Regulation would bring more safety to patients, says a lawyer.
Eight years ago, Vivian Dalla Colletta had her first experience with cannabis. She described herself as “conservative,” someone who had never even consumed soda or alcoholic beverages, and had never considered using cannabis. However, the debilitating pain caused by fibromyalgia led her to explore the medicinal plant for therapeutic relief.
“My jorney with cannabis started eight years ago when I was diagnosed with fibromyalgia, a chronic pain syndrome that causes constant pain throughout my body,” she shared in an interview with Agência Brasil. “For years, I managed my fibromyalgia through physical exercise. However, in 2015, I had appendicitis, leading to an urgent surgery that resulted in a nerve injury in my leg. Then, I began experiencing intense shocks and excruciating pain, which even caused me to faint.”
“As a result, I began using four medications under the guidance of a medical professional, commonly known as red stripe drugs. However, when the doctor suggested adding a fifth medication, I became apprehensive. How could he propose another drug while I was still enduring unbearable pain? And then I remembered a cancer patient who smoked marijuana to relieve pain,” said the pharmacist, who is also a researcher at the Federal University of Santa Catarina (UFSC) and the founder of the Dalla Cannabis Teaching & Research Institute.
“I had always been averse to tobacco cigarettes, and during a particularly desperate time, I considered trying marijuana for relief. However, that approach proved ineffective,” she shared. It was then she discovered cannabis oil, derived from cannabis sativa, the marijuana plant, which acts on the central nervous system. “From that point on, I completely abandoned conventional medication and solely relied on cannabis extract, which I still take today,” she explained.
Cannabis has been a crucial source of support for her during this new chapter of life, following a recent surgery for bowel cancer. “However, when it comes to cancer, there is still a need for comprehensive research on the specific benefits of cannabis,” she emphasized.
Agência Brasil had the opportunity to interview Dalla, as she prefers to be called, at the 2nd edition of the International Conference on Medicinal Cannabis (CICMED), taking place in São Paulo until the upcoming Saturday (Aug. 5). This event brings together esteemed international and national speakers, along with laboratories and distributors of medicinal cannabis-based treatments, to engage in discussions and promote emerging trends in the application of cannabis in diverse medical fields.
Access
Scientific studies have demonstrated the medical efficacy of cannabis in treating various diseases, including neurological conditions, with no reported cases of addiction. Nevertheless, in Brazil, its usage is not unrestricted, and access requires a doctor’s prescription. Until 2015, the sale of any product containing cannabidiol, a cannabis-derived substance, was prohibited in the country. However, since then, Brazil’s national drug regulator Anvisa has included cannabidiol on the list of controlled substances. Consequently, companies intending to manufacture or sell derivatives of this substance must obtain registration with Anvisa, and patients are required to have a valid prescription to purchase these products.
Currently, there are three ways to access cannabidiol: through pharmacies, via associations, or by importation. However, Brazil’s national public health care system SUS has yet to implement a policy for the free distribution of cannabidiol-based products. Nonetheless, there are ongoing initiatives in the National Congress aiming to ensure that patients who require these therapies can access them through SUS.
Navarro argues that cannabis use should be regulated by law – – Paulo Pinto/Agência Brasil
“In the realm of medicinal applications, the victims are the patients. From an industrial standpoint, it’s the companies that lose out, as they could potentially generate income, employment opportunities, and contribute to tax revenue. Furthermore, the matter of adult recreational use remains ambiguous, lacking clear boundaries, which often leads to unwarranted arrests,” highlighted lawyer Leonardo Navarro, a legal expert specializing in medical health law.
According to him, who also relies on medical cannabis to manage a sleep disorder, having a federal law in place would bring much-needed tranquility to the issue, leading to reduced costs and improved accessibility for patients requiring this therapy. “With a well-structured law that outlines the nature of the product, its potential applications, including its use in food or industrial contexts, and establishes clear criteria for defining medicinal purposes, we can ensure security for all stakeholders and establish a system with legal certainty. While the current regulations set forth by Anvisa are commendable, they are based on resolutions from a collegiate board. The concern arises from the possibility that a change in the board’s composition could risk altering what has already been achieved. Thus, we cannot rely solely on secondary regulations; we need robust legal-level regulations,” he explained to Agência Brasil.
Due to the lack of a comprehensive national regulatory framework, various states in Brazil have taken the initiative to propose bills at the state level, aiming to facilitate the availability of cannabis-based products through SUS. “Recently, we have witnessed a significant surge in states and state legislative assemblies actively working to establish mechanisms for the distribution of cannabis-based treatments through SUS. In the latest assessment, approximately 25 states either have an approved law or are currently engaged in legislative discussions. Those with approved laws are now in the process of regulation, wherein they define specific medical conditions, modalities of access, and the types of products eligible,” elucidated the lawyer.
According to biotechnologist Gabriel Barbosa, the Research and Development and Regulatory Affairs supervisor at HempMeds Brasil, implementing a regulatory framework for biotechnologies in Brazil has the potential to significantly reduce the cost of cannabis-based drugs in the country. “We have received estimates suggesting that we might be able to bring down the cost of these medications by 30 percent to 50 percent,” he revealed. He also pointed out that when importing a drug, approximately 30 percent to 35 percent of the overall cost pertains to taxes for nationalization. Moreover, Barbosa emphasized that a proper regulatory system could lead to improved accessibility, benefitting approximately 6 to 7 million Brazilians who currently face difficulties in accessing these medications.
In an interview with Agência Brasil, Gabriel Barbosa emphasized the necessity for legislation to underpin the entire process. While cultivation for medical and scientific objectives is already accounted for in the existing legislation, it is crucial to set clear parameters on how it will be executed, who will be involved, and under what specific conditions. Ensuring that these parameters align with international norms and conventions is equally essential.
The biotechnologist highlights that Brazil has made significant strides in the medicinal use of cannabis. However, one of the key challenges the country faces is the lack of access to raw materials. “Despite being a major agricultural exporter globally, Brazil relies exclusively on foreign sources for the required raw materials, which could be cultivated locally. It is high time for Brazil to not only produce and cultivate cannabis but also become a seller rather than solely a buyer of raw materials. By taking this step, Brazil can not only cater to the needs of its patients but also retain and foster the economic potential within the country. Growing the plant domestically would substantially reduce costs and significantly improve access to cannabis-based products for patients in need,” said Barbosa.
Vivian Dalla Colleta believes that access to medical cannabis in Brazil could be significantly improved through the implementation of Farmácias Vivas, a program established by the Ministry of Health in 2010. This initiative is specifically designed to produce herbal medicines and encompasses all stages, from cultivation and collection to processing, storage, and distribution of medicinal plants.
According to Dalla Colleta, the most effective approach would involve integrating medical cannabis into the Farmácias Vivas program. This federal government project has the potential to grow medicinal plants, convert them into phytomedicines, and make them accessible to the population through SUS. The infrastructure for such a system already exists; however, the main issue is the lack of legal protection for Farmácias Vivas.
