Addressing Medicine Access Challenges in Brazil: The Role of Named Patient Supply

Despite Brazil's Universal Health Policy, accessing high-cost treatments for rare diseases and cancer remains a significant challenge. This analysis examines the barriers to obtaining critical medicines in Brazil in 2024 and explores practical solutions, such as named patient supply, to bridge these gaps. Discover how healthcare providers and patients can access life-saving drugs that are either unavailable locally or prohibitively expensive.

The Cost of Medicines in Brazil

In Brazil, 78% of the population relies solely on the public healthcare system (SUS), while 22% has additional private insurance coverage. Before any medication becomes accessible—whether through SUS, private insurance, or out-of-pocket payments—it must undergo regulatory evaluation by ANVISA (Brazilian Health Regulatory Agency). ANVISA ensures safety and efficacy, while the Pharmaceutical Market Regulation Chamber sets price limits. However, recent price caps on new treatments have further restricted access to these therapies.

Key Barriers in Brazil’s Healthcare System

Despite its commitment to universal healthcare, Brazil faces several challenges in providing equitable access to essential and innovative medicines:

1. High Costs for Rare Disease Treatments
   Treatments for rare diseases are often excluded from SUS coverage due to their high costs and limited clinical evidence proving their superiority. This leaves patients without affordable options.
2. Delays in Accessing New Cancer Medicines
   In addition to ANVISA approval, cancer medicines require further clearance from CONITEC (for SUS coverage) or ANS (for private insurance), creating delays in patient access to potentially life-saving drugs.
3. Uneven Distribution of Essential Medicines
   Regional disparities in public pharmacies contribute to inconsistent availability of essential medicines, with some areas experiencing acute shortages.

Solutions to Address Medicine Access Challenges in Brazil

1. Named Patient Imports
   ANVISA permits individuals to import unapproved medicines for personal use under Resolution RDC 81/2008. Patients can apply for this provision with a valid prescription and supporting documents demonstrating the drug’s approval in its country of origin, as well as its efficacy and safety. This enables access to innovative or affordable medicines that are otherwise inaccessible in Brazil.
2. Legal Action for Healthcare Rights
   Brazil’s constitutional “right to health” empowers citizens to file lawsuits against the state when life-saving treatments are not covered by SUS. Courts often rule in favor of patients, compelling the government to fund these treatments. This approach has been instrumental in providing therapies for conditions like Mucopolysaccharidosis and Fabry disease.
3. Promoting Generic Medicines
   Generic drugs offer a cost-effective alternative for Brazil’s low- and middle-income populations. Advocacy for compulsory licensing of patented drugs, such as Sofosbuvir for Hepatitis C, could pave the way for affordable generic production in Brazil, significantly reducing treatment costs.

A Strategic Path to Better Medicine Access in Brazil

To enhance equitable access to medicines, Brazil must prioritize the following:

1. Increased Public Healthcare Funding
   Allocating more resources to SUS can help mitigate medicine shortages and ensure funding for innovative treatments, reducing the reliance on legal interventions.
2. Enhanced Access to Generics
   Strengthening Brazil’s manufacturing capabilities and approving generics from international markets can lower costs for life-saving treatments, making them more accessible to the public.
3. Raising Awareness of Expanded Access Programs
   ANVISA's provisions for importing unregistered medicines for personal use through the Expanded Access program offer a lifeline for patients. Promoting awareness of these pathways can empower more individuals to seek treatments unavailable in Brazil, fostering greater health equity.

Supporting Patients Through Named Patient Supply

Named Patient Imports are a critical solution for addressing Brazil’s unmet medical needs. By leveraging global networks, patients can access high-quality medicines at competitive prices.

At Medspartner, we specialize in named patient supply to Brazil, connecting patients with trusted manufacturers to provide innovative treatments for life-threatening conditions. Contact us today to learn more about our services and how to navigate the process for named patient imports.