HEALTH FREEDOM WATCHDOG HEALTH FREEDOM WATCHDOG
FILE s1035.is
S 1035 IS
104th CONGRESS
1st Session
To permit an individual to be treated by a health care practitioner
with any method of medical treatment such individual requests, and
for other purposes.
IN THE SENATE OF THE UNITED STATES
July 14 (legislative day, JULY 10), 1995
Mr. DASCHLE (for himself, Mr. DOLE, Mr. HARKIN, Mr. HATCH, Mr.
GRASSLEY, Mr. PELL, Mr. HATFIELD, Mr. SIMON, and Mr. REID)
introduced the following bill; which was read twice and
referred to the Committee on Labor and Human Resources
A BILL
To permit an individual to be treated by a health care practitioner
with any method of medical treatment such individual requests, and
for other purposes.
[Italic-] Be it enacted by the Senate and House of
Representatives of the United States of America in Congress
assembled, [-Italic]
SECTION 1. SHORT TITLE.
This Act may be cited as the `Access to Medical Treatment Act'.
SEC. 2. DEFINITIONS.
As used in this Act:
(1) ADVERTISING CLAIMS- The term `advertising claims' means
any representations made or suggested by statement, word,
design, device, sound, or any combination thereof with respect
to a medical treatment.
(2) DANGER- The term `danger' means any negative reaction
that--
(A) causes serious harm;
(B) occurred as a result of a method of medical treatment;
(C) would not otherwise have occurred; and
(D) is more serious than reactions experienced with
routinely used medical treatments for the same medical
condition or conditions.
(3) DEVICE- The term `device' has the same meaning given such
term in section 201(h) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(h)).
(4) DRUG- The term `drug' has the same meaning given such
term in section 201(g)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(g)(1)).
(5) FOOD- The term `food'--
(A) has the same meaning given such term in section
201(f) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321(f)); and
(B) includes a dietary supplement as defined in section
201(ff) of such Act.
(6) HEALTH CARE PRACTITIONER- The term `health care
practitioner' means a physician or another person who is
legally authorized to provide health professional services in
the State in which the services are provided.
(7) LABEL- The term `label' has the same meaning given such
term in section 201(k) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(k)).
(8) LABELING- The term `labeling' has the same meaning given
such term in section 201(m) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(m)).
(9) LEGAL REPRESENTATIVE- The term `legal representative'
means a parent or an individual who qualifies as a legal
guardian under State law.
(10) MEDICAL TREATMENT- The term `medical treatment' means
any food, drug, device, or procedure that is used and intended
as a cure, mitigation, treatment, or prevention of disease.
(11) SELLER- The term `seller' means a person, company, or
organization that receives payment related to a medical
treatment of a patient of a health practitioner, except that
this term does not apply to a health care practitioner who
receives payment from an individual or representative of such
individual for the administration of a medical treatment to
such individual.
SEC. 3. ACCESS TO MEDICAL TREATMENT.
(a) IN GENERAL- Notwithstanding any other provision of law, and
except as provided in subsection (b), an individual shall have the
right to be treated by a health care practitioner with any medical
treatment (including a medical treatment that is not approved,
certified, or licensed by the Secretary of Health and Human
Services) that such individual desires or the legal representative
of such individual authorizes if--
(1) such practitioner has personally examined such individual
and agrees to treat such individual; and
(2) the administration of such treatment does not violate
licensing laws.
(b) MEDICAL TREATMENT REQUIREMENTS- A health care practitioner
may provide any medical treatment to an individual described in
subsection (a) if--
(1) there is no reasonable basis to conclude that the medical
treatment itself, when used as directed, poses an unreasonable
and significant risk of danger to such individual;
(2) in the case of an individual whose treatment is the
administration of a food, drug, or device that has to be
approved, certified, or licensed by the Secretary of Health and
Human Services, but has not been approved, certified, or
licensed by the Secretary of Health and Human Services--
(A) such individual has been informed in writing that
such food, drug, or device has not yet been approved,
certified, or licensed by the Secretary of Health and Human
Services for use as a medical treatment of the medical
condition of such individual; and
(B) prior to the administration of such treatment, the
practitioner has provided the patient a written statement
that states the following:
`WARNING: This food, drug, or device has not been
declared to be safe and effective by the Federal
Government and any individual who uses such food, drug,
or device, does so at his or her own risk.';
(3) such individual has been informed in writing of the
nature of the medical treatment, including--
(A) the contents and methods of such treatment;
(B) the anticipated benefits of such treatment;
(C) any reasonably foreseeable side effects that may
result from such treatment;
(D) the results of past applications of such treatment by
the health care practitioner and others; and
(E) any other information necessary to fully meet the
requirements for informed consent of human subjects
prescribed by regulations issued by the Food and Drug
Administration;
(4) except as provided in subsection (c), there have been no
advertising claims made with respect to the efficacy of the
medical treatment by the practitioner;
(5) the label or labeling of a food, drug, or device that is
a medical treatment is not false or misleading; and
(6) such individual--
(A) has been provided a written statement that such
individual has been fully informed with respect to the
information described in paragraphs (1) through (4);
(B) desires such treatment; and
(C) signs such statement.
(c) CLAIM EXCEPTIONS-
(1) REPORTING BY A PRACTITIONER- Subsection (b)(4) shall not
apply to an accurate and truthful reporting by a health care
practitioner of the results of the practitioner's
administration of a medical treatment in recognized journals,
at seminars, conventions, or similar meetings, or to others, so
long as the reporting practitioner has no direct or indirect
financial interest in the reporting of the material and has
received no financial benefits of any kind from the
manufacturer, distributor, or other seller for such reporting.
Such reporting may not be used by a manufacturer, distributor,
or other seller to advance the sale of such treatment.
(2) STATEMENTS BY A PRACTITIONER TO A PATIENT- Subsection
(b)(4) shall not apply to any statement made in person by a
health care practitioner to an individual patient or an
individual prospective patient.
(3) DIETARY SUPPLEMENTS STATEMENTS- Subsection (b)(4) shall
not apply to statements or claims permitted under sections 403B
and 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343-2 and 343(r)(6)).
SEC. 4. REPORTING OF A DANGEROUS MEDICAL TREATMENT.
(a) HEALTH CARE PRACTITIONER- If a health care practitioner,
after administering a medical treatment, discovers that the
treatment itself was a danger to the individual receiving such
treatment, the practitioner shall immediately report to the
Secretary of Health and Human Services the nature of such
treatment, the results of such treatment, the complete protocol of
such treatment, and the source from which such treatment or any
part thereof was obtained.
(b) SECRETARY- Upon confirmation that a medical treatment has
proven dangerous to an individual, the Secretary of Health and
Human Services shall properly disseminate information with respect
to the danger of the medical treatment.
SEC. 5. REPORTING OF A BENEFICIAL MEDICAL TREATMENT.
If a health care practitioner, after administering a medical
treatment that is not a conventional medical treatment for a
life-threatening medical condition or conditions, discovers that
such medical treatment has positive effects on such condition or
conditions that are significantly greater than the positive effects
that are expected from a conventional medical treatment for the
same condition or conditions, the practitioner shall immediately
make a reporting, which is accurate and truthful, to the Office of
Alternative Medicine of--
(1) the nature of such medical treatment (which is not a
conventional medical treatment);
(2) the results of such treatment; and
(3) the protocol of such treatment.
SEC. 6. TRANSPORTATION AND PRODUCTION OF FOOD, DRUGS, DEVICES, AND
OTHER EQUIPMENT.
Notwithstanding any other provision of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 201 et seq.), a person may--
(1) introduce or deliver into interstate commerce a food,
drug, device, or any other equipment; and
(2) produce a food, drug, device, or any other equipment,
solely for use in accordance with this Act if there have been no
advertising claims by the manufacturer, distributor, or seller.
SEC. 7. VIOLATION OF THE CONTROLLED SUBSTANCES ACT.
A health care practitioner, manufacturer, distributor, or other
seller may not violate any provision of the Controlled Substances
Act (21 U.S.C. 801 et seq.) in the provision of medical treatment
in accordance with this Act.
SEC. 8. PENALTY.
A health care practitioner who knowingly violates any provisions
under this Act shall not be covered by the protections under this
Act and shall be subject to all other applicable laws and
regulations.
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