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Regulation of the Overindebtedness Act is Approved

August 8, 2022

On July 1, 2021, Statute #14,181, also known as the Overindebtedness Act, was approved. It amended the Brazilian Consumer Protection Code and the Brazilian Elderly Bill of Rights with the purpose of protecting individuals who, in good faith, contracted debts above their ability to pay and without compromising their social minimum, with the exception of consumers of luxury items, which are not protected.

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Registration on the tranparency portal in Brazil

August 30, 2023

The Transparency Portal, at federal level, was developed by the Ministry of Transparency and the Brazilian Office of the Comptroller General during the first term of President Luiz Inácio Lula da Silva, in November 2004, with the initial purpose of giving visibility to financial aspects related to all federal government programs and actions.

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Prison after conviction in appellate courts

February 23, 2023

Going to prison in Brazil is any easy task. The Brazilian procedural law, especially in criminal law, creates so many mechanisms for postponing the final and unappealable decisions that anyone having the resources to hire a lawyer or relying on an active public defender can postpone it. As such, many cases end up time-barred, although Brazilian legislation is slowly advancing in making crimes such as femicide or rape imprescriptible.

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PHRMA updates its code on interactions with health professionals

March 14, 2022

A very sensitive issue for the pharmaceutical industry, and for the medical and hospital products industry concerns the limits in their interaction with health professionals, especially physicians who prescribe drugs, and medical and hospital products.

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Petrobras at the Top of Brazilian Patent Applicants

February 19, 2024

According to a publication on the website of the newspaper A Gazeta, the Brazilian Patent and Trademark Office (BRPTO) has disclosed that, in 2023, 25,367 utility patents were filed in Brazil. This data was divided as follows:

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Only the US and Switzerland effectively enforce their Anti-Corruption Laws Abroad

July 31, 2023

Several countries have anti-corruption legislation, but few extend this legislation to fight corruption alongside foreign authorities outside their territory. Brazil, incidentally, is in the second group of countries having such norms in its set of laws.

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New Regulatory Framework for Clinical Research in Brazil

July 31, 2024

Law #14.874 was enacted on May 28, 2024, providing guidelines for research involving human subjects and establishing the National System of Ethics in research involving human subjects. This statutory framework is of utmost importance as it defines the rights of volunteers and outlines the responsibilities for researchers and sponsors of clinical research.

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More Sanctions Applied By The Brazilian Data Protection Authority signal that Violations of the LGPD Will Not Be Tolerated

October 23, 2023

The Brazilian Data Protection Authority (ANPD) published on October 18, 2023 their third sanction for violation of the General Data Protection Act (LGPD). Similarly to the second penalty, the infraction occurred in the public sector, not involving a private company.

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National Data Protection Authority publishes Security Information Guidelines for Small Processing Agents

November 1, 2021

October 28, 2021 – The National Data Protection Authority (ANPD), which is the regulatory and supervisory body for the protection of personal data in Brazil, has published on October 4, 2021 a new guide called “Information Security Guidelines for Small Processing Agents”.

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ABOUT US

Licks Attorneys Compliance’s Blog provides regular and insightful updates about Ethic and Compliance. The posts are authored by Alexandre Dalmasso, our partner. Licks Attorneys is a top tier Brazilian law firm, specialized in Intellectual Property and recognized for its success handling large and strategic projects in the country.

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Licks Attorneys' COMPLIANCE Blog

Electronic Drug Labels

The Brazilian Congress approved on May 11, 2022, Law #14,388/2022, also known as the Electronic Drug Labels Act. Its aim was to shift from paper package inserts to digital labels, resulting in amendments to Law #11,903/2009, which regulated the tracking of drug production and consumption through electronic data capture, storage, and transmission technology. In turn, this law had already been partially changed by Law #13,410/2016, which addressed the National Medicines Control System.

Electronic Drug LabelsRead Full Article

The Definitive Compliance Guide for Health Care in the USA

Without much ado, the American Office of Inspector General (OIG) has published the General Compliance Program Guidance (GCPG). This guide is intended for use by several segments of the health care sector, such as hospitals, nursing homes, medical equipment suppliers, among others. Its objective is to encourage the development and use of internal control resources, in order to monitor compliance with provisions of applicable statutes, regulations, and programs.

The Definitive Compliance Guide for Health Care in the USARead Full Article

When Corruption Turns the Tables!

The past few years have been tumultuous, particularly for Brazilians, in the battle against corruption. Controversial judicial decisions, sparking significant debate, diminished the effectiveness of Operation Car Wash (“Lava Jato”), a landmark anti-corruption probe, in Brazil. The once unassailable figures in the fight against corruption found themselves vilified in a country prone to casting shadows on those in the spotlight.

When Corruption Turns the Tables!Read Full Article

The Integrity Management Units, and the Brazilian Office of the Comptroller General’s Public Integrity Panel

On November 22, 2017, Decree #9,203 was drafted by the president at the time, Michel Temer, dealing with the governance policy of the Federal Government, its agencies, and foundations.

The Integrity Management Units, and the Brazilian Office of the Comptroller General’s Public Integrity PanelRead Full Article

The French Anti-Corruption Act (Sapin II): A Perspective After 7 Years in Force

The French anti-corruption act called Sapin II, number #1691/2016, is celebrating its anniversary this December 9th, after seven years of existence.

The French Anti-Corruption Act (Sapin II): A Perspective After 7 Years in ForceRead Full Article

Decisions by the Irish Data Protection Authority are undermined

The Data Protection Commission (DPC) of Ireland has been the focus of attention among data protection commissions in other European nations due to the fines they have imposed on technology giants. Despite this, the outcome of the cases leaves much to be desired.

Decisions by the Irish Data Protection Authority are underminedRead Full Article

FDA innovates with new guide for drug approval in the United States

The American agency Food and Drug Administration (FDA) innovated once again by creating a new guide on real-world evidence (RWE) and real-world data (RWD) to support drug approval.

FDA innovates with new guide for drug approval in the United StatesRead Full Article

Artificial intelligence and its regulation in Brazil

On March 29, 2023, “The New York Times” published an article regarding an open letter signed by more than a thousand leaders in the technology sector, including Elon Musk, president of Tesla, Space X, and X (formerly Twitter). The letter requested a stop in the development of artificial intelligence above GPT-4, developed by OpenAI, considering the potential risk of threatening the very existence of society as we know it and even humanity.

Artificial intelligence and its regulation in BrazilRead Full Article

The Fight Against Fake News Around the World

The advancement of technology is overwhelming and inevitable. However, while it revolutionizes communication on a global scale, enabling easy access to information and taking progress to previously inaccessible places, it can have the opposite effect, with a hidden purpose perpetrated by those who maliciously convert a lie into a truth. In fact, as Joseph Goebbels, minister of Nazi propaganda, said, “a lie told a thousand times becomes the truth”.

The Fight Against Fake News Around the WorldRead Full Article

Everything you need to know about ISO

Although the headquarters of the International Organization for Standardization (ISO) is located in Geneva, Switzerland, few people are aware that the organization was founded after a meeting that took place in London, England, in 1946, shortly after the end of the Second World War. At said meeting, 65 representatives from 25 countries sought to discuss the future of international standardization in several areas.

Everything you need to know about ISORead Full Article

How to Implement ERM

ERM, short for enterprise risk management, plays a fundamental role in identifying, preventing, and managing potential risks that may impact business and influence a company's results, ensuring its long-term viability.

How to Implement ERMRead Full Article

More Sanctions Applied By The Brazilian Data Protection Authority signal that Violations of the LGPD Will Not Be Tolerated

The Brazilian Data Protection Authority (ANPD) published on October 18, 2023 their third sanction for violation of the General Data Protection Act (LGPD). Similarly to the second penalty, the infraction occurred in the public sector, not involving a private company.

More Sanctions Applied By The Brazilian Data Protection Authority signal that Violations of the LGPD Will Not Be ToleratedRead Full Article

Brazilian Data Protection Authority Applies Second Penalty for Violation of the Data Protection Act

After a phase where the Brazilian Data Protection Authority (ANPD) focused on regulating important provisions outlined in the General Data Protection Act (LGPD), in addition to editing several manuals and guidelines to assist the public in complying with the law, the ANPD has imposed its first penalty on July 6, 2023, targeting the company Telekall Infoservice.

Brazilian Data Protection Authority Applies Second Penalty for Violation of the Data Protection ActRead Full Article

Antitrust and anti-corruption authorities are already monitoring the 2026 World Cup

Considering the financial scandals fueled by acts of corruption involving the most recent World Cup, which led to the arrest of leaders from several countries, North American antitrust and anti-corruption authorities turned their attention to the 2026 World Cup, which will take place in three countries: United States, Canada, and Mexico. Among the arrests made, one that stood out was that of José Maria Marín, former president of the Brazilian Football Confederation (CBF) between 2012 and 2015 who was also governor of the State of São Paulo between 1982 and 1983, after the death of governor Franco Montoro.

Antitrust and anti-corruption authorities are already monitoring the 2026 World CupRead Full Article

Retaliation against non-disclosure agreements in the USA

Non-disclosure agreements are used by many companies with the purpose of guaranteeing or, at least, trying to hinder the disclosure of their confidential information by employees or former employees. Some companies require the signing of NDAs alongside the employment contract, while others require the signing of these documents upon termination of the employment contract, occasionally offering a bonus and demanding silence in exchange. If the employee violates the agreement, he or she may be forced to return the amount paid, often with interest and/or fines added.

Retaliation against non-disclosure agreements in the USARead Full Article