From cancer treatments to cardiovascular drugs, access to innovative medicines in South America lags behind developed market norms with patients forced to endure considerable delays for therapies that are already considered global standards. According to the Waiting to Access Innovative Therapies (W.A.I.T.) Indicator from FIFARMA, an association representing research-based pharma in the region, Latin American patients must wait 5.6 years on average to access new therapies.
“This delay reflects two major systemic issues,” explains Yaneth Giha, the association’s executive director. “First, regulatory approvals take roughly 3.5 years. Then, it’s more than two and a half years more before those medicines actually appear in the marketplace and start to reach the patients that need them.”
“It’s important to distinguish between regulatory and access timelines,” concurs Renato Porto, President of INTERFARMA, an association representing innovator drug developers in Brazil. “That is because the real bottlenecks tend to be not so much down to regulatory performance per se as the incorporation processes and steps that follow the market authorisation such as purchasing,” he explains using the region’s largest and most influential market as an example. “Brazil is actually an internationally renowned leader in regulatory quality with the nation’s regulatory authority, ANVISA, globally recognised as a technically strong agency,” he points out, “yet the time taken for Brazilian patients to gain access to new medicines nonetheless still mirrors the broader Latin American reality of upwards of five years.”
Moreover, though numerous Latin American countries profess to have properly implemented cradle-to-grave-style universal health coverage, many of the contemporary crop of next-generation, advanced medicines only reach the private sector, where they must be paid out-of-pocket or via private health insurance plans, thus limiting access to only the privileged few. “The paradox in markets like Brazil is that, though they might claim to possess universal healthcare rights for all, actual access proves far less universal than they aspire to achieve,” confirms Rogerio Frabetti, general manager of Biogen’s Brazilian affiliate.
Indeed, when examining the region holistically, a sobering picture emerges. “Public healthcare systems still lack access to transformative medical technologies, particularly in therapeutic areas like oncology, where state-of-the-art, breakthrough therapies have been developed that carry an elevated price tag,” observes Alexandre Gibim, VP for Latin America at AstraZeneca. “Whilst vaccines achieve near-universal coverage and certain primary care products and established medicines demonstrate broad availability, individuals confronting cancer diagnoses unfortunately remain distinctly underserved in most of the region’s jurisdictions,” he adds.
This reality is also reflected in the business models of many pharma companies. “Approximately 90 percent of our sales flow through retail channels rather than institutional procurement,” acknowledges Gianclaudio Broggi, CEO of Megalabs, one of Latin America’s largest biopharma entities with operations spanning more than 20 countries and a workforce exceeding 9,000 employees. “While we do participate in tenders across Uruguay and Colombia through their public health systems as well as in Chile, and certain Central American markets, this does not constitute our primary business model. Our commercial focus centres predominantly on out-of-pocket retail purchasing because of the structure of the markets in question.”
Even more concerning, some advanced therapies never make it at all. FIFARMA calculates that a mere 36 percent of global medicines are currently available in the region. A 2024 study from the Pan American Health Organization (PAHO), meanwhile, 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.
Chronic Underinvestment
Much of the region’s access problem stems from a fundamental issue: inadequate healthcare investment. Compared to OECD countries, Latin America spends considerably less on health, resulting in high out-of-pocket costs and a strained system. “In Mexico, for instance, healthcare spending remains at just 5.5 percent of GDP, well below the OECD’s recommended 9.2 percent,” notes Karla Alcazar, SVP and president for LatAm at Eli Lilly, “And while countries like Brazil and Colombia might invest a bit more, they are still well below that benchmark as well.”
“Frankly, though there has been a concerted effort on the part of policymakers to increase the volume of investment and government budget allocated to advanced therapies, this remains insufficient,” laments Biogen’s Frabetti. “New molecules, products, and clinical trials are accelerating the identification of diseases and treatments far more rapidly than governments and payers can adapt their budgets, so affordability constitutes a constant and relentless challenge,” he explains.
Meanwhile, the region’s below-par economic performance has also narrowed the options available to governments. “Historical analysis reveals that major healthcare advances coincided with periods of robust economic growth. Universal healthcare expansion accelerated when Latin American economies grew at six to eight percent annually, facilitating increased health investment without raising GDP percentage allocations. Current economic reality – approximately two percent average growth – constrains such straightforward expansion,” remarks Roche’s LatAm Area Head Rolf Hoenger.
For many market insiders, the way out of this conundrum is to fundamentally reposition how health spending is conceptualised. “Most policymakers out here still consider rising pharma and medtech spending as an unwanted cost and burden, rather than a proactive strategic investment in a better future,” explains Constanza Losada, VP and general manager for LatAm at BMS. “Yet research from McKinsey suggests that every US dollar invested in health yields two in economic return, and that a well-capitalised healthcare system can deliver important competitive advantages such as enhanced productivity,” she continues.
“There can be absolutely no doubt that healthcare investment yields higher GDP growth, but the question remains of how to convince finance ministers to allocate greater budgetary proportions to enable this repositioning to happen,” muses Sinan Atlig, president of the LatAm Cluster and emerging markets chief commercial officer at Pfizer. “Innovative drug developers should work collectively with Health Ministers to demonstrate that this investment merits real prioritisation, building use cases collaboratively to strengthen their position during budget cycles,” he believes.
“The greatest opportunity lies in elevating governmental awareness that addressing non-communicable diseases enhances national economic performance while simultaneously avoiding greater financial burdens further down the line. Demonstrating this through quantitative evidence constitutes our collective responsibility as an industry,” affirms Hoenger.
BMS, for its part, has made a point of engaging with the region’s key decision-makers to this effect. “We present them with real-life examples of the integral value of innovation, illustrating how treatments in oncology or cardiovascular disease can reduce hospitalisation, prevent long-term complications, enable patients to return to productive lives, and ultimately generate positive returns for society,” details Losada.
Managed Access Pathways
At the same time, innovative drug developers have been promoting public-private collaboration and transformative access models to create the requisite budgetary capacity and ensure that health investments deliver economic and social impact. “It’s imperative to expand the use of managed access agreements: whether that be risk-sharing models, outcome-based contracts, or real-world evidence frameworks that align value, affordability, and long-term sustainability. These tools are essential for enabling responsible access to breakthrough therapies that simultaneously contribute to health system sustainability,” posits INTERFARMA’s Renato Porto.
Already, there are isolated instances of this occurring in markets such as Brazil. “One compelling exemplar is our recently executed risk-sharing agreement with the Sistema Único de Saúde and the Ministry of Health, enabling gene therapy access through the public system. This demonstrates how cutting-edge innovation, representing the apex of genetic therapeutic technology, can reach patients sustainably within the healthcare ecosystem,” recounts Sylvester Feddes, country president of Novartis’ Brazilian affiliate.
French midcap Servier has also been exploring performance-based contracts, where reimbursement is linked to clinical outcomes. “In our discussions with the authorities, we’ve been formulating scenarios whereby our oncology treatment could be paid for only once it delivers the survival benefit demonstrated in trials,” explains Matthieu Mendil, general manager for Servier Brazil.
Unfortunately, one of the reasons why such initiatives are not yet more widespread across Latin America is that the underlying supporting infrastructure is all too often absent. “We occasionally observe governmental reluctance to invest in data collection infrastructure necessary for these agreements to function effectively. Depending upon specific indications, authorities gravitate toward traditional negotiation frameworks, expressing uncertainty regarding their capacity to provide requisite data systems. Some managed entry agreements are operational – not all publicly disclosed – but opportunities remain substantially underutilised,” confides Roche’s Rolf Hoenger.
Regulatory Reform
Indeed, the lack of capabilities within some Latin American countries to conduct proper health technology assessments and pharmaco-economic evaluations ultimately compromises their ability to ensure optimal resource allocation. “In many instances, outdated and costly therapies still consume significant public resources that could potentially be redirected toward new treatments without expanding healthcare budgets, but such decision making requires sound data collection and processing,” opines Mendil.
“We must ensure health systems execute economically rational decisions that optimise outcomes relative to available resources,” agrees Hoenger. “When innovation delivers superior patient outcomes with demonstrable socioeconomic benefit – not merely clinical benefit – expedited registration and access serve national interests far more effectively, so it is to the benefit of all states to develop advanced health technology assessment (HTA) competencies that can swiftly calculate the true value of innovative medicines,” he insists.
“Currently. most HTA bodies across Latin America experience resource constraints and operational challenges that limit their effectiveness. The Mexican regulator COFEPRIS, for instance, still uses many manual processes. Transitioning to digital systems would accelerate these workflows, reducing approval times and improving access to innovative treatments,” believes Eli Lilly’s Karla Alcazar.
Thankfully, tangible progress is being made by some of the region’s other leading regulators. “Our new digital platform shall introduce automated risk-based categorisation for applications, enabling low-risk products to be processed almost instantly while reserving human review for complex or high-risk dossiers. This will drastically reduce waiting times and increase traceability across the workflow,” enthuses Francisco Rossi, director of Colombia’s National Food and Drug Surveillance Institute (INVIMA). “Too often, regulatory debates become legalistic – about procedures rather than substance. We’re determined that technical evaluations are carried out rigorously by qualified experts, in separate tracks from the procedural side,” he declares.
Meanwhile, the Brazilian regulator, ANVISA, has advanced beyond basic digitisation to implement artificial intelligence solutions that are currently undergoing large-scale testing. “One notable application involves AI-powered evaluation of company authorisation processes, transforming individualised analysis into optimised, AI-enhanced assessments. This innovation delivers substantial efficiency gains while maintaining analytical rigour,” assures Romison Rodrigues Mota, the organisation’s director.
Reliance and Convergence
Another promising path seeing progress is regulatory reliance — a mechanism whereby 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 World Health Organization in 2021. Brazil’s ANVISA has subsequently emerged as a leader in this area, launching the region’s first regulatory reliance framework and participating in collaborative evaluation projects, notably the FDA’s ORBIS oncology initiative, which has led to 40 collaborative application approvals.
“Countries sometimes perceive reliance as compromising regulatory independence, when in reality, they recognise other agencies’ work while maintaining national regulatory authority. This conceptual evolution is essential for regional progress on market access,” reflects FIFARMA’s Yaneth Giha. “ANVISA exemplifies successful reliance implementation, having pioneered Latin America’s first regulatory reliance guidelines for new market authorisations. Their comprehensive approach has inspired other regional agencies and established cooperation agreements with the European Medicines Agency to enhance information sharing and strengthen regulatory practices,” he adds.
Meanwhile, tangible progress is being made towards establishing a regional medicines regulatory agency for Latin America and the Caribbean – similar to what the European Union and African Union have achieved. “This is a long process requiring convergence on standards, tariffs, and border issues, but it’s already yielding fine results. Colombia, Mexico, and Cuba are collaborating closely,” explains INVIMA’s Fransisco Rossi.
Indeed, a new Latin American Medicines Agency (AMLAC) was recently established, allowing authorities to harmonise regulatory practices and share inspections. For example, if INVIMA and COFEPRIS conduct a joint inspection and agree on findings, they can mutually recognise those inspections, avoiding duplication and facilitating regional trade. This type of convergence benefits regulators, companies, and ultimately patients with the organisation’s first pilot projects focusing on over-the-counter medicines and inspection protocols, setting the groundwork for broader cooperation across complex therapeutic areas.
“The trend is clearly toward regulatory convergence rather than full harmonisation. Instead of waiting to agree on every detail, we’re focusing on practical collaboration – joint inspections, shared data, mutual recognition, and standardised processes where possible. This pragmatic approach allows us to move faster and deliver tangible benefits for local and regional industries,” explains Rossi.
“As convergence deepens, Latin America’s pharmaceutical sector will likely become more competitive and integrated. We expect to see shorter registration times and better alignment with global standards,” he predicts.
