2000 
[DOCID: f:h3966ih.txt]






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 determined 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 Technology Policy 
to conduct a study of the impact of Federal policies on the innovation 
       process for genomic technologies, and for other purposes.

    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 ``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 technologies and other 
        innovations, and it is in the national interest to speed the 
        development and deployment 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 implemented without an adequate 
        understanding and consideration 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 impacts on basic research 
        and the development of genomic technology for decades to come.
            (5) The Office of Science and Technology Policy is uniquely 
        positioned to lead the development of a coordinated, 
        interagency policy to promote innovation in genomic science and 
        technology. A definitive study coordinated by the Office of 
        Science and Technology 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 pipeline, would contribute significantly 
        to the development of the policy.

SEC. 3. STUDY.

    (a) Requirement.--The Director of the Office of Science and 
Technology Policy shall conduct, or may contract with the National 
Academy of Sciences to conduct, a study that assesses the impact of 
Federal policies, including 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 divisions of agencies the 
Director considers appropriate.
    (c) Advisory Committee.--In conducting the study, the Director of 
the Office of Science and Technology Policy shall consult with an 
advisory committee, organized 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, genetic 
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 levels 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 universities, 
                nonprofit research institutions, and for-profit 
                institutions, including the expected effects 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 materials;
                    (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, improvement, 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 licensing, legal and 
                litigation costs, transaction costs, or the perception 
                of increased legal liability, or hinder the access of 
                researchers to genomic materials and to databases of 
                genomic sequence information;
                    (H) whether Federal innovation policies affect 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 motivation 
                for genetics research and technology development other 
                than intellectual property protection.

SEC. 4. REPORT.

    The Director of the Office of Science and Technology Policy shall, 
within 270 days after the date of the enactment 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, including 
        legislative changes, needed to optimize the genomic technology 
        innovation pipeline.

SEC. 5. COORDINATED POLICY.

    After the report is transmitted to Congress under section 4, the 
Director of the Office of Science and Technology Policy shall 
incorporate the policy recommendations into a coordinated interagency 
policy to promote innovation in genomic science and technology, 
including the sound use of i
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ntellectual 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 intellectual 
        property protection and policies.
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