In the world · Cannabis · 8 June 2021
PL 399/2015: medical cannabis stalled in the Chamber
Approved by a special committee in 2021, bill PL 399/2015 would regulate medical cannabis cultivation. It has since awaited an appeal in the Chamber.
bairogonzalez.com team, drawing on Bairo's story · Published
PL 399/2015, a bill introduced by Deputy Fábio Mitidieri (PSD-SE), proposes changing the Drug Law to allow the production and sale of medicines made with cannabis. On June 8, 2021, a special committee of the Chamber of Deputies approved a substitute text that authorizes cultivation by companies and organizations, under the control of Anvisa and the Ministry of Agriculture. Since then, the bill has been stalled awaiting a decision on an appeal that calls for a floor vote.
What happened
The bill was introduced on February 23, 2015. Originally, its goal was narrow: to amend Article 2 of Law 11,343/2006 to allow the sale of medicines with extracts or parts of the plant. Over the years, the subject grew, a special committee was created and dozens of public hearings were held with doctors, patients, associations and regulators.
In June 2021, the committee voted on the substitute text by the rapporteur, Deputy Luciano Ducci (PSB-PR). The vote ended in a 17-17 tie, and the rapporteur's vote broke the tie in favor. Under the approved text:
- companies, public bodies and organizations could grow cannabis for medical, industrial and research purposes;
- hemp, with low THC, would be under the authorization of the Ministry of Agriculture;
- cannabis with THC would depend on Anvisa's authorization;
- cultivation by individuals and the sale of raw flower would be prohibited.
Since the committee had conclusive power, the text would go straight to the Senate. But Deputy Diego Garcia (Republicanos-PR) filed an appeal for the bill to be voted on by the full floor. Since 2021, the Chamber's official record shows the same status: awaiting deliberation of the appeal by the Board of Directors (Mesa Diretora).
Why it matters
While the bill waited, the country changed through other routes. In November 2023, at a hearing in the Chamber reported by CNN Brasil, deputies were already pointing to the delay of more than two years. In 2024, the STJ ruled that companies may grow hemp with up to 0.3% THC for medical purposes. In 2026, Anvisa published the resolutions regulating cultivation, associations and products.
In other words: much of what PL 399 proposed arrived through court decisions and sanitary rules, not through law. This has a cost. Resolutions can be revised more easily than laws, and court decisions depend on the case. A federal law would give more stability to patients, researchers and companies.
The subject remains in the Chamber. On May 19, 2026, the Committee for the Defense of the Rights of Persons with Disabilities approved holding a seminar on the role of patient associations in access and research under Anvisa's new framework.
In Bairo's view
For Bairo Leandro Gonzalez Martinez, the story of PL 399 is a lesson about time. In his reading, every year of waiting has a face: the family paying in dollars for an imported product, the researcher who cannot work with domestic material, the doctor who prescribes with no one to ask. He knows well the weight of being told something will not move forward.
Bairo does not advocate shortcuts. For him, the urgency that matters is that of well-done research and clear information, not of release without criteria. That is why he welcomes the fact that the debate has advanced in the courts and at Anvisa with a medical focus, traceability and control, and believes that the law, when it comes, should consolidate this path instead of starting over from scratch.
Where this meets the ecosystem
Xperienc Global Labs, founded by Bairo in London, is a biotechnology research and development company that has medical cannabis as a scientific field. The proposal is to bring together laboratories, teleconsultation with a clinical assistant validated by a professional and the Global Language translator for a second clinical opinion, not a medical report. Legal certainty for research is a condition for any laboratory that wants to operate in Brazil.
SOSPROCESSOS, also conceived by Bairo and under development, proposes organizing legal information for lawyers. On a subject regulated by law, resolution and case law at the same time, knowing which rule applies is half the way.
What science already knows is in The plant and the science. Bills change course; for practical decisions, consult whoever follows your case.
Sources
- Chamber of Deputies, legislative tracking page for PL 399/2015 (accessed in 2026): camara.leg.br
- Brasil de Fato, "Comissão aprova produção de cannabis para uso medicinal, industrial e de pesquisa" (Committee approves cannabis production for medical, industrial and research use), 06/08/2021: brasildefato.com.br
- CNN Brasil, "Cannabis para fins medicinais: com projeto parado desde 2021, Câmara debate regulamentação de cultivo" (Cannabis for medical purposes: with a bill stalled since 2021, the Chamber debates regulating cultivation), 11/29/2023: cnnbrasil.com.br