Brazil’s life sciences sector: a 2024 retrospective and what to expect in 2025

2024 was an active year for the Brazilian life sciences sector in terms of legislation and regulations, with changes impacting companies in the pharmaceutical, medical devices, food and cosmetics sectors.

Notable events included the Brazilian government launching a program allowing companies to submit proposals for public-private partnerships within the context of the country’s Health Economic-Industrial Complex, as well as enacting regulatory frameworks for the food and cosmetics sectors. Congress finally passed a legal framework for research on human subjects in Brazil, a development that the life sciences sector has long anticipated. Moreover, Brazil’s judiciary played a prominent role in ruling on and establishing a legal thesis regarding the provision of medications that have not been incorporated into the country’s public healthcare system (SUS), as well as some progress in the field of medicinal cannabis.

An overview of the key topics that shaped the sector in 2024 is provided below. These topics are expected to remain on the agenda in 2025 and should result in further new developments.

2024 overview

Food

The Brazilian Health Regulatory Agency (Anvisa) published two regulations on the regularization of processed food and food packaging in Brazil (Resolution No. 843/2024 and Instruction No. 281/2024). Beyond the existing forms of regularization for these products (registration with Anvisa and communication via an official form), there is now also the possibility of notifying Anvisa via its official petitioning system. This new modality is intended for products classified as being of ‘intermediate risk’, such as baby foods, recycled packaging, and foods with functional properties.

Reliance

In March 2024, Anvisa published Instructions No. 289/2024 and No. 290/2024 to regulate a streamlined analysis process for products that Equivalent Foreign Regulatory Authorities (AREEs) have assessed in their respective countries. Instruction No. 289/2024 specifically governs the procedures for drugs, biological products, vaccines, and the Pharmaceutical Inputs Compliance Letter (Cadifa), while Instruction No. 290/2024 specifically covers procedures for the registration of medical devices.

For further information on this topic, please click here.

Clinical trials

Over seven years after it was first proposed in Brazil’s Congress, Law No. 14,874/2024 was finally enacted in May 2024. In regulating research on human beings in Brazil, this law establishes the National System of Ethics in Research with Human Subjects, the Research Ethics Committee (CEP), and sets parameters for protecting and compensating research subjects, as well as the responsibilities of researchers and sponsors.

Furthermore, Anvisa published Resolution No. 945/2024 to provide guidelines and procedures for conducting clinical trials in Brazil once drug registration has been granted, as well as Instruction No. 338/2024, which establishes categories for classifying risk and complexity categorizations of clinical trials.

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Biosimilar medicines

May 2024 saw Anvisa publish Resolution No. 875/2024 to establish additional requirements for registering biosimilar medicines via the comparability development process. The resolution seeks to simplify the development process of these products by safely relaxing requirements, such as waiving certain stages and specific studies when technically feasible.

Cannabis

In October 2024, Anvisa approved an update to Ministry of Health regulations (SVS/MS Ordinance No. 344/1998) so that Brazil’s Ministry of Agriculture and Livestock (MAPA) can regularize Cannabis sativa-based products for veterinary use. The update also permits veterinarians authorized by the Brazilian Veterinary Medicine Council (CFMV) to prescribe such products.

This development came in the wake of Brazil’s Supreme Court (STF) finalizing its ruling to decriminalize the possession and personal use of cannabis. The court’s decision determined that people found with up to 40 grams of cannabis or six female plants will now be presumed to be drug users rather than traffickers. In turn, the Superior Court of Justice (STJ) authorized medicinal hemp cultivation, establishing an important precedent for importing and cultivating hemp in Brazil. The court set a six-month deadline for Brazil’s government to regulate the matter, with rules for planting, extracting, and selling plant derivatives.

Cosmetovigilance

Anvisa published Resolution No. 894/2024 in August 2024, which covers good practices in relation to cosmetovigilance. Replacing Resolution No. 332/2005, this new resolution is set to come into effect in August 2025 and is directed at companies responsible for regularizing cosmetics. Notably, there are new requirements for reporting and managing adverse events linked to cosmetic products.

Companies with officially registered cosmetic products will be subject to cosmetovigilance inspections (whether announced or unannounced) by Brazilian health authorities to assess compliance with the rules of Resolution No. 894/2024.

The outlook for 2025

Public-private partnerships in health

In mid-2024, the Brazilian government launched two key partnership programs within the scope of the National Development Strategy for the Health Economic-Industrial Complex (CEIS). GM/MS Ordinance No. 4,472/2024 was published to regulate a program for Productive Development Partnerships (PDPs), with GM/MS Ordinance No. 4,473/2024 governing the Local Development and Innovation Program (PDIL). A window was also opened for companies to submit project proposals in relation to both programs, with the deadline ending on September 30, 2024.

In 2025, the results of the first round of projects selected by the Ministry of Health should be published, with further submission periods for PDP and PDIL project proposals expected as well.

For further information on the CEIS and these partnership programs, please see our exclusive e-book on the topic.

Plant-based and alternative proteins

On September 24, 2024, the Ministry of Agriculture and Livestock held a public hearing to discuss proposed regulations for plant-based products. The hearing came in the wake of SDA/Mapa Ordinance No. 831/2023 (published the previous year), which set a 75-day public consultation period as part of the process. The draft regulations seek to establish minimum identity and quality requirements, labeling rules, and registration obligations with the Ministry for plant-based analog products.

In regard to alternative proteins, the publication of Resolution No. 839/2024 represented a significant step forward for the sector, as it updated the regulatory framework for new foods and ingredients. Notably, the resolution contemplates cell cultivation techniques, classifying items as ‘new foods or ingredients’ when they consist of cell cultures or tissue cultures (or when they are produced via such cultures).

Given these developments, there are strong prospects for both topics to be regulated in 2025.

Regulatory sandbox

In September 2024, Anvisa published a preliminary report on its Regulatory Impact Analysis (RIA) of establishing a regulatory sandbox initiative, and also opened a period for receiving public contributions.

In December, the agency then launched a consultation (No. 4/2023) to receive contributions on a draft call notice for selecting participants for a regulatory sandbox focused on personalized cosmetic products. The period for submitting suggestions on this matter ends on January 31, 2025.

As such, further developments concerning Anvisa’s regulatory sandbox initiative are expected in 2025, which may reduce regulatory barriers, foster competition in the sector, and accelerate public access to new technologies.

Review of CMED regulations

In December 2024, the Drug Market Regulation Chamber (CMED) held a public hearing to present a proposal on revising its internal regulations, currently governed by CMED Resolution No. 3/2023. Additionally, the CMED opened a period for submitting contributions on this matter via a form provided by Anvisa.

Among other aspects, the latest proposal (developed by the CMED Executive Technical Committee’s Working Group) aims to update the competencies and obligations of the bodies that make up the CMED, as well as make the chamber’s processes and procedures more predictable.

Artificial intelligence in health

2024 was marked by significant progress in the debate on a legal Framework for artificial intelligence in Brazil. The Brazilian Senate recently approved Bill No. 2,338/2023, which concerns the regulation of the AI system development and use in the country.

This regulatory framework looks set to significantly impact the health sector, as the approved bill classifies AI systems with applications in medical diagnostics and procedures as ‘high risk’ when there are significant risks to people’s physical and mental integrity. This would require AI agents to comply with obligations such as conducting algorithmic impact assessments, ensuring human oversight, and adopting transparency measures to minimize risks to health, safety, and the fundamental rights of the affected individuals or groups.

The Senate-approved text is still subject to further debate in the House of Representatives. If approved there, it will then be signed into law by Brazil’s President.

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Bioinputs

In December 2024, Law No. 15,070/2024 (commonly known as the Legal Framework for Bioinputs) was published in Brazil. The law addresses aspects such as the production, importation, exportation, registration, commercialization, use, inspection, and supervision of bioinputs, which are products and technologies of biological origin (plant, animal, microbial, and mineral) used to combat pests and diseases and improve the development of plants.

Among other aspects, this law establishes official mechanisms to encourage the use of bioinputs in Brazil and exempts bioinputs produced for self-consumption on rural properties from registration.

Supreme Court ruling on the supply of medications not incorporated into public health system

In September 2024, Brazil’s Supreme Court (STF) ruled on two cases linked to public health (RE No. 1,366,243 and RE No. 566,471). The former concerned the federal government’s accountability in meeting demands for the provision of Anvisa-registered medications that have not been incorporated into Brazil’s public health system (SUS), whereas the latter concerned whether it was the duty of the Brazilian State to provide such non-incorporated medications, regardless of their cost.

The following theses were established as a result of the STF’s rulings:

• Binding Precedent No. 60: administrative requests and evaluations of pharmaceuticals in the public health network, related judicial proceedings, and their administrative and jurisdictional outcomes must adhere to the terms of the three inter-federative agreements (and their procedures) approved by the STF under collaborative judicial governance in Theme 1,234 of the general repercussion system (RE No. 1,366,243); and
• Binding Precedent No. 61: the judicial granting of medications registered with Anvisa but not included on the SUS dispensing lists must observe the theses established in the judgment of Theme 6 of General Repercussion (RE No. 566,471).
• The sector should monitor the practical effects of these rulings – in particular, the application of the two precedents in ongoing judicial proceedings concerning these topics.

For more information on any of these topics, please contact Mattos Filho’s Life Sciences & Healthcare practice area.