US PRESSURES GUATEMALA TO STRENGTHEN DATA PROTECTION RULES

The US government has threatened to delay congressional proceedings on the Dominican Republic-Central American Free Trade Agreement (DR-CAFTA) because of US concerns regarding a new intellectual property law overwhelmingly passed by the Guatemalan parliament in December 2004. The Bush administration claims that the new law eliminates the five-year protection period for clinical trial data, and has threatened to delay congressional consideration of the DR-CAFTA unless Guatemala changes it.

Data protection requirements criticised

Critics of such data protection requirements say that they make it harder for generic drugs to become commercially available, since they delay generic drug manufacturers' access to the clinical trial data that brand-name drug producers use to receive marketing approval for their drugs. Generic drug makers need this data to prove that their products are safe as well as biologically equivalent to the brand-name originals.

US trade officials say that the five-year data protection period is necessary to uphold Guatemala's obligations under DR-CAFTA. However, several legislators from the opposition Democratic party have argued that pushing for the five-year protection violated the United States Trade Representative's (USTR's) congressional mandate to uphold the Doha Declaration on TRIPS and Public Health. They contend that the obligation to protect data exclusivity could hinder Guatemala's ability to issue compulsory licenses during a health emergency.

Guatemala likely to follow in DR's footsteps

Guatemalan President Oscar Berger has moved to assuage the USTR's concerns, promising to "correct this problem... so that Guatemala will be in compliance" with its DR-CAFTA obligations. Such a move would give the green light to US congressional proceedings on the seven-country trade bloc.

In late 2004, the Bush administration had threatened to delay congressional consideration of its CAFTA-linked free trade agreement with the Dominican Republic because of another law it found objectionable. However, the issue became moot when the Caribbean island nation repealed the offending import duty on beverages made with high fructose corn sweeteners (see BRIDGES Weekly, 27 October 2004). The Dominican Senate voted on 21 December to repeal the contentious 25 percent tax; President Leonel Fernández signed the legislation into law in early January.

The US signed the CAFTA in May 2004 with Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua. The Dominican Republic joined the pact in August 2004 after a separate negotiation. US business lobby groups that support CAFTA have been urging Congress to move to ratify the agreement as soon as the disagreement with Guatemala is resolved.

ICTSD reporting; "Dominican Republic President Officially Repeals HFCS Tax," AGPROFESSIONAL, 13 January 2005.