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

December 26, 2023

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.

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

December 12, 2023

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

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Decisions by the Irish Data Protection Authority are undermined

December 6, 2023

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.

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

December 1, 2023

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.

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Artificial intelligence and its regulation in Brazil

November 22, 2023

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.

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The Fight Against Fake News Around the World

November 14, 2023

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”.

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Everything you need to know about ISO

November 7, 2023

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.

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How to Implement ERM

October 30, 2023

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.

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

October 16, 2023

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.

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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

USA passes Anti-Money Laundering Whistleblower Improvement Act

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.

USA passes Anti-Money Laundering Whistleblower Improvement Act Read Full Article

The Impeachment of Authorities in Brazil explained

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

The Impeachment of Authorities in Brazil explainedRead Full Article

Brazilian Antitrust Law has been refined

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.

Brazilian Antitrust Law has been refinedRead Full Article

And speaking of Patient Support Programs...

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.

And speaking of Patient Support Programs...Read Full Article

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

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.

Self-regulation in the health care area: Europe's positive exampleRead Full Article

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

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.

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

Standardization and cost of stem cell Treatments in Brazil

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.

Standardization and cost of stem cell Treatments in BrazilRead Full Article

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

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.

Cookies remain in use, FLoC dies, Topics is born!Read Full Article

Research institutes and conflicts of interest

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.

Research institutes and conflicts of interestRead Full Article

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

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.

ANS' role is now Exemplary once again by Law. Read here what this meansRead Full Article

The ANPD Opens a Public Consultation on High-Risk Personal Data Processing

On January 27, 2022, the Brazilian Data Protection Authority (ANPD) edited Rule CD/ANPD #2 to regulate the application of the  Brazilian Data Privacy Act, (LGPD), Statute #13,709/2018 to small processing agents: micro-enterprises, small businesses, startups, legal entities governed by private law, including non-profits, as per the legislation in force, as well as natural persons and depersonalized private entities that process personal data, assuming typical controller or processor obligations.

The ANPD Opens a Public Consultation on High-Risk Personal Data ProcessingRead Full Article

What is Brazil missing in the fight against corruption?

Corruption is definitely not an evil that only plagues Brazil but absolutely all countries without exception, to a greater or lesser extent. The existence of corruptors presupposes the existence of corrupts and vice versa. Therefore, focusing on fighting corruption at both extremes is essential, otherwise the effort may be in vain.

What is Brazil missing in the fight against corruption?Read Full Article

In the US, Directors and Chief Compliance Officers will need to provide Certification

In March of this year, Assistant Attorney General Kenneth Polite, from the Criminal Division of the United States Justice Department, made a speech for his colleagues. The contents of this speech are still unknown to many executives and professionals in the legal and compliance areas, but has brought a very interesting new obligation:

In the US, Directors and Chief Compliance Officers will need to provide CertificationRead Full Article

Brazilian Federal Pharmacy Council regulates the practice of Telepharmacy

On July 20, 2022, the Brazilian Federal Pharmacy Council (CFF) published Rule #727/2022, meeting a pressing need in the sector, with the rampant advancement of technology, by regulating the practice of Telepharmacy in Brazil.

Brazilian Federal Pharmacy Council regulates the practice of TelepharmacyRead Full Article

Italy issues new Transparency Law in Healthcare Sector

The interaction between the pharmaceutical and the medical devices industries and doctors has always been reason of concern for the authorities and the population, due to the potential conflict of interests that can be established with the concession of advantages given by the industry, in form of scientific support, gifts, meals, etc… which could interfere especially in the doctor's judgment in choosing the best treatment for their patient.

Italy issues new Transparency Law in Healthcare SectorRead Full Article