10/07/2025  |  Gov Agency

https://www.gov.br/planalto/pt-br/acompanhe-o-planalto/noticias/2025/10/lula-sanciona-lei-do-agora-tem-especialistas-e-regulamenta-lei-de-pesquisa-clinica-para-fortalecer-a-saude-publica 

The Brazilian government also announced 28 women's health trucks, focusing on Pink October. The mobile units will operate in 22 states.

On Tuesday, October 7, President Luiz Inácio Lula da Silva signed two measures aimed at modernizing and strengthening the Unified Health System (SUS). The initiatives include the regulation of the Clinical Research Law, to accelerate innovation and attract investment, and the sanctioning of the Now There Are Specialists Law, which already begins to expand access to specialized care with mobile units.

The Now There Are Specialists Law, originating from Provisional Measure 1.301/2025, seeks to reduce waiting times in the SUS for consultations, exams, and surgeries, expanding the population's access to medium and high complexity specialized care. Health Minister Alexandre Padilha emphasized that the sanction guarantees more legal certainty and stability for the program, which will be accelerated.

For the minister, this is a new cycle of strengthening the SUS, which is reorganizing after the pandemic to serve with greater efficiency and equity. “It is the post-pandemic SUS being built with increasing strength and serving the Brazilian population. And it is a dream of so many years of President Lula becoming law and reality,” he said.

Several actions are already underway. We have included patients being treated by health plans in private hospitals. Third shift actions in several municipal administrations. Federal hospitals are already working third shifts to perform more surgeries, exams, and consultations. We held two national task forces, through the SUS and federal university hospitals," reported the minister.

“All of this was permitted by the provisional measure. Now that it has become law, it has more force, more security, including for the participation of private hospitals, health plans, and hospitals to serve the population. It gives more sustainability to the Agora Tem Especialistas program,” he added.

TRUCKS — At the time of the sanction, a new stage of the program was announced: the start of care by 28 women's health trucks in all regions of the country, with a focus on Pink October. The mobile units will operate in 22 states. They will be directed to regions with gaps in care and places that are difficult to access, such as cities in the heart of the Amazon and municipalities with poor health infrastructure, with the aim of reducing regional inequalities in relation to specialized care.

The trucks offer mammograms, bilateral breast ultrasounds, breast punctures and biopsies, colposcopies, cervical biopsies, and transvaginal and pelvic ultrasounds, in addition to in-person medical consultations and teleconsultations for specialized care.

The initiative, which has an investment of R$ 18.9 million, is part of the ten strategic axes of Agora Tem Especialistas. According to Alexandre Padilha, “the enactment of the Agora Tem Especialistas law strengthens this initiative because it allows AGSUS, the federal government agency, to directly contract these trucks, in partnership with states and municipalities that request the service.”

The provision of specialized care in the trucks is part of a set of actions under the federal government program, which mobilizes the entire Brazilian health system, both public and private. The program, which aims to reduce waiting times for consultations, exams, and surgeries, plans to have a total of 150 trucks circulating throughout Brazil by 2026.

RESEARCH — On another front highlighted on Tuesday (7), the Clinical Research Law is considered a milestone for scientific development in Brazil. The Minister of Health explained that clinical research involves “studies conducted by the science of drug evaluation, diagnostic tests, procedures, and professional therapies.”

Inspired by international models, the legislation seeks to bring more legal certainty, attract investment in innovation, and boost a strategic sector, while ensuring the protection and safety of participants in an ethical and responsible manner.

"Often, a university or institute wants to conduct a drug evaluation project, and today in Brazil, this takes an average of up to six months, in some cases up to a year, for approval through the various stages of the current system. This system was created in the 1990s and addressed the need for a research ethics system in the country. But with this new instrument approved by Congress and regulated by the president, we are modernizing this system to shorten approval times," explained the Minister of Health.

Although Brazil ranks among the top 20 countries in global clinical trials, it accounts for less than 2% of worldwide clinical research. The new regulations are expected to boost growth in the sector, positioning the country to become one of the world's top ten in this area and reversing the downward trend observed since 2022, when other countries updated their regulatory frameworks. The country has unique conditions to attract investment, with a population of approximately 214 million people and broad genetic and cultural diversity.

In 2024, Brazil registered 254 clinical studies. The expectation is to double this number and reverse the downward trend from 2022, when the regulatory frameworks of other countries became more competitive.

AGILITY — The new model provides for the project evaluation process by the Research Ethics Committees (CEPs) to be reduced from 180 days to 30 days. The evaluation by the National Health Surveillance Agency (Anvisa) will take up to 90 business days. Strategic research for the SUS and health emergencies will be evaluated within 15 business days.

The protection of participants was a central point of the regulation. The new law guarantees the continuity of treatment for up to five years after the end of the research for patients with serious diseases and no alternatives, who present proven benefits, subject to prior approval by the CEP. In addition, the responsibilities of researchers, sponsors, and institutions were clearly defined, and protection was reinforced with specific rules and safeguards for vulnerable groups, such as children, pregnant women, indigenous peoples, and persons deprived of liberty.

ETHICS — The model of the National System of Ethics in Research with Human Beings follows independent collegiate structures already consolidated in several countries, such as Canada and European Union nations. Sinep will be composed of two bodies: the National Research Ethics Body (Inaep) and the research ethics review body, formed by the CEPs.