Brazil - Country Commercial Guide
Healthcare

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-01-22
  • Overview
  • Pharmaceuticals and Nutritional Supplements
  • Medical Devices/Health IT

Overview

Brazil is the largest healthcare market in Latin America and spends 9.1% of its GDP in healthcare. Of the approximately 6,500 hospitals, 70% are private. There are approximately 495,000 hospital beds, 96,000 healthcare supplementary services, 432,000 physicians, 144,000 dentists, and 70,000 drugstores.

SUS, the Unified Healthcare System, is the primary provider of health services to at least 70% of the population. In addition to medical diagnostics and treatment, the public system provides free medication for some chronic diseases and promotes national vaccination programs, mostly focused on the elderly and children. In addition to that, the Ministry of Health has been regulating and encouraging the expansion of Complementary and Integrative Practices in the public system, mostly at the municipal level.

ANVISA is the counterpart of FDA and regulates all health-related products. While certain low-risk products may be exempt from registration, it is mandatory to have an importer or distributor for product liability. Also, it is recommended that foreign companies have local technical staff and replacement parts available locally for customer support.

In Brazil, the healthcare market is price-driven, with products that are manufactured in country having a distinct price advantage. Quality is also important, and companies must meet all sanitary registration requirements to sell to the government. Foreign companies should consider cost-saving concepts and make clear the benefits of new technologies in marketing and promotional materials.

An aging population and poor management of resources in the healthcare sector offer opportunities for U.S. products and services.

COVID-19 Impact

By July 2020, Brazil has more than 2 million patients infected with COVID-19, with more than 80,000 deaths, and 1.4M recoveries. Brazil established temporary hospitals in most of the major cities and suffered from the lack of ventilators and personal protective equipment.

Brazilian public laboratories have partnered with international institutions for the development and tests of vaccines and drugs to combat the pandemic. Universities played a key role in R&D for the development of diagnostic kits, drugs and vaccines.

Pharmaceuticals and Nutritional Supplements

Brazil ranks among the top seven markets in size for drugs and pharmaceuticals, with sales of US$ 17.5 billion in 2019 (including taxes – Source: Sindusfarma). Despite the large increase in the strength of the dollar vs. the real, the market grew 10.74 % in 2019 and it is expected that this positive trend will continue.

In 2019, Brazil increased imports by 1.4 percent in medicines and raw materials reaching $7.3 billion. For high value-added medicines, the United States and Europe are the main exporters to Brazil, while China, India, and Ireland are the main suppliers of raw ingredients. Imports of medicines from the United States represented U$1.09 billion in 2019.

Regulations prohibit sales of medicines and medical devices outside of specialized medical stores or pharmacies.

Brazilians recognize U.S. brands as of high quality and are likely to purchase products with a better reputation and with natural appeal. Nutritional products are classified as food and require labels in Portuguese.  Claims are also regulated by ANVISA.

Leading Sub-Sectors

  • Chronic diseases – blood pressure, diabetes, cardiovascular
  • Contraceptives
  • Rare Diseases
  • Generic Drugs
  • Infectious Diseases – HIV and Hepatitis C
  • Weight Loss, Vitamins and Sport Nutrition

Opportunities

The Government of Brazil is the main buyer of healthcare products to supply the public healthcare system. Foreign companies can participate in bids as long they have local representatives, with some exceptions. It is also possible to participate in a Productive Development Partnership (PDP). PDPs are designed to allow international companies to partner with local laboratories to supply the public system for a period of up to five years, with a reserved market share, with the goal of a technology transfer at the end of the contract. Companies should be well-prepared and fully investigate all terms before committing to a PDP.

E-commerce is a growing channel for end-users to acquire imported products if they are for personal use. To reduce returns, sellers should inform customers that Brazilian Customs charges fees to clear imported goods.

Cannabidiol medicines

ANVISA has recently published a regulation that will allow the marketing of CBD in pharmacies and drugstores, through medical prescription and subject to strict quality controls. Any CBD product must be imported from countries where it is legal to produce CBD.

The Commercial Service (CS) cannot provide export promotion assistance for products that are prohibited by U.S. Federal law, including cannabis products within the scope of the definition of “marijuana” under the Controlled Substances Act (CSA). Clients must provide a Drug Enforcement Administration (DEA)-issued export certificate demonstrating that its product is not within the scope of the definition of “marijuana” under the CSA to be eligible for CS’s export promotion assistance. We cannot accept assertions by a client of the legality of their product under state or local laws, nor can we accept a Food and Drug Administration (FDA) Certificate of Exportability as proof that the product is not within the scope of the definition of “marihuana” under the CSA.

Medical Devices/Health IT

The market size for medical equipment is approximately US$ 10.5b (Source: Abimed), an increase of 4.8% in 2019 (Source: ABIIS).

In 2019, Brazil increased imports of medical devices by 5.4%, reaching U$4.6 billion. Imported medical devices corresponds to 80% of the market in Brazil and the United States represents 29% of this share. Brazil is the 14th largest market for U.S. medical devices and second in Latin America, after Mexico. In 2019, U.S. medical device exports to Brazil reached $947 million (Source: Census Bureau, U.S. Department of Commerce - DOC).

2019 Total Imports of Medical Equipment into Brazil

Group of Products

Imports US$ m

% Variation
from 2018

Total of Medical Devices (ABIIS)

4,625

5.4

Material and Equipment for Health (ABIMED)

3,828

8.7

Prosthesis and Implants -OPDE (ABRAIDI)

1.047

1.9

In Vitro Diagnostic Reagents and equipment (CBDL)

758

-9.1

Source: ABIIS

Brazil is part of the Medical Devices Single Audit Program (MDSAP), in conjunction with the United States, Japan, Canada, and Australia for the acceptance of a mutually recognized international audit program performed by a third-party company. This can expedite processes of approval for new products in the country, though ANVISA maintains their fee, in addition to the MDSAP fees.

Leading Sub-Sectors

U.S. companies can be competitive in the Brazilian market when offering high quality products, innovation and lower cost products.

  • Dental Products – implants, equipment, tools, and aligners.
  • Healthcare IT – telemedicine, EMR, interoperability, big data, and AI.
  • Medical Devices – consumables, imaging diagnostic, in vitro diagnostic, implants

Opportunities

For Healthcare IT, the Ministry of Health announced possible investments of more than US$ 450 million by 2019 to digitalize the public basic care units of the country’s Unified Health System (SUS). Private hospitals are also investing in technology and several new hospitals are formalizing their progress by obtaining international certificates for data management and reduction of paper use.

Due to COVID-19, Brazil approved the use of telemedicine in several practices, which should help speed up efforts to implement and broaden the use of digital solutions for healthcare consultation, diagnostics and treatment. Additionally, Internet of Things and Artificial Intelligence is expected to play a key role in the medical field in the coming years.

Contact

Jefferson Oliveira

Commercial Specialist

Healthcare, Life Sciences, and Biotech Sectors

Jefferson.Oliveira@trade.gov