On May 8, 2025, Law No. 21,743 was published in the Official Gazette, establishing a regulatory framework for the planning, development, and implementation of public policies, programs, and actions related to rare, infrequent, or orphan diseases—those with a prevalence of less than one case per two thousand inhabitants.

Key aspects of the law:

• Guiding principles: Public-private cooperation, protection of personal data, civil society participation, and humanization of treatment.
• Technical Advisory Commission: Will advise the Ministry of Health. Its composition and operation will be defined by ministerial decree.
• List of rare diseases: To be issued by the Ministry with a renewable validity of two years.
• National registry: Will include people diagnosed with these conditions for statistical and research purposes, in compliance with data protection regulations (Law No. 19,628).
• Effective date: The law will enter into force on July 7, 2025, except for the national registry, which will be effective once the relevant technical standard is published.

The Ministry of Health must issue the decree and technical standard within six months of the law's effective date.