FIFARMA W.A.I.T. Indicator 2026: from waiting time to an opportunity to move forward

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A patient in Latin America waits an average of 5,7 years from the moment an innovative medicine is approved in the United States or Europe until they can access it in their own country. That is the central finding of the FIFARMA W.A.I.T. Indicator 2026, developed with IQVIA and covering 447 innovative molecules approved between 2014 and 2025 across ten countries that account for more than 80% of the region’s population.

Measuring the distance between innovation and the patient

Measuring that distance is the first step toward closing it. The wait breaks down into two stages: 36 months (3 years) until local regulatory approval — including submission times — and another 32 months (2.7 years) until the treatment is actually available. In total, 68 months in which the innovation exists and is already approved elsewhere in the world yet still does not reach the people who need it.

The gap keeps growing: the regional average went from 4.5 years in 2023 to 4.8 in 2024, 5.6 in 2025 and 5.7 in 2026. What matters is where the bottleneck has moved: while regulatory timelines improved by as much as 5% in some cases, post-approval delays grew by 10%. Today, the greatest opportunity lies in moving toward more sustainable, value-based solutions that help new treatments reach the people waiting for them.

How long access to innovative therapies takes in each country?

Each country has its own starting point and concrete opportunities to move toward more timely access:

Country	Access time	Country	Access time
Argentina	5,3 years	Ecuador	5,8 years
Brazil	5,5 years	Dominican Rep.	5,9 years
Peru	5,5 years	Chile	7,1 years
Colombia	5,7 years	Costa Rica	7,3 years
Mexico	5,8 years	Panama	7,6 years

Argentina leads with the shortest waiting time; Brazil records the fastest regulatory approval of the ten markets; Peru is the country that reaches the patient most quickly once a treatment has been approved; and Mexico achieves the highest level of full availability in the region.

The road from approval to access

Only 60% of the molecules analyzed reach the region. Regulatory approval, however, is only part of the journey: just 34% achieve full availability with broad reimbursement. The rest is split between limited availability (21%), access through the private market only (27%) and molecules that are approved but not yet available (18%). These differences point to a key opportunity for the region: advancing toward mechanisms that turn approval into effective patient access more quickly, regardless of the health system a patient belongs to.

The gaps also vary by therapeutic area. Oncology shows the highest levels of access, although only 27% of its molecules reach full availability and 18% are available exclusively through private channels. By contrast, central nervous system therapies register barely 14% full availability.

Health is not an expense: it is an investment

The study is clear in its diagnosis: the gap is not caused by a lack of innovation, but by the distance between the pace at which innovation advances and the capacity of health systems to incorporate it. Public health spending in the region averages 4.4% of GDP, below the 6% recommended by the WHO and the 6.5% of OECD countries. For innovative therapies the distance doubles: 0.19% of GDP compared with 0.44% in OECD countries..

“Health is not a priority; it is seen more as a burden or an expense, rather than what it should be: an investment.”

— Former Minister of Health, interviewed for the FIFARMA W.A.I.T. Indicator 2026

Insufficient investment in health does not only limit access to new therapies; it also reduces the capacity of systems to assess and incorporate them efficiently. This can lead to more fragmented processes, longer delays and less predictable access routes, such as litigation.

The challenge will be even greater in the years ahead. With an aging population and the rise of chronic diseases, health spending in the region is projected to grow from the current 7.4% of GDP to around 9.3% by 2050. Investing better today also means preparing health systems to respond more sustainably to the needs of the future.

The way forward: collaboration, technology and planning

The region already has progress to build on. Six Latin American regulatory agencies — COFEPRIS, ANVISA, INVIMA, ISPCH, ARCSA and ANMAT — are now recognized by PAHO as National Regional Reference Authorities, strengthening the conditions to advance reliance mechanisms and move toward faster, more predictable approval processes. Building on this, the report identifies three opportunities to accelerate access: strengthening collaboration between countries and institutions, integrating new technologies such as artificial intelligence into regulatory and assessment processes, and anticipating health system needs in order to prioritize the therapies with the greatest impact.

“Educating and facilitating access to information allows us to identify where the main bottlenecks are. Recognizing them is the first step toward working together and continuing to move toward health systems with greater access and better outcomes.”

— Vitor Nasciben, Co-chair of the FIFARMA access group

“The opportunity lies in sharing and making care pathways more visible, so that every patient knows how to reach the treatment they need in time — especially when time is decisive, as it is in oncology.”

— Alejandra Toro, Founder of Corporación Luz Rosa

Behind every month of waiting there are patients who need an answer. Closing the 5.7 years that today separate innovation from those who need it requires turning evidence into action, strengthening health systems and moving toward decisions that enable more timely and sustainable access.