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.

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

USTR STATEMENT IN WHITE PAPER SPECIFIC COMMENTS
“Promote the availability of life-saving and life-enhancing medicines in TPP

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 medicines.

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” labeling;

-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.