Published federal act that creates the national policy for the prevention and control of cancer and brings relevant changes in the procedure for incorporation of oncological medicines into the SUS

On December 12, 2023, Federal Law 14,758/2023  (“Law”) was published in the Federal Register, which amends Federal Law 8,080/1990 (Organic Health Law), and creates the National Policy for Prevention and Control (“Policy”) of within the scope of the Brazilian Unified System of Health (“SUS”).

Under the terms of the Law – which comes into force on June 18, 2024 – the Policy has as its main goals:

• Reduce the incidence of different types of cancer;
• Ensure adequate access to integral care, which includes prevention, monitoring, early detection and diagnosis of cancer, treatment, rehabilitation, and palliative care for the patient, as well as the psychological support offered to relatives;
• Contribute to improving patients’ quality of life;
• Reduce mortality and disability caused by cancer.

The Law also provides for the maintenance by the Government of a data system for recording suspected and confirmed cases of cancers, as well as the entire assistance process, aiming at effective supervision of the implementation of the Policy.

The Law under discussion also brought relevant changes to Federal Law 8,080/1990, specifically in art. 19-R, which provides for the incorporation procedure of medicines into the SUS.Main changes in  CHANGES in Federal Law 8,080/1990:

• Fast track procedure:
  • the Health Technology Assessment procedure for evaluating the incorporation of new medicines, products and procedures will be processed as a priority, when related to the assistance of people with cancer; and 
• Budgetary agreement within 180 days to make the medicine available to the user:
  • Within the maximum period of 180 days for the SUS to supply the new incorporated technology, an agreement must occur – within the scope of the Tripartite Intermanager Commission – regarding the responsibilities of each public entity in the process of financing, acquiring and distributing the technologies.

In this sense, the acquisition must be centralized by the Ministry of Health (art. 10), as a priority, when related to the following scenarios:

• neoplasms with highly complex treatment;
• incorporations that represent a high financial impact for the SUS; or
• neoplasms with a higher incidence, in order to guarantee greater equity and economy for the country.

The remaining acquisitions of incorporated technologies will occur following the Authorization for Highly Complex Ambulatory Procedures (“APAC”).Last but not least, the SUS intermanagement committees will agree on the responsibilities of the public entities (Federal Government, States, and Municipalities) in their respective lines under the Policy, according to the demographic and epidemiological characteristics and the economic-financial development of the health regions.

Our Life Sciences & Healthcare team is available if you have any questions about the topic and its possible developments via e-mail: lifesciences@soutocorrea.com.br.