With the largest public healthcare system in the world, Latin America’s biggest pharma market, its leading regulatory body, and a huge and diverse population, Brazil is a strategic destination for both regional and global pharma. Read on for five things to watch in 2024 and beyond from this dynamic nation. 

 

Reviving the Union of South American Nations (UNASUR)

As opposed to his predecessor, President Luiz Inacio Lula da Silva is looking to revive cooperation across South America with the UNASUR and in so doing drive pharmaceutical trade across the region. Last year the Brazilian president assembled the first UNASUR summit in nine years and the 12 leaders in attendance signed a pledge of cooperation and for the elimination of unilateral trade measures to eventually reach a South American free trade area similar to that of the EU.

At the summit, President Lula highlighted the need for convergence across the region’s highly fragmented regulatory landscape, as well as simplified processes for pharmaceutical imports and exports. These measures stand to provide fresh incentives for Brazil’s pharma industry, already the largest in South America, generating about USD 14.7 billion in sales per year and with several strong local players.

Another issue emphasized at the summit is the need for a coordinated response to infectious diseases across the region after almost 43 percent of the world’s Covid-19 deaths were found to be in Latin America and the Caribbean.

 

Regulatory Progress: Anvisa Approves Foreign Regulatory Assessments

Long accused of having a lengthy and bureaucratic regulatory processes, Brazil has seen a major regulatory milestone that stands to reduce approval periods and boost the Brazilian National Health Surveillance Agency’s  (ANVISA) alignment with other regulatory agencies. In March, ANVISA established criteria for the use of analyses carried out by an Equivalent Foreign Regulatory Authority (AREE). The new directive applies to the analysis of applications for registration and post-registration of medicines, biological products, and vaccines, as well as active pharmaceutical ingredients (APIs) under the agency’s letter of suitability (Cadifa).

An important step in the Regulatory Reliance Programme, the AREE criteria provide a simplified process for products that have been approved by foreign regulators with regulations and practices equivalent to those of ANVISA, including the European Medicines Agency (EMA), Health Canada, the World Health Organization (WHO), Swissmedic, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) in Australia.

 

New Momentum for Clinical Research

Known for its diverse population –more than 50 percent of Brazil’s people claim multiple ethnical origins– and speedy recruitment processes, Brazil offers unique strengths for clinical trials and a new clinical research law,  Clinical Research Law 14.874/24, stands to streamline the assessment process and reduce bureaucratic obstacles.

Approved in May by Brazilian President Luiz Inacio Lula da Silva, the new law aims to provide a more efficient regulatory pathway for clinical trials in the country giving ANVISA 90 business days to respond to clinical trial applications. In addition, it streamlines the ethical review process, requiring the review of just one local ethics committee in order to start a trial, and adds clearer rules to existing regulations.

 

A Burgeoning Biotech Scene

Brazil’s healthcare biotechnology landscape appears to be thriving. In the recent Guide to Biotechnology Healthcare Start-ups in Brazil prepared by Brazilian pharmaceutical industry association, Sindusfarma, the Brazilian Pharmaceutical Innovation Network (RBIF), and Biominas Brasil, some 40 companies are profiled with expertise in areas as varied as dermatology, medical devices, chronic diseases, rare diseases, oncology and genetics.

Predominantly present in the country’s southeast, particularly in major cities like São Paulo and Rio de Janeiro, Brazil’s biotech start-ups to a large degree remain reliant on public funding with 30.2 percent of startups benefiting from governmental support.

A significant 54.93 percent of the participating companies are in the validation phase, where their technologies undergo rigorous testing to confirm that their foundational principles work under specified conditions while 19.72 percent are in a traction stage and 18.31 percent have reached a scale-up stage of development.

 

Continued Investment

Global pharma clearly understands the potential of the Brazilian market and of the country as a regional hub. In recent votes of confidence, the European CNS specialist Neuraxpharm announced that it would be establishing an affiliate in Brazil, as well as one in Mexico, as its first step towards expansion beyond Europe. Having acquired Sanofi’s portfolio of CNS products which includes one neuroleptic and three antipsychotic products in Brazil, Neuraxpharm also bought out the Brazilian company Libber Pharma to secure distribution and commercialization across the country.

Merck also chose Brazil as the location of its new EUR 20 million distribution centre. After already maintaining a facility in Cotia, São Paulo, the new site in Cajamar, São Paulo will provide 2.5 times more storage capacity.

And, like Mexico, Brazil could also stand to benefit from North America’s post COVID-19 push for nearshoring.