By Martin Vaughan for Intellectual Property Watch

WASHINGTON, DC – Public health activists are condemning recent terms agreed to by Colombia, Peru and Central American countries in bilateral trade negotiations with the United States, that bind those countries to offer patent protections that exceed standards in multilateral agreements. The groups now are hoping for a more favourable outcome in two sets of negotiations currently underway between the United States and countries that have been ravaged by the HIV/AIDS virus – Thailand and the countries of the Southern African Customs Union (SACU).

In a lunch briefing with reporters in Washington, US and Colombian activists rejected as inadequate flexibilities that Colombian President Alvaro Uribe personally negotiated with US officials before the talks were finalized on 27 February.

“Clearly, this is going to have a very negative impact on public health in Colombia,” said Luis Guillermo Restrepo, president of Colombia’s National School of Pharmaceutical Studies. Restrepo was on the negotiating team for the free trade pact representing Colombia’s health ministry before resigning last fall to protest the US negotiating stance.

Uribe obtained two concessions from the United States on intellectual property: a side letter that clarifies a requirement in the text of the accord that the Colombian government verify before granting regulatory approval for new drugs that no patent already exists on the product, the so-called linkage issue. Rather than having Colombia’s drug regulatory authority verify patent status, the side letter would seem to allow the creation of a separate entity to fulfil that obligation, Restrepo said.

But this still puts the burden on the government to show there is no patent violation, while the burden should be on the patent holder to challenge violations in court, argued Stephanie Weinberg, trade policy advisor for Oxfam America.

US negotiator Susan Schwab in a 27 February conference call praised Uribe for personally working in the negotiation with Catholic Church officials from Colombia who “had expressed concerns about the potential intellectual property provisions’ impact on access to medicines.” Schwab said Uribe obtained “assurances” that this would not be a detriment, according to a US Trade Representative’s office (USTR) transcript of the call.

The United States also agreed – though it is unclear whether through a side letter or a footnote to the agreement — that Colombia is under no obligation regarding second-use patents, either to provide an additional twenty-year patent term or additional protection of confidential test data. These are patents that a drug maker may seek when it discovers that a certain drug, originally approved for one use, is effective in treating a different malady.

German Holguin Zamorano, the leader of a coalition of Colombian health groups, called those steps beneficial in a 17 February statement, but opposed the overall agreement, charging that “the health of Colombians has been negotiated in exchange for commercial advantages.”

Provisions on patents in the US-Colombia Free Trade Agreement are nearly identical to those included in the US-Peru agreement, announced in December. Like Peru, Colombia agreed to grant an additional five years of protection for test data for pharmaceuticals –ten years for agrochemicals – and agreed to “link” drug regulatory approval to the absence of a patent infringement.

The sole significant difference on patents in the two agreements, according to a spokeswoman for the US Trade Representative, is that Colombia was given two years before it must abide by the requirement to augment patent terms where there are delays in approval of the patent.

The US-Peru accord could come before the Congress as early as April, and the Colombia agreement as early as June. But it is also possible the Bush administration could seek no action on either deal until after the November US elections. Separately, Ecuadorean officials say they expect to conclude trade talks with the United States in a month.

Ken Johnson, a senior vice-president of the Pharmaceutical Research and Manufacturers of America (PhRMA), declined to comment on specifics of the Colombia deal since it has not yet been made public, but said that “data exclusivity, intellectual property rights and second-use patents are important to create an environment that is conducive to future research and development of life-saving medicines.”

On Guatemala, the United States is seeking more layers of intellectual property protection before it will let the Central American Free Trade Agreement take effect. Activists say what the United States is seeking goes even further than the TRIPS-plus commitments that are included in the CAFTA itself. “There was pressure from the US before and during negotiations, now they are asking for more,” said Weinberg.

Luis Velasquez, director of the Guatemalan trade association of generic drug makers, said the United States wants Guatemala to agree to protect second-use patents and test data from second-use patents. He also said the United States hopes Guatemala will honor patents filed in the United States, even if they are not registered in Guatemala.

USTR spokeswoman Christin Baker denied the charge. “There is no requirement to recognize a US patent that has not been registered in Guatemala,” she said. “We are not seeking this.” Baker said the United States is looking for Guatemala to put a system in place to abide by the requirement in CAFTA to protect test data, and accede to international intellectual property treaties before agreeing to implement CAFTA.

In the Thailand negotiations, the United States has tabled language on patent protection similar to what has been included in CAFTA and agreements with Andean countries. But those talks have been halted pending national elections next month. Talks with the SACU countries have been stalled for some time.

USTR: Exceeding Nations’ International Obligations Creates Markets

In the conference call, Schwab also highlighted that US free trade agreements go further than countries’ international obligations. “What we have in these free trade agreements is significantly deeper and broader than other agreements that we reached, for example, in a multilateral context,” she said. “When it comes to areas like intellectual property rights, investments, services…. These are areas where depending on your multilateral context you can make progress, but rarely progress this profound.”

Schwab added, “So it’s one of the hallmarks of the free trade agreements the United States negotiates in that we are able to set precedents and to really create markets that would not exist otherwise.”