Fair Labeling and Informed Consent Act 2004
Federal bill proposed by Children of God for Life
Background - Purpose of this Act
In August of 2003, Australia passed legislation
that ensures consumers have the right to know when human embryos, human
embryonic stem cells or materials derived from embryos or stem cells are
used in the manufacture or testing of pharmaceuticals. Their reasoning was
three-fold:
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Consumers are entitled to make informed
decisions as to whether they wish to use these products or
non-objectionable, ethical alternatives
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Current labeling practices from the
pharmaceutical companies are inadequate
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The right of conscience and informed
consent must be upheld for all citizens
The legislation also requires that imported
pharmaceutical products comply with the government regulations.
In Scotland, thousands of angry Muslims
protested after their children unknowingly received a vaccine containing
pork preservatives, as it violated their religious beliefs. Other countries
are becoming aware of the need to provide informed consent on medical and
vaccine product content in order to protect the rights of their citizens.
But how can people abstain from a product that one finds morally or
religiously objectionable when they have no idea what the product contains
or how it was obtained?
The United States must be a leader in defending
religious and civil rights as more and more products are being brought to
market that utilize morally objectionable sources. In order to encourage
ethical research and protect the rights of all Americans as well as the
citizens of foreign countries who use our products, the current method of
labeling and informed consent must be amended. Accordingly, the following
draft would:
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Allow medical professionals and
pharmacists to be informed of the product content
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Allow the medical professionals,
pharmacists and consumers to purchase ethical alternatives
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Protect the right of conscience and
religious freedom for all citizens who wish to abstain from these
products, as afforded to them through religious exemption laws in 48
states
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Protect the federal government from
ensuing lawsuits from citizens who have unknowingly used products
directly violating their religious beliefs
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Encourage the production of ethical
alternatives by competing pharmaceutical companies
Comments or suggestions about this bill should be directed to:
Debra L. Vinnedge, Executive Director
Children of God for Life
2130 Catalina Dr
Clearwater, FL 33764
Phone: 727 538-5558 Fax: 727 530-7564
Email: debi@cogforlife.org
[Provided by Children of God for Life]
JANUARY 20, 2004 - PROPOSED DRAFT
Entitled
"Fair Labeling and Informed Consent Act 2004"
SECTION 1. SHORT TITLE.
This Act may be cited as the F.L.I.C.A. in the following sections.
SEC. 2. FEDERAL JURISDICTION
The F.L.I.C.A. applies to -
a) Any prescription or non-prescription drug or medical treatment that is
currently in use and uses human fetal or embryonic tissue, cell lines, DNA
or components from procured abortion in the manufacturing or production of
the product or treatment.
b) Any new prescription or non-prescription drug or medical treatment
that will use human fetal or embryonic tissue, cell lines, DNA or components
from procured abortion or in-vitro fertilized embryos that have been donated
or otherwise produced or reproduced in research.
c) Any health care provider, researcher, technician or other person
required to perform or assist in the administration or research of
prescription or non-prescription drugs, vaccinations or medical treatments.
d) Any person required to fill and dispense such prescription or
non-prescription drugs, vaccinations or medical treatments.
e) Any person or patient who is the recipient of a prescription or
non-prescription drug, vaccination or medical procedure that would involve
the use of human fetal or embryonic tissue, cell lines, DNA or components
from procured abortion or in-vitro fertilized embryos that have been donated
or otherwise produced or reproduced sexually or asexually in research.
f) Any manufacturer or distributor of a prescription or non-prescription
drug, vaccination or medical procedure.
g) Any Institutional Review Board (IRB), Hospital Ethics Committee (HEC)
or other committee reviewing and/or recommending experimental or therapeutic
research or medical provision of a prescription or non-prescription drug,
vaccination, or medical procedure that would involve the use of aborted
fetal or embryonic tissue, DNA, cell lines, components or parts.
SEC. 3: POLICY AND PURPOSES
a) It is the current policy of the United States through the Federal Food
and Drug and Administration to provide information on the ingredients in the
labeling of all prescription and non-prescription drugs including, but not
limited to the descriptions found in the Code of Federal Regulations (CFR)
Part 201, Labeling.
b) In accordance with such procedures of the Federal Register, all
prescription and non-prescription drugs and vaccinations must be labeled in
the required format to include: "Description", "Clinical Pharmacology",
"Indications and Usage", "Warnings", "Precautions", "Adverse Reactions",
"Drug Abuse and Dependence", "Overdose", Dosage and Administration and "How
Supplied". Section 201.57 specifies the exact information that is required
to appear in these sections.
c) It is the purpose of this Act to require that the current labeling
practice of all such prescription and non-prescription drugs, vaccinations
or medical procedures involved in the use of such pharmaceutical treatments
be amended to include full descriptions of human cell lines, tissues, DNA or
cell components that take their origin in procured abortion or in-vitro
fertilized embryos that have been donated or otherwise produced or
reproduced sexually or asexually in research.
d) It is the purpose of this Act to protect the legal right of patients
to give their valid informed consent by requiring that researchers,
technicians, attending physicians, nurses, midwives, pharmacists or any
other health care provider with the appropriate knowledge shall provide all
such information to patients before dispensing any product or treatment that
contains human cell lines, tissues, DNA or components derived from procured
abortion or from human embryos that have been donated or otherwise produced
or reproduced sexually or asexually in research.
e) It is the purpose of this Act to protect the legal right of
researchers, technicians, attending physicians, nurses, midwives,
pharmacists or any other health care provider to give their valid informed
consent by requiring that they be provided all such information before
producing or dispensing any product or treatment that contains human cell
lines, tissues, DNA or components derived from procured abortion or from
human embryos that have been donated or otherwise produced or reproduced
sexually or asexually in research."
f) It is the purpose of this Act to protect the civil rights of all such
individuals when the use of such drugs and vaccinations would violate a
person's religious or moral convictions; and to prohibit all forms of
discrimination, coercion, or liability upon such persons by reason of such
refusal.
g) It has always been the policy of the United States to protect the
rights of religious freedom and to recognize the fundamental rights of the
people including the rights to freedom of thought and conscience, which are
protected in numerous international agreements and declarations as well as
in the US Constitution.
h) It is the current policy of the Federal and State laws of 48 states
and the District of Columbia to allow religious exemptions to vaccine
requirements when the use of such products would violate religious beliefs,
tenets or practices. Yet without informed consent and fair, truthful
labeling such rights have been duly violated. (DS Form 122.1 and related
State exemption laws)
SEC. 4: DEFINITIONS
As used in this F.L.I.C.A:
a) "Health care provider" means any public or private
corporation, partnership, association, organization, agency or other legal
entity that is involved directly or indirectly in providing health care
services, including, without limitation, any public or private hospital,
clinic, medical center, research facility, medical school, nursing school or
other medical training institution, laboratory or diagnostic facility,
physician's office, infirmary, dispensary, ambulatory surgical treatment
center, public health center or school administering vaccinations,
prescription or non-prescription drugs or medical treatments.
b) "Prescription or non-prescription drug" means any
medical product or treatment prescribed by or administered by health care
personnel to patients.
c) "Health care personnel" means any nurse, nurses'
aide, midwife, medical school student, professional, paraprofessional or any
other person who furnishes, or assists in the furnishing of, health care
services.
d) "Patient" means any human being or any parent or
legal guardian of a person acting in behalf of a human being, receiving a
prescription or non-prescription drug, vaccination or medical treatment
subject to the regulations of this Act.
e) "Procured abortion procedure" means: "All the
measures which impair the viability of the zygote [newly-conceived embryo]
at any time from the moment of fertilization through the completion of labor
constitute, in the strict sense, procedures for inducing abortion," as
defined in the U.S. public health service leaflet (#1066).
f) "human embryo" means any human organism produced
sexually (fertilization) or asexually such as blastomere separation,
blastocyst splitting, or any other method of cloning or artificial
reproduction.
g) "Medical treatment" means any medical care given in
the context of standard medical practice, or in therapeutic or experimental
research protocols which involves the direct transfer to a patient of a
product which is derived from, contains or uses human fetal or embryonic
tissue, DNA, components or cell lines or is obtained from procured abortion
or human embryos that have been donated or otherwise produced or reproduced
sexually or asexually in research.
h) "Research" means any theoretical or practical
investigation or experimentation which uses, produces, or reproduces human
fetal or embryonic tissue DNA, components or cell lines obtained from
procured abortion or human embryos that have been donated or otherwise
produced or reproduced sexually or asexually in research.
i) "Fair labeling" shall mean that the procured aborted
fetal or embryonic cell lines, DNA or components shall be clearly labeled as
such and listed under the product's "Description" in the product insert and
packaging.
j) "Informed consent" means that patients, researchers,
technicians, attending physicians, nurses, midwives, pharmacists or any
other health care provider are provided with the appropriate knowledge they
need in order to freely decide to receive, produce, or dispense any product
or treatment that contains human cell lines, tissues, DNA or components
derived from procured abortion or from human embryos that have been donated
or otherwise produced or reproduced sexually or asexually in research.
k) "Religious or moral convictions" means genuine
positions of an individual based on sincerely held religious or moral norms
of conduct."
l) "Conscience" means a person's judgment that
particular actions are right or wrong based on sincerely held religious or
moral convictions.
SEC. 5: FREEDOM OF CONSCIENCE
a) All persons have the right not to receive, produce, provide, perform,
assist, or participate in directly or indirectly the use of health care
products that would be contrary to their religious or moral convictions
b) No individual shall be civilly or criminally, legally or
administratively liable to any person for any refusal to produce, provide,
use, assist, or participate directly or indirectly in health care products
that violate his or her religious or moral convictions.
c) No person shall discriminate against, penalize, discipline, or
retaliate against any individual in employment, privileges, benefits,
remuneration, promotion, termination of employment; or in eligibility for,
admission to, renewal or participation in, or graduation from any
educational, study, or training program; or in any grant, contract, research
or other program because of his or her refusal or unwillingness to provide,
use, perform, assist, or participate directly or indirectly in health care
products that violate his or her religious or moral convictions.
d) It shall be unlawful for any person, public or private institution, or
public official to discriminate against any person, association, health
official or corporation refusing to provide health care products that
violate his or her religious or moral convictions in any manner, including
but not limited to, deprivation, or disqualification of financial aids,
assistance, benefits, or any other privileges.
SEC. 6: AUTHORITY TO ENFORCE THIS ACT
a) The United States may bring an action for injunctive or declaratory
relief to enforce compliance with this Act through the regulatory
requirements actions of the FDA which shall be amended as stated in this
Act, including but not limited to (1) suspension of product licensing for
non-compliance and (2) fines to research or health care providers or
personnel, not to exceed $1,000.00 per occurrence for failure to provide
informed consent to the patient or relevant professionals.
b) No rule or regulation shall impair or delay any person who believes
that his or her or its rights under this Act have been violated from
bringing an action in any State or Federal court.