Publications

Category: Life sciences and healthcare

On July 12, 2024, the National Health Surveillance Agency (Anvisa) published RDC 885 (Anvisa’s RDC 885/24), which approved a pilot project with transitional guidelines for implementing the digital package leaflets. The measure allows for the optional waiver of the printed package leaflets in the packaging of certain medicines. The initiative requires that leaflets in printed format must be made available whenever requested by the health provider, the prescribing professional, or the patient.

The new resolution aims to regulate Law 14,338/22, which, among other aspects, establishes:

• the possibility of Anvisa defining which medicines will have package leaflets in one single format;
• the inclusion of a quick-read two-dimensional barcode that directs to an internet address where the medicine’s digital package leaflet will be available; and
• the minimum characteristics of the digital package leaflet.

The pilot project launched by Anvisa will collect inputs for the ongoing regulatory impact analysis (AIR) conducted by the authority on this subject. AIR is a systemic approach to critically assessing the positive and negative effects of proposed and existing regulations and non-regulatory alternatives. This procedure begins with defining a regulatory problem and is used to support the authority's decision-making.

According to Anvisa, the new RDC was discussed through Public Consultation 1,224/23 and considered structured and standardized data on medicines, seeking regulatory reliance with foreign trends on the subject. Debates and discussions between Anvisa's technical areas and the regulated sector were also considered.

Waived printed package leaflets

To avoid any limitation on the public's access to the information that should appear on the package leaflet, Anvisa has decided to start a transition process by defining  a limited group of medicines will be able to have digital package leaflets. The agency considers that, for these medicines, wavering  the physical version of the package leaflet does not represent a major risk.

The medicines that can have their digital leaflets implemented and waived physical waived are:

• Free samples: the delivery of free samples can only be carried out by health professionals to the patient during the consultation, with guidance on use for each treatment.
• Medicines intended for health providers, except pharmacies and drugstores: medicines restricted to sale in hospitals, clinics, outpatient clinics, and home care services were selected because they are used under the supervision of health professionals.
• Over-the-counter medicines (OTC), sold in multipacks: products considered low risk and offered on pharmacy shelves.
• Medicines intended for the government, packaged containing the Ministry of Health's government brands: RDC Anvisa 769/22, which deals with the rules for preparing, harmonizing, updating, publishing, and making available package leaflets for medicines, has already considerably reduced the requirement for physical package leaflets for products sold to the public health system.

To implement the digital package leaflet, medicines must contain a QR code or equivalent digital mechanism, with specific identification based on an electronic data capture, storage, and transmission system on their secondary packaging. Specifically concerning medicines packaged in multipacks, the QR code or equivalent must also be inserted in the primary packaging.

Information available online

It will also be necessary to adopt a set of information on medicines available online - internationally known as electronic Product Information (ePI). This includes a summary of the characteristics of each product and labeling information.

The new resolution creates the Electronic Product Information Repository (Riep) to store, organize, and make available electronic product information. The aim is to guarantee direct access to the complete and identical content of the latest package leaflet approved by Anvisa.

The agency's intention is that Riep will be interoperable with other digital health platforms in the future, such as the National Health Data Network (RNDS) from the Ministry of Health.

Riep will allow the insertion of images, audios and videos that help patients and health professionals to store, preserve, check the batch number and expiry date, as well as prepare and use medicines correctly. Information on drug recalls and a direct access link to Anvisa's system for reporting adverse events related to medicines and vaccines should also be available.

Consumers' right to request printed package leaflets

Anvisa's RDC 885/24 stipulates that pharmacies and drugstores, as medicine dispensing establishments, must inform consumers, using visual communication, about the possibility of requesting the printed version of the package leaflet in cases where it is not included with the product.

RDC Anvisa 885/24 will come into force on September 12 this year and is expected to be valid until December 31, 2026.

The Life Sciences & Healthcare practice can provide more information on the subject.

Category: Compliance, investigations and corporate governance

The European Federal Government Directive 2024/1,760, published on July 5 in the Official Journal of the European Federal Government (EU), establishes rules on the due diligence procedures  that companies must take to protect human rights and the environment. The rule will come into force on July 26.

Approved by the European Parliament in February and by the Council of the European Federal Government in April, the Corporate Sustainability Due Diligence Directive (known as CS3D) will apply to the Member States of the European Federal Government, which will have two years to adapt their respective national standards to the new rules.

The way the implementation should be made was not specified. It may be a law, regulation or other internal mechanism existing in the legal framework of each country.

As Member States have not yet implemented their regulations, it is not possible to accurately predict the provisions and obligations that will be established for companies based in the EU and for companies from other locations that maintain operations in the European community.

There is, however, consensus that the consequences for the economic system will be relevant. Companies that operate in Brazil may be affected, including those that do not operate in the international market.

Given this scenario, it is relevant to better understand the basic points of this directive and the impacts it brings.

What does the directive mean in practice?

For now, there is no change for companies from a legislative point of view. EU Member States have by July 26, 2026 to adopt and publish laws, regulations and administrative provisions necessary to comply with the directive. Only after the adoption of specific rules in each country companies will be subject to the new rules.

What are the main provisions of the directive?

The directive requires EU member states to implement rules related to procedures for due diligence on human rights and the environment. These due diligence procedures apply to companies that are based in the respective Member State or that operate in its territory.

In general, local laws will regulate human rights and sustainability compliance programs. These programs should embrace several initiatives, such as:

• risk assessment, elaboration and review of policies for the inclusion of due diligence on human rights and sustainability;
• identification and evaluation of adverse impacts;
• prevention of potential adverse effects;
• neutralize and minimize actual adverse effects;
• monitoring and evaluation;
• communication; and
• remediation mechanisms.

How and when will the new rules apply to companies?

The rules will be applied progressively, according to criteria related to the number of workers and net worldwide turnover. The direct impacts should initially reach the largest companies – those with more than 5 thousand employees and a net worldwide turnover of more than 1.5 billion euros – from 2027.

By 2029, organizations covered by the directive will reach:

• EU companies (on an individual or consolidated basis) with more than a thousand employees on average and a net worldwide turnover of more than €450 million; and
• non-EU companies (on an individual or consolidated basis), which generate a net turnover of more than €450 million within the EU.

What is the impact on the value chain?

The directive attracts the attention from the entire world, as it will apply to companies with comprehensive operations and revenues in the EU, but not necessarily based in European territory. The concept of the value chain part of the scope of the directive has an impact beyond the EU's borders.

The rule requires companies to adopt measures to prevent, detect, and repair the negative social impacts of their activities. This duty of diligence of companies extends to the activities of their suppliers and service providers.

As a result, a company based in Brazil may be affected, even if it only operates locally. If, for example, a company based here has a customer subject to the new European laws and regulations, that company will probably be monitored by that customer. This is due to the duty of diligence imposed on him by the new directive.

Under the new rule, companies operating in the EU will have to conduct due diligence involving suppliers and business partners upstream and downstream:

• upstream – business partners related to the production of goods or the provision of services by that company, including the design, extraction, sourcing, manufacture, transport, storage and supply of raw materials, products or parts of products and the development of the product or the service.
• downstream: business partners related to the distribution, transport and storage of a product.

What will be the sanctions?

According to the directive, Member States must to establish one or more independent supervisory authorities to supervise compliance with the norm. These authorities should have adequate power and resources to enforce the law. They will be able to ask for reports from companies and conduct investigations into violations. It will also be up to these agencies to impose penalties to be defined by local rules, respecting the limit of by 5% of the company's global gross revenue in the preceding year of the violation.

For the calculation of the penalty, the seriousness and duration of the violation, the investments made by the company, the company's contribution to remediate the effects, the financial benefits gained or losses avoided by the company, among other factors, will be evaluated.

What is the comprehensiveness of this changing for Brazil?

The heavy sanctions of the directive should lead European multinationals or those with a large presence in the European to be very demanding with their suppliers.

Multinationals operating in Brazil will need to adapt their compliance program to the Brazilian reality and merge it jointly with European laws and regulations, without compromising production efficiency.

Brazilian companies operating in the Europe are likely to be directly affected, and even those that do not operate in the region risks of losing business and customers if they do not have adequate controls in place to prevent, identify, and remedy violations of human rights and environment.

Suppliers without consolidated compliance practices tend to be passed over because they represent a relevant corporate risk. For companies with consolidated programs, the tendency is to have an advantage in the dispute for customers and markets and to earn comprehensive competitiveness.

Brazil is discussing its own rule on the subject in the National Congress. Bill 572/22, which creates the national framework on human rights and business and establishes guidelines for the promotion of public policies on the subject, has already been the subject of (necessary) discussion. The expectation is that this bill will be impacted by the new directive.

Category: Tax

On July 8, the Rio de Janeiro State Treasury Department (Sefaz/RJ) published the Sefaz Resolution 675/24, which makes it mandatory to communicate data regarding the processes of classification and adherence to ICMS tax benefits of a non-general nature.

The communication must be provided exclusively through the Sefaz/RJ website, according to the regulation to be issued by the State Revenue Undersecretary, and the obligation applies to the tax incentives indicated in the annex to the resolution.

Among the tax benefits subject to the new ancillary obligation, Novo RioLog (Law 9.025/20), Regional Industrial Incentive (Law 6.979/15), Rio Importa + (Decree 46.781/19) and other sectoral incentives (pharmaceutical, personal hygiene, automotive, thermoelectric, etc.) stand out.

The data received will be used by Sefaz/RJ to cross-check data and inspect the regularity of the procedure for classification or adherence to ICMS tax benefits.

According to the resolution, Sefaz/RJ will identify taxpayers who have declared or who will declare the use of ICMS tax benefits through the Digital Tax Bookkeeping (EFD) and will verify their regular classification or adherence, according to the specific legislation.

The inspection of the regular classification or adherence to the incentives will begin 30 days after the publication of the resolution and the release of a specific electronic portal for the report of the requested information.

Irregular taxpayers will be subject to sanctions provided for in the legislation, and the receipt of a prior notification through the Taxpayer's Electronic Domicile (DeC) is ensured.

Sefaz/RJ's initiative is similar to the recent institution of the Declaration of Incentives, Waivers, Benefits and Exemptions of a Tax Nature (Dirbi) by the federal government, indicating a greater strictness regarding the use of ICMS tax incentives.

It is recommended a special cautious to taxpayers whose process of classification in tax incentives has not been formally concluded (as in the case of a tacit classification) or in situations in which the legislation of the benefit is not clear in relation to the procedures for certification of the right to use the differentiated tax treatment.

In many cases, the specific tax incentive legislation is not clear on the need for a specific concession act, and there are statements from Sefaz/RJ adopting very strict and restrictive interpretations regarding the use of tax incentives without a corresponding concession act.

The complete list of the legislation instituting tax incentives that are subject to the communication can be found below:

Category: Banking, insurance and finance

On June 25, the Central Bank of Brazil (BCB) published the Public Consultation Notice 101/24 on the proposal for a resolution of the National Monetary Council (CMN). The resolution consolidates and improves the rules on the incorporation, organization and operation of credit, financing and investment companies (SCFIs) – popularly known as "financial companies".

The public consultation notice is part of the effort to review and consolidate normative acts lower than decrees, determined by Decree 12,002/24. Currently, the norms related to SCFI are dispersed in the regulation issued by the CMN, and in several other normative acts.

These rules were issued starting with Ordinance 309/59, of the Ministry of Finance, in a time in which the Brazilian financial market was very different, both from an economic point of view and in terms of its institutionality. The 1959 rule precedes the laws and regulations on financial institutions and capital markets.

The CMN's proposed resolution seeks to to consolidate the existing rules in a single normative act, with the aim of offering legal certainty and competitiveness to institutions in this segment.

Originally included in Ordinance 309/59 was the provision for the existence of:

• credit and financing companies, focused on operating in the credit market;
• investment companies, whose operations took place in the capital markets, but which have lost its legal basis since the entry into force of article 46, item I, of Law 14,754/23; and
• mixed societies.

This division is not maintained in the proposed regulation.

The resolution provides that SCFIs must be incorporated as corporations and have as their corporate purpose:

• providing loans and financing;
• acquiring, assigning, refinancing and administering credit rights; and
• provide guarantees.

These are activities currently practiced by the SCFIs. In addition, these institutions must permanently observe minimum limits of paid-in capital stock and equity fixed BRL 7 million, if they are headquartered in São Paulo or Rio de Janeiro, and BRL 4.9 million, if headquartered in other locations in the country.

In relation to their funding, the SCFIs could use their own funds, as well as funds arising from the issuance of:

• time deposit certificates (CDB);
• agribusiness letters of credit (LCA);
• secured real estate bills (LIG);
• financial bills;
• bills of exchange;
• housing credit certificates;
• time deposit certificates securities (3CB);
• time deposit receipts (RDB);
• interbank deposits (DI);
• secured time deposits; and
• Transfers, loans and financing originating from national and foreign financial institutions, national and foreign entities focused on development and development actions, and official funds.

Also, the proposed resolution also opens up various activities carried out by financial and payment institutions to SCFIs. These activities include:

• purchase and sale of securities;
• operation in non-organized OTC markets;
• management of securities portfolios;
• issuance of e-money and post-paid payment instruments;
• acting as a payment initiation service provider;
• provision of credit analysis and collection of credit rights to third parties;
• acting as fiduciary agent; and
• Acting as an insurance representative for insurance distribution.

In this format, jointly with act or fact of bringing the rules up to date, it is intended that the SCFIs have a regulation that follows the one applicable to institutions operating in segments in which competing or similar activities are performed, in addition to support the transit of the SCFI’s activities between the segments in which they operate.

The aim of the authority is to write up the rules of the SCFI to make them compatible with the current regulatory framework and with the practices currently adopted, harmonizing the regulation of these institutions with the activities of other segments of the financial system.

Individuals and civil society organizations interested in contributing to the public consultation may do up to August 31, through the "Active Consultations" section on the BCB website – where the public consultation notice can also be found – or by e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.

Category: Real estate

The civil liability of the condominium manager is a topic of great relevance in the field of condominium law. The condominium manager, legal representative of the condominium and an administrative reference in the management of the collective assets, has a series of duties and obligations indicated in an exemplifying list in article 1,348 of the Brazilian Civil Code.

Elected by means of an assembly and with a mandate up to two years – which can be renewed – the condominium manager may or may not be a unit owner a unit owner and concentrates the responsibility of maintaining the well-being and the unit of the condominium. In addition, they have prerogatives that legitimize them to enforce compliance with public and private rules to the unit owners.

It is also the responsibility of the condominium manager to supervise and manage the building, execute the decisions taken in the assembly, represent the community in the defense of its rights, in court or outside of it, preserve and value the property, in addition to observe and comply with the charges assigned by the condominium bylaws.

Thus, when the condominium manager does not perform his activities in accordance with legal precepts and the condominium bylaws, fails to perform them, or even when he acts in an abusive manner, especially with regard to the bad tenure of other people's assets, he may to be held responsible personally. This means that it must repair the losses and damages caused to the condominium community, both in the civil and criminal spheres.

In general, the civil liability of the condominium manager is subjective and requires proof of the act or omission that resulted in the unlawful act, the damage caused, the chain of causation and the fault or willful misconduct.

Regarding the statute of limitations for this liability, the Civil Code, in article 189 combined with article 206, paragraph 3, V, provides that the claim of the unit owners of civil redress for damages caused by the condominium manager is time-barred in three years. That period shall be counted from the timing on which the data subjects become aware of their rights being infringed.

The understanding of the Superior Court of Justice (STJ) and the doctrine current follows in the same direction: the statute of limitations begins at the exact timing in which the injured party becomes aware of the damage and the scope of its consequences.

The condominium manager's liability, therefore, does not end at the same time as his mandate. The former condominium manager may be liable civilly and personally for the unlawful acts he or she has provenly committed.

As seen, the civil and personal liability of the condominium manager is a subject of enormous sum that demands attention and care, both on the party part of the condominium manager (in the impeccable conduct that is expected of him) and of the unit owners (in the preservation and awareness of the scope of their rights).

Like both, legal practitioners must also be attentive to ensure the defense of the interests of those involved and, especially, to preserve order and harmony in the social microsystem.

Category: Life sciences and healthcare

On May 27, 2024, the Brazilian National Health Surveillance Agency (Anvisa) approved  Board of Directors' Resolution 873/2024, which establishes criteria and procedures for the creation of the National Prescription Control System (SNCR), through a computerized platform to manage the numbering distribution of notifications and receipts from prescriptions in the national territory.

Controlled use medications

In general, substances containing psychoactive, analgesic properties with high potency, anesthetic, teratogenic, or that may cause dependence are considered to be under stricter control in Brazill. The regulation is established by  Ordinance SVS/MS 344/98, which sets forth control measures, risk classification, and requirements for dispensing medicines containing these substances.

In the case of medicines based on substances listed in Lists A1, A2, A3, B1, B2, C2, and C3 of Annex I of the regulation, dispensing is subject to the presentation of a prescription (prescribed by the physician to the patient) and a prescription notification (a standardized document that enables the sale and sanitary control of the medicines).

Control and traceability

One of the responsibilities of the local health authority (state or municipal) is to issue the numbering of receipts and prescription books for controlled-use medicines. Currently, this process involves diversified procedures, as there is no alignment between the federative units.

The new Board of Directors' Resolution aims to implement a centralized tool for the numbering of notifications of receipts and prescriptions books through the National System for the Control of Prescriptions (SNCR). This regulation is the result of contributions presented in the  Public Hearing 588/18.

Among the positive points of the measure, we highlight the following:

• allow traceability of information and speed up the process;
• greater control in the distribution of prescriptions and better detection of fraud;
• safety and traceability about the use of medicines subject to special control; and
• possibility for local health authorities to consult and extract reports.

National Prescription Control System (SNCR)

Since the platform is already developed and ready for implementation, health authorities who wish to do so will be able to start using it to issue new numbers in 2024, as soon as Anvisa authorizes it.

Moreover, the use of the platform by all health authorities will be mandatory from January 1, 2025.

Prescription books printed before January 1, 2025 (which do not contain the numbering issued by the SNCR) may be distributed by the competent health authority for up to 24 months.

The Life Sciences & Health practice can provide more information on the topic.