Brazilian senate examines rare disease laws

The Brazilian senate has released a list of draft laws in relation to access to rare diseases. In July 2018, the senate approved the National Policy for Rare Diseases in the SUS, making access to treatment for rare diseases part of the scope of the Unified Health System (SUS).

House bill (PLC) 56/2016, which has been approved, states that the policy must be implemented within 3 years, at which time a network for patient access to orphan drugs should be established at union, state and municipality levels.

Draft law 203/2018 aims to provide a temporary registry for drugs used in the treatment of rare diseases that will be valid for one year. This is the time that is taken for ANVISA to complete the registration process of drugs, so the implementation of this bill would mean patient access to treatment is not unduly impeded.

PLS 56/2017 will enable import of prescribed drugs already approved in their home country. Whilst there is a system currently in place that enables patients with serious diseases to access new and experimental drugs not yet registered, this legislation aims to grant patients access to medicines already approved in other countries.


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Published 5. September 2018 in News Brazil