[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 626 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 626

    To require persons who undertake federally funded research and 
 development of drugs to enter into reasonable pricing agreements with 
  the Secretary of Health and Human Services, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 8, 1999

 Mr. Sanders (for himself, Mr. DeFazio, Mr. Rohrabacher, Mr. Campbell, 
Mr. Allen, Mr. Nadler, Mr. Berry, Mrs. Thurman, Mrs. Jones of Ohio, Mr. 
 Stark, Mr. Olver, Mr. Boucher, Mr. Kucinich, Mr. Luther, Mr. Waxman, 
 Ms. Schakowsky, and Ms. Ros-Lehtinen) introduced the following bill; 
            which was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
    To require persons who undertake federally funded research and 
 development of drugs to enter into reasonable pricing agreements with 
  the Secretary of Health and Human Services, 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 ``Health Care Research and Development 
and Taxpayer Protection Act''.

SEC. 2. REASONABLE PRICE AGREEMENT.

    (a) In General.--If any Federal agency or any non-profit entity 
undertakes federally funded health care research and development and is 
to convey or provide a patent or other exclusive right to use such 
research and development for a drug or other health care technology, 
such agency or entity shall not make such conveyance or provide such 
patent or other right until the person who will receive such conveyance 
or patent or other right first agrees to a reasonable pricing agreement 
with the Secretary of Health and Human Services or the Secretary makes 
a determination that the public interest is served by a waiver of the 
reasonable pricing agreement provided in accordance with subsection 
(c).
    (b) Consideration of Competitive Bidding.--In cases where the 
Federal Government conveys or licenses exclusive rights to federally 
funded research under subsection (a), consideration shall be given to 
mechanisms for determining reasonable prices which are based upon a 
competitive bidding process. When appropriate, the mechanisms should be 
considered where--
            (1) qualified bidders compete on the basis of the lowest 
        prices that will be charged to consumers;
            (2) qualified bidders compete on the basis of the least 
        sales revenues before prices are adjusted in accordance with a 
        cost based reasonable pricing formula;
            (3) qualified bidders compete on the basis of the least 
        period of time before prices are adjusted in accordance with a 
        cost based reasonable pricing formula;
            (4) qualified bidders compete on the basis of the shortest 
        period of exclusivity; or
            (5) qualified bidders compete under other competitive 
        bidding systems.
Such competitive bidding process may incorporate requirements for 
minimum levels of expenditures on research, marketing, maximum price, 
or other factors.
    (c) Waiver.--No waiver shall take effect under subsection (a) 
before the public is given notice of the proposed waiver and provided a 
reasonable opportunity to comment on the proposed waiver. A decision to 
grant a waiver shall set out the Secretary's finding that such a waiver 
is in the public interest.
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