Brasília – A petition submitted to Brazil’s Supreme Federal Court (STF) seeks to suspend the regulation of the country’s new clinical trials law while the court analyzes its constitutionality. The request was filed by the Brazilian Society of Bioethics (SBB) and the National Confederation of Health Workers (CNTS), which argue that the Ministry of Health has advanced the implementation of the new regulatory framework even as a constitutional challenge against the legislation remains pending before the court, under the rapporteurship of Justice Cristiano Zanin.

The dispute focuses on the governance model for ethical review of research involving human subjects, including the creation of the National Research Ethics Authority (INAEP). Critics claim the new structure began operating before its full institutional composition, potentially affecting research oversight. Stakeholders linked to the research ecosystem warn that suspending the framework could interrupt ethical approvals for new studies and create uncertainty for clinical trials conducted in Brazil.

Source: Futuro da Saúde