Brasília – Brazil’s Clinical Trials Law, enacted in 2024 to modernize the country’s clinical research framework, is now under review by the Supreme Federal Court (STF) following a constitutional challenge filed by the Brazilian Society of Bioethics (SBB).

The case questions provisions that transfer post-trial treatment obligations from pharmaceutical sponsors to the Unified Health System (SUS) and create a new oversight body, the National Ethics in Research Instance (Inaep), replacing the National Research Ethics Commission (Conep). The SBB argues that these changes weaken ethical oversight and could increase financial pressure on the public health system.

The Ministry of Health has confirmed that the law’s implementing decree is in the final drafting phase at the Chief of Staff’s Office, with publication expected soon. Government sources indicate that the judicial action will not delay the regulation’s release.

Supporters of the law, including Interfarma and ABRACRO, argue that the reform enhances legal certainty, accelerates approval timelines, and positions Brazil as a more competitive hub for clinical research. They project that the new framework could attract foreign investment, create high-skilled jobs, and expand patient access to innovative therapies.

Source: Futuro da Saúde

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