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.
To continue reading, you need a subscription to WIPR. Start a subscription to WIPR for £455.
In-house feature articles, the archive and expert comment require a paid subscription. Subscribe now.
Want to give it a try? We are offering a two week free trial to the WIPR website – register and select “Free Trial” to begin access to the full WIPR archive and read the latest news, features and expert comment. Begin your free trial here.
Is your 2 week free trial about to end? Upgrade to a 12 month subscription for £455 now.
If you have already subscribed please login.
If you have any technical issues please email James Lynn on firstname.lastname@example.org.
Data package exclusivity, pharmaceuticals, Brazil, ANVISA