I
107TH CONGRESS
2D SESSION
H. R. 3966
To direct the Director of the Office of Science and Technology Policy to
conduct a study of the impact of Federal policies on the innovation
process for genomic technologies, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 14, 2002
Ms. RIVERS (for herself and Mr. WELDON of Florida) introduced the following
bill; which was referred to the Committee on Science, and in addition to
the Committee on the Judiciary, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions
as fall within the jurisdiction of the committee concerned
A BILL
To direct the Director of the Office of Science and Tech-
nology Policy to conduct a study of the impact of Federal
policies on the innovation process for genomic tech-
nologies, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Genomic Science and
Technology Innovation Act of 2002’’.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Genomic science promises a revolution in
the development of new and effective genomic tech-
nologies and other innovations, and it is in the na-
tional interest to speed the development and deploy-
ment of these new technologies through policies that
promote innovation in the field of genomic science
and technology.
(2) While Federal innovation policies can help
stimulate innovation by attracting capital investment
to the development of commercial products, such
policies can also inhibit basic research and hinder
sharing of information that is the basis of scientific
progress, thereby slowing the innovation process.
(3) Intellectual property policies for genomic
science and technology products are being imple-
mented without an adequate understanding and con-
sideration of the net impact of such policies on the
innovation process.
(4) Decisions about intellectual property policy
being made now are likely to have significant im-
pacts on basic research and the development of
genomic technology for decades to come.
(5) The Office of Science and Technology Pol-
icy is uniquely positioned to lead the development of
a coordinated, interagency policy to promote innova-
tion in genomic science and technology. A definitive
study coordinated by the Office of Science and Tech-
nology Policy that identifies the impacts of Federal
innovation policy on the innovation pipeline for
genomic technology and includes recommendations
for policies, including any statutory changes needed
to optimize the genomic technology innovation pipe-
line, would contribute significantly to the develop-
ment of the policy.
SEC. 3. STUDY.
(a) REQUIREMENT.—The Director of the Office of
Science and Technology Policy shall conduct, or may con-
tract with the National Academy of Sciences to conduct,
a study that assesses the impact of Federal policies, in-
cluding intellectual property policies, on the innovation
process for genomic technologies.
(b) CONSULTATION.—In conducting the study, the
Director of the Office of Science and Technology Policy
shall consult with the National Science and Technology
Council, the National Science Foundation, the Secretary
of Energy, the Secretary of Commerce, the Secretary of
Health and Human Services, and other agencies or divi-
sions of agencies the Director considers appropriate.
(c) ADVISORY
COMMITTEE.—In conducting the
study, the Director of the Office of Science and Tech-
nology Policy shall consult with an advisory committee, or-
ganized as a subcommittee of the President’s Committee
of Advisors on Science and Technology, that shall include
balanced membership from research universities and other
nonprofit research institutions, industry, economists, legal
experts, bioethicists, clinicians and clinical scientists, ge-
netic practitioners, and advocacy groups.
(d) CONTENTS.—The study shall—
(1) identify and quantify, to extent possible, the
actual and reasonably expected effects of innovation
policy on genomic science and technology innovation;
(2) explicitly consider various alternative levels
of intellectual property protection genomic materials
may receive and the likely impact of the various lev-
els of protection on each element of the innovation
pipeline, including—
(A) fundamental genomic research carried
out at universities and other nonprofit research
institutions;
(B) commercial genomic research at uni-
versities, nonprofit research institutions, and
for-profit institutions, including the expected ef-
fects on intracompany investment and external
private capital;
(C) development of commercial genomic
technologies, including the expected effects on
investment capital; and
(D) access to genomic technologies and
processes; and
(3) include an assessment of the net impact of
Federal innovation policies on innovation for
genomic technologies, including an assessment of—
(A) researchers’ access to genomic mate-
rials;
(B) the rate of innovation;
(C) the quality of innovation;
(D) the cost of new genomic technologies
brought to market;
(E) the impact of restricted access to
genomic diagnostics on evaluation, improve-
ment, and clinical utilization;
(F) the cost and availability of innovative
technology;
(G) whether Federal innovation policies
create barriers to research through denial of
use of a research tool, increased costs of licens-
ing, legal and litigation costs, transaction costs,
or the perception of increased legal liability, or
hinder the access of researchers to genomic ma-
terials and to databases of genomic sequence in-
formation;
(H) whether Federal innovation policies af-
fect the choice of area of research conducted by
researchers or institutions or provide positive
benefits to such research, including additional
funding from private sector partners; and
(I) the range of incentives providing moti-
vation for genetics research and technology de-
velopment other than intellectual property pro-
tection.
SEC. 4. REPORT.
The Director of the Office of Science and Technology
Policy shall, within 270 days after the date of the enact-
ment of this Act, transmit a report to Congress that—
(1) contains the findings of the study conducted
under section 3; and
(2) makes recommendations for policies, includ-
ing legislative changes, needed to optimize the
genomic technology innovation pipeline.
SEC. 5. COORDINATED POLICY.
After the report is transmitted to Congress under sec-
tion 4, the Director of the Office of Science and Tech-
nology Policy shall incorporate the policy recommenda-
tions into a coordinated interagency policy to promote in-
novation in genomic science and technology, including the
sound use of intellectual property policy.
SEC. 6. DEFINITIONS.
For the purposes of this Act—
(1) the term ‘‘genomic materials’’ means any
material containing a human or human pathogen
polynucleotide sequence other than genetic probes
and markers and transgenic organisms;
(2) the term ‘‘genomic technology’’ means any
genetic diagnostic methods or kits, tools, probes, or
markers, and any pharmaceutical or therapy that
uses or incorporates genomic materials; and
(3) the term ‘‘innovation policy’’ includes intel-
lectual property protection and policies.
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