Worldwide, scientific evidence supports the effectiveness of medicinal cannabis in treating a variety of conditions. Research has shown positive effects in treating chronic pain, reducing chemotherapy-induced nausea and vomiting, and controlling severe epilepsy.
Cannabinoids such as CBD and THC are the main compounds studied, with evidence pointing to their potential in neuropsychiatric conditions such as PTSD and anxiety disorders. As a CRO, C2Outcomes is well-positioned to support research in these areas, leveraging global data and regulatory expertise to advance the understanding and application of cannabis-based therapies in medical practice.
Medical access to cannabis in Brazil
In Brazil, access to medicinal cannabis can be obtained through three main routes:
Personal importation: Patients can import cannabis-based products for personal use with a prescription from a healthcare professional and authorization from ANVISA (RDC 660/22).
National purchase: Patients can purchase cannabis-based products produced in the country from authorized companies available in pharmacies or drugstores, with a medical prescription (RDC 327/19).
Cannabis Associations: These are groups formed by patients, family members, health professionals and activists to promote safe access to medicinal cannabis. Although they are not officially recognized by law, at least 16 associations have judicial authorization to cultivate the plant and provide products to their members.
Each method has its own peculiarities in relation to the products available, the professionals who prescribe them and the purchasing logistics, which affects the choice of access method for patients.
The State of the Evidence
The technical note from Fiocruz (the Ministry of Health’s arm for public health policies; knowledge sharing, education, scientific development and advocacy) addresses the evolving landscape of medicinal cannabis in Brazil, providing scientific evidence and technical support for the medicinal cannabis sector and health managers. Issued in April 2023, the document from the Institutional Program for Policies on Drugs, Human Rights and Mental Health advances in terms of the safety and legitimacy of key studies and medical conditions supported by substantial scientific evidence.
Conditions highlighted with the most significant support include chronic pain, refractory epilepsy, neuropsychiatric disorders, spasticity, and issues related to nausea, vomiting, and loss of appetite. The note emphasizes the need for more research to confirm the therapeutic benefits of various cannabinoids for a wide range of medical conditions.
The Real-World Evidence (RWE) approach to medical cannabis involves collecting data from real-world patient experiences rather than controlled clinical trials. This method provides insights into the effectiveness and safety of medical cannabis in a variety of everyday settings, providing a broader understanding of its therapeutic benefits and potential side effects. In the case of medical cannabis, RWE can help identify patterns of use, patient outcomes, and the long-term effects of treatment, which are crucial for developing clinical guidelines and regulatory policies.
It can even help with the product registration process with the regulatory authority. This approach aligns well with emerging healthcare trends that emphasize personalized medicine and patient-centered outcomes.
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