Transcript here - American University Washington College of Law

International Trade
and Medicine Prices
Mike Palmedo
Research Coordinator
Project on Information Justice and Intellectual Property
Washington College of Law, American University
November 30, 2006
Hartford, CT
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Federal Food, Drugs and Cosmetics Act
21 USC 381 (d)(1)
(d) Reimportation
(1) Except as provided in paragraph (2), no drug
subject to section 353(b) of this title or composed
wholly or partly of insulin which is manufactured in a
State and exported may be imported into the United
States unless the drug is imported by the manufacturer
of the drug.
(2) The Secretary may authorize the importation of a
drug the importation of which is prohibited by
paragraph (1) if the drug is required for emergency
medical care.
WTO Agreement on Trade Related
Aspects of Intellectual Property Rights
Article 6
Exhaustion
For the purposes of dispute settlement under this
Agreement, subject to the provisions of Articles 3 and 4
nothing in this Agreement shall be used to address the
issue of the exhaustion of intellectual property rights.
U.S.-Australia Free Trade Agreement
Article 17.9
4. Each Party shall provide that the exclusive right of the
patent owner to prevent importation of a patented
product, or a product that results from a patented
process, without the consent of the patent owner shall
not be limited by the sale or distribution of that product
outside its territory, at least where the patentee has
placed restrictions on importation by contract or other
means.
U.S-Morocco Free Trade Agreement
Article 15.9
4.
Each Party shall provide that the exclusive right of the
patent owner to prevent importation of a patented
product, or a product that results from patented
process, without the consent of the patent owner shall
not be limited by the sale or distribution of that product
outside its territory.10
10
A Party may limit application of this paragraph to cases
where the patent owner has placed restrictions on
importation by contract or other means.
Northup Appropriations Amendment
... None of the funds made
available in this Act may be
used to include in any
bilateral or multilateral trade
agreement the text of
(1) paragraph 2 of Article 16.7 of
the United States-Singapore
Free Trade Agreement;
(2) paragraph 4 of Article 17.9 of
the United States-Australia
Free Trade Agreement; or
(3) paragraph 4 of Article 15.9 of
the United States-Morocco
Free Trade Agreement.
Free Trade Agreements
May Threaten Preferred
Drug Lists
Annex 2(c) of U.S-Australia FTA
1. AGREED PRINCIPLES
The Parties are committed to facilitating high quality health
care and continued improvements in public health for their
nationals. In pursuing these objectives, the Parties are
committed to the following principles:
(c) the need to promote timely and affordable access to
innovative pharmaceuticals through transparent,
expeditious, and accountable procedures, without
impeding a Party’s ability to apply appropriate
standards of quality, safety, and efficacy;
PhRMA Continues to Attack Australian
Pharmaceutical Benefits Scheme
“Government-imposed price and market access
controls serve as a barrier to trade ... Moreover, those
controls deny American firms and workers the ability to
compete on fair and equitable terms in foreign markets
and undercut the value of intellectual property rights.
…It is critical, therefore, that USTR… address the trade
distorting aspects of these foreign government price
controls.”
-Jan, 2006 PhRMA Submission to
USTR for Annual 301 Report
Democratic Representatives “Deeply
Concerned” with Annex 2(c)
First, we are deeply concerned about the
proposal’s implications for the United
States... Individuals potentially affected
by the proposal include the elderly who
receive Medicare, working people on
Medicaid, veterans who receive health
benefits through the Veterans
Administration, and active military men
and women who participate in the
Department of defense TRICARE
program, as well as other people who
participate in programs administered by
the Indian Health Service, the Public
Health Service, and a myriad of state
and local governments throughout the
United States.
U.S-Korea FTA and
Preferred Drug
Lists
GDP Per Capita, A7 v. Korea
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50,000
45,000
40,000
35,000
30,000
25,000
20,000
15,000
10,000
5,000
0
U.S. Threatens Trade Dispute
“…we are concerned about the discriminatory effect
the proposed changes to the pharmaceutical pricing
system would have upon our products. If not
addressed appropriately, this issue is likely to develop
into a serious trade dispute.”
- Commerce Secretary Don Evans
Letter to Korean Health Minister
2001
Planned Korean Reforms to National
Health Insurance
Current Reimbursement:
Negative List
National Health Insurance
reimburses all drugs
purchased by Koreans,
unless the drug has been
placed on a list of drugs
that will not be
reimbursed.
Proposed Reform
Positive List
In order for a new drug
to be reimbursed by the
National Health
Insurance, it must be
placed on a list of costeffective drugs that are
covered.
USTR Strongly Opposes Korean Switch
to Positive Reimbursement List
“…the decision to proceed with this plan is inconsistent
with both the mandate of the pharmaceuticals working
group and the market opening spirit of the KORUS
FTA…
…The positive list system as explained to our
delegation by the Ministry of Health would discriminate
against innovative drugs which are the types of drugs
that are mainly supplied by U.S. and other foreign
companies.”
-Assistant US Trade Representative Wendy Cutler
Chief US Negotiator for the US-Korea FTA
Data Exclusivity
Provisions in FTAs
WTO Agreement on Trade Related
Aspects of Intellectual Property Rights
Section 7: Protection of Undisclosed Information
Article 39
3. Members, when requiring, as a condition of approving
the marketing of pharmaceutical or of agricultural chemical
products which utilize new chemical entities, the submission
of undisclosed test or other data, the origination of which
involves a considerable effort, shall protect such data
against unfair commercial use. In addition, Members shall
protect such data against disclosure, except where
necessary to protect the public, or unless steps are taken to
ensure that the data are protected against unfair
commercial use.
“US+” Data Exclusivity in FTAs
US Law:
Three years of extra
additional data
exclusivity granted
for “new condition of
use” for existing
product when new
use is tested.
FTAs:
Three years of extra
additional data
exclusivity granted for
“same or similar
products” when new
use is tested.
The 110th Congress
Expiration of theTrade
Promotion Act of 2002
Trade Promotion Authority Will Probably
Not Pass House; Better Odds in Senate
“As a practical matter,
whatever law reauthorizes
fast-track authority ... will
have to strengthen labor and
environmental provisions in
some way to win broader
Democratic support.“
- Sen. Max Baucus
Next Senate Finance
Committee Chairman
Trade Promotion Act
Legislates Negotiating
Objectives for U.S.
Trade Negotiators
High Medicine Prices Can Be Deadly in
Middle- and Low-Income Countries
Per Capita GDP of Nations Negotiating
FTAs with the United States ($US)
Korea
16,309
Malaysia
5,134
Thailand
2,749
Colombia
2,804
Peru
2,628
South Africa
5,314
Lesotho
5,298
Namibia
3,016
Botswana
2,414
Swaziland
809
Doha Declaration on the TRIPS
Agreement and Public Health
4. We agree that the TRIPS Agreement does not
and should not prevent members from taking
measures to protect public health. Accordingly,
while reiterating our commitment to the TRIPS
Agreement, we affirm that the Agreement can
and should be interpreted and implemented in
a manner supportive of WTO members' right to
protect public health and, in particular, to
promote access to medicines for all.
Trade Promotion Act of 2002
SEC 2102, (B)...
(4) INTELLECTUAL PROPERTY
The principal negotiating objectives of the United
States regarding trade-related intellectual property are
…(C) to respect the Declaration on the TRIPS
Agreement and Public Health, adopted by the World
Trade Organization at the Fourth Ministerial
Conference at Doha, Qatar on November 14, 2001.
Bush Administration Has Failed to
Follow the Negotiating Objective So Far
“
…here in Congress, we have to do a better job of
insisting that our trade agreements comply with the
letter and the spirit of the Doha Declaration. It's the law
of the land, and it's a matter of life and death for
hundreds of millions of people in other lands.”
- Sen. Edward Kennedy
February 16, 2005
Henry Waxman (D-CA)
 Next Chairman of House
Committee on Government
Reform
 Seeks investigation into
anti-Health provisions in
trade agreements
 Expert on generic markets:
The Hatch-Waxman Act
largely responsible for U.S.
generics industry.
Charles Rangel (D-NY)
 Next Chairman of the
House Committee on Ways
and Means
 Wants to reopen closed
FTA negotiations to protect
labor rights
 Has opposed anti-Health
measures in previous FTAs
Anti-Health Provisions in FTAs Identified
by Congressional Democrats
 Restrictions on reimportation
 Expanding patent coverage to new uses of
existing products
 Expanding patent coverage to include
diagnostics and therapeutics
 At least 5 years of market exclusivity,
regardless of patent coverage
 Linkage between regulatory agencies and
patent
Pro-Health Provisions Missing from FTAs
Identified by Congressional Democrats
 “Bolar” provisions that allow for quick market
entry of generics upon patent expiration
 Requirements that patent holders disclose the
“best mode” for reproducing an invention
 Caps for patent extensions required in cases of
delays of patent issuance or marketing
approval
www.forumdemocracy.net
wcl.american.edu/pijip
Mike Palmedo
American University, Washington College of Law
Project on Information Justice and Intellectual Property
[email protected]
202-274-4442