New Law Expected To Boost Clinical Research In Brazil
By Paulo Fernandes, consultant, board member, Brazilian Clinical Research Alliance
The largest Latin American country, Brazil offers unique strengths, such as its diverse population, efficient patient recruitment, and high-quality data, that make it a very attractive location for conducting clinical trials. With recent improvements in legislation and regulatory frameworks, Brazil will further strengthen its role and that of Latin America in the global clinical research landscape.
The Effect Of The Brazilian Clinical Research Law 14.874/24
Approved by Brazilian President Luiz Inacio Lula da Silva in May 2024 and taking effect in 90 days upon approval, Law 14.874/24 aims to streamline the assessment process for clinical trials, reduce bureaucratic obstacles, and improve assessment predictability, mainly regarding timelines. By providing a clearer and more efficient regulatory pathway, the law can attract more investment and encourage innovation in the sector, from both global and local pharma and biotech. The expected improvements in timelines will make Brazil an even more attractive location for global clinical trials. The law states that the Brazilian Regulatory Authority will have 90 business days to respond to clinical trial applications; it streamlines the ethical review process by counting the review of only local ethics committees for the trials to get started and adds to existing regulations clearer rules that directly improve the country feasibility.
Advocating For Clinical Research
The new law is bolstered by Brazil's well-structured CRO association, ABRACRO, which has supported the clinical research ecosystem for the past 18 years. Recently, ABRACRO has advocated for better regulatory frameworks and promoted the development of the clinical trials workforce in the country. ABRACRO has taken a proactive role in promoting public discussion regarding the new law, fostering interactions with regulators from ANVISA, central and local ethics committees, as well as other sectorial associations such as Sindusfarma (Pharmaceutical Industry Asociation), Interfarma (Pharmaceutical Industry Research Association), Grupo Farma Brasil (National Capital and Research Pharmaceutical Industry Association), and Abiquifi (Brazilian Association of the Farmoquímica Industry – APIs focused).
Approximately seven years ago, ABRACRO created its first extension course on clinical research conduct and has been promoting these courses within the ecosystem. This initiative supports the entry of new professionals and the training and retraining of those already working in the clinical trials arena. Also, part of these courses are offered to professionals coming from public institutions either for free or with discounts to support their upskilling, which improves the overall delivery quality based on a more profound knowledge of ethics, their individual roles, etc. The associated companies and the association's efforts have built a strong foundation for the future.
Diversity And Recruitment Remain Brazil’s Key Strengths
Brazil’s most significant advantage in clinical trials has traditionally been the country’s capacity to accelerate enrollment speed for global clinical trials, often allowing for time spent during regulatory (under the old framework) to be recovered with speedy enrollment. The positive enrollment is the result of a series of combined factors including the strong relationship between the study doctors and their patients, a country in which access to the latest, most advanced technological treatments is still not widespread, and the collective pursuit for better healthcare to all. Combined with the continuous demand from regulators, including the FDA through its guidance document Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry, dated Nov/2020 for more diverse enrollment, this potential improves the country’s attractiveness for clinical trials.
With a significant advantage in terms of population diversity, more than 50% of Brazil’s people claim multiple ethnical origins, 61% of its population is concentrated in urban areas with nearly 40 cities with more than 500,000 habitants, and a high overall index of technological adoption ranks Brazil as the first country in Latin America, per the World Digital Competitiveness Ranking from IMD for 2022. The global burden of disease data for the country is in line with global data, with oncology being one of the most prevalent diseases right now, a sad but increasing trend.
The populational diversity allows researchers to gather more comprehensive and reliable data, which is crucial for developing new treatments and medical interventions supporting bringing safer products into the market faster serving a larger number of patients. By efficiently recruiting patients from various demographic backgrounds, clinical trials in Brazil can produce inclusive and wide-ranging results, benefiting global health outcomes.
High-Quality Data And Sites
Brazilian clinical trial sites maintain high standards and adhere strictly to protocols, resulting in the production of high-quality data. The country boasts a network of well-equipped research centers staffed by experienced professionals and continues to improve its ability to train new staff for clinical research. This existing infrastructure supports the execution of complex clinical trials, ensuring reliable and accurate results.
Brazil has a long track record with multiple therapeutic areas and has recently seen an increase in the number of cell and gene therapy clinical trials. ANVISA, the regulatory authority for the country, has been playing a crucial role in regulating the assessment and implementation of such technologies that end up helping patients for example with its publication in 2020 of the Collegiate Board Resolution – RDC no. 338 exclusively about Advanced Therapy Medicinal Products or its publication in 2023 of a specific guidance document for the sector called Guide to considerations on non-clinical biodistribution studies with gene therapy products - Guide 70/2023 - version 1 in addition to multiple webinars and meetings with the regulated sector to discuss the advancements in the field and its regulations.
Latin America's Expanding Clinical Research Sector
The changes extend beyond Brazil, highlighting the potential of Latin America as a whole. Recent developments in Argentina showcase the growing potential for clinical research in the region. Argentina has experienced significant growth in clinical trials, with a 79% increase in the number of trials between 2017 and 2021 and a 130% rise in clinical R&D investment during the same period, according to its local pharma and CRO association, CAEME/CAOIC. Such growth resulted from government changes a few years ago that promoted a less bureaucratic, more predictable, and faster regulatory environment.
Moreover, Colombia and Mexico also play important roles in the clinical research landscape of Latin America. Both countries host numerous clinical research sites with robust infrastructure, allowing for efficient participant recruitment across various therapeutic areas, including internal medicine, vaccines, and oncology among others. In Colombia, with more than 50 million inhabitants, there are over 130 active clinical research sites that received direct GCP inspections from INVIMA its regulatory authority. Mexico has made significant strides in aligning its regulatory framework with international standards, particularly through its active participation in initiatives such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). This alignment has improved the quality and reliability of clinical trial data, fostering greater confidence among sponsors and researchers.
The existing centers in Colombia and Mexico, supported by experienced professionals and a growing focus on regulatory compliance, further enhance the appeal of the region as a location for clinical trials. The improvements associated with existing capabilities and positive historical results in regulatory inspections demonstrate Latin America's potential to become a major hub for clinical research, offering an attractive environment for global clinical trials and investment in innovation.
Conclusion
Brazil stands at the forefront of clinical research, offering great advantages such as a diverse population, high-quality data, and efficient patient recruitment. Recent legislative advancements further cement Brazil's new possibilities. As these changes take effect, we can expect significant positive impacts on the clinical research landscape in Brazil, making it an even more compelling location for conducting cutting-edge medical research. With simultaneous growth in countries like Argentina, the opportunity for clinical research across Latin America will expand, presenting a promising future for the region's contribution to global health advancements.
About The Author:
Paulo Fernandes is a clinical research executive based in Latin America with 20 years of experience working for different CROs in various functions. Paulo is experienced in diverse roles encompassing project management, site start-up, and site management. Paulo is the former president of the Brazilian CRO Association (ABRACRO) and a board member for the Brazilian Clinical Research Alliance – Aliança Pesquisa Clínica Brasil.