Experts from 31 Brazilian academic and research institutions have just completed a study that identified, mapped, and systematized the main challenges limiting the advancement of research into the medicinal use of cannabis in Brazil.
The group identified what it called seven "critical obstacles" responsible for obstructing both basic and applied research—in clinical, pharmaceutical, veterinary, agronomic, and other areas—and that compromise the effectiveness of studies, the international competitiveness of Brazilians, and the consolidation of the country as a center of excellence in the sector.
The study proposes concrete solutions to support the National Health Surveillance Agency (Anvisa) and the Ministry of Health in developing a comprehensive and operationally efficient regulatory framework for conducting research in this field.
The study was developed with input from 132 researchers from institutions such as the Brazilian Agricultural Research Corporation (Embrapa), the Brazilian Society for the Advancement of Science (SBPC), and federal and state public universities, via an electronic survey. Respondents identified a total of 481 problems and/or obstacles to conducting cannabis research. These problems were analyzed, grouped, and categorized into seven thematic areas.
© Jornal da Unicamp
The first of the obstacles, according to the technical note, is the research authorization processes, marked by slowness, subjectivity, disproportionate bureaucratic demands and overlapping demands from multiple bodies, including Anvisa, the Ministry of Agriculture, Livestock and Supply, the Ministry of Health, the Federal Police and several internal committees, a situation that, the study says, generates legal uncertainty.
Therefore, researchers call for the implementation of an integrated licensing system involving these agencies, with harmonized rules and a single process. Furthermore, they advocate granting global authorizations to science and technology institutions (ICTs), such as universities and research centers, with these authorizations valid for longer periods (five years, for example), replacing the current system of individual project approval.
The second obstacle, according to experts, is dependence on imports and limited access to standardized inputs—such as reference standards, purified cannabinoids, genetic analysis kits, extracts, seeds, and cultivars. This, they say, limits national autonomy and increases costs.
Therefore, the group calls for flexibility in the acquisition and handling, by ICTs, of cannabinoid substances and analytical standards, essential for method validation and quality control.
The third problem, according to the study, lies in restrictions on cultivation for scientific purposes and arbitrary THC limits. Experts believe the lack of institutional autonomy for cultivation and access to breeding stock compromises reproducibility and quality control, in addition to inhibiting the conduct of experiments with crops in different environmental conditions.
© Jornal da UnicampProfessor Priscila Mazzola (FCF): concrete solutions
Scholars call for the establishment of clear regulations on cultivation for research, allowing for different cultivation methods (greenhouses, screened areas, fields and vitro). Furthermore, they advocate allowing institutional autonomy so that each ICT can define the most appropriate cultivation method for its research. These restrictions, the study says, create an obstacle that hinders comparative studies and reproducible protocols.
Experts also point to bureaucracy involving the flow of materials between institutions and uncertainties regarding the use of co-products and derivatives in research as a fifth technical obstacle, and difficulties in inter-institutional collaboration as the sixth. They say these logistical obstacles compromise the development of sustainable production chains.
Finally, they argue that the lack of clear protocols for research involving farm animals hinders advances in areas such as veterinary and agricultural sciences. According to experts, the lack of standardized protocols makes it impossible to generate consistent data on safe dosages, withdrawal periods, and zootechnical efficacy, all of which are essential elements for the development of veterinary products.
For Professor Priscila Mazzola of the Faculty of Pharmaceutical Sciences (FCF) at Unicamp—who participated in the study—the technical note "is extremely relevant for scientific and technological advancement in Brazil." According to Mazzola, the study highlights the main obstacles faced by researchers working with medicinal cannabis in a wide range of fields and proposes concrete solutions, developed collaboratively by institutions from all regions of the country.
"The need for its implementation is urgent, because without a clear and efficient regulatory framework, Brazil will continue to be at a disadvantage compared to other countries that have already made progress in this strategic field," says the professor. "Consolidating a regulatory environment means strengthening academic research and creating conditions for innovation, sustainable development, and national technological autonomy."
The full technical note can be read here (link in Portuguese).
Source: Jornal da Unicamp
