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USA passes Anti-Money Laundering Whistleblower Improvement Act

January 2, 2023

In Brazil the concept of the whistleblower continues to be ignored –  as having been incorporated into our legal system by former Minister Sérgio Moro's anti-crime package, approved by the National Congress underStatute 13,964 of December 24, 2019 (which utilizes the definition of informant rather than the North American definition of whistleblower) – along with the benefits that its employment could bring to the country, especially in the fight against corruption. While the United States, at the end of 2022, have just passed the Anti-Money Laundering Whistleblower Improvement Act, making significant progress in the battle against money laundering.

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The Impeachment of Authorities in Brazil explained

December 20, 2022

According to the Brazilian Constitution of 1988, the Legislative, Executive and the Judiciary Branches are balanced among themselves.

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Brazilian Antitrust Law has been refined

November 28, 2022

Although Brazilian antitrust rules follow the example of US antitrust law, the pioneers in the subject were not them, but their Canadian neighbors, since the first known antitrust law was published in 1889, in Canada. By the way, this was the year in which Brazil ceased to be an empire, when the Republic was proclaimed on November 15, 1889, by Marshal Deodoro da Fonseca.

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And speaking of Patient Support Programs...

November 14, 2022

The Patient Support Programs (PSPs) developed by the pharmaceutical industries are often controversial as to the real benefit they provide, how much they contribute to patient loyalty and the risks they bring to the companies implementing them.

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Self-regulation in the health care area: Europe's positive example

November 7, 2022

One of the great frustrations of those who work in companies where there is a solid compliance culture is dealing with the limits imposed by their internal policies and procedures, as compared to competition that, sometimes, uses dubious and loose processes, which lead to numerous conflicts of interest, but which can translate into increased sales.

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How goes Personal Data Protection in the United States of America?

October 31, 2022

The entry into force of the General Data Protection Regulation (GDPR) in the European Union, in 2018, gave rise to concerns about the issue of protection of personal data in the United States of America, especially after the European Court ruled that the Privacy Shield would no longer be accepted as a guarantee for the transfer of personal data of European citizens to the US.

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Standardization and cost of stem cell Treatments in Brazil

October 24, 2022

Recently, a judge in the State of California, United States, rendered a decision ruling that the Food and Drug Administration cannot regulate stem cell treatments as a medicine. Such a decision generated controversy, as there are other decisions that consider cell therapies as medicines regardless of their nature.

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Cookies remain in use, FLoC dies, Topics is born!

October 17, 2022

Since the GDPR (EU General Data Protection Regulation) came into force on May 25, 2018, the internet search giant Google, which belongs to Alphabet, started to internally and intensively work not only to adapt itself to the GDPR, but also to create tools that mitigate the misuse of personal information from third parties. Such an effort was not just a privilege of Google, but also of companies that develop internet browsers such as Safari and Mozilla Firefox,  which began to offer the option of blocking third-party cookies in their software.

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Research institutes and conflicts of interest

October 10, 2022

After the first round of elections in Brazil on October 2, 2022, which elected some governors, senators, federal and state deputies, the research institutes are the big stars among the fierce dispute over the presidency of the Republic. Research institutes managed to get the attention of society, which was, until then, debating whether the electronic voting machines were reliable or not, since, for some, they would be non-auditable; whereas for others, they would be safe as they do not even have internet connection.

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ANS' role is now Exemplary once again by Law. Read here what this means

September 26, 2022

Last Wednesday (September 21), the press trumpeted the enactment of a new law, especially the G1 news outlet, informing that healthcare providers are obliged to cover treatments outside the list of the Brazilian Supplementary Health Agency (ANS).

This is another chapter in the fierce dispute between providers and patients, mediated by the authorities. Healthcare providers claim an imbalance in their financial health, while patients denounce lack of coverage and excessive costs in their assistance.

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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

Legal Business in Brazil

The legal business is a kind of legal act that arises from the manifestation of a person's will, aiming to produce effects in the legal sphere of another. Therefore, a legal relationship arises between the parties, respecting the requirements established by law for its validity and effectiveness factors that will impact its production of effects.

Legal Business in BrazilRead Full Article

New Regulatory Framework for Clinical Research in Brazil

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.

New Regulatory Framework for Clinical Research in BrazilRead Full Article

ANVISA Approves the Regulation of Biosimilars

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.

ANVISA Approves the Regulation of BiosimilarsRead Full Article

European Council Approves Legislation on Artificial Intelligence

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).

European Council Approves Legislation on Artificial IntelligenceRead Full Article

ANPD Approves Regulation on Security Incident Reporting

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.

ANPD Approves Regulation on Security Incident ReportingRead Full Article

India’s Anti-Corruption Act

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.

India’s Anti-Corruption ActRead Full Article

The Balancing Test in Personal Data Protection

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.

The Balancing Test in Personal Data ProtectionRead Full Article

The Importance and Use of the Limitation of Liability Clause

Initially, it is important to highlight that a company's ability to carry out an economic operation is intrinsically linked to the analysis of several stages, with risk assessment being one of its crucial factors. After the decision to proceed with the operation, a new phase emerges: the negotiation of contractual terms. It is clear that consideration of costs, including possible compensation, is a key element in decision-making in order to avoid compromising the operations.

The Importance and Use of the Limitation of Liability ClauseRead Full Article

The Legitimate Interest in the Processing of Personal Data

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.

The Legitimate Interest in the Processing of Personal DataRead Full Article

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

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.

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

The Unpredictability and the Excessive Burden Theories

An extremely important aspect in contract management is the unpredictability theory. This theory can greatly impact the rights and obligations of one of the parties, completely unbalancing the rights and obligations between them and even making the contract unfair to the detriment of one of the parties.

The Unpredictability and the Excessive Burden TheoriesRead Full Article

Results from the US Securities & Exchange Commission Inspection in 2023

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.

Results from the US Securities & Exchange Commission Inspection in 2023Read Full Article

When Supporting Gender Equality Conflicts with Privacy Rights

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.

When Supporting Gender Equality Conflicts with Privacy RightsRead Full Article

The Fight Against Corruption in Singapore

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.

The Fight Against Corruption in SingaporeRead Full Article

Medication Leaflets of Generic and Patented Medicines

The use of medication is undeniably crucial for extending our lives with the highest possible quality, aligning with advancements in science. As a result, medication leaflets are familiar to everyone, whether or not they are involved in the pharmaceutical sector. However, the same level of familiarity does not extend to the concepts of generic medicines and patented drugs.

Medication Leaflets of Generic and Patented MedicinesRead Full Article