USTR releases new White Paper on Access to Medicine: includes almost no specifics in terms of negotiating positions

USTR has released its new White Paper on Access to Medicine. Here is the press release. A copy of the White Paper is available here:

USTR_11sep2011_TPP_Trade_Goals_Medicines.pdf

The document is very general. No negotiating text is released. At this point, the White Paper is mostly a PR exercise, coming when the White House is blocking mention of the Doha Declaration in the UN high level meeting on non-communicable diseases, abandoning the May 10, 2007 agreement on access to medicines, and presenting very tough new IPR and drug pricing rules for TPPA trading partners -- while demanding total secrecy of the TPPA negotiating text.

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 White also seems to be saying, based on the White Paper as well as other briefings and trade agreements, plus Wikileak cables, that it will press to give drug companies more leverage to litigate or appeal decisions on reimbursements for innovative drugs.

The White House says it will "incorporate important understanding on the availability of public health measures, based on the Doha Declaration on the TRIPS Agreement and Public Health." Earlier this month the White House blocked language about the Doha Declaration in a UN declaration on non-communicable diseases, in order to maintain the fiction that it does not apply to NCDs. Hard to guess what the "understanding" will look like.

The White House notes that the WTO adopted a U.S. proposal to extend the deadline for enforcing patents in Least Developed Countries. It does not mention that the 2016 extension was proposed by President Bush, and that the White House 2011 Special 301 Report expressed opposition to further extensions for LDC countries.

Bureaucratically, the White House announces TEAM, which it describes as follows:

"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."

What do we know about TEAM? Not much at this point. The White Paper says:

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.

KEI will ask USTR for a list of the TEAM members.

Reactions

Peter Maybarduk, Public Citizen (+1.202 588 7755, +1. 202 390 5375, pmaybarduk@citizen.org)

"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.”

Mathew Kavangah, Health Gap (+1 202 355-6343, mob +1 202 486-2488, matthew@healthgap.org)

"USTR is claiming, now, that IP enforcement will somehow ensure access to medicines. Their grand innovation is to propose that those companies most interested in ensuring their IP in countries (i.e. those who register within a period of time) should get mandatory data, patent linkage, and patent term extensions. This is not an access plan, it's a clear subterfuge toward ensuring the Obama administration can continue to carry the water of big pharma. Ensuring the profits of multinational pharmaceutical industry has not proven an effective strategy for getting medicines to people in need, since they are largely unaffordable for both patients and health programs. Obama administration claims that multinational pharmaceuticals are withholding life-saving drugs from patients for in developing countries for periods of time in order to maximize profits should trigger investigations of unethical practices, not efforts to shift policy toward ensuring those profits."

Krista Cox, Knowledge Ecology International (+1.650.787.2200, krista.cox@keionline.org)

"USTR's 'white paper' is basically four pages of spin and PR with little to no substance. It claims to 'enhance access to medicines,' but in reality, the White Paper is more about market access than affordable pricing and access to quality drugs. USTR seems to frame, as an access to medicine strategy, the granting of exclusive rights to rely upon regulatory test data, patent linkage and patent term extensions to innovators who register drugs within a window of time. This is the PhRMA/BIO version of how to promote access, with the White House logo, in a large trade negotiation. This is access for people who can afford to pay monopoly prices for medicine. In developing countries, that is certainly not going to achieve access to medicine for all."

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.

Judit Rius, MSF (+1 917 331 9077, judit.rius@newyork.msf.org)

"The USTR paper on the TPP and access to medicines, released today, is misleading and puts forth the fundamentally flawed premise that speeding up market entrance of brand-name, monopoly-priced drugs will, in itself, solve the challenge of access to affordable medicines,” said Judit Rius Sanjuan, US manager of MSF’s Campaign for Access to Essential Medicines. “At heart, this is an issue of affordability, and USTR simply does not acknowledge that high priced brand-name drugs imposed by monopolies are a principal barrier to access to medicines.”

James Love, KEI (james.love@keionline.org)

The USTR White Paper reads more like a white wash. It repeats a litany of positive things the US government has done, some of them going back ten years, and few relevant to policies the White House tabled in Chicago on September 12. The White Paper could have shed light on the actual positions the USTR presented in the TPPA negotiations. After all, the drug companies lobbying USTR know, and all of the TPPA country negotiators now know. Only the general public is kept in the dark. The Congress needs to reign in the Obama White House campaign for secret negotiations on intellectual property and medicines. Someone in the White House needs to tell Ambassador Kirk that the public, the people who vote for Presidents, have a right to know what our own government's actual positions are, in this negotiation.

This is from a blog by USAID

“A cornerstone of the Obama Administration’s global public health strategy has been to focus aid on strengthening entire health systems in developing countries in order to improve public health, including improved access to medicines,” said Ariel Pablos-Mendez, Assistant Administrator for Global Health, U.S. Agency for International Development. “Today’s announcement by the United States Trade Representative confirms the role of trade policy in the Administration’s broader efforts.”

Tido von Schoen-Angerer, MSF

The leaked papers reveal a number of U.S. objectives: to make it impossible to challenge a patent before it is granted; to lower the bar required to get a patent (so that even drugs that are merely new forms of existing medicines, and don't show a therapeutic improvement, can be protected by monopolies); and to push for new forms of intellectual property enforcement that give customs officials excessive powers to impound generic medicines suspected of breaching IP.

And there's more.

The U.S. will also reportedly introduce measures to make it harder and more expensive for generic drugs to get regulatory approval, and to lengthen patent monopolies for pharmaceutical firms so that they keep generics out and prop up drug prices for longer. All of these measures are known to hit the availability of affordable medicines in developing countries hard.

This deal is set to be sealed behind closed doors. Under no obligation to make its negotiating texts public, the U.S. Trade Representative's office has instead published a white paper claiming their TPP proposals will remove barriers to access to medicines. The document not only fails to provide the technical details necessary for effective public scrutiny, but also expresses a fundamentally flawed premise that speeding up market entrance of brand-name, monopoly-priced drugs will, in itself, solve the challenge of access to affordable, quality medicines. The truth is that the U.S. position outlined in its leaked TPP proposal actually creates barriers to access and thwarts generic competition.

With this devastating agenda, the U.S. is back-pedalling on the promises made to the developing world.

From: Shooting Itself In the Foot: The Broken Promises of the U.S. Trade Agenda, Huffington Post, September 14, 2011.

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