CATPROS: New Sanitary Agency to Advise Courts in Health-Related Proceedings

On September 11, 2023, the Ministry of Health issued the Decree 468/2023 creating the Technical Assistance Committee for Judicial Proceedings (CATPROS). CATPROS is an advisory and permanent agency tasked with providing technical assistance to federal and local courts on judicial proceedings in which a party requests treating rare diseases or special pathologies using innovative drugs or procedures, or medical technologies, within the scope of Law 26,689. CATPROS’ reports will be non-binding and issued prior to partial or definite rulings.

 

1. Purpose and Grounds

 

The agency will assess the effectiveness of medicines and treatments for preventing, diagnosing, and treating rare diseases, when such medicines are requested through judicial proceedings.

 

The Decree states that this agency is necessary because such drugs or technologies are often approved “under special conditions”, at early stages of their development, thus the need to assess their effectiveness, safety, and quality.

 

2. Proceedings

 

The request for CATPROS assistance will be optional for the intervening courts, and its opinions will be non-binding.

 

CATPROS will issue a report within the timeframe established by the intervening court, who will consider the complexity of the matter under assessment, the severity and/or urgency of the individual case, and the nature of the proceeding. If the court does not determine a specific timeframe, the agency will issue its reports following the Federal Procedural Code.

 

3. Powers Granted to the Agency

 

The agency will be vested to:

1. issue non-binding opinions for individual proceedings,
2. require the production of complementary clinical information,
3. inform of the risks and side effects of the technology or drug under assessment and recommend that a periodic report of the patient’s health evolution is made, among other measures it may deem adequate for following up individual cases.

 

4. Integration

 

CATPROS will be made up of five healthcare professionals:

1. Three members of the Argentine Ministry of Health.
2. One member of the Argentine Agency of Medicines, Food and Medical Technology (ANMAT).
3. One member of the Superintendence of Health Services. 

 

5. Effective date

The Decree will become effective 30 days after its date of publication, i.e., on October 11, 2023.