11/28/2025 | Fernando de Rezende Francisco, Norberto Prestes | JOTA

https://www.jota.info/opiniao-e-analise/artigos/lei-da-pesquisa-com-seres-humanos-pode-atrair-milhoes-de-investimentos-ao-pais 

Modernization of the regulatory framework ensures legal security and predictability for the IFA industry.

Legal certainty and predictability are the fundamental bases for the sustainable development of the pharmaceutical input industry established in the country, regardless of its capital origin.

Premises to attract investments to a sector that invests large sums in new molecules, APIs, and drugs, to foster innovation and increase access for the Brazilian population to medicines, therapies, and treatments that can save lives.

And it is precisely on this wave of legal certainty that the regulation of Law 14.874, of May 28, 2024, rides, which modernizes the Brazilian regulatory framework regarding research with human beings and establishes the National System of Ethics in Research with Human Beings, ensuring predictability, defined approval timelines, and safety for all involved, especially for research participants.

According to research conducted by the Association of Pharmaceutical Industry Research (Interfarma), in partnership with IQVIA, the Human Research Law could generate an annual boost of R$ 6.3 billion to the Brazilian economy, the creation of 56,000 qualified jobs per year, in addition to directly benefiting around 286,000 patients.

In this fertile field of consolidating a predictable regulatory environment and accelerating regulatory review timelines, the country will have the possibility to advance development phases, reducing the total cycle of new products and the costs involved in the innovation process, as well as encouraging private investments in R&D.

This legal stability, aligned with the best international practices, strengthens Brazil as a destination for international clinical trials, stimulates technology transfer, fosters an increasingly competitive innovation environment, and partnerships with global health reference centers.

The high-ranking officials of the government, now and then, justify actions, laws, and projects in the name of "national sovereignty." Well then, according to data from the Ministry of Health, although Brazil is among the top 20 countries in the global ranking of clinical studies, the country receives less than 2% of the world's clinical research. To give you an idea, in 2024 there were a mere 254, and keep in mind that we are a population of approximately 214 million people, with a wide genetic and cultural diversity.

There is no sovereign country without solid and robust public health policies, let alone without a healthy population. With the Human Research Law, we take an important step in these directions.
It is also worth noting that this greater clarity on ethical and operational requirements facilitates the planning of clinical pipelines, especially for companies focused on novel molecules and new APIs. Again, innovation in the service of public health.

Benefits for the SUS
Even with the structure and a contingent of professionals that cannot meet the needs of our population, the Brazilian Unified Health System (SUS) is a reference for the world. And the recent Law on Research with Human Beings can be an ally in expanding this access, especially to innovative treatments.

If achieved, the Ministry of Health's goal of at least doubling the number of clinical trials conducted in the country will favor a greater supply of medications with new active pharmaceutical ingredients (APIs), including the local development of therapeutic solutions for neglected or tropical diseases, thus reducing our external dependence.

Speaking of external dependence, Brazil currently imports about 95% of the APIs used in the production of medicines — a scenario that limits the competitiveness of the industry established in the country and increases the vulnerability of the healthcare system to exchange rate and geopolitical variations, a fact exemplified during the Covid-19 pandemic with the production of vaccines. Again, "national sovereignty," or the lack thereof, is evident.

Returning to the benefits of the new regulatory framework, it extends to public coffers, as the greater availability of clinical studies can generate considerable savings for the SUS thru partnerships, robust private sector investment directly in the care of thousands of patients who become research participants, the generation of robust data, and strategic national production.

Radical innovation and Brazil's insertion in the global R&D landscape
The Law on Research with Human Beings is a driving force for radical innovation, as it brings Brazil closer to regulatory frameworks used in mature markets, such as the United States and Europe, thus facilitating the conduct of multicentric studies.

While Law 14.874/2024 ensures legal security and predictability for clinical studies, initiatives that articulate an integrated ecosystem connecting industry, startups, academia, and investors, such as Abiquifi's Radical Innovation Program, create conditions for the development of novel molecules and the expansion of national API production.

This synergy not only accelerates radical innovation but also strengthens health sovereignty and positions the country as an attractive destination for international capital in strategic areas such as biotechnology and advanced therapies, in which Brazil is also in line with international best practices.

In a less hyper-globalized world, Brazil has essential characteristics that can put us back in the spotlight of the global economy. And this necessarily involves "national sovereignty" in the realm of innovative health solutions to keep up with the new trends and habits of the Brazilian population – and the world. May everyone do their part.