Here is the complete translation of this proposed legislation in Brazil by MS Word. Thanks Starric for the cite. I have highlighted reference to DCVAX.
FEDERAL SENATE
BILL NO. 126, OF 2025
Establishes the Regulatory Framework for Vaccines and High-Cost Drugs Against Cancer in Brazil and creates standards for the development, research, production, distribution and access of cancer vaccines, with a focus on scientific innovation, universal access and equity in the Unified Health System (SUS), and establishes guidelines for the promotion of research, national production and international collaboration.
AUTHORSHIP: Senator Dr. Eudócia (PL/AL)
Separate from PL 126/2025 [1 of 10]
FEDERAL SENATE
Office of Senator Dr. Eudócia
BILL NO. , OF 2025
Establishes the Regulatory Framework for Vaccines and High-Cost Drugs Against Cancer in Brazil and creates standards for the development, research, production, distribution and access of cancer vaccines, with a focus on scientific innovation, universal access and equity in the Unified Health System (SUS), and establishes guidelines for the promotion of research, national production and international collaboration.
The NATIONAL CONGRESS decrees:
CHAPTER I GENERAL PROVISIONS
Art. 1 The Regulatory Framework for Vaccines and High-Cost Drugs Against Cancer is hereby established with the objective of fostering research, development, production and distribution of vaccines and drugs against cancer in Brazil, ensuring universal and equal access to all citizens, in accordance with the principles of the Unified Health System (SUS).
Art. 2 Vaccination and high-cost cancer drugs will be a national priority, based on the following principles:
I - Scientific and technological innovation;
II - Safety and efficacy;
III - Universal and equitable access;
FEDERAL SENATE
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IV - Continuous training of health professionals;
V - Sustainable development and national production.
CHAPTER II
PROMOTION OF RESEARCH AND INNOVATION
Art. 3 The National Fund for Research and Innovation in Oncology (FUNPIO) is hereby created, with the objective of financing research, projects and studies related to the development of vaccines and the national production of high-cost drugs against cancer in Brazil.
Sole Paragraph. The fund will consist of:
I - Federal budget resources;
II - Contributions from private and public companies and non-governmental organizations (NGOs);
III - International partnerships in scientific research;
IV – Other funds that are destined to FUNPIO.
Art. 4 The Executive Branch shall create a program to encourage research in oncology, including:
I - Funding of basic and applied research projects;
II - Partnerships with universities and research centers, public and private;
III - Fostering the creation of biotechnology startups focused on vaccines and high-cost drugs against cancer;
IV – Encouraging the use of artificial intelligence (AI) in the research and development of vaccines and high-cost drugs against cancer;
V - Encouragement of the use and sequencing of DNA, allowing advances in the identification of cancer and in the personalization of treatment.
FEDERAL SENATE
Office of Senator Dr. Eudócia
CHAPTER III
REGULATION AND APPROVAL OF VACCINES AND MEDICINES
Art. 5 The National Health Surveillance Agency (ANVISA) shall establish an accelerated and specific process for the evaluation, approval and registration of high-cost vaccines and drugs against cancer, taking into account:
I - Their efficacy and safety, according to clinical studies and trials carried out;
II - Transparency in the approval process, with the publication of technical opinions and opinions of independent scientific committees;
III - The cost-benefit analysis of vaccines and high-cost cancer drugs for public health.
Art. 6 ANVISA will have a maximum period of 6 months to issue a conclusive opinion on the approval of vaccines and high-cost oncological drugs, from the formal request for registration.
CHAPTER IV
UNIVERSAL ACCESS AND DISTRIBUTION
Art. 7 The SUS shall be responsible for the free and universal distribution of vaccines and high-cost drugs against cancer to the entire Brazilian population, with priority for:
I - Patients at High Risk of Cancer (Preventive Vaccines);
II - Patients with Localized or Early Cancer (Therapeutic Vaccines);
III - Patients with Advanced or Metastatic Cancer;
IV - Patients with metastatic melanoma (Experimental Vaccines Associated with Immunotherapies);
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V - Patients with metastatic non-small cell lung cancer (NSCLC) (studies investigating personalized neoantigen-based vaccines).
VI - Patients with glioblastoma (Experimental Vaccines such as DCVax-L);
VII - Immunocompetent Patients with Good Immune Response;
VIII - Patients who maintain a robust immune response, capable of generating an effective response against tumor antigens;
IX - Patients without significant immunosuppression, such as those without chronic use of corticosteroids or immunosuppressants;
X - Patients with Favorable Biomarkers;
XI - Patients with tumors with high mutational load (high BMR), which can generate a greater response to immunogenic vaccines;
XII - Patients with moderate to high PD-L1 expression, who may benefit from the combination of vaccines and immunotherapy;
XIII - Patients with the presence of specific neoantigens, which can be targets of personalized vaccines;
XIV - Patients with indication for immunotherapy or other high-risk oncological drugs, resulting from randomized clinical trials.
Art. 8 - Implementation in the SUS shall be carried out through specific programs, coordinated by the Ministry of Health, with the support of the state and municipal health departments.
Art. 9 - The Executive Branch shall promote public education campaigns on the importance of vaccines and oncological drugs, their benefits and the access process, in order to raise awareness among the population about the prevention and treatment of cancer.
FEDERAL SENATE
Office of Senator Dr. Eudócia
CHAPTER V
STIMULUS TO NATIONAL PRODUCTION
Art. 10 - The Executive Branch and public and private research centers shall be encouraged to develop and produce oncological vaccines and medicines locally, through:
I - Tax incentives for production and distribution;
II - Public-private partnerships for the production and transfer of technology;
III - Technological training programs aimed at the national pharmaceutical industry.
Art. 11 The Oncology Technology Transfer Program is hereby created, with the objective of promoting the transfer of technology for vaccines and high-cost medicines for national production.
Art. 12 - The Executive Branch shall create a favorable regulatory environment for the entry of new players in the market of vaccines and oncological drugs, with a simplified regime for domestic production and the importation of necessary technologies.
CHAPTER VI FINAL PROVISIONS
Art. 13 - The Executive Branch shall establish, after the enactment of this Law, the specific regulation for the implementation of the policies and programs provided for in the Regulatory Framework for Vaccines and High-Cost Drugs Against Cancer.
Art. 14 This Law enters into force on the date of its publication.
FEDERAL SENATE
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JUSTIFICATION:
Cancer is one of the main causes of mortality in Brazil and represents one of the greatest challenges for the public health system. The advancement of cancer vaccines and immunotherapies has demonstrated a significant impact on the prevention and treatment of malignant neoplasms, reducing mortality and improving the quality of life of patients. However, the dependence on imports of high-cost medicines and the high rate of judicialization represent financial and operational challenges for the Unified Health System (SUS). This bill proposes measures to strengthen national production, reduce costs, and ensure equitable access to these technologies.
1. Epidemiological Impact of Cancer in Brazil
The National Cancer Institute (INCA) estimates that there will be 704 thousand new cases of cancer per year in Brazil between 2023 and 2025.
FEDERAL SENATE
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Cancer is the second leading cause of death in the country, responsible for more than 230 thousand deaths annually. The most common types of cancer are breast, prostate, lung, colon and rectum, and stomach cancer, generating great economic and social impact. Lack of access to innovative technologies and inequality in treatment increase mortality in less developed regions.
2. Importance of National Production for the Self-Sufficiency of the Country
The national production of oncological and immunotherapeutic vaccines is essential to ensure sustainability, safety and health sovereignty. Currently, Brazil relies heavily on the import of high-cost medicines, which:
- It increases public spending, overloading the SUS budget;
- It makes the country vulnerable to international crises, such as supply chain disruptions;
- It delays the incorporation of new technologies, making it difficult for the population to access the most effective treatments.
FEDERAL SENATE
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Countries that have invested in the national production of immunotherapies and cancer vaccines have significantly reduced their costs and improved access to treatment. The expansion of national production capacity also stimulates scientific and technological innovation and strengthens Brazil's position in the global biotechnology scenario.
3. Reduction of Judicialization and Financial Impact on SUS
The lack of clear regulation and the delay in incorporating technologies into the SUS lead to an increase in the judicialization of health, which compromises the public budget and generates inequality in access to treatments.
In 2022, government spending on lawsuits for the supply of oncological drugs was more than R$ 2 billion. 80% of the lawsuits refer to high-cost imported drugs, many of which have not yet been fully evaluated for efficacy for certain subgroups of patients.
Judicialization unbalances the health system, as it favors patients who file individual lawsuits, while others are left without
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access. National production and clear regulations for oncological vaccines and immunotherapies make it possible to:
- Reduction of import dependence, allowing direct price negotiation and stable supply to SUS;
- Programmed and evidence-based inclusion in the list of SUS medicines, avoiding unnecessary lawsuits;
- Creation of biomarker-based prescribing criteria, ensuring that only patients who will truly benefit receive the treatments;
- Greater control over costs, enabling the sustainability of the financing of next-generation oncology medicines.
The implementation of this bill will ensure broad, equitable, and sustainable access to new cancer technologies, benefiting thousands of patients and strengthening national sovereignty in the production of strategic medicines.
Session Room,
Senator DR. EUDÓCIA
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