The combined populations of the three most populous countries in Latin America – Brazil, Mexico, and Colombia – account for more than 350 million people. Pharmaceutical companies have long sought access to the growing market in Latin America and many have faced difficulties in doing so. The region’s regulatory schemes remain fragmented and requirements can differ widely. While harmonization efforts continue, navigating entry to Latin America can be complex and quality requirements continue to gain rigor. Recent years have also brought tumultuous government and economic changes in several countries which will also likely impact the pharmaceutical sector in the future. As pharmaceutical supply chains have become more global, companies in Latin America have also worked to increase their presence internationally, expanding manufacturing and supply to markets worldwide.
Although Latin America’s active pharmaceutical ingredient manufacturing base is comparatively small (Figure 1), it is growing, with much investment focusing on biotechnology. As regulators have become more stringent with rules governing all parts of the pharmaceutical manufacturing supply chain, several of the region’s producers have run into issues with regulators from highly regulated markets, like the U.S. and Europe. Consequences for deviations from good manufacturing practices identified during inspections have resulted in FDA warning letters and European export bans for some Latin American companies.
Newport Premium, from Clarivate Analytics, assesses the capabilities and experience of API manufacturers according to a proprietary scheme using objective regulatory data, with ratings ranging from “local” to “established.” While the majority of companies in the region focus on serving local markets, some companies have made moves into regulated markets, with the majority of these players coming from Argentina and Mexico. Additionally, API manufacturers in Latin America hold 145 active U.S. Drug Master Files (DMF) and 66 valid European Certificates of Suitability (COS) (Figure 2).
Lengthy patent and drug approval have stymied companies seeking to access many markets. The Brazilian government has taken steps to help alleviate these issues, including moves to address the double patent review that occurred in some cases between Anvisa and INPI, the Brazilian patent authority. In April 2017, coordination between Anvisa and INPI was formalized, with the scope of Anvisa’s patent assessments focusing on reviewing the application for potential impacts on public health and patentability criteria falling under INPI’s purview.
Data from Clarivate’s Cortellis Regulatory Intelligence demonstrates that the majority of drug approvals in Brazil from 2015 and 2016 were for biologic drugs and new generics. As Brazil faces an aging population, the need for medications to manage lifestyle and chronic diseases will continue to grow, placing increased emphasis on generic access.
Deals, acquisitions and technology transfers have played greater roles for companies looking to enter Latin America, as well as local companies expanding globally. The past half year has seen some interesting deals involving companies in Latin America, including acquisitions and licensing deals with companies in Europe.
Latin America remains an attractive though complex market, and navigating it successfully will require adaptability, local expertise and an informed strategy.
For further insight into the regulatory environment in Latin America, read “The changing regulatory environment in Latin America: Focus on good review practices,” from the Centre for Innovation in Regulatory Science (CIRS). CIRS is a neutral, independent UK-based subsidiary company, forming part of Clarivate Analytics.