Drug Deal

For Luis Lopez, a 42-year-old single dad in Guatemala, globalization has nada to do with economics or democracy. On the contrary, for Lopez, it's about something much more basic: los anti-marcas (against brands), los genericos -- the cheap, generic medications that poor AIDS patients like him need to stay alive.

More than 78,000 Guatemalans are currently living with HIV/AIDS , according to Doctors Without Borders (also called Medecins Sans Frontieres, or MSF). Approximately 13,500 of them are in urgent need of antiretroviral (ARV) treatment; only 3,600 were receiving it as of December 2004. If, in coming weeks, Congress ratifies the bill President Bush signed last year -- the Dominican Republic-Central American Free Trade Agreement (DR-CAFTA) -- many of these patients could wind up literally dying for cheap drugs.

According to groups such as Oxfam and MSF, CAFTA's intellectual property protections will give monopoly-like status to high-priced, brand-name drugs in poor markets; potentially killing off generics in El Salvador, Nicaragua, Guatemala, Costa Rica, Honduras and the Dominican Republic, and preventing millions of AIDS patients from being able to afford the meds they need.

"People here are very worried about laws that will amplify patents and the testing time for drugs," Lopez said via telephone from Guatemala City.

Here's a look at some public health ramifications of CAFTA's intellectual property provisions -- a rarely acknowledged set of dangers that illustrates how pharma-friendly U.S. trade negotiators use back-door legalisms to stamp out generic medications.

Umm, That's My Data

To understand CAFTA's most controversial aspect, consider "data exclusivity." As it stands, the World Trade Organization's TRIPS agreement (Trade Related Aspects of Intellectual Property), gives poor countries the right to break drug patents in health emergencies. The U.S. signed on to that deal, as well as a subsequent agreement called the Doha Declaration, which further clarified the public health aspects of intellectual property and reaffirmed poor countries' rights to essential medicines.

But critics claim that CAFTA, through the "data exclusivity" provision, dilutes those rights by erecting barriers around pharmaceutical test data to delay the registration of generic drugs in poor markets.

To encourage the use of generic medicines, U.S. law states that generic drug-makers need not conduct their own trials; instead, they can rely on safety and efficacy data gathered by brand-name companies and placed on file with the FDA. To compensate the brand-names for their costly work, Congress restricted generic manufacturers' access to that key data -- they won't be able to use it for the next five years. CAFTA takes that even further, extending the prohibition window to "at least five years" of exclusivity for the brand-name companies. This detail could translate to long delays in bringing life-saving generics to the market.

There's more: public health experts worry that data exclusivity could ban generics from poor markets where even the brand-name originator drugs aren't sold -- shutting down all drug access until the prohibition window runs out.

CAFTA does agree to let generic companies conduct their own test data in order to enter a market. But this position could stink of hypocrisy. Multinational drug companies -- which justify high drug prices by citing massive R&D cost for new drugs -- know that generic companies in poor countries likely can't afford such costly trials. Plus, it would be an ethical breach to subject patients in Costa Rica or Guatemala to drug studies that have already been conducted elsewhere in the world.

Without the power to compulsory license the test data (just as they can compulsory license brand-name drugs through TRIPS), poor nations have their hands tied through an indirect but restrictive patent law nuance.