Life Sciences Newsletter | January 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

STJ decides that healthcare plans cannot deny services to defaulters

 On January 18, 2024, the Third Panel of the Superior Court of Justice (“STJ”) ruled on Special Appeal No. 2019136, by a majority vote, that healthcare plan operators cannot deny the contracting of a plan based on the list of defaulters (delinquent debtors).

The STJ decided that denying the right to essential services based on this reasoning goes against the dignity of an individual and the principles of the Consumer Protection Code.

In addition, Minister Moura Ribeiro stressed that freedom of contract must not exceed the limits of the contractual social responsibility, under the terms of Article 421 of the Code of Civil Procedures, given that contractual relationships related to essential services extend beyond the mere will of the parties.

TJSP orders healthcare plan to authorize grace period portability

On December 31, 2023, the Court of Appeals of the State of São Paulo (“TJSP”) granted an injunction on Interlocutory Appeal No. 2351178-75.2023.8.26.0000to require that a healthcare plan regulate the contract of a family and authorize portability without the fulfillment of the grace period.

The TJSP based the measure on ANS Normative Resolution No. 438/2018, which provides for the possibility of special grace period portability in the event of cancellation of the original operator’s registration. In addition, the decision highlights a “risk of damage”, given that any beneficiaries linked to the original operator’s contract would be left without healthcare coverage.

MS – BRAZILIAN MINISTRY OF HEALTH

Ministry of Health announces national ophthalmology program involving the public and private healthcare network

In January 2024, the Ministry of Health announced the launch of the Brazilian Ophthalmology Program by March of this year.

The initiative aims to streamline the diagnosis and correction of eye conditions and diseases through the public and private healthcare system, and university hospitals.

The expansion of telehealth services seeks to offer better treatment for patients, enabling closer and more frequent monitoring of patients with ophthalmologic risks.

In addition, the project involves diagnostics initiatives in schools to resolve potential eye illness-related learning obstacles and ensure that students can develop appropriately.

People’s Pharmacy of Brazil distributes free menstrual health products

In January 2024, the Ministry of Health authorized the free dispensing of menstrual health products and geriatric diapers by the People’s Pharmacy of Brazil (Programa Farmácia Popular) to ensure access to menstrual healthcare to socially vulnerable citizens.

Citizens can obtain the products by presenting a valid ID document that includes their individual taxpayer number (CPF) at one of the program’s accredit units. Only citizens aged between 10 and 49 years old, enrolled in the Unified Registry for Social Programs of the Brazilian Government (CadÚnico), and whose monthly family income is lower than BRL 218 per individual, can enjoy these benefits.

Cancer treatment submitted to CONITEC’s approval for distribution by SUS

Dinutuximab beta, a medicine used in the treatment of neuroblastoma in children, was submitted to the evaluation of the National Committee for Health Technology Incorporation (“CONITEC”) of the Brazilian Unified Health System (“SUS”).

Given that this medicine is currently available exclusively in the private network, CONITEC’s potential approval will expand the population’s access to a new treatment option.

CONITEC will have 180 days – extendable for 90 days – to analyze the proposal aimed at addressing the restricted access to high-cost cancer treatment.

Federal Government reinstates strategy to boost the production of health products in Brazil

In 2023, the Federal Government reinstated the National Strategy for the Development of the Economic-Industrial Health Complex (“CEIS”), aimed at expanding access to health products and technologies to reduce the vulnerability of the Brazilian Unified Health System (“SUS”) and reduce dependence on imports.

The government plans to invest BRL 42 billion by 2026 to ensure that the CEIS can efficiently support Brazil’s healthcare demands.

To stimulate national production, the government created the Productive Development Partnerships (“PDPs”) and the Local Innovation Development Program (“PDIL”). While the first concentrate in the local production of strategic technologies and products to meet SUS’ demands, the latter focuses on research and development activities aimed at creating innovative products, procedures, and services.

The next step is to establish rules and criteria for the programs to succeed. In this regard, public consultations received contributions on the proposals until February 08, 2024.

LEGISLATIONS

FEDERAL LEGISLATION

Federal law establishes mandatory warning of “doping” substances in medicines

On January 12, 2024, Law No. 14,806/2024 was published, amending Law No. 6,360/1976, to require that pharmaceutical laboratories include a warning regarding substances whose use is deemed doping on labels, package inserts, and advertising.

This warning encompasses all substances listed in the World Anti-Doping Code (WADA) and is aimed at preventing misuse of such substances by professionals, especially athletes.

Federal law provides for annual review of service prices in the private healthcare sector

On January 17, 2024, Law No. 14,820/2024 was published, amending the Organic Health Law(Law No. 8,080/1990), to establish a yearly review of remuneration amounts for services provided by the private sector to the Brazilian Unified Health System (“SUS”), seeking to ensure quality and economic-financial balance.

As a result, every December, as of 2024, the Ministry of Health will review and establish the prices of health services provided by the private sector.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

ANS amends resolution on healthcare plan operators’ technical provisions

On January 16, 2024, the ANS published Normative Resolution No. 597, which provides for criteria that healthcare plan operators must comply with regarding technical provisions, amending Normative Resolution No. 574/2022.

Resolution No. 597 updates the calculation method for Provisions on Incurred but not Reported Losses to SUS (“PEONA SUS”) within the scope of healthcare plan operators. Previously, the ANS provided for PEONA SUS as the lowest amount between:

• 80% (maximum) of the total reported events in the last 24 months, regarding SUS procedures; and
• The PEONA SUS individual factor multiplied by the total of the reported events in the last 24 months, regarding SUS procedures.

After Resolution No. 597 entered into force on February 01, 2024, the maximum factor will be reduced to 66%.

PUBLIC CONSULTATIONS AND HEARINGS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

ANVISA receives contributions to improve National Health Oversight System

On January 10, 2024, ANVISA published Public Call Notice No. 1/2024, to receive contributions from society on the proposed regulation to establish guidelines and requirements aimed at improving the National Health Oversight System (“SNVS”), as well as decentralize the health inspection and oversight practices carried out by the Federal Government, the states, the Federal District and the municipalities. 

The contributions will be used to validate data and conclusions of the Preliminary Regulatory Impact Analysis (“RIA”) Report published in December 2023, and subsequently consolidate the Final RIA Report, which will serve as the basis of ANVISA’s final decision.

Contributions were received until February 08, 2024.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Public consultation addresses proportional fines to healthcare plan operators

On January 03, 2024, ANS opened Public Consultation No. 124, to collect contributions from society regarding the fines against healthcare plan violations provided for in Normative Resolution No. 489/2022.

Article 9 of this resolution states that fines must be applied in proportion to the operators’ number of beneficiaries. As such, the public consultation will analyze updated regulation and proportional fine criteria considering the economic size of the operators.

Contributions can be submitted by February 16, 2024.