217625 Cafta And Intellectual Property In Guatemala: Have Stronger IP Laws Reduced Access To Medicines?

Tuesday, November 9, 2010 : 3:10 PM - 3:30 PM

Joshua Rolnick, ScB , School of Medicine, Stanford, Palo Alto, CA
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.

Learning Areas:
Provision of health care to the public
Public health or related laws, regulations, standards, or guidelines
Public health or related public policy

Learning Objectives:
Assess the perceptions of Guatemalan physicians, drug purchasers, and generic manufacturers regarding the impact, if any, of the country's new IP regime Analyze the extent to which Guatemala has generics capacity through a survey and analysis of the list of 15,000 registered drugs Evaluate whether pharmaceutical companies are taking advantage of the new intellectual property rules

Keywords: Access, Law

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I conducted fieldwork in Guatemala during summer 2008, under the supervision of the Facultad de Farmacia at the University of San Carlos. I personally distributed and collected all surveys, obtained and analyzed all data, and interviewed a number of key informants in Guatemala.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.