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.
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Demarest’s Life Sciences Team
ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY
Federal Supreme Court decriminalizes cannabis for personal use
On June 26, 2024, the Brazilian Federal Supreme Court (“STF”) decided to decriminalize the possession of marijuana for personal use in Brazil, concluding Extraordinary Appeal 635659. While being in possession of up to 40 grams is still an illicit practice, any attached penalties to users will now be administrative only, rather than criminal.
ANVISA updates good regulatory practices procedures
On May 29, 2024, Ordinance No. 673 was published, providing for the guidelines and procedures for improving regulatory quality in ANVISA.
In June, Decree 11,243/2022 and Decree 12,002/2024 entered into force, which required quality improvements in ANVISA’s regulatory practices. The main change involves the possibilities of exemption from public consultation, which will be the same as those provided for in cases of non-applicability or exemption from Regulatory Impact Analysis (RIA).
ANVISA initiates review of reliance procedure regulation
In June 2024, ANVISA announced the ongoing correction of Normative Instruction No. 292/2024, which provides for specific criteria and procedures for defining the Equivalent Foreign Regulatory Authorities (“AREE”) that will conduct the health inspection of certain products for obtaining a Good Manufacturing Practices (“GMP”) Certificate.
The first paragraph of article 4 currently states that “AREE with a level of mutual recognition of regulatory reliance approved by ANVISA’s Collegiate Board of Directors are listed in the Annex to this Normative Instruction”, however, to date, ANVISA has no Mutual Recognition Agreement within the GMP area.
This error does not affect reliance procedures in other cases where mutual recognition agreement is not mandatory.
Regulation prohibits sale of phenol-based products to be used in general health or aesthetic procedures
On June 25, 2024, ANVISA published Resolution 2,384/2024, which prohibits the import, manufacture, manipulation, sale, advertising and use of phenol-based products in general health or aesthetic procedures.
Products duly regulated with ANVISA under the exact conditions of registration and products used in analytical laboratories or clinical analysis remain authorized.
The regulation will remain in force while the potential damage associated with the use of phenol is investigated.
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
Preliminary injunction prohibits exclusion of people with autism spectrum disorder from healthcare plans
On May 22, 2024, the ANS issued a preliminary injunction in the proceedings of collective action No. 0720060 41.2024.8-07.0001., prohibiting healthcare plan operators from excluding beneficiaries with Autistic Spectrum Disorder (ASD) and ordering the reinstatement of contracts terminated unilaterally within the same context.
Healthcare plan ordered to cover medication from ANS list during judicial proceedings about supply
On March 29, 2024, the Third Panel of the Superior Court of Justice (“STJ”) judged Special Appeal 2,105,812 and decided that healthcare plan operators are required to cover household medicines included in the ANS list while there are pending judicial proceedings regarding their supply.
ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY
ANVISA updates regulation on post-registration of biological products
On June 03, 2024, Collegiate Board Resolution (“RDC”) 876/2024 entered into force, which amends the regulation that provides for post-registration changes and cancellation of biological products (RDC 413/2020).
The amendment seeks to optimize the filing of petitions necessary to update the registration of biological products, as well as their analysis by ANVISA.
Resolution reduces regulatory costs for sanitizing products
On June 03, 2024, ANVISA published RDC No. 878/2024, which amends regulations to reduce regulatory costs for the sanitizers production sector.
The new regulation waives the need to change sanitizer product labels to include statements regarding the donation of products that require petition and prior statements from ANVISA.
RDC No. 878/2024, which amended RDC No. 492/2001, has been in force since its publication, and the measure is valid for sanitizers of Risk 1 and Risk 2.
Regulation amends exemption criteria for import Operating Authorization
On May 08, 2024, RDC No. 860/2024 entered into force, establishing which companies, institutions and activities are exempt from an Operating Authorization.
The new regulation amended RDC 16/2014, which regulates the criteria for companies to file for an Operating Authorization and Special Authorization (AE). The measure aims at simplifying import approval procedures, especially for companies dealing with products subject to health intervention.
ANVISA updates biossimilars registration regulations
On May 29, 2024, ANVISA published RDC No. 875/2024, which establishes additional provisions on the registration of biosimilars through development and comparability studies.
RDC 875 establishes requirements that supplement RDC No. 55, of December 16, 2010, for the registration of biosimilars in Brazil, aiming to guarantee the quality, safety and efficacy of these products.
The resolution entered into force on June 17, 2024.
Regulation approves National Prescription Control System
On June 03, 2024, ANVISA published RDC No. 873/2024, which provides for the improvement of the numbering and control of prescriptions for medicines.
The goal is to improve the concession and control of the numbering of the prescription notices used to prescribe medicines and products subject to special control.
ANVISA updates post-registration regulations for biological products
On June 03, 2024, RDC No. 876/2024 entered into force, amending the procedure to file petitions for the update of biological product registration, in addition to their analysis by ANVISA.
The measure amends RDC No. 413/2019, aiming to optimize the procedure by waiving other protocols other than the main change or set of related main changes.
Regulation provides for criteria to classify prescription medicines
On June 21, 2024, ANVISA published RDC No. 882/2024, which establishes health requirements and procedures to exempt medicines from prescriptions, and for the reframing of prescription medicines.
The measure aims to:
- increase the availability of over-the-counter medicines, expanding the population’s access to low-risk treatments;
- increase the safety of medicines available on the market; and
- strengthen the performance of pharmacists in providing guidance on the use of these medicines.
The RDC entered into force on July 01, 2024.
ANVISA updates food supplement health requirements
On July 01, 2024, Normative Instruction No. 304/2024 entered into force, amending Normative Instruction No. 28/2018, which establishes the lists of ingredients, limits of use, alleged benefits and supplementary labeling of food supplements.
The measure aims to provide clarity to the consumer about the benefits of these supplements.
Resolution amends regulated medical device identification regulations
On May 10, 2024, RDC 866/2024 entered into force, which amends the regulations regarding the identification of medical devices regulated by ANVISA (RDC No. 591/202), through the Unique Device Identification (UDI) system.
The measure aims to ensure the traceability and safety of medical devices in Brazil, in line with international standards defined by the International Medical Device Regulators Forum (IMDRF).
ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY
Project prohibits operator from canceling healthcare plan for older individuals and people with disabilities
In response to the increase in user complaints regarding the unilateral cancellations of healthcare plans, Senator Fabiano Contarato (PT-ES) proposed Bill 2,036/2024.
The bill bans healthcare plan operators from canceling contracts unilaterally with older individuals or people with disabilities, which would apply to both employer and association-based group policies.
ANS postpones new regulations on disaccredited hospitals due to budget cuts
On July 02, 2024, the ANS announced it will postpone the entry into force of new regulations that would benefit healthcare plan beneficiaries in cases of disaccredited hospitals or emergency services.
The changes were initially set to enter into force on September 01, 2024, but will now only be implemented in December 2024. Among the main innovations is portability without a grace period, which authorizes beneficiaries unsatisfied with the exclusion of health services to change operators immediately. Such grace period currently ranges from one to three years.
MS – BRAZILIAN MINISTRY OF HEALTH
Ministry of Health establishes National Policy for Palliative Care
On May 22, 2024, GM/MS Ordinance No. 3.681/2024 entered into force, establishing the National Policy for Palliative Care under the Brazilian Unified Health System (“SUS”), through the amendment of GM/MS Consolidation Ordinance No. 2 , of September 28 , 2017.
The measure seeks to integrate palliative care with the Health Care Network with emphasis on primary care. The policy seeks to improve quality of life for patients who need palliative care, in addition to increasing the availability of medicines for symptom control.
Ministry of Health regulates Productive Development Partnership program
On June 21, 2024, the Ministry of Health published GM/MS Ordinance No. 4,472, which provides for the Productive Development Partnership (PDP) program, amending GM/MS Consolidation Ordinance No. 4,472 , of September 28, 2017.
The measure enables the establishment of strategic partnerships between public, scientific and technological institutions and private non-profit entities, improving collaboration among different sectors for technological and productive development.
Ministry of Health establishes Local Development and Innovation Program
On June 21, 2024, GM/MS Ordinance No. 4,473 entered into force, which establishes the Local Development and Innovation Program, amending MS Consolidation Ordinance No. 5, of September 28, 2017.
The measure aims to bolster local productive and technological capacity, in addition to fostering innovation within the SUS. The program will reduce dependence on imports and increase the resilience of the SUS through the development of innovative technological solutions.
PUBLIC CONSULTATIONS AND HEARINGS
ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY
ANVISA opens public consultation for proposal on patent medicines
On June 25, 2024, a public consultation was opened to receive contributions on the proposed criteria for indicating, including and excluding medicines from the list of patent medicines.
The approved proposal subject to public consultation brings regulatory tools aimed at improving the efficacy of the list of patent medicines.
The public consultation will receive contributions by August 23, 2024.
ANVISA receives contributions on proposal regarding of good storage practices requirements in customs warehouses
On June 11, 2024, ANVISA opened Public Consultation No. 1.259/2024 to receive contributions regarding the proposed RDC that provides for Good Storage Practices and the Certification of Good Practices for Storing Goods and Products subject to health inspection in customs warehouses.
ANVISA opens public consultation on operating authorizations and good practices in customs warehouses
On June 11, 2024, ANVISA opened Public Consultation No. 1,260 to receive contributions regarding the RDC proposal that provides for the criteria to apply for:
- Operating Authorization (“AFE”) and Special Operating Authorization (“AE”) for service providers involved in the storage of goods and products subject to health control and inspection in customs warehouses;
- AFE for importers on behalf and by order ofthird parties or or for the ordering of goods and products subject to health control and inspection; and
- Waiver ofAFE foradditional service providers in ports, airports and borders.
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