Preserving Access to Safe Affordable Canadian Medicines Act of 2003

Preserving Access to Safe, Affordable Canadian Medicines Act of 2003 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations prohibiting discrimination against imports of prescription medications from Canada. Defines discrimination as any measure which has the effect of providing U.S. consumers access to prescription medications on terms or conditions that are less favorable than the terms or conditions provided to any foreign purchaser of such products, or which otherwise restricts or reduces access by United States consumers to a prescription medication from Canadian pharmacies. Imposes a civil penalty against manufacturers who violate this Act.

[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 847 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 847

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
             importation of prescription drugs from Canada.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 13, 2003

   Mr. Sanders (for himself, Mr. Burton of Indiana, Ms. DeLauro, Mr. 
    Crowley, Mrs. Emerson, Mr. Berry, Ms. Kaptur, Mr. McGovern, Mr. 
DeFazio, Mr. Tierney, Mr. Doggett, Mr. Stark, Ms. Woolsey, Ms. Lee, Mr. 
 Olver, Ms. Solis, Mr. Evans, Mr. Owens, Mr. Serrano, Mr. Abercrombie, 
  Mr. Nadler, Ms. Corrine Brown of Florida, Mr. Sabo, Mr. Jackson of 
 Illinois, Ms. Velazquez, Mr. Capuano, Mr. Hinchey, Mr. Kucinich, Mr. 
Meehan, Mr. Levin, Mr. Pallone, Mr. Brown of Ohio, Ms. Baldwin, and Mr. 
   Filner) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
             importation of prescription drugs from Canada.

    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 ``Preserving Access to Safe, 
Affordable Canadian Medicines Act of 2003''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Prescription drug manufacturers charge substantially 
        more for their products in the United States than in Canada.
            (2) Many Americans cannot afford the higher U.S. prices and 
        are forced to either go without their needed medications or 
        sacrifice other necessities of life in order to afford them.
            (3) Increasingly, Americans have turned to the Canadian 
        market to purchase their needed medications at substantially 
        lower prices and the Food and Drug Administration now estimates 
        that two million parcels containing prescription drugs enter 
        the U.S. for personal use each year.
            (4) The Congressional Research Service has confirmed that 
        Canada has a drug approval and distribution system comparable 
        to that of the United States.
            (5) Drug manufacturers are trying to cut off the supply of 
        prescription drugs accessed by U.S. consumers on the Canadian 
        market in blatant disregard of the health consequences for 
        Americans.

SEC. 3. NONDISCRIMINATION AGAINST IMPORTS OF PRESCRIPTION DRUGS.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.) is amended--
            (1) in section 801(d)(1), by striking ``section 804,'' and 
        inserting ``sections 804 and 805,''; and
            (2) by adding at the end the following:

          ``prohibition against discrimination against imports

    ``Sec. 805. (a) Regulations.--The Secretary, after consultation 
with the United States Trade Representative and the Commissioner of 
Customs, shall promulgate regulations prohibiting manufacturers of 
prescription medications from taking actions that discriminate against, 
or cause other persons to discriminate against, United States consumers 
regarding the purchase of prescription medications from Canadian 
pharmacies.
    ``(b) Nondiscrimination.--No manufacturer of a prescription 
medication may take actions that discriminate against, or cause other 
persons to discriminate against, United States consumers regarding the 
purchase of a prescription medication from Canadian pharmacies.
    ``(c) Definition.--For purposes of this section, the term 
`discrimination' means a contract provision, a limitation on supply, or 
other measure which has the effect of providing U.S. consumers access 
to prescription medications on terms or conditions that are less 
favorable than the terms or conditions provided to any foreign 
purchaser of such products, or otherwise has the effect of restricting 
or reducing access by United States consumers to a prescription 
medication from Canadian pharmacies.''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(hh) Discrimination by a manufacturer in violation of section 
805.''.
    (c) Civil Penalties.--Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the 
following subsection:
    ``(h)(1) Any manufacturer of a prescription medication that 
knowingly violates section 805(b) shall be liable to the United States 
for a civil penalty in an amount not to exceed $1,000,000.
    ``(2) Paragraphs (3) through (5) of subsection (g) apply with 
respect to a civil penalty under paragraph (1) of this subsection to 
the same extent and in the same manner as such paragraphs (3) through 
(5) apply with respect to a civil penalty under paragraph (1) or (2) of 
subsection (g).''.
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