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ANVISA Approves the Regulation of Biosimilars

June 18, 2024

The Brazilian FDA, ANVISA, approved Rule RDC #875 of May 28, 2024, which provided, in an ancillary manner, for the registration of biosimilars through the comparability development route, aiming to guarantee the quality, safety, and efficacy of these products.

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European Council Approves Legislation on Artificial Intelligence

May 29, 2024

In contrast to Mercosur, which struggles to evolve from an economic bloc to a political and monetary union due to challenges in socio-political integration caused by alternating conservative and progressive governments, the European Union continues to demonstrate efficiency in integrating its member countries. Despite the United Kingdom's departure, the EU remains committed to regulating fundamental issues related to the incorporation of new technologies, which will significantly impact personal, educational, and professional relationships. We are specifically discussing Artificial Intelligence (AI).

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ANPD Approves Regulation on Security Incident Reporting

May 8, 2024

The Brazilian Data Protection Authority (ANPD), a public entity created by the General Data Protection Act (LGPD), responsible for regulating, supervising, guiding, educating, and acting on security incidents involving personal data, as well as for cooperating with other similar international entities, published CD/ANPD’s Rule #15, dated April 24, 2024, in the Federal Register on April 26, 2024. Taking advantage of the last public consultation on the topic, the Rule approved the Regulation on Security Incident Reporting.

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India’s Anti-Corruption Act

April 30, 2024

While Brazil adopted its Anti-Corruption Act aimed at companies only on August 1, 2013, with Law #12,846, India adopted an Anti-Corruption Act known as “The Prevention of Corruption Act” on September 9, 1988, which typifies and penalizes bribery offenses involving both individuals (natural persons) and companies (legal entities). Now, let’s delve into the main points of this act below.

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The Balancing Test in Personal Data Protection

April 24, 2024

There are numerous situations in a business that result in a company having to deal with personal data, and obtaining the data subject's consent is not always possible or even viable. Bearing this in mind the legislator made 9 other legal bases available in the Brazilian General Data Protection Act (LGPD) so that companies, controllers or operators of such personal data can use them to classify the processing of the respective data.

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The Legitimate Interest in the Processing of Personal Data

April 15, 2024

Since the creation of the Brazilian General Data Protection Act (LGPD) on August 14, 2018, the comparison with the European GDPR was inevitable, after all, the Brazilian LGPD was greatly influenced by the similar law published just over two years earlier in Europe. While the LGPD had ten legal bases to support the processing of personal data, the GDPR had only six legal bases.

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CGU's Lilac Guide to Combating Moral Harassment, Sexual Harassment, and Discrimination in the Public Service

April 8, 2024

The ongoing battle waged by companies and governments to address moral harassment, sexual harassment, and discrimination among employees, whether in the private or public sector, is nothing new. A poignant illustration of this perpetual struggle was the resignation of the president of the Brazilian Savings Bank (Caixa Econômica Federal – CEF) on June 29, 2022, following allegations of sexual harassment made by CEF employees.

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Results from the US Securities & Exchange Commission Inspection in 2023

April 1, 2024

Many people wonder why the US Securities & Exchange Commission (SEC) has been so successful, which has anequivalent agency in Brazil. The reason for its effectiveness is not hard to understand: the agency does not hesitate to investigate and impose penalties to curb irregularities that impact the day-to-day operations of the US stock market, including instances of corruption.

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When Supporting Gender Equality Conflicts with Privacy Rights

March 15, 2024

At a time in history when the topics of diversity and inclusion are more and more relevant, a federal law enacted in 2023 is causing great controversy, even forcing a rush to the courts to ensure its compliance.

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The Fight Against Corruption in Singapore

March 6, 2024

Corruption poses anever-present concern for democracies on every continent. It is no different inAsia, especially in Singapore, which alongside New Zealand and Scandinaviancountries stand out as examples of best practices in infrastructure and legal frameworkemployed to combat corruption.

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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

Items required for the Compliance Program are changed by New Regulation

The Brazilian government edited Decree #11,129 on this Monday, July 11, 2022, updating the regulation of the Brazilian Anti-Corruption Act (Statute #12,846 of August 1, 2013) and bringing some changes to the content of Decree #8,420 of March 18, 2015, which was responsible for such regulation.

Items required for the Compliance Program are changed by New RegulationRead Full Article

Brazilian Comptroller General Launches a Handbook for Handling Conflicts of Interest

The Office of the Comptroller General (CGU) announced on June 4, 2022, the release of its newest document: the Handbook for Handling Conflicts of Interest.

Brazilian Comptroller General Launches a Handbook for Handling Conflicts of InterestRead Full Article

Sexual harassment complaints at CEF and the integrity program

On June 29, 2022, several media outlets, including the Isto É Dinheiro magazine, published revelations that, despite the political capitalization by the government's opponents, brought to light a worrying threat to the effectiveness of the integrity programs implemented in the various government entities.

Sexual harassment complaints at CEF and the integrity programRead Full Article

Information Wall – A Growing Need

On May 9, 2022, the website “Policy & Medicine” published an interesting article signed by Thomas Sullivan titled “McKinsey – Serving as a Double Agent?”. It describes that the Oversight and Reform Committee on the US House of Representatives issued a report concluding that 22 consultants from the renowned McKinsey consulting firm were assigned to work simultaneously with the US government and with opioid manufacturers.

Information Wall – A Growing NeedRead Full Article

ANPD is transformed into an Autonomous Agency

On this 13th of June, the Brazilian government issued the Executive Order #1,124, which was also published in the Federal Gazette on June 14, 2022. Containing 10 articles, it enters into force on the date of its publication.

ANPD is transformed into an Autonomous AgencyRead Full Article

ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?

On June 8, 2022, Brazil witnessed the unfolding of another chapter involving healthcare plans, patients and the Brazilian Agency of Supplementary Health (ANS), this time at the headquarters of the Brazilian Superior Court of Justice (STJ), in Brasilia.

ANS' List of Procedures is exhaustive, according to the Brazilian Superior Court of Justice. What does this mean for us?Read Full Article

COOKIES, UNDERSTAND IT ONCE AND FOR ALL!

There are many definitions out there for cookies, but the one I like the most is found on the Positivo website, as well as some other websites, which clarifies that cookies are simple text files sent by the website to the browser the first time you visit it. A simple and effective definition. It’s there so that when the user visits the website again, their browser sends the data collected by the cookie, depending on its goal.

COOKIES, UNDERSTAND IT ONCE AND FOR ALL!Read Full Article

Webinar LGPD – Data Leaks and first decisions

On the afternoon of April 22, the webinar ‘Data Leaks and first decisions’ was presented by partner Douglas Leite and Attorneys at Law and data protection specialists Flávio Buzanovsky and Angela Fonseca.

Webinar LGPD – Data Leaks and first decisionsRead Full Article