[Ip-health] Statement of Sean Flynn on USTR Release of White Paper on "Trans Pacific PartnershipTrade Goals to Enhance Access to Medicines"

Michael Palmedo mpalmedo at wcl.american.edu
Mon Sep 12 13:46:55 PDT 2011



Statement of Sean Flynn on USTR Release of White Paper on "Trans Pacific
PartnershipTrade Goals to Enhance Access to Medicines"

September 12, 2011

The statement of the administration today continues its practice of
actively thwarting the release of meaningful information about its
positions in closed door international law making.  The statement says
little about what the administration's actual trade policy on medicines
issues is or what justifies it.

*	It does not explain any of the positions it has taken in the
leaked intellectual property proposal;
*	It does not explain what its position is in the bracketed text
on data exclusivity, patent term extensions or patent-pharmaceutical
*	It  does not answer whether it has abandoned the May 10th
agreement between the Bush administration and Congress safeguarding some
TRIPS flexibilities in developing countries;
*	It does not include any evidence supporting how its policy
positions promote access to medicines.

Thanks to leaked proposals, we know what the administration's actual
position is. This administration has endorsed a set of policy proposals
in its trade negotiations with developing countries that is much worse
for access to medicine concerns than those of any other past

The administration is proposing to:

*	Grant patent rights on substances that are already discovered,
*	Increase in-transit seizures on medicines,
*	Extend monopoly rights through data protection that operate
independent of patent rights,
*	Get rid of the so-called "May 10th" deal between the Bush
Administration and Congress protecting key access to medicines
flexibilities in developing countries,
*	Add a first ever restriction on the operation of pharmaceutical
reimbursement programs as a cost saving mechanism in developing

Calling this an "access to medicine" policy is Orwellian.

As described in the table below, assuming that the administration has
not changed its actual policy positions promoting many of its previously
leaked positions, the statement made today is incredibly vague and some
parts are potentially deceitful.

Access to medicine is not the only public interest concern in the US
intellectual property proposal. The proposal also includes controversial
internet regulations, including graduated response disconnections from
the internet and criminalization of non-commercial file-sharing.

The administration's statement is another glaring example of its
inability to live within the standards it proposes for others. The US
TPP standards demand that policy changes affecting the pharmaceutical
industry be clear and published and follow a public process including
notice and solicitation of comment followed by written reasons
explaining any comments not adopted. Today's announcement followed none
of these procedures.

Comparison of White Paper Statements and Leaked Intellectual Property
and Pharmaceutical Proposals



"Promote the availability of life-saving and life-enhancing medicines in

markets and simultaneously establish a pathway for generics to enter
those markets as quickly as possible by conditioning obligations to
apply certain pharmaceutical-specific intellectual property protections
on the requirement that innovators bring medicines to TPP markets within
an agreed window of time."


This appears to be a veiled reference to the idea that the US may be
proposing to extend part of the May 10th flexibility on data exclusivity
to all countries. The May 10th agreement made data exclusivity in the
FTA countries run concurrently with that in the US. If this is all being
signaled here, it gives nothing to developing countries beyond May 10th,
and likely takes away other flexibilities like permissive linkage
requirements and the freedom to compulsory license data. 

The concept of triggers for IP protection is not new and may be useful.
For example, many countries have "working" requirements for patents,
requiring that demand in the country be met on "reasonable terms." It
would be good for developing countries to adopt working requirements for
the exercise of all intellectual property rights, particularly for

The restriction of the US proposal to  "pharmaceutical-specific
intellectual property protections" raises interesting issues about
whether the proposal violates the TRIPS agreement bans on discrimination
by field of technology.

"Minimize import barriers, such as discriminatory, burdensome, and
unpredictable customs procedures, that impede access to innovative and
generic medicines." 

"Make customs and criminal enforcement measures available to prevent
medicines bearing counterfeit trademarks from entering TPP markets, and
thus support efforts of TPP countries to address the serious risks to
patients posed by such counterfeits."

The statements claiming that the US is proposing the reduction of trade
barriers for medicines is at odds with the text of its leaked proposal.
The leaked proposal proposes more barriers to the free flow of generics.
For example, the leaked proposal included: 

-promotion of in-transit seizures for suspected "confusingly similar"

-expanded criminalization  and increased warrantless seizures for
non-counterfeiting trademark infringement, including "confusingly
similar" labeling.

"Promote transparency and procedural fairness: To ensure the fairest
possible opportunity for both generic and innovative medicines to enter
TPP markets, require respect for basic norms of transparency and
procedural fairness in the operation of national government healthcare
reimbursement programs."

This section describes the US intent to export restrictions on
pharmaceutical reimbursement programs abroad that US drug reimbursement
programs do not presently comply with. It has been opposed by the
Governors of Maine and Vermont and a large number of state legislators.
The provision would be the first US proposed FTA to contain restrictions
on pharmaceutical pricing programs in developing countries. It is ironic
to call this an "access to medicines" proposal.

"Reaffirm TPP Parties' commitment to the Doha Declaration on TRIPS and
Public Health: Incorporate important understandings on the availability
of public health measures, based on the Doha Declaration on the TRIPS
Agreement and Public Health."

The administration's statement on the Doha Declaration is incredibly
vague. In the Bush administration, the Doha Declaration on TRIPS and
Public Health was interpreted as consistent with US policy promoting
restrictions on TRIPS flexibilities in developing countries. That
administration argued that every expansion of intellectual property
promoted access to medicines by raising incentives to innovate. No
serious academic backs this position and the administration has
presented no evidence to back its claims. The US government has never
repeated its affirmation of the core of the Doha Declaration - that
developing countries be able to exercise all TRIPS flexibilities "to the
full." Real commitment to that idea is inconsistent with the US
proposals in TPP.

"USTR will convene a TEAM Task Force composed of experts throughout the
government to consider innovative trade policy approaches to promoting
access to medicines. Through the TEAM Task Force and direct
agency-to-agency discussions, USTR will continue to consult regularly
with experts from USAID, PEPFAR and other components of the Global
Health Initiative, and all other Federal departments and agencies with
relevant expertise. The Task Force will report to the interagency Trade
Policy Staff Committee."

What is left very unclear is whether this is a change that will promote
greater public interest participation in policy making. Will the task
force operate in the public? Will its meetings be public? Will they
operate consistent with open government and open meeting laws? If not,
why not?

"Reflecting the principles underlying the TEAM initiative, the U.S.
Government will continue to seek out new ideas from all sources,
including from the public at large"

The whole public was not consulted for the introduction of this
proposal. It comes as a surprise to most access to medicines advocates
in the US.





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