Life Sciences Newsletter | February 2024

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

NEWS

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

TJSP decides that healthcare plans must cover bipolar disorder treatment

On January 16, 2024, on appeal, the 1st Chamber of Private Law of the Court of Appeals of São Paulo (TJSP) ordered a health insurance operator to cover the costs of medicines prescribed for the treatment of bipolar disorder, subject to a BRL 1,000 daily fine.

The decision states that healthcare plans can define which medical conditions have coverage, but not the diagnosis or treatment methods. As such, the court decided that healthcare plan operators cannot deny coverage to the treatment that physicians prescribed, to ensure that patients are not exposed to potential health risks.

This decision draws attention to the extension of healthcare plan coverage to medicines prescribed outside hospitals.

Access the proceedings of the case.

STJ decides that Brazilian Federation units can charge court-ordered procedure expenses to healthcare plans

On October 17, 2023, the 1st Chamber of the Superior Court of Justice ruled on Special Appeal No. 1945959, by a majority vote, deciding that units of the Brazilian Federation (Federal Government, Federal District, states and municipalities) have legal claim to reimbursement from private healthcare plan operators for expenses relating to the court-ordered treatment by the Brazilian Unified Health System (SUS) of a patient insured by these private plans.

In this regard, the collegiate ordered an operator to reimburse the state of Rio Grande do Sul for the court-ordered bariatric surgery of a patient insured by such healthcare plan operator. The rapporteur deemed reasonable that the state of Rio Grande do Sul file suit to charge the surgery expenses directly to the operator, without the need for a previous administrative proceeding with the ANS.

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Judiciary branch authorizes import of cannabis-based product

On February 07, 2024, the Federal Regional Court (TRF) of the 4th Region of the state of Paraná decided that ANVISA must clear the import of a cannabis-based product for medicinal purposes (“Cannabis Product”).

In line with the applicable case law, the judiciary branch took Collegiate Board Resolution (“RDC”) No. 660/2022 into consideration, which regulates the procedure to import cannabidiol for medicinal purposes, in addition to Technical Note (“NT”) No. 65/2023, which authorizes the automatic issuance of import authorizations for the products it provides for, including the Cannabis Product in question.

Federal courts establish new deadline for compliance with food labeling guidelines

On February 14, 2024, the federal courts gave food producers two months to adjust their packaging according to the new regulation provided for in Collegiate Board Resolution No. 429/2020 regarding the nutrition labeling of packaged foods.

The federal courts decided to advance the deadline to include front-label warnings regarding high levels of sugar, salt and fats. As such, the decision dismisses Collegiate Board Resolution No. 819/2023, which authorized companies to deplete their existing stocks by October 08, 2024.

MS – BRAZILIAN MINISTRY OF HEALTH

25 years later, generic medicines amount to 37% of the pharmaceutical market in Brazil

February 10, 2024, has marked the 25th anniversary of the regulatory framework for the generic medicines policy. The regulatory framework expanded access to pharmacological treatment by offering affordable medicines that currently account for 37% of Brazil’s pharmaceutical market.

In Brazil, all generics are tested to assess their quality and effectiveness. These procedures evaluate the performance of generics in humans compared to patent medicines.

LEGISLATIONS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

ANVISA updates list of authorized food additives in foods

On February 23, 2024, Normative Instruction No. 274/2023 was published to amend Normative Instruction No. 211/2023, which provides for the technological functions, limits and conditions of use for authorized food additives and processing co-formulants.

The main amendment is a new list of food additives in the list of products authorized for use in foods, establishing the maximum authorized quantities and respective functions of each substance.

Food supplement labeling regulations amended

On February 23, 2024, Normative Instruction No. 275/2024 was published to amend Normative Instruction No. 28/2018, which establishes the lists of ingredients, limits of use, alleged benefits and supplementary labeling of food supplements.

The new regulation amends the minimum and maximum daily quantities of nutrients and substances that food supplement producers can recommend in the label for a given population group.

ANVISA publishes new food and packaging regulations

On February 28, 2024, ANVISA published two new food and packaging regulations:

• (i) Normative Instruction No. 281/2024: Provides for the procedure and necessary documentation to bring different food and packaging categories in line with the regulation; and
• (ii) Collegiate Board Resolution No. 843/2024: Provides for the requirements to bring food products and respective packaging under the competence of the National Health Oversight System’s (SNVS) in line with the applicable regulation for distribution in Brazil.

These regulations aim to improve efficiency, given that the current procedures are crammed with red tape, lopsided and outdated. In this regard, the regulations provide for the list of foods and packages that must or not be in good standing with ANVISA, in addition to the registration procedure.

The new regulations will enter into force on September 01, 2024.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Amendment to hospital network modification regulation delayed

On February 15, 2024, Normative Resolution No. 598/2024 was published was published to delay the entry into force of Normative Resolution No. 585/2023, as well as the deadline for healthcare plan operators to comply with the new regulation. 

In summary, Normative Resolution 585 updates the regulation to modify the hospital network covered by healthcare plans, which affects consumers, operators and hospitals. The update grants consumers the right to portability in case of changes within the hospital network, regardless of the effective insurance period or the price of new insurer’s plan, applicable to network changes in the city where the insured resides or contracted the plan. In turn, operators can exclude underutilized hospitals from their network, provided that major hospitals in a given region be replaced with an equally efficient hospital. Finally, hospitals must now follow specific criteria and regulation regarding the partial exclusion of hospital services.

Normative Instruction No. 585/2023 was scheduled to enter into force on March 01, 2024, and would be reviewed within 24 months of this date. However, the new regulation put off this entry into force until September 01, 2024, maintaining the 24-month period for a review.

PUBLIC CONSULTATIONS AND HEARINGS

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

ANS opens public consultation to review mandatory coverage in healthcare plans

In February 2024, the ANS received proposals through Public Consultation No. 125 regarding the update of the list of mandatory health events and procedures in supplementary health.

The public consultation aimed to obtain contributions regarding the proposed normative resolution that amends Normative Resolution No. 465/2021, which provides for the list of mandatory health events and procedures in supplementary health. The subsequent goal is to regulate the mandatory coverage of Osimertinib, an oral antineoplastic medicine used in adjuvant therapy after tumor resection procedures in non-small cell lung cancer (NSCLC) patients.

Public call for contributions opened regarding priority care pathways

On November 29, 2023, Public Call for Contributions No. 2 was published to receive proposals regarding priority care pathways in supplementary health for cardiovascular, metabolic, cardiorespiratory, renal, mental, oncological, musculoskeletal and oral diseases.

Proposals must provide for care flows, clinical protocols, therapeutic guidelines, and health indicators, and must be designed according to different priority of care levels (primary, specialized, hospital and home care). Contributions will be analyzed by a selection committee formed by the teams in charge of healthcare quality assurance programs by the Sectorial Development Board. These proposals will serve as technical contributions for the development of priority care pathway structures in the supplementary health sector by the ANS.

Proposals can be submitted by June 30, 2024, through an application form with the name of the applicant and the proposed care pathway according to the criteria set out in NT No. 4/2023/DIRAD-DIDES/DIDES.

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Public consultation analyzes proposed regulation on health requirements for silicone materials in contact with food

On February 28, 2024, a notice for Public Consultations No. 1,235/2024 and No. 1,236/2024 was published. These consultations aim to obtain normative act proposals to provide for health requirements for silicone material used in packaging, coating and equipment that come into contact with food, and for the list of substances that can be used to produce such materials.

Within this context, we emphasize that these legislative proposals are related to Subject 3.12 of the 2024-2025 Regulatory Agenda, which provides for the regulation of health requires for silicone materials that come into contact with food.

Contributions can be submitted by May 05, 2024, through the public contribution form.