Unprecedented law in the state of São Paulo authorizes SUS to provide Cannabis-derived medicines

On February 01, 2023, Law No. 17,618/2023 was published, which establishes a state policy for the free dispensing of cannabidiol-based medicines, in association with other substances that are derived from cannabis – including tetrahydrocannabinol – in exceptional terms,  across public and private health facilities associated with the Brazilian Unified Health System (“SUS”) in the State of São Paulo.

This regulation aims to address the high number of judicial claims requesting that cannabidiol-based products and medicines be provided by SUS free of charge. In the State of São Paulo alone, there has been a 1,750% increase in the number of such claims since 2015, according to data provided in Bill No. 1,180/2019.

Only four provisions were approved in the final wording of the Law, given that the governor of São Paulo vetoed six other provisions, which provided for the criteria, scope and procedures to access such medicines. As a result, the new Law is limited to general provisions regarding the main goals and guidelines of the public policy, such as:

(i) Aligning the use of medicinal cannabis to public health guidelines in the state of São Paulo, based on scientific studies and international sources. Such effort is aimed at ensuring the supply of and access to cannabidiol plant-based medicines, in association with other cannabis-derived substances, including tetrahydrocannabinol, to patients who bear diseases whose clinical and social effects have been scientifically proven to improve through such treatment.

(ii) Diagnosing and treating patients whose treatment through medicinal cannabis has been scientifically proven or supported.

(iii) Implementing public policies to foster debate and access to information regarding the use of medicinal cannabis – through lectures, forums, symposiums, management qualification courses and other measures aimed at increasing widespread knowledge of the population regarding medicinal cannabis, as well as establishing public-private partnerships with – preferentially – non-profit organizations.

(iv) The creation of a working committee, by the state’s Health Department, to implement the policy’s guidelines in the State of São Paulo, within 30 days from the publication of the new Law. The committee will be formed by technical agents and representatives of non-profit organizations that support cannabis research, as well as organizations that represent patients.

It is important to reinforce that the new Law only provides for the free dispensing of “cannabidiol plant-based medicines, in association with other cannabis-derived substances, including tetrahydrocannabidiol” – and not “Cannabis Products”.

By November 28, 2022, Brazil’s National Health Regulatory Agency (“ANVISA”) had approved the production and import of 23 Cannabis-based products for medicinal purposes, under RDC No. 327/2019, which include 9 Cannabis sativa-based products and 14 cannabidiol-based products. As of the publication of this Client Alert, we have not been able to verify the exact number of medicines registered with ANVISA that fit into the requirements of the new Law. However, such an amount is highly likely to be lower than the number of Cannabis Products currently registered with ANVISA.

Despite uncertainties surrounding  Law No. 17,618/2023, its publication represents a landmark victory for patients and companies of the sector and it may encourage other states to publish similar regulations, further stimulating an already promising sector. 

The Law will enter into force on May 02, 2023.

Find more details regarding the regulatory landscape of Cannabis Products in Brazil, by accessing our Guide to Cannabis Products Regulation in Brazil, guide to the Regulation on Cannabis Products in Brazil.

Demarest’s Life Sciences team is monitoring the updates in the industry and is available to provide any further clarifications that may be necessary.