Better to Best: Thoughts on Global Health Care Systems

AMSA Response to USTR Proposal for Trans-Pacific Partnership Agreement

Posted in Health Rights, PharmFree by reshmagar on September 14, 2011

On Tuesday, the US Trade Representative Office released a white paper with a proposal towards the Trans-Pacific Partnership Agreement. Document is attached below:

White Paper

Highlights and summary:

As part of this initiative, the Office of the United States Trade Representative (USTR) has
presented a variety of trade proposals to TPP partners that are aimed at promoting access to
medicines in TPP partner markets. These proposals are the product of a new strategic initiative,
Trade Enhancing Access to Medicines (TEAM), which is designed to deploy the tools of trade
policy to promote trade in, and reduce obstacles to, access to both innovative and generic
medicines, while supporting the innovation and intellectual property protection that is vital to
developing new medicines and achieving other medical breakthroughs.

The TEAM initiative reflects fresh thinking about trade and access to medicines. It is about
more than allowing access to medicines. It is about working with trading partners to develop
strong and common standards to help drive access – propelling the TPP countries to the front of
the line for important innovative medicines and for generic competition, while promoting U.S.
jobs and exports.

The paper goes on to list a set of goals the United States along with the countries under the TPP would address. Great goals, but not really a clear sense of how the goals would be achieved.

Knowledge Ecology International commented:
One has to read between the lines, and guess what the White House is trying to say (or avoid saying plainly). It appears as though USTR will demand TPPA partners agree to several years of exclusive rights in regulatory test data for new medicines, including biologic drugs. What we don’t know is how many years, when the clock starts to run, or how iron clad the protection is expected to be.

The Wall Street Journal published an article about this as well with an excellent comment from Peter Maybarduk, Public Citizen (+1.202 588 7755, +1. 202 390 5375,
It is insulting that USTR has released this paper on ‘access to medicines’ on the same day that it has tabled its most controversial and access-restricting provisions at the Trans-Pacific FTA negotiations — and then failed entirely to address those provisions, or the other access-restricting elements of its aggressive intellectual property proposal, in this paper. The Obama administration is heading rapidly in the wrong direction, at the expense of global public health. This paper is primarily window dressing for USTR’s pro-Big Pharma, anti-access to medicines status quo.

Another set of comments I quite enjoyed:

Sean Flynn, American University
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 linkage;
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 administration.
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 countries.
Calling this an “access to medicine” policy is Orwellian.

AMSA also released a response as well:

The American Medical Students Association (AMSA) appreciates the opportunity to offer comments on the proposed Trans Pacific Partnership Agreement (TPPA). As the nation’s oldest and largest independent organization for physicians-in-training representing more than 35,000 members, AMSA supports global health equity through international agreements that secure patients’ rights to life-saving medications in resource-poor settings and encourage investment in public health as outlined in the Doha Declaration.

AMSA strongly urges a revision of the proposed TPPA to ensure access to essential, affordable medicines for patients living in TPPA negotiating nations including the United States. It is critical countries be permitted to engage in parallel importation to ensure citizens’ access to inexpensive medications. Therefore, we recommend that the TPPA refrain from granting copyright holders the right to prohibit importation of their works. Consistent with President Obama’s 2012 budget proposal request, AMSA strongly urges that the term for data protection be limited to 7 years for biologic products. Similarly, pharmaceutical companies should not be eligible for new 20-year patents based on minor modifications to existing products that do not meaningfully benefit patients. Such provisions would allow for timely access to generic medications for suffering patients that could save lives.

When will governments and even pharmaceutical companies realize that their responsibilities should be for their constituents/clients rather than profits?

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