Trade agreements and drug access: assessment of the impact of the 2009 Peruvian new drug policy on anti-infectives registration and availability

BACKGROUND: The United States-Peru Free Trade Agreement required changes in the Peruvian pharmaceutical legislation that resulted in the National Drug Policy (NDP) of 2009. This study evaluated the registration of brand and generic anti-infectives before and after the agreement and implementation of the NDP and assessed the availability of anti-infectives in community pharmacies located in Arequipa-Peru. METHODS: Anti-infectives registration database, provided by DIGEMID (Peruvian Drug Regulatory Authority), was evaluated from January 2005 to August 2014. Registration status included: new registrations, re-registrations, awaiting registration; or expired, denied, suspended, canceled and disregarded registrations. In addition, ten retail pharmacies located in different socio-economic areas in Arequipa were sampled in August 2014. Descriptive statistics and chi-square test were used for the analysis. RESULTS: A total of 6112 anti-infectives registrations were categorized (5007 = antibacterials, 340 = antimycotics, 143 = antimycobacterials, and 622 = antiviral drugs). New registrations for brand and generic anti-infectives decreased from 2005 to 2013 (311 to 60 and 164 to 20 respectively). Re-registrations were from 121 (brand) and 115 (generics) in 2005 to 6 (brand) and 5 (generics) in 2013. Anti-infectives awaiting registration increased from 0 in 2005 to 351 (brand) and 137 (generics) in 2013. The retail pharmacy survey included 1105 anti-infectives. These pharmacies carried 647 (58.6%) products awaiting registration, 74 (6.7%) expired (mostly combination of sulfonamides and trimethoprim followed by penicillin with extended spectrum, and fluoroquinolones), 4 (0.4%) suspended, and 2 (0.2%) denied registrations. Pharmacies in the low socio-economic area of the city had the highest proportion of generics (59.0% vs. 16.1%) from foreign origin (mainly India), and brand anti-infectives from Peruvian manufacturers (68.8% vs. 48.1%). High socio-economic areas had highest proportion of branded anti-infectives (83.9% vs. 41.0%). CONCLUSIONS: The new NDP reduced the number of brand and generic registrations; generics had the largest decline in registrations. Anti-infectives found in pharmacies located in low-income areas were more likely to be generics, and less likely to be currently registered by DIGEMID. The potential reduction in generic registrations resulting from the implementation of the NDP as a consequence of the bilateral trade agreement could result in lower availability of low cost medicines, but may increase the safety, efficacy and quality of marketed medicines.