The Brazilian pharmaceutical market is the third largest in the Americas region, behind the US and Canada; it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuelled by increasing disposable income. Despite this positive outlook, the trade deficit in Brazil grew from US$700 million at the end of the 1980s to a cumulative US$7.13 billion in 2008. In 2008 alone, Brazil imported US$1.4 billion in vaccines, serum and blood products, while exporting US$37 million in medicinal products with low added value.
In Brazil, the Unified Health System (Sistema Único de Saúde, SUS) and the policy of the Ministry of Health (Ministério da Saúde, MS) according to decree GM/MS No. 2.981 of 26 November 2009 grants access to the general population to specialized medicines including some biologicals.
Expenditure on medicines as a whole, and specialized medicines, is constantly increasing in Brazil, see Figure 1. In 2011, 31% of the total amount spent on medicine was for specialized medications including biologicals.
Expenditure on strategic medicines, on the other hand, has reduced. The list of strategic medicines under the SUS is defined according to Decree GM/MS No. 1.284 of 26 May 2010. Strategic drugs are defined as those of higher value, i.e. costing the Brazilian Ministry of Health more than R$10 million per year. Examples of strategic products include filgrastim and somatropin.
Figure 1: Spending on medicines by the Brazilian Ministry of Health
There is therefore an urgent need to combat this increasing expenditure on foreign biologicals. How follow-on biological products as they are called in Brazil, might be produced in Brazil is discussed in the following article.
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