Check out our monthly Life Sciences Newsletter, which gathers information about recent legislation, news, public consultations, and bills concerning the health and agriculture sectors in Brazil.
For more information, please contact our lawyers.
Enjoy reading!
Demarest’s Life Sciences Team
ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY
Agreement with Health Canada bolsters communication between health authorities
ANVISA has entered into a confidentiality agreement with Health Canada’s Regulatory Operations and Enforcement Branch.
The agreement aims to improve the exchange of technical knowledge and evaluation reports between both authorities regarding quality production standards for drugs, biological products, pharmaceutical inputs, and medical devices.
In this regard, ANVISA has been bolstering “reliance” rules so that product registration requests can be evaluated through an optimized procedure based on previous assessments from Equivalent Foreign Regulatory Authorities.
Startups participate in public call aimed at producing new drugs
In April 2024, ANVISA published Public Call Notice No. 01/2024, aimed at startups interested in joining a pilot project for the regulatory assessment of herbal medicines, new synthetic medicines, and biological products of interest for health services in Brazil.
The public call is an attempt at developing new drugs in Brazil. As such, this notice aims to select three startups in Brazil: a herbal medicine developer, a new synthetic drug developer, and a biological product developer. These startups will take part in the pilot project to receive regulatory guidance regarding innovation involving drugs at early development stages.
The application deadline ended on May 07, 2024, but the selected startups have not yet been disclosed.
MEC – MINISTRY OF EDUCATION AND MS – MINISTRY OF HEALTH
MEC announces public call regarding authorization to offer undergraduate medical courses
On April 30, 2024, the Ministry of Education published Notice No. 05/2024, which announces a public call regarding the qualification of higher education institutions sponsored by a hospital to obtain authorization to provide undergraduate medical courses.
The qualification process will follow the schedule below:
| Activity | Expected date/period | |
| 1 | Update of the sponsor’s legal representative’s data on the e-MEC system (if necessary) | April 30, 2024 to April 14, 2025 |
| 2 | Application for qualification on the MM-Avaliação electronic platform from the MEC. | May 30, 2024 to April 29, 2025 |
| 3 | Announcement of preliminary qualification results by the Department of Regulation and Supervision of Higher Education (SERES) | Up to 90 days after application |
| 4 | Opportunity to appeal, if necessary, against the preliminary results | Up to 10 business days from the announcement of the preliminary result |
| 5 | Publication of the final result on the Federal Official Gazette of Brazil by SERES | Up to 30 days from the appeal filing date |
| 6 | Application on the e-MEC platform by the higher education institution for authorization to offer a medical course | Up to 45 days after publication of the final result in the Federal Official Gazette of Brazil |
CFM – BRAZILIAN FEDERAL COUNCIL OF MEDICINE
Regulation of fetal asystole for abortion addressed in judicial proceedings
Since the publication of CFM Resolution No. 2,378/2024, which regulates the medical practice of inducing fetal asystole in rape-related abortion cases provided for by law, this topic has been the focus point of several judicial disputes.
On April 18, 2024, the 8th Federal Court of Porto Alegre issued a preliminary injunction suspending the effects of the decision on the grounds that the Federal Council of Medicine exceeded its regulatory competence.
Subsequently, the Federal Regional Court of the 4th Region issued an interlocutory appeal to suspend the injunction and reinstate the effects of the CFM Resolution, arguing that this regulation requires a case-by-case analysis.
The resolution is currently in force and fully effective.
ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY
ANVISA updates ban on electronic smoking devices
On April 24, 2024, Collegiate Board Resolution No. 855/2024 was published to update the regulation that bans the production, import, sale, distribution, storage, transportation, and advertising of all electronic smoking devices, including their accessories, parts and refills.
Additionally, travelers remain prohibited from entering Brazil with such products, including in carry-on luggage. This update comes 15 years after the publication of Collegiate Board Resolution No. 49/2009, which banned electronic smoking devices in the country after the results of Public Consultation No. 1,222/2023, which received around 850 contributions.
New regulation sets rules to request regulatory “reliance” procedure
On April 08, 2024, Normative Instruction No. 290/2024 was published, establishing parameters for requesting an optimized procedure to assess and rule on medical device registration requests. Such procedure involves the use of assessments conducted by Equivalent Foreign Regulatory Authorities (“EFRA”), provide for by Collegiate Board Resolution No. 741/2022.
According to the new regulation, this request must include the following documents and information:
- Eligibility assessment statement.
- Proof of registration or authorization issued by an EFRA detailing the essentially identical medical device to be registered in Brazil, its instructions for use/intended use, and its manufacturer(s).
- Instructions for use of the medical device currently in force in the respective EFRA’s jurisdiction.
For more information on the topic, read our Client Alert. The normative instruction will enter into force on June 03, 2024.
ANVISA updates regulation on health inspection fee
On April 30, 2024, ANVISA’S Collegiate Board of Directors approved a new proposed resolution that provides for the procedure to request health inspections and collect a specific health inspection fee (Taxa de Fiscalização em Vigilância Sanitária – “TFVS”).
According to ANVISA, the proposed regulation addresses new payment and reimbursement methods, and includes an administrative tax proceeding, among others. The Federal Official Gazette of Brazil has not yet published the new regulation.
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
ANS postpones mandatory notification to healthcare plan beneficiaries in default
On April 22, 2024, the ANS postponed the entry into force of Normative Resolution No. 593/2023, which requires healthcare plan operators to send nonpayment notifications to private plan beneficiaries and collective plan beneficiaries that pay directly to the operator. The normative resolution also repeals the ANS’ binding precedent (Súmula Normativa) No. 28, of November 30, 2015.
According to Normative Resolution No. 602/2024, the effective mandatory notification was pushed from April 01, 2024, to September 01, 2024.
Superior Court of Justice upholds decision regarding “non-exhaustive” list of ANS procedures
The 2nd District of the Superior Court of Justice upheld the decision to not consider Law No. 14,454/2022 an exhaustive list of mandatory health events and procedures, given that it merely provides examples regarding health events and procedures covered by healthcare plan operators.
FEDERAL GOVERNMENT
Federal Senate approves regulation providing for clinical trials with humans
On April 23, 2024, the Federal Senate approved Bill No. 200/2015, which provides for clinical trials involving humans and establishes the National Ethics System for Clinical Trials with Humans.
The bill is aimed at increasing the conduction of clinical trials in Brazil to stimulate the development of products for advanced therapies, which are still an underdeveloped resource in Brazil. In parallel, ANVISA has been working toward establishing a regulatory environment that warrants legal certainty in clinical trials in Brazil. The bill is pending approval by the President of Brazil.
PUBLIC CONSULTATIONS AND HEARINGS
ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY
Review of clinical trial regulation will be subject to public consultation
On April 30, 2024, ANVISA’s Collegiate Board of Directors approved the opening of a 45-day public consultation to review Collegiate Board Resolution No. 09/2015, which provides for the conduction of drug trials in Brazil.
According to ANVISA, a regulatory impact analysis report confirmed the need to adjust the current legislation in force in line with regulatory innovations and international standards.
ANVISA has not opened the public consultation yet.
ANVISA proposes repeal of 77 obsolete regulations
On April 15, 2024, ANVISA opened Public Consultation No. 1,247/2024 to analyze a proposed resolution for repealing 77 regulations deemed obsolete across numerous matters.
Contributions can be submitted by May 29, 2024.
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
Rules on self-insured health plans subject to public call
On April 10, 2024, Public Call for Contributions No. 03 was opened to receive contributions regarding self-insured health plan regulations.
These plans are operated by non-profit entities that are specific groups of individuals.
This type of organization is governed by NBs No. 137/2006 and No. 148/2007.
Contributions can be submitted by May 27, 2024.
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