BRAZIL Trends and Developments Contributed by: Marianne Albers, Thais Fernandes and Mariana Vianna, Felsberg Advogados
signing of a PDP does not prevent the private company from continuing to market its prod- ucts in Brazil. In the case of medicines, after the technology transfer is completed, the product manufactured by the public laboratory receives an independent registration. Cannabis and Its Medicinal Use The use of cannabis for medicinal purposes, both for humans and animals, has increasingly been advocated by Brazilian healthcare profes- sionals, creating growing pressure for regula- tions regarding the cultivation of the plant within Brazilian territory. In some Brazilian states and municipalities, cannabis-based products are even provided free of charge through the SUS. Since 2015, the use of cannabis-based products has been permitted in Brazil. In 2019, ANVISA regulated the importation, manufacturing and commercialisation of cannabis products by legal entities. While cultivation remains prohib- ited, this situation is expected to change after the second half of 2025. A recent Superior Court of Justice order has mandated that the Brazilian government pub- lish regulations concerning cannabis cultivation, with the deadline for compliance set for May. This regulation on medicinal cannabis cultiva- tion is highly anticipated in the Brazilian market, not only by pharmaceutical companies but also by research institutions in fields like healthcare and agriculture. It is expected that once cultiva- tion is authorised, the cannabis market will see significant growth due to the reduction in costs associated with importing raw materials. Studies indicate that in 2024, the medicinal can- nabis market grew by 22% compared to 2023, reaching a total of BRL852 million in revenue
in just the last year. This market is continually evolving. Innovation in the Healthcare Sector – Regulatory Sandbox The emergence of new business models and innovative technologies in the healthcare sector has created a need for ANVISA to lose certain regulations to enable the development of these groundbreaking solutions. This need has led to the creation of “regulatory sandbox” , a type of “experimental regulatory environment” , where companies will receive a temporary licence from ANVISA to develop and test experimental techniques and technologies through a simplified process. ANVISA’s sandbox will cover a wide range of healthcare products (medications, cosmetics, medical devices), and it represents a valuable tool for developing and testing innovations, including Software as a Medical Device (SaMD). The first project to be launched in ANVISA’s regulatory sandbox will focus on personalised cosmetics, which are products whose formula- tion, characteristics, or presentation are tailored at the point of sale to meet the specific needs of each consumer. Though still a new and challenging area, this initiative presents an excellent opportunity to explore solutions that currently challenge exist- ing regulations but promise substantial benefits for the healthcare sector. There is high anticipa- tion for the inclusion of SaMD projects in the experimental regulatory environment, which would allow solutions already in use internation - ally to be introduced to the Brazilian market.
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