1. Authors: Rene Soria-Saucedo 1, Veronika J. Wirtz 1, Warren A. Kaplan 2 Institutions: 1 Center for Health Systems Research, National Institute of Public Health, Mexico; 2 Center for Global Health and Development, Boston University, USA

2. Study Objective Analyze the relationship between the volume share of generic medicines in Mexico and Brazil between 1999 and 2009 and public policies to promote their use

3. Study Design Setting: Brazil and Mexico retail market Methodology: Time Series Analysis of the retail pharmaceutical market volume between 1999-2009 (IMS Health data). Public policies’ assessment regarding promotion of generic medicines (literature review).

4. Data analysis Total annual sales volume in standard units Stratification by: Originator and licensed brand Branded generic Unbranded generic Only retail data (sales volume) Brazil: around 85% of total volume corresponds to retail Mexico: about 50% of total volume corresponds to retail

5. Data analysis Literature review to identify policies implemented to promote generic medicines uptake Agencies and organizations in charge of policy implementation Mechanisms used to increase generic uptake (price regulations, labeling, public campaigns, etc) Role of the national pharmaceutical industry Differences between the policies implemented in the public and the private sector

6. Results: Brazil Retail Sector Source: IMS Health

7. Results: Mexico Retail Sector

8. StrategiesBrazilMexico WHO guidelinesAppliedNot Applied All generics are bioequivalentSince 1999Since 2005 Highly positioned in the policy agenda YesNo Medicines Regulatory Agency role ANVISA: Medicines only Highly positioned Financial support to promote generic medicines COFEPRIS: Sanitary risks in general Low positioned Overwhelmed by responsibilities National Pharmaceutical IndustryKey player in supporting the policy Fragmented and was not an active player Potential reasons why generic market share increased faster in Brazil than in Mexico

9. Study Conclusions Even though both countries had similar political objectives to promote generic medicines, the strategies differed largely. Brazilian pharmaceutical policies highly placed in the political agenda, ensured the technical, logistical and financial preconditions for medium and long term implementation of the policy and key stakeholders from the private sector supported the initiative. Mexico targeted more effectively generic utilization in the public sector but was not successful in the retail market.