BRAZIL 

On February 23, the Chamber of Deputies approved the initiative that seeks to amend the Organic Law of Health, to provide for the processes of incorporation of technologies to the Unified Health System (SUS in Portuguese) and for the use of drugs whose indications are different from those contained in the registry of the National Health Surveillance Agency (Anvisa in Portuguese). Now, the initiative will be sent to the Executive Branch for its enactment. You may access the text by clicking here.

The initiative seeks to demonstrate scientific evidence on the efficacy, effectiveness and safety of the drug for the new use, with standardization in a protocol established by the Ministry of Health. It also seeks to allow the use of drugs or products recommended by the committee and acquired through international multilateral organizations, such as the Pan American Health Organization (PAHO).

It should be recalled that the text had already been approved in the plenary of the Chamber of Deputies in July 2021, however, a separate vote was requested for amendments to the text, which was held today. In any case, the text was maintained in its original version already approved previously by the Chamber of Senators.