Now, the Bill has become Law 14,874/2024.

On May 26, 2024, the President of the Republic signed Bill 6007/2023, now known as Law 14,874/2024, which establishes guidelines on research with human beings and establishes the National System of Ethics in Research with Human Beings. The publication in the Federal Official Gazette — DOU, marks a significant advance in the regulation and ethics of clinical research in Brazil. However, two points of the Bill were vetoed and are subject to deliberation by the National Congress within 30 calendar days:

Paragraph 3 of art. 24 of the Bill - The need to report to the MP the participation of members of indigenous groups in research: “Despite the good intention of the legislator, the provision, by providing that the participation of members of an indigenous group in research must be reported to the Public Prosecutor's Office, violates the principle of equality and points to the possible situation of state protection in relation to indigenous peoples, a condition that has already been overcome by legislation.”

Section VI of art. 33 of the Bill - The end of the supply of experimental drugs to patients after 5 years of their commercial availability in the country: “Despite the good intention of the legislator, the legislative proposal is contrary to the public interest by establishing a period of five years for the continuation of the free supply of the experimental drug after the closure of the study”.

The sanction of Law 14,874/2024 represents an important step for ethics and regulation in clinical research, and the Cura Project Institute will continue to work tirelessly to promote health and well-being through research, remaining aware of the consequences of this law in the National Congress and will release any relevant news.

Reflections from the Cura Talks event - May

Bill 6007/2023 was sanctioned shortly after the Cura Talks - May Research Month event, held on May 21 in São Paulo. The event, organized by the Cura Project Institute in partnership with the Brazilian Society of Clinical Oncology (SBOC), continued the theme “Regulatory Pathways of Clinical Research in Brazil”. This was a fundamental space to discuss and understand the rights of research participants within the framework of the Bill.

Cura Talks Maio was attended by lawyers Angela Kung and Anna Luiza Bertin, both rapporteurs of the Research Ethics Committee of the Federal University of São Paulo (CEP/UNIFESP). They provided a detailed overview of the legal and ethical aspects of clinical research in Brazil, highlighting the benefits that these changes will bring to the health system. Fernanda Schwyter, President of the Cura Project Institute, was the host and mediator of the event, which was also welcomed by the President of SBOC, Dr. Marisa Madi.

May is the month of awareness about Clinical Research and the Cura Project Institute, in this month and every other month of the year, is committed to promoting events that inform and educate society about the importance of clinical research and the rights of participants.

If you missed the Cura Talks Maio broadcast or want to review the most important moments, the recording is available on our YouTube channel. Don't miss this opportunity to get up to date on a topic so relevant to the advancement of science and health in Brazil.

https://www.youtube.com/watch?v=_B3EAQ5epZM&t=326s

The Cura Project Institute remains committed to following and disseminating all updates regarding Law 14,874/2024 and the impacts it will bring to the future of clinical research in the country.

Cura's commitment to Clinical Research

The events promoted by the Cura Project Institute, such as Cura Talks, Cura Meetings, as well as initiatives such as the Research Save Lives Movement, play an essential role in disseminating information and raising awareness about the importance of clinical research. These actions educate the public about advances and challenges in the area of health, in addition to promoting active community, lay and medical engagement, encouraging participation and support for research.

We, members of the Cura Project Institute, a cutting-edge institution in Latin America, are happy to see our work being understood by society and achieving its objectives, leading the mission of strengthening and expanding clinical research, contributing significantly to scientific progress, improving the quality of life of cancer patients and increasing resources for funding academic studies in the region.

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