Tips for Entering the Life Sciences Market in Brazil
For life sciences companies, Brazil’s market offers both an abundance of business opportunities and a myriad of on-the-ground regulatory compliance challenges for new entrants. Getting the market-entry strategy right will mean the difference between success or failure.
With a population of more than 200 million people and representing the largest healthcare market in Latin America, Brazil is a lucrative market for the life sciences industry. Its burgeoning healthcare IT market equally offers lucrative new business opportunities.
In 2020, the Ministry of Health issued its “National Digital Health Strategy,” which aims to boost the integration of digital health solutions in the country’s public Unified Health System (SUS), which is “the primary provider of health services to at least 70% of the population,” according to the International Trade Administration (ITA). “Private hospitals are also investing in technology, and several new hospitals are formalizing their progress by obtaining international certificates for data management,” the ITA said.
The global COVID-19 pandemic has also brought about new business opportunities for the life sciences industry. As ITA noted, “Brazil temporarily approved the use of telemedicine in several areas, which should help speed up efforts to implement and broaden the use of digital solutions for healthcare consultation, diagnostics, and treatment.”
Regulatory Complexities
Alongside the business opportunities, Brazil also brings with it an abundance of market-entry regulatory compliance challenges unique to the region, unlike anyplace else in Latin America. “Different languages, cultures, and colonial backgrounds distinguish Brazil from neighboring countries,” said Benny Spiewak, a partner at SPLAW and chair of its Life Sciences practice.Additionally, Brazil’s economy and population are primarily internally oriented, so its culture is less prone to rely on foreign companies, Spiwak added. “Brazilians are familiar with and accustomed to local brands and culture,” he said. “If your company is unwilling to adapt, Brazil may not be your market.”Brazilian life sciences companies must navigate several regulatory hurdles for the approval of their products as well. Healthcare products—for example, pharmaceuticals and medical devices—are subject to strict regulation by federal and regional authorities,” Spiewak said.Not only that, Brazil has in place stringent consumer rights protections as it concerns access to healthcare and affordable drug prices, for example. Companies not in compliance with regulations may be subject to harsh administrative penalties. “Regulatory and consumer rights compliance is essential to conducting business in Brazil,” said Marco Aurélio Torronteguy, a partner in TozziniFreire’s Life Sciences and Healthcare practice group in São Paulo.So, it is not surprising that life sciences companies entering the Brazilian market for the first time often cite Brazil’s unique market nuances and the navigation of its regulatory complexities as significant obstacles.
Developing a Market-Entry Strategy
Before a life sciences company can enter the Brazilian market, it’s important to have a thorough market-entry strategy in place that necessarily requires multiple steps. “It is crucial to plan the corporate, regulatory, and operational aspects in advance, in coordination with the company’s headquarters abroad, with aligned steps and a detailed timeline,” Torronteguy said.
