Brazil: A 200,000,000 People Healthcare Market with Great Opportunities for Innovative Pharmaceutical Companies.

Friday, February 27, 2015

Brazil, a signature country of South America just surpassed 200 million residents. It is the main economy in Latin America and one of the most important at world level, regionally considered industrialized in spite of the variety of income, from very low in rural and peripheral areas, to very high in the most populous cities. Taking in consideration that Brazil has more than 15 cities with over 1 million people and 38 over 500.000, being the Sao Paulo the most populated city in Latin America, with a metro population of 20 million people.

The health system is universal and available to all citizens for free and financed by the state, with an extensive use of other non-vital health products related, like cosmetics and alternative medicine and aesthetic surgery. Private medicine is well developed for the people with higher income mostly wanting a better and faster service. Research also demands an important investment by the government and universities, particularly related to tropical diseases. For citizens, healthcare comes in 3rd place as priority after home ownership and quality education1.

The healthcare market spends annually almost 138 billion USD, with 54% of that amount in the private sector. Local private laboratories have the highest profit in this area and they already are aware of the high bureaucracy involved to get the approval of any new product to market.

The government agency ANVISA (National Agency for Sanitary Control) was created in 1999 and is dedicated to the control of all matters related to health regulation as well as market regulation in healthcare. Being mostly independent in management and budget, the organization is anyway closely related to the directives of the Brazilian Health Ministry.

ANVISA embraces many issues related to healthcare, such as approval of the commercialization and control of:

New pharmaceutical products and recommendation for its use in state sponsored lists for patients
Regulation of healthcare product's importing
Laboratory testing
Cosmetics
Food and supplements
Bioequivalence of new drugs in comparison to those ones already approved and used in the health system
Health providers
Tissue, blood and organ use for transplantation.
Sanitary control at airports, ports and borders.

As any of us can imagine, having a product approved for commercialization here can mean a fast exponential growth for any pharmaceutical company. To introduce any new product it is necessary to register it and get the approval of ANVISA. Currently, the organization manages too many healthcare issues other than this so the process for foreign companies of any size is time and money consuming without the proper knowledge of the process, language and idiosyncrasy of the Brazilian public sector. According to the Brazilian Research and Development Institute of Pharmaceuticals, the approval of a given product can take in average more than 15 months, even if previously approved in other countries by agencies like FDA3. Companies trying to introduce a new product can have a real headache learning the right way to register, losing time and money in the process.

Counseling companies4 for medium and bigger investors in pharmaceuticals and related healthcare products are a great way to facilitate the insertion of a new product through the knowledge of regulatory affairs and step by step guide in this process with ANVISA, saving money, time and risks (and nerves) when entering a competitive market like this. Counseling companies overview every point including market and distribution studies, authorization to carry out a preliminary analysis, audit and identification of required certifications, determination of fees for necessary registration or notifications, monitoring and securing a business environment and the procedures for registration, that include filing and following up with relevant agencies.

One of the firms advocated to assisting new game players include Mandala International and their Brazilian branch, which in a recent interview the chairman Stephan Fontanel commented that “most of our companies that come seek our services are companies that tried to register a product in Brazil by themselves and realized it is far from being a peaceful walk at the park”

Currently, important facts that attract foreign pharmaceutical companies to invest in this extensive market in spite of the ANVISA bureaucracy and regulations include:

Improving living standard of the population.
The population is growing older, with the related needs of medical treatment.
Progressive organization and better regulation of the healthcare industry, which benefits foreign companies.
Higher investment in technology and communications.

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