As the US and eight other countries negotiate the Trans-Pacific Free Trade Agreement, newly leaked documents indicate the Obama administration has reversed reforms to trade policies made during the Bush adminstration that were designed to ease access to affordable medicines by poorer countries, according to consumer and patient advocacy groups.

The texts suggest the White House is demanding new rights for drugmakers to challenge pricing and other drug formulary policies used by many countries to keep down prices, the groups charge. Earlier this year, Australia and New Zealand, for instance, were reportedly ressured to change the procedures used for negotiating prices and coverage with drugmakers (see here).

Overall, the groups say the changes would restrict generic competition, eliminate safeguards against patent abuse, grant additional exclusive controls over clinical trial data and, essentially, raise the cost of medicines for people in the Asia-Pacific region. Among the other countries participating in the TTP talks are Malaysia, Peru, Brunei Darussalam, Singapore, Vietnam and Chile.

The document leak occurs just one month after the Obama administration released a white paper that emphasized a commitment to providing access to needed medicines as part of its goals for the current TTP negotiations. However, the paper was met with scorn by activists who claim the US Trade Representative is too closely aligned with the pharmaceutical industry.

The behind-the-scenes trade talks are a crucial front in finding a balance between fostering intellectual property protection and providing access to medicines to people in poorer countries. Drugmakers say strong patent protection is needed to shield investments made to develop medicines. And the White House has made trade deals a key element of its plans to foster job growth.

“The leaked texts show that U.S. officials’ recently-announced medicines ‘access window’ is window dressing for piling on monopoly privileges for Big Pharma that will in fact undermine access to medicine,” says Peter Maybarduk, Access to Medicines Program Director at Public Citizen, which made the leaked documents available (you can read them here, here and here, as well the Public Citizen briefing memo).

The groups also argue that ongoing trade talks threaten to roll back progress of the past few years and suggest the documents indicate that terms of a trade deal reached four years ago with Peru, Colombia and Panama Peru would be undermined (read an analysis here of the leaked proposal and Peruvian intellectual property law).

In analyzing the documents, activists note that various provisions could threaten healthcare programs serving vulnerable populations in the US. You may recall that US agencies and state governments negotiate drug prices in similar ways as foreign governments and pay similar prices. And since trade deals are reciprocal, any deal that restricts pricing mechanisms in other countries may then be imposed in the US. The governor of Vermont earlier this year expressed this concern to the US Trade Rep Ron Kirk (read here).

“The US proposal would require bad public policy contrary to best practices in the US itself. Ironically and ominously, US drug pricing programs do not comply with the standards that the US is proposing. In particular, the operation of preferred drug lists by the Federal Medicaid program would violate the terms of the agreement, including because they do not provide appeals for pharmaceutical companies on whether the prices achieved adequately value patents,” writes Sean Flynn, Sean Flynn, associate director of the Program on Information Justice and Intellectual Property at the Washington College of Law, in this analysis of the leaked documents.

Just last week, Public Citizen and other groups wrote a letter to US Trade Rep Ron Kirk asking that he release Trans Pacific Partnership negotiating documents after learning that a confidentiality agreement was signed by the negotiating parties. The closed-door approach, the groups argued, contradicts a vow by the Obama administration toward greater transparency (back story).