Effect of the 2009 US-Peru Free Trade Agreement on Peruvian new drug policies and the registration and quality of pharmaceutical products

Purpose: The controversial issues surrounding the 2009 US-Peru Free Trade Agreement (FTA) are patent protection and access to medicines. The FTA necessitated changes in Peruvian legislation to meet requirements of the treaty. This study evaluated the impact of the FTA on the number and quality of brand and generic pharmaceuticals registered before and after the agreement and implementation of the New Drug Policies (NDP) of 2009. The impact also was evaluated on the registration status and quality of anti­infectives at the retail level in Peru.;Methods: Data provided by the Peruvian drug regulatory authority, DIGEMID, was evaluated from January 2005 to August 2014. The frequency and proportion of brand and generic products registered at DIGEMID were determined using the variables 'authorization date of first registration,' 'authorization and expiration date of registration,' and 'status of application.' The anti-infectives registration statuses were determined as: new registrations, re-registrations, awaiting registration; or expired, denied, suspended, canceled and disregarded registrations. Ten private retail Peruvian pharmacies were sampled. Key informant interviews were performed to complement the literature review. Chi-square was used to assess differences in proportions.;Results: A total of 30,201 pharmaceuticals (including 6,112 anti-infectives) and 913 biologic products were evaluated. Registration of brand products was greater than generics before and after the FTA and new legislation. However, the frequency of new registrations and re-registrations of brand and generic products decreased after 2009. There were statistically significant differences. The proportion of awaiting registrations was 3 times greater for brand than for generic products from 2009 to 2013. Anti­ infectives from DIGEMID database were categorized and compared with 1,105 anti­infectives from 10 retail pharmacies (Arequipa, Peru). By August 2014, 647 awaiting registrations, 74 expired, 4 suspended, and 2 denied registrations were found in the retail pharmacies. The antibiotic found the most often in stock was penicillin. Critical non­compliance quality control reports dropped by one-half for all pharmaceuticals and by one-third for anti-infectives after 2009.;Conclusions: The FTA and changes in the Peruvian legislation have resulted in a decline in the number of registrations of pharmaceutical specialties and poor quality control reports. The NDP implementation is in the process to ensure that good quality, safe and efficacious products reach the Peruvian population. However, the Peruvian government should promote quality generics manufacturing and guarantee their availability to the poorest population. At the same time, strengthening surveillance at the manufacturing and retail pharmaceutical level will ensure quality, safety and rational use of medicines, mainly of anti-infectives.