Concept Paper Access to Medical Treatment Act

The Problem:
The United States has the best medicine in the world, and the Food and Drug Administration plays an essential role in evaluating the safety and efficacy of medical treatments. However, the current health care delivery system serves to discourage the development and utilization of alternative medical treatments that may have untold potential.

The time and expense currently required to gain FDA approval of treatment works to limit participation in this system to large pharmaceutical companies. It makes it difficult to take advantage of the potentially innovative contributions of individual practitioners, scientists, smaller companies and others who do not have the financial resources to complete the FDA approval process. It also serves to prevent low-cost treatments from gaining access to the market.

Therefore, it makes sense to consider opening up the system to alternative treatments that may help patients and are not proven harmful under certain carefully circumscribed conditions.

The Proposal:
S. 578 would allow an individual to be treated by any licensed health care practitioner with any method of medical treatment the individual desires, so long as:

1) there is no basis to conclude that the treatment would be dangerous to the individual; and
2) the patient is fully informed of its side effects.

The bill also strictly regulates the circumstances under which claims can be made with respect to the efficacy of a treatment.

FDA’s role would not be changed.
The Access to Medical Treatment Act would not dismantle or appreciably change the current operations of the FDA or the conventional medical community. The FDA would still have responsibility for certifying treatments as safe and effective. This legislation merely attempts to open up the system to the utilization of certain new alternative treatments. The claims restriction in the bill is designed to remove incentive for major marketing efforts of non-FDA approved treatments, and should address the legitimate concern that this legislation could inadvertently become a “bypass” for the FDA approval process.

Consumer protections are an essential element of the bill
The bill contains several important protections to address the issue of consumer safety. In addition to the claims restriction, these protections include a tight definition of who qualifies as a health care practitioner, strict informed consent requirements, and a stipulation that treatments administered under this legislation may not pose a known danger to the patient.

This is a freedom of choice issue
Freedom of choice is one of the bedrock principles upon which our nation rests. Permitting administration of alternative medical treatments, provided that individuals are not misled or misinformed, extends freedom of choice to the realm of medicine. This legislation stems from the conviction that an individual suffering from a life-threatening or otherwise serious disease for which conventional medicine offers limited hope should not be denied access to a non-conventional treatment if there is reason to believe that it might be beneficial.

Prepared by Clinton Ray Miller, Health Freedom Legislative Advocate for the National Council For Improved Health (NCIH). Contact Miller: Box 77034, Washington, D.C. 20013; (202) 543-6441; or (704) 924-8615 (limit-1) (97-17)

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For help with a relative legislative project or consultation, Mr. Miller can be reached at:
Miller, Clinton Ray
Health Freedom Legislative Advocate
Box 77034
Washington, D.C. 20013
202-543-6441 voice
202-543-7109 fax
704-924-8615 voice
704-924-8616 fax
cmiller@calcoast.com



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