Psychedelic Medicines 2024 Comparisons

The main laws and regulations relating to psychedelic medicines in Brazil are:

• Law No 6,360/1976 ‒ provides regulation for health surveillance of medicines, drugs, pharmaceutical ingredients, cosmetics, sanitisers and other products;
• Law No 9,279/1999 ‒ established the National System of Health Surveillance (Sistema Nacional de Vigilância Sanitária, or SNVS) and created the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, or ANVISA);
• Law No 9,961/2000 ‒ created the National Regulatory Agency for Private Health Insurance and Plans (Agência Nacional de Saúde Suplementar, or ANS);
• Law No 10,742/2003 ‒ provides regulatory standards for the pharmaceutical sector and created the Drugs Market Regulation Chamber (Câmara de Regulação do Mercado de Medicamentos, or CMED);
• Law No 11,343/2006 (the “Anti-Drugs Law”) ‒ established the National System of Public Policies on Drugs (Sistema Nacional de Políticas Públicas sobre Drogas, orSisnad), provides measures for the prevention of misuse, care and social reintegration of drug users and addicts, establishes rules for the repression of unauthorised production and illicit trafficking of drugs, defines crimes, and makes other provisions;
• Ministry of Health (MoH) Ordinance No 344/1998 ‒ technical regulation concerning substances and drugs subject to special control; and
• ANVISA Ordinance No 898/2015 ‒ established a Working Group between ANVISA and the Ministry of Justice to optimise the classification and control of narcotic, psychotropic, precursor and proscribed substances (as well as other substances and plants subject to special control).

ANVISA Resolution of the Collegiate Board (Resolução da Diretoria Colegiada, or RDC) No 38/2013 regulates expanded access, compassionate use and post-study drug supply programmes. In summary, ANVISA RDC No 38/2013 establishes the following definitions.

• Expanded access programme ‒ a programme to make available a promising new drug (not yet registered with ANVISA or commercially available in Brazil) that is undergoing or has completed a phase III trial and is aimed at a group of patients who have serious debilitating and/or life-threatening diseases and no satisfactory therapeutic alternative with registered products.
• Compassionate use programme ‒ a programme to allow the supply for personal use by a patient, who is not a participant in an expanded access or clinical research programme, of a promising new drug (not yet registered with ANVISA) that is in the process of clinical development and intended for patients who have serious debilitating and/or life-threatening diseases and no satisfactory therapeutic alternative with products registered in Brazil. The allowance granted by ANVISA for compassionate use is personal and not transferrable.
• Post-study drug supply programme ‒ a programme to allow the continued supply of medicines to research subjects at no cost, applicable in cases of termination of the study or when their participation ends.

ANVISA’s approval process for expanded access, compassionate use and post-study drug supply programmes begins with a request from the sponsor of a clinical trial or the sponsor’s representative organisation. Requests for approval of expanded access and compassionate use programmes are analysed by ANVISA according to the following criteria:

• severity and stage of the disease;
• absence of a satisfactory therapeutic alternative in Brazil for the clinical condition and its stages;
• severity of the clinical condition and presence of co-morbidities; and
• assessment of the risk-benefit ratio of using the requested medication.

With ANVISA’s permission, the supply of the medicine authorised in the expanded access and compassionate use programmes should be guaranteed as long as there is benefit to the patient, at the doctor’s discretion.

In Brazil, medicines are governed by a comprehensive and complex regime of legislation and regulations spanning many different areas of law. The legislative and regulatory landscapes are also very dynamic, as government authorities constantly update regulatory processes and policies.

In the Brazilian health regulatory system introduced by Law No 6,360/76, a drug may be marketed only if:

• it has been previously registered with ANVISA, according to Law No 9,782/99; and
• its price has been established by the CMED, as per Law No 10,742/03.

As regards access to drugs, given that the healthcare system is primarily public in Brazil, patients do not have out-of-pocket expenses in most cases, inasmuch as drugs considered to be essential to public health are provided by the Brazilian government. In the private healthcare system, health insurance companies must at least supply patients with drugs included in the List of Procedures issued by ANS.

Accordingly, the main regulatory bodies charged with enforcing the laws and regulations governing the medical psychedelics industry are:

• ANVISA ‒ the Brazilian regulatory body (created in 1999 within the MoH) entitled to enforce public health protections, oversee drug approvals and sanitary standards, regulate the import of drugs, and issue regulatory approval for clinical trials;
• ANS ‒ the regulatory body (created in 2000 within the MoH) responsible for the regulation, standardisation, control and inspection of activities that guarantee private healthcare;
• National Committee for Technology Incorporation (Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde, or CONITEC) ‒ the body responsible for advising the MoH in the incorporation or disinvestment of health technologies into the Unified Healthcare System (Sistema Único de Saúde, or SUS); and
• National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa, or CONEP) ‒ provides ethical review and approval for clinical trials.

There are no self-regulatory authorities that govern the psychedelic medicine industry or psychedelic trials in Brazil.

The Brazilian market of psychedelic drugs is incipient, even though it seems to be gradually evolving by acknowledging the therapeutic potential of psychedelic substances following the development of clinical data and new regulatory approaches on the matter in other jurisdictions.

In a notable regulatory development, ANVISA approved esketamine (S-isomer of ketamine) hydrochloride in 2020 for treating treatment-resistant depression. Ketamine, although not a classic psychedelic, shares some pharmacological properties with this class of substances. The substance had already been used in the past as an anaesthetic in diagnostic and surgical interventions; however, until 2020, it did not have regulatory approval for psychiatric treatment. For further details, please see “Esketamine and ketamine as regulatory precedents” in the Brazilian Trends and Developments chapter of this guide.

In addition, during the past few decades, Brazil has made limited exceptions for traditional and cultural uses of psychedelics. Ayahuasca, a traditional Amazonian brew containing dimethyltryptamine (DMT), has been legally permitted for use within certain religious practices since the 1980s. For more on the case of ayahuasca, please see “Ayahuasca: balancing freedom of religion and drug prohibition” in the Brazilian Trends and Developments chapter of this guide.

However, other psychedelics remain firmly restricted, with minimal legal permissions for research purposes.

Brazil is at a critical point in its approach to psychedelic substances as potential treatments for mental health disorders. The historical and regulatory landscape has shaped public perception and legal frameworks, often hindering research and clinical applications. Even though the therapeutic potential of substances such as psilocybin, 3,4-Methylenedioxymethamphetamine (MDMA), and DMT is increasingly recognised, regulatory bodies require compliance with strict rules to ensure patient safety and evidence quality assurance.

Difficulties faced by applicants in obtaining approval to conduct clinical trials with psychedelic substances reinforces the need for regulatory reforms that facilitate research while maintaining safety standards.

There are no common or specific cross-jurisdictional issues concerning psychedelic substances in Brazil.

Even though foreign law and regulation are not applicable in Brazil, the Brazilian regulatory approach to psychedelics has historically mirrored global trends, with strict prohibitions influenced by international drug control conventions. Substances such as lysergic acid diethylamide (LSD), MDMA, psilocybin and DMT were widely classified as illegal amid global drug control efforts, without differentiation between their recreational and potential therapeutic uses. This policy approach placed psychedelics in the same category as addictive narcotics, imposing restrictions that have hindered research and clinical applications for many years.

Brazil’s current legislative and regulatory landscapes concerning psychedelic drugs is restrictive. Even though Brazil’s regulatory stance on psychedelics reflects a gradual shift shaped by international research developments and the increasing interest in alternative mental health treatments, most psychedelic substances such as LSD, psilocybin, MDMA, mescaline and DMT are categorised as proscribed substances, pursuant to MoH Ordinance No 344/1998 ‒ marking them as prohibited drugs with no authorised therapeutic use.

Applicants for clinical trials are also facing difficulties in obtaining regulatory approval and, ultimately, this jeopardises patients’ access to potential treatments. In Brazil, clinical trials are strictly regulated to ensure the safety and efficacy of ‒ and ethical standards for ‒ investigational drugs. For further details, please see “Regulatory barriers to psychedelic research” in the Brazilian Trends and Developments chapter of this guide.

Although access to medical psychedelics does not seem to be a top priority in the regulators’ agenda, recent developments (eg, the approval of esketamine for treating treatment-resistent depression mentioned in 1.4 Existing Market) have set a positive precedent. Such developments suggest that medicines based on psychedelic substances can be approved by ANVISA and made available safely to the population when GCP requirements and the conditions of safety, quality and efficacy are met.

Initial legislative routes should acknowledge the therapeutical potential of psychedelic substances and create mechanisms to allow and foster the conduction of clinical trials and the review of marketing authorisation applications related to psychedelic drugs in an efficient manner while ensuring patient’s safety and deterring abusive practices.

Brazil has a robust legislative and regulatory structure in respect of pharmaceutical drugs. However, the challenges involved in the therapeutic use of psychedelic drugs are not addressed in a specific, objective manner.

One example of how the lack of specific, formal regulation focused on the therapeutic use of psychedelic drugs may jeopardise patients’ access to potential treatments is the Instituto Phaneros case. Owing to the absence of clear provisions on the current regulation, a research organisation called the Phaneros Institute (Instituto Phaneros) ‒ focused on the evaluation, research and development of Psychedelic-Assisted Psychotherapy (PAP) in Brazil – struggled to obtain proper authorisations from ANVISA to conduct clinical trials with MDMA and psilocybin for treatment of post-traumatic stress disorder and major depression, respectively.

Instituto Phaneros was only able to compel ANVISA to review the merits of the authorisation applications for the referred clinical trials upon a court order. However, ANVISA eventually denied the applications by concluding that:

• as the research involved the administration of a psychedelic substance to human beings and therefore a high health risk would be involved in the intended activities, the focus of the assessment should be on the prevention of product deviation and on the safety conditions for conducting clinical studies, including the safe administration of the product to patients; and
• Instituto Phaneros would have not complied with all regulatory requirements to demonstrate safety in the administration to patients, as well as in the handling, safe-keeping and disposal of the psilocybin substance.

For further details and analysis of the Instituto Phaneros case, please see “Instituto Phaneros case: strict requirements for psychedelic research” in the Brazilian Trends and Developments chapter of this guide.

Currently, the chances of a regulated “adult-use market” for psychedelic substances in Brazil seem to be low. There has been some deliberation in the sense of decriminalising possession of prohibited substances for personal use ‒ for example, June 2024, the Supreme Court decided to decriminalise marijuana possession for personal use and set the amount at up to 40 grams or six female plants to differentiate the user from the trafficker. Nonetheless, the Brazilian Congress is reviewing Constitutional Bill No 43/23, which aims at including a provision in the Federal Constitution stating that it is a crime to possess or carry any quantity of drugs or narcotics “without authorisation or in disagreement with a legal or regulatory determination”.

Given that Brazil’s regulatory approach to psychedelics has historically mirrored global trends, it seems the development of regulated markets for the recreational use of psychedelic drugs might encourage increased debate in Brazilian society and, as a consequence, legislative initiatives addressing the matter in the country. However, the absence of legislative initiatives to regulate and foster the therapeutic use of psychedelic substances indicates that it will take a long time for Brazilian authorities ‒ including members of the executive, legislative and judiciary branches ‒ to embark on thoughtful discussions concerning the recreational use of psychedelic substances.