In a world where medical innovation is accelerating, Latin America–a region of some 662 million people—is falling dangerously behind. Patients face wait times of up to 5.6 years to access life-saving therapies already available elsewhere. This is not merely a delay, but a systemic failure rooted in chronic underinvestment and operational inefficiencies. Drawing on exclusive insights from regional leaders in innovative biopharma, we explore the barriers limiting access to innovation—and what it will take to overcome them.
Long Wait Times, Limited Availability
From cancer therapies to cardiovascular drugs, access to innovative medicines in Latin America lags far behind global standards. According to the W.A.I.T. Indicator from FIFARMA, the organisation representing research-based pharma in the region, LatAm patients wait 5.6 years on average to access new therapies. Even more concerning: only 33 percent of global medicines are currently available in Latin America.
A 2024 study from the Pan American Health Organization (PAHO) adds urgency to the issue, revealing major access gaps even for essential hypertension medications—this in a region where cardiovascular disease remains the leading cause of death.
“The 5.6-year average waiting period reflects two major systemic issues,” explains Yaneth Giha, executive director of FIFARMA. “First, regulatory approvals take roughly 3.5 years. Then, it takes another 2.5 years before those medicines actually reach patients.”
For innovators, this is unacceptable. Karla Alcazar, SVP and President LatAm at Eli Lilly, puts it bluntly: “Imagine knowing that a life-saving treatment exists but not being able to access it for years. It is heart-breaking for patients and their families. This must change.”
Underinvestment: A Root Cause
Much of the region’s access problem stems from a fundamental issue: inadequate healthcare investment. Compared to OECD countries, Latin America spends far less on health, resulting in high out-of-pocket costs and a strained system.
“In Mexico, healthcare spending is just 5.5 percent of GDP, well below the OECD’s recommended 9.2 percent,” notes Alcazar. “While countries like Brazil and Colombia invest a bit more, they are still below that benchmark.”
This shortfall impacts not just access, but overall system sustainability. “Latin America must reconceptualise health as a strategic investment rather than an expenditure,” argues Giha.
“We need to shift the focus from solely looking at the cost of innovation to understanding its broader impact. Innovative treatments improve quality of life, reduce hospitalisations, prevent complications, and boost workplace efficiency,” Lilly’s Alcazar concurs. “These factors drive economic growth and reduce long-term healthcare costs.”
Regulatory Fragmentation: A Barrier to Progress
Beyond spending, regulatory inefficiency and fragmentation are significant barriers. Approval processes across the region are not only lengthy and inconsistent, but often under-resourced and reliant on outdated systems.
“Regulatory agencies face capacity constraints and resource limitations that impact approval efficiency,” Giha explains. Similarly, “Health Technology Assessment bodies across Latin America experience resource constraints and operational challenges that limit their effectiveness.”
The digital systems that could stand to speed up processes are yet to be fully embraced by Latin American regulators; Alcazar indicates. “COFEPRIS still has many manual processes. Transitioning to digital systems will accelerate these workflows, reducing approval times and improving access to innovative treatments.”
However, some progress is underway as governments increasingly embrace digitalisation. “One encouraging sign is that Mexico’s Health Ministry has prioritised digital transformation within its broader strategy. This focus is essential given the resource constraints many regulatory agencies face,” she adds.
Another promising path seeing progress is regulatory reliance—a mechanism where one country’s agency accepts or leverages the evaluations of another trusted authority. This could drastically cut duplication and accelerate access.
The groundwork for regional reliance was laid by the Pan American Network for Drug Regulatory Harmonization in 2018 and reinforced by the WHO in 2021, yet according to Giha, “implementation depth [still] varies significantly across the region.”
Brazil’s ANVISA has emerged as a leader in this area, launching the region’s first regulatory reliance framework—an example for other regional regulators to follow. Additionally, the Brazilian agency is participating in collaborative evaluation projects, notably the FDA’s ORBIS oncology initiative, which has led to 40 collaborative application approvals.
Untapped Potential in Clinical Research
Clinical trials offer a dual benefit: early access to cutting-edge therapies and a pathway to developing new treatments suited for the local population. Latin America, with its diverse patient populations and low operating costs, offers huge and as-of-yet not fully tapped potential for clinical research.
“Latin America possesses the capacity for substantially greater clinical research participation,” says Giha, a potential that in her view can only be realised through “enhanced regulatory harmonisation, expanded reliance mechanisms, and comprehensive capacity building initiatives.”
Some companies are, however, investing heavily. Sanofi, for example, reports a strong research presence. “We maintain a robust clinical trial presence across Latin America,” says Emily Morris, head of LatAm. “Within Sanofi’s MCOs—representing 40 percent of the global population—Latin America has one of the highest clinical trial enrolments.”
At Lilly, the largest industry investor in clinical trials in Mexico, the commitment is also strong. “We are prepared to double our investment as digitalisation accelerates regulatory processes,” says Alcazar.
Collaboration: The Key to Change
To advance access to medicines, industry leaders are calling for multi-stakeholder collaboration as a key facilitator.
FIFARMA is leading efforts to build regional coalitions across industry, regulatory agencies, governments, patient advocacy groups, and academic institutions with collaborative platforms like its Annual Summit. “These forums facilitate convergence among diverse regional actors to advance critical healthcare agendas,” Giha asserts.
Sanofi’s Morris emphasizes the urgency: “It’s crucial for the pharma industry to unite in advocating for better access, especially for high unmet medical needs.”
Ultimately, as Giha puts it, the challenge is one of collective commitment: “The fundamental obstacle [to improved access] involves achieving genuine collaborative commitment among all stakeholders to define collective actions and honour individual responsibilities for required progress.”
