A leading decision enforcing data package exclusivity for pharmaceuticals for human use reveals the positive impact of enforcing the rule on widening access to medicine in Brazil.
A leading decision rendered by a Brazilian federal judge enforcing data package exclusivity for pharmaceuticals for human use demonstrates the Brazilian government’s attitude towards eight private companies and reveals the positive impact of enforcing the rule of law on widening access to medicine in Brazil.
When Federal Trial Judge Jose Marcio da Silveira e Silva issued his ruling on the enforcement of Lundbeck’s data package exclusivity for its Lexapro drug against two powerful family-owned Brazilian companies and ANVISA, both parties and the association of generics industries immediately voiced concerns that the Brazilian population would suffer from lack of affordable medicine.
Their arguments can be summarised as follows: Silva’s decision will spark thousands of new lawsuits, with negative impacts on public health, public order, the national treasury and the national budget, and will also impair national pharmaceutical policy, as well as resulting in negative consequences for access to drugs in Brazil.
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Data package exclusivity, pharmaceuticals, Brazil, ANVISA