Foreign Corrupt Practices Act

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.

Below are some practical steps to consider:

Choose a location of incorporation. To obtain marketing authorization in Brazil for pharmaceutical products, medical devices, or other products linked to the life sciences industry, manufacturers and/or distributors must be incorporated in the country. Because Brazil is a federation with its own federal, state, and municipal laws, it’s important to consider in advance what region to incorporate, said Fabio Alonso Vieira, founding partner at Kestener & Vieira in São Paulo. In the life sciences industry, many companies have headquarters in São Paulo or Rio de Janeiro, and then branch out to other cities as the business expands and develops, he said. “Branches can be opened in warehouse centers, duly set-up by third parties/service providers, across the country.”

Develop a business model and strategy in advance. Another pre-market step is to decide in advance what products the company intends to manufacture or distribute—both in the near-term and in the future. “Making projections about the future will help you avoid regulatory or bureaucratic delays in approvals in obtaining certifications or licenses from authorities, both for companies and products,” Vieira said.

Develop and nurture on-the-ground partnerships. Partnerships are not only highly valued in Brazil, but also are necessary for succeeding as a life sciences company in the country. If you wish to start doing business in the life science industry in Brazil, look for a local partner who meets the necessary conditions for distributing and marketing products in Brazil, Vieira advised.

“Because you must have a physical presence in Brazil to hold marketing authorization, what we do is hire a certain kind of company to obtain the marketing authorization of the product or enter into a distribution agreement with a local partner who will hold the marketing authorization during the agreement,” Vieira said. Seeking the help of a local distribution partner in Brazil is another recommended step, he said.

Obtain necessary permits and licenses. Brazil’s National Health Surveillance Agency (ANVISA) is a self-governing regulatory body linked to the Ministry of Health, equivalent to the Food and Drug Administration in the United States. The complexity of obtaining licenses from ANVISA depends on the nature and complexity of the product, Vieira said.

Vieira recommended seeking the help of a regulatory advisor or a Brazil-based law firm advise the company from the get-go in terms of helping with obtaining the necessary licenses. Seeking the help of a local external party can also help with other nuanced compliance requirements—for example, how to handle sponsorship agreements or providing free samples to healthcare professionals. Vieira further recommended having a tax analysis done, “because depending on the region or country, some states or municipalities will be able to grant you tax benefits.”

Consider a productive development partnership (PDP). The Brazilian government is the main buyer of healthcare products supplying the public healthcare system. “Foreign companies can participate in bids as long they have local representation, with some exceptions,” the ITA said.

A PDP is a way for foreign private life sciences companies to participate in the government bidding process in Brazil by partnering with a local laboratory. Using an example of a drug company, that company enters into a partnership with an already established Brazilian pharmaceutical company, and a state-funded research institute.

Through this partnership, the foreign drug company transfers its production technology to the Brazilian pharmaceutical company and research institution for a specified period of time—five to 10 years, for example. During that time, the foreign drug company receives a certain amount of royalties against the share of sales.

The goal is for a technology transfer to take place at the end of the contract, enabling the private company to take control over the manufacturing and commercialization of the drug within Brazil. ITA recommends, however, that companies “be well-prepared and fully investigate all terms before committing to a PDP.”

Have in place a strong anticorruption compliance program. According to Transparency International’s 2022 Corruption Perceptions Index, Brazil ranked 94 out of 180 countries, with a score of 38 out of 100, which points to a region that poses an elevated risk for bribery and corruption. Brazil’s high regulatory burdens in the life sciences industry exacerbate the risk. Thus, companies wanting to enter the region should already have in place robust anticorruption policies, procedures, and internal controls, and ensure employees are trained to identify and report to the compliance function any red flags while doing business in the region.

Have patience, and plan for the long-term. Obtaining all the necessary licenses and approvals, including product approval, to be able to manufacture or distribute a drug or medical device in Brazil will take at least two years from start to finish. Obtaining a corporate license, for example, will take approximately six to nine months, while receiving marketing authorization for a product will take approximately an additional two years, “so, it’s a long-term business plan,” Vieira said.

Appreciating Brazil’s unique market-entry challenges and creating a plan in advance are critical factors for success, alongside building partnerships on the ground. Being successful in the Brazilian market as a life sciences company demands “adaptability and planning,” Spiewak said. “Ultimately, Brazil may not yet be for you if taking the time and investing in planning is not an option.”

ACI will be holding its “FCPA & Anti-Corruption for the Life Sciences Industry” conference, taking place May 10-11, in New York | For more information, please visit:
https://www.americanconference.com/fcpa-life-sciences/

For questions, concerns or more information about ACI Insights, please contact:
Chris Corbin
Associate Director of Marketing
American Conference Institute | The Canadian Institute | C5
E: [email protected]