USTR Holding Off On Tabling Key Access To Medicines Details In TPP

At the thirteenth round of Trans-Pacific Partnership (TPP) negotiations, which kicks off next week in San Diego, the Office of the U.S. Trade Representative will once again refrain from tabling the most important missing pieces from its controversial access to medicines proposal. When it comes to intellectual property rights, USTR is expected to focus the group discussions on less controversial areas, including copyrights and general IPR provisions, sources said.

USTR has long held off on tabling details on the length of the "access window," which is a crucial element of its proposal that will help determine the strength of protections in areas like data exclusivity or patent linkage. It has also held off on clarifying which IPR protections it is proposing for biologic drugs, and both topics are hotly debated by public health groups, generic drug companies, and the brand-name pharmaceutical industry.

There are no indications that USTR wants to table these pieces anytime soon, and some observers believe that USTR may want to hold off until after the November elections, for a number of reasons. For instance, some said that the administration may want to avoid any potential negative political repercussions that could result from focusing on this issue and taking a definitive stance.

Moreover, USTR is facing stiff and uniform resistance from other TPP partners to its access to medicines proposal generally, and those same partners would also likely object if USTR were to advocate special protections for biologic drugs. At this point, the administration may not see the value in trying to push forward on those issues if it can hold more productive discussions in other, less controversial areas, sources speculated.

That said, USTR is working to schedule bilateral meetings on IPR with other TPP partners during the round next week. USTR officials may look to use these one-on-one meetings to hear out objections from other governments to the U.S. access to medicines proposal, and to try to seek a path forward, sources speculated.

A USTR spokeswoman this week confirmed that USTR "will be discussing IPR bilaterally as well as in the negotiating group, where we will discuss copyright and related rights and general provisions."

On biologic drugs, the spokeswoman said U.S. officials "have been engaging with our TPP negotiating partners to learn more about how their systems address the issue of biologics and biosimilars before proposing any specific provisions regarding exclusivity for biologic medicines." These talks are continuing "because we want to get the substance right," she added.

USTR privately concedes that a proposal for 12 years of data exclusivity for biologic drugs, as demanded by brand-name pharmaceutical companies, is not likely to gain any traction among TPP partners, sources said. The U.S. provides 12 years of exclusivity for biologic drugs and five years for conventional drugs, but it is the only country in the world that differentiates in this way between these two types of drugs.

The issue of biologic drugs is particularly complex for USTR because of competing views within the administration on whether the data exclusivity period should be 12 years, as is currently written in the 2010 health care reform law, or seven years, as was included in a fiscal year 2012 White House budget proposal. One industry source said there still appears to be no high-level political guidance on this issue from the White House.

Data exclusivity refers to a period of time where a drug manufacturer can protect its monopoly by requiring countries to restrict access to test data required to make a generic version of the drug.

Sources said it would not be advantageous for Obama for a public debate on access to medicines to unfold prior to the election. They noted that the issue became a problem in 1999, during the presidential campaign of Al Gore. Gore was repeatedly harassed at campaign events by activists who accused him of undermining access to AIDS medicines in South Africa through his involvement in a Clinton administration effort to convince that country to alter its patent laws in ways that would benefit brand-name pharmaceutical companies.

President Clinton -- and as a result Gore, who was then serving as vice president -- reversed their position when Clinton announced at the December 1999 World Trade Organization ministerial meeting that the Office of the U.S. Trade Representative and the Department of Health and Human Services would be committed "to make sure that our intellectual property policy is flexible enough to respond to legitimate public health crises," sources said.

USTR tabled its access to medicines proposal last September. Generally speaking, it establishes a window of time during which a pharmaceutical company can apply for marketing approval of a product in a TPP country in exchange for a commitment that its product will enjoy the highest level of patent protections. TPP countries like Peru object because it would still require more stringent protections than what they agreed to in past bilateral deals with the U.S.

The U.S. has not yet proposed how long the access window should be, which is a critical component of the proposal. A long window would provide less of an incentive for brand-name companies to seek marketing approval in poorer TPP countries, because they could act later and still receive the toughest protections. Public health advocates favor a short window to speed up the process of introducing brand-name, and then generic drugs, in poorer countries.

USTR also did not focus discussions on its access to medicines proposal at the Dallas round of TPP talks, which took place in May. As host of these rounds, the U.S. gets to decide the agenda for the talks. The U.S. is also expected to host the next formal round in early September, meaning it will be able to continue shaping the agenda. However, the fifteenth round, slated for sometime in December, is expected to take place in another TPP country.

At the Dallas round of negotiations, the U.S. failed to advance its proposal in another patent area. Countries opposed a U.S. proposal on patentable subject matter with the objection that it was a reversal of a commitment in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The U.S. proposal would require each TPP country to make patents available for plants and animals as well as diagnostic, therapeutic and surgical methods for the treatment of humans or animals. The TRIPS Agreement, however, allows WTO member to exclude from patentability plants and animals as well as diagnostic, therapeutic and surgical methods.

Source: insidetrade.com