[Ip-health] Bernie Sander's 1996 bill on drug R&D, transparency, pricing of drugs benefiting from government subsidized R&D

Jamie Love james.love at keionline.org
Fri Nov 27 10:24:16 PST 2015


In addition to the extensive provisions on transparency and pricing of
drugs, Bernie Sander's 1996 bill had a Section 7, which would allow the
U.S. government to offset any negative impact on R&D from lower drug
prices, by creating and increasing minimum R&D mandates.

Jamie

--------------------------
SEC. 7. PROMOTION OF RESEARCH AND DEVELOPMENT.

    (a) Account.--Any person engaged in the manufacture of drugs for
introduction into interstate commerce shall, in accordance with
subsection (b), establish for each drug an account for funds to be
reinvested in research and development for health care technologies.

    (b) Reinvestment in Research and Development.--To insure that
adequate funds are being made available for research and development of
new health care technologies, the Secretary of Health and Human
Services shall establish for persons engaged in the manufacture of
drugs for introduction into interstate commerce the minimum amount such
person should make available for research and development of its new
health care technologies based upon a percentage of sales revenue for
that drug. The Secretary may require different percentages for minimum
reinvestment for different classes of drugs based upon patient
protection, orphan drug status, or magnitude of sales.
-------------------------


https://www.congress.gov/bill/104th-congress/house-bill/4270

[Congressional Bills 104th Congress]
[From the U.S. Government Printing Office]
[H.R. 4270 Introduced in House (IH)]

104th CONGRESS
  2d Session
                                H. R. 4270

To require reporting on research and development expenditures for drugs
            approved for marketing, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 27, 1996

 Mr. Sanders introduced the following bill; which was referred to the
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL

To require reporting on research and development expenditures for drugs
            approved for marketing, 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 Consumer Protection Act''.

SEC. 2. FINDINGS.

    The Congress makes the following findings:
            (1) Public health needs are advanced by the development and
        distribution of new drug therapies
            (2) The public interest in the development of new drug
        therapies is parallel to the public interest in controlling
        public and private health care costs.
            (3) The Federal Government needs mechanisms to ensure that
        portions of revenues from the sale of drugs to consumers are
        reinvested in the research and development of new technologies.
            (4) The Federal Government is the single largest supporter
        of biomedical research in the world, spending $33 billion in
        1994 alone for biomedical and related health research.
            (5) The Federal Government provides 80 percent of the
        monies spent each year for fundamental biomedical research at
        universities, medical schools, and other non-profit
        institutions.
            (6) Of all the cancer drugs developed since the founding of
        the National Cancer Institute's new drug program in 1955 and
        approved for marketing by the Food and Drug Administration
        through 1992, 34 of 37 cancer drugs, or 92 percent, were
        developed with taxpayer funds.
            (7) The public should not have to pay twice for health care
        inventions, first as taxpayers and second as consumers.
            (8) The Department of Health and Human Services has the
        responsibility for funding basic biomedical research, for
        funding medical treatment through the programs under titles
        XVIII and XIX of the Social Security Act, for providing direct
        medical care, and, more generally, for protecting the health
        and safety of the public, it is incumbent upon the Secretary of
        Health and Human Services to require a reasonable relationship
        between the pricing of drugs, the public investment in those
        drugs, and the health and safety needs of the public.
            (9) The Department of Health and Human Services, academic
        researchers, and the general public have the right to know, but
        lack the necessary information about, information about the
        actual costs for drug development, the general revenues
        generated from the sale of pharmaceutical drugs, and the
        taxpayer's investment in new drug development.
            (10) The Department of Health and Human Services lacks the
        necessary information to make appropriate decisions about the
        reasonableness of drug prices or the impact of its policies on
research and development of new medical technologies.

SEC. 3. REPORT ON RESEARCH OF THE FEDERAL GOVERNMENT.

    (a) Involvement of the Federal Government.--For each drug for which
an application under section 505, 507, or 512 of the Federal Food,
Drug, and Cosmetic Act has been approved the following shall be
reported to the Secretary of Health and Human Services:
            (1) Each patent, cooperative research and development
        agreement under section 12 of the Stevenson-Wydler Technology
        Innovation Act of 1980, or other contractual agreement with the
        Federal Government which contributed to the development of the
        drug. The dollar amount of Federal funds expended, the agency
        of the Federal Government which provided such funds, the dates
        of any contractual agreements, and the nature of the research
        and development activity shall be included in the report.
            (2) Each grant, contract, or other funding mechanism of the
        Federal Government which was used to support research or
        development activities with respect to the drug, including any
        grant or contract by the Federal Government to an institution
        of higher education or other non profit institution or other
        funds expended by the Federal Government on research and
        development which directly contributed to the development of
        the drug. The dollar amount of Federal funds expended, the
        agency of the Federal Government which provided such funds, the
        dates of any contractual agreements, and the nature of the
        research and development activity shall be included in the
        report.
The Secretary shall make such report available to the public.
    (b) Research and Development.--
            (1) In general.--For each drug for which an application
        under section 505, 507, or 512 of the Federal Food, Drug, and
        Cosmetic Act has been approved the total amount expended for
        each type of research and development of the drug in each
        calendar year, including pre-clinical research and phase I, II,
        and III clinical trials, the entity which made the
        expenditures, and the amount provided by the Federal Government
        shall be reported to the Secretary of Health and Human
        Services.
            (2) Public Disclosure of Data.--If a drug is protected
        under section 527(a) of the Federal Food, Drug, and Cosmetic
        Act or under a patent, the material reported under paragraph
        (1) for such drug shall be made available by the Secretary to
        the public. If a drug is not protected under such section or a
        patent, the Secretary shall make the report available to the
        public in a form which does not identify individual entities.

SEC. 4. 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 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
(b).
    (b) 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.

SEC. 5. PURCHASE OF DRUGS DEVELOPED WITH TAXPAYER SUPPORT.

    For any drug approved for marketing by the Food and Drug
Administration which was developed with significant Federal support,
the Secretary of Health and Human Services shall review the price of
the drug for purposes of determining a reasonable price for Federal
reimbursements under the programs under titles XVIII and XIX of the
Social Security Act and other Federal programs that elect to
participate in the Secretary's reasonable pricing program, In
determining a reasonable price for a drug, the Secretary shall
consider--
            (1) the public interest in continued health care research
        and development,
            (2) the contribution of the person marketing such drug to
        the drug research and development expenses, including the
        amount, timing, and risk of investment in such research and
        development,
            (3) the contribution of the Federal Government to the
        research and development of such drug, including the amount,
        timing, and risk of investment in such research and
        development,
            (4) the therapeutic value of such drug,
            (5) the number of patients who are expected to purchase
        such drug,
            (6) the cost of producing and marketing of such drug,
            (7) the cost of therapies which are similar to the therapy
        using such drug, and
            (8) other relevant factors.

SEC. 6. MATERIAL TRANSFER AGREEMENT.

    If in connection with research and development for health care
technologies, the Secretary of Health and Human Services determines
that the public interest will be advanced by the ability of the
Secretary to conduct research on biological substances or other
materials, the Secretary shall have the authority to compel the owner
of such substances or materials to provide the Secretary with such
substances or materials in accordance with a materials transfer
agreement. The agreement shall--
            (1) provide the owner of such substances or materials
        compensation for the costs incurred in making the transfer to
        the Secretary;
            (2) define the terms and conditions under which the
        Secretary may use the materials;
            (3) not grant rights in intellectual property or rights for
        commercial purposes; and
            (4) require that the material be used for research purposes
        only.

SEC. 7. PROMOTION OF RESEARCH AND DEVELOPMENT.

    (a) Account.--Any person engaged in the manufacture of drugs for
introduction into interstate commerce shall, in accordance with
subsection (b), establish for each drug an account for funds to be
reinvested in research and development for health care technologies.
    (b) Reinvestment in Research and Development.--To insure that
adequate funds are being made available for research and development of
new health care technologies, the Secretary of Health and Human
Services shall establish for persons engaged in the manufacture of
drugs for introduction into interstate commerce the minimum amount such
person should make available for research and development of its new
health care technologies based upon a percentage of sales revenue for
that drug. The Secretary may require different percentages for minimum
reinvestment for different classes of drugs based upon patient
protection, orphan drug status, or magnitude of sales.
    (c) Additional Rules.--The Secretary shall adopt regulations
concerning qualifying research and development expenditures and the
reporting requirements for persons who are subject to subsections (a)
and (b).

SEC. 8. REPORTS ON SALES.

    Any person engaged in the manufacture and sale of drugs approved
under section 505, 507, or 512 of the Federal Food, Drug, and Cosmetic
Act shall report to the Health Care Financing Administration the total
number of each drug it has sold and the total revenue it has received
from such sales, including sales made outside the United States.

SEC. 9. GOVERNMENT EXPENDITURE ON PRESCRIPTION DRUGS.

    The Secretary of Health and Human Services shall report to the
Congress annually on the estimate of the amount of money the Federal
government expends, directly or through reimbursement, for the purchase
of prescription drugs, including an estimate of the amount of money
expended each year on drugs which were developed with significant
Federal support.

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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