II

103D CONGRESS

2D SESSION S. 2140

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

MAY 19 (legislative day, MAY 16), 1994

Mr. DASCHLE (for himself, Mr. HARKIN, Mr. PELL, Mr. GRASSLEY, Mr. HATFIELD, and Mr. DECONCINI) 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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Access to Medical

5 Treatment Act’’.

6 SEC. 2. DEFINITIONS.

7 As used in this Act:

8 (1) ADVERTISING OR LABELING CLAIMS.—The

9 term ‘‘advertising or labeling claims’’ means any
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1 representations made or suggested by statement,

2 word, design, device, sound, or any combination

3 thereof with respect to treatment, including a rep4 resentation made or suggested by a label.

5 (2) DANGER.—The term ‘‘danger’’ means any

6 serious negative reaction that—

7 (A) occurred as a result of a method of

8 treatment;

9 (B) would not otherwise have occurred;

10 and

11 (C) is more serious than reactions fre12 quently experienced with accepted treatments

13 for the same or similar health problems.

14 (3) DEVICE.—The term ‘‘device’’ has the same

15 meaning given such term in section 201(h) of the

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

17 321(h)).

18 (4) DRUG.—The term ‘‘drug’’ has the same

19 meaning given such term in section 201(g)(1) of the

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

21 321(g)(1)).

22 (5) FOOD.—The term ‘‘food’’ has the same

23 meaning given such term in section 201(f) of the

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

25 321(f)).
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1 (6) HEALTH CARE PRACTITIONER.—The term

2 ‘‘health care practitioner’’ means any properly li3 censed medical doctor, osteopath, chiropractor, or

4 naturopath.

5 (7) LABEL.—The term ‘‘label’’ has the same

6 meaning given such term in section 201(k) of the

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

8 321(k)).

9 (8) LEGAL REPRESENTATIVE.—The term ‘‘legal

10 representative’’ means a parent or an individual who

11 qualifies as a legal guardian under State law.

12 (9) TREATMENT.—The term ‘‘treatment’’

13 means the use of any food, drug, device, or proce14 dure.

15 SEC. 3. ACCESS TO MEDICAL TREATMENT.

16 (a) IN GENERAL.—Notwithstanding any other provi17 sion of law, and except as provided in subsection (b), an

18 individual shall be permitted to be treated by a health care

19 practitioner with any method of medical treatment that

20 such individual desires or the legal representative of such

21 individual authorizes if—

22 (1) such practitioner agrees to treat such indi23 vidual; and

24 (2) the administration of such treatment falls

25 within the scope of the practice of such practitioner.
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1 (b) TREATMENT REQUIREMENTS.—A health care

2 practitioner may provide any method of treatment to an

3 individual described in subsection (a) if—

4 (1) there is no evidence that such treatment it5 self, when taken as prescribed, is a danger to such

6 individual;

7 (2) in the case of an individual whose treatment

8 is the administration of a food, drug, or device that

9 has not been approved by the Food and Drug Ad10 ministration—

11 (A) such individual has been informed that

12 such food, drug, or device has not yet been ap13 proved or certified by the Food and Drug Ad14 ministration for use of the medical condition of

15 such individual; and

16 (B) such food, drug, or device (or informa17 tion accompanying the administration of such

18 food, drug, or device) contains the following

19 warning:

20 ‘‘WARNING: This food, drug, or de21 vice has not been proved safe and effective

22 by the Federal Government and any indi23 vidual who uses such food, drug, or device,

24 does so at his or her own risk.’’;
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1 (3) such individual has been informed of the

2 nature of the treatment, including—

3 (A) the contents of such treatment;

4 (B) any reasonably foreseeable side effects

5 that may result from such treatment; and

6 (C) the results of past applications of such

7 treatment by the health care practitioner and

8 others;

9 (4) except as provided in subsection (c), there

10 have been no claims, including advertising and label11 ing claims, made with respect to the efficacy of such

12 treatment; and

13 (5) such individual—

14 (A) has been provided a written statement

15 that such individual has been fully informed

16 with respect to the information described in

17 paragraphs (1) through (4);

18 (B) desires such treatment; and

19 (C) signs such statement.

20 (c) CLAIM EXCEPTIONS.—Subsection (b)(4) shall not

21 apply to an accurate and truthful reporting by a practi22 tioner of the results of the practitioner’s administration

23 of a treatment in recognized journals or at seminars, con24 ventions, or similar meetings, if the only financial gain of

25 such practitioner with respect to such treatment is the
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1 payment received from an individual or representative of

2 such individual for the administration of such treatment

3 to such individual.

4 SEC. 4. REPORTING OF A DANGEROUS TREATMENT.

5 If a practitioner, after administering such treatment,

6 discovers that the treatment itself (when taken as pre7 scribed) was a danger to the individual receiving the treat8 ment, the practitioner shall immediately report to the Sec9 retary of Health and Human Services the nature of the

10 treatment, the results of such treatment, the complete pro11 tocol of such treatment, and the source from which such

12 treatment or any part thereof was obtained.

13 SEC. 5. TRANSPORTATION OF MEDICATION AND EQUIP14 MENT.

15 Notwithstanding any other provision of the Federal

16 Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq.),

17 a person may introduce or deliver into interstate com18 merce medication or equipment for use in accordance with

19 this Act.

20 SEC. 6. RESTRICTIONS ON LICENSING BOARDS.

21 A licensing board that issues licenses to health care

22 practitioners may not deny, suspend, or revoke the license

23 of a health care practitioner solely because such practi24 tioner provides treatment to which section 3 applies.
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1 SEC. 7. PENALTY.

2 A health care practitioner who violates any provisions

3 under this Act shall not be covered by the protections

4 under this Act and shall be subject to all other applicable

5 laws and regulations.

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