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Latin America And Clinical Research: From Regulations To Opportunities

In order to try and attract investment from their North American neighbors and other Western investors, Latin American countries have improved their healthcare and clinical guidelines. During this period of increased interest it is sometimes possible to disregard the fact that Latin America is made up of twenty different countries, cultures, regulations, standards and care. It is important to remember that each Latin America country has its own strong and unique identity, history, culture and tradition when investing, and country each presents new, interesting and different opportunities.


Latin America Market

Latin America has two official languages, Spanish and Portuguese. For investment opportunities, this holds an advantage over continents such as Europe, as uniform, translated documents and training materials can be produced in just these two languages. There are obvious and important differences in the dialects and linguistics, meaning that professional translations often give you and your business added value by avoiding miscommunication problems. As Latin America is seen as a developing continent, many of the highly populated cities have the potential for large numbers of treatment naive patients. This presents an obvious opportunity and market for new products and services, through educating the population of these urban and non-urban areas. The relatively new and expanding medical market has resulted in high enrollment and retention rates for medical trials as well as relatively low study costs in Latin America.

Who To Watch Out For In Latin America

Whilst Argentina, Brazil and Mexico remain the major players in the Latin American medical industry, new opportunities in previously disregarded countries has increased the competition. Chile with its stable economy and government as well as attractive globalization schemes has seen a rise in the amount of medical studies, trials and investment. Peru, with its favorable and fast regulatory approval times has become a relatively new participant of foreign medical investment. The constant change and rebranding of Colombia, once the home to the world’s drugs production, has been nothing short of commendable. With Medellin being voted the most innovative city in the world as well as a new marketing campaign by the Colombian Government, the country is reaping the benefits of its recent turnaround. Seen as one of the most advanced, value for money healthcare destinations in the world, North Americans are taking advantage of the high level of medical care and cheaper prices, turning Colombia into the new, up and coming, major competitor in the world’s medical industry.

With Every Challenge, Lies An Opportunity

Bureaucracy, the occasional workers strike and a more relaxed attitude means that approval times for clinical research can sometimes be double or even triple the original expected approval period. There is also no uniformity in many of the decisions made due to the variety of study design and the sponsor’s knowledge of the regulations within their chosen Latin American country. Although there are some obvious drawbacks such as changing governments and the greater potential for economic collapse such as that of 2001 in Argentina; the region is beginning to stabilize and announce its arrival on the world’s stage for all the right reasons. The large population density of the major Latin American cities, often mean that although there may be delays, the vast market results in fast recruitment; compensating for the delay in clinical study approval. Another advantage due to the culture and tradition of the region is the often strong patient – study site personnel relationships formed, resulting in higher patient retention rates than other regions in the world.

Understanding The Environment Presents A Road For Success

Although as mentioned above there are some drawbacks, by fully understanding the environment, regulations and country-specific requirements, Latin America has a market ready to receive investment. By working with the local regulators, the clinical study sponsors are able to take advantage of the high recruitment rates in order to offset the setbacks incurred.

However, it is not only the sponsors that need to learn about the environment and improve. If the Latin American countries want to take advantage of the current growth and development opportunities those in power and regulators, need to create clear processes, procedures, regulations and realistic timelines in order to provide a healthy and attractive environment for clinical study sponsors.

Latin America is rising to the challenges, and although a steep learning curve, many of the Latin American countries such as Colombia, have started to reap the rewards of investing in research and development. This has brought about a positive change for their populations by providing greater access to technology, a more developed infrastructure and a rise in the level and quality of care.