Leaked TPPA Texts Reveal U.S. Undermining Access To Medicine
Leaked Trans-Pacific FTA Texts
Reveal U.S. Undermining Access to
Medicine
http://www.citizenstrade.org/ctc/blog/2011/10/22/leaked-trans-pacific-fta-texts-reveal-u-s-undermining-access-to-medicine/
Leaked Trans-Pacific Free Trade Agreement Texts Reveal U.S. Pushing Extreme Pharmaceutical Corporation Demands that Would Undermine Consumers’ Access to Affordable Medicine
Obama Administration Positions Roll Back Initial 2007 Reforms Made by Bush Administration on Medicines Patents, Abandon Access to Medicines Commitments
Leaks of U.S. proposals for the Trans-Pacific Free Trade Agreement (FTA) reveal that the Obama administration has reversed reforms designed to enhance access to affordable medicines made during the George W. Bush administration and is instead demanding new rights for pharmaceutical firms to challenge pricing and other drug formulary policies used by many developed countries to keep down prices. The leaked draft text raises multiple concerns, including the following:
EMPOWERING BIG PHARMA TO ATTACK
COST-SAVING DRUG FORMULARIES
This is a new
proposal to empower pharmaceutical firms to attack the
medicine formulary systems that New Zealand, Australia and
other developed countries have used so successfully to
reduce sky-high drug prices. Governments use formularies to
control health costs by listing medicines approved for
government purchase or reimbursement and negotiating with
drug firms to obtain the lowest prices. Using the
Trans-Pacific FTA to undermine Australia’s Pharmaceutical
Benefits Scheme (PBS) and New Zealand’s Pharmaceutical
Management Agency (PHARMAC) is a goal U.S. pharmaceutical
firms. U.S. states and some U.S. national programs also use
formulary systems.
See the leaked U.S. proposal for a TRANSPARENCY CHAPTER – ANNEX ON TRANSPARENCY AND PROCEDURAL FAIRNESS FOR HEALTHCARE TECHNOLOGIES and see civil society groups’ analyses of what it would mean below.
Also see the leaked U.S. proposal for TBT ANNEXES ON MEDICAL DEVICES, PHARMACEUTICAL PRODUCTS AND COSMETIC PRODUCTS.
NEW MONOPOLY PATENT RIGHTS FOR BIG
PHARMA THAT WILL UNDERMINE ACCESS TO
MEDICINE
The leaked texts show that U.S.
officials’ recently-announced medicines “access
window” is window dressing for piling on monopoly
privileges for Big Pharma that will in fact undermine access
to medicine for millions. This U.S. intellectual property
proposal, which rolls back initial reforms made in a trade
pact that the Bush administration signed with Peru only four
years ago, would lengthen pharmaceutical monopolies,
eliminate safeguards against patent abuse, grant additional
exclusive controls over clinical trial data and favor the
giant pharmaceutical companies’ monopoly interests at
every stage.
See the leaked U.S. proposal for the INTELLECTUAL PROPERTY CHAPTER and see civil society groups’ analyses of what it would mean below.
NEW CROSS-CUTTING LIMITS ON REGULATION OF
GOODS AND SERVICES
The leaked draft text of the
regulatory coherence chapter shows an attempt to impose a
structure and set of procedures for domestic decisions on
all forms of regulation in current and prospective
Trans-Pacific FTA countries. It expands on Asian Pacific
Economic Cooperation initiatives led by New Zealand,
Australia and the U.S. that push deregulation and
self-regulation. While some elements of the draft text are
conducive to well-informed and consistent good decision
making, it is inappropriate for a “trade” agreement to
dictate to governments how they should structure their
domestic regulatory agencies and procedures and make
decision on domestic regulatory policy. Despite the
procedural appearance of the proposal, it contains
substantive biases in favor of light-handed regulation — a
model that has proved highly problematic in many countries
and sectors, not least the financial industry. Moreover, the
chapter’s links to regulatory constraint provisions in
other proposed chapters of the agreement would confer undue
corporate influence over national policy and regulatory
decisions.
See the leaked text for the REGULATORY COHERENCE CHAPTER and see civil society groups’ analyses of what it would mean below.
LEAKS SHOW WHY CIVIL SOCIETY
DEMANDS FOR REGULAR ACCESS TO NEGOTIATING TEXTS IS
CRITICAL
The leaks highlight the need for
regular release of Trans-Pacific FTA negotiating texts,
which has been a repeated demand of civil society
organizations in the involved countries. Twenty-two U.S.
labor, consumer, faith, environmental and human rights
organizations — including the Citizens Trade Campaign,
AFL-CIO, Sierra Club, Presbyterian Church (USA) and Public
Citizen — again wrote U.S. Trade Representative Ron Kirk
in October 2011 calling on the U.S. government to implement
the administration’s transparency pledges and release
draft negotiating texts. Past demands have been rebuffed. In
September at the Chicago round of negotiations,
Trans-Pacific FTA negotiators admitted that they had signed
a special pact to keep all documents relating to these trade
talks secret. The U.S. organizations’ letter, as well as
letters from civil society groups in the other involved
countries to their governments can be viewed at http://bit.ly/nmiw4v.
CIVIL SOCIETY’S ANALYSES OF LEAKED U.S. PROPOSALS
Public Citizen’s Memo on Obama
Administration Backtracking from Bush Era Access to Medicine
Commitments
Professor Sean Flynn’s Analysis of
Leaked U.S. Proposal for a Trans-Pacific FTA Pharmaceutical
Chapter
Public Citizen’s Comparative Analysis of
the U.S. Intellectual Property Proposal and Peruvian
Law
Professor Jane Kelsey’s Preliminary
Analysis of the Draft Chapter on Domestic
Coherence
Doctors Without Borders’ Release and Memo
on How the Trans-Pacific FTA Undermines Access to
Medicines
“New leaked texts proposed by the United
States to the Trans-Pacific Free Trade Agreement show that
the Obama administration has again increased demands on
developing countries to trade away access to medicines. The
new leaked proposals on intellectual property roll back even
modest Bush era commitments to safeguard public health in
trade pacts.”
— Peter Maybarduk, Public
Citizen [see full analysis]
“The leaked text
confirms the worst fears of health officials. The Obama
White House is walking back the core concessions on patent
extensions, patent linkage and test data protection that
were negotiated with the Bush White House in May 2007.
Obama is now objectively much worse than Bush on these
issues. It may help the White House raise campaign money
from big drug companies, or help USTR officials find their
next high paying job working as lobbyists for the drug
companies. It is a huge disappointment for us. The texts
cover complex issues, and it is hard to summarize all that
is important. Even as regards to the reference to the WTO
Doha Agreement, the White House tries to sneak in text that
makes it appear as though it is limited to only some
diseases or emergencies. Collectively, the provisions are
designed to strengthen IPR monopolies on drugs, and make it
harder to regulate prices. The consequences of stronger
monopolies and higher prices are less access to
medicine.”
— James Love, Knowledge Ecology
International
“All countries negotiating
the Trans Pacific Partnership agreement should reject the US
proposal regulating pharmaceutical reimbursement programs.
This is an extreme proposal that has no place in a trade
negotiation, particularly one with some of the poorest
countries in the world.”
— Prof. Sean
Flynn, Program on Information Justice and Intellectual
Property, American University Washington College of Law
[see full analysis]
“Despite the
apparent focus on procedures, the [regulatory coherence]
proposal also has substantive biases in favour of
light-handed regulation — a model that has proved highly
problematic in many countries and sectors, not the least the
financial industry.”
— Prof. Jane Kelsey,
School of Law, University of Auckland [see full analysis]
“The leaked
draft intellectual property proposals by the United States
for the Trans-Pacific Free Trade Agreement have confirmed
our fears that the Obama administration is walking away from
previous efforts to ensure that developing countries can
access affordable medicines, setting a dangerous new
standard that will likely be replicated in future trade
agreements with developing nations. The administration is
touting a so-called ‘access window’ as a mechanism to
boost access to medicines. In fact, the administration is
confusing access with affordability. The ‘access window’
is all about getting brand-name drugs to market faster, and
giving their producers longer monopoly rights that prevent
price-lowering competition and keeping medicines out of the
hands of the millions of people who need them. Our doctors
who work across the developing world rely on affordable
generic medicines to trade patients. For example,
competition among generic manufacturers is what brought down
drug prices for HIV/AIDS by 99 percent, from US$10,000 per
person per year to roughly $100 today. Trade agreements of
the type being pushed this week in Peru threaten these types
of crucial gains in access to life-saving
medicines.”
— Judit Rius Sanjuan, Medecins
Sans Frontieres/Doctors Without Borders [see full analysis]
ENDS
[Scoop
copies of documents:
TransPacificTransparency.pdf
TransPacificTBTwMedicalAnnexes.pdf
TransPacificIP1.pdf
TransPacificRegulatoryCoherence.pdf]