10) Whether the egg provider was told that the medical community has not yet

adequately studied the effects of the egg harvesting procedure and therefore the

egg provider cannot be completely informed of all potential risks or effects;

(11) Whether the egg provider had a particular physician or other contact person

within the institution harvesting the eggs and, if so, the name and position of

that physician or other person;

(12) The name of the institution or facility harvesting the eggs;

(13) The total number of eggs harvested;

(14) The particular disposition [or use] of the eggs harvested;

(15) Whether and to what extent the egg provider received any follow-up care;

(16) Any side effects or adverse events in the health of the egg provider which

happened during the administration of hormones or other drugs, during the

harvesting procedure, or up to one year following the ingestion of hormones or

drugs and/or the harvesting procedure, whichever is later;

(17) Any medical treatment or procedure provided to the egg provider as a result of

the hormones or other drugs or egg harvesting procedure;

(18) The total amount of money paid to the egg provider for time, transportation,

discomfort, or other services related to the egg harvesting procedure;

(19) An itemized list of the amounts of money paid to the egg provider, the source

of each amount, and the consideration for each amount.

For purposes of this Act, an adverse event shall be dened according to the Food and Drug

Administration (FDA) criteria given in the Medwatch Reporting System.

(b) Any person or institution that harvests human eggs shall collect and maintain the

information required in Subsection (a) of this Section, and shall report it within fteen

(15) days after the last day of each calendar month to the Department on such forms as the

Department shall prescribe.

(c) The Department shall summarize aggregate data from the reports required under this


32/36

Defending Life 2011

611

Section and submit the data to the Centers for Disease Control and Prevention (CDC) for the

purpose of inclusion in the annual Vital Statistics Report. The aggregated data shall also be

made independently available to the public by the Department in a downloadable format.

(d) In addition to the information enumerated in part (a) of this Section, any person or

institution that harvests human eggs shall report to the Department the name of the egg providerfor which the information was collected and reported. That name shall not be included in the

Departments aggregate report. The Department shall assign a unique identication number for

each egg provider for the purposes of the aggregate report.

(e) The Department shall maintain a separate registry containing the names of the egg

providers with their unique identication numbers. This registry will be accessible only

by petition to the Department and for good cause, including but not limited to statistical

compilation and research on the effects and risks of the egg harvesting procedure.

Section 9. Prohibition on Use of Taxpayer Funds for Human Egg Harvesting.

(a) Notwithstanding any other law, no public funds shall be used to facilitate the harvesting

of human eggs, pay for the procedure of egg harvesting, or compensate those who perform or

undergo the procedure.

(b) For purposes of this section, egg harvesting includes the extraction of human

oocytes from a womans reproductive organs for the purpose of reproduction.


(a) Criminal Penalty. Any person or entity that violates any section of this Act shall be


(b) Civil Penalty. Any person or entity that violates any provision of this Act shall be ned

[Insert amount] or twice the amount of gross pecuniary gain derived from such a violation, or

any amount intermediate between the forgoing, at the discretion of the court.

(c) Unprofessional Conduct. Any violation of this Act shall constitute unprofessional

conduct pursuant to [Insert appropriate statutes for 1) medical doctors and surgeons and

2) osteopathic doctors] and shall result in permanent revocation of the violators license to

practice medicine.

(d) Trade, Occupation, or Profession. Any violation of this Act may be the basis for

denying an application for, denying an application for the renewal of, or revoking any license,


33/36

612


permit, certicate, or any other form of permission required to practice or engage in a trade,



Any provision of this Act held to be invalid or unenforceable by its terms, or as applied to anyperson or circumstance, shall be construed so as give it the maximum effect permitted by law,




circumstances.



or co-sponsored this Act, as a matter of right and in his or her ofcial capacity, to intervene todefend this law in any case in which its constitutionality is challenged or questioned.




34/36

613


EMBRYO ADOPTION ACT

HOUSE/SENATE Bill No. _____


Section 1. Title.

This Act may be known as the Embryo Adoption Act.



(1) There are an estimated 700,000 cryopreserved (frozen) human embryos in

laboratories and facilities in the United States, and that number grows annually

(2) There is scant guidance from federal or state law for the disposition of frozen

embryos given that few states have laws governing the disposition of frozen

embryos.

(3) The lack of clear guidance in federal or state law has resulted in numerous

bitterly-contested lawsuits stemming from disputes over the status of and

rights to frozen embryos, including cases decided by the Supreme Courts of

Massachusetts, New Jersey, New York, Tennessee, and Washington.

(4) Embryo transfer is a haphazard process, with little consistency between in vitro

fertilization (IVF) clinics and a general lack of dispositional agreements. The

process provides insufcient protection for the best interests of the child and

insufcient certainty for the rights and responsibilities of genetic and potential

adoptive parents.

(5) The number of embryo transfers completed each year is unknown, and nearly

all occur without the oversight of established adoption laws and procedures.

(6) It is doubtful that embryo adoption will lead to the production of more stored

embryos because of the medical burden and nancial expense of conceiving

them.

(7) Despite growing use of the term embryo adoption, the term, in the absence

of legal changes, may create a false sense of security for donors who believe


35/36

614


that they have legally terminated their parental rights and responsibilitieswhen

they transfer an embryo to adoptive parents.

(8) Bringing embryo transfer within the auspices of adoption procedures will

create greater protection for the child, greater certainty for the termination of

rights of the genetic parents, and greater certainty for the rights of the adoptingparents.

(9) Whereas assisted reproductive technologies (ART) create the possibility

that a child might have no parents or more than two parents (with sperm

donors, egg donors, gestational surrogates, and commissioning couples),

applying adoption procedures to embryo donation will help to ensure that a

child does not have more than two legally-recognized parents at one time.

(b) The [Legislature]s purposes in enacting this law are to:

(1) Clarify the rights of genetic and adoptive parents;

(2) Apply established procedures in adoption law to embryo adoption;

(3) Clarify the legal status of children placed for adoption as embryos; and

(4) Promote the best interests of the child.



(a) Human embryo or embryo means an individual organism [fertilized

ovum] of the human species, from the single cell stage to eight (8) weeks development.

(b) Embryo transfer means the relinquishment of rights and responsibilities

by the genetic parent(s) of a human embryo and the acceptance of said rights and

responsibilities by adopting parent(s).

Section 4. Amendment to Denition Section of State Adoption Law.

For purposes of this Act and the [Insert denition section(s) of this States adoption

law(s)], child [or minor] shall include a human embryo.


36/36

615

Section 5. Exclusivity.

The transfer of human embryos from genetic to adoptive parents shall be conducted pursuant to

the adoption laws of this state.

Section 6. Time of Relinquishment of Rights.

Relinquishment of rights by genetic parents to a human embryo shall take place before

implantation.

Section 7. Surrender of Rights.

Written surrender of rights shall be obtained from the genetic mother and father, unless the

embryo was derived from donor gametes.

Section 8. Status of Prior Agreements for Disposition of Embryos.

A written surrender of rights to an embryo pursuant to Section 7 shall cancel any prior written

agreement governing disposition of the embryo.





provision shall be deemed severable here from and shall not affect the remainder hereof orthe application of such provision to other persons not similarly situated or to other, dissimilar

circumstances.


The [Legislature], by joint resolution, may appoint one or more of its members who

sponsored or co-sponsored this Act, as a matter of right and in his or her ofcial

capacity, to intervene to defend this law in any case in which its constitutionality is

challenged or questioned.



Dl2011 Bioethics Legislation

Documents