[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4705 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 4705

To provide for the recoupment of a portion of the Federal investment in 
    research and development supporting the production and sale of 
             pharmaceutical, biologic, or genetic products.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 21, 2000

Mr. Capuano (for himself and Mr. Stark) introduced the following bill; 
which was referred to the Committee on Commerce, and in addition to the 
     Committees on Science, and Ways and Means, 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 provide for the recoupment of a portion of the Federal investment in 
    research and development supporting the production and sale of 
             pharmaceutical, biologic, or genetic products.

    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 ``Public Investment Recovery Act of 
2000''.

SEC. 2. RECOUPMENT REQUIREMENT.

    Each transaction entered into by an agency of the Federal 
Government under which Federal support is provided for research and 
development which leads or may lead to the production and sale of a 
pharmaceutical, biologic, or genetic product shall include provisions 
requiring that payments described in section 4 shall be paid annually 
to the Federal agency for deposit in the Public Investment Recovery 
Trust Fund established under section 6.

SEC. 3. PUBLIC INVESTMENT RECOVERY BOARD.

    (a) Establishment.--There shall be established a Public Investment 
Recovery Board, consisting of--
            (1) a chairperson, who shall be an employee of the National 
        Science Foundation appointed by the Director of the National 
        Science Foundation;
            (2) a representative of the Internal Revenue Service;
            (3) a representative of the Food and Drug Administration;
            (4) a representative of the Department of the Treasury;
            (5) a representative of the National Institutes of Health;
            (6) a representative of the Office of Science and 
        Technology Policy; and
            (7) 3 nonvoting members appointed under subsection (b)(1).
    (b) Nonvoting Members.--
            (1) Appointment.--The President shall appoint 3 nonvoting 
        members to the Board from among appropriate nonprofit 
        scientific and medical societies, such as the American 
        Association of Medical Colleges, the American Pharmaceutical 
        Association, and the Biotechnology Industry Organization. The 
        President shall seek to ensure broad representation of 
        appropriate points of view in making appointments under this 
        paragraph.
            (2) Terms.--Members appointed under paragraph (1) shall 
        serve 3-year terms, except that of the initial appointments 1 
        member shall be appointed to a 1-year term and 1 member shall 
        be appointed to a 2-year term.
            (3) Compensation.--Members appointed under this subsection 
        shall receive no compensation for service on the Board.
    (c) Functions.--The Board shall--
            (1) determine, for purposes of section 4(a), the total 
        amount of profits that have been received with respect to a 
        pharmaceutical, biologic, or genetic product, including profits 
        received by a person not a party to the transaction with the 
        Federal agency; and
            (2) make calculations under section 5 of the proportion of 
        Federal support for research and development which lead to the 
        production and sale of a pharmaceutical, biologic, or genetic 
        product.
    (d) Administrative Support.--The National Science Foundation shall 
provide necessary administrative support for the Board and its staff.

SEC. 4. AMOUNT OF PAYMENT REQUIRED.

    (a) General Rule.--Except as provided in subsection (b), the amount 
that shall be required to be paid under section 2 to a Federal agency 
shall be equal to the total amount of profits determined by the Board 
under section 3(c)(1) to have been received with respect to the 
pharmaceutical, biologic, or genetic product up to the time of payment, 
multiplied by the percentage calculated by the Board under section 5.
    (b) Limitation.--No annual payment shall be required under this Act 
that exceeds 20 percent of the profits determined by the Board to have 
been received during the year for which the payment is made.
    (c) Expiration of Requirement.--The requirement to make payments 
under this Act shall expire on the expiration of the initial patent 
issued for the pharmaceutical, biologic, or genetic product.

SEC. 5. CALCULATION OF PERCENTAGE.

    The Board shall calculate, for each pharmaceutical, biologic, or 
genetic product sold for which Federal support was provided through a 
transaction described in section 2, the percentage that Federal support 
represents of the total research and development that supported the 
production and sale of the product.

SEC. 6. PUBLIC INVESTMENT RECOVERY TRUST FUND.

    (a) Establishment.--The Secretary of the Treasury shall establish 
an account in the Treasury to be known as the ``Public Investment 
Recovery Trust Fund'', into which shall be deposited all payments 
received by the Federal Government pursuant to this Act.
    (b) Purposes.--Amounts in the Trust Fund may be used, to the extent 
provided in advance in appropriations Acts, for the following purposes:
            (1) Not more than 2 percent may be used by the Food and 
        Drug Administration or the National Institutes of Health to 
        support research on the comparative efficiency and 
        effectiveness of pharmaceutical, biologic, or genetic products 
        and the reporting thereof.
            (2) Not more than--
                    (A) 20 percent, in each of the first 5 fiscal years 
                after the date of the enactment of this Act; and
                    (B) 3 percent, in subsequent fiscal years,
        may be used to help pay the administrative expenses of carrying 
        out this Act.
            (3) Not more than 20 percent may be used by the National 
        Institutes of Health to support pharmaceutical, biologic, or 
        genetic research and development, unless no Medicare 
        prescription drug benefit has been enacted by the Congress, in 
        which case the remainder of the funds in the Trust Fund may be 
        used for the purpose under this paragraph.
            (4) If a Medicare prescription drug benefit has been 
        enacted by the Congress, the remainder of the funds in the 
        Trust Fund shall be used for financing such prescription drug 
        benefit, except that any amounts available in the Trust Fund in 
        excess of amounts required for financing such prescription drug 
        benefit may be used for the purpose stated in paragraph (3).

SEC. 7. DEFINITIONS.

    In this Act--
            (1) the term ``Board'' means the Public Investment Recovery 
        Board established under section 3;
            (2) the term ``Federal support'' includes direct Federal 
        research and development funding support, the cost of research 
        and development conducted by the Federal Government and used in 
        support of the production and sale of a product, and the 
        relevant proportion of Federal funding support for any 
        nonprofit organization conducting research and development that 
        is used in support of the production and sale of a product; and
            (3) the term ``pharmaceutical, biologic, or genetic 
        product'' has the meaning given the term ``covered outpatient 
        drug'' under section 1927(k)(2) of the Social Security Act (42 
        U.S.C. 1396r-8(k)(2)).
                                 <all>