Life Sciences Newsletter No. 28

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 NATIONAL HEALTH REGULATORY AGENCY

ANVISA publishes translation of mandatory ingredients in labels of personal hygiene products, cosmetics and perfumes

On September 04, 2023, ANVISA released a translated list of nomenclatures for hygiene products, cosmetics and perfumes ingredients.

Previously, in March 2022, ANVISA had published RDC No. 646/2022, which provided for guidelines on the Portuguese translation and description of products, and established that such products must be described in Portuguese as of November 01, 2023.

As a result, the list will assist companies in complying with the new regulation through two different searching methods:

• by the International Nomenclature of Cosmetic Ingredients (“INCI”); and
• by the Portuguese translation of the nomenclature or registration number.

Access the list of ingredients.

ANS – BRAZILIAN SUPPLEMENTARY HEALTHCARE AGENCY

STJ compels health to fund registered medicines for off-label use

In September 2023, the 4th Chamber of the Superior Court of Justice (“STJ”) ruled that even experimental treatment will require health insurance operators to subsidize prescription medicines for off-label use that have been registered with ANVISA.

In addition, the court defined the refusal of the operator to pay for these treatments as potentially abusive.

In this regard, Minister Raul Araújo established criteria for mandatory coverage. As such, operators must cover off-label use in specific circumstances if there are no other therapeutic alternatives in ANS’ list of mandatory procedures.

MS – BRAZILIAN MINISTRY OF HEALTH 

Cannabis: STJ reinforces case law on the authorization of home cultivation for therapeutic purposes

On September 13, 2023, the STJ approved a safe-conduct application for home cultivation of Cannabis sativa.
The plant will be used in the treatment of a man diagnosed with generalized anxiety disorder.

This authorization will be valid until the end of the treatment and was based on the argument that cannabis will be used for exclusively therapeutic purposes, supported by the medical prescription and report of a specialized medical professional.

The decision is in line with previous case law of the STJ in favor of authorizing home cultivation of cannabis for therapeutic purposes.

The judgment has not yet been published in full, but you can access the proceedings of the case.[/vc_column_text][vc_empty_space height=”40px”][vc_separator border_width=”3″][vc_empty_space height=”40px”][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]LEGISLATIONS

Federal Government amends Sanitary Violation Code

On September 12, 2023, Law No. 14,671/2023 was published, which amends the Sanitary Violation Code (Law No. 6,437/1977), to provide for the execution of a commitment agreement to correct and adjust the law to the current health legislation.

The new law authorizes control and supervision bodies of the National Health Oversight System (“SNVS”) to execute a commitment agreement with offenders, which had not yet been legally provided for. The application must be reviewed within 90 days of the protocol and the execution of the agreement will suspend administrative sanctions, except for provisional and precautionary sanctions.

Find out more in our Client Alert.

Decree establishes National Strategy for Development of the Health Economic-Industrial Complex

On September 27, 2023, the Federal Government published Decree No. 11,715/2023, which establishes the National Strategy for Development of the Health Economic-Industrial Complex.

This strategy aims to expand national production of priority items for the Brazilian Unified Health System (“SUS”) and reduce Brazil’s dependence on imported health products to reduce the country’s vulnerability against the public health sector’s increasing demand.

In addition, the Ministry of Health published Ordinance No. 1,354/2023, establishing guidelines for implementing this national strategy, which includes six programs, such as the Program for Preparation of Vaccines, Saline Solutions and Blood Products (“PPVACSH”) and the Partnership Program for Productive Development (“PDP”).

These measures have been introduced within the context of large investments in the health sector, which can be allocated to the private sector, such as the new Acceleration and Growth Program (“PAC”) published in August through Decree No. 11,632/2023.

Federal law establishes criteria for private vaccination services

On September 14, 2023, Law No. 14,675/2023 was published, providing for criteria regarding the operation of private human vaccination services.

The new law establishes general requirements regarding facilities and activities used in private services, such as information registering, and appropriate transport and storage procedures. Additionally, the new regulation expressly authorizes extramural vaccination, that is, outside an official vaccination facility.

Currently, ANVISA regulates general requirements for human vaccination services through Collegiate Board Resolution No. 197/2017. However, there was no regulation through an ordinary law.

Wines: New decree changes corrective substance limits

On September 12, 2023,  Decree No. 11,698/2023 was published, amending the regulation regarding the production, distribution, and sale of wine and grape/wine derivatives (Decree No. 8.198/2014).

The new decree amends the provisions regarding the fermenting “must” (grape concentrate before fermentation), and the limit of corrective additives that can be added in the production of wine.

In short:

• Sparkling muscat wines are limited to corrective substances that amount to a maximum of 1.5% alcohol (as opposed to the previous authorized limit of 2%) – and must not exceed the total 4.5% alcohol content.
• For all other wines, the final product must not be lower than 9% or exceed 10% in alcohol content.

The decree entered into force on the date of its publication.

MS – MINISTRY OF HEALTH AND MEC – MINISTRY OF EDUCATION

MEC extends deadline for public calls on the authorization of Medicine courses

On September 04, 2023, the MEC published Ordinance No. 1,771/2023, which provides for processing guidelines to applications for increasing slots in Medicine courses within the federal higher education system.

The Department for Regulation and Supervision of Higher Education (“Seres”) will be in charge of analyzing the requests.

Among the highlights of the ordinance are:

• the increase of slots is limited to 30% calculated from the number of slots that have already been authorized for the course; and
• the maximum of 240 slots for courses in private institutions.

Finally, the ordinance extended the deadline to publish public call notices on the authorization of new private Medicine courses, until November 30, 2023.

MAPA – MINISTRY OF AGRICULTURE, LIVESTOCK AND FOOD SUPPLY

MAPA announces procedures for annual beverage production and stock report

On September 14, 2023, Ordinance No. 615/2023 was published, which established administrative procedures for regulating the annual reporting of production and stocks by companies that sell beverages, wines and grape/wine derivatives, fruit pulps, and artisanal fruit juices.

MAPA aims to ensure that consumers are offered high-quality products. The report must be submitted electronically and in accordance with annual production, initial stock and final stock criteria.

Ordinance establishes seedling production regulation

On September 14, 2023, Ordinance No. 616/2023 established the new regulation on production, certification, technical responsibility, repackaging, storage, sampling, trade, and use of seedlings and propagation material with the sole purpose of producing seedlings.

The ordinance also repeals Normative Instruction No. 24/2005, which approved regulations on the same topic.

MAPA established a series of obligations for producers, such as:

• enrolling with the Brazilian Register of Seeds and Seedlings (“Renasem”), as provided for in specific regulations;
• monitor the production and quality/identification control of propagation material and seedlings at all production stages;
• ensuring appropriate infrastructure, human resources, equipment and facilities for producing propagation material and seedlings; and
• in case of collaborators or partners, stipulating contractual conditions for production propagation material and seedlings.

The ordinance will enter into force on December 01, 2023.

Ordinance establishes guidelines to classify meat products as artisanal

On September 20, 2023, MAPA published Ordinance No. 621/2023 to provide for guidelines to the classification of meat products as artisanal, required to obtain the Selo ARTE certification (in English, ART Seal), which attests to the identification and quality of artisanal foods for sale.

Decree No. 11,099/2022 establishes that animal source foods produced through artisanal methods are eligible for Selo ARTE, which confirms that the product is artisanal, provided that all legal criteria are met.

The new ordinance designates MAPA’s Department of Innovation, Sustainable Development, Irrigation and Cooperativism to grant the seals, and establishes that local authorities are responsible for identifying artisanal products in their respective regions, through specific procedures and considering the traceability of the raw material.

CFM – BRAZILIAN FEDERAL COUNCIL OF MEDICINE

New regulation on medical marketing published by the CFM

On September 13, 2023, the Brazilian Federal Council of Medicine (“CFM”) published Resolution No. 2,336/2023, which updates the regulation that provides for medical marketing in Brazil.

One of the main changes is the permission to publicize “before and after” images – which used to be banned – as long as the pictures do not identify patients. In addition, patient images can only be uploaded to databases for educational purposes within a supervising physician’s specialty.

Among other provisions, the resolution authorizes the use of patient feedback in marketing, provided these comments do not imply guaranteed results, or that the physician is more qualified than others.

PUBLIC HEARINGS AND CONSULTATIONS

ANVISA – BRAZILIAN NATIONAL HEALTH REGULATORY AGENCY

ANVISA opens public consultations to regulate analyses by foreign authorities

In September, ANVISA published two public consultations to analyze proposed resolutions regarding the procedure to validate analyses and evaluations performed by Equivalent Foreign Regulatory Authorities, in the following cases:

• Analysis and decision on medical device registration petitions – contributions can be submitted by October 25, 2023.
• Analysis and decision on technical product registration petitions – contributions can be submitted by November 09, 2023.

Currently, there is no specific regulation on this optimized procedure, which complicates the analysis of studies by analogy. In August 2022, ANVISA published Collegiate Board Resolution No. 741/2022, which established the general analysis admission criteria. However, specific criteria and procedures had not been established.

Proposed resolution on biosimilars analyzed in public consultation

On September 27, 2023, during the 15th Ordinary Public Meeting, ANVISA approved the filing of an administrative proceeding and a public consultation to update RDC No. 55/2010, the current Brazilian Biosimilars Regulation.

This review is aimed at simplifying and speeding up the analysis of registration petitions, to increase biosimilars supply. The public consultation and the proposed regulation are expected to be published in October.

Read the vote in full here.

Changes on health requirements for vegetable oils and fats analyzed in public consultation

In September, a public consultation was held regarding the proposed amendment of Collegiate Board Resolution No. 481/2021, which establishes health requirements for vegetable oils and fats.

The proposal aims to correct inconsistencies in the definition of virgin oils, virgin olive oils, compound oils and fats, and hydrogenated vegetable oils and fats, as well as to clarify the classification and nomenclature of vegetable oils and fats mixtures. These definitions are relevant to establishing MAPA’s and ANVISA’s jurisdiction under Law No. 9,972/2000.

If the new resolution is approved and published, companies in the sector will have two years to adjust the labels of these products.

Proposed normative instruction suggests limiting harmful substances in food supplements

In September, a public consultation was held to address a proposed update to Normative Instruction No. 28/2018, which provides for lists of ingredients, use limits, claims and supplementary labels of food supplements.

In summary, ANVISA considers changing the current authorizations for the use of D-ribose in the formula of food supplements for athletes. In this regard, the proposal suggests limiting the use of this substance based on European Food Safety Authority (EFSA) studies that point to health risks in case of excessive use.

Given the urgency of the matter, this normative instruction should be published this month.