Common guidelines from groups like the Pan American Health Organization (PAHO), part of the World Health Organization (WHO), and the Mercado Común del Sur (Mercosur), a lead trade organization, are just beginning to be implemented. There’s interest in greater harmonization, like Eastern Europe, across the region, but there still remains great divergence between individual countries.
With its population reaching 600 million people in 2011, Latin America is a fast growing region with equally fast growing economies. The top four Latin American economies and pharmaceutical markets account for more than 60% of the total population: Brazil (194 million), Mexico (115 million), Colombia (46 million), and Argentina (41 million). Other major players include Chile, Peru, and Venezuela (1). Latin American pharmaceutical sales in 2011 were at $62.9 billion, registering 8.9% growth in 2012. This is particularly significant when considered within the context of global sales of $995 billion in 2011. The diversity of the region, however, presents some challenges. In addition to the fact that guidelines from PAHO and Mercosur are just beginning to be implemented, it’s also worth noting that what exists are just guidelines, subject to regional and country specific variations. Other differences (e.g., economic differences, population differences, political differences) have profound implications for the pharmaceutical marketplace in Latin America.Key regulatory considerations
The primary regulatory consideration across the Latin American region for pharmaceutical companies is the increasing trend toward standardized regulations. Each of the seven major markets has adopted regulations that are based on Mercosur or PAHO’s recommendations. For example, Brazil revised its GMP standards in 2010 to ensure greater consistency with Mercosur/PAHO recommendations. Updates to Brazil’s GMPs addressed the areas of quality, sanitation, hygiene, qualification and validation, contracts, and computer system validation. Since then, Brazil has been moving ahead with implementation, including the release of a guidebook for inspections in May 2012.
In other cases, such as Mexico, international agreements like the North American Free Trade Agreement protect foreign companies interested in expanding their business into the region. The Mexican federal commission for sanitary risk (COFEPRIS) also holds equivalence agreements with Health Canada and FDA for the regulation of drugs and medical devices. Additionally, in September 2012, COFEPRIS and the Chilean Public Health Institute signed a cooperation agreement that will allow for the harmonization of regulatory requirements within the Americas region, breaking the entry barrier present in many countries. The agreement, which is still at the “memorandum of understanding” (MOU) stage, is a bilateral mechanism that is eventually expected to allow the mutual recognition of marketing authorizations, inspection visits, and GMP certification. Mexico has also signed other equivalence MOUs with El Salvador and Ecuador, and a MOU is in the making with Colombia. MOUs with Brazil and Argentina are expected in the near future.
Even with all of these agreements, there is no Latin American equivalent of the European Medicines Agency—no common body with the power to facilitate greater consistency across countries. Mercosur and PAHO can make recommendations, but cannot enforce a common set of rules the way a common governing body can. And to complicate matters, even as countries implement regulations to be more aligned with Mercosur and PAHO recommendations, they may not implement the same regulations at the same time.
Despite the many efforts carried out by the major Latin American markets, the road toward total harmonization is steep. The main reasons are the size of the region and the number of countries included in the area, each of them with their own regulatory system, political background, and policy approach to healthcare and pharmaceuticals. One proposal has been that of convergence rather than harmonization similar to what is in use in the Asia Pacific Economic Cooperation Area (APEC). Regulatory convergence is a voluntary process in which the countries in question agree to work toward regulatory requirements that are similar, but not fully harmonized. Harmonization would require changing laws in each country and is, therefore, more difficult to achieve. Convergence of regulations is considered as the most viable solution for the Latin American region.
Other considerations for pharmaceutical companies interested in expanding in Latin America include regulatory risk profile. In general, Latin American pharmacovigilance systems have developed considerably since the early 1990s and continue to strengthen. Several countries have set up adverse events reporting systems for products in the market, and 10 countries have regulations reporting adverse events during clinical trials.
Countries that currently have low pharmacovigilance requirement levels must still develop a system and appropriate monitoring measures. They are strongly encouraged by the WHO to do so in a timely fashion. The Subregional Pharmacovigilance Programmme and the Pan American Network for Drug Regulatory Harmonization also assist countries in Latin America in developing pharmacovigilance regulations that are harmonized with other Latin American countries.