In 2019 the pharma industry financed some 700 clinical studies in Latin America with investments of more than USD one billion and according to FIFARMA, the leading association of innovators in the region, LatAm currently supports about 10 percent of the world’s clinical research. Local industry leaders discuss the advantages and some of the challenges of locating global trials in the region.
An Attractive Hub
With a diverse population of over 650 million people and strong clinical research centres, LatAm has already become an increasingly attractive location for international pharma companies to conduct their clinical trials.
This region has an ethnically diverse population, strong doctor-patient relationships, and great clinical research centres, all of which are increasingly attracting the eye of our member companies when choosing where to base their clinical trials.
Yaneth Giha, Executive Director, FIFARMA
FIFARMA’s executive director, Yaneth Giha, asserts: “LatAm can be a great place for clinical research. This region has an ethnically diverse population, strong doctor-patient relationships, and great clinical research centres, all of which are increasingly attracting the eye of our member companies when choosing where to base their clinical trials.”
BMS is among the organization’s members and a company that has already recognized the region as central to its clinical research strategy: “LatAm’s clinical trials operations are significant, and the company has invested USD 200 million in this area over the last five years. More than 2,000 patients are receiving treatment with BMS medicines via clinical trials in more than 484 centres in the region,” says Florencia Davel, VP, general manager LatAm & local representatives center of excellence, BMS.
GSK is also banking on the region, particularly on Brazil. “We are running about 32 clinical trials here now. Not only that, Brazil is now considered an end-to-end country in which to engage in clinical trials,” says Andre Vivan da Silva, country manager at GSK Brazil.
We are running about 32 clinical trials here now. Not only that, Brazil is now considered an end-to-end country in which to engage in clinical trials.
Andre Vivan da Silva, Country Manager, GSK Brazil
One of the factors that make Latin America so attractive as a clinical trials hub is the level of research centres available. “There are some very important and very sophisticated centres in LatAm … with very high-quality service and physicians at the level of top international institutions across the world,” says Sandra Ramirez, Latin America area lead at Astellas Pharma.
“Many LatAm countries – especially those where we have clinical trial hubs – stand out from other emerging markets for the high level of infrastructure they have in place, particularly in the private sector,” states Davel.
Three Countries in the Lead
The bulk of LatAm’s clinical research is being carried out in Brazil, Argentina, and Mexico. “Four years ago, Argentina defined clinical research as a governmental priority, catching up to Brazil and Mexico, which have long had a strong footprint thanks to their large populations and local markets,” Giha comments.
The Link between Clinical trials and Access
Industry stakeholders express the need to align clinical research activities with their access goals in the region. “To ensure that we provide access to patients, we need to ensure that we have the capacity to hold clinical trials in our markets,” says Ramirez.
To ensure that we provide access to patients, we need to ensure what we have the capacity to hold clinical trials in our markets.
Sandra Ramirez, Latin America area lead, Astellas Pharma
“Two of the company’s five global diversity and inclusion commitments are directly related to clinical trials. These two commitments – addressing health inequities and building more clinical trial diversity – fit perfectly with our work in LatAm, where there is significant health inequity which can be addressed through clinical trials as well as a diverse multi-ethnic population,” asserts Davel.
“To address both our health equity and clinical trial diversity commitments by ensuring that the supporting infrastructure is in place for public sector hospitals to participate in clinical trials,” she continues.
Building clinical trial capabilities in the region is not without its difficulties, yet industry leaders also recognize that progress has been made, particularly on the regulatory front.
“One challenge is making our regulatory systems and the regulations surrounding clinical research more attractive. For example, in Colombia, the regulatory agency was previously taking around six months to approve a clinical trial. Then it moved to around two months, which sends a strong message, as did Argentina’s move to change its regulation four years ago to incentivise clinical research investments and make the process more efficient. The ethics commissions that have sprung up can also create obstacles, but these commissions are now improving and have a better understanding of how to create solutions,” says Giha.
Only the Beginning
Our clinical trial investments in the region grew by 20 percent last year, and we foresee this trend continuing.
Florencia Davel, VP, General Manager LatAm & local representatives center of excellence, BMS