Cafta And Intellectual Property In Guatemala: Have Stronger IP Laws Reduced Access To Medicines?

Since 1994, treaties like CAFTA have forced lower-income countries to implement patents and other intellectual property (IP) rules for pharmaceuticals. In 2009, Health Affairs published the first empirical assessment of the impact these rules had on access to medicines. Drawing on key informant interviews, the study found that several generics had been removed from the Guatemalan market. The magnitude of any impact, however, remained unknown. This project extended work in Guatemala through a survey and market analysis, finding that the perception of impact exceeded actual evidence of it. In 2008, 29 surveys were distributed (8 physicians, 12 purchasers, 9 generics) and 17 (6 physicians, 8 purchasers, 3 generics) were returned. All purchasers noticed an impact of patents, and 75% reported decreasing the quantity of drugs purchased. Additionally, all reported that certain drugs had become unavailable. Registration is required to sell drugs legally in Guatemala. Guatemalan companies account for 40.8% of registered drugs (n = 15,194), of which 53.7% are generics, concentrated in five companies (31%). However, of 361 pharmaceutical patents, Pfizer alone holds 52%. Of 89 drugs with “data exclusivity,” the most common clinical domains are cancer (15%), anti-retrovirals (15%), and vaccines (11%). No drugs on the WHO Essential Medicines list have exclusivity. Guatemala has little capacity to manufacture biologics or vaccines and receives anti-retrovirals through special programs. Guatemala has some generics capacity but IP protections do not target the Guatemalan industry. It is unclear how many generics have been affected, or if the effect has reduced access to medicines.