Regulation, Science, and Quality Define the Future of Medicinal Cannabis in Brazil

The Brazilian market for medicinal cannabis is going through a decisive moment, driven by recent regulatory changes that are likely to directly impact companies, healthcare professionals, and patients. The publication of the new RDC No. 1,015 by the National Health Surveillance Agency (Anvisa), followed by technical adjustments to the standard, signals a movement towards greater sanitary rigor and the consolidation of the regulatory framework for cannabis in Brazil.

According to Leandro Neto, Director of Institutional Relations at Health Meds, this scenario creates significant opportunities, especially after the authorization for the cultivation of cannabis for commercial and research purposes. He believes that the measure strengthens national science and expands therapeutic possibilities. "The importance is evident, considering the enrichment of the sector (medicinal cannabis) through national research, both in new products and new therapies (different therapeutic approaches from those known today)," he states.

According to Neto, cultivation focused on research allows Brazilian companies and researchers to advance in developing solutions aligned with the real needs of the population, reducing external dependence and stimulating innovation. This progress is directly connected to the new regulatory framework for medicinal cannabis, which now categorizes products under a logic closer to the traditional pharmaceutical industry.

A Regulatory Framework Still Under Construction

Despite recent advancements, the director believes that the regulatory path for medicinal cannabis in Brazil is still in its early stages. "The regulatory path for medicinal cannabis is still in an embryonic stage, but it has been gaining greater sanitary and legal support in recent years," he notes. He believes that the sector's sustainability depends on building solid foundations supported by science, clear legislation, and well-defined sanitary standards.

In this sense, he emphasizes the importance of a regulatory environment capable of generating positive chain effects. "It is necessary to build a solid foundation, supported by science and legal and sanitary regulations, capable of creating a virtuous circle regarding the effective applicability of cannabis in medical therapies, where it is the main pillar," he says. In his view, this scenario could position Brazil as a reference in research, product development, and new therapies.

Adjustments in RDC 1,015 and Legal Certainty

Shortly after the publication of the new standard, Anvisa promoted the rectification of RDC No. 1,015, with adjustments mainly related to product labeling and technical aspects of the magistral manipulation of cannabidiol (CBD). Although specific, these corrections had a direct impact on the market by clarifying doubts and aligning interpretations.

For Leandro Neto, revisions and updates are part of the sector's regulatory maturation. "A robust regulatory framework, coupled with the effective development and applicability of therapeutic solutions and alternatives, provides security and expands opportunities," he emphasizes. According to him, clear and predictable rules are essential to strengthen the confidence of prescribers and patients.

Importation, RDC 660, and Focus on Quality

Another sensitive point for the sector is the importation of cannabis-based products, currently governed by RDC 660. When commenting on Anvisa's indication to promote a specific review of the standard, Neto views the move positively. "Reviews and updates are always welcome, especially at this moment of prominence of cannabis applied to medical therapies," he states.

He points out that, although RDC 660 has expanded access, not all imported products meet the real therapeutic needs. "RDC 660 has expanded and facilitated Brazilian access to different medicinal cannabis products. However, not everything that is imported actually meets the health needs for which medicinal cannabis is indicated," he points out.

In this context, quality and origin take center stage. "The traceability of a product's production chain functions, for example, as a requirement for ensuring a safe and quality product," he emphasizes. For him, the absence of adequate standards can compromise the perception of treatment effectiveness. "Products without quality can lead the prescriber and the patient to think that 'cannabis products do not work'," he warns.

Perspectives for the Coming Years

Despite regulatory challenges, Leandro Neto is confident about the future of medicinal cannabis in Brazil. "This is a path that has been paved in recent years and is gaining strength in the public opinion, the Brazilian State, and the scientific community," he states.

In his assessment, the consolidation of the sector is inevitable. "It would be like saying it is 'a path of no return,' in other words, it is a reality that has come to stay because it has added quality of life to many people who were hopeless about their health," he concludes.