RDC 1,015: what changes for fibromyalgia and lupus

RDC 1,015/2026, published by Anvisa (Brazil's health regulator) on February 3, 2026, replaced RDC 327/2019 as the rule for cannabis products for medicinal purposes. The most visible change for patients: people with serious debilitating diseases, such as fibromyalgia and lupus, can now use products with THC above 0.2%, which were previously restricted to those in palliative care. The rule also expands the routes of use and tightens prescription documentation.

What happened

RDC 327/2019 was the rule that, for six years, allowed the sale of cannabis products in Brazilian pharmacies with a prescription. RDC 1,015 updates that framework. According to Anvisa and coverage by Portal Afya and Migalhas, the main points are:

• more patients with access to higher-THC products: the door, previously limited to palliative care, now includes serious debilitating diseases, with fibromyalgia and lupus cited by the agency itself;
• more routes of administration: in addition to those that already existed, dermatological, sublingual, buccal and inhaled routes are added;
• more formal prescribing: prescribing falls to doctors and dentists who follow the patient, and the informed consent form becomes mandatory;
• controlled dispensing: through regular pharmacies, with registration in the national system for controlled products;
• advertising: according to Migalhas, it remains banned to the public and may only be directed to prescribers, with approved informational material;
• compounding pharmacies: Anvisa accepted the possibility, but left it for a separate rule, still to be written.

According to Portal Afya, RDC 1,015 took effect on May 4, 2026.

Why it matters

Those who live with chronic pain, fatigue and inflammation know the pilgrimage: treatment after treatment, partial response, side effects. For some of these patients, doctors were already discussing cannabis products, but the rule created an artificial barrier when the product had more THC.

RDC 1,015 removes this barrier for serious debilitating diseases, but it does not turn cannabis into an automatic answer. What it does is give doctors more options and more responsibility. The consent form exists precisely so that the patient knows, in writing, what is known and what is not known about the product they will use.

This speaks to the state of the science. In the 2017 review by the U.S. National Academies of Sciences, chronic pain in adults appears among the situations with substantial evidence of effect. For many other conditions, the evidence is still limited or insufficient. A more open rule is not the same as stronger evidence.

In Bairo's view

For Bairo Leandro Gonzalez Martinez, RDC 1,015 is an advance in access that only makes sense with serious information alongside it. In his reading, broadening the list of patients is recognizing that many people were left out by a criterion that did not keep pace with medicine. But the same rule makes it clear who decides: the professional who follows the patient, with the patient informed.

In his reading, lived experience is not evidence. One person's experience proves nothing for anyone else, which is why he argues that the conversation about cannabis should use graded evidence, honestly described conduct and no promise of results. For him, the consent form is a good symbol of this stance: saying in writing what is known and what is still being studied.

Where this meets the ecosystem

Xperienc Global Labs, founded by Bairo in London, proposes a teleconsultation environment with a clinical assistant validated by a professional and with the Global Language translator. For a patient with fibromyalgia or lupus, the proposal is to be able to hear a specialist from another country as a second clinical opinion, not a medical report, taken to the doctor who follows them.

Xperienc's clinical partner, Hospital Granja Julieta, in São Paulo, is a separate company that plans a wing for cannabinoid protocols under medical supervision.

What science already knows, condition by condition, is in The plant and the science. This text does not recommend any product or dose. If cannabis is part of your question, the path begins with a consultation.

Sources

• Anvisa, "Anvisa publica regras para produção de cannabis medicinal" (Anvisa publishes rules for medical cannabis production), 02/03/2026: gov.br/anvisa
• Portal Afya, "Anvisa publica resolução e altera prescrição de produtos de cannabis medicinal" (Anvisa publishes resolution and changes prescribing of medical cannabis products), Feb. 2026: portal.afya.com.br
• Migalhas, "Anvisa autoriza cultivo e amplia uso medicinal da cannabis no Brasil" (Anvisa authorizes cultivation and expands medical use of cannabis in Brazil), Jan. 2026: migalhas.com.br
• National Academies of Sciences, Engineering, and Medicine, The Health Effects of Cannabis and Cannabinoids, 2017: nap.nationalacademies.org

Read also

• RDCs 1,013, 1,014 and 1,015: what Anvisa changed
• What science says about medical cannabis
• How Anvisa regulates medical cannabis