Life Sciences Newsletter | March 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

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Regulatory chamber approves 2024 adjustment of medicine prices

On March 28, 2024, the Medicines Market Regulation Chamber (“CMED”) authorized the annual adjustment of medicines prices in Brazil, which has been in force since March 31, 2024.

Resolution CM-CMED No. 01/2024 established the adjustments, which were limited to a 4.50% increase in medicine prices.

The deadline for companies to adjust these prices ended on April 12.   

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

Superior Court of Justice decides that healthcare plan must cover psoriasis medicine

On March 19, 2024, the Superior Court of Justice (“STJ”) decided that a healthcare plan operator must provide a beneficiary with the drug rizankizumab, which is used in psoriasis treatment.

The lower courts had already granted the beneficiary’s request for the medicine to be covered by their healthcare plan. The operator, however, appealed to the STJ, arguing that the refusal to supply the medicine happened before rizankizumab was included in the exhaustive list of the ANS, which occurred on May 06, 2022.

This decision is regulatory landmark for the health market, representing the first precedent regarding a healthcare plan’s obligation to cover medicines outside of a hospital environment.

LEGISLATIONS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Term of certification to produce medical devices extended to 4 years

On March 22, 2024, Collegiate Board Resolution (“RDC”) No. 850/2024 was published, amending RDC No. 497/2021 to establish a 4-year term for the Certificate of Good Manufacturing Practices (“CBPF”) granted to medical device producers.

This certificate is granted through the Medical Device Single Audit Program (“MDSAP”) and the new term is only effective for as long as the producer participates in the program.

ANVISA approves regulation that aims to prevent the spread of influenza

On March 06, 2024, ANVISA published RDC No. 846/2024, which provides for the conditions and procedures to:

• Register pre-pandemic influenza vaccines;
• Update vaccines to a pandemic strain; and
• Obtain authorization to use, sell and follow up on pandemic influenza vaccines.

According to ANVISA, the regulation aims to speed up decision-making to establish a vaccination strategy and minimize potential damage against a potential pandemic.

In addition, the new resolution aligns with ANVISA’s goal to effectively address the regulatory demands of a potential health crisis.

 RDC No. 846/2024 was published in the Federal Official Gazette of Brazil on March 08, 2024.

ANVISA publishes new regulation on paints and varnishes with sanitizing properties

On March 08, 2024, RDC No. 847/2024 was published to provide for technical requirements to regulate paints and varnishes with sanitizing properties that are applied on walls.

ANVISA explained that paints with disinfectant (antimicrobial resistance) or disinfesting (insecticides or repellents) properties are deemed health products due to their sanitizing effects. As such, the sale of these products requires proof that their are effective and safe when used by any individual.  Accordingly, the resolution aims to standardize regulatory procedures and structure this new market segment.

The RDC entered into force on April 01, 2024.

ANVISA approves regulations on the use of analyses carried out by Equivalent Foreign Regulatory Authorities

On March 25, 2024, ANVISA published Normative Instruction (“IN”) No. 289, of March 20, 2024, which establishes criteria for the optimized procedure of analysis that uses assessments conducted by an Equivalent Foreign Regulatory Authority to analyze petitions for registration and post-registration of medicines, biological products, vaccines and letters of suitability of the active pharmaceutical ingredient (CADIFA) in Brazil.

The regulation is based on “reliance”, which means that a National Regulatory Authority (NRA) makes decisions with high regard for assessments carried out by another NRA or reliable institution. This measure has the potential to facilitate access to quality medicines and biological products, which would benefit all parties involved.

Find out more in our Client Alert.

Regulation updates medical devices safety and performance requirements

On March 08, 2024, ANVISA published RDC No. 848/2024, which provides for safety and performance requirements applicable to medical devices in general and in vitro medical (“IVD”).

According to ANVISA, there was a need to update the safety and efficiency requirements provided for in RDC No. 546/2021, so that ANVISA can evaluate compliance with these requirements in face of new technologies and diverse medical devices and IVD that are regulated by ANVISA.

This resolution will enter into force on September 04, 2024.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

ANS publishes regulation on authorization requests by liquidators to contract services

On March 26, 2024, the ANS published Normative Instruction No. 34/2024,which provides for the contracting of services and other expenses addressed in Normative Resolution No. 524, of April 29, 2022, in the course of extrajudicial liquidations adjudicated by the ANS.

The main topics addressed by the normative instruction include:

• General criteria;
• Contracting of:
  • specialized services;
  • legal services;
  • accounting services;
  • lower complexity and unit cost services;
• Appointment of a liquidation assistant;
• Framing of the estate in liquidation and respective expenses; and
• Final provisions.

MS – BRAZILIAN MINISTRY OF HEALTH

Ministry of Health updates list of over-the-counter medicines

On March 12, 2024, the Ministry of Health published Normative Instruction No. 285/2024, which establishes the list of over-the-counter medicines, that is, medicines that can be sold in pharmacies and drugstores without a prescription.

The regulation classifies these medicines into:

• Synthetic, Specific, and Biological medicines, which amount to 260 types of medicine; and
• Phytotherapics, which amount to 57 types of medicine.

According to RDC No. 98/2016, these medicines:

• Are recommended for treating non-serious illnesses that progress slowly or not at all;
• Must only have well-known adverse reactions with low potential for toxicity and drug interactions;
• Must only be used for a short period, or for the period established in the package insert, in the case of preventive medicines;
• Must be easy to manage, for a patient or caretaker, or with a pharmacist’s instructions;
• Must be low risk to the patient;
• Must not potentially generate chemical or psychological dependency.

PUBLIC CONSULTATIONS

ANVISA – BRAZILIAN HEALTH REGULATORY AGENCY

Validation of bioanalytical methods used to analyze in-study samples subject to public consultation

On March 22, 2024, ANVISA opened a public consultation to obtain contributions regarding a proposed RDC that provides for the validation of bioanalytical methods to be used in the analysis of in-study samples for regulatory submissions of industrialized medicines for human use.

Contributions can be submitted by May 14, 2024 through an online form.

ANVISA opens public consultations food safety and composition requirements

On March 22, 2024, ANVISA opened public consultations to receive contributions regarding the following matters:

• Proposed normative act to amend RDC No. 56/2012, which provides for the list of monomers, other starting substances, and polymers authorized for use in the production of packages and plastic equipment that will have contact with food. Contributions can be submitted by May 14, 2024 through an online form.
• Proposed normative act to amend RDC No. 326/2019, which clarifies which components must be used in the production of materials that can have contact with food without health risks. Contributions can be submitted by June 28, 2024 through an online form.
• Proposed normative instruction that provides for requirements regarding composition and quality, nutritional information, and the list of authorized ingredients constituents for infant formulas, transitional foods and cereal-based foods for infants and children in early childhood, enteral nutrition formulas and dietary supplements to address inborn errors of metabolism.Contributions can be submitted by June 28, 2024 through an online form.

Deadline to contribute in consultation regarding authorization operation expires 

The deadline to submit contributions to a consultation regarding the review of RDC No. 45/2002, RDC No. 346/2002 and RDC No. 61/2004, which provide for ANVISA’s Company Operation Authorization (“AFE”), expired on April 05, 2024.

Airport and port managers, airlines, auxiliary air transport service companies, shipping companies, customs offices and health oversight authorities were authorized to submit contributions. 

The regulations provide for the following topics:

• RDC No. 345/2002: Approves the AFE technical regulation for companies interested in providing public interest services in land vehicles operating international collective passenger transport, ships, aircraft, waterway terminals, organized ports, airports, border posts and customs precincts.
• DRC No 346/2002: Approves the AFE technical regulation for companies interested in operating the storage of goods under health oversight in waterway terminals, organized ports, airports, border posts and customs precincts.
• RDC No. 61/2004: Provides for the AFE for companies that provide foreign trade services on behalf of and as ordered by a third party registered with ANVISA.