Guatemala to Reintroduce Drug Data Protection

Guatemalan President Oscar Berger has submitted legislation that would reinstate that country's drug test data protection laws. The move has divided opinions in the US, with some politicians claiming that, while certain drugs would now receive better patent protection under the legislation, access to badly needed generic medicines for the poor could be limited.

If passed, the legislation would provide a five-year exclusivity period on all drugs marketed in Guatemala. The proposal would effectively reverse last December's repeal of Decree 9-2003, which was welcomed by humanitarian groups, including France-based charity Medicins Sans Frontieres.

To confuse matters more, some legislators have claimed that the US-Central American Free Trade Agreement's (CAFTA) patent provisions violate a 2001 World Trade Organisation agreement, under which developing countries are permitted to take certain measures to protect public health and promote universal access to medicines. Further, some US legislators note that this ambiguity confuses the issue of whether CAFTA signatories will be able to issue compulsory generics production licences in the event of a national health emergency.