Data Exclusivity - Access to Medicines Denied - The case of an ARV Atazanavir in Guatemala

How Data Exclusivity Will Affect an Important ARV?
The Example ofAtazanavir

In November 2004, the Congress of Guatemala repealed Decree 9-2003 (seeAnnex 2), which provided for five-year data exclusivity. In December, the Congress replaced Decree 9-2003 with Decree 34-2004, which passed by an important majority and was seen by Guatemalan civil society groups, MSF,and others as a positive step forward, and a critical moment for the government to commit to ensuring treatment for greater numbers of people with HIV/AIDS in Guatemala. In the roughly 18 months during which Decree9-2003 was in effect in Guatemala, 25 medicines received “data exclusivity”protection under the law. Among those medicines affected is the ARVatazananir. Atazanavir is a protease inhibitor, which is a key part of second-line therapy for people with HIV/AIDS once they experience treatment failure on their first-line regimen, and is used widely, in the US, Europe,and Brazil.

Today, the US price of atazanavir is more than US$10,000 per person per year – there is no differential price for developing countries and it must be combined with at least two additional ARVs. There is no generic version of atazanavir available on the world market because it is a relatively newdrug, but based on experience with other ARVs, it is possible that the price could drop by approximately 95% with robust generic competition.

If a more affordable generic version of atazanavir is developed, however,it will not be able to enter the Guatemalan market until 2009 (given that the original atazanavir of Bristol-Myers Squibb was registered in Guatemala in February 2004). This means that BMS will have a monopoly during the entire period of exclusivity (at least five years) and, free from competition, will be able to charge whatever the market will bear – far more than what the average Guatemalan will be able to afford. It is therefore unlikely that the vast majority of Guatemalans who will need this medicine will be able to access it.

This is just one example of what could happen to all new medicines enteringthe Guatemalan market – not only AIDS drugs – if Decree 34-2004 is repealed and a US-style data exclusivity law is implemented, either through newnational legislation or enactment of DR-CAFTA. And newer medicines will be crucial to the longer-term survival of people with HIV/AIDS and otherillnesses.

Source: MSF, Campaign for Access to Essential Medicines - Feb. 2005