The Pharmaceutical Industry
Brazil is the world's ninth-largest market for pharmaceuticals and drugs and important companies have operations in the country. Brazilian companies lead the domestic market in sales and invest heavily in research, backed by the power of generic drugs. Generic drugs are those for whom the patents have expired and which can therefore be sold without a brand label, at cheaper prices.
According to Brazil's Ministry of Health, the pharmaceutical market is worth R$ 28 billion a year and is expanding. Among the six largest pharmaceutical companies in the world, four are Brazilian and their production of generic drugs is growing rapidly. Currently there are around 540 pharmaceutical companies registered in Brazil, and 90 produce what are known as 'similar medicinal products.'
Brazilian companies produce the most such similar medicinal products, which have the same characteristics and quality of the reference product, but are not interchangeable. Generics account for 20.6% of sales on the Brazilian pharmaceutical market.
Despite the progress made in the sale of generics since the launch of the program - from 1999 to 2009 - the production of reference drugs made by foreign-owned multinationals with operations in Brazil is still greater than the production of generics and similar medicinal products. This is down to heavy investment in research at these companies' high-tech centers.
The advantages of buying generic drugs range from price - they are at least 35% cheaper than the reference products - to the strengthening and development of the domestic industry through market growth.
As a result of policy backing, generic drug sales are growing, as are new product launches. In 2009, similar medicinal products had a 19.2% share of the pharmaceutical market in Brazil. Between 2002 and 2009, total sales jumped from R$ 588 million to R$ 4.8 billion. In this same period, the number of products registered rose from 213 to 2,972.
The Brazilian market today offers generic drugs for the treatment of a variety of health problems, such as for cardiovascular disease, ant-infective drugs, digestive and metabolic conditions, and central nervous system problems.
The domestic industry also produces hormonal and non-hormonal anti-inflammatory drugs, drug treatments for dermatological, respiratory, urinary tract and sexually transmitted diseases, ophthalmological conditions, anti-thrombosis and anemia treatments, drugs to treat parasite-related conditions and cancer, and contraceptives.
Companies interested in manufacturing and importing generic drugs in Brazil must meet certain basic requirements. The documentation required to apply for registration at the National Health Surveillance Agency (ANVISA) is in Resolution No. 135, of May 29, 2003.