Rogers / 5 Senator Paley

S.R._____
A BILL

To regulate 3D organ printing.

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Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE
This act may be cited as the 3D Printing Act of 2015.
SECTION 2. FINDINGS
Congress hereby finds and declares that,
1) Within the next ten years it is expected that 3D printing will become an $8.9 billion industry $1.9 billion (21%) of
which will be focused on medical applications.
2) Bioprinting black markets where replacement body parts are printed illegally have been on the rise ever since
bioprinters have become available for purchase.
3) 3D printers used in black markets range in quality from sufficient for providing medical aid to life-threatening
because they produce low-quality organs that are unsafe for use.
4) 3D printing is a cost-efficient alternative to traditional manufacturing methods, especially in the case of smallsized standard implants or prosthetics, such as those used for spinal, dental, or craniofacial disorders.
5) In 2014, the National Institutes of Health created 3D Print Exchange which allows for the sharing of 3D print files
for medical and anatomical models, custom labware, and replicas of proteins, viruses, and bacteria.
6) The bioprinting of organs is a complex and expensive process; as of today functional 3D organs cost millions of
dollars to manufacture.
7) The bioprinting of organs is advancing at such a quick rate that real medical applications as expected as soon as
2016.
8) A higher-end 3D printer ranges from $2,500-$3,000 in price.
9) The first patients to receive 3D-printed organs will be undergoing a procedure that has not gone through sufficient
testing.
10) Since bioprinting organs will be a more expensive procedure than traditional organ transplants, patients who
cannot afford to bioprint organs will be stuck waiting for organs even though bioprinting is available as an
alternative.
SECTION 3. STATUTORY LANGUAGE
A) The bioprinting of humans in their entirety shall hereby be prohibited and deemed illegal in all states. The sale or
transfer of ownership of 3D bioprinters to any entities other than licensed medical organizations shall hereby be
prohibited. All 3D print files with medical applications shall be made universally available through the National
Institute of Health 3D Print Exchange. All enactment, implementation, and enforcement of this bill shall be overseen
by the Department of Health and Human Services.
B) The Department of Justice shall be responsible for the regulation and oversight of all sales and exchanges of
bioprinters between licensed medical organizations. The Department of Justice shall be responsible for the
prevention of a bioprinter black market where bioprinters are sold illegally in the United States. The Department of
Justice shall be responsible for the investigation, prosecution, and punishment of all individuals and organizations
suspected of violating the guidelines set forth in this bill as it sees fit. The Department of Health and Human Services
shall be responsible for overseeing 3D printing practices including but not limited to cost of 3D printing procedures,
public access to medical uses of 3D printing, and the extent of medical applications of 3D printing. Funding shall be
provided by the Department of Justice and the Department of Health and Human Services.
C)Violation of this bill will result in federal investigation and possible prosecution by the Department of Justice.
Medical organizations suspected of violating this bill shall be suspect to investigation by the Department of Justice
and will be subjected to the possibility of withdrawal of said organization's medical license. This bill shall be enacted
on January 1, 2017.