09/02/2025 | Luciana Murad Costa | Medicina SA

https://medicinasa.com.br/cenario-pesquisas-clinicas/ 

In recent years, Brazil has stood out in the global clinical research landscape, ranking among the 20 leading countries in this segment, according to data from Anvisa.

Among the favorable factors that make the country a privileged location for conducting these studies are the ethnic and genetic diversity of its population, competitive costs compared to other countries, the technical excellence of national research centers, and a favorable regulatory environment.

Industry stakeholders point out that Brazil has the potential to achieve even greater prominence in the global clinical research landscape, attracting international investment, stimulating scientific advancement, and bringing direct benefits to the population. However, the country still faces regulatory obstacles that limit the exploitation of this potential.

Also called clinical trials, clinical research is a scientific study conducted with human beings to evaluate the action, safety, and efficacy of medications, techniques, procedures, or medical devices before they are released onto the market. It constitutes a necessary preliminary step for new drugs, vaccines, and therapies to reach the general public.

Most clinical studies focus on oncology, infectious diseases, rare or chronic diseases, and gene therapies. Thus, in addition to enabling the development of new treatments, clinical research provides patients with early access to innovative alternatives and contributes to scientific and technological advancement in Brazil.

The clinical research ecosystem includes the sponsor, usually represented by the pharmaceutical industry; the research center, the institution where the study is conducted; the investigator, the physician responsible for conducting the research and ensuring the safety of the participants; and the patient, the person who voluntarily and unpaidly participates in the clinical trial.

For clinical research to be conducted in Brazil, its protocol must undergo rigorous analysis of technical and ethical criteria. It must also obtain prior approval from the National Health Surveillance Agency (Anvisa), which verifies good clinical practice guidelines, and from Research Ethics Committees (CEPs), responsible for evaluating ethical aspects and ensuring the rights, safety, and well-being of participants.

However, the bureaucracy and lengthy nature of these approval processes often hampered research, leading foreign sponsors to migrate their studies to other markets.

In this context, the enactment of Law No. 14,874 of May 18, 2024, the legal framework for research involving human subjects in Brazil, represented a major advance by aligning national regulations with international standards of good clinical practice. It also promoted greater speed and streamlining of the research protocol approval process. It also brought greater rationality and predictability to the process, including the establishment of maximum review deadlines.

Although Law No. 14.874/2024 is about to complete one year of enactment, its guidelines have not yet been fully implemented, as several provisions of the law still require regulation by the Executive branch to become effective, such as the operation of the National System of Ethics in Research involving Human Beings, the accreditation of ethical review bodies, and the list of documents required to support the review process.

Recently, the National Congress overturned the presidential veto on provisions of the Clinical Research Law, reinserting, among other points, the possibility of discontinuing the free provision of medication to patients in the post-study period, five years after its entry into the market. The veto was motivated by the protection of the interests of research participants, creating an obligation for the sponsor to provide the medication to patients after the end of the study, without a time limit. This issue, although controversial, was considered by sponsors to be a significant burden and a disincentive to conduct clinical research in the country.

What is clear is that the great challenge lies in promoting scientific innovation and fostering clinical research, without neglecting the protection of participants. Therefore, regulation must simultaneously encourage the development of new therapies in the country, attracting international sponsors, and guarantee the ethics of studies, safety, and the rights of the patients involved.

Given this scenario of opportunities for sector growth and regulatory gaps to fully implement Law No. 14,874/2024, contracts signed between national research centers, researchers, and sponsors require extra attention, especially considering that most sponsors are large foreign pharmaceutical companies. Clear clauses regarding the parties' obligations, delineation of responsibilities, remuneration criteria, insurance, country of jurisdiction and jurisdiction, documentation maintenance deadlines, data protection, and intellectual property are critical aspects of good contract management in these projects.