The Ministry of Health approved a comprehensive set of regulations intended to discipline the implementation of the Pharmaceutical Assistance Component in Oncology (AF-Onco).

Created by GM/MS Ordinance No. 8,477/2025, this component is part of the National Policy for the Prevention and Control of Cancer (PNPCC), with the mission of qualifying the prevention, diagnosis, and provision of specialized treatments within the Unified Health System (SUS)¹.

The agreement between the Union, the States and the Municipalities sets out guidelines for the distribution of logistical competences, the sharing of high-cost doses and the governance of care data².

The main regulatory guidelines of the new governance of AF-Onco

The package of regulations issued by the Executive Secretariat of the Ministry of Health structures the flow of supply of high-cost oncology drugs under new premises³:

• Dosing and dose optimization centers (GM Regulations No. 11.540 and No. 12.085/2026): They foresee the joint action of federal entities to implement centers that allow the fractionation and sharing of doses among patients from the same region, minimizing the disposal of leftovers and optimizing public spending.
• Flow control and authorization (SAES/MS Circular No. 4,329/2026): regulates the administrative procedures for the request and authorization of therapies by accredited oncology services, reinforcing the traceability of dispensations.
• Exclusive APAC Onco Platform (SAES/MS Circular No. 4,331/2026): it makes the integration of this tool into national information systems mandatory for the individualized monitoring of the administration of medicines.
• Official list of medicines (Joint Order SCTIE/SAES/MS No. 2/2026): defines the standardized relationship of high-cost oncology therapies provided under the component.

The expected impact on litigation and the judicialization of health care

The reorganization of the AF-Onco flow has a direct relationship with the mitigation of judicial litigation in public health.

According to consolidated data from the National Council of Justice (CNJ), Brazil ended 2025 with more than 895 thousand ongoing cases in the health sector, approximately 495 thousand of which are related to the SUS, with a significant predominance of requests for oncological medications⁴.

In this scenario, the expectation of the Pharmaceutical Assistance Coordination Office of the State of São Paulo (CAF/SP) is for a gradual reduction in judicialization as access to oncology drugs and treatments becomes more structured through more clear protocols. As highlighted by the CAF/SP, the AF-Onco contributes to this by establishing more defined rules, distributing responsibilities among the entities, and reducing ambiguities that lead patients to the courts due to administrative failures, rather than a lack of supply.

Reactions from the pharmaceutical industry and suppliers

For laboratories and distributors of oncological technologies, the structuring of the AF-Onco initiative inaugurates a more demanding dynamic of compliance and supply chain management:

• End-to-end traceability: Nominal tracking through the digital platform will require greater rigor in the reconciliation of stocks and batches delivered.
• Contracts and supply models: The creation of regional dilution centers and the direct delivery to federal hospitals and institutions such as INCA require logistical and operational adjustments in public contracts.
• Predictability of demand: The unified planning among the federal entities tends to provide greater predictability for public purchases of innovative therapies.
  
  

The careful monitoring of these regulations is essential to anticipate impacts on pricing, existing contracts, and the processes of incorporating technological innovations into the SUS.

Strategic Questions about AF-Onco