E-drug: HR 1885, USA parallel import Bill
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[copied from PHARM-POLICY with thanks]
Text of HR 1885, a bill in US Congress to authorize
parallel imports of pharmacuetical drugs
This is a copy of a new bill in the US Congress that would authorize
parallel imports of pharmacuetical drugs. It is interesting to note
that the legislation would authorize parallel imports of pharmacuetical
drugs simply by eliminating regulatory barriers. According to the
drafting experts in the US Congress, it is not necessary to change
US laws on patents, trademarks or copyrights to accomplish this.
In other words, the US has sufficient international exhaustion of
patents and trademarks already, and the copyright exhaustion issue
is not relevant.
Also, the bill is bipartisan, and appears to be gaining more traction
in the House, as the simple message, "should American consumers
be permited to buy drugs at the lowest world prices?" has some
obvious voter appeal.
The legislation also contrasts with the intense efforts of US
Vice President Gore and US trade officials to prevent foreign
governments in South Africa, Equator, Thailand, New Zealand,
Australia and elsewhere from authorizing parallel imports, based
upon controversial assertions by US trade officials that parallel
imports violate intellectual property rights and/or trade
agreements. It also raises the question: if the US Congress can
vote on this legislation, why can't the parliaments in South Africa
and other countries choose to enact similar measures?
Jamie Love <love@cptech.org>
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For more info on this bill, contact
Tate Heuer <tate.heuer@mail.house.gov>
or
Danielle LeClair <danielle.leclair@mail.house.gov>
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HR 1885 IH
106th CONGRESS
1st Session
H. R. 1885
To amend the Federal Food, Drug, and Cosmetic Act to provide for
facilitating the importation into the United States of certain drugs
that have been approved by the Food and Drug Administration.
IN THE HOUSE OF REPRESENTATIVES
May 20, 1999
Mr. BERRY (for himself, Mr. SANDERS, Mrs. EMERSON, Mr. ROHRABACHER, Mr.
ABERCROMBIE, and Mr. LEWIS of Georgia) introduced the
following bill; which was referred to the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for
facilitating the importation into the United States of certain drugs
that have been approved by the Food and Drug Administration.
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 `International Prescription Drug
Parity Act'.
SEC. 2. FACILITATION OF IMPORTATION OF DRUGS APPROVED BY FOOD AND DRUG
ADMINISTRATION.
(a) IN GENERAL- Section 801(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(d)) is amended--
(1) by redesignating paragraphs (3) and (4) as paragraphs (4)
and (5), respectively; and
(2) by striking `(d)(1)' and all that follows through the end
of paragraph (2) and inserting the following:
`(d)(1) If a covered drug (as defined in paragraph (3)) is
domestically approved and is manufactured in a State and then exported,
or is domestically approved and is for commercial distribution
manufactured in a foreign establishment registered under section 510,
the manufacturer shall, as a condition of maintaining the domestic
approval of the drug, comply with the following:
`(A) For each shipment of the drug that is manufactured in
compliance with current good manufacturing practice and other standards
under section 501, the manufacturer shall maintain a record that
identifies the shipment and states the fact of such compliance, without
regard to whether the shipment is intended for importation into the
United States.
`(B) For each such shipment, the manufacturer shall maintain a
record that identifies the shipment and provides the labeling required
for the drug pursuant to section 501 and pursuant to the application
for domestic approval, without regard to whether the shipment is
intended for importation into the United States.
`(C) Upon the request of a person who intends to import into
the United States drugs from such shipment (and who meets applicable
legal requirements to be an importer of covered drugs), the
manufacturer shall provide to the person a copy of each of the records
maintained under subparagraphs (A) and (B) with respect to the
shipment.
`(2) For the purpose of facilitating the importation into the
United States of covered drugs, the Secretary shall by regulation
establish the following criteria:
`(A) Criteria regarding the records required in paragraph (1)
and the use of the records to demonstrate the domestic approval of the
drugs and compliance of the drugs with sections 501 and 502.
`(B) Such criteria regarding the labeling of the drugs as the
Secretary determines to be appropriate.
`(C) Criteria regarding the amount of charges that may be
imposed by manufacturers of the drugs for maintaining and providing the
records specified in subparagraph (A).
`(3) For purposes of this subsection:
`(A) The term `covered drug' means a drug that is described in
section 503(b) or is composed wholly or partly of insulin.
`(B) The term `domestically approved', with respect to a drug,
means a drug for which an application is approved under section 505, or
as applicable, under section 351 of the Public Health Service Act.
The term `domestic approval', with respect to a drug, means approval of
an application for a drug under such a section.'.
(b) CONFORMING AMENDMENT- Section 801(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(d)) is amended in paragraph (5)
(as redesignated by subsection (a)(1) of this section) by striking
`paragraph (3)' each place such term appears and inserting `paragraph
(4)'.
END
--
James Love, Director, Consumer Project on Technology
I can be reached at love@cptech.org, by telephone 202.387.8030,
by fax at 202.234.5176. CPT web page is http://www.cptech.org
--
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