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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

Discussing the conflict of interest in the federal government

Today, after reading an article authored by the renowned legal scholar Wálter Maierovitch, I was taken aback by the way some authorities handle conflicts of interest.

Discussing the conflict of interest in the federal governmentRead Full Article

Dealing with ethical dilemmas in business

Ethics is a word derived from the Greek vernacular “ethos", which, in turn, means "way of life". Philosophically, ethics focuses on the behavior of a human being within a social environment.

Dealing with ethical dilemmas in businessRead Full Article

Highest award ever paid by the US Securities and Exchange Commission to a whistleblower

The United States Securities and Exchange Commission announced the payment of the highest award ever paid to a whistleblower since the awards were instituted by the Dodd-Frank Act, sanctioned in 2010.

Highest award ever paid by the US Securities and Exchange Commission to a whistleblowerRead Full Article

The controversy on data sharing between Europe and the USA

Ireland’s Data Protection Commission (DPC) has published a press release on May 22, announcing that the inquiry into Meta Ireland, the Dublin-based company that manages Facebook not only in Ireland but throughout Europe, has been concluded.

The controversy on data sharing between Europe and the USARead Full Article

The German supply chain due diligence act (LKSG)

In the previous article, the “United Nations Guiding Principles on Business and Human Rights”, created in 2011 and which still influences several laws in many countries, was highlighted.

The German supply chain due diligence act (LKSG)Read Full Article

United Nations guiding principles on business and human rights

Although ESG (which stands for Environmental, Social and Governance) is a popular topic, few are aware of the document “Guiding Principles on Business and Human Rights”. Launched in 2011 by the United Nations, the text has influenced countless laws in several countries around the world to this day.

United Nations guiding principles on business and human rightsRead Full Article

How to investigate corruption

With regard to investigations of corruption in Brazil, the police authority, the Brazilian Office of the Comptroller General (CGU), the Prosecution Office and even the Internal Affairs of various public entities are invariably involved.

How to investigate corruptionRead Full Article

Dark patterns in data protection

In a time where fake news is so prevalent, the topic of dark patterns has gained a lot of relevance. The term was purely academic but, in recent times, has been commonly seen in data protection regulations worldwide.

Dark patterns in data protectionRead Full Article

U.S Department of justice updates its guide to corporate compliance programs

Now under the Biden administration, the U.S. Department of Justice (DOJ) has published, on March 3, 2023, an update to its guide for evaluating compliance programs. It assists prosecutors in this task, allowing them to identify whether the program is efficient at the time of the offense and whether it is effective at the time of a charging decision or resolution.

U.S Department of justice updates its guide to corporate compliance programsRead Full Article

The EDPB publishes new guidelines for personal data protection

The European Data Protection Board (EDPB) has recently published, after a public inquiry with different segments of European society, three new guidelines related to the protection of personal data.

The EDPB publishes new guidelines for personal data protectionRead Full Article

The sponsorship ethics of pharmaceutical and medical companies for physicians speaking in conferences

This is certainly one of the most controversial topics in recent years with regard to the interaction of the medical profession with the health industry – which encompasses the pharmaceutical industry, medical and hospital products and even cosmetics and food.

The sponsorship ethics of pharmaceutical and medical companies for physicians speaking in conferencesRead Full Article

ANPD REGULATES THE APPLICATION OF ADMINISTRATIVE SANCTIONS

Administrative Sanctions Regulation on Dosimetry and Application of Administrative Sanctions, which establishes the dosimetry guidelines for sentences, especially calculating the base value for fines the agency may apply. It is an initiative of the rapporteur and director of the ANPD – Arthur Sabbat, in which he was unanimously followed by the rest of the board. Although the criteria set out below establish clear guidelines, the ANPD may depart from its methodology or review the penalty, if impaired proportionality is found between the severity of the violation and the intensity of the sanction.

ANPD REGULATES THE APPLICATION OF ADMINISTRATIVE SANCTIONSRead Full Article

Prison after conviction in appellate courts

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.

Prison after conviction in appellate courtsRead Full Article

Transparency International launches the 2022 Corruption Perceptions Index

Transparency International is a non-profit anti-corruption organization headquartered on Berlin that operates internationally. Its purpose is to combat corruption and criminal activities related to corrupt acts.

Transparency International launches the 2022 Corruption Perceptions IndexRead Full Article

ANPD launches new security incident form

In the second half of December 2022, the National Data Protection Authority (ANPD) published an amendment to the Security Incident Reporting form, to be used by all those who need to report security incidents starting January 1, 2023.

ANPD launches new security incident formRead Full Article